All Knowledge & Insights By Date

A noteworthy development in the U.S. Environmental Protection Agency’s (EPA) ongoing and controversial consideration of the potential use of epidemiological data in its pesticide risk assessments occurred on May 25, 2017, when EPA placed in the public dockets for certain organophosphate (OP) pesticides an “update” of the September 15, 2015, Literature Review and Food Quality Protection Act (FQPA) determination, along with a response to comments on the original document.  These...

On June 29, 2017, Charles M. Auer, Senior Regulatory and Policy Advisor with Bergeson & Campbell, P.C. (B&C®), was quoted by Inside EPA in an article regarding Toxic Substance Control Act (TSCA) framework rules and how they should be implemented. His comments were made on June 27, 2017, during an Environmental Law Institute (ELI) conference celebrating the reformed law’s first anniversary. […] Former career EPA toxics chief Charles Auer, now with the law firm...

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...

The World Health Organization’s (WHO) International Program on Chemical Safety (IPCS) published a draft Environmental Health Criteria (EHC) Document, Principles and Methods to Assess the Risk of Immunotoxicity Associated with Exposure to Nanomaterials.  According to IPCS, the target audience is risk assessors in a regulatory setting, researchers, and industry that needs to provide the data for assessment.  The draft EHC Document states that recent reports have identified...

On June 14, 2017, Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), was quoted by Inside EPA discussing the impacts of a possible requirement by the U.S. Environmental Protection Agency (EPA) to consider all possible use conditions while conducting risk assessments. […] Speaking at a recent seminar on environmental regulation hosted by the Practising Law Institute in New York, NY, attorney Lynn Bergeson said competing calls from industry and...

On June 9, 2017, the European Chemicals Agency (ECHA) announced that the Committee for Risk Assessment (RAC) “concluded that the available scientific evidence meets the criteria in the [Classification, Labeling and Packaging (CLP)] Regulation to classify titanium dioxide as a substance suspected of causing cancer through the inhalation route.”  In May 2016, France submitted a proposal for harmonized classification and labeling (CLH).  The proposal’s...

On June 12, 2017, Bloomberg BNA presented the webinar "Reviewing New Chemicals Under Amended TSCA: Impact on Innovation," featuring Charles M. Auer, Senior Regulatory and Policy Advisor at Bergeson & Campbell P.C. (B&C®); Richard E. Engler, Ph.D., Senior Chemist at B&C.; and Lynn L. Bergeson, Managing Partner at B&C; as well as Jeffery Morris, Director, U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics; Beth Bosley, President,...

Germany’s Commission for Occupational Health and Safety (KAN) released in May 2017 a report entitled Standardization in nanotechnology — Status review and requirements analysis from the occupational safety and health perspective.  According to the report, which is in German but includes an English summary, the authors conducted a structured status review of the standardization situation in the field of nanotechnology.  Approximately 260 standardization documents related to...

On May 31, 2017, the U.S. Environmental Protection Agency (EPA) announced the release of its Food Contact Sanitizing Solutions Model (FCSSM), a pesticide risk assessment model that has been developed to “estimate indirect dietary exposure to components of sanitizing solutions used in commercial settings.”  EPA states that “the model offers guidance for estimating exposure where there may be inadvertent transfer of residue to edible items prepared or transported on surfaces...

On May 25, 2017, the U.S. Environmental Protection Agency (EPA) announced the release of ecological risk assessments for four neonicotinoid active ingredients for public comment as well as the Registration Review Update for Four Neonicotinoid Insecticides (Update).  82 Fed. Reg. 24113.  The ecological risk assessments are: The preliminary aquatic risk assessment for imidacloprid; The combined preliminary bee risk assessment for clothianidin and thiamethoxam; and The draft...

On May 30, 2007, the Canadian Institute for Environmental Law and Policy (CIELAP) released a document entitled Discussion Paper on a Policy Framework for Nanotechnology, which builds on policy issues discussed at a March 16, 2007, workshop. CIELAP states that it supports a goal statement and context for nanotechnology policy that is centered on an explicit recognition and endorsement of sustainable development.  According to CIELAP, the policy challenges for nanotechnology are...

