81_FR_85668 81 FR 85440 - Addition of Hexabromocyclododecane (HBCD) Category; Community Right-to-Know Toxic Chemical Release Reporting

81 FR 85440 - Addition of Hexabromocyclododecane (HBCD) Category; Community Right-to-Know Toxic Chemical Release Reporting

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 228 (November 28, 2016)

Page Range85440-85445
FR Document2016-28102

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.

Federal Register, Volume 81 Issue 228 (Monday, November 28, 2016)
[Federal Register Volume 81, Number 228 (Monday, November 28, 2016)]
[Rules and Regulations]
[Pages 85440-85445]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-28102]


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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.

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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 
http://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 http://www.regulations.gov. Additional instructions on visiting 
the docket, along with more information about dockets generally, is 
available at http://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: [email protected].
    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 http://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 http://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]
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                                                85440            Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations

                                                action will have no net regulatory                      H. Executive Order 13211: Actions                     ENVIRONMENTAL PROTECTION
                                                burden for all directly regulated small                 Concerning Regulations That                           AGENCY
                                                entities.                                               Significantly Affect Energy Supply,
                                                                                                        Distribution or Use                                   40 CFR Part 372
                                                D. Unfunded Mandates Reform Act
                                                (UMRA)                                                                                                        [EPA–HQ–TRI–2015–0607; FRL–9953–28]
                                                                                                          This action is not subject to Executive
                                                                                                        Order 13211, because it is not a                      RIN 2025–AA42
                                                   This action does not contain any
                                                                                                        significant regulatory action under
                                                unfunded mandate as described in                                                                              Addition of Hexabromocyclododecane
                                                                                                        Executive Order 12866.
                                                UMRA, 2 U.S.C. 1531–1538, and does                                                                            (HBCD) Category; Community Right-
                                                not significantly or uniquely affect small              I. National Technology Transfer and                   to-Know Toxic Chemical Release
                                                governments. The action imposes no                      Advancement Act (NTTAA)                               Reporting
                                                enforceable duty on any state, local, or                                                                      AGENCY:  Environmental Protection
                                                tribal governments or the private sector.                 This rulemaking does not involve
                                                                                                        technical standards.                                  Agency (EPA).
                                                The costs involved in this action are                                                                         ACTION: Final rule.
                                                imposed only by voluntary participation                 J. Executive Order 12898: Federal
                                                in a federal program.                                   Actions To Address Environmental                      SUMMARY:    EPA is adding a
                                                                                                        Justice in Minority Populations and                   hexabromocyclododecane (HBCD)
                                                E. Executive Order 13132: Federalism                                                                          category to the list of toxic chemicals
                                                                                                        Low-Income Populations
                                                  This action does not have federalism                                                                        subject to reporting under section 313 of
                                                implications. It will not have substantial                 The purpose of this action is to                   the Emergency Planning and
                                                direct effects on the states, on the                    approve amendments to Washington’s                    Community Right-to-Know Act (EPCRA)
                                                                                                        MSWLF permitting program which                        and section 6607 of the Pollution
                                                relationship between the national
                                                                                                        result in it meeting all of the statutory             Prevention Act (PPA). EPA is adding
                                                government and the states, or on the
                                                                                                        and regulatory requirements established               this chemical category to the EPCRA
                                                distribution of power and                                                                                     section 313 list because EPA has
                                                responsibilities among the various                      by RCRA. The EPA believes that the
                                                                                                        human health and environmental risk                   determined that HBCD meets the
                                                levels of government.                                                                                         EPCRA section 313(d)(2)(B) and (C)
                                                                                                        addressed by this action will not have
                                                F. Executive Order 13175: Consultation                  a new disproportionately high and                     toxicity criteria. Specifically, EPA has
                                                and Coordination With Indian Tribal                     adverse human health or environmental                 determined that HBCD can reasonably
                                                Governments                                                                                                   be anticipated to cause developmental
                                                                                                        effects on minority, low-income or
                                                                                                                                                              and reproductive effects in humans and
                                                                                                        indigenous populations.
                                                  This action does not have tribal                                                                            is highly toxic to aquatic and terrestrial
                                                implications as specified in Executive                  K. Congressional Review Act (CRA)                     organisms. In addition, based on the
                                                Order 13175. The EPA has concluded                                                                            available bioaccumulation and
                                                that this action will have no new tribal                  This action is subject to the CRA, and              persistence data, EPA has determined
                                                implications, nor would it present any                  the EPA will submit a rule report to                  that HBCD should be classified as a
                                                additional burden on the tribes. It will                each House of the Congress and to the                 persistent, bioaccumulative, and toxic
                                                neither impose substantial direct                       Comptroller General of the United                     (PBT) chemical and assigned a 100-
                                                compliance costs on tribal governments,                 States. This action is not a ‘‘major rule’’           pound reporting threshold.
                                                nor preempt tribal law. Thus, Executive                 as defined by 5 U.S.C. 804(2).                        DATES: Effective Date: This final rule is
                                                Order 13175 does not apply to this                                                                            effective November 30, 2016.
                                                                                                        List of Subjects                                         Applicability date: This final rule will
                                                action.
                                                                                                        40 CFR Part 239                                       apply for the reporting year beginning
                                                G. Executive Order 13045: Protection of                                                                       January 1, 2017 (reports due July 1,
                                                Children From Environmental Health                         Environmental protection,                          2018).
                                                Risks and Safety Risks                                  Administrative practice and procedure,                ADDRESSES: EPA has established a
                                                                                                        Intergovernmental relations, Waste                    docket for this action under Docket ID
                                                  This action is not subject to Executive               treatment and disposal.                               No. EPA–HQ–TRI–2015–0607. All
                                                Order 13045, because it is not
                                                                                                        40 CFR Part 258                                       documents in the docket are listed on
                                                economically significant as defined in
                                                                                                                                                              http://www.regulations.gov. Although
                                                Executive Order 12866, and because the                     Environmental protection, Reporting                listed in the index, some information is
                                                EPA does not believe the environmental                  and recordkeeping requirements, Waste                 not publicly available, e.g., Confidential
                                                health or safety risks addressed by this                treatment and disposal, Water pollution               Business Information or other
                                                action present a disproportionate risk to               control.                                              information whose disclosure is
                                                children. Washington has incorporated                                                                         restricted by statute. Certain other
                                                those requirements from the Federal                       Authority: This action is issued under the
                                                                                                        authority of section 2002, 4005 and 4010(c)
                                                                                                                                                              material, such as copyrighted material,
                                                MSWLF landfill criteria (40 CFR part                                                                          is not placed on the Internet and will be
                                                                                                        of the Solid Waste Disposal Act, as amended,
                                                258) not found in Washington’s existing                                                                       publicly available only in hard copy
                                                                                                        42 U.S.C. 6912, 6945 and 6949(a).
                                                program and EPA has determined that                                                                           form. Publicly available docket
                                                Washington’s program includes terms                       Dated: October 20, 2016.                            materials are available electronically
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                                                and conditions that are at least as                     Dennis J. McLerran,                                   through http://www.regulations.gov.
                                                protective as the MSWLF landfill                        Regional Administrator, EPA Region 10.                Additional instructions on visiting the
                                                criteria for municipal solid waste                      [FR Doc. 2016–26754 Filed 11–25–16; 8:45 am]          docket, along with more information
                                                landfills, to assure protection of human                BILLING CODE 6560–50–P
                                                                                                                                                              about dockets generally, is available at
                                                health and the environment.                                                                                   http://www.epa.gov/dockets/
                                                                                                                                                              commenting-epa-dockets.
                                                                                                                                                              FOR FURTHER INFORMATION CONTACT:



