EPA names five PBT chemicals for expedited action.

Yesterday, the U.S. Environmental Protection Agency (EPA) announced that five chemicals will be subject to expedited action under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which overhauls the Toxic Substances Control Act (TSCA). The affected chemicals and their uses, as described by EPA, are:

  • Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics and polyurethane foam;
  • Hexachlorobutadiene (HCBD), used in the manufacture of rubber compounds and lubricants and as a solvent;
  • Pentachlorothio-phenol (PCTP), used as an agent to make rubber more pliable in industrial uses;
  • Tris (4-isopropylphenyl) phosphate, used as a flame retardant in consumer products and other industrial uses; and
  • 2,4,6-Tris(tert-butyl)phenol, used as a fuel, oil, gasoline or lubricant additive.

Last month, we wrote that as required by the Lautenberg Act, EPA would fast-track the regulation of certain persistent, bioaccumulative, and toxic (PBT) chemicals unless manufacturers nominated them for risk evaluation by September 19. Two of the seven PBT chemicals, which are used in fragrance mixtures, Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthalenyl) and Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl), were nominated for risk assessment.

Under the Lautenberg Act, EPA must skip conducting risk assessments for these five chemicals and take expedited action to reduce exposure to the extent practicable. The agency will first determine “where these chemicals are used and how people are exposed to them” before proposing limitations on use. According to agency guidance, EPA may restrict the chemicals in one or more of the following ways:

  • Prohibit or otherwise restrict manufacturing, processing, or distribution in commerce.
  • Prohibit or otherwise restrict manufacturing, processing, or distribution in commerce for particular uses or for uses in excess of a specified concentration.
  • Require minimum warning labels and instructions.
  • Require record keeping or testing.
  • Prohibit or regulate any manner or method of commercial use or disposal.
  • Direct manufacturers and processors to notify distributors and the public and replace or repurchase chemicals substances or mixtures.

EPA must propose expedited actions for these chemicals by June 22, 2019, and final rules must be issued within the following 18 months.

Ninth Circuit rules on “all natural” food claims.

Last week, the Court of Appeals for the Ninth Circuit reversed in part and affirmed in part orders issued by a district court judge in a putative class action case involving “all natural” claims made by Dole Foods. In Brazil v. Dole, No. 14-17480 (9th Cir. Sept. 30, 2016), the plaintiff, Chad Brazil, alleged that Dole’s “All Natural Fruit” labels for packaged fruit products were deceptive under the California Unfair Competition Law (UCL), California False Advertising Law (FAL), and California Consumer Legal Remedies Law (CLRA).

The plaintiff claimed that the labels were deceptive because the products contain synthetic citric and ascorbic acid, citing evidence including informal policy issued in 1993 by the federal Food and Drug Administration (FDA), as well as more recent FDA warning letters to food sellers making similar claims (“100% Natural” or “All Natural”). The FDA’s informal policy [PDF] states that a “natural” claim on a food label is truthful and non-misleading when “nothing artificial or synthetic… has been included in, or added to, a food that would not normally be expected in the food.” In the warning letters, FDA described “natural” claims as deceptive because the food products included synthetic citrus acid, among other substances.

Upon appeal, the Ninth Circuit affirmed the lower court’s order decertifying the class because the plaintiff failed to show how to calculate the price premium with proof common to the class. The Court also affirmed the dismissal of the plaintiff’s claims for the sale of “illegal products.”

However, the Ninth Circuit reversed the district court’s granting of summary judgment on the merits of Brazil’s claims. The Court held that the evidence presented “could allow a trier of fact to conclude that Dole’s description… is misleading to a reasonable consumer.” Interestingly, the Court noted that the FDA warning letters “did not always rely on the limitation that an artificial or synthetic product would ‘not normally be expected to be in the food’ – and, in fact, asserted that foods that naturally contain citric acid (such as tomatoes) may not be labeled ‘all natural’ if synthetic citric acid is added to them.”

While unpublished, the Ninth Circuit’s opinion [PDF] may prove consequential because it suggests how the Court may interpret “natural” claims in the future. In addition, a number of other cases involving “natural” claims have been stayed while this case has been pending and the plaintiff’s bar may be emboldened to pursue further litigation.

The case has been remanded to the lower court to allow the plaintiff “injunctive relief on behalf of the class and his remaining individual claim for restitution.”

