EPA agrees to clarify data requirement rule for antimicrobial pesticides.

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EPA and the American Chemistry Council (ACC) have reached a settlement regarding the ACC’s petition concerning data requirements for antimicrobial pesticides. This settlement addresses a Final Rule published by EPA on May 8, 2013, “Data Requirements for Antimicrobial Pesticides,” for which the ACC, the chemical industry trade group, sought judicial review in the U.S. Court of Appeals for the D.C. Circuit.

Under the settlement, EPA will within the next four months release for public comment a proposed guidance document, “Antimicrobial Pesticide Use Site Index.” This guidance will include “a compilation of existing antimicrobial pesticide use sites and identify how each use site fits within the 12 use patterns established in the regulation.” The Use Site Index will include the following descriptions, as set forth in the settlement:

  • Direct Food Use: a use is generally considered to be a direct food use if an antimicrobial pesticide is intended to be directly applied to food (defined for purposes of the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. § 321(f)) or applied to a material or article for the purpose of treating food.
  • Indirect Food Use: a use is generally considered to be an indirect food use if the use involves application of the antimicrobial pesticide in or on a material or article that comes into contact with food and may result in residues in or on food, but the use is not intended for pesticidal treatment of food.
  • Nonfood Use: a use is generally considered to be a nonfood use when there is a reasonable certainty of no residues in or on food, for example because the antimicrobial pesticide is not expected to come into contact (directly or indirectly) with food as a result of its intended use.

In addition to the Site Index proposed guidance, the settlement agreement provides that EPA shall propose an interim guidance document and then a “correction to the Final Rule” regarding the 200 ppb level for antimicrobial residues in or on a food item, as established at 40 C.F.R. § 158.2230(d). Under the Final Rule, additional toxicology tests are required for indirect food uses with antimicrobial residue levels greater than 200 ppb. Within 60 days, EPA must issue an interim guidance document “explaining EPA’s interpretation of the 200 ppb level established in the Final Rule.” Within two and a half years, EPA must propose a “correction” to make “clear that the 200 ppb level established in the Final Rule is based on total estimated daily dietary intake, and is not based on the amount of residue present on only a single commodity.”

EPA replaces Design for the Environment with new “Safer Choice” label.

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Today, EPA unveiled its new “Safer Choice” label, which replaces the Design for the Environment (DfE) label for cleaning and other chemical products that meet the agency’s standards for safer chemical ingredients. The new label underscores the program’s focus on human health and environmental safety standards with the hope of making it easier for families to choose safer products for families. EPA Administrator Gina McCarthy even appears with her dog in a short YouTube video to emphasize that children and pets are more vulnerable to chemicals.

The new “Safer Choice” label has different versions for products used in homes and for those used in office buildings, schools, and other institutions.

Speaking at a conference in Baltimore yesterday, Wendy Cleland-Hamnett, director of EPA’s Office of Pollution Prevention and Toxics, said the agency consulted with the Federal Trade Commission (FTC) in developing in the new logo to ensure that it would comply with the FTC’s Green Guides on environmental marketing claims.

EPA also introduced a new label to substantiate fragrance-free claims in Safer Choice products. The revised “Safer Choice Standard” [PDF] specifies changes related to the new fragrance-free standard. Products that qualify for the Safer Choice label are eligible for the additional fragrance-free certification and label if no fragrance materials are in the product ingredients.

In addition, the agency announced that it “is aligning across product types the requirements applied to labeled products that contain sensitizers that exceed the de minimis level (0.01%) in the end-use product.” All Safer Choice products, not just consumer products, will now be required to disclose on the label if fragrance materials that are skin sensitizers are present above the de minimis level. Manufacturers of such products will also be required to provide EPA with information that the sensitizing ingredients are:

  • critical to the fragrance essence or product identity;
  • otherwise in compliance with the fragrances criteria;
  • the subject of good faith explorations of alternatives; and
  • subject to a monitoring system that would alert the Agency if a user reports any adverse effects from the product.

The new label does not change other aspects of the DfE program, such as safer chemical criteria.

On the agency’s blog, Administrator McCarthy wrote that producers and retailers including Clorox, Walmart, and Wegmans are on board to start putting products with the new label on shelves this year.

EPA’s chemicals outlook for 2015.

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Jim Jones, the EPA Assistant Administrator for Chemical Safety and Pollution Prevention, writes in Chemical Watch that his highest priority in 2015 is “to continue building on the progress” of the last few years in making a “credible” program to manage existing chemicals, “despite the widely acknowledged shortcomings of the Toxic Substances Control Act (TSCA).” In his outlook for 2015, Assistant Administrator Jones highlighted progress on the TSCA Work Plan for Chemical Assessments as well as various regulatory actions.