The European Chemicals Agency (ECHA) announced on May 24, 2017, publication of five documents that it intends to help registrants preparing dossiers that cover nanoforms ahead of the 2018 registration deadline under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  ECHA published two new guidance documents: Nano-specific appendix to Chapter R.6 of the Guidance on information requirements and chemical safety assessment...

On May 23, 2017, Lisa R. Burchi, Of Counsel with Bergeson & Campbell, P.C. (B&C®), presented “The New TSCA: Impact on States and Worker Safety Programs” at ORCHSE Strategies, LLC’s Western Occupational Safety and Health Group meeting. Ms. Burchi’s presentation addressed the new Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, and its impact on worker safety programs nationwide. Specifically, she...

The European Commission (EC) Joint Research Center (JRC) has published a Science for Policy report entitled NANoREG framework for the safety assessment of nanomaterials.  The report was developed within the NANoREG project, “A common European approach to the regulatory testing of nanomaterials.”  The NANoREG framework represents the project’s proposal for a common understanding in the field of environmental health and safety (EHS) assessment of nanomaterials under the...

NanoMONITOR announced on May 3, 2017, the launch of a survey intended to refine the design of the real-time information and monitoring system to support the risk assessment of nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  NanoMONITOR states that the ten-minute survey will help it: Elicit stakeholders’ requirements on the NanoMONITOR web platform; Elicit stakeholders’ requirements on the NanoMONITOR station...

Bergeson & Campbell, P.C. (B&C®) is pleased to announce the publication of The Year in Review 2016:  Environment, Energy, and Resources Law by the American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER).  The Year in Review provides an annual summary of developments in environmental, energy, and resources law.  B&C Managing Partner Lynn L. Bergeson and Senior Chemist Richard E. Engler,...

According to press reports, Nancy Beck, Ph.D., DABT has been hired as the Principal Deputy Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP).  Dr. Beck holds a doctorate in environmental health from the University of Washington.  For the past five years she served as the Senior Director for Regulatory Science Policy at the American Chemistry Council (ACC).  For a decade prior to ACC, she was an analyst...

NanoMONITOR, a project partly funded by the European Commission Life+ with grant agreement LIFE14 ENV/ES/000662, is intended to develop a real-time information and monitoring system to support the risk assessment of nanomaterials under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation.  The overall objective of the NanoMONITOR project is to improve the use of environmental monitoring data to support the implementation of REACH and to promote the...

On April 5, 2017, Petitioners Pesticide Action Network North America (PANNA) and the Natural Resources Defense Council (NRDC) (Petitioners) filed a Motion for Further Mandamus Relief in the Ninth Circuit Court of Appeals proceedings regarding the chlorpyrifos tolerances.  In the motion, Petitioners respond to the U.S. Environmental Protection Agency’s (EPA) order signed on March 29, 2017, which denied the petition to revoke tolerances.  Petitioners state that EPA’s response to the...

On March 29, 2017, the American Industrial Hygiene Association (AIHA) announced the availability of nanomaterial stewardship guidance sponsored by the AIHA Nanotechnology Working Group.  The guidance addresses stewardship considerations for nanomaterials and nanoproducts based on the evolving state of the science for human health hazard, exposure, and risk assessment.  The guidance promotes a life cycle approach and safer design principles for particles, production,...

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...

On March 10, 2017, the Scientific Committee on Consumer Safety (SCCS) began a public consultation on its opinion on titanium dioxide (nanoform) as an ultraviolet (UV)-filter in sprays.  In July 2015, the European Commission (EC) received new data from industry to support the safe use of nano titanium dioxide when used as a UV-filter in sunscreens and personal care spray products at a concentration up to 5.5 percent.  The EC asked SCCS whether, in light of the data provided, nano...

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...

