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Click here for a PDF brochure of the memorandum, and click here to listen to the special Forecast 2020 edition of the All Things Chemical podcast. Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2020. In this detailed and comprehensive document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and policy, and provide our...

On December 4, 2019, the U.S. Environmental Protection Agency (EPA) published an advance notice of proposed rulemaking (ANPRM) soliciting information as EPA considers a future rulemaking to add certain per- and polyfluoroalkyl substances (PFAS) to the list of toxic chemicals subject to reporting under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA) and Section 6607 of the Pollution Prevention Act (PPA) (more commonly known as the Toxics Release Inventory...

By Lynn L. Bergeson On November 15, 2019, Sarah Yim, M.D., acting director of the Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars in FDA’s Center for Drug Evaluation and Research, released a statement on FDA’s continued progress facilitating competition in the biologic marketplace with approval of its 25th biosimilar project. In her statement, Dr. Yim highlights FDA’s approval of one of nine new biosimilar products approved in 2019. Bringing...

By Lynn L. Bergeson On October 3, 2019, the U.S. Food and Drug Administration (FDA) announced that a technical guidance for industry titled “Bioanalytical Methods Templates” is now available.  The technical specifications guidance provides ready-to-use templates for sponsors to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation.  The templates provided are applicable to bioanalytical...

We are pleased to announce that the Fall 2019 issue of The SciTech Lawyer, published by the American Bar Association’s (ABA) Section of Science and Technology Law, includes an article co-authored by Lynn L. Bergeson and Carla N. Hutton, “Nanotechnology and Regulatory Certainty Closer Now Than Ever.”  Nanoscale technologies and their resultant innovations have long captured the imaginations of scientists and inventors, the scrutiny of regulators, and the apprehension of...

By Lynn L. Bergeson The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.” The draft GFI describes how EPA intends to evaluate requests for waiving the requirement for performing in vivo...

By Lynn L. Bergeson On August 19, 2019, the U.S. Food and Drug Administration (FDA) announced in the Federal Register that a proposed collection of information on the Review Transparency and Communication in Reviews of 351(k) Biologics License Applications in Biosimilars User Fee Act has been submitted to the Office of Management and Budget (OMB) for review and approval. This information collection supports the review program under the Prescription Drug User Fee Act (PDUFA), which allows FDA to...

By Lynn L. Bergeson On August 2, 2019, the U.S. Department of Health and Human Services (HHS)’s Food and Drug Administration (FDA) announced via the Federal Register the rates for biosimilar user fees for FY 2020. The Federal Food, Drug, and Cosmetic Act (FFDCA) authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar...

PlasticsToday, “A Visual Tour of Packaging and Products from Ocean Plastics” geek.com, “Scientist Creates Bioplastic from Mango Peels and Seaweed” foodingredientsfirst.com, “European Scientists Call for EU Rethink of ‘Retrograde’ Gene-Editing Legislation” New Atlas, “Wormy Chemicals Used to Trick Crops into Protecting Themselves” Regulatory Focus, “Industry Groups Support FDA’s Latest Biosimilar Analytic Assessment...

Bergeson & Campbell, P.C. (B&C®) was pleased to present the complimentary webinar “FDA FSMA Food Defense Plan Requirements.” Karin F. Baron, MSPH, Senior Regulatory Consultant, B&C, and Scott J. Burya, Ph.D., Regulatory Chemist, B&C, presented.

Register NowFDA FSMA Food Defense Plan Requirements Wednesday, July 24, 20191:00 p.m. - 2:00 p.m. (EDT) Overview:The U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) is the most comprehensive reform measure created to prevent food-borne illness.  Enacted in 2011, FSMA includes massive legislative changes aimed to prevent food-borne diseases.  One of the FSMA foundational rules, Mitigation Strategies to Protect against Intentional Adulteration, requires...

Registration has opened for the National Nanotechnology Initiative’s (NNI) July 9, 2019, webinar, “Nanotechnology-Related Standards: Availability and Applications.”  According to NNI, the development and use of nanotechnology-related standards is critical to ensuring validated measurements and methods to specify nanomaterial-containing products.  NNI states that standards are also necessary for comparative evaluation and assessment of the environmental, health, and...

Wednesday, July 24, 20191:00 p.m. - 2:00 p.m. (EDT) View this webinar on demand online. Overview: The U.S. Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) is the most comprehensive reform measure created to prevent food-borne illness.  Enacted in 2011, FSMA includes massive legislative changes aimed to prevent food-borne diseases.  One of the FSMA foundational rules, Mitigation Strategies to Protect against Intentional Adulteration, requires...

The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued a proposed rule on June 6, 2019, on the movement of certain genetically engineered (GE) organisms. 84 Fed. Reg. 26514. The proposed rule would revise the regulations regarding the movement, including the importation, interstate movement, and environmental release of certain GE organisms in response to advances in genetic engineering and APHIS’ understanding of the plant pest risk...

As reported in our May 30, 2019, blog item, the Organization for Economic Cooperation and Development (OECD) recently published several reports in its Series on the Safety of Manufactured Nanomaterials, including Developments in Delegations on the Safety of Manufactured Nanomaterials — Tour de Table.  The Tour de Table compiles information provided by delegations on the occasion of the 19th meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in February...