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                                                                 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                        85441

                                                  For technical information contact:                    in solvent recovery services on a                     least one criterion is met, but need not
                                                Daniel R. Bushman, Toxics Release                       contract or fee basis (previously                     determine whether any other criterion is
                                                Inventory Program Division (7410M),                     classified under SIC code 7389,                       met. Conversely, to remove a chemical
                                                Office of Pollution Prevention and                      Business Services, NEC)); or 562211,                  from the list, EPCRA section 313(d)(3)
                                                Toxics, Environmental Protection                        562212, 562213, 562219, 562920                        dictates that EPA must demonstrate that
                                                Agency, 1200 Pennsylvania Ave. NW.,                     (Limited to facilities regulated under the            none of the criteria in EPCRA section
                                                Washington, DC 20460–0001; telephone                    Resource Conservation and Recovery                    313(d)(2) are met. The listing criteria in
                                                number: (202) 566–0743; email:                          Act, subtitle C, 42 U.S.C. 6921 et seq.)              EPCRA section 313(d)(2)(A)–(C) are as
                                                bushman.daniel@epa.gov.                                 (corresponds to SIC code 4953, Refuse                 follows:
                                                  For general information contact: The                  Systems).                                                • The chemical is known to cause or
                                                EPCRA Hotline; telephone numbers:                          • Federal facilities.                              can reasonably be anticipated to cause
                                                Toll free at (800) 424–9346 (select menu                   To determine whether your facility                 significant adverse acute human health
                                                option 3) or (703) 412–9810 in                          would be affected by this action, you                 effects at concentration levels that are
                                                Washington DC and International; or                     should carefully examine the                          reasonably likely to exist beyond facility
                                                toll free, TDD (800) 553–7672; or go to                 applicability criteria in part 372, subpart           site boundaries as a result of
                                                http://www.epa.gov/superfund/                           B of Title 40 of the Code of Federal                  continuous, or frequently recurring,
                                                contacts/infocenter/.                                   Regulations. If you have questions                    releases.
                                                SUPPLEMENTARY INFORMATION:                              regarding the applicability of this action               • The chemical is known to cause or
                                                                                                        to a particular entity, consult the person            can reasonably be anticipated to cause
                                                I. General Information                                  listed under FOR FURTHER INFORMATION                  in humans: Cancer or teratogenic effects,
                                                A. Does this document apply to me?                      CONTACT.                                              or serious or irreversible reproductive
                                                   You may be potentially affected by                   B. What action is the Agency taking?                  dysfunctions, neurological disorders,
                                                this action if you manufacture, process,                                                                      heritable genetic mutations, or other
                                                                                                          EPA is adding an HBCD category to                   chronic health effects.
                                                or otherwise use HBCD. The following                    the list of toxic chemicals subject to
                                                list of North American Industrial                                                                                • The chemical is known to cause or
                                                                                                        reporting under EPCRA section 313 and                 can be reasonably anticipated to cause,
                                                Classification System (NAICS) codes is                  PPA section 6607. EPA is adding this
                                                not intended to be exhaustive, but rather                                                                     because of its toxicity, its toxicity and
                                                                                                        chemical category to the EPCRA section                persistence in the environment, or its
                                                provides a guide to help readers                        313 list because EPA has determined
                                                determine whether this document                                                                               toxicity and tendency to bioaccumulate
                                                                                                        that HBCD meets the EPCRA section                     in the environment, a significant
                                                applies to them. Potentially affected
                                                                                                        313(d)(2)(B) and (C) toxicity criteria.               adverse effect on the environment of
                                                entities may include:
                                                   • Facilities included in the following               EPA is also adding the HBCD category                  sufficient seriousness, in the judgment
                                                NAICS manufacturing codes                               to the list of chemicals with special                 of the Administrator, to warrant
                                                (corresponding to Standard Industrial                   concern (see 40 CFR 372.28(a)(2)) and                 reporting under this section.
                                                Classification (SIC) codes 20 through                   establishing a 100-pound reporting                       EPA often refers to the EPCRA section
                                                39): 311*, 312*, 313*, 314*, 315*, 316,                 threshold.                                            313(d)(2)(A) criterion as the ‘‘acute
                                                321, 322, 323*, 324, 325*, 326*, 327,                   C. What is the Agency’s authority for                 human health effects criterion;’’ the
