Federal Register Vol. 80, No.244,

This rule requires official establishments and retail stores that grind raw beef for sale in commerce to maintain specific information about their grinding activities. This rule is necessary to improve FSIS's ability to accurately trace the source of foodborne illness outbreaks involving ground beef and to identify the source materials that need to be recalled. The recordkeeping requirements in this final rule will greatly assist FSIS in doing so.

FSIS has often been impeded in its efforts to trace ground beef products back to a supplier because of the lack of documentation identifying all source materials used in their preparation. On July 22, 2014, FSIS published a proposed rule (79 FR 42464) to require official establishments and retail stores to maintain records concerning their suppliers and source materials received. Having reviewed and considered all comments received in response to the proposed rule, FSIS is finalizing the rule and making several changes in response to comments. Most of the proposed requirements are retained in this final rule. This final rule requires establishments and retail facilities that grind raw beef to keep the following records: The establishment numbers of the establishments supplying the materials used to prepare each lot of raw ground beef; all supplier lot numbers and production dates; the names of the supplied materials, including beef components and any materials carried over from one production lot to the next; the date and time each lot of raw ground beef is produced; and the date and time when grinding equipment and other related food-contact surfaces are cleaned and sanitized. These requirements also apply when official establishments and retail stores grind new source materials at an individual customer's request.

In response to comments, FSIS is not adopting two proposed requirements. First, under this final rule, establishments and retail stores that grind raw beef products will not have to maintain records concerning the weight of each source component used in a lot of ground beef. After considering comments, FSIS concluded that weighing each component in a lot of ground beef was time-consuming and offered little food safety benefit because contamination in a lot of ground beef is not dependent on the weight of any contaminated component. FSIS is also not requiring that establishments and stores that grind raw beef products maintain records of the names, points of contact, and phone numbers of each official establishment supplying source material because FSIS already has this information in its Public Health Information System (PHIS). Any marginal benefit presented by these two proposed requirements would be outweighed by the time burden associated with recording the information. In response to comments, this rule also differs from the proposed rule in terms of the place where the records must be maintained and the retention period. Under the proposed rule, based on existing recordkeeping requirements (9 CFR 320.1), establishments and retail stores would have been allowed to keep the required records at a business headquarters location if the grinding activity is conducted at multiple locations. In response to comments, however, this rule requires the grinding records to be kept at the location where the beef is ground. This change in the final rule will save investigators valuable time and will reduce the risk that records will be lost or misplaced. Finally, in response to comments, for purposes of this rule, FSIS is including the definition of a lot as set out in the regulatory text at the end of this document (9 CFR 320.1(b)(4)(iii)).

Under the proposed rule, based on existing regulations (9 CFR 320.3(a)), the required grinding records would have been required to be maintained for up to three years. However, in response to comments, FSIS concluded that because the records required by this rule are needed primarily to investigate foodborne illness outbreaks, their utility diminishes over time. FSIS consulted with its investigators and public health experts and determined that the records would rarely be needed after one year. Considering this fact and comments concerning the burden of keeping records on-site, particularly at retail stores, FSIS shortened the retention period in the final rule to one year after the date of the recorded grinding activity.

The final rule will result in storage and labor costs to official establishments and retail stores that grind raw beef for sale in commerce. Benefits will accrue in terms of averted foodborne illnesses, less costly outbreaks and recalls, and increased consumer confidence when purchasing ground beef. These costs and benefits are listed in Table 1.

Under the authority of the Federal Meat Inspection Act (FMIA) and its implementing regulations (9 CFR 329.1 and 329.6), FSIS investigates reports of consumer foodborne illness associated with FSIS-regulated products. FSIS investigators and other public health officials use records kept at all levels of the food distribution chain, including the retail level, to identify the sources of outbreaks.

FSIS has often been impeded in these efforts when an outbreak involves ground beef because of a lack of documentation identifying all source materials used in its preparation (79 FR 42464). In some situations, official establishments and retail stores have not kept adequate records that would allow effective traceback and traceforward activities. Without such records, FSIS cannot conduct timely and effective consumer foodborne illness investigations and other public health activities throughout the stream of commerce.

As FSIS also explained in the proposed rule, official establishments and retail stores that grind raw beef products for sale in commerce must keep records that will fully and correctly disclose all transactions involved in their business that are subject to the FMIA (see 21 U.S.C. 642) (79 FR 42465). Businesses must also provide access to, and permit inspection of, these records by FSIS personnel.

The proposed rule also explained that under 9 CFR 320.1(a), every person, firm, or corporation required by 21 U.S.C. 642 to keep records must keep records that will fully and correctly disclose all transactions involved in the aspects of their business that are subject to the FMIA. Records specifically required to be kept under 9 CFR 320.1(b) include, but are not limited to, bills of sale, invoices, bills of lading, and receiving and shipping papers. With respect to each transaction, the records must provide the name or description of the livestock or article, the number of outside containers, the name and address of the buyer or seller of the livestock or animal, and the date and method of shipment.

The recordkeeping requirements contained in the FMIA and 9 CFR part 320 are intended to permit FSIS to trace product, including raw ground beef product associated with consumer foodborne illness, from the consumer, or the place where the consumer purchased the product, back through its distribution chain to the establishment that was the source of the product. Having this information available will make it easier to determine where the contamination occurred. Investigators should also be able to conduct effective traceforward investigations so as to identify other potentially contaminated product that has been shipped from the point of origin of its contamination to other official establishments, retail stores, warehouses, distributors, restaurants, or other firms. FSIS must be able to carry out these investigations using records that should be kept routinely by official establishments and retail stores.

In the proposed rule, FSIS explained past efforts it has made to ensure that official establishments and retail stores that produce raw ground beef maintain necessary records. For example, the proposal explained that in 2002, FSIS published a Federal Register notice that listed the data that FSIS intended to collect when any samples of raw ground beef produced at an official establishment tested positive for E. coli O157:H7 (67 FR 62325, Oct. 7, 2002). FSIS also listed the information it intended to gather from retail stores at the time it collected a sample of raw ground beef for E. coli O157:H7 testing.

In the proposed rule in the present rulemaking, FSIS explained that shortly after issuing the 2002 Federal Register notice, the Agency began collecting the information listed in the Federal Register notice from official establishments and retail stores (79 FR 42465).1 However, as the proposal explained, some retail stores and official establishments still did not maintain records sufficient for traceback, and some retail stores did not document or maintain supplier information at times other than when FSIS collected samples of ground raw beef product from the stores for E. coli O157:H7 testing.2 As a result, FSIS was, and remains, disadvantaged in its foodborne disease investigations.

In 2009, FSIS provided guidance to a retail industry association, which was made available on the FSIS Web site, stating that retail stores should keep appropriate records to aid in investigations involving FSIS-regulated products associated with foodborne illnesses and other food safety incidents.

To further address the issue, on December 9-10, 2009, the Food and Drug Administration (FDA) and FSIS held a public meeting to discuss the essential elements of product tracing systems, gaps in then-current product tracing systems, and mechanisms to enhance product tracing systems for food.3 This meeting was followed on March 10, 2010, by an FSIS public meeting that discussed its procedures for identifying suppliers of source material used to produce raw beef product that FSIS found positive for E. coli O157:H7. FSIS sought input from meeting participants on ways to improve its procedures for identifying product that may be positive for E. coli O157:H7.

Despite these actions, as explained in the proposed rule, some official establishments and retail stores still did not keep and maintain the records necessary for effective investigation by FSIS. With this history in mind, FSIS conducted a retrospective review of 28 foodborne disease investigations from October 2007 through September 2011 in which beef products were ground or re-ground at retail stores.4 When records were available and complete, enabling FSIS to identify specific production in an official establishment, the Agency was able to request a recall of product from the supplying establishment in six of eleven investigations. In contrast, when records were not available or incomplete, FSIS was able to request a product recall only two of seventeen times. These results confirmed FSIS's experience in specific cases where the presence of records at the retail level was often instrumental in identifying the source of an outbreak, as well as the implicated products that should be recalled. The proposed rule includes a fuller description of this review, including specific examples (79 FR 42464).

