October 20, 2017

California and New York Require Manufacturers to Disclose Ingredients in Cleaning Products

On October 15, 2017, California Governor Jerry Brown (D) signed the Cleaning Product Right to Know Act of 2017 (S.B. 258). The new law requires manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The online disclosure requirements apply to a designated product sold in California on or after January 1, 2020. The product label disclosure requirements would apply to a designated product sold in...
October 19, 2017

Proposition 65: OEHHA Releases Q&A Regarding Proposition 65 Regulations for Clear and Reasonable Warnings

In August 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) released a Questions and Answers for Businesses (Q&A) document related to its August 28, 2016, adopted revisions to its Proposition 65 (Prop 65) Article 6 regulations covering “clear and reasonable warnings” requirements. Information related to OEHHA’s past actions modifying Prop 65 warning regulations, including the August 28, 2016, adoption and the November 27, 2015, and March 25, 2016,...
October 17, 2017

Prop 65 Amendments Now Effective Regarding Content of Notices of Violation Involving Occupational Exposures

On October 1, 2017, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment’s (OEHHA) regulations amending the content required in Proposition 65 (Prop 65) Notices of Violation involving occupational exposure became effective.  The regulations (found at Title 27 of the California Code of Regulations, Section 25903(b)(2)(E)), first proposed on May 19, 2017, are intended to clarify that the “Special Compliance Procedure Proof of...
October 16, 2017

Turkey Continues Progress Towards Comprehensive KKDIK Implementation And Support

KKDIK, Turkey REACH, was published on June 23, 2017, after long delays, and will enter into force on December 23, 2017. Turkey’s Ministry of Environment and Urbanization (MoEU) will make available 13 guidance documents by the end of the year to assist industry with compliance. Guidance documents to be issued by the end of the year will address the following issues, among others: (1) dossier and substance evaluation; (2) dossier preparation and harmonized...
October 5, 2017

FDA Guidance Addresses FDA and EPA Jurisdiction over Mosquito-Related Products

On October 4, 2017, the U.S. Food and Drug Administration (FDA) announced the availability of final guidance that helps to clarify FDA and U.S. Environmental Protection Agency (EPA) jurisdiction over the regulation of mosquito-related products intended to function as pesticides, including those produced through the use of biotechnology.  The notice was published in the Federal Register on October 5, 2017.  82 Fed. Reg. 46500.  Guidance for Industry #236,...
October 2, 2017

Methods and Guidance for Testing the Efficacy of Antimicrobials against Spores of Clostridium difficile

On September 29, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of two final test method Standard Operating Procedures (SOP) for evaluating the efficacy of antimicrobials against spores of Clostridium difficile (C. diff).  EPA also released regulatory guidance for test criteria and pesticide claims for these products, specifically “Methods and Guidance for Testing the Efficacy of Antimicrobial Products Against Spores of Clostridium...
September 21, 2017

California Bill Would Require Disclosure of Cleaning Product Ingredients

On September 13, 2017, the California Senate passed the final version of the Cleaning Product Right to Know Act of 2017 (S.B. 258), which would require manufacturers of cleaning products to disclose certain chemical ingredients on the product label and on the manufacturer’s website. The Senate passed the bill by a vote of 27 to 13. The California Assembly passed the bill by a vote of 55 to 15, with nine votes not recorded, on...
September 15, 2017

Turkey REACH Documents Available In English

As reported in our Global Regulatory Update for August 2017, on June 23, 2017, Turkey’s Ministry of Environment and Urbanization (MoEU) published its REACH-like KKDIK Regulation. As reported in The Acta Group’s memorandum entitled “Turkey Catching Up with the [EU’s REACH] Regulation,” the name “KKDIK” is derived from the first letters of “Registration,” “Evaluation,” “Authorization,” and “Restriction” in Turkish. Similar to EU REACH, KKDIK requires companies to...
September 14, 2017

Cefic Provides Circular Economy Comments On EC’s Stakeholder Consultation, and Other Recent REACH Developments

Cefic Provides Circular Economy Comments On EC’s Stakeholder Consultation: In July, the European Chemical Industry Council (Cefic) provided comments in response to the European Commission’s (EC) “Stakeholder Consultation Paper” on chemicals, products, and waste legislation. In its “feedback to the targeted consultation,” Cefic responded to each of the key issues identified in the EC’s consultation paper. Regarding the first issue of “insufficient information about...
September 13, 2017

EC Officially Adopts EDC Identification Criteria For BPR, and Other Recent BPR Developments

EC Officially Adopts EDC Identification Criteria For BPR: On September 4, 2017, the European Commission (EC) issued a press release entitled “Endocrine disruptors: adoption of scientific criteria for biocides.” The EC’s press release stated that following endorsement by Member States, on July 4, 2017, of the scientific criteria for identification of endocrine disrupting chemicals (EDC) in pesticides, the EC adopted on September 4, 2017, the scientific criteria for identification of...
September 12, 2017

Revised Data Requirements for China New Chemical Notification Released

The Ministry of Environmental Protection of China (MEP) released on August 31, 2017, the Amendment on Data Requirements to the “Guidance for New Chemical Substance Notification and Registration.”  The revisions are expected to become effective on October 15, 2017.  As explained below, the new requirements reduce the data requirements for registration of low tonnage bands, particularly for the Level 1 regular registration but, as the amendment is in abbreviated table...
September 5, 2017

The September 19th CBI Substantiation Deadline Fast Approaching

As Toxic Substances Control Act (TSCA) aficionados know well, September 19, 2017, is a banner date.  By then, information that was submitted and claimed as Confidential Business Information (CBI) between June 22, 2016, and March 21, 2017, must be substantiated.  If you have not already done so, the September 19th deadline looms large. Background On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued an interpretation of TSCA Section 14 concerning...
August 14, 2017

Bergeson & Campbell, P.C. Forms “TSCA New Chemicals Coalition”

TSCA New Chemicals Coalition will give the chemical community greater opportunity to engage with EPA on constructive, helpful, and informed improvements to the new chemicals review process. JOIN NOW BACKGROUND Section 5 of the Toxic Substances Control Act (TSCA) addresses new chemical notifications and, as such, is chemical innovation’s regulatory gatekeeper.  The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) amended Section 5.  The U.S. Environmental...
August 3, 2017

EPA Seeks Comment on Nominations to “Augmented” Science Advisory Committee on Chemicals

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on August 3, 2017, providing the names and affiliations of additional candidates currently under consideration for appointment to the Science Advisory Committee on Chemicals (SACC). The notice states that the purpose of the SACC is to provide independent advice and expert consultation at the request of the EPA Administrator with respect to the scientific and technical aspects of risk assessments,...
July 27, 2017

Bergeson & Campbell, P.C.’s Comments on New Category Documents under the New Chemicals Program

Bergeson & Campbell, P.C. (B&C®) appreciates the efforts being made by the U.S. Environmental Protection Agency (EPA) to upgrade and update several of the category documents in the New Chemicals Program, encourage EPA’s continued activity in this area, and encourage EPA to engage in a broader effort to solicit public comments.  We recognize the critical role that the new chemicals categories have played in the implementation of the New Chemicals Program.  Over time, however, we...
July 18, 2017

Court Tosses RCRA Verified Recycler Exclusion but Retains Balance of Definition of Solid Waste Rule

On July 7, 2017, the U.S. Court of Appeals for the D.C. Circuit found “unreasonable,” and thus threw out, the “verified recycler” exclusion promulgated by the U.S. Environmental Protection Agency (EPA) in its 2015 revisions to the definition of solid waste under the Resource Conservation and Recovery Act (RCRA).  The court reinstated the “transfer-based” exclusion promulgated by EPA under the Bush Administration.  In the case, American Petroleum Institute v....
July 3, 2017

RCRA Hazardous Waste Generator Improvements Rule Becomes Effective

On May 30, 2017, the Resource Conservation and Recovery Act (RCRA) Hazardous Waste Generator Improvements Rule became effective. 81 Fed. Reg. 85732 (Nov. 28, 2016). The rule will not become effective in RCRA-authorized states, however, until the states adopt the provisions and the U.S. Environmental Protection Agency (EPA) approves those state programs that adopt the rule. Please see our Monthly Update for December 2016 for additional detail on the rule. The potential scope of the...
June 28, 2017

Brazil Inches Forward On Industrial Chemicals Regulation Implementation

The Acta Group (Acta®) has been closely tracking the development of Brazil’s Industrial Chemicals Regulation (Regulação de Substâncias Químicas Industriais, or Regulação), which still only exists in draft form. As discussed in our Global Regulatory Update for June 2017, “on May 22, 2017, it was announced that, due to changes inside the Brazilian Ministry of Environment (Ministério do Meio Ambiente, or MMA), the extraordinary meetings of the National Commission of...
June 26, 2017

EPA Issues Final TSCA Framework Rules

The U.S. Environmental Protection Agency (EPA) released on June 22, 2017, the pre-publication Federal Register notices of the final framework actions under the Toxic Substances Control Act (TSCA), as revised by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (new TSCA). The final rules include the prioritization process rule, which establishes EPA’s process and criteria for identifying High-Priority chemicals for risk evaluation and Low-Priority chemicals for which...
June 20, 2017

Minamata Convention on Mercury Achieves Ratification: International Use and Mining of Mercury Targeted for Scale Down

The Minamata Convention on Mercury (Convention), a global treaty aimed at scaling down mercury use and production developed by the United Nations Environment Program (UNEP), recently surpassed the 50-country threshold required for it to become legally binding for all of its parties.  This occurred on May 18, 2017, when the European Union (EU) and seven of its member states (Bulgaria, Denmark, Hungary, Malta, the Netherlands, Romania, and Sweden) ratified the Convention.  The...
June 7, 2017

President’s FY18 Budget Proposes Historic Cuts to EPA Funding and Staffing

On May 23, 2017, the White House unveiled the full version of President Trump’s proposed budget for fiscal year (FY) 2018 entitled “A New Foundation for American Greatness.”  As signaled in the President’s “skinny budget” released earlier this year, the proposed budget would fund the U.S. Environmental Protection Agency (EPA) at $5.7 billion — a more than 30 percent decrease from the current funding of nearly eight billion.  EPA’s congressionally enacted budget has...
June 6, 2017

Preparing for the Inventory Reset: It Is Not That Easy

With the recent release of the 2016 Chemical Data Reporting (CDR) dataset and the initial interim list of active substances released with the February 2017 copy of the Toxic Substances Control Act (TSCA) Inventory (Inventory), the magnitude of effort that will be needed for the Section 8(b)(4) Inventory Reset is becoming clear.  Stakeholders should waste no time in preparing to meet their obligations. Non-confidential Portion of the Inventory Bergeson & Campbell, P.C. (B&C®)...
June 5, 2017

Bergeson & Campbell, P.C. Suggests New Approaches to EPA in Managing New Chemical Polymers

One of the consequences of the new Toxic Substances Control Act (TSCA) is the need for the U.S. Environmental Protection Agency (EPA) to review and make determinations under Section 5(a)(3)(B) on premanufacture notification (PMN) chemicals submitted to EPA, and then to take required actions.  These requirements raise particular and sometimes challenging issues for new chemical polymers because the way polymers are identified allows for multiple different forms of the polymer to be...
May 31, 2017

Appellate Court Vacates Conditional Nanosilver Registration

On May 30, 2017, the U.S. Court of Appeals for the Ninth Circuit responded to two petitions for review of the U.S. Environmental Protection Agency’s (EPA) conditional registration of a nanosilver pesticide product and vacated the conditional registration. NRDC v. EPA, No. 15-72308. The Natural Resources Defense Council (NRDC) as well as the Center for Food Safety (CFS) and the International Center for Technology Assessment (ICTA) filed petitions in 2015 asking the court to set aside...
May 16, 2017

EPA Seeks Comment on Draft Guidance for Nanoscale Materials Reporting Rule

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on May 16, 2017, announcing the availability of and requesting public comment on a draft guidance document entitled “Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce.” The promised guidance provides answers to questions EPA has received from manufacturers (includes importers) and processors of certain chemical substances when they are manufactured or processed...
May 8, 2017

EPA to Host Meeting and Solicit Comments on Assignment and Application of Unique Identifiers under TSCA Section 14

On May 8, 2017, the U.S. Environmental Protection Agency (EPA) issued in the Federal Register a notification stating that a public meeting will be held to elicit public input on approaches for assigning and applying Unique Identifiers (UID) that are now required whenever it approves a Confidential Business Information (CBI) claim for the specific chemical identity of a chemical substance.  82 Fed. Reg. 21386.  The meeting will be held on May 24, 2017, from 1:00 p.m. to...
April 30, 2017

Senate Bill Seeks To Make America 100 Percent Clean Energy By 2050

On April 27, 2017, Senators Jeff Merkley (D-OR), Bernie Sanders (I-VT), Edward J. Markey (D-MA) and Cory Booker (D-NJ) introduced legislation that would transition the U.S to 100 percent clean energy by the year 2050. The bill is the first introduced in Congress that fully envisions a transition off of fossil fuels for the U.S. The 100 By ’50 Act (S. 967) bill has seven core components:...
April 26, 2017

