Memoranda

On November 27, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) took two actions: (1) it withdrew its proposed rule issued on January 16, 2015, that would have repealed and replaced the existing Article 6 regulations regarding the all-important “clear and reasonable warnings” requirements under Proposition 65 (Prop 65); and (2) it replaced it with a new proposed rule that will repeal and replace the Prop 65 Article 6 regulations (Proposed Rule),...

EPA Launches eDisclosure Portal: On December 9, 2015, the U.S. Environmental Protection Agency (EPA) announced that it is modernizing implementation of its self-disclosure policies by creating a centralized web-based ”eDisclosure” portal to receive and automatically process self-disclosed civil violations of environmental law. 80 Fed. Reg. 76476. Under the automated eDisclosure system, “large and small businesses will quickly be able to get some of their more routine types...

EPA Seeks To Vacate Enlist Duo Herbicide FIFRA Registration: On November 24, 2015, in the U.S. Court of Appeals for the Ninth Circuit, Case No. 14-7335, the U.S. Environmental Protection Agency (EPA) filed a motion to vacate voluntarily and remand its registration of Dow AgroSciences LLC’s (DowAgro) Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The motion for vacatur is unusual and noteworthy to all pesticide registrants. The case...

On November 19, 2015, the U.S. Food and Drug Administration (FDA) announced it had approved AquaBounty Technologies’ application for the genetically engineered (GE) salmon (AquAdvantage Salmon), the first time FDA has approved a GE animal. FDA regulates GE animals under the new animal drug requirements through the Center for Veterinary Medicine in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA states in the news release that it...

On November 12, 2015, the U.S. Food and Drug Administration (FDA) requested comment on the use of the term “natural” in the labeling of human food products. The notice states that it is establishing “a docket to receive information and comments on the use of the term ‘natural’ in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering.” FDA states that this...

The U.S. Environmental Protection Agency (EPA) recently reminded stakeholders that new requirements for submitting Toxic Substances Control Act (TSCA) Section 5 notices and support documents will take effect on January 19, 2016. EPA issued a direct final rule on July 20, 2015, amending the TSCA Section 5 electronic reporting regulations. Submitters will be required to use the new Chemical Safety and Pesticide Programs (CSPP) data flow, referred to as the new version of the electronic...

As most recently reported in The Acta Group’s (ACTA®) October 28, 2015, Global Regulatory Update, the Australian government is implementing reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). According to an item in the October 6, 2015, issue of The NICNAS Bulletin, the September 2015 implementation plan outlines opportunities for community and industry consultation; timing of legislative and information technology (IT) system...

On October 30, 2015, a public meeting was held to discuss Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology (Framework). FDA’s role in responding to the July 2015 memorandum issued by OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative (USTR), and the Council on Environmental Quality (CEQ) entitled...

On October 20, 2015, the United States Federal Trade Commission (FTC) released a Final Order with a corresponding Opinion against ECM BioFilms, Inc. (ECM) stating that ECM made false and unsubstantiated environmental claims that its additives for plastics (ECM Plastics) would make treated plastics biodegrade in a landfill. The FTC Final Order and Opinion come two years after FTC issued an administrative complaint against ECM and ten months after an FTC Administrative Law...

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) hosted “Leveraging Synthetic Biology’s Promise and Managing Potential Risk,” a panel discussion featuring Lynn L. Bergeson, Sheryl Lindros Dolan, and Richard E. Engler, Ph.D., of B&C, and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincided with the release of “The DNA of the U.S. Regulatory...

Panel Discussion to Be Held Wednesday, October 15, 2015, from 12:00 p.m. – 2:00 p.m. (EDT) On October 15, 2015, the Woodrow Wilson International Center for Scholars (Wilson Center) will host “Leveraging Synthetic Biology’s Promise and Managing Potential Risk,” a panel discussion featuring Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The...

On October 6, 2015, the White House Office of Science and Technology Policy (OSTP) issued a Request for Information (RFI) to solicit relevant data and information, including case studies that may assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (CF). The RFI will assist OSTP in clarifying the current roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and...

On September 28, 2015, the U.S. Environmental Protection Agency (EPA) announced revisions to its worker protection standard.  EPA states that these revisions are intended to “enhance the protections provided to agricultural workers, pesticide handlers, and other persons under the Worker Protection Standard (WPS) by strengthening elements of the existing regulation, such as training, notification, pesticide safety and hazard communication information, use of personal protective...

California’s Department of Toxic Substances Control (DTSC) released for comment its Draft Stage 1 Alternatives Analysis Guide (Draft AA Guide). Under the Safer Consumer Products Regulations (SCPR), responsible entities (generally, manufacturers) must perform an AA for the listed Chemical of Concern (COC) and Priority Product (PP) combination to determine how best to limit potential exposures or the level of potential adverse public health and environmental impacts posed by the...

