Federal Register Vol. 80, No.225,

I. Background

In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.

Section 513(f)(2) of the FD&C Act, as amended by section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), provides two procedures by which a person may request FDA to classify a device under the criteria set forth in section 513(a)(1). Under the first procedure, the person submits a premarket notification under section 510(k) of the FD&C Act for a device that has not previously been classified and, within 30 days of receiving an order classifying the device into class III under section 513(f)(1) of the FD&C Act, the person requests a classification under section 513(f)(2). Under the second procedure, rather than first submitting a premarket notification under section 510(k) of the FD&C Act and then a request for classification under the first procedure, the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence and requests a classification under section 513(f)(2) of the FD&C Act. If the person submits a request to classify the device under this second procedure, FDA may decline to undertake the classification request if FDA identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence with the device or if FDA determines that the device submitted is not of “low-moderate risk” or that general controls would be inadequate to control the risks and special controls to mitigate the risks cannot be developed.

In response to a request to classify a device under either procedure provided by section 513(f)(2) of the FD&C Act, FDA will classify the device by written order within 120 days. This classification will be the initial classification of the device.

In accordance with section 513(f)(1) of the FD&C Act, FDA issued an order on April 22, 2010, classifying the prostate mechanical imager into class III, because it was neither substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, nor a device which was subsequently reclassified into class I or class II. On May 21, 2010, Artann Laboratories, Inc., submitted a request for classification of the prostate mechanical imager under section 513(f)(2) of the FD&C Act. The manufacturer recommended that the device be classified into class II (Ref. 1).

In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed the request for de novo classification in order to classify the device under the criteria for classification set forth in section 513(a)(1). FDA classifies devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. After review of the information submitted in the request, FDA determined that the device can be classified into class II with the establishment of special controls. FDA believes these special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on April 27, 2012, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 876.2050.

Following the effective date of this final classification order, any firm submitting a premarket notification (510(k)) for a prostate lesion documentation system will need to comply with the special controls named in this final order. The device is assigned the generic name prostate lesion documentation system, and it is identified as a prescription device intended for use in producing an image of the prostate as an aid in documenting prostate abnormalities previously identified during a digital rectal examination. The device uses pressure sensors and image reconstruction software to produce a prostate image that highlights regional differences in intraprostatic tissue elasticity or stiffness. The device is limited to use as a documentation tool and is not intended for diagnostic purposes or for influencing any clinical decisions.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks intable 1.

FDA believes that the measures set forth in the following special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of the safety and effectiveness:

• Non-clinical and clinical performance testing must demonstrate the accuracy and reproducibility of the constructed image.

• Appropriate analysis/testing must validate electromagnetic compatibility, electrical safety, thermal safety, and mechanical safety.

• Appropriate software verification, validation, and hazard analysis must be performed.

• All elements of the device that may contact the patient must be demonstrated to be biocompatible.

• Methods and instructions for reprocessing of any reusable components must be properly validated.

• The labeling must include specific information needed to ensure proper use of the device.

Prostate lesion documentation systems are prescription devices restricted to patient use only upon the authorization of a practitioner licensed by law to administer or use the device; see 21 CFR 801.109 (Prescription devices).

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. For this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the device. Therefore, this device is not exempt from premarket notification requirements. Persons who intend to market this type of device must submit to FDA a premarket notification, prior to marketing the device, which contains information about the prostate lesion documentation system they intend to market.

We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final administrative order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485.

The following reference has been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 876 is amended as follows:

The United States Postal Service® gives notice that on October 22, 2015, the Postal Service filed with the Postal Regulatory Commission a notice of a minor classification change to add Bonaire, Sint Eustatius, and Saba to the Mail Classification Schedule (MCS). The Commission concurred with the notice in its Order No. 2808, issued on November 9, 2015. Documents are available at www.prc.gov, Docket No. MC2016-10. Consequently, the Postal Service will revise IMM sections 213.5, 292.45, 293.45, the Index of Countries and Localities, the Country Price Groups and Weight Limits, and the Individual Country Listings, to add a new listing for Bonaire, Sint Eustatius, and Saba and to modify Curaçao's listing.

Accordingly, 39 CFR part 20 is amended as follows:

On June 5, 2015 (80 FR 32078), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Virginia. In the NPR, EPA proposed approval of Virginia's May 12, 2014 SIP submittal. The revision incorporates PAL provisions for GHGs into Virginia's PSD program.

In a June 3, 2010 final rulemaking action, EPA promulgated regulations known as “the Tailoring Rule,” which phased in permitting requirements for GHG emissions from stationary sources under the CAA PSD and title V permitting programs. See 75 FR 31514. For Step 1 of the Tailoring Rule, which began on January 2, 2011, PSD or title V requirements applied to sources of GHG emissions only if the sources were subject to PSD or title V “anyway” due to their emissions of non-GHG pollutants. These sources are referred to as “anyway sources.” Step 2 of the Tailoring Rule, which began on July 1, 2011, applied the PSD and title V permitting requirements under the CAA to sources that were classified as major, and, thus, required to obtain a permit, based solely on their potential GHG emissions and to modifications of otherwise major sources that required a PSD permit because they increased only GHGs above applicable levels in the EPA regulations. Subsequently, on May 13, 2011, EPA took final action to approve a revision to Virginia's PSD SIP, incorporating preconstruction permitting requirements for major stationary sources and major modifications of GHGs, consistent with the Federal PSD requirements at the time. See 76 FR 27898.

In a June 12, 2012 final rulemaking action entitled “Prevention of Significant Deterioration and Title V Greenhouse Gas Tailoring Rule Step 3 and GHG Plantwide Applicability Limits” 1 (hereafter, Tailoring Rule Step 3), EPA promulgated a number of streamlining measures intended to improve the administration of GHG PSD permitting programs. Included in that rulemaking were provisions to allow sources to obtain GHG PALs on a carbon dioxide equivalent (CO2e) 2 basis, rather than strictly on a mass basis. A PAL is an emissions limitation for a single pollutant expressed in tons per year (tpy) that is enforceable as a practical matter and is established source-wide in accordance with specific criteria. See 40 CFR 52.21(aa)(2)(v). PALs offer an alternative method for determining major New Source Review (NSR) applicability: If a source can maintain its overall emissions of the PAL pollutant below the PAL level, the source can make a change without triggering PSD review. Virginia's May 12, 2014 submittal incorporates PAL provisions into Virginia's PSD program, consistent with EPA's Tailoring Rule Step 3.

On June 23, 2014, the United States Supreme Court, in Utility Air Regulatory Group v. Environmental Protection Agency, 3 issued a decision addressing the Tailoring Rule and the application of PSD permitting requirements to GHG emissions. The Supreme Court said that the EPA may not treat GHGs as an air pollutant for purposes of determining whether a source is a major source required to obtain a PSD permit. The Court also said that the EPA could continue to require that PSD permits, otherwise required based on emissions of pollutants other than GHGs, contain limitations on GHG emissions based on the application of Best Available Control Technology (BACT). The Supreme Court decision effectively upheld PSD permitting requirements for GHG emissions under Step 1 of the Tailoring Rule for “anyway sources” and invalidated PSD permitting requirements for Step 2 sources.

In accordance with the Supreme Court decision, on April 10, 2015, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) issued an amended judgment vacating the regulations that implemented Step 2 of the Tailoring Rule, but not the regulations that implement Step 1 of the Tailoring Rule.4 The amended judgment preserves, without the need for additional rulemaking by the EPA, the application of the BACT requirement to GHG emissions from sources that are required to obtain a PSD permit based on emissions of pollutants other than GHGs (i.e., the “anyway” sources). The D.C. Circuit's judgment vacated the regulations at issue in the litigation, including 40 CFR 51.166(b)(48)(v), “to the extent they require a stationary source to obtain a PSD permit if greenhouse gases are the only pollutant (i) that the source emits or has the potential to emit above the applicable major source thresholds, or (ii) for which there is a significant emissions increase from a modification.” 5

EPA may need to take additional steps to revise federal PSD rules in light of the Supreme Court decision and recent D.C. Circuit judgment. In addition, EPA anticipates that many states will revise their existing SIP-approved PSD programs. EPA is not expecting states to have revised their existing PSD program regulations at this juncture. However, EPA is evaluating PSD program submissions to assure that the state's program correctly addresses GHGs consistent with both decisions.

Virginia's currently approved PSD SIP continues to require that PSD permits (otherwise required based on emissions of pollutants other than GHGs) contain limitations on GHG emissions based on the application of BACT when sources emit or increase GHGs in the amount of 75,000 tpy, measured as CO2e. Although Virginia's SIP may also currently contain provisions that are no longer necessary in light of the D.C. Circuit's judgment or the Supreme Court decision, this does not prevent EPA from approving the submission addressed in this rule. This rulemaking action does not add any GHG permitting requirements that are inconsistent with either decision.

Likewise, the GHG PAL provisions being approved in this action include some provisions that may no longer be appropriate in light of both the D.C. Circuit judgment and the Supreme Court decision. Since the Supreme Court has determined that sources and modifications may not be defined as “major” solely on the basis of the level of GHGs emitted or increased, PALs for GHGs may no longer have value in some situations where a source might have triggered PSD based on GHG emissions alone. However, PALs for GHGs may still have a role to play in determining whether a modification that triggers PSD for a pollutant other than GHGs should also be subject to BACT for GHGs. These provisions, like the other GHG provisions discussed previously, may be revised at some future time. However, these provisions do not add new requirements for sources or modifications that only emit or increase GHGs above the major source threshold or the 75,000 tpy GHG level in 40 CFR 52.21(b)(49)(iv). Rather, the PAL provisions provide increased flexibility to sources that wish to address their GHG emissions in a PAL. Since this flexibility may still be valuable to sources in at least one context described above, EPA is approving these provisions as a revision to the Virginia SIP at this juncture.

