29078 Federal Register / Vol. 87, No. 92 / Thursday, May 12, 2022 / Proposed Rules 

Name Chart No. or 

meridian name Area description Longitude/latitude 

(CCCCCCC) Patterson Bay—Road 

Location 1.

Section 5, T. 49 S., 

R. 60 E., Copper 

River Meridian.

The location begins in Section 5 at a point described as N 57°39′18.2448′′ W 

135°48′42.4836′′, thence easterly N 57°39′18.3312′′ W 135°48′39.5748′′, 

thence southerly N 57°39′17.6472′′ W 135°48′39.5028′′, thence westerly N 

57°39′17.5608′′ W 135°48′42.4116′′, thence northerly to the point of beginning.

Approx. N 

57°39′18.2448′′ 

W 

135°48′42.4836′′. 

(DDDDDDD) Patterson Bay—Road 

Location 2.

Section 4, T. 49 S., 

R. 60 E., Copper 

River Meridian.

The location begins in Section 4 at a point described as N 57°39′21.5244′′ W 

135°48′20.7036′′, thence southeasterly N 57°39′21.0564′′ W 

135°48′19.9764′′, thence southwesterly N 57°39′20.0700′′ W 

135°48′22.1940′′, thence northwesterly N 57°39′20.5380′′ W 

135°48′22.9212′′, thence northeasterly to the point of beginning.

Approx. N 

57°39′21.5244′′ 

W 

135°48′20.7036′′. 

(EEEEEEE) Patterson Bay LTF.Section 36, T. 48 

S., R. 59 E., and 

Section 4, T. 49 

S., R. 60 E. Copper River Meridian.

The location begins in Section 36, T. 48 S., R. 59 E., CRM at a point described as N 57°39′26.6544′′ W 135°47′42.2844′′, thence easterly N 

57°39′27.2520′′ W 135°47′30.6852′′, thence southerly N 57°39′25.5960′′ W 

135°47′30.3900′′, thence westerly N 57°39′25.0020′′ W 135°47′41.9892′′, 

thence northerly to the point of beginning.

Approx. N 

57°39′26.6544′′ 

W 

135°47′42.2844′′. 

(FFFFFFF) Thorne 

Bay—Davidson 

Landing.

Section 34, T. 72 

S., R. 84 E., 

Copper River 

Meridian.

The location begins in Section 34 at a point described as N 55°40′13.1628′′, 

W 132°31′26.3388′′, thence easterly to N 55°40′13.2312′′, W 

132°31′23.8332′′, thence southerly to N 55°40′10.9056′′, W 

132°31′23.6388′′, thence westerly to N 55°40′10.8372′′, W 

132°31′26.1444′′, thence northerly to the point of beginning.

Approx. N 

55°40′13.1628′′, 

W 

132°31′26.3388′′. 

* * * * * 

Joan M. Mooney, 

Principal Deputy Assistant Secretary, Policy, 

Management and Budget. 

David E. Schmid, 

Regional Forester, Alaska Region, U.S. Forest 

Service. 

[FR Doc. 2022–10053 Filed 5–11–22; 8:45 am] 

BILLING CODE 4333–15–P; 3410–11–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 2, 702, 703, 704, 707, 716, 

717, 720, 723, 725, and 790 

[EPA–HQ–OPPT–2021–0419; FRL–8223–01– 

OCSPP] 

RIN 2070–AK68 

Confidential Business Information 

Claims Under the Toxic Substances 

Control Act (TSCA) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing new and 

amended requirements concerning the 

assertion and treatment of confidential 

business information (CBI) claims for 

information reported to or otherwise 

obtained by EPA under the Toxic 

Substances Control Act (TSCA). 

Amendments to TSCA in 2016 included 

many new provisions concerning the 

assertion, Agency review, and treatment 

of confidentiality claims. This 

document proposes procedures for 

submitting such claims in TSCA 

submissions. It addresses issues such as 

substantiation requirements, 

exemptions, electronic reporting 

enhancements (including expanding 

electronic reporting requirements), 

maintenance or withdrawal of 

confidentiality claims, and provisions in 

current rules that are inconsistent with 

amended TSCA. The proposed rule also 

addresses EPA procedures for reviewing 

and communicating with TSCA 

submitters about confidentiality claims. 

DATES: Comments must be received on 

or before July 11, 2022. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2021–0419, 

using the Federal eRulemaking Portal at 

http://www.regulations.gov. Follow the 

online instructions for submitting 

comments. Do not submit electronically 

any information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Additional 

instructions on commenting or visiting 

the docket, along with more information 

about dockets generally, is available at 

https://www.epa.gov/dockets. 

Due to the public health concerns 

related to COVID–19, the EPA Docket 

Center (EPA/DC) and reading room is 

open by appointment only. For the 

latest status information on EPA/DC 

services and in-person docket access, 

visit https://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Jessica Barkas, Project Management and 

Operations Division (7401), Office of 

Pollution Prevention and Toxics, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW, Washington, DC 

20460–0001; telephone number: (202) 

250–8880; email address: 

barkas.jessica@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 affected by this action if 

you have submitted or expect to submit 

information to EPA under TSCA and 

have made or expect to make any 

confidentiality claims concerning that 

information. Persons who seek 

information on such submissions may 

also be affected by this action. The 

following list of North American 

Industrial Classification System 

(NAICS) codes is not intended to be 

exhaustive, but rather provides a guide 

to help readers determine whether this 

document applies to them. Potentially 

affected entities may include: 

• Manufacturers, importers, or 

processors of chemical substances 

(NAICS codes 325 and 324110), e.g., 

chemical manufacturing and petroleum 

refineries. 

If you have any questions regarding 

the applicability of this action to a 

particular entity, consult the technical 

contact person listed under FOR FURTHER

INFORMATION CONTACT. 

B. What is the Agency’s authority for 

taking this action? 

TSCA section 14, 15 U.S.C. 2613, 

includes requirements for asserting 

confidentiality claims and for EPA 

review of such claims to determine 

whether the information is entitled to 

the requested protections. Implementing 


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rules are explicitly contemplated for 

some provisions of TSCA section 14 

(e.g., TSCA section 14(c)(1)(a) requires 

persons seeking to protect information 

from disclosure to assert such a claim 

concurrent with submission of the 

information, in accordance with existing 

or future rules; TSCA section 14(c)(3) 

generally requires that confidentiality 

claims be substantiated ‘‘in accordance 

with such rules as the Administrator has 

promulgated or may promulgate 

pursuant to this section’’). In addition, 

other TSCA section 14 requirements 

imply authority to promulgate rules 

addressing the form and manner in 

which those requirements should be 

fulfilled (e.g., manner of submitting 

confidentiality claims, manner in which 

EPA will make required notices under 

TSCA sections 14(g) or 14(e)). 

Discussion of authority to require 

electronic reporting under TSCA may be 

found in the preamble to the final rule 

entitled ‘‘Electronic Reporting under the 

Toxic Substances Control Act; Final 

Rule’’ (Ref. 1). In addition, the 

Government Paperwork Elimination Act 

(GPEA), 44 U.S.C. 3504, provides that, 

when practicable, Federal organizations 

use electronic forms, electronic filings, 

and electronic signatures to conduct 

official business with the public. 

C. What action is the Agency taking? 

EPA is proposing new and amended 

requirements concerning the assertion 

and treatment of CBI claims under 

TSCA, 15 U.S.C. 2601, et seq. The Frank 

R. Lautenberg Chemical Safety for the 

21st Century Act of 2016, Public Law 

114–182 (referred to in this Notice as 

‘‘the Lautenberg amendments’’), made 

significant amendments to TSCA, 

including new provisions governing the 

assertion and review of CBI claims that 

EPA is proposing to implement in this 

action. 

In this document, EPA is proposing to 

specify procedures for submitting and 

supporting CBI claims under TSCA, 

including among other things: (1) 

Substantiation requirements applicable 

at the time of submission; (2) Electronic 

reporting requirements; (3) 

Requirements to provide certification 

statements and generic names when 

making confidentiality claims; (4) 

Treatment of information used for TSCA 

purposes that EPA could obtain under 

TSCA but was originally submitted via 

other means; and (5) Maintenance or 

withdrawal of confidentiality claims. 

EPA is also proposing to specify 

procedures for reviewing and 

communicating with TSCA submitters 

about confidentiality claims, including 

requirements for submitters to maintain 

contact information, and procedures for 

EPA to provide notices to submitters 

concerning their claims. 

EPA is proposing new provisions, as 

well as to amend and reorganize 

existing provisions concerning assertion 

of confidentiality claims under TSCA. 

Regulatory provisions concerning TSCA 

CBI claims are currently spread over a 

large number of parts in the Code of 

Federal Regulations (CFR). EPA has 

general provisions regarding 

confidentiality claims at 40 CFR part 2, 

subpart B. Those general provisions are 

accompanied by sections pertaining to 

confidentiality for many of the statutes 

administered by the Agency. The TSCAspecific provisions of the Agency’s 

general business confidentiality 

regulations are at 40 CFR 2.306. In 

addition, many of the specific TSCA 

regulations in title 40 of the CFR contain 

their own provisions regarding CBI, 

such as in parts 711 (Chemical Data 

Reporting) and 720 (Premanufacture 

Notification). 

In this proposed rule, most procedural 

requirements for asserting and 

maintaining confidentiality claims 

would be organized into a proposed 

new part of title 40 of the CFR, i.e., in 

part 703. The provisions in proposed 

part 703 would apply to any TSCA 

submission, except as modified 

elsewhere in part 2 or other TSCAspecific regulations, as spelled out in 

this proposed rule. Further discussion 

of the interactions between the various 

provisions regarding confidentiality can 

be found in Unit II.B. of this document. 

D. What are the incremental costs and 

benefits of this action? 

EPA has evaluated the potential 

incremental impacts of this proposed 

rulemaking, including alternative 

options. The details are presented in the 

economic analysis prepared for the 

proposed rule (Ref. 2), which is 

available in the docket and is briefly 

summarized here. 

The benefits of the proposed rule 

include improvements to EPA’s 

management of CBI, specifically in cases 

of deficient claims, and improved 

communication and increased public 

transparency for chemical information. 

The proposed rule is expected to 

decrease the frequency of submitter 

error and increase efficiency in the 

processes for asserting and maintaining 

CBI claims. Lastly, the proposed rule 

would bring TSCA confidentiality 

regulations in line with the changes to 

TSCA section 14 brought about by the 

Lautenberg amendments. 

EPA estimates that the public will 

incur a one-time burden and cost of 

approximately 2,945 hours with an 

associated cost of approximately 

$271,000 in the first year after the rule 

is finalized and an annual, ongoing 

burden of approximately 525 hours with 

an associated cost of approximately 

$45,000 in each following year. 

E. Are there potentially disproportionate 

impacts for children health? 

The proposed rule does not involve 

environmental health or safety risks that 

the EPA has reason to believe may 

disproportionately affect children. 

However, the Agency believes that the 

information collected under this 

proposed rule, if finalized, will assist 

EPA and others in evaluating potential 

hazards and risks associated with 

chemicals. Although not directly 

impacting environmental health or 

safety risks, this information will enable 

the Agency to better protect human 

health and the environment, including 

the health of children. 

F. What are the environmental justice 

impacts? 

This proposed action does not address 

human health or environmental risks or 

otherwise have disproportionately high 

and adverse human health or 

environmental effects on minority 

populations, low-income populations 

and/or indigenous peoples. Although 

not directly impacting environmental 

justice-related concerns, the information 

collected under this proposed rule will 

enable the Agency to better protect 

human health and the environment, 

including in low-income and minority 

communities. 

II. Background 

The Lautenberg amendments 

included several significant changes to 

TSCA section 14. These include 

requirements that persons submitting 

information under TSCA substantiate 

most confidentiality claims at the time 

of submission, as well as additional 

statement, certification, and generic 

name requirements. Under TSCA 

section 14(e), in order to maintain most 

claims beyond a 10-year period, 

submitters are required to reassert and 

resubstantiate those claims. Several new 

requirements also apply to EPA, 

including requirements at TSCA section 

14(g) to review and approve or deny all 

chemical identity claims asserted since 

the Lautenberg amendments were 

enacted concerning substances that are 

offered for commercial distribution, as 

well as a subset of all other 

confidentiality claims, within 90 days of 

assertion of the claim. Further 

requirements that EPA review all 

confidentiality claims for the chemical 

identity of substances listed as active on 

the TSCA Inventory, a requirement to 


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29080 Federal Register / Vol. 87, No. 92 / Thursday, May 12, 2022 / Proposed Rules 

assign and apply unique identifiers 

(UIDs) to substances with approved 

confidentiality claims for chemical 

identity, as well as new provisions 

providing expanded access to TSCA 

CBI, have been discussed in previous 

documents that published in the 

Federal Register, see e.g., Refs. 3 (about 

the CBI review plan), 4 (about UIDs) and 

5 (about expanded access to CBI). 

Additionally, some TSCA regulations 

promulgated or amended since the 

Lautenberg amendments have included 

confidentiality provisions conforming to 

the amendments (e.g., Chemical Data 

Reporting at 40 CFR 711.30 and Active/ 

Inactive Inventory Reporting at 40 CFR 

710.37). 

A. Existing Regulations Governing 

Confidentiality Under TSCA 

As proposed, this rulemaking would 

implement additional requirements of 

the Lautenberg amendments concerning 

confidentiality claims and would apply 

to all TSCA submissions. The proposal 

is intended to clarify the TSCA section 

14 requirements for submitters of TSCA 

confidentiality claims. This would 

reduce the likelihood of claims being 

denied because of procedural 

insufficiencies and facilitate the public 

availability of information for which 

confidentiality is either not requested or 

not allowed under TSCA. The proposed 

procedural rules would aid efficient and 

timely EPA review of confidentiality 

claims and reduce the likelihood of 

inadvertent disclosure of CBI. 

Currently, CBI claims are asserted 

according to TSCA section 14 and 

existing TSCA rule requirements that 

are specific to certain reporting 

requirements (see Unit II.E. of this 

document). In some cases, further claim 

assertion procedures are included in 

EPA’s general CBI regulations at 40 CFR 

part 2. 

The procedures currently used by 

EPA to review TSCA CBI claims are 

found in 40 CFR part 2, subpart B. 

These regulations were developed to, 

among other things, apply Exemption 4 

of the Freedom of Information Act 

(FOIA), 5 U.S.C. 552, relating to 

business confidentiality, to review CBI 

claims in response to a FOIA request. 

Some TSCA-specific provisions in 40 

CFR 2.306 add to or modify the general 

CBI regulations found in 40 CFR 2.201 

through 2.215. 40 CFR 2.306 was last 

modified in 1993. In the absence of 

revisions to accommodate the changes 

introduced by the Lautenberg 

amendments, EPA has continued to use 

the 40 CFR part 2 regulations to 

complete the mandatory confidentiality 

determinations required by the 

Lautenberg amendments. 

The proposed rule would tailor all 

TSCA CBI claim assertion and review 

procedures to the requirements of TSCA 

rules and consolidate them in the TSCA 

rules—primarily in the proposed new 

part 703. 40 CFR 2.306 would be 

reduced in scope. It would clarify that 

most of the general claim assertion and 

review rules found in the 40 CFR part 

2 CBI rules no longer apply to TSCA CBI 

claims and to elaborate on special 

circumstances where CBI may be 

disclosed based on the provisions of 

TSCA section 14(d) (disclosure to states, 

local governments and tribes under 

TSCA section 14(d)(4); health or 

environmental professionals under 

TSCA section 14(d)(5); or to certain 

emergency responders under TSCA 

section 14(d)(6) or as relevant to a 

proceeding under TSCA section 

14(d)(7)). EPA is proposing to retain 

certain notice requirements in 40 CFR 

part 2 that are not required by TSCA 

Section 14. Specifically, under TSCA 

section 14(g)(2)(C)(iii), EPA is not 

required to provide notice prior to 

disclosure of information pursuant to 

TSCA sections 14(d)(1), (2), (7), or (8), 

i.e., to Federal employees or officers, to 

contractors, if relevant to a proceeding, 

or required to be made public under 

other Federal law. EPA is proposing to 

retain certain existing notice 

requirements in 40 CFR part 2 for 

disclosure to Federal employees at 40 

CFR 2.306(d), if relevant to a proceeding 

at 40 CFR 2.306(e), and for contractors 

and subcontractors at 40 CFR 2.306(f). 

Additionally, the consolidation of 

TSCA CBI claim review procedures into 

the proposed new part 703 includes the 

review procedures relating to FOIA 

requests (i.e., CBI claim review required 

by TSCA section 14(f)(2)(A)). CBI claim 

review procedures in 40 CFR 2.306(d), 

(e), and (g), and the procedures in 40 

CFR 2.204 and 2.205 that are currently 

cross-referenced in 40 CFR 2.306 are 

replaced with corresponding provisions 

in the proposed new part 703. 

B. Purpose and Applicability 

EPA intends for the proposed 

requirements to apply broadly to any 

information that is reported to, or 

otherwise obtained by, the Agency 

under TSCA. 15 U.S.C. 2613(a)(1). This 

includes, for example, information that 

is submitted pursuant to a requirement 

of TSCA or its implementing regulations 

(e.g., a TSCA section 5 Premanufacture 

Notification (PMN) or a TSCA section 

8(e) notice of substantial risk), 

information that is collected in the 

course of a TSCA inspection or other 

TSCA enforcement-related activity, and 

materials that are subpoenaed pursuant 

to TSCA. The proposed rule would also 

cover information which is first 

obtained by EPA under an authority 

other than TSCA but which meets the 

following criteria: (1) EPA has authority 

to collect the information under TSCA; 

and (2) the information is either used to 

satisfy the obligation of a person under 

TSCA or used by EPA in the course of 

carrying out its responsibilities under 

TSCA. EPA is proposing to interpret the 

phrase ‘‘that is reported to, or otherwise 

obtained by, the Administrator under 

TSCA’’ to include information that 

meets the two criteria identified above. 

The term ‘‘under’’ is not defined in 

TSCA section 14; therefore, EPA is 

proposing to interpret this term as it is 

commonly used as well as from its 

statutory context. See Kucana v. Holder, 

558 U.S. 233, 245 (2010) (quoting 

Ardestani v. INS, 502 U.S. 129, 135 

(1991)) (‘‘The word ‘under’ ‘has many 

dictionary definitions and must draw its 

meaning from its context.’ ’’). Dictionary 

definitions can provide some insight 

into how a reasonable or ordinary 

person would interpret the term. 

‘‘Under’’ is defined as ‘‘subject to the 

authority, control, guidance, or 

instruction of,’’ under, Merriam-Webster 

Online (2021), and ‘‘subject to’’ is 

defined as ‘‘affected by or possibly 

affected by (something).’’ Subject to, 

Merriam-Webster Online (2021). In 

addition, the broad inclusive language 

used—‘‘reported to, or otherwise 

obtained by’’—suggests that Congress 

intended the provision to apply broadly. 

It applies not only to information 

reported under TSCA but also to 

information obtained under TSCA in 

manners other than reporting. 

Language added to TSCA by the 

Lautenberg amendments also supports 

the proposed interpretation that any 

information EPA has the authority to 

collect under TSCA and is used for 

TSCA purposes should be considered 

obtained ‘‘under’’ TSCA. First, TSCA 

section 4(h)(3)(A) refers to the 

submission ‘‘under this subchapter’’ of 

voluntary information, suggesting 

information need not be required by a 

rule or order to be submitted ‘‘under’’ 

TSCA. Section 26(j) further provides 

that subject to TSCA section 14, the 

Administrator shall make available to 

the public ‘‘a list of the studies 

considered by the Administrator in 

carrying out each such risk evaluation, 

along with the results of those studies.’’ 

15 U.S.C. 2625(j)(4). Moreover, TSCA 

section 26(k) requires the Administrator 

to consider ‘‘reasonably available’’ 

information when conducting a risk 

evaluation. This language appears to 

suggest that TSCA section 14 would 

govern confidentiality determinations 


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for all studies considered by the Agency 

under TSCA section 6(b), regardless of 

where the studies originated or how 

they were obtained. 

