Addition of Hexabromocyclododecane (HBCD) Category; Community Right-to-Know Toxic Chemical Release Reporting, 85440-85445 [2016-28102]

Download as PDF 85440 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations action will have no net regulatory burden for all directly regulated small entities. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution or Use D. Unfunded Mandates Reform Act (UMRA) This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531–1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector. The costs involved in this action are imposed only by voluntary participation in a federal program. E. Executive Order 13132: Federalism 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. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have tribal implications as specified in Executive Order 13175. The EPA has concluded that this action will have no new tribal implications, nor would it present any additional burden on the tribes. It will neither impose substantial direct compliance costs on tribal governments, nor preempt tribal law. Thus, Executive Order 13175 does not apply to this action. mstockstill on DSK3G9T082PROD with RULES G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks This action is not subject to Executive Order 13045, because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. Washington has incorporated those requirements from the Federal MSWLF landfill criteria (40 CFR part 258) not found in Washington’s existing program and EPA has determined that Washington’s program includes terms and conditions that are at least as protective as the MSWLF landfill criteria for municipal solid waste landfills, to assure protection of human health and the environment. VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866. I. National Technology Transfer and Advancement Act (NTTAA) This rulemaking does not involve technical standards. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations The purpose of this action is to approve amendments to Washington’s MSWLF permitting program which result in it meeting all of the statutory and regulatory requirements established by RCRA. The EPA believes that the human health and environmental risk addressed by this action will not have a new disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. K. Congressional Review Act (CRA) 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). List of Subjects 40 CFR Part 239 Environmental protection, Administrative practice and procedure, Intergovernmental relations, Waste treatment and disposal. 40 CFR Part 258 Environmental protection, Reporting and recordkeeping requirements, Waste treatment and disposal, Water pollution control. Authority: This action is issued under the authority of section 2002, 4005 and 4010(c) of the Solid Waste Disposal Act, as amended, 42 U.S.C. 6912, 6945 and 6949(a). Dated: October 20, 2016. Dennis J. McLerran, Regional Administrator, EPA Region 10. [FR Doc. 2016–26754 Filed 11–25–16; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 372 [EPA–HQ–TRI–2015–0607; FRL–9953–28] RIN 2025–AA42 Addition of Hexabromocyclododecane (HBCD) Category; Community Rightto-Know Toxic Chemical Release Reporting Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: EPA is adding a hexabromocyclododecane (HBCD) category to the list of toxic chemicals subject to reporting under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and section 6607 of the Pollution Prevention Act (PPA). EPA is adding this chemical category to the EPCRA section 313 list because EPA has determined that HBCD meets the EPCRA section 313(d)(2)(B) and (C) toxicity criteria. Specifically, EPA has determined that HBCD can reasonably be anticipated to cause developmental and reproductive effects in humans and is highly toxic to aquatic and terrestrial organisms. In addition, based on the available bioaccumulation and persistence data, EPA has determined that HBCD should be classified as a persistent, bioaccumulative, and toxic (PBT) chemical and assigned a 100pound reporting threshold. DATES: Effective Date: This final rule is effective November 30, 2016. Applicability date: This final rule will apply for the reporting year beginning January 1, 2017 (reports due July 1, 2018). ADDRESSES: EPA has established a docket for this action under Docket ID No. EPA–HQ–TRI–2015–0607. All documents in the docket are listed on https://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available electronically through https://www.regulations.gov. Additional instructions on visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets/ commenting-epa-dockets. FOR FURTHER INFORMATION CONTACT: SUMMARY: E:\FR\FM\28NOR1.SGM 28NOR1 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations For technical information contact: Daniel R. Bushman, Toxics Release Inventory Program Division (7410M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (202) 566–0743; email: bushman.daniel@epa.gov. For general information contact: The EPCRA Hotline; telephone numbers: Toll free at (800) 424–9346 (select menu option 3) or (703) 412–9810 in Washington DC and International; or toll free, TDD (800) 553–7672; or go to https://www.epa.gov/superfund/ contacts/infocenter/. SUPPLEMENTARY INFORMATION: mstockstill on DSK3G9T082PROD with RULES I. General Information A. Does this document apply to me? You may be potentially affected by this action if you manufacture, process, or otherwise use HBCD. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • Facilities included in the following NAICS manufacturing codes (corresponding to Standard Industrial Classification (SIC) codes 20 through 39): 311*, 312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324, 325*, 326*, 327, 331, 332, 333, 334*, 335*, 336, 337*, 339*, 111998*, 211112*, 212324*, 212325*, 212393*, 212399*, 488390*, 511110, 511120, 511130, 511140*, 511191, 511199, 512220, 512230*, 519130*, 541712*, or 811490*. *Exceptions and/or limitations exist for these NAICS codes. • Facilities included in the following NAICS codes (corresponding to SIC codes other than SIC codes 20 through 39): 212111, 212112, 212113 (corresponds to SIC code 12, Coal Mining (except 1241)); or 212221, 212222, 212231, 212234, 212299 (corresponds to SIC code 10, Metal Mining (except 1011, 1081, and 1094)); or 221111, 221112, 221113, 221118, 221121, 221122, 221330 (Limited to facilities that combust coal and/or oil for the purpose of generating power for distribution in commerce) (corresponds to SIC codes 4911, 4931, and 4939, Electric Utilities); or 424690, 425110, 425120 (Limited to facilities previously classified in SIC code 5169, Chemicals and Allied Products, Not Elsewhere Classified); or 424710 (corresponds to SIC code 5171, Petroleum Bulk Terminals and Plants); or 562112 (Limited to facilities primarily engaged VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 in solvent recovery services on a contract or fee basis (previously classified under SIC code 7389, Business Services, NEC)); or 562211, 562212, 562213, 562219, 562920 (Limited to facilities regulated under the Resource Conservation and Recovery Act, subtitle C, 42 U.S.C. 6921 et seq.) (corresponds to SIC code 4953, Refuse Systems). • Federal facilities. 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 under FOR FURTHER INFORMATION CONTACT. B. What action is the Agency taking? EPA is adding an HBCD category to the list of toxic chemicals subject to reporting under EPCRA section 313 and PPA section 6607. EPA is adding this chemical category to the EPCRA section 313 list because EPA has determined that HBCD meets the EPCRA section 313(d)(2)(B) and (C) toxicity criteria. EPA is also adding the HBCD category to the list of chemicals with special concern (see 40 CFR 372.28(a)(2)) and establishing a 100-pound reporting threshold. C. What is the Agency’s authority for taking this action? This action is issued under EPCRA sections 313(d) and 328, 42 U.S.C. 11023 et seq., and PPA section 6607, 42 U.S.C. 13106. 