The revision includes amendments to 9VAC5-85: “Permits for Stationary Sources of Pollutants Subject to Regulation.” Specifically, 9VAC5-85-40: “Prevention of Significant Deterioration Area Permit Actions,” and 9VAC5-85-50: “Definitions” are being amended. Additionally, 9VAC5-85-55: “Actual plantwide applicability limits,” is being added to the SIP. The amendments are consistent with the GHG PAL provisions of 40 CFR 52.21 as promulgated by EPA on July 12, 2012. See 77 FR 41072-41075. These provisions were effective in Virginia on March 13, 2014. Other specific requirements of the May 12, 2014 SIP submittal and the rationale for EPA's approval are explained in the NPR and will not be restated here. No comments were received on the NPR.

EPA is approving VADEQ's May 12, 2014 SIP submittal as a revision to the Virginia SIP.

In this rulemaking action, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the VADEQ rules regarding GHG PALs discussed in section II of this preamble. EPA has made, and will continue to make, these documents generally available electronically through www.regulations.gov, or they may be viewed at the appropriate EPA office (see the ADDRESSES section of this preamble for more information).

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginia's Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information that: (1) Are generated or developed before the commencement of a voluntary environmental assessment; (2) are prepared independently of the assessment process; (3) demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts . . . .” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.”

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its PSD program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law.

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 Order 12866 (58 FR 51735, October 4, 1993);

• 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).

The SIP is not approved to apply on any Indian reservation land as defined in 18 U.S.C. 1151 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 January 22, 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 pertaining to Virginia's PSD program may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

I. General Information A. Does this notice apply to me?

You may be potentially affected by this action if you manufacture, process, or otherwise use 1-bromopropane. Potentially affected categories and entities may include, but are not limited to:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Some of the entities listed in the table have exemptions and/or limitations regarding coverage, and other types of entities not listed in the table could also be affected. To determine whether your facility would be affected by this action, you should carefully examine the applicability criteria in part 372 subpart B of Title 40 of the Code of Federal Regulations. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

This rule is issued under EPCRA section 313(d) and section 328, 42 U.S.C. 11023 et seq. EPCRA is also referred to as Title III of the Superfund Amendments and Reauthorization Act of 1986.

Section 313 of EPCRA, 42 U.S.C. 11023, requires certain facilities that manufacture, process, or otherwise use listed toxic chemicals in amounts above reporting threshold levels to report their environmental releases and other waste management quantities of such chemicals annually. These facilities must also report pollution prevention and recycling data for such chemicals, pursuant to section 6607 of the PPA, 42 U.S.C. 13106. Congress established an initial list of toxic chemicals that comprised 308 individually listed chemicals and 20 chemical categories.

EPCRA section 313(d) authorizes the EPA to add or delete chemicals from the list and sets criteria for these actions. EPCRA section 313(d)(2) states that the EPA may add a chemical to the list if any of the listing criteria in Section 313(d)(2) are met. Therefore, to add a chemical, the EPA must demonstrate that at least one criterion is met, but need not determine whether any other criterion is met. Conversely, to remove a chemical from the list, EPCRA section 313(d)(3) dictates that the EPA must demonstrate that none of the listing criteria in Section 313(d)(2)(A)-(C) are met. The EPCRA section 313(d)(2)(A)-(C) criteria are:

• The chemical is known to cause or can reasonably be anticipated to cause significant adverse acute human health effects at concentration levels that are reasonably likely to exist beyond facility site boundaries as a result of continuous, or frequently recurring, releases.

• The chemical is known to cause or can reasonably be anticipated to cause in humans:

Reproductive dysfunctions,

neurological disorders,

heritable genetic mutations, or

other chronic health effects.

• The chemical is known to cause or can be reasonably anticipated to cause, because of:

○ Its toxicity,

○ its toxicity and persistence in the environment, or

○ its toxicity and tendency to bioaccumulate in the environment, a significant adverse effect on the environment of sufficient seriousness, in the judgment of the Administrator, to warrant reporting under this section.

The EPA often refers to the section 313(d)(2)(A) criterion as the “acute human health effects criterion;” the section 313(d)(2)(B) criterion as the “chronic human health effects criterion;” and the section 313(d)(2)(C) criterion as the “environmental effects criterion.”

The EPA published in the Federal Register of November 30, 1994 (59 FR 61432), a statement clarifying its interpretation of the section 313(d)(2) and (d)(3) criteria for modifying the section 313 list of toxic chemicals.

As discussed in the proposed rule (80 FR 20189, April 15, 2015), the EPA proposed to add 1-bromopropane to the EPCRA section 313 list of toxic chemicals. 1-Bromopropane had been classified as “reasonably anticipated to be a human carcinogen” by the National Toxicology Program (NTP) in its 13th Report on Carcinogens (RoC) document. In addition, based on a review of the available production and use information, the EPA determined that 1-bromopropane is expected to be manufactured, processed, or otherwise used in quantities that would exceed the EPCRA section 313 reporting thresholds. The NTP is an interagency program within the Department of Health and Human Services (DHHS) headquartered at the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health (NIH). As part of the NTP's cancer evaluation work, it periodically publishes the RoC document which contains cancer classifications from the NTP's most recent chemical evaluations as well as the classifications from previous versions of the RoC. There is an extensive review process for the RoC which includes evaluations by scientists from the NTP, other Federal health research and regulatory agencies (including the EPA), and nongovernmental institutions. The RoC review process also includes external peer review and several opportunities for public comment.

As the EPA stated in the proposed rule (80 FR 20189, April 15, 2015), the NTP RoC document undergoes significant scientific review and public comment and mirrors the review the EPA has historically done to assess chemicals for listing under EPCRA section 313 on the basis of carcinogenicity. The conclusions regarding the potential for chemicals in the NTP RoC to cause cancer in humans are based on established sound scientific principles. The EPA believes that the NTP RoC is an excellent and reliable source of information on the potential for chemicals covered therein to cause cancer in humans. Based on the EPA's review of the data contained in the 13th NTP RoC (Reference (Ref.) 1) for 1-bromopropane, the Agency agreed that 1-bromopropane can reasonably be anticipated to cause cancer. Therefore, the EPA determined that the evidence was sufficient for listing 1-bromopropane on the EPCRA section 313 toxic chemical list pursuant to EPCRA section 313(d)(2)(B) based on the available carcinogenicity data for 1-bromopropane as presented in the 13th RoC (Ref. 2).

The EPA received four comments on the proposed rule to add 1-bromopropane to the EPCRA section 313 chemical list. Three of the comments were supportive of the EPA's proposed addition of 1-bromopropane while one commenter objected to the addition. The commenters that supported the proposed rule included two anonymous comments from the general public (Refs. 3 and 4) and a comment from the Halogenated Solvents Industry Alliance, Inc. (HSIA) (Ref. 5). Members of the HSIA include The Dow Chemical Company, INEOS Chlor Americas, Inc., Occidental Chemical, and Axiall Corporation. The commenter who objected to the addition was the Albemarle Corporation (Ref. 6). The most significant comments are summarized and responded to below. The complete set of comments and the EPA's responses can be found in the response to comment document in the docket for this rulemaking (Ref. 7). Note that in some of the comments 1-bromopropane is referred to as nPB, which is the acronym for the alternative chemical name n-propyl bromide.

The HSIA (Ref. 5) stated that the proposed rule presented substantial evidence to support the conclusion that 1-bromopropane is known to cause or can reasonably be anticipated to cause cancer in humans. The HSIA also noted that other published studies indicate that 1-bromopropane is neurotoxic, may cause reproductive dysfunction, and is acutely or chronically toxic. The HSIA concluded that clearly, the scientific literature supports the addition of 1-bromopropane to the list of chemicals subject to reporting under EPCRA section 313.

EPA agrees with the commenter's statement that the EPA provided substantial evidence to support the conclusion that 1-bromopropane is known to cause or can reasonably be anticipated to cause cancer in humans. The EPA also agrees with the commenter's conclusion that the scientific literature supports the addition of 1-bromopropane to the EPCRA section 313 chemical list. The EPA acknowledges that there may be other toxicological effects that may also be a basis for listing. However, the EPA believes the available cancer data are sufficient for adding 1-bromopropane to the EPCRA section 313 chemical list.

The first anonymous commenter (Ref. 3) supported the addition of 1-bromopropane to the EPCRA section 313 list and cited additional toxicity information, neurotoxicity and reproductive toxicity, as being of concern.

EPA agrees that 1-bromopropane should be added to the EPCRA section 313 chemical list. The EPA also acknowledges that there may be other toxicological effects (such as neurotoxicity) that may also be a basis for listing. However, the available cancer data are sufficient for adding 1-bromopropane to the EPCRA section 313 chemical list.

The second anonymous commenter (Ref. 4) supported the listing of 1-bromopropane as long as the benefits substantially outweigh the costs. The commenter also expressed concern that there may be “significant costs to local businesses, i.e., laundry services, that have to update or replace their equipment as well as significant costs and time spent in order to comply with the rule.”

