Memoranda

On February 24, 2017, President Trump issued Executive Order (EO) 13777, “Enforcing the Regulatory Reform Agenda.” Issuance of the EO, and the subsequent measures undertaken by U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt offer unique opportunities for chemical stakeholders.  This memorandum summarizes EPA’s efforts to date in this regard, and identifies opportunities that stakeholders may wish to pursue to eliminate or amend regulatory...

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...

The U.S. Environmental Protection Agency (EPA) proposed on January 17, 2017, procedures to establish the risk-based screening process and criteria that EPA will use to identify chemical substances under the Toxic Substances Control Act (TSCA) as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. 82 Fed. Reg. 4825. The proposed rule describes the processes for identifying potential candidates for...

On January 13, 2017, the U.S. Environmental Protection Agency (EPA) published a proposed rule that would require an electronic notification for chemical substances listed on the Toxic Substances Control Act (TSCA) Inventory that were manufactured (including imported) for non-exempt commercial purposes during the ten-year time period ending on June 21, 2016. 82 Fed. Reg. 4255. EPA would also accept such notices for chemical substances that were processed. The recent TSCA amendments require EPA to...

In an expected action, on January 11, 2017, the Administrator of the U.S. Environmental Protection Agency (EPA) signed a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to regulate the use of trichloroethylene (TCE) in vapor degreasing.  The proposed rule has not yet been published in the Federal Register, but a pre-publication version of the proposed rule is available on EPA’s website, along with a fact sheet and other information.  The...

EPA Issues Final RMP Rule: On January 13, 2017, EPA published in the Federal Register its final rule amending the Accidental Release Prevention Requirements for Risk Management Programs (RMP) under Clean Air Act (CAA) Section 112(r)(7). 82 Fed. Reg. 4594. The amendments are intended to modernize EPA’s RMP regulations as required under Executive Order (EO) 13650, which directs the federal government to carry out certain tasks intended to prevent chemical incidents, such as...

In a final rule issued on January 12, 2017, EPA adjusted the level of statutory civil monetary penalty amounts under the statutes EPA administers. 82 Fed. Reg. 3633. The adjustments are mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The latter law prescribes a formula for annually adjusting statutory civil penalties to reflect inflation, maintain the deterrent effect...

After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. 82 Fed. Reg. 3641. Manufacturers and processers, or persons who intend to manufacture or process new discrete forms of certain existing chemical nanoscale...

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology.  The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with the National Strategy for Modernizing the...

Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2017 Click here for a PDF brochure of the memorandum 2016 was full of surprises, two of which will drive much of the agenda for OCSPP during 2017. First, Congress significantly amended the Toxic Substances Control Act (TSCA). The changes are intended to reform the program to address the widely recognized deficiencies in the law, especially regarding existing chemicals, chemical testing,...

On January 4, 2017, the U.S. Environmental Protection Agency (EPA) published its final rule revising its regulation concerning the certification of applicators of restricted use pesticides (RUP).  EPA states that the final rule is intended to ensure federal certification program standards adequately protect applicators, the public, and the environment from risks associated with the use of RUPs.  According to EPA, the final rule will improve the competency of certified...