Since the review in the proposed rule, FSIS has completed nine ground beef outbreak investigations. Of these nine investigations, grinding records were available and complete in four of them and incomplete or not available in five. When records were available and complete, FSIS was able to request a recall of product from the supplying establishment in one of four investigations. For the remaining three, two led to store level recalls. For these two, FSIS did not request recalls at supplier establishments because in one investigation, the trim for retail product had over ten suppliers, and in the other, FSIS was not able to narrow down the list of suppliers because the retailer did not clean up in between grinding different products. FSIS did not request a recall for the third case in which records were available and complete because there were multiple products and multiple federal establishments involved, and FSIS was not able to identify the product associated with the illnesses or the supplying establishment. In the five investigations where records were not available or incomplete, FSIS was unable to request a recall from a supplying establishment.

The investigations reviewed in the proposed rule, and those reviewed since the proposed rule, confirm the Agency's findings that the records kept by official establishments and retail stores vary in type and quality and are often incomplete or inaccurate. Overall, FSIS has concluded that voluntary recordkeeping by retail stores that grind raw beef has been insufficient, as evidenced by continuing outbreaks linked to pathogens in raw ground beef that FSIS cannot trace back to the source. The lack of specific information about supplier lot numbers, product codes, production dates, and the cleaning and sanitizing of grinding equipment has prevented or delayed FSIS in identifying the source of outbreaks, as well as other product that might be adulterated. The cleaning and sanitizing of equipment used to grind raw beef is important because it prevents the transfer of E. coli O157:H7 and other bacteria from one lot of product to another.

On July 22, 2014 (79 FR 42464), FSIS proposed to amend the Federal meat inspection regulations to require that all official establishments and retail stores that grind raw beef for sale keep records disclosing the following: The names, points of contact, phone numbers, and establishment numbers of suppliers of source materials used in the preparation of each lot of raw ground beef; the names of each source material, including any components carried over from one production lot to the next; the supplier lot numbers and production dates; the weight of each beef component used in each lot (in pounds); the date and time each lot was produced; and the date and time when grinding equipment and other related food-contact surfaces were cleaned and sanitized. FSIS also proposed that official establishments and retail stores would have to comply with these requirements with respect to raw beef products ground at an individual customer's request when new source materials are used.

FSIS posted the sample grinding log record below (Table 2) on its Web site in late 2011 and included it with the 2009 guidance and the proposed rule. FSIS proposed requiring the items in the sample record marked with asterisks. The proposed rule specifically stated that the information under the other column headings would not be required, but that some official establishments and retail stores might choose to keep and maintain this information.

The Dodd-Frank Act 1 provided for a substantial reorganization of the regulation of State and Federal savings associations and their holding companies. Beginning July 21, 2011, the transfer date established by section 311 of the Dodd-Frank Act, codified at 12 U.S.C. 5411, the powers, duties, and functions formerly performed by the OTS were divided among the FDIC, as to State savings associations, the Office of the Comptroller of the Currency (“OCC”), as to Federal savings associations, and the Board of Governors of the Federal Reserve System (“FRB”), as to savings and loan holding companies. Section 316(b) of the Dodd-Frank Act, codified at 12 U.S.C. 5414(b), provides the manner of treatment for all orders, resolutions, determinations, regulations, and advisory materials that had been issued, made, prescribed, or allowed to become effective by the OTS. The section provides that if such materials were in effect on the day before the transfer date, they continue to be in effect and are enforceable by or against the appropriate successor agency until they are modified, terminated, set aside, or superseded in accordance with applicable law by such successor agency, by any court of competent jurisdiction, or by operation of law.

Section 316(c) of the Dodd-Frank Act, codified at 12 U.S.C. 5414(c), further directed the FDIC and the OCC to consult with one another and to publish a list of the continued OTS regulations that would be enforced by the FDIC and the OCC, respectively. On June 14, 2011, the FDIC's Board of Directors approved a “List of OTS Regulations to be Enforced by the OCC and the FDIC Pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act.” This list was published by the FDIC and the OCC as a Joint Notice in the Federal Register on July 6, 2011.2

Although section 312(b)(2)(B)(i)(II) of the Dodd-Frank Act, codified at 12 U.S.C. 5412(b)(2)(B)(i)(II), granted the OCC rulemaking authority relating to both State and Federal savings associations, nothing in the Dodd-Frank Act affected the FDIC's existing authority to issue regulations under the Federal Deposit Insurance Act (“FDI Act”) and other laws as the “appropriate Federal banking agency” or under similar statutory terminology. Section 312(c) of the Dodd-Frank Act amended the definition of “appropriate Federal banking agency” contained in section 3(q) of the FDI Act, 12 U.S.C. 1813(q), to add State savings associations to the list of entities for which the FDIC is designated as the “appropriate Federal banking agency.” As a result, when the FDIC acts as the designated “appropriate Federal banking agency” (or under similar terminology) for State savings associations, as it does here, the FDIC is authorized to issue, modify and rescind regulations involving such associations, as well as for State nonmember banks and insured branches of foreign banks.

As noted, on June 14, 2011, pursuant to this authority, the FDIC's Board of Directors reissued and redesignated certain transferring regulations of the former OTS. These transferred OTS regulations were published as new FDIC regulations in the Federal Register on August 5, 2011.3 When it republished the transferred OTS regulations as new FDIC regulations, the FDIC specifically noted that its staff would evaluate the transferred OTS rules and might later recommend incorporating the transferred OTS regulations into other FDIC rules, amending them, or rescinding them, as appropriate.

One of the OTS rules transferred to the FDIC governs OTS oversight of management official interlocks in the context of State savings associations. The OTS rule, formerly found at 12 CFR part 563f, was transferred to the FDIC with only minor nonsubstantive changes and is now found in the FDIC's rules at 12 CFR part 390, subpart V (“part 390, subpart V”), entitled “Management Official Interlocks.” Before the transfer of the OTS rules and continuing today, the FDIC's rules contained 12 CFR part 348 (“part 348”), also entitled “Management Official Interlocks,” a rule governing FDIC oversight of management official interlocks with respect to IDIs for which the FDIC has been designated the appropriate Federal banking agency. After careful review and comparison of part 390, subpart V and part 348, the FDIC has decided to (1) rescind part 390, subpart V, because, as discussed below, it is substantively redundant to existing part 348; and (2) simultaneously make technical conforming edits to part 348.

On July 21, 2014, the FDIC published a Notice of Proposed Rulemaking (“NPR” or “Proposed Rule”) regarding the removal of part 390, subpart V, which governs management official interlocks for State savings associations and their affiliates.4 The former OTS rule was transferred to the FDIC with only nominal changes. The NPR proposed removing part 390, subpart V from the CFR in an effort to streamline FDIC regulations for all FDIC-supervised institutions. As discussed in the Proposed Rule, the FDIC carefully reviewed the transferred rule, part 390, subpart V, and compared it with part 348, an FDIC regulation that existed before the transfer of part 390, subpart V and that continues to remain in effect today. Like the transferred rule, part 348 governs management official interlocks for State nonmember insured banks and their affiliates. Although the two rules were substantively the same, minor technical and conforming amendments were proposed.

The FDIC proposed to modify the scope of part 348, section 348.1(c), to apply to “management officials of FDIC-supervised institutions and their affiliates” to conform to and reflect the scope of the FDIC's current supervisory responsibilities as the appropriate Federal banking agency. The FDIC also proposed to add two new definitions into section 348.2. A newly created subsection (i) would have defined an “FDIC-supervised institution” as “either an insured nonmember bank or a State savings association.” A newly created subsection (p) would have defined “State savings association” as having “the same meaning as in section 3(b)(3) of the Federal Deposit Insurance Act, 12 U.S.C. 1813(b)(3).” The proposal would also have inserted an exemption from part 390, subpart V, section 390.403(i), into a newly created subsection (j) of section 348.4. The exemption would have allowed certain interlocking relationships for any State savings association that has issued stock in connection with a qualified stock issuance pursuant to section 10(q) of the Home Owners' Loan Act (“HOLA”).

If these proposals are finalized, oversight of management official interlocks in part 348 will apply to all FDIC-supervised institutions, including State savings associations, and part 390, subpart V would be removed because it is largely redundant of those rules found in part 348. Rescinding part 390, subpart V will serve to streamline the FDIC's rules and eliminate unnecessary regulations.