EPA's cost-benefit analysis was contained in the economic analysis for the proposed rule “Economic Analysis of the Proposed Rule to add 1-Bromopropane to the EPCRA Section 313 List of Toxic Chemicals” (Ref. 8), which was reference 8 in the proposed rule (80 FR 20189, April 15, 2015). The economic analysis contains a quantitative estimate of the costs and a qualitative discussion of the benefits of the rule. The EPA considers the benefits of reporting under this rule to be primarily reflected by the purposes served by reporting of information under EPCRA section 313. The EPA believes the benefits provided by the information to be reported under this rule outweigh the costs.

With regard to laundry services (such as dry cleaners) these facilities are not subject to reporting under EPCRA section 313. Even if such facilities were subject to reporting, listing a chemical under EPCRA section 313 does not require covered facilities to update or replace any equipment. EPCRA section 313 only requires the reporting of release and waste management information, it does not impose any restrictions on the use of chemicals.

The majority of comments provided by the Albemarle Corporation (Ref. 6) are the same comments they submitted in response to the “Receipt of a complete petition” to add 1-bromopropane to the Hazardous Air Pollutant (HAP) List (80 FR 6676, February 6, 2015). The only comments submitted by the Albemarle Corporation specific to the EPA's proposed rule to add 1-bromopropane to the EPCRA section 313 chemical list were provided in a letter from Charles R. Nestrud of the law firm Chisenhall, Nestrud & Julian, P.A. dated June 10, 2015 (Nestrud letter). The EPA is providing responses to all of the comments in the Nestrud letter.

The vast majority of the comments submitted by the Albemarle Corporation on the HAP listing petition dealt with issues of emissions, exposure, risk values, and risk assessment, which are not relevant to the proposed addition of 1-bromopropane to the EPCRA section 313 chemical list since the addition is based on hazard and not risk. The addition of 1-bromopropane to the EPCRA section 313 chemical list is based on the cancer hazard evaluation carried out by the NTP and reviewed by the EPA to ensure its consistency with the EPA Guidelines for Carcinogen Risk Assessment (Ref. 9). Consistent with the EPA guidelines (Ref. 9), the NTP 13th RoC (Ref. 2) evaluates the scientific literature and publicly available, peer-reviewed technical reports of human and laboratory studies to evaluate whether substances are possible human carcinogens. The NTP RoC does not present a quantitative assessment of the risks of cancer associated with a given chemical. Rather, it indicates the potential hazard associated with chemicals but does not establish the exposure conditions that would pose cancer risks to individuals. In the 13th RoC, the NTP classified 1-bromopropane as “reasonably anticipated to be a human carcinogen.” The conclusions of the NTP 13th RoC for 1-bromopropane were consistent with how the EPA would consider the carcinogenicity data available for 1-bromopropane. Therefore, for the purposes of listing 1-bromopropane on the EPCRA section 313 chemical list, the EPA concluded that 1-bromopropane can reasonably be anticipated to cause cancer in humans. Since the listing of 1-bromopropane under EPCRA section 313 is based on the available cancer data, the EPA is not responding to the comments from Albemarle Corporation on the HAP listing petition that dealt with issues of emissions, exposure, risk values, and risk assessment.

While not specific to the materials the EPA cited to support the addition of 1-bromopropane to the EPCRA section 313 chemical list, there were some comments on the cancer data for 1-bromopropane in the materials that the Albemarle Corporation submitted in response to the HAP listing petition (Ref. 6). Specifically, these comments are contained in sections 2.2 and 2.3 of the document “Comments on the Petition to Add n-Propyl Bromide to the List of Hazardous Air Pollutants Regulated under § 112 of the Clean Air Act” prepared by the Gradient Corporation (Gradient Corp.). Since these comments dealt with the toxic endpoint (cancer) that is the basis for the addition of 1-bromopropane to the EPCRA section 313 chemical list, the EPA has addressed these comments as well.

In the Nestrud letter, the commenter stated that:

EPA disagrees that the information submitted to support the proposed rule to add 1-bromopropane to the EPCRA section 313 chemical list is “out of date, incorrect, and insufficient to support the Proposed Rule.” The EPA provided information from the NTP 13th RoC which was released on October 2, 2014 (Ref. 2). The EPA's evaluation of the data used to support the findings for 1-bromopropane was conducted shortly after the release of the 13th RoC and completed on November 3, 2014 (Ref. 1). The EPA's economic analysis of the potential costs of the proposed rule including the estimate of the number of facilities expected to file reports was completed on February 17, 2015 (Ref. 8). The EPA notes that the commenter did not provide any comments specific to the EPA's evaluation of the NTP 13th RoC data and findings for 1-bromopropane (Ref. 1), which was reference 6 in the proposed rule (80 FR 20189, April 15, 2015), or specific to the NTP 13th RoC materials prepared for 1-bromopropane (Refs. 10 and 11), which were references 5 and 7 in the proposed rule (80 FR 20189, April 15, 2015), or on the EPA's economic analysis for the addition of 1-bromopropane (Ref. 8), which was reference 8 in the proposed rule (80 FR 20189, April 15, 2015). It is, therefore, unclear which technical information that the EPA submitted to support the proposed rule that the commenter believes is out of date, incorrect, or insufficient to support the proposed rule. Comments regarding the available cancer data and relevance of emissions data are discussed in other responses below.

The Nestrud letter also provided comments concerning screening criteria that the EPA had used in a previous rulemaking:

The information that the commenter cited regarding the criteria the EPA identified for evaluating chemicals for addition to the EPCRA section 313 chemical list are the criteria the EPA used for its 1994 chemical expansion rulemaking to evaluate large numbers of chemicals for potential addition. These screening criteria are not the criteria used to determine whether or not a chemical can be added to the EPCRA section 313 chemical list, that criteria is established under EPCRA section 313(d)(2). As the EPA noted in the 1994 chemical expansion rule:

EPA did not screen 1-bromopropane for addition, but rather conducted a hazard evaluation of the available cancer data and based on the classification by the NTP in their 13th RoC as “reasonably anticipated to be a human carcinogen” and our review of that data, concluded 1-bromopropane should be added to the EPCRA section 313 chemical list. As noted in the proposed rule, the EPA reviewed the data used by the NTP to make this determination and agreed with the NTP's classification (Ref. 1), which was reference 6 in the proposed rule (80 FR 20189, April 15, 2015). As the EPA noted in the 1994 chemical expansion rule, cancer is an extreme toxic effect:

If the EPA had conducted a toxicity screen like that used in the 1994 chemical expansion rule, the available cancer data would have been sufficient to classify 1-bromopropane as a high priority for listing. In fact, the NTP's 6th RoC was a primary source reviewed for chemicals for potential addition (59 FR 1789, January 12, 1994). As previously noted, the commenter did not provide any comments specifically on the NTP's classification of 1-bromopropane as “reasonably anticipated to be a human carcinogen” in the 13th RoC, nor did they provide any comments on the EPA's evaluation of the NTP cancer data and classification (Ref. 1), as provided in reference 6 of the proposed rule (80 FR 20189, April 15, 2015).

The Nestrud letter also commented on the issue of a production volume screen:

Reference 8 in the proposed rule was the economic analysis for the addition of 1-bromopropane to the EPCRA section 313 chemical list (Ref. 8). As indicated in the economic analysis, the EPA estimates that 140 reports (126 Form Rs and 14 Form As) from 23 different industry sectors will be filed for 1-bromopropane. Therefore, the EPA has determined that there is sufficient production and use of 1-bromopropane such that reports will be filed. As previously noted, the commenter provided no specific comments on the EPA's economic analysis. Certain spray adhesives industries may be required to report under EPCRA section 313, but dry cleaning facilities are not a covered industry sector and thus are not required to file reports under EPCRA section 313. While it has been the EPA's policy to focus on the addition of chemicals for which reports are expected to be filed, it is not a statutory requirement. As the EPA noted in the 2010 proposed rule for the addition of 16 NTP carcinogens to the EPCRA section 313 chemical list:

The Nestrud letter also commented on the issue of conducting a hazard evaluation to support the listing of 1-bromopropane to the EPCRA section 313 list:

The commenter states that the EPA should conduct a “Hazard Evaluation” for 1-bromopropane, but that is exactly what the EPA did. The EPA's hazard evaluation included the NTP's classification of 1-bromopropane as “reasonably anticipated to be a human carcinogen” (Refs. 2 and 10) and the EPA's review of the data used by the NTP to support that classification (Ref. 1). As noted in the proposed rule, the NTP conducted an extensive review (including public comment and peer review) of the cancer data for 1-bromopropane in making the classification for the NTP 13th RoC. The EPA's review of that information, as discussed in reference 6 of the proposed rule, concluded that:

EPA believes the cancer data for 1-bromopropane sufficiently support listing under EPCRA section 313(d)(2)(B). None of the information concerning the cancer data that the commenter submitted in their response to the petition to add 1-bromopropane to the hazardous air pollutant (HAP) list changes the EPA's conclusion with regard to the potential for 1-bromopropane to cause cancer in humans. Responses to the specific comments on certain portions of the hazard evaluation are addressed in other responses.

With regard to the commenter's conclusions concerning the cancer risks from facilities identified in the HAP petition, this information is not relevant to the addition of 1-bromopropane to the EPCRA section 313 chemical list. The EPA did not base the proposed addition of 1-bromopropane to the EPCRA section 313 chemical list on any exposure or risk evaluation. 1-Bromopropane meets the EPCRA section 313(d)(2)(B) listing criteria based on the cancer data alone and there are no statutory requirements to consider exposure or risk under EPCRA section 313(d)(2)(B). While the statutory criteria of EPCRA section 313(d)(2)(B) do not require consideration of exposure or risk, the EPA has a policy concerning when it may be appropriate to consider potential exposures when adding chemicals under EPCRA section 313(d)(2)(B). As the EPA stated in the proposed rule:

The EPA disagrees with the conclusion of the commenter that there is no information that would support adding 1-bromopropane to the EPCRA section 313 chemical list. In fact, it is the EPA's position that there are extensive cancer data that support this addition as discussed and referenced in the proposed rule.

