Monthly Federal Developments Memorandum

Lynn L. Bergeson Named President Of The Product Stewardship Society: The Product Stewardship Society (PSS) Board of Directors inducted Lynn L. Bergeson as President during its annual board meeting preceding the Product Stewardship conference held in Columbus, Ohio, on September 10 – 12, 2019. Ms. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®) and President of The Acta Group (Acta®), will serve as President...

Product Stewardship 2019, September 10-12, 2019, Columbus, OH: Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), has served as president-elect of the Product Stewardship Society (PSS) since 2017 and will begin her term as the PSS President during the Product Stewardship Conference. Scott J. Burya, Ph.D., Regulatory Chemist, B&C, will present on regulatory barriers to innovation and how to address them. WEBINAR — Implementation of RMP: A...

WEBINAR — New TSCA At 3: Key Implementation Issues, Thursday, July 25, 2019, 1:00 p.m. – 2:00 p.m. (EDT): Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R....

TSCA: Three Years Later, Monday, June 24, 2019, 9:00 a.m. – 4:30 p.m. (EDT), Milken Institute School Of Public Health, Washington, D.C.: Join the Environmental Law Institute (ELI), the George Washington University Milken Institute School of Public Health, and Bergeson & Campbell, P.C. (B&C®) for a one-day conference providing updates and insights regarding year three of the federal government’s implementation of the Frank R. Lautenberg Chemical...

Registration Now Open For “TSCA: Three Years Later”: Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present the one day conference “TSCA: Three Years Later” on June 24, 2019. Panelists Alexandra Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA), and Lynn R....

WEBINAR — FIFRA Hot Topics In Pesticide, Biocides, And Other Agricultural Chemicals Regulation And Litigation, April 24, 2019, 1:00 p.m. – 2:00 p.m. (EDT): Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “FIFRA Hot Topics in Pesticide, Biocides, and Other Agricultural Chemicals Regulation and Litigation.” Throughout the first few months of 2019, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) issues have been dynamic,...

Lynn L. Bergeson, Managing Partner, and Jane S. Vergnes, Ph.D., DABT®, Director of Toxicology, presented “Overview of the Proposed Rule: Strengthening Transparency in Regulatory Science” during the “Data for Chemical Evaluations: Secret or Otherwise” session at The Society of Toxicology’s 58th Annual Meeting held this week in Baltimore, Maryland. For a copy of the presentation, please contact Lynn Bergeson. WEBINAR NEXT WEEK: On March 20, 2019, from 1:00 pm....

LAST CHANCE — register now! “Chemical Regulation After the Mid-Terms: What We Can Expect to See in 2019” webinar, Wednesday, February 20, 2019, 1:00 p.m. – 2:00 p.m. EST will feature Alexandra Dunn, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSSP); Beau Greenwood, Executive Vice President, CropLife America; Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®); and James V. Aidala, Senior Government Affairs...

Forecast For U.S. Federal And International Chemical Regulatory Policy 2019: Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2019. In this richly detailed document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and provide our best informed judgment as to the shape of key developments we are likely to see in 2019. We...

Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, peaceful, and safe New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf. “All Things Chemical” Podcast Focuses On Chemical Law, Business,...

B&C Launches All Things Chemical™ Podcast: Bergeson & Campbell, P.C. (B&C®) is pleased to announce the launch of All Things Chemical™, a podcast engaging listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and...

Register now for our Wednesday webinar — “Keeping up with FSMA — Rules, Obligations, and Key Compliance Dates,” October 17, 2018, 1:00 p.m. – 2:00 p.m. (EDT). With the pending implementation dates of several core elements of the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA), many manufacturers are challenged in addressing efficiently and smartly supply chain complexities. This webinar will help you prepare for the forthcoming deadlines...

WEBINAR — TSCA Confidential Business Information And Generic Naming: Analyzing The New Rules, September 18, 2018, 1:00 p.m. – 2:00 p.m. (EDT): Bergeson & Campbell, P.C. (B&C®) and Bloomberg BNA are pleased to present “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules,” the fourth webinar in the 2018 Chemical Policy Summit Series. Protecting confidential business information (CBI), including chemical identity, has never been easy...

PRE-ORDER NOW “Chemical Regulation In The Middle East” By Michael S. Wenk, M.S.: Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce the August 27, 2018, publication of “Chemical Regulation in the Middle East,” written by Michael S. Wenk, M.S., Senior Regulatory Consultant with B&C and Acta. This handbook offers an essential guide to the patchwork of chemical regulatory programs and the complex system of permits and licenses that manage...

Available On-Demand – TSCA At 2: An Update On Implementation And Hot Topics: A recording of “TSCA at 2: An Update on Implementation and Hot Topics,” the third webinar in the 2018 Chemical Policy Summit Series, is now available. This webinar featured news and updates on Toxic Substances Control Act (TSCA) implementation from Nancy B. Beck, Ph.D., D.A.B.T.®, Deputy Assistant Administrator, U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution...

Lynn L. Bergeson, Richard E. Engler, Ph.D., And Susan M. Kirsch Contribute To ABA SEER’s The Year In Review 2017: Bergeson & Campbell, P.C. (B&C®) is pleased to announce the publication of The Year in Review 2017: Environment, Energy, and Resources Law by the American Bar Association (ABA) Section of Environment, Energy, and Resources (SEER). The Year in Review 2017 provides an annual summary of developments in environmental, energy, and resources law....

TSCA/FIFRA/TRI Webinar: TSCA at 2: An Update on Implementation and Hot Topics: June 25, 2018 11:00 a.m. – 12:00 p.m. (EDT) Register Today Presenters: Nancy B. Beck, Ph.D., D.A.B.T.® Deputy Assistant Administrator Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA) Lynn L. Bergeson Managing Partner Bergeson & Campbell, P.C. (B&C®) Others to be announced soon. Overview: Since enactment on June 22, 2016, of the Frank R. Lautenberg Chemical...

TSCA/FIFRA/TRI EPA Issues Draft Guidance On Expanded Access To Confidential Business Information: On March 16, 2018, the U.S. Environmental Protection Agency (EPA) released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose Toxic Substances Control Act (TSCA) confidential business information (CBI) with an expanded set of people. 83 Fed. Reg. 17748. Amended TSCA Section 14(d) expanded the categories of people to whom EPA may disclose...

TSCA/FIFRA/TRI EPA Settles With Syngenta On FIFRA Violation Related To Restricted-Use Pesticide: On February 12, 2018, the U.S. Environmental Protection Agency (EPA) announced it has reached an agreement with Syngenta Seeds, LLC (Syngenta), a pesticide company in Hawaii, to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) at its farm in Kekaha, Kauai. The settlement includes two penalty components: a $400,000 Supplemental Environmental Project...

TSCA/FIFRA/TRI Recording Available From “Chemical Regulation In 2018: A Sneak Preview Of Things To Come” Webinar: A recording is now available of “Chemical Regulation in 2018: A Sneak Preview of Things to Come,” the first webinar in the Bergeson & Campbell, P.C. (B&C®)/ Bloomberg Environment 2018 Chemical Policy Summit Series. This focused discussion featured Nancy B. Beck, Ph.D., D.A.B.T., Deputy Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA)...

Bergeson & Campbell, P.C.’s (B&C®) much anticipated and highly acclaimed annual Forecast, “Predictions and Outlook for U.S. Federal and International Chemical Regulatory Policy 2018,” is now available. In the Forecast, the lawyers, scientists, and chemical regulatory specialists at B&C and its affiliated consulting firm, The Acta Group (Acta®), offer comprehensive and highly useful observations on the fast-changing and nuanced area of domestic and global chemical legal,...

Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, peaceful, and safe New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf. TSCA/FIFRA Deadline Approaching For Comments On EPA’s Proposed Reporting...

TSCA/FIFRA EPA Extends Comment Period For Draft Guidance For Pesticide Registrants On Notifications, Non-notifications, And Minor Formulation Amendments: On October 5, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice of extension of the comment period for the draft guidance Pesticide Registration Notice (PR Notice) 2017-XX: Notifications, Non-notifications and Minor Formulation Amendment issued on September 6, 2017. 82 Fed. Reg. 46491. Comments now must be...

TSCA/FIFRA/TRI EPA Schedules PPDC Meeting: On October 13, 2017, the U.S. Environmental Protection Agency (EPA) announced the scheduling of a Pesticide Program Dialogue Committee (PPDC) meeting for November 1-2, 2017. 82 Fed. Reg. 47733. An agenda is expected to be made available by October 18, 2017.PPDC meetings provide the EPA Administrator with advice and information on pesticide issues from stakeholders, including the public, states, and others. EPA Issues Test Methods And...

TSCA/FIFRA/TRI EPA Adopts 2017 NAICS Codes For TRI: On August 16, 2017, the U.S. Environmental Protection Agency (EPA) announced that it is updating the list of North American Industry Classification System (NAICS) codes subject to reporting under the Toxics Release Inventory (TRI) to reflect the Office of Management and Budget’s (OMB) 2017 NAICS code revision. 82 Fed. Reg. 39038. As a result, facilities would be required to use 2017 NAICS codes when reporting to TRI beginning...

TSCA/FIFRA Bergeson & Campbell, P.C. Forms “TSCA New Chemicals Coalition” JOIN NOW 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 Protection Agency’s (EPA) interpretation of these amendments has changed significantly the Section 5 review process in ways that none...