However, there may be instances 

where information covered under 

proposed new part 703 was originally 

submitted to EPA pursuant to a statute 

with provisions regarding 

confidentiality, disclosure and 

treatment of information that materially 

differ from those in TSCA. EPA has 

addressed conflicts between regulatory 

provisions in 40 CFR 2.202(d), which 

states that the ‘‘rule which provides 

greater or wider availability to the 

public of the information shall govern,’’ 

and more specifically in the existing 40 

CFR 2.306(b), which provides that 

under the appropriate circumstances 

TSCA provisions would apply to certain 

information originally submitted to EPA 

for some non-TSCA purpose. But under 

the Lautenberg amendments to TSCA, 

EPA will be making use of significant 

amounts of data originating from a 

variety of sources, including existing 

studies submitted under the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA). 

An example of a scenario in which 

such a situation may occur is where a 

health and safety study is originally 

submitted to EPA under FIFRA, but is 

subsequently used for TSCA purposes 

(e.g., in support of a TSCA section 6 risk 

evaluation) and where the health and 

safety study could have been collected 

under a TSCA authority (e.g., pursuant 

to TSCA section 8(d)). Under FIFRA 

section 10(g), the disclosure of such a 

study is limited to protect against 

disclosure to foreign or multinational 

pesticide producers, but if the study 

were submitted under TSCA, much of 

the information in the study would not 

be protected from disclosure under 

TSCA section 14(b)(2). 

The potential for conflict between 

statutory data protection regimes, and 

the potential for disclosure of 

information originally submitted under 

the expectation of specified information 

protection requirements, has greatly 

increased from when the earlier 

regulations were promulgated. EPA 

recognizes that there are several options 

for dealing with these potential 

conflicts. As noted above, EPA is 

proposing that in certain circumstances 

some information obtained under 

authorities other than TSCA are 

information obtained under TSCA. EPA 

also seeks to ensure that when 

information is submitted to EPA under 

a statutory provision that provides an 

assurance of privacy, those privacy 

protections continue to apply even 

when the information is used for a 

different purpose. Cf Food Marketing 

Institute v. Argus Leader Media, 139 

S.Ct. 2356, 2366 (2019) (acknowledging 

the importance of assurances of privacy 

to determinations regarding the 

confidentiality of information). Thus, 

EPA is proposing that when there is a 

conflict between statutory data 

protection regimes, the rules regarding 

the treatment of information in that 

statute under which the information 

was originally collected should 

continue to apply to the information, 

regardless of how it is used by the 

Agency under TSCA. The proposed 

regulations establishing this approach to 

potential conflicts appear in proposed 

section 703.1. In addition, there are 

procedures in TSCA section 14 that 

would be appropriate to apply to such 

data, such as the limited disclosure 

authority, often under confidentiality 

agreements, that is provided by TSCA 

section 14(d). 

Other alternatives on which EPA 

requests comment include the approach 

embodied in 40 CFR 2.202(d) that the 

statute which provides for the greatest 

disclosure of the information governs, or 

the opposite, that the most disclosurerestrictive statute governs. Either 

approach could be implemented by 

applying the most (or least) restrictive 

statute as a whole or by comparing 

specific statutory provisions with TSCA 

section 14 and applying the least (or 

most) restrictive provision on a 

provision-by provision basis. EPA 

believes that the approach presented in 

proposed section 703.1 strikes an 

appropriate balance and provides 

greater clarity, as well as being 

consistent with the disclosure 

requirements applicable when the 

submitter originally provided the 

information to EPA. 

EPA requests comment broadly on 

these and any other options for 

addressing, minimizing, or eliminating 

conflict between provisions under 

different statutes regarding 

confidentiality, disclosure, and 

treatment of information, including but 

not limited to alternative statutory 

interpretations, principles that should 

govern the resolution of conflicts, and 

options for resolving specific conflicts. 

EPA specifically requests comment on 

whether the proposed approach 

appropriately balances transparency 

under TSCA while also ensuring 

appropriate protections for information 

obtained initially under another statute 

consistent with the assurance of privacy 

implicitly or explicitly provided by the 

government when such information is 

obtained. See Food Marketing Institute 

v. Argus Leader Media, 139 S.Ct. 2356, 

2366 (2019). 

EPA also specifically seeks public 

comment on the proposed scope of the 

rulemaking, particularly that 

information originally obtained without 

the use of a TSCA authority is 

nevertheless obtained under TSCA if the 

Agency has the authority to collect the 

information and it was used for a TSCA 

purpose. EPA is also seeking comment 

on whether EPA needs to exercise its 

TSCA authority or invoke its TSCA 

authority in the original information 

collection in order for information to be 

covered by TSCA section 14. EPA also 

seeks public comment on the proposed 

treatment of information that was 

originally submitted under another 

statute, as well as the alternatives 

identified. EPA is particularly interested 

in comments on how studies that were 

originally submitted under FIFRA 

should be treated under the TSCA 

regulations. 

Finally, EPA is interested in 

comments on whether and, if so, how 

the term ‘‘TSCA submission’’ should be 

defined in proposed section 703.3. 

C. Requirements for Asserting a 

Confidentiality Claim 

TSCA section 14(c) governs assertion 

of confidentiality claims for TSCA 

submissions. This provision requires 

that persons submitting information 

under TSCA substantiate most 

confidentiality claims at the time of 

submission. It also includes additional 

certification and generic name 

requirements. These and related 

requirements are elaborated upon in 

Unit III.C. 

1. Assertion of Confidentiality Claim 

Upon Submission of Information to EPA 

TSCA section 14(c)(1)(a) requires an 

affected business to assert a claim for 

protection from disclosure concurrent 

with submission of the information. 

Consistent with this provision, 

proposed section 703.5 would require 

that confidentiality claims be asserted at 

the time of submission. If no such claim 

is made, the information may be made 

available to the public without prior 

notice to the person who submitted the 

information. While similar language 

appears in some of the existing 

regulations that implement TSCA (e.g., 

40 CFR 711.30(e)), this proposal would 

clarify that the up-front assertion 

requirement is applicable to all nonexempt TSCA CBI claims, in accordance 

with TSCA section 14(c)(1)(A). 

Proposed section 703.5 would further 

clarify and reiterate that where a TSCA 

submission identifies a chemical 

substance listed on the confidential 

portion of the TSCA Inventory but does 

not assert a confidentiality claim for the 


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chemical identity as required by TSCA 

section 14 or in the manner required by 

the applicable rule (see, e.g., 40 CFR 

711.30), the specific chemical identity 

would no longer be eligible for 

confidential treatment on the TSCA 

Inventory. This would not apply where 

the submission does not pertain to 

manufacture or processing for 

commercial purposes, e.g., research and 

development. 

The TSCA Inventory is a list of 

chemical substances manufactured or 

processed for a commercial purpose. A 

substance may be afforded confidential 

Inventory treatment (e.g., listing by 

generic name and accession number) so 

long as the fact that anyone 

manufactures or processes that 

substance for commercial purposes in 

the United States has not been disclosed 

to the public. By making a nonconfidential report of having 

manufactured or processed a particular 

substance, the reporter in effect 

discloses their activities concerning the 

substance to the public and renders the 

substance ineligible for continued 

confidential Inventory treatment. EPA 

would update the TSCA Inventory to 

publicly list the specific chemical name 

and Chemical Abstracts Service Registry 

Number (CASRN), if available, without 

further notice (to any person who may 

have made a CBI claim for this 

substance). (Updates to individual 

submissions that contain a prior claim 

for what appears to be the same 

information would occur only after that 

claim is withdrawn or as result of a 

review and final determination in 

accordance with TSCA section 14 

denying the claim in that submission.) 

Under some existing rules, once the 

chemical identity is listed on the public 

portion of the TSCA Inventory, claims 

can no longer be asserted for such 

information (see, e.g., 40 CFR 

711.30(a)(2)(i)). This is also intended to 

clarify that the Agency will not provide 

notice to submitters with previously 

approved or pending claims for the 

same chemical identity prior to such 

disclosure on the TSCA Inventory. 40 

CFR 711.30(a)(2)(i)). In addition, other 

chemical identity CBI claims for the 

substance would likely be denied upon 

review. However, claims for information 

related to the chemical identity, e.g., the 

identity of the submitter, would not be 

precluded. 

2. Substantiation and Exemptions 

EPA previously published an 

interpretation concerning the 

requirement to substantiate CBI claims 

in TSCA section 14(c)(3), see (Ref. 6). In 

that document, EPA stated that the 

statute requires persons asserting CBI 

claims to substantiate those claims at 

the time the affected business submits 

the claimed information to EPA. This 

proposed rule, in proposed section 

703.5(b)(1), would make EPA’s TSCA 

confidentiality regulations consistent 

with TSCA section 14(c)(3). 

Subsequent to the interpretation that 

published in the Federal Register of 

January 19, 2017 (Ref. 6), some TSCA 

rules were updated to include a set of 

required substantiation questions and 

apply the substantiation exemptions in 

TSCA section 14(c)(2). See, e.g., 

Chemical Data Reporting at 40 CFR 

711.30. This proposed rule includes a 

standard set of substantiation questions 

in proposed sections 703.5(b)(3) and (4) 

that would be applicable to any 

confidentiality claim in any TSCA 

submission for which substantiation is 

required and includes additional 

substantiation questions specific to 

chemical identity claims. However, 

proposed section 703.4(b)(3) would 

provide that individual TSCA rules may 

modify the questions (by, for example, 

not requiring answers to substantiation 

questions that are not applicable in a 

particular TSCA submission type). 

The substantiation questions in 

proposed sections 703.5(b)(3) and (4) 

have been designed to elicit information 

to allow EPA to determine whether the 

submitter’s claim for confidentiality 

meets the substantive review criteria set 

forth in proposed section 703.7(f). EPA 

is interested in public comment 

concerning the proposed question set, 

including whether some questions 

might be consolidated or revised to 

minimize burden while also assuring 

responses are adequate to support a 

confidentiality determination (i.e., 

according to the criteria in proposed 

section 703.7(f)). The questions 

proposed here are similar to those 

included in the 2020 amendments to the 

Chemical Data Reporting (CDR) rule (see 

40 CFR part 711) which the Agency 

believes are adequate to support its 

review of confidentiality claims in those 

submissions. 

a. Patents 

EPA is proposing a question on 

patents in proposed section 

703.5(b)(3)(iii)(C) and is seeking 

comment on alternatives to the 

proposed question language, or whether 

a standalone patent question is 

necessary at all. The Agency requests 

comment on whether a standalone 

patent question is necessary or if it can 

be reasonably added to the publications 

question found in proposed section 

703.5(b)(3)(iii)(B). In the Agency’s 

experience, patents related to 

information claimed as CBI under TSCA 

rarely if ever disclose information in the 

same context or with the same level of 

detail as in the related TSCA 

submission. The Agency notes that 

asking whether information appears in 

a patent is not the same thing as asking 

whether the information is covered by a 

patent. For the purposes of TSCA 

confidentiality claims, the Agency is 

interested in both whether the same 

information claimed to be confidential 

in the TSCA submission appears in a 

patent and whether it is covered by a 

patent. More specifically, if the exact 

same information appears in both a 

published patent and in the TSCA 

submission, then the information 

should not be entitled to confidential 

treatment. Also, if the information is 

covered (i.e., legally protected) by a 

patent in such a way that no substantial 

harm to the competitive position of the 

business would result from the release 

of the information, then the information 

is not subject to confidential treatment 

on that ground as well. If the question 

of whether TSCA information claimed 

as CBI can both appear in and be 

covered by a patent without destroying 

the CBI claim can always be answered 

with a yes or no response with no 

additional explanation, then a 

standalone patent question may not be 

necessary. The Agency seeks comment 

from submitters explaining why they 

believe existence of a patent that 

contains and covers the information 

claimed CBI should not affect the ability 

of the submitter to the claim the same 

information as CBI under TSCA. 

Alternatively, the Agency requests 

comment on whether the standalone 

patent question used in the 2020 CDR 

rule (40 CFR 711.30) and proposed 

section 703.5(b)(3)(iii)(C) is adequate, or 

whether can be improved to elicit more 

pertinent responses from submitters 

regarding the potential public disclosure 

in a patent of the information claimed 

confidential in the TSCA submission. 

The existing question is as follows: Does 

any of the information claimed as 

confidential appear in one or more 

patents or patent applications? If yes, 

provide the associated patent number or 

patent application number (or numbers) 

and explain why the information should 

be treated as confidential. 

Particularly, the Agency would like to 

know how a company would be 

reasonably likely to suffer substantial 

competitive harm if the information is 

released under TSCA if the company 

already enjoys legal protections against 

competitors for patent infringement. 

Further, should the patent question 

elicit substantiation to explain why the 

information claimed to be confidential 

in the TSCA submission is not actually 


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revealed in the particular patent? The 

Agency proposes the following as an 

alternative substantiation question: Has 

a patent been published for the 

chemical identity you claim 

confidential? What chemical identity 

information is not revealed by the 

patent? How is release of that specific 

information likely to cause substantial 

competitive harm? Failure to explain 

this harm may lead to denial of your 

confidentiality claim. 

The Agency requests comment on 

whether the proposed alternative 

question is more likely to elicit 

pertinent responses on the relevance of 

a patent and invites suggestions that 

may help improve how the Agency 

considers patents in its CBI reviews. 

b. Trade Secrets 

EPA has observed that the question 

concerning trade secrets found in 

several existing TSCA rules, e.g., at 40 

CFR 711.30(b)(4), tends to elicit answers 

that are either redundant with the 

answers to other substantiation 

questions, or otherwise do not tend to 

include information that is useful for 

the agency to consider whether the 

information meets the specific legal 

standard for trade secrets. This is rooted 

in confusion about trade secrets and 

CBI, which are distinct but related 

concepts. 

TSCA section 14(a) invokes FOIA 

Exemption 4 as a ceiling for protecting 

business information. Exemption 4 

protects ‘‘trade secrets and commercial 

or financial information obtained from a 

person and privileged or confidential.’’ 

5 U.S.C. 552(b)(4). Trade secrecy has 

long been held as grounds for 

Exemption 4 protection distinct from 

that for ‘‘commercial or financial 

information obtained from a person and 

privileged or confidential.’’ See, e.g., 

Public Citizen Health Research Group v. 

FDA, 704 F.2d 1280, 1286 (D.C. Cir. 

1983). 

A trade secret has been defined by the 

D.C. Circuit as ‘‘a secret, commercially 

valuable plan, formula, process, or 

device that is used for the making, 

preparing, compounding, or processing 

of trade commodities and that can be 

said to be the end product of either 

innovation or substantial effort.’’ Public 

Citizen at 1288. This definition also 

incorporates a requirement that there be 

a ‘‘direct relationship’’ between the 

trade secret and the productive process. 

CBI is defined by 5 U.S.C. 552(b)(4) as 

information that is (a) commercial or 

financial, (b) obtained from a person, 

and (c) privileged or confidential. The 

U.S. Supreme Court has addressed the 

meaning of the word ‘‘confidential’’ in 

5 U.S.C. 552(b)(4) stating that 

‘‘confidential’’ must be given its 

‘‘ordinary’’ meaning, which is 

information that is ‘‘private’’ or 

‘‘secret.’’ Food Marketing Institute v. 

Argus Leader Media, 139 S. Ct. 2356, 

2363 (2019). The Court held that at least 

where commercial or financial 

information is both customarily and 

actually treated as private by its owner 

and provided to the government under 

an assurance of privacy, the information 

is ‘‘confidential’’ within the meaning of 

FOIA Exemption 4. Food Marketing at 

2366. In addition, TSCA section 14 

requires the submitter to demonstrate 

that it has a reasonable basis to 

conclude that disclosure of the 

information is likely to cause substantial 

harm to the competitive position of the 

business. 

While the trade secret standard and 

CBI standard could theoretically 

provide two avenues to protect 

information from disclosure, EPA is not 

aware of any situation where 

information submitted under TSCA was 

determined to be entitled to trade secret 

protection but not CBI protection. EPA 

does not believe that asking a specific 

trade secret question for TSCA 

confidentiality substantiations will 

generate useful information because of 

the considerable overlap between the 

two standards. EPA seeks comment on 

whether the trade secret question still 

has value in the context of TSCA 

confidentiality claims. 

c. Specificity of Competitive Harm 

In order to properly evaluate the 

various CBI claims in a single 

submission, EPA needs a separate 

explanation from the submitter for each 

type of information claimed as 

confidential to explain why disclosure 

of that information would be likely to 

cause substantial competitive harm. To 

that end, EPA proposes two versions of 

the substantiation question concerning 

substantial competitive harm in this 

rulemaking. The first version of the 

question comes directly from the CDR 

rule, which states: ‘‘will disclosure of 

the information claimed as confidential 

likely cause substantial harm to your 

business’s competitive position? If you 

answered yes, describe the substantial 

harmful effects that would likely result 

to your competitive position if the 

information is disclosed, including but 

not limited to how a competitor could 

use such information, and the causal 

relationship between the disclosure and 

the harmful effects.’’ 40 CFR 711.30(b). 

The second version for consideration 

is in proposed section 703.5(b)(3)(i): 

Please specifically explain what harm to 

the competitive position of your 

business would be likely to result from 

the release of the information claimed as 

confidential. How would that harm be 

substantial? Why is the substantial harm 

to your competitive position likely (i.e., 

probable) to be caused by release of the 

information rather than just possible? If 

you claimed multiple types of 

information to be confidential (e.g., site 

information, exposure information, 

environmental release information, etc.), 

explain how disclosure of each type of 

information would be likely to cause 

substantial harm to the competitive 

position of your business. 

The version of the question in 

proposed section 703.5(b)(3)(i) may 

enable EPA to better determine whether 

disclosure of the information is likely to 

cause substantial harm to the 

competitive position of the submitter. 

For purposes of this question, the term 

‘‘substantial’’ means ‘‘of considerable 

importance.’’ Oxford English Dictionary 

(2021). ‘‘Likely’’ means ‘‘probable.’’ 

Oxford English Dictionary (2021). The 

last portion of the question is intended 

to help submitters explain how each 

type of information claimed confidential 

could harm the business if released. For 

instance, the harm to the business that 

could result from release of a 

confidential chemical identity may be 

different from the harm that could result 

from release of information concerning 

the number of workers exposed to the 

chemical during processing. 

EPA requests comment from 

submitters and the public on which of 

the two proposed versions of the 

question would be most likely to elicit 

information from submitters that will 

best allow EPA to determine that the 

submitter has demonstrated a 

reasonable basis to conclude that 

disclosure of the information is likely to 

cause substantial harm to the 

competitive position of its business. 

EPA is also seeking comment on how 

‘‘substantial’’ and ‘‘likelihood’’ should 

be defined. 

d. Exemptions 

The proposed section 703.5(b)(5) 

addresses the TSCA section 14(c)(2) 

exemptions from the substantiation 

requirement. This proposed provision 

includes criteria for the exemption in 

TSCA section 14(c)(2)(G) pertaining to 

substances that have not been offered 

for commercial distribution. The other 

proposed exemptions include: 

• Specific information describing the 

processes used to manufacture or 

process a chemical (e.g., information 

reported under 40 CFR 720.45(g)(2)); 

• Marketing and sales information 

(note that submitting company 

identifiers are not generally themselves 


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considered marketing and sales 

information); 

• Information identifying a supplier 

or customer (such as the identities of 

some joint submitters reporting 

information under 40 CFR720.40(e) or 

711.15); 

• Details on mixture composition and 

percentage (such as might be included 

in a TSCA section 8(e) notice of 

substantial risk that concerns a 

mixture); 

• Specific chemical substance use 

information (such as is required to be 

reported under 40 CFR 720.45(f) and 

725.155(g)); and 

• Specific production or import 

volumes (such as are required to be 

reported under 40 CFR 711.15 and 

720.45(e). 

