Federal Register Vol. 80, No.145,

The Secretary of Homeland Security has authority under 5 U.S.C. 301, 552, and 552a, and 6 U.S.C. 112(e), to issue FOIA and Privacy Act regulations. On January 27, 2003, the Department of Homeland Security (Department or DHS) published an interim rule in the Federal Register (68 FR 4056) that established DHS procedures for obtaining agency records under the FOIA, 5 U.S.C. 552, or Privacy Act, 5 U.S.C. 552a. DHS solicited comments on this interim rule, but received none.1

In 2005, Executive Order 13392 called for the designation of a Chief FOIA Officer and FOIA Public Liaisons, along with the establishment of FOIA Requester Service Centers as appropriate. Subsequently, the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act), Public Law 110-175, required agencies to designate a Chief FOIA Officer who is then to designate one or more FOIA Public Liaisons (5 U.S.C. 552(j) and 552(k)(6)). Sections 6, 7, 9, and 10 of the OPEN Government Act amended provisions of the FOIA by setting time limits for agencies to act on misdirected requests and limiting the tolling of response times (5 U.S.C. 552(a)(6)(A)); requiring tracking numbers for requests that will take more than 10 days to process (5 U.S.C. 552 (a)(7)(A)); providing requesters a telephone line or Internet service to obtain information about the status of their requests, including an estimated date of completion (5 U.S.C. 552(a)(7)(B)); expanding the definition of “record” to include records “maintained for an agency by an entity under Government contract, for the purposes of records management” (5 U.S.C. 552(f)(2)); and introducing alternative dispute resolution to the FOIA process through FOIA Public Liaisons (5 U.S.C. 552(a)(6)(B)(ii) & (l)) and the Office of Government Information Services (5 U.S.C. 552(h)(3)).

DHS now proposes to revise its FOIA regulations at 6 CFR part 5, which apply to all components of DHS. This proposed rule would implement changes required by the OPEN Government Act and make other revisions to DHS FOIA regulations to improve access to Departmental records.

DHS describes the primary proposed changes in the section-by-section analysis below. DHS invites public comment on each of the proposed changes described, as well as any other matters within the scope of the rulemaking.

The proposed rules continue to inform the public of the responsibilities of DHS in conjunction with requests received under the Freedom of Information Act as well as the requirements for filing a proper FOIA request.

DHS is proposing to amend Subpart A to eliminate the provision for “brick and mortar” public reading rooms, amend DHS rules for third-party requests for records, and add information about proactive DHS disclosures.

DHS is proposing to amend this part to incorporate reference to additional DHS policies and procedures relevant to the FOIA process. These resources, which are available at http://www.dhs.gov/freedom-information-act-foia, also include descriptions of the types of records maintained by different DHS components. DHS is also proposing to amend this section to clarify the definition of a component for purposes of this proposed rule. Component means each separate organizational entity within DHS that reports directly to the Office of the Secretary. A full list of all DHS components would be provided in appendix I of this proposed rule (as well as in the web resources described above) for informational purposes.

DHS is proposing to add paragraph (d) to section 5.1, “Unofficial release of DHS information.” This proposed paragraph seeks to inform the public about how information that is not released through official DHS channels will be treated in the FOIA process. DHS does not consider information that is either inadvertently or inappropriately released by means other than the official release process used by DHS, whether in FOIA or otherwise, to be a FOIA release and accordingly, DHS does not waive its ability to assert exemptions to withhold some or all of the same records in response to a FOIA request.

Finally, DHS is proposing to remove at least two additional portions of current section 5.1. First, current paragraph (a)(1) clarifies that “[i]nformation routinely provided to the public as part of a regular DHS activity . . . may be provided to the public without following this subpart.” Second, current paragraph (a)(2) provides that “Departmental components may issue their own guidance under this subpart pursuant to approval by DHS.” DHS considers each of these provisions to be self-evident, and therefore proposes to remove them from the regulation.

DHS proposes to replace prior section 5.2, “Public Reading Rooms,” which was outdated, with a new section describing the proactive disclosure of DHS records. The FOIA requires DHS to make certain records available for public inspection and copying. Such records are available via the internet through the electronic reading rooms of each component. For those individuals with no access to the internet, the DHS Privacy Office or the component Public Liaison can provide assistance with access to records available in the electronic reading rooms. Contact information is provided in Appendix I to this subpart.

DHS proposes to amend paragraph 5.3(a) to eliminate the requirement that third-party requesters of records pertaining to an individual provide a written authorization from the individual that is the subject of the records (or proof of death of the individual) as a prerequisite to making such a request for records. As proposed, paragraph (a)(4) would inform third-party requesters that they may receive greater access if they provide written authorization from, or proof of death of, the subject of the records. In certain circumstances, they may in fact receive no access absent such authorization or proof. This paragraph would further advise that DHS may exercise its administrative discretion in seeking additional information from the requester to ensure that the proper consent has been received from the subject of the records.

DHS also proposes to amend paragraph (b) to direct requesters to contact the FOIA Public Liaison for each component if the requester has questions about how to describe the records that the requester seeks. DHS also proposes to amend this part to eliminate paragraph (c), which would be addressed under section 5.11, “Fees.” DHS proposes to insert a new paragraph (c), which describes the process under which DHS may administratively close a request if a requester fails to comply with a request for additional information.

DHS proposes to insert a new paragraph (c), “Re-routing of misdirected requests,” to advise requesters that a component that is in receipt of a misdirected request within DHS will redirect such a request to the proper component without the need for further action from the requester. In the event that a component receives a request that should be directed outside DHS entirely, the component would inform the requester that DHS does not collect or retain the type of records requested. Proposed paragraph (c) would cover a different situation than current paragraph (c), which only applies “[w]hen a component receives a request for a record in its possession.”

DHS proposes to combine paragraph 5.4(c), “Consultations and referrals,” with current paragraph (d), “Law Enforcement Information,” which covers consultation and referral of law enforcement records. Proposed paragraph (d) would describe the process of consultation, coordination, and referral of all records, to include law enforcement records, consistent with equities of components, agencies, or departments other than the responding component. Proposed paragraph (e) restates much of the current content of section 5.7, “Classified information.”

DHS proposes to revise current paragraph (f), “Notice of referral.” Paragraph (f) currently provides that when a component refers a request to another component or agency, it ordinarily shall notify the requester of such referral. Consistent with current law, DHS proposes to insert an exception to this requirement, such that the component should not refer the records if disclosure of the identity of the component or agency would harm an interest protected by an applicable exemption. Instead, the component should coordinate the response with the other component or agency, as appropriate.

DHS proposes a new paragraph, paragraph 5.4(i), “Electronic records and searches,” to advise requesters of DHS's responsibilities under the FOIA with regard to conducting searches of electronic records and databases. DHS adheres to the requirement in 5 U.S.C. 552(a)(3)(C), which states that agencies will make reasonable efforts to search for records in electronic form or format, except when such efforts would significantly interfere with the operation of the agency's automated information systems. Proposed paragraph 5.4(i) seeks to clarify to requesters the types of situations that would amount to “significant interference” with the operation of agency information systems such that DHS would not conduct a search for the requested records.

DHS proposes to amend paragraph 5.5(a) to advise requesters that the response time for misdirected requests that are re-routed under paragraph 5.4(c) will commence on the date the request is received by the proper component, but in any event, no later than ten working days after the request is first received by any component. DHS proposes to amend paragraph (b), “Multitrack Processing,” to include a specific provision for a track for requests granted expedited processing.

DHS proposes to split current paragraph (c), “Unusual Circumstances,” into two separately designated paragraphs. As revised, the rule would include in paragraph 5.5(d) information on how DHS will aggregate multiple related requests submitted by a single requester or a group of requesters acting in concert.

DHS also proposes to redesignate current paragraph 5.5(d), “Expedited Processing,” as paragraph 5.5(e). DHS proposes in proposed paragraph 5.5(e) to amend text that describes the procedures for making a request for expedited processing of an initial request or an appeal (current paragraph (d)), to include two new available justifications for requesting expedited processing.

5.6 Responses to requests. DHS proposes to revise paragraph 5.6(a) to encourage components to communicate with FOIA requesters having access to the internet through electronic means, to the extent practicable. This new paragraph is intended to address the increasing number of FOIA requesters who are corresponding with DHS via electronic mail and web portals. DHS proposes to move paragraph (a) to paragraph (b), “Acknowledgment of Requests.” DHS proposes to amend this paragraph to specify that DHS and its components will acknowledge a request and assign the request an individualized tracking number if the request will take more than ten working days to process. DHS also proposes to require acknowledgment letters to contain a brief description of the request to allow requesters to more easily keep track of their requests. The provision in paragraph (a) referencing that the acknowledgment letter will confirm the requester's agreement to pay fees would be addressed in proposed section 5.11(e).

DHS proposes to move paragraph (b), “Grants of requests,” to paragraph (c). DHS proposes to amend paragraph (b) by removing the description of the treatment of information, both released and redacted in documents provided to the requester. Substantially the same information is now included in a new proposed paragraph, paragraph 5.6(f), “Markings on Released Documents.” DHS proposes to move the remainder of current paragraph 5.6(c), “Adverse determinations of requests,” to two paragraphs, (d) and (e), “Adverse determinations of requests” and “Content of denial.” The language regarding adverse determination of requests remains substantially the same. DHS proposes to describe the content and process for denial letters in the newly proposed paragraph (e), but does not intend this paragraph to significantly change the current regulatory requirements concerning denial letters.

DHS also proposes new paragraph (g), “Use of record exclusions,” which describes the DHS's use of exclusions under 5 U.S.C. 552(c). This paragraph proposes to incorporate the requirement set forth by the Department of Justice's Office of Information Policy (OIP) that all federal agencies obtain the approval of OIP prior to invoking an exclusion. This proposed paragraph also includes a requirement that DHS maintain an administrative record of the process of the invocation of the exclusion and approval by OIP.

5.7 Confidential commercial information. Proposed section 5.7, “Confidential commercial information,” would replace current section 5.8 of the current regulations, “Business information.” DHS proposes to reorder several paragraphs within this section. The changes are for clarity and to better advise requesters and providers of commercial information how DHS will treat requests for confidential commercial information, but the information contained in the proposed section remains substantively the same.

DHS proposes to amend the “Notice of intent to disclose” paragraph by splitting it into two paragraphs, proposed new paragraph (f), “Analysis of objections” and proposed new paragraph (g), “Notice of intent to disclose.” The proposed division of the information previously contained in a single paragraph is intended to improve clarity by highlighting in a separate paragraph that DHS will consider a submitter's objections and specific grounds for nondisclosure in deciding whether to disclose the requested information. Otherwise, the information contained in the new proposed paragraphs remains substantively the same.

Finally, DHS proposes to include an exception to this section for commercial information provided to U.S. Customs and Border Protection (CBP) by a business submitter. Although CBP's FOIA regulations (located at 19 CFR part 103, subpart A) are displaced by the DHS FOIA regulations, this rule proposes to allow CBP to continue treating commercial information in the same manner as it has since the promulgation of current 19 CFR 103.35.

5.8 Administrative appeals. This section corresponds to section 5.9 of the current regulations. In the time following the publication of the interim regulations in January 2003, DHS has designated Appeals Officers for each component. As such, DHS proposes to amend paragraph (a) to direct requesters seeking to appeal adverse determinations to the DHS Web site or FOIA phone line for FOIA information to obtain the name and address of the appropriate appeals officer.

DHS proposes new paragraph (b) “Adjudication of appeal,” which replaces former paragraph (c) “When appeal is required.” The proposed new paragraph informs requesters that the DHS Office of the General Counsel or its designee component appeals officers are the authorized appeals authority for DHS. New proposed paragraph (b) also informs requesters about the treatment of appeals involving classified information. Finally, former paragraph (a)(3), which informs requesters that appeals will not normally be adjudicated if a FOIA lawsuit is filed, is incorporated into proposed paragraph (b).

DHS proposes to add a new paragraph (c), “Appeal decisions,” which is substantially similar to current paragraph 5.9(b). Proposed paragraph (c) would advise requesters that appeal decisions will be made in writing, and that decisions will inform requesters of their right to file a lawsuit and about mediation services offered by the Office of Government Information Services. Proposed paragraph (c) would also advise requesters of what to expect if the appeals officer reverses or modifies the original administrative decision on appeal. DHS also proposes to add a new paragraph (d), “Time limit for issuing appeal decision,” which advises requesters of the statutory 20-day time limit for responding to appeals, and also of the statutory 10-day extension of the 20-day limit available to the appeals officers in certain circumstances.

Finally, DHS proposes to add paragraph (e), “Appeal necessary before seeking court review,” which advises requesters that an administrative appeal is generally required before seeking judicial review of a component's adverse determination. This language is substantially similar to current paragraph 5.9(c). This proposed paragraph also advises requesters that there is no administrative appeal requirement prior to seeking judicial review of a denial of request for expedited processing.

5.9 Preservation of records. DHS proposes to redesignate current section 5.10 “Preservation of records” as section 5.9. There is no change to the substantive information in the section.

5.10 FOIA requests for information contained in a Privacy Act system of records. DHS proposes to add the new above-referenced section, to explain to requesters how DHS treats FOIA requests for information protected by the Privacy Act. When applicable, DHS analyzes all requests under both the FOIA and the Privacy Act to ensure that the requester receives the greatest amount of information possible under federal law. This proposed section also explains the circumstances under which a third-party requester can obtain access to information protected by the Privacy Act.

5.11 Fees. DHS proposes to address all fee issues in section 5.11. Most of this section remains essentially unchanged. Proposed changes to paragraph (b) would clarify some of the definitions used by DHS in determining a requester's fee category. For instance, paragraph (b)(1) “Commercial use request,” would clarify that components will make determinations on commercial use on a case-by-case basis. Paragraph (b)(4) “Educational institution,” would add several examples to help requesters understand the analysis that DHS will apply to determine whether a requester meets the criteria to be considered an educational institution. Paragraph (b)(6), “News media,” clarifies the criteria used by DHS to determine whether a requester qualifies to be considered a member of the news media for fee purposes. Paragraph (b)(8) “Search,” would eliminate superfluous language that does not improve the comprehensibility of the paragraph. Because these and similar proposed changes are consistent with current regulations and describe current process, DHS does not expect that they will result in additional costs for the government or the public.

DHS also proposes to change paragraph (c)(1)(iii), which discusses direct costs associated with conducting any search that requires the creation of a new computer program, as discussed in new proposed paragraph 5.4(i), to locate the requested records. This change is intended to improve comprehension and to more accurately describe the circumstances under which a requester may be charged for a computerized search or a search of electronic records. It does not represent a change in practice, as DHS currently charges direct costs for specialized data searches. Again, because these proposed changes are consistent with current regulations and describe current process, DHS does not expect that they will result in additional costs for the government or the public.

DHS proposes to restructure paragraph (c)(3)(d), “Restrictions on charging fees.” Under this proposal, search fees, and in some cases, duplication fees may not be charged if a component fails to comply with the time limits in which to respond to a request provided no unusual or exceptional circumstances are present. This provision directly tracks a mandatory provision from section 6 of the OPEN Government Act of 2007, Public Law 110-175, 121 Stat. 2524, 5 U.S.C. 552(a)(4)(A)(viii).

In addition, DHS proposes to renumber former paragraph (d)(2) as paragraph (d)(3), and paragraph (d)(3) as (d)(4). DHS proposes minor changes in paragraph (d)(4) to improve clarity. Current paragraphs (d)(4) and (d)(5) would be combined into proposed paragraph (d)(5). DHS proposes changes to paragraphs (e) and (f) to improve clarity; no significant changes are intended with respect to those paragraphs. DHS proposes no major changes to paragraphs (g), (h), (i), or (j), but proposes to modify a number of procedural provisions consistent with the practices of other agencies in this area. DHS also proposes minor changes to paragraph (k) to improve clarity. DHS proposes to eliminate current paragraph (l), “Payment of outstanding fees,” as the information in that paragraph is largely duplicative of the information contained within proposed paragraph (i)(3)—although proposed paragraph (i)(3) is discretionary, DHS anticipates that the result will be substantially the same as under current paragraph (l). Except in extraordinary circumstances, DHS will not process a FOIA request from persons with an unpaid fee from any previous FOIA request to any Federal agency until that outstanding fee has been paid in full to the agency. Finally, DHS proposes to insert a chart showing fee applicability, for ease of reference.

5.12 Confidential commercial information; CBP procedures.

As noted above, DHS proposes to include an exception to proposed § 5.7 for commercial information provided to U.S. Customs and Border Protection (CBP) by a business submitter. Although CBP's FOIA regulations (located at 19 CFR part 103, subpart A) are displaced by the DHS FOIA regulations, because of the unique nature of CBP's mission, this rule proposes to allow CBP to continue treating commercial information in the same manner as it has since the promulgation of current 19 CFR 103.35. CBP's FOIA regulations, located at 19 CFR part 103, subpart A, will be removed no later than the effective date of the final rule for this rulemaking. CBP may, however, retain cCurrent 19 CFR 103.35 as an interim measure.

5.13 Other rights and services. DHS proposes no substantive changes to this section.

DHS also proposes to remove FEMA's outdated FOIA regulations at 44 CFR part 5, subparts A through E. FEMA is currently operating under DHS's title 6 FOIA regulations for all purposes.

Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget.

DHS has considered the costs and benefits of this proposed rule. Previously in this preamble, DHS has provided a section-by-section analysis of the provisions in this proposed rule and concludes this rule does not impose additional costs on the public or the government. This rule does not collect any additional fee revenues compared to current practices or otherwise introduce new regulatory mandates. The rule's benefits include additional clarity for the public and DHS personnel with respect to DHS's implementation of the FOIA and subsequent statutory amendments.

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

Under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, and section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 601 note, agencies must consider the impact of their rulemakings on “small entities” (small businesses, small organizations and local governments). The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. DHS has reviewed this regulation and by approving it certifies that this regulation will not have a significant economic impact on a substantial number of small entities. Based on the previous discussion in this preamble, DHS does not believe this rule imposes any additional direct costs on small entities.

This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996 (as amended), 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

For the reasons stated in the preamble, the Department of Homeland Security proposes to amend 6 CFR chapter I, part 5, 19 CFR chapter I, part 103, and 44 CFR chapter I, part 5, as follows:

On May 14, 2015, the Federal Election Commission received a Petition for Rulemaking from Make Your Laws PAC, Inc. and Make Your Laws Advocacy, Inc. The petition asks the Commission to modify its regulations requiring disclosure of contributions from corporations and other organizations to political committees.

The Federal Election Campaign Act, 52 U.S.C. 30101-46 (the “Act”), and Commission regulations require all political committees to abide by certain organizational, record-keeping, and reporting requirements. See 52 U.S.C. 30102, 30103, 30104; 11 CFR 102.1, 102.2, 102.7, 104.3. This includes maintaining records of contribution receipts and disbursements, reporting independent expenditures, and filing periodic disclosure reports that identify the source of each contribution exceeding $200. See 11 CFR 104.3(a)(4)(i), 104.4, 104.5(c). Commission regulations also require every person who makes electioneering communications aggregating in excess of $10,000 in a calendar year and every person (other than a political committee) that makes independent expenditures in excess of $250 with respect to a given election in a calendar year to report certain information to the Commission. 11 CFR 104.20(b) and (c), 109.10(b) and (e); 52 U.S.C. 30104(c)(1) and (2), (f).

The petition asks the Commission to establish a new rule requiring that “any person, other than a natural person, contributing an aggregate of more than $1,000 in any calendar year to any political committee, whether directly or indirectly” (emphasis omitted), must do so from an account subject to certain reporting requirements. Specifically, the petition asks the Commission to require that these accounts disclose “the original source of all election-related contributions and expenditures, traceable through all intermediary entities to a natural person, regardless of the amounts or entities involved” (emphasis omitted). The petition also asks the Commission to apply to these accounts the identification requirements of 11 CFR 100.12; the Act's prohibition on foreign national contributions, 52 U.S.C. 30121; allocation rules for administrative expenses; and, in some circumstances, the Act's limitations on contributions to political committees.

The Commission seeks comments on the petition. The public may inspect the petition on the Commission's Web site at http://www.fec.gov/fosers, or in the Commission's Public Records Office, 999 E Street NW., Washington, DC 20463, Monday through Friday, from 9 a.m. to 5 p.m. Interested persons may also obtain a copy of the petition by dialing the Commission's Faxline service at (202) 501-3413 and following its instructions. Request document #279.

The Commission will not consider the petition's merits until after the comment period closes. If the Commission decides that the petition has merit, it may begin a rulemaking proceeding. The Commission will announce any action that it takes in the Federal Register.

On June 19, 2015, the Federal Election Commission received a Petition for Rulemaking from Make Your Laws PAC, Inc. and Make Your Laws Advocacy, Inc. On June 22, 2015, the Commission received a Petition for Rulemaking from Craig Holman and Public Citizen. Both petitions, citing Citizens United v. FEC, 558 U.S. 310 (2010), ask the Commission to modify its regulations in four respects.

First, the Federal Election Campaign Act, 52 U.S.C. 30101-46 (the “Act”), and Commission regulations require every person who makes an electioneering communication aggregating in excess of $10,000 in a calendar year and every person (other than a political committee) that makes independent expenditures in excess of $250 with respect to a given election in a calendar year to report certain information to the Commission. 11 CFR 104.20(b) and (c), 109.10(b), (e); 52 U.S.C. 30104(c)(1) and (2), (f). The petitions ask the Commission to “[e]nsure full public disclosure of corporate and labor organization independent spending” by “requir[ing] that outside spending groups disclose their donors.”

Second, the Act and Commission regulations prohibit foreign nationals from “directly or indirectly” making contributions, expenditures, and electioneering communications. 11 CFR 110.20; 52 U.S.C. 30121(a). The petitions ask the Commission to “[c]larify that th[is] prohibition on foreign national campaign-related spending restricts such spending by U.S. corporations owned or controlled by a foreign national.”

Third, Commission regulations prohibit corporations and labor organizations from “using coercion . . . to urge any individual to make a contribution or engage in fundraising activities on behalf of a candidate or political committee,” 11 CFR 114.2(f)(2)(iv), and restrict how corporations and labor organizations may solicit contributions to their separate segregated funds from employees and members. 11 CFR 114.5(a)(2) through (5); see also 52 U.S.C. 30118(b)(3). The petitions ask the Commission to “[c]larify that corporations and labor organizations are prohibited from coercing their employees and members into providing financial or other support for the corporation's or labor organization's independent political activities.”

Finally, the petitions ask the Commission to “[e]nsure that the expenditures made by” independent-expenditure-only political committees and accounts, see, e.g., SpeechNow.org v. FEC, 599 F.3d. 686 (D.C. Cir. 2010), “are truly independent of federal candidates.”

The Commission seeks comments on the petitions. The public may inspect the petitions on the Commission's Web site at http://www.fec.gov/fosers, or in the Commission's Public Records Office, 999 E Street NW., Washington, DC 20463, Monday through Friday, from 9 a.m. to 5 p.m. Interested persons may also obtain copies of the petitions by dialing the Commission's Faxline service at (202) 501-3413 and following its instructions. Request document #280.

The Commission will not consider the petitions' merits until after the comment period closes. If the Commission decides that the petitions have merit, it may begin a rulemaking proceeding. The Commission will announce any action that it takes in the Federal Register.

The Occupational Safety and Health Act of 1970 (OSH Act or Act) arose out of a Congressional finding that personal injuries and illnesses arising out of work situations impose a substantial burden upon, and are a hindrance to, interstate commerce in terms of lost production, wage loss, medical expenses, and disability compensation payments. See 29 U.S.C. 651(a). Accordingly, the purpose of the statute is to assure so far as possible every working man and woman in the Nation safe and healthful working conditions. See 29 U.S.C. 651(b).

To effectuate the Act's purpose, Congress authorized the Secretary of Labor to promulgate occupational safety and health standards (29 U.S.C. 655); a standard, as defined in the Act, requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe or healthful employment and places of employment. See 29 U.S.C. 652(8). The Act also grants broad authority to the Secretary to promulgate regulations related to recordkeeping, employer self-inspections, and keeping employees informed of matters related to occupational safety and health. 29 U.S.C. 657(c). OSHA issues citations and assesses monetary penalties when it finds that employers are not complying with applicable standards and regulations. 29 U.S.C. 658, 659, 666.

Section 9(c) of the OSH Act contains a statute of limitations providing that no citation may be issued after the expiration of six months following “the occurrence of any violation.” 29 U.S.C. 658(c). Generally, OSH Act violations continue to occur for as long as employees are exposed to the hazard posed by the non-compliant workplace. See Sec'y of Labor v. Cent. of Georgia R.R. Co., 5 BNA OSHC 1209, 1211 (Rev. Comm'n 1977) (explaining that a violation occurs “whenever . . . [a] standard is not complied with and an employee has access to the resulting zone of danger”). Thus, employers have an ongoing obligation to correct conditions that violate OSHA standards and regulations, and under section 9(c), violations are subject to citations and penalties for up to six months after the last instance of employee exposure to the relevant hazard.

The OSH Act requires the Secretary of Labor to promulgate regulations requiring employers to make and maintain accurate records of work-related injuries and illnesses. 29 U.S.C. 657(c)(1) and (2), 673(a); see also 651(b)(12), 657(g)(2), 673(e). In 1971, the Secretary (via OSHA) issued the first recordkeeping regulations at 29 CFR part 1904. The Agency promulgated revisions to these regulations in 2001 in an effort to improve the quality of workplace injury and illness records by making OSHA's recordkeeping system easier to use and understand. See 66 FR 5916 (January 19, 2001).

OSHA's recordkeeping regulations require employers to record information about certain injuries and illnesses occurring in their workplaces, and to make that information available to employees, OSHA, and the Bureau of Labor Statistics (BLS). Employers must record work-related injuries and illnesses that meet one or more recording criteria, including injuries and illnesses resulting in death, loss of consciousness, days away from work, restricted work activity or job transfer, medical treatment beyond first aid, or a diagnosis of a significant injury or illness by a physician or other licensed health care professional. 29 CFR 1904.7. Employers must document each recordable injury or illness on an “OSHA 300” form, which is a log of all work-related injuries and illnesses. 29 CFR 1904.29(a) through (b)(1). Employers also must prepare a supplementary “OSHA 301 Incident Report” or equivalent form for each recordable injury and illness; the Incident Reports provide additional details about the injuries and illnesses recorded in the 300 Log. 29 CFR 1904.29(b)(2).

At the end of each calendar year, employers must review their 300 Logs to verify that the entries are complete and accurate. 29 CFR 1904.32(a)(1). Employers also must correct any deficiencies identified during the annual review. Id. By February 1 of each year, employers must create, certify, and post annual summaries of the cases listed on their 300 Logs for the prior calendar year. 29 CFR 1904.32(a)(2) through (4) and (b)(6). Annual summaries must remain posted until April 30 each year. 29 CFR 1904.32(b)(6). Employers must retain their OSHA Logs, Incident Reports, and annual summaries for five years following the end of the calendar year that they cover. 29 CFR 1904.33(a). During the retention period, employers must update their 300 Logs to include newly discovered recordable cases and to show any changes in the classification, description, or outcome of previously-recorded cases. 29 CFR 1904.33(b)(1). The regulations do not require employers to update Incident Reports or annual summaries during the retention period. 29 CFR 1904.33(b)(2) and (3).

Accurate injury and illness records serve several important purposes. See 66 FR at 5916-17, January 19, 2001. One purpose is to provide information to employers. The information in the OSHA-required records makes employers more aware of the kinds of injuries and illnesses occurring and the hazards that cause or contribute to them. When employers analyze and review the information in their records, they can identify and correct hazardous workplace conditions. Injury and illness records are essential for employers to effectively manage their safety and health programs; these records permit employers to track injuries and illnesses over time so they can evaluate the effectiveness of protective measures implemented in response to identified hazards.

Similarly, employees—who have access to OSHA injury and illness records throughout the five-year retention period (see 29 CFR 1904.35)—can use information about the occupational injuries and illnesses occurring in their workplaces to become better informed about, and more alert to, the hazards they face. Employees who are aware of the hazards around them may be more likely to follow safe work practices and to report workplace hazards to their employers. When employees are aware of workplace hazards, and participate in the identification and control of those hazards, the overall level of safety and health in the workplace can improve.

OSHA also has access to employer injury and illness records during the retention period (see 29 CFR 1904.40 and 1904.41), and these records are an important source of information for the Agency and enhance the Agency's enforcement efforts. During the initial stages of an inspection, an OSHA representative reviews the employer's injury and illness data so that the Agency can focus its inspection on the hazards revealed by the records. In some years, OSHA has also surveyed a subset of employers covered by the OSH Act for their injury and illness data, and used that information to help identify the most dangerous types of worksites and the most prevalent types of safety and health hazards.

Additionally, BLS uses data derived from employers' injury and illness records to develop national statistics on workplace injuries and illnesses. These statistics include information about the source, nature, and type of the injuries and illnesses that are occurring in the nation's workplaces. To obtain the data to develop national statistics, BLS and participating State agencies conduct an annual survey of employers in almost all sectors of private industry. BLS makes the aggregate survey results available for research purposes and for public information. This data provides information about the incidence of workplace injuries and illnesses and the nature and magnitude of workplace safety and health problems. Congress, OSHA, and safety and health policymakers in Federal, State, and local governments use BLS statistics to make decisions concerning safety and health legislation, programs, and standards. And employers and employees can use BLS statistics to compare the injury and illness data from their workplaces with data from the nation as a whole.

A continuing violation exists when there is noncompliance with “the text of . . . [a] pertinent law [that] imposes a continuing obligation to act or refrain from acting.” Earle v. Dist. of Columbia, 707 F.3d 299, 307 (D.C. Cir. 2012). Where there is an ongoing obligation to act, each day the action is not taken results in a continuing, ongoing violation. In other words, “a new claim accrues each day the violation is extant.” Interamericas Inv., Ltd. v. Fed. Reserve Sys., 111 F.3d 376, 382 (5th Cir. 1997). For example, in United States v. Edelkind, 525 F.3d 388 (5th Cir. 2008), the Fifth Circuit found that the crime of willfully failing to pay child support as required by federal law was a continuing offense because “each day's acts . . . [brought] a renewed threat of the substantive evil Congress sought to prevent.” Id. at 394-95 (internal quotation marks and citations omitted). And in Postow v. OBA Federal Savings & Loan Association, 627 F.2d 1370 (D.C. Cir. 1980), the D.C. Circuit held that a lender's failure to provide required disclosures to borrowers was a continuing violation of the Truth-in-Lending Act because the violation subverted the goals of the statute every day the borrowers did not have the information. Id. at 1379-80. See, also, e.g., United States v. Bailey, 444 U.S. 394, 413 (1980) (escape from federal custody is a continuing offense in light of “the continuing threat to society posed by an escaped prisoner”); United States v. George, 625 F.3d 1124 (9th Cir. 2010) (failure to comply with statute requiring registration as a sex offender is a continuing offense), vacated on other grounds, 672 F.3d 1126 (9th Cir. 2012); United States v. Franklin, 188 F.2d 182 (7th Cir. 1951) (Alien Registration Act imposes ongoing registration obligation; failure to register is a continuing violation).

