EPA Assistant Administrator Steve Owens Resigns

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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

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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:

CAS

Number

Name

98-09-9

Benzenesulfonyl chloride

98-56-6

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

111-44-4

Ethane, 1,1′-oxybis[2-chloro-.

127-68-4

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

515-40-2

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

2494-89-5

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

5026-74-4

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

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

70693-50-4

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

72162-15-3

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

Name

56-40-6

Glycine

67-72-1

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

78-00-2

Plumbane, tetraethyl-

95-14-7

1H-Benzotriazole

118-48-9

2H-3,1-Benzoxazine-2,4(1H)-dione

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

25377-73-5

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

26544-38-7

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

27859-58-1

Butanedioic acid,2-(tetrapropenyl)-

28777-98-2

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

29385-43-1

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

32072-96-1

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

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

69834-17-9

Benzene, decylphenoxy-

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

CAS Number

Name

98-16-8

Benzenamine, 3-(trifluoromethyl)-

100-53-8

Benzenemethanethiol

104-91-6

Phenol, 4-nitroso-

110-03-2

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

124-63-0

Methanesulfonyl chloride

142-30-3

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

460-00-4

Benzene, 1-bromo-4-fluoro-

542-92-7

1,3-Cyclopentadiene

553-26-4

4,4′-Bipyridine

8007-45-2

Tar, coal

28106-30-1

Benzene, ethenylethyl-

35203-06-6

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

35203-08-8

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

37734-45-5

Carbonochloridothioic acid, S-(phenylmethyl) ester

37764-25-3

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

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

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.

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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.

EPA to Identify Priority Chemicals for Review

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Readers interested in EPA chemical risk management efforts may be interested in the Agency’s new initiative to identify priority chemicals for review and possible risk management action under TSCA. This initiative is part Agency efforts to enhance its chemical management program.  The Office of Pollution Prevention and Toxics notes that strengthening EPA’s chemicals management and risk assessment program is an Agency priority. Goals for the chemical prioritization initiative include identification of highest priority chemicals, determination of whether risk is significant, and whether risk management or other action under TSCA is warranted. The Agency plans to release an initial list of priority chemicals by late fall.

To identify candidate chemicals for review, EPA will consider risk-based prioritization factors similar to those used for selecting chemicals on which EPA has recently prepared Chemical Action Plans. Children’s health issues, PBT chemicals, and carcinogens are among the Agency’s highest hazard-based priorities.

The Agency has specifically solicited public input on which prioritization factors should receive greatest consideration. Following this data collection, EPA will refine the list of priority chemicals for review using a broader range of data sources. It has also requested comments on which data sources the Agency should consider to help identify priority chemicals. Potential data sources for both exposure and use-related information and hazard data sources are listed in the Discussion Guide for Identifying Priority Chemicals for Review and Assessment (available here). A web-based discussion forum is available for submitting suggestions. Submissions will be accepted only until 5:00 PM Eastern Daylight Time on September 14, 2011. At a later date this information will also be available in docket, EPA-HQ-OPPT-2011-0516, at http://www.regulations.gov.

EPA stresses that decisions about whether or not a chemical presents a risk to human health or the environment will be made only after review and assessment efforts are completed. That is, identification of a chemical as a priority chemical for review is not an Agency “finding” under TSCA.

The Agency anticipates that the chemicals identified as priority chemicals for review will likely be well-characterized for hazard and have information indicating exposure potential. The discussion guide notes that EPA will continue to use its TSCA information collection, testing, and subpoena authorities, including sections 4, 8, and 11(c) of TSCA, to develop needed information on additional chemicals that currently have less robust hazard or exposure databases.

A webinar describing this effort was conducted September 7, 2001. The slides presented during that program are available here.

More Information on EPA’s efforts to Identify Priority Chemicals for Review available here.

General information on EPA’s Enhancing EPA’s Chemical Management Program available here.

Information on EPA Development of Chemical Action Plans available here.

Upcoming Event: Chemical Regulation in Canada – Lessons for U.S. Reforms

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TSCA/CEPA:

Readers attending the ABA’s meeting in Toronto in August may be interested in the following event concerning the Canadian system for regulating industrial chemicals and lessons that system may offer the United States as it debates TSCA Reform.  A short description is embedded below, and more information about the annual meeting is available here.  The list of speakers is impressive, so the event should prove worth the time investment. 

3:45 p.m. to 5:15 p.m.

