EPA is proposing to require testing based on its preliminary findings under TSCA Section 4(a)(1)(B)(i) relating to “substantial” production and “substantial human exposure,” as well as findings under TSCA Sections 4(a)(1)(B)(ii) and (iii) relating to sufficient data and the need for testing. Tests that would be required include environmental fate (including five tests for physical/chemical properties and biodegradation); ecotoxicity (in fish, Daphnia, and algae); acute toxicity; genetic toxicity (gene mutations and chromosomal aberrations); repeat dose toxicity; and developmental and reproductive toxicity. The proposed rule specifies the tests proposed for each chemical.

According to the proposed rule, EPA intends to use the data obtained to support development of preliminary hazard and risk characterizations for these HPV chemicals as part of the Chemical Assessment and Management Program (ChAMP) process, fulfilling the U.S. commitments under the Security and Prosperity Partnership of North America to set initial priorities for potential future appropriate action, including possible further testing that would produce more definitive hazard information where needed on such chemical substances. EPA states that such additional information is needed by EPA, other federal agencies, the public, industry and others to ensure that adequate hazard and risk assessments can be conducted on these chemical substances.

EPA has used data from other test rules to support such activities as the development of water quality criteria, Toxic Release Inventory listings, chemical advisories and input for actions resulting in reduction of workplace exposures. Comments on the proposed rule are due by Oct. 22, 2008.

The proposed testing requirements are not effective until and unless EPA issues a final rule. Based on the effective date of the final rule, which is typically 30 days after the publication of a final rule in the Federal Register, the test sponsor may plan the initiation of any required testing as appropriate to submit the required final report by the deadline indicated as the number of months after the effective date that would be shown in Section 799.5087(j) of the proposed regulatory text. Persons required to comply with the final rule would have to conduct the necessary testing in accordance with the testing and reporting requirements established in the regulatory text of the final rule, and with TSCA Good Laboratory Practice.

Protecting Your Assets
As noted, while relatively few readers may be subject to any forthcoming TSCA Section 4 test rule, many readers may be implicated by virtue of their use of any of the 19 chemical substances. This rule is but one of many that may well be issued in the months and years ahead as a result of intense interest in the safety of existing chemicals used in commerce. To ensure you are fully aware of the implications of such rules, readers are urged to monitor and participate as appropriate in these proceedings and, at the least, assess and plan for the commercial and business consequences of any final test rules. 

Those to Watch
The 19 chemicals included in the proposed rule are listed below:

CAS No.
Chemical Name

75-07-0
Acetaldehyde

78-11-5
1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester)

84-65-1
9,10-Anthracenedione

89-32-7
1H,3H-Benzo[1,2-c:4,5-c']difuran-1,3,5,7-tetrone

110-44-1
2,4-Hexadienoic acid, (E,E)-

118-82-1
Phenol, 4,4'-methylenebis[2,6-bis(1,1 dimethylethyl)

119-61-9
Methanone, diphenyl

144-62-7
Ethanedioic acid

149-44-0
Methanesulfinic acid, hydroxy-, monosodium salt

2524-04-1
Phosphorochloridothioic acid, O,O-diethyl ester

4719-04-4
1,3,5-Triazine-1,3,5(2H,4H,6H)-triethanol

6381-77-7
D-erythro-Hex-2-enonic acid, g-lactone, monosodium salt

31138-65-5
D-gluco-Heptonic acid, monosodium salt, (2.xi.)

66241-11-0
C.I. Leuco Sulphur Black 1

68187-76-8
Castor oil, sulfated, sodium salt

68187-84-8
Castor oil, oxidized

68479-98-1
Benzenediamine, ar,ar-diethyl-ar-methyl

68527-02-6
Alkenes, C12-24, chloro

68647-60-9
Hydrocarbons, C >4

Lynn L. Bergeson is a managing director of Bergeson & Campbell P.C., a Washington, D.C., law firm focusing on chemical, pesticide and other specialty chemical product approval and regulation, environmental, health and safety law, chemical product litigation and associated business issues. She is also president of The Acta Group LLC and The Acta Group EU Ltd. with offices in Washington, D.C., and Manchester, U.K. Bergeson is legal counsel to the American Chemistry Counsel Nanotechnology Panel. She can be reached at 202-557-3800.