EPA Announces New CASAC Members, Begins Ozone and PM NAAQS Reviews

On October 10, 2018, EPA issued a press release announcing the new members of the Clean Air Scientific Advisory Committee (CASAC) who will participate in the current reviews of the national ambient air quality standards (NAAQS) for ozone and PM. The press release also expands the description of the Committee’s charge, as previewed in the prior NAAQS reform materials issued by the Administration, to include examination of the relative contribution of background to current ambient concentrations and consideration of the potential social, economic and energy effects of various NAAQS implementation strategies.

The press release also announced the first draft of the Integrated Science Assessment (ISA) for PM, which was released a few days later. The ISA is the comprehensive scientific document on which EPA’s decision whether to revise the current standards must be based. The new draft ISA was announced in the Federal Register on October 23, with a comment deadline of December 11. A CASAC meeting to review the draft ISA has not yet been announced, but the Committee reportedly is considering a meeting to review the draft on December 12-13.

With respect to ozone, the press release announced a series of webinar workshops the agency currently is holding to consider new studies that should be included in the new ISA. Following those a draft integrated review plan will be released for public and CASAC review. (These steps have long been completed for the PM review.) EPA is attempting, on a very short time frame compared to past reviews, to complete both the ozone and PM reviews by the end of 2020.

Separately, EPA announced that the expanded scientific review panels that have assisted CASAC in recent ozone and PM reviews have been disbanded. These review panels, which grew over time to include 12-15 members, acted as consultants to CASAC, but only the seven formal Committee members voted on the final language in advice letters to the Administrators. The large CASAC consultant panels were one of the reasons that reviews in recent years have stretched far beyond the statutorily mandated 5-year period. One principle of the Administration’s NAAQS reform policy is to stay on the review schedule and finish both the PM and ozone reviews by the end of 2020.

Amazon Issues Responsible Sourcing Policy

Amazon recently issued a Responsible Sourcing Policy that restricts some chemicals and encourages the use of safer ones.  The policy is comprised of a Supplier Code of Conduct and a Chemicals Policy.

Supplier Code of Conduct

The Supplier Code of Conduct sets out Amazon’s expectations for suppliers of goods and services. The policy notes that Amazon expects its suppliers to hold their suppliers and subcontractors to the standards and practices covered by the code.

The code addresses:

  • Health and safety in production areas and any living quarters
  • The right to legal wages and benefits
  • Appropriate working hours and overtime pay
  • Prevention of child labor or forced labor
  • Fair and ethical treatment, including non-discrimination

The company notes that it conducts risk assessments and audits supplier compliance with the program.

Amazon Chemicals Policy

Amazon announced that the company is committed to avoiding chemicals of concern in its products.  The policy identifies chemicals of concern as those that can affect human health and/or the environment.  Amazon specified that chemicals of concern are those that: 1) meet the criteria for classification as a carcinogen, mutagen, reproductive, or other systemic toxicant; or 2) are persistent, bioaccumulative, and toxic. The company notes that it prioritizes chemicals of concern to focus on product types, customer concerns, and the availability of safer alternatives.

A baseline list of chemicals of concern comprise the company’s Restricted Substance List (RSL).   These are chemicals that Amazon seeks to avoid in its own private brand for baby, household cleaning, personal care, and beauty products in the U.S. The company notes that this policy has been imposed in addition to applicable local legal requirements and associated compliance plans. Amazon plans to expand the plan over time to additional brands, product categories, and geographies.

Elements of the policy include the following:

  • Reduce Usage of Chemicals of Concern. Amazon explained that it encourages manufacturers to phase out potentially hazardous chemistries and adopt green chemistry alternatives, such as those defined in U.S. EPA’s Safer Choice Safer Chemicals Ingredients List.  As noted above, Amazon has begun to reformulate its own Private Brand products to phase out RSL chemicals.
  • Enable Transparency.  The company announced that it is working on website features that will make it easier for customers to access comprehensive information about product ingredients and third-party certifications (e.g., Safer Choice, Made Safe, Green Seal, and Cradle to Cradle).  It explained that it hopes that by making this information more readily available for customers, it will encourage additional brands to move away from potentially hazardous chemistries in their products.
  • Implement a Restricted Substance List. The RSL will apply to all consumer private brand for baby (shampoo, lotion, wipes), household cleaning (all-purpose, kitchen, and bathroom cleaners), personal care (shampoo, sanitizers, moisturizers), and beauty products (make-up).  It focuses on paraben preservatives, formaldehyde donor preservatives, phthalate solvents, nonylphenol (NP) and nonylphenol ethoxylate (NPE) surfactants, toluene, and triclosan. The RSL chemicals will be reviewed and updated periodically.
  • Enhance Transparency with Customers and Stakeholders. The company has reformatted “Amazon Pages” and its “A+ Enhanced Marketing Content” to allow brands to explain the steps they are taking to ensure that their product selection is safe and healthy.  Amazon notes that the framework developed to enable this display employs guidelines to maintain high quality content that is comprised of factual, easily verifiable, and objective information. The company announced that it plans to work to achieve fuller ingredient disclosure on its Private Brand product detail pages in 2019.

