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).

* * * *

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. 

Senate Subcommittee Holds Hearing on TSCA Reform

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TSCA Reform:

On Thursday, February 3, 2010, the Senate Committee on Environment and Public Works, Subcommittee on Superfund, Toxics, and Environmental Health held a hearing titled “Assessing the Effectiveness of U.S. Chemical Safety Laws.”  Although the hearing’s title suggests that a broader discussion of US chemical control laws occurred, reforming the federal TSCA statute was the primary focus.  Representatives from industry, academia, the environmental community, and EPA testified on two different panels, and all witnesses supported TSCA reform.  The level of interest in the hearing seems to have surprised Subcommittee staff – the chamber was completely full, and with no room made available for overflow, the hall outside remained crowded for nearly the entire hearing. 

Readers will recall that the Subcommittee Chair, Senator Frank Lautenberg (D-NJ), introduced a bill last year – the “Safe Chemicals Act of 2010” – that would have substantially revised TSCA.   Thursday’s hearing undoubtedly served to demonstrate the importance that Senator Lautenberg places on revising TSCA and his commitment to maintaining active debate on the topic.  Whether his commitment will enable the parties in both houses to reach consensus and pass legislation in 2011, or even 2012, remains to be seen.  There are plenty of reasons for skepticism; however, passage of a revised TSCA is likely to occur in the next few years. 

Senator Lautenberg began the hearing with a review of the testimony the Subcommittee received during the 111th Congress.  Other Subcommittee members, including Senator James Inhofe (R-Okla.) and Senator David Vitter (R-LA) also provided statements. 

In his statement, Senator Inhofe expressed hope that the parties could “reach an agreement to develop a workable bill, one based on the best available science, one that protects human health, and one that balances the need to protect jobs and economic growth.”  Senator Inhofe alluded to concerns in the House of Representatives about the potential impact on jobs and innovation that might result from a revised TSCA statute, concerns that could very well make passage of a revised statute difficult while fears of a double-dip recession still linger.  He also stated that modernization of TSCA should (1) be based on the best available science, (2) use a risk-based standard for chemical reviews, (3) include more rigorous cost-benefit requirements, (4) protect proprietary information, (5) reduce the likelihood of litigation, (6) avoid compelling product substitution, and (7) prioritize reviews for existing chemicals.

Senator Vitter offered six broad principles for the upcoming debate: (1) the need for EPA to update the TSCA Inventory to remove those chemicals which are no longer in commerce, which he estimated to be nearly three-quarters of the approximately 80,000 currently listed, (2) the unacceptability of adopting a program modeled after the European Union’s Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation since it would threaten innovation and US competitiveness, (3) the mistake of prematurely assuming REACH will become the global standard for chemicals regulation, (4) the need for any scientific studies to be repeatable when used by EPA to restrict or prohibit use of a chemical, (5) the need for peer review processes to be truly independent; and (6) the need for sound science, and not media attention, to provide the basis for any EPA decision to re-review a chemical prior to an established schedule. 

A total of six witnesses testified on the two panels, with EPA testifying exclusively on the first.  Again, all witnesses supported reforming or “modernizing” the TSCA statute.  They included:

  • The Honorable Steve Owens, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), EPA;
  • Ms. Kelly M. Semrau, Senior Vice President for Global Corporate Affairs, Communication, and Sustainability, S.C. Johnson & Son, Inc.;
  • Mr. Steven J. Goldberg, Vice President and Associate General Counsel, BASF Corporation;
  • Ms. Frances Beinecke, President, Natural Resources Defense Council (NRDC);
  • Mr. Cal Dooley, President, American Chemistry Council (ACC); and
  • Dr. Lynn Goldman, MD, MPH, Dean, George Washington University School of Public Health and Health Services.