The FDIC issued the NPR with a 60-day comment period, which closed on September 19, 2014. The FDIC received no comments on its Proposed Rule, and consequently the final rule (“Final Rule”) is adopted as proposed without any changes.

As discussed in the NPR, part 390, subpart V is substantively similar to part 348, and the designation of part 348 as a single authority of management official interlocks for all FDIC-supervised institutions will serve to streamline the FDIC's rules and eliminate unnecessary regulations. To that effect, the Final Rule removes and rescinds 12 CFR part 390, subpart V in its entirety.

Consistent with the Proposed Rule, the Final Rule also amends section 348.1(c) to modify the scope of part 348. The modified scope, reflecting the FDIC's current supervisory responsibilities as the appropriate Federal banking agency includes State savings associations and their subsidiaries. The Final Rule also adds two new definitions into section 348.2. A newly created subsection (i) would define an “FDIC-supervised institution” as “either an insured nonmember bank or a State savings association.” A newly created subsection (p) would define “State savings association” as having “the same meaning as in section 3(b)(3) of the Federal Deposit Insurance Act, 12 U.S.C. 1813(b)(3).” The Final Rule also inserts an exemption from part 390, subpart V, section 390.403(i), into a newly created subsection (j) of section 348.4. The exemption allows certain interlocking relationships for any State savings association that has issued stock in connection with a qualified stock issuance pursuant to section 10(q) of HOLA.

In accordance with the requirements of the Paperwork Reduction Act (“PRA”) of 1995, 44 U.S.C. 3501-3521, the FDIC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (“OMB”) control number. The information collections contained in part 348 are cleared by OMB under the FDIC's “Management Official Interlocks” information collection (OMB No. 3064-0118). The FDIC's burden estimates were updated in connection with the collection's 2012 renewal to include State savings associations transferred from the OTS to the FDIC. The FDIC reviewed its burden estimates for the collection at the time it assumed responsibility for supervision of State savings associations transferred from the OTS and determined that no changes to the burden estimates were necessary. This Final Rule does not modify the FDIC's existing collection and does not create any new collections of information pursuant to the PRA. Therefore, no information collection request has been submitted to the OMB for review.

The Regulatory Flexibility Act (“RFA”), 5 U.S.C. 601 et seq., generally requires an agency to consider whether a final rule will have a significant economic impact on a substantial number of small entities (defined in regulations promulgated by the Small Business Administration to include banking organizations with total assets of less than or equal to $550 million).5 Pursuant to section 605(b) of the RFA, a final regulatory flexibility analysis is not required if the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities, and publishes its certification and a short explanatory statement in the Federal Register together with the rule. For the reasons provided below, the FDIC certifies that the Final Rule will not have a significant economic impact on a substantial number of small entities. Accordingly, a regulatory flexibility analysis is not required.

As discussed in the notice of proposed rulemaking, part 390, subpart V was transferred from OTS part 563f, which governed management official interlocks. OTS part 563f had been in effect since 1979, and all State savings associations were required to comply with it. Because it is redundant of existing part 348 of the FDIC's rules, the FDIC proposes rescinding and removing part 390, subpart V. As a result, all FDIC-supervised institutions—including State savings associations and their affiliates—would be required to comply with part 348 for management official interlocks. Because all State savings associations and their affiliates have been required to comply with substantially similar management official interlocks rules since 1979, the FDIC certifies that the Final Rule will have no significant economic impact on small entities or State savings associations.

The Office of Management and Budget has determined that the Final Rule is not a “major rule” within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996 (“SBREFA”), 5 U.S.C. 801 et seq.

Section 722 of the Gramm-Leach-Bliley Act, 12 U.S.C. 4809, requires each Federal banking agency to use plain language in all of its proposed and final rules published after January 1, 2000. In the NPR, the FDIC invited comments on whether the Proposed Rule was clearly stated and effectively organized, and how the FDIC might make it easier to understand. Although the FDIC did not receive any comments, the FDIC sought to present the Final Rule in a simple and straightforward manner.

Under section 2222 of the Economic Growth and Regulatory Paperwork Reduction Act of 1996 (“EGRPRA”), the FDIC is required to review all of its regulations, at least once every 10 years, in order to identify any outdated or otherwise unnecessary regulations imposed on insured depository institutions.6 The FDIC completed the last comprehensive review of its regulations under EGRPRA in 2006 and is commencing the next decennial review, which is expected to be completed by 2016. The NPR solicited comments on whether the proposed rescission of part 390, subpart V and amendments to part 348 would impose any outdated or unnecessary regulatory requirements on insured depository institutions. No comments on this issue were received. Upon review, the FDIC does not believe that part 348, as amended by the Final Rule, imposes any outdated or unnecessary regulatory requirements on any insured depository institutions.

For the reasons stated in the preamble, the Board of Directors of the Federal Deposit Insurance Corporation amends parts 348 and 390 of title 12 of the Code of Federal Regulations as follows:

On December 16, 2015, the Department of Transportation and the Federal Aviation Administration published the interim final rule Registration and Marking Requirements for Small Unmanned Aircraft (80 FR 78593). That rule provided an alternative, streamlined and simple, web-based aircraft registration process for the registration of small unmanned aircraft, including small unmanned aircraft operated as model aircraft, to facilitate compliance with the statutory requirement that all aircraft register prior to operation.

That rule contained an information collection, Registration of Small Unmanned Aircraft. That information collection requirement had not been approved by OMB at the time of publication of the interim final rule.

In accordance with the Paperwork Reduction Act, the FAA submitted a copy of the new information collection requirements to OMB for its review. OMB approved the collection on December 16, 2015, and assigned the information collection OMB Control Number 2120-0765. This final rule provides the control number of that information collection and adds the information collection to the list of FAA's approved information collections in 14 CFR part 11.

In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Alpha Aviation Concept Limited Model R2160 airplanes. That NPRM was published in the Federal Register on September 25, 2015 (80 FR 57753), and proposed to supersede AD 2008-09-01, Amendment 39-15481 (73 FR 21519, April 22, 2008).

Since we issued AD 2008-09-01, Amendment 39-15481 (73 FR 21519, April 22, 2008), Alpha Aviation Concept Limited developed a longer life limit for the wing structure and wing attachments and transferred the life limit information from the related service information to the airplane maintenance manual. Subsequently, Alpha Aviation Concept Limited discovered that the analysis that allowed the life limit increase was incorrect and the previous life limit and inspection provisions of the related service bulletin should be retained.

The NPRM proposed to correct an unsafe condition for the specified products and was based on mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country. The Civil Aviation Authority (CAA), which is the aviation authority for New Zealand, has issued AD DCA/R2000/43, dated August 7, 2015 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states that:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 57753, September 25, 2015) or on the determination of the cost to the public.

We reviewed the relevant data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (80 FR 57753, September 25, 2015) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (80 FR 57753, September 25, 2015).

Alpha Aviation Concept Limited has revised its Alpha Aviation APEX R2000 Service Manual, S/N 001 to 378, and Alpha Aviation R2000 Service Manual. The updated service manuals include a revision to Section 3: Airworthiness Limitations, Time Limits, & Maintenance Inspections, Issued August 2015, that adds periodic internal wing structure and wing attachment inspections. These revisions to the Airworthiness Limitations section of the applicable service manuals are reasonably available because the interested parties have access to them through their normal course of business or by the means identified in the ADDRESSES section.

We estimate that this AD will affect 9 products of U.S. registry. We also estimate that it will take about 3 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour.

Based on these figures, we estimate the cost of this AD on U.S. operators to be $2,295, or $255 per product.

In addition, we estimate that any necessary follow-on actions will take about 12 work-hours and require parts costing $1,326, for a cost of $2,346 per product. We have no way of determining the number of products that may need these actions.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, and

(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-3956 or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

On November 19, 2015, BIA published a final rule addressing rights-of-way on Indian land and BIA land. See 80 FR 72492. Since publication, BIA has received comments from tribes and industry requesting an extension of the effective date of the rule in order to provide additional time to prepare for implementation to ensure compliance. This document extends the effective date of the final rule to March 21, 2016, and likewise extends the deadline for providing BIA with documentation of past assignments to July 17, 2016. The substance of the rule remains unchanged.