The company also reports that it has joined the Retail Leadership Council of the Green Chemistry and Commerce Council (GC3) and the Beauty and Personal Care Products Sustainability Project (BPC), which encourage the retail sector to use safer formulations and produce more sustainable products.

California Bans Flame-Retardant Chemicals from Mattresses, Upholstered Furniture and Children’s Home Products

California bill AB 2998 prohibits the sale of mattresses, upholstered furniture, and children’s products containing flame retardants at levels above 1,000 parts per million (ppm) after December 31, 2019.  With some limited exceptions, the bill prohibits “persons,” including manufacturers, from selling or distributing these products at levels above 1,000 ppm, and prohibits custom upholsterers from repairing upholstered furniture or reupholstered furniture using replacement components that contain the covered chemicals at levels above 1,000 ppm.

The bill authorizes the Bureau of Electronic and Appliance Repair, Home Furnishings, and Thermal Insulation (Bureau) to assess fines up to $10,000 against manufacturers for violation of the flame retardant prohibitions.

The bill defines “mattress” as  a ticking filled with a resilient material used alone or in combination with other products intended or promoted for sleeping upon, including, but not limited to, adult mattresses, youth mattresses, crib mattresses, bunk bed mattresses, futons, convertible sofa bed mattresses, corner group mattresses, day bed mattresses, roll-a-way bed mattresses, high risers, and trundle bed mattresses.  (See 16 CFR §1632.1 for further details.)

“Upholstered furniture” is defined as any flexible polyurethane foam or upholstered or reupholstered furniture sold in California that is required to meet certain test requirements set forth in Technical Bulletin 117-2013.

“Juvenile product” means a product designed for residential use by infants and children under 12 years of age, including, but not limited to, bassinets, booster seats, changing pads, floor playmats, highchairs, infant carriers, infant seats, infant swings, nursing pads, nursing pillows, strollers, and children’s nap mats.

A “covered flame retardant chemical” means any chemical that meets both of the following criteria:

  • A functional use for the chemical is to resist or inhibit the spread of fire or as a synergist to chemicals that resist or inhibit the spread of fire, including, but not limited to, any chemical for which the term “flame retardant” appears on the Occupational Safety and Health Administration substance safety data sheet pursuant to subdivision (g) of Section 19100.1200 of Title 29 of the Code of Federal Regulations as it reads on January 1, 2019.
  • The chemical is one of the following:
    • A halogenated, organophosphorus, organonitrogen, or nanoscale chemical,
    • A chemical defined as a “designated chemical” in Section 105440 of the Health and Safety Code, or
    • A chemical listed on the Washington State Department of Ecology’s list of Chemicals of High Concern to Children in Section 173-334-130 of Title 173 of the Washington Administrative Code as of January 1, 2019, and identified as a flame retardant or as a synergist to flame retardants in the rationale for inclusion in the list.

The bill makes a number of findings about flame retardants, including that:

  • Scientists have found that many of the flame-retardant chemicals commonly used in furniture exhibit one or more of the key characteristics of Persistent Organic Pollutants, and that these chemicals accumulate in our bodies and in the environment, persist in the environment for long periods of time, are capable of long-range transport, and are toxic to humans and animals.
  • Children living in California have some of the highest documented blood concentrations of certain flame retardant chemicals compared to other children in the United States.
  • The State of California has found that flame retardant chemicals are not needed to provide fire safety.

The bill also discusses the 2017 guidance document issued by the United States Consumer Product Safety Commission (Commission). That document found that, based on the overwhelming scientific evidence, the Commission should alert the public to serious concerns about the toxicity of organohalogen flame retardants added to children’s products, furniture, mattresses, and plastic casings surrounding electronics. The Commission requested that manufacturers eliminate the use of these chemicals in their products. It also recommended that retailers obtain assurance from manufacturers that their products do not contain these chemicals and that consumers, especially those who are pregnant or with young children, avoid products containing these chemicals.

