Document ID: EPA-HQ-TRI-2017-0434-0551
Agency: epa
Document Type: Rule
Title: Addition of Certain Chemicals: Community Right-to-Know Toxic Chemical Release Reporting
Posted Date: 2022-11-30T05:00Z

[Federal Register Volume 87, Number 229 (Wednesday, November 30, 2022)]
[Rules and Regulations]
[Pages 73475-73488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25946]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[EPA-HQ-TRI-2017-0434; FRL-5927-02-OCSPP]
RIN 2070-AK26

Addition of Certain Chemicals; Community Right-to-Know Toxic 
Chemical Release Reporting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: In response to a petition filed under the Emergency Planning 
and Community Right-to-Know Act (EPCRA), the Environmental Protection 
Agency (EPA) is adding 12 chemicals to the list of toxic chemicals 
subject to the reporting requirements under EPCRA and the Pollution 
Prevention Act (PPA). EPA has determined that each of the 12 chemicals 
meets the EPCRA criteria. In addition, based on the available 
bioaccumulation and persistence data, EPA has determined that one 
chemical should be classified as a persistent, bioaccumulative, and 
toxic (PBT) chemical and designated as a chemical of special concern 
with a 100-pound reporting threshold.

DATES: 
    Effective date: November 30, 2022.
    Applicability date: This final rule will apply for the reporting 
year beginning January 1, 2023 (reports are due July 1, 2024).

ADDRESSES: The docket for this action, identified under docket 
identification (ID) number EPA-HQ-TRI-2017-0434, is available online at 
https://www.regulations.gov or in person at the Office of Pollution 
Prevention and Toxics Docket (OPPT Docket) in the Environmental 
Protection Agency Docket Center (EPA/DC). All documents in the docket 
are listed on https://www.regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available electronically through https://www.regulations.gov. 
Additional instructions on visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Daniel R. Bushman, Toxics 
Release Inventory Program Division (7406M), 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 Emergency Planning and 
Community Right-to-Know Hotline; telephone numbers: toll free at (800) 
424-9346 (select menu option 3) or (703) 348-5070 in the Washington, DC 
Area and International, https://www.epa.gov/home/epa-hotlines, or go to 
the website: https://www.epa.gov/aboutepa/epa-hotlines#epcraic.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you own or 
operate a facility that manufactures, processes, or otherwise uses any 
of the 12 chemicals included in this final rule. 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 
facilities 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*, 
113310, 211130*, 212324*, 212325*, 212393*, 212399*, 488390*, 511110, 
511120, 511130, 511140*, 511191, 511199, 512230*, 512250*, 519130*, 
541713*, 541715* 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, 212230, 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.
     Facilities that the EPA Administrator has specifically 
required to report to TRI pursuant to a determination under EPCRA 
section 313(b)(2).
    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?

    In response to a petition submitted by the Toxics Use Reduction 
Institute (TURI) that requested the addition of 25 chemicals to the 
EPCRA section 313 toxic chemicals list (Ref. 1), EPA is adding 12 
chemicals to the EPCRA section 313 toxic chemical list. EPA has 
determined that each of the 12 chemicals meets the EPCRA section 
313(d)(2)(B) and/or (C) criteria for listing. EPA is also classifying 
one chemical as a PBT chemical and adding it to the list of chemicals 
of special concern with 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), 313(e)(1) and 
328, 42 U.S.C. 11023(d), 11023(e)(1) and 11048. 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 (also known as the Toxics 
Release Inventory (TRI)), requires owners/operators of certain 
facilities that manufacture, process, or otherwise use listed toxic 
chemicals in amounts above reporting threshold levels to report their 
facilities' environmental releases and other waste management 
information on such chemicals annually. These facility

[[Page 73476]]

owners/operators must also report pollution prevention and recycling 
data for such chemicals, pursuant to section 6607 of the PPA, 42 U.S.C. 
13106.
    Under EPCRA section 313(c), Congress established an initial list of 
toxic chemicals subject to EPCRA toxic chemical reporting requirements 
that was comprised of 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 determine 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 determine 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 (EPCRA section 
313(d)(2)(C)(i)), its toxicity and persistence in the environment 
(EPCRA section 313(d)(2)(C)(ii)), or its toxicity and tendency to 
bioaccumulate in the environment (EPCRA section 313(d)(2)(C)(iii)), 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.''
    Under EPCRA section 313(e)(1), any person may petition EPA to add 
chemicals to or delete chemicals from the list. EPA issued a statement 
of policy in the Federal Register of February 4, 1987 (52 FR 3479) 
providing guidance regarding the recommended content of and format for 
petitions. On May 23, 1991 (56 FR 23703), EPA issued guidance regarding 
the recommended content of petitions to delete individual members of 
the metal compounds categories reportable under EPCRA section 313. EPA 
published in the Federal Register of November 30, 1994 (59 FR 61432) 
(FRL-4922-2) (Ref. 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.

D. Why is the Agency's taking this action?

    EPA is taking this action in response to a petition submitted under 
EPCRA section 313(e)(1). EPA is required to respond to petitions by 
ether initiating a rulemaking to grant the petition or publishing an 
explanation of why the petition is denied. In this case EPA is 
partially granting the petition to add 25 chemicals to the EPCRA 
section 313 toxic chemicals list.

E. What are the estimated incremental impacts of this action?

    EPA prepared an addendum to its economic analysis for this action 
entitled, ``Economic Analysis Addendum for the Final Rule to Add Twelve 
Chemicals Identified in a Petition from the Toxics Use Reduction 
Institute to the EPCRA Section 313 List of Toxic Chemicals'' which 
presents an updated analysis of the costs of the addition of the twelve 
chemicals (Ref. 3). EPA estimates that this action would result in an 
additional 1,342 reports being filed annually. EPA estimates that the 
costs of this action will be approximately $6,660,633 in the first year 
of reporting and approximately $3,172,080 in the subsequent years. In 
addition, EPA has determined that of the 1,283 small businesses 
affected by this action, none are estimated to incur annualized cost 
impacts of more than 1%. Thus, this action is not expected to have a 
significant adverse economic impact on a substantial number of small 
entities.

II. Summary of Proposed Rule

A. Who submitted the petition and what was requested?

    On May 6, 2014, EPA received a petition from the TURI requesting 
the addition of 25 chemicals to the EPCRA section 313 toxic chemicals 
list (Ref. 1). The petitioner believed that each of these 25 chemicals 
meets the EPCRA section 313(d)(2) listing criteria and that the 25 
chemicals should be added to the EPCRA section 313 toxic chemical list 
so that releases can be monitored and reported. The 25 chemicals, 
listed by name and Chemical Abstracts Service Registry Number (CASRN), 
are shown here (note that some chemical names are different than those 
used in the petition because they are listed here using the EPA 
Registry Name):

 Azodicarbonamide; 123-77-3;
 1-Bromopropane; 106-94-5;
 4-Chlorobenzotrichloride; 5216-25-1;
 Cyclododecane; 294-62-2;
 Dibutyltin dichloride; 683-18-1;
 1,3-Dichloro-2-propanol; 96-23-1;
 Dimethylacetamide; 127-19-5;
 2,3-Dinitrotoluene; 602-01-7;
 2,5-Dinitrotoluene; 619-15-8;
 Formamide; 75-12-7;
 1,2,5,6,9,10-Hexabromocyclododecane; 3194-55-6;
 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2-
benzopyran; 1222-05-5;
 Hexahydrophthalic anhydride; 85-42-7;
 N-Hydroxyethylethylenediamine; 111-41-1;
 N-Methylformamide; 123-39-7;
 Methylhexahydrophthalic anhydride; 25550-51-0;
 Nitrilotriacetic acid trisodium salt; 5064-31-3;
 Nonylphenol; 25154-52-3;
 Octabromodiphenyl ether; 32536-52-0;
 p-(1,1,3,3-Tetramethylbutyl)phenol; 140-66-9;
 1,2,3-Trichlorobenzene; 87-61-6;
 Triglycidyl isocyanurate; 2451-62-9;
 Tris(2-chloroethyl) phosphate; 115-96-8;
 Tris(1,3-dichloro-2-propyl) phosphate; 13674-87-8; and
     Tris(dimethylphenol) phosphate; 25155-23-1.

B. How did EPA respond to the petition?

    On October 18, 2021, EPA proposed to add 12 of the 25 chemicals 
included in the TURI petition to the EPCRA section 313 toxic chemicals 
list (Ref. 4). In separate, unrelated actions, three of the 25 
chemicals (1-bromopropane (80 FR 72906, November 23, 2015 (FRL-9937-12-
OEI)), nonylphenol (79 FR 58686, September 30, 2014 (FRL-9915-59-OEI)) 
and 1,2,5,6,9,10-hexabromocyclododecane (81 FR 85440, November 28, 2016 
(FRL-9953-28)) have already been added to the EPCRA section 313 
chemical list. Of the remaining 10 chemicals, EPA determined that the 
available data for nine chemicals was not sufficient for EPA to find 
that the chemicals meet the EPCRA section 313 listing criteria for 
human health or ecological effects (Refs.

[[Page 73477]]

5 and 6). Therefore, EPA did not propose to add the nine chemicals 
listed here:

 Azodicarbonamide; 123-77-3;
 4-Chlorobenzotrichloride; 5216-25-1;
 Cyclododecane; 294-62-2;
 Dimethylacetamide; 127-19-5;
 2,3-Dinitrotoluene; 602-01-7;
 2,5-Dinitrotoluene; 619-15-8;
 Hexahydrophthalic anhydride; 85-42-7;
 Methylhexahydrophthalic anhydride; 25550-51-0; and
 N-Methylformamide; 123-39-7.

