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.

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.

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.