100756 Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211, because it is not a 

significant regulatory action under 

Executive Order 12866. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

This rulemaking does not involve 

technical standards. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

The EPA believes the human health or 

environmental risk addressed by this 

action will not have potential 

disproportionately high and adverse 

human health or environmental effects 

on minority, low-income or indigenous 

populations because it does not affect 

the level of protection provided to 

human health or the environment. As 

discussed in section I.C. of the preamble 

to this action, the NPL is a list of 

national priorities. The NPL is intended 

primarily to guide the EPA in 

determining which sites warrant further 

investigation to assess the nature and 

extent of public health and 

environmental risks associated with a 

release of hazardous substances, 

pollutants or contaminants. The NPL is 

of only limited significance as it does 

not assign liability to any party. Also, 

placing a site on the NPL does not mean 

that any remedial or removal action 

necessarily need be taken. 

K. Congressional Review Act 

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). 

Provisions of the Congressional 

Review Act (CRA) or section 305 of 

CERCLA may alter the effective date of 

this regulation. Under 5 U.S.C. 

801(b)(1), a rule shall not take effect, or 

continue in effect, if Congress enacts 

(and the President signs) a joint 

resolution of disapproval, described 

under section 802. Another statutory 

provision that may affect this rule is 

CERCLA section 305, which provides 

for a legislative veto of regulations 

promulgated under CERCLA. Although 

INS v. Chadha, 462 U.S. 919,103 S. Ct. 

2764 (1983), and Bd. of Regents of the 

University of Washington v. EPA, 86 

F.3d 1214,1222 (D.C. Cir. 1996), cast the 

validity of the legislative veto into 

question, the EPA has transmitted a 

copy of this regulation to the Secretary 

of the Senate and the Clerk of the House 

of Representatives. 

If action by Congress under either the 

CRA or CERCLA section 305 calls the 

effective date of this regulation into 

question, the EPA will publish a 

document of clarification in the Federal 

Register. 

List of Subjects in 40 CFR Part 300 

Environmental protection, Air 

pollution control, Chemicals, Hazardous 

substances, Hazardous waste, 

Intergovernmental relations, Natural 

resources, Oil pollution, Penalties, 

Reporting and recordkeeping 

requirements, Superfund, Water 

pollution control, Water supply. 

Barry N. Breen, 

Principal Deputy Assistant Administrator, 

Office of Land and Emergency Management. 

For the reasons set out in the 

preamble, the Environmental Protection 

Agency amends title 40, chapter I, part 

300, of the Code of Federal Regulations 

as follows: 

PART 300—NATIONAL OIL AND 

HAZARDOUS SUBSTANCES 

POLLUTION CONTINGENCY PLAN 

■ 1. The authority citation for part 300 

continues to read as follows: 

Authority: 33 U.S.C. 1251 et seq.; 42 

U.S.C. 9601–9657; E.O. 13626, 77 FR 56749, 

3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 

FR 54757, 3 CFR, 1991 Comp., p. 351; E.O. 

12580, 52 FR 2923, 3 CFR, 1987 Comp., p. 

193. 

■ 2. Amend table 1 of Appendix B to 

part 300 by adding the entry for ‘‘WA, 

Upper Columbia River’’, in alphabetical 

order, to read as follows: 

Appendix B to Part 300—National 

Priorities List 

TABLE 1—GENERAL SUPERFUND SECTION

State Site name City/county Notes a

*******

WA ......................... Upper Columbia River .......................... Upper Columbia River.

*******

aA = Based on issuance of health advisory by Agency for Toxic Substances and Disease Registry (if scored, HRS score need not be greater 

than or equal to 28.50). 

* * * * * 

[FR Doc. 2024–29006 Filed 12–12–24; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 716 

[EPA–HQ–OPPT–2023–0360; FRL–11164– 

02–OCSPP] 

RIN 2070–AL15 

Certain Existing Chemicals; Request 

To Submit Unpublished Health and 

Safety Data Under the Toxic 

Substances Control Act (TSCA) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA or Agency) is finalizing 

the Health and Safety Reporting Rule 

under the Toxic Substance Control Act 

(TSCA) to require manufacturers 

(including importers) of the sixteen 

chemical substances identified in this 

rulemaking to submit copies and lists of 

certain unpublished health and safety 

studies to EPA. Health and safety 

studies sought by this action will inform 

EPA actions in carrying out its 

responsibilities pursuant to TSCA, 

including prioritization, risk evaluation, 

and risk management. 


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Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations 100757 

DATES: This rule is effective on January 

13, 2025. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2023–0360, is 

available online at https://

www.regulations.gov. Additional 

information about dockets generally, 

along with instructions for visiting the 

docket in-person, is available at https:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

For technical information: Lameka 

Smith, Data Gathering, Management, 

and Policy Division (7406M), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; telephone number: (202) 

564–1629; email address: 

smith.lameka@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCA-Hotline@

epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you manufacture 

(including import) chemical substances 

and mixtures. The North American 

Industrial Classification System 

(NAICS) codes affected by this rule are 

those that align with these activities. 

This typically includes manufacturing 

and chemical processing sectors, as well 

as any related industries where these 

chemicals might be used or introduced 

into commerce, including those who fall 

within the following list of NAICS 

codes: 

• Chemical manufacturing (NAICS 

code 325); and 

• Petroleum refineries (NAICS code 

324110). 

This action applies to manufacturers 

in these NAICS codes who are currently 

manufacturing (including importing) a 

listed chemical substance (or will do so 

during the chemical’s reporting period), 

or who have manufactured (including 

imported) or proposed to manufacture 

(including import) a listed chemical 

substance within the last 10 years. 

