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.                       

Leading Consumer Products Companies Explain How and Why They Share Chemical Data Along the Supply Chain

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Green Chemistry/Sustainable Supply Chain Management:

The Green Chemistry and Commerce Council (GC3) recently published a report titled, Meeting Customers’ Needs for Chemical Data: A Guidance Document for Suppliers.  The Guidance Document is designed to improve supply chain communication between suppliers and their customers concerning chemical identities and health and safety data.  In the report, leading companies such as HP, Johnson & Johnson, Method, Nike, SC Johnson, and Wal-Mart explain why they want such data and how they interact with their suppliers to obtain it. 

Readers unfamiliar with GC3 should know that it is a business-to-business forum for members to discuss and share information and experiences relating to the advancement of green chemistry, design for the environment, and sustainable supply chain management.  GC3, which began in 2005, is a project of Lowell Center for Sustainable Production at the University of Massachusetts Lowell.  GC3 prepared the Guidance Document with two goals in mind: “(1) to advance the efforts of companies trying to obtain the chemical data needed for regulatory and corporate sustainability programs and in response to market demands, and (2) to advance the efforts of suppliers to provide chemical data needed by their customers.”

The Guidance Document is a response to the growing demand for increased transparency concerning chemical-related data. Companies attempting to bring “green” or “safer” products to the market need chemical identity and health and safety data at the product design phase.  Access to this information enables them to evaluate and manage market, regulatory, and tort liability risks, as well as respond to requests from their customers, including consumers, wanting more information.

The Guidance Document should prove helpful to suppliers less familiar with the trend toward greater transparency, the rationale supporting it, and the techniques used to sustain it.  The document explains why fabricators and formulators are requesting chemical data, what chemical data are being sought, how suppliers can benefit from sharing data, why Material Safety Data Sheets (MSDS) often provide inadequate data, how companies are handling confidential business information, how fabricators and formulators collect data from their suppliers and what they are doing with the data, and where suppliers can obtain the data being requested.  In addition to describing the chemical data collection practices of different companies, the Guidance Document also provides customizable letters and forms that companies can use to facilitate their communications. 

More information about GC3 is available here.

Reminder: Upcoming Teleconferences and Meetings of the DTSC Green Ribbon Science Panel

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Green Chemistry:

Readers will recall that the Green Ribbon Science Panel convened on February 4, 2011 to discuss its role in advising DTSC on green chemistry matters.  During that call, the Panel agreed to arrange itself into three subcommittees to work on specific aspects of the Safer Consumer Product Alternative Regulations.  Below is an excerpt from the DTSC website describing each subcommittee and providing its upcoming teleconference schedule.  Also, the full Panel will convene in-person May 5 – 6, 2011. 

Although more focused attention by the Panel will be welcomed by some, the numerous teleconferences and meetings will make it incredibly difficult for stakeholders to remain actively engaged throughout the Panel’s deliberations.

 

GRSP Topic Subcommittees

The Green Ribbon Science Panel has formed three subcommittees to more deeply discuss issues related to DTSC’s Green Chemistry Program. The subcommittees will each meet via teleconference twice prior to the next scheduled meeting of the entire Panel (scheduled for May 5 and 6, 2011, in Sacramento). At that time, there will be a discussion of these issues by the entire GRSP. All GRSP subcommittee meetings are open to the public, and will include an opportunity for the public to make comments to the GRSP subcommittee.

Green Ribbon Science Panel Subcommittees

#1: Chemical Identification and Prioritization
(chaired by GRSP Co-Chair Ken Geiser, Ph.D.)

#2: Product Identification and Prioritization
(chaired by GRSP Co-Chair Debbie Raphael, M.A.)

#3: De Minimis and Unintentionally-Added Chemicals
(chaired by GRSP Co-Chair Bill Carroll, Ph.D.)

This subcommittee will meet:

  • April 4, 2011, from 9:30 to 12 noon Pacific Time. See the agenda and public notice.
  • April 13, 2011 (time and other details to be determined). 

This subcommittee will meet:

  • April 11, 2011 (time and other details to be determined).
  • April 19, 2011 (time and other details to be determined).

This subcommittee will meet:

  • April 6, 2011, from 9:30 to 12 noon Pacific Time. See the agenda and public notice.
  • April 18, 2011 (time and other details to be determined).

Subcommittee #1 members are:

  • Julia Quint, Ph.D.
  • George Daston, Ph.D.
  • Meg Schwarzman, M.D.
  • Julie Zimmerman, Ph.D.
  • Lauren Heine, Ph.D.
  • Art Fong, Ph.D.
  • Rich Liroff, Ph.D.
  • Tim Malloy, J.D.