California’s Department of Toxic Substances Control is Seeking Collaboration on the Next Round of Products

The Safer Consumer Products (SCP) program, under CA’s Department of Toxic Substances Control (DTSC), is using a four-step process to reduce toxic chemicals in products that consumers buy and use. One of these steps includes developing Priority Products, which are products that contain one or more Candidate Chemicals. The DTSC is now seeking stakeholder engagement for implementing its Priority Product Work Plan (PPWP) in a webinar, scheduled for November 15. 2016 from 10:30am- 12:00pm PST.

The webinar will provide an overview of DTSC’s progress towards Priority Product selection. The webinar will also focus on three topics, which the DTSC would like stakeholder engagement in:

  • Potential aquatic impacts and continued uses of nonylphenol ethoxylates (NPEs) and triclosan,
  • Nail products, and
  • Perfluoroalkyl and polyfluoroalkyl substances (PFASS) in carpets, rugs, upholstered furniture, and their care and treatment products.

Potential Aquatic Impacts and Continued Uses of Nonylphenol Ethoxylates and Triclosan:

This category contains chemicals that may adversely impact aquatic resources, or that have been observed through water quality monitoring. SCP identified NPEs, triclosan, and some of their transformation products as Candidate Chemicals that may warrant further research. A Candidate Chemical as a chemical that exhibits a “hazard trait and/or an environmental or toxicological endpoint” and is either: 1) found on one or more of the authoritative lists specified in Section 69502.2(a) of the regulations; or 2) listed by DTSC using the criteria specified in Section 69502.2(b). SCP would like to better understand the presence of these Candidate Chemicals in the aquatic environment, and would like current product use information for these Candidate Chemicals in cleaning, personal care, and clothing products.

Nail Products:

Nail salon workers have daily exposure to a variety of hazardous chemicals in nail products. Additionally, nail products in salons and at home are used by potentially sensitive subpopulations such as pregnant women and children. Three key questions being explored for this topic are:

  • What are the potentially hazardous chemicals present in nail products?
  • Why are these potentially hazardous chemicals being used in nail products?
  • What alternative chemicals are being used including products marketed as green, safer, or free of specific chemicals?

PFASS in Carpets, Rugs, Upholstered Furniture, and Their Care and Treatment Products:

DTSC is concerned about the hazard traits of PFASs and their widespread presence in the environment, humans, and other living organisms. Carpets, rugs, and upholstered furniture treated with PFASs for stain-, soil-, oil-, or water-resistance, as well as their PFASs-based care and treatment products, are potential long-term sources of widespread human and ecological exposures to this class of chemicals. DTSC is requesting public input to better understand:

  • The exposure potential from the use of PFASs in these consumer products, and
  • The hazard traits of short-chain PFASs, fluorinated ethers, and other “novel” PFASs.

EPA to Extend CDR Submission Deadline by One Month

EPA is amending the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations by extending the submission deadline for 2016 reports from September 30, 2016 to October 31, 2016. This is a one-time extension for the 2016 submission period only, and will be reported in the Federal Register. The deadline is being extended in response to comments from the regulated community that raised concerns about the ability to make timely reports due to issues with the electronic filing system — EPA’s Central Data Exchange system.

The CDR regulations require manufacturers (including importers) of certain chemical substances included on the TSCA Chemical Substance Inventory to report current data on the manufacturing, processing, and use of the chemical substances. For the 2016 submission period, a company must report under CDR if, at one or more U.S. sites, it manufactured or imported at least 25,000 pounds of a reportable chemical substance during any year between 2012 and 2015. For some substances, which are subject to certain other TSCA restrictions or requirements, the reporting threshold is 2,500 pounds per year per site.

Final Rule Issued by California on Proposition 65 Article 6: Clear and Reasonable Warnings

On September 2, 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) issued a final rule amending Article 6 (California Health & Safety Code §§25600-25607.9) of the regulations implementing Proposition 65 (Prop 65). The final rule imposes requirements on content and methods of transmission, which includes, in some instances, disclosure of one or more Prop 65-listed chemicals that resulted in the warning. An abbreviated warning, however, will be permitted when a company provides an “on product” warning for consumer products.

The new requirements become effective on August 30, 2018, however, companies can use either the old or the new regulatory warnings during the two-year transition period.

The new clear and reasonable warning requirement for consumer products, other than food or alcoholic beverages, requires the warning language to be preceded by a warning label – a bold, black outlined, yellow equilateral triangle, with an exclamation point in the center.


The warning symbol should be followed by one of the following warnings:

When the product can cause exposure to a carcinogen:

WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known in the State of California to cause cancer. For more information, go to  www.P65Warnings.ca.gov.

When the product can cause exposure to a reproductive toxicant:

WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known in the State of California to cause birth defects or other reproductive harm. For more information, go to  www.P65Warnings.ca.gov.

