EPA will withdraw proposed rules for fourth set of High Production Volume chemicals.

The EPA will withdraw a 2011 proposed rule requiring testing and other data for 23 High Production Volume (HPV) chemicals and imposing Significant New Use Rules (SNURs) on 22 other HPV chemicals. Last week, Bloomberg BNA reported that the agency had confirmed in an email that the rule will be formally withdrawn, although a timeline has not been established yet. Under the Toxic Substances Control Act (TSCA), HPV chemicals are those produced or imported into the U.S. at the rate of at least 1 million pounds per year. However, significant data gaps exist regarding the hazards associated with these substances.

The rules were part of the EPA’s HPV Challenge Program, which encouraged the voluntary submission of health and hazard data for approximately 1,400 HPV chemicals sponsored by companies. EPA previously issued three other test rules for “unsponsored chemicals.”

EPA justified the withdrawal of the fourth set of rules by alluding to higher priorities, such as the agency’s TSCA Work Plan, an initiative launched in 2012 that identified 83 substances on which to conduct risk assessments. When the regulatory package was proposed, industry groups commented that the proposal was duplicative in requesting data already developed for and collected by the European Chemicals Agency (ECHA), which implements REACH.

Data from over 860 chemicals was made publicly available to the HPV Challenge Program through international efforts. However, of the over 2,200 chemicals sponsored through the voluntary part of the HPV Challenge Program, data was received for only 82 percent of the substances – and not all of that data is complete.

Until the regulatory package is withdrawn, the substances subject to the SNURs remain subject to 12(b) export notification requirements.

EPA Assistant Administrator Steve Owens Resigns

EPA Administration/Chemical Regulation:

On Tuesday, October 25, 2011, the Environmental Protection Agency (EPA) announced the resignation of Assistant Administrator Steve Owens.  Readers will recall that President Obama appointed Mr. Owens the Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), which is the office implementing the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Pollution Prevention Act, and other federal laws concerning chemicals management.  November 30, 2011, will be Mr. Owens’ last day in office before returning home to Arizona where he previously served as the Director of the Arizona Department of Environmental Quality.  It is unclear at this time who will assume Mr. Owen’s responsibilities and what effect his departure will have on EPA’s various chemicals management initiatives.

Mr. Owens served the EPA during a two-year period in which Congress, the courts, and various stakeholders engaged in vigorous debate and litigation over the appropriate regulation of chemicals in the United States.  In a 2010 brown-bag session (available on podcast), sponsored by the American Bar Association’s Pesticides, Chemical Regulation, and Right-to-Know Committee, Mr. Owens discussed many of the initiatives the Agency was undertaking and some of the challenges it faced as it participated and attempted to shape the debate. 

In a letter to EPA staff announcing his resignation, Mr. Owens said:

“I am writing to tell you that, after more than two years of working closely with all of you to protect Americans’ health and environment, I have made the difficult decision to leave EPA. My last day in the office will be November 30, 2011.
As many of you know, my family has remained in Arizona while I have been working at EPA headquarters in Washington. Although I have been able to get home to see my family periodically, I have essentially been away from them for more than two years. After a lot of hard thinking, we have decided that it is time for me to come home. My wife needs her husband; my sons need their father; and I need them.
While I am very happy that I will be back with my family, I will miss all of you greatly. It has been a true privilege to work with so many incredibly talented and dedicated people who are doing so much to protect the health and safety of the American people and our environment.
I am extremely grateful to Lisa Jackson for her wonderful friendship and the remarkable vision and leadership she provides to this Agency. We are truly fortunate that she is EPA’s Administrator.
As I said earlier, I will continue working alongside you all through November 30. Administrator Jackson will share additional information about the transition process shortly.
In closing, let me thank you so much for the friendship and support you have given me during my time at EPA. Please know how much I appreciate you and all that you are doing for our country.”