Recordkeeping violations under the OSH Act are likewise continuing violations. OSHA's longstanding position is that an employer's duty to record an injury or illness continues for the full duration of the record-retention-and-access period, i.e., for five years after the end of the calendar year in which the injury or illness became recordable. This means that if an employer initially fails to record a recordable injury or illness, the employer still has an ongoing duty to record that case; the recording obligation does not expire simply because the employer failed to record the case when it was first required to do so. As long as an employer fails to comply with its ongoing duty to record an injury or illness, there is an ongoing violation of OSHA's recordkeeping requirements that continues to occur every day employees work at the site. Therefore, OSHA can cite employers for such recordkeeping violations for up to six months after the five-year retention period expires without running afoul of the OSH Act's statute of limitations.1

The Occupational Safety and Health Review Commission has upheld OSHA's position on the continuing nature of recordkeeping violations. See, e.g., Sec'y of Labor v. Gen. Dynamics, 15 BNA OSHC 2122 (Rev. Comm'n 1993) (recordkeeping violations “occur” at any point during the retention period when records are inaccurate, so citations for those violations are not barred simply because they are issued more than six months after the obligation to record first arose); Sec'y of Labor v. Johnson Controls, Inc., 15 BNA OSHC 2132 (Rev. Comm'n 1993) (recordkeeping violations continue until correction or expiration of the retention period). The Commission addressed this issue most recently in Secretary of Labor v. AKM LLC (Volks I), 23 BNA OSHC 1414 (Rev. Comm'n 2011), confirming that an employer's failure to make a required OSHA record is a continuing violation, and that an uncorrected violation continues until the employer is no longer required to keep OSHA records for the year at issue.

A panel of the D.C. Circuit reviewed the Commission's Volks I decision, and on April 6, 2012, issued a decision—Volks II—reversing the Commission. AKM LLC v. Sec'y of Labor (Volks II), 675 F.3d 752 (D.C. Cir. 2012). The majority opinion in Volks II disagreed with the Commission and held that “the . . . language in [the OSH Act] . . . which deals with record-keeping is not authorization for OSHA to cite the employer for a record-making violation more than six months after the recording failure.” Id. at 758. According to the majority opinion, OSHA must cite an employer for failing to record an injury or illness within six months of the first day on which the regulations require the recording; a citation issued later than that is barred by the OSH Act's statute of limitations. Id. at 753-59.

In a separate concurring opinion in Volks II, Judge Garland recognized that the OSH Act allows for continuing violations of recordkeeping requirements. He concluded, however, that the specific language in OSHA's existing recordkeeping regulations does not implement this statutory authority and does not create continuing recordkeeping obligations. Id. at 759-64. No other appellate court has ruled on these issues.

The Volks II decision has led to a need for OSHA to clarify employers' obligations under its recordkeeping regulations and to elaborate on its understanding of the statutory basis for those obligations. The Agency is proposing changes to its recordkeeping regulations to clarify that the duty to make and maintain an accurate record of a work-related illness or injury is an ongoing obligation that continues until the required record is made or until the end of the record-retention-and-access period prescribed by the regulations. To that end, OSHA is proposing revisions to the titles of some existing sections and subparts in part 1904, and changes to the text of some existing recordkeeping requirements. The Agency describes the proposed changes in SUPPLEMENTARY INFORMATION, Section IV, later in this notice.

OSHA consulted with the Advisory Committee on Construction Safety and Health (ACCSH) on this rulemaking. The Agency provided ACCSH with a summary and explanation of this proposal and a statement regarding the need for the proposed revisions to 29 CFR part 1904. On December 4, 2014, ACCSH voted to recommend that OSHA proceed with this proposal.

As explained previously, in SUPPLEMENTARY INFORMATION, Section II.A, the OSH Act authorizes the Secretary of Labor to issue “standards” and other “regulations.” See, e.g., 29 U.S.C. 655, 657. An occupational safety and health standard, issued pursuant to section 6 of the Act, prescribes measures to be taken to remedy an identified occupational hazard. Other regulations, issued pursuant to general rulemaking authority found, inter alia, in section 8 of the Act, establish enforcement or detection procedures designed to further the goals of the Act generally. 29 U.S.C. 657(c); Workplace Health and Safety Council v. Reich, 56 F. 3d 1465, 1468 (D.C. Cir. 1995). The proposed amendments are to a regulation issued pursuant to authority expressly granted by sections 8 and 24 of the Act. 29 U.S.C. 657, 673. They simply clarify existing duties under part 1904, and do not impose any new substantive recordkeeping requirements. Numerous provisions of the OSH Act both underscore Congress' acknowledgement that accurate injury and illness records are a critical component of the national occupational safety and health program and give the Secretary broad authority to enact recordkeeping regulations that create a continuing obligation for employers to make and maintain accurate records of work-related illnesses and injuries. Section 2(b)(12) of the Act states that one of the purposes of the OSH Act is to assure, so far as possible, safe and healthful working conditions by providing for appropriate reporting procedures that will help achieve the objectives of the Act and “accurately describe” the nature of the occupational safety and health problem. See 29 U.S.C. 651(b)(12). Section 8(c)(1) requires each employer to “make, keep and preserve” and “make available” to the Secretary such records prescribed by regulation as necessary or appropriate for the enforcement of the Act or for developing information regarding the causes and prevention of occupational accidents and illnesses. See 29 U.S.C. 657(c)(1). Section 8(c)(2) requires the Secretary to prescribe regulations requiring employers to “maintain accurate records” of, and to make periodic reports on, work-related deaths, injuries and illnesses. See 29 U.S.C. 657(c)(2). Section 8(g)(2) of the Act generally empowers the Secretary to prescribe such rules and regulations as he may deem necessary to carry out his responsibilities under the Act. See 29 U.S.C. 657(g)(2). Section 24(a) requires the Secretary to develop and maintain an effective program of collection, compilation and analysis of occupational safety and health statistics and to compile accurate statistics on work injuries and illnesses. See 29 U.S.C. 673(a). Section 24(e) provides that on the basis of the records made and kept pursuant to section 8(c) of the Act, employers must file such reports with the Secretary that the Secretary prescribes by regulation as necessary to carry out his functions under the Act. See 29 U.S.C. 673(e). Some of these provisions will be addressed more thoroughly in SUPPLEMENTARY INFORMATION, Section III.B, later in this notice.

“Whether [an] . . . obligation is continuing is a question of statutory construction,” Earle, 707 F.3d at 307. The express language of the OSH Act readily supports a continuing violation theory in recordkeeping cases. And, section 8(c) grants the Secretary broad authority to issue requirements he considers “necessary or appropriate,” including recordkeeping regulations that provide that an employer's duty to make records of injuries and illnesses is an ongoing obligation. 29 U.S.C. 657(c).

Section 8(c)(2) requires the Secretary to prescribe regulations requiring employers to “maintain accurate records” of work-related deaths, injuries and illnesses. See 29 U.S.C. 657(c)(2) (emphasis added). And section 8(c)(1) requires employers to “make, keep and preserve” and to “make available” records that the Secretary identifies as necessary or appropriate for the enforcement of the Act or for developing information regarding the causes and prevention of occupational accidents and illnesses. See 29 U.S.C. 657(c)(1) (emphasis added). The language Congress used in these provisions therefore authorizes the Secretary to require employers to have on hand and make available records that accurately reflect all of the recordable injuries and illnesses that occurred during the years for which the Agency requires the keeping of records. And this statutory language also is inconsistent with any suggestion that Congress intended the duty to record an injury or illness to be a discrete obligation that expires if the employer fails to comply on the first day the Agency's regulations require recording.

Moreover, the words “accurate” and “maintain” in section 8(c)(2) of the Act connote a continued course of conduct that includes an ongoing obligation to create records. The word “maintain” means to “[c]ause or enable (a condition or state of affairs) to continue,” an example being when one works to ensure that something stays “in good condition or in working order by checking or repairing it regularly.” http://www.oxforddictionaries.com/us/definition/american_english/maintain?searchDictCode=all. “Maintain” is also synonymous with “keep.” http://thesaurus.com/browse/maintain. In ordinary speech, an instruction to “keep records” of something requires both creating and preserving the records, and may include organizing and managing them as well. Therefore, “maintain” plainly implies an ongoing action. See, e.g., Carey v. Shiley, Inc., 32 F.Supp.2d 1093, 1103 (S.D. Iowa 1998) (“continuing duty to maintain records for” the Food and Drug Administration). And “accurate” means “conforming exactly to truth,” and is synonymous with “exact.”http://www.meriam-webster.com/dictionary/accurate. See also, e.g., Huntington Sec. Corp. v. Busey, 112 F.2d 368, 370 (6th Cir. 1940) (noting that the term “ `accurately' . . . in its ordinary use[ ] means precisely, exactly correctly, without error or defect”). Therefore, the OSH Act's call for regulations requiring employers to “maintain accurate [injury and illness] records” is a mandate for the Secretary to impose an ongoing or continuing duty on employers to have (or keep) true or exact documentation of recordable incidents. An employer cannot be said to have (or to be keeping or maintaining) accurate (or true or exact) records of injuries and illnesses for a particular calendar year if there are recordable injuries or illnesses that occurred during that year that are missing from those records. Put simply, the Secretary cannot fulfill the statutory obligation of ensuring that employers “maintain” (or keep) “accurate records” without imposing on employers an ongoing duty to create records for injuries and illnesses in the first place; a duty to make and maintain accurate records inherently implies an ongoing obligation to create the records that must be maintained.

The Fourth Circuit recognized as much in Sierra Club v. Simkins Industries, 847 F.2d 1109, 1115 (4th Cir. 1988), a Clean Water Act case, when it refused to allow a company to defend against its failure to file and retain water sampling records on the grounds that it never collected the data it needed to create the records in the first place. The court ruled that an ongoing duty to maintain records implies a corresponding, and continuing, duty to have those records, explaining that it would not allow the company “to escape liability . . . by failing at the outset to sample and to create and retain the necessary . . . records.” Id. See also, e.g., Big Bear Super Mkt. No. 3 v. INS, 913 F.2d 754, 757 (9th Cir. 1990) (per curiam) (statutory and regulatory scheme described by the court as requiring companies to “maintain” documents is interpreted to impose a “continuing duty” on those companies “to prepare and make” the documents in the first instance); Park v. Comm'r of Internal Revenue, 136 T.C. 569, 574 (U.S. Tax Ct. 2011) (noting that a party that did not create required records thereby failed to “keep” those records), rev'd and remanded on other grounds, 722 F.3d 384 (D.C. Cir. 2013).

The “make, keep, and preserve” and “make available” language in section 8(c)(1) similarly envisions a continuing duty to record and provides additional support for the Agency's interpretation of the “maintain accurate records” language in section 8(c)(2). The corresponding authorization to the Secretary to prescribe such recordkeeping regulations as he considers “necessary or appropriate” emphasizes the breadth of the Secretary's discretion in implementing the statute. As mentioned previously, “keep” is a synonym for “maintain,” and both words imply a continued course of conduct, as of course does “preserve.” 2 See e.g., Powerstein v. Comm'r of Internal Revenue, T.C. Memo 2011-271, 2011 WL 5572600, at *13 (U.S. Tax Ct. Nov. 16, 2011) (interpreting statutory and regulatory requirements to “keep” tax records to mean that taxpayers must “maintain” such records); Freedman v. Comm'r of Internal Revenue, T.C. Memo 2010-155, 2010 WL 2942167, at *1 (U.S. Tax Ct. July 21, 2010) (same).

The fact that Congress included the word “make” in a phrase with two other terms that both call for a continuing action suggests that “make” was also intended to signify a continuing course of conduct in the recordkeeping context. The most reasonable reading of section 8(c)(1), particularly in light of the “maintain accurate records” language in section 8(c)(2), is that the phrase “make, keep, and preserve” authorizes one continuous recordkeeping requirement that includes both the creation and the keeping of records. See, e.g., Davis v. Michigan Dep't of Treasury, 489 U.S. 803, 809 (1989) (noting a “fundamental canon of statutory construction that the words of a statute must be read in their context and with a view to their place in the overall statutory scheme”).

Thus, the Secretary does not believe that section 8(c) authorizes two and only two discrete duties: A duty to create a record that can arise at only one moment in time, and a duty to preserve that record, if it should be created. Such a view would be inconsistent with the most relevant provision of the Act, section 8(c)(2), which is the provision that specifically addresses the Secretary's authority to prescribe regulations for injury and illness recordkeeping, i.e., to prescribe regulations that require employers to “maintain accurate records” of workplace illnesses and injuries. Nothing about the Congressional direction to “maintain accurate records” is naturally read as creating two entirely discrete obligations, or as conveying Congressional intent to limit the duty to make a required record to a single point in time. Records that omit work-related injuries and illnesses are not accurate, and no purpose is served by maintaining inaccurate records. Instead, Congress intended employees, and the Secretary, to have access to accurate information about injuries and illnesses occurring in workplaces.

The requirement in section 8(c)(1) that employers “make available” such records as the Secretary prescribes regarding accidents and illnesses further illustrates that section 9(c)'s statute of limitations does not limit the Secretary to acquiring only six months of injury and illness data. A regulation requiring employers, if requested, to make available accurate records showing injuries and illness that have occurred within the past few years is on its face well within the OSH Act's grant of authority. Nothing in the statutory language suggests that the Secretary can only require employers to provide information regarding work-related injuries and illnesses that have occurred within the past six months. Such a limitation would cripple the Agency's ability to gather complete information and to improve understanding of safety and health issues, contrary to Congressional intent. Furthermore, the duty to make accurate multi-year records available upon request arises when the request is made, and the statute of limitations therefore does not begin to run until the request is made and the employer fails to comply.3

EPA published a proposed finding that greenhouse gas emissions from aircraft cause or contribute to air pollution that may reasonably be anticipated to endanger public health and welfare and an advance notice of proposed rulemaking regarding aircraft engine greenhouse gas emissions on July 1, 2015 (80 FR 37758). This action corrects a typographical error in the street address for the public hearing and provides notice of availability of a conference call-in number for the public to listen to the hearing. Additionally, this action provides notice that video recording will be allowed in the hearing room provided that it does not interfere with or interrupt the public hearing.

The DATES section of the proposed finding and advance notice of proposed rulemaking published in the Federal Register on July 1, 2015 (78 FR 37758), provided information on the public hearing. This action updates that information.

The EPA will hold a public hearing on August 11, 2015 in Washington, DC, at the William Jefferson Clinton East Building, Room 1153, 1201 Constitution Avenue NW., Washington, DC 20004. The EPA will provide the opportunity for the public to listen to the hearing through the following conference call-in line: 1-866-299-3188, conference code 1433527160. Please note that this conference line will allow the public to listen only; persons listening will not be able to give an oral presentation via the conference line.

Additionally, the proposed finding and advance notice of proposed rulemaking stated that no large signs will be allowed in the building, cameras may only be used outside of the building and demonstrations will not be allowed on federal property for security reasons. This update confirms that video recording will be allowed in the hearing room provided that it does not interfere with or interrupt the public hearing.

The President encourages Federal agencies through Executive Order 13563 to develop balanced regulations by encouraging broad public participation in the regulatory process and an open exchange of ideas. The Department of Health and Human Services (HHS) accordingly urges all interested parties to examine this regulatory proposal carefully and to share your views with us, including any data to support your positions. If you have questions before submitting comments, please see the “For Further Information” box below for the name and contact information of the subject-matter expert involved in this proposal's development. We must consider all written comments received during the comment period before issuing a final rule.

If you are a person with a disability and/or a user of assistive technology who has difficulty accessing this document, please contact HRSA's Regulations Officer at Parklawn Building, Room 14-101, 5600 Fishers Lane, Rockville, MD 20857; or by telephone at 301-443-1785, to obtain this information in an accessible format. This is not a toll free telephone number. Please visit http://www.HHS.gov/regulations for more information on HHS rulemaking and opportunities to comment on proposed and existing rules.

A public hearing on this proposed rule will be held before the end of the public comment period. A separate notice will be published in the Federal Register providing details of this hearing. Subject to consideration of the comments received, the Secretary intends to publish a final regulation.

The National Childhood Vaccine Injury Act of 1986, title III of Public Law 99-660 (42 U.S.C. 300aa-10 et seq.), established a Federal compensation program for persons thought to be injured by vaccines. The statute governing the program has been amended several times since 1986 and is hereinafter referred to as “the Act.” Petitions for compensation under this Program are filed in the United States Court of Federal Claims, with a copy served on the Secretary, who is denominated the “Respondent.” The Court, acting through judicial officers called Special Masters, makes findings as to eligibility for, and amount of, compensation.

In order to receive an award under this Program, a petitioner must establish a vaccine-related injury or death, either by proving that a vaccine actually caused or significantly aggravated an injury (causation-in-fact) or by demonstrating the occurrence of what has been referred to as a “Table Injury.” That is, a petitioner may show that the vaccine recipient suffered an injury of the type enumerated in the regulations at 42 CFR 100.3—the “Vaccine Injury Table”—corresponding to the vaccination in question, and that the onset of such injury took place within a time period also specified in the Table. If so, the injury is presumed to have been caused by the vaccination, and the petitioner is entitled to compensation (assuming that other requirements are satisfied), unless the respondent affirmatively shows that the injury was caused by some factor other than the vaccination (see sections 300aa-11(c)(1)(C)(i), 300aa-13(a)(1)(B)), and 300aa-14(a) of the Act). Currently, cases are often resolved by settlements reached by both parties and approved by the Court.

When Congress first enacted the Act, it mandated reviews by the Institute of Medicine (IOM) of the National Academy of Sciences with the express purpose of providing a better scientific rationale for any presumptions of vaccine causation. Under sections 312 and 313 of Public Law 99-660, Congress mandated that the IOM review the scientific literature and other information on specific adverse consequences of vaccines covered by the Program. Congress enacted a mechanism for modification of the statutory Table, through the promulgation of regulatory changes by the Secretary, after consultation with the Advisory Commission on Childhood Vaccines (ACCV). By statutory directive, the membership of the ACCV reflects a variety of stakeholders with different perspectives (42 U.S.C. 300aa-19).

Efforts by the Secretary to modify the initial statutory Table, and its definitional counterpart, the Qualifications and Aids to Interpretation (QAI) began with publication of the two congressionally mandated IOM reviews in 1991 and 1994, respectively. With a few exceptions, the approach by the Secretary was straightforward: If the IOM concluded that there was evidence that a condition was “causally related,” it was added to or left on the Table. However, if there was no proven scientific evidence of an association, it was not added to the Table or it was removed. The entire process, from publication of the IOM reports, to promulgation of final rules in 1995 and 1997 took approximately 3 to 4 years.

The IOM has analyzed numerous possible vaccine injury connections over the years and after conducting a third comprehensive review of the scientific literature on vaccines and adverse events, released a report entitled, Adverse Effects of Vaccines: Evidence and Causality (2012). This third IOM report was conducted under the Department's initiative and was not statutorily mandated. The committee charged with undertaking this review consisted of 16 members with expertise in the following fields: Pediatrics, internal medicine, neurology, immunology, immunotoxicology, neurobiology, rheumatology, epidemiology, biostatistics, and law (http://www.iom.edu/reports/2011/Adverse-Effects-of-Vaccines-Evidence-and-Causality.aspx). The members of the review committee are subject to the stringent conflict of interest criteria imposed by the IOM. The committee met eight times over the course of 35 months, surveying more than 11,000 abstracts and reviewing in-depth 1,487 scientific and medical studies. The committee did not perform any original research.

The IOM Committee undertook the task of judging whether, based on available scientific evidence, a causal relationship exists between each adverse event examined and exposure to the following eight vaccines: Measles-mumps-rubella vaccine, varicella virus vaccine, seasonal influenza vaccines (which did not include the H1N1 influenza vaccine distributed in 2009), hepatitis A vaccine, hepatitis B vaccine, human papillomavirus vaccine, diphtheria tetanus toxoid and acellular pertussis-containing vaccines, and meningococcal vaccine. The charge to the Committee involved these eight vaccines because they are the vaccines with the vast majority of alleged adverse events in the claims for compensation filed under the Program. In addition, some of these vaccines had not been reviewed previously by the IOM.

Two types of evidence were utilized by the IOM in determining the strength of a causal association: Epidemiologic evidence from studies of populations and mechanistic evidence derived primarily from biological and clinical studies in animals and humans such as case reports. To determine the weight of the evidence, the IOM used a summary classification scheme that incorporated both the quality and quantity of the individual articles and the consistency of the group of articles in terms of direction of effect. Four weight-of-evidence categories were utilized, with epidemiologic evidence assessed to be high, moderate, limited or insufficient, and mechanistic evidence assessments of strong, intermediate, weak or lacking.

The IOM started each adverse event assessment from a position of neutrality, moving in either direction (i.e., evidence favoring or rejecting causation) only when the epidemiologic and/or mechanistic evidence suggested a more definitive assessment. As with the previous IOM studies, a classification system was used to categorize the IOM's conclusions about the strength of a causal association. These categories are as follows:

1. Evidence convincingly supports a causal relationship;

2. Evidence favors acceptance of a causal relationship;

3. Evidence favors rejection of a causal relationship; or

4. Evidence is inadequate to accept or reject a causal relationship.

The IOM Committee concluded in certain circumstances that the evidence convincingly supports, or favors acceptance of, a causal relationship based only on a mechanistic assessment, even when the epidemiological evidence was inconclusive or absent. The 2012 IOM Report, on pages 17-18 explains that strong mechanistic evidence “always carries sufficient weight for the committee to conclude the evidence convincingly supports a causal relationship. . .This conclusion [attributing the disease to the vaccine and not to other etiologies] can be reached even if the epidemiologic evidence is rated high in the direction of no increased risk or even decreased risk.”

The IOM concluded the evidence convincingly supports 14 specific vaccine-adverse event relationships, with all but one based on strong mechanistic evidence, and the epidemiologic evidence rated as either having limited confidence or being insufficient. Four vaccine adverse events judged to have either epidemiologic evidence of moderate certainty or mechanistic evidence of intermediate weight were placed in the “evidence favors acceptance of a causal relationship” category, while five other vaccine adverse events were placed in the “evidence favors rejection” category. A finding against a causal relationship required high or moderate epidemiologic evidence in the direction of no effect or decreased risk along with the absence of strong or intermediate mechanistic evidence supporting a causal relationship. The vast majority (135 vaccine-adverse event combinations) were placed in the “evidence is inadequate to accept or reject a causal relationship” category.

After release of the report, nine HHS workgroups including HRSA and the Centers for Disease Control and Prevention (CDC) medical staff reviewed the IOM conclusions on 158 vaccine-adverse events, as well as any newly published scientific literature not contained in the IOM report, and developed a set of proposed changes to the Table and QAI. The work of the HHS workgroups ended and HRSA continued to monitor the literature.

In 2006, the ACCV established “Guiding Principles for Recommending Changes to the Vaccine Injury Table” (Guiding Principles) to assist the ACCV in evaluating proposed Table revisions and determining whether to recommend changes to the Table to the Secretary. The Guiding Principles consist of two overarching principles: (1) The Table should be scientifically and medically credible; and (2) where there is credible scientific and medical evidence both to support and to reject a proposed change (addition or deletion) to the Table, the change should, whenever possible, be made to the benefit of petitioners. The Guiding Principles also state, among other factors, that “[t]o the extent that the [IOM] has studied the possible association between a vaccine and an adverse effect, the conclusions of the IOM should be considered by the ACCV and deemed credible but those conclusions should not limit the deliberations of the ACCV.” Although not binding on the Secretary, the ACCV Guiding Principles were utilized by the nine HHS workgroups in the development of the proposed changes to the Table. In particular, recommendations regarding appropriate time intervals for the onset of a Table injury, or diagnostic criteria in the QAI were influenced by the Guiding Principles. As part of its mandate under the Act, the ACCV considered the proposed changes set forth in this NPRM in its quarterly meetings on March 8, 2012, September 5, 2013, December 5, 2013, June 5, 2014, and September 4, 2014. The ACCV deliberations included scientific and public policy considerations, and were also influenced by the 2006 Guiding Principles. For each proposed change by the Secretary, the ACCV voted for one of three options:

1. ACCV concurs with the proposed change(s) to the Table (and QAI) and would like the Secretary to move forward (with or without comments);

2. ACCV does not concur with the proposed change(s) to the Table (and QAI) and would not like the Secretary to move forward; or

3. ACCV would like to defer a recommendation on the proposed change(s) to the Table (and QAI) pending further review at a future ACCV meeting.

In prior Table revisions, the Secretary determined that the appropriate framework for making changes to the Table is to make specific findings as to the illnesses or conditions that can reasonably be determined in some circumstances to be caused or significantly aggravated by the vaccines under review and the circumstances under which such causation or aggravation can reasonably be determined to occur. The Secretary continues this approach based on the 2012 IOM report, the work of the nine workgroups that reviewed the IOM findings, and after giving due consideration to the ACCV's recommendations.

For the vast majority of the vaccine adverse event pairs that were reviewed by the IOM (135), the IOM determined that the evidence is inadequate to accept or reject a causal relationship. With the exception of seasonal influenza vaccine and Guillain-Barré Syndrome (GBS), unless the IOM findings addressed a condition that was already on the Table, the Secretary makes no additional findings and proposes no change to the Table with regard to the vaccine adverse event pairs in this category. For seasonal influenza vaccines, the Secretary proposes to add the injury of GBS to the Table for the policy reasons discussed in this NPRM. For any vaccine adverse event pairs for which future scientific evidence develops to support a finding of a causal relationship, the Secretary will consider future rulemaking to revise the Table accordingly.

Applying the remaining IOM conclusions, with the Guiding Principles, the Secretary intends to make certain changes to the Table, and also intends to leave certain items already on the Table unchanged. In so doing, the Secretary makes the following findings:

1. The scientific evidence convincingly supports a causal relationship between measles-mumps-rubella (MMR) vaccine and measles inclusion body encephalitis.

2. The scientific evidence convincingly supports a causal relationship between varicella vaccine and vaccine disseminated varicella infection (widespread chickenpox rash shortly after vaccination).

3. The scientific evidence convincingly supports a causal relationship between varicella vaccine and disseminated varicella infection with subsequent infection resulting in pneumonia, meningitis, or hepatitis in individuals with demonstrated immunodeficiencies.

4. The scientific evidence convincingly supports a causal relationship between varicella vaccine and vaccine strain viral reactivation.

5. The scientific evidence convincingly supports a causal relationship between varicella vaccine and vaccine strain viral reactivation with subsequent infection resulting in meningitis or encephalitis.

6. The scientific evidence convincingly supports a causal relationship between varicella vaccine and anaphylaxis.

7. The scientific evidence convincingly supports a causal relationship between influenza vaccines and anaphylaxis.

8. The scientific evidence convincingly supports a causal relationship between meningococcal vaccines and anaphylaxis.

9. The scientific evidence favors acceptance of a causal relationship between human papillomavirus vaccines and anaphylaxis.

10. The scientific evidence convincingly supports a causal relationship between an injection-related event and deltoid bursitis. For reasons detailed below, the Secretary proposed adding a more expansive injury of Shoulder Injury Related to Vaccine Administration (SIRVA) to the Table.

11. The scientific evidence convincingly supports a causal relationship between an injection-related event and syncope.

12. The scientific evidence is inadequate to accept or reject a causal relationship between seasonal influenza vaccines and GBS. However, the Secretary proposes a Table change for the reasons discussed in this NPRM.

1. The scientific evidence convincingly supports a causal relationship between MMR vaccine and anaphylaxis.

2. The scientific evidence convincingly supports a causal relationship between Hepatitis B vaccine and anaphylaxis.

3. The scientific evidence convincingly supports a causal relationship between tetanus toxoid vaccine and anaphylaxis.

4. The scientific evidence is inadequate to accept or reject a causal relationship between tetanus toxoid-containing vaccines (including those containing the acellular pertussis component but not the whole cell pertussis component) and encephalopathy and encephalitis.

5. The scientific evidence is inadequate to accept or reject a causal relationship between MMR vaccine and chronic arthritis in women.

6. The scientific evidence is inadequate to accept or reject a causal relationship between MMR vaccine and chronic arthritis in children.

7. The scientific evidence is inadequate to accept or reject a causal relationship between MMR vaccine and encephalopathy or encephalitis.

1. The scientific evidence convincingly supports a causal relationship between MMR vaccine and febrile seizures.

2. The scientific evidence favors acceptance of a causal relationship between MMR vaccine and transient arthralgia in women.

3. The scientific evidence favors acceptance of a causal relationship between MMR vaccine and transient arthralgia in children.

1. The scientific evidence favors a rejection of a causal relationship between MMR vaccine and autism.

2. The scientific evidence favors a rejection of a causal relationship between MMR vaccine and type 1diabetes.

3. The scientific evidence favors a rejection of a causal relationship between DTaP (tetanus) vaccine and type 1diabetes.

4. The scientific evidence favors a rejection of a causal relationship between inactivated (as opposed to the live intranasal) influenza vaccine and Bell's palsy.

5. The scientific evidence favors a rejection of a causal relationship between inactivated influenza vaccine and exacerbation of asthma or reactive airway disease episodes in children and adults.

The Secretary has examined the recommendations of the ACCV and proposes that the Table set forth at 42 CFR 100.3 be revised as described below. Following each vaccine and adverse event there is a discussion of the IOM conclusion and, where applicable, other relevant conclusions, as well as the Department's proposal. It should be noted that the ACCV concurred with all of the proposals regarding the Table and QAI. Each of the changes proposed by the Department and the rationale for the proposal is described in detail. An important consideration in proposing changes to the Table is the need to make the Table as easy to understand and as clear as possible. With this goal in mind, the Secretary has proposed new language and clarified certain sections of the QAI which must be used by the Special Masters and the parties in understanding when a particular set of symptoms is consistent with a particular Table injury.

As provided in 42 U.S.C. 300aa-14(c)(4), the modified Table will apply only to petitions filed under the Program after the effective date of the final regulation. Petitions must also be filed within the applicable statute of limitations. The general statute of limitations applicable to petitions filed with the VICP, set forth in 42 U.S.C. 300aa-16(a), continues to apply. In addition, the statute identifies a specific exception to this statute of limitations that applies when the effect of a revision to the Table makes a previously ineligible person eligible to receive compensation or when an eligible person's likelihood of obtaining compensation significantly increases. Under this section, an individual who may be eligible to file a petition based on the revised Table may file the petition for compensation not later than 2 years after the effective date of the revision if the injury or death occurred not more than 8 years before the effective date of the revision of the Table (42 U.S.C. 300aa-16(b)). This is true even if such individual previously filed a petition for compensation, and is thus an exception to the “one petition per injury” limitation of 42 U.S.C. 300aa-11(b)(2).

Based on the requirements of the Administrative Procedure Act, the Department publishes a Notice of Proposed Rulemaking in the Federal Register before a regulation is promulgated. The public is invited to submit comments on the proposed rule. In addition, a public hearing will be held for this proposed rule. After the public comment period has expired, the comments received and the Department's responses to the comments will be addressed in the preamble to the final regulation. The Department will publish the final rule in the Federal Register.

In the following sections, background information on different categories of vaccines as well as the Secretary's rationale for any proposed Table change is provided. It should also be noted that the proposed QAIs are designed to define the conditions covered on the Table and to rule out other conditions that are not covered on the Table (and for which there has been no finding of a causal relation to the vaccines). In addition, the QAIs make clear that if certain other circumstances exist that do not, in the Secretary's view, warrant a presumption of causation, the Table presumption will not be apply.

Currently there are four tetanus-diptheria (Td) vaccines licensed in the United States, two of which also contain acellular pertussis vaccines (Tdap and DTap); a diphtheria-tetanus (DT) vaccine for children younger than age 7 years; and one tetanus toxoid vaccine (TT). In addition, there are three combination vaccines approved for use in children, including (DTaP-IPV-HepB), (DTaP-IPV-Hib), and (DTaP-IPV). Immunity to tetanus wanes over time, so booster doses are needed. According to the CDC recommended schedule of immunizations for children, an infant and child should receive four doses of DTaP in the first 18 months of life and a booster dose between 4 to 6 years. Tdap is recommended at age 11 to 12 years.

Since 2005, the Advisory Committee on Immunization Practices (ACIP) and the CDC have recommended a Tdap vaccine booster dose for all adolescents aged 11 through 18 years of age and for adults aged 19 through 64 years who have not received a dose. A Td booster is recommended every 10 years thereafter. As part of wound management care to prevent tetanus, a tetanus toxoid-containing vaccine is recommended for wound management in anyone who has not received a tetanus-containing vaccine for 5 years or more. The CDC recommends that one dose of Tdap be administered to pregnant women during each pregnancy regardless of the interval since the prior Td or Tdap vaccination.