The Federal Trade Commission (FTC) announced in a September 14, 2015, press release, “FTC Sends Warning Letters about Green Certification Seals,” that it sent warning letters to five providers of environmental certification seals and 32 businesses using those seals, “alerting them to the agency’s concerns that the seals could be considered deceptive and may not comply with the FTC’s environmental marketing guidelines.” FTC states that environmental...

The U.S. Environmental Protection Agency (EPA) released on September 17, 2015, a signed final significant new use rule (SNUR) for hexabromocyclododecane or 1,2,5,6,9,10-hexabromocyclododecane (HBCD). Under the final rule, persons who intend to manufacture (including import) or process HBCD for use in consumer textiles (other than for use in motor vehicles) must notify EPA at least 90 days before commencing that activity. EPA notes that in this SNUR, the exemption for persons importing or...

On September 2, 2015, the U.S. Department of Health and Human Services’ (HHS) Agency for Toxic Substances and Disease Registry (ATSDR), in accordance with guidelines developed by ATSDR and the U.S. Environmental Protection Agency (EPA), issued a proposed Toxicological Profile for Perfluoroalkyls for review and comment that included updated toxicological profiles for 13 perfluorinated chemicals, including two well-studied perfluorinated chemicals, perfluorooctane sulfonic acid...

The U.S. Environmental Protection Agency (EPA) published a notice in the August 25, 2015, Federal Register announcing a public meeting on September 30, 2015, to receive public input and comments on EPA’s data needs to support risk assessments of biotechnology products subject to oversight under the Toxic Substances Control Act (TSCA) that make use of genetically engineered algae and cyanobacteria. The notice states that the workshop will inform an update to an...

The U.S. Environmental Protection Agency (EPA) has posted a document concerning its development of a project intended to support public dialog concerning the development and use of biotechnology.  EPA has oversight responsibility for the production and use of intergeneric cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches.  EPA’s recently posted document, US Environmental Protection Agency Biotechnology Algae Project, states...

On July 20, 2015, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) issued OSHA Directive Number CPL 02-02-079. The Directive is intended to establish “policies and procedures to ensure uniform enforcement of the Hazard Communication standard” (HCS 2012). The Directive repeals previous instructions CPL 02-02-038 and CPL 02-02-039. It also cancels both enforcement memorandums effective February 9, 2015, and May 29, 2015, respectively. For more...

The release of the first Tier 1 assessments in the Endocrine Disruptor Screening Program (EDSP) by the U.S. Environmental Protection Agency (EPA) on June 30, 2015, is a significant benchmark in the program since the original List 1 test orders were initially issued in October 2009. Fifteen of the original 67 List 1 chemicals were subsequently cancelled or discontinued by the respective pesticide registrants. The intended purpose of the Tier 1 screening was to identify potential...

On June 23, 2015, the House passed the TSCA Modernization Act of 2015 (H.R. 2576) by a vote of 398-1. The House Committee on Energy and Commerce issued a press release on June 22, 2015, noting that the bill “would bring much-needed reform to the decades-old Toxic Substances Control Act (TSCA), and is a true bipartisan breakthrough for the committee.” According to the press release, support “has poured in for this bill as it works to improve the protection...

With little fanfare or advanced notice to the general public, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of...

After over a year of review and revision, on June 25, 2015, the Chinese Ministry of Environmental Protection Solid Waste and Chemical Management Center (MEP-SCC) published the “Guidance for New Chemical Substance Notification and Registration (Draft)” (Guidance) for public comment. The deadline to submit comments to MEP-SCC regarding the Guidance is July 31, 2015. Comments should be submitted to MEP-SCC via e-mail (guidance@mepscc.cn). In addition, MEP-SCC will hold a meeting to...

On June 11, 2015, the U.S. Environmental Protection Agency (EPA) held a meeting on its Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale. Jeff Morris, Deputy Director for Programs, Office of Pollution Prevention and Toxics (OPPT), and Jim Alwood, OPPT Chemical Control Division, provided further insight into EPA’s goals, directives, and...

The House is scheduled to vote late today, June 23, 2015 (around 6:30 p.m. or 7:00 p.m.), on the TSCA Modernization Act of 2015 (H.R. 2576). The House Committee on Energy and Commerce issued a press release on June 22, 2015, noting that the bill “would bring much-needed reform to the decades-old Toxic Substances Control Act (TSCA), and is a true bipartisan breakthrough for the committee.” According to the press release, support “has poured in for this...