EPA expects to update the reporting 

forms and applications for most TSCA 

submissions to prompt the submitter for 

substantiation where required, but not 

to prompt the submitter for types of data 

the Agency has concluded are always 

covered by a substantiation exemption. 

3. Public Copies of Submissions 

In proposed section 703.5(c), EPA 

proposes to require public copies of 

submissions that include confidentiality 

claims. The proposed rule would not 

require preparation of a separate public 

copy where the reporting form or 

electronic reporting application 

contains a specific CBI designation 

identifying specifically what is claimed 

as CBI. However, where the submission 

is made without the use of such a TSCA 

reporting form (e.g., subpoena 

responses), or includes attachments or 

other ‘‘non-fielded’’ data, the submitter 

would be required to produce and 

submit a public (sanitized) copy of the 

submission and/or attachments. Some 

existing TSCA rules already include 

such a requirement. See, e.g., 40 CFR 

720.40(d)(2) and 716.55(b). This 

proposed rule would consolidate 

existing requirements in proposed new 

part 703 and extend them generally. 

The proposed provision would also 

provide that the sanitized version would 

have to redact only that information that 

is claimed as confidential. Any 

information not included in the 

sanitized version, or redacted from the 

sanitized version, must be subject to a 

confidentiality claim and as such must 

be substantiated as described in this 

unit. It further states that a public copy 

that redacts all or substantially all of the 

original submission would most likely 

not meet the requirements of the rule 

because it is unlikely that all of the 

information in a form or attachment can 

be appropriately claimed CBI. 

Additionally, any information not 

included in or redacted from a public 

copy is subject to the supporting 

statement in TSCA section 14(c)(1)(B) 

and the certification requirement in 

TSCA section 14(c)(5). False statements 

may give rise to criminal liability under 

18 U.S.C. 1001. 

4. Supporting Statement and 

Certification 

TSCA section 14(c)(1)(B) requires that 

each claim of confidentiality be 

accompanied by a standard supporting 

statement regarding the eligibility of the 

information for confidential treatment. 

TSCA section 14(c)(5) also requires a 

certification that the TSCA section 

14(c)(1)(B) statement and information 

required to substantiate the claim under 

TSCA section 14(c)(3) are true and 

correct. (See explanation in Unit III.A.2. 

of the preamble to the CDR rule (Ref. 7)). 

This supporting statement and 

certification language has already been 

incorporated in most TSCA reporting 

forms (example available at https://

www.epa.gov/tsca-cbi/making-cbiclaims-tsca-submissions#howto). To the 

extent that the submission is not being 

made on such a reporting form (e.g., a 

subpoena response), proposed section 

703.5(a) provides language that may be 

included in a cover letter or other 

attachment to a submission. 

5. Generic Names 

TSCA section 14(c)(1)(C) requires the 

submission of a generic name any time 

a specific chemical identity is claimed 

as confidential. This provision further 

requires that the generic name be 

‘‘structurally descriptive’’ and that it 

‘‘describe the chemical structure [. . .] 

as specifically as practicable’’ while also 

protecting the features of the chemical 

substance that are claimed confidential 

or where disclosure would likely cause 

substantial harm. 15 U.S.C. 

2613(c)(1)(C)(ii). The generic name must 

also be consistent with the generic name 

guidance developed in accordance with 

TSCA section 14(c)(4)(A), 15 U.S.C. 

2613(c)(1)(C)(i). See Refs. 8, 9 and 10. 

The generic name guidance document 

provides information to assist 

companies in creating structurally 

descriptive generic names for chemical 

substances whose specific chemical 

identities are claimed confidential, for 

the purposes of protecting the specific 

chemical identities from disclosure 

while describing the chemical substance 

as specifically as practicable, and for 

listing substances on the TSCA 

Chemical Substance Inventory. The 

proposed rule acknowledges that the 

TSCA Inventory already includes 

generic names for confidential 

substances, and that in most cases, such 

generic names are expected to be 

acceptable for the purposes of 

compliance with TSCA section 

14(c)(1)(C) (possible exceptions may 

include generic names for some 

substances added to the TSCA Inventory 

prior to June 22, 2016, which would be 

addressed under proposed section 

703.5(d)(2)). 

For substances that are not on the 

TSCA Inventory (e.g., new chemical 

submissions under TSCA sections 5 or 

8(e) submissions concerning pre-market 

chemical substances), the proposed rule 

includes a few basic criteria, drawn 

mainly from the TSCA section 

14(c)(4)(A) guidance (e.g., the generic 

name should mask only the confidential 

portions of the specific chemical name, 

generally only one structural element of 

a specific chemical name may be 

masked to protect a confidential 

chemical identity), and would require 

that where the submitter believes those 

criteria are in some way inappropriate 

or inapplicable to a particular substance 

or generic name, the submission must 

also include an explanation for why 

more extensive masking of the specific 

chemical identity is necessary in the 

particular case. 

In proposed section 703.5(d)(3), EPA 

is also proposing that where a generic 

name submitted for a substance that is 

not on the TSCA Inventory is acceptable 

for the purposes of meeting the 

requirements of TSCA section 

14(c)(1)(C), the generic name might 

nonetheless be later subject to 

additional review and potential change 

when commercial manufacture of the 

substance is commenced (e.g., when a 

Notice of Commencement (NOC) is 

submitted). Further procedures and 

requirements for review and acceptance 

of generic names submitted with an 

NOC are elaborated in proposed 

revisions to 40 CFR 720.102 and 

725.190, As discussed in Unit II.E.5. 

Finally, in proposed section 

703.5(d)(4), EPA is proposing to provide 

an opportunity to revise proposed 

generic names that EPA concludes are 

not in compliance with 15 U.S.C. 

2613(c)(1)(C). EPA would provide an 

electronic notice of the deficiency to the 

submitting company, who would then 

be afforded ten days to propose a 

revised generic name. If the submitter 

does not submit a compliant generic 

name, EPA would reject the underlying 

submission and may ultimately deny 

the CBI claim. (See discussion in Unit 

III.C.4. and proposed section 703.5(e) on 

deficient submissions.) 

6. Deficient Submissions 

In proposed section 703.5(e), EPA is 

proposing to specify that confidentiality 


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claims, identified for review pursuant to 

proposed section 703.7(a), that are 

missing the certification, substantiation, 

or generic name (where applicable) 

required by TSCA section 14(c) will be 

considered deficient. Submissions that 

are missing a public copy or where the 

public copy does not meet the 

requirements of proposed section 

703.5(b)(6) would also be considered 

deficient-EPA has observed many 

instances where the attachments to 

TSCA submissions appear over-redacted 

(e.g., public copies of health and safety 

studies or the Safety Data Sheets (SDSs) 

that are often provided with TSCA 

section 5 PMN submissions might be 

entirely or largely blank). This level of 

redaction is rarely if ever consistent 

with the limitations that TSCA section 

14(b) places on CBI protections for 

health and safety information. 

Submissions that include a generic 

name that does not meet the 

requirements of proposed section 

703.5(d) or rely on inappropriate 

substantiation exemption assertions 

would also be considered deficient. 

EPA anticipates that electronic 

reporting requirements, coupled with 

modifications to new and existing 

reporting forms to incorporate the 

certification statements and prompt for 

substantiation and generic names, will 

eliminate most such deficiencies. 

However, to the extent TSCA 

submissions are occasionally still made 

on paper or are not made using a TSCA 

form for which entries can be 

automatically validated (e.g., 

unformatted information in attachments 

to TSCA forms, such as health and 

safety study reports or SDSs), such 

deficiencies may still occur. EPA is 

proposing that when such deficiencies 

are identified, EPA would initially place 

a hold on the submission. 

In such an instance, EPA would 

provide notice of the deficiency to the 

submitter and provide them with a ten 

(10) business day opportunity to fix the 

deficiency. Meanwhile, any applicable 

review periods for the underlying 

submission and for the confidentiality 

claim would be suspended while the 

hold is in place. For example, if EPA 

held a PMN for an inadequate public 

copy, both the CBI review period and 

the 90-day review period for the PMN 

would be suspended until either (1) the 

deficiency in the CBI claim is remedied, 

or (2) ten (10) business days pass 

without the deficiency being remedied. 

If the deficiency is not remedied 

within ten (10) business days of EPA 

providing the notice of deficiency, EPA 

will resume the review of the 

submission and will likely deny the CBI 

claim(s). 

EPA is interested in public comment 

on this approach to claim deficiencies, 

and on alternative approaches, such as 

strictly interpreting the requirements of 

TSCA section 14(c) as necessary to 

making a valid confidentiality claim 

(i.e., claims that don’t meet the 

requirements of TSCA section 14(c) 

would not be recognized, and could 

thereby be released to the public 

without prior notice to the submitter). 

Additionally, EPA is not proposing a 

time window in which the Agency may 

identify deficiencies, which potentially 

leaves open the possibility that a 

deficiency is identified, for example, on 

day 45 of the review period for the 

underlying submission. EPA is 

particularly interested in public 

comment on whether a time period for 

identifying deficiencies, e.g., between 

10 to 15 business days from the date of 

submission, would be appropriate. 

7. Electronic Reporting 

Most TSCA submissions must now be 

made electronically, using various 

reporting tools built into CISS 

(Chemical Information Submission 

System, EPA’s web-based reporting tool 

for preparing and submitting TSCA 

submissions) and submitted via EPA’s 

CDX system (Central Data Exchange, 

EPA’s centralized electronic document 

reporting portal). The proposed section 

703.5(f) would fill most of the current 

gaps in electronic reporting 

requirements by requiring that nearly all 

TSCA confidentiality claims be asserted 

electronically. For example, while 

current TSCA section 8(e) notices of 

substantial risk may be made either on 

paper or via an optional electronic 

reporting form, EPA is proposing that all 

TSCA section 8(e) notices that include 

a confidentiality claim would be 

required to be submitted electronically, 

using an EPA-provided reporting tool. 

Similarly, electronic reporting 

applications would be developed or 

updated for TSCA section 12(b) notices 

of export and TSCA section 5 polymer 

exemption notifications. Means of 

providing information via CDX relating 

to TSCA section 6 prioritization, risk 

evaluation, and risk management have 

already been made available. These new 

and updated reporting applications 

would be available by the time the new 

electronic reporting provisions become 

effective. This proposal would expand 

the electronic reporting requirement to 

all TSCA section 12(b) notices of export 

and TSCA section 5 polymer exemption 

notifications (whether or not they 

include confidentiality claims), thereby 

closing most remaining gaps in 

electronic reporting requirements under 

TSCA. A discussion on the benefits of 

electronic reporting under TSCA 

relevant to the expansion described in 

this proposed rule was provided in a 

previous document (Ref. 1). Some 

exceptions to the general requirement to 

report CBI-containing materials 

electronically will remain, such as for 

materials that EPA has subpoenaed or 

requested or collected in the course of 

a TSCA inspection, which may be 

collected in person, and/or in a format 

or volume that makes electronic 

submission impractical. 

Closing these gaps in electronic 

reporting is intended to reduce the 

likelihood of submitter error when 

asserting a confidentiality claim, 

facilitate EPA’s ability to review 

confidentiality claims in a timely 

manner, reduce resources required to 

process, handle, and store TSCA 

submissions, reduce the opportunity for 

errors related to the handling of CBI, 

facilitate public access to information 

not claimed as CBI, and enable or 

enhance EPA and TSCA submitters’ 

ability to promptly communicate about 

the status of confidentiality claims in 

the submission in the future. EPA will 

enhance its current practice of assigning 

a document or ‘‘case’’ number to each 

TSCA submission (e.g., P–20–0XXX or 

8EHQ–2020–0XXXX) by assigning and 

making that submission identifier 

available to the submitter within the 

submitter’s CDX account. 

As stated above, EPA is proposing to 

require any information or materials not 

obtained under TSCA section 11 to be 

submitted through CDX if they contain 

a TSCA CBI claim. The Agency is 

requesting public comment broadly on 

this approach, and on whether there are 

scenarios the Agency should consider 

where a person providing TSCA CBI to 

EPA via an irregular means (e.g., a 

letter) would not be able to or would 

face substantial difficulties in using 

CDX to submit information claimed CBI. 

8. Requirement To Report Health and 

Safety Information Using Harmonized 

Templates 

In proposed section 703.5(g), EPA is 

proposing a requirement to provide 

health and safety studies and 

information from health and safety 

studies in a templated format, using 

Organisation for Economic Co-operation 

and Development (OECD) Harmonized 

Templates, where an applicable 

template is available. See https://

www.oecd.org/ehs/templates/ 

harmonised-templates.htm. EPA is 

interested in comment on this proposed 

requirement. Many TSCA submitters 

may be familiar with and already have 

created templated versions of health and 

safety study reports they may be 


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required to submit under TSCA, owing 

to reporting requirements in other 

countries. For these submitters, the 

burden associated with this requirement 

to submit templated data is expected to 

be minimal. EPA anticipates that data 

that has been put into one of these 

standardized templates will be more 

readily used and shared within the 

Agency, and (where permitted by 

confidentiality restrictions and other 

agreements) across jurisdictions. In 

addition, CBI clams may be more clearly 

indicated if asserted via a templated 

format (e.g., CBI claims could be 

indicated by checking a box for each 

discrete data element, rather than by 

redacting sections of text piecemeal 

from a study report line by line). It 

should be noted, however, that the 

proposed requirement to provide data in 

a templated format does not supersede 

existing regulatory requirements to also 

submit a full study report, such as the 

present requirement for TSCA section 4 

test reports. 

EPA is soliciting public comment on 

the proposed requirement that 

information obtained from a study, in 

addition to whole study submissions, be 

provided in templated form to the 

Agency. EPA is also interested in public 

comments on the requirement that 

submitters identify the ‘‘appropriate’’ 

OECD template for a particular 

submission. 

9. Maintenance of Company Contact 

Information and Communications 

Concerning Claims 

From time to time, EPA needs to 

contact a company about CBI claims 

made in a TSCA submission. These 

contacts may be made relatively soon 

after submission, in order to clarify 

something about a claim or provide an 

opportunity to correct a deficiency with 

the claim (see proposed section 

703.5(e)), or they may be required 

notifications made months or years 

later, such as a notice concerning a 

denied confidentiality claim, or a notice 

concerning a pending confidentiality 

review under TSCA section 14(f). In the 

future, EPA will also need to contact or 

notify companies about expiring 

confidentiality claims, pursuant to 

TSCA section 14(e). For all of these 

reasons, it is important for EPA to have 

current contact information for the 

submitter of each TSCA submission and 

an efficient means for satisfying the 

notice requirements under the statute. 

EPA is proposing to require companies 

to maintain current contact information 

for all individuals associated with a 

submission (which reinforces and 

complements existing CDX terms and 

conditions concerning maintenance of 

CDX accounts, particularly the 

requirement to notify EPA when 

individual account access is no longer 

needed so that the account can be 

deactivated; see https://cdx.epa.gov/ 

Terms), enhance the means by which 

companies update contact information, 

and require the submission of notices of 

transfer of ownership via CDX. 

In light of the significant resources 

and document tracking concerns related 

to continuing to largely rely on paper 

correspondence for such 

communication and notifications, the 

rulemaking proposes that most such 

correspondence would be electronic, via 

CDX. See proposed section 703.5(h). 

‘‘Two-way’’ communication via CDX 

provides a secure means for EPA and 

companies to correspond about a TSCA 

submission or confidentiality claims. 

EPA can more readily assure that a 

communication is available to a 

company or specific submitter by using 

CDX to communicate, rather than 

certified mail or a courier. In CDX, EPA 

is able to verify that a particular 

communication is available to the 

submitter of a particular submission and 

is able to track the date the 

communication was sent. EPA believes 

that these facts satisfy the requirement 

in TSCA section 14(g)(2)(A) that 

notification, including for the denial of 

a confidentiality claim, be sent by 

means that ‘‘allows verification of the 

fact and date of receipt.’’ This would be 

the case even if EPA does not receive a 

‘‘read receipt’’ or cannot otherwise 

verify that the submitter opened the 

electronic notice, much as EPA cannot 

verify whether or when a recipient of 

certified mail opens the envelope and 

reads the contents. 

The proposed rule describes how EPA 

expects to furnish the required notices 

concerning expiration of confidentiality 

claims under TSCA section 14(e). The 

first expirations will occur in 2026, for 

claims that were asserted in 2016 and 

that were not exempt from 

substantiation and review according to 

TSCA sections 14(c)(2) and 14(g). As 

proposed, EPA would periodically 

publish a list of TSCA case numbers 

that are approaching claim expiration 

on the EPA website, or other 

appropriate platform. In addition, EPA 

intends to send individual notices of 

upcoming claim expiration and other 

individual notices concerning CBI 

claims to the company via CDX. 

The proposed rule includes similar 

notice and communication provisions 

for when review of claims is initiated 

under TSCA section 14(f) (e.g., in 

response to a FOIA request for 

information that has been claimed as 

confidential). EPA would provide any 

necessary notice of review and/or 

opportunity to substantiate or 

resubstantiate to the Authorized Official 

or Technical Contact listed on the most 

recent version of the submission (or as 

listed in a more recent notice of transfer 

of ownership relating to that 

submission), along with instructions for 

response. Alternatively, if the 

submission with the relevant CBI claim 

is not associated with a CDX account, 

EPA would send the notice via CDX to 

the company contact provided in the 

most recent TSCA submission made by 

that company. 

For TSCA submissions that were not 

originally made via CDX, EPA is 

proposing to send the notice by certified 

mail or courier to the address provided 

in the most recent TSCA submission 

from that company, or via other means 

that allows verification of the fact and 

date of receipt. For example, EPA is also 

considering further development of twoway CDX communication to permit EPA 

to also send these notices, likely using 

the contact information in the most 

recent CDX submission from the same 

company. 

10. Withdrawing Claims 

TSCA confidentiality claims may be 

voluntarily withdrawn by the submitter 

at any time. See 15 U.S.C. 

2613(e)(1)(A)(i) and (B)(ii)(I). Proposed 

section 703.5(i) includes instructions for 

voluntarily withdrawing confidentiality 

claims prior to automatic expiration or 

denial. The preferred approach is for the 

company to amend the submission 

electronically, via CDX, to withdraw the 

claims (i.e., ‘‘uncheck’’ the CBI boxes or 

unredact the submission and resubmit 

it). When this is not possible (for 

example, when the submission was not 

originally submitted via CDX, or 

because the company does not have 

access to the electronic submission), 

claims may be withdrawn by CDX 

submission as well, using a new 

correspondence tool that enables 

efficient linking of the withdrawal letter 

with the related submission, and 

permits EPA to communicate with the 

company about the withdrawal (e.g., if 

clarification is needed). 

11. Amending a Public Copy Following 

Claim Denial or Expiration 

Following the denial or expiration of 

a confidentiality claim, the public copy 

of the submission must be revised to 

provide public access to the newly nonCBI information. For some electronic 

submissions this may be a more or less 

straightforward process of un-checking 

some boxes and generating a new public 

copy of the submission, but for other 

TSCA submissions, the denied or 


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expired claims may be intermingled 

with still-valid or approved claims, or 

the claims may have been indicated by 

numerous redactions throughout a 

voluminous text. The proposed rule (see 

proposed section 703.5(j)) would 

encourage companies to prepare this 

updated public copy themselves. EPA 

believes that submitters are in the best 

position to assert and indicate their 

remaining claims accurately. However, 

in the case that the submitter is 

unavailable or otherwise unable to 

update the public copy, the proposed 

rule makes clear that EPA will 

undertake this function, as needed. 

EPA invites comment on the option of 

requiring TSCA submitters to update 

their original submission to reflect CBI 

claims that have been withdrawn or 

denied. 

D. EPA Review of Confidentiality Claims 

1. Representative Subset 

TSCA section 14(g)(1)(A) requires that 

EPA approve or deny confidentiality 

claims, except for claims exempt from 

review under TSCA section 14(c)(2). 

