On April 22, 2016, California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) issued a final notice listing styrene as known to the state to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65). OEHHA also issued a proposal to adopt a Prop 65 No Significant Risk Level (NSRL) of 27 micrograms per day for styrene. The listing of styrene has been contentious. OEHHA previously attempted to propose...
On April 11, 2016, the U.S. Environmental Protection Agency (EPA) issued a memorandum entitled “Coverage for ZirconizationTM Under 40 CFR Part 433 (Metal Finishing ELG),” which concludes that “wastewater generated by ZirconizationTM or a process that applies a zirconium oxide finish to a metal substrate is subject to the Metal Finishing [Effluent Limitation Guidelines (ELG)].” Zirconization is the trade name for a process that produces a zirconium oxide...
On April 22, 2016, the National Toxicology Program (NTP) issued a monograph concluding that cobalt and cobalt compounds that release cobalt ions in vivo are expected to cause human cancer. Specifically, NTP stated that “[t]here is sufficient evidence for the carcinogenicity of cobalt and cobalt compounds that release cobalt ions in vivo (collectively referred to as cobalt) in experimental animals based on increased incidence of malignant and/or a combination of...
April 11, 2016
FIFRA: EPA Announces Updated Guidance for Antimicrobial Pesticide Products Intended to Combat Emerging Pathogens
In response to the increasing concerns regarding emerging viral pathogens that are not on U.S. Environmental Protection Agency (EPA)-registered disinfectant labels, EPA announced on April 7, 2016, that it was updating its Guidance regarding emerging viral pathogens. Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is authorized to evaluate the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health. Many believe...
On April 4, 2016, the U.S. Environmental Protection Agency (EPA) published its updated Recommended Aquatic Life Ambient Water Quality Criteria for Cadmium — 2016 under Section 304(a) of the Clean Water Act (CWA). 81 Fed. Reg. 19176. The updated cadmium criteria recommendations replace the criteria values that EPA last issued in 2001. The CWA directs EPA to develop, publish, and periodically revise the ambient water quality criteria for aquatic life and human health that best...
April 5, 2016
Proposition 65: OEHHA Proposes Revisions to Its Proposed Proposition 65 Warning Regulations
On March 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) modified its November 27, 2015, proposed rule that would repeal and replace the Proposition 65 (Prop 65) Article 6 regulations covering “clear and reasonable warnings” requirements. OEHHA states that the proposed changes are based on its response to the written comments it received on the proposed rule, and on oral comments provided during a January 13, 2016, public hearing. The...
On March 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a final rule exempting manufacturers of six biodiesel chemicals from reporting processing and use information under the Chemical Data Reporting (CDR) rule under the Toxic Substances Control Act (TSCA) Section 8(a). 81 Fed. Reg. 17392. In 2014, the Biobased and Renewable Products Advocacy Group (BRAG®), managed by Bergeson & Campbell, P.C.’s (B&C®) affiliate, B&C® Consortia Management, L.L.C. (BCCM)...
March 25, 2016
OEHHA Proposes MADL For BPA (Dermal Exposure From Solid Materials), And Other Recent Endocrine Disruptor Developments
OEHHA Proposes MADL For BPA (Dermal Exposure From Solid Materials): On March 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed a maximum allowable dose level (MADL) for bisphenol A (BPA) (dermal exposure from solid materials) of three micrograms per day. OEHHA states that it reviewed the transcript of the May 7, 2015, meeting of the Developmental and Reproductive Toxicant Identification Committee (DARTIC) and the hazard identification materials...
On March 18, 2016, the National Academies of Science, Engineering, and Medicine (NAS) announced the appointment of its provisional committee on “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.” This study is being commissioned pursuant to the White House Office of Science and Technology Policy’s (OSTP) July 2, 2015, memorandum, “Modernizing the Regulatory System for Biotechnology Products,” that states...