Mr. Owens summarized the Obama Administration’s principles for TSCA reform, first articulated in 2009.   In response to questions, Mr. Owens also expressed concern about the potential over-use of claims of confidentiality – i.e., confidential business information (CBI) – to protect the identity of chemicals listed on the TSCA Inventory.  According to Mr. Owens, approximately 17,ooo of the 84,000 listed chemicals have their identities claimed as CBI, affecting the ability to study and understand their potential effects. 

Ms. Semrau testified that S.C. Johnson supports the modernization of TSCA, but stressed the need to protect product innovation. She observed that although S.C. Johnson evaluates all chemicals used in its products, data gaps remain and revising TSCA would provide an opportunity to examine where data gaps occur and how they could be filled. She also expressed the company’s concern about chemicals being regulated on a state-by-state basis, noting the potential for the states to adopt different, and potentially conflicting, chemical management requirements.

Mr. Goldberg emphasized the need for Congress to act, so that chemicals are managed at the federal level rather than on a state-by-state basis. He noted that American Chemistry Council, the Consumer Specialty Products Association, and the American Cleaning Institute have circulated principles for TSCA modernization, which BASF supports. Interestingly, he also stated that he believed, after reviewing the principles articulated by the various stakeholders, that industry and the environmental community had more in common than is often assumed. 

Ms. Beinecke expressed appreciation for the Subcommittee’s decision to convene a hearing on TSCA reform early in the 112th Congress. She, like the other witnesses, noted that the states are adopting their own chemical regulations due to federal inaction. She observed that, in the last eight years, 18 states have adopted 71 measures concerning controls on the use of specific chemicals or classes of chemicals, and that some have adopted broader reform initiatives, most of which received strong bipartisan support.  She also noted that legislators in more than 30 states introduced or announced plans to introduce chemical control legislation this year, and that various industrialized countries around the globe are also undertaking efforts to reform or adopt chemical management programs.

Mr. Dooley agreed on the need for TSCA modernization.  He urged Congressional action so that the U.S. would remain competitive globally, seemingly anticipating objections that may come from some in the House of Representatives.  He also urged action to discourage states from passing their own laws. Mr. Dooley stated that ACC and a broad coalition of its “value chain partners” are calling for “good TSCA modernization.” According to Mr. Dooley, a revised TSCA should require scientific objectivity, prioritize to identify data needs, and use a risk-based safety standard that considers a chemical’s use when taking regulatory actions.

Dr. Goldman, a former Assistant Administrator for EPA’s Office of Prevention, Pesticides, and Toxic Substances (OPPTS) — currently called the Office of Chemical Safety and Pollution Prevention — reviewed a paper recently prepared by an American Bar Association Section of Environment, Energy, and Resources Special Committee on TSCA Reform.  The Special Committee includes a bipartisan group of former EPA officials.  According to Dr. Goldman, the officials agreed on several points, including: (1) the necessity of a practical approach to amending TSCA because of the need for a flexible and a prioritized system to regulate chemicals, (2) the limited organizational capacity and resources currently available to EPA’s TSCA program, (3) the understanding that all chemicals are not created equal and therefore TSCA modernization should not become a “numbers game” where EPA is required to review a certain number of chemicals each year instead of first determining priorities for regulatory attention, (4) the need to preserve, but strengthen, much of the current chemical management system, (5) the availability and usefulness of other regulatory systems, in addition to REACH, that should be evaluated and potentially have elements incorporated into a revised TSCA, and (6) the need for Congress not to legislate how EPA should do the science since it can evolve quickly.

Whether Senator Lautenberg’s enthusiasm for reform will enable him to achieve a bipartisan and bicameral consensus remains to be seen.  Certainly, the calls for reforming TSCA are increasing among the various stakeholders.  However, as noted elsewhere, economic considerations are certain to affect the extent of any near-term progress.  Those considerations will influence not only the Congressional resources devoted to TSCA reform, but also the details of any legislative proposals.

TSCA Reform Likely to Be a Lower Priority in 2011

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TSCA Reform:

Chemical and Engineering News reports that representatives from several major US trade associations have stated publicly that they don’t expect modernization of the federal Toxic Substances Control Act (TSCA) to be a high priority for Congress in early 2011. Their statements are not surprising.  With fears of a double-dip recession still lingering, passage of a substantially revised TSCA seems unlikely in 2011, but with continued industry support, an improved economy, and a little bipartisan cooperation, it might occur in 2012.  (Assuming, of course, that the election doesn’t get in the way.  A big “if.”)

The Republican party controls the House of Representatives and it’s clearly stated its intentions.  Among other things, Republicans are determined to reduce the impacts on the deficit, national debt, and jobs that are associated with government regulation, including some forms of environmental regulation.  Adopting a more robust chemical control statute would likely require a substantial increase in EPA’s budget and it could have a significant ripple effect throughout the economy as downstream companies that don’t manufacture, but “process,” chemicals faced new requirements.  Also, at least some chemical manufacturers would need to generate expensive new health and environmental data.  And finally, there’s the risk that a new program could stifle innovation and affect the global competitiveness of the United States.

Notwithstanding support for reform coming from the American Chemistry Council (ACC), a trade association comprised primarily of chemical manufacturers, economic concerns – real or stated – could prove dissuasive in 2011 to a majority of Republicans in the House.  The Democratically-controlled Senate may be more inclined towards major near-term reform, but in the absence of sufficient support in the House, and with any Senate proposal likely less palatable to the chemical industry, such a goal seems unattainable.  At a minimum, the delay will give key members of the 112th Congress time to try to reach consensus on important points in the reform debate.

So, what will 2011 look like?  Unless there’s another crisis, such as tainted imported consumer products or an oil spill requiring the use of chemicals for which little safety information is publicly available, readers will probably see limited progress through 2011.  Closed-door meetings are certain to occur, a few hearings will take place and a bill may be introduced in the Senate – a bill may even be introduced in the House – but proposals are unlikely to advance significantly in the near-term.  Economic considerations will affect both the resources committed to the TSCA reform debate, as well as the details of any legislative proposals.  Efforts occurring in 2011 will be undertaken in the name of trying to adopt “sensible” reform that protects the environment and health without damaging the economy. 

With the Administration already taking steps to reconcile past differences with business leaders in preparation for the 2012 election, it seems unlikely that the White House will push for robust new legislation either.  So, don’t look for major legislative proposals coming from EPA anytime soon.  However, expect the ACC and others to try to persuade the Administration that TSCA Reform is a potential opportunity for bipartisanship. 

But what about the public’s and the states’ outcry for a more robust federal chemical regulatory program?  And what about the consensus among the chemicals industry, EPA, and environmental groups on the need for reform?  The outcry and the consensus are important and should not be dismissed for ultimately they will help ensure passage of a revised TSCA.  However, for the next year (and possibly longer), jobs creation, debt reduction, election politics, and efforts to reach consensus, are likely to delay reform.  In the interim, EPA will probably continue with its attempts to use existing authority to address chemical risks, despite promises of increasing Congressional oversight.  

EPA Requires Testing of 19 High Production Volume (HPV) Chemicals

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TSCA/HPV Chemicals:

On January 7, 2011, EPA published a final rule under section 4(a)(1)(B) of theToxic Substances Control Act (TSCA), (15U.S.C. 2603(a)(1)(B)), requiring manufacturers, importers, and processors to test 19 high production volume (HPV) chemicals.  The rule, which takes effect on February 7, 2011, requires these persons to obtain screening level data for health and environmental effects and chemical fate, and then provide that data to the Agency.  The rule is one of a series of actions that EPA is taking to ensure that it has the data necessary to adequately review priority chemicals.  In addition, now that the Agency has issued a final test rule, any person (including those required to test) who exports, or intends to export, any of the 19 chemicals will be subject to the export notification requirements in 40 CFR part 707, subpart D.  The chemicals 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

diphenylmethanone

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

The 19 chemicals were originally included in the voluntary High Production Volume (HPV) Challenge Program, which “challenged” companies to make health and environmental effects data publicly available on chemicals produced or imported in the United States in the greatest quantities.  HPV chemicals are classified as those chemicals produced or imported in the United States in quantities of 1 million pounds or more per year.  EPA has determined that HPV chemicals account for approximately 95% of total chemical production in the United States.  As of June 2007, companies sponsored more than 2,200 HPV chemicals, with approximately 1,400 chemicals sponsored directly through the HPV Challenge Program and over 860 chemicals sponsored indirectly through international efforts.  However, no data were provided for the 19 chemicals, making a mandatory test rule necessary.

More information on EPA’s HPV Challenge Program is available here.

EPA Issues Proposed TSCA IUR Modifications Rule

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TSCA:

On August 13, 2010, the Environmental Protection Agency (EPA) published a notice in the Federal Register, proposing to modify the Inventory Update Reporting (IUR) rule.  For readers less familiar with the IUR, this is a rule established under section 8(a) of the Toxic Substances Control Act (TSCA).  It enables EPA to collect, and then make public, critical information on the manufacture (including import), processing, and use of certain chemicals listed on the TSCA Chemical Substances Inventory.  This includes current information on volumes of chemical production, manufacturing facility data, and how the chemicals are used.  EPA uses this information to help identify and, when necessary, manage potential risks that some chemicals may pose to human health or the environment.

The proposed rule includes a number of important changes that will impact industry.  Among these include: requiring electronic reporting; increasing the reporting frequency; requiring process and use information for substances over 25,000 pounds; changing the method for determining whether the reporting threshold has been exceeded; replacing the “readily obtainable” reporting threshold with “reasonably ascertainable” for processing and use information; and requiring submission of production volume information for all years in between reporting periods. 

EPA intends to issue the final rule in advance of, and have it apply to, the 2011 submissions.  That submission period runs from June 1, 2011 through September 30, 2011.  Reporting companies are closely monitoring this development to ensure compliance with the requirements EPA ultimately adopts.  Comments must be received on or before October 12, 2010.

EPA states that it is modifying the rule to meet four primary goals:

  • To tailor the information collected to better meet the Agency’s overall information needs;
  • To increase its ability to effectively provide public access to the information;
  • To obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory; and
  • To improve the usefulness of the information reported.

The changes the Agency is proposing to meet these goals are discussed in further detail below.

I.      General Reporting Changes

  • The reporting frequency would be increased.  Reporting would return to its previous four-year cycle, making the first post-2011 submission due in 2015.  EPA also requested comment on whether to require a different reporting frequency. 
  • The method would change for determining whether a report was required. 
    • In general, an IUR report would be required for any post-2011 submission whenever a non-exempt chemical is manufactured or imported in volumes of 25,000 lbs. or more at any single site owned or controlled by the manufacturer in any calendar year since the last principal reporting year.
    • EPA also requested comment on whether alternative methods would provide an equally accurate picture of chemical production, and whether more frequent reporting on a limited set of chemicals would be more appropriate.
    • However, the 25,000 lb. threshold would eliminated for reporting on chemicals subject to a rule promulgated pursuant to TSCA sections 5(a)(2), 5(b)(4) or (6), subject to a TSCA section 5(e) or section 5(f) order, or that is the subject of relief granted in a civil action under TSCA sections 5 or 7.  EPA also requested comment on whether chemicals included in a proposedrule under sections 5(a)(2), 5(b)(4), or 6 should be part of this group as well, and whether a de minimus reporting threshold should set for the group.
    • EPA also requested comment on changing the applicability threshold from 25,000 lbs. to 10,000 lbs.
  • Electronic reporting, using reporting software and the internet, would be required for preparation and submission of all IUR information.  Paper reporting and submitting reports as files on electronic media (e.g., CD-ROM) would no longer be allowed.
  • The requirements concerning assertion of claims of confidential business information (CBI) and EPA’s response to such claims would be changed.
    • EPA would release publicly chemical identity information without notice to the reporting company for those chemicals already on the public portion of the TSCA Inventory.
    • Substantiation would need to be provided up front for processing and use information; otherwise, the Agency would not consider the information confidential and would make it publicly available without notice to the reporting company.
    • EPA would disallow confidentiality claims for processing and use data elements identified as not “known to or reasonably ascertainable.”
    • EPA would consider the name and site identity to be separate items, requiring separate claims and substantiation for each.

