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Legal Standards on TSCA Section 4, 8(a), 8(c), 8(d) and Applicability to a Section 21 Petition

1. Legal standard regarding TSCA section 8(a) rules.

Section 8(a) of TSCA authorizes the EPA Administrator to promulgate rules under which 

manufacturers and processors of chemical substances must maintain such records and submit 

such information as the EPA Administrator may reasonably require. Regarding mixtures, section 

8(a) of TSCA authorizes the EPA Administrator to promulgate rules under which manufacturers 

and processors of mixtures must maintain such records and submit such information to the extent 

the EPA Administrator determines the maintenance of records or submission or reports, or both, 

is necessary for the effective enforcement of TSCA. Section 8(a) of TSCA generally excludes 

small manufacturers and processors of chemical substances or mixtures from the reporting 

requirements established in TSCA section 8(a). However, EPA is authorized by TSCA section 

8(a)(3)(A)(ii) to require TSCA section 8(a) reporting from small manufacturers and processors 

with respect to any chemical substance or mixture that is the subject of a rule proposed or 

promulgated under TSCA section 4, 5(b)(4), or 6, or that is the subject of an order in effect under 

TSCA section 5(e), or that is the subject of relief granted pursuant to a civil action under TSCA 

section 5 or 7. The standard for determining whether an entity qualifies as a small manufacturer 

is found at 40 CFR 704.3. 

Section 21(b)(4)(B) of TSCA provides the standard for judicial review should EPA deny

a request for rulemaking under TSCA section 8(a): ‘‘If the petitioner demonstrates to the 

satisfaction of the court by a preponderance of the evidence that ...there is a reasonable basis to 

conclude that the issuance of such a rule ...is necessary to protect health or the environment 
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against an unreasonable risk of injury,’’ the court shall order the Administrator to initiate the 

requested action. 15 U.S.C. 2620(b)(4)(B).

2. Legal standard regarding TSCA section 8(d) rules.

Section 8(d) of TSCA authorizes EPA to require the submission of unpublished health 

and safety studies initiated or conducted by, or known to or reasonably ascertainable by, 

manufacturers, processors, and distributors of chemical substances or mixtures. Studies may be 

excluded ‘‘if the Administrator finds that submission of lists of such studies are unnecessary to 

carry out the purposes of [TSCA].’’ 15 U.S.C. 2607(d)(1). 

Section 21(b)(4)(B) of TSCA provides the standard for judicial review should EPA deny

a request for rulemaking under TSCA section 8(d): ‘‘If the petitioner demonstrates to the 

satisfaction of the court by a preponderance of the evidence that ...there is a reasonable basis to 

conclude that the issuance of such a rule ...is necessary to protect health or the environment 

against an unreasonable risk of injury,’’ the court shall order the Administrator to initiate the 

requested action. 15 U.S.C. 2620(b)(4)(B).

3. Legal standard regarding TSCA section 8(c) call-in.

TSCA section 8(c) requires manufacturers, processors, and distributors of chemical 

substances or mixtures 1) to keep records of significant adverse reactions to health or the 

environment, as determined by the Administrator by rule, alleged to have been caused by the 

chemical substance or mixture and 2) to permit inspection and submit copies of such records 

upon request of any duly designated representative of the Administrator. EPA’s implementing 

regulations are at 40 CFR part 717. 
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Among the actions potentially available under TSCA section 8, only rules are proper 

objects of a TSCA section 21 petition. Pursuant to TSCA section 8(c) and EPA’s implementing 

regulations at 40 CFR 717.17, allegations of adverse reactions are not called in by rule. In 

contrast, other provisions of TSCA—including part of TSCA section 8(c)—require or authorize 

the Administrator to act by rule. Section 21 of TSCA allows any person to petition ‘‘to initiate a 

proceeding for the issuance, amendment, or repeal of a rule under section 2603, 2605, or 2607.” 

15 U.S.C. 2620(a). EPA interprets TSCA section 21 to apply only to the enumerated actions. 

4. Legal standard regarding TSCA section 4 rules. 

To issue a TSCA section 4 test rule, EPA must find that data and experience are 

insufficient to reasonably determine or predict the effects of a chemical substance or mixture on 

health or the environment and that testing of the chemical substance or mixture is necessary to 

develop the missing data. 15 U.S.C. 2603(a)(1). In addition, EPA must find either that the 

chemical substance or mixture may present an unreasonable risk of injury or that the chemical 

substance or mixture is produced in substantial quantities and may either result in significant or 

substantial human exposure or result in substantial environmental release. 15 U.S.C. 2603(a)(1).

In the case of a mixture, EPA must also find that ‘‘the effects which the mixture’s 

manufacture, distribution in commerce, processing, use, or disposal or any combination of such 

activities may have on health or the environment may not be reasonably and more efficiently 

determined or predicted by testing the chemical substances which comprise the mixture.’’ 15 

U.S.C. 2603(a)(2).

TSCA section 21 omits the finding that ‘‘testing is necessary to develop the data’’ from 

the findings that a petitioner must demonstrate in order for a court to require EPA to initiate 
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TSCA section 4 rulemaking. 15 U.S.C. 2620(b)(4)(B)(i). Nonetheless, EPA believes TSCA 

section 21(b)(4) is best interpreted as incorporating this finding. The alternative would be to read 

the statute as empowering a court to require EPA to initiate a rulemaking even where the Agency

could not make proposed findings consistent with TSCA section 4 or take final action on the 

rule. EPA’s interpretation is supported by legislative history (Ref. 1).

TSCA section 21(b)(4)(B)(i) provides for judicial review of a petition to promulgate a 

TSCA section 4 rule for chemical substances. In contrast, TSCA section 21 does not provide for 

judicial review of a petition to promulgate a test rule for mixtures. Section 3 of TSCA gives 

distinct definitions for “chemical substance” and “mixture”, and section 21(b)(4)(B)(i) of TSCA 

specifies that the court’s review pertains to application of the TSCA section 4 factors to chemical 

substances. Moreover, TSCA section 21(b)(4)(B)(i) does not contain the additional finding that 

TSCA section 4 requires for issuing a test rule for mixtures (that the effect may not be 

reasonably and more efficiently determined or predicted by testing the chemical components). 

Congress left the complex issues associated with the testing of mixtures to the Administrator’s 

discretion.