Section 8(d) of the Toxic Substances Control Act (TSCA) had been effectively a dead provision of TSCA for over a decade. EPA has just revived it by adopting an immediate final rule mandating the submission of health and safety studies on 50 chemical substances by September 27, 2021. The rule applies to chemical manufacturers (and importers) of the 50 substances, as well as petroleum refiners.  The 50 substances are the 20 High-Priority Substances for which EPA is conducting risk evaluations and 30 organohalogen flame retardants for which CPSC has requested testing. The rule appears at 86 Fed. Reg. 341747 (June 29, 2021).

Key Takeaways

• This is the first section 8(d) rule since 2008, so many companies may not be familiar with the section 8(d) requirements.

• The rule applies only to chemical manufacturers and petroleum refiners, i.e., entities covered by NAICS codes 325 and 324110. Companies in other industries are not covered by the rule.

• The rule applies to former manufacturers in the affected NAICS codes who ceased manufacture of a listed substance since July 27, 2011.

• The rule has no exemption for articles, byproducts, impurities, test marketing, or R&D, and it has no de minimis threshold. 

• Persons subject to the rule must conduct an “adequate” file search, then submit both copies of all unpublished studies on the 50 substances in their possession and lists of such studies.

• The required studies include monitoring data that have been aggregated and analyzed, as well as specified toxicology and ecotoxicology studies.

• Reporting is due by September 27, 2021. Requests for extensions must be submitted by September 5, 2021.

• All submissions must be made through the CISS tool on CDX.

Background

This is the first EPA section 8(d) rule since 2008, when EPA added lead in children’s products. 73 Fed. Reg. 5109 (Jan. 20, 2008). Its subsequent rule adding cadmium, 77 Fed. Reg. 17561 (Dec. 3, 2012), was quickly withdrawn.  77 Fed. Reg. 76419 (Dec. 28, 2012). Since regulated entities have not had to grapple with section 8(d) requirements in over 13 years, they may want to review the section 8(d) regulations in 40 C.F.R. Part 716, as well as the rule itself.

This is an immediate final rule, meaning that there is no opportunity for comment on the contents of the rule. (There was an opportunity until July 13 to request EPA to withdraw one or more of the 50 substances being added.)

Under Part 716, EPA may issue an immediate final rule requiring manufacturers to submit lists and/or studies for specific chemical substances. 40 C.F.R. § 716.105(b). This authority only relates to substances that the Interagency Testing Committee (ITC) adds to the Priority Testing List established under section 4(e).

EPA published the 74^th ITC report in April 2021. 86 Fed. Reg. 22414 (Apr. 28, 2021). That report added to the Priority Testing List the 15 High-Priority Substances not already on the list, and the 20 organohalogen flame retardants not already on the list. This was the first ITC report adding substances to the Priority Testing List since 2012.

The ITC’s objective is to “make recommendations to the EPA Administrator on prioritizing and selecting chemicals for testing or information reporting to meet the coordinated data needs of its member U.S. Government organizations.” The ITC is comprised of 14 federal government organizations, including the Food and Drug Administration, Department of Commerce, and the Occupational Safety and Health Administration. The ITC also works with “liaison members,” including the Agency for Toxic Substances and Disease Registry, and the Departments of Defense, Interior, and Agriculture.

Who must submit studies and lists of studies?

Under section 8(d), any person “who manufactures, processes, or distributes in commerce or who proposes to manufacture, process, or distribute in commerce” any listed chemical is required to submit health and safety studies. For this rule, EPA narrowed the applicability of section 8(d) reporting requirements to chemical manufacturers and petroleum refiners, i.e., entities covered by NAICS codes 325 (chemical manufacturing and allied products) and 34110 (petroleum refining). 40 C.F.R. § 716.5(a). 

The rule applies to chemical manufacturers and petroleum refiners who manufacture any of the 50 substances as an impurity, a byproduct, or in R&D, or who import any of the substances as a component of an article.

The rule also applies to former manufacturers in the affected NAICS codes who ceased manufacture of a listed substance since July 27, 2011.

Which Chemicals Did EPA Add to the Health and Safety Data Submission List?

