Memoranda

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...

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...

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...

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...

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...

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 created...

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...

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...

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...

The OSPAR Commission’s (OSPAR) Harmonized Offshore Chemical Notification Format (HOCNF) is of paramount importance for a wide range of personnel, including chemical manufacturers and product manufacturers whose products are used on an offshore oil platform. Despite its significance, many in the U.S. are largely unaware of its role in the petrochemical community. We describe the program generally below focusing on the interrelations with other chemical programs, including the Registration,...

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,...

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. §...

The U.S. Environmental Protection Agency (EPA) announced on June 12, 2014, safer alternatives to flame retardants currently used in consumer and commercial products, including building insulation and products with flexible polyurethane foam. According to EPA, flame retardant chemicals such as hexabromocyclododecane (HBCD) and pentabromodiphenyl ether (pentaBDE) “raise concerns for human health and the environment including potential reproductive, developmental, and neurological effects and...

Within the next 12-18 months, companies are facing multiple deadlines for various country adaptations of the United Nations’ Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS). These include major re-evaluations of how chemical mixtures and substances are classified, re-authoring of Safety Data Sheets (SDS), and re-labeling requirements for the U.S., the European Region, Brazil, Serbia, Malaysia, Australia, and South Africa. Each country or region has adopted...

On June 6, 2014, the U.S. Environmental Protection Agency (EPA) announced that Liphatech, Inc. (Liphatech), a pesticide manufacturer based in Milwaukee, WI, paid a $738,000 civil penalty for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) violations. The vast majority of the penalty was based on violations of FIFRA Section 12(a)(2)(E), because, EPA alleged, Liphatech failed to identify Rozol, a rodenticide used to control prairie dogs, as a Restricted Use Pesticide (RUP) in its...

In April 2013, an explosion destroyed a fertilizer plant in West, Texas, killing 15. In response to this and other recent catastrophic and fatal incidents at chemical facilities, President Obama on August 1, 2013, issued Executive Order (EO) 13650 — Improving Chemical Facility Safety and Security. The purpose of the EO is to enhance the safety and security of chemical facilities and reduce risks associated with hazardous chemicals to facility workers and operators, communities, and...

The Democratic Minority has circulated a redline version of the April 22, 2014, discussion draft of the Chemicals in Commerce Act (CICA2). A copy of the redline version of CICA2 is available online. The redline version is an interesting mix of substantial rewrites, deletions, and additions. The redline version, which we will refer to as CICA2-D to distinguish it from CICA2 and the original discussion draft, CICA1, proposes changes that favorably respond to numerous non-governmental...

The U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) recently noted that it successfully completed the Agency’s reorganization process and that the effective date will be sometime after June 9, 2014. The reorganization, which The Acta Group (Acta) had discussed in its “Predictions” memo, available online, represents a significant shuffle in responsibilities and also reduces the number of OPPT Divisions by one with the...

The House Science, Space, and Technology Subcommittee on Research and Technology held a hearing on May 20, 2014, on “Nanotechnology: From Laboratories to Commercial Products.” The purpose of the hearing was to examine the current state of nanotechnology research and development (R&D), as well as future opportunities and challenges. In addition, the hearing discussed policy issues surrounding nanotechnology applications and activities, federal funding levels for nanotechnology...

The U.S. Environmental Protection Agency (EPA) published in the May 19, 2014, Federal Register an advance notice of proposed rulemaking (ANPR) to seek comment on the information that should be reported or disclosed for hydraulic fracturing chemical substances and mixtures and the mechanism for obtaining this information. According to EPA, this mechanism could be regulatory (under Sections 8(a) and/or 8(d) of the Toxic Substances Control Act (TSCA)), voluntary, or a combination of both....

On April 29, 2014, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing to review a revised draft of the Chemicals in Commerce Act (CICA2). Representative John Shimkus (R-IL), Chair of the Subcommittee, released CICA2 on April 22, 2014. According to Shimkus, since he first released the discussion draft in March 2014 (CICA1), he has been working on a bipartisan basis to find common ground to reform the Toxic Substances...

On April 22, 2014, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, announced that the Subcommittee will hold a hearing on April 29, 2014, to review a revised draft of the Chemicals in Commerce Act (CICA2). According to Shimkus, the revised draft “reflects suggestions from members on both sides of the aisle, as well as stakeholders and the administration.” CICA would reform the Toxic Substances Control Act...

The U.S. Environmental Protection Agency (EPA) published a notice on April 4, 2014, announcing that it issued a testing consent order that incorporates an enforceable consent agreement (ECA) for octamethylcyclotetrasiloxane (D4), a chemical intermediate and component of personal care products. 79 Fed. Reg. 18822. There are two big take away messages here. First, that EPA issued a testing order at all under Toxic Substances Control Act (TSCA) Section 4 is big news as none has...

On March 7, 2014, the Office of Environmental Health Hazard Assessment (OEHHA) released a pre-regulatory proposal for a potential draft regulation amending Proposition 65 regulations. Significantly — and likely controversially — the proposal seeks changes to the warning requirements to require more detailed information, including the names of the chemicals covered by individual warnings, the ways that individuals are exposed to these chemicals, and how individuals can avoid or reduce...