Shoulder Injury Related to Vaccine Administration (SIRVA) is an adverse event following vaccination thought to be related to the technique of intramuscular percutaneous injection (the procedure where access to a muscle is obtained by using a needle to puncture the skin) into an arm resulting in trauma from the needle and/or the unintentional injection of a vaccine into tissues and structures lying underneath the deltoid muscle of the shoulder. As the proposed definition indicates, SIRVA is an injury related to the intramuscular injection of a vaccine. Consequently, by definition, a Table injury of SIRVA will not result for those vaccines that are not administered by intramuscular injection, including oral polio and rotavirus; subcutaneous MMR, MMRV, varicella, and meningococcal-polysaccharide; intranasal influenza; and intradermal influenza. In addition, a Table injury of SIRVA will not result for those vaccines that are administered via a needleless jet device. Jet injectors are needleless systems for vaccine or medication administration that utilize a high-pressure jet of liquid to penetrate the skin. During administration, the needleless syringe is placed against the injection site and as the medication or vaccine passes through the injector under high pressure it forms a jet of fluid that penetrates the skin. These devices do not penetrate the skin to a degree that would result in SIRVA. Current information regarding routes of administration for various vaccine formulations is available on the Centers for Disease Control and Prevention's Web site: http://www.cdc.gov/vaccines/recs/vac-admin/default.htm?s_cid=.

Clinical signs of shoulder pain and restricted motion in the affected shoulder appear shortly after vaccination. Medical review of VICP claims shows more than 30 cases of severe, persistent shoulder pain beginning shortly after vaccination and resulting in prolonged restriction of function. Often these cases were diagnosed as deltoid bursitis. [Atanasoff S, Ryan T, Lightfoot R, and Johann-Liang R, 2010, Shoulder injury related to vaccine administration (SIRVA), Vaccine 28(51):8049-8052.]

The IOM reviewed the scientific and medical literature finding evidence that convincingly supports a causal relationship between vaccine injection (with a needle) into an arm and deltoid bursitis. The report noted that the published VICP case series (Atanasoff et al.), as described, were clinically consistent with deltoid bursitis. The VICP case series found that 93 percent of patients had the onset of shoulder pain within 24 hours of vaccine administration and 54 percent had immediate pain following vaccine injection. The VICP case series found several diagnoses, beyond deltoid bursitis, that resulted in shoulder pain following vaccination, including tendonitis, impingement syndrome, frozen shoulder syndrome, and adhesive capsulitis. Another case series reported two cases of shoulder pain, weakness and reduced range of motion following vaccination with onset of symptoms within 48 hours of vaccination. [Bodor M, Montalvo E, Vaccination related shoulder dysfunction, Vaccine 25(2007) 585-587.]

In order to capture the broader array of potential injuries, the Secretary proposes to add SIRVA for all tetanus toxoid-containing vaccines that are administered intramuscularly through percutaneous injection into the upper arm. The interval of onset will be less than or equal to 48 hours.

While the Secretary proposes adding SIRVA to the Table for the MMR and Varicella vaccines, to meet the proposed QAI for SIRVA, the vaccine must be one intended for intramuscular administration in the upper arm. The Secretary acknowledges that currently there are no MMR or Varicella vaccines that are administered by intramuscular injection. However, the Secretary proposes that the Table include SIRVA as an injury for those vaccines, recognizing that, presently, the absence of an intramuscular formulation of the vaccines will prevent petitioners from meeting the Table QAI for SIRVA with respect to those vaccines. The advantage of such proposal is that the Table would not require modification should an intramuscular formulation of those vaccines develop. The disadvantage of this proposal could be confusion about whether a Table injury for SIRVA may be satisfied for those vaccines, despite the QAI's requirement that the associated vaccine be intended for intramuscular administration. Accordingly, the Secretary specifically seeks the public's views on her proposal to include SIRVA as a Table injury for the MMR and varicella vaccines notwithstanding the fact that there currently is not an intramuscular formulation. Consequently, by definition, a Table injury of SIRVA will not result for those vaccines that are not administered by intramuscular injection, including oral polio and rotavirus; subcutaneous MMR, MMRV, varicella, and meningococcal-polysaccharide; intranasal influenza; and intradermal influenza.

Vasovagal syncope is the loss of consciousness (fainting) caused by a transient decrease in blood flow to the brain. Vasovagal syncope is usually a benign condition but may result in falling and injury. Vaccination is known to be one cause of vasovagal syncope. Both serious and non-serious injuries can occur as a result of syncope. The types of serious injuries that may occur following a syncopal episode include, but are not limited to, skin lacerations, bone fractures, dental injuries, traumatic brain injuries, and death. Other injuries include traumatic injuries sustained from automobile accidents that occurred due to a vaccinee experiencing syncope while driving within a short time period after vaccine receipt.

The IOM reviewed the literature concerning a possible link between the injection of a vaccine and syncope. Although the Committee found the epidemiologic evidence was insufficient or absent to assess an association between the injection of a vaccine (with a needle) and syncope, the Committee concluded the mechanistic evidence was strong based on 35 cases presenting definitive clinical evidence. In addition, the HHS's Division of Injury Compensation Programs (DICP) has identified eight cases from its database alleging syncope as a vaccine injury (unpublished data). All had six months of residual symptoms as a result of syncope. In all eight cases, DICP found that syncope was directly related to vaccine administration.

The IOM concluded that the evidence convincingly supports a causal relationship between the injection of a vaccine (with a needle) and syncope. It did not limit this conclusion to a particular vaccine and explained that the evidence from one case report it examined as part of the mechanistic evidence it reviewed suggested “that the injection, and not the contents of the vaccine, contributed to the development of syncope.”

In order to be eligible for compensation, the Act requires that the residual effects of the alleged vaccine injury must have continued for a period of at least 6 months (unless the injury results in in-patient hospitalization and surgery, or death). The Secretary recognizes that in many instances cases involving syncope will not meet the statutory severity criteria, as the reaction can be short-lived and treated effectively. However, there is a known risk of serious residual injury or of death from syncope.

Although syncope typically has no long term consequences, the Program has found that not infrequently, syncope is associated with residual effects lasting more than 6 months. Therefore, the Secretary proposes to add vasovagal syncope to the Table for all tetanus toxoid containing vaccines that are administered through percutaneous injection to permit an award of compensation in serious cases meeting the severity criteria. The proposed time interval of onset is less than or equal to 1 hour following vaccination. Syncope is an injury related to the injection of a vaccine. Consequently, the Secretary does not propose adding syncope as a Table injury for those vaccines that are not administered by injection, including oral polio and rotavirus vaccine. With respect to other vaccines, such as the intranasal influenza vaccine, while syncope is proposed as an injury for the general category of vaccines (i.e., seasonal influenza vaccines), the specific formulation will not result in a Table injury of syncope by definition because it is not administered by injection. The Secretary is not aware of any reliable and persuasive evidence demonstrating that syncope occurs following administration of a vaccine via a needleless jet device; however, it may be plausible for syncope to occur with this route of administration. Therefore, the Secretary seeks the public's views as to whether the Secretary should include syncope as a Table injury for those vaccines that are administered via a needleless jet device. The Secretary also seeks the public's views as to whether syncope should be a Table injury for other categories of vaccines (e.g., rotavirus) notwithstanding the fact that there currently is not a formulation that is administered by injection in order to encompass future formulations that may be administered by injection.

Diphtheria, tetanus, and whole cell pertussis (DTwP) vaccines were used for much of the 20th century to control pertussis (whooping cough) disease. Concerns about the safety of DTwP (also referred to as DTP) vaccine prompted development of vaccines with an acellular pertussis component. With data showing fewer local, systemic, and more serious adverse events after acellular (DTaP) vaccine when compared to whole cell DTwP vaccine, the FDA licensed diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccines in 1991 for use in children aged 15 months to 6 years, and in 1996 for use in infants and children aged 6 weeks to 6 years. By 2000, DTaP had replaced DTwP and, like the whole cell pertussis vaccine, was subsequently licensed in combination with other vaccines for routine use in children. Further, in 2005, FDA licensed tetanus and diphtheria toxoid (Td) and, acellular pertussis (Tdap) vaccine, for use in persons 10 years of age and older, as this vaccine is thought to decrease the number of pertussis carriers in the population, which would lead to a decrease in the number of pertussis outbreaks.

The Secretary notes that there are significant differences between whole cell and acellular pertussis vaccines. Although both vaccine types were developed for the same purpose (i.e., immunization against pertussis), they have significantly different compositions, and different effects on biological systems (e.g., the immune and nervous systems). DTwP is distinct from DTaP because the former contains many bacterial proteins, including endotoxins (some of which are known neurotoxins) and the latter does not. These neurotoxins are thought to possibly act synergistically to cause adverse neurologic events in susceptible DTwP vaccine recipients. To date, no adequate study has been published that demonstrates a causal relationship between acellular pertussis vaccines and encephalopathy/encephalitis. Furthermore, studies have demonstrated a significant reduction in the number of common adverse events with acellular pertussis, such as crying and fevers, and less common ones, such as febrile seizures. [Pertussis vaccination: use of acellular pertussis vaccines among infants and young children recommendations of the advisory committee on immunization practices (ACIP), MMWR, 1997; 46(RR-7):1-25.] [Le Saux N, et al. Health Canada Immunization Monitoring Program-Active (IMPACT)] [Decrease in hospital admissions for febrile seizures and reports of hypotonic-hyporesponsive episodes presenting to hospital emergency departments since switching to acellular pertussis vaccine in Canada: A report from IMPACT. Pediatrics. 2003; 112(5):e348.] Pertussis antigen-containing vaccines were included in the original statutory Table.

The initial Table and QAI set forth in the 1986 statute reflected Congress' initial legislative determinations on vaccine-related injuries for DTwP vaccine. Further, modifications to the Table and QAI promulgated by the Secretary in 1995 were based on the scientific findings related to DTwP vaccine, the key study being the British National Childhood Encephalopathy Study (NCES), which found some evidence of acute neurologic illness (encephalopathy) 1 to 7 days after vaccination with the whole cell pertussis vaccine. Similarly, a 10 year NCES follow-up found evidence of chronic nervous system effects. However, the evidence from this follow-up study remained insufficient to indicate the presence or absence of a causal relation between DTP and chronic nervous system dysfunction. On the other hand, a more recent epidemiologic study of whole cell pertussis-containing vaccines did not show a relationship with encephalopathy or encephalitis (Ray et al). The IOM conclusions in 1991 and 1994 were mixed regarding the statistically significant findings of encephalopathy in both the original NCES and its 10 year follow-up. [IOM, Adverse Effects of Pertussis and Rubella Vaccines, 1991. IOM, Adverse Events Associated with Childhood Vaccines, 1994.] In the end, the Secretary, with unanimous support of the ACCV, retained encephalopathy on the Table, but clarified the definition of encephalopathy in the QAI to make it more clinically precise. [Miller D, Wadsworth J, Ross E, Severe neurological illness: Further analysis of the British National Childhood Encephalopathy Study. Tokai J Exp Clin Med. 1988; 13(suppl):145-155; Miller D, Madge N, Diamond J, Wadsworth J, and Ross E, Pertussis Immunization and Serious Acute Neurological Illnesses in Children, BMJ, 1993;307:1171-6; Ray P, Hayward J, Michelson D, Lewis E, Schwalbe J, Black S, Shinefield H, Marcy M, Huff K, Ward J, Mullooly J, Chen R, Davis R, and the Vaccine Safety Datalink Group, Encephalopathy After Whole-Cell Pertussis or Measles Vaccination: Lack of Evidence for a Causal Association in a Retrospective Case-Control Study. Ped Infec Dis J. 2006; 25(9):768-773.]

Acellular pertussis-containing vaccines were developed because of concerns about events due to whole cell pertussis. Toxicologists argue that components in these two types of pertussis vaccines differ greatly and should be treated as separate entities. Animal models have demonstrated that whole cell pertussis constituents have different effects than those with acellular pertussis. In one study, only whole cell pertussis vaccines caused seizure activity in mice. Levels of inflammatory markers were elevated in the whole cell pertussis group but not the acellular pertussis group. In another study, mice that received whole cell pertussis intravenously succumbed while those that received acellular pertussis did not. [Sato Y, Sato H, Comparison of Toxicities of Acellular Pertussis Vaccine with Whole Cell Pertussis Vaccine in Experimental Animals, Dev Biol Stand, 1991; 73:251-62; Donnelly S, Loscher CE, Lynch MA, Mills KH, Whole-cell but not Acellular Pertussis Vaccines Induce Convulsive Activity in Mice: evidence of a role for toxin-induced interleukin-1beta in a new murine model for analysis of neuronal side effects of vaccination. Infect Immun. 2001 July; 69(7):4217-4223.]

The 2012 IOM report on adverse events found that the evidence was inadequate to accept or reject a causal association between acellular pertussis-containing vaccines and encephalopathy and encephalitis. As previously stated, there is no credible evidence of a causal relationship between acellular pertussis vaccines and encephalopathy/encephalitis. Clinical studies have demonstrated a significant reduction in the number of common adverse events with acellular pertussis vaccine, as compared to whole cell pertussis vaccine, such as crying and fevers, and less common ones, such as febrile seizures. Although there have been large-scale surveillance studies conducted on the effects of acellular pertussis vaccines in infants and young children, such as those done in Canada and Australia, the study design used passive surveillance and therefore, the evidence is not as definitive as a controlled, well-designed epidemiologic study using a case control or cohort design [Le Saux N, et al. e348] [Lawrence G., Menzies R., Burgess M., McIntyre P., Wood N., Boyd I., Purcell P., Isaacs D. Surveillance of adverse events following immunization: Australia, 2000-2002. Commun Dis Intell. 2003; 27(3):307-23]. With regard to adolescents and adults, the Committee included a study by Yih (2009) which found that the number of encephalitis, encephalopathy or meningitis cases within 42 days of Tdap vaccination were less than a historical Td cohort with a relative risk of 0.84. [Yih W. K., Nordin J.D., Kulldorff M., Lewis E., Lieu T.A., Shi P., and Weintraub E. S., 2009, An assessment of the safety of adolescent and adult tetanus-diphtheria-acellular pertussis (Tdap) vaccine, using active surveillance for adverse events in the vaccine safety datalink, Vaccine 27(32):4257-4262]

In view of the limited epidemiological data, and as influenced by the Guiding Principles, the Secretary does not propose to make any changes to the Table, leaving intact the Table injury of encephalopathy/encephalitis for vaccines containing pertussis antigens, with an onset less than 72 hours from vaccination. However, the Secretary proposes to re-organize, clarify, and update the QAI for acute and chronic encephalopathy, and to include a new definition for acute encephalitis based on the Brighton Collaboration criteria and several other references. The Brighton Collaboration is an international voluntary collaboration that develops globally accepted and standardized case definitions of adverse events following immunizations. More information can be found at: https://brightoncollaboration.org/public.

The Secretary proposes to add SIRVA for pertussis antigen-containing vaccines. [See I.A.] The interval of onset will be less than or equal to 48 hours.

The Secretary proposes to add vasovagal syncope to the Table for pertussis antigen-containing vaccines. [See I.B.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

Since the 1960s, measles, mumps, and rubella (MMR), a live, attenuated virus vaccine, has been routinely administered to children in the U.S. In 2005, the tetravalent measles, mumps, rubella, and varicella (MMRV) vaccine was added to the immunization schedule. MMR vaccine was included in the original statutory Table.

Severe complications associated with the measles virus or a mutated form of the virus, such as measles inclusion body encephalitis (MIBE), can be broadly categorized as measles viral diseases. The Table currently lists “vaccine-strain measles viral infection in an immunodeficient recipient” as a Table injury for vaccines containing measles virus, with an onset of 6 months. This condition is defined in the QAI as “a disease caused by the vaccine-strain that should be determined by vaccine-specific monoclonal antibody or polymerase chain reaction tests.”

MIBE is a rare, slow encephalitis caused by chronic with the measles virus, and is thus a subset of the condition already listed on the Table. MIBE is confined to immunodeficient individuals and is frequently fatal. MIBE occurs primarily in children and young adults, and typically occurs within 1 year of the initial infection or vaccination. A gradual decline in intellectual abilities and behavioral alterations are followed by progressive myoclonus; muscle spasticity; seizures; dementia; autonomic dysfunction; and ataxia. Death usually occurs 1 to 3 years after disease onset. Pathologic features include perivascular cuffing, eosinophilic cytoplasmic inclusions, neurophagia, and fibrous gliosis.

The IOM concluded that the evidence convincingly supports a causal relationship between MMR vaccine and MIBE in individuals with demonstrated immunodeficiencies. Out of the five case reports the IOM found, two had wild-type measles infection and these did not contribute to the weight of evidence. Only one out of the three contributing case reports had vaccine-strain measles virus isolated. Because of limitations due to testing and viral properties, in most cases it is difficult to characterize wild-type versus vaccine-strain measles. [Bitnun A., Shannon P., Durward A., Rota P.A., Bellini W.J., Graham C., Wang E., Ford-Jones E.L., Cox P., Becker L., Fearon M., Petric M., and Tellier R.,. 1999. Measles inclusion-body encephalitis caused by the vaccine strain of measles virus. Clinical Infectious Diseases 29(4):855-861.] The current Table lists “Vaccine-strain measles viral infection in an immunodeficient recipient” for measles virus-containing vaccines with a time interval of onset of 6 months. Case reports of MIBE cited by the IOM showed a time interval of onset that varied from 8 days to 11 months.

For the reasons discussed above and in keeping with the spirit of the Guiding Principles, the Secretary proposes to change the injury of “vaccine-strain measles viral infection in an immunodeficient recipient” to “vaccine-strain measles viral disease in an immunodeficient recipient.” Because MIBE is a type of measles virus-associated disease occurring in immunodeficient individuals, the Secretary proposes a new time interval of onset of up to 12 months from the date of vaccination for those cases in which the typing of vaccine strain was not performed, because most cases of vaccine-strain disease occur within 1 year of vaccination. There is no time interval for onset proposed if the vaccine strain of the virus is identified, as it can be concluded that the vaccine was a contributing cause of the injury. Cases in which wild-type measles strain is isolated will be excluded. Revisions to the Table will distinguish between cases in which the measles vaccine strain is identified versus those cases in which laboratory testing was not done or the results were inconclusive. In addition, the Secretary proposes adding diagnostic criteria to the QAI.

The IOM concluded that the evidence is inadequate to accept or reject a causal relationship between MMR vaccine and encephalopathy or encephalitis. Not only is there limited epidemiologic evidence on a possible causal association, the mechanistic evidence is weak, based on current knowledge about natural infection and few case reports. Natural (wild-type) infection (measles, mumps, and/or rubella virus) is thought to cause neurologic illness through damage to the neurons by direct viral invasion. This is thought to be either from direct viral infection and/or viral reactivation (particularly in immunocompromised patients). These same mechanisms may be responsible for vaccine-associated encephalopathy/encephalitis, but evidence linking these mechanisms directly to MMR vaccine strains (detection of viral antigens or antibodies) has not been shown. [Makela A., J. P. Nuorti, and H. Peltola. 2002. Neurologic disorders after measles-mumps-rubella vaccination. Pediatrics 110(5):957-963.] [Ray, P., J. Hayward, D. Michelson, E. Lewis, J. Schwalbe, S. Black, H. Shinefield, M. Marcy, K. Huff, J. Ward, J. Mullooly, R. Chen, and R. Davis. 2006. Encephalopathy after whole-cell pertussis or measles vaccination: Lack of evidence for a causal association in a retrospective case-control study. Pediatric Infectious Disease Journal 25(9):768-773.]

In view of the limited mechanistic data, and as influenced by the Guiding Principles, the Secretary does not propose to make any changes to the Table, leaving intact the Table injury of encephalopathy/encephalitis for MMR vaccines, with an onset not less than 5 days and no more than 15 days from vaccination. However, the Secretary proposes to re-organize, clarify, and update the QAI for acute and chronic encephalopathy and include a new definition for acute encephalitis based on the Brighton Collaboration criteria and several other references. [Ford-Jones L., MacGregor D., Richardson S., et al. Acute childhood encephalitis and meningoencephalitis: Diagnosis and management. Paediatr Child Health (1988). Jan-Feb;3(1):33-40] [Ball R., Halsey N., Braun M., et al. Development of case definitions for acute encephalopathy, encephalitis, and multiple sclerosis reports to the Vaccine Adverse Event Reporting System. Journal of Clinical Epidemiology (2002). 55:819-824.]

Febrile seizures are a common cause of convulsions in young children. Generally viewed as benign and not indicative of brain disease, they occur in two to four percent of children up to age 5 years. Febrile seizures are often seen as the body temperature increases rapidly; but, may develop as the fever is declining. Most events last a minute or two, although some can be as brief as a few seconds. A family history of febrile seizures increases the child's risk of occurrence. Anything that causes fever, such as viral or bacterial infections, can bring on a febrile seizure.

The IOM Committee concluded that the evidence convincingly supports a causal relationship between MMR vaccine and febrile seizures. Based on seven epidemiologic studies, the Committee had a high degree of confidence that there is an increased risk of febrile seizures after receipt of MMR vaccine. The Committee assessed the mechanistic evidence regarding an association between MMR vaccine and febrile seizures as intermediate based on 12 cases presenting clinical evidence. [Farrington, P., S. Pugh, A. Colville, A. Flower, J. Nash, P. Morgan-Capner, M. Rush, and E. Miller. 1995. A new method for active surveillance of adverse events from diphtheria/tetanus/pertussis and measles/mumps/rubella vaccines. Lancet 345(8949):567-569.] [Miller, E., N. Andrews, J. Stowe, A. Grant, P. Waight, and B. Taylor. 2007. Risks of convulsion and aseptic meningitis following measles-mumps-rubella vaccination in the United Kingdom. American Journal of Epidemiology 165(6):704-709.] [Barlow, W. E., R. L. Davis, J. W. Glasser, P. H. Rhodes, R. S. Thompson, J. P. Mullooly, S. B. Black, H. R. Shinefield, J. I. Ward, S. M. Marcy, F. DeStefano, and R. T. Chen. 2001. The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine. New England Journal of Medicine 345(9):656-661.]

Patients who had post-MMR vaccination febrile seizures had no higher risk of subsequent seizure or neurodevelopmental disability than other children with febrile seizures in the absence of vaccine administration. The long-term rate of epilepsy was not increased in children who had febrile seizures following MMR vaccination compared with children who had febrile seizures of a different etiology [Vestergaard, M., A. Hviid, K. M. Madsen, J. Wohlfahrt, P. Thorsen, D. Schendel, M. Melbye, and J. Olsen. 2004. MMR vaccination and febrile seizures: Evaluation of susceptible subgroups and long-term prognosis. Journal of the American Medical Association 292(3):351-357.] [Barlow, W. E., R. L. Davis, J. W. Glasser, P. H. Rhodes, R. S. Thompson, J. P. Mullooly, S. B. Black, H. R. Shinefield, J. I. Ward, S. M. Marcy, F. DeStefano, and R. T. Chen. 2001. The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine. New England Journal of Medicine 345(9):656-661.]

Although febrile seizures can be alarming to parents and other family members, the overwhelming majority of children who have febrile seizures recover quickly and have no lasting effects. Only very rarely can febrile seizures lead to serious injury or disability.

The National Childhood Vaccine Injury Act of 1986 requires the effects of the alleged vaccine injury must have continued for at least 6 months (unless the injury results in in-patient hospitalization and surgery, or death). Because the current medical literature supports febrile seizures only very rarely have long term consequences this condition is not being proposed for inclusion on the Table. However, the Program will consider causation-in-fact claims for febrile seizures leading to serious injury or death on a case-by-case basis.

Arthralgia means joint pain without signs of inflammation (e.g. erythema, warmth, pallor, edema, or decreased range of movement). Arthritis is arthralgia with signs of inflammation. Arthropathy encompasses arthralgia or arthritis and refers to any joint disease. Unlike arthritis, arthralgia is a symptom and there may be no objective measures for confirmation. The IOM concluded that the evidence favors acceptance of a causal relationship between MMR vaccine (attributable to the rubella component) and transient arthralgia in women and children. The IOM had a moderate degree of confidence in the epidemiologic evidence for women (based on four studies) that consistently reported an increased risk of transient arthralgia after MMR vaccination. Similarly, the mechanistic evidence regarding an association between rubella vaccine and transient arthralgia in women was intermediate based on 13 case reports. Two-thirds of the studies involved post-partum women. [Slater, P. E., T. Ben-Zvi, A. Fogel, M. Ehrenfeld, and S. Ever-Hadani. 1995. Absence of an association between rubella vaccination and arthritis in underimmune postpartum women. Vaccine 13(16):1529-1532.] [Ray, P., S. Black, H. Shinefield, A. Dillon, J. Schwalbe, S. Holmes, S. Hadler, R. Chen, S. Cochi, and S. Wassilak. 1997. Risk of chronic arthropathy among women after rubella vaccination. Journal of the American Medical Association 278(7):551-556] [Tingle, A. J., L. A. Mitchell, M. Grace, P. Middleton, R. Mathias, L. MacWilliam, and A. Chalmers. 1997. Randomised double-blind placebo-controlled study on adverse effects of rubella immunisation in seronegative women. Lancet 349(9061):1277-1281.] [Mitchell, L. A., A. J. Tingle, L. MacWilliam, C. Home, P. Keown, L. K. Gaur, and G. T. Nepom. 1998. HLA-DR class II associations with rubella vaccine-induced joint manifestations. Journal of Infectious Diseases 177(1):5-12.]

There were seven epidemiologic studies of children that consistently reported an increased risk of arthralgia after MMR vaccination. The IOM had a moderate degree of confidence in the epidemiologic evidence based on the seven studies with sufficient validity and precision to assess an association between MMR vaccine and transient arthralgia in children. The mechanistic evidence was weak based on knowledge about natural rubella infection. [Peltola, H., and O. P. Heinonen. 1986. Frequency of true adverse reactions to measles-mumps-rubella vaccine. Lancet 327(8487):939-942.] [Virtanen, M., H. Peltola, M. Paunio, and O. P. Heinonen. 2000. Day-to-day reactogenicity and the healthy vaccinee effect of measles-mumps-rubella vaccination. Pediatrics 106(5):E62.] [Benjamin, C. M., G. C. Chew, and A. J. Silman. 1992. Joint and limb symptoms in children after immunization with measles, mumps, and rubella vaccine. BMJ 304(6834):1075-1078.] [Davis, R. L., E. Marcuse, S. Black, H. Shinefield, et al. 1997. MMR2 immunization at 4 to 5 years and 10 to 12 years of age: A comparison of adverse clinical events after immunization in the vaccine safety datalink project. Pediatrics 100(5):767-771] [dos Santos, B. A., T. S. Ranieri, M. Bercini, M. T. Schermann, S. Famer, R. Mohrdieck, T. Maraskin, and M. B. Wagner. 2002. An evaluation of the adverse reaction potential of three measles-mumps-rubella combination vaccines. Revista Panamericana de Salud Publica/Pan American Journal of Public Health 12(4):240-246.] [LeBaron, C. W., D. Bi, B. J. Sullivan, C. Beck, and P. Gargiullo. 2006. Evaluation of potentially common adverse events associated with the first and second doses of measles-mumps-rubella vaccine. Pediatrics 118(4):1422-143] [Heijstek, M. W., G. C. S. Pileggi, E. Zonneveld-Huijssoon, et al. 2007. Safety of measles, mumps and rubella vaccination in juvenile idiopathic arthritis. Annals of the Rheumatic Diseases 66(10):1384-1387.]

Because transient arthralgia is a subjective symptom that frequently lacks objective evidence for confirmation and has no long-term effects or consequences, this condition is not being proposed for inclusion on the Table.

The IOM concluded that the evidence was inadequate to accept or reject a causal relationship between MMR vaccine and chronic arthropathy in women and children, as well as arthropathy in men. The committee had limited confidence in the epidemiologic evidence for rubella vaccine and chronic arthralgia or arthritis. The epidemiologic evidence was insufficient or absent to assess an association between measles or mumps vaccine and chronic arthralgia or chronic arthritis in women. The IOM assessed the mechanistic evidence regarding rubella vaccine and chronic arthralgia or chronic arthritis in women as low-intermediate; and as lacking between measles or mumps vaccine and chronic arthralgia or chronic arthritis in women. In children, the IOM found the epidemiologic evidence to be insufficient or absent for the association between MMR and chronic arthropathy. The IOM found the mechanistic evidence between rubella vaccine and chronic arthropathy to be weak and they found the evidence to be lacking for measles and mumps vaccines. The IOM had limited confidence in the epidemiologic evidence for an association between MMR vaccine and arthropathy in men. The IOM found the mechanistic evidence regarding the association between rubella vaccine and arthropathy in men to be weak. The IOM found the mechanistic evidence between measles or mumps vaccine and arthropathy in men as lacking. [Ray, P., S. Black, H. Shinefield, A. Dillon, J. Schwalbe, S. Holmes, S. Hadler, R. Chen, S. Cochi, and S. Wassilak. 1997. Risk of chronic arthropathy among women after rubella vaccination. Journal of the American Medical Association 278(7):551-556.] [Tingle, A. J., L. A. Mitchell, M. Grace, P. Middleton, R. Mathias, L. MacWilliam, and A. Chalmers. 1997. Randomised double-blind placebo-controlled study on adverse effects of rubella immunization in seronegative women. Lancet 349(9061):1277-1281.] Peters, M. E., and S. Horowitz. 1984. Bone changes after rubella vaccination. American Journal of Roentgenology 143(1):27-28. Geiger, R., F. M. Fink, B. Solder, M. Sailer, and G. Enders. 1995. Persistent rubella infection after erroneous vaccination in an immunocompromised patient with acute lymphoblastic-leukemia in remission. Journal of Medical Virology 47(4):442-444.]

In spite of the limited epidemiological and mechanistic data, based on the Guiding Principles, the Secretary does not propose to make any changes to the Table, leaving intact the Table injury of chronic arthritis for MMR vaccines, with an onset not less than 7 days and no more than 42 days from vaccination. However, the Secretary proposes to provide a definition for chronic arthritis in the QAI, based on the Brighton Collaboration criteria and several other references.

The Secretary proposes to add SIRVA to the Table for vaccines containing measles, mumps and/or rubella virus. [See section I.A above.] The interval of onset will be less than or equal to 48 hours. However, the Secretary recognizes that there currently is no intramuscular formulation of this vaccine available and therefore, petitioners alleging an injury of SIRVA associated with this vaccine presently cannot meet the QAI for SIRVA. Please see section I.A., above, for additional discussion on this point.

The Secretary proposes to add vasovagal syncope to the Table for vaccines containing measles, mumps and/or rubella virus. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

Since 2000, inactivated polio vaccine (IPV) has been the only polio vaccine used in the United States, although live virus oral polio vaccine (OPV) is still used in many parts of the world. The Secretary proposes changes to the Table related only to IPV, as an injected vaccine. OPV was included in the original statutory Table and remains on the regulatory Table.

The Secretary proposes to add SIRVA as a Table injury for vaccines containing polio inactivated virus. [See Section I.A above.] The interval of onset will be less than or equal to 48 hours.

The Secretary proposes to add vasovagal syncope to the Table for vaccines containing polio inactivated virus. [See Section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

The recombinant hepatitis B vaccine was first licensed by the FDA in 1986. Produced from cultured and purified yeast cells, it is the current form of vaccine used in the United States. Prior to 1991, the vaccine was recommended only for high risk individuals. However, the recommendation was extended to include all infants, since infected infants and children are at higher risk for developing chronic liver disease with subsequent liver cancer, and approximately one-third of those who acquire hepatitis B infection do not have any identified risk factors, and, therefore, were frequently not immunized. The effective date of coverage for hepatitis B vaccine is August 6, 1997.