In the comments the Albemarle Corporation submitted on the HAP listing petition (Ref. 6), the report by Gradient Corp. included section “2.2 Human Relevance of the Petitioner's Inhalation Unit Risk Factor.” In that section, issues regarding the cancer data for 1-bromopropane were raised. These issues include the petitioners' use of alveolar/bronchiolar adenomas and carcinomas in B6C3F1 mice for their risk assessment. The commenter took issue with the petitioners' suggestion that “there are no reasons to assume that the mode, or modes, of action by which tumors are induced by nPB are not relevant to man.” The commenter stated that the petitioners' supporting information lacked an analysis of the human relevance of the mouse lung tumors or any other cancer endpoint and cited recommendations in the EPA's Guidelines for Carcinogen Risk Assessment for collecting relevant information on the mode of action. The commenter stated that alveolar/bronchiolar adenomas and carcinomas have been reviewed and debated for a number of chemical compounds and were the subject of a 2014 technical workshop sponsored by the EPA. The commenter also provided summaries of relevant information that they claim are available for 1-bromopropane to explore mode of action questions. The commenter concluded that there is evidence that the mode of action for the endpoint selected to predict risks for 1-bromopropane may not be relevant for humans. The commenter stated that, considering the state-of-the-science surrounding this health endpoint, the EPA should not rely on the data for alveolar/bronchiolar adenomas and carcinomas in B6C3F1 mice for characterizing cancer risks in humans from exposure to 1-bromopropane.

As the EPA previously noted, the proposed addition of 1-bromopropane to the EPCRA section 313 chemical list is based on hazard alone and not on any consideration of exposures or potential risks. For the purposes of listing under EPCRA section 313(d)(2)(B), the EPA is not relying on the data for alveolar/bronchiolar adenomas and carcinomas in B6C3F1 mice for characterizing cancer risks in humans from exposure to 1-bromopropane. While the EPA convened a technical workshop on the state-of-the-science for chemically-induced mouse lung tumors, there was no consensus on the relevance of this tumor to humans (Ref. 12). Rather, one of the workshop outcomes included the future application of the information discussed during the workshop to develop a mode of action framework on a chemical by chemical basis. As stated in the EPA Guidelines for Carcinogen Risk Assessment (Ref. 9):

The NTP monograph for 1-bromopropane (Ref. 10) discussed the issue of mode of action in the section on mechanistic considerations:

After considering the mode of action issues, the NTP classified 1-bromopropane as “reasonably anticipated to be a human carcinogen.” The EPA believes that this classification is consistent with how the data would be evaluated under the EPA's Guidelines for Carcinogen Risk Assessment (Ref. 9).

In the comments the Albemarle Corporation submitted on the HAP listing petition, the report by Gradient Corp. included section “2.3 Human Relevance of NTP Results.” In that section, issues regarding the cancer data for 1-bromopropane were raised. The commenter stated that the petitioners cited NTP results for the mouse and rat bioassays as evidence of the potential carcinogenic activity of 1-bromopropane (Ref. 13). The commenter claims that the petitioner did not consider potential uncertainties that the commenter believes are found in the underlying mutagenicity, genotoxicity, and carcinogenicity data for 1-bromopropane. The commenter claimed that this was not consistent with the EPA's cancer guidelines, which recommend evaluating the weight of evidence prior to determining the carcinogenic potential of a chemical substance. The commenter went on to summarize information from studies they believe show potential uncertainties that are apparent in the toxicological information for 1-bromopropane.

Since the publication of the NTP bioassay cited by the commenter (Ref. 13), the NTP published its 13th RoC (Ref. 2). In this report, the NTP concluded that there is sufficient evidence of carcinogenicity for 1-bromopropane based on (1) skin tumors in male rats, (2) tumors of the large intestine in female and male rats, and (3) lung tumors in female mice. The report also cited malignant mesothelioma of the abdominal cavity and pancreatic islet tumors in male rats and skin tumors (squamous-cell papilloma, keratoacanthoma, and basal-cell adenoma or carcinoma) in female rats as supporting evidence. The NTP's monograph for 1-bromopropane addresses all of the data issues that the commenter raised (Ref. 10).

According to the EPA's Guidelines for Carcinogen Risk Assessment (Ref. 9), an agent can be classified as “Likely to Be Carcinogenic to Humans” if it “has tested positive in animal experiments in more than one species, sex, strain, site, or exposure route, with or without evidence of carcinogenicity in humans.” Inconsistencies between how the data were interpreted by the NTP and how that same data might be interpreted under the EPA's Guidelines for Carcinogen Risk Assessment (Ref. 9) were not identified (see reference 6 in the proposed rule). The EPA Guidelines for Carcinogen Risk Assessment reference the NTP criteria for assessing individual studies in the assessment of carcinogenicity, stating “(c)riteria for the technical adequacy of animal carcinogenicity studies have been published and should be used as guidance to judge the acceptability of individual studies, e.g., NTP, 1984 . . .” (pages 2-16).

While the EPA acknowledges that uncertainties exist when evaluating any agent, the EPA agrees with NTP's assessment of the data and conclusions regarding the carcinogenicity of 1-bromopropane. Indeed, according to the EPA's Guidelines for Carcinogen Risk Assessment (Ref. 9) “The default option is that positive effects in animal cancer studies indicate that the agent under study can have carcinogenic potential in humans. Thus, if no adequate human or mode of action data are present, positive effects in animal cancer studies are a basis for assessing the carcinogenic hazard to humans.” The EPA believes that the evaluation of the available data are consistent with the EPA's guidelines including the EPA's “Supplemental guidance for assessing susceptibility from early-life exposure to carcinogens (Final)” (Ref. 14).

The NTP in its monograph of 1-bromopropane (Ref. 10), which supported the 13th RoC listing (Ref. 2), concluded the following:

The EPA agrees with the NTP's conclusions regarding the mutagenicity of 1-bromopropane and its metabolites. With the exception of the summary information provided by the commenter for one unpublished study, all of the studies cited by the commenter in their assessment of the mutagenicity data for 1-bromopropane were cited by the NTP in their monograph for 1-bromopropane (Ref. 10). Also, the commenter focused on the mutagenicity data for 1-bromopropane, but the data on the mutagenicity of the metabolites of 1-bromopropane are an important part of the assessment as well. The summarized results of the unpublished study provided by the commenter do not change the conclusion regarding the mutagenicity of 1-bromopropane and its metabolites.

The EPA is finalizing the addition of 1-bromopropane to the EPCRA section 313 list of toxic chemicals. The EPA has determined that 1-bromopropane meets the listing criteria under EPCRA section 313(d)(2)(B) based on the available carcinogenicity data.

The EPA has established an official public docket for this action under Docket ID No. EPA-HQ-TRI-2015-0011. The public docket includes information considered by the EPA in developing this action, including the documents listed below, which are electronically or physically located in the docket. In addition, interested parties should consult documents that are referenced in the documents that the EPA has placed in the docket, regardless of whether these referenced documents are electronically or physically located in the docket. For assistance in locating documents that are referenced in documents that the EPA has placed in the docket, but that are not electronically or physically located in the docket, please consult the person listed in the above FOR FURTHER INFORMATION CONTACT section. For convenience, the docket also includes all of the Federal Register documents cited in this action.

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action does not contain any new information collection requirements that require additional approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA). OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control numbers 2025-0009 and 2050-0078. Currently, the facilities subject to the reporting requirements under EPCRA 313 and PPA 6607 may use either the EPA Toxic Chemicals Release Inventory Form R (EPA Form 1B9350-1), or the EPA Toxic Chemicals Release Inventory Form A (EPA Form 1B9350-2). The Form R must be completed if a facility manufactures, processes, or otherwise uses any listed chemical above threshold quantities and meets certain other criteria. For the Form A, the EPA established an alternative threshold for facilities with low annual reportable amounts of a listed toxic chemical. A facility that meets the appropriate reporting thresholds, but estimates that the total annual reportable amount of the chemical does not exceed 500 pounds per year, can take advantage of an alternative manufacture, process, or otherwise use threshold of 1 million pounds per year of the chemical, provided that certain conditions are met, and submit the Form A instead of the Form R. In addition, respondents may designate the specific chemical identity of a substance as a trade secret pursuant to EPCRA section 322, 42 U.S.C. 11042, 40 CFR part 350.

OMB has approved the reporting and recordkeeping requirements related to Forms A and R, supplier notification, and petitions under OMB Control number 2025-0009 (EPA Information Collection Request (ICR) No. 1363) and those related to trade secret designations under OMB Control 2050-0078 (EPA ICR No. 1428). As provided in 5 CFR 1320.5(b) and 1320.6(a), an Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers relevant to the EPA's regulations are listed in 40 CFR part 9, 48 CFR chapter 15, and displayed on the information collection instruments (e.g., forms, instructions).

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are small manufacturing facilities. The Agency has determined that of the 140 entities estimated to be impacted by this action, 136 are small businesses; no small governments or small organizations are expected to be affected by this action. All 136 small businesses affected by this action are estimated to incur annualized cost impacts of less than 1%. Facilities eligible to use Form A (those meeting the appropriate activity threshold which have 500 pounds per year or less of reportable amounts of the chemical) will have a lower burden. Thus, this action is not expected to have a significant adverse economic impact on a substantial number of small entities. A more detailed analysis of the impacts on small entities is located in the EPA's economic analysis support document (Ref. 8).