Gov. Jerry Brown (D) signed the measure into law on September 29, 2018.

EPA Publishes A Working Approach for Identifying Potential Candidate Chemicals for Prioritization

On September 28, 2018 EPA released the approach it will use to identify chemicals that could be included in the next group of risk evaluations under the Toxic Substances Control Act (TSCA).  The approach is documented in the publication A Working Approach for Identifying Potential Candidate Chemicals for Prioritization (A Working Approach). EPA also announced that the Agency will be looking for input from the public on which chemicals should be prioritized for risk evaluation and which chemicals may be low priorities under TSCA.   By December 2019, EPA must designate at least 20 chemical substances as High-Priority for risk evaluation and 20 chemical substances as Low-Priority for which risk evaluation is not currently warranted.

A Working Approach lays out EPA’s near-term approach for identifying potential chemicals for prioritization, the initial step in evaluating the safety of existing chemicals under TSCA.  The Agency notes that it expects its approach for identifying candidates for prioritization to evolve over time as it develops expertise in identifying chemicals to enter prioritization, as well as in conducting prioritization and risk evaluations.

EPA’s working approach is to primarily look to the 2014 Work Plan for high-priority potential candidates.  The Agency explains that it generally intends to consider the three factors described below for selecting potential chemicals for prioritization.

  • In selecting chemicals as potential candidates for prioritization EPA expects to consider overarching Agency priorities. This may include, but is not limited to, a chemical or group of chemicals that are priorities for the Agency, including chemicals that other EPA program offices have deemed a priority for their program and suitable for current prioritization. In addition, EPA is committed to engaging and collaborating with partner federal agencies prior to and during the prioritization process.
  • Quantity and Quality of Information. EPA intends to consider the quantity and quality of information when identifying potential candidate chemicals for prioritization and risk evaluation.
  • Work Load. To address workload issues, EPA could use diverse approaches to consider current expertise or facilitate the analysis of candidate chemicals. For example, EPA could identify potential candidate chemicals that share certain characteristics with the first 10 chemical substances undergoing risk evaluation, 15 such as solvents, since focusing on the solvents remaining on the 2014 Work Plan would take advantage of the expertise developed on the six solvents currently undergoing risk evaluation (e.g., development of exposure scenarios).

In identifying potential candidates for low priority chemical designation, A Working Approach explains that EPA will use the best available science.  The document reports that EPA may identify substances from multiple sources, including one or more of the following chemical information resources:

  • EPA’s Safer Chemical Ingredients List;
  • EPA’s Chemical Assessment Management Program; and
  • Organization for Economic and Co-Operation Development Screening Information Data Sets assessment documents.

A Working Approach states that EPA intends to preferentially select CAS numbers that represent discretely defined structures, which can be more confidently associated with information on hazard, conditions of use, and exposure.

The document also includes a longer-term risk-based strategy for managing the larger TSCA chemical landscape which, according to the TSCA Inventory, is composed of more than 40,000 active chemicals. This longer-term approach proposes parsing chemicals into “bins” that can be used to inform multiple activities and priorities throughout EPA, including within the TSCA program.  In the near future, EPA will open a public docket to accept comments on this longer-term strategy.  In addition, the Agency plans to hold a public meeting on the strategy in early 2019.

EPA will also open 73 chemical-specific public dockets, one for each of the remaining chemicals on the 2014 TSCA Work Plan.  Additionally, there will be a general docket open for the public to suggest chemicals for risk evaluation that are not on the Work Plan.  Through these dockets, the public will have the opportunity to submit use, hazard, and exposure information on these chemicals.  The Agency will use this data to inform TSCA prioritization and risk evaluation for these chemicals.

Two Seasoned Former EPA Enforcement Attorneys Join Verdant

Verdant is pleased to announce the addition of two seasoned former EPA enforcement attorneys — Jon Jacobs and Marie Quintin.  Both bring expertise in chemical products enforcement.