Chemical Regulation in Canada—Lessons for U.S. Reforms

Room 801A, 800 Level, MTCC, South Building

Everyone agrees that chemical regulation in the US needs to be updated. Industry, NGOs and the EPA all find fault with TSCA, the 1976 law that still governs the process. The EU and Canada are both implementing new, ambitious programs that provide models and cautionary experiences for US reforms. The EU’s REACH program has been widely criticized for needless expense and complexity and for producing slow results. The Canadian Environmental Protection Act, by contrast, is frequently cited by stakeholders as a better approach. This program will focus on features of CEPA that make it apparently more efficient and productive, and explore how compatible those processes would be with US law and expectations regarding transparency, participation and due process.

Moderator:

James Conrad, Washington, D.C.

Panelists:

Joseph Castrilli, Toronto, Ontario, Canada

Mark Duvall, Washington, D.C.

Robert Fishlock, Toronto, Ontario, Canada

Karen Levins, Mississauga, Ontario, Canada

Additional Sponsor:

Section of Environment, Energy, and Resources

 

EPA Publicly Discloses More Chemical Identities Claimed Confidential under TSCA

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TSCA/CBI:

On June 8, 2011, EPA announced the public disclosure of the identities of more than 150 chemicals contained in 104 health and safety studies that had been claimed confidential under the Toxic Substances Control Act (TSCA).  For those 104 studies, the chemical identity will no longer be redacted, or kept from public view.  According to EPA, the chemicals at issue are used in dispersant formulations and consumer products such as air fresheners, non-stick and stain resistant materials, fire resistant materials, nonylphenol compounds, perfluorinated compounds, and lead.  This latest development is another demonstration of EPA’s commitment to increasing transparency under the Toxic Substances Control Act (TSCA) by making publicly available more information about chemical hazards.

Readers will recall that, in 2010, EPA challenged industry to declassify voluntarily unwarranted claims of confidential business information (CBI).  EPA also issued new guidance outlining plans to deny CBI claims for chemical identity in health and safety studies under TSCA.  Based on this guidance, EPA notified a number of companies in February 2011 that it had determined that their CBI claims were not eligible for confidential treatment under TSCA and that EPA intended to make the information public.  (See related posts here and here.)   The health and safety studies included in the lastest disclosure  include some declassified by EPA and other voluntary declassifications by companies in response to EPA’s challenge.

In addition to these actions, EPA over the past several months has taken a number of other steps to make chemical information more readily available.  EPA provided the public, for the first time ever, with free access to the consolidated TSCA Inventory on the EPA and Data.Gov websites.  EPA also launched a new chemical data access tool that gives the public the ability electronically to search EPA’s database of more than 10,000 health and safety documents on a wide range of chemicals that they may come in contact with every day. (See related post here.)  More information about EPA’s transparency initiative under TSCA is avaialble here.

New EPA Rule for Carbon-Nanotubes

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Readers engaged in nanomaterial applications may be interested in EPA’s new Significant New Use Rule (SNUR) for multi-walled carbon nanotubes (MWCNTs). Enterprises wishing to manufacture, import, or process MWCNTS are now potentially subject to Significant New Use Notice (SNUN) regulatory procedures which include the submission of ‘appropriate’ health and safety data. This rule is incorporated into the Code of Federal Regulations at 40 CFR § 721.10183.

EPA evaluation of MWCNTs, and carbon nanotubes generally, has established that exposure may cause lung effects (pulmonary toxicity, fibrosis, carcinogenicity), immunotoxicity, and mutagenicity. More information on toxicological effects is reported in the Summary of EPA’s Current Assessments of Health and Environmental Effects of Carbon Nanotubes (available in the MWCNT SNUR Docket).

EPA recommends SNUNs provide detailed information on the following:

  • Human exposure and environmental release that may result from the significant new use of the chemical substance.
  • Potential benefits of the chemical substance.
  • Information on risks posed by the chemical substance compared to risks posed by potential substitutes.

EPA notes that upon review of a SNUN, the Agency has the authority to require additional testing. Any manufacturers, importers, or processors who intend to conduct testing or submit a SNUN are encouraged to contact EPA to determine ‘appropriate’ testing methods. Substantial detail about this and other governing TSCA provisions is provided in the FR notice (76 FR 26186 (available in the MWCNT SNUR Docket)). More information on SNUN requirements generally is available here and information on requirements for test data is available from EPA and the ACC.