The BIA has determined that the extension of the effective date and compliance date without prior public notice and comment is in the public interest because it would allow more time for the public to comply with the rule and for BIA to implement the rule. This is a rule of agency procedure or practice that is exempt from notice and comment rulemaking under 5 U.S.C. 553(b)(A).

In FR Rule Doc. No. 2015-28548, published November 19, 2015, at 80 FR 72492, make the following corrections:

1. On page 72357, in the center and right columns, in revised § 169.7, remove the date “December 21, 2015” wherever it appears and add in its place “March 21, 2016”.

2. On page 72357, in the right column, in paragraph (d) of revised § 169.7, remove the date “April 18, 2016” and add in its place “July 17, 2016”.

The proposed rule was published in the Federal Register on February 27, 2014 (79 FR 11048-11050, Docket ID: DoD-2014-OS-0024). One comment was received. The writer raised a number of personal concerns (issues with neighbor, banking, and family). The issues identified have no relevance to the proposed exemption of the Identity Management Engine for Security and Analysis (IMESA) from portions of the Privacy Act.

Additionally, the title of the system has been changed from Interoperability Layer Service (IoLS) to Identity Management Engine for Security and Analysis (IMESA). This title change is reflected in the final rule.

It has been determined that this rule is not a significant rule. This rule does not:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive orders.

It has been determined that this rule does not have significant economic impact on a substantial number of small entities because it is concerned only with the administration of Privacy Act systems of records within the Department of Defense. A Regulatory Flexibility Analysis is not required.

This rule does not contain any information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

It has been determined that this rule does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and will not significantly or uniquely affect small governments.

Executive Order 13132 requires regulations be reviewed for Federalism effects on the institutional interest of states and local governments, and if the effects are sufficiently substantial, preparation of the Federal assessment is required to assist senior policy makers. The amendments will not have any substantial direct effects on state and local governments within the meaning of the EO. Therefore, no Federalism assessment is required.

Accordingly, 32 CFR part 311 is amended to read as follows:

The Canadian Pacific Railroad requested a temporary deviation for the Sabula Railroad Drawbridge, across the Upper Mississippi River, mile 535.0, at Sabula, Iowa to open on signal if at least 24-hours advance notice is given for 78 days from 7 a.m., December 16, 2015 until 7 a.m., March 4, 2016 for scheduled maintenance on the bridge.

The Sabula Railroad Drawbridge currently operates in accordance with 33 CFR 117.5, which states the general requirement that the drawbridge shall open on signal.

There are no alternate routes for vessels transiting this section of the Upper Mississippi River. The bridge cannot open in case of emergency.

Winter conditions on the Upper Mississippi River coupled with the closure of Army Corps of Engineer's Lock No. 13 (Mile 522.5 UMR) and Lock No. 21 (Mile 324.9 UMR) from 7 a.m. January 4, 2016 until 12 p.m., March 4, 2016 will preclude any significant navigation demands for the drawspan opening. In addition, Army Corps Lock No. 14 (Mile 493.3 UMR) and Lock No. 17 (Mile 437.1 UMR) will be closed from 7 a.m. December 14, 2015 until 12 p.m. March 2, 2016.

The Sabula Railroad Drawbridge provides a vertical clearance of 18.1 feet above normal pool in the closed-to-navigation position. Navigation on the waterway consists primarily of commercial tows and recreational watercraft and will not be significantly impacted. The drawbridge will open if at least 24-hours advance notice is given. This temporary deviation has been coordinated with waterway users. No objections were received.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The 7th Annual Quintiles Wrightsville Beach Marathon committee on behalf of the North Carolina Department of Transportation (NCDOT) has requested a temporary deviation from the current operating schedule for the SR 74 Bascule Drawbridge across the AIWW, mile 283.1, at Wrightsville Beach, NC. The requested deviation will accommodate the 7th Annual Quintiles Wrightsville Beach Marathon scheduled for Sunday, March 20, 2016. To facilitate this event, the draw of the bridge will be maintained in the closed-to-navigation position from 5 a.m. to 10:30 a.m. to allow race participants to cross during the scheduled event.

The current operation schedule is set out in 33 CFR 117.821(a)(4). The regulation requires the bridge to open on signal for vessels at all times except that from 7 a.m. until 7 p.m. the bridge shall open on the hour; every third and fourth Saturday in September the bridge shall remain closed from 7 a.m. until 11 a.m.; and the last Saturday of October or the first or second Saturday of November the bridge shall remain closed from 7 a.m. until 10:30 a.m. The bascule drawbridge has a vertical clearance of 20 feet above mean high water (MHW) in the closed position.

Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will be able to open for emergencies and there is no immediate alternate route for vessels. Most waterway traffic consists of recreational boats with a few barges and tugs during the daytime. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

National Passenger Railroad Corporation (Amtrak) requested this temporary deviation from the normal operating schedule to perform gear box replacement.

The Amtrak Old Saybrook-Old Lyme Bridge, mile 3.4, across the Connecticut River has a vertical clearance in the closed position of 19 feet at mean high water and 22 feet at mean low water. The existing bridge operating regulations are found at 33 CFR 117.205(b).

The waterway is transited by one commercial user and recreation vessel traffic.

Under this temporary deviation, the Amtrak Old Saybrook-Old Lyme Bridge may remain in the closed position from 7:00 a.m. on January 25, 2016 to 7:00 a.m. on January 30, 2016 with rain date from 7:00 a.m. on February 1, 2016 to 7:00 a.m. on February 6, 2016.

Vessels able to pass through the bridge in the closed positions may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternate route for vessels to pass.

The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:

On June 24, 2011, Illinois submitted a plan to address the requirements of the Regional Haze Rule, as codified at 40 CFR 51.308. EPA approved Illinois' Regional Haze SIP on July 6, 2012 (77 FR 39943). In its approval, EPA determined that the emission reductions from sources included in the Illinois plan are significantly greater than even conservative definitions of best available retrofit technology (BART) applied to BART subject units. Id. at 39946. EPA also addressed whether the Illinois plan can also be expected to achieve greater visibility protection than application of BART on BART-subject units. Given that, in general, the Illinois power plants are substantial distances from any Class I area, and given that the averaging in Illinois' plan is only authorized within the somewhat limited region within which each utility's plants are located, EPA determined that a reallocation of emission reductions from one plant to another is unlikely to change the visibility impact of those emission reductions significantly. Consequently, EPA concluded that the significantly greater emission reductions that Illinois required in its Regional Haze SIP will yield greater progress toward visibility protection as compared to the benefits of a conservative estimate of BART.

One of the rules approved in that action to meet BART requirements is 35 Illinois Administrative Code (Ill. Adm. Code) rule 225.233, Multi-Pollutant Standard (MPS), specifically subsections (a), (b), (e), and (g). Section 225.233(e)(3)(C) contains the sulfur dioxide (SO2) emission standards applicable to the Ameren MPS Group. Section 225.233(e)(3)(C)(i) establishes an overall SO2 annual emission rate for EGUs in the Ameren MPS group of 0.50 pounds per million Btu (lb/mmBtu) for calendar years 2010 through 2013. Section 225.233(e)(3)(C)(ii) establishes an overall SO2 annual emission rate for EGUs in the Ameren MPS group of 0.43 lb/mmBtu for calendar year 2014. Section 225.233(e)(3)(C)(iii) establishes an overall SO2 annual emission rate for EGUs in the Ameren MPS group of 0.25 lb/mmBtu for calendar years 2015 and 2016. Section 225.233(e)(3)(C)(iv) establishes an overall SO2 annual emission rate for EGUs in the Ameren MPS group of 0.23 lb/mmBtu beginning in calendar year 2017 and continuing each calendar year thereafter.

