EPA Announces Action Plans for Chemicals Used in Dyes, Detergents, and Flame Retardants

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TSCA/EPCRA:

On August 18, EPA posted action plans for benzidine dyes, nonylphenol and nonylphenol ethoxylates, and hexabromocyclododecane.   The chemicals at issue are “existing,” meaning that they are currently included on the inventory established under the Toxic Substances Control Act (TSCA) and therefore may be lawfully manufactured, processed, and used in the United States, subject to whatever restrictions or other requirements the Agency imposes.   According to EPA, these chemicals are widely used in both consumer and industrial applications, including as dyes, flame retardants, and industrial laundry detergents, respectively.   Restrictions or further conditions on their use could therefore have significant economic implications for certain stakeholders.

The action plans summarize available hazard, exposure, and use information; outline the risks that each chemical may present; and identify the specific steps EPA is contemplating to address those concerns.   According to the plans, the Agency is contemplating a range of actions under TSCA as well as listings under the Toxic Release Inventory (TRI) established pursuant to Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA).   As it undertakes the proposed actions, EPA will provide opportunities for public and stakeholder comment and involvement. 

The action plans are a further demonstration of EPA’s commitment to using its existing legal authorities to regulate chemicals that may pose a risk to human health and the environment.   Until new legislation amending TSCA is enacted, readers should anticipate EPA’s creative and robust use of its existing authorities to implement the Administration’s chemicals management policies. 

More information, including copies of the action plans, is available here.   A summary of the plans is provided below.

Benzidine Dyes

This action plan addresses 48 dyes derived from benzidine and its congeners, 3,3′-dichlorobenzidine, 3,3′-dimethylbenzidine, and 3,3′-dimethoxybenzidine.

According to EPA, Benzidine and its congeners are important precursors in the synthesis of dyes.   Some of these dyes have the potential to metabolize to aromatic amines that are considered to be carcinogenic.   Benzidine and dyes metabolized to benzidine are classified as known human carcinogens, and Benzidine’s congeners, 3,3′-dichlorobenzidine, 3,3′-dimethylbenzidine, and 3,3′-dimethoxybenzidine and dyes metabolized to the latter two congeners have all been classified as “reasonably anticipated to be human carcinogens.”

The dyes are used in the production of textiles, paints, printing inks, paper, and pharmaceuticals.   According to the Agency, they have the potential to be leached from textiles, such as clothing, that are in prolonged contact with human skin.   They are also used as reagents and biological stains in laboratories, are used in the food industries, and have more recent uses in laser, liquid crystal displays, ink-jet printers, and electro-optical devices.   Because the dyes have the potential to metabolize to carcinogenic amines both in and on the human body, EPA is concerned about the potential risk from exposure, including exposure of children, from using products containing benzidine and congener-based dyes.

On the basis of existing information, EPA has concluded that the following actions would be warranted:

1.   Initiate rulemaking to add four benzidine-based dyes to an existing TSCA section 5(a)(2)significant new use rule (SNUR) for benzidine-based substances at 40 CFR 721.1660.  (A SNUR requires manufacturers who intend to use a chemical for the identified significant new use to submit an application, known as a Significant New Use Notice (SNUN), to the Agency for review at least 90 days prior to beginning that activity.  The Agency’s review of the SNUN provides an opportunity to take other regulatory action if appropriate.)

2.   Initiate rulemaking to establish a new TSCA section 5(a)(2)SNUR for benzidine congener-based dyes, including 44 specific such dyes.

3.   Consider proposing to eliminate the article exemption applied to SNURs to address potential concerns for exposure to these dyes on imported finished textiles.

4.   Consider initiating action under TSCA section 6, if EPA learns that these dyes are present in imported finished textiles.

5.   Consider additional regulatory action, if EPA determines that there are other ongoing uses for these dyes and needs to obtain information necessary to determine whether those uses present concerns which need to be addressed.

Nonylphenol and Nonylphenol Ethoxylates 

This action plan addresses Nonylphenol (NP) and Nonylphenol Ethoxylates (NPEs).  NP and NPEs are produced in large volumes, with uses that lead to widespread release to the aquatic environment. 

NP is persistent in the aquatic environment, moderately bioaccumulative, and extremely toxic to aquatic organisms.   NP has also been shown to exhibit estrogenic properties in in vitro and in vivo assays.   NP’s main use is in the manufacture of NPEs.

NPEs are nonionic surfactants that are used in a wide variety of industrial applications and consumer products.   Many of these, such as laundry detergents, are “down-the-drain” applications.  Some others, such as dust-control agents and deicers, lead to direct release to the environment. NPEs, though less toxic and persistent than NP, are also highly toxic to aquatic organisms, and, in the environment, degrade into NP.

According to the Agency, NP and NPEs have been found in environmental samples taken from freshwater, saltwater, groundwater, sediment, soil and aquatic biota.   NP has also been detected in human breast milk, blood, and urine and is associated with reproductive and developmental effects in rodents.

EPA is initiating both voluntary and regulatory actions to manage potential risks from NP and NPEs. EPA intends to:

1.   Support and encourage the ongoing voluntary phase-out of NPEs in industrial laundry detergents, as  agreed to by the Textile Rental Services Association of America (TRSA).   The phase out, which has already begun, is being coordinated with EPA’s DfE Safer Detergents Stewardship Initiative (SDSI)program and would end the use of NPEs in industrial laundry detergents by 2013 for liquid detergents and 2014 for powder detergents.   In addition, EPA intends to encourage the manufacturers of all NPE-containing direct-release products (e.g., firefighting gels and foams, dust-control agents and deicers) to move to NPE-free formulations.   EPA will develop an alternatives analysis and encourage the elimination of NPE in other industries that discharge NPEs to water, such as the pulp and paper processing and textile processing sectors, where safer alternatives may be available.

2.   Initiate rulemaking to simultaneously propose a SNUR under TSCA section 5(a)and a test rule for NP and NPEs under TSCA section 4.    The SNUR would designate use of NPEs in detergents and cleaning products as a significant new use, which would require submission of a SNUN at least 90 days before beginning that use.   The proposed test rule would require development of the information necessary to determine the effects that NPEs and NP may have on human health or the environment.  

3.   Consider initiating rulemaking under TSCA section 5(b)(4)to add NP and NPEs to the Concern List of chemicals that present or may present an unreasonable risk of injury to health or the environment.

4.   Initiate rulemaking to add NP and NPEs to the Toxics Release Inventory (TRI) established under EPCRA, which would require facilities to report releases of these chemicals to the environment.

Hexabromocyclododecane

This action plan addresses EPA’s review of hexabromocyclododecane (HBCD), a category of brominated flame retardants.  HBCD is used in expanded polystyrene foam (EPS) in the building and construction industry, as well as in consumer products. 

According to EPA, people may be exposed to HBCD from products and dust in the home and workplace, as well as its presence in the environment.   HBCD is supposedly found world-wide in the environment and wildlife.   EPA claims that HBCD is found in human breast milk, adipose tissue, and blood.   It supposedly bioaccumulates in living organisms and biomagnifies in the food chain, and it is persistent in the environment and is transported long distances.

The action plan finds that HBCD is highly toxic to aquatic organisms.  It also presents human health concerns based on animal test results indicating potential reproductive, developmental and neurological effects.

EPA intends to initiate the following actions to manage the risk that may be presented by HBCD.

1.   Consider initiating rulemaking under TSCA section 5(b)(4)to add HBCD to the Concern List of chemicals which present or may present an unreasonable risk of injury to health or the environment.   EPA intends to publish this notice of proposed rulemaking by the end of 2011.

2.   Initiate rulemaking under TSCA section 5(a)(2) to designate manufacture or processing of HBCD for use as a flame retardant in consumer textiles as a significant new use.   This would require manufacturers and processors to file a SNUN 90 days before manufacturing or processing HBCD for this use.   The SNUR also would be proposed to apply to imports of consumer textiles articles containing HBCD.  

3.   Consider initiating rulemaking under TSCA section 6(a)to regulate HBCD.   A section 6(a) action could take the form of a comprehensive ban on the manufacturing, processing, distribution in commerce and use of a chemical substance, or a more targeted regulation to address specific activities.   The extent of the rule for HBCD would be determined during the rulemaking process.

4.   Initiate rulemaking in 2011 to add HBCD to the Toxics Release Inventory (TRI).   Listing on TRI will require manufacturers or importers to provide environmental release information.

5.   Conduct a Design for the Environment (DfE)alternatives assessment of HBCD.   The information developed may be used to encourage industry to move away from HBCD instead of, in addition to, or as part of any regulatory action taken under TSCA.   The alternatives assessment would build upon existing knowledge and would consider various exposed populations, including sensitive human subpopulations, as well as environmental exposure.   The work will begin in 2011, with completion expected in 2013.

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Follow the Green Chemistry Law Report for future updates on EPA’s contemplated actions for these chemicals.

House of Representatives Introduces Bill to Modernize TSCA

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TSCA Reform:

On July 22, Representatives Bobby Rush (D-IL), Chair of the Subcommittee on Commerce, Trade, and Consumer Protection, and Henry Waxman (D-CA), Chair of the Energy and Commerce Committee, introduced the Toxic Chemicals Safety Act of 2010 (H.R. 5820) (“TCSA,” confusingly similar to the acronym of the current statute).  The bill is intended to modernize the current Toxic Substances Control Act (“TSCA”).  The introduced bill is different in many respects from the discussion draft the Representatives circulated back in April.  In some instances the introduced bill is better and in others it is worse.   A short summary of the bill, provided by the House Committee on Energy and Commerce, is set out below.   A more detailed analysis will be available in a future posting on the Green Chemistry Law Report.

According to the House Committee, the bill would:

  • Establish a framework to ensure that all chemical substances to which the American people are exposed will be reviewed for safety and restricted where necessary to protect public health and the environment;
  • Require the chemical industry to develop and provide to the U.S. Environmental Protection Agency (EPA) essential data, and improve EPA’s authority to compel testing where necessary;
  • Ensure that non-confidential information submitted to EPA is shared with the public and that critical confidential information is shared among regulators, with states, and with workers in the chemical industry;
  • Establish an expedited process for EPA to reduce exposure to chemical substances that are known to be persistent, bioaccumulative, and toxic;
  • Create incentives and a review process for safer alternatives to existing chemicals, promoting innovation and investment in green chemistry;
  • Create a workforce education and training program in green chemistry, promoting and ensuring long-term viability of American jobs;
  • Encourage the reduction of the use of animals in chemical testing;
  • Allow EPA to exempt chemicals already known to be safe from requirements of the TCSA;
  • Promote research to advance understanding of children’s vulnerability to the harms of chemicals;
  • Direct EPA to address community exposures to toxic chemicals in certain “hot spot” locations;
  • Require EPA to engage in international efforts to control dangerous chemicals;
  • Ensure that EPA actions are transparent, open to public comment, and subject to judicial review, without unreasonable procedural burdens; and
  • Give EPA the resources needed to carry out the TCSA.

Key documents, including a copy of the bill, are available here.

EPA Promulgates Direct Final SNURs under TSCA for Seventeen Chemicals

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TSCA:

On June 24, 2010, EPA promulgated significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances
Control Act (TSCA) for 17 chemical substances that were the subject of premanufacture notices (PMNs), the type of notice submitted prior to manufacturing or importing a “new chemical” for commercial purposes.  The Federal Register notice announcing the SNURs can be found at 75 Fed. Reg. 35977.

Two of the substances are subject to ‘‘risk-based’’ consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the substances may present unreasonable risks to human health or the environment.  The SNURs for these two substances are based on and consistent with the provisions in the underlying consent orders.  The 5(e) SNURs designate as a ‘‘significant new use’’ the absence of the protective measures required in the corresponding consent orders.

The other 15 substances are not subject to consent orders under section 5(e).  EPA did not find that the use scenarios described in their PMNs triggered the determinations set forth under TSCA section 5(e).  Nonetheless, the Agency concluded that certain changes from the use scenarios could result in increased exposures potentially causing adverse human health or environmental effects, or both, and thereby would constitute ‘‘significant new uses.’’

The Agency used its direct final rulemaking procedure to promulgate the SNURs, which means the rules will become effective on August 23, 2010, if EPA does not receive by July 26, 2010, written adverse or critical comments, or notice of intent to submit such comments.  In that instance, EPA would withdraw the SNUR for the substance(s) for which it received comments or notices, and instead it would issue a proposed SNUR and provide a 30-day public comment period.

A short overview of each substance, and the next steps some companies will likely consider, are set out below.

Overview of the Chemicals Affected

Persons who intend to manufacture, import, or process any of these 17 substances for an activity that is designated as a significant new use are required to notify EPA at least 90 days before commencing that activity. The required notification will give EPA the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

Each substance is listed below – typically with a generic name to protect Confidential Business Information (CBI) – along with the Code of Federal Regulations (CFR) citation to its respective SNUR, the PMN number, and the use(s) identified in its PMN.

  • Aliphatic triamine (generic). CAS number not available.  PMN Number P–02–996.  Will be used as a monomer for polymers with amide or imide links; a crosslinker for epoxy type coatings, adhesives and sealants; a crosslinker for epoxy type composites; a monomer for urea and urethane urea polymers used in coatings; a chemical intermediate for functional chemicals: amides, imides; a chemical intermediate for functional chemicals: isocyanates, salts; and a chemical intermediate for functional chemicals: cyclic amines, etc..  SNUR to be codified at 40 CFR § 721.10184.

  • 1,2-Propanediol, 3-(diethylamino)-, polymers with 5-isocyanato-1- (isocyanatomethyl)-1,3,3-trimethylcyclohexane, propylene glycol and reduced Me esters of reduced polymd. oxidized tetrafluoroethylene, 2-ethyl-1-hexanol-blocked, acetates (salts). CAS number: 328389–90–8.  PMN Number P–03–106.  Will be used as a surface treatment agent.  SNUR to be codified at 40 CFR § 721.10185.

  • Ethylhexyl oxetane (generic). CAS number not available.  PMN P–04–132.  Will be used as an additive for industrial applications.  SNUR to be codified at 40 CFR § 721.10186.

  • 4-Morpholinepropanamine, N-(1,3-dimethylbutylidene)-. CAS No. 1003863–30–6.  PMN P–05–186.  Will be used as a curing agent for epoxy coating systems.  SNUR to be codified at 40 CFR § 721.10187.

  • Fatty acids, tall-oil, reaction products with 4-methyl-2-pentanone and aliphatic polyamine (generic). CAS number not available.  PMN P–05–186.  Will be used as a curing agent for epoxy coating systems.  SNUR to be codified at 40 CFR § 721.10188.

  • Fatty acids, tall-oil, reaction products with (butoxymethyl) oxirane formaldehyde-phenol polymer glycidyl ether, morpholinepropanamine, propylene glycol diamine and aliphatic polyamine, N-(1,3 -dimethylbutylidene) derivs (generic). CAS number not available.  PMN P–05–186.  Will be used as a curing agent for epoxy coating systems.  SNUR to be codified at 40 CFR § 721.10189.

  • Formaldehyde, polymer with aliphatic diamine and phenol, reaction products with 4-methyl-2-pentanone (generic). CAS number not available.  PMN P–05–186.  Will be used as a curing agent for epoxy coating systems.  SNUR to be codified at 40 CFR § 721.10190.

  • Amides, coco, N-[3-(dibutylamino)propyl]. CAS No. 851544–20–2.  PMN P–06–262.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10191.

  • Amides, coco, N-[3-(dibutylamino)propyl], acrylates. CAS No. 851545–09–0.  PMN P–06–263.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10192.

  • 1-Butanaminium, N-(3-aminopropyl)-N-butyl-N-(2-carboxyethyl)-,N-coco acyl derivs., inner salts. CAS No. 851545–17–0.   PMN P–06–263.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10193.

  • Dialkylcocoamidoalkylpropionate (generic). CAS number not available.  PMN P–06–264.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10194.

  • Dialkylcornoilamidoalkylamine (generic). CAS number not available.  PMN P–06–265.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10195.

  • Dialkylcornoilamidoacrylate (generic). CAS number not available.  PMN P–06–266.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10196.

  • Dialkycornoilamidoalkylbetaine (generic). CAS number not available.  PMN P–06–266.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10197.

  • Dialkylcornoilamidopropionate (generic). CAS number not available.  PMN P–06–267.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10198.

  • Substituted aliphatic amine (generic). CAS number not available.  PMN P–06–702.  Will be used as a polymer curative.  SNUR to be codified at 40 CFR § 721.10199.

  • Benzenacetonitrile, cyclohexylidene-alkyl substituted (generic). CAS number not available. PMN P–09–75.  Will be used as a component of odorant compositions for highly dispersive applications..  SNUR to be codified at 40 CFR § 721.10200.

Next Steps

First, many companies are probably determining whether they currently manufacture, import, or process any of these substances, or have plans to do so in the future.   If so, they may be assessing whether and how these rules would affect their business and deciding whether to submit comments to EPA by the deadline noted above.

Second, companies that import any of these substances are likely confirming that they are prepared to make the necessary import certifications.  TSCA section 13 (15 U.S.C. 2612) requires importers to certify that each shipment of a chemical substance complies with all applicable rules and orders under TSCA.  Importers of chemical substances subject to a final SNUR must certify their compliance with the SNUR requirements.  The import certification requirements are set out in the regulations at 19 CFR 12.118 – 12.127, and 127.28 (the corresponding EPA policy is codified at 40 CFR part 707, subpart B).

Lastly, companies may also be confirming that they are prepared to make the necessary export certifications.  In general, any person who exports or intends to export a chemical substance that is the subject of a proposed or final SNUR is subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and the regulations at 40 CFR part 707, subpart D. The export notification requirements apply even when a company does not manufacture, import, or process the substance in a manner restricted by the SNUR.  The notification requirement applies regardless of whether the company is required to take any action under the SNUR.

Review of the ABA Conference: "Chemicals Regulation: REACHing for TSCA Reform"

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TSCA Reform, Green Chemistry:

Last week, on Friday, June 11, I attended the ABA conference: “Chemicals Regulation:  REACHing for TSCA Reform.”  In my opinion, the conference was a success.  It was well-attended by a range of stakeholders and the speakers’ topics were generally interesting.  Blake Biles did a fantastic job in his opening remarks setting the context in which TSCA was passed in 1976 and the challenges that EPA has faced implementing the statue.  All in all, I think the conference was worth the investment.

The conference provided a brief overview of the Congressional bills to modify TSCA and more detail regarding the role of states in chemicals regulation, the recent green chemistry initiatives, and some of the legal issues that go beyond regulatory compliance.  If anyone would like a copy of the agenda, which includes a biography (of sorts) of supplementary reading material, please let me know.  The suite of conference materials is probably available from the ABA.

I was a little disappointed that the speakers did not cover the mechanics of the new bills in any detail, however.  Presumably this was because they felt that it was premature to do so. In other words, they probably expect the final legislation to differ from what’s currently proposed. Based on what I’m hearing, I would generally agree with that conclusion. However, the recent convergence of chemical industry executives on Capitol Hill suggests that there may be some residual concern about the bills passing this session in something similar to their present form, so more discussion of the mechanics would have been helpful to some attendees, I’m sure.

TSCA CBI – New Practices Adopted at EPA While Further Changes Are Debated in Congress

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TSCA, TSCA Reform: 

Confidential Business Information (CBI) continues to be a focal point of the debates over improving implementation of the current version of TSCA, as well as amending the statute.  Here’s a short update on where those debates currently stand.

EPA Adopts New Practices under TSCA

On May 27, 2009, EPA announced in a Federal Register notice that the Agency will begin a “general practice” of reviewing CBI claims for chemical identities in health and safety studies and related data, submitted under TSCA in accordance with EPA regulations at 40 C.F.R. Part 2, Subpart B.  According to the notice, “Section 14(b) of TSCA does not extend confidential treatment to health and safety studies, or data from health and safety studies, which, if made public, would not disclose processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.” If the chemical identity does not clearly reveal mixture portions or process information, EPA is unlikely to find the information eligible for confidential treatment.  EPA will apply its new practice to both newly submitted and existing claims, beginning August 25, 2010. 

Stakeholders supporting or opposing this new practice are likely to submit comments to the Agency in advance of the August implementation.

Congressional Debate over the Bills to Modernize TSCA

Both the Senate and House bills would revise and narrow the protections for CBI.  The bills would require all CBI claims to be justified up front.  EPA would have to review the claims within a prescribed time period.  Only those that withstood the review – applying standards that EPA would adopt within one year of enactment of the legislation – would be eligible for protection.  Approved claims would receive protection for up to five years. 

Similar to the current version of Section 14, the bills would not allow “the release of any data which discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the release of data disclosing the portion of the mixture comprised by any of the chemical substances in the mixture.” Nonetheless, the chemical industry remains concerned about the negative impact the new CBI provisions would have on innovation, jobs, and the U.S. industry’s general competitiveness.   ICIS reports that the CEOs from 30 different chemical companies planned to meet this past Wednesday with 50 different members of Congress or their staff to discuss the bills, and the CBI provisions concerning chemical identities were on the top of their list of concerns. 

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Watch for future postings as the debates over CBI evolve.

 

Upcoming ABA-UM Law Conference on TSCA Reform in Baltimore, MD

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TSCA Reform:

38th National Spring Conference on the Environment

Chemicals Regulation: REACHing For TSCA Reform

Date:   June 11, 2010

Enacted in 1976, the Toxic Substance Control Act (TSCA) is the primary means by which the United States regulates commercial chemicals. Although intended to be ambitious in scope, TSCA has proven to be a poor regulatory framework and generally is considered inadequate. In the 33 years since its enactment, advances in toxicology and analytical chemistry have raised new questions about the effects of certain chemicals on human health and the environment. These questions have left the public anxious and confused about the safety of myriad different products. Technology seems to have outstripped the regulatory regime.

There is a growing national consensus that the United States needs to modernize its chemical management law. In recent years, individual states have entered what they perceive to be a regulatory vacuum, raising the prospect of an inconsistent regulatory patchwork. The European Union’s recently enacted REACH initiative has dramatically expanded the regulatory compliance obligations for United States companies doing business in the EU. Moreover, the Obama Administration has identified risk-based chemical regulation as one of its environmental priorities. While affirming the Administration’s commitment to green innovation, U.S. EPA Administrator Lisa Jackson also has called on Congress to grant the Agency new enforcement authority and has proposed a new funding mechanism for generating the information necessary to assess chemical safety. Recent high-profile Congressional hearings also underscore the momentum for change. It is very likely that both Houses of Congress will take up the issue of TSCA reform in the next turn.

This 38th National Spring Conference on the Environment addresses the question of chemical management regulation. Featuring prominent federal, state, and private-sector experts at the center of the emerging proposals for TSCA reform, the day-long conference will provide a wide-ranging discussion about the unprecedented opportunities and challenges inherent in crafting a national regulatory framework capable of ensuring public and environmental safety while also promoting green-chemistry innovation. The conference will consider the legal implications of regulatory change and will focus on the key policy choices at the heart of the reform process.

Keynote presentations from the primary initiator of TSCA and the Senior U.S. EPA Policy Advisor responsible for the Agency’s current TSCA efforts will add unique and timely perspectives to this critical set of discussions.