This rule adds 20 High-Priority Substances and 30 organohalogen flame retardants to the list in 40 C.F.R. § 716.120 of chemical substances for which health and safety study reporting is required. These substances were also added to 40 C.F.R. § 716.21(a). The 50 substances are listed at the end of this alert.

What Studies Must Be Submitted?

EPA has broadly defined the term “health and safety study” to include any information or data that relates to, or bear on, the effects of a listed substance on health or the environment.

Chemical manufacturers and petroleum refiners must submit “any study of any effect of a chemical substance or mixture on health or the environment or on both, including underlying data and epidemiological studies, studies of occupational exposure to a chemical substance or mixture, toxicological, clinical, and ecological or other studies of a chemical substance or mixture, and any test performed under TSCA.” 40 C.F.R. § 716.3. (Underlying data is not required unless specifically requested. 40 C.F.R. § 716.10(a)(4).)

Along with toxicology and ecotoxicology studies, the rule requires submission of studies of human and environmental exposure. According to the preamble, this includes:

All unpublished studies on occupational (both users and non-users), general population, consumer, and environmental exposure, such as: Unpublished studies on inhalation and dermal exposure, human biomonitoring, environmental monitoring of indoor and outdoor air, soil, water, and household dust, chamber emission rates from products or polymeric matrices, and unpublished modelling studies that estimate environmental concentrations or human exposures.

Raw industrial hygiene and environmental monitoring data need not be submitted. EPA only requires monitoring data that has been “aggregated and analyzed.” EPA provided guidance on the meaning of that term in 1989 guidance that does not appear on the EPA website, but which is available from Beveridge & Diamond.

All persons subject to the rule must conduct an “adequate” file search, then submit both copies of all unpublished studies in their possession and lists of such studies.

Studies that are exempt from reporting requirements include, for example, published studies; studies previously submitted to EPA Office of Pollution Prevention and Toxics; studies conducted or initiated by another person who is subject to reporting requirements of Part 716; and studies of mixtures containing one or more listed chemicals where the data are not analyzed to determine the exposure or concentration levels of the listed substance. These and additional exemptions are listed in 40 C.F.R. § 716.20.   

When Must Studies Be Submitted?

Copies of studies must be submitted within 60 days of the effective date of the rule. 40 C.F.R. § 716.60(a). The effective date is July 29, so submissions are due by September 27, 2021. Lists of those studies are also due by that date.

Confidentiality Claims

Part 716 allows confidentiality claims only for the following information:

• Processes used in the manufacturing, importing, or processing of the substance or mixture

• The portion of a mixture comprised by any of the substances in the mixture

• Company name or address, financial statistics, and product codes

• Other information, the disclosure of which would clearly be an unwarranted invasion of personal privacy (such as individual medical records)

40 C.F.R. § 716.55(a).

How Are Submissions to Be Made?

Persons subject to the rule must submit studies and lists of studies electronically using the CISS tool in CDX.  40 C.F.R. §§ 716.30(c), 716.35(c).  Requests for extensions must also be submitted in this manner.  40 C.F.R. § 716.60(c). 

List of Substances for Which Reporting Is Required

The 20 High-Priority substances include the following:

5 phthalates:

1. Butyl benzyl phthalate (BBP) – 1,2-Benzenedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester (CAS No. 85-68-7)

2. Dibutyl phthalate (DBP) – 1,2-Benzenedicarboxylic acid, 1,2-dibutyl ester (CAS No. 84-74-2)

3. Dicyclohexyl phthalate – 1,2-Benzenedicarboxylic acid, 1,2-dicyclohexyl ester (CAS No. 84-61-7)

4. Diethylhexyl phthalate (DEHP) – 1,2-Benzenedicarboxylic acid, 1,2-bis(2-ethylhexyl) ester (CAS No. 117-81-7)

5. Diisobutyl phthalate (DIBP) – 1,2-Benzenedicarboxylic acid, 1,2-bis(2-methylpropyl) ester (CAS No. 84-69-5)

3 flame retardants:

1. 4,4’-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) (CAS No. 79-94-7)

