NIOSH Actions Threaten Lower Exposure Limits for Carcinogens

The National Institute for Occupational Safety and Health (NIOSH), the workplace research arm of the federal Centers for Disease Control, recently has taken two actions likely to lead to much lower occupational exposure recommendations for known or suspected carcinogens. First, in December 2016, the agency finalized its new Carcinogen Policy. The new policy provides “that there is no known safe level of exposure to a carcinogen, and therefore that reduction of worker exposure to chemical carcinogens as much as possible through elimination or substitution and engineering controls is the pri¬mary way to prevent occupational cancer.” NIOSH no longer will use the term recommended exposure limit (REL) for chemical carcinogens; rather NIOSH will only rec¬ommend an initial starting point for control, called the Risk Management Limit for Car¬cinogens (RML-CA). For each chemical identified as a carcinogen, the RML-CA will be set at the level deemed necessary to ensure no more than one excess cancer case in 10,000 workers in a 45-year working lifetime. When measurement of the occupational carcinogen at the RML-CA is not analytically feasible at the 1 in 10,000 risk estimate, NIOSH will set the RML-CA at the limit of quantifi¬cation (LOQ) of the analytical method. This is a major change from the prior NIOSH policy, which recognized that acceptable exposure limits can be established for carcinogens and focused on risks of 1/1000 or greater.

Second, in March 2017 NIOSH published draft guidance for using Occupational Exposure Banding (OEB) to evaluate chemical hazards.  The guidance would be used by NIOSH to establish and update RELs and the new carcinogen limits, and also appears intended to allow chemical users and others to set their own internal limits.  It includes formulas for deriving upper and lower limit values (bands) on the basis of available data. The preferred databases for carcinogens include EPA’s IRIS listings and the Cal OSHA database, among others.

These two developments, taken together, are likely to lead to major reductions in NIOSH exposure recommendations for known or suspected carcinogens. While NIOSH has no enforcement authority, the NIOSH recommendations can be enforced by OSHA pursuant to the General Duty Clause of the Occupational Safety and Health Act, and they often are used as internal corporate standards.

The Carcinogen Policy is final; therefore, revision likely would require a petition for reconsideration. Comments on the OEB guidance are due by June 13, and could include arguments that it cannot be used to supersede current RELs and that the new Carcinogen Policy should not be applied.

Council of Better Business Bureaus’ National Advertising Division Recommends Kauai Coffee to Modify and Discontinue Environmental-Benefits Claims for Coffee Pods

The National Advertising Division (NAD), of the Council of Better Business Bureaus, recommended that Kauai Coffee Company, LLC, discontinue certain environmental-benefits claims for the company’s single-serve coffee pods. In addition, NAD found that the company’s webpage fails to meet FTC Green Guide requirements for advertising claims. The NAD decision recommends that Kauai Coffee company discontinue and modify several advertising claims. It also requested that the company provide substantiation for a number of express claims.

NAD’s purpose is to provide efficient, cost-effective resolution to disputes between private parties regarding national advertisements. The process is voluntary. This type of voluntary enforcement allows the NAD to use alternative dispute resolution to address and settle disputes within 60 to 90 days. Advertisements challenged under the NAD are subjected to the “claim substantiation” standard promulgated by the Federal Trade Commission (FTC). Companies can appeal the NAD decisions to the National Advertising Review Board, which appoints appellate panels to review decisions issued by the NAD. NAD reserves the right to refer the claims to the appropriate federal agency, usually the FTC, for further action. It is this threat of a potential FTC investigation that incentivizes those to participate in the voluntary NAD process.

Much of the Kauai Coffee NAD decision addresses claims regarding the compostability of the Kauai coffee pods. Although the company obtained third party certification that the pods meet the requirements of ASTM standards D6400 and D6868, the certification does not extend to typical disposal methods. Indeed, the pods will disintegrate and biodegrade swiftly and safely only in a professionally managed industrial composting facility, which is not readily available to most consumers, and the pods are not suitable for home compositing. NAD found that Kauai Coffee must prominently discloses these facts.