TSCA section 14(g)(1)(C) further 

specifies that EPA review all 

confidentiality claims for chemical 

identity (except those exempt under 

TSCA section 14(c)(2)(G)) and a 

‘‘representative subset’’ comprising at 

least 25% of all other claims, with the 

exception (as provided in TSCA section 

14(g)(1)(A)) of information exempted 

from substantiation under TSCA section 

14(c)(2). 

Proposed section 703.7 would codify 

EPA’s current practice of reviewing all 

claims (except those exempt from 

substantiation requirements under 

TSCA section 14(c)(2)) in every fourth 

submission received via CDX that 

contains CBI claims besides those 

pertaining to chemical identity. 

Consistent with current practice, 

submissions with CBI claims not 

submitted through CDX would be 

excluded from the representative subset. 

As explained above, all submissions 

other than those submitted pursuant to 

TSCA section 11 will be required to be 

submitted through CDX (see proposed 

section 703.5(f)), so the Agency believes 

that only a small number of infrequent 

TSCA submissions would not be 

included in the total number of claims 

received for purposes of determining the 

representative subset. Moreover, these 

materials are not representative of TSCA 

submissions because they are collected 

irregularly, from widely spread 

geographic locations, may be 

voluminous, provided in multiple 

batches, be of assorted media type 

(photos, large maps, etc.) or exist only 

on paper or other physical media at the 

time of collection. EPA is also proposing 

that amendments to submissions would 

not be counted as new submissions for 

purposes of selecting the representative 

subset—rather, the confidentiality claim 

review will include amendments 

available at the time of review. EPA is 

interested in public comment 

concerning its selection of the 

representative subset, including 

possible alternative representative 

selection methods. 

EPA is proposing that two additional 

types of submissions not be included in 

the representative subset as they are not 

representative of TSCA submissions as 

a whole. These include: (1) Bona fide 

inquiries under 40 CFR 720.25, and 

721.11 and (2) TSCA section 5 prenotice 

communications (correspondence 

submitted prior to a prospective TSCA 

section 5 submission asking questions 

or requesting a meeting to discuss 

whether and how a prospective TSCA 

submission should be made). These 

document types are not representative 

of TSCA submissions as a whole. These 

submission types help submitters 

ascertain whether a TSCA submission is 

required in a particular situation and/or 

what type or format should be used to 

make a particular submission. 

Moreover, in each case in which EPA 

confirms that a specific TSCA 

submission is required, these pre-notice 

or bona fide submissions would be 

followed by the corresponding TSCA 

submission, which itself would be 

subject to selection as part of the 

representative subset (e.g., a PMN or 

Significant New Use Notice). 

Conversely, where no TSCA submission 

is deemed necessary, the information in 

these documents does not relate to 

EPA’s regulation of chemical substances 

under TSCA. 

EPA is interested in public comment 

concerning the universe of claims that 

contribute to the representative subset 

and its identification of, and exclusions 

from, the representative subset, 

including possible alternatives. 

2. EPA Review of Claims 

a. Procedures 

EPA is proposing to revise EPA’s 

procedures for reviewing confidentiality 

claims. As noted in previous EPA 

statements (e.g., Ref. 6), EPA reviews 

confidentiality claims in accordance 

with the requirements in TSCA section 

14 and has relied to date on the review 

procedures set out in 40 CFR part 2 for 

all TSCA CBI reviews. However, the 

review procedures described in 40 CFR 

part 2 (including TSCA-specific 

provisions at section 2.306), which were 

promulgated prior to the Lautenberg 

amendments, do not fully accommodate 

or account for the requirements in TSCA 

section 14, particularly the demands of 

the TSCA section 14(g)(1) mandatory 

review program. Rather than extensively 

update the EPA review procedures for 

TSCA CBI in 40 CFR part 2 to reflect the 

amendments to TSCA section 14, this 

rulemaking proposes to consolidate 

most of them in the proposed new part 

703, consistent with the broader effort to 

centralize regulations on TSCA CBI. 

In many respects, the procedures and 

substantive review criteria in proposed 

new part 703 mirror those in 40 CFR 

part 2 but include adaptations to reflect 

the requirements of TSCA section 14, 

and to facilitate the high volume, timelimited review process required to meet 

the requirements of TSCA sections 14(e) 

and 14(g). For example, the substantive 

criteria in 40 CFR 2.208, as referenced 

and modified by 40 CFR 2.306(g), would 

be retained, but would be somewhat 

modified to align with the substantial 

competitive harm language in TSCA 

section 14. (The other criteria include 

that the CBI claim has not expired, been 

waived, or withdrawn; that the business 

protects the confidentiality of the 

information; and that no statute 

prohibits confidential protection.) 

The criteria would also be revised to 

clarify that whether a substance may be 

readily reverse engineered is among the 

factors EPA considers as part of the 

criterion on whether the CBI-claimed 

information is legitimately and 

reasonably obtainable without the 

business’s consent. Alternatively, the 

Agency could consider whether a 

substance may be readily reverse 

engineered as a stand-alone criterion. 

The Agency requests comment on how 

this reverse engineering component 

should be incorporated into the 

Agency’s substantive review criteria in 

proposed section 703.7(f), either as a 

stand-alone review criterion or as part of 

the existing criterion. The substantive 

review criteria in proposed section 

703.7(f) will establish the Agency’s 

standard of review for all TSCA CBI 

claims. For each claim to be approved, 

submitters’ substantiations would be 

required to adequately address all of the 

criteria set forth in proposed section 

703.7(f). Accordingly, the Agency would 

then be able to deny TSCA CBI claims 

for failure to address any one of the 

proposed criteria in the substantiation. 

The requirement in 40 CFR 2.306(e)(1) 

that EPA’s Office of General Counsel 

(OGC) make most final confidentiality 

determinations would no longer be 

required by regulation under the 

proposed new part 703; rather, final 

determinations may be made by OGC or 


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other EPA offices (e.g., the EPA Office 

of Pollution Prevention and Toxics), as 

designated by the General Counsel. 

Regardless of which office within EPA 

issues a given final determination, EPA 

expects to continue to publish final CBI 

determinations on its website. 

EPA also proposes, in proposed 

section 703.7(g), to add a means to 

request reconsideration by OGC of 

determinations denying confidential 

treatment. Reconsideration would be 

available during the 30-day notice and 

appeal period prior to disclosure of the 

information. This mechanism is 

intended to permit parties to identify 

any EPA errors in the determination 

prior to the point that the information 

is disclosed, and without immediately 

proceeding to judicial review of the 

decision. If a request for reconsideration 

is timely received, EPA will suspend the 

30-day notice period described in 

proposed section 703.7(e) while OGC 

reconsiders the Agency’s determination. 

OGC will review the submission de 

novo and will only consider the 

submission record as it existed for the 

final determination. EPA requests 

comment on this reconsideration 

approach and the suspension of the 30- 

day notice period. 

The proposed rule sets forth review 

procedures to apply to CBI reviews 

initiated under TSCA section 14(g)(1) 

(including reviewing requests for 

extension under TSCA section 14(e)) as 

well as some additional procedures to 

implement CBI reviews initiated under 

TSCA section 14(f). In proposed section 

703.7(b)(2), EPA proposes to permit 

submitters requesting extension of 

confidentiality protections under TSCA 

section 14(e) to either submit new 

substantiation or rely on substantiation 

that was provided with the initial 

submission, certifying that the 

substantiation remains true and correct. 

In proposed section 703.8, EPA 

proposes similar procedures for reviews 

initiated under TSCA section 14(f) as for 

those under TSCA section 14(g), though 

the notice and resubstantiation 

provisions necessarily vary to reflect the 

fact that the review of different claims 

may be triggered by TSCA section 14(f) 

versus TSCA section 14(g). The 

proposed rule also clarifies that EPA is 

not required to review claims as 

designated in TSCA section 14(f)(1) 

(claims concerning active or TSCA 

section 6(b) high-priority substances or 

where disclosure would assist EPA in 

conducting a risk evaluation under 

TSCA section 6); rather, reviews of such 

claims are discretionary. 

The proposed rule also elaborates on 

the timing and scope of review in 

proposed section 703.7(c). For the 

purposes of TSCA section 14(g), the 

proposed rule specifies that the 90-day 

review period begins on the day EPA 

accepts a new TSCA submission that 

includes confidentiality claims (TSCA 

submissions under TSCA section 5 must 

clear a brief ‘‘pre-screen’’ review for 

basic completeness to ensure 

consistency with requirements in 40 

CFR part 720, which is usually complete 

within a few days of submission; 

following that review, the submission is 

considered ‘‘accepted’’), and that 

amendments to non-chemical identity 

information in the submission will be 

considered in the confidentiality review 

for that submission up to 60 days after 

the original submission date. (New 

confidentiality claims concerning 

chemical identity would be reviewed 

within 90 days of EPA accepting the 

submission or amendment including the 

new chemical identity claim.) The date 

that the submission is considered 

‘‘accepted’’ will be used to calculate the 

10-year sunset period for purposes of 

TSCA section 14(e). ‘‘Accepted’’ is 

defined in the proposed section 703.3. 

EPA notes that some submission types 

are often amended one or more times 

after submission (e.g., new chemicalrelated submissions under TSCA section 

5) as new information is developed, or 

as requested by EPA. In order to meet 

the 90-day statutory review deadline, 

EPA believes it is important that 

submissions be complete, at least 

procedurally, prior to starting review, 

and notes that there is a point in the 90- 

day period past which significant 

amendments to the submission and 

related claims would be difficult or 

impossible to consider while still 

meeting the statutory review deadline. 

EPA has considered some alternatives 

in developing this proposed rule, 

including either resetting the 90-day 

clock every time an amendment is 

received, or not commencing 

confidentiality claim review at all until 

some period of time after initial 

submission, to allow for a majority of 

amendments to be made prior to 

beginning the confidentiality review. In 

the first case, EPA identified that 

resetting the 90-day clock with each 

amendment would likely require a lot of 

duplicative effort. EPA also anticipates 

that either of these options would often 

delay confidentiality determinations 

considerably, especially for new 

chemical submissions, in which public 

interest has been heightened in recent 

years. EPA invites public comment on 

the proposed approach described in 

proposed section 703.7(c), as well as 

these and other alternatives. 

b. Substantial Competitive Harm 

In the preamble of the 2020 final rule 

on CDR (Ref. 7), EPA noted that the 

Agency did not view the Supreme 

Court’s decision in Food Marketing 

Institute v. Argus Leader Media, 139 S. 

Ct. 2356, 2363 (2019) as necessitating 

the Agency to remove the ‘‘substantial 

competitive harm’’ substantiation 

question for TSCA CBI claims. See also 

Ref. 11. Congress amended TSCA 

section 14 in 2016 to, among other 

things, specifically require any person 

asserting a CBI claim under TSCA to 

include a certified statement that the 

person has ‘‘a reasonable basis to 

conclude that disclosure of the 

information is likely to cause substantial 

harm to the competitive position of the 

person.’’ TSCA section 14(c)(1)(B)(iii) 

and (c)(5); see also TSCA section 

14(c)(1)(C)(ii)(II) (referencing substantial 

competitive harm). For each claim, the 

Agency’s review will determine whether 

the business has made a satisfactory 

showing that it has a reasonable basis to 

conclude that disclosure of the 

information is likely to cause substantial 

harm to the competitive position of the 

business. 

The proposed rule clarifies that the 

Agency requires the certification 

statement on substantial competitive 

harm and considers substantial 

competitive harm as part of its 

substantive review criteria for TSCA CBI 

claims. 

c. Information From Health and Safety 

Studies 

The proposed rule also elaborates on 

the limitations on confidentiality 

protections for health and safety 

information described in TSCA section 

14(b). TSCA section 14(b)(2), which 

denies confidentiality protection to 

health and safety studies and 

information from health and safety 

studies, excludes from its coverage 

certain categories of information in 

health and safety studies, such as 

formulas. In addition, existing 

regulations allow withholding of 

specified information beyond that 

provided in TSCA section 14(b)(2). See, 

e.g., 40 CFR 720.90(3) (allowing 

withholding of ‘‘[i]nformation which is 

not in any way related to the effects of 

a substance on human health or the 

environment, such as the name of the 

submitting company, cost or other 

financial data, product development or 

marketing plans, and advertising 

plans’’). However, the applicable 

regulations are not uniform in this 

respect; nor has the statutory basis for 

these provisions (which itself has 

changed under the Lautenberg 


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amendments) been previously 

enunciated by EPA. The Agency is 

proposing here to systematize these 

provisions, generally allowing CBI 

claims for very limited categories of 

information contained within a health 

and safety study. 

While such ancillary information may 

be contained in a study document 

submitted under TSCA, EPA does not 

consider such information to be part of 

a ‘‘health and safety study’’ as defined 

in TSCA section 3(8). That definition 

states that the term ‘health and safety 

study’ means any study of any effect of 

a chemical substance or mixture on 

health or the environment or on both, 

including underlying information and 

epidemiological studies, studies of 

occupational exposure to a chemical 

substance or mixture, toxicological, 

clinical, and ecological studies of a 

chemical substance or mixture, and any 

test performed pursuant to this chapter. 

This definition does not seek to provide 

an exclusive list of what is or is not 

‘‘included’’ in the health and safety 

study but instead clarifies that all 

‘‘underlying’’ information must be 

considered part of the study. The term 

‘‘underlying’’ is an adjective ‘‘used to 

describe something on which something 

else is based.’’ Cambridge Dictionary 

(Online). A study report may contain 

information beyond that which is the 

basis for the study. Information such as 

the names of lab technicians neither 

form the basis for the study nor are 

relevant to the study results. 

Additionally, TSCA section 14(b)(1) 

provides that information that is 

protected from disclosure under this 

section, and which is mixed with 

information that is not protected from 

disclosure under this section, does not 

lose its protection from disclosure 

notwithstanding that it is mixed with 

information that is not protected from 

disclosure. TSCA section 14(b)(1) is 

consistent with the interpretation that a 

study report can contain information 

not included within the definition of a 

‘‘health and safety study’’ under TSCA 

section 3(8) and adopting such an 

interpretation gives effect to TSCA 

section 14(b)(1). 

EPA is therefore proposing a 

definition of ‘‘health and safety study’’ 

(for purposes of this proposed rule) in 

proposed section 703.3 that specifies 

types of information that are not within 

the scope of TSCA section 3(8): 

• Name of the submitting company; 

• Name of the laboratory; 

• Internal product codes; 

• Names of laboratory personnel; 

• Names and other private 

information included in study data or 

reports; 

• Cost or other financial data; and 

• Product development, advertising, 

or marketing plans. 

The Agency is requesting comment on 

the underlying interpretation and this 

list. 

This proposed rule would clarify 

these existing provisions and make 

them uniform for all TSCA submissions. 

EPA invites comment on the proposed 

examples of information that might be 

in a study, but nonetheless permissible 

to withhold as confidential, should the 

information otherwise meet the 

confidentiality criteria in TSCA section 

14. 

E. Related or Corresponding Revisions 

to Other TSCA Rules 

In addition to proposing a new 

confidentiality claim section of the 

TSCA rules, the proposed rule would 

revise confidentiality provisions in 

existing rules. In some cases, the 

proposed revisions would replace 

existing provisions with a cross 

reference to the proposed new part 703. 

In others, more specific and extensive 

revision is proposed. 

1. Proposed Revisions to 40 CFR Parts 

702, 704, 707, 716, 717, 723, and 790 

EPA is proposing to revise the 

following provisions to reference the 

general CBI provisions in the proposed 

new part 703: 

• 40 CFR 702.37(d), the 

confidentiality provisions for 

manufacturer requests for risk 

evaluations; 

• 40 CFR 704.7, the confidentiality 

provision for TSCA section 8(a) rules; 

• 40 CFR 707.75(d), the 

confidentiality provision of rules 

concerning TSCA section 12(b) notices 

of export; 

• 40 CFR 716.55, the confidentiality 

provisions for TSCA section 8(d) 

reporting rules; 

• 40 CFR 717.19, the confidentiality 

provision for TSCA section 8(c) 

recordkeeping and reporting rules; 

• 40 CFR 723.50(l) and 723.250 (f), 

the confidentiality provision for certain 

exemption requests under TSCA section 

5 (low volume exemption and low 

releases and low exposures exemption); 

and 

• 40 CFR part 790, the confidentiality 

provision of rules concerning TSCA 

section 4 test rules, orders, and 

agreements. 

2. Further Clarification Proposed for 40 

CFR Part 707 

EPA is proposing to revise the 

provision concerning the contents of 

TSCA section 12(b) notices of export, 40 

CFR 707.67(a), by adding a sentence to 

provide that in most cases, a 

confidential specific chemical identity 

need not be included in the notice (the 

primary exception would be in the case 

where the substance to be reported 

under TSCA section 12(b) is claimed as 

confidential but does not have a TSCA 

accession number). Instead, the TSCA 

section 12(b) notice of export may 

identify the substance by the generic 

name and accession number that 

appeared in the TSCA section 4, 5, 6, or 

7 action that triggered the TSCA section 

12(b) reporting requirement. EPA 

anticipates that with this change, TSCA 

section 12(b) submitters would submit 

fewer confidentiality claims for specific 

chemical identity, which in almost all 

cases is unnecessary to report under the 

existing TSCA section 12(b) rules. 

3. Proposed Revision in 40 CFR 717.17 

and 723.250 To Reflect Electronic 

Reporting 

EPA proposes to modify 40 CFR 

717.17 and 723.250(f) to reflect the 

proposed new electronic reporting 

requirement discussed in Unit II.C.5. 

4. Proposed Revisions to Confidentiality 

Provisions in the PMN Rules 

EPA is proposing to simplify and 

replace many of the confidentiality 

provisions in 40 CFR part 720, subpart 

E with a cross reference to the general 

confidentiality provisions in proposed 

new part 703. The general provisions on 

confidentiality in PMNs, 40 CFR 720.80, 

is proposed to be replaced with this 

cross reference. Requirements in 40 CFR 

720.85 and 720.90 are proposed to be 

deleted, with portions moved to 40 CFR 

part 720, subpart F, the provisions 

concerning NOCs. 

The existing provisions concerning 

chemical identity claims in PMNs and 

in health and safety studies would be 

covered in the proposed new part 703. 

In addition, TSCA section 14(c)(2)(G) 

created an exemption from the 

substantiation requirement for 

confidentiality claims for chemical 

identity when identity information is 

submitted before substance is offered for 

commercial distribution. The CBI claim 

review provisions of TSCA section 14(g) 

exclude these exempt claims from 

routine EPA review requirements, 

diminishing the need to elaborate on 

requirements for asserting and 

maintaining such claims in the PMN 

rules. 

Relatedly, a confidentiality claim 

review process in existing 40 CFR 

720.90, whereby claims that were made 

in health and safety studies in the PMN 

are revisited at the NOC stage, is a poor 

fit with new TSCA section 14(g) 

requirements that confidentiality claims 


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be reviewed within 90 days of receipt, 

or in accordance with the discretionary 

or mandatory provisions of TSCA 

section 14(f). In practice, PMNs and 

NOCs (the latter of which may be 

submitted many months or years after 

the corresponding PMN, if at all) are 

treated by EPA as separate submissions 

for the purposes of routine CBI review. 

At the PMN stage, chemical identity 

claims, including claims made in health 

and safety studies, are generally exempt 

from review, per the exemptions from 

substantiation and review set out in 

TSCA sections 14(c) and (g). NOCs, on 

the other hand, do not include health 

and safety information. With the 

proposed deletion of 40 CFR 720.90, the 

review of confidentiality claims in NOC 

submissions would be limited to the 

information included in the NOC 

submission—principally chemical 

identity and submitting company 

information. Claims that were made in 

the PMN submission may be revisited at 

a later time, in accordance with either 

mandatory or discretionary review 

provisions in TSCA section 14(f). 

5. PMN NOC Provisions 

The proposed rule leaves much of 40 

CFR part 720, subpart F, intact, but 

reorganizes some provisions that 

concern specific chemical identity 

claims in or following submission of an 

NOC. These provisions are presently in 

subpart E and would move to subpart F. 