When a product can cause exposure to both a carcinogen and a reproductive toxicant:

WARNING: This product can expose you to chemicals including [name of one or more chemicals], which is [are] known in the State of California to cause cancer, and [name of one or more chemicals], which is [are] known in the State or California to cause birth defects or other reproductive harm. For more information, go to  www.P65Warnings.ca.gov.

When a product can cause exposure to a substance listed as both a carcinogen and a reproductive toxicant (e.g. lead):

WARNING: This product can exposure you to chemicals including [name of one or more chemicals], which is [are] known in the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to  www.P65Warnings.ca.gov.

Most importantly, there is now an abbreviated “on-product” warning that is permitted that would not require disclosure of one or more listed chemicals in the product. OEHHA clarified that on-product referred to the product itself, as well as the immediate container, box, or wrapper of the product. On-product warnings must appear in a type size no smaller than the largest type size used for consumer information on the product, and must be no smaller than 6-point font. Consumer information is defined to include warnings, directions for use, and ingredient lists.

When providing an on-product warning, the same warning symbol is required, as above, followed by one of the following warnings:

When the product can cause exposure to a carcinogen:

WARNING: Cancer – www.P65Warnings.ca.gov

When the product can cause exposure to a reproductive toxicant:

WARNING: Reproductive Harm – www.P65Warnings.ca.gov

When a product can cause exposure to both a carcinogen and a reproductive toxicant:

WARNING: Cancer and Reproductive Harm – www.P65Warnings.ca.gov

The regulations now permit a manufacturer, producer, packager, importer, supplier, or distributor to comply with Article 6 by either affixing a label to the product with an appropriate warning (as described above) or by sending the authorized agent for a retail seller in California a written notice that: (1) states the product at issue may result in an exposure to one or more listed chemicals, (2) identifies the product with specificity (e.g., by Universal Product Code), and (3) includes all necessary warning materials (or warning language, with respect to internet sales). The manufacturer, producer, packager, importer, supplier, or distributor must obtain confirmation of receipt by the retailer electronically or in writing. The notice must be renewed within six months during the first year after August 30, 2018, and then annually thereafter. If a retailer fails to post a warning when the manufacturer, producer, packager, importer, supplier, or distributor has provided the appropriate written notice, liability falls on the retailer for failure to warn.

Expedited action chemicals: EPA posts guidance on requesting risk evaluation.

Seven chemicals will be subject to the expedited action provision of the amended Toxic Substances Control Act (TSCA) unless manufacturers nominate them for risk evaluation by September 19. However, the scope of the risk evaluation will not be limited even if the manufacturer requests evaluation of only certain uses.

EPA recently posted online guidance interpreting the expedited action provision, which was added by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. EPA must propose rules by June 22, 2019 to restrict or regulate certain persistent, bioaccumulative, and toxic (PBT) chemicals identified in the 2014 update to the TSCA Work Plan. The chemicals subject to expedited action are:

  • Decabromodiphenyl ethers (DecaBDE) (CASRN 1163-19-5)
  • Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthalenyl)- (CASRN 54464-59-4)
  • Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl)- (CASRN 54464-57-2)
  • Hexachlorobutadiene (CASRN 87-68-3)
  • Pentachlorothio-phenol (CASRN 133-49-3)
  • Phenol, isopropylated, phosphate (3:1) (iPTPP) (CASRN 68937-41-7)
  • 2,4,6-Tris(-tert-butyl)phenol (CASRN 732-26-3)

Under this provision, EPA is not required to conduct a risk assessment and may impose one or more of a variety of restrictions so that the chemical no longer presents an unreasonable risk of injury to health or the environment. The agency may levy prohibitions or restrictions on manufacturing, processing, or distribution for a certain use or in excess of a certain concentration. EPA is also authorized to set requirements for record-keeping, testing, or marking substances with warnings. These expedited actions must “address the risks of injury to health or the environment …presented by the chemical substance” and “reduce exposure to the substance to the extent practicable.”

The new guidance also provides instructions on how manufacturers should submit their requests for a risk evaluation, including new requirements for making claims for Confidential Business Information (CBI).

Manufacturers requesting risk revaluations will be required to pay a fee, which will be set by a rule which EPA expects to finalize by June 22, 2017. The guidance notes that risk evaluation requests may not be withdrawn and will be considered “a firm commitment …to pay for the risk evaluation.”

In addition to requesting a risk evaluation, a chemical may also be removed from expedited action eligibility if EPA designates it as a high-priority substance for risk evaluation. In either case, any subsequent regulation of the chemical must “reduce exposure to the substance to the extent practicable.”

California refers five chemicals to Prop. 65 Carcinogen Identification Committee.

This week, California’s Office of Environmental Health Hazard Assessment (OEHHA) announced that five chemicals, including methyl chloride and vinyl acetate will be considered by the Proposition 65 Carcinogen Identification Committee (CIC) at its November 15, 2016 meeting. The chemicals or chemical groups are:

  • Aspartame
  • Asphalt and Asphalt Emissions Associated with Road Paving and Asphalt and Asphalt Emissions Associated with Roofing
  • Methyl Chloride
  • Type I Pyrethroids
  • Vinyl Acetate

Methyl chloride and vinyl acetate are both common intermediates in polymer production, while the latter is a High Production Volume chemical. Type I Pyrethroids are a group of synthetic insecticides also found in home and garden pest control products. Aspartame is a widely used artificial sweetener.

The CIC will advise OEHHA on prioritizing the chemicals for possible preparation of hazard identification materials, an intermediate step toward listing a chemical as carcinogenic under Prop. 65. No listing decisions will be made for these chemicals at the November meeting. However, the CIC will consider listing “nitrite in combination with amines or amides” at this meeting.

The five chemicals were chosen based on epidemiologic and animal data screens, followed by a preliminary toxicological evaluation. OEHHA prepared and has made available summaries of the relevant studies identified during the preliminary toxicological evaluation for each of the five chemicals.

The announcement marks the beginning of a public comment period which runs to October 24, 2016.

CPSC petitioned over labeling requirements for paint strippers containing DCM.

The Consumer Product Safety Commission (CPSC) is accepting public comments on a petition requesting that the Commission revise its Statement of Interpretation and Enforcement Policy regarding labeling household products containing methylene chloride (Policy Statement). As discussed in a Federal Register notice published today, the petition from the Halogenated Solvents Industry Alliance (HSIA) asks that the CPSC expand the Policy Statement’s labeling requirements to address acute hazards from inhaling vapors from methylene chloride. Methylene chloride is a widely used chemical solvent also known as dichloromethane (DCM).

The HSIA petition [PDF] notes that the Occupational Safety and Health Administration (OSHA) and National Institute for Occupational Health (NIOSH) have issued a Hazard Alert about methylene chloride in stripping agents used in bathtub refinishing, identifying at least 14 related worker deaths. The Hazard Alert also recommends ways to reduce or eliminate risk in refinishing bathtubs.

In its Policy Statement, which was issued in 1987 under the Federal Hazardous Substances Act (FHSA), the CPSC advised on labeling household products containing methylene chloride, with a focus on paint strippers. This guidance includes statements of principles and examples of how to warn consumers about the chemical’s potential cancer hazards, but does not address acute hazards.

In its petition, HSIA states that, to prevent future fatalities like those addressed in the OSHA/NIOSH Hazard Alert, “all that is needed is to extend the cautionary labeling so that it also warns of the threat of asphyxiation if DCM-based products are used in an enclosed space.” Consulting with CPSC, the industry group developed warning language and sample labels that have been circulated in the industry. However, HSIA seeks a revision to the Policy Statement because it would receive greater attention and avoid confusion among product manufacturers.

The petition further notes that revising the Policy Statement “is also important to ensure against inconsistent labeling requirements at the state or local level directed at the same risk.” Paint strippers containing DCM are on the draft list of initial Priority Products under California’s Safer Consumer Products program.

CPSC will accept comments on the petition through October 31, 2016.

Science advisors urge EPA to complete 1-BP risk assessment.

The Chemical Safety Advisory Committee is urging the Environmental Protection Agency (EPA) to complete and publish its risk assessment of 1-bromopropane without delay, due to “the high risks of adverse effects” in occupational and consumer use scenarios that have already been evaluated. In meeting minutes [PDF] submitted to EPA last week, some Committee members commented that these risks might have been under-estimated. The chemical, also known as 1-BP, is used in spray adhesives, dry cleaning, and degreasing, and was among the chemicals identified in the 2012 Toxic Substances Control Act (TSCA) Work Plan.

The Committee, an independent panel of scientific advisors comprised of experts in toxicology, environmental risk assessment, exposure assessment and related fields, met in May to review the scientific and technical merit of EPA’s draft risk assessment for 1-BP, which was released in March 2016.