TSCA/FIFRA EPA Releases Final Test Guideline For Performance Against Bed Bugs: On June 14, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of a final test guideline, Laboratory Product Performance Testing Methods for Bed Bug Pesticide Products; OCSPP Test Guideline 810.3900, part of a series of test guidelines established by the EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances. 82...

Join the Environmental Law Institute (ELI) and the George Washington University Milken Institute School of Public Health on June 27, 2017, for a day-long conference exploring the federal government’s implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which significantly amended the Toxic Substances Control Act (TSCA), just over one year after it was signed into law. This event is free and open to the public. Speakers will discuss key...

Lynn L. Bergeson, Environmental Quality Management, Winter 2016: On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act. The text of the law is available at http://www.congress.gov/bill/114th-congress/house-bill/2576/text. The law substantially amends the Toxic Substances Control Act (TSCA), and in so doing, fundamentally alters the domestic management of industrial chemicals, the lifeblood of many manufacturing processes....

TSCA/FIFRA EPA Denies TSCA Section 21 TBBPA Petition: On March 17, 2017, the U.S. Environmental Protection Agency (EPA) denied a Toxic Substances Control Act (TSCA) Section 21 petition submitted by, among others, Earthjustice, seeking a TSCA Section 4 test rule for tetrabromobisphenol A (TBBPA). 82 Fed. Reg. 14171. EPA determined that the petition failed to set forth facts demonstrating that there is insufficient information available to EPA to determine or predict reasonably effects from...

TSCA/FIFRA/NTP Lynn L. Bergeson, Charles M. Auer, and Carla Hutton, “Practitioner Insights: A Review and Analysis of TSCA Reform Provisions Pertinent to Manufacturers and Processors of Nanoscale Materials,” Bloomberg BNA Daily Environment Report, January 26, 2017: On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. No. 114-182, and in so doing significantly revised the Toxic Substances Control Act (TSCA) for the...

TSCA/FIFRA/NTP EPA Proposes Regulation Of TCE Use In Vapor Degreasing Under TSCA Section 6(a): On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) to regulate the use of trichloroethylene (TCE) in vapor degreasing. 82 Fed. Reg. 7432. The proposed rule would prohibit the manufacture (including import), processing, and distribution in commerce of TCE for use in vapor degreasing, prohibit...

Bergeson & Campbell, P.C. wishes everyone a healthy, safe, and Happy New Year. If you have not already done so, please read our 2017 Forecast Memorandum, available at /regulatory-developments/entry/predictions-and-outlook-for-u.s.-federal-and-international-chemical-regulat. Register for our complimentary WEBINAR – Chemical Substance Regulation in Central and South America: A Deeper Dive, Thursday, February 16, 2017, 2:00 p.m. Eastern Standard Time. More information...

Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, peaceful, and safe New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf. TSCA/FIFRA/IRIS/NTP/TRI EPA Proposes To Add Nonylphenol Ethoxylates To Section...

TSCA/FIFRA/IRIS/NTP/TRI EPA Extends Comment Period On Proposed SNUR: On October 21, 2016, the U.S. Environmental Protection Agency (EPA) announced that it has reopened the comment period on a proposed Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) as requested by a commenter. 81 Fed. Reg. 72759. The proposed rule would amend the TSCA significant new use regulations to align them with revisions to the Occupational Safety and Health Administration’s (OSHA)...

TSCA/FIFRA/IRIS/NTP/TRI EPA Issues Statements Of Findings For September 2016: On September 23, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice announcing its findings after its review of Toxic Substances Control Act (TSCA) Section 5(a) notices when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. 81 Fed. Reg. 65636. Such statements apply to premanufacture...

TSCA/FIFRA/IRIS/NTP/TRI EPA Extends Comment Period On PIPs: On August 17, 2016, the U.S. Environmental Protection Agency (EPA) extended the comment period on its White Paper describing how EPA intends to modify its current approach to plant-incorporated protectants (PIP) in breeding line intermediates. 81 Fed. Reg. 54803. Comments are now due on September 29, 2016. EPA Seeks Comment On Draft Integrated Risk Information System (IRIS) Assessment For Ethyl Tertiary Butyl Ether: On...

TSCA/FIFRA/IRIS/NTP/TRI EPA Releases TRI Preliminary Dataset For Calendar Year 2015: On July 20, 2016, the U.S. Environmental Protection Agency (EPA) announced the availability of the Toxics Release Inventory (TRI) preliminary dataset for calendar year 2015. This dataset contains the most current TRI data on toxic chemical releases and pollution prevention activities at U.S. industrial facilities. EPA intends to update the dataset several times during the summer and early fall based on...