By Lynn L. Bergeson On May 22, 2019, the U.S. Food and Drug Administration’s (FDA) Department of Health and Human Services (HHS) announced via the Federal Register the availability of a draft guidance for industry titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The draft guidance is a revision of the 2015 guidance titled “Quality Considerations in Demonstrating Biosimilarity of a...

Preserving Cosmetics on a Global Scale: It is Harder than You Think Wednesday, May 22, 2019 1:00 p.m. - 2:00 p.m. (EDT) Register Today Overview: Cosmetic formulations often contain preservatives to protect the product’s integrity and extend its shelf life. The regulatory requirements that product manufacturers must adhere to when incorporating preservatives into their products and what claims are permissible on their product labels is far from harmonized globally, and the path is not getting...

By Lynn L. Bergeson On May 13, 2019, the U.S. Food and Drug Administration (FDA) issued in final guidance designed to assist sponsors in demonstrating that a proposed biological product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement. This would mean that an abbreviated licensure pathway would be created, where biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product may be...

By Lynn L. Bergeson From July 23-24, 2019, the Food and Drug Law Institute (FDLI) will be hosting the Introduction to Drug, Biologics, and Biosimilars Law and Regulation conference in Boston, MA. The conference will cover an overview of administrative agencies that impact these industries and how they interact with the U.S. Food and Drug Administration (FDA). It will also include sessions on the development of drug and biological products, FDA’s review and approval of marketing...

On May 3, 2019, the U.S. Environmental Protection Agency (EPA) announced it was making final a single correction to the data requirements for antimicrobial pesticide products codified in 40 C.F.R. Part 158, subpart W.  84 Fed. Reg. 18993.  The correction clarifies that the 200 parts per billion (ppb) level described in the antimicrobial pesticides data requirements regulations (40 C.F.R. § 158.2230(d)) “is based on total estimated daily dietary intake for an individual and...

On April 18, 2019, the Food and Drug Administration (FDA) published a Federal Register notice announcing that it is extending the comment period for its February 26, 2019, proposed rule that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not...

Science Daily, “Novel Role of Water in Production of Renewable Fuels” AgWeb, “Gene Editing Promise Stalled at FDA” World Economic Forum, “This Mexican Company is Making Biofuel from Cactus Plants” Feedstuffs, “Biofuel Groups Testify at EPA Hearing on Year-round E15” KFGO, “Aerion Designing Supersonic Jet to Run Completely on Biofuels: CEO” The Hill, “Ocasio-Cortez Says She Encouraged Senate Dems to Vote ‘Present’ on...

By Lynn L. Bergeson On April 2, 2019, U.S. Food and Drug Administration (FDA) Commissioner, Scott Gottlieb, M.D., and Deputy Commissioner for Policy, Legislation and International Affairs, Anna Abram, released a statement on the status of FDA’s Plant and Animal Biotechnology Innovation Action Plan (Action Plan). Focused on FDA’s risk-based regulatory framework, the Action Plan aims at securing confidence in the safety and performance of plant and animal-based products for consumers,...

By Lynn L. Bergeson In a recent statement prepared by U.S. Food and Drug Administration’s (FDA) Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, and by Dennis Keefe, Ph.D, Director of FDA’s Office of Food Additive Safety, FDA highlights its commitment to assisting plant biotechnology developers to foster innovation and ensure that consumers can confidently trust FDA’s high safety standards.  Plant biotechnology consists of methods...

By Lynn L. Bergeson On March 8, 2019, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., released a statement on the continued efforts to advance safe biotechnology innovations, and the deactivation of an import alert on genetically engineered (GE) salmon.  In his statement, Dr. Gottlieb emphasized FDA’s mission to evaluate the safety of intentional genomic alterations (IGA) in animals that will ultimately be sold for consumption in the U.S.  According to...

The U.S. Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  Under the proposed rule, products that...

The U.S. Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded. According to FDA’s February 21, 2019, press...

The Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.

The Food and Drug Administration (FDA) is scheduled to publish a proposed rule in the Federal Register on February 26, 2019, that would put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products.  The proposed rule describes the conditions under which FDA proposes that OTC sunscreen monograph products are generally recognized as safe and effective (GRASE) and not misbranded.  FDA notes that it has not established...

Click here for a PDF brochure of the memorandum 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 the New Year. Our unique business platform and growing...

Chemical & Engineering News, “To Fulfill Biofuels’ Promise, Scientists Boost Plant Oils with Gene Editing” Ethanol Producer Magazine, “New Tax, Oversight Bill Aims to Extend Biofuel Tax Credits” MuscaDaily.com, “Omani Woman Scientist Wins UNESCO Fellowship for Research in Biofuels” The Times of India, “CSIR Working on Developing Biofuels on a Commercial Scale” Biofuels International, “Biodiesel By-product Has Potential as Clean...

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 15, 2018, announcing the availability of and seeking public comment on the first draft chemical risk evaluation under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).  The draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 is intended to determine whether C.I. Pigment Violet 29...