    In addition, EPA did not propose to add octabromodiphenyl ether 
(OctaBDE) (32536-52-0) to the EPCRA section 313 toxic chemical list. 
EPA issued a significant new use rule (SNUR) that requires notification 
to EPA 90 days prior to the intended manufacture or import for any use 
of OctaBDE ether after January 1, 2005 (71 FR 34015, June 13, 2006 
(FRL-7743-2); 40 CFR 721.10000). The lack of significant new use 
notices (SNUNs) under this SNUR indicates that there has been no non-
exempt manufacture or import for any use of OctaBDE in the United 
States since January 1, 2005. In addition, there have been no 
submissions for OctaBDE under the Chemical Data Reporting (CDR) Rule 
(https://www.epa.gov/chemical-data-reporting) since 2006. In a 2008 
evaluation, the United Nations noted that, as of 2005, the manufacture 
and import of OctaBDE had been phased out by industry and estimated 
that most of the remaining processing of OctaBDE in the United States 
was likely negligible and only occurring where remaining stockpiles 
were being used up or in waste processing facilities (http://chm.pops.int/portals/0/repository/poprc4/unep-pops-poprc.4-6.english.pdf). Given that the phase out occurred more than ten years 
ago, it is even more likely today that there is a negligible amount of 
OctaBDE remaining that is processed or otherwise used by facilities in 
the United States. Therefore, EPA did not propose to add OctaBDE to the 
EPCRA section 313 list since EPA expects that no TRI reports would be 
filed for this chemical. Section 313(d)(2) of EPCRA provides EPA the 
discretion to add chemicals to the TRI list when there is sufficient 
evidence to establish any of the listing criteria. EPA can add a 
chemical that meets one criterion regardless of its production volume. 
However, consistent with the Agency's previously articulated position 
on the use of manufacturing volume thresholds (e.g., 58 FR 63500, 
December 1, 1993) and as in past chemical reviews (e.g., 59 FR 61432, 
November 30, 1994) (Ref. 2), EPA adopted a production volume screen for 
the development of this rule to screen out those chemicals for which no 
reports are expected to be submitted. If chemicals that did not meet 
the production volume screen were listed, there would be an economic 
burden for firms that would have to determine that they did not exceed 
the reporting threshold. Since the production volume screen indicates 
that no reports would be filed for such chemicals, there would be no 
information provided to the public. EPA's position is that it is 
appropriate at this time to focus on chemicals for which reports are 
likely to be filed.
    In addition to proposing to add HHCB to the EPCRA section 313 toxic 
chemical list, EPA proposed to add HHCB to the list of chemicals of 
special concern. 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 (see 40 CFR 
372.28(a)(2)). In a final rule published in the Federal Register of 
October 29, 1999 (64 FR 58666) (FRL-6389-11) (Ref. 7), 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. Most 
chemicals meeting the PBT criteria are assigned 100-pound 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 since 
these chemicals are considered highly PBT chemicals. The data presented 
in the hazard assessment for the proposed rule support classifying HHCB 
as a PBT chemical and designating it as a chemical of special concern 
with a 100-pound reporting threshold.

III. Summary of Comments Received and EPA Responses

    EPA received 31 comments on the proposed rule. Twenty-one of the 
comments came from private citizens or anonymous commenters. Five 
comments were received from trade associations including, the American 
Chemistry Council (ACC) (Ref. 8), Alkylphenols & Ethoxylates Research 
Council (APERC) (Ref. 9), Fragrance Creators Association and American 
Cleaning Institute (Ref. 10), Fragrance Science & Advocacy Council 
(Ref. 11), and Household & Commercial Products Association (Ref. 12). 
Three comments were received from environmental/public interest groups 
including, CleanEarth4Kids.org (Ref. 13), Earthjustice (on behalf of 
Sierra Club, Toxic-Free Future, and Defend Our Health) (Ref. 14), and 
Silent Spring Institute (Ref. 15). Lastly, two comments were received 
from government organizations including, the Small Business 
Administration (Ref. 16) and TURI (Ref. 17). This unit provides 
summaries of some of the more significant comments and EPA's responses. 
A complete set of comments and EPA's detailed responses can be found in 
the Response to Comments (RTC) document that is available in the docket 
for this rulemaking (Ref. 18).

A. Comments Supporting EPA's Proposed Listing of 12 Chemicals

    The 21 private citizens or anonymous commenters and the three 
commenters from environmental/public interest groups, 
CleanEarth4Kids.org (Ref. 13), Earthjustice (on behalf of Sierra Club, 
Toxic-Free Future, and Defend Our Health) (Ref. 14), and Silent Spring 
Institute (Ref. 15) all supported EPA's proposed addition of the 12 
chemicals to the TRI list. Though, as discussed Unit III.E., certain 
commenters believe that EPA should have proposed the listing of some of 
the other chemicals included in the TURI petition.

B. Comments on Risk Evaluations Under TSCA Section 6

    Comment: ACC (Ref. 8) and the Fragrance Creators Association and 
American Cleaning Institute (Ref. 10) commented that EPA should 
complete the risk evaluation being conducted for HHCB under TSCA 
section 6 before finalizing the proposed addition of HHCB to the TRI 
chemical list. ACC also stated that, as a matter of policy, EPA should 
defer from consideration the addition of any chemical to the TRI list 
that is undergoing a TSCA risk evaluation until that risk evaluation is 
completed.
    EPA Response: TSCA section 6 (i.e., the existing chemicals program) 
and EPCRA section 313 are two separate EPA programs operating under two 
separate statutory authorities with different purposes and criteria. 
EPA does not agree that it should wait until the TSCA section 6 risk 
evaluation has been completed for HHCB (or any other chemical) before 
adding HHCB (or any other chemical) to the TRI chemical list. The 
addition of chemicals to the TRI list is primarily based on an 
assessment of hazard (i.e., not a risk assessment). The

[[Page 73478]]

TSCA section 6 risk evaluations go far beyond what is needed to list a 
chemical under EPCRA section 313(d)(2) and are for the purpose of 
determining if there is an unreasonable risk that needs to be 
mitigated. Moreover, under TSCA, EPA may take actions that could 
severely limit or even ban the use of a chemical because of 
unreasonable risk. In contrast, a decision to add a substance to TRI 
pursuant to EPCRA section 313 does not impose any restrictions on the 
use or manufacturing of that substance; it establishes requirements for 
the reporting of releases and other waste management information. In 
addition, information obtained through TRI can be very helpful to the 
risk evaluation process, as TRI data can provide information concerning 
releases and waste management activities.

C. Comments on p-(1,1,3,3-tetramethylbutyl)phenol (CASRN 140-66-9).

    Comment: APERC (Ref. 9) commented that they support the addition of 
p-(1,1,3,3-tetramethylbutyl)phenol (TMBP) to the TRI list for the 
purpose of providing exposure data that could support future 
prioritization and risk evaluations of TMBP under TSCA. While 
supporting the addition of TMBP to the TRI list, APERC did object to 
some of the hazard characterizations that EPA presented in support of 
the listing of TMBP. APERC also stated that EPA proposed to list TMBP 
on the TRI based on it ecotoxicity and ``tendency to bioaccumulate.''
    EPA Response: EPA has addressed in detail APERC's comments 
regarding bioaccumulation potential, toxicity data, and monitoring data 
in the RTC document (Ref. 18). However, EPA would like to clarify that 
TMBP meets the listing criteria based on ecological toxicity alone. As 
EPA stated in the proposed rule ``EPA believes that the evidence is 
sufficient to list p-(1,1,3,3-Tetramethylbutyl)phenol (TMBP) on the 
EPCRA section 313 toxic chemicals list pursuant to EPCRA section 
313(d)(2)(C) based on the available ecotoxicity information for this 
chemical alone and also based on its toxicity and tendency to 
bioaccumulate'' (see 86 FR 57619) (Ref. 4). EPA clearly stated that 
TMBP meets the EPCRA section 313(d)(2)(C) criteria based on the 
ecotoxicity data alone (i.e., ``. . . based on the available 
ecotoxicity information for this chemical alone . . .'') which is 
covered under section 313(d)(2)(C)(i). In addition, EPA stated that 
TMBP also meets the 313(d)(2)(C) criteria ``. . . based on ecotoxicity 
and bioaccumulation potential'' which is covered under section 
313(d)(2)(C)(iii). EPA summarized the toxicity data as follows ``In 
summary, the available data demonstrate that TMBP can cause acute and 
chronic toxicity to aquatic organisms at low concentrations indicating 
that TMBP is highly toxic to aquatic organisms'' (see 86 FR 57619) 
(Ref. 4).

D. Comments on Data Supporting the Addition of HHCB and Its Addition to 
the List of Chemicals of Special Concern

    Comment: The Fragrance Creators Association and American Cleaning 
Institute (Ref. 10), and the Fragrance Science & Advocacy Council (Ref. 
11) provided comments on the toxicity, persistence, and bioaccumulation 
data for HHCB. The commenters contend that the data do not support 
classifying HHCB as a PBT chemical under the criteria established for 
EPCRA section 313. Both commenters provided or cited to additional 
information, some of it previously submitted for the TSCA risk 
evaluation process, that they said EPA should consider before 
finalizing the listing of HHCB.
    EPA Response: As discussed in the RTC document (Ref. 18), EPA has 
reviewed the suggested information. Short summaries of some of their 
specific comments and EPA's responses are provided here, complete 
detailed comments and EPA responses can be found in the RTC document 
(Ref. 18).