The Secretary proposes to add SIRVA as a Table injury for hepatitis B vaccines. [See section I.A above.] The interval of onset will be less than or equal to 48 hours.

The Secretary proposes to add vasovagal syncope to the Table for hepatitis B vaccines. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

Haemophilus influenzae type b (Hib) conjugate vaccines were first licensed by the FDA in 1987 and have been recommended by the CDC for routine use since 1991. The vaccine is given to infants and children up to the age of school entry. The effective date of coverage for Hib vaccines is August 6, 1997, with no injuries or conditions specified.

In order for a category of vaccines to be covered under the VICP, the category of vaccine must be recommended for routine administration to children by the Centers for Disease Control and Prevention (for example, vaccines that protect against seasonal influenza), subject to an excise tax by Federal law, and added to the Program by the Secretary of Health and Human Services. The Internal Revenue Code defines a “taxable vaccine” as including “[a]ny HIB vaccine”. See 26 U.S.C. 4132(a)(1)(H). Thus, the Secretary proposes to modify category IX on the Table from “Haemophilus influenzae type b polysaccharide conjugate vaccines” to “Haemophilus influenza type b vaccines,” as a technical change in order to be most inclusive.

The Secretary proposes to add SIRVA as a Table injury for Hib vaccines. [See section I.A above.] The interval of onset will be less than or equal to 48 hours.

The Secretary proposes to add vasovagal syncope to the Table for Hib vaccines. [See I.B.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

The varicella (chickenpox) virus vaccine, which was first licensed by the Food and Drug Administration in 1995, contains a live, attenuated strain of the varicella virus. Chickenpox is a highly contagious disease and although usually mild, infants, adolescents, adults, pregnant women, and immunocompromised individuals are at higher risk for serious complications. Since the introduction of the vaccine there has been a significant decrease in the number of cases of the disease with the greatest effect in states with the highest vaccination coverage. Varicella vaccine is listed on the Table, effective August 6, 1997, with no injuries or conditions specified.

Disseminated varicella vaccine-strain viral disease is a condition in which the affected individual develops the varicella rash caused by the vaccine strain that spreads beyond the dermatome (an area of skin supplied by the nerve fibers of a single spinal root) involved in the vaccination and/or there is involvement of other organs such as the brain, lungs, and liver. For organs other than the skin, disease, not just mildly abnormal laboratory values, must be demonstrated in the involved organ. In this section, the word “disseminated” is defined by the IOM as the spreading of the rash (or the virus) beyond the dermatome involved in the vaccination.

The IOM reviewed the evidence for vaccine causation of disseminated varicella disease with and without involvement of organs beyond the skin. They found three case reports in which vaccinated individuals developed lesions confined to the skin after immunization, and in whose lesions the vaccine strain of the varicella virus was identified. In addition, the IOM identified 550 cases reported to passive surveillance systems in which an attempt was made to identify the virus from skin lesions in individuals who developed disseminated varicella disease after vaccination without involvement of another organ. The wild-type virus was identified in 210 cases; the vaccine-strain virus was identified in 125 cases; and in the remaining cases either the sample was inadequate, the virus could not be identified, or there was no virus present. The committee also identified nine cases in which the vaccine strain of the virus was identified in individuals who had meningitis, pneumonia or hepatitis in addition to skin lesions. Cases of disseminated disease, which were reviewed by the IOM in individuals who were thought to be immunocompetent, all occurred within 42 days of immunization. The time of onset was not further specified. In many cases the timeframe from vaccination to onset of disseminated illness, without other organ involvement, was not provided for immunocompromised individuals, but in the cases for which there was data, there was a broad range of onset, spanning from 1 week in one case to “up to 87 days” in another. For four cases, in which onset was reported, the interval following vaccination was 18 days to 6 weeks. For disseminated disease with other organ involvement, onset was 13 days after vaccination in the only immunocompetent patient for whom data was available, and onset was between 10 and 35 days in eight immunocompromised individuals. [Wise, R. P., M. E. Salive, M. M. Braun, G. T. Mootrey, J. F. Seward, L. G. Rider, and P. R. Krause. 2000. Postlicensure safety surveillance for varicella vaccine. Journal of the American Medical Association 284(10):1271-1279.] [Goulleret, N., E. Mauvisseau, M. Essevaz-Roulet, M. Quinlivan, and J. Breuer. 2010. Safety profile of live varicella virus vaccine (Oka/Merck): Five-year results of the European varicella zoster virus identification program (EU VZVIP). Vaccine 28 (36):5878-5882.]

The IOM found the evidence convincingly supports a causal relationship between varicella vaccine and disseminated varicella disease, both for cases confined to the skin and for cases where the spread involves other organs. However, the IOM limited their finding of causation in cases in which organs beyond the skin were involved to those with demonstrated immunodeficiencies. The Secretary notes that there is a significant overlap in the time-frames involved in the onset of disseminated disease in both immunocompetent and immunocompromised individuals. The Secretary further notes that although the IOM found convincing support for disseminated disease with other organ involvement only in immunocompromised individuals, the Secretary proposes, in accordance with the ACCV Guiding Principles, that the Table injury apply to all individuals, regardless of the status of their immune system, because it is possible that an individual so affected may not have been completely evaluated for an existing immunodeficiency, or suffered from an immunodeficiency that is subtle and beyond our current ability to test.

The Secretary proposes to add disseminated vaccine-strain infection, both with and without other organ involvement, as a Table injury for varicella-containing vaccines. There is no time interval for onset if the vaccine strain of the virus is identified. However, if testing is not done or does not identify the virus, it is proposed that the injury qualify as a Table injury if the onset is 7 to 42 days following vaccination. If the wild-type virus or another non-vaccine-strain virus is identified, there will be no presumption of causation and it will not meet the Table criteria. If there is involvement of an organ beyond the skin, and no virus was identified in that organ, the involvement of all organs must occur as part of the same discrete illness.

Varicella vaccine-strain viral reactivation disease is defined as the presence of the rash of herpes zoster (shingles) with or without concurrent disease in another organ. Shingles is a painful, blistering skin rash due to the reactivation of varicella (chickenpox) virus that involves one or more sensory dermatomes. After natural varicella infection, the virus lies dormant in the spinal dorsal root ganglia. Shingles occurs after the virus becomes active again.

There is a significant body of literature showing that the vaccine-strain of the virus can cause shingles without other organ involvement. However, the wild-type chickenpox virus has been identified in many of the cases occurring after vaccination. The Committee reviewed 111 cases in which individuals who received a varicella-containing vaccine developed reactivated varicella disease without other organ involvement and in whom the vaccine-strain of the virus was identified. The IOM found six cases in which individuals who had received varicella vaccine developed reactivated disease in another organ, and in all the cases, the vaccine-strain of the virus was identified in the other organ. In four of those cases, the vaccine-strain of the virus was also identified in the skin. The findings for other organ involvement in these case reports were limited to the meninges and brain. The IOM concluded that the evidence convincingly supports a causal relationship between varicella vaccine and vaccine-strain viral reactivation, with or without involvement of an organ other than the skin. [Chaves, S. S., P. Haber, K. Walton, R. P. Wise, H. S. Izurieta, D. S. Schmid, and J. F. Seward. 2008. Safety of varicella vaccine after licensure in the United States: Experience from reports to the vaccine adverse event reporting system, 1995-2005. Journal of Infectious Diseases 197(SUPPL. 2):S170-S177.] [Iyer, S., M. K. Mittal, and R. L. Hodinka. 2009. Herpes zoster and meningitis resulting from reactivation of varicella vaccine virus in an immunocompetent child. Annals of Emergency Medicine 53(6):792-795.] [Levin, M. J., R. L. DeBiasi, V. Bostik, and D. S. Schmid. 2008. Herpes zoster with skin lesions and meningitis caused by two different genotypes of the Oka varicella-zoster virus vaccine. Journal of Infectious Diseases 198(10):1444-1447.]

The Secretary proposes to add vaccine-strain viral reactivation, both with and without other organ involvement, as a Table injury for varicella-containing vaccines. Although the IOM specified whether they considered immunocompetent or immunocompromised individuals, their causality conclusions for vaccine-strain reactivation, with and without other organ involvement, did not differentiate between these two groups. Because disease caused by varicella virus reactivation can occur many years, or even decades, after the initial disease or vaccination, the Secretary proposes that the QAI require laboratory confirmation of the presence of the vaccine-strain of the virus. With such confirmation, the status of the affected individual's immune system is not relevant. In addition, there is no proposed time interval for this injury, as laboratory confirmation of vaccine-strain virus obviates the need for such a proposal. Since petitioners must demonstrate the presence of vaccine-strain varicella infection, the presumption includes the involvement of skin and other organs.

Anaphylaxis is a single discrete event that presents as a severe and potentially life threatening multi-organ reaction, particularly affecting the skin, respiratory tract, cardiovascular system, and the gastrointestinal tract. The diagnosis of anaphylaxis requires the simultaneous involvement of two or more organ systems. In an anaphylactic reaction, an immediate reaction generally occurs within minutes after exposure, and in most cases, the individual develops signs and symptoms within 4 hours after exposure to the antigen. The immediate reaction leads to a combination of skin rash, mucus membrane swelling, leakage of fluid from the blood into surrounding tissues, tightening of the air passages in the lungs with tissue swelling, and gastrointestinal symptoms that can lead to shock, organ damage, and death if not promptly treated.

Symptoms may include swelling, itching, rash, trouble breathing, chest tightness, and/or dizziness. Death, if it occurs, usually results from airway obstruction caused by laryngeal edema (throat swelling) or bronchospasm and may be associated with cardiovascular collapse.

Other significant clinical signs and symptoms may include the following: cyanosis (bluish coloration in the skin due to low blood oxygen levels), hypotension (low blood pressure), bradycardia (slow heart rate), tachycardia (fast heart rate), arrhythmia (irregular heart rhythm), edema (swelling) of the pharynx and/or larynx (throat or upper airway) with stridor (noisy breathing on inspiration), dyspnea (shortness of breath), diarrhea, vomiting, and abdominal pain. Autopsy findings may include acute emphysema (a type of lung abnormality), which results from lower respiratory tract obstruction, edema (swelling) of the upper airway, and minimal findings of eosinophilia (an excess of a type of white blood cell associated with allergy) in the liver. When death occurs within minutes of exposure without signs of respiratory distress, lack of significant pathologic findings would not exclude a diagnosis of anaphylaxis.

Anaphylaxis may occur following exposure to allergens from a variety of sources including food, aeroallergens, insect venom, drugs, and immunizations. Most treated cases resolve without sequela. Anaphylaxis can be due to an exaggerated acute systemic hypersensitivity reaction, especially involving immunoglobulin E antibodies, as in allergic anaphylaxis, or it could be a non-immunologically mediated reaction leading to similar clinical symptomatology as in non-immune anaphylaxis. Non-immune anaphylaxis cannot be detected by skin tests or in vitro allergy diagnostic procedures. As stated, anaphylaxis is a single discrete event. It is not an initial episode of a chronic condition such as chronic urticaria (hives).

Anaphylaxis following immunization is a rare occurrence with estimates in the range of 1-10 per 1 million doses distributed, depending on the vaccine studied. [The Brighton Collaboration Anaphylaxis Working Group, “Anaphylaxis: Case Definition and Guidelines for Data Collection, Analysis, and Presentation of Immunization Safety Data, Vaccine, Aug. 2007; 5676.] The IOM has reported that the evidence favors acceptance of a causal relationship between certain vaccines and anaphylaxis based on case reports and case series. The IOM has reported that causality could be inferred with reasonable certainty based on one or more case reports because of the unique nature and timing of anaphylaxis following vaccine administration and provided there is an absence of likely alternative causes. [Institute of Medicine (IOM), Immunization Safety Review Vaccination and Sudden Unexpected Death in Infancy, Washington, DC: The National Academies Press, 2003) 55.] The IOM concluded that the scientific evidence convincingly supports a causal relationship between varicella vaccine and anaphylaxis. There are multiple, well-documented reports in the literature that anaphylaxis occurs after receipt of the varicella vaccine. One case series reported 16 cases of anaphylaxis after vaccination against varicella, with nearly all demonstrating anti-gelatin immunoglobulin E (IgE) antibodies. [Sakaguchi, M., T. Nakayama, H. Fujita, M. Toda, and S. Inouye. 2000b. Minimum estimated incidence in Japan of anaphylaxis to live virus vaccines including gelatin. Vaccine 19(4-5):431-436.]

There is a long history of including anaphylaxis as a known adverse effect of vaccines, including in the initial Table contained in the Act. The time-frame for the first symptom or manifestation of onset contained in the original statutory Table was shortened from 24 hours to 4 hours in the Table changes promulgated in 1995. Since that time, anaphylaxis has been added as an injury for the Hepatitis B vaccine.

The statute requires that injuries eligible for compensation under the Program be of sufficient seriousness to cause continued effects for more than 6 months, result in death, or result in inpatient hospitalization and surgical intervention. The Secretary continues to recognize that in many instances, cases involving anaphylaxis will not meet the statutory severity criteria, as the reaction can be short-lived and treated effectively. However, because there is a known risk of serious residual injury or death from anaphylaxis, the Secretary continues to recommend that anaphylaxis be included on the Table for other vaccines, and be added for varicella virus vaccines.

The Secretary proposes to add anaphylaxis as a Table injury for varicella virus-containing vaccines, with an onset less than or equal to 4 hours from the administration of the vaccine. In addition, the Secretary proposes to update the definition of anaphylaxis in the QAI. (see proposed regulation text at proposed paragraph (c)(1)).

The Secretary proposes to add SIRVA as a Table injury for varicella virus-containing vaccines. [See section I.A above.] The interval of onset will be less than or equal to 48 hours. However, the Secretary recognizes that there currently is no intramuscular formulation of this vaccine available, and therefore petitioners alleging an injury of SIRVA associated with this vaccine presently cannot meet the QAI for SIRVA. Please see section I.A., above, for additional discussion on this point.

The Secretary proposes to add vasovagal syncope to the Table for varicella virus-containing vaccines. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

Pneumococcal conjugate vaccines were first licensed by FDA in 2000. Over the next decade, the heptavalent (seven serotypes) vaccine dramatically reduced the rate of invasive pneumococcal disease in young infants and nasal carriage of the vaccine serotypes among all age groups, including the immunocompromised and older individuals. A 13-valent pneumococcal conjugate vaccine licensed in 2010 has replaced the 7-valent product in the infant schedule. Pneumococcal conjugate vaccines are included on the Table, with an effective date of coverage of December 19, 1999, with no injuries or conditions specified.

The Secretary proposes to add SIRVA as a Table injury for pneumococcal conjugate vaccines. [See section I.A above.] The interval of onset will be less than or equal to 48 hours.

The Secretary proposes to add vasovagal syncope to the Table for pneumococcal conjugate vaccines. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

Hepatitis A vaccine was first licensed by FDA in 1996 and introduced incrementally, first for children living in communities with the highest rates of disease and then in 1999 for children living in States/communities with consistently elevated rates of infection. The impact of immunization with hepatitis A vaccine has been a dramatic decline in the rates of disease and a sharp reduction in the groups with the highest risk of infection: Native Americans and Alaskan natives. Rates of hepatitis A infection are now similar in most areas of the United States. As a consequence, hepatitis A vaccine has now been recommended for all children in the United States who are 12-23 months of age. Hepatitis A vaccine is included on the Table, with an effective date of December 1, 2004.

The Secretary proposes to add SIRVA as a Table injury for hepatitis A vaccines. [See section I.A above.] The interval of onset will be less than or equal to 48 hours.

The Secretary proposes to add vasovagal syncope to the Table for hepatitis A vaccines. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

All seasonal trivalent influenza vaccines have been covered under the VICP since July 1, 2005. At that time, all seasonal influenza vaccines were trivalent. Quadrivalent vaccines for seasonal influenza became available for general use for the 2013-14 influenza season. On June 25, 2013, Public Law 113-15 was enacted, extending the applicable excise tax on trivalent influenza vaccines to also include any other vaccines against seasonal influenza. See Public Law 113-15 (amending 26 U.S.C. 4132(a)(1)(N)). The amendment included in Public Law 113-15 ensured that seasonal influenza vaccines are covered under the Program. Seasonal influenza vaccines (other than trivalent influenza vaccines) were added to the Table under the final catch-all category (42 CFR 100.3(c)(8)) with an effective date of November 12, 2013. The Secretary proposes to modify category XIV on the Table from “Trivalent influenza vaccines” to “Seasonal influenza vaccines.”

There are currently six types of seasonal influenza vaccines distributed during flu season. The standard dose trivalent inactivated influenza vaccine (IIV3) contains three killed virus strains and is injected. IIV3 is indicated in individuals 6 months of age or older, including healthy people and those with chronic medical conditions (such as asthma, diabetes, or heart disease). High dose trivalent inactivated influenza vaccine (IIV3 High dose) is indicated in individuals who are 65 years of age or older. Trivalent recombinant influenza vaccine (RIV3) is indicated for individuals between the ages of 18 and 49 years. The standard dose quadrivalent inactivated influenza vaccine (IIV4) has the same indications as IIV3. The quadrivalent live attenuated influenza vaccine (LAIV4) is indicated for healthy, non-pregnant persons aged 2-49 years. The cell-culture based inactivated influenza vaccine (ccIIV3) is indicated for individuals who are 18 years of age and older.

The covered injuries proposed for seasonal influenza vaccines are the same as those proposed for trivalent influenza vaccines. The trivalent influenza vaccine and the quadrivalent influenza vaccine, distributed each year during flu season, are types of seasonal influenza vaccines.

The Secretary proposes to add anaphylaxis as a Table injury for seasonal influenza vaccines. [See section VII.C above.] The IOM concluded that the scientific evidence convincingly supports a causal relationship between trivalent influenza vaccines and anaphylaxis. Sensitivity to eggs has long been known to cause allergic reactions to influenza vaccination in some individuals. The IOM assessed the mechanistic evidence as strong, including the following: 21 case reports of potential anaphylaxis following influenza vaccine; a strong temporal relationship between vaccine administration and anaphylactic reaction; isolation of anti-gelatin IgE in two cases; positive skin testing as a positive re-challenge in two cases; and repeated symptoms to vaccination against influenza on two occasions. Their conclusion made no distinction between the intranasal live attenuated vaccine and the injected vaccine. [Coop, C.A., S.K. Balanon, K.M. White, B. A. Whisman, and M.M. Rathkopf. 2008. Anaphylaxis from the influenza virus vaccine. International Archives of Allergy and Immunology 146(1):85-88.] [Chung, E.Y., L. Huang, and L. Schneider. 2010. Safety of influenza vaccine administration in egg-allergic patients. Pediatrics 125(5):e1024-e1030.] [Lasley, M.V. 2007. Anaphylaxis after booster influenza vaccine due to gelatin allergy. Pediatric Asthma, Allergy and Immunology 20(3):201-205.]

The Secretary proposes to add anaphylaxis as a Table injury for seasonal influenza vaccines, with an onset of less than or equal to 4 hours from the administration of the vaccine. In addition, the Secretary proposes to update the definition of anaphylaxis in the QAI.

The Secretary proposes to add SIRVA only for seasonal influenza vaccines that are injected intramuscularly (as detailed in the proposed QAI). As proposed, this injury would not apply to formulations of the live attenuated influenza vaccine (LAIV), as LAIV is not administered intramuscularly with a needle. [See section I.A above.] In addition, this injury would not apply to the formulations of influenza vaccine where the route of administration is intradermal, such as the formulation that delivers 0.1 milliliters of vaccine through a prefilled microinjection system that contains a needle that is only 1.5 millimeters long. This needle is not long enough to enter the deltoid bursa or any other structure in the shoulder related to the development of SIRVA. SIRVA would apply only to formulations of the seasonal influenza vaccine that are administered through intramuscular injection. The interval of onset will be less than or equal to 48 hours.

The Secretary proposes to add vasovagal syncope to the Table for injected vaccines only (as detailed in the proposed QAI). As proposed, this injury would apply to the seasonal inactivated influenza vaccine that is injected intramuscularly but not to the LAIV, as LAIV is not administered with a needle, and the syncopal reaction appears to be related to the act of injection. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

GBS is an acute paralysis caused by dysfunction in the peripheral nervous system (i.e., the nervous system outside the brain and spinal cord). GBS may manifest with weakness, abnormal sensations, and/or abnormality in the autonomic (involuntary) nervous system. In the United States, each year approximately 3,000 to 4,000 cases of GBS are reported, and the incidence of GBS increases in older individuals. Senior citizens tend to have a poorer prognosis. Most people fully recover from GBS, but some people can either develop permanent disability or die due to respiratory difficulties. It is not fully understood why some people develop GBS, but it is believed that stimulation of the body's immune system, as occurs with infections, can lead to the formation of autoimmune antibodies and cell-mediated immunity that play a role in its development.

GBS may present as one of several clinicopathological subtypes. The most common type in North America and Europe, comprising more than 90 percent of cases, is acute inflammatory demyelinating polyneuropathy (AIDP), which has the pathologic and electrodiagnostic features of focal demyelination of motor and sensory peripheral nerves and roots. Demyelination refers to a loss or disruption of the myelin sheath, which wraps around the axons of some nerve cells and which is necessary for the normal conduction of nerve impulses in those nerves that contain myelin. Polyneuropathy refers to the involvement of multiple peripheral nerves. Motor nerves affect muscles or glands. Sensory nerves transmit sensations. The axon is a portion of the nerve cell that transmits nerve impulses away from the nerve cell body. Another subtype of GBS, called acute motor axonal neuropathy (AMAN), is generally seen in other parts of the world and is predominated by axonal damage that primarily affects motor nerves. AMAN lacks features of demyelination. Another less common subtype of GBS includes acute motor and sensory neuropathy (AMSAN), which is an axonal form of GBS that is similar to AMAN, but also affects the axons of sensory nerves and roots.

The diagnosis of the AIDP, AMAN, and AMSAN subtypes of GBS requires bilateral flaccid (relaxed with decreased muscle tone) limb weakness and decreased or absent deep tendon reflexes in weak limbs, and a monophasic illness pattern with the interval between onset and nadir of weakness between 12 hours and 28 days with a subsequent clinical plateau. The clinical plateau leads to either stabilization at the nadir of symptoms, or subsequent improvement without significant relapse. Death may occur without clinical plateau. Treatment-related fluctuations in all subtypes of GBS can occur within 9 weeks of GBS symptom onset and recurrence of symptoms after this time-frame would not be consistent with GBS. In addition, there must not be a more likely alternative diagnosis for the weakness.

Other factors in all subtypes of GBS that add to diagnostic certainty, but are not required for diagnosis, include electrophysiologic findings consistent with GBS or cytoalbuminologic dissociation (i.e., elevation of cerebral spinal fluid (CSF) protein and a total white cell count in the CSF less than 50 cells per microliter).

The weakness in the AIDP, AMAN, and AMSAN subtypes of GBS is usually, but not always, symmetric and usually has an ascending pattern of progression from legs to arms. However, other patterns of progression may occur. The cranial nerves can be involved. Respiratory failure can occur due to respiratory involvement. Fluctuations in the degree of weakness prior to reaching the point of greatest weakness or during the plateau or improvement phase may occur, especially in response to treatment. These fluctuations occur in the first 9 weeks after onset and are generally followed by eventual improvement.

According to the Brighton Collaboration, Fisher Syndrome (FS), also known as Miller Fisher Syndrome, is a subtype of GBS characterized by ataxia, areflexia, and ophthalmoplegia, and overlap between FS and GBS may be seen with limb weakness. [James J. Sejvar et. al. Guillain-Barre Syndrome and Fisher Syndrome: Case definitions and guidelines for collection, analysis, and presentation of immunization safety data Vaccine 29(3):599-612]. The diagnosis of FS requires bilateral ophthalmoparesis; bilateral reduced or absent tendon reflexes; ataxia; the absence of limb weakness (the presence of limb weakness suggests a diagnosis of AIDP, AMAN, or AMSAN); a monophasic illness pattern; an interval between onset and nadir of weakness between 12 hours and 28 days; subsequent clinical plateau (the clinical plateau leads to either stabilization at the nadir of symptoms or subsequent improvement without significant relapse); no alteration in consciousness; no corticospinal track signs; and the absence of an identified, more likely, alternative diagnosis. Death may occur without a clinical plateau.

Exclusionary criteria for the diagnosis of GBS include the ultimate diagnosis of any of the following conditions: Chronic inflammatory demyelinating polyneuropathy (CIDP), carcinomatous meningitis, brain stem encephalitis (other than Bickerstaff brainstem encephalitis), myelitis, spinal cord infarct, spinal cord compression, anterior horn cell diseases such as polio or West Nile virus infection, subacute inflammatory demyelinating polyradiculoneuropathy, multiple sclerosis, cauda equina compression, metabolic conditions such as hypermagnesemia or hypophosphatemia, tick paralysis, heavy metal toxicity (such as arsenic, gold, or thallium), drug-induced neuropathy (such as vincristine, platinum compounds, or nitrofurantoin), porphyria, critical illness neuropathy, vasculitis, diphtheria, myasthenia gravis, organophosphate poisoning, botulism, critical illness myopathy, polymyositis, dermatomyositis, hypokalemia, or hyperkalemia. The above list is not exhaustive. [Sejvar 599-612].

For all subtypes of GBS (AIDP, AMAN, AMSAN, and FS), the onset of symptoms less than 3 days (72 hours) after exposure excludes that exposure as a cause because the immunologic steps necessary to create symptomatic disease require a minimum of 3 days.

CIDP is clinically and pathologically distinct from GBS. The onset phase of CIDP is generally greater than 8 weeks and the weakness may remit and relapse. CIDP is also not monophasic. [Sejvar 599-612.]

In the past, GBS has been causally associated with certain vaccines. For example, the 1976 influenza A (swine flu) vaccine was found by the IOM to be causally associated with GBS. The risk of developing GBS in the 6 week period after receiving the 1976 swine flu vaccine was 9.2 times higher than the risk for those who were not vaccinated. [Lawrence B. Schonberger, et al., “Guillain-Barre Syndrome Following Vaccination in the National Influenza Immunization Program, United States, 1976-1977,” American Journal of Epidemiology, 25 Apr. 1979; 118 and IOM, “Immunization Safety Review: Influenza Vaccines and Neurological Complications,” (Washington, DC: The National Academies Press, 2004) 25]. Since the 1976 influenza season, numerous studies have been conducted to evaluate whether other influenza vaccines were associated with GBS. In most published studies, no association was found, but one large study published in the New England Journal of Medicine evaluated the 1992-93 and 1993-94 influenza seasons and suggested approximately one additional case of GBS out of 1 million persons vaccinated, in the 6 weeks following vaccination, may be attributable to the vaccine formulation used in those years. The background incidence of GBS not associated with a vaccine among adults was documented in the study to be 0.87 cases per million persons for any 6 week period. [Tamar Lasky, et al., “The Guillain-Barré Syndrome and the 1992-1993 and 1993-1994 Influenza Vaccines,” The New England Journal of Medicine, Dec. 17, 1998; 1797.]

The IOM published a thorough scientific review of the peer-reviewed literature in 2004 and concluded that people who received the 1976 swine influenza vaccine had an increased risk for developing GBS [IOM, Immunization Safety Review: Influenza Vaccines and Neurological Complications, 25]. Based on its review of the published literature, the IOM also decided that the evidence linking GBS and influenza vaccines in influenza seasons other than 1976 was not clear. This led to the IOM's conclusion that the evidence was inadequate to accept or reject a causal relationship between influenza immunization and GBS for years other than 1976.

In 2012, the IOM published another report that evaluated the association of seasonal influenza vaccine and GBS. Pandemic vaccines, such as the influenza vaccine used in 1976 and the monovalent 2009 H1N1 influenza vaccine, were specifically excluded and not evaluated. The IOM concluded that the evidence is inadequate to accept or reject a causal relationship between seasonal influenza vaccine and GBS. (IOM, Adverse Effects of Vaccines 334). It is important to note that monovalent vaccines are usually only given in response to an actual or potential pandemic, while seasonal influenza vaccines are offered annually. The monovalent 2009 H1N1 vaccine, a type of pandemic vaccine, is covered under the Countermeasures Injury Compensation Program. The VICP does not cover pandemic influenza vaccines, such as the 2009 H1N1 Influenza vaccine.

A meta-analysis of the VSD, EIP (Emerging Infections Program—an active population-based surveillance program), and PRISM (Post-Licensure- Rapid Immunization Safety Monitoring—a cohort-based active surveillance network) data was performed and published, together with additional data from safety surveillance studies performed by Medicare, the Department of Defense, and the Department of Veterans Affairs, which, in total, analyzed data from 23 million people who were vaccinated with the influenza A (H1N1) 2009 monovalent vaccine. [Daniel A. Salmon et al., “Association between Guillain-Barré syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis,” Lancet, electronically published March 13, 2013, http://dx.doi.org/10.1016/S0140-6736(12)62189-8.] The meta-analysis provides the benefit of additional statistical power. Additional power allows for the analyses of certain hypotheses which were not possible to analyze individually in the six studies that made up the meta-analysis. The meta-analysis found that the 2009 H1N1 inactivated vaccine was associated with a small increased risk of GBS within 6 weeks of vaccination. This excess risk is equivalent to 1.6 excess cases in the 6 weeks after vaccination per million people vaccinated. This increased risk found in the meta-analysis was consistent: (1) Across studies looking at different groups of people; (2) using different definitions of illness; (3) in people who received or did not receive a concurrent seasonal influenza vaccine or had influenza-like symptoms; (4) across various time windows; and (5) in different age categories. This suggests that these five factors did not affect the risk of developing GBS.

Considering the totality of the evidence with the enhanced surveillance studies and meta-analysis performed to monitor the safety of the monovalent 2009 H1N1 vaccine, scientific evidence demonstrates a small increased risk of GBS in the 6 weeks following administration of the monovalent 2009 H1N1 vaccines.

Presently, there is no scientific evidence demonstrating that current formulations of the seasonal influenza vaccine, which contain the H1N1 virus, can cause GBS. However, the degree of surveillance needed to detect an increased risk of one case per million vaccinations, as was seen with the monovalent 2009 H1N1 vaccine, is unlikely to be routinely performed as the strains in the flu vaccines change from year to year. Nonetheless, numerous studies have been conducted in order to determine whether a possible association between seasonal influenza vaccines and GBS exists, and almost all have not shown any causal relationship. The IOM reviewed literature concerning such studies and concluded that the evidence was inadequate to accept or reject a causal association for all versions of seasonal influenza vaccines since 1976.

Using studies demonstrating a causal association between the 2009 H1N1 and 1976 swine flu vaccines and GBS as background, the Secretary proposes to add the injury of GBS to the Table for seasonal influenza vaccines. Although the scientific evidence does not show a causal association for current formulations of seasonal flu vaccines and GBS, the Secretary proposes including the injury of GBS for seasonal influenza vaccines on the Table in accordance with the ACCV Guiding Principles, acknowledging the fact that seasonal influenza vaccine formulations, unlike other vaccines, change from year-to-year and that enhanced surveillance activities may not occur with each virus strain change. This is done even though it appears that any instances of GBS caused by seasonal influenza vaccines, if they exist at all, are very rare. The Secretary proposes adding GBS to the Table for seasonal influenza vaccines and recognizes that this will create a presumption of causation that will result in compensation for numerous instances of GBS that are not vaccine-related.

While there is no evidence demonstrating that current formulations of the seasonal influenza vaccine can cause GBS, the totality of the evidence, particularly the enhanced surveillance studies and meta-analysis performed to monitor the safety of the 2009 H1N1 vaccine, provides compelling evidence of a small increased risk of GBS in the 6 weeks following the administration of the 2009 H1N1 vaccine. Utilizing this scientific data as background, the Secretary proposes an onset interval of 3-42 days for GBS presumed to be caused by the seasonal influenza vaccine to be covered under the proposed Table. Day 3 begins 72 hours after administration of the vaccination and takes into account the time interval needed to show first signs or symptoms after exposure. [Peripheral Neuropathy (Philadelphia, PA: Elsevier Saunders, 2005, 626].