This action may also affect 

manufacturers of substances for 

commercial purposes that 

coincidentally produce the substance 

during the manufacture, processing, use, 

or disposal of another substance or 

mixture, including byproducts and 

impurities. Such byproducts and 

impurities may, or may not, in 

themselves have commercial value. 

They are nonetheless produced for the 

purpose of obtaining a commercial 

advantage since they are part of the 

manufacture of a chemical product for 

a commercial purpose. 

B. What action is the Agency taking? 

EPA is requiring manufacturers of 

chemical substances listed in this 

document to submit copies and lists of 

certain unpublished health and safety 

studies to EPA. EPA is taking final 

action on the proposed rule published 

on March 26, 2024 (89 FR 20918 (FRL– 

11164–01–OCSPP). This rulemaking is 

intended to provide EPA with useful 

information for prioritization, risk 

evaluations, and risk management 

activities under TSCA section 6 

regarding the chemical substances 

identified in this final rule. This action 

lists the chemical substances and their 

Chemical Abstracts Service Registry 

Numbers (CASRNs) being added to 40 

CFR 716. It also lists specific data 

reporting requirements. 

C. What is the Agency’s authority for 

taking this action? 

EPA promulgated the Health and 

Safety Data Reporting Rule that is 

codified at 40 CFR part 716 under TSCA 

section 8(d) (15 U.S.C. 2607(d)). EPA is 

finalizing this rule under its authority in 

TSCA section 8(d) to require submission 

of health and safety studies, and lists of 

studies, regarding certain chemical 

substances. 

D. What are the estimated incremental 

impacts of this action? 

EPA prepared an economic analysis 

for the addition of the 16 chemical 

substances to the TSCA section 8(d) 

Health and Safety Data Reporting rule 

(Ref. 1), which is available in the docket 

and summarized here. EPA estimates 

that the costs of this action will be 

approximately $5,884,568 in the first 

year of reporting and involve 70,630 

burden hours (Ref. 1). In addition, EPA 

has determined that, of the 35 small 

businesses affected by this action, 2 are 

estimated to incur a maximum 

annualized cost impact of more than 1% 

of revenues. Thus, this action is not 

expected to have a significant adverse 

economic impact on a substantial 

number of small entities (Ref. 1). 

II. Background 

A. What chemical substances is EPA 

adding to the final rule? 

EPA is amending the list at 40 CFR 

716.120 to add 16 chemical substances. 

The list at 40 CFR 716.120 contains 

chemical substances for which the 

health and safety study data reporting is 

required. Additionally, the chemical 

specific reporting requirements will be 

incorporated into 40 CFR 716.21(a)(11). 

Any special exemptions are required for 

a specific chemical substance are 

identified in the table at 40 CFR 716.120 

under special exemptions. Special 

exemptions are reporting requirements 

that are specific to a chemical substance 

and include specific language about 

specific studies and requirements. The 

chemical substances addressed in this 

final rule are as follows: 

• 4,4-Methylene bis(2-chloraniline) 

(CASRN 101–14–4); 

• 4-tert-octylphenol(4-(1,1,3,3- 

Tetramethylbutyl)-phenol) (CASRN 

140–66–9); 

• Acetaldehyde (CASRN 75–07–0); 

• Acrylonitrile (CASRN 107–13–1); 

• Benzenamine (CASRN 62–53–3); 

• Benzene (CASRN 71–43–2); 

• Bisphenol A (CASRN 80–05–7); 

• Ethylbenzene (CASRN 100–41–4); 

• Naphthalene (CASRN 91–20–3); 

• Vinyl Chloride (CASRN 75–01–4); 

• Styrene (CASRN 100–42–5); 

• Tribromomethane (Bromoform) 

(CASRN 75–25–2); 

• Triglycidyl isocyanurate; (CASRN 

2451–62–9); 

• Hydrogen fluoride (CASRN 7664– 

39–3); 

• N-(1,3-Dimethylbutyl)-N′-phenyl-pphenylenediamine (6PPD) (CASRN 793– 

24–8); and 

• 2-anilino-5-[(4-methylpentan-2-yl) 

amino]cyclohexa-2,5-diene-1,4-dione 

(6PPD-quinone) (CASRN 2754428–18– 

5). 

B. What are the reporting requirements? 

Listed in Unit II. are the reporting 

requirements for the 16 chemical 

substances identified in Unit II.A. 

Generally, the reporting described in 

Unit II.D. is required by March 13, 2025. 

The specific types of health and safety 

studies are listed in Unit II.D. and 

include the following: 

• Manufacturers who, in the 10 years 

preceding the date a chemical substance 

is listed, either have proposed to 

manufacture or have manufactured any 

of the listed chemical substances must 

submit to EPA, during the 60-day 

reporting period specified in 40 CFR 

716.65 and according to the reporting 

schedule set forth at 40 CFR 716.60, a 

copy of each specified type of health 

and safety study which is in their 

possession at the time the chemical 

substance is listed in part 716. 

• Manufacturers who, either at the 

time of or after the chemical substance 

is listed in 40 CFR 716, propose to 

manufacture or are manufacturing the 

listed chemical substance must submit 

to EPA during the 60-day reporting 


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period specified in 40 CFR 716.65 and 

according to the reporting schedule set 

forth at 40 CFR 716.60: 

•A copy of each specified type of 

health and safety study which is in their 

possession at the time the chemical 

substance is listed; 

• A list of the specified types of 

health and safety studies known to them 

but not in their possession at the time 

the chemical substance is listed; 

• A list of the specified types of 

health and safety studies that are 

ongoing at the time the chemical 

substance is listed and are being 

conducted by or for them; 

• A list of the specified types of 

health and safety studies that are 

initiated after the date the chemical 

substance is listed and will be 

conducted by or for them; and 

• A copy of each specified type of 

health and safety study that was 

previously listed as ongoing or 

subsequently initiated (i.e., listed in 

accordance with reporting requirements 

in Unit II.D., respectively) and is now 

complete regardless of completion date. 