E. Comments on HHCB Not Meeting the Persistence Criteria Established 
for EPCRA Section 313 for PBT Classification

    Comment: The Fragrance Creators Association and American Cleaning 
Institute (Ref. 10) stated that in EPA's 2014 TSCA risk assessment 
(Ref. 19), EPA cited half-lives of HHCB in water for days to weeks 
which is below the TRI 2-month half-life criteria. The commenter noted 
that EPA cited half-lives for HHCB in sludge of 10-69 hours and that 
since the majority of release of HHCB are to wastewater treatment 
plants (WWTPs), removal during treatment and degradation in sludge is 
important. The commenter state that EPA cited a single study on the 
fate of HHCB in sediments that resulted in a half-life of 79 days (Ref. 
20), which they contend may be artificially high due to the high 
concentration of the test material (Ref. 21). The commenter also cited 
sampling data that they said show low concentrations of HHCB in the 
environment (Ref. 22). The commenter stated that several studies found 
half-lives of HHCB in soils amended with biosolids (i.e., sewage 
sludge) that ranged from 105 days to 144 days. The commenter stated 
that for at least one of the studies (Ref. 23), the soil was frozen for 
three months of the study and the concentrations of HHCB were stable 
(after one month, the concentrations of HHCB in the four soils were 30 
to 90 percent of the initial concentration, and after 90 days, 
concentrations ranged from 8 to 60 percent of the initial 
concentration).
    EPA Response: EPA's determination that HHCB meets the persistence 
portion of the PBT criteria and is thus a chemical of special concern 
was not based on half-lives of HHCB in water. The determination was 
based on the half-lives for HHCB in soil and sediment which are above 
the 60-day criteria. The International Flavors and Fragrances (IFF) has 
submitted a study from 1998 with CBI indicating that HHCB has a half-
life of less than 1 year, but this study does not provide sufficient 
clarity to negate the 60-day window. Similarly, there is not sufficient 
evidence to support that the half-life of HHCB in river sediments is 
affected by concentration. Some researchers have published data 
depicting that the half-life may be impacted by sediment dwelling 
organisms (Refs. 24 and 25) as well sediment conditions (Ref. 26). 
However, more information is needed to understand how concentration 
might impact the half-life of HHCB in sediments. Regarding the data on 
environmental concentrations and treatment, these are not factors 
considered under the PBT criteria established for the TRI program 
(Refs. 7 and 27)). According to the commenter's reference 7 (Ref. 21) 
the European Union (EU) used a half-life of 79 days for sediment:

    Final conclusion for HHCB's fate in sediment: A limited 
documented study is present showing a DT50 of 79-days in a lab study 
at 22 [deg]C but this is considered too high due to too high 
concentrations used (10 mg/kg soil). In addition, aquatic and soil 
studies indicate DT50s between 4 and 35-days and therefore this DT50 
of 79-days is considered too conservative. In view of the too high 
concentration which will have limited the biodegradation and too 
high temperature which will have enhanced the biodegradation, the 
result of 79-days will be used for the risk assessment, without 
temperature correction: In conclusion:--The DT50 of 79 days at 12 
[deg]C will be used for the risk assessment. (Ref. 21)

    EPA's 2014 risk assessment (Ref. 19) concluded the following 
regarding HHCB persistence in soil and sediment:

    Observed soil and sediment half-lives consistently exceeded 60 
days (Table 2-6). Field measurements on biosolids-amended soil 
indicated that HHCB disappeared almost completely from soil within 
one year. The half-life based on unfrozen conditions in

[[Page 73479]]

biosolids-amended soil studies was around 140 to 144 days 
(DiFrancesco et al., 2004). The residues in soil after one year 
ranged from below 10 to 14 percent of the initial concentrations. In 
the EU RAR (EC, 2008), a half-life of 105 days in the biosolids-
amended soil was deemed most relevant for modeling the fate of HHCB 
in soil using the European Union System for the Evaluation of 
Substances (EUSES) model, while 79 days was noted for the sediment 
(Envirogen, 1998; as cited in EC, 2008). EPA/OPPT agrees that these 
values are reasonable for modeling and assessment purposes. (Ref. 
19, page 29)

    EPA cited the same data in its assessment for listing under EPCRA 
section 313. These data exceed the persistence criteria of half-lives 
in soil or sediment of 60 days or longer under the PBT criteria 
established for the TRI program. Regarding biodegradation in sludge, in 
a wastewater environment, HHCB is expected to partition strongly to 
solid phases based on its high measured log KOW (octanol-
water partition coefficient) of 5.9 (see Rimkus, 1999 for a summary of 
values for musks (Ref. 28)) and the soil/sediment organic carbon 
partition coefficient (log Koc = 3.6-3.9; Ref. 29) which is supported 
by the estimated log KOC of 4.1-4.3 (KOCWINTM 
program v2.00; in EPI SuiteTM v4.11, (Ref. 30)). In 
addition, Schaefer & Koper (2009) (Ref. 31) extrapolated an average Log 
Kow of 7.1 conferring more evidence for partitioning to solid phases. 
Values for both Kd (sorption coefficient) and KOC 
(organic carbon-normalized sorption coefficient) are generally in the 
range of 3 to 4 on a logarithmic scale. This means that HHCB will be 
substantially removed by sorption to sludge in WWTPs; will have low 
mobility in soil; and will bind strongly to benthic and suspended 
sediment. In addition to this knowledge, the Office of Water has 
documented the presence of HHCB in sludge via the National Sewage 
Sludge Survey in 2005, 2007, 2009, and 2011 (Ref. 32).
    The half-life of HHCB in activated sludge at concentrations of 5, 
17.4, 25, 25 micrograms per liter ([mu]g/L) has been reported as 69, 
10-15, 21, 33 hours, respectively (Refs. 33, 34 and 35--33). HHCB 
disappearance with subsequent appearance of more polar entities was 
observed (Ref. 35). The geometric mean from these studies for activated 
sludge half-disappearance time was 22.5 hours. This corresponds to 
``moderate-to-slow'' biodegradation in activated sludge; see guidance 
in the Estimation Programs Interface (EPI) Suite v4.11 (Ref. 30). 
Overall complete biodegradation rates have been reported as 15.39% 
 8.29% and a steady state average biodegradation of 12.74% 
 8.29% (Ref. 31); these rates also confer ``moderate-to-
slow'' biodegradation rates.
    Chen et al. (2014) (Ref. 36) evaluated the dissipation rate of HHCB 
among other personal care products in soils amended with biosolids 
(concentration = 2950 micrograms per kilogram ([micro]g/kg)) after a 
single application and a repeated annual application at three different 
sites. The dissipation half-life was found to be 900 days for the 
single treatment and 83 days for an annual treatment. Yager et al. 
(2014) (Ref. 37) reported that HHCB had migrated down in soil profile 
and was still detectable 468 days after being amended with biosolids. 
Poulsen and Bester (2010) (Ref. 38) reported a shorter half-life 
(t1/2 = 20 days) when HHCB was present at lower 
concentrations (1000 [micro]g/kg) but in a high temperature compost 
environment with regular turning. As the commentor also notes: ``[. . . 
several studies found half-lives of HHCB in soils amended with 
biosolids (sewage sludge) ranging from 105 days to 144 days . . .].''
    These results indicate that the half-life of HHCB in soil amended 
with biosolids or sludge is substantial and demonstrate the substance 
is persistent under these conditions.
    The Fragrance Science & Advocacy Council (Ref. 11) also questioned 
the persistence data for HHCB and provided studies and references for 
EPA to consider.
    Regarding the range of values identified for persistence in soils, 
EPA utilizes conservative values to account for a range of possible 
soil types and land management practices. As the commentor notes: FSAC 
has calculated half-lives from this study ranging 35-116 days depending 
on treatment and soil type, further supporting the USGS study.
    Because the upper range of these half-lives exceeds the 60-day 
window, HHCB would still be considered persistent in this compartment. 
The commentors also note that the concentrations cited by EPA are too 
high and unrealistic pointing to a technical report submitted to EPA as 
CBI. Though the concentrations in the technical report are lower than 
those cited by EPA, the conclusions of that study do not negate that 
HHCB can persist in soils and biosolids amended soils for >60 days. The 
major conclusion of the report indicates that ``. . . HHCB has a half-
life in soils and sediments significantly less than one year.'' This 
conclusion was determined by evaluating HHCB concentration in amended 
soils in microcosms after 365 days and does not provide any precision 
on the half-life of HHCB in a variety of soil conditions. Thus, the 
study does not refute the concentrations cited by EPA.
    Regarding the review of studies presented in commenter's Appendix 2 
of their comments, these studies are currently subject to OPPT's 
Systematic Review Protocol. The studies and their assigned Health and 
Environmental Research Online Identification numbers (HEROIDs) 
included: Litz et al. 2007: 100883141 (Ref. 39), DiFrancesco et al. 
2004: 76939752 (Ref. 23), Yager et al. 2014: 23460273 (Ref. 37), Chen 
et al. 2014a: 54285094 (Ref. 40), Chen et al. 2014b: 54284935 (Ref. 
36), and Yang & Metcalfe 2006: 54278926 (Ref. 41). Worth noting is that 
many of the values reported in these studies are considered high 
quality according to the commenter and these values also exceed the 60-
day half-life criteria. EPA also notes that the DiFrancesco et al. 
study (Ref. 23) was cited in EPA's ecological hazard assessment for 
HHCB (Ref. 42).
    EPA has concluded that none of the data provide by the commenters 
change EPA's determination that HHCB meets the persistence criteria 
established for evaluations under EPCRA section 313 (Refs. 7 and 27).