There are two types of meningococcal vaccines administered in the United States. The polysaccharide vaccine was licensed by the FDA in 1978, and is indicated for persons 2 years of age and older; the meningococcal conjugate vaccines were licensed starting in 2005. The conjugate vaccines were developed with the expectation that they would provide more long-lasting immunity, a more rapid immune response upon exposure to Neisseria meningitidis, and the development of “herd immunity” through reduction of the asymptomatic carrier state. The meningococcal polysaccharide and conjugate vaccines were added to the Table with an effective date of February 1, 2007.

The Secretary proposes to add anaphylaxis as a Table injury for meningococcal vaccines. [See section VII.C above.] The IOM Committee, following an extensive review of the scientific and medical literature, concluded that the evidence convincingly supported a causal relationship between meningococcal vaccines and anaphylaxis. The Institute of Medicine based their conclusion on a case report of anaphylaxis with onset 30 minutes following vaccination. [Yergeau, A., L. Alain, R. Pless, and Y. Robert. 1996. Adverse events temporally associated with meningococcal vaccines. Canadian Medical Association Journal 154(4):503-507.]

The Secretary proposes to add anaphylaxis as a Table injury for meningococcal vaccines, with an onset less than or equal to 4 hours from the administration of the vaccine. In addition, the Secretary proposes to update the definition of anaphylaxis in the QAI.

The Secretary proposes to add SIRVA as a Table injury for meningococcal vaccines. [See section I.A above.] The interval of onset will be less than or equal to 48 hours.

The Secretary proposes to add vasovagal syncope to the Table for meningococcal vaccines. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

The first human papillomavirus (HPV) vaccine was licensed by the FDA in June 2006 for females between the ages of 9-26 years. In 2011, one of the two licensed HPV vaccines was given a permissive use recommendation in males by the CDC and other recommending bodies (i.e., the American Academy of Pediatrics and the American Academy of Family Physicians). HPV vaccine was added to the Table with an effective date of February 1, 2007.

The Secretary proposes to add anaphylaxis as a Table injury for HPV vaccines. [See VII.C] The IOM Committee concluded that the evidence favors acceptance of a causal relationship between human papillomavirus vaccines and anaphylaxis. They based their conclusion on temporality and clinical symptoms consistent with anaphylaxis in 9 reports from VAERS over 31 months of surveillance. [Slade, B.A., L. Leidel, C. Vellozzi E.J. et al. Post licensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine. Journal of the American Medical Association 2009. 302(7):750-757.]

The Secretary notes that there are limitations to the VAERS passive reporting system. First, there is underreporting; not all adverse events following vaccines are reported to the system. The rates of underreporting have been examined for different disorders and are greatest for adverse events of mild severity. Second, many reports are filed before a complete clinical evaluation has been conducted. Therefore, the presumptive diagnosis that has been provided at the time of the report may not be the correct diagnosis. Third, investigations conducted after the initial report sometimes reveal alternative causes for the adverse event. In many instances, incomplete information is provided in the initial report. Follow-up of the reports by the CDC and FDA may be conducted to collect additional information from the healthcare providers. The primary purpose of VAERS is to look for signals for evidence of unexpected adverse events that would require other investigations to try to determine causal relationships. Although conclusions about causation are not possible for most adverse events reported to VAERS, the IOM found likely causality based on the distinctive nature of anaphylactic reactions and the temporal relationship between the HPV vaccine administration and the event. The Secretary proposes to add anaphylaxis as a Table injury for HPV vaccines, with an onset of less than or equal to 4 hours from the administration of the vaccine. In addition, the Secretary proposes to update the definition of anaphylaxis in the QAI.

The Secretary proposes to add SIRVA as a Table injury for HPV vaccines. [See section I.A above.] The proposed time interval of onset is less than or equal to 48 hours.

The Secretary proposes to add vasovagal syncope to the Table for HPV vaccines. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

Category XVII of the current Table pertains to any new vaccine recommended by the CDC for routine administration to children, after publication by the Secretary of a notice of coverage. This category pertains to vaccines that are covered under the Program, but with respect to which the Secretary has not yet finalized actions adding the vaccines as separate categories to the Table. Through this rule, the Secretary proposes retaining this category and adding two associated injuries for vaccines covered by this category.

The Secretary proposes to add SIRVA for the category of vaccines captured under Category XVII of the Table. [See section I.A above.] As detailed in the proposed QAI, this injury would only apply to intramuscular vaccines injected into the upper arm. The interval of onset will less than or equal to 48 hours.

The Secretary proposes to add vasovagal syncope to the Table for this category of vaccines. As detailed in the proposed QAI, this injury would apply only to injected vaccines as the syncopal reaction appears to be related to the act of injection. [See section I.B above.] The proposed time interval of onset is less than or equal to 1 hour following vaccination.

The Secretary is proposing a number of organizational and structural changes to the Table and QAI designed to increase clarity and scientific accuracy, including the addition of a glossary of terms used within the Table and the QAI.

• To streamline the Table, the Secretary proposes a new paragraph (b), Provision that applies to all vaccines listed. This section includes any acute complication or sequela, including death, of the illness, disability, injury, or condition listed, rather than adding this provision to every line of the Table.

• To further streamline the Table, the Secretary proposes the deletion of redundant wording in the various definitions, particularly with regard to any references to the presumption of causation, and the importance of the entire medical record. These elements have been included in paragraph (b). In addition, complicated language previously included in the definition of encephalopathy, which indicated that idiopathic injuries do not rebut the Table presumption, has been simplified and made generally applicable to all injuries. This has also been included in paragraph (b).

• The QAI (proposed paragraph (c)) contain definitions for those terms that are used in the Table (paragraphs (a) and (b)).

• The newly added glossary (proposed paragraphs (d)) defines terms used in multiple places in the QAI (proposed paragraph (c)). Most of these terms were formerly contained in the QAI, and have been moved to the glossary so that each reference is consistent. These definitions include: chronic encephalopathy, significantly decreased level of consciousness, injected, and seizure.

• The proposed Table and QAI include some changes made by the Final Rule adding Intussusception as an Injury for Rotavirus Vaccines to the Vaccine Injury Table (80 FR 35848, June 23, 2015).

• The Secretary proposes to add definitions for new Table injuries, including SIRVA, disseminated varicella-strain virus disease, varicella vaccine-strain viral reactivation disease, GBS, and vasovagal syncope.

• The Secretary proposes to add definitions of terms that had been on the Table or in the QAI, but that previously were undefined, including encephalitis, injected, and immunodeficient recipient.

• The Secretary proposes additional changes to the QAI to address certain changes in scientific nomenclature. Definitions, such as acute encephalopathy and acute encephalitis, both of which lead to chronic encephalopathy, have been harmonized. Definitions for brachial neuritis and SIRVA have also been harmonized.

• The Secretary proposes modification of category XIV on the Table from “Trivalent influenza vaccines” to “Seasonal influenza vaccines”.

• The Secretary proposes modification of category IX on the Table from “Haemophilus influenzae type b polysaccharide conjugate vaccines” to “Haemophilus influenzae type b vaccines”.

• Minor technical changes resulting from updated medical information have been included in the definitions of anaphylaxis, encephalopathy, chronic arthritis, brachial neuritis, thrombocytopenic purpura, and seizure.

All of the proposed changes were discussed and approved by the ACCV, although the ACCV expressed some reservations regarding the definition of “immunodeficient recipient”. The discussion was reviewed, and the Secretary has modified the definition to address the concerns raised by the ACCV.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety, distributive, and equity effects). In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities the Secretary must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule.

Executive Order 12866 requires that all regulations reflect consideration of alternatives, of costs, of benefits, of incentives, of equity, and of available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations that are “significant” because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues require special analysis.

The Secretary has determined that no resources are required to implement the requirements in this rule. Compensation will be made in the same manner. This proposed rule only lessens the burden of proof for potential petitioners. Therefore, in accordance with the Regulatory Flexibility Act of 1980 (RFA), and the Small Business Regulatory Enforcement Act of 1996, which amended the RFA, the Secretary certifies that this rule will not have a significant impact on a substantial number of small entities.

The Secretary has also determined that this proposed rule does not meet the criteria for a major rule as defined by Executive Order 12866 and would have no major effect on the economy or Federal expenditures. We have determined that the proposed rule is not a “major rule” within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on State, local, and tribal governments and on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995.

Nor on the basis of family well-being will the provisions of this rule affect the following family elements: family safety; family stability; marital commitment; parental rights in the education, nurture and supervision of their children; family functioning; disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999.

This rule is not being treated as a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget.

As stated above, this proposed rule would modify the Vaccine Injury Table based on legal authority.

This proposed rule will have the effect of making it easier for future petitioners alleging injuries that meet the criteria in the Vaccine Injury Table to receive the Table's presumption of causation (which relieves them of having to prove that the vaccine actually caused or significantly aggravated the injury).

This proposed rule has no information collection requirements.

Accordingly, 42 CFR part 100 is proposed to be amended as set forth below:

In the United States, the African elephant is primarily protected and managed under the Endangered Species Act (ESA) (16 U.S.C. 1531 et seq.); the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES or Convention) (27 U.S.T. 1087), as implemented in the United States through the ESA; and the African Elephant Conservation Act (AfECA) (16 U.S.C. 4201 et seq.).

Under the ESA, species may be listed either as “threatened” or as “endangered.” When a species is listed as endangered under the ESA, certain actions are prohibited under section 9 (16 U.S.C. 1538), as specified at 50 CFR 17.21. These include prohibitions on take within the United States, within the territorial seas of the United States, or upon the high seas; import; export; sale and offer for sale in interstate or foreign commerce; and delivery, receipt, carrying, transport, or shipment in interstate or foreign commerce in the course of a commercial activity.

The ESA does not specify particular prohibitions and exceptions to those prohibitions for threatened species. Instead, under section 4(d) of the ESA, the Secretary of the Interior is given the discretion to issue such regulations as deemed necessary and advisable to provide for the conservation of the species. The Secretary also has the discretion to prohibit by regulation with respect to any threatened species any act prohibited under section 9(a)(1) of the ESA for endangered species. Exercising this discretion under section 4(d), the Service has developed general prohibitions (50 CFR 17.31) and established a permit process for specified exceptions to those prohibitions (50 CFR 17.32) that apply to most threatened species. Permits issued under 50 CFR 17.32 must be for “Scientific purposes, or the enhancement of propagation or survival, or economic hardship, or zoological exhibition, or educational purposes, or incidental taking, or special purposes consistent with the purposes of the [ESA].”

Under section 4(d) of the ESA, the Service may also develop specific prohibitions and exceptions tailored to the particular conservation needs of a threatened species. In such cases, the Service issues a 4(d) rule that may include some of the prohibitions and authorizations set out at 50 CFR 17.31 and 17.32, but that also may be more or less restrictive than the general provisions at 50 CFR 17.31 and 17.32.

CITES entered into force in 1975, and is currently implemented by 180 countries (called Parties), including the United States. The aim of CITES is to regulate international trade in listed animal and plant species, including their parts and products, to ensure the trade is legal and does not threaten the survival of species. CITES regulates both commercial and noncommercial international trade through a system of permits and certificates that must be presented when leaving and entering a country with CITES specimens. Species are listed in one of three appendices, which provide different levels of protection. In some circumstances, different populations of a species are listed at different levels. Appendix I includes species that are threatened with extinction and are or may be affected by trade. The Convention states that Appendix-I species must be subject to “particularly strict regulation” and trade in specimens of these species should only be authorized “in exceptional circumstances.” Appendix II includes species that are not necessarily threatened with extinction now, but may become so if international trade is not regulated. Appendix III includes species that a range country has identified as being subject to regulation within its jurisdiction and as needing cooperation of other Parties in the control of international trade.

Import and export of CITES species is prohibited unless accompanied by any required CITES documents. Documentation requirements vary depending on the appendix in which the species or population is listed and other factors. CITES documents cannot be issued until specific biological and legal findings have been made. CITES does not regulate take or domestic trade of listed species. It contributes to the conservation of listed species by regulating international trade and, in order to make the necessary findings, encouraging assessment and analysis of the population status of species in trade and the effects of international trade on wild populations to ensure that trade is legal and does not threaten the survival of the species.

The AfECA was enacted in 1988, to “perpetuate healthy populations of African elephants” by regulating the import and export of certain African elephant ivory to and from the United States. Building from and supporting existing programs under CITES, the AfECA called on the Service to establish moratoria on the import of raw and worked ivory from both African elephant range countries and intermediary countries (those that export ivory that does not originate in that country) that failed to meet certain statutory criteria. The statute also states that it does not provide authority for the Service to establish a moratorium that prohibits the import of sport-hunted trophies that meet certain standards.

In addition to authorizing establishment of the moratoria and prohibiting any import in violation of the terms of any moratorium, the AfECA prohibits: The import of raw African elephant ivory from any country that is not a range country; the import of raw or worked ivory exported from a range country in violation of that country's laws or applicable CITES programs; the import of worked ivory, other than certain personal effects, unless the exporting country has determined that the ivory was legally acquired; and the export of all raw (but not worked) African elephant ivory. While the AfECA comprehensively addresses the import of ivory into the United States, it does not address other uses of ivory or African elephant specimens other than ivory and sport-hunted trophies. The AfECA does not regulate the use of ivory within the United States and, other than the prohibition on the export of raw ivory, does not regulate export of ivory from the United States. The AfECA also does not regulate the import or export of live African elephants.

Ghana first listed the African elephant in CITES Appendix III on February 26, 1976. Later that year, the CITES Parties agreed to add African elephants to Appendix II, effective February 4, 1977. In October 1989, all populations of African elephants were transferred from CITES Appendix II to Appendix I (effective in January 1990), which ended much of the previous legal commercial trade in African elephant ivory.

In 1997, based on proposals submitted by Botswana, Namibia, and Zimbabwe and the report of a Panel of Experts (which concluded, among other things, that populations in these countries were stable or increasing and that poaching pressure was low) the CITES Parties agreed to transfer the African elephant populations in these three countries to CITES Appendix II. The Appendix-II listing included an annotation that allowed noncommercial export of hunting trophies, export of live animals to appropriate and acceptable destinations, export of hides from Zimbabwe, and noncommercial export of leather goods and some ivory carvings from Zimbabwe. It also allowed for a one-time export of raw ivory to Japan (which took place in 1999), once certain conditions had been met. All other African elephant specimens from these three countries were deemed to be specimens of a species listed in Appendix I and regulated accordingly.

The population of South Africa was transferred from CITES Appendix I to Appendix II in 2000, with an annotation that allowed trade in hunting trophies for noncommercial purposes, trade in live animals for reintroduction purposes, and trade in hides and leather goods. (At that time, the Panel of Experts reviewing South Africa's proposal concluded, among other things, that South Africa's elephant population was increasing, that there were no apparent threats to the status of the population, and that the country's anti-poaching measures were “extremely effective.”) Since then, the CITES Parties have revised the Appendix-II listing annotation three times. The current annotation, in place since 2007, covers the Appendix-II populations of Botswana, Namibia, South Africa, and Zimbabwe and allows export of: Sport-hunted trophies for noncommercial purposes; live animals to appropriate and acceptable destinations; hides; hair; certain ivory carvings from Namibia and Zimbabwe for noncommercial purposes; and a one-time export of specific quantities of raw ivory, once certain conditions had been met (this export, to China and Japan, took place in 2009). As in previous versions of the annotation, all other African elephant specimens from these four populations are deemed to be specimens of species included in Appendix I and the trade in them is regulated accordingly.

The African elephant was listed as threatened under the ESA, effective June 11, 1978 (43 FR 20499, May 12, 1978). A review of the status of the species at that time showed that the African elephant was declining in many parts of its range and that habitat loss, illegal killing of elephants for their ivory, and inadequacy of existing regulatory mechanisms were factors contributing to the decline. At the same time the African elephant was designated as a threatened species, the Service promulgated a 4(d) rule to regulate import and certain interstate commerce of the species in the United States (43 FR 20499, May 12, 1978).

The 1978 4(d) rule for the African elephant stated that the prohibitions at 50 CFR 17.31 applied to any African elephant, alive or dead, and to any part, product, or offspring thereof, with certain exceptions. Specifically, under the 1978 rule, the prohibition at 50 CFR 17.31 against importation did not apply to African elephant specimens that had originated in the wild in a country that was a Party to CITES if they had been exported or re-exported in accordance with Article IV of the Convention, and had remained in customs control in any country not party to the Convention that they transited en route to the United States. (At that time, the only African elephant range States that were Parties to CITES were Botswana, Ghana, Niger, Nigeria, Senegal, South Africa, and Zaire [now the Democratic Republic of the Congo].) The 1978 rule allowed for a special purpose permit to be issued in accordance with the provisions of 50 CFR 17.32 to authorize any activity otherwise prohibited with regard to the African elephant, upon submission of proof that the specimens were already in the United States on June 11, 1978, or that the specimens were imported under the exception described above.

The 4(d) rule has been amended twice in response to changes in the status of African elephants and the illegal trade in elephant ivory, and to more closely align U.S. requirements with actions taken by the CITES Parties. On July 20, 1982, the Service amended the 4(d) rule for the African elephant (47 FR 31384) to ease restrictions on domestic activities and to more closely align its requirements with provisions in CITES Resolution Conf. 3.12, Trade in African elephant ivory, adopted by the CITES Parties at the third meeting of the Conference of the Parties (CoP3, 1981). The 1982 rule applied only to import and export of ivory (and not other elephant specimens) and eliminated the prohibitions under the ESA against taking, possession of unlawfully taken specimens, and certain activities for the purpose of engaging in interstate and foreign commerce, including the sale and offer for sale in interstate commerce of African elephant specimens. At that time, the Service concluded that the restrictions on interstate commerce contained in the 1978 rule were unnecessary and that the most effective means of utilizing limited resources to control ivory trade was through enforcement efforts focused on imports.

Following enactment of the AfECA (in October 1988), the Service established, on December 27, 1988, a moratorium on the import into the United States of African elephant ivory from countries that were not parties to CITES (53 FR 52242). On February 24, 1989, the Service established a second moratorium on all ivory imports into the United States from Somalia (54 FR 8008). On June 9, 1989, the Service put in place the current moratorium, which bans the import of ivory other than sport-hunted trophies from both range and intermediary countries (54 FR 24758).

The 4(d) rule was revised on August 10, 1992 (57 FR 35473), following establishment of the 1989 moratorium under the AfECA on the import of African elephant ivory into the United States, and again on June 26, 2014 (79 FR 30400, May 27, 2014), associated with the update of U.S. CITES implementing regulations. In the 2014 revision of the 4(d) rule, we removed the CITES marking requirements for African elephant sport-hunted trophies. At the same time, these marking requirements were updated and incorporated into our CITES regulations at 50 CFR 23.74. The purpose of this change was to make clear what is required under CITES (at 50 CFR part 23) for trade in sport-hunted trophies and what is required under the ESA (at 50 CFR part 17).

We have reevaluated the provisions of the 4(d) rule and considered other administrative actions in response to unprecedented increases in the illegal killing of elephants, an alarming growth in illegal trade of elephant ivory, recommendations adopted by the CITES Parties in March 2013 to help curb the illegal killing and illegal trade, issuance of Executive Order 13648 on Combating Wildlife Trafficking in July 2013, and the stated priorities in the National Strategy for Combating Wildlife Trafficking, issued by President Obama in February 2014.

The increase in poaching of elephants and the escalation of the illegal trade in ivory are described in documents made available at CoP16. See, in particular, CoP16 Doc. 53.1, Monitoring the illegal killing of elephants (including the Addendum); CoP16 Doc. 53.2.2, Monitoring of illegal trade in ivory and other elephant specimens; and Elephants in the Dust—the African Elephant Crisis, all available at http://www.cites.org. Status of African elephant populations and levels of illegal killing and the illegal trade in ivory: A report to the African Elephant Summit, December 2013 (also available at http://www.cites.org) provides an update to information presented at CoP16. A further update on the status of African elephants was prepared for the 65th meeting of the CITES Standing Committee (SC65), in July 2014, and presented in Annex 1 to document SC65 Doc. 42.1, Elephant conservation, illegal killing and ivory trade.

CoP16 Doc. 53.1 and its Addendum (prepared by the CITES Secretariat), the December 2013 report for the African Elephant Summit (prepared by the CITES Secretariat, the International Union for Conservation of Nature (IUCN), and TRAFFIC, the Wildlife Trade Monitoring Network), and Annex 1 to SC65 Doc. 42.1 (prepared by the IUCN/Species Survival Commission Asian and African Elephant Specialists Groups, the CITES Secretariat, the United Nations Environment Programme's World Conservation Monitoring Centre (UNEP-WCMC), and TRAFFIC) provide analyses of trends in levels of illegal killing of elephants based on data from the CITES Monitoring the Illegal Killing of Elephants (MIKE) program. MIKE is a site-based monitoring system intended to measure levels and trends in the illegal killing of elephants and to determine changes in these trends over time. Data are collected by ranger patrols and others at established MIKE sites and reported to the CITES Secretariat. The reports in CoP16 Doc. 53.1 and its Addendum contain analyses of data collected between 2002 and 2011, from more than 40 MIKE sites across Africa. The report prepared for the African Elephant Summit in December 2013 contains an updated MIKE analysis using 2012 data, and the report in the Annex to SC65 Doc. 42.1 contains a further updated MIKE analysis using data collected through 2013. The data set used for the most recent analysis (in SC65 Doc. 42.1) consists of 12,073 records of elephant carcasses found between 2002 and the end of 2013, at 53 MIKE sites in 29 countries across Africa.

MIKE data are used to evaluate relative poaching levels based on the Proportion of Illegally Killed Elephants (PIKE), which is calculated as the number of illegally killed elephants found divided by the total number of elephant carcasses encountered by patrols or other means, aggregated by year for each site. The data in these reports show a steady increase in levels of illegal killing starting in 2006, with 2011 having the highest levels of poaching since MIKE records began in 2002. In 2012 and 2013, there appears to be a gradual decline, with 2013 levels close to those recorded in 2010. Despite the decline since 2011, poaching levels overall remain alarmingly high, with nearly two-thirds of dead elephants found in 2013 deemed to have been illegally killed. These reports state that the PIKE levels translate to 17,000 elephants killed at African MIKE sites in 2011, and 15,000 elephants killed at African MIKE sites in 2012. These numbers were estimated using models. The authors of the 2014 report prepared for SC65 note that it was not possible to derive an estimate for 2013 using the same method as in previous years because some of the required covariates for 2013 were not yet available. However, the authors provide a “preliminary and rough calculation” using a different method that estimates more than 14,000 elephants were killed at MIKE sites in 2013. The authors stress that this estimate must be treated with caution, but they state that “there are good reasons to believe that the number of elephants illegally killed in Africa in 2013 ran, as in previous years, into the tens of thousands, perhaps in the order of 20 to 22 thousand.”

A joint press release, issued by the CITES Secretariat, IUCN, and TRAFFIC International on December 2, 2013, at the opening of the African Elephant Summit in Gabarone, Botswana, asserted that the figures for MIKE sites amount to an estimated 25,000 elephants killed illegally across Africa in 2011, and 22,000 killed illegally in 2012. Others have suggested that the numbers killed continent-wide are likely even higher. The statistical model used to evaluate MIKE data estimates that the “threshold of sustainability” at MIKE sites was crossed in 2010, with poaching rates remaining above the population growth rate of 4 to 5 percent for healthy elephant populations every year since.

A recent study, published in the Proceedings of the National Academy of Sciences (in July 2014), reaffirmed these assertions. Wittemyer et al. (2014) used MIKE data to analyze the impacts of illegal killing on elephant populations across the African continent, using two different approaches. The results demonstrate “an over-harvest driven decline in African elephants likely began in 2010.” The authors assumed an average annual population increase in the absence of illegal killing of 4.2 percent. They estimated that illegal killing rates averaged about 6.8 percent between 2010 and 2012, which the authors estimate corresponds to more than 33,000 elephants killed per year (based on current population estimates). They also noted that preliminary data for 2013 suggest regional and continental levels were slightly lower than for 2012, but still unsustainable.

CoP16 Doc. 53.2.2 and Annex 1 to SC65 Doc. 42.1 contain reports, prepared by TRAFFIC, on data in the CITES Elephant Trade Information System (ETIS). ETIS is a system for collecting and compiling law enforcement data on seizures and confiscations in order to monitor the pattern and scale of illegal trade in elephant specimens. TRAFFIC receives seizure and confiscation data from CITES Parties, manages and coordinates the ETIS system, and produces a comprehensive report for meetings of the CoP and updates for meetings of the Standing Committee.

The report in CoP16 Doc. 53.2.2 covers the period 1996 through 2011, and the report in SC65 Doc. 42.1 covers the period 1996 through 2012 (data for 2013 were not yet complete when the report was prepared). The data set used for the analysis presented in SC65 Doc. 42.1 includes 14,070 separate raw or worked ivory seizure records from 72 countries or territories during 1996-2012. Using 1998 as a baseline (because it is the first full year after some populations of African elephant were transferred from Appendix I to Appendix II and, at the same time, the development of monitoring systems, including ETIS, was mandated by the Parties), the reports examine trends in both the frequency of illegal ivory trade transactions and the scale of the illegal trade in ivory.

Illegal trade activity (frequency of transactions) remained at or slightly above 1998 levels up to 2006. In 2006, a gradual increase in activity began and grew with each successive year, with a “major surge” in 2011. The authors report that the frequency of illegal ivory trade transactions in 2011 represented “a three-fold increase in illegal trade activity since 1998.”

The scale of illegal trade was assessed by evaluating the weight of ivory traded illegally. The authors caution that there is more uncertainty in evaluating the weight of ivory in illegal trade than in evaluating the frequency of illegal transactions, but the trend is clear. Like the trend in frequency of transactions, there was relative stability in the weight of ivory in illegal trade through 2007, followed by a sharp increase in the following years. The authors estimate that the quantity of illegal ivory in trade in 2011, measured by weight, was nearly three times 1998 levels, and, although 2012 data show a slight decrease compared to 2011, levels in 2012 represent a value that is about two and a half times the 1998 levels. This upward trend reflects a major increase in large consignments of ivory (over 100 kg) in illegal trade, which, the authors note, points to the increasing involvement of international criminal syndicates. In its 2014 report to SC65, TRAFFIC states that the frequency of large-scale ivory seizures has increased greatly since 2000, and that the “upward surge in the weight of ivory seized from 2009 through 2012 has been primarily driven by increased seizures in the large ivory weight class.” Although 2013 data were not complete when the report was written and, therefore, were not included in the analysis, the authors note that the 18 seizures made in 2013 for which they had data “collectively constitute the greatest quantity of ivory derived from large-scale seizure events going back to 1989.”

Elephants in the Dust—the African Elephant Crisis is a report commissioned by the CITES Secretariat through its MIKE program and prepared by UNEP, the CITES Secretariat, IUCN, and TRAFFIC for presentation at CoP16. This report highlights the long-term threats to African elephants posed by habitat loss due to human population growth and large-scale conversion of land for agriculture. It also raises alarm at the added impact of the increasing poaching levels on elephant populations, not only in central Africa but also in previously secure areas of east, west, and southern Africa. Both the TRAFFIC report to CoP16 and Elephants in the Dust conclude that elephants are facing the most serious conservation crisis since 1989, when the African elephant was transferred from CITES Appendix II to Appendix I. The poaching of African elephants to supply international demand for ivory has reached unprecedented levels, and opportunistic poaching has been replaced by coordinated slaughter commissioned by organized networks or syndicates.

The CITES Parties have taken steps to address the growing illegal trade in ivory, including, at CoP16, calling on countries to ensure that they have comprehensive measures in place to regulate the domestic trade in raw and worked ivory. At SC65, the Standing Committee took steps to hold countries that have been identified as being significantly involved in illegal ivory trade (either as source, transit, or destination countries for illegal ivory) accountable. Identified countries that fail to take actions to resolve problems by the agreed deadlines may be subject to CITES trade sanctions.

Demand for ivory is driving the current poaching crisis. Although the primary markets are in Asia, particularly in China and Thailand, the United States continues to play a role as a destination and transit country for illegally traded elephant ivory. Service wildlife inspectors stationed at major U.S. ports intercept smuggled wildlife and ensure that wildlife importers and exporters comply with declaration, permit, and other requirements for international trade in elephants and other wildlife species. Over the years, seizures of unlawfully imported and exported elephant specimens at U.S. ports have ranged from whole elephant tusks and large ivory carvings to knife handles, jewelry made from ivory or hair, and tourist souvenirs including items made from elephant feet and bones. The Service provides seizure data to TRAFFIC annually for inclusion in the CITES ETIS database. Since 1990, the annual number of seizure cases involving elephant specimens at U.S. ports has ranged from over 450 (in 1990) to 60 (in 2008); in most other years the number falls between 75 and 250 cases. In 2012, the most recent year for which we have complete data, there were about 225 seizure cases involving elephant specimens, which resulted in seizure of over 1,500 items that contained or consisted of elephant parts or products. Nearly 1,000 of those items contained or consisted of elephant ivory. (About 300 of the items were elephant hairs.)

Service special agents have investigated multiple smuggling operations involving the trafficking of elephant ivory for U.S. markets. Some examples of major investigations are provided here. In September 2012, the owner of a Philadelphia African art store was arrested and pleaded guilty to smuggling African elephant ivory into the United States. Approximately one ton of elephant ivory was seized from his store; it was the largest ivory seizure in U.S. history. According to the indictment, the art store owner paid a co-conspirator to travel to Africa to purchase raw elephant ivory and have it carved to his specifications and stained or dyed so that the carvings would appear old. He sold the carvings at his store in Philadelphia and elsewhere in the United States as “antiques.”

The arrest in Philadelphia was an outgrowth of a multi-year investigation that documented over 20 shipments of newly carved elephant ivory smuggled into the United States in air and ocean cargo from Cameroon, Ivory Coast, Nigeria, and Uganda. The smuggled ivory came into the country through New Jersey and New York, and was distributed to collectors and retailers across the United States, including to Chicago, Houston, Memphis, New York City, Philadelphia, and Trenton. A total of 10 individuals were charged and later convicted as part of this investigation. Much of the ivory in this case was sent via parcel accompanied by fraudulent shipping and customs documents, and disguised with clay and other substances to look like musical instruments and wooden statues.

Service investigators teamed with officers from the New York Department of Environmental Conservation to probe illegal ivory sales by a New York City jeweler distributor and two Manhattan retailers. This investigation documented a booming and unauthorized trade in ivory. Prosecutions were pursued by the Attorney General for the State of New York based on violations of State laws regulating the sale of elephant ivory. The stores prosecuted paid $50,000 in fines and forfeited over one ton of elephant ivory (which was destroyed at the Service's “ivory crush” described below). The distributor forfeited 70 pounds of elephant ivory valued at $30,000 and paid $10,000 in restitution.

Service special agents worked with the Thai Royal Police to secure the 2010 U.S. indictment of two businessmen (the owner of a Los Angeles area donut shop and a Thai trafficker) and four arrests in Thailand in a case that exposed transcontinental trafficking in elephant ivory. Over the course of this 5-year undercover investigation, officers showed that ivory was being smuggled from Africa into Thailand by Thai operatives who then sold it to clients in the United States and other countries. The investigation began in 2006, when Service wildlife inspectors conducting an inspection “blitz” at the international mail facility in Los Angeles intercepted a package of elephant ivory that had been mailed from Thailand to a U.S. business and labeled as toys. The U.S. defendant pleaded guilty to Federal charges.