• For this rulemaking, EPA is 

requiring submission of information 

only on those studies in which the 

listed chemical is specifically identified 

in the studies. 

Any person who manufactures 

(including imports) or who proposes to 

manufacture the listed chemical 

substance from January 13, 2025 to 

March 13, 2025 must: 

(1) Inform EPA (by submitting a list) 

of any studies initiated during the 

period from January 13, 2025 to March 

13, 2025 within 30 days of their 

initiation, but in no case later than April 

14, 2025; and 

(2) For those who submitted lists of 

studies that were ongoing or initiated 

during the period from January 13, 2025 

to March 13, 2025, such persons must 

submit a copy of each study within 30 

days after its completion, regardless of 

the study’s completion date. See 40 CFR 

716.60 and 716.65. 

C. What are the exemptions under this 

rule? 

Requirements for reporting 

unpublished health and safety data is 

provided at 40 CFR part 716, and with 

explanations of reporting exemptions 

detailed in 40 CFR 716.20. As explained 

in the proposed rule (89 FR 20918 

March 26, 2024 (FRL–11164–01– 

OCSPP)), EPA did not include the 

exemption listed at 40 CFR 716.20(a)(9), 

which allows for the inclusion of an 

exemption for persons manufacturing a 

substance only as an impurity. A person 

manufacturing or proposing to 

manufacture a substance listed in this 

rule must report on the substance where 

it was only manufactured (or is being 

proposed for manufacturing) as an 

impurity. An impurity is defined at 40 

CFR 716.3 as a chemical substance that 

is unintentionally present with another 

chemical substance. Additionally, 

pursuant to the procedure at 40 CFR 

716.20(b)(5) that requires EPA to 

identify the chemical grade/purity, EPA 

is requiring reporting on any chemical 

grade/purity level of the chemical. 

EPA is requiring submissions of 

health and safety studies from 

companies manufacturing the identified 

chemical substances, including when a 

company is importing the chemical 

substance as a pure substance, or within 

a mixture, formulated product, or article 

that contains the subject chemical 

substance. This includes instances 

where the chemical substance is 

manufactured only as an impurity. EPA 

considers conditions of use, as 

discussed in further detail in Unit II. F., 

associated with circumstances where a 

chemical substance subject to a risk 

evaluation even where the chemical 

substance is an impurity. To such ends, 

health and safety information associated 

with the conditions of use, whether as 

a pure chemical, part of a mixture or 

article, or as an impurity helps inform 

such risk evaluation (see e.g., 89 FR 

37028, 37033 (‘‘[EPA must include 

consideration of] known circumstances 

associated with the chemical (e.g., [. . .] 

de minimis amounts such as an 

impurity or within an article, etc.)’’)). 

For this rulemaking, EPA is requiring 

submission of information only on those 

studies in which the listed chemical is 

specifically identified in the studies. 

Accordingly, the chemicals included 

in this final rule are of particular 

interest to EPA because they are either 

in the process of prioritization as 

candidates for high-priority designation 

or are expected to be candidates in the 

upcoming years. For those found to be 

of high-priority designation, EPA is 

required to initiate a risk evaluation 

under TSCA section 6(b). Collecting 

health and safety studies on the 

chemicals included in this final rule 

will assist EPA in selecting chemicals to 

designate as high-priority chemicals, as 

well as in conducting the risk 

evaluation on such chemicals. 

D. What types of studies must be 

submitted? 

Pursuant to 40 CFR 716.10 and 

716.50, manufacturers are required to 

submit the following types of 

information: 

• Lists and copies of unpublished 

health and safety studies for all 

substances specified in this rule on 

health effects, such as toxicity studies 

(e.g., in vivo, in vitro) on 

carcinogenicity, reproductive and 

developmental effects, genotoxicity, 

neurotoxicity, immunotoxicity, 

endocrine effects, and other systemic 

toxicity and toxicokinetic (absorption, 

distribution, metabolism, or 

elimination), including modeling 

studies, in humans or animals. 

• All unpublished studies on 

environmental effects and physicalchemical properties if performed as 

described in 40 CFR 716.50. 

• All unpublished studies on 

occupational, general population, 

consumer, bystander, and 

environmental exposure, such as: 

unpublished studies on inhalation and 

dermal exposure, human biomonitoring, 

environmental monitoring of indoor and 

outdoor air, soil, water, and household 

dust, chamber emission rates from 

products or polymeric matrices, and 

unpublished modeling studies that 

estimate environmental concentrations 

or human exposures. 

• Studies showing any measurable 

content of the listed substance (single 

substance or mixture). The composition 

and purity of test substances must be 

reported if included as part of the study. 

• Surveys, tests, and studies of 

biological, photochemical, and chemical 

degradation. Chemical identities are 

part of the submitted health and safety 

studies or data and must be submitted 

to EPA. Information from health and 

safety studies and/or data relating to 

chemical substances offered for 

commercial distribution or subject to 

reporting under TSCA Section 4 or 5 is 

not protected from disclosure, with 

limited exceptions as stated in 15 U.S.C. 

2613(2)(B). 

The following types of information 

are not included in this action and need 

not be submitted to EPA: 

• Studies previously submitted to 

EPA pursuant to a requirement under 

TSCA or of the submitter’s own accord 

and studies conducted or to be 

conducted pursuant to a TSCA section 

4 action are exempt from the submission 

of lists of health and safety studies 

required under 40 CFR 716.35 and the 

submission of studies required under 

this rule. 