2. Phosphoric acid, triphenyl ester (TPP) (CAS No. 115-86-6)

3. Tris(2-chloroethyl) phosphate (TCEP) (CAS No. 115–96–8)

7 chlorinated solvents:

1. o-Dichlorobenzene (CAS No. 95-50-1)

2. p-Dichlorobenzene (CAS No. 106-46-7)

3. 1,1-Dichloroethane (CAS No. 75-34-3)

4. 1,2-Dichloroethane (CAS No. 107-06-2)

5. trans-1,2-Dichloroethylene (CAS No. 156-60-5)

6. 1,2-Dichloropropane (CAS No. 78-87-5)

7. 1,1,2-Trichloroethane (CAS No. 79-00-5),

5 other substances:

1. 1,3-Butadiene (CAS No. 106-99-0)

2. Ethylene dibromide (CAS No. 106-93-4)

3. Formaldehyde (CAS No. 50-00-0)

4. Cyclopenta[g]-2-benzopyran, 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethyl- (HHCB) (CAS No. 1222-05-5)

5. Phthalic anhydride (CAS No. 85-44-9)

The 30 organohalogen flame retardants are the following:

1. Bis(2-ethylhexyl) tetrabromophthalate (CAS No. 26040-51-7)

2. Bis(hexachlorocyclopentadieno)cyclooctane (CAS No. 13560-89-9)

3. 1,2-Bis(2,4,6-tribromophenoxy)ethane (CAS No. 37853-59-1)

4. 1,1’-Ethane-1,2-diylbis(pentabromobenzene) (CAS No. 84852-53-9)

5. 2-Ethylhexyl-2,3,4,5-tetrabromobenzoate (CAS No. 183658-27-7)

6. 2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-tetrabromophthalate (CAS No. 20566-35-2)

7. 2,2’-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-phenylene) oxymethylene]]bis[oxirane] (CAS No. 3072-84-2)

8. 1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, 1-[2-(2-hydroxyethoxy)ethyl] 2-(2-hydroxypropyl) ester (CAS No. 20566-35-2)

9. 2,2’-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-phenylene) oxymethylene]]bis[oxirane] (CAS No. 3072-84-2)

10. Mixture of chlorinated linear alkanes C_14-17 with 45–52% chlorine (CAS No. 85535-85-9)

11. N,N-Ethylene-bis(tetrabromophthalimide) (CAS No. 32588-76-4)

12. Pentabromochlorocyclohexane (CAS No. 87-84-3)

13. Perbromo-1,4-diphenoxybenzene (CAS No. 58965-66-5)

14. Phosphonic acid, (2-chloroethyl)-, bis(2-chloroethyl) ester (CAS No. 6294-34-4

15. Phosphoric acid, 2,2-bis(chloromethyl)-1,3-propanediyl tetrakis(2-chloroethyl) ester (CAS No. 38051-10-4)

16. Propanoic acid, 2-bromo-, methyl ester (CAS No. 5445-17-0)

17. Tetrabromobisphenol A-bis(2,3-dibromopropyl ether) (CAS No. 21850-44-2)

18. Tetrabromobisphenol A bis(2-hydroxyethyl) ether (CAS No. 4162-45-2)

19. Tetrabromobisphenol A diallyl ether (CAS No. 25327-89-3)

20. Tetrabromobisphenol A dimethyl ether (CAS No. 37853-61-5)

21. 2,4,6-Tribromoaniline (CAS No. 147-82-0)

22. 1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene (CAS No. 3278-89-5)

23. Tris(2-chloroethyl)phosphite (CAS No. 140-08-9)

24. Tris(1-chloro-2-propyl)phosphate (CAS No. 13674-84-5)

25. Tris(2-chloro-1-propyl)phosphate (CAS No. 6145-73-9)

26. Tris(2,3-dibromopropyl)phosphate (CAS No. 126-72-7)

27. 1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (CAS No. 52434-90-9)

28. Tris(1,3-dichloro-2-propyl)phosphate (CAS No. 13674-87-8)

29. Tris(tribromoneopentyl)phosphate (CAS No. 19186-97-1)

30. 2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine (CAS No. 25713-60-4)