On November 21, 2013, the Illinois Pollution Control Board (IPCB) granted IPH and Medina Valley a variance from the applicable requirements of Section 225.233(e)(3)(C)(iii) for a period beginning January 1, 2015, through December 31, 2019, and Section 225.233(e)(3)(C)(iv) for a period beginning January 1, 2017, through December 31, 2019, subject to certain conditions. The IPH facilities included in the Ameren MPS Group and subject to the variance are Coffeen Energy Center (Montgomery County), Duck Creek Energy Center (Fulton County), E.D. Edwards Energy Center (Peoria County), Joppa Energy Center (Massac County), and Newton Energy Center (Jasper County). The Medina Valley facilities included in the Ameren MPS Group and subject to the variance are the Meredosia Energy Center (Morgan County) and the Hutsonville Energy Center (Crawford County). IEPA submitted the variance as a revision to the Illinois Regional Haze SIP on September 3, 2014.

EPA proposed to approve the variance on April 20, 2015 (80 FR 21681). As discussed in the proposal, the variance results in less SO2 emissions than the currently approved Regional Haze SIP. Id. at 21683. In addition, EPA determined that the significantly lower SO2 emissions under the variance versus application of Best Available Control Technology (BACT) to BART-subject sources, will yield greater progress toward visibility protection. Id. at 21684. Finally, with respect to the requirements of section 110(l) of the Clean Air Act (CAA) (42 U.S.C. 7410(l)), because the variance will result in less SO2 emissions than the currently approved Regional Haze SIP and will continue to provide better visibility protection than the application of BART to BART-subject units, EPA has determined that the variance will not interfere with attainment, reasonable further progress, or any other applicable requirement of the CAA. Id. at 21684.

EPA received joint adverse comments from Earthjustice and Sierra Club, as summarized in the comments/responses below.

Comment 1: The proposed SIP revision unlawfully substitutes fleet-wide emission limits for the unit-specific five factor BART analysis required by the CAA.

Response 1: Section 169A(b)(2)(A) of the CAA, 42 U.S.C. 7491(b)(2)(A), requires states to revise their SIPs to contain such measures as may be necessary to make reasonable progress towards the natural visibility goal, including a requirement that certain existing major stationary sources procure, install, and operate BART, as determined by the state. In some cases, this requirement is met with an analysis of potential controls for each source subject to BART considering five factors set out in EPA's regional haze rule. 40 CFR 51.308(e)(1)(ii)(A). However, as described in several previous rules, EPA has concluded that CAA section 169A may reasonably be interpreted to provide that the requirement for BART may be satisfied by an alternate program that provides greater reasonable progress toward visibility improvement than direct application of BART to individual sources determined to be subject to the BART requirement. See 40 CFR 51.308(e), 64 FR 35714, 35741-35743 (July 1, 1999), 70 FR 39104, 39136 (July 6, 2005), 71 FR 60612 (October 13, 2006), and 77 FR 33642 (June 7, 2012).

In 1999, EPA promulgated the Regional Haze Rule, which established a comprehensive visibility protection program for mandatory Class I Federal areas (including many national parks and wilderness areas). In the preamble to the Regional Haze Rule, EPA stated that, to demonstrate that emission reductions of an alternative program would result in greater emission reductions, “the State must estimate the emission reductions that would result from the use of BART-level controls. To do this, the State could undertake a source-specific review of the sources in the State subject to BART, or it could use a modified approach that simplifies the analysis.” 64 FR 35742 (July 1, 1999).

In a final rule revising certain provisions of the Regional Haze Rule published on October 13, 2006, EPA offered further clarification for states for assessing alternative strategies, in particular regarding the benchmark definition of BART to use in judging whether the alternative is better. 71 FR 60612. In this rulemaking, EPA stated in the preamble that the presumptive BART levels given in the BART guidelines 1 would be a suitable baseline against which to compare alternative strategies, where the alternatives have been designed to meet a requirement other than BART. Id. at 60619; see also 40 CFR 51.308(e)(2)(i)(C). As described in the EPA's proposed approval of the Illinois variance, EPA took a more conservative approach and compared emissions under the variance to the application of typical BACT control levels to the BART subject units in the Ameren MPS Group.2 80 FR 21681, 21683 (April 20, 2015). In brief, EPA found that the alternative restrictions imposed by Illinois under the variance can be demonstrated to provide greater emission reductions and greater visibility improvement than conservative definitions of BART, even without a full analysis of the emission levels that constitute BART. The demonstration is discussed below, in the context of response to comments addressing the magnitude of emission reductions under the variance.

Comment 2: The plain language of the CAA “provides that EPA's regulations `shall require' each SIP to contain various elements, and those elements must include BART as a minimum requirement of every haze SIP.” The CAA does not permit a state to exempt units from BART without going through the exemption process outlined in the statute. The statute specifies the only circumstances in which a source may be exempted from BART, none of which apply here. 42 U.S.C. 7491(c). The CAA provision that allows some limited exemptions from BART makes plain that any such exemption must be assessed and determined on a source-specific, not a state-wide basis. Id. at 7491(c)(1). Furthermore, EPA may exempt a unit from the source-specific BART requirements of the CAA only where the Federal Land Managers concur with the EPA determination of an exemption. Id. at 7491(c)(3).

Response 2: We do not agree that the provisions governing exemptions to BART apply. Neither the Illinois Regional Haze SIP previously approved by EPA nor the revisions to that SIP contained in the variance being approved in this action exempt BART-eligible sources from BART requirements, but rather satisfy the BART requirements through the adoption of an alternative program that provides greater reasonable progress towards improving visibility.

Section 169A(b)(2) of the CAA, 42 U.S.C. 9491(b)(2), requires each visibility SIP to contain “such emission limits, schedules of compliance and other measures as may be necessary to make reasonable progress toward meeting the national goal * * * including * * * a requirement that [certain major stationary sources] * * * procure, install, and operate * * * [BART].” Based on this language, EPA concluded in the Regional Haze Rule that if an alternative program can be shown to make greater reasonable progress toward eliminating or reducing visibility impairment, then installing BART for the purpose of making reasonable progress toward the national goal is no longer necessary. 64 FR 35714, 35739 (July 1, 1999).

This interpretation of the visibility provisions of the CAA has been previously challenged and upheld by the D.C. Circuit. In the first case challenging the provisions in the Regional Haze Rule allowing for states to adopt alternative programs in lieu of BART, the court affirmed EPA's interpretation of CAA section 169A(b)(2) as allowing for alternatives to BART where those alternatives will result in greater reasonable progress than BART. Center for Energy and Economic Development v. EPA, 398 F.3d 653, 660 (D.C. Cir. 2005) (“CEED”) (finding reasonable EPA's interpretation of CAA section 169(a)(2) as requiring BART only as necessary to make reasonable progress). In the second case, Utility Air Regulatory Group v. EPA, 471 F.3d 1333 (D.C. Cir. 2006) (“UARG”), the court specifically upheld EPA's determination that states could rely on the Clean Air Interstate Rule (“CAIR”) as an alternative program to BART for EGUs in the CAIR-affected states. The court concluded that the EPA's two-pronged test for determining whether an alternative program achieves greater reasonable progress was a reasonable one and also agreed with EPA that nothing in the CAA required the EPA to “impose a separate technology mandate for sources whose emissions affect Class I areas, rather than piggy-backing on solutions devised under other statutory categories, where such solutions meet the statutory requirements.” Id. at 1340. See also Central Arizona Water Conservation District v. EPA, 990 F.2d 1531, 1543 (9th Cir. 1993) (upholding EPA's interpretation of CAA section 169A(b)(2)).

Comment 3: An interpretation of the statute which allows a state to substitute an alternative for BART on a state-wide or fleet-wide basis cannot be reconciled with Congress specifying very narrow standards for exempting a source from BART. If EPA relies on the D.C. Circuit Court of Appeals decisions upholding its interpretation of the statute, “the cases are incorrect in that the D.C. Circuit Court of Appeals has rewritten the statute by failing to give effect to the plain language requiring each SIP to include BART and by disregarding the very specific parameters in the statute for exemptions from BART.” In addition, “these decisions are not binding precedent in the 7th Circuit, which has jurisdiction over EPA's approval of the Illinois Regional Haze SIP.”

