Memoranda

On April 11, 2017, the U.S. Court of Appeals for the District of Columbia issued a decision vacating the U.S. Environmental Protection Agency’s (EPA) rule exempting livestock feeding operations from air reporting requirements under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and the Emergency Planning and Community Right-to-Know Act (EPCRA). Large-scale animal feeding operations that confine, for example, more than 1,000 cattle, 2,500 hogs, or...

On April 6, 2017, the U.S. Food and Drug Administration (FDA) published three waivers to the now final Sanitary Transportation rule mandated by the FDA Food Safety Modernization Act (FSMA) for businesses whose transportation operations are subject to separate state-federal controls in the Federal Register. 82 Fed. Reg. 16733. The waivers include: FDA reviewed comments on the waivers after they were included in the proposed rule and found that the waivers would not result in...

A trio of recent internal U.S. Environmental Protection Agency (EPA) memoranda are providing insight into how EPA intends to implement President Trump’s review and potential pogrom of EPA regulations. Virtually no program or regulation appears to be secure from the chopping block. Many stakeholders in industry and other sectors may be alarmed to see programs that are of benefit to them assigned a slot in the guillotine. Supporters of these programs, thus, would be wise...

On March 29, 2017, U.S. Environment Protection Agency (EPA) Administrator Pruitt signed an order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for the pesticide chlorpyrifos.  This is the latest EPA action in a long and contentious battle concerning chlorpyrifos tolerances and registrations, and is likely not the end of this...

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a report entitled Preparing for Future Products of Biotechnology, prepared by the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee). Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), was an external contributor to the Committee’s deliberations and presented...

President Trump’s February 28, 2017, Executive Order (E.O.) directing the U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (Corps) to rescind and replace the Clean Water Rule (CWR) is the latest development in the attempt to resolve the long-standing question of which surface waters and wetlands may be federally regulated and subjected to permitting under the Clean Water Act (CWA). In the decade since the U.S. Supreme Court issued its fractured opinion...

EPA Updates RCRA Public Participation Manual: For the first time in 20 years, the U.S. Environmental Protection Agency (EPA) has revised its Resource Conservation and Recovery Act (RCRA) Public Participation Manual. The revised document, issued by EPA in January 2017, replaces the 1996 version. EPA has updated the document to reflect current regulations, policies, and practices. It also presents new information about technical assistance, environmental justice, social media, and other...

Representative Markwayne Mullin (R-OK) on February 1, 2017, introduced a resolution (H.J. Res. 59) under the CRA to repeal the U.S. Environmental Protection Agency’s (EPA) final rule revising its Risk Management Plan (RMP) program. EPA promulgated the final RMP rule on January 13, 2017, in response to Executive Order 13650, which required EPA and other federal agencies to improve chemical facility safety and security. 82 Fed. Reg. 4594. The CRA allows Congress to pass disapproval...

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued an interpretation of Toxic Substances Control Act (TSCA) Section 14 concerning substantiation of confidential business information (CBI) claims for information submitted to EPA.  82 Fed. Reg. 6522.  Under the interpretation, EPA expresses its view that new TSCA requires substantiation of all non-exempt CBI claims at the time the information claimed as confidential is submitted to EPA.  In the notice, EPA...

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) proposed a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. 82 Fed, Reg. 7562. The process would not consider costs or other non-risk factors. Risk evaluation is the second step, after prioritization, in a new...