EPA Issues Testing Rules and a Significant New Use Rule for HPV Chemicals

TSCA/HPV Chemical Testing:

On October 21, 2011, utilizing its authority under the Toxic Substances Control Act (TSCA), 15 U.S.C. §2601 et seq., EPA published two Federal Register notices announcing testing rules for certain high production volume (HPV) chemicals as well as significant new use rules (SNURs) for other HPV chemicals.  HPV chemicals are those with a production/import volume equal to or greater than 1 million pounds (lbs) per year.  The first notice promulgates a final testing rule for 15 HPV chemicals.  The second notice adopts an innovative approach to regulating HPV chemicals, proposing a testing rule for 23 HPV chemicals and a SNUR for 22 others, along with an alternative proposal to regulate any of the 23 chemicals via a SNUR should public comments indicate a testing rule is unecessary.  Additional details about the rules and the affected chemicals are provided below.

Final Test Rule

The first notice promulgates a final rule under section 4(a)(1)(B) that requires manufacturers, importers, and processors to conduct testing to obtain screening level data for health and environmental effects and chemical fate for 15 HPV chemicals.  (As a general matter, only certain manufacturers/importers actually perform testing required under section 4.)  The chemicals are part of the so-called “Third Group of Unsponsored HPV Chemicals (HPV3),” a group of 29 chemicals for which no manufacturer or importer accepted the “challenge” to make publicly available health and environmental effects data under the voluntary High Production Volume Challenge Program launched in 1998.  The rule will be effective on November 21, 2011.

According to EPA, there are insufficient data to reasonably determine or predict the effects on human health or the environment from the manufacture, distribution in commerce, processing, use, or disposal of these chemicals, or from any combination of these activities.  Thus, the Agency concluded that testing is needed.  Data developed under this final rule supposedly will provide EPA with critical information about the environmental fate and potential hazards associated with these chemicals which, when combined with information about exposure and uses, will allow the Agency and others to evaluate potential health and environmental risks and to take appropriate action.

EPA’s action affects more persons than those who are required to perform testing.  Persons who export or intend to export any of the chemicals in any form (e.g., as byproducts, impurities, components of Class 2 chemical substances, etc.) included in the final rule would be subject to the export notification requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart D.  Export notification is generally not required for articles, as provided by 40 CFR 707.60(b).  Section 12(b) of TSCA states, in part, that any person who exports or intends to export to a foreign country a chemical for which the submission of data is required under TSCA section 4 must notify EPA of such export or intent to export.  EPA in turn will notify the government of the importing country of the Agency’s regulatory action with respect to the chemical.

The following chemicals are the subject of this final rule:





Benzenesulfonyl chloride


Benzene, 1-chloro-4-(trifluoromethyl)-


Ethane, 1,1′-oxybis[2-chloro-.


Benzenesulfonic acid, 3-nitro-, sodium salt (1:1)


Benzene, (2-chloro-1,1-dimethylethyl)-


Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate)


2-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-


Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester


Benzenesulfonic acid, dimethyl-


1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)


Lard, oil, Me esters


Acetaldehyde, reaction products with formaldehyde, by-products from


2-Butenedioic acid (2E)-, di-C8-18-alkyl esters


Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-


1-Decene, sulfurized

Proposed Test Rule and SNUR

The proposed test rule, adopted pursuant to section 4(a)(1)(B) of TSCA, would require manufacturers, importers, and processors of 23 HPV chemicals to develop screening-level health, environmental, and fate data, based on the potential for substantial exposures of workers and consumers to these chemicals. The proposed significant new use rule (SNUR), adopted pursuant to section 5(a)(2), would require persons to file a “significant new use” notice (SNUN) with EPA prior to manufacturing, importing, or processing any of a separate group of 22 chemicals for (1) use in a consumer product or (2) for any use, or combination of uses, that is reasonably likely to expose 1,000 or more workers at a single corporate entity.  The chemicals are part of the so-called “Fourth Group of Unsponsored HPV Chemicals (HPV4).”  Public comments are due by January 19, 2012.