Jon Jacobs spent 27 years at EPA, first in the Office of Administrative Law Judges, then in the Office of Enforcement and Compliance Assurance.  During his tenure, Jon held many positions.  He was a senior attorney in EPA’s Office of Criminal Enforcement, Forensics, and Training where he specialized in environmental crimes involving EPA’s chemicals (TSCA) and pesticides (FIFRA) laws.  He also had national program management responsibilities such as drafting federal legislation, regulations, guidance, and policy.  Jon also served in OCEFT’s Washington Area Criminal Investigation Office as a regional criminal enforcement counsel where he advised EPA’s special agents in over 30 investigations of environmental crimes under all of EPA’s statutes.  Jon was a Special Assistant U.S. Attorney (SAUSA) assisting U.S. Attorney’s Offices in prosecuting cases in Maryland, Virginia, and the District of Columbia.    He has earned an international reputation for his expertise in pesticides, toxic substances, and emergency planning (EPCRA) issues.

Jon’s insider knowledge of EPA, DOJ, and other federal and state agencies offers a unique understanding of how EPA and the federal government operate.  He maintains well established relationships with many key players at EPA allowing him to develop innovative strategies, options, and solutions that many others are unable to accomplish.

Prior to entering private practice, Marie Quintin was a Regional Criminal Enforcement Counsel in the EPA’s regional office in New York City.  She served as legal advisor to the Criminal Investigation Division Special Agent in Charge and federal agents regarding legal issues related to criminal investigations, as well as advisor to the Regional Counsel and Regional program managers.  Marie developed and managed Clean Air Act (CAA) enforcement cases and represented the Agency in administrative and civil enforcement negotiations and litigation for cases in New York, New Jersey, Puerto Rico and the U.S. Virgin Islands.  She won a Gold Medal for her work as a member of the prosecutorial team in the Tonawanda Coke Corporation (TCC) Criminal case in 2014, in which TCC was convicted by a federal jury and ordered to pay a $12.5 million penalty and make $12.2 million in community service payments for criminal violations of the CAA and the Resource Conservation and Recovery Act (RCRA).

Over the course of Marie’s career, she has established strong relationships with influential decision makers at all levels of the EPA. She has served as an instructor for EPA Region 2’s Criminal Enforcement Division and taught courses in subjects such as environmental crimes, clean air act enforcement and policy.

“We welcome Jon and Marie to the firm – and we know our clients will too.  Marie and Jon enhance our pesticides and toxic substances practices, and they also bring substantial expertise with EPA enforcement of its air, water, and waste programs.  Both have robust civil and criminal enforcement experience, including litigation,” said Phil Moffat, the firm’s managing principal.

Jon Jacob said that “Verdant has an excellent reputation for helping clients navigate a complicated and quickly evolving landscape.  I look forward to deepening Verdant’s capabilities in these practice areas and enhancing its ability to serve our clients at the highest level across various industry sectors.”

California Proposal to List Nonylphenol Ethoxylates in Laundry Detergent as a Priority Product

The California Department of Toxic Substances Control has proposed listing nonylphenol ethoxylates (NPEs) in laundry detergent as a Priority Product. This would require manufacturers to use safer alternatives.  The detergents at issue are used by on-premises industrial laundries like hotels and hospitals.

DTSC is concerned about the hazard traits of NPEs and their degradation products.  NPEs are included on the European Union’s list of Substances of Very High Concern.  Laundry detergents with NPEs are sources of exposure to the environment and aquatic organisms.  In May, DTSC released a technical document Product-Chemical Profile for NPEs in Laundry Detergent, to explain the scientific, regulatory, and policy basis for the proposal.  The Department held a public workshop on June 11, 2018 to discuss its proposal.  DTSC is now preparing to undertake a rulemaking on these products.

Systematic Review for TSCA Risk Evaluations

On May 31, 2018 EPA released  Application of Systematic Review in TSCA Risk Evaluations.  The document presents a detailed description of EPA’s approach to the Risk Evaluations required by the Lautenberg amendments to TSCA.

The announcement by the Office of Pollution Prevention and Toxics (OPPT) explains that “[it] will guide EPA’s selection and review of studies in addition to providing the public with continued transparency regarding how the Agency plans to evaluate scientific information.”  In the document OPPT explains that the Agency intends to apply systematic review principles in the development of the risk evaluations required by the amended statute. The Application of Systematic Review in TSCA Risk Evaluations will serve as internal guidance for this process.  The document describes OPPT’s plan for identifying, evaluating and integrating evidence for the TSCA risk evaluation process.