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action is not subject to the requirements of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. Small governments are not subject to the EPCRA section 313 reporting requirements. The EPA's economic analysis indicates that the total cost of this action is estimated to be $531,002 in the first year of reporting (Ref. 8).

This action does not have federalism implications. It will not have substantial direct effects 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.

This action does not have tribal implications, as specified in Executive Order 13175. This action relates to toxic chemical reporting under EPCRA section 313, which primarily affects private sector facilities. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. The results of this evaluation are contained below.

This action does not address any human health or environmental risks and does not affect the level of protection provided to human health or the environment. This action adds an additional chemical to the EPCRA section 313 reporting requirements. By adding a chemical to the list of toxic chemicals subject to reporting under section 313 of EPCRA, the EPA would be providing communities across the United States (including minority populations and low income populations) with access to data which they may use to seek lower exposures and consequently reductions in chemical risks for themselves and their children. This information can also be used by government agencies and others to identify potential problems, set priorities, and take appropriate steps to reduce any potential risks to human health and the environment. Therefore, the informational benefits of the action will have a positive impact on the human health and environmental impacts of minority populations, low-income populations, and children.

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

For the reasons set forth in the preamble, the EPA amends 40 CFR part 372 as follows:

I. Background II. Section-by-Section Review III. Regulatory Analyses and Notices A. Statutory/Legal Authority for the Rulemaking B. Executive Orders 12866 and 13563 and DOT Regulatory Policies and Procedures C. Executive Order 13132 D. Executive Order 13175 E. Regulatory Flexibility Act, Executive Order 13272, and DOT Policies and Procedures F. Executive Order 13563 Improving Regulation and Regulatory Review G. Paperwork Reduction Act H. Regulatory Identifier Number (RIN) I. Unfunded Mandates Reform Act J. Environmental Assessment K. Privacy Act I. Background

The Pipeline and Hazardous Materials Safety Administration (PHMSA) annually reviews the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180) to identify typographical errors, outdated addresses or other contact information, and similar errors. In this final rule, we are correcting typographical errors, incorrect references to the Code of Federal Regulations (CFR) and international standards citations, inconsistent use of terminology, misstatements of certain regulatory requirements, and inadvertent omissions of information, and making revisions to clarify the regulations. Of the corrections and clarifications made in this final rule, a significant number originate from three recent final rules under the following dockets: PHMSA-2009-0063 (HM-250) [79 FR 40590]; PHMSA-2009-0095 (HM-224F)] [79 FR 46012]; and PHMSA-2013-0260 (HM-215M) [80 FR 1075]. Because these amendments do not impose new requirements, notice and public comment are unnecessary.

The following is a section-by-section summary of the minor editorial corrections and clarifications made in this final rule.

This section prescribes the authorization and conditions for use of international standards and regulations. The wording at the end of paragraph (f)(4) applicable to shipping paper retention, states “§ 172.201(e) of this part”, which incorrectly assigns it to 49 CFR part 171. As § 172.201(e), is not in part 171, in this final rule, the text is revised to read “§ 172.201(e) of this subchapter.”

Section 171.23 prescribes requirements for specific materials and packagings transported under various international standards. Paragraph (a)(4)(ii) contains a grammatical error stating the word “drive” instead of “device.” In this final rule, we are correcting this grammatical error.

Additionally, the text in the middle of paragraph (a)(5), applicable to cylinders not equipped with pressure relief devices, states the cylinders must be “tested and marked in accordance with part 178 of this subchapter and otherwise conforms to the requirements of part 173 for the gas involved”, but does not reference that part 173 belongs to subchapter C. In this final rule, we are revising (a)(5) to make this clarification.

Section 171.24 provides additional requirements for the use of the International Civil Aviation Organization's Technical Instructions (ICAO TI) for the Safe Transport of Dangerous Goods by Air. The text at the end of paragraph (c), applicable to transportation by highway prior to or after transportation by aircraft, states a “motor vehicle must be placarded in accordance with subpart F of part 172”, but does not reference that part 172 belongs to Subchapter C. In this final rule, we are revising paragraph (c) to make this clarification.

This section prescribes the purpose and instructions for use of the § 172.102 Hazardous Materials Table (HMT). We are making a number of editorial corrections to several entries in the HMT. The editorial corrections are as follows:

• In a final rule published under Docket Number PHMSA-2012-0080 (HM-244E) [77 FR 60935], the entry for “Aminophenols (o-; m-; p-), UN2512” was amended to correct a publication error in Column (2). In making the correction, the text in Columns (3) through (10B) was inadvertently removed and left blank. This final rule corrects that error by reinstating the text in Columns (3) through (10B) for UN2512 as it read on prior to the HM-244E rulemaking October 5, 2012.

• For the entry “Environmentally hazardous substances, solid, n.o.s, UN3077,” the symbol “G” is added to Column (1) as it was inadvertently removed when the entry was amended in a final rule published under Docket Number PHMSA 2011-0158 (HM-233C) [79 FR 15033].

• For the entry “Self-heating solid, organic, n.o.s, UN3088,” the symbol “G” is added to Column (1) as it was inadvertently removed when the entry was amended in a final rule published under Docket Number PHMSA 2011-0158 (HM-233C) [79 FR 15033].

• For the entry “N-Aminoethyl piperazine, UN2815,” the space between “N-Aminoethyl” and “piperazine” is removed to read “N-Aminoethylpiperazine” as the space was inadvertently introduced in the HM-215M final rule.

• For the entry “Ammonia solutions, relative density less than 0.880 at 15 degrees C in water, with more than 35 percent but not more than 50 percent ammonia, UN2073,” the plural “solutions” is revised to read “solution” consistent with the International Maritime Dangerous Goods (IMDG) Code, the ICAO TI, the United Nations Recommendations on the Transport of Dangerous Goods (UN Model Regulations).

• For the entry “Ammonia solutions, relative density between 0.880 and 0.957 at 15 degrees C in water, with more than 10 percent but not more than 35 percent ammonia, UN2672,” the plural “solutions” is revised to read “solution” as it was inadvertently changed when the entry was amended in a final rule published under Docket Number PHMSA 2011-0158 (HM-233C) [79 FR 15033].

• For the entry “Batteries, dry, containing potassium hydroxide solid, electric storage, UN3028,” the phrase “electric storage” was inadvertently changed from italicized to non-italicized text in the HM-215M final rule. In this final rule, the italicized text is reinstated.

• For the entry “Environmentally hazardous substances, solid, n.o.s, UN3077,” the plural “substances” is revised to read “substance” as it was inadvertently changed when the entry was amended in a final rule published under Docket Number PHMSA 2011-0158 (HM-233C) [79 FR 15033].

• For the entry “Paint, corrosive, flammable (including paint, lacquer, enamel, stain, shellac solutions, varnish, polish, liquid filler, and liquid lacquer base), UN3470,” the word “solutions” was inadvertently added to the italicized text in the HM-215M final rule. In this final rule, the word “solutions” is removed.

• For the entry “Printing ink, flammable or Printing ink related material (including printing ink thinning or reducing compound), flammable, UN1210,” the first instance of the word “flammable” was inadvertently changed from italicized to non-italicized text in the HM-215M final rule. In this final rule, the italicized text is reinstated.

• For the entry “Trinitrobenzene, wetted with not less than 30 percent water, by mass, UN1354,” the word “wetted” was inadvertently changed from non-italicized to italicized text in the HM-215M final rule. In this final rule, the non-italicized text is reinstated.

• For the entry “Cells, containing sodium, UN3292,” the Packing Group in Column (5) is removed for consistency with “Batteries, containing sodium, UN3292,” as amended in the HM-215M final rule.

• In a final rule published under Docket Number PHMSA-2013-0041 (HM-215K, HM-215L, HM-218G and HM-219) [77 FR 65453], PHMSA revised the HMT entry “Petroleum sour crude oil, flammable, toxic, UN3494,” that had been erroneously placed between the Packing Group II and III petroleum oil entries under NA1270. In making the correction, the Packing Group II and III entries for UN3494 were inadvertently omitted. This final rule corrects that error by reinstating the Packing Group II and III entries for UN3494.

• For “Organometallic substance, liquid, water-reactive, UN3398,” the Class 3 subsidiary hazard code is removed from the Packing Group II and III entries. These subsidiary hazard codes were inadvertently added when the entries were revised in the HM-215 final rule.

• For the entry “Combustible liquid, n.o.s., NA1993,” special provision T4 is removed. Special Provisions T1 and T4 are both currently assigned to this entry; however, only one portable tank code should be listed as both cannot be used when building and constructing a portable tank. Special provision T1 is listed correctly. Special provision T4 was inadvertently added when amending the entry in a final rule published under Docket Number RSPA-2000-7702 (HM-215D) [66 FR 33316].

• For the entries “Lithium ion batteries including lithium ion polymer batteries, UN3480” and “Lithium metal batteries including lithium alloy batteries, UN3090,” special provision A54 is added in Column (7). Special provision A54 was inadvertently removed when these entries were revised in the HM-215M final rule.

• For the entry “Self-heating solid, organic, n.o.s, UN3088, PG III,” the packaging authorization is revised to read “213” as it was inadvertently changed when the entry was amended in a final rule published under Docket Number PHMSA 2011-0158 (HM-233C) [79 FR 15033].