Operation Scratchoff was a multi-year investigation, launched by the Service in New York in 2006. It documented and disrupted the illegal activities of both international smugglers who were bringing ivory into the country from Africa and U.S. retailers involved in this black market trade. Special agents documented smuggled ivory entering the United States from Cameroon, Gabon, Ghana, Ivory Coast, Kenya, Nigeria, and Uganda. Most of the ivory smuggled by defendants in this case was shipped from Africa via mail parcel through John F. Kennedy International Airport. The shipments were accompanied by fraudulent shipping and customs documents identifying their contents as African wooden handicrafts or wooden statues. The ivory itself was painted to look like wood; covered with clay; or hidden inside wooden handicrafts, such as traditional African musical instruments. Work on this investigation resulted in the arrest and conviction of eight individuals in the United States on felony smuggling and/or Lacey Act (16 U.S.C. 3371 et seq.) charges with final sentencing in 2010 and 2011. Prison terms for five of these defendants, which included a 33-month sentence for one, totaled more than 7 years. Operation Scratchoff also led to the arrest in January 2010 of an ivory supplier in Uganda by Ugandan authorities, and the identification of additional ivory trafficking suspects.

In 2008, a Canadian citizen was sentenced to 5 years in prison and ordered to pay a $100,000 fine for illegally smuggling ivory from Cameroon into the United States for sale here. The perpetrator operated art import and export businesses in Montreal, Canada and in Cameroon that were fronts for smuggling products made from protected wildlife species, including raw elephant ivory. She ran a sophisticated smuggling operation that utilized local artists and craftsmen in Cameroon, operatives within international shipping companies, contacts in the illegal ivory trade, her business in Canada, and partners in three countries. Two of her shipments, sent to Ohio, included fresh ivory from more than 20 recently killed elephants.

In 2006, Service special agents secured a 20-count criminal indictment against Primitive Art Works, a Chicago art gallery specializing in high-end exotic artifacts from around the world, and its two owners for smuggling elephant ivory and products made from other protected species into the United States. The Service seized over 1,000 ivory carvings and tusks from the defendants, who were asking as much as $50,000 a piece for these items. Both owners pleaded guilty to wildlife violations later that year.

In 2001, during Operation Loxa, Service officers in Los Angeles intercepted more than 250 pounds of smuggled African elephant ivory, the largest ivory seizure ever on the west coast of the United States. The two shipments, which were smuggled from Nigeria, were declared to customs as handcrafted furniture. The ivory included whole tusks and pieces hidden inside furniture and concealed in beaded cloth. Four individuals were arrested and indicted for conspiracy to smuggle elephant ivory into the United States. Three of them were convicted.

Service special agents have also investigated cases involving smuggling of elephant ivory out of the United States to other markets, particularly in Asia. In an investigation, known as Operation Crash, an Asian antique dealer was convicted for his role in the conspiracy to smuggle items made from elephant ivory and rhinoceros horn valued at over $1,000,000. The investigation revealed that this individual worked in the United States as a buyer for four different Asian dealers, who were purchasing numerous ivory carvings from auction houses in the United States. After purchasing the ivory at auctions, the antique dealer smuggled the ivory (through the mail) to various locations in Hong Kong, using false declarations to avoid export controls.

In 2011, a Chinese national was intercepted at John F. Kennedy International Airport prior to boarding a plane to Shanghai, China. Service investigators found 18 elephant ivory carvings concealed in his luggage. This individual was an Asian art dealer who purchased the carvings at various U.S. auction houses during a week-long buying trip. Upon arrest, he told agents that he wrapped the ivory carvings in tin foil to avoid x-ray detection.

At auctions in the United States, Service law enforcement officers have documented foreign buyers placing absentee bids on wildlife items, including those made from African elephant ivory. In some cases, the ivory items are smuggled directly to the foreign buyers. In many instances, however, the foreign buyers employ couriers with residences in the United States to collect the elephant ivory and smuggle it overseas on their behalf. We are concerned that foreign ivory buyers and couriers view the United States as a significant source and market for elephant ivory.

In November 2013, the Service destroyed nearly six tons of contraband African and Asian elephant ivory that had been either seized at U.S. ports or as part of law enforcement investigations over the past 25 years for violation of wildlife laws. We crushed this contraband ivory, which had been stored at the Service's National Wildlife Property Repository, to raise public awareness about the current African elephant poaching crisis and to send a clear message that the United States will not tolerate ivory trafficking and the toll it is taking on wild elephant populations. The six tons of ivory crushed in 2013 underscores the continuing U.S. role in the illegal market and the need for us to take further actions to curtail that role.

There is also a legal market for ivory within the United States. We do not have comprehensive information on the U.S. domestic ivory market. Tackling the Ivories, a 2004 report by Douglas Williamson for TRAFFIC North America, described the status of U.S. trade in elephant and hippopotamus ivory. At that time, the author noted that “as one of the world's largest markets for wildlife products, the [United States] has long played a significant role in the international ivory trade.” He concluded that the ivory trade within the United States was not closely monitored and that its full extent was unknown. In addition to ivory available from retail outlets, he noted that there was “significant trade conducted via the internet, with little oversight.” The domestic trade involved both raw and worked ivory. Worked ivory was readily available in the form of carvings, jewelry, piano keys, and other items. Raw ivory was bought by companies and individuals to be fashioned into specialty items including knife handles, gun grips, and pool cues. Along with legal trade, Williamson found evidence of illegal trade, including internet sellers in China that routinely shipped ivory to the United States, via express delivery service, and offered to falsely label the shipments as “bone carvings.”

In a 2006-2007 survey of selected metropolitan areas across the United States, Martin and Stiles (2008) identified retail establishments trading in worked ivory, including ivory from African elephants. In each area surveyed, the surveyors visited major flea markets, antique markets, main shopping areas for antiques and crafts, department stores, and luxury hotel gift shops. The study does not identify all establishments trading in ivory, but gives a general idea of the number of establishments and geographic scope. In the 16 areas surveyed, the authors identified a total of 652 retail outlets offering a total of more than 23,000 ivory products for sale. Of the areas surveyed, those with the most retail outlets and the greatest number of ivory products for sale were: New York City (124 retail outlets containing a total of 11,376 ivory products); San Francisco Bay area (40 retail outlets containing a total of 2,777 ivory products); and greater Los Angeles (170 retail outlets containing a total of 2,605 ivory products). Martin and Stiles estimated that as much as one-third of the items they found were imported illegally after the 1989 AfECA import moratorium.

In March and April of 2014, one of the authors of the 2008 study conducted a follow-up survey (Stiles 2015) in Los Angeles and San Francisco, California. He found a total of more than 1,250 ivory items offered for sale by 107 vendors in these two California cities, “with 777 items and 77 vendors in Los Angeles and well over 473 ivory items and 30 vendors in San Francisco.” While there were “significantly fewer venders” offering ivory for sale, compared to the 2006-2007 survey, Stiles noted “a much higher incidence of what appears to be ivory of recent manufacture in California, roughly doubling from approximately 25% in 2006 to about half in 2014. In addition, many of the ivory items seen for sale in California advertised as antiques (i.e., more than 100 years old) appear to be more likely from recently killed elephants.”

It is often impossible to distinguish ivory legally imported into the United States from that which has been smuggled into the country, which significantly undermines enforcement efforts and provides an opportunity for illegal ivory to be laundered through U.S. markets. In addition, U.S. citizens may be involved in the global ivory market with ivory that has never been imported into the United States. The Service has reevaluated our domestic controls, given the current poaching crisis in Africa and the associated increase in illegal trade in ivory, the recent CITES recommendations, and evidence that substantial quantities of illegal ivory are making their way into U.S. markets. We have determined that it is appropriate to take certain regulatory actions, including revision of the 4(d) rule as necessary and advisable for the conservation of the species and to include certain prohibitions from section 9(a)(1) of the ESA, to more strictly regulate U.S. trade in ivory. The proposed revisions would regulate import, export, and commercial use of African elephant ivory and sport-hunted trophies and appropriately protect live elephants within the United States, while including certain limited exceptions for items and activities that we do not believe, based on all available evidence, are contributing to the poaching of elephants in Africa, including trade in live animals, parts and products other than ivory, and certain manufactured items containing ivory that meet specific criteria.

These new restrictions would facilitate enforcement efforts within the United States and improve regulation of both domestic and foreign trade in elephant ivory by U.S. citizens. Improved domestic controls will make it more difficult to launder illegal elephant ivory through U.S. markets, which will contribute to a reduction in poaching of African elephants.

This proposed action is consistent with Executive Order 13648 on Combating Wildlife Trafficking signed by President Obama on July 1, 2013, to “address the significant effects of wildlife trafficking on the national interests of the United States.” The Executive Order calls on executive departments and agencies to take all appropriate actions within their authority to “enhance domestic efforts to combat wildlife trafficking, to assist foreign nations in building capacity to combat wildlife trafficking, and to assist in combating transnational organized crime.” Increased control of the U.S. market for elephant ivory is also among the administrative actions called for in the National Strategy for Combating Wildlife Trafficking, issued by President Obama on February 11, 2014. Director's Order No. 210, issued by the Director of the U.S. Fish and Wildlife Service, established policy and procedures for the Service to follow in implementing the National Strategy with regard to trade in African elephant ivory and parts and products of other ESA-listed species.

This proposal is also in line with international efforts. At CoP16, in March 2013, the CITES Parties adopted a revised resolution on trade in elephant specimens (Resolution Conf. 10.10 (Rev. CoP16)), which, among other things, urges Parties with a legal domestic ivory market to ensure that they have in place “comprehensive internal legislative, regulatory, enforcement and other measures to regulate the domestic trade in raw and worked ivory.” Wittemyer et al. (2014) concluded that it is obvious that stemming the rate of illegal killing of elephants is paramount. They call for a global response, including heavy in situ conservation efforts, enforcement of end-use markets, and curbing demand to reduce black market prices for ivory and “alleviate the unsustainable pressure from illegal killing on wild populations.”

In developing this proposed rule, we have also considered the provisions already in place for protection of African elephants under CITES, the AfECA, and the guidance provided in Director's Order No. 210. Provisions for African elephants under CITES and the AfECA can help to address current threats to the species, but the ESA can reach activities that are not regulated under these other laws. For each type of activity and specimen, the available protections provided through the combination of all applicable laws are analyzed to explain why the overall proposed regulatory framework is appropriate for the conservation of this species.

We are proposing to revise the 4(d) rule for the African elephant, in 50 CFR 17.40(e), so that all of the provisions at 50 CFR 17.31 and 17.32 would apply unless specifically indicated otherwise in the rule. Any activity that would be prohibited or exempted under 50 CFR 17.31 and any activity that would require authorization under 50 CFR 17.32 would be regulated as indicated in those sections except as provided in this proposed rule. This legal framework provides far greater protections for African elephants compared to the current rule, which regulates only certain import to and export from the United States; possession, sale, offer for sale, transport, and similar activities with any African elephant specimen illegally imported into the United States; and sale or offer for sale of any sport-hunted trophy imported into the United States in violation of a permit condition. The protections that would be offered to African elephants through this proposed rule and reasons each of the measures is appropriate for the conservation of the species are explained below.

Nothing in this rule would affect other legal requirements applicable to African elephants and their parts and products under other laws such as the AfECA and CITES. For example, while an import into the United States that met all standards as a noncommercial transshipment under section 10(i) of the ESA would not be a violation of the ESA, it would remain a violation of the import moratorium under the AfECA. In addition, any person importing or exporting African elephants or their parts and products to or from the United States would need to comply with all applicable CITES requirements beyond what are described in this proposed rule, as well as the general wildlife import/export requirements found at 50 CFR part 14 and general permitting requirements in 50 CFR part 13. These additional requirements, when applicable, are noted in the text of the rule.

The current 4(d) rule does not regulate the taking of live African elephants. Take means to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or attempt to engage in any such conduct, an ESA-protected species and therefore includes both lethal and certain non-lethal effects on protected wildlife. Under the proposed rule, the taking of any live African elephant would be prohibited within the United States, within the U.S. territorial sea, or upon the high seas (with the latter two acts possibly occurring during transport of a live elephant, such as during transport to or from the United States). Take of endangered or threatened species is not regulated under the ESA beyond these geographic areas, so this change to the 4(d) rule would not have any effect on the ability of U.S. citizens to travel to countries that allow hunting of African elephants and engage in sport hunting. However, the import of any associated sport-hunted trophy into the United States would be regulated as described below. For any African elephant held in captivity within the United States, take would not include animal husbandry practices that meet minimum standards under the Animal Welfare Act (AWA; 7 U.S.C. 2131 et seq.), breeding procedures, and veterinary care that is not likely to result in injury to the elephant. (See the definition of “harass” at 50 CFR 17.3.) Therefore this new restriction would not affect routine procedures for care of African elephants that are held in zoos and similar facilities in the United States. This prohibition is the same as the prohibition on take of Asian elephants, which has been in place since the Asian elephant was listed under the ESA in 1976.

The proposed rule would help to ensure that elephants held in captivity receive an appropriate standard of care. Any activities that qualify as take, including those beyond the standard veterinary care, breeding procedures, and AWA care standards described in the definition of “harass,” would have to qualify for one of the purposes that allow for issuance of a threatened species permit under 50 CFR 17.32. While the taking of live African elephants held in captivity within the United States or being transported is not a threat to the species, including a prohibition against take, even for species that are not native to the United States, is a standard protection for threatened species and ensures an adequate level of care for wildlife held in captivity.

The current 4(d) rule for the African elephant does not regulate sale or offer for sale in interstate or foreign commerce or delivery, receipt, carrying, transport, or shipment in interstate or foreign commerce in the course of a commercial activity of African elephants (including live animals, parts and products, and sport-hunted trophies). The only commercial activities regulated under the current 4(d) rule are possession, sale or offer for sale, and receipt, delivery, transport, or shipment of African elephants (including parts and products) that were illegally imported into the United States and sale or offer for sale of any sport-hunted trophy imported into the United States in violation of a permit condition. These restrictions will remain in place through the ESA section 9(c)(1) prohibition on possession of any CITES specimen that was imported or exported contrary to the Convention, prohibitions under the Lacey Act (16 U.S.C. 3371 et seq.), and ESA section 11 penalties for violations of ESA or CITES permit conditions. We propose to allow continued sale or offer for sale in interstate or foreign commerce and delivery, receipt, carrying, transport, or shipment in interstate or foreign commerce in the course of a commercial activity of live animals and African elephant parts and products other than ivory and sport-hunted trophies without a threatened species permit.

The poaching crisis is driven by demand for elephant ivory. There is no information to indicate that commercial activities involving live elephants or commercial use of elephant parts and products other than ivory has had any effect on the rates or patterns of illegal killing of elephants and the illegal trade in ivory. Live animals are occasionally removed from the wild and placed in captivity, often from populations in small management areas where there have been local over-population issues and consequent negative impacts to habitat. African elephant parts other than ivory (such as hides) that are commercialized generally become available when animals are culled for management purposes, during salvage of animals poached for their ivory, or when problem animals have to be killed. African elephants are not killed primarily for their hides or for parts other than ivory. In addition, the import and export of live African elephants and parts and products are regulated under CITES and other U.S. law. This includes import into and export from the United States for both commercial and noncommercial purposes. It is only commercial activity associated with interstate or foreign commerce not involving import or export that would not be regulated. We have no information indicating that such commercial activity is having any effect on the conservation status of African elephants. Requiring individuals to obtain a threatened species permit under 50 CFR 17.32 when the removal of a small number of live elephants or the incidental harvest of their hides or hair has no negative impact on the species would provide no meaningful protective measures for African elephants, especially when activities that also involve import or export to or from the United States are already regulated under CITES. For these reasons, we have determined that it is not necessary to propose restrictions on commercial activities in interstate or foreign commerce with live African elephants, leather goods, and other African elephant non-ivory parts and products.

We do, however, propose to prohibit sale or offer for sale of ivory in interstate or foreign commerce and delivery, receipt, carrying, transport, or shipment of ivory in interstate or foreign commerce in the course of a commercial activity, with some exceptions, and to prohibit the same commercial activities with sport-hunted African elephant trophies. “Foreign commerce” is defined in section 3 the ESA (16 U.S.C. 1532(9)). “Commercial activity” as used in the term “in the course of a commercial activity” is also defined in section 3 the ESA and means “all activities of industry and trade, including, but not limited to, the buying or selling of commodities and activities conducted for the purpose of facilitating such buying and selling” (16 U.S.C. 1532(2)). The Service has defined “industry or trade” at 50 CFR 17.3 to mean “the actual or intended transfer of wildlife . . . from one person to another person in the pursuit of gain or profit.” The ESA definition of “commercial activity” includes an exception for “exhibitions of commodities by museums or similar cultural or historical organizations.” “Person” is defined in the ESA to include corporations, partnerships, trusts, associations, or any other private entity along with Federal, State, local, and foreign governments, as well as individuals. Activities that would be prohibited could be authorized through a threatened species permit under 50 CFR 17.32 for scientific purposes, enhancement of propagation or survival of the species, zoological exhibition, educational purposes, or other special purposes consistent with the purposes of the ESA. The ESA does not reach sale or offer for sale or activities in the course of a commercial activity that occur solely within the boundaries of a State (i.e., intrastate commerce).

There are a number of potential activities involving ivory or sport-hunted trophies that would not be prohibited under these ESA standards, provided the activity did not qualify as “sale” or “offer for sale.” Under our definition of “industry or trade,” commercial use of threatened specimens does not fall under the prohibition for “commercial activity” unless the transaction involves the transfer of the specimen from one person to another person in the pursuit of gain or profit. Activities that would involve the movement of ivory or sport-hunted trophies in interstate or foreign commerce for gain or profit where there would be no transfer of the item to another person would not be a violation of this rule. For example, a person who transported an item containing ivory across State lines for the purpose of having the item repaired would not fall under the prohibition for “commercial activity.” Not every transaction that involves the exchange of money qualifies as commercial activity under the ESA. In this case, the repair person would gain financially and the item may increase in value once repaired, but the payment of money would be to compensate the repair person for his or her labor and expenses and not involve gain or profit from the ivory item itself (unless the activity involved using additional ivory to repair the item, which would not be allowed). The donation of an item consisting of or containing ivory also would not be considered commercial activity, even if the donor qualified for a tax benefit where the tax benefit is not income. Exhibitions of ivory items or sport-hunted trophies involving gain or profit would remain exempt under the ESA definition of “commercial activity,” provided that all entities involved in the transaction qualified as “museums or similar cultural or historical organizations.” Finally, the exemption available through section 10(h) of the ESA (16 U.S.C. 1539(h)) would continue to allow commercialization of qualifying antiques in interstate and foreign commerce. There are, however, other Federal and State restrictions that may apply to commercial activities involving ivory, including “use after import” restrictions on certain specimens that have been imported under CITES (see below).

As explained in the section Need for Regulatory Actions, while there has long been poaching of African elephants for their ivory and illegal trade in that ivory, since 2006, there has been an unprecedented increase in the illegal killing of African elephants, with estimates exceeding 20,000 per year in recent years. Concurrent with this increase in illegal killing there has been an alarming increase in illegal trade in ivory. Recent law enforcement efforts have demonstrated that the United States plays a role in the illegal trade and the associated illegal killing. The study by Martin and Stiles (2008) estimated that as much as one-third of the ivory found in selected metropolitan areas had been imported into the United States illegally since the 1989 AfECA moratorium. Stiles estimated, in his 2014 follow-up study, that as much as one half of the ivory for sale in two California cities during his survey had been imported illegally. All of this demonstrates the need to impose restrictions on commercializing elephant ivory within the United States. The proposed rule would restrict commercial activities with African elephant ivory consistent with the restrictions in place for endangered species and those in place for other threatened species, with a narrow exception for manufactured items containing a small (de minimis) quantity of ivory. Sale or offer for sale of ivory in interstate or foreign commerce and delivery, receipt, carrying, transport, or shipment of ivory in interstate or foreign commerce in the course of a commercial activity would also remain available by threatened species permit under 50 CFR 17.32, provided the person met all of the requirements of that section as well as the general permitting requirements under 50 CFR part 13.

For the same reasons that it is appropriate for the conservation of African elephants to restrict commercial activities involving ivory in interstate and foreign commerce, it is appropriate to restrict commercial activities involving sport-hunted trophies in interstate and foreign commerce. African elephant trophies contain raw or worked ivory, and in fact sometimes only the raw or worked ivory from the animal is imported into the United States as the trophy. Sport hunting is considered a noncommercial activity and CITES regulation of import and export of sport-hunted trophies reflects this approach. For example, the listing of the African elephant in CITES Appendix II for Botswana, Namibia, South Africa, and Zimbabwe is specifically annotated to note that trade in hunting trophies is for noncommercial purposes only. In Resolution Conf. 12.3 (Rev. CoP16), the CITES Parties have specified that a hunting trophy is an animal that was taken for the hunter's personal use. In addition, a CITES import permit for an African elephant trophy hunted in an Appendix I country can only be issued if the importing government finds that the specimen is not to be used for primarily commercial purposes. Reflecting these restrictions, CITES permits for African elephant sport-hunted trophies include a permit condition that the specimen can be used for noncommercial purposes only.

Consistent with these and similar restrictions for other CITES species, in the 2007 revisions to our CITES-implementing regulations, we clarified that in situations where commercial import would be prohibited under CITES, an item imported for noncommercial purposes could not be used for commercial purposes after import into the United States. Under our CITES regulations, Appendix-I specimens (except those imported under a CITES exemption document or before the species was listed in Appendix I), CITES Appendix-II specimens with an annotation that trade is for noncommercial purposes only, and CITES Appendix-II specimens without a noncommercial annotation but listed as threatened under the ESA can only be used within the United States for noncommercial purposes (see 50 CFR 23.55). This restriction under the authority of CITES reaches intrastate as well as interstate and foreign commerce. We propose to prohibit the commercialization of sport-hunted African elephant trophies in a manner consistent with other legal standards under CITES, including the commercialization of any manufactured items that might otherwise qualify under the de minimis exception discussed below.

Since announcing our intentions to remove or revise the 4(d) rule, we have received input from the public, including musicians and musical instrument manufacturers, museums, antique dealers, and others who may be impacted by these proposed changes. Having considered relevant information provided by these groups, in this proposed rule we would allow for continued commercialization of African elephant ivory in interstate and foreign commerce that is not contributing to the poaching of elephants and where we believe the risk of illegal trade is low.

We propose to allow sale and offer for sale of ivory in interstate or foreign commerce along with delivery, receipt, carrying, transport, or shipment of ivory in interstate or foreign commerce in the course of a commercial activity without a threatened species permit for manufactured items containing de minimis amounts of ivory, provided they meet the following criteria:

• For items located in the United States, the ivory was imported into the United States prior to January 18, 1990 (the date the African elephant was listed in CITES Appendix I) or was imported into the United States under a CITES pre-Convention certificate with no limitation on its commercial use;

• For items located outside the United States, the ivory is pre-Convention (removed from the wild prior to February 26, 1976 (the date the African elephant was first listed under CITES));

• The ivory is a fixed component or components of a larger manufactured item and is not, in its current form, the primary source of value of the item;

• The manufactured item is not made wholly or primarily of ivory;

• The total weight of the ivory component or components is less than 200 grams;

• The ivory is not raw; and

• The item was manufactured before the effective date of the final rule for this action.

We have included the phrase “in its current form” in the criterion stating that the ivory is not the primary source of value of the item, to make clear that we would consider the value added by the craftsmanship (carving, etc.) that went into the ivory component, not just the value of the ivory itself. We use the phrase “wholly or primarily” (in the next criterion) as those terms are commonly defined in the dictionary. We consider “wholly” to mean “entirely, totally, altogether” and “primarily” to mean “essentially, mostly, chiefly, principally.” We have chosen 200 grams as the weight limit because we understand that this is the approximate maximum weight of the ivory veneer on a piano with a full set of ivory keys and that this quantity would also cover most other musical instruments with ivory trim or appointments. We also understand the 200-gram limit would cover a broad range of decorative and utilitarian objects containing small amounts of ivory (insulators on old tea pots, decorative trim on baskets, and knife handles, for example).

We have intentionally crafted this exception to allow commercial activity in a very narrow class of items. While we have given careful consideration to the types of items containing African elephant ivory for which we could allow continued commercialization in interstate and foreign commerce (because we do not believe the trade is contributing to the poaching of elephants and we believe the risk of illegal trade is low) we seek comment from the public on the specific criteria we have proposed to qualify for this de minimis exception. In particular, we are interested in input on criterion (iii), the ivory is a fixed component or components of a larger manufactured item and is not in its current form the primary source of value of the item and criterion (v), the manufactured item is not made wholly or primarily of ivory. We seek comment on the impact of not including these criteria in the rule and whether these criteria are clearly understandable.

Examples of items that we do not expect would qualify for the de minimis exception include chess sets with ivory chess pieces (both because we would not consider the pieces to be fixed components of a larger manufactured item and because the ivory would likely be the primary source of value of the chess set), an ivory carving on a wooden base (both because it would likely be primarily made of ivory and the ivory would likely be the primary source of its value), and ivory earrings or a pendant with metal fittings (again both because they would likely be primarily made of ivory and the ivory would likely be the primary source of its value). For the reasons discussed in the section Import and export of ivory, other than sport-hunted trophies, this de minimis exception would not apply to manufactured items containing ivory that were imported to or exported from the United States for law enforcement or scientific purposes or to otherwise qualifying inherited items or items in a household move that were imported or exported under one of the exceptions in this rule.

Our law enforcement experience over the last 25 years (see the U.S. involvement in the illegal ivory trade section) has shown that the vast majority of items in the illegal ivory trade are either raw ivory (tusks and pieces of tusks) or manufactured pieces (mostly carvings) that are composed entirely or primarily of ivory. As described earlier, in November 2013, the Service destroyed six tons of seized ivory that represented over 25 years of law enforcement efforts to control illegal ivory trade in the United States. The six tons of contraband ivory did not include any items that would be covered by this exception. As demonstrated by the thousands of seized ivory items destroyed in the “crush,” ivory traffickers are not manufacturing items with small amounts of pre-Convention ivory or dealing in such items. Rather, because the incentive to deal in illegal ivory is economic, the trade focuses on raw ivory and large pieces of carved ivory from which the highest profits can be made. Likewise, in the case described earlier involving the Philadelphia African art dealer, which included the seizure of approximately one ton of ivory, all of the seized ivory was in the form of whole ivory carvings and did not include any items that would qualify under the proposed de minimis exception.

The information we have about the domestic market, including the surveys conducted by Martin and Stiles and our own investigations, indicates that trade in the types of manufactured items that would qualify for this proposed de minimis exception is not contributing to or driving the illegal ivory trade. Martin and Stiles identify recently made and presumably illegally imported items as figurines, netsukes, and jewelry, none of which would qualify under the criteria proposed for a de minimis exception.

The requirement that the ivory is either pre-Convention (removed from the wild prior to February 26, 1976) or was imported into the United States prior to 1990, and the requirement that the item must have been manufactured before the effective date of a final rule would make it unlikely that commercialization of ivory under this exception would directly contribute to the future illegal killing of elephants. Noting the types of items that make up the illegal trade, and requiring that the ivory be a fixed component of a larger manufactured item, that the ivory is not raw, that it is not the primary source of value of the item, that the total weight of the ivory is less than 200 grams, and that the manufactured item is not made wholly or primarily of ivory would minimize the possibility of the ivory contributing to either global or U.S. illegal ivory markets or that the de minimis exception could be exploited as a cover for the illegal trade.

These changes will allow us to appropriately regulate the U.S. domestic market in ivory as well as U.S. participation in global markets for ivory and achieve our goal of conserving the African elephant, while allowing limited continued trade that is not contributing to the poaching of elephants. Improved domestic controls will make it more difficult to launder illegal elephant ivory through U.S. markets, which we believe will ultimately contribute to a reduction in the illegal killing of African elephants.

Since announcing our intention to revise the 4(d) rule for the African elephant and prohibit sale and offer for sale of African elephant ivory in interstate commerce, we have heard from a number of representatives of the U.S. museum community. They have expressed their concern about how prohibitions on interstate commerce will impact their ability to acquire items for museum collections. We recognize that museums can play a unique role in society by curating objects that are of historical and cultural significance. We are considering including an exception to the prohibitions on interstate commerce for museums, either through this rulemaking process or through a separate rulemaking under the ESA. We seek comment from the public on this issue. Additionally, we seek comment on how to best define museums in this regard, given the diverse interests that they serve.

Under the current 4(d) rule, African elephants and African elephant parts and products other than sport-hunted trophies and ivory (e.g., live elephants, including those with tusks, and leather products) may be imported into or exported from the United States without a threatened species permit, provided all permit requirements of 50 CFR parts 13 (general permitting regulations) and 23 (CITES regulations) have been met. This would not change with the proposed revisions to the 4(d) rule. We would, however, add a clarification that the requirements at 50 CFR part 14 (general import, export, and transport regulations) must also be met.

As noted earlier, the import into the United States of live elephants, including those with tusks, is not regulated under the AfECA. In section 4202(2) (16 U.S.C. 4202(2)) of the statute, Congress found that it is the large illegal trade in ivory that is the major cause of decline of the species and threatens its existence. Although live elephants may have tusks, there is no information indicating that the limited import of live elephants for conservation or zoological exhibition purposes has ever negatively affected the species. Live African elephants are only occasionally imported into the United States (most live elephants held in captivity in the United States are Asian elephants). During the 5 years from 2009 to 2013, there were eight live African elephants imported into the United States (four in 2011 and four in 2013), all for zoological or educational purposes. Three of these animals were pre-Convention (removed from the wild prior to 1976); the other five were either captive born or captive bred. In addition, the AfECA's focus on regulating ivory primarily through moratoria on the import of raw and worked ivory (not elephants themselves) indicates Congress' intent to regulate ivory as a commodity, not ivory that is attached to a live elephant and therefore cannot be commercialized separate from the elephant itself. Likewise, the AfECA prohibitions all address the import or export of raw or worked “ivory,” not elephants. Finally, the definition of “raw ivory” also indicates that Congress intended the term not to apply to live elephants. The term raw ivory in section 4244(10) (16 U.S.C. 4244(10)) means any “tusk, and any piece thereof, the surface of which, polished or unpolished, is unaltered or minimally carved.” The references to pieces of tusks and the polishing or carving of tusks when read in the context of the definition and application of the term “raw ivory” in the statute indicate that the definition is speaking of tusks that are no longer attached to a live animal.

When establishing regulations for threatened species under the ESA, the Service has generally adopted restrictions on the import and export of live as well as dead animals and their parts and products, either through a 4(d) rule or through the provisions of 50 CFR 17.31. In this case, import and export of both live and dead African elephants and all parts and products are already carefully regulated under CITES. Under CITES and the U.S. regulations that implement CITES at 50 CFR part 23, the United States regulates and monitors all commercial and noncommercial trade in African elephants and any parts and products that are imported into or exported from the country. All African elephant populations are protected under CITES, with most populations listed in Appendix I and only four populations (those in Botswana, Namibia, South Africa, and Zimbabwe) listed in Appendix II. Import into and export from the United States of African elephant specimens will continue to require CITES documentation.

Under CITES, for nearly all live or dead elephants and elephant parts or products, including those from Appendix II populations, the exporting country must issue an export permit that is supported by findings that the specimen was legally acquired under national laws, that the export will not be detrimental to the survival of the species, and, for live animals, that the elephant will be shipped in a manner that minimizes the risk of injury, damage to health, or cruel treatment. The CITES export permit must be presented upon export and must also be presented to U.S. officials upon import into the United States. For nearly all Appendix-I African elephant specimens, a CITES import permit would also have to be issued by the Service after finding that the import will be for purposes that are not detrimental to the survival of the species, that the specimen will not be used for primarily commercial purposes, and, for a live animal, that the proposed recipient is suitably equipped to house and care for the elephant. Any later re-export of African elephant specimens would require additional CITES documents.

