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TSCA Developments at EPA: Looking Back at 2012

Beveridge & Diamond, P.C., February 22, 2013

When Administrator Lisa Jackson’s term concluded on February 14, 2013, the Environmental Protection Agency had largely lived up to her incoming promise to make “managing chemical risks” a top priority. EPA’s efforts to enhance its chemicals management program expanded and refocused in February 2012, with the release of a new Existing Chemicals Program Strategy. This report summarizes a pivotal year for chemicals management in the United States and takes stock of EPA’s chemicals programs under the Toxic Substances Control Act (TSCA) at the conclusion of Lisa Jackson’s tenure as EPA Administrator.[1]

A.  Work Plan for Chemical Risk Assessment

In February 2012, EPA released an updated Existing Chemicals Program Strategy, highlighting risk assessment and risk reduction, data collection and screening, and public access to chemical data and information. The following month, EPA identified a “work plan” of 83 chemicals for further assessment.[2] Seven of the chemicals were scheduled for risk assessment in 2012. EPA published risk assessment peer review plans for those chemicals in August 2012. EPA also scheduled 18 more of the work plan chemicals for assessment in 2013 and 2014. EPA is accepting data from chemical manufacturers on those 18 chemicals and is placing the data it receives in the applicable docket.[3] EPA has stated that it intends to use work plan to help focus and direct the activities of its Existing Chemicals Program over the next several years. 

On January 4, 2013, EPA released five draft Work Plan Chemical risk assessments, focusing either on human health or ecological hazards for specific uses:

  • Antimony trioxide (ATO) as a synergist in halogenated flame retardants;
  • 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[?]-2-benzopyran (HHCB) as a fragrance ingredient in commercial and consumer products;
  • Methylene chloride or dichloromethane (DCM) in paint stripper products;
  • N-methylpyrrolidone (NMP) in paint stripper products; and
  • Trichloroethylene (TCE) as a degreaser and a spray-on protective coating.

Three of the draft risk assessments, for DCM, NMP, and TCE, indicate a potential concern for human health under specific exposure scenarios. The preliminary assessments for ATO and HHCB, however, indicate a low concern for ecological health. EPA is accepting comments on the five draft risk assessments through March 11, 2013. The draft risk assessments on long-chain and medium-chain chlorinated paraffins, the final two chemicals in the initial review group of seven, will be released for public comment through a separate Federal Register notice when they are complete.

EPA’s adoption of a work plan was intended to respond to criticisms regarding the transparency of chemical screening, selection, and assessment earlier in the Obama Administration as well as the pace of chemical reviews. While the work plan and resulting assessments continue to be criticized from numerous angles, they are generally considered an improvement over the previous use of action plans to address individual chemicals (or groups of related chemicals) deemed by EPA to be of concern.

B.  Action Plan Chemicals

Despite the shift to the work plan strategy, EPA continued in 2012 to work through the first iteration of its Enhanced Chemicals Management Program strategy for existing chemicals, the Chemical Action Plans. The ten issued action plans are in the midst of implementation; one more, for siloxanes, is still identified on EPA’s website as being under development.[4] EPA’s proposal to add a number of action plan chemicals to a “chemicals of concern” list under TSCA section 5(b)(4) has not been released by the White House Office of Management and Budget (OMB) where it has been held “under review” for more than two years,[5] and that proposal did not appear in EPA’s most recent Regulatory Agenda issued in December 2012.[6] Other developments relating to action plan chemicals since our previous report in March 2012 include the following:

  • Polybrominated Diphenyl Ethers (PBDEs): As summarized in our previous report on EPA actions under TSCA, EPA proposed a significant new use rule (SNUR) in March 2012 to designate the manufacture (including import) or processing of the flame retardant decaBDE or articles containing decaBDE for any use which is not ongoing after the end of 2013 as a significant new use. In addition, in the same action, EPA proposed a section 4 test rule to require any person who manufactures or processes commercial pentaBDE, octaBDE, or decaBDE, including in articles, for any use after the end of 2013 to conduct testing on their effects on health and the environment.

    This PBDEs proposal, in particular its extraordinary provisions imposing SNUR obligations on importers of articles, has generated intense continuing discussion. EPA extended the comment period for the rule until July 31, 2012.[7] EPA posted an important draft alternatives assessment for decaBDE on the day before the close of the comment period.[8] Various industry stakeholder groups have objected to EPA’s proposal for failure to gather sufficient information from industry and other affected federal agencies prior to release of the proposal, insufficient accounting for replacement parts and recycling, over-breadth beyond consumer exposures, and other issues. On the other hand, on July 9, 2012, 26 Senators wrote a letter to EPA Administrator Lisa Jackson supporting these and other aspects of the PBDEs Action Plan,[9] and PBDEs were a focus of EPA’s remarks at the hearing on the Safe Chemicals Act on July 24, 2012.[10]
  • Long-Chain Perfluorinated Chemicals: On August 15, 2012, EPA published a proposed SNUR for both classes of PFCs, perfluoroalkyl sulfonates and long-chain perfluoroalkyl carboxylates.[11] For the latter, EPA would not apply the articles exemption that is usually applied to SNURs and would designate uses in carpeting as a significant new use.
  • Bisphenol A (BPA): Through its DfE program, on July 31, 2012, EPA released a draft alternatives assessment for BPA in thermal paper.[12] The comment period on the draft closed in October 2012.

C.  Other Regulatory Information Gathering and Risk Management Actions

The Enhanced Chemicals Management Program identified several high profile chemicals for regulatory action in coordination with other EPA programs and agencies. Since our previous report in March 2012, the pace of EPA actions on these chemicals has slowed somewhat. In May 2012, EPA issued a SNUR for the use of elemental mercury in barometers and certain other meter devices, effective June 29, 2012.[13] Also in May 2012, EPA held a public meeting on a proposed test rule and SNUR for the fourth and final group of high production volume chemical substances.[14] Proposed formaldehyde emissions standards for composite wood products have still not yet been issued, although they are expected in early 2013.[15] In December 2012, EPA proposed an interpretation of the polychlorinated biphenyl (PCB) regulations that would generally allow for recycling of plastic separated from automobile and other shredder residue, and received generally supportive comments from industry but some opposition from NGOs.[16]

For other chemicals, in fiscal year 2012 EPA issued a net 304 SNURs as information-gathering and risk management measures, and has issued a net 96 SNURs in FY 2013 to date. When EPA issues a SNUR, manufacturers, processors, and sometimes others depending on the specific rule, must notify EPA before engaging in designated “uses,” broadly defined to include production quantities, worksite practices, disposal methods, and more. The notice requirement serves not only to dissuade companies from engaging in the designated uses, but also to provide EPA the opportunity under section 5(e) to object or impose restrictions if a company does give notice.

EPA’s policies for confidential business information (CBI) are a focus of attention for both existing and new chemicals. A proposed rule change targeting CBI in health is still shown on the OMB website as being under review, but does not appear in EPA’s Fall 2012 Regulatory Agenda that was released in December 2012.[17] The proposal would have built on a 2010 policy to increase review and limit CBI protections for chemical identities in health and safety studies. Chemical manufacturers and other importers, along with environmental organizations, have had a number of meetings and communications with EPA on this topic.

D.  Conclusion

The last year of Lisa Jackson’s tenure as Administrator saw a shift in EPA’s implementation of her chemicals management priority. The main locus of the shift was the release of EPA’s Existing Chemicals Program Strategy and its accompanying shift from a handful of single chemical risk management action plans to a more methodical work plan for several dozen chemicals. However, the continued emphasis on SNURs is another indicator of EPA’s intention to use its existing authority under TSCA more aggressively. As shown by its busy past year, EPA has certainly kept to Lisa Jackson’s promise to prioritize chemicals management, and it looks poised to continue to do so.

As discussed in the accompanying reports,[18] the groundwork laid in 2012 will form the basis for EPA’s activities during President Obama’s second term. It will also influence the direction of Congress’s maneuvering to shape and potentially pass legislation to modernize TSCA’s chemicals management framework.

For more information about TSCA developments in Congress and at EPA, please contact Mark Duvall, mduvall@bdlaw.com, or Alexandra Wyatt, awyatt@bdlaw.com.

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


[1] For previous developments, see Beveridge & Diamond, P.C., “EPA Targets Articles Containing Action Plan Chemicals” (April 4, 2012), http://www.bdlaw.com/news-1327.html; Beveridge & Diamond, P.C., “Update on TSCA Developments in Congress and at EPA” (March 22, 2012), http://www.bdlaw.com/news-1328.html; Beveridge & Diamond, P.C., “TSCA Developments in Congress and at EPA” (Aug. 11, 2011), http://www.bdlaw.com/news-1193.html.

[2] See generally EPA, TSCA Work Plan Chemicals, http://www.epa.gov/opptintr/existingchemicals/pubs/workplans.html.

[3] See EPA Docket EPA-HQ-OPPT-2011-0516, “Selecting Chemicals for Priority Review Under TSCA,” http://www.regulations.gov/#!docketBrowser;dct=PS;rpp=25;po=0;D=EPA-HQ-OPPT-2011-0516.

[4] EPA, Existing Chemical Action Plans, http://www.epa.gov/opptintr/existingchemicals/pubs/ecactionpln.html.

[5] OMB Regulatory Review Page for TSCA Chemicals of Concern List Under Section 5(b)(4) of the Toxic Substances Control Act, http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201010&RIN=2070-AJ70.

[6] EPA, Semiannual Regulatory Agenda - Fall 2012 (Dec. 24, 2012), available at  http://resources.regulations.gov/ public/ContentViewer?objectId=090000648119910f&disposition=attachment&contentType=pdf.

[7] 77 Fed. Reg. 30972 (May 24, 2012) (extending comment period through July 2012).

[8] EPA, An Alternatives Assessment for the Flame Retardant Decabromodiphenyl Ether (July 2012), http://www.epa.gov/oppt/dfe/pubs/projects/decaBDE/deca_fullreport.pdf.

[9] Letter from Senator Lautenberg and others to Lisa Jackson re PBDEs (July 9, 2012), available at http://www.lautenberg.senate.gov/assets/pbde.pdf.

[10] See Testimony of James J. Jones, EPA, before Senate Committee on Environment and Public Works (July 24, 2012), available at http://epw.senate.gov/public/index.cfm?FuseAction=Files.View&FileStore_id=bef3d3ec-ff01-4d25-b0bd-ce38fb37edb3.

[11] 77 Fed. Reg. 48924 (Aug. 15, 2012).

[12] EPA, Bisphenol A Alternatives in Thermal Paper – Draft for Public Comment (July 2012), http://www.epa.gov/opptintr/existingchemicals/pubs/actionplans/aa-for-bpa-full-version.pdf.

[13] 77 Fed. Reg. 31728 (May 30, 2012).

[14] 77 Fed. Reg. 21065 (Apr. 9, 2012).

[15] See OMB Regulatory Dashboard, http://www.reginfo.gov/public/jsp/EO/eoDashboard.jsp.

[16] 77 Fed. Reg. 74006 (Dec. 12, 2012); EPA Docket EPA-HQ-OPPT-2012-0902, http://www.regulations.gov/#!docketDetail;D=EPA-HQ-OPPT-2012-0902.

[17] EPA, Semiannual Regulatory Agenda - Fall 2012, supra note 6; OMB RIN 2070-AJ87, “CBI: PMN Amendments Claiming Chemical and Microorganism Identity as Confidential in Data From Health and Safety Studies Submitted Under TSCA Prior to the Commencement of Manufacture,” http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201110&RIN=2070-AJ87.

[18]

See Beveridge & Diamond, P.C., "TSCA Modernization Proposals in Congress: Recent History and Prospects" (Feb. 25, 2013), available at http://www.bdlaw.com/news-1447.html; Beveridge & Diamond, P.C., "TSCA Implementation at EPA: Looking Ahead" (Feb. 22, 2013), available at http://www.bdlaw.com/news-1444.html

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