Proposed reporting requirements for nanomaterials released.

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Companies that manufacture, import or process nanoscale materials would be subject to reporting requirements under a new proposed rule released today by EPA. EPA is proposing reporting obligations concerning use, exposure, and other factors under section 8(a) of the Toxic Substances Control Act (TSCA). The proposed rule would apply to nanoscale chemical substances in the marketplace that have unique properties related to their size. The agency intends to use this information to determine if any further action under TSCA is needed.

Under the proposed rule [pre-publication version, PDF], companies would be required to report if they manufactured or processed a “discrete form” of a reportable nanoscale substance during the three years preceding the rule’s final effective date. EPA also proposes a continuing reporting requirement for companies intending to manufacture or process a discrete form of a reportable chemical substance after the rule’s final effective date. These manufacturers or processors would be required to report to EPA 135 days before the commencement of manufacturing or processing.

To the extent that it is known or reasonably ascertainable to the reporter, companies would have to submit the following information:

  • Specific chemical identity;
  • Material characteristics like morphology and surface modifications;
  • Physical and chemical properties;
  • Maximum weight percentage of impurities and byproducts;
  • Production volumes;
  • Use information;
  • Detailed methods of manufacturing or processing;
  • Exposure information, including estimates of numbers of individuals exposed in the workplace or in other scenarios;
  • Release information, including estimates of amounts released;
  • Risk management practices, such as protective equipment or hazard warnings; and
  • Existing data concerning environmental and health effects.

Generally, nanoscale materials are chemical substances that have structures with dimensions “at the nanoscale,” meaning 1-100 nanometers (nm), and may have properties different from the same chemicals with structures at a larger scale, such as greater strength or lighter weight.  The proposed rule would apply to substances that are:

  • Solid at 25°C and atmospheric pressure; and are
  • Manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100nm and exhibit unique and novel characteristics or properties because of their size.

The proposed reporting requirements apply to “discrete forms” of reportable chemical substances. In some cases, companies would be required to report separately for multiple nanoscale forms of the same chemical substance. The agency’s intent is to focus on “intentionally manufactured chemical substances at the nanoscale,” so unintended variations in particle sizes between production batches, for example, should not trigger § 8(a) reporting. EPA proposes to distinguish between these “discrete forms” based on a combination of the following three factors:

  1. a change in process to affect a change in size and/or a change in properties of the chemical substances manufactured at the nanoscale;
  2. a change in mean particle size of 10% or greater; and
  3. the measured change in at least one of the following properties, zeta potential, specific surface area, dispersion stability, or surface reactivity, is greater than 7 times the standard deviation of the measured values.

Other examples of discrete forms include nanomaterials with different morphologies (spheres vs. rods) and nanoscale forms of the same material but coated with different substances.

The proposed rule applies to mixtures, including when nanomaterials are manufactured or processed “solely as a component of a mixture, encapsulated material, or composite.” However, if a nanomaterial is incorporated into a mixture, encapsulated material, or composite by the nanomaterial’s manufacturer, the incorporation step does not have to be separately reported.

EPA proposes to apply a modified version of the existing small manufacturer/processor exemption to § 8(a) requirements. Because nanoscale materials are produced at much lower production volumes, EPA seeks to eliminate the 100,000 pound volume threshold for exempted small manufacturers or processors. Instead, a company could qualify as a small manufacturer/processor if it has “sales of less than $4 million” per year.

The proposed rule also excludes certain substances, including nanoclays, DNA, RNA, proteins, and chemical substances “which dissociate completely in water to form ions that are smaller than 1 nanometer.” Certain reporting which would be duplicative is also excepted; e.g., companies that submitted information under EPA’s voluntary Nanoscale Materials Stewardship Program do not need to re-submit, nor do submitters of Premanufacture Notices (PMNs) filed since January 1, 2005.

Information would be collected electronically, using a modified version of the reporting form used by the voluntary NMSP initiative, and compatible with EPA’s existing Central Data Exchange (CDX) and Chemical Information Submission System (CISS), both used for other TSCA reporting. EPA is not proposing an inventory for nanoscale materials, although non-confidential information collected through this proposed rule would be published in ChemView.

In addition to the above proposed reporting requirements, EPA is seeking input on various related issues, including “the possibility of a future rule that would require periodic reporting of chemical substances manufactured at the nanoscale, similar to reporting that occurs under the Chemical Data Reporting (CDR) rule.”

EPA is accepting comments on the proposed rule for 90 days following its publication in the Federal Register. The agency also anticipates holding a public meeting during the comment period.

EPA completes risk assessment for n-methylpyrrolidone (NMP).

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EPA has made more progress with its Toxic Substances Control Act (TSCA) Work Plan with yesterday’s release of the agency’s final risk assessment for N-Methylpyrrolidone (NMP) or 1-methyl-2-pyrrolidinone, a chemical commonly used in paint and coating removal products. NMP is estimated to be used at over 184 million pounds per year, in paint strippers, agricultural chemicals, electronic cleaning, and petrochemical processing. The risk assessment identifies developmental toxicity risks for pregnant women and women of child-bearing age who have high exposure to NMP, as either consumers or workers. Risks were identified for both acute and chronic exposures, although acute exposure risks could be mitigated by using chemical-resistant gloves and using NMP products for less than four hours a day.

EPA is considering a range of voluntary and regulatory actions to reduce risks from NMP exposure. This is the fifth final risk assessment completed under the TSCA Work Plan.

EPA and FDA announce data sharing agreement for CBI.

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Today, EPA and the Food and Drug Administration (FDA) announced a Memorandum of Understanding (MOU) to share data on pesticides and toxic substances. According to a notice published last month in the Federal Register, in response to the FDA’s spring 2014 request, EPA will grant FDA access to information collected under the Toxic Substances Control Act (TSCA) and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including information claimed by submitters as Confidential Business Information (CBI). This data-sharing initiative “is intended to maximize the utility of data collected under those statutes, and enhance the efficiency of the participants’ regulatory processes and facilitate better risk management activities.” The MOU applies specifically to EPA’s Office of Chemical Safety and Pollution Prevention and FDA’s Foods and Veterinary Medicine Program, Center for Food Safety and Applied Nutrition, and Center for Veterinary Medicine.

FDA and EPA “have complementary roles” regulating substances incorporated into food (including animal feed), animal drugs, and cosmetics. Antimicrobial food wash products, for example, must meet different standards for safety and non-adulteration of food (FDA), and no adverse environmental effects (EPA).

The MOU covers the sharing of non-public information exempt from public disclosure, including CBI and “confidential commercial information” (CCI). Information will be shared “on a reciprocal and as-needed basis” for substances that may be present in human food, animal food and feed, animal drugs, and cosmetics. The MOU provides that each agency will develop internal procedures and designate liaison officers for the information-sharing exchanges and to protect against unauthorized disclosure of CBI or CCI. Appendices to the MOU establish a framework process for information sharing, including specific language to be used in requesting information or responding to a request.

The MOU does not specify any limits as to programmatic uses for shared information. The disclosure of non-public information remains governed by applicable laws and regulations, and non-public information may not be disclosed further or shared with personnel at the other agency that have not been authorized to access non-public information. If EPA requests information from FDA identified as a trade secret, FDA will assess whether the information is in fact trade secret. TSCA/FIFRA-designated CBI requested by FDA will have to be returned to EPA or destroyed when no longer needed. Either agency may choose not to share requested information, or may choose to limit the scope of information provided in response to a request. The agencies may also protect information “in connection with research that has not been peer reviewed.”

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.