Some limited exceptions to these permitting requirements exist. Consistent with an exception in the Convention, the Service provides an exemption from permitting requirements for personal and household effects, but only for dead specimens and not for most Appendix-I specimens. Personal and household effects must be personally owned for noncommercial purposes, and the quantity imported or exported must be necessary or appropriate for the nature of the trip or household use. The exemption is extremely limited for items containing African elephant ivory (see 50 CFR 23.15(f)). Not all CITES countries have adopted the personal and household effects exemption, so individuals who might cross an international border with an African elephant item and want to take advantage of this exemption would need to check with the Service and any country of transit in advance for documentation requirements. There is also an exemption for pre-Convention animals and parts or products, but a person who wants to transport an item under this exemption must obtain and present to government officials upon export and import a CITES pre-Convention certificate that verifies that the specimen was acquired before the Convention applied to it.

In addition to the requirements under CITES, individuals who import or export wildlife and wildlife products into or from the United States must file wildlife declaration forms with the Service's Office of Law Enforcement and must use designated ports. Individuals who are in the business of importing and exporting wildlife and wildlife products must be licensed by the Service. These requirements allow us to monitor the species and quantity of wildlife that are imported into and exported from the United States and ensure that such trade is legal.

The need to address the increase in illegal killing and illegal trade of African elephants is linked to the economic value of and international market in ivory. There is no information indicating that the conservation status and management needs of the species are linked to the occasional import of live elephants into the United States for captive propagation programs or public education and display, or to the market in hides and other non-ivory parts or products. The Service monitors U.S. imports and exports of elephant specimens through wildlife declaration forms, and all CITES Parties are required to submit annual reports on trade in CITES species and the number and types of CITES permits and certificates issued each year. This information verifies that import and export of live African elephants and parts or products other than ivory and sport-hunted trophies is small and does not affect the conservation of the species. There is no evidence of an illegal market in live elephants or parts and products other than ivory.

In addition, as noted above, import and export of African elephant specimens would continue to be strictly regulated through the documentation procedures and required findings under CITES. Particularly relevant to the major threats facing African elephants, these CITES documents are not issued unless the importing or exporting countries find that the import or export would not be detrimental to the survival of the species, that the live animal or part or product was legally acquired, and that the specimen will not be used for primarily commercial purposes. Requiring individuals to obtain an ESA threatened species permit in addition to the required CITES documents prior to import or export of live animals and parts or products other than ivory and trophies would add no meaningful protection for the species and would be an unnecessary overlay of authorization on top of existing documentation that already ensures that the import or export is legal and not detrimental to the survival of the species. Therefore, because the import and export of live African elephants and parts or products other than ivory and sport-hunted trophies must comply with the strict provisions of CITES and other U.S. import/export requirements and because the import or export of such animals and parts or products poses no risk to the species, we find that authorization under the ESA to import or export African elephant specimens other than sport-hunted trophies or ivory remains neither necessary nor appropriate provided that all import and export requirements under CITES and other U.S. laws have been met.

As noted earlier, the ESA does not prohibit U.S. hunters from traveling to other countries and taking threatened species, but authorization may be required under the ESA to import the sport-hunted trophy into the United States. We are proposing to limit the number of sport-hunted African elephant trophies that may be imported into the United States to two per hunter per year. This action is intended to address a small number of circumstances in which U.S. hunters have participated in legal elephant culling operations and imported, as sport-hunted trophies, a large number of elephant tusks from animals taken as part of the cull. We propose to disallow this activity, which has resulted, in some cases, in the import of commercial quantities of ivory as sport-hunted trophies. Based on our import records, we expect this proposed change to impact fewer than 10 hunters per year.

This proposed change is consistent with the purposes of the ESA and CITES. Sport hunting is meant to be a personal, noncommercial activity. Engaging in hunting that results in acquiring quantities of ivory that exceed what would reasonably be expected for personal use and enjoyment is inconsistent with sport hunting as a noncommercial activity. Given the current conservation concerns with escalating illegal trade in ivory and the associated levels of illegal killing to supply that trade, it is consistent with the purposes of the ESA and other provisions in this proposed rule regulating commercialization of ivory to more closely regulate activities that have resulted in the import of large quantities of raw ivory into the United States.

This provision is also consistent with Congress' intent under the AfECA. Congress included in the AfECA an exemption from the import moratorium for sport-hunted trophies legally taken in an elephant range country, but that was on the basis of finding that sport hunting does not directly or indirectly contribute to the illegal trade in African elephant ivory. The escalating illegal trade of ivory is currently driving unprecedented increases in the illegal killing of elephants. We therefore find it is necessary to use our authority under section 4(d) of the ESA to ensure that ivory imported into the United States as sport-hunted trophies is in fact the result of sport hunting and is not commercialized. Section 4241 of the AfECA (16 U.S.C. 4241) expressly states that the Service's authority under the AfECA is in addition to and does not affect the Service's legal authority under the ESA, which includes our legal authority under section 4(d). The AfECA therefore does not preclude us from using our authority under the ESA to limit the number of African elephant trophies imported by an individual hunter each year to appropriate levels. For certain species, the parties to CITES have set limits on the number of trophies that any one hunter may import in a calendar year, which currently for leopards is no more than two, for markhor is no more than one, and for black rhinoceros is no more than one. See 50 CFR 23.74(d). Taking into consideration these decisions by the parties to CITES, we similarly propose to set the limit at two African elephants per hunter per year.

We are also proposing to require issuance of a threatened species permit under 50 CFR 17.32 for import of all African elephant sport-hunted trophies. The current 4(d) rule provides conditions under which sport-hunted African elephant trophies may be imported into the United States, one of which is that the Service has made a determination that the killing of the trophy animal would enhance the survival of the species.

For elephant trophies taken from CITES Appendix-I populations, we issue a combined CITES/ESA import permit and the ESA finding is communicated through that permit. Under the current 4(d) rule, we do not issue an import permit for trophies from Appendix-II populations and the ESA finding is communicated through public notification, including in the Federal Register.

For the import of sport-hunted trophies from Appendix-II populations, revision of the 4(d) rule would mean that the enhancement finding required under the current 4(d) rule would be communicated through the threatened species permitting process under 50 CFR 17.32. This change in procedure would not result in any significant burden to U.S. hunters and would not affect whether future hunters would be able to obtain trophy import permits. The standards for making enhancement findings for each African elephant range country under the current 4(d) rule are the same as the standards for making findings for import permits for sport-hunted trophies of other species classified as threatened, where such findings are required. The standards for making enhancement findings under the current 4(d) rule are also the same as the standards that would be used in the future for making enhancement findings for African elephant trophy imports through the threatened species permit process. Permits have always been required for the import of African elephant trophies from any Appendix-I country, so it is only trophies from the four Appendix-II countries that would now also require import authorization through a threatened species permit. Hunters would benefit from the consistency of having all African elephant import authorizations provided through the permitting process (we expect it would reduce confusion regarding the process for obtaining import authorization, depending on the country) and benefit from a process that would allow them to submit relevant information through the permit application. Hunters seeking authorization to import a trophy from an Appendix-II population would also now be able to take advantage of the process for requesting reconsideration and appeal of a permit denial under 50 CFR 13.29. The Service would benefit from having a consistent process for authorizing ESA importation of African elephant sport-hunted trophies, as well as having the ability to obtain current information from hunters that is relevant to making the enhancement findings.

As provided in section 9(c)(2) (16 U.S.C. 1538(c)(2)) and our regulations at 50 CFR 17.8, the ESA provides a limited exemption for the import of some threatened species, which is frequently used by hunters to import sport-hunted trophies. Importation of threatened species that are also listed under CITES Appendix II are presumed not to be in violation of the ESA if the importation is not made in the course of a commercial activity, all CITES requirements have been met, and all general wildlife import requirements under 50 CFR part 14 have been met. This presumption can be rebutted, however, when information shows that the species' conservation and survival would benefit from the granting of ESA authorization prior to import. The Service determined that this was the case in 1997 and 2000, when the four populations of African elephants were transferred from CITES Appendix I to CITES Appendix II and we retained the requirement for ESA enhancement findings prior to the import of sport-hunted trophies. We amended the African elephant 4(d) rule in June of 2014, again maintaining the requirement for an ESA enhancement finding prior to allowing the import of African elephant sport-hunted trophies.

Our proposal to require issuance of threatened species enhancement permits under 50 CFR 17.32 for the import of any African elephant hunting trophy would change the procedure for issuing ESA authorization but not change the requirement that an enhancement finding be made prior to import into the United States. As described in the Need for Regulatory Actions section, the overall conservation status of African elephants has deteriorated in the years following the transfer of the four populations of African elephants to CITES Appendix II. Extensive and well-documented information indicates that the escalating rate of illegal killing of African elephants is driven by the illegal markets for elephant ivory. This information affirms the need to continue making enhancement findings prior to allowing the import of sport-hunted trophies that consist entirely or in part of the ivory tusks from the elephant. Authorizing importation of all sport-hunted trophies through threatened species enhancement permits would allow us to more carefully evaluate trophy imports in accordance with legal standards and the conservation needs of the species. For example, the issuance of threatened species enhancement permits under 50 CFR 17.32 would mean that the standards under 50 CFR part 13 would also be in effect, such as the requirement that an applicant submit complete and accurate information during the application process and the ability of the Service to deny permits in situations where the applicant has been assessed a civil or criminal penalty under certain circumstances, failed to disclose material information, or made false statements. Therefore, we have determined that the additional safeguard of requiring the issuance of threatened species enhancement permits under 50 CFR 17.32 prior to the import of sport-hunted trophies is warranted.

In addition, the 4(d) rule would incorporate certain restrictions under the AfECA on the import and export of sport-hunted trophies. We do not have separate AfECA regulations and consider that including restrictions in the 4(d) rule that have their source in the AfECA would provide hunters and other members of the public easy access to information on all requirements that apply to activities with African elephant sport-hunted trophies. All of these provisions are also appropriate conservation measures for the species under the ESA that ensure that hunting of African elephants by U.S. citizens is sustainable and legal under the laws of the range country and that any ivory associated with the trophy does not contribute to the illegal killing of elephants. Adopting these AfECA provisions as appropriate conservation measures for the species under section 4(d) of the ESA would also make a violation of relevant provisions of the AfECA a violation of the ESA, thus increasing protections for African elephants when a person violates the AfECA.

The AfECA provides for the import of sport-hunted African elephant trophies but only if the trophy was legally taken in an African elephant range country that has declared an ivory export quota to the CITES Secretariat. These requirements have been incorporated into the proposed 4(d) rule. Also, the AfECA provides an exemption from any moratorium for the import of African elephant sport-hunted trophies, but the exemption applies to import only, not export. The export of all raw ivory is prohibited under section 4223(2) of the AfECA (16 U.S.C. 4223(2)). We propose to incorporate into the 4(d) rule the AfECA prohibition on the export of raw ivory. Export of raw ivory would not be allowed even under an ESA threatened species permit because the AfECA prohibition would still stand; similarly, export of raw ivory that qualified as an antique under the ESA, while not regulated under the proposed 4(d) rule, would still be prohibited under the AfECA. We have also proposed minor revisions to the 4(d) rule to clarify that general wildlife import requirements under 50 CFR part 14 also apply to the import of sport-hunted trophies and to more closely align import requirements with the recommendations in CITES Resolution Conf. 10.10 (Rev. CoP16), Trade in elephant specimens.

The revised 4(d) rule would also allow the noncommercial export of worked ivory that was imported as part of a sport-hunted trophy provided it meets one of the exceptions we have proposed for scientific or law enforcement purposes or as part of a musical instrument, traveling exhibition, or household move or inheritance. Worked ivory that had been imported as a sport-hunted trophy could also be exported if it qualifies as an ESA antique.

Under the current 4(d) rule, import of raw or worked ivory other than sport-hunted trophies is allowed only if it is a bona fide antique greater than 100 years old or it is being imported following export from the United States after being registered with the Service. Under the terms of the 1989 AfECA moratorium, the import of raw and worked African elephant ivory, other than ivory from legally taken sport-hunted trophies, is prohibited from both African elephant range countries and intermediary countries (i.e., countries that export ivory that did not originate in the country).

Under the proposed revisions to the 4(d) rule, import of ivory other than sport-hunted trophies would be prohibited, with limited, narrow exceptions including: the import of raw ivory by a government agency for law enforcement purposes or for a genuine scientific purpose that will contribute to the conservation of the African elephant; and the import of worked ivory under these same exceptions for law enforcement or scientific purposes that will contribute to the conservation of the species, or as part of a musical instrument, an item in a traveling exhibition, or as part of a household move or inheritance. The export of raw ivory would be prohibited under the proposed revisions to the 4(d) rule and the export of worked ivory would be limited to those items that qualify for the exceptions described above. Section 4(d) of the ESA does not apply to items that qualify as antiques and therefore these proposed prohibitions on import and export of ivory do not apply to ESA antiques. However, as noted previously, the prohibitions on import and export of ivory under the AfECA would still apply, regardless of the age of the item. The proposed revisions are consistent with the 1989 AfECA moratorium, and are generally consistent with the Service's Director's Order No. 210, as amended on May 15, 2014. We have determined that these provisions are appropriate under the ESA for the conservation of the African elephant.

Restrictions on import and export are appropriate under both the AfECA and the ESA because strict regulation of the import and export of ivory are necessary to prevent U.S. citizens and others subject to the jurisdiction of the United States from engaging in activities that could contribute to the illegal killing of elephants. Nonetheless, situations where not allowing the activity could actually be detrimental to the conservation of the species, or limited circumstances where careful controls would be in place to make it likely that the activity will not contribute to illegal trade in ivory or the killing of elephants for their ivory, can be allowed. Adopting the AfECA provisions as appropriate conservation measures for the species under section 4(d) of the ESA would make a violation of the AfECA a violation of the ESA, thus increasing protections for African elephants when a person violates the AfECA. Finally, because there are no AfECA regulations in the Code of Federal Regulations, the public would benefit from having all legal requirements relating to the import and export of African elephant ivory located in one place through the 4(d) rule.

On June 9, 1989, the Service established the current moratorium on the importation of both raw and worked ivory (other than that from sport-hunted trophies) after finding that most ivory was traded outside of the CITES Ivory Trade Control System that existed at that time and that illegal and excessive taking of elephants was taking place at unsustainable levels (54 FR 24758). African elephant range countries were unable to effectively control taking of elephants and intermediary countries could not ensure that all ivory in trade originated from legal sources. Specifically, the Service found that most ivory range countries had such low elephant populations that the countries had determined that no sustainable harvest was possible and had requested no ivory export quota for that year; that there was likely no sustainable harvest of elephants throughout most of Africa, even for those countries that had export quotas, due to declining populations; and that most African elephant range countries had significant poaching problems. For intermediary countries, the Service determined that all major intermediary countries that were parties to CITES at that time had engaged in import of raw ivory from other intermediary countries (alone a criterion for establishment of a moratorium under the AfECA) and that due to the virtual impossibility of distinguishing legal from illegal ivory, it was no longer possible for any intermediary country to ensure that it was not importing ivory from a range country in violation of the laws of that country.

In recent years, many of the conditions that supported imposing the moratorium have continued or even worsened. In particular, recent information shows that for elephant range countries, the taking of elephants is not effectively controlled and the amounts of raw ivory that are being illegally exported from these countries are undermining the conservation of elephants. For intermediary countries, recent information on the scope and extent of illegal ivory trade shows that these countries are importing (through illegal trade) raw or worked ivory that originates in range countries in violation of the laws of the range countries. However, some actions in the United States, in other countries, and through CITES, have been taken to strengthen controls on poaching and illegal trade. In January 1990, all populations of African elephants were transferred from CITES Appendix II to Appendix I, which generally ended legal commercial trade in African elephant ivory. In 1997, based on proposals submitted by Botswana, Namibia, and Zimbabwe and the report of a Panel of Experts, the CITES Parties agreed to transfer the African elephant populations in these three countries to CITES Appendix II. The Appendix-II listing included an annotation that allowed noncommercial export of hunting trophies, export of live animals to appropriate and acceptable destinations, export of hides from Zimbabwe, and noncommercial export of leather goods and some ivory carvings from Zimbabwe. It also allowed for a one-time export of raw ivory to Japan (which took place in 1999), once certain conditions had been met. All other African elephant specimens from these three countries were deemed to be specimens of a species listed in Appendix I and regulated accordingly.

The population of South Africa was transferred from CITES Appendix I to Appendix II in 2000, with an annotation that allowed trade in hunting trophies for noncommercial purposes, trade in live animals for reintroduction purposes, and trade in hides and leather goods. Since then, the CITES Parties have revised the Appendix-II listing annotation three times. The current annotation, in place since 2007, covers the Appendix-II populations of Botswana, Namibia, South Africa, and Zimbabwe and allows export of: Sport-hunted trophies for noncommercial purposes; live animals to appropriate and acceptable destinations; hides; hair; certain ivory carvings from Namibia and Zimbabwe for noncommercial purposes; and a one-time export of specific quantities of raw ivory, once certain conditions had been met (this export, to China and Japan, took place in 2009). As in previous versions of the annotation, all other African elephant specimens from these four populations are deemed to be specimens of species included in Appendix I and the trade in them is regulated accordingly.

Most recently, the Service determined in April 2014 that import of sport-hunted trophies from Tanzania and Zimbabwe could not be allowed until new information is received, because the killing of African elephants for trophies does not meet the enhancement standard under the current 4(d) rule. The Service understands that Botswana has closed its sport-hunting program on government land for 2014 (although hunting on private concessions continues) and is not currently allowing exports. South Africa and Namibia continue to have well-managed elephant conservation programs; the Service's findings remain in place that the killing of trophy animals from these countries for import into the United States enhances the survival of the species.

All of this information, along with the recent levels of illegal killing and illegal trade as described in the section Need for Regulatory Actions, indicates that the circumstances facing African elephants and involving ivory in both range countries and intermediary countries support adoption of these restrictions for the species under the ESA. The threats facing the species call for all appropriate actions to restrict the import of African elephant ivory where that import is likely to contribute to commercializing elephant ivory. We believe that it is appropriate to allow certain limited exceptions to these import restrictions under the 4(d) rule, however, where import either would be beneficial to law enforcement or the conservation of the species, or where import of certain worked ivory meets strict criteria and is regulated in such a manner that it does not contribute to the illegal trade in ivory and poses no risk to elephant populations.

We propose to allow the import of raw or worked ivory into the United States or the export of worked ivory from the United States when it would be directly beneficial for law enforcement efforts. Under this exception, raw or worked ivory could be imported into the United States and worked ivory could be exported from the United States only by an employee or agent of a Federal, State, or tribal government agency for law enforcement purposes. Specimens from protected species are frequently used as evidence to prosecute violations of law in the United States, and this may require the import of ivory from other countries. Likewise, there may be situations where worked ivory would need to be exported from the United States by a Federal, State, or tribal agency to assist with a law enforcement action in another country. Not having this exception would hinder the Service's ability to enforce Federal laws such as the AfECA, the ESA, and the Lacey Act that protect African elephants and other wildlife. It could also hinder other Federal agencies, States, and tribes from effective enforcement of their laws. Not including this exception would be contrary to the AfECA's policy to assist in the conservation and protection of the African elephant by supporting the conservation programs of African countries and the CITES Secretariat, which represents the interests of all parties to CITES including the United States. The limitation that ivory could only be imported or exported by an employee or agent of a Federal, State, or tribal government would ensure that the exception is invoked only in appropriate circumstances. Any ivory imported or exported under this exception would be strictly for noncommercial law enforcement purposes, and therefore could not subsequently be sold or offered for sale in interstate or foreign commerce or delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity, even if it qualified under the de minimis exception. The limited applicability of this exception to noncommercial import or export by government officials for law enforcement purposes indicates that no ESA threatened species permit should be required. Such a permit would provide no protection for the species and would inhibit law enforcement officials' ability to respond quickly to enforcement needs involving the import or export of African elephant ivory.

We also propose to allow the import or export of ivory when it would contribute to the conservation of African elephants. Under this exception, either raw or worked African elephant ivory could be imported into the United States and worked ivory could be exported from the United States for genuine scientific purposes that would benefit elephant conservation. For example, researchers in the United States have developed techniques to determine the origin of ivory, and the import of ivory samples is essential to this work. In such instances, prohibition of import would hinder science that could assist in protecting the species from poaching or illegal trade in ivory, or could result in valuable information that addresses other threats to the species. Similarly, the export of worked African elephant ivory could assist both U.S. scientists that are located outside the United States and scientists from other countries in their work to conserve the species. We believe that allowing under the 4(d) rule import and export of ivory in these circumstances is necessary and appropriate for the conservation of the African elephant; it is also consistent with the AfECA's purpose to “perpetuate healthy populations of African elephants.” Any ivory imported or exported under this exception would be strictly for genuine scientific purposes, and could not subsequently be sold or offered for sale in interstate or foreign commerce or delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity, even if it qualified under the de minimis exception. The requirement to obtain a threatened species permit under 50 CFR 17.32 prior to import or export would ensure that the activity meets the standard of being for a genuine scientific purpose and that the science will actually contribute to the conservation of African elephants.

We are also proposing to allow the noncommercial import or export of carefully regulated items containing worked elephant ivory that are appropriate exceptions to the import moratorium and appropriate provisions under the 4(d) rule. None of these exceptions allows the import or export of raw ivory. The exceptions are for qualifying musical instruments, items in certain travelling exhibitions, and qualifying items that are part of an inheritance or household move.

Under all three of these exceptions, the importer or exporter would need to show that the African elephant ivory in the item was legally acquired and removed from the wild prior to February 26, 1976 (the date the African elephant was first listed under CITES). This does not necessarily mean that the current owner of an item containing ivory, a musical instrument, for example, acquired the instrument or the ivory in the instrument prior to February 1976. It means that there is sufficient information to show that the ivory was harvested (taken from the wild) prior to February 26, 1976, even though the instrument may not have been manufactured until after that date. It also means that there is sufficient information to show that the ivory was harvested in compliance with all applicable laws of the range country and that any subsequent import and export of the ivory and the instrument containing the ivory was legal under CITES and other applicable laws (understanding that the instrument may have changed hands many times before being acquired by the current owner).

These requirements would ensure that any item imported or exported under one of these three exceptions originated from elephants that were legally taken prior to the date that African elephants were first protected under CITES, the ESA, and the AfECA and therefore before contemporary laws and programs were developed to address current threats to the species. The ivory would have originated from elephants taken prior to development of the conservation programs of African countries and the CITES Secretariat referenced in section 4203 of the AfECA that the AfECA was enacted to support. This would also mean that any ivory imported or exported under the exceptions originated before U.S. citizens and other individuals subject to the jurisdiction of the United States were first regulated under these laws. The showing that the ivory was legally acquired would ensure that the ivory contained in the item was not previously part of the global market in illegal ivory. Thus these requirements would minimize the chances that the worked ivory in items imported or exported under these three exceptions contributed to the killing of elephants that the AfECA and listing under the ESA and CITES were designed to address or that the owner or others who may have owned the ivory played a role in the taking of the elephant in contravention of U.S. laws to protect the species.

Under all three of these exceptions, the importer or exporter would have to obtain the appropriate CITES document showing that the import or export is in full compliance with CITES requirements. The requirement to obtain appropriate CITES documents would ensure that each item imported or exported under one of these three exceptions qualifies under CITES' strict standards and that all such import and export will be monitored and reported to the CITES Secretariat in each Party's annual report. Any musical instrument or item in a traveling exhibition would also have to be securely marked or uniquely identified so that authorities at U.S. and foreign ports can verify that the item presented for import or export is actually the specimen for which the CITES document was issued. While items imported or exported under a CITES pre-Convention certificate (as part of a household move or inheritance) do not specifically need to be marked or identified, port authorities would verify that the description and quantity of any items presented for import or export match what is described in the CITES document. All of this would ensure that each import or export of items under these exceptions is verified and monitored, which ensures that all such import and export remains legal.

A CITES musical instrument certificate or equivalent CITES document would be issued for the import and export of personally owned instruments containing African elephant ivory to facilitate the frequent, noncommercial, cross-border movement of instruments that are being used for noncommercial purposes. Noncommercial purposes could include personal use, performance, display, or competition where the musician is financially compensated for his or her participation, but does not include financial gain through activities such as sale or lease of the instrument itself. Under the terms for obtaining a CITES musical instrument certificate (contained in CITES Resolution Conf. 16.8, Frequent cross-border non-commercial movements of musical instruments), the individual seeking a certificate would need to demonstrate that the CITES specimens contained in the instrument, in this case African elephant ivory, were acquired (removed from the wild) prior to February 26, 1976 (the date that African elephants were first listed under CITES). In addition, the country issuing the certificate would need to find that the elephant ivory used to manufacture the instrument was legally acquired under CITES. The issuing country would also include as a condition on the certificate a statement that the ivory covered by the certificate is for noncommercial use only and may not be sold, traded, or otherwise disposed of outside the certificate holder's country of usual residence. This restriction would also be included as a prohibition in the 4(d) rule, although musical instruments containing ivory that are owned by individuals whose residence is the United States could be sold or offered for sale in interstate or foreign commerce or delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity once the instrument was returned to the United States if the instrument qualified under the de minimis exception. Musical instrument certificates are used like passports. Upon each export and import, the original certificate is presented to the appropriate border control officer, who inspects the certificate, verifies that the certificate corresponds to the instrument presented for import, and validates the certificate to document the history of each cross-border movement. All of these requirements would limit use of the exception to personally owned musical instruments containing legally acquired, pre-Convention ivory, and ensure that any instrument entering the United States would be used for noncommercial purposes only, and that an instrument would not be commercialized while traveling under the authorization of the CITES certificate. These requirements provide adequate assurances that any import or export of such instruments would not contribute to either the illegal trade in elephant ivory or the illegal killing of elephants.

A CITES traveling exhibition certificate would be issued for the import and export of items consisting of or containing African elephant ivory to facilitate the frequent cross-border movement of items that are part of an orchestra, museum, or similar exhibition registered in the country in which the traveling exhibition is based. Under the terms for obtaining the CITES certificate (contained in CITES Resolution 12.3 (Rev. CoP16), Permits and certificates and in our regulations at 50 CFR 23.49), the ivory in the traveling exhibition must be pre-Convention ivory (i.e., it was acquired prior to February 26, 1976, the date that African elephants were first listed under CITES). Similar to the musical instrument certificate, the country issuing the certificate would need to find that any item containing elephant ivory was legally acquired under CITES and would be returned to the country in which the exhibition is based. The country issuing the certificate would also include the condition that the ivory covered by the certificate may not be sold or otherwise transferred in any country other than the country in which the exhibition is based and registered. This restriction would also be included as a prohibition in the 4(d) rule, although exhibition items containing ivory that are owned by persons who are based in the United States could be sold or offered for sale in interstate or foreign commerce or delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity if the item qualified under the de minimis exception and the exhibition was back in the United States. Like musical instrument certificates, traveling exhibition certificates are used like passports. Upon each import or export, the original certificate is presented to the appropriate border control officer, who inspects the certificate, verifies that the certificate corresponds to the item presented for import, and validates the certificate to document the history of each cross-border movement. Similar to the strict regulation of musical instruments, these requirements would limit use of the exception to items consisting of or containing African elephant ivory legally acquired prior to February 26, 1976, and ensure that the item would not be commercialized while outside the country in which the exhibition is based while traveling under the authorization of the CITES certificate. These requirements provide adequate assurances that any import or export of these items would not contribute to either the illegal trade in elephant ivory or the illegal killing of elephants.

Items imported or exported as part of an inheritance or a household move under the final exception would need to be for personal use only and accompanied by a valid CITES pre-Convention certificate. To qualify for a pre-Convention certificate, the importer or exporter of an item containing African elephant ivory would need to present sufficient information to show that the ivory was removed from the wild prior to February 26, 1976. There must also be sufficient information to show that the ivory was harvested in compliance with all applicable laws of the range country and that any subsequent import and export of the ivory and the instrument containing the ivory was legal under CITES and other applicable laws. For any item imported or exported as an inheritance, the importer or exporter would also need to show that the item was received through an inheritance. For any item imported or exported as part of a household move, the importer or exporter would need to show that they own the item, that it was legally acquired, and that they are moving it for personal use. Any such items would need to be imported or exported within 1 year of changing residence from one country to another and the shipment would need to contain only ivory items purchased, inherited, or otherwise acquired prior to the change in residence. Finally, the type and quantity of ivory items imported or exported under this exception would need to be appropriate for a household move. Because any ivory imported or exported under this exception would be solely for personal use, any such ivory could not subsequently be sold or offered for sale in interstate or foreign commerce or delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity, even if it qualified under the de minimis exception.

All of these requirements would help to ensure that any imports or exports under these proposed exceptions did not contribute to past poaching and smuggling, did not contribute to the recent increase in illegal killing of elephants and illegal trade of ivory, and would be in compliance with AfECA requirements. In addition, the requirements that items under most of the exceptions must be imported or exported for personal or noncommercial use only, the limits on sale or other disposal of musical instruments and exhibition items while the item is traveling under the CITES certificate, the requirement that inherited items must be documented as acquired through an inheritance and not purchase, the requirement that household move items are limited to the number and type that would reasonably be expected for a person's move of their household, the requirement that household move items must be imported or exported within 1 year of a documented change of residence, and the prohibition on commercialization of inherited or household move items even if they qualify under the de minimis exception would minimize the chances of these exceptions being used as a means to commercialize ivory.

Because of the strict requirements that must be met to be eligible for import or export of any item under these three exceptions, we are proposing that no additional threatened species permit would be required under 50 CFR 17.32. The requirements to obtain the relevant CITES document, the findings that must be made before the CITES document can be issued, and the requirement to present the item along with all required CITES and general wildlife import/export documents to Federal officials upon import or export would ensure that each import or export is legal and adequately monitored. Presentation of the items and documents upon import or export would also provide Federal officials the opportunity to make sure that all other requirements have been met. Requiring individuals to obtain an ESA threatened species permit in addition to the required CITES documents prior to import or export of items under these limited exceptions would be an unnecessary overlay of documents on top of existing CITES documentation that ensures that such import or export is not contributing to the illegal killing of elephants.

All of these exceptions are identical or similar to the exceptions to the AfECA import moratorium that were provided as a matter of law enforcement discretion through Director's Order No. 210, as amended on May 15, 2014. The only substantive change is that the Director's Order contained an additional standard that any musical instrument, item in a traveling exhibition, item in a household move, or inherited item containing ivory could not be imported if it had been transferred from one person to another person for financial gain or profit since February 25, 2014 (the date of the original Director's Order). We have determined that this restriction is not needed because with this proposed rule it would be a violation of the ESA for any person to sell or offer for sale ivory or sport-hunted trophies in interstate or foreign commerce or to deliver, receive, carry, transport, or ship ivory or sport-hunted trophies in interstate or foreign commerce in the course of a commercial activity except for certain manufactured items that would qualify under the de minimis exception. Therefore any U.S. citizen or other person subject to the jurisdiction of the United States who commercialized an item containing ivory or a sport-hunted trophy in violation of these prohibitions would be in violation of this rule regardless of whether this additional restriction were in place.

Under the current 4(d) rule, worked ivory may be exported in accordance with the requirements in 50 CFR parts 13 and 23, and raw ivory may not be exported from the United States for commercial purposes under any circumstances. Under the AfECA, the export of all raw ivory is prohibited. We propose to revise the 4(d) rule to prohibit export of raw ivory, consistent with the AfECA prohibition, with the exception of antiques. For the same reasons discussed above, we also propose to prohibit export of worked ivory, other than antiques, except in the same limited circumstances and for the same limited purposes allowed for import: By a government agency for law enforcement purposes, for a genuine scientific purpose that will contribute to the conservation of the African elephant, as part of a qualifying musical instrument, as a qualifying item in a traveling exhibition, or as a qualifying item that is part of a household move or inheritance.

