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...
May 14, 2015
TSCA Reform: House Subcommittee Holds Markup of Revised Draft TSCA Bill and Passes Amended Draft
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...
April 2, 2015
ECHA Publishes List Of Pending Article 95 Applications and Other Recent BPR Developments
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...
March 24, 2015
TSCA Reform: Detailed Analysis of the Alan Reinstein and Trevor Schaefer Toxic Chemical Protection Act
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...
March 19, 2015
TSCA Reform: Senate Committee Holds Hearing on Frank R. Lautenberg Chemical Safety for the 21st Century Act
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....
March 16, 2015
Supreme Court Confirms That Agency Interpretative Rules Do Not Require Notice and Comment
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...
March 6, 2015
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 cutting comments between Senators of the same party, and nuanced comments by interest groups that have to calibrate how much and who to support or how intensely...
March 4, 2015
DPR Issues California Notice 2015-3 Regarding Concurrent Application Submissions to DPR and EPA
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, and how...
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 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...
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 Administration...
February 5, 2015
FTC: Warning Letters to Manufacturers of Dog Waste Bags Suggest They May Be in Deep Doo-Doo
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...
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,...
January 23, 2015
TSCA: EPA Proposes a Significant New Use Rule That Would Close a Chapter on Perfluorinated Chemicals
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...
January 22, 2015
RCRA Definition of Solid Waste Final Rule Published in Federal Register, and Other Recent RCRA Developments
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). Perhaps the biggest revision in...
January 22, 2015
EPA Seeks Additional Comment on NPDES Electronic Reporting Rule, and Other Recent CWA Developments
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 entities and regulatory...
January 22, 2015
EPA Reviews National Ambient Air Quality Standards for Ozone, and Other Recent CAA Developments
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 to...
January 5, 2015
Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2015
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...
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...
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...
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...
October 23, 2014
TSCA Work Plan for Chemical Assessments: EPA Adds and Removes Chemicals Based on New Data
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...
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...
Following the release last week of our Firm Clients and Friends Memorandum “Summary of Changes in the Chemical Safety Improvement Act (CSIA, S. 1009) and the Boxer TSCA Version Released September 18, 2014,” Bergeson & Campbell, P.C. (B&C®) received copies of a number of documents relating to what is now described as the “Udall-Vitter Discussion Draft” (U-V DD) of the original CSIA (CSIA1). The documents obtained include: This Memorandum briefly summarizes these...
September 25, 2014
Summary of Changes in the Chemical Safety Improvement Act(CSIA, S. 1009) and the Boxer TSCA Version Released September 18, 2014
Background This analysis reviews the changes made to the original version of the Chemical Safety Improvement Act (CSIA) (identified as CSIA1 in this memorandum) based on Senator Barbara Boxer’s (D-CA) version of the Toxic Substances Control Act (TSCA) reform legislation released on September 18, 2014 (Boxer TSCA). This analysis attempts to analyze both the interim changes made to the bill and the changes that appear as underlined text in Boxer TSCA. Boxer TSCA was reportedly...
September 17, 2014
Spray Drift and Volatilization: Issues to Navigate Carefully as EPA Develops Registration Review Decisions
Spray drift and volatilization issues increasingly are significant issues in pesticide product risk assessments. Earlier this year, the U.S. Environmental Protection Agency (EPA) issued drafts of key guidance documents, which focused on issues that were key in the chlorpyrifos petition response, and more recently, at least one registration review decision that reflects current and still evolving EPA policy on spray drift and volatilization issues. How potential for spray drift and for...
On September 12, 2014, the California Department of Toxic Substances Control (DTSC) released its much anticipated draft Initial Priority Product Work Plan under the Safer Consumer Products Regulations. The Regulations require that DTSC, by October 2014, develop an Initial Priority Product Work Plan that describes product categories it will use to evaluate and identify product-chemical combinations to be added to the Priority Products. The Work Plan is available online and more detailed...
On August 9, 2014, the Government of Canada published in Gazette I (Vol. 148, no. 32) a proposal for adopting the Globally Harmonized System for Classification and Labeling of Chemicals (GHS). The regulatory proposal seeks to align current systems for classification, material safety data sheets (MSDS), and labels with the U.S. Occupational Safety and Health Administration (OSHA) Hazard Communications Standard published on May 26, 2012 (HCS 2012) and the approaches used in other...
