EPA Issues Proposed and Final HPV Test Rules; EPA Seeks Innovative Use of SNURs
The October 21, 2011, Federal Register includes two test rules concerning high production volume (HPV) chemicals: a final test rule for certain chemicals from the third group, and a proposed test rule and proposed significant new use rule (SNUR) for the fourth group of chemicals. See 76 Fed. Reg. 65385 and 65580, respectively. The proposed “SNUR plus test rule” represents a novel approach for the U.S. Environmental Protection Agency (EPA) in handling HPV chemicals and may presage the approach used in the future. As discussed in the proposal, EPA is “considering issuing further coordinated proposals of test rules and SNURs…in conjunction with future” data releases from the Chemical Data Reporting (CDR) rule and “covering all newly-HPV chemical substances.” This memorandum summarizes both test rules.
The final test rule applies to 15 of the 29 chemicals in EPA’s February 25, 2010, proposed rule, and will be effective November 21, 2011. Under the final test rule, manufacturers, importers, and processors are to subject to testing requirements to obtain screening level data for health and environmental effects and chemical fate for 15 HPV chemical substances. Test rule findings could not be made for the 14 removed chemicals.
The proposed test rule would require manufacturers, importers, and processors of 23 HPV chemical substances to develop screening-level health, environmental, and fate data based on the chemicals’ HPV and the potential for substantial exposures of workers and consumers to these chemicals. The proposed SNUR would apply to another 22 HPV chemical substances for which EPA could not make “exposure-based” findings, and would require persons to file a significant new use notice (SNUN) with EPA prior to manufacturing, importing, or processing any of these chemical substances for use in a consumer product or for any use, or combination of uses, that is reasonably likely to expose 1,000 or more workers at a “single corporate entity.” Comments on the proposed test rule and SNUR are due January 19, 2012. According to the proposed rule, this action would complete the work started under the HPV Challenge Program in 1998 as it represents the final test rule needed to address unsponsored/orphan chemicals under that Program.
For those companies that are directly impacted by the final test rule and interested in forming a consortium to address the HPV test rule, B&C Consortia Management, L.L.C. (BCCM) provides cost effective administrative and management services to consortia engaged in regulatory activities. BCCM efficiently can support efforts to conduct outreach to other impacted parties and offers the infrastructure and staff needed to transform quickly newly-organized groups into established business entities so that shared testing requirements can be pursued promptly and with little administrative cost. BCCM staff can assist consortium members in identifying potential testing laboratories, reviewing test proposals and protocols, putting contracts into place, and providing updates to EPA on testing program status. If you are interested in more information on BCCM services, please contact contact Kathleen M. Roberts.
Final Test Rule for Third Group of HPV Chemicals
EPA promulgated the final rule under Section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA). The final rule requires manufacturers and processors of 15 HPV chemical substances to conduct testing for 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 chemical substances are HPV chemicals (i.e., chemical substances with a production/import volume equal to or greater than one million pounds per year).