Response 3: EPA disagrees with the commenter that BART alternatives are impermissible under the CAA. As the commenter notes, EPA's interpretation that the CAA allows States to devise alternative programs in lieu of source-specific BART was upheld in both the CEED and UARG decisions. The conclusions in these cases have not been upset or overturned by any subsequent decision of the D.C. Circuit, and we disagree with the commenter's contention that CEED and UARG were decided erroneously. The D.C. Circuit has exclusive jurisdiction over the review of nationally applicable rules. The Illinois' SIP has been evaluated against nationally applicable rules (upheld by the D.C. Circuit) that allow States to adopt alternative measures in lieu of BART.

Comment 4: The IEPA has not met its burden to show that the Multi-Pollutant Standard is approvable as a BART alternative because it has not performed modeling of the visibility impacts for the MPS compared to BART. “By design, the MPS allows the flexibility to implement emissions reductions other than by imposing uniform reductions at specific units subject to BART.” There is, therefore, no basis for claiming that the distribution of emissions under the MPS is not substantially different than under BART. Instead, the MPS limits can be met in such a way that the distribution of emissions is significantly different than it would be if its subject-to-BART units had to meet unit specific BART limits. “If the distribution of emissions is significantly different under an alternate program, a state must conduct visibility modeling in order to meet its burden of securing approval for the alternative program.”

Response 4: EPA disagrees with the commenter that visibility modeling is required. EPA found in its original approval of Illinois' BART plan that the distances from the relevant power plants to the affected Class I areas are substantial and that the averaging in Illinois' plan is only allowed within somewhat limited regions. Given this, EPA concluded that “a reallocation of emission reductions from one plant to another is unlikely to change the impact of those emission reductions significantly” and that the much greater emission reductions from Illinois' plan will result in greater reasonable progress than would source-specific BART controls. 77 FR 39946. The commenter has provided no evidence that EPA's conclusion that the greater reductions in emissions from these facilities under the terms of the variance should lead to a different conclusion.

The commenter points to a test set out in 40 CFR 51.308(e)(3) to support its argument that visibility modeling is necessary to determine whether an alternative to BART provides for greater reasonable progress. States are not required to use this test, however, as 40 CFR 51.308(e)(2)(i)(E) makes clear: A demonstration that an alternative measure will make greater reasonable progress may be based on the clear weight of evidence. Although there is no requirement that States use the test in 51.308(e)(3), EPA nevertheless reexamined whether modeling is necessary to conclude that the greater emission reductions of Illinois' revised plan provide for better visibility than imposition of source-specific BART. There are seven facilities in the Ameren MPS Group: Coffeen Energy Center (Montgomery County), Duck Creek Energy Center (Fulton County), E.D. Edwards Energy Center (Peoria County), Joppa Energy Center (Massac County), Newton Energy Center (Jasper County), Meredosia Energy Center (Morgan County) and Hutsonville Energy Center (Crawford County). Of these facilities, only Coffeen, Duck Creek, and E.D. Edwards were determined to be subject to BART. The least distance from any of these three BART-subject sources to any Class I area is from Coffeen to the Mingo Wilderness Area, a distance of about 240 kilometers (km). Duck Creek and E.D. Edwards are approximately 390 km and 410 km, respectively, from the Mingo Wilderness area. The distance from the Mingo Wilderness Area to remaining Ameren MPS Group facilities ranges from approximately 120 km to 330 km, with an average distance of 260 km. Further, an evaluation for the Class I areas within 500 km of any Ameren MPS Group source shows that in every case the average distance from the BART-subject facilities is greater than the average distance from the facilities that would not be subject to BART. That is, even if Illinois' plan achieved no more emission reductions than source-specific BART, the plan would likely yield better visibility because the reductions would likely be reallocated to closer plants. Given these distances and given the relative location of these facilities, a reallocation of emission reductions from one plant to another among this group is unlikely to change the visibility impact of these emission reductions meaningfully. As noted above, however, the Illinois plan (originally and as revised) achieves significantly greater reductions than source-specific BART. Consequently, in these circumstances, EPA is confident that visibility modeling is not necessary to conclude that the significantly greater emission reductions that are required under the variance will yield greater progress toward visibility protection as compared to the benefits of a conservative estimate of BART.

Comment 5: The variance from the MPS authorizes the IPH fleet to emit greater SO2 emissions than would be emitted if BART were required, and thus EPA cannot find that the MPS will lead to greater reasonable progress than would BART.

Of the seven plants included in the original Ameren MPS Group, five plants still in operation are now owned and operated by IPH and two plants that retired in 2011, Hutsonville and Meredosia, are now owned by Medina Valley and are no longer part of the fleet. Because of the variance, the MPS will no longer require SO2 reductions from the IPH coal fleet during the period of the first long-term strategy for regional haze (i.e., before 2018) that are greater than the reductions that would result from requiring IPH to install and operate BART on its BART-subject plants.

The commenter supports this assertion by comparing emissions reductions from the variance to emissions reductions from BACT at BART-subject facilities, excluding emissions reductions from the retired Meredosia and Hutsonville units (now owned by Medina Valley) and emissions reductions from the Edwards Unit 1 (owned by IPH). The commenter states that these sources were not included in the analysis because Meredosia and Hutsonville “have been retired for several years due to economic reasons,” and Edwards Unit 1 is currently being operated only for grid reliability purposes subject to a short-term System Support Resource agreement with the Midcontinent Independent System Operator (MISO). The commenter argues that the MPS is not driving emissions reductions at those sources and they should not be included in any analysis of emissions reductions at the IPH fleet. The commenter's analysis shows that, in 2017, implementation of BART at BART-subject sources would reduce SO2 emissions by 74,348 tons and the variance would reduce SO2 by 69,555 tons.

Response 5: EPA disagrees with the commenter's assertion that EPA cannot find that the MPS will lead to greater reasonable progress than would BART. The premise of the commenter's analysis, that only currently operating units in the IPH fleet should be evaluated, is flawed. As discussed above, the requirement for BART may be satisfied by an alternate program that provides greater reasonable progress toward visibility improvement than direct application of BART to individual sources determined to be subject to the BART requirement. The alternate program being evaluated, as contained in the MPS and revised by the variance, applies to the seven sources in the Ameren MPS Group, not only to the five sources currently owned and operated by IPH.

The variance prohibits the Meredosia and Hutsonville power stations from operating until after December 31, 2020, at which point they would remain subject to the emission limits in the MPS. In addition, the variance requires IPH to permanently retire E.D. Edwards Unit 1 as soon as allowed by MISO. The fact that there are reasons other than the MPS that influenced the decisions to cease operation of these plants does not change the fact that under the currently approved Regional Haze SIP these sources are permitted to operate. The variance makes these shutdowns enforceable and prohibits emissions that would otherwise have been allowed under the SIP. Further, these facilities ceased operating late in 2011, well after the 2000-2004 baseline established in the Regional Haze Rule (40 CFR 51.308(d)(2)) and before the 2017 deadline for implementing BART controls in Illinois, so the emission reductions from the shutdown of these facilities are fully creditable. Therefore, comparing emission reductions at all seven Ameren MPS Group sources under the variance to emission reductions from application of BACT limits to BART-subject units is the appropriate test for determining whether the alternate program would result in greater emission reductions.

The analysis included by EPA in the proposed rule shows SO2 emission reductions of 74,348 tons in 2017 if typical BACT limits were applied to BART subject sources and SO2 emission reductions of 119,833 tons in 2017 under the variance. 80 FR 21683-21684. The analysis is conservative in that it assumes that E.D. Edwards Unit 1 is still operating, since an absolute shutdown date was not included in the variance. Further, even assuming that the 22,360,000 MMBtu previously generated at Meredosia and Hutsonville were shifted to the five remaining facilities in the Ameren MPS Group, applying the 0.35 pound/MMBtu group average emission limit results in an additional 3,913 tons of SO2 emissions under the variance in 2017, or a total of 54,188 tons of SO2. Thus, SO2 emissions reductions in 2017 under the variance would be 115,920 tons, which is still 41,572 fewer tons of SO2 emissions than what the SO2 emissions would be if BACT were applied at BART-subject sources.