• Certain types of studies when the 

subject of the study is a mixture known 

to contain a listed substance. These 

studies include acute oral toxicity; acute 

dermal toxicity; acute inhalation 

toxicity; primary eye irritation; primary 

dermal irritation; dermal sensitization; 

and physical-chemical properties. 

• Analyzed aggregations of 

monitoring data when either based on 

monitoring data acquired over five years 


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prior to the date of this rule, or when 

the data are not analyzed to determine 

the exposure or concentration levels of 

the listed chemical. 

E. How to report? 

All submitters must report TSCA 

section 8(d) data electronically using the 

Chemical Safety and Pesticide Programs 

(CSPP) Software, which is accessible via 

EPA’s Central Data Exchange (CDX) 

system available at https://cdx.epa.gov/ 

. The CSPP Software provides a TSCA 

8(d) Health and Safety Data Reporting 

application that a registered CDX user 

will access to submit TSCA section 8(d) 

records. Information on how to submit 

TSCA section 8(d) data is available in 

the docket (EPA–HQ–OPPT–2023–0360) 

and via EPA’s TSCA section 8(d) web 

page at https://www.epa.gov/assessingand-managing-chemicals-under-tsca/ 

section-8d-health-safety-data-reportinguser-guide-0. Submitters may also 

contact EPA’s TSCA Hotline at tscahotline@epa.gov or 202–554–1404. For 

help with accessing your CDX account, 

please contact the CDX help desk at 

https://cdx.epa.gov/contact or (888) 

890–1995 (for international callers: 

(970) 494–5500). 

1. Submitting CBI. Any person 

submitting copies of records may assert 

a business confidentiality claim 

covering all or part of the submitted 

information in accordance with the 

procedures described in 40 CFR part 

703, and using the CSPP Software. 

Requirements for asserting and 

maintaining confidentiality claims are 

described in 40 CFR 703.5. Such claims 

must be made concurrent with 

submission of the information. If no 

claim accompanies the submission, EPA 

will not recognize a confidentiality 

claim, and the information in that 

submission may be made available to 

the public without further notice. 

Confidentiality claims must be 

substantiated at the time of submission 

to EPA pursuant to the requirements of 

40 CFR 703.5(b). To assert a claim of 

confidentiality for information 

contained in a submitted record, the 

respondent must submit two copies of 

the document. One copy must be 

complete, and, on each page containing 

information claimed as confidential, the 

respondent must indicate what 

information, if any, is claimed as 

confidential by marking the specific 

information on that page with a label 

such as ‘‘confidential’’, ‘‘proprietary’’, or 

‘‘CBI.’’ The other copy must be a public 

version of the submission and 

attachments, with all information that is 

claimed as confidential removed (40 

CFR 703.5(c)). Both the copy containing 

information claimed as CBI and the 

‘‘sanitized’’ copy must be submitted 

electronically. The TSCA section 8(d) 

Health and Safety Data Reporting 

application incorporates many of the 

requirements for asserting CBI claims, 

including substantiation questions, a 

required certification statement, and 

prompts to provide a sanitized copy. 

Further details regarding the 

requirements for confidentiality claims 

can be found in 40 CFR part 703. 

2. Submitting OECD harmonized 

templates. Additionally, EPA is 

requiring all existing information 

concerning health and environmental 

effects and that have CBI claims as 

described in Unit II.E.1. to be submitted 

in the format of Organization of 

Economic Cooperation and 

Development’s (OECD) harmonized 

templates (OHTs), where such templates 

exist for the type of data pursuant to 40 

CFR 703. OECD templates are accessible 

to the public online at https://oecd.org/ 

ehs/templates/harmonisedtemplates.htm. This can be 

accomplished by using the freely 

available IUCLID6 software by exporting 

the dossier in the OECD Harmonized 

Template working context. EPA can 

accept any dossiers generated using any 

version of IUCLID6 available at https:// 

www.epa.gov/tsca-cbi/final-rulerequirements-confidential-businessinformation-claims-undertsca#Implementation. EPA believes that 

some of the data will already be 

available as an OECD template if the 

company had already submitted the 

studies under the European Union’s 

Registration, Evaluation, Authorization 

and Restriction of Chemicals (REACH) 

regulation. In addition to the required 

template format, those subject to this 

rulemaking must submit any associated 

full study reports or underlying data as 

support documents. The full study 

reports and support documents are 

necessary for EPA to understand the full 

context and evaluate the quality of the 

data, which is necessary for the Agency 

to review to determine whether such 

data may be used for any future Agency 

actions. If an OHT is not available for a 

particular endpoint for which the 

manufacturer has relevant information, 

then the manufacturer must still submit 

the study under 40 CFR 716. 

This rule does not require the 

submission of OHTs for health and 

safety studies that do not have CBI 

claims. As explained in the Response to 

Comments document (Ref. 2), 40 CFR 

703.5(g) already requires that studies 

containing CBI claims be submitted 

using OHTs. However, EPA is declining 

to extend this requirement to those 

studies without CBI claims. Forgoing an 

OHT requirement for non-CBI claims 

alleviates some of the overall 

submission burden. However, EPA 

welcomes any OHTs for those non-CBI 

studies, especially if they have already 

been prepared pursuant to other 

authorities (e.g., REACH). EPA also 

advises manufacturers that it reserves 

the authority to promulgate OHT 

requirements for non-CBI health and 

safety studies in future rulemakings and 

anticipates doing so. 

F. What is the rationale for adding the 

16 chemical substances? 