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 EPA to add or delete chemicals from the list and sets criteria for these actions. EPCRA section 313(d)(2) states that EPA may add a chemical to the list if any of the listing criteria in EPCRA section 313(d)(2) are met. Therefore, to add a chemical, EPA must demonstrate that at PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 85441 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 EPA must demonstrate that none of the criteria in EPCRA section 313(d)(2) are met. The listing criteria in EPCRA section 313(d)(2)(A)–(C) are as follows: • 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: Cancer or teratogenic effects, or serious or irreversible 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. EPA often refers to the EPCRA section 313(d)(2)(A) criterion as the ‘‘acute human health effects criterion;’’ the EPCRA section 313(d)(2)(B) criterion as the ‘‘chronic human health effects criterion;’’ and the EPCRA section 313(d)(2)(C) criterion as the ‘‘environmental effects criterion.’’ EPA published in the Federal Register of November 30, 1994 (59 FR 61432) (FRL–4922–2), a statement clarifying its interpretation of the EPCRA section 313(d)(2) and (d)(3) criteria for modifying the EPCRA section 313 list of toxic chemicals. II. Summary of Proposed Rule A. What chemical did EPA propose to add to the EPCRA section 313 list of toxic chemicals? As discussed in the proposed rule June 2, 2016 (81 FR 35275) (FRL–9943– 55), EPA proposed to add HBCD which is a cyclic aliphatic hydrocarbon consisting of a 12-membered carbon ring with 6 bromine atoms attached (molecular formula C12H18Br6). HBCD has 16 possible stereoisomers. HBCD may be designated as a non-specific mixture of all isomers (hexabromocyclododecane, Chemical Abstracts Service Registry Number (CASRN) 25637–99–4) or as a mixture of the three main diastereomers E:\FR\FM\28NOR1.SGM 28NOR1 85442 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations (1,2,5,6,9,10-hexabromocyclododecane, CASRN 3194–55–6). EPA proposed to create an HBCD category that would cover these two chemical names and CASRNs and would be defined as: Hexabromocyclododecane, includes those chemicals covered by the following CAS numbers: • 3194–55–6; 1,2,5,6,9,10Hexabromocyclododecane • 25637–99–4; Hexabromocyclododecane. As a category, facilities that manufacture, process, or otherwise use HBCD covered under both of these names and CASRNs would file just one report. B. What reporting threshold did EPA propose to establish for the HBCD category? As EPA stated in the proposed rule June 2, 2016 (81 FR 35275) (FRL–9943– 55), EPA proposed to add the HBCD category to the list of chemicals of special concern (see 40 CFR 372.28(a)(2)). There are several chemicals and chemical categories on the EPCRA section 313 chemical list that have been classified as chemicals of special concern because they are PBT chemicals. In a final rule published in the Federal Register of October 29, 1999 (64 FR 58666) (FRL–6389–11), EPA established the PBT classification criteria for chemicals on the EPCRA section 313 chemical list. The data presented in the proposed rule supported classifying the HBCD category as a PBT chemical category with a 100-pound reporting threshold. mstockstill on DSK3G9T082PROD with RULES C. What was EPA’s rationale for proposing to list the HBCD category? As discussed in the proposed rule June 2, 2016 (81 FR 35275) (FRL–9943– 55), HBCD has been shown to cause developmental effects at doses as low as 146.3 milligrams per kilogram per day (mg/kg/day) lowest-observed-adverseeffect level (LOAEL) in male rats. Developmental effects have also been observed with a benchmark dose lower bound confidence limit (BMDL) of 0.056 mg/kg/day (benchmark dose (BMD) of 0.18 mg/kg/day) based on effects in female rats and a BMDL of 0.46 mg/kg/ day (BMD of 1.45 mg/kg/day) based on effects in male rats. HBCD also causes reproductive toxicity at doses as low 138 mg/kg/day (LOAEL) in female rats. Based on the available developmental and reproductive toxicity, EPA stated that HBCD can be reasonably anticipated to cause moderately high to high chronic toxicity in humans. EPA stated that the evidence was sufficient for listing the HBCD category on the VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 EPCRA section 313 toxic chemical list pursuant to EPCRA section 313(d)(2)(B) based on the available developmental and reproductive toxicity data. As also discussed in the proposed rule, HBCD has been shown to be highly toxic to both aquatic and terrestrial species with acute aquatic toxicity values as low as 0.009 milligrams per liter (mg/L) and chronic aquatic toxicity values as low as 0.0042 mg/L. HBCD is highly toxic to terrestrial species as well with observed toxic doses as low as 0.51 and 2.1 mg/kg/day. In addition to being highly toxic, HBCD is also bioaccumulative and persistent in the environment, which further supports a high concern for the toxicity to aquatic and terrestrial species. EPA stated that HBCD meets the EPCRA section 313(d)(2)(C) listing criteria on toxicity alone but also based on toxicity and bioaccumulation as well as toxicity and persistence in the environment. Therefore, EPA stated that the evidence is sufficient for listing the HBCD category on the EPCRA section 313 toxic chemical list pursuant to EPCRA section 313(d)(2)(C) based on the available ecological toxicity data as well as the bioaccumulation and persistence data. D. What was EPA’s rationale for lowering the reporting threshold for HBCD? EPA stated in the proposed rule that the available bioaccumulation and persistence data for HBCD support a classification of HBCD as a PBT chemical June 2, 2016 (81 FR 35275) (FRL–9943–55). HBCD has been shown to be highly bioaccumulative in aquatic species and to also biomagnify in aquatic and terrestrial food chains. While there is limited data on the halflife of HBCD in soil and sediment, the best available data supports a determination that the half-life of HBCD in soil and sediment is at least 2 months. This determination is further supported by the data from environmental monitoring studies, which indicate that HBCD has significant persistence in the environment. The widespread presence of HBCD in numerous terrestrial and aquatic species also supports the conclusion that HBCD has significant persistence in the environment. Therefore, consistent with EPA’s established policy for PBT chemicals (See 64 FR 58666, October 29, 1999) (FRL–6389–11) EPA proposed to establish a 100-pound reporting threshold for the HBCD category. PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 III. What comments did EPA receive on the proposed rule? EPA received three comments on the proposed rule, two from individuals (Refs. 1 and 2) and one from a coalition of environmental and public interest groups and individuals (the coalition) (Ref. 3). All commenters supported the addition of the HBCD category to the EPCRA section 313 toxic chemical list. However, in their comments the coalition stated that HBCD is highly bioaccumulative and highly persistent and based on EPA’s PBT classification criteria, a reporting threshold of 10 pounds should be established for the HBCD category. EPA provided the following background information in the proposed rule: ‘‘In a final rule published in the Federal Register of October 29, 1999 (64 FR 58666) (FRL–6389–11), EPA established the PBT classification criteria for chemicals on the EPCRA section 313 chemical list. For purposes of EPCRA section 313 reporting, EPA established persistence half-life criteria for PBT chemicals of 2 months in water/ sediment and soil and 2 days in air, and established bioaccumulation criteria for PBT chemicals as a bioconcentration factor (BCF) or bioaccumulation factor (BAF) of 1,000 or higher. Chemicals meeting the PBT criteria were assigned 100-pound reporting thresholds. With regards to setting the EPCRA section 313 reporting thresholds, EPA set lower reporting thresholds (10 pounds) for those PBT chemicals with persistence half-lives of 6 months or more in water/ sediment or soil and with BCF or BAF values of 5,000 or higher, these chemicals were considered highly PBT chemicals. The data presented in this proposed rule support classifying the HBCD category as a PBT chemical category with a 100-pound reporting threshold.’’ June 2, 2016 (81 FR 35277) (FRL–9943–55). EPA agrees with the commenter that HBCD is highly bioaccumulative but does not agree that HBCD meets the established criteria for highly persistent. The commenter stated that ‘‘While halflife data is limited, several studies estimate the half-life in sediment and soil to be greater than 120 days, while one study estimates a half-life of 190 days in abiotic sediment.’’ The study that the commenter cited as estimating a half-life of 190 days in abiotic sediment was Davis et al. 2005 (Ref. 4), which, as EPA discussed in the proposed rule, is a study that had a number of problems. For example, EPA noted that: ‘‘Additionally, the Davis et al. 2005 study (Ref. 96) was considered to be of E:\FR\FM\28NOR1.SGM 28NOR1 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations uncertain reliability for quantifying HBCD persistence because of concerns regarding potential contamination of sediment samples, an interfering peak corresponding to g-HBCD in the liquid chromatography/mass spectrometry (LC/MS) chromatograms, and poor extraction of HBCD leading to HBCD recoveries of 33–125% (Refs. 44 and 101).’’ June 2, 2016 (81 FR 35284). A better-conducted subsequent study by the same authors Davis et al. 2006 (Ref. 5) resulted in longer overall halflife values but no specific value equal to or above 180 days. As stated in the proposed rule, ‘‘While there is limited data on the half-life of HBCD in soil and sediment, the best available data supports a determination that the halflife of HBCD in soil and sediment is at least 2 months.’’ EPA does not believe that it would be appropriate to set a lower reporting threshold based on one half-life value of 190 days from a study that had a number of identified problems. mstockstill on DSK3G9T082PROD with RULES IV. Summary of Final Rule EPA is finalizing the addition of an HBCD category to the EPCRA section 313 list of toxic chemicals. EPA has determined that HBCD meets the listing criteria under EPCRA section 313(d)(2)(B) and (C). The HBCD category will be defined as: Hexabromocyclododecane (This category includes only those chemicals covered by the CAS numbers listed here) • 3194–55–6; 1,2,5,6,9,10Hexabromocyclododecane • 25637–99–4; Hexabromocyclododecane. EPA is also finalizing the addition of the HBCD category to the list of chemicals with special concern (see 40 CFR 372.28(a)(2)) and establishing a 100-pound reporting threshold. EPA has determined that the data support classifying the HBCD category as a PBT chemical category with a 100-pound reporting threshold. V. References The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not itself physically located in the docket. For assistance in locating these other documents, please consult the person listed under FOR FURTHER INFORMATION CONTACT. 1. Comment submitted by M. Clark. July 22, 2016. EPA–HQ–TRI–2015–0607–0217. VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 2. Anonymous public comment. July 31, 2016. EPA–HQ–TRI–2015–0607–0218. 3. Comment submitted by E. Gartner, Staff Attorney, Earthjustice et al. Re: Addition of Hexabromocyclododecane (HBCD) Category; Community Right-to-Know Toxic Chemical Release Reporting, August 1, 2016. EPA–HQ– TRI–2015–0607–0219. 4. Davis, J.W., Gonsior, S.J., Marty, G.T., et al. 2005. The transformation of hexabromocyclododecane in aerobic and anaerobic soils and aquatic sediments. Water Res. 39:1075–1084. 5. Davis, J.W., Gonsior, S.J., Markham, D.A., et al. 2006. Biodegradation and product identification of [14C]hexabromocyclododecane in wastewater sludge and freshwater aquatic sediment. Environ. Sci. Technol. 40:5395–5401. Including supporting information document. 6. USEPA, OCSPP. 2016. Economic Analysis of the Final Rule to add HBCD to the List of TRI Reportable Chemicals. August 10, 2016. VI. What are the Statutory and Executive Orders reviews associated with this action? Additional information about these statutes and Executive Orders can be found at https://www2.epa.gov/lawsregulations/laws-and-executive-orders. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). B. Paperwork Reduction Act (PRA) This action does not contain any new information collection requirements that require additional approval by OMB under the PRA, 44 U.S.C. 3501 et seq. 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 section 313 and PPA section 6607 may use either EPA Toxic Chemicals Release Inventory Form R (EPA Form 1B9350–1), or 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, EPA established an alternative threshold for facilities with low annual reportable amounts of a listed toxic chemical. A facility that meets the appropriate PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 85443 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. Since the HBCD category would be classified a PBT category, it is designated as a chemical of special concern, for which Form A reporting is not allowed. 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 EPA’s regulations are listed in 40 CFR part 9 or 48 CFR chapter 15, and displayed on the information collection instruments (e.g., forms, instructions). C. Regulatory Flexibility Act (RFA) I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. The small entities subject to the requirements of this action are small manufacturing facilities. The Agency has determined that of the 55 entities estimated to be impacted by this action, 42 are small businesses; no small governments or small organizations are expected to be affected by this action. All 42 small businesses affected by this action are estimated to incur annualized cost impacts of less than 1%. 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 EPA’s economic analysis (Ref. 6). D. Unfunded Mandates Reform Act (UMRA) 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 E:\FR\FM\28NOR1.SGM 28NOR1 85444 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations 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. EPA’s economic analysis indicates that the total cost of this action is estimated to be $372,973 in the first year of reporting (Ref. 6). H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not a significant regulatory action under Executive Order 12866. E. Executive Order 13132: Federalism I. National Technology Transfer and Advancement Act (NTTAA) This rulemaking does not involve technical standards and is therefore not subject to considerations under section 12(d) of NTTAA, 15 U.S.C. 272 note. This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). 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. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). 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. G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern environmental health or safety risks that 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. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations EPA has determined that this action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). 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, 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 positive human health and environmental impacts on minority populations, low-income populations, and children. K. Congressional Review Act (CRA) 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). List of Subjects in 40 CFR Part 372 Environmental protection, Community right-to-know, Reporting and recordkeeping requirements, and Toxic chemicals. Dated: November 15, 2016. Gina McCarthy, Administrator. Therefore, 40 CFR chapter I is amended as follows: PART 372—[AMENDED] 1. The authority citation for part 372 continues to read as follows: ■ Authority: 42 U.S.C. 11023 and 11048. 2. In § 372.28, amend the table in paragraph (a)(2) as follows: ■ a. Revise the second column header to read ‘‘Reporting threshold (in pounds unless otherwise noted)’’, and ■ b. Alphabetically add the category ‘‘Hexabromocyclododecane (This category includes only those chemicals covered by the CAS numbers listed here)’’ and entries ‘‘3194–55–6 (1,2,5,6,9,10Hexabromocyclododecane)’’ and ‘‘25637–99–4 (Hexabromocyclododecane)’’. The additions read as follows: ■ § 372.28 Lower thresholds for chemicals of special concern. (a) * * * (2) * * * Reporting threshold (in pounds unless otherwise noted) Category name mstockstill on DSK3G9T082PROD with RULES * * * * * * Hexabromocyclododecane (This category includes only those chemicals covered by the CAS numbers listed here) 3194–55–6 1,2,5,6,9,10-Hexabromocyclododecane 25637–99–4 Hexabromocyclododecane * * * * * * * * 3. In § 372.65, paragraph (c) is amended by adding alphabetically an ■ VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 * * entry for ‘‘Hexabromocyclododecane (This category includes only those chemicals covered by the CAS numbers PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 * * 100 ........................ ........................ * listed here)’’ to the table to read as follows: E:\FR\FM\28NOR1.SGM 28NOR1 85445 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations § 372.65 Chemicals and chemical categories to which this part applies. * * * * (c) * * * * Category name Effective date * * * * * * Hexabromocyclododecane (This category includes only those chemicals covered by the CAS numbers listed here) 3194–55–6 1,2,5,6,9,10-Hexabromocyclododecane 25637–99–4 Hexabromocyclododecane * * * [FR Doc. 2016–28102 Filed 11–25–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 435 [EPA–HQ–OW–2014–0598; FRL–9955–65– OW] RIN 2040–AF68 Effluent Limitations Guidelines and Standards for the Oil and Gas Extraction Point Source Category— Implementation Date Extension Environmental Protection Agency (EPA). ACTION: Withdrawal of direct final rule. AGENCY: Because the Environmental Protection Agency (EPA) received comments that could be construed as adverse, the EPA is withdrawing the direct final rule issued on September 30, 2016, to extend the implementation date for certain facilities subject to the EPA’s final rule establishing pretreatment standards under the Clean Water Act (CWA) for discharges of pollutants into publicly-owned treatment works (POTWs) from unconventional oil and gas extraction. DATES: Effective November 28, 2016, the EPA withdraws the direct final rule published September 30, 2016 (81 FR 67191). SUMMARY: For more information, see EPA’s Web site: https://www.epa.gov/eg/ unconventional-oil-and-gas-extractioneffluent-guidelines. For technical information, contact Karen Milam, Engineering and Analysis Division (4303T), Office of Water, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone: 202–566–1915; email: milam.karen@epa.gov. SUPPLEMENTARY INFORMATION: On September 30, 2016, the EPA published a direct final rule that mstockstill on DSK3G9T082PROD with RULES FOR FURTHER INFORMATION CONTACT: VerDate Sep<11>2014 16:28 Nov 25, 2016 Jkt 241001 * * extended the implementation date for certain facilities to meet the requirements of the final pretreatment standards rule for unconventional oil and gas extraction. (81 FR 67191; September 30, 2016). In that direct final rule, the EPA stated that if we received adverse comments by October 31, 2016, the EPA would publish a timely withdrawal and address the comments in a final rule based on the proposed rule also published on September 30, 2016. (81 FR 67266; September 30, 2016). The direct final rule specifically indicated that ‘‘EPA will not consider any comment submitted on the direct final rule published today on any topic other than the appropriateness of an extension of the compliance date; any other comments will be considered to be outside the scope of this rulemaking.’’ (81 FR 67192; September 30, 2016). Commenters supported the compliance date being extended; the EPA did not receive any comments opposing the extension of the compliance date, and thus maintains that there were no adverse comments on the direct final rule. As indicated in the direct final rule, the EPA considers any comments on topics other than the extension of the compliance date—including comments submitted on the applicability of the underlying final pretreatment standards rule—to be outside the scope of this rulemaking. However, to the extent that any of the comments could be broadly interpreted as seeking an alternative compliance period, and thus arguably within scope, the EPA, in its discretion, is withdrawing the direct final rule and instead will issue a final action to address the compliance date, which will be based on the parallel proposed rule also published on September 30, 2016. (81 FR 67266; September 30, 2016). For purposes of this withdrawal, compliance date and implementation date are used interchangeably. As stated in the parallel proposal, we will not institute a second comment period on this proposed action. PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 * 1/1/17 ........................ ........................ * * Withdrawal of this direct final rule removes the extension of the compliance date for the subset of facilities identified in the direct final rule. It does not withdraw, or otherwise impact, the underlying final pretreatment standards rule for unconventional oil and gas extraction, which continues to apply to all facilities that meet the definition of ‘‘unconventional’’ in that rule. List of Subjects in 40 CFR Part 435 Environmental protection, Pretreatment, Waste treatment and disposal, Water pollution control, Unconventional oil and gas extraction. Dated: November 17, 2016. Michael H. Shapiro, Deputy Assistant Administrator. Accordingly, the direct final rule, published in the Federal Register on September 30, 2016, at 81 FR 67191, is withdrawn as of November 28, 2016. [FR Doc. 2016–28566 Filed 11–25–16; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 140819686–5999–02] RIN 0648–XF045 Snapper-Grouper Fishery of the South Atlantic; 2016 Recreational Accountability Measure and Closure for South Atlantic Greater Amberjack National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Temporary rule; closure. AGENCY: NMFS implements accountability measures (AMs) for the recreational sector of greater amberjack in the exclusive economic zone (EEZ) of the South Atlantic for the current SUMMARY: E:\FR\FM\28NOR1.SGM 28NOR1