EPA is finalizing approval of the IPH and Medina Valley variance submitted by IEPA on September 3, 2014, as a revision to the Illinois Regional Haze SIP.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Illinois Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov and/or in hard copy at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 19, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

On October 27, 2015, the EPA proposed to approve Oregon's June 28, 2010 submittal as meeting the interstate transport requirements of CAA section 110(a)(2)(D)(i)(I) for the 2008 ozone NAAQS (80 FR 65680). An explanation of the CAA requirements, a detailed analysis of the submittal, and the EPA's reasons for approval were provided in the notice of proposed rulemaking, and will not be restated here. The public comment period for this proposed rule ended on November 27, 2015. The EPA received no comments on the proposal.

The EPA is approving Oregon's June 28, 2010 submittal as meeting the CAA section 110(a)(2)(D)(i)(I) interstate transport requirements for the 2008 ozone NAAQS.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because this action does not involve technical standards; and

• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by February 19, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. See section 307(b)(2).

For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0397 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before February 19, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0397, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-9918-90), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP) 4E8282 by Interregional Research Project Number 4 (IR-4), 500 College Road East, Princeton, NJ 08540. The petition requested that 40 CFR 180.361 be amended by establishing tolerances for residues of the herbicide pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, in or on caneberry subgroup 13-07A at 0.10 parts per million (ppm) and bushberry subgroup 13-07B at 0.10 ppm, and amending the existing crop group tolerance for nut, tree, group 14 to nut, tree, group 14-12. That document referenced a summary of the petition prepared on behalf of IR-4 by BASF, the registrant, which is available in the docket EPA-HQ-OPP-2014-0397 at http://www.regulations.gov.

In the Federal Register of August 26, 2015 (80 FR 51759) (FRL-9931-74), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP) 4F8261 by BASF Corp., 26 Davis Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.361 be amended by establishing tolerances for residues of the herbicide pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, in or on milk at 0.04 parts per million (ppm); cattle, fat at 0.30 ppm; cattle, liver at 1.5 ppm; cattle, meat at 0.1 ppm; cattle, meat byproducts, except liver at 3.0 ppm; goat, fat at 0.30 ppm; goat, liver at 1.5 ppm; goat, meat at 0.10 ppm; goat, meat byproducts, except liver at 3.0 ppm; horse, fat at 0.30 ppm; horse, liver at 1.5 ppm; horse, meat at 0.10 ppm; horse, meat byproducts, except liver at 3.0 ppm; sheep, fat at 0.30 ppm; sheep, liver at 1.5 ppm; sheep, meat at 0.10 ppm; and sheep, meat byproducts, except liver at 3.0 ppm. This petition additionally requested that 40 CFR 180.361 be amended by revising the existing tolerance in or on grass forage, fodder, and hay crop group 17, forage at 1,000 ppm and grass forage, fodder, and hay crop group 17, hay at 2,000 ppm. That document referenced a summary of the petition prepared on behalf of IR-4 by BASF, the registrant, which is available in the docket EPA-HQ-OPP-2014-0397 at http://www.regulations.gov.

Two comments were received on these notices of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has revised the petitioned-for tolerance in or on cattle, meat byproduct, meat byproduct except liver, and liver; goat, meat byproduct, meat byproduct except liver, and liver; horse, meat byproduct, meat byproduct except liver, and liver; and sheep, meat byproduct, meat byproduct except liver, and liver. The Agency has determined that the tolerance expression for the ruminant commodities is different than that for plant commodities. Additionally, the EPA is removing existing tolerances for Juneberry; nut, tree, group 14; and pistachio since they are superseded by this action. The reason for these changes are explained in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for pendimethalin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pendimethalin follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The target organ for pendimethalin is the thyroid. Thyroid toxicity in chronic and subchronic rat and mouse studies was manifested as alterations in thyroid hormones (decreased total T4, and T3, increased percent of free T4 and T3), increased thyroid weight, and microscopic thyroid lesions (including increased thyroid follicular cell height, follicular cell hyperplasia, as well as follicular cell adenomas). Due to these effects, the Agency required that a developmental thyroid assay be conducted to evaluate the impact of pendimethalin on thyroid hormones, structure, and/or thyroid hormone homeostasis during development. A developmental thyroid study was submitted and demonstrated that there is no potential thyroid toxicity following pre- and/or post-natal exposure to pendimethalin.

The points of departure (PODs) used for the chronic and short-term risk assessments were based on co-critical studies of a 92-day thyroid function study in rats, a 56-day thyroid study in rats, and a 14-day intra thyroid metabolism study in rats. An uncertainty factor (UF) of 30X (3X for interspecies extrapolation and 10X for intraspecies variation) is applied for the chronic and short-term risk assessments. The interspecies UF which used to account for animal to human differences in toxicokinetics and toxicodynamics was reduced to 3X due to several important quantitative dynamic differences between rats and humans with respect to thyroid function. A UF of 100X (10X for interspecies extrapolation and 10X for intraspecies variation) was used in the acute risk assessment because the POD was based on an acute neurotoxicity study, not a thyroid study.

There is no evidence that pendimethalin is a developmental, reproductive, neurotoxic, or immunotoxic chemical. There is no evidence of increased qualitative or quantitative susceptibility in the young. EPA classified pendimethalin as a “Group C”, possible human carcinogen based on a statistically significant increased trend and pair-wise comparison between the high-dose group and controls for thyroid follicular cell adenomas in male and female rats. A non-quantitative approach (i.e., non-linear, reference dose (RfD) approach) was used to assess cancer risk since mode-of-action studies are available to demonstrate that the thyroid tumors are due to a thyroid-pituitary imbalance, and also since pendimethalin was shown to be non-mutagenic in mammalian somatic cells and germ cells. Specific information on the studies received and the nature of the adverse effects caused by pendimethalin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, “Pendimethalin—Human Health Risk Assessment to Support the Proposed New Uses on the Caneberry Subgroup 13-07A, and the Bushberry Subgroup 13-07B, Amended Use on Grasses and Establishment of Tolerances for Pendimethalin in/on Grass Forage, Fodder, and Hay (Crop Group 17) with New Ruminant Tolerances; Crop Group Conversion for Tree Nut Crop Group 14.” in pages 14-20 in docket ID number EPA-HQ-OPP-2014-0397.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for Pendimethalin used for human risk assessment is discussed in the final rule published in the Federal Register of August 29, 2012 (77 FR 52240) (FRL-9360-5).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to pendimethalin, EPA considered exposure under the petitioned-for tolerances as well as all existing pendimethalin tolerances in 40 CFR 180.361. EPA assessed dietary exposures from pendimethalin in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for pendimethalin. In estimating acute dietary exposure, EPA Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA used tolerance-level residues, and 100 percent crop treated (PCT) for all commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the DEEM-FCID, Version 3.16 software with 2003-2008 food consumption data from the USDA's NHANES/WWEIA. As to residue levels in food, EPA used tolerance-level residues, and 100 percent crop treated (PCT) for all commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to pendimethalin. Cancer risk was assessed using the same exposure estimates as discussed in Unit III.C.1.ii., chronic exposure.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for pendimethalin. Tolerance-level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. In drinking water, the residue of concern is pendimethalin parent only. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for pendimethalin in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of pendimethalin. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Pesticide Root Zone Model Ground Water (PRZM GW) and Surface Water Concentration Calculator (SWCC) models, the estimated drinking water concentrations (EDWCs) of pendimethalin for acute exposures are estimated to be 96.4 parts per billion (ppb) for surface water and 4.38 × 10− 9 ppb for ground water. For chronic exposures for non-cancer assessments, they are estimated to be 9.73 ppb for surface water.

For acute dietary risk assessment, the water concentration value of 96.4 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 9.73 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Pendimethalin is currently registered for the following uses that could result in residential exposures: Turf, home gardens, and ornamentals. EPA assessed residential exposure using the following assumptions:

• For handlers, it is assumed that residential use will result in short-term (1 to 30 days) duration dermal and inhalation exposures.

• Residential post-application exposure is also assumed to be short-term (1-30 days) in duration, resulting from the following exposure scenarios:

○ Gardening: Adults (dermal) and children 6 < 11 years old (dermal);

○ Physical activities on turf: Adults (dermal) and children 1-2 years old (dermal and incidental oral);

○ Mowing turf: Adults (dermal) and children 11 < 16 years old (dermal); and

○ Exposure to golf courses during golfing: Adults (dermal), children 11 < 16 years old (dermal), and children 6 < 11 years old (dermal).