This SNUR is specific to MWCNTs of a specific structure. However, confidentiality claims preclude a more detailed description of the identity of this MWCNT. To determine whether a specific CNT, MWCNT, or single-wall carbon nanotube is on the TSCA Inventory, manufacturers should submit a bona fide intent to manufacture or import to EPA.

Exempt from the rule are MWCNTs that are completely reacted (cured), incorporated or embedded into a polymer matrix that itself has been reacted (cured), or embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing.

EPA Publishes Chemical Action Plans For Diisocyanate Compounds

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TSCA:

On April 13, 2011, EPA published chemical action plans for methylene diphenyl diisocyanate (MDI), toluene diisocyanate (TDI) and related compounds.  According to EPA, diisocyanates are well known dermal and inhalation sensitizers in the workplace and have been documented to cause asthma, lung damage, and in severe cases, fatal reactions. Worker exposures are already subject to protective controls in occupational settings, but EPA is concerned about potential health effects that may result from exposures to the consumer or self-employed worker while using products containing uncured (unreacted) MDI, TDI, and their related polyisocyanates (e.g., spray-applied foam sealants, adhesives, and coatings) or incidental exposures to the general population while such products are used in or around buildings including homes or schools. 

The Agency is proposing a number of regulatory actions under the Toxic Substances Control Act.  These include promulgation of significant new use rules (SNURs) under Section 5(a)(2) for TDI and its related polyisocyanates in consumer products; Section 4 test rules requesting certain exposure monitoring; reporting and data call-ins under Section 8(c) and 8(d); and certain restrictions adopted pursuant to Section 6.  The chemical action plan for MDI and related compounds is available here.  The plan for TDI and related compounds is available here. 

Senator Lautenberg Continues in His Quest to Reform TSCA

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TSCA Reform:

Guest Columnist: 
Irene Hantman
University of Maryland Law Fellow
US EPA Office of Civil Enforcement
Waste and Chemical Enforcement Division

On April 14, 2011, Senator Lautenberg of New Jersey introduced the 2011 Safe Chemicals Act (2011 SCA), almost a year after he introduced a similar bill (S. 3209) that failed to garner sufficient Congressional support.  Senator Barbara Boxer of California, Senators Amy Klobuchar and Al Franken of Minnesota, and Senator Charles Schumer of New York co-sponsored the bill.  The 2011SCA is intended “to modernize the ‘Toxic Substances Control Act of 1976’ (TSCA) and protect Americans from exposure to dangerous toxins.”  Readers familiar with the bill introduced in 2010, S. 3209, will find many of the same concepts and requirements in the 2011 SCA.  Whether this latest bill will progress further than its predecessor is unknown, but there are many reasons to believe that it will not, despite support from the high-ranking Democratic Senators Boxer and Schumer.

According to Senator Lautenberg, the 2011 SCA addresses many of TSCA’s weaknesses identified by the US Government Accountability Office in its 2005 Report to Congress, Options Exist to Improve EPA’s Ability to Assess Health Risks and Manage Its Chemical Review Program.  It also adopts many of the recommendations for US Chemicals Management Policy advocated by the American Academy of Pediatrics, former EPA Associate Administrators for the Office of Prevention, Pesticides, and Toxic Substances, and National Institutes of Health officials.  Readers unfamiliar with those recommendations should know that they stressed that efforts to modernize TSCA must: (1) ensure that chemicals in commerce demonstrate reasonable certainty of no harm, at all stages of human development, and through all possible exposure routes; (2) provide EPA practical tools to assess the safety of chemicals currently in use; and (3) establish public access to chemical safety information.  Senator Lautenberg also emphasized that the 2011 SCA would require safety testing of all industrial chemicals, and put the burden on industry to prove that chemicals are safe in order to get on, or remain on, the market.  In contrast, current TSCA parameters generally do not require chemical companies to test new chemicals for toxicity or to gauge exposure levels before they are submitted for EPA’s review.