While EPA included 29 chemicals in its February 25, 2010, proposed rule, the final rule applies only to 15 of the 29 chemicals. EPA states that, in consideration of comments on its proposed rule, EPA changed some testing requirements for certain HPV chemical substances and is not including certain other HPV chemical substances. EPA reduced the number of tests required for two chemical substances for which adequate data are available for certain proposed testing endpoints; for another chemical substance, EPA dropped all testing requirements and is not including that chemical substance in this final rule. In addition, EPA is not including 12 of the proposed chemical substances in the final rule because EPA obtained data indicating that these chemical substances are no longer HPV, no longer have substantial human exposure, or no longer have substantial environmental release. Furthermore, EPA is deferring final action for one chemical substance, chloroalkanes (CASRN 61788-76-9). The reason given for this deferral is “an unresolved issue regarding whether all the production previously reported” to EPA under that CASRN “should in fact be covered by that listing.” The 15 chemicals included in the notice are:
|Chemical Abstracts Service (CAS) Number||Chemical Name|
|127-68-4||Benzenesulfonic acid, 3-nitro-, sodium salt (1:1)|
|2494-89-5||Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate)|
|22527-63-5||Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester|
|25321-41-9||Benzenesulfonic acid, dimethyl-|
|52556-42-0||1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)|
|68082-78-0||Lard, oil, Me esters|
|68442-60-4||Acetaldehyde, reaction products with formaldehyde, by-products from|
|68610-90-2||2-Butenedioic acid (2E)-, di-C8-18-alkyl esters|
All persons who are subject to the final rule fall into one of two groups, designated as Tier 1 and Tier 2 (this is the typical procedure relied on in test rules). Persons in Tier 1 must initially comply with the final rule. To comply, they must either submit to EPA letters-of-intent-to-conduct-testing, conduct the testing, and submit the test data to EPA; or apply to and obtain from EPA exemptions from testing. Persons in Tier 2 do not have to comply initially with the final rule. Tier 1 includes chemical manufacturers that, in the experience of EPA, have traditionally conducted testing or participated in testing consortia under previous TSCA Section 4(a) test rules. Tier 2 includes: processors, manufacturers of less than 500 kilograms (1,100 pounds) per year (small-volume manufacturers), manufacturers of small quantities for research and development (R&D), byproduct manufacturers, impurity manufacturers, manufacturers of naturally occurring substances, manufacturers of non-isolated intermediates, and manufacturers of components of Class 2 chemical substances. The final rule is effective November 21, 2011. The letter-of-intent-to-test or the exemption application is due December 20, 2011. Study plans are due February 20, 2012. Final reports for each specific test are due December 21, 2012.
Proposed Test Rule and SNUR for the Fourth Group of HPV Chemicals
EPA is proposing to regulate 45 HPV chemical substances with either a test rule or a SNUR. EPA is proposing a test rule under TSCA Section 4(a)(1)(B) for 23 of the chemicals, and a SNUR under TSCA Section 5(a)(2) for the other 22 chemicals. EPA included these 45 chemicals in its HPV Challenge Program initiated in 1998, and they either were not sponsored or their sponsorships were withdrawn. According to the October 21, 2011, notice, EPA is proposing these two actions together because it believes the actions are complementary and will best ensure the chemicals are adequately evaluated. For example, EPA states, if it receives comments sufficient to establish that one of the 23 chemical substances proposed to be regulated under the test rule is not used in a way that meets the substantial exposure criteria, but information received indicates that the chemical substance meets the criteria for the SNUR, EPA intends to include the chemical substance in the final SNUR rather than the test rule, without further public notice and comment. If public comment is sufficient to establish that any of the uses to be covered for the 22 chemical substances proposed in the SNUR are, in fact, on-going, yet such comments also establish that there is already substantial exposure to the chemical substance, EPA states that it intends to review the status of the chemical substance and, as warranted, take appropriate steps to promulgate a test rule rather than a SNUR for the chemical substance. These “steps” would appear to require EPA to develop a proposed rule insofar as some of the required findings under TSCA Section 4 were not discussed for these chemicals.
Regarding the SNUR chemicals, EPA believes, based on 2006 Inventory Update Reporting (IUR) data, that these HPV chemicals are not used in consumer products and that there are less than 1,000 workers exposed, and thus EPA was not able to satisfy these exposure-based criteria from EPA’s so-called “B Policy.” EPA is proposing to apply these exposure-based factors as triggers for SNUR reporting. Accordingly, following promulgation, planned use of such chemicals in a consumer product or exposure that is reasonably likely to involve 1,000 or more workers at a single corporate entity (which is defined as the aggregate of all of the domestic facilities owned or operated by an individual corporation) would trigger a SNUN requirement.