Subcommittee #2 members are:

  • Bruce Cords, Ph.D.
  • Jae Choi, Ph.D.
  • Mike Kirschner
  • Scott Matthews, Ph.D.
  • Kelly Moran, Ph.D.
  • Dele Ogunseitan, Ph.D.
  • Julie Schoenung, Ph.D.
  • Roger McFadden
  • Mike Wilson, Ph.D.

Subcommittee #3 members are:

  • Ann Blake, Ph.D.
  • Tod Delaney, Ph.D.
  • Richard Denison, Ph.D.
  • Dale Johnson, Ph.D.
  • Bob Peoples, Ph.D.
  • Joe Guth, J.D., Ph.D.

 

 

 

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's Chemical Screening Gets a Big Boost – From a Robot!

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Chemical Screening:

On March 10, 2011, the U.S. Environmental Protection Agency (EPA) officially launched a robust new tool for screening chemicals for health and environmental hazards.  It’s a robot called the Tox21 Robotic Testing System, or “ToRTS” for readers preferring acronyms.  Robots have been used previously for chemical testing, but ToRTs appears to be one of the bigger systems.  EPA says it will use the robot to test 10,000 different chemicals for potential toxicity.  A video of the robot is available here.

ToRTS is located at the National Institutes for Health (NIH) Chemical Genomics Center (NCGC) in Rockville, MD.  It is part of the Tox21 project, which merges existing agency resources (research, funding, and testing tools) to develop ways to more effectively predict how chemicals will affect human health and the environment. The ToRTS system marks the beginning of a new phase of the Tox21 collaboration, which aims to working to protect human health by improving how chemicals are tested in the United States.

Tox21 was established in 2008 between the National Institute of Environmental Health Sciences National Toxicology Program (NTP), the National Human Genome Research Institute (NHGRI), and the EPA.  The U.S. Food and Drug Administration (FDA) joined in 2010.  More information on Tox21 is 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. 

California DTSC Green Ribbon Science Panel Discusses Changes to Its Advisory Role in the Green Chemistry Program

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Green Chemistry Regulations:

On February 4, 2011, the Green Ribbon Science Panel (GRSP), a panel of experts advising the Department of Toxic Substances Control (DTSC) on green chemistry-related matters, convened via teleconference to consider how it might better fulfill its role as an advisor to the Department.  The teleconference focused on GRSP process rather than on substantive topics such as the Safer Consumer Product Alternatives Regulations, which remain in draft form.  However, it was clear from the teleconference that frustration over the latest draft of the Regulations – in terms of how the draft was proposed as well as its content – was at the core of some GRSP members’ concerns.

Readers will recall that the Department delayed adoption of the Regulations on December 23, 2010 in response to widespread criticism of the latest draft.  No deadline for completing the rulemaking has been publicly announced.

Update:  An audio file of the GRSP teleconference is now available on DTSC’s website.

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.

EPA Reissues FIFRA Guidance on Cleaning Products

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FIFRA:

On January 11, 2011, EPA issued revised guidance regarding the types of claims that would require registration of cleaning products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. §136 et seq.  Readers may recall that, in early 2010, the Agency initially issued guidance that could have made claims such as “removes mold, mildew and algae stains” potentially subject to registration, differing from the established interpretation of the “cleaning agents” exemption set out at 40 CFR § 152.10.  EPA reasoned that, in certain contexts, such statements would constitute claims of pest mitigation.  At the same time, EPA Headquarters was also coordinating with the Agency’s regional offices to undertake an enforcement initiative based in part on that 2010 guidance.  However, a large-scale enforcement initiative did not occur.  Industry trade associations and others were successful in convincing EPA that its expanded application of FIFRA was unnecessary and potentially unlawful.  EPA responded by issuing revised guidance essentially reducing the number of scenarios in which pesticidal intent would be inferred.

Under FIFRA a “pesticide” is “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.”  FIFRA § 2(u), 7 U.S.C. § 136(u) (emphasis added).  Unless otherwise exempted from registration under 40 CFR §§ 152.20, 152.25 or 152.30, pesticide products that are intended for a pesticidal purpose must be registered.  In general, a product is considered to be intended for a pesticidal purpose when the person who distributes or sells it claims, states, or implies that the product prevents, destroys, repels or mitigates a pest.  Therefore, once a product label (or other statement made in connection with the sale or distribution of the product) includes any claim of pest mitigation, under 40 CFR § 152.15, the product is one that is intended for a pesticidal purpose and becomes subject to registration.  For cleaning products, claims of pest mitigation are frequently what trigger the registration requirement. 

According to EPA, a product need not act directly on a pest in order for it to mitigate the pest and be considered a pesticide.  See IN THE MATTER OF AQUARIUM PRODUCTS, INC. (IF&R Docket No. 1 1 1 – 4-C) (1995).  However, certain products may have effects that mitigate pests without being intended for a pesticidal purpose.  As noted above, the regulation at 40 CFR § 152.10 sets out three groups of products that are not pesticides because they are not intended to prevent, destroy, repel or mitigate a pest.  One of these includes deodorizers, bleaches and cleaning agents.  However, the regulation provides that these products are not pesticides only if no pesticidal claim, express or implied, is made on their labeling or in connection with their sale and distribution (e.g., web sites, advertising, promotional or sales activities and testimonials, or even website links to research demonstrating pesticidal efficacy).  This includes claims about the use of a cleaning product alone or in combination with other substances.

Some cleaning products claim pest mitigation, noting their ability to affect the habitat or food source of a pest, but others merely claim the ability to remove dirt or other debris.  Although such distinctions may appear subtle, they’re important from a regulatory standpoint.  Moreover, many claims are not so easily categorized, so the context in which they occur must be evaluated.  Thus, with the range of claims occurring in the marketplace, EPA guidance distinguishing between claims subject to registration and those not subject is important. 

EPA offers many examples of claims that would require registration because of a linkage to mitigating a pest, its food, food source, or its habitat.  These include the following:

  • Cleans away, washes away or removes any pest, biofilm or scum, allergen or allergen associated with a pest.
  • Removes pests by suffocating or drowning.
  • Cleans or removes pest habitats or breeding sites.
  • Cleans, precipitates or removes contaminants, nutrients or matter that provide food or habitat for pests.
  • Cleans, reduces or removes scum or sludge where pests breed, feed or live.
  • Out-competes or displaces a pest for nutrition or habitat.
  • Cleans or removes the habitat where biofilm, germs, allergens or microorganisms can hide, thrive or grow.
  • Prevents, blocks, removes, neutralizes or controls bacteria or other pests that cause odors.
  • Sanitizes, disinfects or sterilizes.
  • Images of pests or pest habitats (e.g., nest, hive or web) that imply cleaning or removal of pest habitats, or of nutrition or sources of nutrition for pests.
  • A banner, logo, design, header or any claim on a label or labeling, or through other means such as web sites, advertising, etc. that specifically links the cleaning product to pest control, Integrated Pest Management (IPM), pests or a specific kind of pest. 

In contrast, claims lacking a linkage to mitigation would not require registration.  Examples of such claims include:

  • Cleans or removes stains.
  • Cleans or removes stains from algae, mold, mildew or other non-public health organisms.
  • Cleans or removes dirt, soil, dust, debris, inanimate scum, inanimate nutrients, inanimate organic particulates, or inanimate contaminants.
  • Cleans a site (e.g., ponds, aquariums, etc.).
  • Prevents, blocks, neutralizes, reduces, eliminates, encapsulates or removes odors; deodorizes.
  • Cleans, reduces or removes sludge.
  • Cleans or removes inanimate scum such as “soap scum.”
  • Cleans, washes or prepares the surface for application of a registered disinfectant intended to kill biofilm.
  • Combines suspended inanimate particulates for easy removal by a filtration system.
  • Cleans away or removes inanimate dust-mite matter, non-living matter, or  allergens from non-living sources (e.g., pet dander allergens, cockroach matter allergens, dust mite matter allergens) (emphasis added).

Despite the numerous examples, there are scenarios for which EPA cautions companies to undertake a careful evaluation of the entire context.  These include the following types of scenarios:

  • Catalogs or web sites that list both cleaning products and pesticidal products in close proximity since these could imply that the cleaning products are pesticidal.   
  • Use of references to IPM on a cleaning product’s label.  (Although EPA considers IPM an effective and environmentally sensitive approach to pest management that relies on a combination of common-sense practices, references to IPM could imply by association that a clean product may control or mitigate a pest.)

The Agency’s guidance appears generally consistent with the longstanding practice of many companies.  However, FIFRA’s registration requirement has proven to be a source of confusion for others, so there are undoubtedly companies out there currently evaluating the guidance and adjusting their practices accordingly.