In developing this proposed rule, we have given very careful consideration to the types of circumstances and purposes for which we could allow exceptions to the prohibitions on import and export of African elephant ivory. However, we seek information and comment regarding the need for and advisability of finalizing a rule that includes a broader exception to those prohibitions for the noncommercial import or export of worked ivory in circumstances that are not covered by the exceptions for musical instrument, traveling exhibitions, household moves or inheritances, or genuine scientific purposes. In particular, we seek information from individuals who may wish to engage in noncommercial import or export of worked African elephant ivory that would be prohibited by this proposed rule. We are also interested in the potential impacts of these prohibitions on segments of the trade not covered by these exceptions.

Information regarding the illegal killing of elephants and the alarming growth in illegal trade in elephant ivory shows that all appropriate actions are needed to restrict the export of raw and worked African elephant ivory where that export is likely to contribute to commercializing elephant ivory. It is appropriate, however, to allow certain limited exceptions to the export prohibition where export either would be beneficial to law enforcement or the conservation of the species, or where export of certain articles of worked ivory meet strict criteria and are regulated in such a manner that their export would not contribute to the illegal trade in ivory and pose no risk to elephant populations. Export of worked African elephant ivory would also be available by threatened species permit under 50 CFR 17.32, provided the person met all of the requirements of that section as well as the general permitting requirements under 50 CFR part 13.

As noted previously, Section 4(d) of the ESA does not apply to items that qualify as antiques. While the prohibitions on import and export of ivory proposed here thus do not apply to ESA antiques, the prohibitions on import and export of ivory under AfECA would still apply, regardless of the age of the item. In addition, certain worked ivory items that qualify under the ESA section 9(b)(1) “pre-Act” exemption (see below) could also be exported (see below). No ESA permit would be required for any worked ivory that qualified under any of these provisions, but it would still need to be accompanied by any required CITES document and meet all requirements under the Service's general wildlife import/export regulations.

The ESA provides an exemption in section 9(b)(1) from any prohibitions contained in a 4(d) rule for specimens of threatened species “held in captivity or in a controlled environment” on the date the ESA entered into effect (December 28, 1973) or the date the final rule listing the species under the ESA was published in the Federal Register (which for the African elephant was May 12, 1978), whichever is later. The exemption applies only if “such holding and any subsequent holding or use of the fish or wildlife was not in the course of a commercial activity.” As noted above in Interstate and foreign commerce, activities with threatened species do not qualify as “commercial activity” unless the activity involves the transfer of the specimen from one person to another person in the pursuit of gain or profit. Therefore, the exemption would apply unless commercial activity with an African elephant specimen (including ivory) on or after May 12, 1978, involved the transfer of the specimen from one person to another person in pursuit of gain or profit. (See the discussion on activities that occur “in the course of a commercial activity” under Interstate and foreign commerce, above.)

Persons wishing to engage in activities that otherwise would be prohibited under this 4(d) rule would have the burden of showing that their activities qualify for this “pre-Act” exemption. The statutory exemption would not change with revision of the 4(d) rule, but it is also important to remember that nothing in the ESA provides that an exemption under that law modifies or supersedes provisions in other applicable statutes such as the AfECA. (See Antique specimens, below, for a full discussion on the relationship between ESA exemptions and AfECA restrictions.) Therefore, activities prohibited under the AfECA remain prohibited, even if the ESA “pre-Act” exemption applies.

The pre-Act exemption would apply to the following examples if the activity met all requirements of the ESA: The prohibition against take for qualifying live elephants that were held in captivity on May 12, 1978; the prohibition on the export of worked ivory that was held in a controlled environment on May 12, 1978; and the requirement to get a threatened species permit for the export of worked ivory to be used for genuine scientific purposes for ivory that was held in a controlled environment on May 12, 1978, provided that in each case the holding and any subsequent holding or use of the live animal or specimen since 1978 did not include transfer from one person to another person in the pursuit of gain or profit.

In addition, if the holding as of May 12, 1978, or any subsequent holding or use included a transfer from one person to another person in the pursuit of gain or profit, the exemption would still be available if the activities qualified as exhibition of commodities by a museum or similar cultural or historical organization. All import and export requirements under CITES and the general wildlife import/export regulations at 50 CFR part 14 would still need to be met. Section 9(b)(1) of the ESA provides an exemption from ESA threatened-species prohibitions only, not from requirements that arise under CITES and the general import/export requirements under the ESA.

Section 10(h) of the ESA provides an exemption for antique articles that are: (a) Not less than 100 years of age; (b) composed in whole or in part of any endangered species or threatened species; (c) have not been repaired or modified with any part of any such species on or after the date of the enactment of the ESA; and (d) are entered at a port designated for ESA antiques. Any person who is conducting activities with a qualifying ESA antique is exempt from, among other things, any restrictions provided in a 4(d) rule for that species, including restrictions on import; export; sale or offer for sale in interstate or foreign commerce; and delivery, receipt, carrying, transport, or shipment in interstate or foreign commerce and in the course of a commercial activity. The taking prohibition would not apply to dead specimens such as antiques. Anyone wishing to engage in activities under this antiques exception must be able to demonstrate that the item meets the requirements of the ESA.

Items that qualify as antiques under the ESA are not subject to the prohibitions in the proposed 4(d) rule. The ESA antiques exemption does not apply, however, to prohibitions imposed under the AfECA on the import of raw and worked African elephant ivory into the United States and the export of raw ivory from the United States. As with the ESA section 9(b)(1) “pre-Act” exemption, nothing in the ESA provides that an exemption under that law modifies or supersedes provisions in other applicable statutes such as the AfECA. The provisions in the AfECA regarding the import and certain export of African elephant ivory were specifically enacted to address conservation concerns with African elephants and were enacted later in time than the earlier, more general ESA exemption applicable to all endangered and threatened species, so the later, more specific restrictions on import and export in the AfECA take precedence over the earlier, more general exemption in the ESA. As noted previously, section 4241 of the AfECA (16 U.S.C. 4241) specifies that the authority of the Service under the AfECA is in addition to and does not affect the authority of the Service under the ESA.

A qualifying ESA antique containing African elephant ivory could thus only be imported if it also qualified for one of the exceptions from enforcement of the AfECA moratorium created by Director's Order No. 210: antique raw or worked ivory for law enforcement purposes, antique raw or worked ivory for scientific purposes, antique worked ivory that is part of a musical instrument, antique worked ivory in a traveling exhibition, antique worked ivory that is part of a household move, or antique worked ivory that was inherited. As noted previously, we believe these exceptions are consistent with Congressional intent in enacting the AfECA, which focused on the harm caused by poaching to supply the illegal trade in ivory. An antique sport-hunted trophy could not qualify for import because it would not be able to meet the requirements under the AfECA that it was taken from an elephant range country with an elephant quota declared to the CITES Secretariat (which did not exist 100 years ago). Because the prohibition on the export of all raw ivory is under the AfECA, the ESA antique exemption also could not be used to export antique raw ivory.

For qualifying ESA antiques containing African elephant ivory that could be imported as described above and antiques containing African elephant ivory that meet all of the requirements under section 10(h) of the ESA and were imported before the AfECA import moratorium was put in place in 1989, whether those antiques could be commercialized in interstate or foreign commerce would depend on whether restrictions are based on the ESA or CITES. Any restrictions that are based on CITES or laws other than the ESA would remain in place.

As discussed earlier, one of the requirements to qualify for the ESA antiques exemption is that the antique must have been imported into the United States through a port designated for the import of ESA antiques. These ports were first designated on September 22, 1982. Therefore, under the terms of the ESA, no item that contains parts of any endangered or threatened species (including African elephant ivory) can qualify under the ESA antiques exemption unless it was imported into the United States through one of the designated ESA antiques ports on some date after September 22, 1982.

On February 25, 2014 (as amended on May 15, 2014), the Service issued Director's Order No. 210, which, among other things, provides direction to Service employees on implementation and enforcement of the ESA antiques exemption. Appendix A to Director's Order No. 210 reiterates the four statutory requirements for an item to qualify as an ESA antique and states that, as a matter of law enforcement discretion, the prohibitions under the ESA would not be enforced for antiques that meet the requirements of being at least 100 years old; being composed of an endangered or threatened species; and not having been repaired or modified with any part of an endangered or threatened species since December 28, 1973, but were imported prior to September 22, 1982, or were created in the United States and never imported and therefore do not meet the requirement of having been imported at a designated ESA antiques port. This Director's Order remains in place. The Service will apply its law enforcement discretion regarding otherwise qualifying antiques that were imported prior to September 22, 1982, or were produced in the United States and never imported, allowing them to be exported, sold or offered for sale in interstate or foreign commerce, and delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity, provided all other legal requirements are met. Appendix A of the Director's Order also contains guidance on documentation needed and other information for conducting activities with ESA antiques. Director's Order No. 210, as amended on May 15, 2014, including Appendix A can be found at http://www.fws.gov/policy/do210.html.

As described in Director's Order No. 210, the person claiming the benefit of the ESA antiques exemption must provide evidence to demonstrate that the item qualifies as an ESA antique. This evidence may include a qualified appraisal, documents that provide detailed provenance, and/or scientific testing. Since issuance of the Director's Order, we have heard from some people who are concerned about what the Service might require in terms of documentation or authentication of their antique items. We want to be clear that establishing provenance does not necessarily require destructive testing; there may be other ways to establish provenance, such as a qualified appraisal or another method that documents the age by establishing the origin of the item. We have listed scientific testing (in the Appendix to Director's Order No. 210) as an option for people who may want to make use of it in certain circumstance for certain items. However, this is only one option, in a suite of possible options. The provenance may be determined through a detailed history of the item, including but not limited to family photos, ethnographic fieldwork, or other information that authenticates the item and assigns the work to a known period of time or, where possible, to a known artist. Scientific testing could be necessary if there is no other way to establish the provenance of an item.

In addition, we want to be clear that we do not require scientific testing of the ivory components in a manufactured antique item. Where a person can demonstrate that an item, for example a table with ivory inlays, is older than 100 years, and that the table has not been repaired or modified with ivory (or any other threatened or endangered species) since December 28, 1973, the Service considers the age criteria in Section 10(h) to be met. We would not require testing of the ivory itself to determine its age. Of course, to qualify for the ESA antiques exemption a person must demonstrate that all four of the criteria in Section 10(h) of the ESA have been met.

We also want to clarify that these documentation requirements are not new. The ESA itself places the burden of proof on the person claiming the benefit of the exemption (Sec. 10(g)) and the Service has required documentation for antique items since the 1970s. This documentation requirement is also not unique to African elephant ivory; it applies to specimens of any species listed under the ESA when a person is claiming the benefit of this exemption from prohibitions. Over the years, the Service has provided information regarding acceptable documentation for establishing age and provenance; most recently, in the Appendix to Director's Order No. 210. Our CITES regulations at 50 CFR 23.34 also provide information on the kinds of records a person can use to show the origin of a specimen. We seek comment from the public on whether additional guidance is needed in the regulatory code regarding implementation of the ESA antiques exemption.

Section 4(d) of the ESA states that the “Secretary shall issue such regulations as [s]he deems necessary and advisable to provide for the conservation” of species listed as threatened. Additionally, section 4(d) of the ESA provides that the Secretary “may by regulation prohibit with respect to any threatened species any act prohibited under section 9(a)(1).” Thus regulations promulgated under section 4(d) of the ESA provide the Secretary, as delegated to the Service, discretion to select appropriate provisions for threatened species, including prohibitions, exceptions, and required authorizations. Some of the ESA prohibitions and exceptions from section 9(a)(1) of the ESA and from 50 CFR 17.31 and 17.32 may be appropriate for the species and be incorporated into a 4(d) rule. However, the 4(d) rule may also include other provisions that take into account other applicable laws and are tailored to the specific conservation needs of the listed species, and therefore may be more or less restrictive than the general provisions for threatened species. As noted by Congress when the ESA was initially enacted, “once an animal is on the threatened list, the Secretary has an almost infinite number of options available to [her] with regard to the permitted activities for those species. [She] may, for example, permit taking, but not importation of such species, or [she] may choose to forbid both taking and importation but allow the transportation of such species,” as long as the measures will “serve to conserve, protect, or restore the species concerned in accordance with the purposes of the [ESA]” (H.R. Rep. No. 412, 93rd Cong., 1st Sess. 1973).

This proposed rule includes appropriate provisions that are necessary and advisable to provide for the conservation of the African elephant, while also including appropriate prohibitions from Section 9(a)(1) of the ESA. The primary threat to the African elephant is poaching of elephants for their tusks and the associated illegal trade in both raw and worked ivory. To restrict this illegal trade, the proposed provisions under this rule prohibit the import of African elephant ivory, with certain narrow exceptions, restrict the import of sport-hunted trophies, and prohibit the export of raw ivory. The rule provides two exceptions from the prohibition on import of ivory that would directly benefit law enforcement efforts that involve African elephants and science that would contribute to the conservation of the species. The rule provides three additional exceptions, which apply to the noncommercial import or export of worked ivory only, for qualifying musical instruments, items in a traveling exhibition, inherited items, and items that are part of a household move. Any worked ivory imported or exported under these exceptions would need to meet strict criteria under both CITES and this rule, resulting in restrictions that safeguard against import or export of ivory that could contribute to the illegal trade in ivory or pose a risk to elephant populations. The import and export of ivory is also subject to applicable restrictions under the AfECA, except to the extent allowed under Director's Order No. 210, as amended on May 15, 2014. Our information indicates that these strict controls on the import and export of African elephant ivory will help to ensure that U.S. participation in the ivory trade will not contribute to the illegal killing of elephants.

For the same reasons that the import and export of raw and worked ivory need to be carefully regulated, the import and export of African elephant sport-hunted trophies must be regulated in a manner that would ensure that the import and export does not contribute to the illegal trade of ivory. The proposed rule would require that the import of all sport-hunted trophies, regardless of the CITES status of the source population, be authorized through the issuance of a threatened species permit under 50 CFR 17.32. Authorizing importation through threatened species enhancement permits would allow us to more carefully evaluate trophy imports in accordance with legal requirements and the conservation needs of the species. The limitation of two trophies per hunter per year would ensure that the importation of African elephant trophies is actually the result of personal, noncommercial sport hunting and would prevent the importation of commercial quantities of ivory.

Perhaps the biggest change from the current 4(d) rule would be new restrictions on the commercialization of ivory in interstate and foreign commerce. The proposed rule would prohibit the sale or offer for sale of ivory and sport-hunted trophies in interstate or foreign commerce and the delivery, receipt, carrying, transport, or shipment of ivory and sport-hunted trophies in interstate or foreign commerce in the course of a commercial activity. Exceptions would be available for qualifying antiques and for certain items manufactured before the date of the final rule for this rulemaking that contain less than 200 grams of ivory and meet other conditions, while certain commercial activities could also be authorized through a threatened species permit under 50 CFR 17.32. However, the de minimis exception and threatened species permits would not be available for sport-hunted trophies and ivory items that were imported as part of a household move or inheritance. We have determined that items meeting the de minimis exception, including the requirements that the ivory be a fixed component of a larger manufactured item, that the ivory is not raw, that the ivory is not the primary source of value of the item, that the total weight of the ivory is less than 200 grams, and that the manufactured item is not made wholly or primarily of ivory, would minimize the possibility of the ivory contributing to either the global or U.S. markets in illegal ivory.

The proposed rule, however, would continue to allow certain activities that pose no risk to African elephants. Live elephants and elephant parts or products other than ivory and sport-hunted trophies could continue to be imported into or exported from the United States, sold or offered for sale in interstate or foreign commerce, and delivered, received, carried, transported, or shipped in interstate or foreign commerce in the course of a commercial activity, provided all other requirements under CITES and the Service's general import/export regulations were met. CITES requirements, including findings that must be made before documents can be issued, would continue to ensure that all import and export of live animals and parts or products other than ivory and sport-hunted trophies remain legal and non-detrimental to the survival of the species. There is no information that indicates that import, export, or commercialization of live elephants or non-ivory parts and products as currently regulated under CITES has any negative effect on African elephants or is contributing in any way to the current crisis involving the killing of elephants for their ivory. The new restriction on the taking of live elephants held in captivity within the United States or during transport would help to ensure that animals in captivity receive an appropriate standard of care.

In addition to this proposed rule being necessary and advisable to provide for the conservation of the species and including appropriate prohibitions from section 9(a)(1) of the ESA, it also is consistent with other efforts to improve elephant conservation. With this rule, the United States would ensure that we have in place comprehensive internal regulatory and enforcement measures to regulate domestic trade in raw and worked ivory, as called for at the 16th meeting of the Conference of the Parties to CITES in March 2013 (see Resolution Conf. 10.10 (Rev. CoP16)). More broadly, the proposed rule would respond to the President's Executive Order of July 1, 2013, calling for all Federal agencies to take action to combat wildlife trafficking in all wildlife and to reduce demand for illegally traded wildlife, both at home and abroad. All of the proposed revisions to the African elephant 4(d) rule would allow us to better regulate the U.S. domestic market and U.S. participation in the global market for African elephant ivory, which we believe will lead to a reduction of the illegal killing of elephants for their ivory.

Regulatory Planning and Review: Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is significant because it may raise novel legal or policy issues. Executive Order 13563 reaffirms the principles of Executive Order 12866 while calling for improvements in the Nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The Executive Order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

A brief assessment to identify the economic costs and benefits associated with this proposed rule follows. The Service has prepared an economic analysis, as part of our review under the National Environmental Policy Act (NEPA), which we will make available for review and comment (see the paragraph in this Required Determinations section on the National Environmental Policy Act). The proposed rule would revise the 4(d) rule, which regulates trade of African elephants (Loxodonta africana), including African elephant parts and products. We are proposing to revise the 4(d) rule to more strictly control U.S. trade in African elephant ivory. Revision of the 4(d) rule as proposed would mean that African elephants are subject to some of the standard provisions for species classified as threatened under the ESA. This means that the taking of live elephants and (with certain exceptions) import, export, and commercial activities in interstate or foreign commerce of African elephant parts and products containing ivory would generally be prohibited without a permit issued under 50 CFR 17.32 for “Scientific purposes, or the enhancement of propagation or survival, or economic hardship, or zoological exhibition, or educational purposes, or incidental taking, or special purposes consistent with the purposes of the [ESA].” There are specific exceptions for certain activities with specimens containing de minimis quantities of ivory; ivory items that meet certain requirements for musical instruments, traveling exhibitions, inherited items, and items that are part of a household move; ivory imported or exported for scientific purposes or law enforcement; certain live elephants; and ivory items that qualify as “pre-Act” or as antiques under the ESA.

This rule would regulate only African elephants and African elephant ivory. Asian elephants and parts or products from Asian elephants, including ivory, are regulated separately under the ESA. Ivory from other species such as walrus is also regulated separately under the Marine Mammal Protection Act (16 U.S.C. 1361 et seq.). Ivory from extinct species such as mammoths is not regulated under statutes implemented by the Service.

Impacted markets include those involving U.S. citizens or other persons subject to the jurisdiction of the United States that buy, sell, or otherwise commercialize African elephant ivory products across State lines and those that buy, sell, or otherwise commercialize such specimens in international trade. Examples of products in trade containing African elephant ivory include cue sticks, pool balls, knife handles, gun grips, furniture inlay, jewelry, artwork, and musical instrument parts.

The market for African elephant products, including ivory, is not large enough to have major data collections or reporting requirements, which results in a limited amount of available data for economic analysis. Some import and export data are available from the Service's Office of Law Enforcement and Division of Management Authority, and from reports produced by other organizations. On the whole, the available data provide a general overview of the African elephant ivory market. Using this information, we can make reasonable assumptions to approximate the potential economic impact of revision of the 4(d) rule for the African elephant. With this proposed rule, we solicit public input on impacts to sales, percentage of revenue impacted, and the number of businesses affected, particularly with regard to interstate and foreign commerce, for which we have the least amount of information, to help quantify these costs and benefits. Please see the Public Comments section at the end of SUPPLEMENTARY INFORMATION for further information about submitting comments.

Imports. There has been a moratorium on the import of African elephant ivory other than sport-hunted trophies, established under the AfECA and in place since 1989. In recent years, the Service has allowed, as a matter of law enforcement discretion, the import of certain antique African elephant ivory. Director's Order No. 210, issued in February 2014, clarified that we will no longer allow any commercial import of African elephant ivory, regardless of its age. We are proposing to reflect this provision of Director's Order No. 210 in the 4(d) rule (except for antiques, which are exempt from this 4(d) rule, but remain subject to the AfECA moratorium). Import of live African elephants and non-ivory African elephant parts and products would continue to be allowed under the proposed revisions, provided the requirements at 50 CFR parts 13, 14, and 23 are met. Import of African elephant sport-hunted trophies would be limited to two trophies per hunter per year. This may impact about seven hunters, representing about 3 percent to 4 percent of hunters, annually.

Exports. Under the current 4(d) rule, raw ivory may not be exported from the United States for commercial purposes under any circumstances. In addition, export of raw ivory from the United States is prohibited under the AfECA. Therefore, the revisions to the 4(d) rule would have no impact on exports of raw ivory. Revision of the 4(d) rule as proposed would mean that export of worked African elephant ivory would be prohibited without an ESA permit issued under 50 CFR 17.32, except for specimens that qualify as “pre-Act” or as ESA antiques and certain musical instruments; items in a traveling exhibition; items that are part of a household move or inheritance; items exported for scientific purposes; and items exported for law enforcement purposes that meet specific conditions and, therefore, may be exported without an ESA permit. Export of live African elephants and non-ivory products made from African elephants would continue to be allowed provided the requirements at 50 CFR parts 13, 14, and 23 are met.

From 2007 to 2011, the total declared value of worked African elephant ivory exported from the United States varied widely from $32.1 million to $175.7 million. The declared value of items containing African elephant ivory that were less than 100 years old (and, therefore, could not qualify as ESA antiques) ranged from $607,000 to $3.7 million annually during the same time period. As this rule would no longer permit the commercial export of non-antique ivory, we expect based on the information currently available that, on average, commercial export of worked ivory would decrease by about 2 percent annually.

Domestic and Foreign Commerce. The proposed rule would prohibit certain commercial activities such as sale in interstate or foreign commerce of African elephant ivory and delivery, receipt, carrying, transport, or shipment of ivory in interstate or foreign commerce in the course of a commercial activity (except for qualifying ESA antiques and certain manufactured items containing de minimis amounts of ivory) without an ESA permit issued under 50 CFR 17.32. Otherwise, commercial activities in interstate and foreign commerce with live African elephants and African elephant parts and products other than ivory would continue to be allowed under the proposed revisions to the 4(d) rule. While revisions to the 4(d) rule would generally result in prohibitions on sale or offer for sale in interstate or foreign commerce as well as prohibitions on delivery, receipt, carrying, transport, or shipment in interstate or foreign commerce in the course of a commercial activity of both raw and worked African elephant ivory, it would not have an impact on intrastate commerce. Businesses would not be prohibited by the 4(d) rule from selling raw or worked ivory within the State in which they are located. (There are, however, restrictions under our CITES regulations at 50 CFR 23.55 for intrastate sale of elephant ivory.) As noted earlier, available data provide only a general overview of the African elephant ivory market. Assuming that the domestic market is similar to the export market, then non-antique worked ivory domestic sales would also decrease about 2 percent annually under the proposed rule. We request information from the public about the potential impact to the domestic market. Because we are proposing to allow domestic and foreign commerce commercial activities with certain items containing de minimis amounts of ivory, and many of these items would be precluded from export, it is possible that an even smaller percentage of the domestic market would be impacted compared to the export market. Certain commercial activities such as sale in interstate or foreign commerce with raw ivory and non-antique worked ivory, with the exception of those items containing de minimis amounts of worked ivory mentioned above, would no longer be permitted.

Revising the 4(d) rule for African elephant, as proposed here, would improve domestic regulation of the U.S. market as well as foreign markets where commercial activities involving elephant ivory are conducted by U.S. citizens and facilitate enforcement efforts within the United States. We are proposing to take this action to increase protection for African elephants in response to the alarming rise in poaching of African elephants, which is fueling the rapidly expanding illegal trade in ivory. As noted in the preamble to this proposed rule, the United States continues to play a role as a destination and transit country for illegally traded elephant ivory. Increased control of the U.S. domestic market and foreign markets where commercial activities involving elephant ivory are conducted by U.S. citizens would benefit the conservation of the African elephant.

Regulatory Flexibility Act: Under the Regulatory Flexibility Act (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever a Federal agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions) (5 U.S.C. 601 et seq.). However, no regulatory flexibility analysis is required if the head of an agency certifies that the rule would not have a significant economic impact on a substantial number of small entities. Thus, for a regulatory flexibility analysis to be required, impacts must exceed a threshold for “significant impact” and a threshold for a “substantial number of small entities.” See 5 U.S.C. 605(b). SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule would not have a significant economic impact on a substantial number of small entities.

The U.S. Small Business Administration (SBA) defines a small business as one with annual revenue or employment that meets or is below an established size standard. To assess the effects of the rule on small entities, we focus on businesses that buy or sell elephant ivory. Businesses produce a variety of products from elephant ivory including cue sticks, pool balls, knife handles, gun grips, furniture inlay, jewelry, and instrument parts. Depending on the type of product produced, these businesses could be included in a number of different industries, including (1) Musical Instrument Manufacturing (North American Industry Classification System (NAICS) 339992), where small businesses have less than $10.0 million revenue; (2) Sporting and Recreational Goods and Supplies Merchant Wholesalers (NAICS 423910), where small businesses have fewer than 100 employees; (3) All Other Miscellaneous Wood Product Manufacturing (NAICS 321999), where small businesses have fewer than 500 employees; (4) Metal Kitchen Cookware, Utensil, Cutlery, and Flatware (except Precious) Manufacturing (NAICS 332215), where small businesses have fewer than 500 employees; (5) Jewelry and Silverware Manufacturing, (NAICS 339910), where small businesses have fewer than 500 employees; (6) Used Merchandise Stores (NAICS 453310), where small businesses have less than $7.5 million in revenue; and (7) Art Dealers (NAICS 453920), where small businesses have less than $7.5 million in revenue. Table 2 describes the number of businesses within each industry and the estimated percentage of small businesses. The U.S. Economic Census does not capture the detail necessary to determine the number of small businesses that are engaged in commerce with African elephant ivory products within these industries. Based on the distribution of small businesses with these industries as shown in Table 2, we expect that the majority of the entities involved with trade in African elephant ivory would be considered small as defined by the SBA.

The impact on individual businesses is dependent on the percentage of interstate and export sales that involve non-antique African elephant ivory that would not fall under the de minimis exception. That is, the impact depends on where businesses are located, where their customers are located, and the kinds of items containing ivory that they sell. Information on business profiles to determine the percent of revenues affected by the rule is currently unavailable. Overall, we estimate that worked ivory exports would decrease about $2.1 million annually, which represents about 2 percent of the total declared value of worked ivory exported from 2007 to 2011. We also expect that domestic sales would decrease by about 2 percent annually. Because we are proposing to allow domestic commercial activities with certain items containing de minimis amounts of ivory, and many of these items would be precluded from export, it is possible that an even smaller percentage of the domestic market would be impacted compared to the export market.

Based on the available information, we do not expect these changes to have a substantial impact on small entities within the five affected industries listed above. We, therefore, certify that this proposed rule would not have a significant economic effect on a substantial number of small entities as defined under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). A Regulatory Flexibility Analysis is not required. Accordingly, a Small Entity Compliance Guide is not required.

This proposed rule would create no substantial fee or paperwork changes in the permitting process. The regulatory changes would require issuance of ESA permits for import of sport-hunted African elephant trophies. We estimate that we would issue 300 ESA permits per year for these sport-hunted trophies, with a fee of $100 per permit. These changes are not major in scope and would create only a modest financial or paperwork burden on the affected members of the general public. The authority to regulate activities involving ESA-listed species already exists under the ESA and is carried out through regulations contained in 50 CFR part 17.

Small Business Regulatory Enforcement Fairness Act: This proposed rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

a. Would not have an annual effect on the economy of $100 million or more. This proposed rule revises the 4(d) rule for African elephant, which makes the African elephant subject to the same of the provisions applied to other threatened species not covered by a 4(d) rule, with certain exceptions. This proposed rule would not have a negative effect on this part of the economy. It would affect all importers, exporters, re-exporters, and domestic and certain traders in foreign commerce of African elephant ivory equally, and the impacts would be evenly spread among all businesses, whether large or small. There is not a disproportionate impact for small or large businesses.

b. Would not cause a major increase in costs or prices for consumers; individual industries; Federal, State, tribal, or local government agencies; or geographic regions.

c. Would not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

Unfunded Mandates Reform Act: Under the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.):

a. This proposed rule would not significantly or uniquely affect small governments. A Small Government Agency Plan is not required. The proposed rule imposes no unfunded mandates. Therefore, this proposed rule would have no effect on small governments' responsibilities.

b. This proposed rule would not produce a Federal requirement of $100 million or greater in any year and is not a “significant regulatory action” under the Unfunded Mandates Reform Act.

Takings: Under Executive Order 12630, this proposed rule does not have significant takings implications. While certain activities that were previously unregulated would now be regulated, possession and other activities with African elephant ivory such as sale in intrastate commerce would remain unregulated. A takings implication assessment is not required.

Federalism: These proposed revisions to part 17 do not contain significant Federalism implications. A federalism summary impact statement under Executive Order 13132 is not required.

Civil Justice Reform: Under Executive Order 12988, the Office of the Solicitor has determined that this proposed rule does not unduly burden the judicial system and meets the requirements of sections 3(a) and 3(b)(2) of the Order.

Paperwork Reduction Act: This proposed rule does not contain new collections of information that require approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). OMB has reviewed and approved the information collection requirements associated with applications and reporting for CITES and ESA permits and assigned OMB Control No. 1018-0093, which expires May 31, 2017. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

National Environmental Policy Act (NEPA): This proposed rule is being analyzed under the criteria of the National Environmental Policy Act, the Department of the Interior procedures for compliance with NEPA (Departmental Manual (DM) and 43 CFR part 46), and Council on Environmental Quality regulations for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508). We have prepared a draft environmental assessment to determine whether this rule will have a significant impact on the quality of the human environment under the National Environmental Policy Act of 1969. The draft environmental assessment is available online at http://www.regulations.gov at Docket Number FWS-HQ-IA-2013-0091.

Government-to-Government Relationship with Tribes: The Department of the Interior strives to strengthen its government-to-government relationship with Indian tribes through a commitment to consultation with Indian tribes and recognition of their right to self-governance and tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on federally recognized Indian tribes and that consultation under the Department's tribal consultation policy is not required. Individual tribal members must meet the same regulatory requirements as other individuals who trade in African elephants, including African elephant parts and products.

Energy Supply, Distribution, or Use: Executive Order 13211 pertains to regulations that significantly affect energy supply, distribution, or use. This proposed rule would revise the current regulations in 50 CFR part 17 regarding trade in African elephants and African elephant parts and products. This proposed rule would not significantly affect energy supplies, distribution, and use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.

Clarity of the Rule: We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(a) Be logically organized;

(b) Use the active voice to address readers directly;

(c) Use clear language rather than jargon;

(d) Be divided into short sections and sentences; and

(e) Use lists and tables wherever possible.

If you feel that we have not met these requirements, please send us comments by one of the methods listed under ADDRESSES. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

We are seeking comments on the impact of the provisions in this proposed rule on the affected public. You may submit your comments and materials concerning this proposed rule by one of the methods listed under ADDRESSES. We will not accept comments sent by email or fax or to an address not listed under ADDRESSES.

We will post your entire comment—including your personal identifying information—on http://www.regulations.gov. If you provide personal identifying information in your written comments, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, between 8 a.m. and 4 p.m., Monday through Friday, except Federal holidays, at the U.S. Fish and Wildlife Service; Division of Management Authority; 5275 Leesburg Pike; Falls Church, VA 22041; telephone, (703) 358-2093.

A list of references cited is available online at http://www.regulations.gov at Docket Number FWS-HQ-IA-2013-0091.

For the reasons given in the preamble, we propose to amend title 50, chapter I, subchapter B of the Code of Federal Regulations as follows: