Got Unpublished Studies?

If you have unpublished studies on 50 chemicals currently under EPA’s microscope, you may need to report them to the Agency by next month.

Manufacturers and importers of chemicals (including importers of articles) should immediately understand the impacts of a Final Rule that the U.S. Environmental Protection Agency (EPA or Agency) issued on June 29, 2021, which adds fifty chemical substances (listed at the end of this post) to the Toxic Substances Control Act (TSCA) section 8(d) Health and Safety Data Reporting list. This rule requires certain past, current, and prospective manufacturers of these fifty chemicals to submit copies and/or lists of unpublished health and safety studies to the Agency by no later than September 27, 2021. Respondents who cannot meet the deadline may submit a request for an extension to EPA by September 7, 2021. Despite ambiguous language in the Federal Register notice that the listed North American Industrial Classification Systems (NAICS) codes are not “exhaustive,” this reporting requirement applies only to chemical manufacturers (including importers) and petroleum refiners.

What You Need to Know

The fifty chemicals include (1) the twenty chemicals designated by EPA as TSCA high-priority substances currently undergoing TSCA risk evaluations and (2) thirty organohalogen flame retardants being evaluated for health risks by the Consumer Product Safety Commission. Chemical manufacturers and petroleum refiners who manufactured, proposed to manufacture, or imported any one of these fifty substances, including imported articles with any of them, in the last ten years need to consider whether they must submit copies and/or lists of unpublished health and safety studies on those substances to the EPA. The rule also includes reporting requirements for entities who manufacture or propose to manufacture one of the substances from July 29, 2021, to September 27, 2021. Responders should be aware that the rule applies to unpublished studies “showing any measurable content” of the chemical substance.

EPA requires a broad range of health and safety studies to be reported or submitted, including:

• Lists and copies of unpublished health and safety data on health effects, such as toxicity studies, including modeling studies in humans or animals;
• All unpublished studies on environmental effects, environmental fate, and physical-chemical properties if performed as described in 40 CFR 716.50; and
• All unpublished studies on occupational (users and non-users), general population, consumer, and environmental exposure and unpublished modeling studies that estimate environmental concentrations or human exposure.

Who Is Required to Report

EPA’s Federal Register notice for the Final Rule states that “[y]ou may be potentially affected by this action if you manufacture (defined by statute to include import) any of the chemical substances” listed below. The Agency provided two NAICS codes—NAICS codes 325 and 324110 (for chemical manufacturers and petroleum refiners, respectively)—but explicitly cautioned that these two examples are “not intended to be exhaustive, but rather [to] provide[] a guide to help readers determine whether this document applies to them.”

Under the applicable regulation, generally only manufacturers and importers who fall within NAICS codes 325 and 32411 are required to report health and safety data studies. But an exception to this rule allows EPA to require any person who falls outside these two NAICS codes to report. As one would expect, the preamble language may confuse potentially impacted industries about the scope of the Final Rule. Regardless of EPA’s intent, the Agency cannot legally expand the scope of this reporting requirement without actually changing the express regulatory text—something that EPA did not do in the Final Rule.

Why You Are Hearing About this Rule Only Now

If you are surprised to see a final rule, it was because there was no proposal. EPA’s regulations state that the Agency can issue a final rule for chemical substances added to the TSCA section 4(e) priority list by the TSCA Interagency Testing Committee (ITC)—without first publishing a proposal and taking public comment. The ITC added these chemical substances to the TSCA Priority Testing List through its 69th (May 2012) or 74th (April 2021) Reports. The regulations set forth that the rule becomes effective thirty days after publication of a Federal Register notice, the public has fourteen days after the list is published in the Federal Register to provide comment on whether there is good cause to withdraw chemical substance, and submissions to the Agency must be made sixty days after the effective date of the rule.

If you have any questions regarding the applicability of the rule to your company’s products, Wiley can help. Please contact us for more information.

20 TSCA High-Priority Substances

• 1,3-Butadiene (106–99–0)
• Butyl benzyl phthalate (BBP)—1,2-Benzene-dicarboxylic acid, 1- butyl 2(phenylmethyl) ester (85–68–7)
• Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl ester) (84–74–2)
• o-Dichlorobenzene (95–50–1)
• p-Dichlorobenzene (106–46–7)
• 1,1-Dichloroethane (75–34–3)
• 1,2-Dichloroethane (107–06–2)
• Trans-1,2-Dichloroethylene (156–60–5)
• 1,2-Dichloropropane (78–87–5)
• Dicyclohexyl phthalate (84–61–7)
• Di-ethylhexyl phthalate (DEHP)—(1,2-Benzene-dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester) (117–81–7)
• Di-isobutyl phthalate (DIBP)—(1,2-Benzene-dicarboxylic acid, 1,2- bis-(2methylpropyl) ester) (84–69–5)
• Ethylene dibromide (106–93–4)
• Formaldehyde (50–00–0)
• 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2- benzopyran (HHCB) (1222–05–5)
• 4,4′-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) (79–94–7)
• Phosphoric acid, triphenyl ester (TPP) (115–86–6)
• Phthalic anhydride (85–44–9)
• 1,1,2-Trichloroethane (79–00–5)
• Tris(2-chloroethyl) phosphate (TCEP) (115–96–8)

30 Organohalogen Flame Retardants

• Bis(2-ethylhexyl) tetrabromophthalate (26040–51–7)
• Bis(hexachlorocyclopentadieno)cyclooctane (13560–89–9)
• 1,2-Bis(2,4,6-tribromophenoxy)ethane (37853–59–1)
• 1,1′-Ethane-1,2-diylbis(pentabromobenzene) (84852–53–9)
• 2-Ethylhexyl-2,3,4,5-tetrabromobenzoate (183658–27–7)
• 2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6- tetrabromophthalate (20566–35–2)
• 2,2′-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bis[oxirane] (3072–84–2)
• Mixture of chlorinated linear alkanes C14–17 with 45–52% chlorine (85535–85–9)
• N,N-Ethylene-bis(tetrabromophthalimide) (32588–76–4)
• Pentabromochlorocyclohexane (87–84–3)
• (Pentabromophenyl)methyl acrylate (59447–55–1)
• Pentabromotoluene (87–83–2)
• Perbromo-1,4-diphenoxybenzene (58965–66–5)
• Phosphonic acid, (2-chloroethyl)-, bis(2-chloroethyl) ester (6294–34–4)
• Phosphoric acid, 2,2-bis(chloromethyl)-1,3-propanediyl tetrakis(2- chloroethyl) ester (38051–10–4)
• Propanoic acid, 2-bromo-, methyl ester (5445–17–0)
• Tetrabromobisphenol A-bis(2,3-dibromopropyl ether) (21850–44–2)
• Tetrabromobisphenol A bis(2-hydroxyethyl) ether (4162–45–2)
• Tetrabromobisphenol A diallyl ether (25327–89–3)
• Tetrabromobisphenol A dimethyl ether (37853–61–5)
• 2,4,6-Tribromoaniline (147–82–0)
• 1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene (3278–89–5)
• Tris(2-chloroethyl)phosphite (140–08–9)
• Tris(1-chloro-2-propyl)phosphate (13674–84–5)
• Tris(2-chloro-1-propyl)phosphate (6145–73–9)
• Tris(2,3-dibromopropyl)phosphate (126–72–7)
• 1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (52434–90–9)
• Tris(1,3-dichloro-2-propyl)phosphate (13674–87–8)
• Tris(tribromoneopentyl)phosphate (19186–97–1)
• 2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine (25713–60–4)