Memoranda

On May 8, 2017, the U.S. Environmental Protection Agency (EPA) issued in the Federal Register a notification stating that a public meeting will be held to elicit public input on approaches for assigning and applying Unique Identifiers (UID) that are now required whenever it approves a Confidential Business Information (CBI) claim for the specific chemical identity of a chemical substance.  82 Fed. Reg. 21386.  The meeting will be held on May 24, 2017,...

During its spring meeting in April, the Environmental Council of the States (ECOS) adopted several resolutions. ECOS is the national nonprofit, nonpartisan association of state and territorial environmental agency leaders. The resolutions ECOS adopted are: Resolution 04-3: Small Community Challenges: This resolution requests that the federal government work with state and local governments to address current and future small community drinking water and wastewater requirements...

On April 27, 2017, Senators Jeff Merkley (D-OR), Bernie Sanders (I-VT), Edward J. Markey (D-MA) and Cory Booker (D-NJ) introduced legislation that would transition the U.S to 100 percent clean energy by the year 2050. The bill is the first introduced in Congress that fully envisions a transition off of fossil fuels for the U.S. The 100 By ’50 Act (S. 967) bill has seven core components: Greening the Grid -- Phase-out fossil fuel electricity...

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: Businesses holding valid permits that are inspected under the National Conference on Interstate Milk Shipments’ Grade “A” Milk Safety Program,...

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 to educate senior EPA...

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, President of The Acta Group (Acta®), was an external contributor to the Committee’s deliberations and presented before the...

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...

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 resolutions...

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...

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 of...

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...

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...

On December 20, 2016, EPA announced the start of a pilot program to evaluate the usefulness and acceptability of a mathematical tool (the GHS Mixtures Equation), which is used in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). EPA states that the goal of the pilot program is to “evaluate the utility and acceptability of the GHS Mixtures Equation as an alternative to animal oral and inhalation toxicity studies for pesticide formulations.” For this pilot...

The U.S. Environmental Protection Agency (EPA) is scheduled to publish in the December 21, 2016, Federal Register a final rule regarding procedures for rulemaking under Section 6 of the Toxic Substances Control Act (TSCA).  Under TSCA Section 6, EPA has the authority to address risks from chemical substances, and Section 6 includes procedures that EPA must follow.  As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, TSCA no longer mandates...

EPA Proposes To Add Nonylphenol Ethoxylates To Section 313: On November 16, 2016, the U.S. Environmental Protection Agency (EPA) proposed to add nonylphenol ethoxylates (NPE) as a category for which reporting is needed under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). 81 Fed. Reg. 80624. EPA is proposing to add this chemical category to the EPCRA Section 313 list because EPA believes NPEs meet the EPCRA Section 313(d)(2)(C)...

On December 8, 2016, President-Elect Donald Trump confirmed his intention to nominate Oklahoma Attorney General (AG) E. Scott Pruitt to head the U.S. Environmental Protection Agency (EPA).  Rumors about Mr. Pruitt’s nomination have been circulating for some time, but his nomination was confirmed via a Facebook post.  Mr. Pruitt has been the Oklahoma AG since November 2010.  Mr. Pruitt received a B.A. from Georgetown College in Georgetown, Kentucky, in Political Science and...

On June 23, 2016, more than 30 million people voted in a referendum to decide whether the United Kingdom (UK) should “Leave” or “Remain” in the European Union (EU).  The referendum turnout was 71.8 percent and the Leave Campaign won by 52 percent to 48 percent, making “Brexit” an important and imminent probability with potentially significant implications for a range of stakeholders, including the chemicals industry.  The following statement from current UK Prime Minister...

As reported in The Acta Group EU, Ltd's (Acta EU®) August 26, 2016, Global Regulatory Update, this summer, Thailand's Department of Industrial Works (DIW) published a preliminary inventory of existing chemicals (Preliminary of Thailand Existing Chemicals Inventory). The preliminary inventory can be searched by Chemical Abstracts Service (CAS) number or trade name. DIW created the preliminary inventory by combining the hazardous substance list; the most recent hazardous chemical...