On June 10, 2015, and June 15, 2015, EPA held a webinar entitled “eDisclosure: EPA’s Plan to Modernize the Implementation of the Audit Policy and the Small Business Compliance Policy.” During the webinar, EPA set forth its plans to release in the fall 2015 a centralized online portal called eDisclosure to allow companies to submit self-disclosures electronically under EPA’s Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention of...

The House Energy and Commerce Committee convened a markup session on June 2 and 3, 2015, to consider a slightly revised version of the TSCA Modernization Act of 2015 as H.R. 2576. As reported in our June 3, 2015, memorandum, the House Committee passed the marked up bill. The House Energy and Commerce Subcommittee on Environment and the Economy had considered and passed an earlier discussion draft version of the TSCA Modernization Act (TMA2 DD) in...

On June 2-3, 2015, the House Committee on Energy and Commerce held a markup hearing on the TSCA Modernization Act of 2015 (H.R. 2576). Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, formally introduced the bill on May 26, 2015. On June 2, 2015, the Committee heard opening statements only. Energy and Commerce Committee Vice Chair Marsha Blackburn (R-TN) made the first statement, noting the broad bipartisan support...

On May 29, 2015, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) published the “Interim Enforcement Guidance for Hazard Communication 2012 (HCS 2012) June 1, 2015 Effective Date” (Interim Guidance). This is a follow-up document to the February 9, 2015, “Enforcement Guidance for the Hazard Communication Standard’s (HCS) June 1, 2015 Effective Date” (Enforcement Guidance). The Interim Guidance offers clarity on a few specific...

On May 12, 2015, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released a new (second) draft of the TSCA Modernization Act of 2015 (TMA2 DD). In April, Shimkus released an initial discussion draft of the TSCA Modernization Act of 2015 (TMA1); our memorandum on TMA1 is available online. In the previous Congress, Shimkus introduced first a discussion draft of the Chemicals in Commerce Act (CICA1), and then a...

The U.S. Occupational Safety and Health Administration’s (OSHA) Hazard Communication Standard (HCS) deadline of June 1, 2015, is fast approaching. Below is a brief summary of what is at stake, and what needs to be in place by the deadline. On March 26, 2012, OSHA issued a final rule modifying its HCS to conform to the United Nations’ Globally Harmonized System of Classification and Labeling of Chemicals (GHS), Revision 3. In the final rule, OSHA drastically...

On May 8, 2015, in El Comite Para El Bienestar De Earlimart v. EPA, a Panel of the U.S. Court of Appeals for the Ninth Circuit denied a petition for review filed by several groups that the court describes as “community organizations” who challenged the U.S. Environmental Protection Agency’s (EPA) 2012 approval of California State Implementation Plan (SIP) elements under the Clean Air Act (CAA), including its related approval of certain fumigant regulations.  This challenge was...

On May 14, 2015, the House Energy and Commerce Subcommittee on Environment and the Economy held a markup of a revised discussion draft of the TSCA Modernization Act of 2015, prepared by Subcommittee Chair John Shimkus (R-IL) and released on May 12, 2015. The May 12, 2015, press release announcing the revised discussion draft and markup emphasizes the bipartisan nature of the bill, which is supported by Shimkus, Subcommittee Ranking Member Paul Tonko (D-NY), Committee Chair...

Background A new version of the Frank R. Lautenberg Chemical Safety for the 21st Century Act was considered for markup by the Senate Environment and Public Works (EPW) Committee on April 28, 2015. The revised version, which we identify here as Lautenberg2, includes changes that appear to be intended to address issues and concerns identified by Senators with the previous version of the bill (Lautenberg1). Our review of Lautenberg1 is available online. We reviewed the key changes...

DOT Inspector General To Audit PHMSA Progress In Meeting Congressional Mandates: On May 5, 2015, U.S. Department of Transportation (DOT) announced that its Inspector General (IG) has launched an audit of DOT’s Pipeline and Hazardous Materials Safety Administration (PHMSA) at the request of Representative Peter DeFazio (D-OR), Ranking Member of the House Transportation and Infrastructure Committee. In its announcement of the audit, the IG’s office stated that DeFazio is...

FDA Announces GUDID Public Website: On May 4, 2015, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced that the data submitted to the Global Unique Device Identification Database (GUDID) are now publicly available. The website, in partnership with the National Library of Medicine, is part of the phase-in for the Unique Device Identification compliance timeline and offers anyone access to search or download information submitted for...