According to NAD, the Kauai Coffee webpage violated the FTC Green Guides requirements by not clearly and prominently disclosing both that the pods are not suitable for home composting and that industrial composting programs are not readily available to most consumers. Indeed, NAD noted, “it is well-established that any material disclosures must be clear and conspicuous and appear in close proximity to the claim it is qualifying.”

In addition, NAD has asked the company to substantiate a number of its environmental-benefits claims including:

• “Don’t trash the Earth with your coffee. Brew & Renew.”

• Kauai Coffee comes in “new certified 100% compostable pods that work in all K-Cup brewers.”

• “Compostable in industrial facilities. Check locally, as these do not exist in many communities. Not certified for backyard composting.”

• “Now you can enjoy the great taste and convenience of single-serve coffee without worrying about the environmental impact. Our certified 100% compostable pod is compatible with all K-cup brewers and is designed to go back to the land – not the landfill.”

NAD has also asked that Kauai Coffee discontinue use of the following statements:

• “Don’t trash the Earth with your coffee. BREW & RENEW” along with the image of the trash can imprinted with a green/blue image of the earth.

• “Now you can enjoy the great taste and convenience of single-serve coffee without worrying about the environmental impact. Our certified 100% compostable pod is compatible with all K-cup brewers and is designed to go back to the land – not the landfill.”

NAD reports that Kauai Coffee will comply with NAD’s recommendations.

EPA Grants First ‘Conditional’ Approval Under TSCA Reform

EPA recently approved a new chemical additive subject to the conditions of the polymer exemption criteria.  The Agency found that the chemical substance is “not likely to present an unreasonable risk” under TSCA (5(a)(3)(C)), so long as it meets the requirements of the polymer exemption as described under 40 CFR §723.250(e)(1).  Specifically the Agency found that the substance presents both a low human hazards and a low environmental hazard.  The requirement that “the chemical must be manufactured such that it meets the polymer exemption criteria” gives little insight into restrictions that EPA might impose on future conditional approvals.

EPA’s Determination for Premanufacture Notice explains that although the agency estimates that the new chemical substance will be very persistent, it is unlikely that the chemical substance would present an unreasonable risk, given that it has low potential for bioaccumulation, low human health hazard, and low environmental hazard.  The Determination’s discussion of potential exposures is particularly interesting.  The Agency explained that, although the exposure to a new chemical substance is potentially relevant to whether a new chemical substance is likely to present unreasonable risks, EPA did not estimate the exposure.  The Agency elected not to estimate exposure because the substance present low health and environmental hazard.  The Determination concludes that, “Due to low hazard, EPA believes that this chemical substance would be unlikely to present an unreasonable risk even if exposures were high.”

The name of the substance was claimed confidential business information, as was the manufacturers name. The generic substance name is 2–alkenoic acid, 2–alkyl–, alkyl ester, polymer with 2–alkyl 2–propenoate and a-(2–alkyl-1-oxo-2-alken-1-yl-[iquest]-alkoxypoly(oxy-1,2-alkanediyl), ester with a–2–alken–1–yl–[iquest]–hydroxypoly(oxy–1,2–alkanediyl).

The approval, announced online on May 12, 2017, was the first time EPA has approved a new chemical with a condition since the Toxic Substances Control Act was amended in June 2016.

EPA Reopens Consultation on TSCA Small Manufacturer and Small Processor Definition

The EPA reopened its consultation with the public regarding the definition of “small manufacturer” and “small processor” under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amends the Toxic Substances Control Act (TSCA).

TSCA, as amended, requires EPA to review the size standards for small manufacturers and processors, which are currently used in connection with reporting regulations under TSCA Section 8(a). EPA preliminary decided that a revision in the size standards was warranted, but it wanted the public’s input as well. As such, EPA requested public comment on whether a revision of the current size standard definitions is necessary. It also requested a consultation with the Small Business Association to review the definition.

The comment period ended in January, but EPA is now accepting further comment on this issue until May 24, 2017.