• For the entry “Self-heating solid, organic, n.o.s, UN3088, PG III,” the Quantity Limitation in Column (9A) is revised to read “25 kg” as it was inadvertently changed when the entry was amended in a final rule published under Docket Number PHMSA 2011-0158 (HM-233C) [79 FR 15033].

• For the entry “Self-heating solid, organic, n.o.s, UN3088, PG III,” the Quantity Limitation in Column (9B) is revised to read “100 kg” as it was inadvertently changed when the entry was amended in a final rule published under Docket Number PHMSA 2011-0158 (HM-233C) [79 FR 15033].

• For the entry “Self-reactive solid type B, UN3222,” the Quantity Limitation in Columns (9A) and (9B) are revised to read “Forbidden.” When this entry was revised in a final rule published under Docket Number PHMSA 2011-0142 (HM-219) [78 FR 14702], Columns (9A) and (9B) were inadvertently revised from “Forbidden” to “(1)” and “(2)” respectively. This entry was subsequently revised in a Federal Register correction document (78 FR 17874), but due to a publication error it was not transitioned into the printed or electronic versions of the CFR. In this rulemaking, PHMSA is reinstating the correct quantity limitation notation of “Forbidden” in Columns (9A) and (9B) for this entry.

• Two entries exist for “Trinitrobenzene, dry or wetted with less than 30 percent water, by mass, UN0214.” One entry indicates “4” in Column (10A) and the other “04”. In this final rule both entries are removed and the correct entry with “04” in Column (10A) is re-added.

• For the PG III entry for “Oxidizing solid, corrosive, n.o.s, UN3085,” the Vessel Stowage in Column (10B) is corrected from “F56” to read “56” as the “F” was inadvertently added when the entry was revised in the HM-215M final rule.

Section 172.102 lists special provisions applicable to the transportation of specific hazardous materials. Special provisions contain packaging requirements, prohibitions, and exceptions applicable to particular quantities or forms of hazardous materials. In a final rule published under Docket Number PHMSA 2011-0158 (HM-233C) [79 FR 15033], PHMSA incorporated DOT-SP 12825 to the entry in the HMT for “UN2990, Life-saving appliances, self-inflating,” by adding a new special provision 338 in Column 7. The special permit was limited only to transport by motor vehicle; however, the special provision was added without the modal limitation. Therefore, in this final rule, PHMSA is revising special provision 338 to clarify applicability to motor vehicle only.

In the HM-250 final rule, the paragraphs contained in § 173.421 were renumbered. The HM-215M rulemaking subsequently added special provision 369, but did not incorporate the paragraph renumbering of § 173.421. In this final rule, PHMSA is revising special provision 369 to reflect the appropriate paragraphs of § 173.421 along with some grammatical revisions.

Section 172.202 establishes requirements for shipping descriptions on shipping papers. In paragraph (d), the example for a technical name in association with the basic description is in a sequence that is no longer authorized under the HMR. In this final rule, the sequence is revised by placing the identification number at the beginning of the sequence.

Section 172.203 prescribes additional shipping paper requirements for “n.o.s.” and generic shipping descriptions. The example in paragraph (k)(1) for “UN2924” is missing the Class 8 subsidiary risk. In this final rule, the subsidiary risk is added to the example.

Section 172.502 specifies prohibited and permissive placarding requirements. In this final rule, paragraph (b)(3), applicable to use of a safety sign or safety slogan (e.g., “Drive Safely” or “Drive Carefully”), is removed as the transitional provision is expired.

Section 172.704 specifies the requirements for hazardous materials training. In this final rule, the expired transitional provision in paragraph (e)(2), applicable to training for railway employees, is removed.

This section provides requirements for shipments of small quantities by highway and rail. In the HM-250 final rule, the paragraphs contained in § 173.421 were renumbered. Multiple sections referencing the previous paragraph numbering of § 173.421 were not amended in the HM-250 rulemaking. In this final rule, PHMSA is revising paragraph (b) to reflect the appropriate paragraphs of § 173.421.

This section provides exceptions for non-specification packagings used in intrastate transportation. Paragraph (a) of § 173.8, authorizes transport of non-specification bulk packaging by an intrastate motor carrier until July 1, 2000. In this final rule, we are removing and reserving paragraph (a) as this transition date has expired.

This section provides requirements for packages utilizing overpacks. In the HM-250 final rule, paragraph (a)(4) was revised to require the “OVERPACK” marking for Class 7 (radioactive) material when a Type A, Type B(U), Type B(M) or industrial package is required. Paragraph (a)(4) was subsequently revised in the HM-215M final rule by specifying the minimum size requirement for the “OVERPACK” marking. In making the HM-215M revision the requirement added in the HM-250 final rule was inadvertently omitted. We are revising paragraph (a)(4) to include the requirements added in both the HM-250 and HM-215 final rules.

Section 173.127 provides a definition and criteria for the assignment of packing groups for Division 5.1 oxidizers. In the HM-215M final rule, PHMSA authorized an alternative test for assigning packing groups to Division 5.1 oxidizing solids. Due to an incorrect regulatory instruction, the paragraph (b)(2) was inadvertently removed. In this final rule, PHMSA is reinstating the paragraph (b)(2) text.

Section 173.156 prescribes exceptions for limited quantity and ORM material. In a final rule published under Docket Number PHMSA-2013-0041 (HM-215K, HM-215L, HM-218G and HM-219) [78 FR 65454], paragraph (b)(2)(vi) was removed which was the last paragraph in the section. As a result, the preceding paragraph (b)(2)(v) became the last paragraph in the section and presently ends with “; and” instead of a period. In this rule, we are replacing “and” at the end of paragraph (b)(2)(v) with a period and adding “and” to the end of paragraph (b)(2)(iv).

Section 173.185 sets forth packaging requirements and certain conditional exceptions for the transport of lithium batteries. The HM-224F final rule revised this section in its entirety. This final rule makes thirteen editorial corrections and clarifications to § 173.185 as follows:

1. Paragraph (b)(4)(i) is revised to clarify that the outer packaging requirement only applies to lithium cells or batteries contained in equipment when an outer packaging is used.

2. In paragraph (b)(4)(iii) applicable to spare lithium cells or batteries packed with equipment the word “ion” is removed to clarify that this requirement applies not only to lithium ion cells and batteries, but also to lithium metal cells and batteries. This editorial revision clarifies the intent discussed in the HM-224 final rule preamble on 79 FR 46019 (third column).

3. In paragraph (b)(5), the reference to (b)(4) is replaced with (b)(3)(iii) as (b)(4) does not contain UN performance packaging requirements.

4. Paragraph (c) is revised to clarify that the UN performance packaging requirements in both paragraphs (b)(3)(ii) and (b)(3)(iii) do not apply to any packages containing smaller lithium cells and batteries meeting the conditions of paragraph (c) including packages that contain lithium metal cells and batteries packed with, or contained in equipment. Previous to the revision in this final rule, paragraph (c) excepted smaller lithium cells and batteries from the UN performance packaging requirements in paragraphs (b)(3)(ii) and (b)(4) of this section. While the original intent was to except all smaller lithium cells and batteries from the UN performance packaging, a potential conflict was identified with regard to smaller lithium cells and batteries packed with equipment because the requirements in (b)(3)(iii)(A) and (B) indicate that such batteries must meet the Packing Group II performance requirements as specified in paragraph (b)(3)(ii). Because the requirements of (b)(3)(iii) were not specifically excepted in paragraph (c), this caused confusion leading some offerors and carriers to inquire if smaller lithium cells and batteries packed with equipment are subject to the UN performance packaging requirements. As a result, in this final rule, we are revising paragraph (c) to clarify smaller lithium cells and batteries are excepted from the entirety of UN performance packaging requirements in paragraphs (b)(3)(ii) and (b)(3)(iii) while also removing the reference to (b)(4) because it does not contain UN performance packaging requirements.

5. In paragraph (c)(1)(v) applicable to markings for lithium metal batteries, incorrect references to paragraphs (c)(1)(ii) and (c)(1)(iii) are replaced with correct references to paragraphs (c)(1)(iii) and (c)(1)(iv).

6. Paragraph (c)(2) is revised to clarify that for lithium batteries packed with equipment, either the package containing the batteries may be individually drop tested, or the completed package containing both the batteries and equipment may be subjected to the 1.2 meter drop test. This is consistent with intent of the HM-224F final rule to align the provisions of the HMR with the provisions prescribed in Packing Instruction(s) 966 and 969 of the 2013-2014 edition of the ICAO TI.

7. Paragraph (c)(3) is revised to eliminate redundant requirements for air transportation by moving marking requirements from paragraph (c)(4)(i) to paragraph (c)(3). This revision clarifies that all four of the documentation requirements in (c)(3)(ii)(A)-(D) [now (c)(3)(iii)(A)-(D)] are applicable to air shipments. This revision also clarifies that for air transport both the markings prescribed in (c)(3)(i)(A)-(D) and the air handling mark are not required. Paragraph (c)(3)(i) is revised to clarify that the marking requirements prescribed in (c)(3)(i)(A)-(D) are applicable for transport by highway, rail, and vessel and may be alternatively satisfied by use of the air handling mark. In addition, by consolidating the small battery hazard communication requirements in paragraph (c)(3), it is clarified that the handling marking is not required for a package containing button cell batteries installed in equipment (including circuit boards), or no more than four lithium cells or two lithium batteries installed in the equipment. Although this particular exception is unchanged in paragraph (c)(3), there was some confusion on the part of shippers and carriers as to whether the exception was also intended to apply to air shipments as there was previously no clear exception from the requirement in paragraph (c)(4) to apply the air handling mark for batteries installed in equipment.