Agencies

[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)]
[Rules and Regulations]
[Pages 85440-85445]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28102]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[EPA-HQ-TRI-2015-0607; FRL-9953-28]
RIN 2025-AA42


Addition of Hexabromocyclododecane (HBCD) Category; Community 
Right-to-Know Toxic Chemical Release Reporting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is adding a hexabromocyclododecane (HBCD) category to the 
list of toxic chemicals subject to reporting under section 313 of the 
Emergency Planning and Community Right-to-Know Act (EPCRA) and section 
6607 of the Pollution Prevention Act (PPA). EPA is adding this chemical 
category to the EPCRA section 313 list because EPA has determined that 
HBCD meets the EPCRA section 313(d)(2)(B) and (C) toxicity criteria. 
Specifically, EPA has determined that HBCD can reasonably be 
anticipated to cause developmental and reproductive effects in humans 
and is highly toxic to aquatic and terrestrial organisms. In addition, 
based on the available bioaccumulation and persistence data, EPA has 
determined that HBCD should be classified as a persistent, 
bioaccumulative, and toxic (PBT) chemical and assigned a 100-pound 
reporting threshold.

DATES:  Effective Date: This final rule is effective November 30, 2016.
    Applicability date: This final rule will apply for the reporting 
year beginning January 1, 2017 (reports due July 1, 2018).

ADDRESSES: EPA has established a docket for this action under Docket ID 
No. EPA-HQ-TRI-2015-0607. All documents in the docket are listed on 
https://www.regulations.gov. Although listed in the index, some 
information is not publicly available, e.g., Confidential Business 
Information or other information whose disclosure is restricted by 
statute. Certain other material, such as copyrighted material, is not 
placed on the Internet and will be publicly available only in hard copy 
form. Publicly available docket materials are available electronically 
through https://www.regulations.gov. Additional instructions on visiting 
the docket, along with more information about dockets generally, is 
available at https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: 

[[Page 85441]]

    For technical information contact: Daniel R. Bushman, Toxics 
Release Inventory Program Division (7410M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 566-0743; email: bushman.daniel@epa.gov.
    For general information contact: The EPCRA Hotline; telephone 
numbers: Toll free at (800) 424-9346 (select menu option 3) or (703) 
412-9810 in Washington DC and International; or toll free, TDD (800) 
553-7672; or go to https://www.epa.gov/superfund/contacts/infocenter/.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this document apply to me?

    You may be potentially affected by this action if you manufacture, 
process, or otherwise use HBCD. The following list of North American 
Industrial Classification System (NAICS) codes is not intended to be 
exhaustive, but rather provides a guide to help readers determine 
whether this document applies to them. Potentially affected entities 
may include:
     Facilities included in the following NAICS manufacturing 
codes (corresponding to Standard Industrial Classification (SIC) codes 
20 through 39): 311*, 312*, 313*, 314*, 315*, 316, 321, 322, 323*, 324, 
325*, 326*, 327, 331, 332, 333, 334*, 335*, 336, 337*, 339*, 111998*, 
211112*, 212324*, 212325*, 212393*, 212399*, 488390*, 511110, 511120, 
511130, 511140*, 511191, 511199, 512220, 512230*, 519130*, 541712*, or 
811490*.

*Exceptions and/or limitations exist for these NAICS codes.