New York to Require Manufacturers to Disclose Chemical Ingredients in Cleaning Products

New York announced the launch of its Household Cleansing Product Information Disclosure Program on April 25, 2017. This program will require manufacturers of household cleaning products sold in New York to disclose – on their websites – information on the chemical ingredients of those products. The state has issued draft guidance on the disclosure requirements and the Household Cleansing Product Information Disclosure Program Certification Form. Public comment on the form will be accepted through June 14, 2017. Manufacturers are to post all required information by no less than six months following publication of the final guidance document. In a press release announcing the program, the governor’s office noted that this program will serve as a pilot for potential expansion to other consumer products of concern, such as personal care or children’s products.

The Household Cleansing Product Information Disclosure Program is based on New York’s Environmental Conservation Law Article 35 enacted in the 1970s. It authorizes the state to require manufacturers to furnish product information for the public record. These requirements have been codified in the state’s Code of Rules and Regulations (NYCRR) at Part 659.6.

Detailed instructions for posting the information required are provided in the guidance document. The guidance discusses where on a manufacturer’s website the information should be located. It also notes that “information disclosed under this program must not be restricted from indexing by search engines, such as Google and Bing.”

Information requirements include

• Whether the product contains fragrance ingredients, including ingredients added to mask the scent of other ingredients (solvents, surfactants, etc.) in so-called “unscented” products;
• Intentionally added ingredients;
• Trace quantities; and
• Ingredients present only as an unintentional consequence of manufacturing.

Manufacturers will also be required to report on which of the chemicals in their products have been subject to the GreenScreen® comparative chemical hazard assessment (for information on the GreenScreen® Benchmark program see, the Clean Product Action website). In addition, manufacturers must disclose whether their products contain any nanomaterials and whether any of the chemicals in their products are included on a list of chemicals of concern (for information on the lists of chemicals of concern at issue, see the guidance document).

Manufacturers will be required to update their disclosures each time the ingredients in a product are changed, or a new product is introduced to the market.

Petition for Toxicity and Exposure Testing on Flame Retardants Denied

On April 12, 2017, EPA published a notice in the Federal Register denying a TSCA section 21 petition regarding a group of flame retardants.  EPA explained that the petition did not demonstrate that there was insufficient data on these chemicals, and therefore the EPA found that the testing requested was not necessary.   The petition was submitted by Earthjustice, Natural Resources Defense Council, Toxic-Free Future, Safer Chemicals, Health Families, BlueGreen Alliance, and Environmental Health Strategy Center (“Earthjustice Petition”).

Under TSCA section 21, any person can petition EPA to initiate a rulemaking for the issuance, amendment, or repeal of a rule under TSCA section 4, 6, or 8 or an order under TSCA section 4 or 5(e) or (f).  The Earthjustice petition asked EPA to issue an order under section 4, requiring toxicity and exposure tests testing on particular flame retardants.  The flame retardants at issue are chlorinated phosphate esters (“CPE”).  The CPE Cluster is comprised of

  • tris(2-chloroethyl) phosphate ((“TCEP”) (CAS No. 115-96-8),
  • 2-propanol, 1-chloro-, phosphate (“TCCP”) (CAS No. 13674-84-5), and
  • 2-propanol, 1,3- dichloro, phosphate (“TDCPP”) (CAS No 13674-87-8).

These substances had previously been evaluated during EPA’s TSCA Work Plan Chemical Problem Formulation and Initial Assessment.  Millions of pounds of the substances are manufactured and imported annually.

The Federal Register notice explained that EPA must make several findings in order to issue a rule or order to require testing under section 4.  EPA must find that information and experience are insufficient to reasonably determine or predict the effects of a chemical substance on health or the environment and that testing is necessary to develop the missing information.  EPA must also find that the chemical substance may present an unreasonable risk of injury under section 4.  EPA did find that the manufacture, distribution in commerce, processing, use, or disposal of the CPE Cluster chemicals may present an unreasonable risk of injury to health or the environment.  However, EPA stated that the petitioners failed to demonstrate that the information and experience available to EPA are insufficient to reasonably determine or predict the effects on health or the environment from “manufacture, distribution in commerce, processing, use, or disposal” (or any combination of such activities) of the CPE Cluster chemicals, and therefore the Agency found that the testing requested by the petitioners is unnecessary.

In March, EPA denied a section 21 petition by Earthjustice and others to require additional testing on the flame retardant tetrabromobisphenol A (CAS No. 79-94-7).