A January 20, 2016, letter from U.S. Environmental Protection Agency (EPA) Administrator Gina McCarthy provides the Administration’s reaction to, and comments on, the Toxic Substances Control Act (TSCA) reform legislation that has passed both the House and the Senate in somewhat different forms. The differences between the bills are currently being sorted out and reconciled. The bills at issue are the TSCA Modernization Act of 2015 (H.R. 2576) and the Frank R....
March 3, 2016
Agencies Convene Second Meeting On Modernizing Regulatory System For Biotechnology Products
On March 2, 2016, EPA and other federal agencies announced that the second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products” would be held March 9, 2016, in Dallas, Texas. 81 Fed. Reg. 10858. According to EPA, the March 9, 2016, meeting was convened to solicit comment on the current federal roles and responsibilities regarding biotechnology products. The July 2, 2015, memorandum was jointly issued by the...
February 29, 2016
Biotechnology: Second Meeting on Modernizing the Regulatory System for Biotechnology Products Will Be Held March 9
The second public meeting on the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products” will be held March 9, 2016, from 9:30 a.m. to 1:00 p.m. (CT) in Dallas, Texas. Registration is now open. To participate in person, registration should be completed by March 4, 2016. Registration is also required to view and participate in a live streaming of the public meeting. According to the U.S. Environmental Protection Agency...
February 11, 2016
House Bill Would Delete International Regulatory Provisions From Clean Air Act, And Other Recent CAA Developments
House Bill Would Delete International Regulatory Provisions From Clean Air Act: Stating that “this assault on our Constitution and states’ rights must be stopped,” Representative Scott Perry (R-PA) on February 11, 2016, introduced a bill that would deny the U.S. Environmental Protection Agency (EPA) “the ability to bypass Congress and take control of every states’ energy program.” The Energy Sovereignty Act (H.R. 4544) seeks to do so by eliminating...
On January 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) announced the adoption of final regulations (Regulations) related to the development and maintenance of a website to “provide information to the public regarding exposures to listed chemicals for which warnings are being provided” under Proposition 65 (Prop 65). Final Statement of Reasons (FSOR) at 11. OEHHA states that its intent with these Regulations is to “increase the...
February 5, 2016
Biotechnology: APHIS Seeks Comment on Potentially Significant Changes to Regulations Regarding GE Organisms
According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced its intent to “prepare a programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.” The notice...
On January 21, 2016, the American National Standards Institute (ANSI) hosted a presentation on enforcement under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation. The topics covered included “Enforcement — the Actors and the Activities”; “[the European Chemicals Agency (ECHA) Forum for Exchange of Information on Enforcement (ECHA Forum)]’s Role and Initiatives”; “Enforcement Targeted to...
On January 7, 2016, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register the beginning of a 45-day comment period on the peer review draft of the Guidelines for Human Exposure Assessment (draft Guidelines). According to EPA, the draft Guidelines benefit from over two decades of experience with assessments conducted by EPA programs under their respective authorities and constraints, as well as from input from external panels, including the...
February 2, 2016
OSTP Announces Second and Third Public Engagement Sessions for Modernizing the Regulatory System for Biotechnology Products
On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the second and third public engagement sessions that will discuss the July 2, 2015, memorandum entitled “Modernizing the Regulatory System for Biotechnology Products.” The second public meeting will be held on March 9, 2016, at the U.S. Environmental Protection Agency’s (EPA) Region 6 office at 1445 Ross Avenue in Dallas, Texas. The third public meeting...
On January 4, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule amending its food additive regulations to no longer allow the use of three specific perfluoroalkyl ethyl-containing food contact substances (FCS) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods. All three of the FCSs contain extended perfluorinated alkyl chains greater than or equal to eight carbons in length and as such are long-chain...
January 5, 2016
Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2016
Click here for a PDF version of the memorandum. Even if Toxic Substances Control Act (TSCA) legislation is not enacted, 2016 will be a momentous year. As the curtain closes on eight years of the Obama Administration, there are a number of items expected to be among the “legacy” issues in the chemical and pesticide regulation space. Enhanced protections for farmworkers, more protective assessment policies, and a re-energized toxic chemical assessment program are among the...