                                                331, 332, 333, 334*, 335*, 336, 337*,                   taking this action?                                   EPCRA section 313(d)(2)(B) criterion as
                                                339*, 111998*, 211112*, 212324*,                                                                              the ‘‘chronic human health effects
                                                                                                           This action is issued under EPCRA
                                                212325*, 212393*, 212399*, 488390*,                                                                           criterion;’’ and the EPCRA section
                                                                                                        sections 313(d) and 328, 42 U.S.C.
                                                511110, 511120, 511130, 511140*,                                                                              313(d)(2)(C) criterion as the
                                                                                                        11023 et seq., and PPA section 6607, 42
                                                511191, 511199, 512220, 512230*,                                                                              ‘‘environmental effects criterion.’’
                                                                                                        U.S.C. 13106. EPCRA is also referred to
                                                519130*, 541712*, or 811490*.                                                                                    EPA published in the Federal
                                                                                                        as Title III of the Superfund
                                                *Exceptions and/or limitations exist for                                                                      Register of November 30, 1994 (59 FR
                                                                                                        Amendments and Reauthorization Act
                                                these NAICS codes.                                                                                            61432) (FRL–4922–2), a statement
                                                                                                        of 1986.
                                                   • Facilities included in the following                                                                     clarifying its interpretation of the
                                                                                                           Section 313 of EPCRA, 42 U.S.C.
                                                NAICS codes (corresponding to SIC                                                                             EPCRA section 313(d)(2) and (d)(3)
                                                                                                        11023, requires certain facilities that
                                                codes other than SIC codes 20 through                                                                         criteria for modifying the EPCRA
                                                                                                        manufacture, process, or otherwise use
                                                39): 212111, 212112, 212113                                                                                   section 313 list of toxic chemicals.
                                                                                                        listed toxic chemicals in amounts above
                                                (corresponds to SIC code 12, Coal                       reporting threshold levels to report their            II. Summary of Proposed Rule
                                                Mining (except 1241)); or 212221,                       environmental releases and other waste
                                                212222, 212231, 212234, 212299                                                                                A. What chemical did EPA propose to
                                                                                                        management quantities of such
                                                (corresponds to SIC code 10, Metal                                                                            add to the EPCRA section 313 list of
                                                                                                        chemicals annually. These facilities
                                                Mining (except 1011, 1081, and 1094));                                                                        toxic chemicals?
                                                                                                        must also report pollution prevention
                                                or 221111, 221112, 221113, 221118,                      and recycling data for such chemicals,                   As discussed in the proposed rule
                                                221121, 221122, 221330 (Limited to                      pursuant to section 6607 of the PPA, 42               June 2, 2016 (81 FR 35275) (FRL–9943–
                                                facilities that combust coal and/or oil                 U.S.C. 13106. Congress established an                 55), EPA proposed to add HBCD which
                                                for the purpose of generating power for                 initial list of toxic chemicals that                  is a cyclic aliphatic hydrocarbon
                                                distribution in commerce) (corresponds                  comprised 308 individually listed                     consisting of a 12-membered carbon ring
                                                to SIC codes 4911, 4931, and 4939,                      chemicals and 20 chemical categories.                 with 6 bromine atoms attached
                                                Electric Utilities); or 424690, 425110,                    EPCRA section 313(d) authorizes EPA                (molecular formula C12H18Br6). HBCD
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                                                425120 (Limited to facilities previously                to add or delete chemicals from the list              has 16 possible stereoisomers. HBCD
                                                classified in SIC code 5169, Chemicals                  and sets criteria for these actions.                  may be designated as a non-specific
                                                and Allied Products, Not Elsewhere                      EPCRA section 313(d)(2) states that EPA               mixture of all isomers
                                                Classified); or 424710 (corresponds to                  may add a chemical to the list if any of              (hexabromocyclododecane, Chemical
                                                SIC code 5171, Petroleum Bulk                           the listing criteria in EPCRA section                 Abstracts Service Registry Number
                                                Terminals and Plants); or 562112                        313(d)(2) are met. Therefore, to add a                (CASRN) 25637–99–4) or as a mixture of
                                                (Limited to facilities primarily engaged                chemical, EPA must demonstrate that at                the three main diastereomers


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                                                85442            Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations

                                                (1,2,5,6,9,10-hexabromocyclododecane,                   EPCRA section 313 toxic chemical list                 III. What comments did EPA receive on
                                                CASRN 3194–55–6). EPA proposed to                       pursuant to EPCRA section 313(d)(2)(B)                the proposed rule?
                                                create an HBCD category that would                      based on the available developmental                     EPA received three comments on the
                                                cover these two chemical names and                      and reproductive toxicity data.                       proposed rule, two from individuals
                                                CASRNs and would be defined as:                            As also discussed in the proposed                  (Refs. 1 and 2) and one from a coalition
                                                Hexabromocyclododecane, includes                                                                              of environmental and public interest
                                                                                                        rule, HBCD has been shown to be highly
                                                those chemicals covered by the                                                                                groups and individuals (the coalition)
                                                                                                        toxic to both aquatic and terrestrial
                                                following CAS numbers:                                                                                        (Ref. 3). All commenters supported the
                                                                                                        species with acute aquatic toxicity
                                                • 3194–55–6; 1,2,5,6,9,10-                              values as low as 0.009 milligrams per                 addition of the HBCD category to the
                                                  Hexabromocyclododecane                                liter (mg/L) and chronic aquatic toxicity             EPCRA section 313 toxic chemical list.
                                                • 25637–99–4;                                                                                                 However, in their comments the
                                                                                                        values as low as 0.0042 mg/L. HBCD is
                                                  Hexabromocyclododecane.                                                                                     coalition stated that HBCD is highly
                                                                                                        highly toxic to terrestrial species as well
                                                As a category, facilities that                          with observed toxic doses as low as 0.51              bioaccumulative and highly persistent
                                                manufacture, process, or otherwise use                  and 2.1 mg/kg/day. In addition to being               and based on EPA’s PBT classification
                                                HBCD covered under both of these                                                                              criteria, a reporting threshold of 10
                                                                                                        highly toxic, HBCD is also
                                                names and CASRNs would file just one                                                                          pounds should be established for the
                                                                                                        bioaccumulative and persistent in the
                                                report.                                                                                                       HBCD category. EPA provided the
                                                                                                        environment, which further supports a                 following background information in
                                                B. What reporting threshold did EPA                     high concern for the toxicity to aquatic              the proposed rule:
                                                propose to establish for the HBCD                       and terrestrial species. EPA stated that                 ‘‘In a final rule published in the
                                                category?                                               HBCD meets the EPCRA section                          Federal Register of October 29, 1999 (64
                                                  As EPA stated in the proposed rule                    313(d)(2)(C) listing criteria on toxicity             FR 58666) (FRL–6389–11), EPA
                                                June 2, 2016 (81 FR 35275) (FRL–9943–                   alone but also based on toxicity and                  established the PBT classification
                                                55), EPA proposed to add the HBCD                       bioaccumulation as well as toxicity and               criteria for chemicals on the EPCRA
                                                category to the list of chemicals of                    persistence in the environment.                       section 313 chemical list. For purposes
                                                special concern (see 40 CFR                             Therefore, EPA stated that the evidence               of EPCRA section 313 reporting, EPA
                                                372.28(a)(2)). There are several                        is sufficient for listing the HBCD                    established persistence half-life criteria
                                                chemicals and chemical categories on                    category on the EPCRA section 313 toxic               for PBT chemicals of 2 months in water/
                                                the EPCRA section 313 chemical list                     chemical list pursuant to EPCRA section               sediment and soil and 2 days in air, and
                                                that have been classified as chemicals of               313(d)(2)(C) based on the available                   established bioaccumulation criteria for
                                                special concern because they are PBT                    ecological toxicity data as well as the               PBT chemicals as a bioconcentration
                                                chemicals. In a final rule published in                 bioaccumulation and persistence data.                 factor (BCF) or bioaccumulation factor
                                                the Federal Register of October 29, 1999                                                                      (BAF) of 1,000 or higher. Chemicals
                                                (64 FR 58666) (FRL–6389–11), EPA                        D. What was EPA’s rationale for                       meeting the PBT criteria were assigned
                                                established the PBT classification                      lowering the reporting threshold for                  100-pound reporting thresholds. With
                                                criteria for chemicals on the EPCRA                     HBCD?                                                 regards to setting the EPCRA section 313
                                                section 313 chemical list. The data                                                                           reporting thresholds, EPA set lower
                                                                                                           EPA stated in the proposed rule that               reporting thresholds (10 pounds) for
                                                presented in the proposed rule
                                                supported classifying the HBCD                          the available bioaccumulation and                     those PBT chemicals with persistence
                                                category as a PBT chemical category                     persistence data for HBCD support a                   half-lives of 6 months or more in water/
                                                with a 100-pound reporting threshold.                   classification of HBCD as a PBT                       sediment or soil and with BCF or BAF
                                                                                                        chemical June 2, 2016 (81 FR 35275)                   values of 5,000 or higher, these
                                                C. What was EPA’s rationale for                         (FRL–9943–55). HBCD has been shown                    chemicals were considered highly PBT
                                                proposing to list the HBCD category?                    to be highly bioaccumulative in aquatic               chemicals. The data presented in this
                                                   As discussed in the proposed rule                    species and to also biomagnify in                     proposed rule support classifying the
                                                June 2, 2016 (81 FR 35275) (FRL–9943–                   aquatic and terrestrial food chains.                  HBCD category as a PBT chemical
                                                55), HBCD has been shown to cause                       While there is limited data on the half-              category with a 100-pound reporting
                                                developmental effects at doses as low as                life of HBCD in soil and sediment, the                threshold.’’ June 2, 2016 (81 FR 35277)
                                                146.3 milligrams per kilogram per day                   best available data supports a                        (FRL–9943–55).
                                                (mg/kg/day) lowest-observed-adverse-                    determination that the half-life of HBCD                 EPA agrees with the commenter that
                                                effect level (LOAEL) in male rats.                      in soil and sediment is at least 2                    HBCD is highly bioaccumulative but
                                                Developmental effects have also been                    months. This determination is further                 does not agree that HBCD meets the
                                                observed with a benchmark dose lower                    supported by the data from                            established criteria for highly persistent.
                                                bound confidence limit (BMDL) of 0.056                  environmental monitoring studies,                     The commenter stated that ‘‘While half-
                                                mg/kg/day (benchmark dose (BMD) of                      which indicate that HBCD has                          life data is limited, several studies
                                                0.18 mg/kg/day) based on effects in                     significant persistence in the                        estimate the half-life in sediment and
                                                female rats and a BMDL of 0.46 mg/kg/                   environment. The widespread presence                  soil to be greater than 120 days, while
                                                day (BMD of 1.45 mg/kg/day) based on                                                                          one study estimates a half-life of 190
                                                                                                        of HBCD in numerous terrestrial and
                                                effects in male rats. HBCD also causes                                                                        days in abiotic sediment.’’ The study
                                                                                                        aquatic species also supports the
                                                reproductive toxicity at doses as low                                                                         that the commenter cited as estimating
                                                                                                        conclusion that HBCD has significant
                                                138 mg/kg/day (LOAEL) in female rats.                                                                         a half-life of 190 days in abiotic
                                                                                                        persistence in the environment.
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                                                Based on the available developmental                                                                          sediment was Davis et al. 2005 (Ref. 4),
                                                and reproductive toxicity, EPA stated                   Therefore, consistent with EPA’s                      which, as EPA discussed in the
                                                that HBCD can be reasonably                             established policy for PBT chemicals                  proposed rule, is a study that had a
                                                anticipated to cause moderately high to                 (See 64 FR 58666, October 29, 1999)                   number of problems. For example, EPA
                                                high chronic toxicity in humans. EPA                    (FRL–6389–11) EPA proposed to                         noted that:
                                                stated that the evidence was sufficient                 establish a 100-pound reporting                          ‘‘Additionally, the Davis et al. 2005
                                                for listing the HBCD category on the                    threshold for the HBCD category.                      study (Ref. 96) was considered to be of


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                                                                 Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                         85443

                                                uncertain reliability for quantifying                      2. Anonymous public comment. July 31,              reporting thresholds, but estimates that
                                                HBCD persistence because of concerns                    2016. EPA–HQ–TRI–2015–0607–0218.                      the total annual reportable amount of
                                                regarding potential contamination of                       3. Comment submitted by E. Gartner, Staff          the chemical does not exceed 500
                                                sediment samples, an interfering peak                   Attorney, Earthjustice et al. Re: Addition of         pounds per year, can take advantage of
                                                                                                        Hexabromocyclododecane (HBCD) Category;
                                                corresponding to g-HBCD in the liquid                   Community Right-to-Know Toxic Chemical
                                                                                                                                                              an alternative manufacture, process, or
                                                chromatography/mass spectrometry                        Release Reporting, August 1, 2016. EPA–HQ–            otherwise use threshold of 1 million
                                                (LC/MS) chromatograms, and poor                         TRI–2015–0607–0219.                                   pounds per year of the chemical,
                                                extraction of HBCD leading to HBCD                         4. Davis, J.W., Gonsior, S.J., Marty, G.T., et     provided that certain conditions are
                                                recoveries of 33–125% (Refs. 44 and                     al. 2005. The transformation of                       met, and submit the Form A instead of
                                                101).’’ June 2, 2016 (81 FR 35284).                     hexabromocyclododecane in aerobic and                 the Form R. Since the HBCD category
                                                   A better-conducted subsequent study                  anaerobic soils and aquatic sediments. Water          would be classified a PBT category, it is
                                                by the same authors Davis et al. 2006                   Res. 39:1075–1084.                                    designated as a chemical of special
                                                (Ref. 5) resulted in longer overall half-                  5. Davis, J.W., Gonsior, S.J., Markham,            concern, for which Form A reporting is
                                                                                                        D.A., et al. 2006. Biodegradation and product         not allowed. In addition, respondents
                                                life values but no specific value equal to
                                                                                                        identification of
                                                or above 180 days. As stated in the                     [14C]hexabromocyclododecane in wastewater
                                                                                                                                                              may designate the specific chemical
                                                proposed rule, ‘‘While there is limited                 sludge and freshwater aquatic sediment.               identity of a substance as a trade secret
                                                data on the half-life of HBCD in soil and               Environ. Sci. Technol. 40:5395–5401.                  pursuant to EPCRA section 322, 42
                                                sediment, the best available data                       Including supporting information document.            U.S.C. 11042, 40 CFR part 350.
                                                supports a determination that the half-                    6. USEPA, OCSPP. 2016. Economic                      OMB has approved the reporting and
                                                life of HBCD in soil and sediment is at                 Analysis of the Final Rule to add HBCD to             recordkeeping requirements related to
                                                least 2 months.’’ EPA does not believe                  the List of TRI Reportable Chemicals. August          Forms A and R, supplier notification,
                                                that it would be appropriate to set a                   10, 2016.                                             and petitions under OMB Control
                                                lower reporting threshold based on one                  VI. What are the Statutory and                        number 2025–0009 (EPA Information
                                                half-life value of 190 days from a study                Executive Orders reviews associated                   Collection Request (ICR) No. 1363) and
                                                that had a number of identified                         with this action?                                     those related to trade secret designations
                                                problems.                                                                                                     under OMB Control 2050–0078 (EPA
                                                                                                          Additional information about these                  ICR No. 1428). As provided in 5 CFR
                                                IV. Summary of Final Rule                               statutes and Executive Orders can be                  1320.5(b) and 1320.6(a), an Agency may
                                                  EPA is finalizing the addition of an                  found at http://www2.epa.gov/laws-                    not conduct or sponsor, and a person is
                                                HBCD category to the EPCRA section                      regulations/laws-and-executive-orders.                not required to respond to, a collection
                                                313 list of toxic chemicals. EPA has                    A. Executive Order 12866: Regulatory                  of information unless it displays a
                                                determined that HBCD meets the listing                  Planning and Review and Executive                     currently valid OMB control number.
                                                criteria under EPCRA section                            Order 13563: Improving Regulation and                 The OMB control numbers relevant to
                                                313(d)(2)(B) and (C). The HBCD category                 Regulatory Review                                     EPA’s regulations are listed in 40 CFR
                                                will be defined as:                                                                                           part 9 or 48 CFR chapter 15, and
                                                Hexabromocyclododecane (This                              This action is not a significant                    displayed on the information collection
                                                category includes only those chemicals                  regulatory action and was therefore not               instruments (e.g., forms, instructions).
                                                covered by the CAS numbers listed                       submitted to the Office of Management
                                                                                                        and Budget (OMB) for review under                     C. Regulatory Flexibility Act (RFA)
                                                here)
                                                • 3194–55–6; 1,2,5,6,9,10-                              Executive Orders 12866 (58 FR 51735,                     I certify that this action will not have
                                                  Hexabromocyclododecane                                October 4, 1993) and 13563 (76 FR 3821,               a significant economic impact on a
                                                • 25637–99–4;                                           January 21, 2011).                                    substantial number of small entities
                                                  Hexabromocyclododecane.                               B. Paperwork Reduction Act (PRA)                      under the RFA, 5 U.S.C. 601 et seq. The
                                                  EPA is also finalizing the addition of                                                                      small entities subject to the
                                                the HBCD category to the list of                          This action does not contain any new                requirements of this action are small
                                                chemicals with special concern (see 40                  information collection requirements that              manufacturing facilities. The Agency
                                                CFR 372.28(a)(2)) and establishing a                    require additional approval by OMB                    has determined that of the 55 entities
                                                100-pound reporting threshold. EPA has                  under the PRA, 44 U.S.C. 3501 et seq.                 estimated to be impacted by this action,
                                                determined that the data support                        OMB has previously approved the                       42 are small businesses; no small
                                                classifying the HBCD category as a PBT                  information collection activities                     governments or small organizations are
                                                chemical category with a 100-pound                      contained in the existing regulations                 expected to be affected by this action.
                                                reporting threshold.                                    and has assigned OMB control numbers                  All 42 small businesses affected by this
                                                                                                        2025–0009 and 2050–0078. Currently,                   action are estimated to incur annualized
                                                V. References                                           the facilities subject to the reporting               cost impacts of less than 1%. Thus, this
                                                  The following is a listing of the                     requirements under EPCRA section 313                  action is not expected to have a
                                                documents that are specifically                         and PPA section 6607 may use either                   significant adverse economic impact on
                                                referenced in this document. The docket                 EPA Toxic Chemicals Release Inventory                 a substantial number of small entities. A
                                                includes these documents and other                      Form R (EPA Form 1B9350–1), or EPA                    more detailed analysis of the impacts on
                                                information considered by EPA,                          Toxic Chemicals Release Inventory                     small entities is located in EPA’s
                                                including documents that are referenced                 Form A (EPA Form 1B9350–2). The                       economic analysis (Ref. 6).
                                                within the documents that are included                  Form R must be completed if a facility
                                                                                                        manufactures, processes, or otherwise                 D. Unfunded Mandates Reform Act
                                                in the docket, even if the referenced
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                                                                                                        uses any listed chemical above                        (UMRA)
                                                document is not itself physically located
                                                in the docket. For assistance in locating               threshold quantities and meets certain                  This action does not contain an
                                                these other documents, please consult                   other criteria. For the Form A, EPA                   unfunded mandate of $100 million or
                                                the person listed under FOR FURTHER                     established an alternative threshold for              more as described in UMRA, 2 U.S.C.
                                                INFORMATION CONTACT.                                    facilities with low annual reportable                 1531–1538, and does not significantly or
                                                  1. Comment submitted by M. Clark. July                amounts of a listed toxic chemical. A                 uniquely affect small governments. This
                                                22, 2016. EPA–HQ–TRI–2015–0607–0217.                    facility that meets the appropriate                   action is not subject to the requirements


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                                                85444            Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations

                                                of UMRA because it contains no                          H. Executive Order 13211: Actions                     will have positive human health and
                                                regulatory requirements that might                      Concerning Regulations That                           environmental impacts on minority
                                                significantly or uniquely affect small                  Significantly Affect Energy Supply,                   populations, low-income populations,
                                                governments. Small governments are                      Distribution, or Use                                  and children.
                                                not subject to the EPCRA section 313                      This action is not subject to Executive             K. Congressional Review Act (CRA)
                                                reporting requirements. EPA’s economic                  Order 13211 (66 FR 28355, May 22,
                                                analysis indicates that the total cost of               2001), because it is not a significant                  This action is subject to the CRA, and
                                                this action is estimated to be $372,973                 regulatory action under Executive Order               the EPA will submit a rule report to
                                                in the first year of reporting (Ref. 6).                12866.                                                each House of the Congress and to the
                                                                                                                                                              Comptroller General of the United
                                                E. Executive Order 13132: Federalism                    I. National Technology Transfer and                   States. This action is not a ‘‘major rule’’
                                                                                                        Advancement Act (NTTAA)                               as defined by 5 U.S.C. 804(2).
                                                   This action does not have federalism
                                                implications as specified in Executive                     This rulemaking does not involve
                                                                                                                                                              List of Subjects in 40 CFR Part 372
                                                Order 13132 (64 FR 43255, August 10,                    technical standards and is therefore not
                                                1999). It will not have substantial direct              subject to considerations under section                 Environmental protection,
                                                effects on the States, on the relationship              12(d) of NTTAA, 15 U.S.C. 272 note.                   Community right-to-know, Reporting
                                                between the national government and                                                                           and recordkeeping requirements, and
                                                                                                        J. Executive Order 12898: Federal
                                                the States, or on the distribution of                                                                         Toxic chemicals.
                                                                                                        Actions To Address Environmental
                                                power and responsibilities among the                    Justice in Minority Populations and                     Dated: November 15, 2016.
                                                various levels of government.                           Low-Income Populations                                Gina McCarthy,
                                                F. Executive Order 13175: Consultation                     EPA has determined that this action                Administrator.
                                                and Coordination With Indian Tribal                     will not have disproportionately high                   Therefore, 40 CFR chapter I is
                                                Governments                                             and adverse human health or                           amended as follows:
                                                                                                        environmental effects on minority or
                                                  This action does not have tribal                      low-income populations as specified in                PART 372—[AMENDED]
                                                implications as specified in Executive                  Executive Order 12898 (59 FR 7629,
                                                Order 13175 (65 FR 67249, November 9,                   February 16, 1994). This action does not              ■ 1. The authority citation for part 372
                                                2000). This action relates to toxic                     address any human health or                           continues to read as follows:
                                                chemical reporting under EPCRA                          environmental risks and does not affect                   Authority: 42 U.S.C. 11023 and 11048.
                                                section 313, which primarily affects                    the level of protection provided to
                                                private sector facilities. Thus, Executive              human health or the environment. This                 ■  2. In § 372.28, amend the table in
                                                Order 13175 does not apply to this                      action adds an additional chemical to                 paragraph (a)(2) as follows:
                                                action.                                                 the EPCRA section 313 reporting                       ■ a. Revise the second column header to
                                                                                                        requirements. By adding a chemical to                 read ‘‘Reporting threshold (in pounds
                                                G. Executive Order 13045: Protection of
                                                                                                        the list of toxic chemicals subject to                unless otherwise noted)’’, and
                                                Children From Environmental Health
                                                                                                        reporting under section 313 of EPCRA,                 ■ b. Alphabetically add the category
                                                Risks and Safety Risks
                                                                                                        EPA would be providing communities                    ‘‘Hexabromocyclododecane (This
                                                  EPA interprets Executive Order 13045                  across the United States (including                   category includes only those chemicals
                                                (62 FR 19885, April 23, 1997) as                        minority populations and low income                   covered by the CAS numbers listed
                                                applying only to those regulatory                       populations) with access to data which                here)’’ and entries ‘‘3194–55–6
                                                actions that concern environmental                      they may use to seek lower exposures                  (1,2,5,6,9,10-
                                                health or safety risks that EPA has                     and consequently reductions in                        Hexabromocyclododecane)’’ and
                                                reason to believe may                                   chemical risks for themselves and their               ‘‘25637–99–4
                                                disproportionately affect children, per                 children. This information can also be                (Hexabromocyclododecane)’’.
                                                the definition of ‘‘covered regulatory                  used by government agencies and others                   The additions read as follows:
                                                action’’ in section 2–202 of the                        to identify potential problems, set
                                                Executive Order. This action is not                     priorities, and take appropriate steps to             § 372.28 Lower thresholds for chemicals
                                                                                                                                                              of special concern.
                                                subject to Executive Order 13045                        reduce any potential risks to human
                                                because it does not concern an                          health and the environment. Therefore,                    (a) * * *
                                                environmental health risk or safety risk.               the informational benefits of the action                  (2) * * *

                                                                                                                                                                                                Reporting
                                                                                                                                                                                              threshold (in
                                                                                                                Category name                                                                pounds unless
                                                                                                                                                                                                otherwise
                                                                                                                                                                                                  noted)


                                                        *                 *                    *                   *                  *                    *                                        *
                                                Hexabromocyclododecane (This category includes only those chemicals covered by the CAS numbers listed here)                                                    100
                                                3194–55–6 1,2,5,6,9,10-Hexabromocyclododecane                                                                                                ........................
                                                25637–99–4 Hexabromocyclododecane                                                                                                            ........................
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                                                          *                       *                       *                      *                       *                      *                   *



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


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                                                                   Federal Register / Vol. 81, No. 228 / Monday, November 28, 2016 / Rules and Regulations                                                  85445

                                                § 372.65 Chemicals and chemical                             (c) * * *
                                                categories to which this part applies.
                                                *      *       *       *      *

                                                                                                                  Category name                                                                  Effective date


                                                        *                 *                    *                   *                  *                    *                                            *
                                                Hexabromocyclododecane (This category includes only those chemicals covered by the CAS numbers listed here)                                                    1/1/17
                                                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]              extended the implementation date for                     Withdrawal of this direct final rule
                                                BILLING CODE 6560–50–P                                    certain facilities to meet the                        removes the extension of the
                                                                                                          requirements of the final pretreatment                compliance date for the subset of
                                                                                                          standards rule for unconventional oil                 facilities identified in the direct final
                                                ENVIRONMENTAL PROTECTION                                  and gas extraction. (81 FR 67191;                     rule. It does not withdraw, or otherwise
                                                AGENCY                                                    September 30, 2016). In that direct final             impact, the underlying final
                                                                                                          rule, the EPA stated that if we received              pretreatment standards rule for
                                                40 CFR Part 435                                           adverse comments by October 31, 2016,                 unconventional oil and gas extraction,
                                                [EPA–HQ–OW–2014–0598; FRL–9955–65–                        the EPA would publish a timely                        which continues to apply to all facilities
                                                OW]                                                       withdrawal and address the comments                   that meet the definition of
                                                                                                          in a final rule based on the proposed                 ‘‘unconventional’’ in that rule.
                                                RIN 2040–AF68                                             rule also published on September 30,                  List of Subjects in 40 CFR Part 435
                                                Effluent Limitations Guidelines and                       2016. (81 FR 67266; September 30,
                                                                                                          2016).                                                  Environmental protection,
                                                Standards for the Oil and Gas                                                                                   Pretreatment, Waste treatment and
                                                Extraction Point Source Category—                            The direct final rule specifically                 disposal, Water pollution control,
                                                Implementation Date Extension                             indicated that ‘‘EPA will not consider                Unconventional oil and gas extraction.
                                                                                                          any comment submitted on the direct
                                                AGENCY: Environmental Protection                          final rule published today on any topic                 Dated: November 17, 2016.
                                                Agency (EPA).                                             other than the appropriateness of an                  Michael H. Shapiro,
                                                ACTION: Withdrawal of direct final rule.                  extension of the compliance date; any                 Deputy Assistant Administrator.
                                                                                                          other comments will be considered to be                 Accordingly, the direct final rule,
                                                SUMMARY:   Because the Environmental                      outside the scope of this rulemaking.’’
                                                Protection Agency (EPA) received                                                                                published in the Federal Register on
                                                                                                          (81 FR 67192; September 30, 2016).                    September 30, 2016, at 81 FR 67191, is
                                                comments that could be construed as
                                                                                                          Commenters supported the compliance                   withdrawn as of November 28, 2016.
                                                adverse, the EPA is withdrawing the
                                                                                                          date being extended; the EPA did not                  [FR Doc. 2016–28566 Filed 11–25–16; 8:45 am]
                                                direct final rule issued on September 30,
                                                                                                          receive any comments opposing the
                                                2016, to extend the implementation date                                                                         BILLING CODE 6560–50–P
                                                                                                          extension of the compliance date, and
                                                for certain facilities subject to the EPA’s
                                                                                                          thus maintains that there were no
                                                final rule establishing pretreatment
                                                                                                          adverse comments on the direct final
                                                standards under the Clean Water Act                                                                             DEPARTMENT OF COMMERCE
                                                                                                          rule. As indicated in the direct final
                                                (CWA) for discharges of pollutants into
                                                                                                          rule, the EPA considers any comments                  National Oceanic and Atmospheric
                                                publicly-owned treatment works
                                                                                                          on topics other than the extension of the             Administration
                                                (POTWs) from unconventional oil and
                                                                                                          compliance date—including comments
                                                gas extraction.
                                                                                                          submitted on the applicability of the                 50 CFR Part 622
                                                DATES: Effective November 28, 2016, the                   underlying final pretreatment standards
                                                EPA withdraws the direct final rule                       rule—to be outside the scope of this                  [Docket No. 140819686–5999–02]
                                                published September 30, 2016 (81 FR                       rulemaking. However, to the extent that               RIN 0648–XF045
                                                67191).                                                   any of the comments could be broadly
                                                FOR FURTHER INFORMATION CONTACT:   For                    interpreted as seeking an alternative                 Snapper-Grouper Fishery of the South
                                                more information, see EPA’s Web site:                     compliance period, and thus arguably                  Atlantic; 2016 Recreational
                                                https://www.epa.gov/eg/                                   within scope, the EPA, in its discretion,             Accountability Measure and Closure
                                                unconventional-oil-and-gas-extraction-                    is withdrawing the direct final rule and              for South Atlantic Greater Amberjack
                                                effluent-guidelines. For technical                        instead will issue a final action to
                                                                                                                                                                AGENCY:  National Marine Fisheries
                                                information, contact Karen Milam,                         address the compliance date, which will
                                                                                                                                                                Service (NMFS), National Oceanic and
                                                Engineering and Analysis Division                         be based on the parallel proposed rule
                                                                                                                                                                Atmospheric Administration (NOAA),
                                                (4303T), Office of Water, Environmental                   also published on September 30, 2016.
                                                                                                                                                                Commerce.
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                                                Protection Agency, 1200 Pennsylvania                      (81 FR 67266; September 30, 2016). For
                                                                                                          purposes of this withdrawal,                          ACTION: Temporary rule; closure.
                                                Ave. NW., Washington, DC 20460–0001;
                                                telephone: 202–566–1915; email:                           compliance date and implementation                    SUMMARY:   NMFS implements
                                                milam.karen@epa.gov.                                      date are used interchangeably. As stated              accountability measures (AMs) for the
                                                SUPPLEMENTARY INFORMATION:                                in the parallel proposal, we will not                 recreational sector of greater amberjack
                                                  On September 30, 2016, the EPA                             institute a second comment period on               in the exclusive economic zone (EEZ) of
                                                published a direct final rule that                        this proposed action.                                 the South Atlantic for the current


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Document Created: 2018-02-14 08:36:08
Document Modified: 2018-02-14 08:36:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesEffective Date: This final rule is effective November 30, 2016.
ContactFor 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: [email protected]
FR Citation81 FR 85440 
RIN Number2025-AA42
CFR AssociatedEnvironmental Protection; Community Right-To-Know; Reporting and Recordkeeping Requirements and Toxic Chemicals

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