Additionally, the proposed revisions 

would update and clarify NOC reporting 

instructions in 40 CFR 720.102(c)(2), 

concerning the assertion and 

substantiation of confidentiality claims 

throughout the NOC reporting form. The 

existing rule only reflects the 

substantiation requirements that predated the Lautenberg amendments, 

which were limited to specific chemical 

identity confidentiality claims, and do 

not reflect the newer generic name and 

certification requirements in TSCA 

section 14(c). 

Revisions include adding a new 

paragraph (e) in 40 CFR 720.102, the 

substance of which is currently in 40 

CFR 720.85(b)(3), concerning 

requirements that apply when asserting 

a confidentiality claim for chemical 

identity in the period after commencing 

commercial manufacture. Additionally, 

there is a cross-reference to the 

requirements of proposed new part 703, 

which, among other things, would 

replace the list of substantiation 

questions currently in 40 CFR 720.85 

(which under existing rules, only apply 

to chemical identity claims in NOCs). 

Finally, the proposed revisions to 40 

CFR 720.102 would include a new 

paragraph (f), concerning generic names. 

These provisions are intended to be 

consistent with generic name provisions 

in proposed new part 703, but include 

some additional provisions specific to 

the submission and review of generic 

names for the purposes of listing on the 

TSCA Inventory, including additional 

procedures intended to aid the prompt 

negotiation by the submitter and EPA of 

more difficult generic names (which are 

themselves based in part on procedures 

presently in 40 CFR 720.85), and a 

provision that NOCs will be temporarily 

held in situations where the submitter 

has not provided an acceptable generic 

name despite the negotiation. If the 

submission is not corrected, EPA would 

proceed with review of the CBI claim for 

chemical identity and would likely 

deny the claim. EPA invites comments 

on these and other possible approaches 

to efficiently developing an acceptable 

generic name for purposes of listing on 

the TSCA Inventory. 

6. Microorganisms 

EPA is proposing to replace much of 

the confidentiality provisions currently 

in 40 CFR part 725, subpart C, with a 

new, simplified subpart C, which 

largely relies on a cross-reference to the 

proposed new general confidentiality 

provisions to be placed in proposed new 

part 703. The proposed amendments 

would remove current provisions that 

are inconsistent with the Lautenberg 

amendments, such as existing 

requirements to provide upfront 

substantiation of organism identity 

confidentiality claims prior to the 

commencement of commercial 

manufacture. The proposed rule also 

proposes some adjustments to the 

general confidentiality provisions in 

proposed new part 703 when they are 

applied to genetically modified 

microorganisms and other products of 

biotechnology covered by 40 CFR part 

725. These include some adjustments to 

the substantiation questions to reflect 

some practical differences between 

these products and other types of TSCA 

chemical substances. 

The proposed rule also includes 

proposed revisions to 40 CFR 725.190, 

concerning NOCs, that are similar to the 

proposed revisions to the parallel 

conventional chemical NOC provisions 

in 40 CFR 720.102, including some 

elaboration on what must be included in 

a generic name. As in the case with 

NOCs relating to PMNs, EPA proposes 

to update 40 CFR 725.190 to be 

generally consistent with generic name 

provisions in proposed new part 703, 

but with some additional provisions 

specific to the review of generic names 

for the purposes of listing on the TSCA 

Inventory, including additional 

procedures intended to aid the prompt 

negotiation of more difficult generic 

names, and a provision that NOCs will 

be held in situations where the 

submitter has not provided an 

acceptable generic name despite the 

negotiation (and that such deficiencies, 

if not promptly corrected, may result in 

denial of the claim). EPA invites 

comments on these and other possible 

approaches to efficiently developing an 

acceptable generic name for purposes of 

listing on the TSCA Inventory. 

7. Changes in Proposed Regulations 

This action proposes a significant 

number of new and revised CBI 

provisions to be included in proposed 

new part 703 and proposes to revise 

confidentiality provisions in other 

existing regulatory provisions to cross 

reference the proposed new part 703. 

EPA recognizes that during the 

pendency of this rulemaking process, 

EPA is developing other rulemakings 

that may address confidentiality 

provisions. For example, EPA is 

developing a proposed rule regarding 

asbestos reporting under TSCA section 

8(a). Until this CBI rule is finalized, 

however, additional regulations 

proposed or finalized need to refer to 

the existing CBI regulations, rather than 

to the new and revised CBI provisions 

addressed in this rulemaking. EPA 

requests comment on options for 

harmonizing such provisions. 

Specifically, EPA requests comment on 

using this action to make any needed 

conforming amendments, e.g., adding 

cross references to the new and revised 

CBI provisions proposed here to any CBI 

provisions finalized during the 

pendency of this action including any 

CBI provisions finalized in the asbestos 

TSCA section 8(a) rule. 

III. Request for Comments 

EPA is seeking public comment on all 

aspects of this proposed rule and the 

Economic Analysis prepared in support 

of this proposed rule (Ref. 2). In 

addition to specific requests for 

comment included throughout this 

document, EPA is interested in 

comments pertaining to specific issues 

discussed in this unit. EPA encourages 

all interested persons to submit 

comments on the issues identified in 

this proposed rule and to identify any 

other relevant issues as well. This input 

will assist the Agency in developing a 

final rule that successfully addresses 

information needs while minimizing 

potential reporting burdens associated 

with the rulemaking. EPA requests that 

commenters making specific 

recommendations include supporting 


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documentation where appropriate. EPA 

invites specific comment on: 

• EPA’s interpretation of the coverage 

of TSCA section 14(a) (proposed section 

703.1), and how this may impact 

submitters of information to the Agency 

under other statutes, such as FIFRA. 

EPA is particularly interested in 

comments on the treatment of FIFRA 

studies on inert ingredients under TSCA 

section 14(b)(2). 

• The applicability of the proposed 

new or revised requirements to 

submissions received before the 

effective date of the subsequent final 

rule. Specifically, EPA requests 

comment on whether each proposed 

new or revised requirement should 

apply only to submissions received on 

or after the effective date of the final 

rule; to all submissions received on or 

after the effective date of the Lautenberg 

amendments; or to all submissions 

regardless of submission date. 

• The proposed substantiation 

questions (proposed section 703.5(b)), 

especially the proposal to omit a trade 

secrets-specific question; on how the 

patents question might be modified to 

elicit more pertinent information; and 

comment on the alternative substantial 

competitive harm question. 

• The proposed list of information 

that might be included with health and 

safety information, but that might be 

permissible to withhold as confidential 

(proposed section 703.5(b)(6)). EPA is 

also interested in comment on 

alternatives to the proposal that might 

better assure that health and safety 

information is not inappropriately 

treated as confidential. 

• The proposed approach to CBI 

claim deficiencies (proposed section 

703.5(e)) and on alternative approaches. 

• Whether submitting templated data 

should be required (proposed section 

703.5(g)). 

• The option of requiring TSCA 

submitters to update their original 

submission to reflect CBI claims that 

have been withdrawn or denied 

(proposed section 703.5(j)). 

• Selection of the representative 

subset, including possible alternative 

representative selection methods 

(proposed section 703.7). 

• Whether bona fide or pre-notice 

inquiries or correspondence should be 

considered part of a representative 

subset of TSCA submissions (proposed 

section 703.7). 

• On the proposed approach to 

determining when a TSCA section 14(g) 

CBI review period begins and how 

amendments to the submission are 

included in the review (proposed 

section 703.7). 

• The proposed and alternative 

possible approaches to efficiently 

developing an acceptable generic name 

for purposes of listing on the TSCA 

Inventory, as described in proposed 

sections 720.102 and 725.190. 

• On how to incorporate whether a 

substance may be readily reverse 

engineered into the Agency’s 

substantive review criteria in proposed 

section 703.7(f). 

IV. References 

The following is a list 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 physically located in 

the docket. For assistance in locating 

these other documents, please consult 

the technical person listed under FOR

FURTHER INFORMATION CONTACT. 

1. U.S. EPA. Electronic Reporting under the 

Toxic Substances Control Act; Final 

Rule. Federal Register. 78 FR 72818, 

December 4, 2013 (FRL–9394–6). 

2. U.S. EPA. Economic Impact Analysis for 

the Procedures for Submitting 

Information Subject to Business 

Confidentiality Claims under the Toxic 

Substances Control Act (TSCA); 

Proposed Rule. April 4, 2022. 

3. U.S. EPA. Procedures for Review of CBI 

Claims for the Identity of Chemicals on 

the TSCA Inventory; Final Rule. Federal 

Register. 85 FR 13062, March 6, 2020 

(FRL–10005–48). 

4. U.S. EPA. TSCA Chemical Substances; 

Unique Identifier Assignment and 

Application Policy; Notice of 

Availability. Federal Register. 83 FR 

30168, June 27, 2018 (FRL–9979–59). 

5. U.S. EPA. Guidance on Expanded Access 

to TSCA Confidential Business 

Information; Notice of Availability. 

Federal Register. 83 FR 30171, June 27, 

2018 (FRL–9979–75). 

6. U.S. EPA. Statutory Requirements for 

Substantiation of Confidential Business 

Information (CBI) Claims Under the 

Toxic Substances Control Act (TSCA); 

Notice. Federal Register. 82 FR 6522, 

January 19, 2017 (FRL–9958–34). 

7. U.S. EPA. TSCA Chemical Data Reporting 

Revisions Under TSCA Section 8(a); 

Final Rule. Federal Register. 85 FR 

20122, April 9, 2020 (FRL–10005–56). 

8. U.S. EPA. Guidance for Creating Generic 

Names for Confidential Chemical 

Substance Identity Reporting Under the 

Toxic Substances Control Act; Notice of 

Availability. Federal Register. 83 FR 

30173, June 27, 2018 (FRL–9979–02). 

9. U.S. EPA. Guidance for Creating Generic 

Names for Confidential Chemical 

Substance Identity Reporting under 

TSCA. Publication ID No. EPA 

743B18001. June 2018. Available at: 

https://www.epa.gov/sites/production/ 

files/2018-06/documents/san6814_

guidance_for_creating_tsca_generic_

names_2018-06-13_final.pdf. 

10. U.S. EPA, Office of Pollution Prevention 

and Toxics. Points to Consider in the 

Preparation of TSCA Biotechnology 

Submissions for Microorganisms. June 2, 

1997. Available at: https://www.epa.gov/ 

sites/production/files/2015-08/ 

documents/biotech_points_to_

consider.pdf. 

11. U.S. EPA. Response to Public Comments, 

TSCA Chemical Data Reporting 

Revisions for Reporting and 

Recordkeeping Requirements under 

TSCA Section 8(a) (RIN 2070–AK33). 

Document ID No. EPA–HQ–OPPT–2018– 

0321–0140. March 2020. Available at: 

https://www.regulations.gov/document/ 

EPA-HQ-OPPT-2018-0321-0140. 

12. U.S. EPA. Information Collection Request 

(ICR) entitled: Confidential Business 

Information Claims under the Toxic 

Substances Control Act (TSCA)— 

Proposed Rule (RIN 2070–AK68). EPA 

ICR No.: 2706.01; OMB Control No.: 

2070–NEW. April 4, 2022. 

V. Statutory and Executive Orders 

Reviews 

Additional information about these 

statutes and Executive Orders can be 

found at http://www2.epa.gov/lawsregulations/laws-and-executive-orders. 

A. Executive Order 12866: Regulatory 

Planning and Review and Executive 

Order 13563: Improving Regulation and 

Regulatory Review 

This action is a significant regulatory 

action that was 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). 

EPA prepared an analysis of the 

estimated costs and benefits associated 

with this action (Ref. 2), which is 

available in the docket and is 

summarized in Unit I.D. Any changes 

made in response to OMB 

recommendations have been 

documented in the docket for this action 

as required by section 6(a)(3)(E) of 

Executive Order 12866. 

B. Paperwork Reduction Act (PRA) 

The information collection activities 

in this proposed rule have been 

submitted for approval to OMB under 

the PRA, 44 U.S.C. 3501 et seq. The 

Information Collection Request (ICR) 

document that EPA prepared has been 

assigned EPA ICR No. 2706.01 (Ref. 12). 

You can find a copy of the ICR in the 

docket for this action, and it is briefly 

summarized here. 

The reporting requirements identified 

in this proposed rule implement 

statutory requirements in TSCA section 

14, including new requirements that 

persons submitting information under 


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TSCA must substantiate most 

confidentiality claims at the time of 

submission, as well as additional 

certification and generic name 

requirements. In order to maintain most 

claims beyond a 10-year period, 

submitters will also be required to 

reassert and substantiate those claims. 

Several new requirements also apply to 

EPA, including requirements to review 

and approve or deny all chemical 

identity claims asserted concerning 

substances that are offered for 

commercial distribution, as well a 

subset of all other confidentiality 

claims, within 90 days of the claim 

being asserted. Further requirements 

that EPA review all confidentiality 

claims concerning substances listed as 

active on the TSCA Inventory, a 

requirement to assign and apply unique 

identifiers (UIDs) to substances with 

approved confidentiality claims for 

chemical identity, as well as new 

provisions providing expanded access 

to TSCA Confidential Business 

Information (CBI), have been discussed 

in previous Federal Register 

documents. Additionally, TSCA rules 

promulgated since the Lautenberg 

amendments have included 

confidentiality provisions conforming to 

the amendments (e.g., 40 CFR parts 710 

and 711). 

Respondents/affected entities: Firms 

asserting claims for confidentiality in 

submissions to EPA under TSCA. 

Respondent’s obligation to respond: 

Required to obtain or retain a benefit. 

TSCA section 14; 15 U.S.C. 2613. 

Estimated number of respondents: 

1,100 firms with an estimated additional 

55 new firms each year. 

Frequency of response: On occasion. 

Total estimated burden: 2,945 hours 

paperwork burden in the first year and 

523 hours in each following year. 

Burden is defined at 5 CFR 1320.3(b). 

Total estimated cost: $ 270,783 in the 

first year and $ 44,605 in each following 

year (2020$), and an estimated cost of $ 

0 for non-burden hour paperwork costs, 

e.g., capital investment or maintenance 

and operational costs. 

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 EPA’s regulations in title 40 

of the CFR, after appearing in the 

Federal Register, are listed in 40 CFR 

part 9, and displayed on the information 

collection instruments (e.g., forms, 

instructions). 

Submit your comments on the 

Agency’s need for this information, the 

accuracy of the provided burden 

estimates, and any suggested methods 

for minimizing respondent burden to 

EPA using the docket identified at the 

beginning of this proposed rule. You 

may also send your ICR-related 

comments to OMB’s Office of 

Information and Regulatory Affairs 

using the interface at https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular ICR by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. Since OMB is required 

to make a decision concerning the ICR 

between 30 and 60 days after receipt, 

OMB must receive comments no later 

than June 13, 2022. The EPA will 

respond to ICR-related comments in the 

final rule. 

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 chemical 

manufacturers (including importers). 

EPA estimates that 1,096 small firms 

would be affected by the proposed 

requirements. Of those small firms, 

100% would have cost impacts of less 

than 1% of annual revenues, which EPA 

has determined does not qualify as a 

significant impact. Details of this 

analysis are presented in the Economic 

Analysis of the proposed rule (Ref. 2), 

which is available in the docket. 

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. The 

action imposes no enforceable duty on 

any state, local or tribal governments or 

the private sector. 

E. Executive Order 13132: Federalism 

This action does not have federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 4, 

1999). It will not have substantial direct 

effects on the states, on the relationship 

between the national government and 

the states, or on the distribution of 

power and responsibilities among the 

various levels of government. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have tribal 

implications as specified in Executive 

Order 13175 (65 FR 67249, November 9, 

2000). It does not have substantial direct 

effects on tribal government because 

asbestos is not manufactured (including 

imported) or processed by tribes and 

would not impose substantial direct 

compliance costs on tribal governments. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

Risks and Safety Risks 

The 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 the EPA has 

reason to believe may 

disproportionately affect children, per 

the definition of ‘‘covered regulatory 

action’’ in section 2–202 of the 

Executive Order. This action is not 

subject to Executive Order 13045 

because it does not concern an 

environmental health risk or safety risk. 

H. Executive Order 13211: Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution or Use 

This action is not a ‘‘significant 

energy action’’ under Executive Order 

13211 (66 FR 28355, May 22, 2001) 

because it is not likely to have a 

significant adverse effect on the supply, 

distribution or use of energy and has not 

otherwise been designated by the 

Administrator of OMB’s Office of 

Information and Regulatory Affairs as a 

‘‘significant energy action.’’ The action 

is predicted to reduce energy use and is 

not expected to reduce energy supply or 

increase energy prices. 

I. National Technology Transfer and 

Advancement Act (NTTAA) 

This proposed action does not involve 

any technical standards as specified in 

NTTAA section 12(d), 15 U.S.C. 272 

note. 

J. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

The EPA believes that this action does 

not have disproportionately high and 

adverse human health or environmental 

effects on minority populations, lowincome populations and/or indigenous 

peoples, as specified in Executive Order 

12898 (59 FR 7629, February 16, 1994). 

List of Subjects 

40 CFR Part 2 

Administrative practice and 

procedure, Confidential business 

information, Courts, Environmental 

protection, Freedom of information, 

Government employees. 


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40 CFR Part 702 

Administrative practice and 

procedure, Chemicals, Environmental 

protection, Hazardous substances. 

40 CFR Part 703 

Administrative practice and 

procedure, Chemicals, Confidential 

business information, Environmental 

protection, Exports, Hazardous 

substances, Imports, Reporting and 

recordkeeping requirements. 

40 CFR Part 704 

Chemicals, Environmental protection, 

Exports, Hazardous substances, Imports, 

Reporting and recordkeeping 

requirements. 

40 CFR Part 707 

Chemicals, Environmental protection, 

Exports, Hazardous substances, Imports, 

Reporting and recordkeeping 

requirements. 

40 CFR Part 716 

Chemicals, Confidential business 

information, Environmental protection, 

Hazardous substances, Health, 

Reporting and recordkeeping 

requirements, Safety. 

40 CFR Part 717 

Chemicals, Environmental protection, 

Hazardous substances, Reporting and 

recordkeeping requirements. 

40 CFR Part 720 

Chemicals, Environmental protection, 

Hazardous substances, Imports, 

Reporting and recordkeeping 

requirements. 

40 CFR Part 723 

Chemicals, Environmental protection, 

Hazardous substances, Phosphate, 

Reporting and recordkeeping 

requirements. 

40 CFR Part 725 

Administrative practice and 

procedure, Biologics, Chemicals, 

Environmental protection, Hazardous 

substances, Imports, Labeling, 

Microorganisms, Occupational safety 

and health, Reporting and 

recordkeeping requirements. 

40 CFR Part 790 

Administrative practice and 

procedure, Biologics, Chemicals, 

Environmental protection, Hazardous 

substances, Imports, Labeling, 

Microorganisms, Occupational safety 

and health, Reporting and 

recordkeeping requirements. 

Authority: 15 U.S.C. 2603, 2604, 2605, 

2607, 2613, 2619, and 2625 et seq. 

Michael S. Regan, 

Administrator. 

Therefore, for the reasons stated in the 

preamble, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 2—PUBLIC INFORMATION 

■ 1. The authority citation for part 2 

continues to read as follows: 

Authority: 5 U.S.C. 552, 552a, 553; 28 

U.S.C. 509, 510, 534; 31 U.S.C. 3717. 

■ 2. Revise § 2.306 to read as follows: 

§ 2.306 Special rules governing certain 

information obtained under the Toxic 

Substances Control Act. 

(a) Definitions. For the purposes of 

this section: 

(1) Act means the Toxic Substances 

Control Act, 15 U.S.C. 2601 et seq. 

(2) Chemical substance has the 

meaning given it in section 3(2) of the 

Act, 15 U.S.C. 2602(2). 

(3) EPA Legal Office means the EPA 

Office of General Counsel and any EPA 

office over which the EPA General 

Counsel exercises supervisory authority. 

(4) Proceeding means any rulemaking, 

adjudication, or licensing conducted by 

EPA under the Act or under regulations 

which implement the Act, except for 

determinations under this subpart. 