EPA’s assessment of chemical 

substances under TSCA section 6 

involves a three-stage process: (1) 

Prioritization; (2) Risk evaluation; and, 

as applicable, (3) Risk management. 

Prioritization and risk evaluation are 

carried out in accordance with 

procedural regulations at 40 CFR part 

702, subparts A and B, respectively. 

During prioritization, EPA identifies 

chemical substances that are candidates 

for prioritization and then uses 

reasonably available information to 

screen each candidate chemical 

substance against certain criteria and 

considerations specified in TSCA 

section 6(b)(1)(A): 

• Hazard and exposure potential of 

the chemical substance; 

• Persistence and bioaccumulation of 

the chemical substance; 

• Potentially exposed or susceptible 

subpopulations; 

• Storage near significant sources of 

drinking water; 

• Conditions of use or significant 

changes in the conditions of use of the 

chemical substance. Conditions of use is 

defined under TSCA section 3(4) to 

mean ‘‘the circumstances, as determined 

by the Administrator, under which a 

chemical substance is intended, known, 

or reasonably foreseen to be 

manufactured, processed, distributed in 

commerce, used or disposed of.’’; 

• Volume or significant changes in 

the volume of the chemical substance 

manufactured or processed; and 

• Other risk-based criteria that EPA 

determines to be relevant to the 

designation of the chemical substance’s 

priority. 

EPA identified 15 chemical 

substances that are the subject of this 

rule as potential candidates for 

prioritization based on a screening 

process that is based on a combination 

of hazard, exposure (including uses), 

and persistence and bioaccumulation 

characteristics. To support the 

prioritization process as well as to 

inform its risk evaluation findings on 

any of these substances that EPA might 

designate as a high-priority substance, 

EPA is seeking unpublished health and 


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safety studies on these chemical 

substances to ensure that such studies 

are available to EPA to inform any 

activities undertaken pursuant to TSCA 

section 6. 

EPA is also including the 6PPD 

transformation product, 2-anilino-5-[(4- 

methylpentan-2-yl) amino]cyclohexa2,5-diene-1,4-dione (6PPD-quinone) 

(CASRN: 2754428–18–5) in response to 

a citizen’s petition filed under TSCA 

section 21 regarding 6PPD and 6PPDquinone. Cited in the petition are the 

potential impacts of 6PPD-quinone to 

aquatic organisms and on population 

levels for some fish, such as the coho 

salmon. The Agency is including this 

chemical in this request for unpublished 

health and safety studies to address data 

needs and to better understand and 

characterize potential risks associated 

with this chemical. For details on 6PPD 

and 6PPD-quinone and EPA’s current 

key actions to address this chemical, 

please visit, https://www.epa.gov/ 

chemical-research/6ppd-quinone. 

Information received pursuant to this 

rulemaking will help inform other EPA 

activities involving these chemical 

substances. Additionally, non-CBI 

collected pursuant to this final rule will 

be made public via ChemView (https:// 

chemview.epa.gov/chemview/), the EPA 

online system that contains information 

EPA receives and develops about 

chemicals regulated under TSCA. 

ChemView is part of EPA’s commitment 

to strengthen its chemicals management 

programs by improving access to and 

the usefulness of chemical information. 

The goal is for people to easily get 

information they need to make safe 

chemical choices and to help 

businesses, individuals and others make 

more informed decisions about the 

chemicals they use. 

Benefits of this final rule include 

addressing market failure stemming 

from incomplete or imperfect 

information regarding the hazards 

associated with the listed chemicals. 

This final rule addresses market failure 

by making information about the health 

and safety effects of the listed chemicals 

available to EPA. By making this 

information available, EPA will be able 

to base decisions on actual data rather 

than relying on assumptions. 

Additionally, the information provided 

by this rule can aid in addressing 

negative externalities that occur when 

the costs associated with known hazards 

are external to manufacturers’ decisionmaking and may result in overuse and/ 

or overproduction of certain harmful 

products. 

III. Summary of Public Comments on 

the Proposed Rule 

EPA received 35 unique public 

comments during the public comment 

period for the proposed rule (89 FR 

20918, March 26, 2024 (FRL–11164–01– 

OCSPP)). Comments were submitted by 

citizens, industry groups and 

companies, non-governmental 

organizations, and a state agency. The 

public comments revealed varied 

perspectives across different types of 

commenters. 

Industry stakeholders were generally 

supportive of the need for 

comprehensive chemical data under 

TSCA section 6. Some industry 

commenters, however, expressed 

concerns about the utility of studies 

involving low concentrations of 

chemicals or cases in which the 

chemical is not the test substance (e.g., 

included in the study as an impurity of 

the test substance or test mixture). Many 

such commenters were not supportive 

of EPA lifting the impurity exemption 

and/or requiring the submission of 

studies with the listed chemical 

substance at any concentration or 

purity. Several industry commenters 

also discussed the proposed OHTs 

requirement, with different points of 

view. While some supported the use of 

templated and standardized 

submissions, others expressed concerns 

about the administrative and financial 

burdens of compliance, particularly 

with reporting on impurities. Some 

industry stakeholders suggested 

extending the reporting deadlines from 

90 to 180 days to allow more time for 

compliance. Finally, many comments 

from companies or trade groups 

discussed EPA’s draft burden analysis, 

with many claiming that EPA had 

underestimated the time and cost 

related to preparing and submitting 

OHTs. 

Environmental groups and NGOs 

strongly supported the rule as proposed, 

including the requirement to submit 

studies with the chemical substances 

even when present as impurities. These 

commenters also highlighted the 

importance of gathering data on 6PPD 

and its degradant, 6PPD-quinone, and 

urged EPA to finalize this rule quickly. 