Office of Chemical Safety and Pollution Prevention (OCSPP): Take Advantage of This Regulatory Reform Advocacy Opportunity

On February 24, 2017, President Trump issued Executive Order (EO) 13777, “Enforcing the Regulatory Reform Agenda.” Issuance of the EO, and the subsequent measures undertaken by U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt offer unique opportunities for chemical stakeholders.  This memorandum summarizes EPA’s efforts to date in this regard, and identifies opportunities that stakeholders may wish to pursue to eliminate or amend regulatory...
April 14, 2017

Federal Court Invalidates Air Reporting Exemption For Large-Scale Livestock Operations

On April 11, 2017, the U.S. Court of Appeals for the District of Columbia issued a decision vacating the U.S. Environmental Protection Agency’s (EPA) rule exempting livestock feeding operations from air reporting requirements under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and the Emergency Planning and Community Right-to-Know Act (EPCRA). Large-scale animal feeding operations that confine, for example, more than 1,000 cattle, 2,500 hogs, or...
April 7, 2017

FDA Announces Three Waivers To Sanitary Transportation Rule

On April 6, 2017, the U.S. Food and Drug Administration (FDA) published three waivers to the now final Sanitary Transportation rule mandated by the FDA Food Safety Modernization Act (FSMA) for businesses whose transportation operations are subject to separate state-federal controls in the Federal Register. 82 Fed. Reg. 16733. The waivers include: FDA reviewed comments on the waivers after they were included in the proposed rule and found that the waivers would not result in...
April 7, 2017

Internal EPA Memoranda Outline Approach for Regulatory Deconstruction; Stakeholders Have the Opportunity to Seek to Protect Programs at Risk

A trio of recent internal U.S. Environmental Protection Agency (EPA) memoranda are providing insight into how EPA intends to implement President Trump’s review and potential pogrom of EPA regulations. Virtually no program or regulation appears to be secure from the chopping block. Many stakeholders in industry and other sectors may be alarmed to see programs that are of benefit to them assigned a slot in the guillotine. Supporters of these programs, thus, would be wise...
April 3, 2017

EPA Denies Petition to Ban Chlorpyrifos

On March 29, 2017, U.S. Environment Protection Agency (EPA) Administrator Pruitt signed an order denying the September 2007 petition of the Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) requesting that EPA revoke all tolerances and cancel all registrations for the pesticide chlorpyrifos.  This is the latest EPA action in a long and contentious battle concerning chlorpyrifos tolerances and registrations, and is likely not the end of this...
March 13, 2017

National Academies Report Finds Future Biotechnology Products May Overwhelm Agencies

On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (National Academies) published a report entitled Preparing for Future Products of Biotechnology, prepared by the Committee on Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System (Committee). Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), was an external contributor to the Committee’s deliberations and presented...
March 8, 2017

What’s Next for “Waters of the U.S.” (WOTUS)?

President Trump’s February 28, 2017, Executive Order (E.O.) directing the U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (Corps) to rescind and replace the Clean Water Rule (CWR) is the latest development in the attempt to resolve the long-standing question of which surface waters and wetlands may be federally regulated and subjected to permitting under the Clean Water Act (CWA). In the decade since the U.S. Supreme Court issued its fractured opinion...
February 5, 2017

EPA Updates RCRA Public Participation Manual and Other Recent EPA Developments

EPA Updates RCRA Public Participation Manual: For the first time in 20 years, the U.S. Environmental Protection Agency (EPA) has revised its Resource Conservation and Recovery Act (RCRA) Public Participation Manual. The revised document, issued by EPA in January 2017, replaces the 1996 version. EPA has updated the document to reflect current regulations, policies, and practices. It also presents new information about technical assistance, environmental justice, social media, and other...
February 3, 2017

Resolution Would Nullify RMP Final Rule

Representative Markwayne Mullin (R-OK) on February 1, 2017, introduced a resolution (H.J. Res. 59) under the CRA to repeal the U.S. Environmental Protection Agency’s (EPA) final rule revising its Risk Management Plan (RMP) program. EPA promulgated the final RMP rule on January 13, 2017, in response to Executive Order 13650, which required EPA and other federal agencies to improve chemical facility safety and security. 82 Fed. Reg. 4594. The CRA allows Congress to pass disapproval...
January 26, 2017