8. As required by the previous paragraph (c)(4)(i)(C) [now (c)(3)(ii)(C)], the asterisk on the air handling mark must be replaced with the phrase “lithium ion battery” and/or “Lithium metal battery.” Consistent with the ICAO TI, there is no requirement in the previous paragraph (c)(4)(i)(C) [now (c)(3)(ii)(C)], to indicate that the word “cell” is marked on a package containing lithium “cells,” meaning that word “battery” is used to describe packages containing both lithium cells and batteries. This differs from (c)(3)(i)(A), which requires an indication that the package contains “lithium metal” or “lithium ion” cells or batteries, as appropriate. As discussed in the HM-224F preamble (79 FR 46022, third column) we stated the lithium-battery handling label that is required for air transport may be used by all modes provided it conveys the information required by the HMR. The present air transportation requirements for the lithium battery handling marking in both the HMR and the ICAO only require use of the word “battery” (even for packages containing cells). Therefore a “lithium battery handling marking” that would be compliant when transporting lithium cells by air would not satisfy the hazard communication requirement for other modes that require an indication the package contains “cells”. As a result, we are revising (c)(3)(i)(A) to clarify that the word “battery” may be used to satisfy the marking requirements of packages containing “cells.”

9. Paragraph (c)(3)(i)(A) applicable to marking requirements for excepted lithium batteries is revised to clarify that a package must be marked with an indication that it contains “lithium metal” and/or “lithium ion” batteries and is not limited to one or the other type and for consistency with (c)(4)(i)(C) [now (c)(3)(ii)(C)], which contains the text “and/or.”

10. Paragraph (c)(4)(ii) [now (c)(4)(iii)] is revised by removing the redundant documentation requirements already required in paragraph (c)(3).

11. Paragraph (c)(4)(v) [now (c)(4)(vi)], is revised to clarify that it does not apply to lithium cells or batteries packed with or contained in equipment. When transported by air, for small lithium cells or batteries packed with or contained in equipment, the quantity limitations are prescribed in (c)(4)(iii) [now (c)(4)(iv].

12. In paragraph (e)(3), the reference to (b)(4) is replaced with (b)(3)(iii) as (b)(4) does not contain UN performance packaging requirements.

13. Paragraph (f)(3)(iii) is revised by removing the word “large” from the phrase “single large battery” as the term “large” refers to the package, not the battery.

This section prescribes the packaging requirements and exceptions for Category B infectious substances. In the HM-215M final rule, paragraph (a)(5) was revised for consistency with the UN Model Regulations. In making the revision, the square-on-point marking graphic “UN3373” was inadvertently removed. In this final rule, the graphic is reinstated in paragraph (a)(5).

This section specifies requirements for the filling of cylinders with non-liquefied (permanent) compressed gases. In the HM-215M final rule, PHMSA adopted the provisions in UN Model Regulations for the transportation of adsorbed gases in cylinders. PHMSA amended the title of this section and paragraph (a) to include and specify requirements for the transportation of adsorbed gases. Due to a regulatory instruction error, the revisions to paragraph (a) were not included in the CFR. In this final rule, PHMSA is adding the revisions to paragraph (a) as intended in the HM-215M final rule as published in 80 FR 1161, instruction number 48.

Section 173.309 prescribes requirements for fire extinguishers. In the HM-215M final rule, provisions for transporting large fire extinguishers unpackaged were added in a new paragraph (e). Paragraph (e)(2) requires that the valves must be protected in accordance with § 173.301(c)(2)(i), (ii), (iii) or (v). The references to § 173.301(c) are incorrect as the applicable requirements are located in § 173.301b(c). In this final rule, PHMSA is revising paragraph (e)(2) to correctly reference § 173.301b(c)(2)(i), (ii), (iii) or (v).

This section prescribes requirements for transporting compressed gases in tank cars and multi-unit tank cars. In paragraph (k)(2), the basic description for chlorine is in a sequence that is no longer authorized under the HMR. In this final rule, the sequence is revised by placing the identification number at the beginning of the sequence.

Section 173.334 prescribes packaging and filling requirements for organic phosphates mixed with compressed gas. In paragraph (b), the word “education” is replaced with the word “eduction,” as originally intended.

Section 173.417 discusses authorized fissile materials packages. The HM-250 final rule removed paragraph (b)(3) leaving the preceding paragraph (b)(2) ending with “; or”. In this final rule, “;or” is replaced with a period (“.”).

Section 173.420 prescribes the transport conditions for uranium hexafluoride. The HM-250 final rule removed and reserved paragraph (a)(2)(ii) which ended in “; or”. In this rule, the word “or” is added to the end of the preceding paragraph (a)(2)(i). In addition, in this rule, paragraph (d)(2) is amended to correct an error made in HM-215M by replacing references to §§ 173.421(a)(1) and (a)(4) with §§ 173.421(a) and (d).

Section 173.422 prescribes additional requirements for excepted packages containing Class 7 (radioactive) materials. Paragraph (c) requires the reporting of decontamination in accordance with §§ 174.750, 175.700(b), or 176.710 dependent on the mode of transportation. In a final rule published under Docket Number RSPA-02-11654 (HM-228) [71 FR 14586], the reporting requirements in § 175.700(b) were moved to § 175.705. In this final rule, PHMSA is revising paragraph (c) by replacing the reference to § 175.700(b) with § 175.705.

Section 173.423 prescribes requirements for multiple hazard limited quantity Class 7 materials. In the HM-250 final rule, the paragraphs contained in § 173.421 were renumbered. Multiple sections referencing the previous paragraph numbering of § 173.421 were not amended in the HM-250 rulemaking. In this final rule, PHMSA is revising paragraph (a)(2) to reflect the appropriate paragraphs of § 173.421.

Section 173.426 prescribes requirements for excepted packages for articles containing natural uranium or thorium. In the HM-250 final rule, the paragraphs contained in § 173.421 were renumbered. Multiple sections referencing the previous paragraph numbering of § 173.421 were not amended in the HM-250 rulemaking. In this final rule, PHMSA is revising paragraph (c) to reflect the appropriate paragraphs of § 173.421.

This section provides transport requirements for empty Class 7 (radioactive) materials packaging. In the HM-250 final rule, the paragraphs contained in § 173.421 were renumbered. Multiple sections referencing the previous paragraph numbering of § 173.421 were not amended in the HM-250 rulemaking. In this final rule, PHMSA is revising paragraph (a) to reflect the appropriate paragraphs of § 173.421.

This section contains exempt material activity concentrations and exempt consignment activity limits for radionuclides. In the HM-250 final rule, footnote b, which provides a list of parent nuclides and their progeny listed in secular equilibrium was amended. For the entry “RA-226,” Bi-214 was listed twice. In this final rule, PHMSA is removing the duplicate progeny entry of Bi-214 from footnote b.

Section 175.10 specifies the conditions for which passengers, crew members, or an operator may carry hazardous materials aboard a passenger aircraft. In the HM-224F final rule, Watt-hours were adopted in place of “equivalent lithium content,” as the measure of power (or size) of a lithium ion cell or battery (see 79 FR 46012 and 46015). In paragraph (a)(17)(v), applicable to wheelchairs or other mobility aids powered by lithium ion batteries the phrase “equivalent lithium content” was inadvertently retained. We are revising § 175.10(a)(17)(v)(D) and (E) by replacing references to equivalent lithium content with Watt-hours. The revision states that the battery must not exceed 300 Watt-hours and that a maximum of one spare battery not exceeding 300 Watt-hours or two spares not exceeding 160 Watt-hours each may be carried.

Section 176.104 prescribes requirements for loading and unloading Class 1 materials. Paragraph (c)(3) contains a grammatical error stating the word “hoods” instead of “hooks.” In this final rule, we are correcting this grammatical error.

Section 176.116 prescribes the general stowage conditions for Class 1 explosive materials. Paragraph (e)(3) contains a reference to the Class A60 standard that is defined in 46 CFR 72.05-10(a)(1). However, 46 CFR 72.05-10(a)(1) does not exist and, therefore, does not provide the definition for the Class A60 standard. In this final rule, the citation is corrected to read 46 CFR 72.05-10(c)(1).

Section 176.905 prescribes specific requirements for motor vehicles or mechanical equipment powered by internal combustion engines that are offered for transportation and transported by vessel. In the HM-215M final rule, PHMSA aligned the conditions for exception from the subchapter in paragraph (i) with those recently adopted by the IMO. Due to an incorrect regulatory instruction, the paragraph (i) introductory text was inadvertently removed. In this final rule, PHMSA is reinstating the paragraph (i) introductory text.

Section 177.838 prescribes specific loading and unloading requirements for Class 4 (flammable solid) materials, Class 5 (oxidizing) materials, and Division 4.2 (pyrophoric liquid) materials when carried by public highway. In this final rule, PHMSA is revising the section heading by replacing the word “pyroforic” with the correct spelling “pyrophoric.” In addition, paragraph (g) of § 177.838 is revised to clarify that the limitation that a motor vehicle may only contain 45.4 kg (100 pounds) or less net mass of material described as “Smokeless powder for small arms, Division 4.1” also includes “Black powder for small arms, Division 4.1”. This clarification will provide consistency with the requirements and limitations of §§ 173.170 and 173.171 which respectively authorize Black powder for small arms that has been classed in Division 1.1 and Smokeless powder for small arms that has been classed as Division 1.3 or Division 1.4 to be reclassed as a Division 4.1 material for domestic transportation by highway, provided certain conditions are met. Sections 173.170 and 173.171 further provide, respectively, that the total quantity of the re-classed black powder or smokeless powder in one motor vehicle may not exceed 45.4 kg (100 pounds) net mass.

