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EPA Focuses on Chemicals in Articles With Expected PBDEs SNUR

Beveridge & Diamond, P.C., January 28, 2011

The Environmental Protection Agency (EPA) is preparing to propose to amend a significant new use rule (SNUR) for certain polybrominated diphenyl ethers (PBDEs) that would, unlike the vast majority of SNURs to date, restrict the importation of articles containing the target chemicals.  The forthcoming SNUR amendment proposal, along with a test rule to be proposed around the same time, will further commitments made by EPA in its PBDEs chemical action plan issued under the Toxic Substances Control Act (TSCA).1  While the PBDEs SNUR amendments will have important direct impacts on a number of industry sectors, it is also important as a possible harbinger of a shift by EPA toward greater regulation of chemicals in articles or products. 

1.        TSCA and Articles

TSCA gives EPA authority to regulate chemical substances, including those contained in articles.  TSCA refers specifically to articles in several provisions.2  (TSCA does not define “article,” but EPA has adopted several similar definitions.3)  Nevertheless, EPA has chosen to adopt administrative exemptions from many of its provisions for chemicals in articles, including general information-gathering rules,4 export notifications,5 import notifications,6 Inventory Update Rule reporting,7 premanufacture notifications (PMNs),8 SNURs,9 and restrictions on use of certain chemicals regulated under section 6.10  EPA adopted these article exemptions largely due to concerns about the practical difficulties importers would have in finding out what chemical substances are in the articles they import.11  Nevertheless, EPA does retain the authority to regulate or require reporting on chemical substances in articles.

Much of the recent debate regarding chemicals management in the United States has focused on chemicals in products.  For example, when EPA Administrator Lisa Jackson announced the Obama Administration’s principles for TSCA reform in 2009, her speech cited chemical additives in cell phones, bisphenol A in baby bottles, phthalates in medical devices, and lead in toys.12 

Regulation of chemical substances in articles became a heightened topic of interest in 2010 due to the provisions of the two bills introduced to overhaul TSCA.  The Senate bill would have redefined the core term “chemical substance” to include “any chemical substance contained in or formed into an article.”13  The apparent purpose was to affirm that chemicals in articles are subject to TSCA.  The House bill would have gone further to prohibit administrative exemptions from EPA requirements under sections 4, 5, 6, or 8 of TSCA for chemical substances in articles.14

2.        Earlier EPA SNUR for PBDEs

PBDEs are a family of chemicals comprising a brominated diphenyl ether molecule attached to one to ten bromine atoms.  PBDEs, especially the three commercial PBDE mixtures c-pentaBDE, c-octaBDE, and c-decaBDE, have historically been widely used as flame retardants in electronics, vehicles, furniture, textiles, and a variety of other applications.  However, some PBDEs may be persistent, bioaccumulative, and toxic, especially the lower-brominated congeners.  Because of the potential risks of PBDEs as shown by animal studies, and the presence of PBDEs in human tissues as shown by biomonitoring studies, a number of countries and international bodies have instituted programs to severely restrict some of these chemicals.15 

In the United States, manufacture of penta- and octaBDE was phased out in 2004.  In 2006, EPA promulgated a SNUR for these chemicals—as well as for tetraBDE, hexaBDE, heptaBDE, and nonaBDE—in order to prevent recommencement of their domestic manufacture or import without prior notice to the Agency.16  A SNUR requires a manufacturer (including an importer) to notify EPA 90 days in advance of the designated “significant new use,” providing EPA with the opportunity to evaluate the intended use and, if necessary, to limit it before it occurs. 

The 2006 PBDEs SNUR incorporated the general SNUR provisions, including the standard exemption for chemicals processed or imported only as components of articles (i.e., manufactured products).17  EPA said that this exemption was necessary because the importation of articles containing PBDEs could be ongoing, and if this were the case, such importation could not be deemed “new” for a SNUR.18  The 2006 SNUR did not include decaBDE, which is still manufactured in the United States and which EPA believes may break down in the environment to more harmful congeners. 

3.        PBDEs Chemical Action Plan

Due to lingering concerns regarding decaBDE and other PBDEs in articles, EPA issued a PBDEs chemical action plan in 2009 as part of its efforts to enhance management of existing chemicals under TSCA.  The action plan called for amending the SNUR to address imports of penta- and octaBDE in articles.  It also called for continued efforts to phase out decaBDE, and a SNUR for decaBDE, including in articles; an alternatives analysis for decaBDE; and the addition of commercial PBDEs to the Concern List under TSCA section 5(b)(4) as chemicals that present or may present an unreasonable risk of injury to health or the environment.19  The action plan also called for a test rule for decaBDE under TSCA section 4.20

4.        Forthcoming Proposed SNUR Amendments

The Office of Management and Budget began its 90-day regulatory review of the SNUR amendments proposal on December 17, 2010, with an indication that EPA plans to publish it in March 2011.21  The chemical action plan had predicted publication of a proposed SNUR in 2010.

The amendments will need to address the issue of any ongoing importation of articles containing the PBDEs, since a SNUR can only apply to uses that are “new.”  In promulgating the original SNUR, EPA had considered applying the SNUR to PBDEs in articles, but ultimately decided not to do so, saying:

EPA may not issue a SNUR covering as a significant new use import of the subject PBDEs as a part of articles for any use if that activity is ongoing.  EPA received no comments on the proposed rule suggesting import of the subject PBDEs as a part of articles was ongoing.  However, comments received from the Polyurethane Foam Association (PFA) after the close of the comment period for the proposed rule indicate the potential for presence of the subject PBDEs in imported articles.22

The chemical action plan stated that while “it does not appear that [penta- or octaBDE] treated articles are currently being imported,” EPA recognizes that “imported articles treated with c-pentaBDE and c-octaBDE could be a source of human and environmental exposure to these PBDE congeners.”23  According to the chemical action plan, importation of decaBDE-treated articles is even more likely to be ongoing, despite the voluntary phase-out agreed to in December 2009 by its main U.S. manufacturers and importer.24 

The SNUR amendments are based in part on EPA’s belief that that there may be suitable alternatives for all of the major uses of PBDEs.  However, concerns have been raised regarding the safety of replacements for PBDEs, especially certain new brominated and chlorinated flame retardants.25  (PBDEs themselves were replacements for other hazardous flame retardants used in the 1970s.26)

5.        Analysis:  EPA Regulation of Chemicals in Products

The PBDEs SNUR amendments exemplify a broadening of EPA’s regulatory focus from just industrial chemicals as such to chemicals in consumer products in the United States. 

To date, EPA has issued very few SNURs that waive the articles exemption contained in TSCA’s general SNUR provisions.  These include SNURs for elemental mercury,27 erionite fiber,28 and a chemical formerly covered by a SNUR that has been revoked.29  Thus, the PBDEs SNUR amendments would not be unique in addressing articles, but they would be notable in this regard.

Other chemical action plans also call for regulatory action addressed to chemical substances in articles, including those for long-chain perfluorinated chemicals,30 benzidine dyes,31 hexabromocyclododecane,32 and nonylphenol and nonylphenol ethoxylates.33

EPA is not alone in regulating chemicals in articles.  For example, the Consumer Product Safety Improvement Act of 2008 (CPSIA) banned the sale of children’s toys or child care articles containing more than 0.1% of certain phthalates34 and children’s products containing lead above certain thresholds.35  The Consumer Product Safety Commission was asked recently to restrict cadmium in children’s products,36 although it decided to recommend a voluntary standard instead.37  Furthermore, many states are regulating consumer products containing chemicals of concern.

In light of these pressures, the promulgation of SNURs and other rules without the standard TSCA articles exemption may become less of a rarity. 

For more information, please contact Mark Duvall at mduvall@bdlaw.com or Alexandra Wyatt at awyatt@bdlaw.com.

For a printable PDF of this article, please click here


1 See Beveridge & Diamond, P.C., “EPA Issues Four Chemical action plans Under TSCA” (Jan. 5, 2010), http://www.bdlaw.com/news-764.html; EPA, Polybrominated Diphenyl Ethers (PBDEs) Action Plan (Dec. 30, 2009), http://www.epa.gov/oppt/existingchemicals/pubs/pbdes_ap_2009_1230
_final.pdf
.

2 E.g., TSCA §§ 2(4) (definition of “distribute in commerce"), 5(d)(1)(B) (contents of a PMN), 6(a)(3) and 6(a)(6)(A) (control of unreasonable risks), 7 (imminent hazards), 12(a) (exports), 13(a) (imports), 17(b) (seizure), 18 (preemption).

3 For example, 40 C.F.R. § 704.3 defines “article” to mean “a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.”

4 40 C.F.R. § 704.5(a).

5 40 C.F.R. § 707.60(b) (other than PCB articles).

6 19 C.F.R. § 12.121(b) (unless specifically required by a rule under TSCA).

7 40 C.F.R. § 710.50(b).

8 40 C.F.R. § 720.22(b)(1) (chemical substances in imported articles).

9 40 C.F.R. § 721.45(f) (chemical substances imported or processed as part of an article, unless specifically required by a SNUR).

10 40 C.F.R. §§ 747.115(f)(3) (mixed mono and diamides of an organic acid), 747.195(f)(3) (triethanolamine salt of a substituted organic acid), 747.200(f)(3) (triethanolamine salt of tricarboxylic acid).

11 For example, in adopting the PMN exemption, EPA explained, “[b]ecause it would be enormously difficult for an importer to determine the identity and Inventory status of each chemical substance in imported articles (e.g., automobiles), the rule does not require persons to submit notices on new substances imported as part of articles.”  48 Fed. Reg. 21722, 21726 (May 13, 1983).

12 Administrator Lisa P. Jackson, Remarks to the Commonwealth Club of San Francisco (Sep. 29, 2009), http://yosemite.epa.gov/opa/admpress.nsf/ 12a744ff56dbff8585257590004750b6/fc4e2a8c05343b3285257640007
081c5
.

13 The Safe Chemicals Act of 2010, S. 3209, § 4(1)(iv).

14 The Toxic Chemicals Safety Act of 2010, H.R. 5820, § 13(2).

15 See generally EPA, supra note 1, at 8-11.  One of the most important actions was the listing in 2009 of commercial pentaBDE and octaBDE as targets for elimination under the Stockholm Convention on Persistent Organic Pollutants.  See Stockholm Convention, The 9 new POPs under the Stockholm Convention (May 2009), http://chm.pops.int/Programmes/
NewPOPs/The9newPOPs/tabid/672/language/en-US/Default.aspx
.  In addition, certain PBDEs are restricted in electrical and electronic products under the European Union’s Restriction of Hazardous Substances (RoHS) Directive (2002/95/EC).

16 71 Fed. Reg. 34015 (Jun. 13, 2006) (adding new 40 C.F.R. § 721.10000).

17 40 C.F.R. § 721.10000(b) (incorporating provisions of 40 C.F.R. Part 721, Subpart A); 40 C.F.R. § 721.45(f) (exempting, unless otherwise specified in a particular SNUR, any person who “imports or processes the substance as part of an article”).

18 71 Fed. Reg. at 34018. 

19 See Beveridge & Diamond, P.C., supra note 1; EPA, supra note 1, at 13-14. 

20 See EPA, supra note 1, at 10.  According to available regulatory review information, the proposed test rule will apparently encompass penta- and octaBDE, as well as decaBDE.  It is unclear whether importers of these chemicals in articles would be subject to the test rule. 

21 See OIRA, Executive Order Submissions Under Review, http://www.reginfo.gov/public/do/eoReviewSearch (indicating that a draft for Regulation Identifier Number (RIN) 2070-AJ08, “Certain Polybrominated Diphenyl Ethers (PBDEs); Test Rule and Significant New Use Rule (SNUR)” was received by OIRA on December 17, 2010). 

22 71 Fed. Reg. 34015, 34018 (June 13, 2006).

23 See EPA, supra note 1 at 1, 12. 

24 Id. at 5.

25 See, e.g., Linda S. Birnbaum and Åke Bergman, Brominated and Chlorinated Flame Retardants: The San Antonio Statement, 118 Env. Health Perspectives (Dec. 2010), available at http://ehp03.niehs.nih.gov/article/info:doi/10.1289/ehp.1003088.

26 Id.

27 40 C.F.R. § 721.10068(c)(1).

28 40 C.F.R. § 721.2800(b)(1).

29 SNUR for ethane, 2-chloro-1,1,1,2-tetrafluoro-, former 21 C.F.R. § 721.3180(b)(2), 57 Fed. Reg. 32441 (July 22, 1992), revoked based on receipt of new data, 65 Fed. Reg. 30913 (May 15, 2000).

30 EPA, Long-Chain Perfluorinated Chemicals (PFCs) Action Plan (Dec. 30, 2009), http://www.epa.gov/oppt/existingchemicals/
pubs/actionplans/pfcs_action_plan1230_09.pdf
(“For example, the [section 6] rule could address PFAS-containing articles.”).

31 EPA, Dyes Derived From Benzidine and Its Congeners (Aug. 18, 2010), http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/
DCB%20Action%20Plan_06232010.noheader.pdf
(“Because there is concern for exposure to azo dyes on imported finished textiles, EPA could propose eliminating the article exemption applied to the above SNURs.”).

32 EPA, Hexabromocyclododecane (HBCD) Action Plan (Aug. 18, 2010), http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/
RIN2070-AZ10_HBCD%20action%20plan_Final_2010-08-09.pdf
(“This Significant New Use Rule (SNUR) also would be proposed to apply to imports of consumer textiles articles containing HBCD.”)

33 EPA, Nonylphenol (NP) and Nonylphenol Ethoxylates (NPEs) Action Plan (Aug. 18, 2010), http://www.epa.gov/oppt/existingchemicals/
pubs/actionplans/RIN2070-ZA09_NP-NPEs%20Action%20Plan_
Final_2010-08-09.pdf
(“The proposed SNUR would propose to designate NPEs in detergents and cleaning products as a significant new use”).

34 CPSIA § 108, 15 U.S.C. § 2057c.

35 CPSIA § 101, 15 U.S.C. § 1278a.

36 75 Fed. Reg. 51246 (Aug. 19, 2011).

37 CPSC letter to Fashion Jewelry and Accessories Trade Association (Oct. 19, 2010), http://www.cpsc.gov/library/foia/foia11/os/cadmiumjewelry.pdf.