EPA did not combine exposure resulting from adult handler and post-application exposure resulting from treated gardens, lawns, and/or golfing because of the conservative assumptions and inputs within each estimated exposure scenario. The Agency believes that combining exposures resulting from handler and post-application activities would result in an overestimate of adult exposure. EPA selected the most conservative adult residential scenario (adult dermal post-application exposure from gardening) as the contributing source of residential exposure to be combined with the dietary exposure for the aggregate assessment. The children's oral exposure is based on post-application hand-to-mouth exposures. To include exposure from object-to-mouth and soil ingestion in addition to hand-to-mouth would overestimate the potential for oral exposure. However, there is the potential for co-occurrence of dermal and oral exposure, since the toxicological effects from the dermal and oral routes of exposure are the same. As a result, the children's aggregate assessment combines post-application dermal and oral exposure along with dietary exposure from food and water. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found pendimethalin to share a common mechanism of toxicity with any other substances, and pendimethalin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pendimethalin does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site athttp://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There was no indication of pre- and/or post-natal qualitative or quantitative increased susceptibility in the developmental studies in rats and rabbits or the 2-generation reproduction studies in rats. A developmental thyroid toxicity study demonstrated that there is no potential thyroid toxicity following pre- and/or post-natal exposure to pendimethalin.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for pendimethalin is complete. Although a subchronic inhalation study was not available in the database, EPA determined that one is not needed at this time based on a weight-of-evidence analysis, considering the following: (1) All relevant hazard and exposure information, which indicates its low acute inhalation toxicity; (2) its physical/chemical properties, which indicate its low volatility; and (3) the use of an oral POD that results in a residential inhalation margin of exposure (MOE) more than 10X the level of concern (in the case of pendimethalin MOE = 30 based on thyroid POD).

ii. There is no indication that pendimethalin is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that pendimethalin results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. In addition, a developmental thyroid toxicity study demonstrated that there is no potential thyroid toxicity following pre- and/or post-natal exposure to pendimethalin.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to pendimethalin in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pendimethalin.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to pendimethalin will occupy 2% of the aPAD for all infants less than 1 year old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to pendimethalin from food and water will utilize 2.4% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of pendimethalin is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Pendimethalin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to pendimethalin.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 130 for adults and 92 for children 1 to 2 years old, the two population subgroups receiving the greatest combined dietary and non-dietary exposure. Because EPA's level of concern for pendimethalin is a MOE of 30 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

An intermediate-term adverse effect was identified; however, pendimethalin is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for pendimethalin.

5. Aggregate cancer risk for U.S. population. As discussed in Unit III.A., EPA has determined that an RfD approach based on the chronic point of departure is appropriate for evaluating cancer risk. As there are not chronic aggregate risks of concern, there are no cancer aggregate risk concerns.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to pendimethalin residues.

Adequate enforcement methodology, gas chromatography with electron capture detection (GC/ECD), is available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

There are currently no established Codex MRLs for the residues of pendimethalin.

Two comments were received to the Notices of Filing for PP 4E8282 and PP 4F8261. One commenter stated: “Pesticide/Herbicide contents must be made available to the public due to allergies. Labeling foods that have been exposed to Pesticides/Herbicides protects the public from potentially ingesting a known allergen. This safe practice allows health care professionals to determine the cause of a life threatening severe reaction to avoid these products in the future. I am a nurse hence my concern.” The second commenter stated that no residue should be allowed for pendimethalin and that they do not support manufacture or use of this product. The Agency understands the commenters' concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. These comments appear to be directed at the underlying statute and not EPA's implementation of it; the citizens have made no contention that EPA has acted in violation of the statutory framework. EPA has found that there is a reasonable certainty of no harm to humans after considering the toxicological studies and the exposure levels of humans to pendimethalin.

Based on review of the data supporting the petitions, EPA has revised the petitioned-for tolerance in or on “meat byproduct” (at 3.0 ppm) based on anticipated residues in kidney which contained the highest residue amongst all ruminant tissues and will therefore cover anticipated residues in liver and fat. BASF, proposed setting a tolerance on “meat byproduct except liver”, also at 3.0 ppm based on anticipated residues in kidney with a separate lower tolerance on liver at 1.5 ppm. However, the anticipated residues in liver versus kidney, on which the tolerance for meat byproduct is based on, are not significantly different given the limited number of data for those tissues and that both are greater than LOQ and within 1 ppm of each other. Therefore, a single tolerance on “meat byproduct” without a separate tolerance on liver is adequate.

Additionally, the current tolerance expression for pendimethalin for plant commodities includes the combined residues of pendimethalin and its 3,5-dinitrobenzyl alcohol metabolite (CL 202,347). EPA has determined, based on the review of the ruminant feeding study, that the residues of concern for setting tolerances and assessing risks in ruminants is the parent compound, pendimethalin, and its metabolite, 1-(1-ethylpropyl)-5, 6-dimethyl-7-nitro-1H-benzimidazole (also known as metabolite 6).

Finally, the Agency is removing Juneberry at 0.1 ppm as it is superseded by fruit, bushberry, subgroup 13-07B; as well as nut, tree, group 14 and pistachio at 0.1 ppm to account for an updated crop group conversion.

Therefore, tolerances are established for plant residues by measuring only the sum of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol calculated as the stoichiometric equivalent of pendimethalin, in or on bushberry subgroup 13-07B at 0.10 ppm; caneberry subgroup 13-07A at 0.10 ppm; grass forage, fodder, and hay crop group 17, forage at 1,000 ppm; grass forage, fodder, and hay crop group 17, hay at 2,000 ppm; and nut, tree group 14-12 at 0.1 ppm. Tolerances are established for livestock commodities is by measuring only the sum of pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite, 1-[(1-ethylpropyl)-5,6-dimethyl-7-nitro-1H-benzimidazole (metabolite 6), calculated as the stoichiometric equivalent of pendimethalin in or on cattle, fat at 0.30 ppm; cattle, meat at 0.10 ppm; cattle, meat byproduct 3.0 ppm; goat, fat at 0.30 ppm; goat, meat at 0.10 ppm; goat, meat byproduct at 3.0 ppm; horse, fat at 0.30 ppm; horse, meat at 0.10 ppm; horse, byproduct at 3.0 ppm; milk at 0.04 ppm; sheep, fat at 0.30 ppm; sheep, meat at 0.10 ppm; and sheep, meat byproduct at 3.0 ppm. Additionally, the existing tolerances for Juneberry; nut, tree, group 14; and pistachio are removed.

This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

On April, 23, 2015, FMCSA published a final rule adopting regulations to facilitate the electronic transmission of MEC information from FMCSA's National Registry to the State driver's license agencies (SDLA) for holders of Commercial Driver's Licenses (CDL) and Commercial Learner's Permits (CLP). (80 FR 22790). On June 22, 2015, FMCSA published a document correcting the effective date for use of new forms prescribed in the final rule to December 22, 2015. (80 FR 35577). See 49 CFR 391.43(f)(1) and (2) and 391.43(h)(1) and (2).

The final rule, as corrected, requires certified MEs performing physical examinations of CMV drivers to use a newly developed MER Form, MCSA-5875, in place of the current MER form, and for use of the newly developed MEC Form MCSA-5876 for the current MEC form, beginning on December 22, 2015.

On December 14, FMCSA posted the fillable pdf versions of the new driver examination forms. The Agency had planned to make the forms available prior to this date but experienced technical difficulties. As a result, FMCSA has received numerous requests from the public asking to have the effective date for use of the MER Form, MCSA-5875, and the MEC, MCSA-5876, to be delayed. FMCSA acknowledges that enforcement of this December 22, 2015, compliance date would not provide sufficient time for Medical Examiners to become familiar with the new driver examination forms and/or program electronic medical records systems. For this reason, FMCSA will provide a 120-day grace period during which Medical Examiners may use either the current or the newly revised versions of the Medical Examination Report Form and Medical Examiner's Certificate, which will be from December 22, 2015, until April 20, 2016. Both sets of forms have been posted on the FMCSA Web site,1 and Medical Examiners have the option to use either set of forms from December 22, 2015 until April 20, 2016.