(b) Applicability. This section applies 

as set forth in 40 CFR 703.1. 

(c) Basic rules that apply without 

change. Sections 2.210, 2.211, 2.212, 

2.214, and 2.215 apply without change 

to information to which this section 

applies. Unless otherwise specified in 

§ 2.306, the provisions in §§ 2.201 

through 2.205 and 2.208 do not apply to 

information subject to this section. 

Instead, the provisions of 40 CFR part 

703 provide the requirements and 

procedures relevant to confidentiality 

determinations for information 

submitted to EPA under the Act. 

(d) Disclosure in special 

circumstances. Disclosures of 

information claimed as confidential 

under TSCA section 14(d)(4), (5), and 

(6) may be made in accordance with the 

provisions of the Act, § 2.306 and any 

applicable EPA guidance required by 

section 14(c)(4)(B) of the Act. Section 

2.209 applies to information to which 

this section applies, except that: 

(1) The following two additional 

provisions apply to § 2.209(c): 

(i) The official purpose for which the 

information is needed must be in 

connection with the agency’s duties 

under any law for protection of health 

or the environment or for specific law 

enforcement purposes; and 

(ii) EPA notifies the other agency that 

the information was acquired under 

authority of the Act and that any 

knowing disclosure of the information 

may subject the officers and employees 

of the other agency to the penalties in 

section 14(h) of the Act (15 U.S.C. 

2613(h)). 

(2) The 10 business day period for 

notification specified in § 2.209(b)(2) is 

instead 15 business days. 

(3) The timeline for notification in 

§ 2.209(d) is replaced by the timeline for 

notification in 15 U.S.C. 2613(g)(2)(B). 

(e) Disclosure of information relevant 

in a proceeding. (1) Under section 

14(d)(7) of the Act (15 U.S.C. 

2613(d)(7)), any information to which 

this section applies may be disclosed by 

EPA when the information is relevant in 

a proceeding under the Act, 

notwithstanding the fact that the 

information otherwise might be entitled 

to confidential treatment under this 

subpart. However, any such disclosure 

shall be made in a manner that 

preserves the confidentiality of the 

information to the extent practicable 

without impairing the proceeding. 

Disclosure of information to which this 

section applies because of its relevance 

in a proceeding shall be made only in 

accordance with this paragraph (e). 

(2) The provisions of § 2.301(g)(2) 

through (4) apply to disclosures under 

this paragraph (e). 

(f) Disclosure of information to 

contractors and subcontractors. (1) 

Under section 14(d)(2) of the Act (15 

U.S.C. 2613(d)(2)), any information to 

which this section applies may be 

disclosed by EPA to a contractor or 

subcontractor of the United States that 

is necessary for the satisfactory 

performance of their work in connection 

with the Act, notwithstanding the fact 

that the information otherwise might be 

entitled to confidential treatment under 

this subpart. Subject to the limitations 

in this paragraph (f), information to 

which this section applies may be 

disclosed: 

(i) To a contractor or subcontractor 

with EPA, if the EPA program office 

managing the contract first determines 

in writing that such disclosure is 

necessary for the satisfactory 

performance by the contractor or 

subcontractor of the contract or 

subcontract; or 

(ii) To a contractor or subcontractor 

with an agency other than EPA, if the 

EPA program office which provides the 

information to that agency, contractor, 

or subcontractor first determines in 

writing, in consultation with the 

General Counsel, that such disclosure is 

necessary for the satisfactory 

performance by the contractor or 


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subcontractor of the contract or 

subcontract. 

(2) The provisions of § 2.301(h)(2)(ii) 

through (iv) apply to disclosures under 

this paragraph (f). 

(3) At the time any information is 

furnished to a contractor or 

subcontractor under this paragraph (f), 

the EPA office furnishing the 

information to the contractor or 

subcontractor shall notify the contractor 

or subcontractor that the information 

was acquired under authority of the Act 

and that any knowing disclosure of the 

information may subject the contractor 

or subcontractor and its employees to 

the penalties in section 14(d) of the Act 

(15 U.S.C. 2613(d)). 

(g) Disclosure of information when 

necessary to protect health or the 

environment against an unreasonable 

risk of injury. (1) Under section 14(d)(3) 

of the Act (15 U.S.C 2613(d)(3)), any 

information to which this section 

applies may be disclosed by EPA when 

disclosure is necessary to protect health 

or the environment against an 

unreasonable risk of injury to health or 

the environment, without consideration 

of costs, or other non-risk factors, 

including an unreasonable risk to a 

potentially exposed or susceptible 

subpopulation as relevant by EPA under 

conditions of use. However, any 

disclosure shall be made in a manner 

that preserves the confidentiality of the 

information to the extent not 

inconsistent with protecting health or 

the environment against the 

unreasonable risk of injury. Disclosure 

of information to which this section 

applies because of the need to protect 

health or the environment against an 

unreasonable risk of injury shall be 

made only in accordance with this 

paragraph (g). 

(2) If any EPA office determines that 

there is an unreasonable risk of injury 

to health or the environment and that to 

protect health or the environment 

against the unreasonable risk of injury it 

is necessary to disclose information to 

which this section applies that 

otherwise might be entitled to 

confidential treatment under this 

subpart, the EPA office shall notify the 

EPA Legal Office in writing of the 

nature of the unreasonable risk of 

injury, the extent of the disclosure 

proposed, how the proposed disclosure 

will serve to protect health or the 

environment against the unreasonable 

risk of injury, and the proposed date of 

disclosure. Such notification shall be 

made as soon as practicable after 

discovery of the unreasonable risk of 

injury. If the EPA office determines that 

the risk of injury is so imminent that it 

is impracticable to furnish written 

notification to the EPA Legal Office, the 

EPA office shall notify the EPA Legal 

Office orally. 

(3) Upon receipt of notification under 

paragraph (g)(2) of this section, the EPA 

Legal Office shall make a determination 

in writing whether disclosure of 

information to which this section 

applies that otherwise might be entitled 

to confidential treatment is necessary to 

protect health or the environment 

against an unreasonable risk of injury. 

The EPA Legal Office shall also 

determine the extent of disclosure 

necessary to protect against the 

unreasonable risk of injury as well as 

when the disclosure must be made to 

protect against the unreasonable risk of 

injury. 

(4) If the EPA Legal Office determines 

that disclosure of information to which 

this section applies that otherwise might 

be entitled to confidential treatment is 

necessary to protect health or the 

environment against an unreasonable 

risk of injury, the EPA Legal Office shall 

furnish notice to each affected business 

of the contemplated disclosure and of 

the Legal Office’s determination. Such 

notice shall be made in writing, via 

either electronic notice as described in 

40 CFR 703.5(h) or by certified mail, 

return receipt requested, at least 15 

business days before the disclosure is to 

be made. The notice shall state the date 

upon which disclosure will be made. 

However, if the EPA Legal Office 

determines that disclosure of the 

information is necessary to protect 

against an imminent and substantial 

harm to health or the environment, no 

prior notification is necessary. 

PART 702—GENERAL PRACTICES 

AND PROCEDURES 

■ 3. The authority citation for part 702 

continues to read as follows: 

Authority: 15 U.S.C. 2605 and 2619. 

■ 4. Revise § 702.37(d) to read as 

follows: 

§ 702.37 Submission of manufacturer 

requests for risk evaluations. 

* * * * * 

(d) Confidential business information. 

Claims of confidentiality must be made 

in accordance with the procedures 

described in 40 CFR part 703. 

* * * * * 

■ 5. Add part 703 to read as follows: 

PART 703—CONFIDENTIALITY 

CLAIMS 

Sec. 

703.1 Purpose and applicability. 

703.3 Definitions. 

703.5 Requirements for asserting and 

maintaining confidentiality claims. 

703.7 EPA review of confidentiality claims 

under TSCA Section 14(g). 

703.8 EPA review of confidentiality claims 

under TSCA Section 14(f). 

Authority: 15 U.S.C. 2613. 

§ 703.1 Purpose and applicability. 

(a) The purpose of this part is to 

describe procedures for asserting and 

maintaining confidentiality claims in 

accordance with TSCA section 14, and 

for EPA review of such claims. The 

procedures described in this part are 

generally applicable to the submission 

and EPA review of any TSCA 

submission, except to the extent that 

application of the requirements would 

be inconsistent with TSCA section 14(i). 

The procedures include requirements 

concerning the form and manner in 

which TSCA submissions must be made 

to meet the requirements in TSCA 

section 14(b) and (c), to facilitate EPA 

review of such claims in accordance 

with TSCA section 14(f) and (g), and to 

facilitate disclosure of non-confidential 

information to the public in accordance 

with TSCA, FOIA, and their 

implementing regulations. 

(b) This part applies to all information 

that is reported to or otherwise obtained 

by EPA pursuant to TSCA or its 

implementing regulations. Unless 

otherwise specified in 40 CFR 2.306, the 

provisions of 40 CFR 2.201 through 

2.205 and 40 CFR 2.208 do not apply to 

information subject to this part. This 

part also applies to information that 

satisfies all three of the following 

criteria: 

(1) The information was first obtained 

by EPA other than pursuant to the 

authority of TSCA or its implementing 

regulations; 

(2) EPA has authority to collect the 

information under TSCA; and 

(3) Either: 

(i) Subsequent to its submission the 

information is being used to satisfy the 

obligation of a person under TSCA or its 

implementing regulations; or 

(ii) EPA makes use of the information 

in the course of carrying out its 

responsibilities under TSCA. 

(c)(1) This part applies regardless of: 

(i) Whether the information is 

intended by its submitter to be used by 

EPA in implementing TSCA; 

(ii) Whether TSCA or an 

implementing regulation was cited as 

authority for the request or submission 

of the information; or 

(iii) Whether the information was 

provided directly to EPA or through 

some third person. 

(2) In the event the information 

satisfies the requirements of § 703.1, and 

such information was originally 

submitted to or obtained by EPA under 


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another statute, and the other statute or 

its implementing regulations prescribe 

conflicting rules for the treatment of the 

information, the statute or rule under 

which the information was provided to 

EPA shall govern, except that the 

provisions in 40 CFR 2.306(d) through 

(f) apply, where relevant, to how EPA 

may share such information. 

§ 703.3 Definitions. 

The definitions in this section and the 

definitions in TSCA section 3 apply to 

this part. In addition, the definition in 

§ 720.3(ff) for test data also applies in 

this part. 

Accepted in the context of asserting a 

TSCA CBI claim means the date that 

EPA first approved the submission in 

CISS, or its successor system. 

CDX or Central Data Exchange means 

EPA’s centralized electronic document 

receiving system, or its successor 

system. 

CISS or Chemical Information 

Submission System means EPA’s webbased reporting tool for preparing and 

submitting TSCA submissions, or its 

successor system. 

Confidentiality claim means a claim 

or allegation that business information 

is entitled to confidential treatment. 

Health and safety study has the same 

meaning as that provided in § 720.3(k), 

except that for purposes of this part 703 

the following information is not part of 

a health and safety study: 

(1) The name of the submitting 

company; 

(2) The name of the laboratory 

conducting the study; 

(3) Internal product codes; 

(4) The names of laboratory 

personnel; 

(5) Names of individual study subjects 

and other private information included 

in study data or reports; 

(6) Cost and other financial data; and 

(7) Product development, advertising, 

and marketing plans. 

§ 703.5 Requirements for asserting and 

maintaining confidentiality claims. 

Any person who submits information 

under TSCA or these implementing 

regulations may assert a business 

confidentiality claim to information 

included in such submission. Such 

claim must be made concurrent with 

submission of the information. If no 

such claim accompanies the 

submission, EPA will not recognize a 

confidentiality claim, and the 

information in or referred to in that 

submission may be made available to 

the public (e.g., by publication of 

specific chemical name and CASRN on 

the public portion of the TSCA 

Inventory) without further notice. 

(a) Supporting statement and 

certification. A person asserting a 

confidentiality claim must submit a 

statement that the person has: 

(1) Taken reasonable measures to 

protect the confidentiality of the 

information; 

(2) Determined that the information is 

not required to be disclosed or 

otherwise made available to the public 

under any other Federal law; 

(3) A reasonable basis to conclude 

that disclosure of the information is 

likely to cause substantial harm to the 

competitive position of the person; and 

(4) A reasonable basis to believe that 

the information is not readily 

discoverable through reverse 

engineering. 

(5) The person must also certify that 

these four statements and any 

information required to substantiate the 

confidentiality claim in accordance with 

paragraph (b) of this section are true and 

correct. 

(b) Substantiation. (1) Timing of 

substantiation. Confidentiality claims 

must be substantiated at the time of 

submission to EPA, unless exempt 

under paragraph (b)(5) of this section. In 

the case of information collected by EPA 

or on behalf of EPA in person at the site 

of a TSCA inspection under section 11 

of the Act, the affected company must 

assert its confidentiality claim(s) in 

writing at the time the information is 

collected, and then must provide 

substantiation of its confidentiality 

claims and the supporting statement 

and certification described in paragraph 

(a) of this section within ten working 

days after the inspection ends. 

(2) Confidentiality claims in 

substantiation. Information in 

substantiations may be claimed as 

confidential. Such claims must be 

accompanied by the certification 

described in paragraph (a) of this 

section, but need not be themselves 

substantiated. 

(3) Substantiation questions for all 

claims. Unless otherwise specified 

elsewhere in 40 CFR 700 et seq (e.g., 40 

CFR part 711), answers to the following 

questions must be provided for each 

confidentiality claim in a TSCA 

submission: 

(i) Please specifically explain what 

harm to the competitive position of your 

business would be likely to result from 

the release of the information claimed as 

confidential. How would that harm be 

substantial? Why is the substantial harm 

to your competitive position likely (i.e., 

probable) to be caused by release of the 

information rather than just possible? If 

you claimed multiple types of 

information to be confidential (e.g., site 

information, exposure information, 

environmental release information, etc.), 

explain how disclosure of each type of 

information would be likely to cause 

substantial harm to the competitive 

position of your business. 

(ii) Has your business taken 

precautions to protect the 

confidentiality of the disclosed 

information? If yes, please explain and 

identify the specific measures, 

including but not limited to internal 

controls, that your business has taken to 

protect the information claimed as 

confidential. If the same or similar 

information was previously reported to 

EPA as non-confidential (such as in an 

earlier version of this submission), 

please explain the circumstances of that 

prior submission and reasons for 

believing the information is nonetheless 

still confidential. 

(iii)(A) Is any of the information 

claimed as confidential required to be 

publicly disclosed under any other 

Federal law? If yes, please explain. 

(B) Does any of the information 

claimed as confidential otherwise 

appear in any public documents, 

including (but not limited to) safety data 

sheets; advertising or promotional 

material; professional or trade 

publications; state, local, or Federal 

agency files; or any other media or 

publications available to the general 

public? If yes, please explain why the 

information should be treated as 

confidential. 

(C) Does any of the information 

claimed as confidential appear in one or 

more patents or patent applications? If 

yes, please provide the associated patent 

number or patent application number 

(or numbers) and explain why the 

information should be treated as 

confidential. 

(iv) Is the claim of confidentiality 

intended to last less than 10 years (see 

TSCA section 14(e)(1)(B))? If yes, please 

indicate the number of years (between 1 

and 10 years) or the specific date after 

which the claim is withdrawn. 

(v) Has EPA, another Federal agency, 

or court made any confidentiality 

determination regarding information 

associated with this chemical 

substance? If yes, please provide the 

circumstances associated with the prior 

determination, whether the information 

was found to be entitled to confidential 

treatment, the entity that made the 

decision, and the date of the 

determination. 

(4) Additional substantiation 

questions for chemical identity-related 

claims only. Unless otherwise specified 

in the relevant electronic reporting 

form, answers to the following questions 

must be provided for each chemical 


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identity-related confidentiality claim in 

a TSCA submission: 

(i) Is this chemical substance publicly 

known (including by your competitors) 

to be in U.S. commerce? If yes, please 

explain why the specific chemical 

identity should still be afforded 

confidential status (e.g., the chemical 

substance is publicly known only as 

being distributed in commerce for 

research and development purposes, but 

no other information about the current 

commercial distribution of the chemical 

substance in the United States is 

publicly available). If no, please 

complete the certification statement: 

I certify that on the date referenced I 

searched the internet for the chemical 

substance identity (i.e., by both chemical 

substance name and CASRN). I did not find 

a reference to this chemical substance and 

have no knowledge of public information 

that would indicate that the chemical is 

being manufactured or imported by anyone 

for a commercial purpose in the United 

States. [provide date]. 

(ii) Does this specific chemical 

substance leave the site of manufacture 

(including import) in any form, e.g., as 

a product, effluent, emission? If yes, 

please explain what measures have been 

taken to guard against the discovery of 

its identity. 

(iii) If the chemical substance leaves 

the site in a form that is available to the 

public or your competitors, can the 

chemical identity be readily discovered 

by analysis of the substance (e.g., 

product, effluent, emission), in light of 

existing technologies and any costs, 

difficulties, or limitations associated 

with such technologies? Please explain 

why or why not. 

(iv) Would disclosure of the specific 

chemical identity release confidential 

process information? If yes, please 

explain. 

(5) Exemptions from the 

substantiation requirement. Information 

described in paragraphs (b)(5)(i) and 

(b)(5)(ii) of this section is exempt from 

the requirement to substantiate the 

claim at the time of submission. EPA 

may identify on a reporting form certain 

information as exempt from 

substantiation. Additional assertions of 

exemption from substantiation may be 

asserted by the submitter. Each such 

assertion must include a detailed 

explanation for why the information 

falls within the claimed exemption. If 

the explanation is missing or 

inadequate, and the claim is not 

otherwise substantiated, EPA will place 

a hold on the submission, as described 

in paragraph (d) of this section. 

(i) The following information types 

are exempt from the substantiation 

requirement at the time of information 

submission: 

(A) Specific information describing 

the processes used in manufacture or 

processing of a chemical substance, 

mixture, or article; 

(B) Marketing and sales information; 

(C) Information identifying a supplier 

or customer; 

(D) Details of the full composition of 

a mixture and the respective 

percentages of constituents; 

(E) Specific information regarding the 

use, function, or application of a 

chemical substance or mixture in a 

process, mixture, or article; and 

(F) Specific production or import 

volumes. 

(ii) Exemption for chemical 

substances not yet offered for 

commercial distribution. 

(A) A confidentiality claim for 

specific identity of a chemical 

substance, where the submission is 

made prior to the date on which the 

chemical substance whose identity is 

claimed as confidential is first offered 

for commercial distribution, is exempt 

from the requirement to substantiate 

confidentiality claims at the time of 

submission. 

(B) A specific chemical identity claim 

includes specific chemical names, CAS 

numbers, molecular formulas, reactants 

(if required to be reported as part of the 

identification of the chemical, such as 

for Class 2 substances in § 720.45(a)), 

and structural diagrams; or in the case 

of microorganisms, genus and species 

name and genetic construct. 

(C) This exemption applies where the 

submitter lacks information to 

reasonably conclude that the chemical 

substance has been offered for 

commercial distribution, where both: 

(1) The chemical substance is not on 

the TSCA Inventory, and 

(2) The substance is otherwise not 

publicly known to have been offered for 

commercial distribution. 

(c) Public copies. All TSCA 

submissions and their accompanying 

attachments that include a 

confidentiality claim must be 

accompanied, at the time of submission, 

by a public version of the submission 

and any attachments, with all 

information that is claimed as 

confidential removed. In the case of 

documents collected by EPA or on 

behalf of EPA in person at the site of a 

TSCA inspection under section 11 of the 

Act, the affected company must provide 

such public copies at the same time as 

it provides substantiation of its 

confidentiality claims in accordance 

with paragraph (b)(1) of this section, 

within ten working days after the 

inspection ends. Only information that 

is claimed as confidential may be 

redacted or removed. Generally, a 

public copy that removes all or 

substantially all of the information 

would not meet the requirements of this 

paragraph (c) of this section and the 

submission may be temporarily put on 

hold as deficient. 