EPA considered all comments and 

information in the development of this 

final rule. A comprehensive response to 

comments document can be found in 

the docket (Ref. 2). 

IV. 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. For 

more information about these 

references, please consult the technical 

person listed under FOR FURTHER

INFORMATION CONTACT. 

1. EPA. TSCA section 8(d): Economic Impact 

Analysis for the Addition of Sixteen 

Chemicals to the Health and Reporting 

Data Rule. December 2024. 

2. EPA. Response to Comments. TSCA 

Section 8(d) Certain Existing Chemicals; 

Request to Submit Unpublished Health 

and Safety Data Under TSCA. December 

2024. 

3. EPA. Supporting Statement under the 

Paperwork Reduction Act: Section 8 of 

the Toxic Substances Control Act. EPA 

ICR No. 2703.01 OMB Control No. 2070– 

0224. November 2022. 

V. Statutory and Executive Order 

Reviews 

Additional information about these 

statutes and Executive Orders can be 

found at https://www.epa.gov/lawsregulations/laws-and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 14094: Modernizing Regulatory 

Review 

This action is not a significant 

regulatory action under Executive Order 

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

as amended by Executive Order 14094 

(88 FR 21879, April 11, 2023), and was 

therefore not subject to Executive Order 

12866 review. 

B. Paperwork Reduction Act (PRA) 

As required by the PRA, 44 U.S.C. 

3501 et seq., the information collection 

activities associated with TSCA section 

8(d) reporting are approved by OMB 

under OMB Control No. 2070–0224. The 

Information Collection Request (ICR) 

document that EPA prepared has been 

assigned EPA ICR No. 2703.01 (Ref. 3). 

A copy of the approved ICR is in the 

docket for this rule, and is briefly 

summarized here. 

This action requires the reporting of 

unpublished health and safety studies to 

EPA by manufacturers of certain 

chemical substances that are being 

added to the Health and Safety Data 

Reporting Rule in 40 CFR part 716. EPA 

intends to use the information collected 

to assist in assessing the chemical 

substances under TSCA, and to inform 

any additional work necessary under 

environmental protection mandates 

beyond TSCA. Submitters may 

designate information as confidential, 

trade secret, or proprietary. EPA has 

implemented procedures to protect any 

confidential, trade secret or proprietary 

information from disclosure. These 

procedures comply with TSCA section 


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Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations 100761 

14 and EPA’s confidentiality 

regulations, 40 CFR part 2, subpart B. 

Respondents/affected entities: 

Manufacturers (including importers) of 

the 16 chemical substances identified in 

the rulemaking, see also Unit I.A. and 

the ICR. 

Respondent’s obligation to respond: 

Mandatory, TSCA section 8(d) (15 

U.S.C. 2607(d)), and implementing 

regulations in 40 CFR part 716. 

Estimated number of respondents: 

160. 

Frequency of response: One-time. 

Total estimated burden: 23,962 hours 

(per year). Burden is defined at 5 CFR 

1320.3(b). 

Total estimated cost: $2,011,604 (per 

year), with no annualized capital or 

operation & maintenance costs. (Ref. 1) 

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 for the EPA’s regulations in 40 

CFR are listed 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 

manufacturers of 16 chemicals to be 

added to the Health and Safety Data 

Reporting Rule. The Agency has 

determined that 35 out of 160 of the 

firms in the affected universe are small 

entities. Of those small firms, 2 may 

experience an impact of above 1% and 

1 may have impacts above 3%. Details 

of this analysis are presented in Chapter 

6 of the Economic Analysis for this rule 

(Ref. 1), which can be found in the 

docket. 

D. Unfunded Mandates Reform Act 

(UMRA) 

This action does not contain an 

unfunded mandate of $100 million 

(adjusted annually for inflation) or more 

(in 1995 dollars) as described in UMRA, 

2 U.S.C. 1531–1538, and does not 

significantly or uniquely affect small 

governments. The costs involved in this 

action are estimated not to exceed $183 

million in 2023$ ($100 million in 1995$ 

adjusted for inflation using the GDP 

implicit price deflator) or more in any 

one year. 

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. 

F. Executive Orders 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. This rule affects entities who 

manufacture (including import) 

chemical substances for commercial 

purposes. 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 regulatory actions 

considered significant under section 

3(f)(1) of Executive Order 12866 and 

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 

Executive Order 13045. 

Since this is not a ‘‘covered regulatory 

action,’’ E.O. 13045 does not apply. 

However, the Policy on Children’s 

Health does apply. Although this action 

does not directly concern an 

environmental health or safety risk to 

children, the information obtained from 

the reporting required by this rule will 

be used to inform the Agency’s 

decision-making process regarding 

chemical substances to which children 

may be exposed. This information will 

also assist the Agency and others in 

determining whether the chemical 

substances included in this rule present 

potential risks, allowing the Agency and 

others to take appropriate action to 

investigate and mitigate those risks. 

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 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 and Executive 

Order 14096: Revitalizing Our Nation’s 

Commitment to Environmental Justice 

for All 

The EPA believes that this type of 

action does not concern human health 

or environmental conditions and 

therefore cannot be evaluated with 

respect to potentially disproportionate 

and adverse effects on communities 

with environmental justice concerns. 

Although this action does not directly 

impact human health or environmental 

conditions, EPA identifies and 

addresses environmental justice 

concerns in accordance with Executive 

Orders 12898 (59 FR 7629, February 16, 

1994) and 14096 (88 FR 25251, April 26, 

2023) by requiring reporting of 

unpublished health and safety data. 

This regulatory action requires the 

submission of unpublished health and 

safety data for 16 chemical substances 

that will result in more information 

being available for EPA’s use under 

TSCA section 6, thereby enabling the 

Agency to better protect human health 

and the environment, including in lowincome and minority communities. 