Program Co-Chairs
Rebecca M. Bratspies • Sara K. Orr
Blake A. Biles

This conference is hosted by the University of Maryland of Maryland School of Law and takes place in the Ceremonial Moot Court Room at the Nathan Patz Law Center, 500 W. Baltimore Street, Baltimore, Maryland.

http://new.abanet.org/committees/environmental/Pages/38thNationalSpringConference.aspx

EPA Expands Public Access to Information on Chemicals

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TSCA:

On May 17, EPA issued a press release, announcing that it had added more than 6,300 chemicals and 3,800 facilities, regulated under the Toxic Substances Control Act (TSCA), to the public database known as Envirofacts.   The Agency said its action further demonstrated Administrator Lisa Jackson’s commitment to increasing public access to information on chemicals.   

The Envirofacts database is available on EPA’s website.  The database is designed to provide information on facility activities that may affect air, water, and land in the United States.   Included in the database is information such as facility name and address, aerial imagery, maps, and links to other records such as those available on the Agency’s Enforcement Compliance History Online (ECHO) database, which provides inspection and compliance reports.

In the press release, EPA stated that it has conducted a series of efforts to increase public access to chemical information including reducing confidentiality claims by industry and making the public portion of the TSCA inventory available for free on its website.  EPA supposedly intends to take additional actions in the months ahead to further increase the amount of information available to the public.  Additional details regarding EPA’s plans are available here.

I plan to continue following and reporting on EPA’s public-access initiative, as well as the confidential business information (CBI) provisions in the Congressional bills proposing to modify TSCA.  Stay tuned for future postings here at The Green Chemistry Law Report!

Bills to Modernize TSCA Could Advance Green Chemistry

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TSCA Reform, Green Chemistry:

As many readers know, the recent Senate and House bills to modernize TSCA include provisions to advance green chemistry.  However, funding and other potential obstacles could frustrate this objective.  A short summary of each provision is set out below.

Introduction

The Senate and House bills were released on April 15.  The Senate bill was introduced while the House bill remains a discussion draft.  Both bills include a section entitled, “Safer Alternatives and Green Chemistry and Engineering.”  (See sections 32 and 36 in the Senate and House versions, respectively.)  Each would establish a Safer Alternatives Program, a Green Chemistry Research Network, and a Green Chemistry and Engineering Research Grants Program.  The Senate version goes further and would establish a Green Chemistry Workforce Education and Training Program.  A short discussion of each of these is set out below.

What is Green Chemistry?

Although neither bill defines green chemistry, EPA’s current definition would likely inform its future implementation of either proposal, if enacted into law.  According to EPA, green chemistry is “the design of chemical products and processes that reduce or eliminate the use or generation of hazardous substances.  Green chemistry applies across the life cycle of a chemical product, including its design, manufacture, and use.”  In other words, green chemistry is chemistry designed to reduce the environmental and human health impacts across a product’s lifecycle.  The Agency relies on 12 principles of green chemistry to clarify and implement its definition.  These principles were first established by Paul Anastas and John Warner in their book, Green Chemistry: Theory and Practice, Oxford University Press: New York (1998).

The Safer Alternatives Program

This program would require EPA, within one year of enactment of the law, “to create market incentives for the development of safer alternatives to existing chemical substances that reduce or avoid the use and generation of hazardous substances.”  The program would include at least three components: (1) expedited review of new chemicals for which an alternatives analysis indicates that the new chemical is the safer alternative for a particular use than existing chemicals used for the same purpose; (2) recognition, such as a special designation for marketing, or an award, for a chemical or product that EPA determines to be a safer alternative, and (3) other incentives EPA considers appropriate to encourage the development, marketing, and use of safer alternatives.

