Lautenberg Act: EPA names ten Work Plan chemicals for initial risk evaluations.

/in , ,

The U.S. Environmental Protection Agency (EPA) has announced the ten Work Plan chemicals for review under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which updated the Toxic Substances Control Act (TSCA). Yesterday, the agency released the list of substances, which will be the first to undergo risk evaluations under the new law. The list is mainly made up of flame retardants and industrial solvents, many of which are used in consumer products, as well as asbestos, the notoriously carcinogenic mineral used in building materials.

The chemicals are:

  • 1,4-Dioxane
  • Bromopropane
  • Asbestos
  • Carbon Tetrachloride
  • Cyclic Aliphatic Bromide Cluster
  • Methylene Chloride
  • N-methylpyrrolidone (NMP)
  • Pigment Violet 29
  • Tetrachloroethylene, also known as perchloroethylene
  • Trichloroethylene (TCE)

Under the Lautenberg Act, EPA must select ten chemicals from the 2014 Work Plan by December 19, 2016. The Work Plan contains 90 chemicals with potential for high hazard and exposure, as well as considerations including persistence and bioaccumulation. The agency notes that in choosing the ten chemicals, it “took into account recommendations from the public, industry, environmental and public health groups, and members of Congress and tried to give weight to chemicals where work on assessing risks were underway.”

Among the listed chemicals, EPA has already completed risk assessments for methylene chloride, NMP, and TCE, and taken early steps towards assessments for 1,4-Dioxane and the Cyclic Aliphatic Bromides. For methylene chloride, NMP, and TCE, the agency plans to proceed with Section 6(a) rulemaking for the limited uses defined for the completed risk assessments; the chemicals’ remaining uses will now be newly evaluated. The ongoing rulemaking for these chemicals were included as “Immediate Actions” in EPA’s First Year Implementation Plan for the Lautenberg Act.

The reformed TSCA requires that EPA evaluate existing chemicals to determine whether they “present an unreasonable risk of injury to health or the environment.” The list’s publication in the Federal Register will trigger the three-year statutory deadline for completing the risk evaluations. In the next six months, EPA must release a scoping document for each chemical. The remaining 80 Work Plan chemicals will also be reviewed, as the law requires EPA to begin a new evaluation for every completed evaluation, with half of all EPA-initiated evaluations drawing from the Work Plan list until it is exhausted. In addition, EPA must have at least 20 chemical risk evaluations ongoing by the end of 2019.

Environmental groups mostly praised the decision to prioritize asbestos, a fire-resistant material that causes mesothelioma cancer which outgoing Senator Barbara Boxer (D-CA) called “the poster child for TSCA reform.” However, Earthjustice criticized EPA’s failure to include lead, citing children’s exposure to the neurotoxin via “ongoing, unnecessary uses of lead in consumer products.”

In a statement, the American Chemistry Council emphasized that a chemical’s inclusion in the list was only the first step in a process based on high quality data and the weight of scientific evidence. The industry group also said “it is imperative that EPA engage stakeholders early and often throughout the risk evaluation process, including through peer review and public comment.”

Flurry of Lautenberg Act rulemaking actions begin.

/in

A series of rulemaking actions have begun to implement the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), which recently modernized the Toxic Substances Control Act (TSCA). Last week, the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), received two key proposed rules from the U.S. Environmental Protection Agency (EPA). The proposed rules, which are not yet publicly available, establish the process for prioritization and risk evaluation under the Lautenberg Act changes to TSCA’s framework. The prioritization process rule will establish procedures and criteria for designating chemicals as either “high priority” or “low priority.” The risk evaluation rule sets out the process for evaluating risks in “high priority” chemicals.

According to EPA’s First Year Implementation Plan, the agency’s goal is to publish these proposed rules in mid-December. Finalization of both rules is required by mid-June 2017, the deadline set by the law. The Plan also set mid-December 2016 as a milestone for publishing proposed rules for inventory reporting and fees. In addition, the Lautenberg Act requires the agency to release the list of ten Work Plan chemicals chosen for initial risk evaluations by the same time.

EPA names five PBT chemicals for expedited action.

/in

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.

/in ,

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

/in ,

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

/in ,

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

/in

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.

prop-65

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.

/in

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.

/in ,

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.

/in

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.