TSCA: EPA Issues Interpretation of Statutory Requirements for Substantiation of CBI Claims under TSCA

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued an interpretation of Toxic Substances Control Act (TSCA) Section 14 concerning substantiation of confidential business information (CBI) claims for information submitted to EPA.  82 Fed. Reg. 6522.  Under the interpretation, EPA expresses its view that new TSCA requires substantiation of all non-exempt CBI claims at the time the information claimed as confidential is submitted to EPA.  In the notice, EPA...
January 19, 2017

TSCA: EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) proposed a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. 82 Fed, Reg. 7562. The process would not consider costs or other non-risk factors. Risk evaluation is the second step, after prioritization, in a new...
January 18, 2017

EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA

The U.S. Environmental Protection Agency (EPA) proposed on January 17, 2017, procedures to establish the risk-based screening process and criteria that EPA will use to identify chemical substances under the Toxic Substances Control Act (TSCA) as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. 82 Fed. Reg. 4825. The proposed rule describes the processes for identifying potential candidates for...
January 17, 2017

TSCA: EPA Proposes Requirements for TSCA Inventory Notification (Active-Inactive)

On January 13, 2017, the U.S. Environmental Protection Agency (EPA) published a proposed rule that would require an electronic notification for chemical substances listed on the Toxic Substances Control Act (TSCA) Inventory that were manufactured (including imported) for non-exempt commercial purposes during the ten-year time period ending on June 21, 2016. 82 Fed. Reg. 4255. EPA would also accept such notices for chemical substances that were processed. The recent TSCA amendments require EPA to...
January 17, 2017

TSCA: EPA Proposes Regulation of TCE Use in Vapor Degreasing under TSCA Section 6(a)

In an expected action, on January 11, 2017, the Administrator of the U.S. Environmental Protection Agency (EPA) signed a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to regulate the use of trichloroethylene (TCE) in vapor degreasing.  The proposed rule has not yet been published in the Federal Register, but a pre-publication version of the proposed rule is available on EPA’s website, along with a fact sheet and other information.  The...
January 14, 2017

EPA Issues Final RMP Rule and Other Recent CAA Developments

EPA Issues Final RMP Rule: On January 13, 2017, EPA published in the Federal Register its final rule amending the Accidental Release Prevention Requirements for Risk Management Programs (RMP) under Clean Air Act (CAA) Section 112(r)(7). 82 Fed. Reg. 4594. The amendments are intended to modernize EPA’s RMP regulations as required under Executive Order (EO) 13650, which directs the federal government to carry out certain tasks intended to prevent chemical incidents, such as...
January 13, 2017

EPA Final Rule Raises The Limits For Civil Penalties

In a final rule issued on January 12, 2017, EPA adjusted the level of statutory civil monetary penalty amounts under the statutes EPA administers. 82 Fed. Reg. 3633. The adjustments are mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The latter law prescribes a formula for annually adjusting statutory civil penalties to reflect inflation, maintain the deterrent effect...
January 12, 2017

EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials

After over a decade of effort, the U.S. Environmental Protection Agency (EPA) issued on January 12, 2017, a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) establishing reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. 82 Fed. Reg. 3641. Manufacturers and processers, or persons who intend to manufacture or process new discrete forms of certain existing chemical nanoscale...
January 9, 2017

White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology.  The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with the National Strategy for Modernizing the...
January 4, 2017

Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2017

Predictions and Outlook for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) 2017 Click here for a PDF brochure of the memorandum 2016 was full of surprises, two of which will drive much of the agenda for OCSPP during 2017. First, Congress significantly amended the Toxic Substances Control Act (TSCA). The changes are intended to reform the program to address the widely recognized deficiencies in the law, especially regarding existing chemicals, chemical testing,...
January 4, 2017

FIFRA: Final EPA Rule Requires Stronger Standards for Applying Riskiest Pesticides

On January 4, 2017, the U.S. Environmental Protection Agency (EPA) published its final rule revising its regulation concerning the certification of applicators of restricted use pesticides (RUP).  EPA states that the final rule is intended to ensure federal certification program standards adequately protect applicators, the public, and the environment from risks associated with the use of RUPs.  According to EPA, the final rule will improve the competency of certified...
December 21, 2016

EPA Announces Pilot To Evaluate Alternative Animal Testing Tool

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