EPA’s use of two rules is an innovative approach to regulating this group of 45 HPV chemicals.  If successful, the Agency may use the same approach to regulating future HPV chemicals (i.e., those designated HPV in in 2012 and beyond).  According to EPA, it is proposing the two actions together because the Agency believes they are complementary and will best ensure these HPV chemicals are adequately evaluated.  For example, if EPA receives comments on this proposal sufficient to establish that one of the 23 chemicals proposed for testing is not used in a way that meets the substantial exposure criteria in section 4(a)(1)(B), but information received indicates that the chemical meets the criteria for the SNUR, EPA intends to include the chemical in the final SNUR rather than the test rule, without further public notice and comment.  According to the Agency, simply removing such a chemical from the test rule, without including it in the SNUR, would not provide a regulatory mechanism for timely notification to EPA in the event of changed circumstances that would likely justify the issuance of a test rule for the chemical.  EPA also states that, if public comment on these proposed actions 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 intends to review the status of the chemical and, as warranted, take appropriate steps to promulgate a test rule rather than a SNUR for the chemical.

The 23 chemicals subject to the test rule, and for which the SNUR is an option, are the following:

CAS Number





Ethane, 1,1,1,2,2,2-hexachloro-


Plumbane, tetraethyl-






1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, sodium salt (1:1)


Glycine, N-(carboxymethyl)-, sodium salt (1:2)


Phosphonic acid, dibutyl ester


2,5-Furandione, 3-(dodecen-1-yl)dihydro-


2,5-Furandione, dihydro-3-(tetrapropenyl)-


Butanedioic acid,2-(tetrapropenyl)-


2,5-Furandione, dihydro-3-(octadecen-1-yl)-


1H-Benzotriazole, 6(or75)-methyl-.


2,5-Furandione, 3-(hexadecen-1-yl)dihydro-


Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides


1H-Benzotriazole, 6(or7)-methyl-, sodium salt


Naphthenic acids, reaction products with diethylenetriamine


Fatty acids, tall-oil, reaction products with diethylenetriamine, acetates


Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides


2-Butenediamide, (2E)-, N1,N4-bis[2-(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1-yl)ethyl] derivs.


Quaternary ammonium compounds, (oxydi-2,1-ethanediyl)bis[coco alkyldimethyl, dichlorides


Pyridinium, 1-(phenylmethyl)-, Et Me derivs., chlorides


Benzene, decylphenoxy-

The 22 chemicals subject to the SNUR, and for which a future test rule is an option, are the following:

CAS Number



Benzenamine, 3-(trifluoromethyl)-




Phenol, 4-nitroso-


2,5-Hexanediol, 2,5-dimethyl-


Methanesulfonyl chloride


3-Hexyne-2,5-diol, 2,5-dimethyl-


Benzene, 1-bromo-4-fluoro-






Tar, coal


Benzene, ethenylethyl-


Benzenamine, 2-ethyl-6-methyl-N-methylene-


Benzenamine, 2,6-diethyl-N-methylene-


Carbonochloridothioic acid, S-(phenylmethyl) ester


Acetamide, 2,2-dichloro-N,N-di-2-propen-1-yl-


Quaternary ammonium compounds, benzyl(hydrogenated tallow alkyl)dimethyl, chlorides


Naphthenic acids, sodium salts


Distillates (coal tar), upper


Tail gas (petroleum), cracked distillate hydrotreater stripper


Residues (petroleum), steam-cracked petroleum distillates cyclopentadiene conc., C4-cyclopentadiene-free.


Alkenes, C6-10, hydroformylation products, highboiling


Ethanol, 2,2′-oxybis-, reaction products with ammonia, morpholine derivs. Residues

Similar to the final rule discussed above, EPA’s action affects more persons than those who are required to perform testing or submit SNUNs.  Once the rule became final, exporters of the chemicals subject to the final test rule would be subject to the export notification requirements in section 12(b).  However, exporters of chemicals subject to the proposed SNUR became subject to those requirements upon publication of this proposed rule.


Readers interested in following EPA’s innovative approach to regulating HPV should look for future posts on this topic, here at the Green Chemistry Law Report.