The document includes chapters on scoping and problem formulation, integration of systematic review principles into TSCA risk evaluations, and appendices on strategy for assessing the quality of data supporting TSCA risk evaluations and data quality criteria for each of the categories of information considered in the evaluation (e.g., physical/chemical property data, occupational exposure and release data).  The Agency notes that this document is not necessarily applicable to risk assessments developed to support other EPA’s statutes or programs.  EPA invites the public to provide input on this document at www.regulations.gov, docket# EPA-HQ-OPPT-2018-0210.

For the risk evaluations, OPPT will first conduct scoping and problem formulation to develop an analytical framework.   Problem formulation will describe the exposure pathways, receptors and health endpoints that OPPT expects to consider in the risk evaluations.

The Agency will use “systematic review“ for problem formulation and the other stages of the risk evaluation process.  The Application of Systematic Review in TSCA Risk Evaluations explains that the risk evaluation process will rely on the National Academy of Sciences, Institute of Medicine’s definition of systematic review:  “a scientific investigation that focuses on a specific question and uses explicit, pre-specified scientific methods to identify, select, assess, and summarize the findings of similar but separate studies.”  OPPT reports that key elements of systematic review include:

  • A clearly stated set of objectives defining the research question,
  • Developing a protocol that describes the specific criteria and approaches that will be used throughout the process,
  • Applying the search strategy in a literature search,
  • Selecting the relevant papers using predefined criteria,
  • Assessing the quality of the studies using predefined criteria,
  • Analyzing and synthesizing the data using the predefined methodology, and
  • Interpreting the results and presenting a summary of findings.

Following problem formulation, OPPT will develop a protocol to specify the criteria, methods for data collection, data evaluation and data integration.

Data will be collected under a defined literature search strategy designed to collect information to evaluate the full life cycle of the chemical substance including exposure, human health hazard, and environmental hazard.  OPPT will use a comprehensive chemical-specific literature search of the open literature to identify relevant data.  OPPT will also use data that are submitted by the public and peer reviewers.  In addition, OPPT will search its internal databases for relevant data submitted under TSCA.  The Agency notes that data submitted under TSCA will be used in the risk evaluation whether or not they are claimed as confidential business information (CBI).  However, CBI data will be used in a manner that protects the confidentiality of the information.

Factors for inclusion in the evaluation include whether the data contain information on: 

  • Environmental fate, transport, partitioning and degradation behavior across environmental media of interest,
  • Environmental exposure of ecological receptors to the chemical substance and/or its degradation products and metabolites,
  • Environmental exposure of human receptors to the substance and/or its degradation products and metabolites,
  • Scenarios resulting in releases of the substance into the environment that would expose ecological or human receptors,
  • Quantitative estimates of worker exposures and of environmental releases from occupational settings for the substance, and
  • Human health and environmental hazards.

OPPT explains that the evaluation stage will assess the quality of individual studies.   For this process the Agency will use the criteria identified in the data quality criteria appendices to the Application of Systematic Review in TSCA Risk Evaluations.  The appendices specify criteria for evaluating data on:

  • Physical and chemical properties,
  • Occupational exposure and release,
  • Fate,
  • Consumer, general population, and environmental exposure,
  • Ecological hazards,
  • Animal and in vitro toxicity, and
  • Epidemiology.

The data will then be integrated to evaluate and synthesize multiple evidence streams.  Data integration includes analysis and synthesis of the evidence and development of weight of evidence conclusions.  As part of this process OPPT will document any underlying assumptions that are used to support the risk evaluation.

TSCA requires that EPA make decisions about these data based on the weight of the scientific evidence.  OPPT reports that under TSCA, the weight of the scientific evidence is defined as “a systematic review method, applied in a manner suited to the nature of the evidence or decision, that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance.”   This approach presents the significant issues, strengths, and limitations of the data and the uncertainties that require consideration, in addition to highlighting the major points of interpretation.

OPPT explains that the last step of the systematic review process will be to develop a summary of findings.  The findings summarize the evidence, describe the methods used to weigh evidence, and articulate the basis for the conclusion(s), recommendation(s), and any uncertainties.  Both exposure assessment and hazard assessment will be discussed.

New REACH Registration Requirements for Nanomaterials

On April 26, 2018, EU Member States voted to implement new REACH registration requirements for nanomaterials.  The European Commission announced that the draft regulation will be reviewed by Parliament and Council for three months before being adopted.  The requirement to provide more information on nanomaterials under REACH (Regulation No. 1907/2006) would apply from Jan. 1, 2020.