The California Department of Pesticide Regulation (DPR) recently proposed a regulation that it states is intended to “(1) provide minimum statewide standards for all agricultural pesticide applications near public K-12 schools and child day care facilities; (2) provide an extra margin of safety in case of unintended drift or when other problems with applications occur (e.g., equipment failure causes an unintended release of pesticide, or an abrupt change in weather conditions); (3)...

In our June 29, 2016, Clients and Friends memorandum, “Brazil Moves Closer to National Chemical Inventory,” The Acta Group (Acta®) discussed Brazil’s pending Industrial Chemicals Regulation (Regulação de Substâncias Químicas Industriais, or Regulação), predicting its imminent publication in the Brazilian Official Gazette, the Diário Oficial.  On July 5, 2016, Acta released a memorandum entitled “A Critical Review of Brazil's...

On August 28, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) adopted revisions to its Proposition 65 (Prop 65) Article 6 regulations covering "clear and reasonable warnings" requirements. Bergeson & Campbell, P.C. (B&C®) prepared a memorandum discussing OEHHA's November 27, 2015, proposed rule, Proposition 65: OEHHA Repeals and Re-Proposes Revisions to Proposition 65 Warning Regulations, and the March 25, 2016, revisions to those proposed...

On September 16, 2016, the White House posted a blog item, "Building on 30 Years of Experience to Prepare for the Future of Biotechnology," releasing two documents intended to modernize federal regulation of biotechnology products. In July 2015, the White House directed the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to develop a long-term strategy to ensure that the system is prepared for the future...

On September 16, 2016, the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) issued a notice of intent to list perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) as known to the state to cause reproductive toxicity under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65). OEHHA is proposing the action under the authoritative bodies' listing mechanism. Comments are...

On September 19, 2016, the U.S. Environmental Protection Agency (EPA) posted a notice on the Chemical Data Reporting website that it has amended the CDR regulations to extend the 2016 submission deadline from September 30, 2016, to October 31, 2016. According to the pre-publication version of the Federal Register notice for the final rulemaking, EPA received a request for an extension, citing problems with certain...

On August 16, 2016, the U.S. Environmental Protection Agency (EPA) reached a settlement in Clean Water Act (CWA) lawsuits filed over its 2015 Multi-Sector General Permit (MSGP) for Stormwater Discharges from Industrial Activities. 80 Fed. Reg. 34403 (June 16, 2015). The MSGP is the collective term for the CWA National Pollutant Discharge Elimination System (NPDES) program's general permits for stormwater discharges from industrial facilities spanning 29 sectors, including, but not...

The Ministry of the Environment (MOE) published an amended version of the Act for the Registration and Evaluation of Chemicals (K-REACH) enforcement decree and enforcement rules, which have both entered into force. The amendments include some exemptions from reporting for new chemicals, and an extended 14-day grace period for substances used only for research and development (R&D) purposes. The final amendments do not include a proposal to remove a provision that states...

China Implements Requirements For Shipments From Zika-Infected Countries, Including The U.S.: In March 2016, the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) began requiring all countries on its Zika-infected list to comply with disinsection requirements. The United States Department of Agriculture (USDA) Foreign Agricultural Service's (FAS) August 19, 2016, "Update on China's Requirements for Shipments from Zika-Infected...

On July 28, 2016, the U.S. Environmental Protection Agency (EPA) proposed to update the Toxic Substances Control Act (TSCA) Significant New Use Rule (SNUR) procedures. 81 Fed. Reg. 49598. As discussed in our previous memorandum on this proposed rule, Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards, while some of the proposed changes are not consequential, other changes, such as those related to workplace protections, are more clearly...

The U.S. Environmental Protection Agency (EPA) proposed on July 28, 2016, revisions to the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) with revisions to the Occupational Safety and Health Administration's (OSHA) Hazard Communications Standard (HCS) occasioned by OSHA's March 2012 final rule modifying the HCS to conform to the United Nations' (U.N.) Globally Harmonized System of Classification and Labelling of Chemicals...