(1) Where the applicable reporting 

form or electronic reporting tool 

contains a checkbox or other means of 

designating with specificity what 

information is claimed as confidential, 

no further action by the submitter is 

required to satisfy this requirement. 

(2) For all other information claimed 

as confidential, including but not 

limited to information in attachments 

and in substantiations required under 

paragraph (b) of this section, the 

submitter must prepare and attach a 

public copy. EPA may hold as deficient 

submissions with public or sanitized 

copies that are entirely blank or that are 

substantially reduced in length as 

compared to the CBI version (see 

paragraph (e) of this section). 

(d) Generic name. Each 

confidentiality claim for specific 

chemical identity must be accompanied 

by a structurally descriptive generic 

name for that substance. This generic 

name must be consistent with guidance 

on the determination of structurally 

descriptive generic names developed in 

accordance with TSCA section 

14(c)(4)(A) (e.g., Guidance for Creating 

Generic Names for Confidential 

Chemical Substance Identity Reporting 

under TSCA; available at https://

www.epa.gov/tsca-inventory/guidancecreating-generic-names-confidentialchemical-substance-identity-reporting), 

and 15 U.S.C. 2613(c)(1)(C)(ii). 

(1) At a minimum, the generic name 

must either: 

(i) Be identical to the generic name for 

the same substance included on the 

non-confidential portion of the TSCA 

Inventory (if the substance is listed on 

the TSCA Inventory), or 

(ii) For substances that are not listed 

on the TSCA Inventory, mask only the 

confidential portions of the specific 

chemical name. In most cases, only one 

structural element of a specific chemical 

name may be masked to protect a 

confidential chemical identity—if the 

submitter of a proposed generic name 

wishes to mask more than one such 

element, the submission must include 

an explanation of why masking only one 

element is insufficient to protect the 

confidential identity. 

(2) Notwithstanding paragraph (d)(1) 

of this section, EPA may conclude that 

a generic name provided with the 

submission and listed on the current 

non-confidential version of the TSCA 


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Inventory does not comply with 15 

U.S.C. 2613(c)(1)(C). In such cases, EPA 

will notify the submitting company and 

proceed as described in paragraph (c)(4) 

of this section. 

(3) A generic name that meets the 

requirements of section 14(c)(1)(C) of 

the Act prior to the date on which the 

chemical substance is first offered for 

commercial distribution for the 

purposes of a pre-market submission 

(e.g., a PMN) may not be sufficient for 

the purposes of subsequent listing on 

the TSCA Inventory, as identified upon 

review under section 14(g)(1)(C)(i) of the 

Act of a confidentiality claim for 

specific chemical identity made in a 

Notice of Commencement required 

under § 720.102 or § 725.190(f). In such 

cases, EPA will notify the submitting 

company and proceed as described in 

§ 720.102(f) or § 725.190(f). 

(4) If EPA concludes that the 

proposed generic name does not comply 

with 15 U.S.C. 2613(c)(1)(C), EPA will 

notify the submitter, and provide 10 

business days for the submitter to 

provide a revised generic name. If EPA 

concludes that the revised generic name 

is still not acceptable, EPA will hold the 

submission for an additional period of 

up to 10 business days, and proceed as 

set out in paragraph (e) of this section. 

(e) Deficient confidentiality claims. (1) 

A confidentiality claim under TSCA is 

deficient if it meets one or more of the 

following criteria: 

(i) The confidentiality claim is not 

accompanied by the supporting 

statement and certification required by 

paragraph (a) of this section. 

(ii) The confidentiality claim is not 

accompanied by the substantiation 

required by paragraph (b) of this section. 

If the submitter claims an exemption 

from substantiation under paragraph 

(b)(5) of this section and the exemption 

does not apply or an explanation is not 

provided for the exemption pursuant to 

paragraph (b)(5) of this section, the 

confidentiality claim is deficient. 

(iii) The confidentiality claim is not 

accompanied by a public copy that 

meets the requirements of paragraph (c) 

of this section. 

(iv) The confidentiality claim is for a 

specific chemical identity and is not 

accompanied by a generic name that 

meets the requirements of paragraph (d) 

of this section. 

(2) A submission that is identified as 

deficient under paragraph (e)(1) of this 

section will be held for a period of up 

to 10 business days, and the submitter 

will be notified via CDX as described in 

paragraph (h) of this section. During the 

hold, which commences on the day the 

CDX notice is sent, any applicable 

review period for the underlying 

submission will be suspended until 

either the deficiency is corrected or the 

10 business days elapse without such 

correction. Upon the occurrence of the 

first of either of these events, the 

applicable review period for the 

underlying submission commences or 

comes out of suspension. If the 

deficiency is not remedied during the 

suspension, EPA will proceed with 

review of the submission and may deny 

the CBI claim(s). 

(f) Electronic reporting required. (1) 

Except in the case of information 

subpoenaed under TSCA section 11(c) 

or materials collected or requested by 

EPA as part of an inspection under 

TSCA section 11(a), TSCA submissions 

bearing confidentiality claims must be 

submitted via CDX. 

(2) You must use CISS to complete 

and submit TSCA submissions via CDX. 

To access CISS go to https://

cdx.epa.gov/ and follow the appropriate 

links. 

(3) On receipt by EPA, each electronic 

TSCA submission will be assigned a 

case number or document identifier, 

which will be available to the submitter 

in their CDX account. This identifier 

may be used as a reference in future 

communications that concern the 

substance, and may be used by EPA in 

public communications (e.g., Federal 

Register notices) that concern the 

submission, such as notices of receipt, 

final confidentiality determination, 

pending confidentiality claim 

expiration, or in other regulatory actions 

that concern the TSCA submission. 

(g) Requirement to report health and 

safety studies using templates. 

Submitters of health and safety studies 

or information from such studies must 

provide such data in templated form, 

using an appropriate OECD harmonized 

template, if such template is available 

for the data type (https://www.oecd.org/ 

ehs/templates/). Individual test or data 

submission rules or orders may specify 

an appropriate template or templates. 

Submission of templated data is not a 

substitute for submitting a full study 

report where a specific TSCA rule or 

order requires submission of the full 

study report (e.g., § 720.50(a), or 

according to the terms of a specific 

order under TSCA section 5(e)). 

(h) Requirement to maintain company 

contact information; electronic notices 

concerning confidentiality claims. (1) To 

facilitate ongoing or future 

communication concerning TSCA 

submissions, current contact 

information for all of the individuals 

associated with a particular TSCA 

submission must be maintained. Contact 

information for all the individuals 

associated with a particular TSCA 

submission must be updated by 

amending the submission via CDX, 

except that submissions that are either 

no longer accessible to the submitting 

company or that were not submitted via 

CDX (e.g., submissions that were 

originally provided on paper or other 

physical media), updated company 

contact must be provided via CDX using 

the appropriate EPA-provided electronic 

reporting application in CISS. In 

circumstances where ownership of the 

company or unit of a company has 

changed, such that contact information 

for one or more prior TSCA submissions 

that include confidentiality claims is 

affected, a notice of transfer of 

ownership must be directed to EPA via 

CDX. Instructions for providing this 

notice and for requesting access to 

copies of a prior TSCA submission are 

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

(2) When EPA contacts a TSCA 

submitter concerning confidentiality 

claims (e.g., related to a pending or 

concluded confidentiality claim review, 

a deficient submission, or in relation to 

the 10-year expiration of a 

confidentiality claim (described in 

TSCA section 14(e)), EPA may provide 

notices and other correspondence to the 

submitter via CDX, using the contact 

information provided in the most recent 

version of the submission, or using the 

contact information provided in a more 

recent notice of transfer of ownership 

relating to that submission. The fact and 

date of delivery of such notice is 

verified automatically by CDX. 

(3) In addition to individual notice 

described in paragraph (h)(2) of this 

section, EPA will publish on its website, 

or other appropriate platform, a list of 

TSCA submissions with confidentiality 

claims that are approaching the end of 

the ten-year period of protection 

described in TSCA section 14(e). Such 

TSCA submissions will be referred to by 

the TSCA case or document identifier 

(as described in paragraph (f)(3) of this 

section) that was assigned to the 

submission by EPA when it was 

originally submitted. TSCA submissions 

will be added to this list at least 60 days 

prior to the end of the ten-year period 

of protection, along with instructions for 

reasserting and substantiating expiring 

claims. 

(4) When a confidentiality claim is 

being reviewed pursuant to TSCA 

section 14(f), EPA will provide, when 

necessary, notice of such review and an 

opportunity to substantiate or 

resubstantiate the affected 

confidentiality claim to the submitter 

using the contact information for the 

authorized official or technical contact 

provided in the most recent version of 

the submission or in a more recent 


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notice of transfer of ownership relating 

to that submission. 

(5) Where the submission with the 

relevant CBI claim was not originally 

made via CDX, EPA will send the notice 

via courier or US Mail to the company 

address provided in the most recent 

TSCA submission made by that 

company, or via other means that allows 

verification of the fact and date of 

receipt. The notice will provide 

instructions for substantiating claims 

that were exempt from substantiation 

when the confidentiality claim was 

asserted or for which the submitter was 

otherwise not required to provide 

substantiation at the time of initial 

submission, and for updating or resubstantiating as necessary any claims 

that were previously substantiated. 

(i) Withdrawing confidentiality 

claims. TSCA confidentiality claims 

may be voluntarily withdrawn by the 

submitter at any time. 

(1) Confidentiality claims in TSCA 

submissions that were originally made 

via electronic submission may be 

withdrawn by reopening the submission 

in CDX, removing confidentiality 

markings (e.g., confidential checkmarks 

or bracketing), revising sanitized 

attachments or copies as appropriate, 

and then resubmitting the submission. 

(2) For submissions that were not 

originally made via CDX, or that are no 

longer accessible to the submitting 

company via CDX, confidentiality 

claims may also be withdrawn via CDX 

using the ‘‘TSCA Communications’’ 

application or successor system. The 

withdrawal correspondence must 

indicate the case or document number 

(or other applicable document identifier 

or document identifying details) from 

which CBI claims are being withdrawn, 

identify the submitting company, and 

include a list or description of the 

information for which CBI claims are 

being withdrawn, including page 

numbers where relevant. Current 

contact information for the person 

withdrawing the claim must also be 

provided, in the event EPA needs 

clarification concerning which claim or 

claims are being withdrawn. 

(j) Amending public copy following 

confidentiality claim denial or 

expiration. (1) Following the expiration 

or EPA’s denial of a TSCA 

confidentiality claim, the person who 

asserted the denied or expired claim 

should prepare and submit a revised 

public copy of the submission to EPA, 

following the procedures for voluntarily 

withdrawing claims described in 

§ 703.5(i). 

(2) If the person who asserted the 

denied or expired claim declines or fails 

to provide within 30 days a revised 

public copy of the submission that 

includes the information for which the 

confidentiality claim(s) were denied or 

expired, EPA may prepare an addendum 

to the original public copy, as needed, 

in order to provide the newly available 

information to the public. 

§ 703.7 EPA review of confidentiality 

claims under TSCA Section 14(g) 

(a) Representative subset. (1) 

Definition. A representative subset 

consists of at least 25% of 

confidentiality claims asserted under 

TSCA, not including claims for specific 

chemical identity or for the categories of 

information listed in section 14(c)(2) of 

TSCA. Excluded from the representative 

subset are 

(i) Inquiries with respect to potential 

submission to EPA of a notification 

under 40 CFR part 720, 721, 723 or 725 

by a person who has not submitted the 

notification at the time of the inquiry, 

including inquiries under § 720.25(b) or 

721.11; 

(ii) Submissions or other 

communication not submitted to EPA 

via CDX; and 

(iii) Amendments to previous TSCA 

submissions. 

(2) Selection of submissions for 

review. To satisfy its confidentiality 

claim review obligations under section 

14(g)(1)(C)(ii) of TSCA, EPA may review 

all claims (except those exempt from 

substantiation under TSCA section 

14(c)(2)) in every fourth TSCA 

submission submitted via CDX that is 

part of the representative subset, in 

chronological order of receipt by EPA. 

For each submission selected for review 

as part of the representative subset, EPA 

reviews and approves or denies every 

individual confidentiality claim in that 

submission (except claims that are 

exempt under TSCA sections 14(c)(2) 

and 14(g)), including claims made in 

attachments and amendments available 

to EPA at the time of the review. 

(b) Review of new and expiring 

confidentiality claims under TSCA 

Section 14(g). (1) Under TSCA Section 

14(g), EPA will review: 

(i) All chemical identity claims 

asserted in TSCA submissions except 

those that are exempt from 

substantiation according to TSCA 

Section 14(c)(2)(G), and 

(ii) A representative subset of other 

confidentiality claims as provided in 

paragraph (a) of this section. 

(2) EPA will review all timely 

requests for extension of claims under 

section 14(e) of TSCA within 30 days of 

receipt. 

(3) EPA will also review or re-review 

confidentiality claims under certain 

other circumstances, as set out in TSCA 

section 14(f). TSCA section 14(f) 

reviews are conducted in accordance 

with procedures set out in § 703.8. 

(c) Commencement of the review 

period and effect of amendments. 

Subject to § 703.5(e), the 90-day review 

period described in TSCA section 14(g) 

begins on the day that EPA accepts a 

new TSCA submission that includes 

confidentiality claims. For new 

information, other than specific 

chemical identity, added to a 

submission after EPA first accepts the 

submission, the review will take into 

account such amendments to that 

submission that are made either up to 

60 days from the original submission 

date, or until the Agency issues a final 

confidentiality determination for the 

submission, whichever comes first. If a 

submission is amended to report an 

additional or different chemical 

substance that includes a new specific 

chemical identity claim, the TSCA 

section 14(g) review period for the 

added chemical identity begins on the 

day EPA accepts the amendment 

including the new claim. 

(d) Publication of final 

determinations. Final confidentiality 

determinations will be published on 

EPA’s website, or other platform, 

periodically, in accordance with the 

requirements of TSCA section 26(j). 

(e) Claim denials and notice period. 

Final determinations will be issued by 

the General Counsel or their designee, 

which may include personnel outside of 

the Office of General Counsel. In the 

case that EPA determines that a claim or 

part of a claim is not entitled to 

confidential treatment, EPA will 

provide notice of the denial to the 

person who made the claim and provide 

reasons for the denial or denial in part. 

The notice will be provided 

electronically, as described in 

§ 703.5(h)(2). The 30-day notice period 

described in TSCA section 14(g)(2)(B) 

begins on the next business day 

following the date the notice is made 

available to the submitter in their CDX 

account. 

(f) Substantive criteria for use in 

confidentiality determinations. 

Information claimed as confidential 

under TSCA section 14 will be 

approved if: 

(1) The business has asserted a 

business confidentiality claim which 

has not expired by its terms, nor been 

waived nor withdrawn; 

(2) The business has satisfactorily 

shown that it has taken reasonable 

measures to protect the confidentiality 

of the information, and that it intends to 

continue to take such measures for as 

long as the claim is maintained; 


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(3) The information is not, and has 

not been, reasonably obtainable without 

the business’s consent by other persons 

(other than governmental bodies) by use 

of legitimate means (other than 

discovery based on a showing of special 

need in a judicial or quasi-judicial 

proceeding; e.g., the business has 

demonstrated a reasonable basis to 

believe the information is not readily 

discoverable through reverse 

engineering); 

(4) The business has demonstrated a 

reasonable basis to conclude that 

disclosure of the information is likely to 

cause substantial harm to the 

competitive position of the business; 

and 

(5) No statute denies confidential 

protection to the information. 

Information from health and safety 

studies is not entitled to confidential 

treatment, except that the following 

information may be entitled to 

confidential treatment if it otherwise 

meets the remainder of criteria in this 

paragraph (f): 

(i) Any information, including 

formulas (including molecular 

structures) of a chemical substance or 

mixture, that discloses processes used 

in the manufacturing or processing of a 

chemical substance or mixture; or 

(ii) In the case of a mixture, the 

portion of the mixture comprised by any 

of the chemical substances in the 

mixture. 

(g) Request for Reconsideration. 

Persons who received a denial or partial 

denial notification under paragraph (e) 

of this section may request 

reconsideration by the Office of General 

Counsel prior to the end of the 30-day 

period specified in the notice and 

described under paragraph (e) of this 

section. The business must make its 

request for reconsideration 

electronically via CDX, following the 

instructions in the notice. If a request 

for reconsideration is timely received, 

EPA will suspend the 30-day notice 

period described in paragraph (e) of this 

section while the Office of General 

Counsel reconsiders the Agency’s 

determination. Once the Office of 

General Counsel’s reconsideration is 

complete, the Agency will provide 

notification, pursuant to § 703.5(h), to 

the person of EPA’s decision on the 

request for reconsideration. If upon 

reconsideration the Agency upholds the 

confidentiality determination, the 30- 

day notice period will resume. The 

Office of General Counsel will perform 

its review de novo and will only 

reconsider determinations based on the 

information included with the original 

submission and amendments made up 

until the time the final determination 

was issued. 

(h) Criteria to use in consideration of 

requests for extension under TSCA 

section 14(e). Requests to extend the 

period of confidentiality protection 

under TSCA section 14(e) use the same 

criteria as described under § 703.7(f). 

Requests for extension may rely on a 

substantiation previously provided to 

EPA, but the submitter must recertify 

that the substantiation is still true and 

correct. 

§ 703.8 EPA Review of Confidentiality 

Claims Under TSCA Section 14(f). 

(a) Review of confidentiality claims 

initiated under TSCA Section 14(f). In 

accordance with the procedures 

described in this section, EPA may 

review confidentiality claims that are 

subject to TSCA section 14(f)(1), and 

will review confidentiality claims 

subject to TSCA section 14(f)(2) in the 

following situations: 

(1) In response to a request under the 

Freedom of Information Act (5 U.S.C. 

552) for TSCA information claimed 

confidential; 

(2) If EPA has reason to believe that 

information claimed confidential does 

not qualify for protection from 

disclosure; or 

(3) For any chemical substance EPA 

determines under TSCA section 

6(b)(4)(A) presents an unreasonable risk 

of injury to health or the environment. 

(b) Substantiation exemptions not 

applicable. All confidentiality claims 

asserted in submissions described by 

paragraph (a) of this section are subject 

to the substantiation requirements, 

including those that were initially 

exempt from substantiation according to 

section 14(c)(2) of TSCA. 

(c) Additional substantiation. If 

necessary, such as in the case that 

substantiation has not previously been 

provided for confidentiality claims 

under review, or in the case that EPA 

has reason to believe the substantiation 

is incomplete or out of date, EPA will 

request additional substantiation from 

the person(s) that claimed the 

information as confidential. 

(d) Additional substantiation notice. 

If additional substantiation is necessary, 

EPA will provide notice to the person 

that claimed the information as 

confidential in the manner specified in 

§ 703.5(h)(4). The notice will provide 

the time allowed for additional 

substantiation from the business and the 

method for requesting a time extension 

if necessary. If the person does not make 

a timely response or extension request, 

EPA will consider any existing 

substantiations in its review of the 

claims or, in the case of any 

unsubstantiated claim, EPA will 

construe this as a waiver of the claim 

and may make the information public 

without any further notice to the 

submitter. 

(e) Substantive criteria for use in 

confidentiality determinations. The 

criteria in § 703.7(f) apply to 

confidentiality determinations initiated 

under TSCA section 14(f). For 

determinations required to respond to a 

FOIA request, the criteria in § 703.7(f) 

are supplemented with one additional 

criterion that must be satisfied: The 

business adequately demonstrates that 

the information is commercial or 

financial information obtained from a 

person and is confidential within the 

meaning of FOIA Exemption 4 (5 U.S.C. 

552(b)(4)). 

(f) Adverse determinations and notice 

period. Final determinations will be 

issued by the General Counsel or their 

designee, including personnel outside of 

the Office of General Counsel. Except 

for instances where claims were waived, 

if EPA determines that information 

claimed confidential does not qualify 

for protection from disclosure, EPA will 

provide written notice to the person 

who asserted the claim. The notice will 

be provided electronically, as described 

in § 703.5(h)(2). The 30-day notice 

period described in TSCA section 

14(g)(2)(B) begins on the next business 

day following the date the notice is 

made available to the submitter in their 

CDX account. 