The U.S. Environmental Protection Agency (EPA) released on August 28, 2014, final risk assessments for three Toxic Substances Control Act (TSCA) Work Plan chemicals — methylene chloride or dichloromethane (DCM), antimony trioxide (ATO), and 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8,-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB). The much anticipated release of these assessments marks a real milestone for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), and EPA is to be...
The European Chemicals Agency (ECHA) recently released 25 decisions on data sharing disputes under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program and two decisions on data sharing disputes under the Biocides Product Regulation (BPR). Compensation for data sharing is to be determined under REACH and BPR by the same standard, that is, in a “fair, transparent and non-discriminatory manner,” and as such there are similar issues in the ECHA...
August 18, 2014
New Decision in Mega ESA Case Dismisses Most Consultation Claims with Prejudice, Although Certain Claims Survive Pending Further Submissions
In a wide-ranging decision issued on August 13, 2014, in Center for Biological Diversity v. EPA (N.D. Cal.) (often referred to as the “Mega ESA” case), Magistrate Judge Spero has dismissed most of the claims by the Plaintiffs that the U.S. Environmental Protection Agency (EPA) failed to consult or to reinitiate consultation under Endangered Species Act (ESA) Section 7(a)(2) in connection with EPA’s registration under the Federal Insecticide, Fungicide, and Rodenticide...
On July 7, 2014, the Natural Resources Defense Council (NRDC) filed with the U.S. Environmental Protection Agency (EPA) a petition requesting that EPA commence a Special Review for the neonicotinoid pesticides, including six specific active ingredients (dinotefuran, acetamiprid, clothianidin, thiacloprid, imidacloprid, and thiamethoxam), based on the risk that NRDC believes this class of compounds poses to honey bees and native bees. In the petition, NRDC alleges that neonicotinoids “may...
July 14, 2014
Presidential Memorandum Creates Federal Strategy to Promote Health of Honey Bees and Other Pollinators
On June 20, 2014, President Obama issued a Presidential memorandum entitled “Creating a Federal Strategy to Promote the Health of Honey Bees and Other Pollinators.” The memorandum creates a Pollinator Health Task Force, which will be co-chaired by the U.S. Department Agriculture (USDA) and U.S. Environmental Protection Agency (EPA). The Task Force will develop a National Pollinator Health Strategy, which includes a Pollinator Research Action Plan, Public Education Plan, and...
July 2, 2014
China in Talks to Join the OECD System for the Mutual Acceptance of Data in Assessment of Chemicals
It has recently been reported that China is in discussions with the Organization for Economic Cooperation and Development (OECD) to become a provisional adherent to the Mutual Acceptance of Data (MAD) system. This would require China to accept data from safety testing of chemicals from participating countries generated under the MAD conditions and to establish a Good Laboratory Practice (GLP) compliance monitoring program. If China were to become a provisional adherent to the MAD system,...
On June 26, 2014, the U.S. Food and Drug Administration (FDA) held a public meeting to discuss the proposed changes to the nutrition label and serving sizes. The meeting was attended by interested parties both in Washington, D.C. and via webcast. The Acting U.S. Surgeon General, Rear Admiral Boris D. Lushniak, M.D., M.P.H., gave the opening remarks stating the importance of these changes in relation to the Surgeon General’s national prevention strategy started in June...
The Federal Trade Commission (FTC) has stepped-up its enforcement initiatives and recently settled two cases with companies that market plastic lumber and related products. FTC alleged that these companies misled consumers in violation of Section 5 of the Federal Trade Commission Act (FTC Act) in their marketing materials regarding the environmental attributes of their products. Specifically, these cases hinge on claims related to the recycled content and post-consumer content of their products....
On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide “greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.” One final guidance addresses FDA’s overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals,...
June 25, 2014
EPA’s Enforcement Efforts Regarding FIFRA Supplemental Distribution and How to Avoid Noncompliance
Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(e), a registrant may distribute or sell its registered product under another person’s name and address instead of (or in addition to) its own without a separate FIFRA Section 3 registration. Such distribution and sale is termed “supplemental distribution” (sometimes referred to as a sub-registration) and the product is referred to as a “distributor product.” FIFRA § 3(e), 7 U.S.C. §...