Again, the 2011 SCA has many conceptual similarities to legislation the Senator sponsored in 2010 (S. 3209), but there are differences in some of the details of implementation.   The 2011 SCA would:

  • require manufacturers to submit minimum data sets to allow the EPA to conduct screening-level risk assessments for new and existing chemical substances (see amended §4(a));
  • facilitate data sharing across federal agencies (see amended §4(f));
  • require manufacturers and processors to submit new chemical notifications for chemical substances (and mixtures upon certain EPA findings) that EPA could approve upon a finding that the substance meets the Section 6 safety standard or that the substance does not meet other criteria concerning production volume, release, toxicity, etc. (see amended §5);
  • require manufacturers to submit reports describing current manufacturing or processing (see amended §8(a)), including
    • chemical identity,
    • manufacturing and processing facility location,
    • known uses of, exposure to, and fate information, and
    • health and safety studies not previously filed with the Administrator;
  • allow the Administrator to order manufacturers to make supplemental information submissions (see amended §8(b)) to assist
    • in making safety determinations, and
    • any aspect of administering TSCA; and
  • establish an Internet-accessible database to provide public access to significant chemical safety information (see amended §§5(b)(2), 8(d)), including
    • premanufacture notices (PMNs),
    • safety testing, and
    • Agency decisions.

In addition to maintaining a number of the conceptual changes to TSCA proposed in 2010, the 2011SCA includes new authorities regarding safety standard determinations and confidential information.   For example, the amended Section 6 would establish a risk classification scheme for chemical substances currently in use.

  • Priority Class 1 would comprise chemical substances that are assessed by the Administrator as requiring immediate risk management.  Substances in Class 1 would be those that are degraded and metabolized into persistent, bioaccumulative, and toxic substances with the potential for widespread exposure to humans or other organisms. Within 18 months of assignment to this priority class, the Administrator would be required to impose conditions on the manufacturing, processing, use, distribution in commerce, and disposal of the substance to achieve the greatest practicable reductions in human and environmental exposure.  
  • Priority Class 2 would include chemical substances, presently in commerce, for which the Administrator found a more-than-theoretical concern of uncertainty that they could meet the safety standard required for new chemicals.  Assignment to Class 2 would be conducted in order of risk presented to human health and the environment.  
  • Priority Class 3 would include only those chemical substances for which the Administrator determined no immediate action was required because the substance did not and would not, at any stage of the lifecycle, pose any risk of adverse effects to human health or the environment under existing, proposed, or anticipated levels of exposure to, or production or patterns of use of, that chemical substance.

No judicial review would be available for assignment to any priority class.

The 2011 SCA also specifies minimum considerations for safety standard determinations of both new and existing chemicals (see amended §6(b)).  The legislation would require the Administrator’s risk assessment to include consideration of scientific literature relating to the effect of cumulative exposure to chemical substances.  The Administrator would be permitted to find that a substance meets the safety standard only when there is a reasonable certainty that neither human health nor the environment would be harmed from aggregate exposure.  Judicial review would not available for determinations that manufacturers have not established that chemical substances meet applicable safety standards.

The 2011 SCA would limit protections for confidential business information.  Section 14 would also allow the Administrator to determine that particular information previously considered eligible for confidential treatment is no longer entitled to such treatment.

Lastly, 2011 SCA would have limited preemptive effect.  States and their subdivisions would remain free to adopt or enforce any regulation, requirement, or standard of performance that was different from, or in addition to, a regulation, requirement, liability, or standard of performance established under TSCA, unless it was impossible to comply with both, in which case the TSCA requirement would control.  Although the preemption provision was revised from the 2010 bill, Senator Lautenberg continues to prefer robust state involvement in chemicals management.

The website for Senator Lautenberg’s office provides summaries of and the text of the Safe Chemicals Act of 2010 and 2011 (2010 bill, 2010 summary, 2011 bill, 2011 summary).

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DISCLAIMER:  This work is not a product of the United States Government or the United States Environmental Protection Agency, and the author is not doing this work in any governmental capacity.  The views expressed are those of the author only and do not necessarily represent those of the United States or the US EPA.                       

Chemical Heritage Foundation Posts the Video from its TSCA Reform Event

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TSCA/TSCA Reform:

The Chemical Heritage Foundation (CHF) posted the video from its recent event on the federal Toxic Substances Control Act (TSCA), the primary federal statute governing the safety of chemicals in U.S. commerce.  Readers less familiar with CHF should know that it is a Philadelphia-based non-profit that aims to foster an understanding of chemistry’s impact on society.  CHF is currently completing an oral history project on the statute’s evolution from legislative proposal through implementation and now reform.  The project has required CHF to interview various persons, including former EPA officials, responsible for key aspects of that evolution.  The March 3 event, entitled “TSCA: From Inception to Reform, a Public Dialogue,” was an outgrowth of the oral history project.