Overall, the Committee praised the draft risk assessment, concluding that “the conceptual model appropriately considers worker exposures and consumer uses, with the majority of exposure occurring via inhalation.” The Committee stressed the importance of including consumer uses with acute exposures, and several members called for better consideration of exposure from co-residence and community-level exposures near dry-cleaning facilities. The Committee provided recommendations “intended to improve the clarity and transparency of the scientific analyses,” including the adoption of systematic review processes to clarify how studies were selected and evaluated. Other recommendations include ways to refine occupational and consumer exposure assessments.

Under the new requirements of the Lautenberg Act, EPA must identify 10 Work Plan chemicals for risk evaluations to be initiated by December 2016. EPA will revamp the prioritization process for risk evaluations in 2017 and 2018, using new criteria to be established, through rule-making, by mid-June 2017.

EPA proposes updates to SNUR regulations on workplace protection and hazard communication.

On July 28, EPA published a proposed rule updating the Significant New Use Rule (SNUR) regulations, which implement section 5(a)(2) of the Toxic Substances Control Act (TSCA). In announcing the proposal, EPA emphasized the need to harmonize regulations based on Occupational Safety and Health Administration (OSHA) standards for respiratory protection and hazard communication, which have both been updated since the SNUR regulations were last revised in 1989.

The proposed rule also contains several other changes meant to address “issues identified through EPA’s experience issuing and administering SNURs,” including changes to the bona fide intent to manufacture procedure. Additional, minor changes include correcting typographical errors, updating “material safety data sheet” or “MSDS” to “safety data sheet” or “SDS,” and revising language to “more accurately use the terms manufacture, manufacturer, and manufacturing.”

Notably, many of the proposed changes to the SNUR regulations will affect previously-issued SNURs.

EPA notes that, due to regulatory updates from both the National Institute for Occupational Safety and Health (NIOSH) and OSHA, the current regulatory language for protection in the workplace, concerning respiratory protection, is inconsistent with NIOSH and OSHA requirements. Thus, EPA proposes to replace outdated references to old OSHA standards with the current NIOSH regulations on the certification and testing of respirators, as well as adding specific types of NIOSH-certified respirators to the list of approved respirators. According to the proposed rule, companies subject to previously-issued SNURs containing respirator requirements can either follow the updated requirements or continue using the older respirators, if they are still available, without triggering a Significant New Use Notification (SNUN) requirement.

EPA also proposes to modify a subsection on airborne forms of chemicals by adding “particulate or aerosol,” “gas/vapor,” and combinations thereof.

The proposed rule further revises the workplace protection section by inserting the requirement that a hierarchy of controls – such as enclosure of operations, ventilation, and workplace policies and procedures – must be “considered and implemented to prevent exposure, where feasible” before using personal protective equipment (PPE) for worker protection. This change is reportedly in response to previous comments criticizing “EPA’s approach of exclusively identifying the absence of adequate personal protective equipment as a significant new use” as out of step with best practices in industrial hygiene. EPA notes that the new language has been incorporated in all new chemical SNURs issued since June 26, 2013 and is consistent with OSHA requirements.

The agency’s proposed updates on hazard communication are based on OSHA’s updates to its Hazard Communication Standard (HCS), which was itself modified, in 2012, to conform to the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (GHS). EPA also proposes adding a new requirement which could be used in new SNURs for a written hazard communication program in each workplace in accordance with the OSHA HCS. Another proposed addition provides specific statements and warnings that could be required under a SNUR and “would be based on EPA’s risk assessment of the chemical substance and would be consistent with the OSHA HCS and GHS recommendations.”

In addition to the changes to the workplace protection and hazard communication revisions, EPA proposes various other modifications, including:

  • Bona fide procedure: Currently, when EPA issues a SNUR in which the chemical identity is withheld as confidential business information (CBI), manufacturers and processors may submit information to EPA to “determine whether their substance is subject to the SNUR.” EPA now proposes to amend the process to apply to other kinds of CBI, such as production volume limits, so EPA may inform bona fide submitters whether and how the SNUR applies to them, including any confidential significant new use designations.
  • Notice submission requirements: EPA proposes that notification submissions such as premanufacture notifications or low volume exemptions, among others, must include any SDS that has already been developed for the relevant chemical.

EPA has specifically requested comments on the following issues:

  • the use of “next generation” respirators;
  • the incorporation of the hierarchy of controls approach to worker protection in the SNUR requirements; and
  • “any suggested methods for minimizing respondent burden, including revisions to the automated collection techniques being used for submissions to EPA under TSCA, …the Agency’s Central Data Exchange (CDX) portal.”

The deadline for comments on the proposed rule is September 26, 2016.