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’’ under 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 716 

Environmental protection, Chemicals, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

Dated: December 10, 2024. 

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 716—HEALTH AND SAFETY 

DATA REPORTING 

■ 1. The authority citation for part 716 

continues to read as follows: 

Authority: 15 U.S.C. 2607(d). 

■ 2. Amend § 716.21 by adding 

paragraph (a)(11) to read as follows: 


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100762 Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations 

§ 716.21 Chemical specific reporting 

requirements. 

(a) * * * 

(11) For 4,4-Methylene bis(2- 

chloraniline) (101–14–4); 4-tertoctylphenol(4-(1,1,3,3- 

Tetramethylbutyl)-phenol) (140–66–9); 

Acetaldehyde (75–07–7); Acrylonitrile 

(107–13–1); Benzenamine (62–53–3); 

Benzene (71–43–2); Bisphenol A (80–5– 

7); Ethylbenzene (100–41–4); 

Naphthalene (91–20–3); Vinyl Chloride 

(75–01–4); Styrene (100–42–5); 

Tribomomethane (Bromoform) (75–25– 

2); Triglycidyl isocyanurate (2451–62– 

9); Hydrogen fluoride (7664–39–3); N- 

(1,3-Dimethylbutyl)-N′-phenyl-pphenylenediamine (6PPD) (793–24–8); 

and 2-anilino-5-[(4-methylpentan-2- 

yl)amino]cyclohexa-2,5-diene-1,4-dione 

(6PPD-quinone) (2754428–18–5), all 

unpublished studies on health effects 

(including toxicity studies (in vivo and 

in vitro) on carcinogenicity, 

reproductive and developmental effects, 

genotoxicity, neurotoxicity, 

immunotoxicity, endocrine effects, and 

other systemic toxicity); toxicokinetics 

(absorption, distribution, metabolism, or 

elimination), including modelling 

studies, in humans or animals; 

environmental effects; environmental 

fate; physical-chemical properties if 

performed as described in 40 CFR 

716.50; and occupational (both users 

and non-users), general population, 

consumer, bystander, and 

environmental exposure must be 

submitted. Studies showing any 

measurable content of the substance in 

the tested substance (single substances 

or mixture) must be reported. The 

composition and purity of test 

substances must be reported if included 

as part of the study. Studies previously 

submitted to EPA pursuant to a 

requirement under TSCA or of the 

submitter’s own accord and studies 

conducted or to be conducted pursuant 

to a TSCA section 4 action are exempt 

from the submission of lists of health 

and safety studies required under 40 

CFR 716.35 and the submission of 

studies required under this rule. 

* * * * * 

■ 3. In § 716.120, amend the table in 

paragraph (d) by: 

■ a. Designating the table as table 3 to 

paragraph (d); 

■ b. Adding the category sub-heading 

‘‘OPPT 2024 Chemicals:’’ in 

alphabetical order immediately 

preceding the category ‘‘Organohalogen 

flame retardants:’’; and 

■ c Adding the entries ‘‘Acetaldehyde’’; 

‘‘Acrylonitrile’’; ‘‘2-anilino-5-[(4- 

methylpentan-2-yl)amino]cyclohexa2,5-diene-1,4-dione (6PPD-quinone)’’; 

‘‘Benzenamine’’; ‘‘Benzene’’; ‘‘Bisphenol 

A’’; ‘‘Ethylbenzene’’; ‘‘Hydrogen 

fluoride’’; ‘‘4,4-Methylene bis(2- 

chloraniline)’’; ‘‘N-(1,3-Dimethylbutyl)- 

N′-phenyl-p-phenylenediamine 

(6PPD)’’; ‘‘Naphthalene’’; ‘‘Styrene’’; ‘‘4- 

tert-octylphenol(4-(1,1,3,3- 

Tetramethylbutyl)-phenol)’’; 

‘‘Tribomomethane (Bromoform)’’; 

‘‘Triglycidyl isocyanurate’’; and ‘‘Vinyl 

Chloride’’ after the category sub-heading 

‘‘OPPT 2024 Chemicals:’’. 

The additions read as follows: 

§ 716.120 Substances and listed mixtures 

to which this subpart applies. 

(d) * * * 

TABLE 3 TO PARAGRAPH (d) 

Category CAS No. Special exemptions Effective date Sunset date 

*******

OPPT 2024 Chemicals 

Acetaldehyde .......................................... 75–07–0 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

Acrylonitrile .............................................. 107–13–1 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

2-anilino-5-[(4-methylpentan-2- 

yl)amino]cyclohexa-2,5-diene-1,4- 

dione (6PPD-quinone).

2754428–18–5 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

Benzenamine .......................................... 62–53–3 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

Benzene .................................................. 71–43–2 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

Bisphenol A ............................................. 80–05–7 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

Ethylbenzene .......................................... 100–41–4 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

Hydrogen fluoride .................................... 7664–39–3 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

4,4-Methylene bis(2-chloraniline) ............ 101–14–4 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

N-(1,3-Dimethylbutyl)-N′-phenyl-pphenylenediamine (6PPD).793–24–8 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

Naphthalene ............................................ 91–20–3 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

Styrene .................................................... 100–42–5 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

4-tert-octylphenol(4-(1,1,3,3- 

Tetramethylbutyl)-phenol).

140–66–9 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

Tribomomethane (Bromoform) ................ 75–25–2 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

Triglycidyl isocyanurate ........................... 2451–62–9 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 

Vinyl Chloride .......................................... 75–01–4 § 716.21(a)(11) applies; § 716.20(a)(9) 

does not apply.

January 13, 2025 .... March 13, 2025. 