II.      Reporting of Manufacturing Information

  • More manufacturing (and importing) data elements would reported, such as:
    • The name of the ultimate domestic parent company, making the IUR report consistent with the Toxic Release Inventory (TRI) reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA);
    • The current Chemical Abstracts (CA) Index Name, as used to list the chemical substance on the TSCA Inventory, would be required as part of the chemical identity;
    • Production volume for each year since the previous principal reporting year (i.e., 2005), rather than just the principal reporting year;
    • The production volume of a manufactured (including imported) chemical used at the reporting site;
    • Whether an imported chemical is physically at the reporting site;
    • The production volume of the chemical directly exported and not domestically processed or used; and
    • Whether a manufactured chemical, such as a byproduct, is being recycled, remanufactured, reprocessed, reused, or reworked.

III.      Reporting of Processing and Use Information

  • The threshold would change for reporting processing and use information.  The current 300,000 lb. threshold would be eliminated.  Companies submitting Parts I and II of Form U would also complete Part III.  EPA also requested comments on whether stakeholders disagree and believe that there should be a threshold for this information. 
  • The standard for reporting would be changed from reporting of all information “readily obtainable” to the “known to or reasonably ascertainable to the submitter” standard that applies to the other information reported on Form U.
  • The list of industrial function categories for the reporting of processing and use information would be revised and the five-digit North American Industrial Classification System (NAICS) codes would be replaced with 48 Industrial Sectors (IS), and entries of “other” would be required to include a written description of the use.
  • Reporting on consumer and commercial product categories would be changed.
    • Companies would have to distinguish between consumer and commercial product categories, or indicate if both are relevant.
    • The consumer and commercial product categories would be revised and expanded for consumer and commercial use information, and an explanation would be necessary with the “other” product category is selected.
    • Reporting on the number of commercial workers potentially exposed to the chemical would be required.
  • EPA requested comments on potentially changing the IUR reporting requirements in the future to parallel exposure reporting required on new chemicals via the pre-manufacture notification (PMN), thereby allowing more quantitative exposure assessment, and whether such detailed information might be collected through the IUR, a new reporting mechanism under TSCA Section 8(a), or through the use of TSCA Section 11(c) subpoena authority.
  • EPA also requested comments on whether processors should be subject to future exposure-related reporting.

IV.    Other Proposed Changes

  • Definitions would be adopted or revised to address toll manufacturing, portable manufacturing, and other past reporting challenges.  Among these include: 
    • “Manufacture” would be revised to include production under a toll arrangement and the manufacturing entity and the entity contracting for such service would both be defined as the “manufacturer” and thus, responsible for filing an IUR, although only one report need be filed.
    • “Site” would be revised to address toll manufacturing, portable manufacturing, and importation.  Specifically, the new definition would make the place of production under a toll agreement the “site” for purposes of IUR reporting.  The distribution center would be designated as the “site” for manufacture in portable manufacturing units.  Lastly, the location of an importer’s headquarters in the United States, the location of an operating unit in the United States, or, if neither of those locations exists, the address of the agent in the United States authorized to accept service of process would be designated as the “site.”
  • Several chemicals would receive expanded exemptions and others would be deemed ineligible for exemptions:
    • Manufactured water, water from petroleum streams, and the three polymers that are currently partially exempt from the IUR requirements would be completely exempted; and
    • Chemicals for which an enforceable consent agreement (ECA) to conduct testing has been made would be ineligible.
  • Responding to questions and issues that have arisen concerning byproduct reporting; EPA developed and requests comments on draft guidance for such reporting.