F. Comments on HHCB Not Meeting the Bioaccumulation Criteria 
Established for EPCRA Section 313 for PBT Classification

    Comment: The Fragrance Creators Association and American Cleaning 
Institute (Ref. 10) stated that the proposed rule did not provide the 
complete story regarding the potential for HHCB to bioaccumulation. The 
commenters noted that in EPA's 2014 risk assessment (Ref. 19), EPA 
reported BCF and BAF data for several aquatic species that varied but 
were generally lower than the 1,000 bioaccumulation criteria. The 
commenters noted that EPA's assessment suggests that HHCB does not 
biomagnify. The commenters also stated that EPA's assessment notes that 
metabolism may account for the observation that measured BCFs and BAFs 
are lower than would be estimated based on the log KOW of 
HHCB. The commenters cited data indicating that HHCB is metabolized and 
excreted without significant bioaccumulation. The commenters stated 
that as a result of this metabolism BCFs estimated using the EPA 
EPISuite model may not be accurate. The commenters cited EPA's 2014 
risk assessment as evidence that EPA relied more on the available BAF 
values:

    HHCB is considered to be of low to moderate concern for 
bioaccumulation. BCF values of 1,584 for bluegills and 2,692 for 
Lumbriculus indicate moderate bioaccumulation potential. However, 
BAF

[[Page 73480]]

values are available for several aquatic organisms are in the range 
of 20 to 620, indicating low bioaccumulation. These studies, 
together with results of aquatic food-chain modeling (Arnot- Gobas 
model) and monitoring data for biota, suggest that HHCB is not 
subject to biomagnification.

    EPA Response: The commenters provided no information or evidence 
that the BCF values greater than 1,000 reported in EPA's HHCB 
assessment (Ref. 42) are invalid. These reported values suggest 
significant bioaccumulation potential for at least some species and 
come from solid peer-reviewed studies (BCF: 2692, Artola-Garciano et 
al., 2003 (Ref. 43) and BCF: 1584, Balk & Ford, 1999b (Ref. 26)). Note: 
Both of these studies are cited in the OPPT 2014 risk assessment for 
HHCB (Ref. 19). HHCB meets the bioaccumulation criteria established for 
the TRI program (Refs. 7 and 27). In addition to studies reported in 
the 2014 Risk Evaluation (Ref. 19), numerous articles have been 
published by the science community demonstrating a substantially wider 
range of bioaccumulation values. Yao et al. 2018 (Ref. 44) reported 
bioaccumulation factors ranging from 52.5 to 46,773.5 for fish species 
exposed to 0-133 nanograms per liter (ng/L) of HHCB. Similarly, Reiner 
and Kannan (2011) (Ref. 45) reported BAF values for fish livers ranging 
from 261 to 2,897 when exposed to two different concentrations of HHCB 
in water and sediment. The upper range of these bioaccumulation factors 
further support that HHCB meets the bioaccumulation criteria.
    As EPA has previously stated, in the October 29, 1999 Federal 
Register Notice biomagnification is not required to have a concern for 
biomagnification. (64 FR 58682-58683, October 29, 1999) (Ref. 7)
    Comment: The Fragrance Science & Advocacy Council (Ref. 11) also 
questioned the bioaccumulation and biomagnification data for HHCB and 
provided studies and references for EPA to consider. The commenter 
contends that HHCB has low to moderate bioaccumulation potential, and 
low biomagnification potential. The commenter provided a report that 
they said they had submitted to EPA on behalf of the IFF as a member of 
the International Fragrance Association, entitled, ``Report on 
Bioaccumulation and Tropic Magnification Potential in the Aquatic 
Environment of 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8- 
hexamethylcyclopenta[g]-2-benzopyran (HHCB).'' The commenter stated 
that the report contains information on the bioaccumulation and 
biomagnification potential of HHCB.
    EPA Response: EPA has received the report submitted by IFF and 
assigned it the HEROID 10365931 (Ref. 46). The report included 
bioaccumulation values above the 1,000 criteria. For example, there is 
a BCF value of ~1,550 for Rainbow Trout in Appendix III. In addition to 
the IFF report provided by the commenter, IFF has submitted another 
study (Accumulation and Elimination of 14C-HHCB by Blue Gill Sunfish in 
a Dynamic Flow-Through System, OECD 305E, 1996 (Ref. 47)) indicating a 
BCF of 1,635 for whole fish exposed to 1 [micro]g/L and a BCF of 1,613 
for whole fish exposed to 10 [micro]g/L (mean: 1,624  16). 
Because the studies cited in the two reports provide bioaccumulation 
values >1,000, they further support EPA's conclusion that HHCB meets 
the bioaccumulation criteria established for the TRI program (Refs. 7 
and 27)).
    The biomagnification information/comments do not impact the 
conclusion regarding PBT status since the BCFs exceed the 
bioaccumulation criteria for TRI and as noted above, biomagnification 
is not part of the PBT criteria established for evaluations under EPCRA 
section 313 (Refs. 7 and 27).

G. Comments on HHCB Not Being Particularly Toxic

    Comment: The Fragrance Creators Association and American Cleaning 
Institute (Ref. 10) stated that HHCB is not particularly toxic and 
``does not exhibit any specific toxic mode of action that contributes 
to excess ecotoxicity.'' The commenters also stated that ``Moreover, 
HHCB is typically not found in the aquatic environment above the 
detection limit (0.04 [mu]g/L), and when it is detected, it is 
generally less than 1 ug/L,\11\ well below the EPA chronic 
concentration of concern (COC) of 9.7 ug/L established in the 2014 risk 
assessment.''
    EPA Response: EPA does not limit its ecological toxicity criterion 
to a specific mode of action. For TRI listing purposes, chemicals with 
acute aquatic toxicity values at or below 1 milligram per liter (mg/L) 
are considered highly toxic. As discussed in EPA hazard assessment for 
HHCB, there are numerous acute aquatic toxicity values below 1 mg/L, 
which show that HHCB is highly toxic to aquatic organisms (Ref. 42). 
There are also chronic aquatic toxicity values below 0.1 mg/L which EPA 
also considers highly toxic (Ref. 42). In addition, the studies 
submitted to EPA following the 2014 risk assessment support this 
determination. There are no separate toxicity criteria for PBT 
chemicals. Regarding the presence of HHCB in aquatic environments, EPA 
does not consider potential exposures or environmental concentrations 
for chemicals that are highly toxic to aquatic organisms when 
determining if they meet the EPCRA section 313(d)(2)(C) listing 
criteria. EPA has explained in detail how it evaluates chemicals under 
the EPCRA section 313(d)(2) criteria (see 59 FR 61432, November 30, 
1994 (FRL-4922-2) (Ref. 2)).

H. Comments on Chemicals EPA Declined To List

    Comment: The commenters CleanEarth4Kids.org (Ref. 13), Earthjustice 
(on behalf of Sierra Club, Toxic-Free Future, and Defend Our Health) 
(Ref. 14), Silent Spring Institute (Ref. 15), and TURI (Ref. 17) 
contend that up to eight of the chemicals that EPA determined do not 
meet the EPCRA section 313(d)(2) listing criteria actually have data 
that support their listing. The chemicals in question include 
azodicarbonamide (123-77-3), 4-chlorobenzotrichloride (5216-25-1), 
dimethylacetamide (127-19-5), 2,3-dinitrotoluene (602-01-7), 2,5-
dinitrotoluene (619-15-8), hexahydrophthalic anhydride (85-42-7), 
methylhexahydrophthalic anhydride (25550-51-0), and N-methylformamide 
(123-39-7).
    EPA Response: EPA has addressed the specific comments on the 
toxicity of these chemicals in the RTC document (Ref. 18), some of the 
more general comments are summarized and responded to here.

I. Comments on Chemicals Found on Lists Prepared by the European Union 
(EU)

    Comment: CleanEarth4Kids.org (Ref. 13) cited information on seven 
of the chemicals that included the listing of the chemicals on various 
lists prepared by the EU and/or classifications on such lists.
    EPA Response: The commenter did not provide specific studies for 
EPA to consider but rather cited most of the same organizational 
determinations cited in the TURI petition as evidence that these 
chemicals met the EPCRA section 313(d)(2) listing criteria which EPA 
has already considered.
    The fact that an organization has placed a chemical on a list (such 
as the European Commission: Candidate List of Substances of Very High 
Concern for Authorization) or made some determination as to its 
toxicity under their regulations or criteria does not necessarily mean 
that the chemical meets the EPCRA section 313(d)(2) listing criteria. 
Classifications such as

[[Page 73481]]

``Presumed Human Reproductive Toxicant'' are made under the criteria of 
another regulatory program and do not necessarily mean that there are 
data sufficient to establish that a chemical meets the EPRCA section 
313(d)(2) criteria. As discussed in the RTC document, to the extent 
possible, EPA has reviewed the available data for such classifications 
and did not find sufficient information to support listing any 
additional chemicals. Some of these lists cite concerns for skin, eye 
and respiratory dangers which may indicate a concern for acute human 
health effects. For a chemical to be listed under EPCRA section 
313(d)(2)(A) based on its acute human health effects, EPA would need to 
determine that the chemical ``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.''