(g) Disclosure of Information. After a 

final determination has been made by 

EPA to release some or all of the 

information claimed as confidential, the 

Agency shall make the information 

available to the public (in the absence 

of a court order prohibiting disclosure) 

whenever: 

(1) The period provided for 

commencement by a business of an 

action to obtain judicial review of the 

determination has expired without 

notice to EPA of commencement of such 

an action; or 

(2) The court, in a timely-commenced 

action, has denied the person’s motion 

for a preliminary injunction, or has 

otherwise upheld the EPA 

determination. 

(h) Notice relating to public requests 

for records. Any person whose request 

for release of the information under 5 

U.S.C. 552 is pending at the time notice 

is given under paragraph (f) of this 

section shall be furnished notice under 

5 U.S.C. 552 either stating the 

circumstances under which the some or 

all of the information will be released or 

denying the request if all requested 

information was found to be entitled to 

confidential treatment. 


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PART 704—REPORTING AND 

RECORDKEEPING REQUIREMENTS 

■ 6. The authority citation for part 704 

continues to read as follows: 

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

■ 7. Revise § 704.7 to read as follows: 

§ 704.7 Confidential business information 

claims. 

Claims of confidentiality must be 

made in accordance with the procedures 

described in 40 CFR part 703. 

PART 707—CHEMICAL IMPORTS AND 

EXPORTS 

■ 8. The authority citation for part 707 

continues to read as follows: 

Authority: 15 U.S.C 2611(b) and 2612. 

■ 9. Amend § 707.63 by redesignating 

paragraphs (a) through (d) as paragraphs 

(b) through (e) and adding a new 

paragraph (a) to read as follows: 

§ 707.63 Definitions. 

(a) CDX or Central Data Exchange 

means EPA’s centralized electronic 

document receiving system, or its 

successor system. 

■ 10. Amend § 707.65 by revising 

paragraphs (a)(1) and (2), removing 

paragraph (a)(3), and revising paragraph 

(c) to read as follows: 

§ 707.65 Submission to the Agency. 

(a) * * * 

(1)(i) The notice must be for the first 

export or intended export by an exporter 

to a particular country in a calendar 

year when the chemical substance or 

mixture is the subject of an order issued, 

an action that is pending, or relief that 

has been granted under TSCA section 

5(f), a rule that has been proposed or 

promulgated under TSCA section 6, or 

an action that is pending or relief that 

has been granted under TSCA section 7. 

(ii) The notice must only be for the 

first export or intended export by an 

exporter to a particular country when 

the chemical substance or mixture is the 

subject of an order issued, an action that 

is pending, or relief that has been 

granted under TSCA section 5(e), a rule 

that has been proposed or promulgated 

under TSCA section 5(a)(2), or when the 

submission of data is required under 

TSCA section 4 or 5(b). Under this 

paragraph (a)(1)(ii), notice of export to a 

particular country is not required if an 

exporter previously submitted to EPA a 

notice of export to that country prior to 

January 16, 2007. 

(2) The notice must be submitted to 

EPA within seven days of forming the 

intent to export or on the date of export, 

whichever is earlier. A notice of intent 

to export must be based on a definite 

contractual obligation, or an equivalent 

intra-company agreement, to export the 

regulated chemical. 

* * * * * 

(c) Notices must be submitted via 

CDX, using the TSCA section 12(b) 

Export Notification Application or its 

successor. 

■ 11. Amend § 707.67 by revising 

paragraph (a) to read as follows: 

§ 707.67 Contents of notice. 

* * * * * 

(a) The name of the regulated 

chemical as it appears in the TSCA 

section 4, 5, 6, and/or 7 action. For 

substances on the confidential portion 

of the TSCA Inventory, this means that 

the substance must be identified by 

generic name and accession number, or 

by any other non-confidential identifier 

under which it is listed on the TSCA 

section 12(b) reporting list maintained 

by EPA and available in the TSCA 

section 12(b) Export Notification 

Application described in § 707.65(c). If 

a category is regulated, the name of the 

individual regulated chemical within 

that category, as well as the category, 

must be given. The name must be that 

which appears in the TSCA Inventory, 

if the chemical appears there. 

* * * * * 

■ 12. Amend § 707.75 by revising 

paragraph (d) to read as follows: 

§ 707.75 Confidentiality 

* * * * * 

(d) Claims of confidentiality must be 

made in accordance with the procedures 

described in 40 CFR part 703. 

PART 716—HEALTH AND SAFETY 

DATA REPORTING 

■ 12. The authority citation for part 716 

continues to read as follows: 

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

■ 13. Revise § 716.55 to read as follows: 

§ 716.55 Confidentiality claims. 

Claims of confidentiality must be 

made in accordance with the procedures 

described in 40 CFR part 703. 

PART 717—RECORDS AND REPORTS 

OF ALLEGATIONS THAT CHEMCIAL 

SUBSTANCES CAUSE SIGNIFICANT 

ADVERSE REACTIONS TO HEALTH 

OR THE ENVIRONMENT 

■ 14. The authority citation for part 717 

continues to read as follows: 

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

■ 15. Amend § 717.17 by revising 

paragraph (c) to read as follows: 

§ 717.17 Inspection and reporting 

requirements. 

* * * * * 

(c) How to Report. When required to 

report, firms must submit copies of 

records via CDX https://cdx.epa.gov/ 

using the EPA provided electronic 

reporting application. 

■ 16. Revise § 717.19 to read as follows: 

§ 717.19 Confidentiality. 

Claims of confidentiality must be 

made in accordance with the procedures 

described in 40 CFR part 703. 

PART 720—PREMANUFACTURE 

NOTIFICATION 

■ 17. The authority citation for part 720 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, and 2613. 

■ 18. Revise § 720.80 to read as follows: 

§ 720.80 General provisions. 

Claims of confidentiality must be 

made in accordance with the procedures 

described in 40 CFR part 703. 

* * * * * 

§ 720.85 [Removed] 

■ 19. Remove § 720.85. 

§ 720.90 [Removed] 

■ 20. Remove § 720.90. 

■ 21. Revise § 720.95 to read as follows: 

§ 720.95 Public file. 

All information submitted with a 

notice, including any health and safety 

study and other supporting 

documentation, will become part of the 

public file for that notice, unless such 

materials are claimed confidential in 

accordance with procedures in 40 CFR 

703.5. In addition, EPA may add 

materials to the public file, subject to 

subpart E of this part. Publicly available 

materials are available at the docket 

addresses in § 700.17(b)(1) and (2) of 

this chapter and on EPA’s website. 

■ 22. Amend § 720.102 by revising 

paragraph (c)(2) and adding paragraphs 

(e) and (f) to read as follows: 

§ 720.102 Notice of commencement of 

manufacture or import. 

* * * * * 

(c) * * * 

(2) If the submitter claims any 

information on the form as confidential, 

the claim must be asserted and 

substantiated in accordance with the 

requirements described in 40 CFR part 

703 and must be submitted via EPA 

Form 7710–56. If the submitter wants 

the chemical identity to be listed on the 

confidential portion of the TSCA 

Inventory, the chemical identity must be 

claimed as confidential and the 

submitter must also follow the 


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certification, substantiation, and generic 

name requirements described part 703 

and paragraphs (e) and (f) of this 

section. Otherwise, EPA will list the 

specific chemical identity on the public 

TSCA Inventory. Submitters who did 

not claim the chemical identity, 

submitter identity, or other information 

to be confidential in the PMN cannot 

claim this information as confidential in 

the notice of commencement. 

* * * * * 

(e) Confidentiality. (1) Any person 

who asserts a confidentiality claim for 

chemical identity in a Notice of 

Commencement submitted under 

§ 720.102 must: 

(i) Comply with generic name 

requirements described in part 703 and 

as specified in paragraph (f) of this 

section. 

(ii) Agree that EPA may disclose to a 

person with a bona fide intent to 

manufacture or import the chemical 

substance the fact that the particular 

chemical substance is included on the 

confidential TSCA Inventory for 

purposes of notification under section 

5(a)(1)(A) of the Act. 

(iii) Have available for the particular 

chemical substance, and agree to furnish 

to EPA upon request: 

(A) An elemental analysis. 

(B) Either an X-ray diffraction pattern 

(for inorganic substances), a mass 

spectrum (for most other substances), or 

an infrared spectrum of the particular 

chemical substance, or if such data do 

not resolve uncertainties with respect to 

the identity of the chemical substance, 

additional or alternative spectra or other 

data to identify the chemical substance. 

(2) Claims of confidentiality must be 

made in accordance with the procedures 

described in 40 CFR part 703. 

(f) Generic Name. If a submitter 

asserts a claim of confidentiality for 

chemical identity in a notice of 

commencement, they must provide a 

structurally descriptive generic name. 

(1) Generic names must: 

(i) Be structurally descriptive (e.g., not 

a trade name); 

(ii) Describe the chemical structure of 

the chemical substance as specifically as 

practicable while protecting only those 

features of the chemical structure that 

are claimed as confidential and 

disclosure of which would likely cause 

substantial harm to the competitive 

position of the person—the generic 

name should generally only obscure one 

structural feature, but in any case, 

should conceal only the feature(s) 

necessary to avoid a likelihood of 

substantial competitive harm to the 

submitter; and 

(iii) Be consistent with guidance on 

the determination of structurally 

descriptive generic names, developed in 

accordance with TSCA section 

14(c)(4)(A) (e.g., Guidance for Creating 

Generic Names for Confidential 

Chemical Substance Identity Reporting 

under TSCA; available at https://

www.epa.gov/tsca-inventory/guidancecreating-generic-names-confidentialchemical-substance-identity-reporting). 

(2) Generic names will be reviewed by 

EPA at the time of submission. (i) If EPA 

concludes that a proposed generic name 

meets the criteria in paragraph (f)(1) of 

this section, EPA will include that 

generic name in the public TSCA 

Inventory listing for that substance. 

(ii) If the proposed generic name does 

not meet the criteria in paragraph (f)(1) 

of this section, EPA will notify the 

submitter concerning the deficiency via 

CDX, as described in 40 CFR 703.5(f). 

EPA will provide 10 business days to 

correct the deficiency and provide an 

alternative generic name that would be 

acceptable to EPA. If the alternative 

generic name proposed by EPA is 

acceptable to the submitter (or if the 

submitter does not respond within the 

10-day period), EPA will place that 

alternative generic name on the public 

TSCA Inventory. If the alternative 

generic name proposed by EPA is not 

acceptable to the submitter, the 

submitter must submit a revised generic 

name that meets the criteria in 

paragraph (f)(1) of this section and an 

explanation of how EPA’s proposed 

generic name reveals confidential 

information. If EPA concludes that the 

submitter’s revised generic name also 

does not meet the criteria in paragraph 

(f)(1) of this section, EPA will hold the 

notice of commencement for a period of 

up to 10 business days. Reporting 

requirements will not be considered to 

have been met and the substance will 

not be added to the TSCA Inventory 

during this period. If the submission 

remains deficient after this 10-day 

period, EPA will proceed with CBI 

review of the chemical identity claim 

and will likely deny the claim. 

PART 723—PREMANUFACTURE 

NOTICE EXEMPTIONS 

■ 23. The authority citation for part 723 

continues to read as follows: 

Authority: 15 U.S.C. 2604. 

■ 24. Amend § 723.50, by revising 

paragraph (l) to read as follows: 

§ 723.50 Chemical substances 

manufactured in quantities of 10,000 

kilograms or less per year, and chemical 

substances with low environmental 

releases and human exposures. 

* * * * * 

(l) Confidentiality. Claims of 

confidentiality must be made in 

accordance with the procedures 

described in 40 CFR part 703. 

* * * * * 

■ 25. In § 723.250, revise the 

introductory text of paragraphs (f) and 

(n) to read as follows: 

§ 723.250 Polymers. 

* * * * * 

(f) Exemption report for polymers 

manufactured under the terms of this 

section. For substances exempt under 

paragraphs (e)(1), (e)(2), and (e)(3) of 

this section a report of manufacture or 

import must be submitted by January 31 

of the year subsequent to initial 

manufacture. The report and 

accompanying claims must be 

submitted via CDX (https://cdx.epa.gov/ 

), using the TSCA Section 5 Notices and 

Supports—ePMN application. See 

§ 720.40(a)(2)(ii) for information on how 

to access e-PMN software. The notice 

must include: 

* * * * * 

(n) Confidentiality. Claims of 

confidentiality must be made in 

accordance with the procedures 

described in 40 CFR part 703. 

PART 725—REPORTING 

REQUIREMENTS AND REVIEW 

PROCESSES FOR MICROORGANISMS 

■ 26. The authority citation for part 725 

continues to read as follows: 

Authority: 15 U.S.C. 2604, 2607, 2613, and 

2625. 

■ 27. Revise § 725.80 to read as follows: 

§ 725.80 General provisions. 

Claims of confidentiality must be 

made in accordance with the procedures 

described in 40 CFR part 703, except as 

modified in this paragraph. In general, 

references to ‘‘chemical’’ or ‘‘chemical 

identity’’ in part 703 are equivalent to 

‘‘microorganism’’ or ‘‘microorganism 

identity’’ for the purposes of this part. 

(a) In place of § 703.5(b)(3)(v), the 

following question applies: Has EPA, 

another Federal agency, or court made 

any confidentiality determination 

regarding information associated with 

this microorganism? If yes, please 

provide the circumstances associated 

with the prior determination, whether 

the information was found to be entitled 

to confidential treatment, the entity that 

made the decision, and the date of the 

determination. 

(b) In place of § 703.5(b)(4), the 

following questions apply: 

(1) Has the identity of the 

microorganism been kept confidential to 

the extent that competitors do not know 

it is being manufactured or imported 


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into US commerce? If not, explain why 

the microorganism identity should still 

be afforded confidential status (e.g., the 

microorganism is publicly known only 

as being distributed in commerce for 

research and development purposes, but 

no other information about the current 

commercial distribution of the 

microorganism in the United States is 

publicly available). 

(2) Does the microorganism leave the 

site of production or testing in a form 

which is accessible to the public or to 

competitors? If yes, please explain what 

measures have been taken to guard 

against the discovery of its identity. 

Further, what is the cost to a competitor, 

in time and money, to develop 

appropriate use conditions? What 

factors facilitate or impede product 

analysis? 

§ 725.85 [Removed] 

■ 28. Remove § 725.85. 

§ 725.92 [Removed] 

■ 29. Remove § 725.92. 

§ 725.94 [Removed] 

■ 30. Remove § 725.94. 

■ 31. Revise § 725.95 to read as follows: 

§ 725.95 Public file. 

All information submitted, including 

any health and safety study of a 

microorganism and other supporting 

documentation, will become part of the 

public file for that submission, unless 

such materials are claimed as 

confidential in accordance with this 

section. In addition, EPA may add 

materials to the public file, subject to 

subpart C of this part. Publicly available 

materials are available at the docket 

addresses in § 700.17(b)(1) and (2) of 

this chapter and on EPA’s website. 

■ 32. Amend § 725.190 by revising 

paragraph (c) and adding paragraphs (e) 

and (f) to read as follows: 

§ 725.190 Notice of Commencement of 

manufacture or import. 

* * * * * 

(c) Information to be reported. The 

NOC must contain the following 

information: Specific microorganism 

identity, MCAN number, and the date 

when manufacture or import 

commences. If the person claims any 

information on the form as confidential, 

the claim must be asserted and 

substantiated in accordance with the 

requirements described in part 703 and 

§ 725.80, as indicated in EPA Form 

7710–56. If the submitter wants the 

microorganism identity to be listed on 

the confidential portion of the TSCA 

Inventory, the microorganism identity 

must be claimed as confidential and 

also follow the certification, 

substantiation, and generic name 

requirements described in part 703 and 

paragraph (e) and (f) of this section. 

* * * * * 

(e) Requirements for assertion. Any 

person who asserts a confidentiality 

claim for microorganism identity must: 

(i) Comply with the requirements of 

paragraph (f) of this section regarding 

submission of a generic name. 

(ii) Agree that EPA may disclose to a 

person with a bona fide intent to 

manufacture or import the 

microorganism the fact that the 

particular microorganism is included on 

the confidential TSCA Inventory for 

purposes of notification under section 

5(a)(1)(A) of the Act. 

(iii) Have available and agree to 

furnish to EPA upon request the 

taxonomic designations and 

supplemental information required by 

§ 725.12. 

(iv) Make claims of confidentiality in 

accordance with the procedures 

described in 40 CFR part 703. 

(f) Generic Name. If a submitter 

asserts a claim of confidentiality for 

microorganism identity in a notice of 

commencement, they must provide a 

generic name. 

(1) Generic names must: 

(i) Be structurally descriptive (e.g., not 

a trade name); and 

(ii) Be consistent with guidance on 

the determination of structurally 

descriptive generic names, developed in 

accordance with TSCA section 

14(c)(4)(A) (e.g., Guidance for Creating 

Generic Names for Confidential 

Chemical Substance Identity Reporting 

under TSCA). Generic names for 

microorganisms may only mask the 

portion of microorganism identity that 

the submitter believes is proprietary 

(considering that the identity of a 

microorganism to be listed on the TSCA 

Inventory must include taxonomic 

designations (genus, species, and 

strain), key phenotypic traits, key 

genotypic traits and modifications, 

genetic material that has been 

introduced or modified, any vector 

constructs used, cellular location of 

introduced or modified genes, number 

and type of genes introduced or 

modified, and method of construction or 

modification). Taxonomic designation 

(in most cases down to strain) must be 

included in the generic name except 

where the submitter claims the 

taxonomic designation confidential, in 

which case the person making such 

claim must provide an explanation of 

why such masking is necessary to 

protect proprietary information. 

Additionally, the generic microorganism 

identity must include a statement 

regarding the function and stability of 

the genetic construct. This includes an 

indication of whether the introduced or 

modified genes are present on the 

chromosome or extrachromosomal. 

(2) Generic names will be reviewed by 

EPA at the time of submission. 

(i) If EPA concludes that a proposed 

generic name meets the criteria in 

paragraph (f)(1) of this section, EPA will 

include that generic name in the public 

TSCA Inventory listing for that 

substance. 

(ii) If the proposed generic name does 

not meet the criteria in paragraph (f)(1) 

of this section, EPA will notify the 

submitter concerning the deficiency via 

CDX, as described in § 703.5(h). EPA 

will provide ten business days to correct 

the deficiency and provide an 

alternative generic name that would be 

acceptable to EPA. If the alternative 

generic name proposed by EPA is 

acceptable to the submitter (or if the 

submitter does not respond within the 

ten-day period), EPA will place that 

alternative generic name on the public 

TSCA Inventory. If the alternative 

generic name proposed by EPA is not 

acceptable to the submitter, the 

submitter must submit a revised generic 

name that meets the criteria in 

paragraph (f)(1) of this section and an 

explanation of how EPA’s proposed 

generic name reveals confidential 

information. If EPA concludes that the 

revised generic name also does not meet 

the criteria in paragraph (f)(1) of this 

section, EPA will hold the notice of 

commencement for a period of up to 10 

business days. Reporting requirements 

will not be considered to have been met 

and the microorganism will not be 

added to the TSCA Inventory during 

this period. If the submission remains 

deficient after this 10-day period, EPA 

will proceed with CBI review of the 

microorganism identity claim and will 

likely deny the claim. 

PART 790—PROCEDURES 

GOVERNING TESTING CONSENT 

AGREEMENTS AND TEST RULES 

■ 33. The authority citation for part 790 

continues to read as follows: 

Authority: 15 U.S.C. 2603. 

■ 32. Revise § 790.7 to read as follows: 

§ 790.7 Confidentiality. 

Claims of confidentiality must be 

made in accordance with the procedures 

described in 40 CFR part 703. 

[FR Doc. 2022–09629 Filed 5–11–22; 8:45 am] 

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