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Update on EPA’s Recent and Forthcoming Chemical Action Plans Under TSCA

Beveridge & Diamond, P.C., April 12, 2010

On March 29, 2010, EPA released its chemical action plan (“CAP”) for bisphenol A (“BPA”), describing steps EPA will take to manage environmental concerns.1  Shortly beforehand, on March 17, 2010, EPA announced that it was adding four chemicals or groups of chemicals to its CAP development schedule: nonylphenol/nonylphenol ethoxylates, hexabromocyclododecane (“HBCD”), siloxanes, and diisocyanates.2  A CAP for benzidine dyes and pigments is anticipated shortly, as they, like BPA, were on EPA’s original list of target chemicals. 

These CAPs, which follow four others released on December 30, 2009,3 are core components of EPA’s efforts, announced on September 29, 2009, to enhance its chemicals management program under the Toxic Substances Control Act (TSCA).4  While the plans will have direct and important impacts on a number of supply chains, they also reflect a broader policy shift complemented by EPA’s concurrent efforts to promote reform of TSCA.5  This alert reviews the BPA CAP, previews the next five forthcoming CAPs, and provides context for chemical manufacturers, importers, processors and users who may be impacted to some degree. 

Background and Selection of Chemicals

EPA’s comprehensive approach to “Enhancing EPA’s Chemicals Management Program” follows repeated statements from EPA Administrator Lisa Jackson and others that chemical safety would be a top priority for the Agency, in light of their view that TSCA has proven “inadequate” over time.  “The most important component” of these efforts, according to EPA, is “identifying chemicals that pose a concern to the public, moving quickly to evaluate them and determine what actions need to be taken to address the risks they may pose, [and] initiating appropriate action,” including through the CAPs.6

Administrator Jackson has also initiated actions increasing transparency at the Agency, such as by posting the non-confidential TSCA Inventory for free online on March 15, 2009.7  However, EPA’s selection of chemicals for CAP development has been somewhat controversial for its level of transparency and the absence of stakeholder dialogue.  EPA’s website for its approach to enhance its current chemicals management program under TSCA originally contained (as of September 30, 2009) an assertion that the Agency would “initiate a stakeholder dialogue to address the prioritization of chemicals for future risk management action” and would “formally engage stakeholders and the public in this discussion,” but this language has since been dropped from the website without explanation.8 

BPA Action Plan

BPA is a key component of polycarbonate and epoxy resins widely used in consumer and industrial applications.  It is a suspected endocrine disruptor, based mainly on animal tests.9  A recently released biomonitoring study, the Centers for Disease Control’s Fourth National Report on Human Exposure to Environmental Chemicals, found BPA to be present at detectable levels in a large portion of the U.S. population.10 

Despite Administrator Jackson’s earlier speech remarking on risks from BPA “in baby bottles,”11 the BPA CAP recognizes that most human exposure to BPA is from food contact substances, which fall under the jurisdiction of the Food and Drug Administration (“FDA”) rather than EPA.  FDA announced its new concerns and efforts regarding BPA on January 15, 2010,12 and on April 5, 2010, FDA released for comment a set of scientific study reviews and exposure estimates relating to food contact materials made with BPA.13  EPA’s CAP, therefore, largely focuses on potential environmental effects instead of human health.  This shift potentially expands the scope of industries that may be affected, because BPA enters the environment from non-food-contact uses as well as from food-contact uses. 

The CAP reviews EPA’s current knowledge of the uses, hazards, exposure profiles, and risk management history for BPA, citing federal, state, academic, and international reviews.14  The CAP concludes by proposing the following information-gathering and control actions:

  • Issuing a proposed rule in late 2010 to add BPA to the “Concern List” under TSCA section 5(b)(4) on the basis of its potential for chronic effects on aquatic species.  The Concern List provisions have never before been used, although EPA also proposed adding other chemicals to the list in its December 2009 CAPs for phthalates and polybrominated diphenyl ethers (“PBDEs”).  Under section 5(b)(4), EPA may compile a list of chemical substances for which it finds that the manufacture, processing, distribution, use, or disposal may present an unreasonable risk of injury to health or the environment.  Once a chemical is on the Concern List, data requirements for premanufacture or significant new use notices are increased; export notification provisions of TSCA section 12 apply; and EPA can, by rule, require small businesses to submit reports from which they are otherwise exempt.  However, it is widely expected that the main impact will be on the markets for the listed chemicals and products that contain them. 
  • Issuing a proposed  rule in late 2010 to require environmental effects testing and exposure/concentration monitoring under TSCA section
    4(a). 
  • Using EPA’s Design for the Environment (“DfE”) program under the Pollution Prevention Act to analyze readily available alternatives that would reduce BPA uses and exposures in applications such as thermal and carbonless paper coatings, foundry castings, and pipe linings.

While the BPA CAP is focused on environmental effects, EPA continues to work closely with FDA on analyzing human health impacts.  EPA also states that it will continue to conduct its own evaluations of health impacts from non-food-packaging exposures to BPA. 

Other Chemical Action Plans On the Horizon

Benzidine Dyes and Pigments

The CAP for benzidine dyes and pigments is anticipated prior to those announced on March 17, 2010.  Benzidine dyes and pigments were originally announced in the September 29, 2009 rollout of EPA’s enhancements to its chemicals management program. 

Because they are considered carcinogenic, benzidine dyes and pigments have largely been phased out of U.S. commerce.  EPA issued a significant new use rule (“SNUR”) for a number of benzidine-based chemicals in the mid-1990s, recognizing that there was at that point “no ongoing manufacture, import, or processing, of the listed benzidine-based chemical substances, except for …  a few, limited purposes.”15  The forthcoming CAP for benzidine dyes and pigments therefore likely represents EPA’s efforts to “pick the low-hanging fruit” by taking advantage of control efforts already taken for certain chemicals.  

Nonylphenol/nonylphenol ethoxylates (“NP/NPEs”)

Long-chain NPEs are common surfactants for which there is concern that they may degrade in the environment to short-chain NPEs or to NP, which in turn are suspected to pose both acute hazards to aquatic organisms and to disrupt their endocrine systems.  In 2007, a group of environmental non-governmental organizations including the Sierra Club petitioned EPA to initiate data gathering and chemical control rulemaking proceedings under TSCA sections 4 and 6, respectively.  EPA granted only certain aspects of the petitioners’ section 4 test rule request, and the groups sued EPA.16  After the parties settled, EPA issued an advance notice of proposed rulemaking on June 17, 2009, requesting comment on a test rule that would require aquatic and sediment toxicity testing and potentially other data gathering.17  The Fall 2009 Semiannual Regulatory Agenda indicated that a test rule may be proposed by the end of 2011.18  The forthcoming CAP is likely to refer to this rulemaking. 

Hexabromocyclododecane (“HBCD”)

HBCD is a brominated flame retardant used in some construction materials, electrical parts, and textiles.  It is anticipated to persist and bioaccumulate if released into the environment, and is suspected to have thyroid effects and possibly aquatic toxicity.19  It is also the subject of a forthcoming Integrated Risk Information System (“IRIS”) toxicological review.20  HBCD was assigned an initial risk-based “high priority” by EPA’s now-defunct Chemicals Assessment and Management Program (“ChAMP”).21

Siloxanes

Siloxanes are a broad class of chemicals used in a wide variety of industrial and consumer products.  Six siloxanes deemed representative of the class were the subject of a 1996 Memorandum of Understanding between EPA and Dow Corning Corporation.  Dow Corning agreed to a Product Stewardship Program, from which a set of data was released in 2009.22  Following the theme of selecting chemicals for which chemical management actions have already been taken, these six “representative” siloxanes are likely to be singled out in the upcoming CAP for siloxanes. 

Diisocyanates

Diisocyanates, most prominently methylene diphenyl diisocyanate (“MDI”), toluene diisocyanate (“TDI”), and hexamethylene diisocyanate (“HDI”), are used in the production of polyurethanes and in other applications.  Diisocyanates have been the subject of EPA toxicology profiles and protection recommendations,23 and HDI was tested under a consent order entered into in 1997.24 

Next Steps

At a recent chemical industry conference, GlobalChem 2010, Wendy Cleland-Hamnett, Director of the Office of Pollution Prevention and Toxics, announced that EPA intends to release twelve CAPs during 2010.  Both the identity of the chemicals that will be added to the CAP release schedule next, and exactly how those chemicals will be chosen by EPA, are currently unknown. 

For more information, please contact Mark Duvall, 202-789-6090, mduvall@bdlaw.com.  This alert was prepared with the assistance of Alexandra Wyatt.

For a printable PDF of this alert, please click here.


1 EPA, Bisphenol A Action Plan (March 29, 2010), http://www.epa.gov/
oppt/existingchemicals/pubs/actionplans/bpa_action_plan.pdf
.
2 EPA, Existing Chemical Action Plans, http://www.epa.gov/oppt/
existingchemicals/pubs/ecactionpln.html
.
3 Beveridge & Diamond, P.C., “EPA Issues Four Chemical Action Plans Under TSCA” (Jan. 5, 2010), http://www.bdlaw.com/news-764.html.
4 EPA, “EPA Administrator Jackson Unveils New Administration Framework for Chemical Management Reform in the United States” (Sep. 29, 2009), http://yosemite.epa.gov/opa/admpress.nsf/d0cf6618525a9efb
85257359003fb69d/d07993fdcf801c2285257640005d27a6!OpenDocument
.
5 See EPA, Essential Principles for Reform of Chemicals Management Legislation, http://www.epa.gov/oppt/existingchemicals/pubs/
principles.html
.
6 EPA, supra note 2.
7 EPA, “EPA Makes Chemical Information More Accessible to Public” (Mar. 15, 2010), http://yosemite.epa.gov/opa/admpress.nsf/e77fdd4f5
afd88a3852576b3005a604f/c7860ed6d012f9df852576e7006365b0!OpenDocument
.
8 While the language has been dropped from the main website, it is still available in a PDF at http://www.epa.gov/oppt/existingchemicals/
pubs/Existing.Chem.Fact.sheet.pdf
.
9 Beveridge & Diamond, P.C., Bisphenol A: A Hot Topic at FDA, EPA, States, and the Courts (Feb. 19, 2010), http://www.bdlaw.com/news-810.html.
10 See generally Beveridge & Diamond, P.C., TSCA Reform Efforts Turn to Biomonitoring Studies for Support (Feb. 12, 2010), http://www.bdlaw.com/
news-809.html
.
11 See, e.g., EPA Administrator Lisa Jackson, Remarks to the Commonwealth Club of San Francisco (Sep. 29, 2009), http://yosemite.epa.gov/opa/admpress.nsf/a883dc3da7094
f97852572a00065d7d8/fc4e2a8c05343b3285257640007081c5!OpenDocument
.
12 FDA, Update on Bisphenol A (BPA) for Use in Food, http://www.fda.
gov/NewsEvents/PublicHealthFocus/ucm064437.htm
.
13 75 Fed. Reg. 17145 (April 5, 2010), http://edocket.access.gpo.gov/
2010/pdf/2010-7511.pdf
.
14 The international reviews include: Environment Canada, Health Canada. Screening Assessment for the Challenge Phenol, 4,4' (1-methylethylidene)bis- (Bisphenol A) CAS 80-05-7 (Oct. 2008), http://www.ec.gc.ca/
substances/ese/eng/challenge/batch2/batch2_80-05-7_en.pdf
;
European Union, Updated Risk Assessment Report: Bisphenol A, http://ecb.jrc.ec.europa.eu/documents/Existing-Chemicals/RISK_
ASSESSMENT/REPORT/bisphenolareport325.pdf
; Japan National Institute of Advanced Industrial Science and Technology, Risk Assessment Document Series 4: Bisphenol A (2007), summary at http://unit.aist.go.jp/riss/
crm/mainmenu/BPA_Summary_English.pdf
.
15 61 Fed. Reg. 52287, 52288 (Oct. 7, 1996), http://www.epa.gov/EPA-TOX/1996/October/Day-07/pr-24192DIR/pr-24192.html; 40 C.F.R. § 721.1660.
16 See Beveridge & Diamond, P.C., Citizens’ Petitions Under TSCA Seek to Change EPA’s Agenda (Apr. 28, 2009), http://www.bdlaw.com/news-557.html.
17 74 Fed. Reg. 28654 (June 17, 2009), http://edocket.access.gpo.gov/
2009/E9-14250.htm

18 EPA, Semiannual Regulatory Agenda - Fall 2009, at 300-301, available at http://www.regulations.gov/public/component/main?main=UnifiedAgenda.
19 See, e.g., EPA, Initial Risk-Based Prioritization of High Production Volume Chemicals: HBCD (2008), http://www.epa.gov/hpvis/rbp/HBCD.3194556.
Web.RBP.31308.pdf
.
20 IRISTrack Report for Hexabromocyclododecane Assessment, http://cfpub.epa.gov/ncea/iristrac/index.cfm?fuseaction=viewChemical.showChemical&sw_id=1102.
21 Supra note 19.
22 74 Fed. Reg. 38013 (July 30, 2009), http://www.epa.gov/fedrgstr/EPA-TOX/2009/July/Day-30/t18195.pdf.
23 See EPA Design for the Environment Program, Isocyanates Profile, http://www.epa.gov/dfe/pubs/auto/profile/.
24 See 1,6-Hexamethylene Diisocyanate (HDI) Test Results, http://www.epa.gov/opptintr/chemtest/pubs/hexmetdc.html.

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