K. Comments on Misinterpreted or Inadequate Data

    Comment: Earthjustice (Ref. 14) stated that EPA misinterpreted or 
ignored relevant health effects information, unlawfully concluded that 
there is inadequate evidence to support listing a chemical because of a 
lack of chronic animal toxicity studies and did not follow Congress's 
direction that EPA must also base its listing decisions on 
``appropriately designed and conducted epidemiological or other 
population studies,'' ``laboratory tests'' and other analyses based on 
``generally accepted scientific principles.'' The commenter stated that 
EPA cannot lawfully determine that inadequate evidence exists to 
support listing without rationally analyzing all of these sources for 
chemicals under review, including available case studies and analogue 
data, and utilizing read-across methodologies. The commenter stated 
that EPA failed to provide an adequate explanation of its proposed 
decision to deny part of the TURI Petition, as EPCRA requires. The 
commenter stated that the proposed rule includes only the conclusory 
assertion that ``EPA has determined that the available data for nine 
chemicals'' addressed in the TURI Petition ``are not sufficient for EPA 
to find that the chemicals meet the EPCRA section 313 listing criteria 
for human health or ecological effects.'' The commenter stated that the 
references cited in support of EPA's conclusions are technical 
summaries of the human and ecological toxicity studies reviewed by EPA 
staff, but that neither the memos nor the proposed rule explain why the 
evidence for each chemical is inadequate to establish that the chemical 
``is known to cause or can reasonably be anticipated to cause'' chronic 
adverse health effects in humans or significant adverse effects on the 
environment.
    EPA Response: EPA disagrees with the commenters assertions that EPA 
did not conduct an appropriate review of the toxicity for those 
chemicals that EPA did not propose to list or explain why the data were 
insufficient to support any of the EPCRA section 313(d)(2) criteria. 
Section 313(d)(2) of EPCRA provides that a chemical may be added [to 
the TRI] if the Administrator determines, in his judgment, that there 
is sufficient evidence to establish that the chemical is know to cause 
or can reasonably be anticipated to cause significant adverse acute 
human health effects or reasonably anticipated to cause adverse effects 
such as cancer, reproductive effects, neurological disorders, mutagenic 
effects, and other chronic illnesses EPA included memos (Refs. 5 and 6) 
in the docket for this rulemaking that addressed these chemicals and 
provided a summary of the available relevant toxicity data and a 
conclusion that such data were not sufficient to support listing the 
chemical under any of the EPCRA section 313(d)(2) criteria. In 
responding to the TURI petition, EPA conducted a thorough literature 
search for data relevant to the chemicals named in the petition and the 
criteria described in EPCRA section 313(d)(2).
    In preparing its hazard assessment, EPA conducts a broad review of 
available data and determines which studies should be included in the 
assessment. For example, when reviewing the available toxicity data, 
EPA does not include in its hazard assessment studies that do not 
provide sufficient information to determine whether a chemical causes a 
toxic effect that meets the EPCRA section 313(d)(2) criteria. For 
example, occupational studies and case reports often do not provide 
sufficient data to determine the doses causing adverse effects, or 
whether other factors contributed to the observed effects. If 
available, epidemiological or other population studies can be 
considered, but often they may not contain sufficient information to 
determine whether a chemical meets the listing criteria.
    In addition, for EPA to be able to rely on a given study, EPA must 
be able to determine whether the toxic effects observed in are acute or 
chronic health effects, as this distinction has a significant impact on 
the information required to support the addition of a chemical to the 
TRI. The EPCRA section 313(d)(2)(A) listing criteria for acute human 
health effects contains a requirement that potential exposures must be 
considered.
    In order to list under the acute human health effects criteria, EPA 
must determine that the effects are significant adverse acute human 
health effects, the concentration levels that would be of concern, and 
releases are reasonably likely to exist beyond facility site boundaries 
that would result in concentration levels of concern. If it is unclear 
from the available data whether the observed effects are acute or 
chronic (e.g., epidemiological or occupational studies that lack 
sufficient details), then EPA may not be able to use the data to 
support listing.
    EPCRA section 313(d) provides that the Administrator may add a 
chemical to the subsection (c) list at any time if the Administrator 
determines, in their judgment, that there is sufficient evidence to 
establish the criteria in EPCRA section 313(d)(2)(A), (B), or (C). The 
statute thus gives the Administrator discretion to determine what 
constitutes sufficient evidence to demonstrate these criteria have been 
met. It further states that such determinations shall be based on 
``generally accepted scientific principles or laboratory tests, or 
appropriately designed and conducted epidemiological or other 
population studies available to the Administrator'' (emphasis added). 
The use of the word ``or'' in section 313(d)(2) establishes that a 
determination could be made on just one of the identified types of 
data/information. Moreover, the fact that a study on a particular 
chemical exists, does not mean that it contains information relevant to 
a listing determination. To list a chemical under the criteria of EPCRA 
section 313(d)(2)(A) or (B) for human health effects the statutory 
language requires that EPA be able to support a conclusion that ``The 
chemical is known to cause or can reasonably be anticipated to cause in 
humans'' significant adverse acute human health effects or at least one 
of the listed chronic human health effects. The Agency must determine 
which studies and data are relevant and evaluate their scientific 
merits. If EPA determines that a given study does not include 
sufficient information, for example on whether the effects considered 
are chronic or acute, the doses causing the effects, the severity of 
the effects or whether other chemicals were also present, it may 
determine that further evaluation of the study is not warranted.
    EPCRA section 313(e), in turn, governs the scope of the Agency's

[[Page 73482]]

obligation to respond to petitions to add or delete a chemical from the 
TRI. Specifically, it provides that the Administrator shall take one of 
the following actions in response to a petition to add or delete a 
chemical from the list: (A) Initiate a rulemaking to add or delete the 
chemical to the list, in accordance with subsection (d)(2) or (d)(3); 
or (B) Publish an explanation of why the petition is denied.
    EPA stated in the proposed rule that the available data for the 
chemicals not being listed was not sufficient for EPA to find that the 
chemicals met the EPCRA section 313 listing criteria for human health 
or ecological effects. It further stated that it was therefore not 
proposing to add those chemicals to the TRI. EPA also added two memos 
(Refs. 5 and 6) to the docket providing additional information 
regarding its review of the chemicals identified in the TURI petition 
that EPA was not proposing to add to the TRI. Those memos supported 
EPA's decision not to propose adding 9 of the chemicals to the TRI. 
Further support and rationale for EPA's decision is provided the RTC 
document (Ref. 18).
    It is important to note that the petitioner requested the addition 
of 6 chemicals based on the EPCRA section 313(d)(2)(C) criteria. 
However, the explicit language of EPCRA section 313(e)(1) only allows 
any person to ``petition the Administrator to add or delete a chemical 
from [the TRI] on the basis of the criteria in subparagraph (A) or (B) 
of subsection (d)(2).'' In other words, it allows any person to request 
that a chemical be added or deleted from the TRI list only on the basis 
of the human health criteria in EPCRA section 313(d)(2)(A) and (B). 
EPCRA does not provide an avenue for petitions to add chemicals to TRI 
based on the criteria in subsection (d)(2)(C). The petitioners' request 
to add certain chemicals to the TRI list based on them meeting the 
criteria in paragraph (d)(2)(C) was an impermissible request. 
Nevertheless, to thoroughly assess the overall merits of listing these 
chemicals, EPA conducted an analysis of the available toxicity data and 
proposed to add four of the chemicals to the TRI. EPA determined that 
it was not appropriate to propose adding the other two of these 
chemicals cyclododecane and 2,3-dinitrotoluene to the TRI.
    EPA has reviewed the information provided by the commenters with 
regard to the five specific chemicals for which commenters assert EPA 
ignored evidence regarding chronic human health effects that would 
justify their addition to TRI and with regard to the three chemicals 
for which commenters assert EPA ignored evidence of mutagenic effects. 
As discussed in detail in the RTC document (Ref. 18), EPA concludes 
that based on currently available data none of the eight chemicals 
addressed by the commenter meet the EPCRA section 313(d)(2) listing 
criteria.

L. Comments on Other Factors To Consider for Listing Decisions

    In addition to Earthjustice (Ref. 14), TURI (Ref. 17) suggested 
that other factors or criteria may be useful and appropriate to 
consider for listing decisions. The commenter suggested that while 
toxicity data are lacking for certain chemicals, substantial 
information can be gained by considering analogs and that using read-
across data may be an appropriate approach in these cases. The 
commenter stated that in addition, it essential to take account of 
information available from case reports, epidemiological studies, and 
mechanistic data, even when chronic animal studies are unavailable.
    EPA Response: EPA agrees that using analogs and read-across data 
can be useful but in order to do that information about what structural 
features are important to the toxicity need to be understood. Just 
because two chemicals have similar structures does not always mean they 
will have similar toxic endpoints at similar doses. EPA also agrees 
that case reports, epidemiological studies, and mechanistic data can 
provide useful information about potential toxicity, however, under the 
EPCRA section 313(d)(2)(B) listing criteria that data must be 
sufficient to conclude that ``The chemical is known to cause or can 
reasonably be anticipated to cause in humans'' chronic human health 
effects. In addition, as EPA has previously explained and cited in the 
proposed rule (Ref. 2), in making determinations under EPCRA section 
313(d)(2) EPA considers the severity of the effects and the dose/
concentration at which the effects occur. Case reports, epidemiological 
studies, and mechanistic data don't always provide sufficient 
information to reach a conclusion about a chemical's acute or chronic 
human health effects.