Section 178.71 prescribes specifications for UN pressure receptacles. We are revising paragraph (p)(15) to correct a typographical error by replacing the “1” in “1SO 11114-1” with an “I” to read “ISO 11114-1” .

Section 178.801 sets forth recordkeeping requirements for IBC packaging manufacturers, design type testers, and periodic retesters. In paragraph (l)(2), subparagraph (vii) was inadvertently skipped when the paragraph was revised in a final rule published under Docket Number PHMSA-2013-0041 (HM-215K, HM-215L, HM-218G and HM-219) [77 FR 65453]. We are revising paragraph (l)(2) to correct the subparagraph numbering sequence.

This section prescribes requirements for requalification markings for cylinders. We are revising paragraph (f)(1) to correct the reference to § 173.309(b) to read “§ 173.309(a).”

This final rule is published under authority of 49 U.S.C. 5103(b), which authorizes the Secretary of Transportation to prescribe regulations for the safe transportation, including security, of hazardous material in intrastate, interstate, and foreign commerce. The purpose of this final rule is to remove inadvertent errors in the hazardous materials table, grammatical and typographical errors, and, in response to requests for clarification, improve the clarity of certain provisions in the Hazardous Materials Regulations. The changes made in this final rule are considered non-substantive and this is published as a direct final rule.

This final rule is not considered a significant regulatory action under section 3(f) of Executive Order 12866 and, therefore, was not reviewed by the Office of Management and Budget. This rule is not significant under the Regulatory Policies and Procedures of the Department of Transportation (44 FR 11034). Additionally, E.O. 13563 supplements and reaffirms E.O. 12866, stressing that, to the extent permitted by law, an agency rulemaking action must be based on benefits that justify its costs, impose the least burden, consider cumulative burdens, maximize benefits, use performance objectives, and assess available alternatives. This final rule does not impose new or revised requirements for hazardous materials shippers or carriers; therefore, it is not necessary to prepare a regulatory impact analysis.

This final rule has been analyzed in accordance with the principles and criteria in Executive Order 13132 (“Federalism”). This final rule does not adopt any regulation that: (1) Has substantial direct effects on the states, the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government; or (2) imposes substantial direct compliance costs on state and local governments. PHMSA is not aware of any state, local, or Indian tribe requirements that would be preempted by correcting editorial errors and making minor regulatory changes. This final rule does not have sufficient federalism impacts to warrant the preparation of a federalism assessment.

This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”). Because this final rule does not have tribal implications, does not impose substantial direct compliance costs on Indian tribal governments, and does not preempt tribal law, the funding and consultation requirements of Executive Order 13175 do not apply, and a tribal summary impact statement is not required.

This final rule will not have a significant economic impact on a substantial number of small entities. This rule makes minor editorial changes that will not impose any new requirements on persons subject to the HMR; thus, there are no direct or indirect adverse economic impacts for small units of government, businesses, or other organizations.

Executive Order 13563 supplements and reaffirms the principles, structures, and definitions governing regulatory review that were established in Executive Order 12866 Regulatory Planning and Review of September 30, 1993. In addition, Executive Order 13563 specifically requires agencies to: (1) Involve the public in the regulatory process; (2) promote simplification and harmonization through interagency coordination; (3) identify and consider regulatory approaches that reduce burden and maintain flexibility; and (4) ensure the objectivity of any scientific or technological information used to support regulatory action; consider how to best promote retrospective analysis to modify, streamline, expand, or repeal existing rules that are outmoded, ineffective, insufficient, or excessively burdensome.

A complete review of the existing HMR led to the identification of various minor errors in the HMR.

The correction of these errors will clarify current text while maintaining the intent of the regulations affected. This final rule is designed to address those errors by making non-substantive changes to the HMR such as editorial changes, spelling corrections, removal of transitional requirements that are no longer applicable and formatting modifications. This final rule corrects these errors but does not require the application of Executive Order 13563. The final rule does however clarify the regulatory text thus improving the regulations.

This final rule imposes no new information collection requirements.

A regulation identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.

This rule does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995. It does not result in costs of $141.3 million or more to either state, local, or tribal governments, in the aggregate, or to the private sector, and is the least burdensome alternative that achieves the objectives of the rule.

The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321-4347), and implementing regulations by the Council on Environmental Quality (40 CFR part 1500) require Federal agencies to consider the consequences of Federal actions and prepare a detailed statement on actions that significantly affect the quality of the human environment.

The purpose of this rulemaking is to correct editorial errors, make minor regulatory changes and, in response to requests for clarification, improve the clarity of certain provisions in the HMR. The intended effect of this rule is to enhance the accuracy and reduce misunderstandings of the regulations. The amendments contained in this rule are non-substantive changes and do not impose new requirements. Therefore, PHMSA has determined that the implementation of this final rule will not have any significant impact on the quality of the human environment.

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477), which may be viewed at http://www.dot.gov/privacy.

In consideration of the foregoing, PHMSA is amending 49 CFR Chapter I as follows:

NHTSA administers a program for reducing motor vehicle theft. The central feature of this program is the Federal Motor Vehicle Theft Prevention Standard, 49 CFR part 541. The standard specifies performance requirements for inscribing and affixing vehicle identification numbers (VINs) onto certain major original equipment and replacement parts of high-theft lines of passenger motor vehicles.

The agency is required by 49 U.S.C. 33104(b)(4) to periodically obtain, from the most reliable source, accurate and timely theft data and publish the data for review and comment. To fulfill this statutory mandate, NHTSA has published theft data annually beginning with MYs 1983/84. Continuing to fulfill the section 33104(b)(4) mandate, this document reports the final theft data for CY 2013, the most recent calendar year for which data are available.

In calculating the 2013 theft rates, NHTSA followed the same procedures it used in calculating the MY 2012 theft rates. (For 2012 theft data calculations, see 79 FR 70115). As in all previous reports, NHTSA's data were based on information provided to NHTSA by the National Crime Information Center (NCIC) of the Federal Bureau of Investigation. The NCIC is a government system that receives vehicle theft information from nearly 23,000 criminal justice agencies and other law enforcement authorities throughout the United States. The NCIC data also include reported thefts of self-insured and uninsured vehicles, not all of which are reported to other data sources.

The 2013 theft rate for each vehicle line was calculated by dividing the number of reported thefts of MY 2013 vehicles of that line stolen during calendar year 2013 by the total number of vehicles in that line manufactured for MY 2013, as reported to the Environmental Protection Agency (EPA).

The final 2013 theft data show a slight increase in the vehicle theft rate when compared to the theft rate experienced in CY/MY 2012. The final theft rate for MY 2013 passenger vehicles stolen in calendar year 2013 increased to 1.1562 thefts per thousand vehicles produced, an increase of 2.37 percent from the rate of 1.1294 thefts per thousand vehicles experienced by MY 2012 vehicles in CY 2012.

For MY 2013 vehicles, out of a total of 211 vehicle lines, ten lines had a theft rate higher than 3.5826 per thousand vehicles, the established median theft rate for MYs 1990/1991. (See 59 FR 12400, March 16, 1994). Of the ten vehicle lines with a theft rate higher than 3.5826, nine are passenger car lines, one is a multipurpose passenger vehicle line, and none are light-duty truck lines.

The overall trend using increments of five years show a marked decrease in passenger motor vehicle thefts over a 20-year (1993-2013) period. Specifically, the MY 2013 theft rate (1.16 thefts per thousand vehicles) is 70.85 percent lower than the CY/MY 1993 rate (3.98 thefts per thousand vehicles), 54.33 percent lower than the CY/MY 1998 rate (2.54 thefts per thousand vehicles), 36.96 percent lower than the CY/MY 2003 rate (1.84 thefts per thousand vehicles) and 31.36 percent lower than the CY/MY 2008 rate (1.69 thefts per thousand vehicles). Overall, as indicated by Figure 1, theft rates have continued to show a downward trend since CY/MY 1993, with periods of very moderate increases from one year to the next.

On Thursday, August 6, 2015, NHTSA published the preliminary theft rates for CY 2013 passenger motor vehicles in the Federal Register (80 FR 46930). The agency tentatively ranked each of the MY 2013 vehicle lines in descending order of theft rate. The public was requested to comment on the accuracy of the data and to provide final production figures for individual vehicle lines. As a result of the adjustments, some of the final theft rates and rankings of vehicle lines changed from those published in the August 2015 notice.

The agency received written comments from Volkswagen Group of America, Inc., informing the agency that the production volumes listed for the Audi A3 and the Audi A4/A5 was incorrect. In response to this comment, the production volume for the Audi A3 and the Audi A4/A5 have been corrected and the final theft data has been revised accordingly. As a result of the correction, the Audi A4/A5 previously ranked No. 22 with a theft rate of 2.4792 is now ranked No. 100 with a theft rate of 0.7510 and the Audi A3 previously ranked No. 178 with a theft rate of 0.1346 is now ranked No. 56 with a theft rate of 1.3444.

The following list represents NHTSA's final calculation of theft rates for all 2013 passenger motor vehicle lines. This list is intended to inform the public of calendar year 2013 motor vehicle thefts of model year 2013 vehicles and does not have any effect on the obligations of regulated parties under 49 U.S.C. Chapter 331, Theft Prevention.