Assistant Administrator Jones noted that in 2014, EPA completed final assessments on four chemical substances. Of those, the assessments for trichloroethylene (TCE) and methylene chloride (DCM) identified health risks to consumers and workers working with the chemicals. In 2015, the agency intends to negotiate for voluntary risk reduction measures with TCE and DCM manufacturers, but would turn to TSCA § 6 to mandate risk management – a regulatory tool EPA has not used in 28 years. Under the TSCA Work Plan, assessments scheduled for 2015 will address the following:

  • N-Methylpyrrolidone (NMP) in paint stripper products;
  • three clusters of related chemicals, used as flame retardants;
  • several uses of 1-Bromopropane (1-BP); including occupational uses of 1-BP in dry-cleaning and foam gluing operations, consumer uses in aerosol solvent cleaners and spray adhesives;
  • 1,4-Dioxane; and
  • long- and medium-chained chlorinated paraffins used as metal working and compounding agents and its effects on ecological receptors.

EPA has a variety of regulatory actions planned for 2015. The agency plans to finalize a rule regulating formaldehyde emissions from composite wood products, thus making national the emissions standard already in place in California. In addition, EPA will make a determination on “whether renovations in commercial and public buildings create a hazard from lead-based paint.” Assistant Administrator Jones also announced that the agency will, in late 2015 or early 2016, propose the modification of existing use authorizations for polychlorinated biphenyls (PCBs) in several contexts. Finally, Assistant Administrator jones noted that 2015 would mark a “turning point” for the agency’s green chemistry programs as incentives and obstacles to adoption of greener chemistries are identified.

Other items on EPA’s agenda for 2015 include:

EPA promulgates Significant New Use Rules for 27 PMN substances.

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In yesterday’s Federal Register, the EPA published Significant New Use Rules (SNUR) under the Toxic Substances Control Act (TSCA) for 27 substances that were already the subject of Premanufacture Notices (PMNs). Two of the substances – Phosphoric acid, iron (2+) lithium salt (1:1:1) and Polymer of terephthalic acid and ethyl benzene with multi-walled carbon nanotube (generic) – are also subject to “risk-based” consent orders under TSCA section 5(e), requiring protective measures to limit exposures or otherwise mitigate the potential unreasonable risk to human health and the environment presented by the substances. For these substances, the SNURs designate the absence of those protective measures as a “significant new use.”

Under all of the SNURs, EPA must be notified at least 90 days before beginning to manufacture or process the specified chemicals in a “significant new use.” For the chemicals not subject to § 5(e) consent orders, any use deviating from the use scenario reported in the corresponding PMN is designated as a “significant new use.” Specific requirements for each chemical are specified in the regulatory text.

The SNUR was promulgated by Direct Final Rule, and will go into effect on April 3, 2015, unless adverse comments are submitted by March 4.

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.”

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.

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.

EPA finalizes SNURs, revokes articles exemption for benzidine dyes.

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Today, EPA announced the promulgation of a final Significant New Use Rule (SNUR) [PDF] under Toxic Substances Control Act (TSCA) targeting three different chemical types: certain benzidine-based dyes, di-n-pentyl phthalate (DnPP), and alkanes, C12-13, chloro, a short-chain chlorinated paraffin (SCCP). Benzidine-based dyes can be used in textiles, paints, and inks; DnPP in PVC plastics; and alkanes in industrial lubricants. EPA found that all of the affected chemicals can cause health effects including aquatic toxicity, cancer, persistence and bioaccumulation, and reproductive and developmental effects.

Like other SNURs, the rule requires manufacturers (including importers) or processors of the identified substances to notify EPA at least 90 days before beginning any significant new use. Under this SNUR, any new use is considered a significant new use for the benzidine-based dyes and alkanes. For DnPP, EPA has designated “any use other than as a chemical standard for analytical experiments” as a significant new use. For the benzidine-based dyes, EPA is adding nine chemicals to an existing rule regulating benzidine-based chemicals.

Notably, the SNUR makes inapplicable the usual TSCA exemption for importing or processing chemicals as part of an article, calling it a “loophole.” Thus, 90-day notification will be required of importers or processors of any articles containing benzidine-based chemicals, encompassing both the nine newly-added dyes as well as those first regulated in 1996. The elimination of this articles exemption has been questioned by the chemical industry, and marks a shift in EPA’s policy. In today’s SNUR, the agency notes that it is “concerned that commencement of the manufacture (including import) or processing for any new uses, including resumption of past uses… could significantly increase the magnitude and duration of exposure to humans.”

Today’s rule is not the agency’s only effort at regulating these chemicals; benzidine dyes and SCCPs are both already subject to Action Plans, while other phthalates (not including DnPP), as well as medium-chain and long-chain chlorinated paraffins have been added for assessment under the TSCA Work Plan. SCCPs have been nominated for addition to the Stockholm Convention for Persistent Organic Pollutants, and manufacturing and importing in the U.S. has ceased following EPA enforcement actions in 2012. EPA also notes that its Design for the Environment program has identified safer dye and colorant alternatives on its Safer Chemical Ingredients List.

The SNUR will go into effect 60 days after its publication in the Federal Register, which will likely occur in the next week.