Memoranda

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...

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 of human health and...

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...

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 Violations...

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 May 2015, while an initial discussion draft...

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 points to manufacturers, importers,...

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 modified the...

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...

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...

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...

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...

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 the...

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, retailers,...

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 a revised...

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 Substances Control Act...

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,...

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 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 permits issued...

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...

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...

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. Throughout the...

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...

New York Times (March 6, 2015)" data-title="TSCA Reform: "Tom Udall's Unlikely Alliance With the Chemical Industry" New York Times (March 6, 2015)"> Headlines in The New York Times (NYT) describing a cozy relationship between a liberal Democratic Senator from New Mexico and the chemical industry is not a common occurrence. In this case, understanding the coverage reveals the story of an even more sordid and murky world of political infighting, nasty and...

On February 27, 2015, the California Department of Pesticide Regulation (DPR) released California Notice 2015-3, entitled Concurrent Submission of Pesticide Products to the Department of Pesticide Regulation and the U.S. Environmental Protection Agency. In this Notice, DPR describes the four types of applications that may be submitted concurrently to DPR and to the U.S. Environmental Protection Agency (EPA), the procedure applicants should follow to request concurrent submission,...

On February 9, 2015, the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) published the "Enforcement Guidance for the Hazard Communication Standard's (HCS) June 1, 2015 Effective Date" (Guidance). The Guidance offers important insights into OSHA's HCS enforcement strategy and is a must read for stakeholders. Bergeson & Campbell, P.C., The Acta Group, and 3E Company, a Verisk Analytics business, will present a complimentary...

The California Department of Pesticide Regulation (DPR) announced on February 26, 2015, a revision to the process for evaluation of the potential for a pesticide to move off-site into surface water when the pesticide is used in an urban area. The former evaluation method followed the U.S. Environmental Protection Agency (EPA) approach with California specific parameters. This revision will continue to use the EPA approach but allow incorporation of a module specific for California urban...

On February 11, 2015, the Government of Canada published in Gazette II (Vol. 149, no. 3) the final regulation for adopting the Globally Harmonized System for Classification and Labeling of Chemicals (GHS). The final Hazardous Product Regulation (HPR) appears to be nearly identical to the proposed regulation published in Gazette I in August of 2014 (Vol. 148, no. 32) and is closely aligned with the U.S. Department of Labor's Occupational Safety and Health...

For the dog lovers of the world, this one is for you. The Federal Trade Commission (FTC) recently sent "warning letters" to 20 manufacturers and marketers of dog waste bags that dog owners, walkers, and conscientious others use to pick up after their pets and then discard. FTC expresses in the letters concern with the environmental claims for "biodegradable" or "compostable" that FTC alleges fail to conform with the updated Guides for the Use of Environmental Marketing Claims (Green...

On January 12, 2015, the Office of Environmental Health Hazard Assessment (OEHHA) proposed important new regulations that would repeal and replace the existing Article 6 regulations regarding the all-important "clear and reasonable warnings" requirements under Proposition 65 (Proposed Rule). OEHHA previously released a Pre-Regulatory Proposal for a potential draft regulation amending Proposition 65 (Prop 65) regulations with some sweeping and controversial proposed changes, including, for...

On January 21, 2015, the U.S. Environmental Protection Agency (EPA) issued a proposed amendment to a significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals. According to EPA's January 15, 2015, press release, EPA intends the proposed amendment "to ensure that perfluorinated chemicals that have been phased out do not re-enter the marketplace without review." The proposed amendment would require anyone who intends to import these perfluorinated...

EPA Reviews National Ambient Air Quality Standards For Ozone: On December 17, 2014, the U.S. Environmental Protection Agency (EPA) issued a proposed rule revising the air quality criteria for ozone (O3) and related photochemical oxidants and National Ambient Air Quality Standards (NAAQS) for O3. 79 Fed. Reg. 75234. EPA proposed to revise the primary standard to a level within the range of 0.065 to 0.070 parts per million (ppm), and to revise the secondary standard...

EPA Seeks Additional Comment On NPDES Electronic Reporting Rule: On December 1, 2014, the U.S. Environmental Protection Agency (EPA) requested additional comment on the proposed National Pollutant Discharge Elimination System (NPDES) Electronic Reporting Rule that would require electronic reporting instead of current paper-based NPDES reports. 79 Fed. Reg. 71066. This rule would, according to EPA, modernize NPDES reporting, save time and resources for regulated...

RCRA Definition Of Solid Waste Final Rule Published In Federal Register: On January 13, 2015, the U.S. Environmental Protection Agency (EPA) published its final rule revising the Definition of Solid Waste (DSW) under the Resource Conservation and Recovery Act (RCRA). 80 Fed. Reg. 1693. The rule overturns or significantly revises several hazardous waste recycling exclusions previously contained in a 2008 EPA final rule. 73 Fed. Reg. 64688 (Oct. 30, 2008)....

Click here for a PDF version of the memorandum. 2015 will be a very interesting year. There are two overarching considerations that will make the year more difficult to predict than merely assuming most of this year's issues will simply be extensions of past issues, with a few new initiatives sprinkled in. First, the new Republican majority in the Senate will change the dynamic between the Executive and Legislative branches. Second, the Obama Administration will begin its lame duck status as it...

On December 17, 2014, the U.S. Environmental Protection Agency (EPA) announced that it is taking action to protect the public from certain chemicals that it states have the potential to cause a range of health effects from cancer to reproductive and developmental harm to people and aquatic organisms. EPA's press release, "EPA Prevents Harmful Chemicals from Entering the Marketplace," includes a quote from Jim Jones, Assistant Administrator for the Office of Chemical Safety and Pollution...

On June 20, 2014, the White House issued a "Presidential Memorandum -- Creating a Federal Strategy to Promote the Health of Honey Bees and Other Pollinators." The strategy is directed to all federal agencies and is designed to "expand Federal efforts and take new steps to reverse pollinator losses and help restore populations to healthy levels." The text of the memo lists a number of goals and comments on pollinator health, and has a focus on setting up a government-wide task force, along with...

The U.S. Environmental Protection Agency (EPA) announced on October 3, 2014, the availability of a final document entitled Guidance for Applying Quantitative Data to Develop Data-Derived Extrapolation Factors for Interspecies and Intraspecies Extrapolation (DDEF Guidance). EPA states that the DDEF Guidance "lays out methods for calculation of factors compensating for the application of animal toxicity data to humans (interspecies) and for compensating for sensitive populations...

The U.S. Environmental Protection Agency (EPA) announced on October 23, 2014, that it has updated its Toxic Substances Control Act (TSCA) Work Plan for Chemical Assessments. According to EPA, the updated TSCA Work Plan reflects updated data submitted to EPA on chemical releases and potential exposures that EPA received as part of the Chemical Data Reporting (CDR) Rule and the Toxics Release Inventory (TRI) Program. EPA removed or consolidated 16 chemicals, most of which are believed to be...

On October 1, 2014, the U.S. Environmental Protection Agency (EPA) proposed a Significant New Use Rule (SNUR) for 15 related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE). For 13 NPs and NPEs, EPA would designate any use as a "significant new use," and for two additional NPs, EPA would designate that any use other than use as an intermediate or use as an epoxy cure catalyst would constitute a "significant new use." Persons subject to the SNURs would be...