NanoMONITOR’s first stakeholders’ day, April 4, 2017, will include a workshop on “Development of a real-time information and monitoring system to support the risk assessment of nanomaterials under REACH.”  The overall aim of the NanoMONITOR project is to develop a prototype system to generate robust, accessible, comparable, and interoperable environmental and indoor air monitoring data to support the implementation of the Registration, Evaluation, Authorization and Restriction...

By Lynn L. Bergeson and Margaret R. Graham On March 9, 2017, the National Academies of Sciences, Engineering, and Medicine (NAS) announced the release (pre-publication version) of a new report:  Preparing for Future Products of Biotechnology.  Pursuant to the White House Office of Science and Technology Policy's (OSTP) July 2, 2015, memorandum, “Modernizing the Regulatory System for Biotechnology Products,” NAS was tasked with looking into the future and describing the...

On February 23, 2017, the Center for International Environmental Law (CIEL) issued a press release announcing a new report, commissioned by CIEL, the European Environmental Citizens’ Organization for Standardization (ECOS), and the Oeko-Institute, that “shows that most of the information made available by the Sponsorship Testing Programme of the Organisation for Economic Co-operation and Development (OECD) is of little to no value for the regulatory risk assessment of...

The U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced on its website on February 9, 2017, that it has established the Science Advisory Committee on Chemicals (SACC).  EPA was required to form the SACC within one year after enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The timing is interesting given that the deadline for public comments on the nominees was January 9, 2017, and the EPA...

On February 1, 2017, the National Institute for Occupational Safety and Health (NIOSH) posted a blog item entitled “The Art and Science of OELs for Nanomaterials.”  According to the item, NIOSH searched for proposals for occupational exposure limits (OEL) for new nanomaterials as part of the development of a World Health Organization (WHO) guideline for working safely with nanomaterials.  The blog item cites the article “Occupational exposure limits for manufactured...

The Organization for Economic Cooperation and Development (OECD) published a report entitled Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials:  Current State of Knowledge and Research Needs to Advance Their Use.  Experts from academia, industry, public interest groups, and government researched, analyzed, and discussed how alternative models could be used to advance the risk analysis of manufactured nanomaterials.  The objectives were to...

The Organization for Economic Cooperation and Development (OECD) published a report entitled Alternative Testing Strategies in Risk Assessment of Manufactured Nanomaterials: Current State of Knowledge and Research Needs to Advance Their Use.

On January 13, 2017, the European Chemicals Agency (ECHA) sent the draft appendix on recommendations for nanomaterials applicable to the guidance on registration to the Forum, Member State Committee, and Risk Assessment Committee for consultation.  The draft guidance outlines the minimum elements potential registrants need to consider when registering substances that fulfil the European Commission’s (EC) Recommendation for the definition of nanomaterial.  The aim of the...

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...

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...

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...

REGISTER TODAY Thursday, February 16, 2017, 2:00 p.m. Eastern Standard Time The Central and South American chemical regulatory environment continues to be one that is challenging to understand, navigate, and manage from a business perspective.  These challenges most often stem from one of three aspects:  a lack of knowledge concerning the regulatory and governmental authority structure; a challenge in determining which regulations (local, national, and/or trade bloc) apply;...

The Nano-Portal:  Safe Handling of Nanomaterials, the result of a project supported by the Deutsche Gesetzliche Unfallversicherung (DGUV) and developed by the Innovation Society, is now available in English.  The website is intended to extend knowledge about occupational safety and health in the fields of nanomaterials and nanotechnologies.  The Nano-Portal addresses: Awareness of prevention and safety experts in the safe handling of nanomaterials; Qualification of employees...

On January 12, 2017, the U.S. Environmental Protection Agency (EPA) released its Policy to Mitigate the Acute Risk to Bees from Pesticide Products (Mitigation Policy) which describes methods for addressing acute risks to bees from pesticides.  EPA states that this Mitigation Policy is “more flexible and practical than the proposed policy” that was issued on May 29, 2015, and it has “made modifications to its approach with the goal of better targeting compounds that pose an...

On January 13, 2017, slides from the B&C® Consortia Management’s (BC-CM) NMP Producers Group Meeting with the Office of Management and Budget were discussed in the Inside EPA article “Chemical Makers Cite TSCA Listing In Call For EPA To Drop NMP Proposal.” […] But representatives from Bergeson & Campbell on behalf of NMP producers in a Dec. 5 meeting with EPA and OMB officials ahead of the proposal's release argued that the rulemaking does not appear to...

The attorneys, scientists, policy experts, and regulatory advisors of Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) endeavor year-round to keep you informed on key developments as they happen, and prepared for looming changes and deadlines, to help you maintain compliance and competitive advantage as you market your products throughout the world. As the new year begins, we offer you this look back at the top stories of 2016...

The attorneys, scientists, policy experts, and regulatory advisors of Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) endeavor year-round to keep you informed on key developments as they happen, and prepared for looming changes and deadlines, to help you maintain compliance and competitive advantage as you market your products throughout the world. As the new year begins, we offer you this look back at the top stories of 2016...

The National Nanotechnology Coordination Office (NNCO) periodically holds webinars to share information with the general public and the nanotechnology research and development community.  Upcoming webinars include the following: On January 18, 2017, the National Nanotechnology Initiative (NNI) will hold a webinar on “Water Sustainability through Nanotechnology: Enabling Next-Generation Water Monitoring Systems.” In this webinar, panelists will discuss the current state of and...

On January 10, 2017, Bloomberg BNA Daily Environment Report quoted Bergeson & Campbell, P.C. (B&C®) Senior Government Affairs Consultant James V. Aidala regarding a recent U.S. Environmental Protection Agency (EPA) risk assessment. The risk assessment also could be a sign of how the EPA will address the suite of organophosphate pesticides slated for review later this year, including chlorpyrifos and malathion. Industry groups are concerned this could hamper the...

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,...

On December 20, 2016, the U.S. Environmental Protection Agency (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...

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 this pilot...

On February 7-9, 2017, a conference focused on new tools and approaches for nanomaterial safety assessment will be held in Malaga, Spain.  The conference is jointly organized by five major Seventh Research Framework Program (FP7) projects:  NANOSOLUTIONS, GUIDEnano, Sustainable Nanotechnologies (SUN), NanoMILE, and eNanoMapper.  It will present the main results achieved in the course of the projects, fostering a discussion about their impact...

On November 15, 2016, the Federal Institute for Risk Assessment (BfR) published a report, in English, entitled Nanoview — Influencing factors on the perception of nanotechnology and target group-specific risk communication strategies.  In 2007, BfR conducted a survey concerning the public perception of nanotechnology.  Given the newness of nanotechnology and that large sections of the population did not have any definite opinions or knowledge of it, BfR conducted a follow-up...

On December 7, 2016, the U.S. Environmental Protection Agency (EPA) announced it would be issuing a rule proposing to prohibit the manufacture, processing, and distribution in commerce of trichloroethylene (TCE) for certain uses under Section 6 of the Toxic Substances Control Act (TSCA), due to its determination that there are significant health risks associated with TCE use in aerosol degreasing and for spot cleaning in dry cleaning facilities.  The proposed action is significant for...

On November 29, 2016,  the U.S. Environmental Protection Agency (EPA) announced the initial ten chemical substances on which risk evaluations will be conducted under Toxic Substances Control Act (TSCA) Section 6(b)(2)(A).  The chemicals, all of which were to be drawn from the TSCA Work Plan for Chemical Assessments, are: 1,4-dioxane1-bromopropaneTrichloroethylene (TCE)Carbon tetrachlorideHexabromocyclododecane (HBCD)Methylene chloridePigment violet 29Perchloroethylene...

In November 2016, the Organization for Economic Cooperation and Development (OECD) published the following new reports in its Series on the Safety of Manufactured Nanomaterials: Toxicokinetics of Manufactured Nanomaterials: Report from the OECD Expert Meeting:  As part of its Program on the Safety of Manufactured Nanomaterials, OECD initiated a series of expert meetings to discuss the applicability of the OECD Test Guidelines to nanomaterials.  The Working Party on Manufactured...