M. Comments on EPA's Economic Analysis

    The commenters Household & Commercial Products Association (Ref. 
12); Fragrance Creators Association and American Cleaning Institute 
(Ref. 10); and U.S. Small Business Administration Office of Advocacy 
(Ref. 16) provided comments on EPA's economic analysis for the proposed 
rule. The commenters suggested that EPA's economic analysis for the 
proposed rule underestimated the impacts that would result from 
lowering the reporting threshold for HHCB. These commenters requested 
that EPA revise its economic analysis based on more recent data 
including the 2020 Chemical Data Reporting (CDR) rule (Ref. 48), the 
Final Lists of Manufacturers Subject to Fees for the 20 High Priority 
Substances Undergoing TSCA Risk Evaluations (Ref. 49) and the Site 
Emission Survey of Fragrance Formulation Compounders and Product 
Manufacturers Using HHCB Information to Support the TSCA Risk 
Evaluation (Ref. 50).
    EPA Response: When developing the economic analysis for this final 
rule (Ref. 3), EPA reviewed currently available data on HHCB 
manufacture and import, including the sources identified by the 
commenters, to determine if and how to update the economic analysis to 
provide the best estimates of reporters and reporting burden for HHCB. 
Specifically, EPA reviewed the 2020 CDR data (Ref. 48), the Final Lists 
of Manufacturers Subject to Fees for the 20 High Priority Substances 
Undergoing TSCA Risk Evaluations (Ref. 49) and the Site Emission Survey 
of Fragrance Formulation Compounders and Product Manufacturers Using 
HHCB Information to Support the TSCA Risk Evaluation (Ref. 50). In 
addition, EPA updated wage rates to 2021 dollars to better estimate 
costs of reporting.
    With respect to the CDR data, EPA did not find that the data were 
significantly different from the previous 2016 CDR data to warrant any 
update as the impact on the estimates made by EPA would be 
inconsequential. Overall production of HHCB remained the same and most 
of the importers (no companies reported domestic production of HHCB 
under either the 2016 or 2020 CDR reporting) remained the same. In 
fact, fewer importers reported to CDR in 2020 than did in 2016. 
Similarly, numbers of downstream processers and users, which form the 
basis for EPA's estimates of numbers of reporters and reports for the 
final rule, were largely the same although the identity of some 
importers differed.
    EPA also reviewed information from the final list of HHCB 
manufacturers (including importers) responsible for payment of fees 
under TSCA and included additional HHCB facilities in its estimates of 
facilities that would report under this final rule as a result. This 
resulted in six additional reporters because the companies had either 
been

[[Page 73483]]

previously identified by the economic analysis for the proposed rule 
(Ref. 51) or are operating in NAICS codes that are not subject to TRI 
reporting.
    Finally, EPA also reviewed the Site Emission Survey of Fragrance 
Formulation Compounders and Product Manufacturers Using HHCB 
Information to Support the TSCA Risk Evaluation prepared for the 
Fragrance Creators' Association. As the commenter notes, one of the 
respondents to the survey indicated that downstream processors and 
users was in excess of 500. EPA did not find that the results of the 
survey itself were useful in estimating exact numbers of downstream 
users and formulators. Many respondents failed to provide an estimate 
of downstream users and processors, and it is not possible to determine 
if the respondents also reported under CDR, which is the main data 
source for the economic analysis. However, EPA did interpret the data 
as indicative of more potential reporters of HHCB than estimated in the 
economic analysis for the proposed rule and made adjustments in the 
economic analysis for the final rule to increase the estimated number 
of reporters of HHCB from 237 facilities to 1,072 (Ref. 3).

IV. Summary of the Final Rule

    EPA is finalizing the addition of 12 chemicals to the EPCRA section 
313 list of toxic chemicals. Based on EPA's review of the available 
toxicity data, EPA has determined that the 12 chemicals can reasonably 
be anticipated to cause either adverse chronic human health effects at 
moderately low to low doses and/or environmental effects at low 
concentrations. EPA has determined that the data show that these 12 
chemicals have moderately high to high human health toxicity and/or are 
highly toxic to aquatic organisms. Therefore, EPA has determined that 
the evidence is sufficient for listing the 12 chemicals on the EPCRA 
section 313 toxic chemicals list pursuant to EPCRA section 313(d)(2)(B) 
and/or (C). The 12 chemicals EPA is adding to the EPCRA section 313 
chemical list are listed here by name and CASRN.

 Dibutyltin dichloride; 683-18-1;
 1,3-Dichloro-2-propanol; 96-23-1;
 Formamide; 75-12-7;
 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2-
benzopyran; 1222-05-5;
 N-Hydroxyethylethylenediamine; 111-41-1;
 Nitrilotriacetic acid trisodium salt; 5064-31-3;
 p-(1,1,3,3-Tetramethylbutyl)phenol; 140-66-9;
 1,2,3-Trichlorobenzene; 87-61-6;
 Triglycidyl isocyanurate; 2451-62-9;
 Tris(2-chloroethyl) phosphate; 115-96-8;
 Tris(1,3-dichloro-2-propyl) phosphate; 13674-87-8; and
 Tris(dimethylphenol) phosphate; 25155-23-1.

    In addition, EPA has determined that the available bioaccumulation 
and persistence data for HHCB support a classification of HHCB as a PBT 
chemical. Therefore, consistent with EPA's established policy for PBT 
chemicals (see Ref. 7), EPA is establishing a 100-pound reporting 
threshold for HHCB and including it under 40 CFR 372.28 Lower 
thresholds for chemicals of special concern.

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. Petition from the Massachusetts Toxics Use Reduction Institute 
(TURI), University of Massachusetts Lowell, 600 Suffolk St., Suite 
501, Lowell, MA 01854, May 6, 2014.
2. UESPA. Addition of Certain Chemicals; Toxic Chemical Release 
Reporting; Community Right-to-Know. Federal Register. 59 FR 61432, 
November 30, 1994 (FRL-4922-2).
3.USEPA. 2022. Economic Analysis Addendum for the Final Rule to Add 
Twelve Chemicals Identified in a Petition from the Toxics Use 
Reduction Institute to the EPCRA Section 313 List of Toxic 
Chemicals. August 19.
4. USEPA. Addition of Certain Chemicals; Community Right-to-Know 
Toxic Chemical Release Reporting. Federal Register. 86 FR 57614, 
October 18, 2021 (FRL-5927-03-OCSPP).
5. USEPA, OPPT. Memorandum from Jocelyn Hospital, Toxicologist, 
Regulatory Development Branch to David Turk, Chief, Regulatory 
Development Branch. Subject: Review of Toxics Use Reduction 
Institute (TURI) Petition Chemicals. December 8, 2016.
6. USEPA, OPPT. Memorandum from Kara Koehrn and Thomas Forbes, 
Regulatory Development Branch, to David Turk, Chief, Regulatory 
Development Branch. Subject: Review of Toxics Use Reduction 
Institute (TURI) Petition Chemicals. February 16, 2017.
7. UESPA. Persistent Bioaccumulative Toxic (PBT) Chemicals; Lowering 
of Reporting Thresholds for Certain PBT Chemicals; Addition of 
Certain PBT Chemicals; Community Right-to-Know Toxic Chemical 
Reporting. Federal Register. 64 FR 58666, October 29, 1999 (FRL-
6389-11).
8. American Chemistry Council. Comments on Proposed Rule: Addition 
of Certain Chemicals; Community Right-to-Know Toxic Chemical Release 
Reporting (Docket ID EPA-HQ-TRI-2017-0434). December 17, 2021.
9. Alkylphenols & Ethoxylates Research Council. Comments on US EPA 
Proposed Rule for Addition of Certain Chemicals To Community Right-
to-Know Toxic Chemical Release Reporting List under Section 313 of 
the Emergency Planning and Community Right-to-Know Act Submitted to 
Docket ID No. EP-HQ-TRI-2017-0434. December 17, 2021.
10. Fragrance Creators Association and the American Cleaning 
Institute. Comments on the Proposed Addition of HHCB to the Toxics 
Release Inventory, EPA-HQ-TRI-2017-0434. December 17, 2021.
11. Fragrance Science & Advocacy Council. Comments on the 
classification of 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-
hexamethylcyclopenta[g]-2-benzopyran (HHCB) as a persistent, 
bioaccumulative, and toxic (PBT) chemical and as a chemical of 
special concern. December 17, 2021.
12. Household & Commercial Products Association. Comments on the 
Designation of HHCB as a Chemical of Special Concern as part of 
Addition of Certain Chemicals; Community Right-to-Know Toxic 
Chemical Release Reporting (EPA-HQ-TRI-2017-0434). December 17, 
2021.
13. CleanEarth4Kids.org. Comments on EPA Toxics Release Inventory 
Program. December 16, 2021.
14. Earthjustice on behalf of the Sierra Club, Toxic-Free Future, 
and Defend Our Health. Comments on Proposed Rule, Addition of 
Certain Chemicals; Community Right-to-Know Toxic Chemical Release 
Reporting, 86, Fed. Reg 57,614 (Oct 18, 2021), EPA-HQ-TRI-2017-0434. 
December 17, 2021.
15. Silent Spring Institute. Comments on the Community Right-to-Know 
Toxic Chemical Release Reporting: Addition of Certain Chemicals as 
Proposed by the EPA on October 18th, 2021. December 15, 2021.
16. U.S. Small Business Administration, Office of Advocacy. Comments 
on Addition of Certain Chemicals; Community Right-to-Know Toxic 
Chemical Release Reporting (Docket ID No. EPA-HQ-TRI-2017-0434). 
December 17, 2021.
17. Massachusetts Toxics Use Reduction Institute. Comments in 
response to EPA's proposed rule to add 12 of the 25 chemicals that 
TURI earlier petitioned the EPA to add to EPCRA section 313. 
University of Massachusetts Lowell. The Offices at Boott Mills West 
126 John Street, Suite 14, Lowell, MA 01852. December 17, 2021.
18. USEPA, OPPT. 2022. Response to Comments Received on the October 
18, 2021, Proposed Rule (86 FR 57614): Addition of Certain 
Chemicals;