V.      Concluding Thoughts

EPA’s proposed changes move the Agency closer to meeting its stated goals.  They should help resolve many of the difficulties it encountered using the information received in the last IUR reporting cycle.  The limitations and requirements on the protection of CBI are not surprising given the Agency’s stated interest in expanding public access to information on chemicals.  Nonetheless, it is clear that the proposed changes will increase industry’s reporting burden and place more confidential business information at greater risk of public disclosure. 

EPA Grants TSCA Section 21 Petition on Cadmium

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TSCA/CPSIA/FHSA:

On August 30, 2010, EPA granted a citizen’s petition filed under section 21 of the Toxic Substances Control Act (TSCA) requesting Agency action on cadmium and cadmium compounds.  Empire State Consumer Project, the Sierra Club, the Center for Environmental Health, and Rochesterians Against the Misuse of Pesticides filed the petition on May 28, 2010.  The petitioners wanted the Consumer Product Safety Commission (CPSC) to act to protect children against cadmium present in toy jewelry, but if the CPSC did not act, they wanted EPA to take action under TSCA.  The petitioners argued that analysis of Chinese imports strongly suggested that cadmium was being used in toy jewelry as a cheap substitute for lead, which is now strictly regulated by the CPSC.  The petition followed several recalls ordered by the CPSC and numerous warnings to Chinese exporters and others.

The Petition

The petition demanded that CPSC take several actions, including: (1) classifying as a banned hazardous substance under sections 2 and 3 of the Federal Hazardous Substance Act (FHSA) toy metal jewelry containing cadmium above trace amounts, thereby requiring manufacturers, importers, and processors to test and certify their products under the Consumer Product Safety Safety Improvement Act of 2008 (CPSIA); (2) revising the test method, if the cadmium limit is to be based on the amount that can be extracted, to better reflect usage scenarios; and (3) using its participation on the Interagency Testing Committee (ITC) established under TSCA to request EPA’s immediate adoption of testing and reporting methods, if CPSC believes that it lacks sufficient information on the extent of cadmium in children’s products or needs additional information to determine the appropriate limit for cadmium in those products.

The petition also sought specific EPA actions, including: (1) requiring health and safety data reporting for cadmium and cadmium compounds under section 8(d) of TSCA; and (2) issuing under section 6 a rule setting limits on cadmium and cadmium compounds in toy jewelry.   The section 8(d) rule was to apply to producers, importers, and processors of cadmium and cadmium compounds reasonably likely to be incorporated into consumer products.  Petitioners demanded that EPA seek lists and/or copies of the following types of ongoing and completed health and safety studies:

a.   epidemiological or clinical studies;
b.   studies of occupational exposure;
c.   health effects studies;
d.   ecological effects studies; and
e.   environmental fate studies (including relevant physicochemical properties).

The Agencies Respond

On August 19, 2010, the CPSC published a Federal Register notice, requesting public comments on the petition.  The public comment period closes October 18, 2010.  Many observers anticipate CPSC’s eventual adoption of restrictions on cadmium in certain consumer products, including metal toy jewelry.

EPA is further along in responding to the petition.  In a letter, dated August 30, 2010, EPA Assistant Administrator Steve Owens agreed to have EPA issue a TSCA Section 8(d) rule regarding cadmium and cadmium compounds used in consumer products, especially metal toy jewelry.  The rule will require reporting by producers, importers, and processors of cadmium and cadmium compounds that are reasonably likely to be incorporated into consumer products.   He also indicated that the Agency is willing to consider banning or restricting the metal if the CPSC does not address consumer uses of cadmium; however, the Agency has not used its section 6 authority in many years and it is unlikely to need to do so in light of anticipated CPSC action.

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Check back occasionally for additional posts concerning the evolving debate over the appropriate regulation of cadmium and cadmium compounds.