     Facilities included in the following NAICS codes 
(corresponding to SIC codes other than SIC codes 20 through 39): 
212111, 212112, 212113 (corresponds to SIC code 12, Coal Mining (except 
1241)); or 212221, 212222, 212231, 212234, 212299 (corresponds to SIC 
code 10, Metal Mining (except 1011, 1081, and 1094)); or 221111, 
221112, 221113, 221118, 221121, 221122, 221330 (Limited to facilities 
that combust coal and/or oil for the purpose of generating power for 
distribution in commerce) (corresponds to SIC codes 4911, 4931, and 
4939, Electric Utilities); or 424690, 425110, 425120 (Limited to 
facilities previously classified in SIC code 5169, Chemicals and Allied 
Products, Not Elsewhere Classified); or 424710 (corresponds to SIC code 
5171, Petroleum Bulk Terminals and Plants); or 562112 (Limited to 
facilities primarily engaged in solvent recovery services on a contract 
or fee basis (previously classified under SIC code 7389, Business 
Services, NEC)); or 562211, 562212, 562213, 562219, 562920 (Limited to 
facilities regulated under the Resource Conservation and Recovery Act, 
subtitle C, 42 U.S.C. 6921 et seq.) (corresponds to SIC code 4953, 
Refuse Systems).
     Federal facilities.
    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 under FOR FURTHER 
INFORMATION CONTACT.

B. What action is the Agency taking?

    EPA is adding an HBCD category to the list of toxic chemicals 
subject to reporting under EPCRA section 313 and PPA section 6607. EPA 
is adding this chemical category to the EPCRA section 313 list because 
EPA has determined that HBCD meets the EPCRA section 313(d)(2)(B) and 
(C) toxicity criteria. EPA is also adding the HBCD category to the list 
of chemicals with special concern (see 40 CFR 372.28(a)(2)) and 
establishing a 100-pound reporting threshold.

C. What is the Agency's authority for taking this action?

    This action is issued under EPCRA sections 313(d) and 328, 42 
U.S.C. 11023 et seq., and PPA section 6607, 42 U.S.C. 13106. 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 EPA to add or delete chemicals from 
the list and sets criteria for these actions. EPCRA section 313(d)(2) 
states that EPA may add a chemical to the list if any of the listing 
criteria in EPCRA section 313(d)(2) are met. Therefore, to add a 
chemical, 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 
EPA must demonstrate that none of the criteria in EPCRA section 
313(d)(2) are met. The listing criteria in EPCRA section 313(d)(2)(A)-
(C) are as follows:
     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: Cancer or teratogenic effects, or 
serious or irreversible 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.
    EPA often refers to the EPCRA section 313(d)(2)(A) criterion as the 
``acute human health effects criterion;'' the EPCRA section 
313(d)(2)(B) criterion as the ``chronic human health effects 
criterion;'' and the EPCRA section 313(d)(2)(C) criterion as the 
``environmental effects criterion.''
    EPA published in the Federal Register of November 30, 1994 (59 FR 
61432) (FRL-4922-2), a statement clarifying its interpretation of the 
EPCRA section 313(d)(2) and (d)(3) criteria for modifying the EPCRA 
section 313 list of toxic chemicals.

II. Summary of Proposed Rule

A. What chemical did EPA propose to add to the EPCRA section 313 list 
of toxic chemicals?

    As discussed in the proposed rule June 2, 2016 (81 FR 35275) (FRL-
9943-55), EPA proposed to add HBCD which is a cyclic aliphatic 
hydrocarbon consisting of a 12-membered carbon ring with 6 bromine 
atoms attached (molecular formula 
C12H18Br6). HBCD has 16 possible 
stereoisomers. HBCD may be designated as a non-specific mixture of all 
isomers (hexabromocyclododecane, Chemical Abstracts Service Registry 
Number (CASRN) 25637-99-4) or as a mixture of the three main 
diastereomers

[[Page 85442]]

(1,2,5,6,9,10-hexabromocyclododecane, CASRN 3194-55-6). EPA proposed to 
create an HBCD category that would cover these two chemical names and 
CASRNs and would be defined as: Hexabromocyclododecane, includes those 
chemicals covered by the following CAS numbers:

 3194-55-6; 1,2,5,6,9,10-Hexabromocyclododecane
 25637-99-4; Hexabromocyclododecane.

As a category, facilities that manufacture, process, or otherwise use 
HBCD covered under both of these names and CASRNs would file just one 
report.

B. What reporting threshold did EPA propose to establish for the HBCD 
category?

    As EPA stated in the proposed rule June 2, 2016 (81 FR 35275) (FRL-
9943-55), EPA proposed to add the HBCD category to the list of 
chemicals of special concern (see 40 CFR 372.28(a)(2)). There are 
several chemicals and chemical categories on the EPCRA section 313 
chemical list that have been classified as chemicals of special concern 
because they are PBT chemicals. In a final rule published in the 
Federal Register of October 29, 1999 (64 FR 58666) (FRL-6389-11), EPA 
established the PBT classification criteria for chemicals on the EPCRA 
section 313 chemical list. The data presented in the proposed rule 
supported classifying the HBCD category as a PBT chemical category with 
a 100-pound reporting threshold.

C. What was EPA's rationale for proposing to list the HBCD category?

    As discussed in the proposed rule June 2, 2016 (81 FR 35275) (FRL-
9943-55), HBCD has been shown to cause developmental effects at doses 
as low as 146.3 milligrams per kilogram per day (mg/kg/day) lowest-
observed-adverse-effect level (LOAEL) in male rats. Developmental 
effects have also been observed with a benchmark dose lower bound 
confidence limit (BMDL) of 0.056 mg/kg/day (benchmark dose (BMD) of 
0.18 mg/kg/day) based on effects in female rats and a BMDL of 0.46 mg/
kg/day (BMD of 1.45 mg/kg/day) based on effects in male rats. HBCD also 
causes reproductive toxicity at doses as low 138 mg/kg/day (LOAEL) in 
female rats. Based on the available developmental and reproductive 
toxicity, EPA stated that HBCD can be reasonably anticipated to cause 
moderately high to high chronic toxicity in humans. EPA stated that the 
evidence was sufficient for listing the HBCD category on the EPCRA 
section 313 toxic chemical list pursuant to EPCRA section 313(d)(2)(B) 
based on the available developmental and reproductive toxicity data.
    As also discussed in the proposed rule, HBCD has been shown to be 
highly toxic to both aquatic and terrestrial species with acute aquatic 
toxicity values as low as 0.009 milligrams per liter (mg/L) and chronic 
aquatic toxicity values as low as 0.0042 mg/L. HBCD is highly toxic to 
terrestrial species as well with observed toxic doses as low as 0.51 
and 2.1 mg/kg/day. In addition to being highly toxic, HBCD is also 
bioaccumulative and persistent in the environment, which further 
supports a high concern for the toxicity to aquatic and terrestrial 
species. EPA stated that HBCD meets the EPCRA section 313(d)(2)(C) 
listing criteria on toxicity alone but also based on toxicity and 
bioaccumulation as well as toxicity and persistence in the environment. 
Therefore, EPA stated that the evidence is sufficient for listing the 
HBCD category on the EPCRA section 313 toxic chemical list pursuant to 
EPCRA section 313(d)(2)(C) based on the available ecological toxicity 
data as well as the bioaccumulation and persistence data.