The event featured a panel of five former administrators in the EPA office responsible for implementing the statute at various times since its enactment in 1976. They included James V. Aidala, Charles M. Auer, Charles L. Elkins, Mark A. Greenwood, and Glenn E. Schweitzer.  Each panelist discussed the statute’s perceived strengths and weaknesses, major accomplishments achieved under it, and some of the ways in which Congress could address the perceived weaknesses in future legislative amendments.  Afterward, they answered questions from the audience.

The event was a terrific success.  For readers unable to attend, more information about CHF, its oral history project, and the video recording are available here.

EPA Denies Protection for Chemical Identities in TSCA 8(e) Reports

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TSCA:

As part of EPA’s initiative to increase transparency under the Toxic Substances Control Act (TSCA), on February 10, 2011, the Agency sent a letter to five companies informing them that the identities of 14 chemicals contained in certain health and safety studies were ineligible for protection from public disclosure.  The studies are “substantial risk” reports that the companies submitted to EPA to fulfill their obligations under section 8(e) of TSCA (15 U.S.C. § 2607(e)).  Readers will recall that substantial risk reports disclose information that reasonably supports the conclusion that a chemical substance or mixture (collectively “chemicals”) presents a substantial risk of injury to health or the environment.  EPA reasons that the public has a right to know the identities of chemicals posing such risks.  In contrast, industry frequently contends that disclosure of identities could reveal commercially valuable information about formulations or manufacturing processes.  To stop the disclosure of the identities of its chemicals, a company would need to initiate a legal challenge within 30 days of receiving the Agency’s February letter.

The letters comprise the Agency’s first serious attempt to implement a new transparency policy announced on January 21, 2010.  (The scope of the policy was subsequently expanded in May 2010.)  As announced in January, EPA will deny Confidential Business Information (CBI) protection for the identities of chemicals included in section 8(e) reports when those chemicals are listed on the public version of the TSCA Inventory.  EPA contends that substantial risk reports are a type of health and safety study, as defined under section 3(6) of TSCA (15 U.S.C. § 2602(6)) and the regulations at 40 C.F.R. § 2.306(a)(3).  The Agency also asserts that a chemical’s identity is either part of a health and safety study or the data included within such study, as explained in various TSCA regulations such as those at 40 C.F.R. § 716.3; § 720.3(k).  And because section 14(b)(1) of TSCA (15 U.S.C. § 2613(b)(1)) “does not prohibit disclosure of” health and safety studies (and their data) concerning chemicals offered for commercial distribution, EPA concludes that a chemical’s identity would be eligible for disclosure when it is listed on the public version of the TSCA Inventory and it is the subject of a substantial risk report.

According to EPA’s letter, the chemicals fit squarely within the Agency’s policy.  Each of the chemicals is currently listed on the public version of the TSCA Inventory of “existing” substances.  (The Inventory is EPA’s official list of chemicals that can be lawfully imported or manufactured for commercial distribution without first submitting a premanufacture notice under section 5 of TSCA – the public version lists those chemicals whose identities are not confidential.)  And each of them supposedly was the subject of a substantial risk report.

However, section 14(b)(1) prohibits disclosure of data from health and safety studies when such disclosure would reveal “processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release [would disclose] the portion of the mixture comprised by any of the chemical substances in the mixture.”  These exceptions are designed to prevent the disclosure of trade secrets and other sensitive business information.  EPA’s letter seems to anticipate this objection from the companies, noting “that the [chemical] identity itself, as well as any information that might be derived from it about processes or portions, has already been disclosed” and therefore neither exception applies.

Whether the companies will seek judicial review remains to be seen.  Many challenged CBI claims are withdrawn, and judicial review is expensive.  If the companies seek judicial review, they may challenge EPA’s statutory interpretion or its conclusion that neither disclosure exception applies.  (If a challenge(s) is brought, look for a future blog post discussing the various arguments.)

Regardless of whether there’s a challenge, the Agency’s decision is somewhat controversial – applauded by some and criticized by others.  Unless there’s a successful legal challenge or some other restraint imposed, look for EPA’s continued release of unredacted substantial risk reports and possibly other health and safety studies.  The Agency has clearly signalled its intention to increase the amount of publicly-available information concerning chemical risks.  When balancing commercial interests against environmental and health interests, EPA’s current administration plans to favor the latter at the expense of the former, raising the question:  “Could a better balance be achieved?”  Perhaps – EPA could release the reports with a descriptive generic name in lieu of the chemical’s specific name, a practice the Agency’s used elsewhere under TSCA.