The European Commission reported that the proposed amendments will significantly clarify REACH registration requirements with regard to nanomaterials. According to the Commission, REACH always applied to nanomaterials but did not contain specific provisions for them.  The Commission explained that this meant companies often did not know how to register substances in nanoform.  It noted that the specific requirements will address the current knowledge gap on which substances registered under REACH are placed on the market as nanomaterials and in which quantities.

Under the new requirements, manufacturers and importers will be obligated to assess and document in the chemical safety report that the risks, arising from the identified uses of the substance with nanoforms they manufacture or import, are adequately controlled. To ensure clarity, the chemical safety report should describe whether and which different nanoforms are covered by the assessment and how the information is compiled in the report.  The proposed regulation can be accessed here.

EPA Proposes Rule to Strengthen the Transparency of Regulatory Science

EPA has published a proposed regulation that is “intended to strengthen the transparency of EPA regulatory science.”   Specifically, the proposed regulation limits science used in regulatory actions to data that are publicly available “in a manner sufficient for validation and analysis.”  The Agency argues that the “proposal will help ensure that EPA is pursuing its mission of protecting public health and the environment in a manner that the public can trust and understand.” This proposed regulation is intended to apply prospectively to final regulations that are determined to be “significant regulatory actions” pursuant to E.O. 12866. Comments are due by May 30, 2018.

EPA argues that “enhancing the transparency and validity of the scientific information relied upon by EPA strengthens the integrity of EPA’s regulatory actions and its obligation to ensure the Agency is not arbitrary in its conclusions,”  “will lead to better outcomes, and [will] strengthen public confidence in the health and environmental protections underpinning EPA’s regulatory actions.”  The Agency explained in the Federal Register Notice that the “proposed rule is consistent with the principles underlying the Administrative Procedure Act and programmatic statutes that EPA administers to disclose to the public the bases for agency rules and to rationally execute and adequately explain agency actions.”

The proposed rule includes a provision allowing the Administrator to exempt significant regulatory decisions on a case-by-case basis if he or she determines that compliance is impracticable because it is not feasible to ensure that all dose response data and models underlying pivotal regulatory science are publicly available in a fashion that is consistent with law, protects privacy and confidentiality, and is sensitive to national and homeland security, or in instances where OMB’s Information Quality Bulletin for Peer Review provides for an exemption.

The proposal solicits comments on a number of issues including the following:

  • The effects of this proposed rule on individual EPA programs, including whether certain activities are appropriate to be excepted.
  • Should the proposal apply to other agency actions and promulgations in addition to “significant regulatory actions?”
  • The definitions of “pivotal regulatory science,” and “dose response data and models” and how to implement such definitions.
  • How to incorporate stronger data and model access requirements into the terms and conditions of cooperative agreements and grants.
  • Methodologies and technologies designed to provide protected access to identifiable and sensitive data.
  • How to balance appropriate protection for copyrighted or confidential business information with requirements for increased transparency of pivotal regulatory science.
  • Whether the disclosure requirements applicable to dose response data and models in the proposed rule should be expanded to cover other types of data and information, such as for example economic and environmental impact data.

FDA BPA Study Released

On February 23, 2018, the FDA National Center for Toxicological Research (NCTR) released a draft report on the chronic toxicity of BPA in rats.  NCTR found few significant effects of BPA.  In the press release reporting these findings, FDA announced that “initial review [of the study findings] supports our determination that currently authorized uses of BPA continue to be safe for consumers.” The NCTR study will undergo external peer review April 26, 2018 during a meeting at National Toxicology Program (NTP) offices in Research Triangle Park, North Carolina.

The study evaluated chronic and early life exposure to BPA in rats. Endpoints evaluated include growth; weight; hematology; and tumor development in the liver, kidney, thyroid, parathyroid, uterine, ovary, prostate, and mammary gland. Overall, the study found “minimal effects” in the BPA-dosed rats.  NCTR did report that the study found an increase in mammary gland tumors at 2.5 µg BPA/kg/bw/day dose group.  The findings note that the incidence rate in this group was only marginally higher than historical rates for the strain of rats used for the study.

The study is part of a collaborative effort called the Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY-BPA), which was established by the FDA and the National Institute of Environmental Health Sciences of the National Institutes of Health after a 2008 NTP report raised concerns about developmental effects in rodents exposed to relatively low doses of BPA.  In addition to the NCTR study, the effort involves studies of various health endpoints, conducted at academic institutions, using offspring of rodents derived from the core study.

More information on the NTP meeting is available here.  The NTP website also provides information on submitting public comments on the draft report.