Scientists Issue Letter Criticizing EDC Criteria: On July 6, 2016, a group of 15 European and U.S. researchers wrote to the European Union's (EU) Health and Food Safety Directorate, criticizing recent proposals for the identification of endocrine disrupting chemicals (EDC) under the Plant Protection Products (PPP) Regulation and the Biocidal Products Regulation (BPR). The scientists addressed two major concerns relating to the proposed criteria:...

On July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted on its website the first four Section 5(a)(3) determinations for premanufacture notices (PMN) under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. No. 114-182) (new TSCA). All four of the new chemicals were determined to satisfy the "not likely to present an unreasonable risk" determination at Section 5(a)(3)(C). It is notable that all...

On July 15, 2016, the California Department of Toxic Substances Control (DTSC) announced the release of its proposed regulation on children's foam-padded sleeping products containing tris(1,3-dichloro-2-propyl) phosphate (TDCPP) or tris(2-chloroethyl) phosphate (TCEP) as a Priority Product (PP) under the Safer Consumer Products Regulations (SCPR). DTSC first released information about this PP on March 13, 2014, so this proposed regulation is a major step in the SCPR process and over...

On July 15, 2016, the California Department of Toxic Substances Control (DTSC) announced the release of its proposed regulation on children's foam-padded sleeping products containing tris(1,3-dichloro-2-propyl) phosphate (TDCPP) or tris(2-chloroethyl) phosphate (TCEP) as a Priority Product (PP) under the Safer Consumer Products Regulations (SCPR). DTSC first released information about this PP on March 13, 2014, so this proposed regulation is a major step in the SCPR process and over...

On July 13, 2016, the Department of Transportation's (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA), in coordination with the Federal Railroad Administration (FRA), announced proposed regulations for Oil Spill Response Plans and Information Sharing for High-Hazard Flammable Trains (HHFTs). The rule would expand the comprehensive oil spill response plan requirements under the Clean Water Act (CWA) to certain HHFT trains based on the amount of crude oil being transported....

In our June 29, 2016, Clients and Friends memorandum, Brazil Moves Closer to National Chemical Inventory, The Acta Group (Acta®) discussed Brazil's pending Industrial Chemicals Regulation (Regulação de Substâncias Químicas Industriais, or Regulação) predicting its imminent publication in the Brazilian Official Gazette, the Diário Oficial. On June 30, 2016, the Regulação was released for an approximately 45-day comment period. While generally...

On June 29, 2016, the U.S. Environmental Protection Agency (EPA) posted an Implementation Plan that outlines EPA's plans for early activities and actions under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). The amended TSCA has been identified as Public Law Number (Pub. L. No.) 114-182, and copies are expected to be available from the U.S. Government Publishing...

On October 15, 2015, the Brazilian Ministry of Environment (Ministério do Meio Ambiente, or MME) announced plans to develop a national chemical Inventory (Inventory), with initial legislation expected by December 31, 2015. Due to a sometimes contentious debate between industry and the MME (Authority), the Inventory process had been considerably delayed. In a Brazilian chemical industry forum on June 23, 2016, it was announced that significant progress has been made toward implementing...

EPA Makes Final Revisions To EPCRA Hazard Categories: On June 13, 2016, the U.S. Environmental Protection Agency (EPA) issued final revisions to EPCRA Sections 311 and 312 occasioned by changes to the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS). 81 Fed. Reg. 38104. Under the revised HCS, chemical manufacturers and importers are required to evaluate their chemicals according to the new criteria adopted from the United...

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Later that day, the U.S. Environmental Protection Agency (EPA) announced the creation of a web page on the new law, landmark legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA). EPA's web page includes links for users to access: The text of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Act); ...

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), which makes important changes to the Toxic Substances Control Act (TSCA). Lautenberg results in fundamental shifts in the requirements and approach under TSCA, while introducing important new concepts and approaches. It is our view that the body of changes, including the careful balancing of competing needs and interests and the deft and assiduous drafting, yield a...

On June 7, 2016, the Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) by voice vote and sent it to President Obama for signature. As reported in our memorandum, "An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA," the Act includes new requirements in Sections 4, 5, 6, and 8 of the Toxic Substances Control Act (TSCA). These new requirements, among others, will need to be met in promulgating currently proposed regulations, as well...