D. What was EPA's rationale for lowering the reporting threshold for 
HBCD?

    EPA stated in the proposed rule that the available bioaccumulation 
and persistence data for HBCD support a classification of HBCD as a PBT 
chemical June 2, 2016 (81 FR 35275) (FRL-9943-55). HBCD has been shown 
to be highly bioaccumulative in aquatic species and to also biomagnify 
in aquatic and terrestrial food chains. While there is limited data on 
the half-life of HBCD in soil and sediment, the best available data 
supports a determination that the half-life of HBCD in soil and 
sediment is at least 2 months. This determination is further supported 
by the data from environmental monitoring studies, which indicate that 
HBCD has significant persistence in the environment. The widespread 
presence of HBCD in numerous terrestrial and aquatic species also 
supports the conclusion that HBCD has significant persistence in the 
environment. Therefore, consistent with EPA's established policy for 
PBT chemicals (See 64 FR 58666, October 29, 1999) (FRL-6389-11) EPA 
proposed to establish a 100-pound reporting threshold for the HBCD 
category.

III. What comments did EPA receive on the proposed rule?

    EPA received three comments on the proposed rule, two from 
individuals (Refs. 1 and 2) and one from a coalition of environmental 
and public interest groups and individuals (the coalition) (Ref. 3). 
All commenters supported the addition of the HBCD category to the EPCRA 
section 313 toxic chemical list. However, in their comments the 
coalition stated that HBCD is highly bioaccumulative and highly 
persistent and based on EPA's PBT classification criteria, a reporting 
threshold of 10 pounds should be established for the HBCD category. EPA 
provided the following background information in the proposed rule:
    ``In a final rule published in the Federal Register of October 29, 
1999 (64 FR 58666) (FRL-6389-11), EPA established the PBT 
classification criteria for chemicals on the EPCRA section 313 chemical 
list. For purposes of EPCRA section 313 reporting, EPA established 
persistence half-life criteria for PBT chemicals of 2 months in water/
sediment and soil and 2 days in air, and established bioaccumulation 
criteria for PBT chemicals as a bioconcentration factor (BCF) or 
bioaccumulation factor (BAF) of 1,000 or higher. Chemicals meeting the 
PBT criteria were assigned 100-pound reporting thresholds. With regards 
to setting the EPCRA section 313 reporting thresholds, EPA set lower 
reporting thresholds (10 pounds) for those PBT chemicals with 
persistence half-lives of 6 months or more in water/sediment or soil 
and with BCF or BAF values of 5,000 or higher, these chemicals were 
considered highly PBT chemicals. The data presented in this proposed 
rule support classifying the HBCD category as a PBT chemical category 
with a 100-pound reporting threshold.'' June 2, 2016 (81 FR 35277) 
(FRL-9943-55).
    EPA agrees with the commenter that HBCD is highly bioaccumulative 
but does not agree that HBCD meets the established criteria for highly 
persistent. The commenter stated that ``While half-life data is 
limited, several studies estimate the half-life in sediment and soil to 
be greater than 120 days, while one study estimates a half-life of 190 
days in abiotic sediment.'' The study that the commenter cited as 
estimating a half-life of 190 days in abiotic sediment was Davis et al. 
2005 (Ref. 4), which, as EPA discussed in the proposed rule, is a study 
that had a number of problems. For example, EPA noted that:
    ``Additionally, the Davis et al. 2005 study (Ref. 96) was 
considered to be of

[[Page 85443]]

uncertain reliability for quantifying HBCD persistence because of 
concerns regarding potential contamination of sediment samples, an 
interfering peak corresponding to [gamma]-HBCD in the liquid 
chromatography/mass spectrometry (LC/MS) chromatograms, and poor 
extraction of HBCD leading to HBCD recoveries of 33-125% (Refs. 44 and 
101).'' June 2, 2016 (81 FR 35284).
    A better-conducted subsequent study by the same authors Davis et 
al. 2006 (Ref. 5) resulted in longer overall half-life values but no 
specific value equal to or above 180 days. As stated in the proposed 
rule, ``While there is limited data on the half-life of HBCD in soil 
and sediment, the best available data supports a determination that the 
half-life of HBCD in soil and sediment is at least 2 months.'' EPA does 
not believe that it would be appropriate to set a lower reporting 
threshold based on one half-life value of 190 days from a study that 
had a number of identified problems.

IV. Summary of Final Rule

    EPA is finalizing the addition of an HBCD category to the EPCRA 
section 313 list of toxic chemicals. EPA has determined that HBCD meets 
the listing criteria under EPCRA section 313(d)(2)(B) and (C). The HBCD 
category will be defined as: Hexabromocyclododecane (This category 
includes only those chemicals covered by the CAS numbers listed here)
 3194-55-6; 1,2,5,6,9,10-Hexabromocyclododecane
 25637-99-4; Hexabromocyclododecane.
    EPA is also finalizing the addition of the HBCD category to the 
list of chemicals with special concern (see 40 CFR 372.28(a)(2)) and 
establishing a 100-pound reporting threshold. EPA has determined that 
the data support classifying the HBCD category as a PBT chemical 
category with a 100-pound reporting threshold.

V. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not itself physically located in the 
docket. For assistance in locating these other documents, please 
consult the person listed under FOR FURTHER INFORMATION CONTACT.
    1. Comment submitted by M. Clark. July 22, 2016. EPA-HQ-TRI-
2015-0607-0217.
    2. Anonymous public comment. July 31, 2016. EPA-HQ-TRI-2015-
0607-0218.
    3. Comment submitted by E. Gartner, Staff Attorney, Earthjustice 
et al. Re: Addition of Hexabromocyclododecane (HBCD) Category; 
Community Right-to-Know Toxic Chemical Release Reporting, August 1, 
2016. EPA-HQ-TRI-2015-0607-0219.
    4. Davis, J.W., Gonsior, S.J., Marty, G.T., et al. 2005. The 
transformation of hexabromocyclododecane in aerobic and anaerobic 
soils and aquatic sediments. Water Res. 39:1075-1084.
    5. Davis, J.W., Gonsior, S.J., Markham, D.A., et al. 2006. 
Biodegradation and product identification of 
[\14\C]hexabromocyclododecane in wastewater sludge and freshwater 
aquatic sediment. Environ. Sci. Technol. 40:5395-5401. Including 
supporting information document.
    6. USEPA, OCSPP. 2016. Economic Analysis of the Final Rule to 
add HBCD to the List of TRI Reportable Chemicals. August 10, 2016.

VI. What are the Statutory and Executive Orders reviews associated with 
this action?

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

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was 
therefore not submitted to the Office of Management and Budget (OMB) 
for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) 
and 13563 (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act (PRA)

    This action does not contain any new information collection 
requirements that require additional approval by OMB under the PRA, 44 
U.S.C. 3501 et seq. 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 section 
313 and PPA section 6607 may use either EPA Toxic Chemicals Release 
Inventory Form R (EPA Form 1B9350-1), or 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, 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. Since the HBCD category would be classified a 
PBT category, it is designated as a chemical of special concern, for 
which Form A reporting is not allowed. 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 EPA's regulations are listed in 40 CFR part 9 or 48 CFR 
chapter 15, and displayed on the information collection instruments 
(e.g., forms, instructions).

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA, 5 
U.S.C. 601 et seq. The small entities subject to the requirements of 
this action are small manufacturing facilities. The Agency has 
determined that of the 55 entities estimated to be impacted by this 
action, 42 are small businesses; no small governments or small 
organizations are expected to be affected by this action. All 42 small 
businesses affected by this action are estimated to incur annualized 
cost impacts of less than 1%. 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 EPA's economic analysis (Ref. 6).

D. Unfunded Mandates Reform Act (UMRA)

    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

[[Page 85444]]

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. EPA's 
economic analysis indicates that the total cost of this action is 
estimated to be $372,973 in the first year of reporting (Ref. 6).

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132 (64 FR 43255, August 10, 1999). 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.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have tribal implications as specified in 
Executive Order 13175 (65 FR 67249, November 9, 2000). 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.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) 
as applying only to those regulatory actions that concern environmental 
health or safety risks that 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.

H. Executive Order 13211: Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    This action is not subject to Executive Order 13211 (66 FR 28355, 
May 22, 2001), because it is not a significant regulatory action under 
Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards and is 
therefore not subject to considerations under section 12(d) of NTTAA, 
15 U.S.C. 272 note.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    EPA has determined that this action will not have 
disproportionately high and adverse human health or environmental 
effects on minority or low-income populations as specified in Executive 
Order 12898 (59 FR 7629, February 16, 1994). 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, 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 positive human health and environmental impacts 
on minority populations, low-income populations, and children.

K. Congressional Review Act (CRA)

    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).

List of Subjects in 40 CFR Part 372

    Environmental protection, Community right-to-know, Reporting and 
recordkeeping requirements, and Toxic chemicals.

    Dated: November 15, 2016.
Gina McCarthy,
Administrator.
    Therefore, 40 CFR chapter I is amended as follows:

PART 372--[AMENDED]

0
1. The authority citation for part 372 continues to read as follows:

    Authority: 42 U.S.C. 11023 and 11048.


0
2. In Sec.  372.28, amend the table in paragraph (a)(2) as follows:
0
a. Revise the second column header to read ``Reporting threshold (in 
pounds unless otherwise noted)'', and
0
b. Alphabetically add the category ``Hexabromocyclododecane (This 
category includes only those chemicals covered by the CAS numbers 
listed here)'' and entries ``3194-55-6 (1,2,5,6,9,10-
Hexabromocyclododecane)'' and ``25637-99-4 (Hexabromocyclododecane)''.
    The additions read as follows:


Sec.  372.28  Lower thresholds for chemicals of special concern.

    (a) * * *
    (2) * * *

------------------------------------------------------------------------
                                                             Reporting
                                                           threshold (in
                      Category name                        pounds unless
                                                             otherwise
                                                              noted)
------------------------------------------------------------------------
 
                              * * * * * * *
Hexabromocyclododecane (This category includes only                  100
 those chemicals covered by the CAS numbers listed here)
3194-55-6 1,2,5,6,9,10-Hexabromocyclododecane             ..............
25637-99-4 Hexabromocyclododecane                         ..............
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

0
3. In Sec.  372.65, paragraph (c) is amended by adding alphabetically 
an entry for ``Hexabromocyclododecane (This category includes only 
those chemicals covered by the CAS numbers listed here)'' to the table 
to read as follows:

[[Page 85445]]

Sec.  372.65  Chemicals and chemical categories to which this part 
applies.

* * * * *
    (c) * * *

------------------------------------------------------------------------
                      Category name                       Effective date
------------------------------------------------------------------------
 
                              * * * * * * *
Hexabromocyclododecane (This category includes only               1/1/17
 those chemicals covered by the CAS numbers listed here)
3194-55-6 1,2,5,6,9,10-Hexabromocyclododecane             ..............
25637-99-4 Hexabromocyclododecane                         ..............
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2016-28102 Filed 11-25-16; 8:45 am]
 BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.