On April 28, 2015, the Senate Committee on Environment and Public Works held a hearing to consider several bills, including the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697). Prior to the hearing, on April 27, 2015, Senators Tom Udall (D-NM), Sheldon Whitehouse (D-RI), Jeff Merkley (D-OR), and Cory Booker (D-NJ) announced a bipartisan compromise agreement intended to strengthen protections under S. 697, while expanding states’ authority. During...

On April 16, 2015, the California Department of Toxic Substances Control (DTSC) released its much anticipated Final Priority Product Work Plan under the Safer Consumer Products Regulations. The Work Plan, initially proposed on September 12, 2014, describes product categories it will use to evaluate and identify product-chemical combinations to be added to the Priority Products. The purpose of the Work Plan is to provide a “level of predictability to potential manufacturers, importers,...

On April 14, 2015, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing on the discussion draft of the TSCA Modernization Act of 2015 (TMA DD) introduced by Subcommittee Chair John Shimkus (R-IL) on April 7, 2015. As noted in our April 9, 2015, memorandum, “Shimkus Releases Discussion Draft of TSCA Reform Legislation,” in the previous Congress, Shimkus introduced first a discussion draft of the Chemicals in Commerce Act (CICA1), and then...

On April 7, 2015, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released a Discussion Draft of the “TSCA Modernization Act of 2015” (TMA DD). In the previous Congress, Shimkus introduced first a discussion draft of the Chemicals in Commerce Act (CICA1), and then a revised discussion draft of the bill, CICA2. In addition, Shimkus held “countless” hearings concerning reform of the Toxic...

The U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale was published in the April 6, 2015, Federal Register. EPA proposes to require persons that manufacture or process these chemical substances to report electronically to EPA certain information, including the specific chemical identity,...

On April 1, 2015, the Korean Ministry of Environment submitted the list of priority existing substances for consultation in accordance with Article 9 of Korea’s Registration, Evaluation, Authorization, and Restriction of Chemicals (K-REACH) regulation. The list identifies in Korean and English 518 phase-in (existing) substances that are considered a priority and thus part of the first phase of registration under K-REACH. The deadline for submitting comments is April 30,...

On April 6, 2015, the U.S. Environmental Protection Agency (EPA) issued a Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. EPA proposes to require persons that manufacture or process these chemical substances to report electronically to EPA certain information, including the specific chemical identity, production volume, methods...

House Bill Would Block EPA From Vetoing Dredge And Fill Permits Issued By Army Corps Of Engineers: On March 3, 2015, West Virginia’s entire House of Representatives delegation re-introduced a bill that is intended “to stop the federal Environmental Protection Agency’s unprecedented overreach,” according to the bill’s sponsor, David McKinley (R-WV). The bill (H.R. 1203) would amend the U.S. Environmental Protection Agency’s (EPA) authority to revoke...

ECHA Publishes List Of Pending Article 95 Applications:The European Chemicals Agency (ECHA) announced in a March 31, 2015 press release, that to increase transparency ahead of the September 1, 2015, deadline for the compliance with Biocidal Products Regulation (BPR) Article 95, it has published a list of all pending Article 95 applications. The list contains applications for which the ECHA has not yet taken a decision, and ECHA will update it regularly. ECHA will synchronize its...

As noted in our recent memorandum on the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697, Lautenberg), Senators Barbara Boxer (D-CA) and Ed Markey (D-MA) recently introduced the Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act (S. 725, Boxer-Markey), which presents their approach to revising the Toxic Substances Control Act (TSCA). We had committed to preparing a review comparing Lautenberg with the new Boxer-Markey bill, and that...

On March 18, 2015, the Senate Environment and Public Works Committee held a hearing on the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697). A detailed analysis of S. 697 is available in our March 13, 2015, memorandum. There were a number of references to the late Senator Frank R. Lautenberg (D-NJ), who introduced several bills intended to reform the Toxic Substances Control Act (TSCA), and whether the current bill would accomplish his goals....

In a March 9, 2015, decision in Perez v. Mortgage Bankers Ass’n., the U.S. Supreme Court unanimously held that an interpretative rule issued by an administrative agency does not require notice and opportunity for comment, even if the interpretative rule construes a substantive (or “legislative”) rule previously issued by the agency and even if the interpretative rule alters a prior interpretation of the same rule. In the Perez decision, the Court explicitly...

Background The Senate over the past several years has considered a number of legislative texts to amend the Toxic Substances Control Act (TSCA). These include the Safer Chemicals Act, several versions of which were introduced by Senator Frank Lautenberg (D-NJ), with the most recent in 2013, and the Chemical Safety Improvement Act (S. 1009, CSIA) introduced by Senators Lautenberg and David Vitter (R-LA) in 2013. Senator Lautenberg died shortly after CSIA’s introduction and over time...