The California Department of Toxic Substances Control (DTSC) announced on March 13, 2014, the first draft Priority Products (PP) under the Safer Consumer Products Regulations (SCPR). The three draft PPs are: DTSC states that the designation as a draft PP “imposes no new regulatory requirements on manufacturers until DTSC finalizes it by adopting regulations.” Under the SCPR, DTSC will begin a rulemaking process for each PP, and DTSC anticipates it could take a year to...

On March 12, 2014, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing focused on the discussion draft of the Chemicals in Commerce Act (CICA). On February 27, 2014, Representative John Shimkus (R-IL), Chair of the Subcommittee, released a much anticipated discussion draft that would update the Toxic Substances Control Act (TSCA). The March 12 hearing was intended to provide the Subcommittee an opportunity to review the provisions of CICA....

On February 27, 2014, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released a much anticipated discussion draft that would update the Toxic Substances Control Act (TSCA). According to Shimkus’ press release, the Chemicals in Commerce Act (CICA) “keys off” S. 1009, the Chemical Safety Improvement Act (CSIA), which was introduced on May 22, 2013, by the late Senator Frank R. Lautenberg (D-NJ) and Senator...

The European Commission (EC) recently published Commission Implementing Regulation (EU) 88/2014, specifying a procedure for the addition of new active substances to Annex I to the Biocidal Products Regulation (BPR) No. 528/2012. BPR Annex I lists active substances that are considered “low concern.” Biocidal products utilizing only these active substances are eligible for the simplified authorization procedure in accordance with BPR Article 25. Active substances placed on BPR Annex I...

The U.S. Environmental Protection Agency (EPA) promulgated on February 5, 2014, a final rule revising and updating the regulations governing the procedures for the satisfaction of data requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Given the importance of data compensation rights, and the fact EPA has not weighed-in on this matter for over three decades, the rule is an important must read for pesticide stakeholders. The final rule addresses procedures for the...

On February 4, 2014, the House Energy and Commerce Subcommittee on Environment and the Economy held a hearing entitled “Testing of Chemicals and Reporting and Retention of Information under TSCA Sections 4 and 8.” This was the fifth hearing on the Toxic Substances Control Act (TSCA) convened by the Subcommittee. The Subcommittee held oversight hearings on June 13, 2013, July 11, 2013, September 18, 2013, and November 13, 2013, that reviewed several core sections of...

In direct response to the tragic and in many respects avoidable events that occurred in West Virginia earlier this month, on January 27, 2014, Senators Joe Manchin (D-WV), Barbara Boxer (D-CA), Chair of the Environment and Public Works Committee, and Jay Rockefeller (D-WV) introduced the Chemical Safety and Drinking Water Protection Act of 2014. The bill would amend the Safe Drinking Water Act (SDWA) by adding Part G — Protection of Surface Water from Contamination...

The U.S. Environmental Protection Agency (EPA) has revised the Notice of Arrival (NOA) form (EPA Form 3540-1), the use of which is required for import of pesticides and pest control devices into the United States. Importers should begin using the new form immediately. The revised form and related instructions are available online. EPA has added optional information blocks, recommendations, and certain clarifications to the instructions. Some of these changes may be beneficial and respond to...

On December 30, 2013, Health Canada’s Pest Management Regulatory Agency (PMRA) released a consultation document entitled Proposed Approach to Special Reviews – Consultation Document. The Consultation Document outlines the Pest Control Products Act legislative requirements for special reviews and PMRA’s proposed approach to conduct such special reviews. The document is available online. PMRA is accepting comments until January 29, 2014. PMRA states that any comments...

On November 12, 2013, the United States Environmental Protection Agency (EPA) released an Administrative Law Judge (ALJ) decision ordering Respondent Elementis Chromium Inc., f/k/a Elementis Chromium, LP (Elementis or Company), to pay a $2,571,800 civil penalty for violating Section 8(e) and Section 15(3)(B) of the Toxic Substances Control Act (TSCA). The decision is available online. Although the case is highly fact-specific, the decision, if upheld under any potential appeal, may be used...

The Acta Group (Acta) outlines below thoughts on what may be headed our way in 2014 from the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). We also offer a few thoughts on European and Asian developments pertinent to chemical regulatory matters. Although President Obama is well into his second term, the 2014 off-year elections, combined with the bitter partisan atmosphere in Washington, D.C., will result in a continuing use...

In what may be a test case for the future of neonicotinoids, the first public consultation launched by the European Chemicals Agency (ECHA) for a new active substance under the 2013 Biocidal Products Regulation (BPR) will address dinotefuran (CAS Number 165252-70-0), a neonicotinoid insecticide. According to ECHA’s November 29, 2013, announcement, dinotefuran will be considered as a candidate for substitution under criteria set out in Article 10 of the BPR that are based on the...

On November 20, 2013, the United States Environmental Protection Agency (EPA) announced its intent to release for comment proposed Draft Guidelines for Product Environmental Performance Standards and Ecolabels for Voluntary Use in Federal Procurement (Draft Guidelines). EPA states the Draft Guidelines — developed by EPA, the General Services Administration (GSA), and other federal agencies following several “listening sessions” with a wide range of stakeholders — are...