TSCA/FIFRA/IRIS/NTP/TRI EPA Launches Advisory Panels: On June 15, 2016, the U.S. Environmental Protection Agency (EPA) launched two advisory panels designed to facilitate small businesses to provide feedback to EPA on three solvents. EPA has established a Small Business Advocacy Review (SBAR) Panel for a proposed rulemaking seeking to limit trichloroethylene (TCE), a chemical used in commercial degreasing operations, dry cleaning operations, and consumer products. EPA also created a panel...

TSCA/FIFRA/IRIS/NTP/TRI TSCA Reform Bill Is Sent To President Obama For Signature: It has been reported that on June 14, 2016, House Speaker Paul Ryan (R-WI) and Senate President Pro Tempore Orrin Hatch (R-UT) signed the bill to reform the Toxic Substances Control Act (TSCA), sending it to President Barack Obama for his signature. On June 7, 2016, the Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act by voice vote. It is...

TSCA/FIFRA/IRIS/NTP/TRI Office Of Inspector General Considers Pesticide Imports: In a memorandum dated April 22, 2016, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) informed EPA that it plans “to begin preliminary research to assess the EPA’s inspections of, and enforcement against, illegal pesticide imports.” OIG will review, among other aspects of the program, whether EPA is effectively identifying pesticide imports for...

TSCA/FIFRA/IRIS/NTP/TRI EPA Issues SNUR For TCE: On April 8, 2016, the U.S. Environmental Protection Agency (EPA) issued a final Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) for trichloroethylene (TCE). 81 Fed. Reg. 20535. The significant new use is the manufacture or processing for use in a consumer product, with the exception for use of TCE in cleaners and solvent degreasers, film cleaners, hoof polishes, lubricants, mirror edge sealants, and pepper spray....

TSCA/FIFRA/IRIS/NTP/TRI EPA Extends Comment Period On Chlorinated Paraffins Risk Assessments: On February 22, 2016, the U.S. Environmental Protection Agency (EPA) extended the comment period on the draft risk assessments it has prepared for certain medium and long chain chlorinated paraffins. 81 Fed. Reg. 8712. This is an important opportunity to comment on the risk assessments prepared by EPA following the submission of Premanufacture Notifications (PMN) on certain chlorinated paraffins...

TSCA/FIFRA/IRIS/NTP/TRI NAS Hosts Workshop On Low Dose Toxicity: On February 3, 2016, the National Academies of Sciences (NAS), Engineering, and Medicine Low Dose Committee heard presentations on several chemicals and the potential effect each may have on reproductive systems. The chemicals considered included: bisphenol A, dioxin, and phthalates. The Committee will assess whether these three chemicals are suitable as case studies for review by the U.S. Environmental Protection Agency (EPA)...

TSCA/FIFRA/IRIS/NTP/TRI EPA Seeks Comment And New Information On Risk Assessments For Pending PMNs For Chlorinated Paraffins: On December 23, 2015, the U.S. Environmental Protection Agency (EPA) requested “new available data on certain chlorinated paraffins” in different industries for different uses, and comment on risk assessments for long- and medium-chain chlorinated paraffins prepared in the context of EPA’s review of certain premanufacture notices (PMN) submitted...

Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy, healthy, peaceful, and safe New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf. TSCA/FIFRA/IRIS/NTP/TRI EPA Issues Final Rule Adding 1-Bromopropane To EPCRA...

Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends and we wish you and your family a happy Thanksgiving Day and a delightful holiday season. *     *     *     *     * REGISTER TO ATTEND THE “TSCA REFORM PANEL SUMMIT,” OR TO VIEW THE LIVE WEBCAST, AT THE ELI WEBSITE. George Washington University (GWU) Milken Institute School of Public Health, GWU Law School, Environmental Law Institute, Arnold &...

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) issued a report, “The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic Biology?,” authored by the legal experts, scientists, and policy specialists of B&C and released through the Wilson Center’s Synthetic Biology Project. A panel discussion and live webcast, “Leveraging Synthetic Biology’s Promise...

TSCA/FIFRA/IRIS/NTP/TRI EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents and a Data Needs Assessment (DNA) document for one of four structurally similar flame retardant chemical clusters being reviewed under the Toxic Substances Control Act (TSCA) Work Plan assessment effort. 80 Fed. Reg. 49997. The goal of these...

TSCA/FIFRA/IRIS/NTP/TRI EPA Issues Direct Final Rule On Significant New Use Notification Electronic Reporting: On July 20, 2015, the U.S. Environmental Protection Agency (EPA) issued a direct final rule amending the Toxic Substances Control Act (TSCA) Section 5 electronic reporting regulations. 80 Fed. Reg. 42739. The electronic reporting regulations establish standards and requirements for use of EPA’s Central Data Exchange (CDX) to submit electronically premanufacture notices (PMN),...