The chemical substances for which EPA is proposing a test rule, and for which a SNUR is an alternative option are:
|CAS Number||Chemical Name|
|128-44-9||1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, sodium salt (1:1)|
|928-72-3||Glycine, N-(carboxymethyl)-, sodium salt (1:2)|
|1809-19-4||Phosphonic acid, dibutyl ester|
|61789-73-9||Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides|
|64665-57-2||1H-Benzotriazole, 6(or7)-methyl-, sodium salt|
|68131-13-5||Naphthenic acids, reaction products with diethylenetriamine|
|68153-60-6||Fatty acids, tall-oil, reaction products with diethylenetriamine, acetates|
|68424-85-1||Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides|
|68442-77-3||2-Butenediamide, (2E)-, N1,N4-bis[2-(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1-yl)ethyl] derivs.|
|68607-28-3||Quaternary ammonium compounds, (oxydi-2,1-ethanediyl)bis[coco alkyldimethyl, dichlorides|
|68909-18-2||Pyridinium, 1-(phenylmethyl)-, Et Me derivs., chlorides|
The chemical substances for which a SNUR is proposed and for which a test rule is an alternative option are:
|CAS Number||Chemical Name|
|37734-45-5||Carbonochloridothioic acid, S-(phenylmethyl) ester|
|61789-72-8||Quaternary ammonium compounds, benzyl(hydrogenated tallow alkyl)dimethyl, chlorides|
|61790-13-4||Naphthenic acids, sodium salts|
|65996-91-0||Distillates (coal tar), upper|
|68308-01-0||Tail gas (petroleum), cracked distillate hydrotreater stripper|
|68478-20-6||Residues (petroleum), steam-cracked petroleum distillates cyclopentadiene conc., C4-cyclopentadiene-free.|
|68526-82-9||Alkenes, C6-10, hydroformylation products, highboiling|
|68909-77-3||Ethanol, 2,2′-oxybis-, reaction products with ammonia, morpholine derivs. Residues|
Issues for Comment
The proposed “SNUR plus test rule” also discusses and requests comment on several issues, including:
- EPA’s plans to apply the combined “SNUR plus test rule” approach to “all newly-HPV chemicals” (emphasis added) as determined based on CDR reporting received, e.g., in 2012 or beyond;
- Incorporation of the worker “exposure-based criterion” of greater than or equal to 1,000 workers among the significant new uses designations;
- Alternatives to the SNUR trigger of greater than or equal to 1,000 workers at a “single corporate entity”; and
- Whether the Screening Information Data Set (SIDS) continues to be the most appropriate data set to screen chemicals for health and environmental effects and whether EPA should consider having more than one screening data set depending on the nature of exposures (e.g., children’s exposure or environmental releases).
Through these actions, EPA is making progress on and nearing realization of its commitment to use test rules to complete the HPV Challenge Program. As is clear from the final test rule, however, EPA continues to have difficulty issuing proposed testing in final because of changes in chemical production and use over time. The approach of applying a combined test rule and SNUR represents a new development that EPA hopes will address this issue in the current proposed rule as well as in future test rules. To the extent a company knows that its uses of/exposures to a chemical are likely to trigger a SNUN in the near future, that company may wish to consider whether it is better to address a test rule now or with a SNUN (and its expanded regulatory authorities, including the ability to impose controls on exposures or uses as well as to require testing) in the future. Failure to consider the commercial implications of a SNUR must be balanced against the cost of a test rule and, of course, the probability that testing may yield results that are commercially challenging.
Both of these rules represent, in many ways, the coming of age of IUR/CDR reporting for the purpose of supporting exposure-based test rules. It is notable that the proposed test rule relies solely on 2006 IUR reports for making the proposed exposure-based findings. Previous HPV test rules used a variety of sources, including the 1983 National Occupational Exposure Survey (NOES) and various National Library of Medicine databases, to develop findings concerning worker or consumer exposure. If EPA holds to this practice in the future — particularly with regard to the almost 30-year-old and much criticized NOES data — that will be a positive development in that the finding will be based on the most current information, rather than on historical information that many in industry regard as non-representative of actual exposures.
As noted above, for companies that are directly impacted by the final test rule and interested in forming a consortium to address the HPV test rule, BCCM provides cost effective administrative and management services to consortia engaged in regulatory activities. If you are interested in more information on BCCM services, please contact Kathleen M. Roberts. For companies wishing to comment on the proposed test rule, please contact Lynn L. Bergeson.