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Federal Register / Vol. 89, No. 240 / Friday, December 13, 2024 / Rules and Regulations 100763 

TABLE 3 TO PARAGRAPH (d)—Continued 

Category CAS No. Special exemptions Effective date Sunset date 

*******

[FR Doc. 2024–29406 Filed 12–12–24; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

45 CFR Parts 162 

[CMS–0056–F] 

RIN 0938–AU19 

Administrative Simplification: 

Modifications of Health Insurance 

Portability and Accountability Act of 

1996 (HIPAA) National Council for 

Prescription Drug Programs (NCPDP) 

Retail Pharmacy Standards; and 

Modification of the Medicaid Pharmacy 

Subrogation Standard 

AGENCY: Office of the Secretary, 

Department of Health and Human 

Services (HHS). 

ACTION: Final rule. 

SUMMARY: This final rule adopts updated 

versions of the retail pharmacy 

standards for electronic transactions 

adopted under the Administrative 

Simplification subtitle of the Health 

Insurance Portability and 

Accountability Act of 1996 (HIPAA). 

These updated versions are 

modifications to the currently adopted 

standards for the following retail 

pharmacy transactions: health care 

claims or equivalent encounter 

information; eligibility for a health plan; 

referral certification and authorization; 

and coordination of benefits. This final 

rule also adopts a modification to the 

standard for the Medicaid pharmacy 

subrogation transaction. 

DATES: 

Effective Date: This final rule is 

effective on February 11, 2025. The 

incorporation by reference of certain 

publications listed in the rule is 

approved by the Director of the Federal 

Register beginning February 11, 2025. 

The incorporation by reference of 

certain other publications listed in the 

rule was approved by the Director as of 

March 17, 2009. 

Compliance Date: Compliance with 

this final rule is required beginning 

February 11, 2028. 

FOR FURTHER INFORMATION CONTACT: 

Geanelle G. Herring, (410) 786–4466. 

Christopher S. Wilson, (410) 786– 

3178. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary and Severability 

A. Purpose 

We published a proposed rule titled 

‘‘Administrative Simplification: 

Modifications of Health Insurance 

Portability and Accountability Act of 

1996 (HIPAA) National Council for 

Prescription Drug Programs (NCPDP) 

Retail Pharmacy Standards; and 

Adoption of Pharmacy Subrogation 

Standard’’ (hereafter referred to as the 

November 2022 proposed rule) that 

appeared in the November 9, 2022, 

Federal Register (87 FR 67634). In that 

rule, we proposed to adopt 

modifications to the retail pharmacy 

and Medicaid subrogation standards. 

This final rule adopts modifications to 

standards for electronic retail pharmacy 

transactions and the Medicaid 

pharmacy subrogation transaction 

adopted under the Administrative 

Simplification subtitle of the Health 

Insurance Portability and 

Accountability Act of 1996 (HIPAA). 

1. Need for the Regulatory Action 

The modified standards adopted in 

this rule will benefit the health care 

industry by offering more robust data 

exchange and workflow automation, 

enhanced patient safety, improved 

coordination of benefits, and expanded 

financial fields, so that entities may not 

have to manually enter free text, split 

claims, or prepare and submit a paper 

Universal Claim Form. The current 

retail pharmacy standards adopted in 

2009 remain unchanged. In 2018, the 

National Committee on Vital and Health 

Statistics (NCVHS) recommended that 

HHS adopt more recent standards to 

address evolving industry business 

needs. Consistent with the NCVHS 

recommendations and collaborative 

industry and stakeholder input, we 

believe the updated retail pharmacy 

standards we are adopting are 

sufficiently mature for adoption and 

that covered entities are ready to 

implement them. 

2. Legal Authority for the Regulatory 

Action 

Through subtitle F of title II of 

HIPAA, Congress added to title XI of the 

Social Security Act (the Act) a new Part 

C, titled ‘‘Administrative 

Simplification,’’ which requires the 

Secretary of the Department of Health 

and Human Services (the Secretary) to 

adopt standards for certain transactions 

to enable health information to be 

exchanged more efficiently and to 

achieve greater uniformity in the 

transmission of health information. 

More specifically, section 1174 of the 

Act requires the Secretary to review the 

adopted standards and adopt 

modifications to them, including 

additions to the standards, as 

appropriate, but not more frequently 

than once every 12 months, unless the 

Secretary determines that the 

modification is necessary in order to 

permit compliance with the standard, 

thus providing the legal authority for 

this regulatory action. 

B. Summary of the Major Provisions 

The provisions in this final rule adopt 

the following modifications: the NCPDP 

Telecommunication Standard 

Implementation Guide, Version F6 

(Version F6) and equivalent NCPDP 

Batch Standard Implementation Guide, 

Version 15 (Version 15) and NCPDP 

Batch Standard Subrogation 

Implementation Guide, Version 10 

(Version 10). These updated standards 

will replace the currently adopted 

NCPDP Telecommunication Standard 

Implementation Guide, Version D, 

Release 0 (Version D.0) and the 

equivalent NCPDP Batch Standard 

Implementation Guide, Version 1, 

Release 2 (Version 1.2), and NCPDP 

Batch Standard Medicaid Subrogation 

Implementation Guide, Version 3, 

Release 0 (Version 3.0). 

Version 3.0 was adopted to support 

Federal and State requirements for State 

Medicaid agencies to seek 

reimbursement from the health plan 

responsible for paying the pharmacy 

claim after the State Medicaid agency 

has paid the claim on behalf of the 

Medicaid recipient. 

In the November 2022 proposed rule, 

we proposed to broaden the scope of the 

subrogation transaction to apply not 

only to State Medicaid agencies but to 


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