Of the three components of the Safer Alternatives Program, the expedited review of new chemicals seems the most promising from a near-term commercial perspective.  However, its ”success” – measured by the number of new, safer alternatives reaching the market in an expedited manner – may depend more on the complexity of the alternatives analysis and less on how “expedited” the review is once the Agency receives the analysis in a new chemical notification.  Under its Design for the Environment (DfE) Program, EPA has developed considerable expertise with alternatives assessment, so the Agency may be inclined to follow a similar approach in the Safer Alternatives Program.  Yet participating in the DfE alternatives assessment process can be time-consuming and expensive.  Accordingly, EPA faces a considerable challenge.  Specifically, the Agency must develop a framework for the alternatives analysis that is less expensive and time-consuming in terms of the minimum data set and analysis than a standard new chemical notification, but also enables the Agency to utilize its expertise in alternatives assessment to ensure that only truly safer chemicals are approved.  If EPA instead merely shortens its review period, and does not streamline the alternatives assessment, the objectives of the program may not be accomplished.  Thus, much depends on the Agency’s implementation.

The Green Chemistry Research Network

This program would consist of at least four green chemistry and engineering research centers, located in different regions throughout the United States, that would “support the development and adoption of safer alternatives” to potentially hazardous chemicals, particularly those included on the Section 6(a) priority list.  (In the bills, this is a rolling list of 300 chemicals that EPA would prioritize for risk assessments, called “safety determinations.”)

The Green Chemistry and Engineering Research Grants Program

This program would require EPA to make grants “to promote and support the research, development and adoption of safer alternatives….”  Funding is the Achilles’ heel of this program.

The Green Chemistry Workforce Education and Training Program

This program would require EPA to “facilitate the development of a workforce, including industrial and scientific workers, that produces safer alternatives to existing chemical substances.”  The goals of this program include the: (1) expansion of green chemistry; (2) development of scientific and technical leadership in green chemistry; (3) successful and safe integration of green chemistry into infrastructure projects; (4) informing communities about the benefits of green chemistry; and (5) promotion of innovation and strong public health and environmental protections.  To accomplish these objectives, EPA would be required to make grants, provide outreach, and form partnerships with educational institutions, training organizations, private sector companies, and community organizations.  Again, adequate funding is critical to success.

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All of these are laudable programs – and hopefully they will be included in some form in the final legislation – but, as noted above, there remain unanswered questions and the success of some of these programs depends on the ability and willingness of Congress to continue to provide adequate funding.

Legislation to Modernize TSCA

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TSCA Reform:

The U.S. Toxic Substances Control Act (TSCA) is the primary federal statute governing the safety of chemicals in U.S. commerce.  Revising the statute has been debated for many years, but there have been no substantial amendments since its enactment in 1976.  However, it now seems probable that Congress will enact new legislation modernizing TSCA.

On April 15, 2010, Frank R. Lautenberg (D-NJ), chair of the Senate Subcommittee on Superfund, Toxics and Environmental Health, introduced the “Safe Chemicals Act of 2010.” On the same date, Representatives Bobby Rush (D-IL) and Henry Waxman (D-CA) of the House Energy and Commerce Committee released a discussion draft of their legislation, the “Toxics Chemicals Safety Act of 2010.”

Senator Lautenberg’s legislation would amend TSCA to, among other things:

  • require manufacturers to develop and submit a minimum data set for each chemical that they produce;
  • provide EPA the authority to request additional data from a manufacturer when the Agency believes the information is necessary to determine the safety of a chemical;
  • require EPA to use the data to identify and prioritize chemicals by their likely risk;
  • require expedited action by EPA to reduce risk from chemicals of highest concern;
  • require that a safety threshold is met for chemicals to enter or remain in commerce, shifting the burden of proof to manufacturers to demonstrate safety;
  • establish a public database that would include chemical information submitted to EPA and the Agency’s determinations regarding safety;
  • promote green chemistry and foster the development of “safer” chemical alternatives; and
  • narrow the conditions under which data could be claimed as Confidential Business Information (CBI), expand access to CBI for certain stakeholders, and limit the duration of confidentiality.

Over the coming months, stakeholders will have an opportunity to review the proposals and discuss their various elements with key decision-makers.  It is too early to tell whether a consensus can be reached on key issues, but the outcome may well depend on the willingness of the sponsors to seek meaningful bipartisan support for the legislation.  Copies of the bills, summaries, and other related information are available at the links below: