EPA proposes updates to Chemical Data Reporting rule.

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This week’s Federal Register includes notices from the EPA of two changes to the Chemical Data Reporting (CDR) rule, part of the Toxic Substances Control Act (TSCA). On Tuesday, EPA published a Direct Final Rule that adds six biobased chemicals to the list of chemicals that are partially exempt from certain reporting requirements. Today, EPA published a Notice that the agency has submitted an information collection request to the Office of Management and Budget (OMB).

EPA’s submission to OMB proposes a revision to a previously approved information collection request, which implemented the 2011 updates to the CDR. Information collection requests are reviewed and approved by OMB under the Paperwork Reduction Act. The new request reflects the reporting requirements for the 2016 submission period. The update is estimated to affect almost 5,000 entities once every five years.

The new partial exemptions stem from a petition filed by a group representing the biobased chemicals industry. The Direct Final Rule adds a “biodiesel” category to the list of partially exempt chemicals which are not subject to reporting requirements for processing and use information. Responding to the group’s petition, EPA determined that processing and use information for the six biobased chemicals were of “low current interest.” The chemicals affected are:

  • Fatty acids, tallow, Me esters.
  • Fatty acids, C14-18 and C16-18-unsatd., Me esters.
  • Fatty acids, C16-18 and C-18-unsatd., Me esters.
  • Soybean oil, Me esters.
  • Fatty acids, canola oil, Me esters.
  • Fatty acids, corn oil, Me esters.

The partial exemption puts the biodiesel industry on more equal footing with petroleum-based diesel manufacturers, whose “petroleum process streams” chemicals are already partially exempt.

The partial exemption Direct Final Rule goes into effect on March 30, 2015, unless adverse comments are received by February 26. Comments on the information collection request will be accepted through March 2, 2015.

Industry opposes proposed rule on nonylphenols and nonylphenol ethoxylates.

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Companies and trade groups representing industries ranging from automakers to cleaning products have pushed back against an EPA proposal that would restrict certain chemicals widely used in industrial applications and consumer products such as detergents, cosmetics, paints, and sealants. As Bloomberg BNA reports, industry commenters argue that their ongoing uses of the chemicals preclude EPA from issuing the proposed rule. The commenters also criticize EPA’s nomenclature convention, which they contend is not generally used or understood, as well as EPA’s reliance on Chemical Data Reporting Rule (CDR) results as a basis for the rulemaking.

In late September, we wrote that EPA released its proposed Significant New Use Rule (SNUR), under the Toxic Substances Control Act (TSCA), for nonylphenols (NPs) and nonyphenol ethoxylates (NPEs). EPA later extended the comments period for the proposed rule by 45 days, to January 15, 2015.

The proposed SNUR identifies by CAS number 13 “linear NPs and NPEs” for which any use is a significant new use, as well as two branched NPs, for which any use besides “as an intermediate or use as an epoxy cure catalyst” is a significant new use. However, commenters argue that “the global industry practice is to use CAS names” without distinguishing between “branched” or “linear” forms. The American Chemistry Council contends that EPA has not provided sufficient explanation and guidance on its “poorly-understood” naming convention regarding whether an alkyl chain is linear or branched.

Many commenters were highly critical of EPA’s method of evaluating whether the CAS numbers listed in the proposed SNUR were in commerce, stating that many were identified in ongoing uses and included in a variety of public databases. Various commenters also criticized EPA for using the proposed SNUR as a method of collecting use information.

Other comments reported specific ongoing uses of certain chemical substances by Chemical Abstract Service (CAS) Number.

The San Francisco Bay Regional Water Quality Control Board also weighed in to request that EPA not exempt articles from this SNUR, particularly toilet paper, which “has the potential to be a major source of pollution for aquatic resources receiving treated or untreated wastewater discharges.”

House Republicans planning “more limited” TSCA reform proposal.

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Chemical Watch reports that Rep. John Shimkus (R-IL), head of the House Subcommittee on Environment and the Economy, is planning “a more limited reform measure” to modernize the Toxic Substances Control Act (TSCA) compared to the Chemicals in Commerce Act (CICA) draft that he first introduced last year. Attempts to negotiate a compromise on that legislation stalled when Republicans and Democrats could not agree on revisions and counter-proposals from either side.

Rep. Shimkus’ strategy is to offer Democrats the chance to add amendments in exchange for committing to support the legislation. However, Rep. Shimkus would not reveal what the limited scope of his proposal would target. He did cite Rep. Frank Pallone’s (D-NJ) expression of interest in working on TSCA reform as “a pretty positive sign.”

In terms of timing, Rep. Shimkus said he would like to move the bill “sooner than later, and have it off the floor before the August break.”

Rep. Shimkus also expressed hope that the more limited House proposal, if approved, could be resolved in conference committee with the more expansive TSCA reform legislation expected from the Senate side.

EPA proposes new SNUR for perfluorinated chemicals, again eliminates articles exemption.

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EPA has proposed another Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances, including perfluorooctanoic acid (PFOA) and its salts. Under the proposal, significant new uses that would require filing a 90-day notice with EPA include: manufacturing, importing, or processing “an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemicals substances for which there are currently no ongoing uses.” In addition, EPA is continuing its trend in making the articles exemption inapplicable for these substances when imported as part of an article.

In the same proposed rule, EPA also proposes amending a SNUR for perfluorylalkyl sulfonate (PFAS) substances to make the articles exemption inapplicable for importing PFAS substances as part of carpets.

The affected chemicals are used in a variety of industrial applications and consumer goods, including cleaners, textiles, paper and paints, fire-fighting foams, and wire insulation. Their risks to human health and the environment include toxicity, persistence in the environment, and bioaccumulation in humans and animals. The chemicals are found in the blood of the general U.S. population and studies indicate that they may cause reproductive, developmental and systemic effects.

EPA’s proposal targets LCPFAC chemicals containing PFOA and its higher homologues, including the salts and precursors of these substances. Based on data from the 2012 Chemical Data Reporting (CDR) rule, the LCPFAC substances identified in the proposed SNUR are known to have current or recent ongoing uses. Noting that it is not the agency’s intention to regulate fluoropolymers in this rule, the proposed SNUR’s definition of the LCPFAC category includes a perfluorinated carbon chain length upper limit of 20. However, certain LCPFAC substances intentionally used in fluoropolymer formulation would be subject to reporting for the designated significant new uses.

The proposal defines PFAS substances to mean “a category of perfluorinated sulfonate chemical substances of any chain length.” For PFAS substances, EPA proposes modifying an existing SNUR for the chemical substances listed at 40 CFR 721.9582(a)(1).

The proposed rule is just the latest step in the agency’s ongoing work to regulate perfluorinated chemicals. The SNUR supports EPA’s 2010/2015 PFOA Stewardship Program, a voluntary initiative launched in 2006 with the major global manufacturers of LCPFAC substances. The Stewardship Program aims for a complete emissions and product content phaseout of these chemicals by 2015, and the most recent progress reports on the Program for the years 2014 and 2013, released last week, finds that the participating companies are on track to meet this goal. EPA notes that the SNUR for LCPFACs is proposed “in part in anticipation of this 2015 phase-out deadline.” In addition, the SNUR is consistent with EPA’s 2009 LCPFAC Action Plan. In October 2013, EPA finalized another SNUR on LCPFACs in carpets and PFAS, and earlier SNURs regulated PFAS and perfluorooctane sulfonate (PFOS).

Comments on the proposed rule will be accepted through March 23, 2015. In particular, EPA seeks to confirm through comments on this action whether use (including in articles) of the affected chemicals – or related ones – is still ongoing and will cease by the 2015 deadline. The agency notes that the proposed SNUR would not affect any ongoing uses of the chemicals except those that will be phased out by the end of 2015, although “uses not already ongoing as of the publication date of this proposed rule, and ongoing uses that will be phased out by the end of 2015, would not be considered ongoing uses if they later arise, even if they are in existence upon the issuance of a final rule. Furthermore, uses that are ongoing as of the publication date of this proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule (see Units IV. and VI. for further discussion of what constitutes an ongoing use).” EPA also requests comment on whether PFAS substances are currently imported as part of carpets.

CPSC proposes new ban on phthalates in children's products.

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Regular readers know that in terms of domestic, national regulation, we usually focus on developments coming out of the Environmental Protection Agency (EPA). In the U.S., the EPA is the principal federal agency that regulates chemicals in products, but it’s not the only one. Last month, the U.S. Consumer Product Safety Commission (CPSC) approved for publication a proposed rule prohibiting the use in children’s toys and child care articles of certain phthalates, a type of plasticizer used in teethers, plastic toys, home furnishings, and cosmetics.

The rule expands the existing “permanent ban” on phthalates at levels greater than 0.1% in accessible plasticized components of toys and child care products. Diisononyl phthalate (DINP) is shifted from the “interim ban” list and di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and butyl benzyl phthalate (BBP) remain on the “permanent ban” list. The rule also adds to the “permanent ban list” the following: diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP) in concentrations greater than 0.1%. Two other phthalates, diisodecyl phthalate (DIDP) and di-n-octyl phthalate (DnOP), were removed from the “interim ban” list.

The Commission proposed the rule under § 108 the Consumer Product Safety Improvement Act (CPSIA), which requires promulgation of regulations in response to the Chronic Hazard Advisory Panel’s report and recommendations on the health effects of phthalates in children’s toys and child care articles. Under the CPSIA, a “child care article” is “a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.”

The Commission is accepting public comment on the proposed rule through March 16, 2015.

An early look at TSCA reform's prospects in the 114th Congress.

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As the 114th Congress begins, legislators in both houses are expected to continue trying to reform the outdated Toxic Substances Control Act (TSCA), although which specific proposals and policies will be pursued remains to be seen.

According to E&E Daily, Sen. Tom Udall (D-NM) says he’s already rallying support for a new version of the Chemical Safety Improvement Act (CSIA), a bipartisan bill originally developed and introduced by Sen. David Vitter (R-LA) and the late Sen. Frank Lautenberg (D-NJ) in May 2013. Although Sen. Udall lost his seat in the Senate Environment and Public Works Committee, he is still seen by some advocates as “uniquely positioned to garner the support of more lawmakers.” Moreover, efforts at bipartisan collaboration may fare better under new Committee Chair Sen. James Inhofe (R-OK), who is known to have a collegial relationship with Sen. Barbara Boxer (D-CA), the former Chair and current Ranking Member of the Committee. Last year’s TSCA negotiations in the Senate ended with acrimonious disagreements between Sens. Boxer and Vitter. In discussing his agenda for the new Congress, Sen. Inhofe described the CSIA as a “good starting point” and “a high priority” for the Committee. Among the Democrats, a Committee aide said that Sen. Boxer’s support is predicated on the bill being “stronger than current law.” Sen. Udall said he is still trying to resolve Sen. Boxer’s concerns

On the House side, Rep. John Shimkus (R-IL) said in a statement that he is “hopeful” about attracting the bipartisan support needed to pass chemical reform. Rep. Shimkus, returning as head of the House Energy and Commerce Committee’s Subcommittee on Environment and the Economy, tabled his Chemicals in Commerce Act (CICA) draft bill after failing to win buy-in among Democrats. Rep. Frank Pallone (D-NJ), the new Ranking Member of the Energy and Commerce Committee, has expressed “serious concerns” about CICA, a sentiment echoed by other key Democrats. In addition, at a committee hearing last year, Jim Jones, the EPA Assistant Administrator for Chemical Safety and Pollution Prevention, said that “some in the administration would have some problems” with the draft bill if it advanced, which has been interpreted as an implied veto threat. Nevertheless, whether Rep. Shimkus pursues a similar approach as last year or a more targeted one, at least some in the chemical industry are hopeful that this Congress can pass TSCA reform. Bill Allmond, vice president of government affairs at Society of Chemical Manufacturers and Affiliates (SOCMA), said he is optimistic that Rep. Pallone can encourage his Democrats “to be more open-minded than in the last Congress, on TSCA reform, specifically.”

EPA proposes restrictions on toluene diisocyanates in consumer products.

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Today, EPA released a proposed rule regulating toluene diisocyanates (TDI), a group of chemicals mainly used to make polyurethanes like the flexible foam in furniture, as well as other consumer products, including coatings and adhesives. According to the agency, diisocyanates are “well known dermal and inhalation sensitizers in the workplace and can cause asthma, lung damage, and in severe cases, death.” Today’s proposal is a Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA), and applies to the domestic manufacture, processing, or import of TDI in consumer products.

The proposed SNUR [PDF] designates as a “significant new use” the use of certain types of TDI in any consumer products; for three other types of TDI, the “significant new use” designation contains a carve-out for use in coatings, adhesives, elastomers, binders, and sealants at no greater than 0.1% by weight. Under the SNUR, manufacturers, processors, and importers would be required to notify EPA at least 90 days before beginning or resuming the manufacture, processing, or import of TDI in a consumer product. The 90-day period would allow the EPA to evaluate the potential uses for any associated risks or hazards.

Following a recent trend, EPA has proposed making inapplicable the general SNUR exemption for importing or processing the SNUR chemical as part of an article. In the proposal, EPA explains that the articles exemption “is based on an assumption that people and the environment will generally not be exposed to chemical substances in articles…. However, TDI and related compounds are volatile and as such could migrate out of articles that contain them.” The agency cites studies finding that TDI have migrated from products, leading to potential exposure.

EPA notes that TDI, also a high production volume chemical (HPV), are “widely used in residual amounts.” According to the proposed rule, TDI use in consumer products was not reflected in Chemical Data Reporting (CDR) data, and agency staff only learned of its use, at residual concentrations no more than 0.1% by weight, in coatings, adhesives, and similar products, from direct conversations with manufacturers and a review of published literature and Safety Data Sheets for products in stores. Moreover, due to expected growth in the market for such products, “EPA is concerned that consumer products in the future might contain amounts of TDI above [current] levels.”

The chemicals covered by the proposed SNUR are:

  • Toluene diisocyanate trimer
  • Poly(toluene diisocyanate)
  • Toluene diisocyanate dimer
  • Toluene diisocyanate “cyclic” trimer
  • 2,4-toluene diisocyanate
  • 2,6-toluene diisocyanate
  • Toluene diisocyanate unspecified isomer

EPA requests comment on the proposed SNUR, and is particularly interested in “whether there are any ongoing uses of these consumer products of which the Agency is currently unaware and would welcome specific documentation of any such ongoing uses.” The proposal released today is a prepublication version [PDF], and is expected to appear in the Federal Register in the next week or two; comments will be accepted within 60 days after the proposal’s Federal Register publication. Additional material may be found and comments may be filed on Regulations.gov using the proposed rule’s docket number: EPA-HQ-OPPT-2011-0976.

EPA sued over lack of nanosilver regulations.

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On December 16, a group of NGOs sued [PDF] the U.S. EPA over the agency’s failure to regulate nanosilver in consumer products. The plaintiffs, which include the Center for Food Safety, Center for Environmental Health, and Beyond Pesticides, seek to compel EPA to take action in response to their 2008 petition for rulemaking. The groups’ petition requested that EPA regulate nanosilver products as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), thus requiring product manufacturers to obtain pesticide registrations. The petition also asked EPA to analyze “the potential human health and environmental risks” of nanosilver under FIFRA and other environmental statutes, including the Endangered Species Act (ESA) and National Environmental Policy Act (NEPA).

Since the 2008 petition, EPA has accepted comments on the petition, enforced against companies making antimicrobial claims about nanosilver-containing products, convened a scientific advisory panel, and proposed a policy statement on the subject, but the NGOs maintain that EPA’s actions constitute an “ongoing failure to meaningfully regulate nanotechnology.” The plaintiffs contend that EPA has violated the Administrative Procedure Act by failing to provide a timely response to the 2008 petition.

The case is Center for Food Safety et al v. McCarthy, Case No. 14-cv-2131, in the U.S. District Court for the District of Columbia.