[[Page 73484]]

Community Right-to-Know Toxic Chemical Release Reporting (i.e., 
EPA's Response to the Toxics Use Reduction Institute (TURI) 
Petition). November 2022.
19. USEPA. TSCA Work Plan Chemical Risk Assessment, HHCB, 
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta-g-2-
Benzopyran, CASRN: 1222-05-5. 2014.
20. Envirogen. 1998. Fate of HHCB in Soil Microcosms. Envirogen, 
Inc. Princeton Research Centre, report submitted to International 
Flavors and Fragrances, Lawrenceville, NJ (as cited in Ref. 25).
21. European Chemical Agency. 2022. Biodegradation in water and 
sediment: simulation tests. Registration Dossier for 1,3,4,6,7,8-
hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran EC number: 214-
946-9, CAS number: 1222-05-5. Available at: https://echa.europa.eu/registration-dossier/-/registered-dossier/14504/5/3/3.
22. Integral Consulting Inc. Analysis of Monitoring Data for HHCB in 
Sediment of the United States from 2006 to 2019. December 6, 2021. 
Available at: https://www.regulations.gov/comment/EPA-HQ-OPPT-2018-0430-0047.
23. DiFrancesco, A.M., P.C. Chiu, L.J. Standley, H.E. Allen, and 
D.T. Salvito. 2004. Dissipation of Fragrance Materials in Sludge-
Amended Soils. Environmental Science and Technology, 38(1), 194-201.
24. Peng, F.J., Ying, G.G., Pan, C.G., Selck, H., Salvito, D., & Van 
den Brink, P.J. (2018). Bioaccumulation and biotransformation of 
triclosan and galaxolide in the freshwater oligochaete Limnodrilus 
hoffmeisteri in a water/sediment microcosm. Environmental science & 
technology, 52(15), 8390-8398.
25. Peng, F.J., Kiggen, F., Pan, C.G., Bracewell, S.A., Ying, G.G., 
Salvito, D., . . . & Van den Brink, P.J. (2019). Fate and effects of 
sediment-associated polycyclic musk HHCB in subtropical freshwater 
microcosms. Ecotoxicology and Environmental Safety, 169, 902-910.
26. Balk, F; Ford, RA. (1999). Environmental risk assessment for the 
polycyclic musks AHTN and HHCB in the EU: I. Fate and exposure 
assessment. Toxicol Lett 111:57-79.
27. USEPA. Persistent Bioaccumulative Toxic (PBT) Chemicals; 
Lowering of Reporting Thresholds for Certain PBT Chemicals; Addition 
of Certain PBT Chemicals; Amendments to Proposed Addition of a 
Dioxin and Dioxin-Like Compounds Category; Toxic Chemical Release 
Reporting; Community Right-to- Know. Federal Register. 64 FR 688, 
January 5, 1999 (FRL-6032-3).
28. Rimkus, G.G., 1999. Polycyclic Musk Fragrances in the Aquatic 
Environment. Toxicology Letters, 111(1-2), 37-56.
29. European Commission. 2008. European Union Risk Assessment Report 
for 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylcyclopenta-[gamma]-
2-benzopyran (1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylin-
deno[5,6-C]pyran-HHCB), CAS No. 1222-05-5, EINECS No. 214-916-9, 
Risk Assessment, Final Approved Version. Office for Official 
Publications of the European Communities, Luxembourg, The 
Netherlands.
30. USEPA. 2012. EPI Suite results for CAS 1222-05-5, HHCB. EPI 
SuiteTM v4.11. Available online at https://www.epa.gov/tsca-screening-tools/download-epi-suitetm-estimation-program-interface-v411.
31. Schaefer, E. C., and C.M. Koper, 2009. 14C-HHCB: Removal and/or 
Biodegradation of a Semi-Volatile Organic Compound in an Activated 
Sludge Simulation System. Project No. 558E-112. Wildlife 
International, Ltd. Report submitted to the Research Institute for 
Fragrance Materials, Inc.
32. Richman, T., Arnold, E., & Williams, A.J. (2022). Curation of a 
list of chemicals in biosolids from EPA National Sewage Sludge 
Surveys & Biennial Review Reports. Scientific data, 9(1), 1-8.
33. Federle, T.W., N.R. Itrich, D.M. Lee, and D. Langworthy. 2002. 
Recent Advances in the Environmental Fate of Fragrance Ingredients. 
Poster of P&G presented at SETAC 23rd Annual Meeting, Salt Lake 
City, USA (as cited in Ref. 22 EC, 2008).
34. Schaefer, E.C., 2005. 14C-HHCB: Dieaway of a Semi-Volatile 
Organic Compound in River Water. Project No. 558E-109A. Wildlife 
International, Ltd. Report submitted to the Research Institute for 
Fragrance Materials, Inc.
35. Langworthy, D.E., N.R. Itrich, S.L. Simonich, and T.W. Federle. 
2000. Biotransformation of the Polycyclic Musk HHCB in Activated 
Sludge and River Water. Presented at SETAC, May 2000, Brighton, UK 
(as cited in Ref. 22 EC, 2008).
36. Chen, F., Ying, G.G., Ma, Y.B., Chen, Z.F., Lai, H.J., & Peng, 
F.J. 2014. Field dissipation and risk assessment of typical personal 
care products TCC, TCS, AHTN and HHCB in biosolid-amended soils. 
Science of the Total Environment, 470, 1078-1086.
37. Yager, Tracy, J.B.; Edward T. Furlong, Dana W. Kolpin, Chad A. 
Kinney, Steven D. Zaugg, and Mark R. Burkhardt. 2014. Dissipation of 
Contaminants of Emerging Concern in Biosolids Applied to 
Nonirrigated Framland in Eastern Colorado. Journal of the American 
Water Resources Association. Vol. 50, No. 2. April 2014.
38. Poulsen, T.G., & Bester, K. 2010. Organic micropollutant 
degradation in sewage sludge during composting under thermophilic 
conditions. Environmental science & technology, 44(13), 5086-5091.
39. Litz, N.T.; Muller, J.; Bohmer, W. 2007. Occurrence of 
Polycyclic Musks in Sewage Sludge and their Behaviour in Soils and 
Plants Part 2: Investigation of Polycyclic Musks in Soils and 
Plants. J Soils Sediments 7 (1) 36-44.
40. Chen, Feng; Ying, G.G.; Ma, Y.B.; Chen, Z.F.; and Lai, H.J. 
2014. Field Dissipation of Four Personal Care Products in Biosolids-
Amended Soils in North China. Environmental Toxicology and 
Chemistry, Vol. 33, No. 11, pp. 2413-2421.
41. Jian-Jun Yang and Chris D. Metcalfe. 2006. Fate of synthetic 
musks in a domestic wastewater treatment plant and in an 
agricultural field amended with biosolids. Science of the Total 
Environment 363, 149-165.
42. USEPA, OPPT. Ecological Toxicity Review of Chemicals from the 
Toxics Use Reduction Institute (TURI) Petition. Office of Pollution 
Prevention and Toxics, Toxics Release Inventory Program Division, 
Regulatory Developmental Branch. July 18, 2017.
43. Artola-Garicano, E. Sinnige, T. van Holsteijn, I. Vaes, W. 
Hermens, J. (2003). Bioconcentration and acute toxicology of 
polycyclic musks in two benthic organisms (Chironomus riparius and 
Lumbriculus variegatus) Environ Toxicol Chem 22(5):1086-92.
44. Yao, et al., 2018. Personal care products in wild fish in two 
main Chinese rivers: Bioaccumulation potential and human health 
risks. Science of the Total Environment 621, 1093-1102.
45. Reiner, J.L. and Kannan, K. 2011. Polycyclic Musks in Water, 
Sediment, and Fishes from the Upper Hudson River, New York, USA. 
Water Air Soil Pollution, 214:335-342.
46. International Fragrance Association, Environmental Task Force. 
Report on Bioaccumulation and Tropic Magnification Potential in the 
Aquatic Environment of 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8- 
hexamethylcyclopenta[g]-2-benzopyran (HHCB). September 2020.
47. Van Dijk, A. Accumulation and Elimination of 14C-HHCB by Blue 
Gill Sunfish in a Dynamic Flow-Through System, OECD 305E. RCC 
Umweltchemie Ag. Switzerland. RCC Project 381418. March 1996.
48. USEPA. Chemical Data Reporting for 2020. 2022. Available at: 
https://www.epa.gov/chemical-data-reporting/access-cdr-data#2020.
49. USEPA. Final Lists of Manufacturers Subject to Fees for the 20 
High Priority Substances Undergoing TSCA Risk Evaluations. Available 
at: https://www.epa.gov/sites/default/files/2021-06/documents/revised_final_lists_of_manufacturers_-_updated_4-15-2021.pdf.
50. Integral Consulting, Inc., 2021. Site Emission Survey of 
Fragrance Formulation Compounders and Product Manufacturers Using 
HHCB Information to Support the TSCA Risk Evaluation. Prepared for 
the Fragrance Creators Association. https://www.regulations.gov/comment/EPA-HQ-OPPT-2018-0430-0043.
51. USEPA, OPPT. Economic Analysis of the Proposed Rule to Add 
Twelve Chemicals Identified in a Petition from the Toxics Use 
Reduction Institute to the EPCRA Section 313 List of Toxic 
Chemicals. November 7, 2018.

VI. Statutory and Executive Orders Reviews

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

[[Page 73485]]

regulations/laws-and-executive-orders#influence.

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 2070-0212 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 9350-1), or EPA Toxic 
Chemicals Release Inventory Form A (EPA Form 9350-2), as appropriate 
under 40 CFR part 372. OMB has approved the reporting and recordkeeping 
requirements related to Forms A and R, supplier notification, and 
petitions under OMB Control No. 2070-0212 (EPA Information Collection 
Request (ICR) No. 2613), which includes an estimated burden of 35.7 
hours for submitters of Form R and 21.9 hours for submitters of Form A, 
and those related to trade secret designations under OMB Control No. 
2050-0078 (EPA ICR No. 1428), which includes an estimated average 
burden of 9.7 hours per response. EPA estimates that this action would 
result in an additional 1,342 reports being filed annually, and that 
the costs of this action will be approximately $6,660,633 in the first 
year of reporting and approximately $3,172,080 in the subsequent years. 
See Unit I.E. and Ref. 3.
    Under the PRA, 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 
are displayed either by publication in the Federal Register or by other 
appropriate means, such as on the related collection instrument or 
form, if applicable. The display of OMB control numbers for certain EPA 
regulations is consolidated in 40 CFR part 9.

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 businesses (i.e., manufacturing facilities); no 
small governments or small organizations are expected to be affected by 
this action. The Agency has determined that of the 1,322 entities 
estimated to be impacted by this action, 1,283 are small entities. All 
1,283 small entities 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. 3).

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 of UMRA because it contains no regulatory 
requirements that might significantly or uniquely affect small 
governments. EPA did not identify any small governments that would be 
impacted by this action. EPA's economic analysis indicates that the 
total cost of this action is estimated to be $6,660,633 in the first 
year of reporting (Ref. 3).

E. Executive Order 13132: Federalism

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

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) because it will 
not have substantial direct effects on tribal governments, on the 
relationship between the Federal government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
government and Indian tribes. 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 and has not otherwise been designated as a 
significant energy action by the Administrator of the Office of 
Information and Regulatory Affairs.

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards under the 
NTTAA section 12(d), 15 U.S.C. 272.

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

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs 
federal agencies, to the greatest extent practicable and permitted by 
law, to make environmental justice part of their mission by identifying 
and addressing, as appropriate, disproportionately high and adverse 
human health or environmental effects of their programs, policies, and 
activities on minority populations (people of color) and low-income 
populations.
    Though this action does not address human health or environmental 
conditions, it does increase access to information available to the 
public (including to minority and low-income populations) and improves 
transparency of how certain facilities are managing EPCRA section 313 
toxic chemicals. Reporting forms submitted pursuant to TRI reporting 
requirements provide information on releases and other waste management 
activities conducted by the reporting facilities. By requiring

[[Page 73486]]

reporting on these additional chemicals, this action will be providing 
communities across the U.S. (including minority and low-income 
populations) with access to data which they may use to assess potential 
exposure to these additional chemicals and seek to lower exposures and 
consequently reductions in potential chemical risks. This information 
can also be used by government agencies and others to identify 
potential risks, set priorities, and take appropriate steps to reduce 
potential risks to human health and the environment. Therefore, EPA 
believes that this action will have not have a disproportionately high 
and adverse human health or environmental effect on minority 
populations, low-income populations, and indigenous peoples. To the 
contrary, EPA believes that this action will provide utility in the 
assessment of potential impacts on minority populations (people of 
color) and low-income populations.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and 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 22, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 372--TOXIC CHEMICAL RELEASE REPORTING: COMMUNITY RIGHT-TO-
KNOW--[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)(1) by revising the 
column headings and adding, in alphabetical oder, the chemical 
``1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2-
benzopyran'' to read as follows:

Sec.  372.28   Lower thresholds for chemicals of special concern.

    (a) * * *
    (1) * * *

                       Table 1 to Paragraph (a)(1)
------------------------------------------------------------------------
                                                             Reporting
              Chemical name                   CAS No.     threshold  (in
                                                              pounds)
------------------------------------------------------------------------
 
                              * * * * * * *
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-             1222-05-5             100
 hexamethylcyclopenta[g]-2-benzopyran...
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *

0
3. Amend Sec.  372.65 by:
0
a. In paragraph (a), in table 1, adding in alphabetical order entries 
for ``Dibutyltin dichloride,'' ``1,3-Dichloro-2-propanol,'' 
``Formamide,'' ``1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-
hexamethylcyclopenta[g]-2-benzopyran,'' ``N-
Hydroxyethylethylenediamine,'' ``Nitrilotriacetic acid trisodium 
salt,'' ``p-(1,1,3,3-Tetramethylbutyl)phenol,'' ``1,2,3-
Trichlorobenzene,'' ``Triglycidyl isocyanurate,'' ``Tris(2-chloroethyl) 
phosphate,'' ``Tris(1,3-dichloro-2-propyl) phosphate,'' and 
``Tris(dimethylphenol) phosphate''; and
0
b. In paragraph (b), in table 2, adding in numerical order entries for 
``75-12-7,'' ``87-61-6,'' ``96-23-1,'' ``111-41-1,'' ``115-96-8,'' 
``140-66-9,'' ``683-18-1,'' ``1222-05-5,'' ``2451-62-9,'' ``5064-31-
3,'' ``13674-87-8,'' and ``25155-23-1''.
    The additions read as follows:

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

* * * * *
    (a) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
              Chemical name                   CAS No.     Effective date
------------------------------------------------------------------------
 
                              * * * * * * *
Dibutyltin dichloride...................        683-18-1          1/1/23
 
                              * * * * * * *
1,3-Dichloro-2-propanol.................         96-23-1          1/1/23
 
                              * * * * * * *
Formamide...............................         75-12-7          1/1/23
 
                              * * * * * * *
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-             1222-05-5          1/1/23
 hexamethylcyclopenta[g]-2-benzopyran...
 
                              * * * * * * *
N-Hydroxyethylethylenediamine...........        111-41-1          1/1/23
 
                              * * * * * * *
Nitrilotriacetic acid trisodium salt....       5064-31-3          1/1/23

[[Page 73487]]

 
 
                              * * * * * * *
p-(1,1,3,3-Tetramethylbutyl)phenol......        140-66-9          1/1/23
 
                              * * * * * * *
1,2,3-Trichlorobenzene..................         87-61-6          1/1/23
 
                              * * * * * * *
Triglycidyl isocyanurate................       2451-62-9          1/1/23
 
                              * * * * * * *
Tris(2-chloroethyl) phosphate...........        115-96-8          1/1/23
 
                              * * * * * * *
Tris(1,3-dichloro-2-propyl) phosphate...      13674-87-8          1/1/23
 
                              * * * * * * *
Tris(dimethylphenol) phosphate..........      25155-23-1          1/1/23
 
                              * * * * * * *
------------------------------------------------------------------------

    (b) * * *

                        Table 2 to Paragraph (b)
------------------------------------------------------------------------
    CAS No.                   Chemical name               Effective date
------------------------------------------------------------------------
 
                              * * * * * * *
       75-12-7  Formamide...............................          1/1/23
 
                              * * * * * * *
       87-61-6  1,2,3-Trichlorobenzene..................          1/1/23
 
                              * * * * * * *
       96-23-1  1,3-Dichloro-2-propanol.................          1/1/23
 
                              * * * * * * *
      111-41-1  N-Hydroxyethylethylenediamine...........          1/1/23
 
                              * * * * * * *
      115-96-8  Tris(2-chloroethyl) phosphate...........          1/1/23
 
                              * * * * * * *
      140-66-9  p-(1,1,3,3-Tetramethylbutyl)phenol......          1/1/23
 
                              * * * * * * *
      683-18-1  Dibutyltin dichloride...................          1/1/23
 
                              * * * * * * *
     1222-05-5  1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-                1/1/23
                 hexamethylcyclopenta[g]-2-benzopyran...
 
                              * * * * * * *
     2451-62-9  Triglycidyl isocyanurate................          1/1/23
 
                              * * * * * * *
     5064-31-3  Nitrilotriacetic acid trisodium salt....          1/1/23
 
                              * * * * * * *
    13674-87-8  Tris(1,3-dichloro-2-propyl) phosphate...          1/1/23
 
                              * * * * * * *
    25155-23-1  Tris(dimethylphenol) phosphate..........          1/1/23
 
                              * * * * * * *
------------------------------------------------------------------------

[[Page 73488]]

[FR Doc. 2022-25946 Filed 11-29-22; 8:45 a.m.]
BILLING CODE 6560-50-P