By Lynn L. Bergeson On November 5, 2018, the U.S. Food and Drug Administration (FDA) announced that a proposed collection of information on the Biosimilars User Fee Program was submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. FDA’s Biosimilars User Fee Program was established under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), which amended the Public Health Service Act through the addition...

On November 1, 2018, Bergeson & Campbell, P.C. (B&C®) launched a podcast called All Things Chemical™ that will engage 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 international chemical regulation and...

By Lynn L. Bergeson On October 30, 2018, the U.S. Food and Drug Administration (FDA) published a statement by FDA Commissioner Scott Gottlieb, M.D., and FDA Deputy Commissioner Anna Abram regarding FDA’s new action plan to advance plant and animal biotechnology innovation.  Aimed at ensuring the safety of plant and animal biotechnology products and avoiding unnecessary barriers to future innovation, the Action Plan focuses on three key priorities: Advancing public health by promoting...

On October 17, 2018, Bergeson & Campbell, P.C. (B&C®) presented a complimentary webinar regarding pending implementation dates of key U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) rules. “Keeping up with FSMA – Rules, Obligations, and Key Compliance Dates” was presented by Karin F. Baron, MSPH, Senior Regulatory Consultant, B&C, Lynn L. Bergeson, Managing Partner, B&C, and Scott J. Burya, Ph.D., Regulatory Chemist, B&C, and...

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, presented by Karin F. Baron, MSPH, Senior Regulatory Consultant, Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson, Managing Partner, B&C, and Scott J. Burya, Ph.D., Regulatory Chemist, B&C, showed...

Wednesday, October 17, 2018 1:00 p.m. - 2:00 p.m. (EDT)  Complimentary Registration Available Online  Speakers: ■ Karin F. Baron, MSPHSenior Regulatory Consultant, Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®)■ Lynn L. BergesonManaging Partner, B&C; President, Acta■ Scott J. Burya, Ph.D.Regulatory Chemist, B&C and Acta With key implementation dates of several core elements of the U.S. Food and Drug Administration’s (FDA) Food...

By Lynn L. Bergeson On August 1, 2018, the U.S. Department of Energy (DOE) announced an open meeting of the Biomass Research and Development Technical Advisory Committee under the Food, Conservation, and Energy Act of 2008.  83 Fed. Reg. 37490.  The Committee will meet on August 22, 2018, from 8:30 a.m. to 5:30 p.m. (EDT) and on August 23, 2018, from 8:00 a.m. to 1:30 p.m. (EDT).  The purpose of these meetings is to promote research and development (R&D) that leads to the...

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) signaled on June 29, 2018, its intent to prepare a “programmatic environmental impact statement (EIS) in connection with potential changes to the regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered [(GE)] organisms.”  The EIS will have a significant impact on how APHIS chooses to amend its regulation of GE...

While the intention of food contact regulations in both China and the US is to protect public health, the approaches taken, the obligations for industry and other facets of the regulations differ in notable ways. This article overviews the two regulatory systems, highlighting key similarities and differences between the emerging regulatory regime in China and the established US Food and Drug Administration (FDA) food contact regulations. 

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 Prevention...

By Lynn L. Bergeson On June 21, 2018, the U.S. Food and Drug Administration (FDA) announced it was withdrawing the draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017.  The announcement states that the draft guidance, if issued in final as written, “was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the...

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) published a prepublication version of the final rule regarding reporting requirements for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where “mercury” is defined as “elemental mercury” and “a mercury compound” (mercury). Section 8(b)(10)(B) of the Toxic Substances Control Act (TSCA), as amended by the Frank...

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....

On May 22-23, 2018, the U.S. Environmental Protection Agency (EPA) hosted a Polyfluoroalkyl Substances (PFAS) National Leadership Summit (Summit) in Washington, D.C.  The Summit convened federal and state regulators, including representatives from EPA’s Office of Water (OW), EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), the U.S. Food and Drug Administration (FDA), the U.S. Department of Defense (DOD), a small group of invited industry participants, and...

On May 1, 2018, the Hawaii Senate and House of Representatives passed a bill that will ban the sale, offer of sale, or distribution in Hawaii of any sunscreen that contains oxybenzone or octinoxate, or both, without a prescription issued by a licensed healthcare provider to preserve marine ecosystems, beginning January 1, 2021:  S.B. No. 2571, Environment; Water Pollution; Sunscreen; Oxybenzone; Octinoxate; Sale; Distribution; Prohibition.  The bill received unanimous...

On January 30, 2018, the Senate Committee on Environment and Public Works (EPW) convened an Oversight Hearing to Receive Testimony from U.S. Environmental Protection Agency (EPA) Administrator Scott Pruitt.  In a written statement submitted in advance of the hearing, Pruitt described implementation of the new Frank R. Lautenberg Chemical Safety for the 21st Century Act, or the “new” Toxic Substances Control Act (TSCA), as being of “significant importance” and a “top...

Click here for a PDF brochure of the memorandum Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) are pleased to offer you our Forecast 2018. The document distills key trends in U.S. and global chemical law and regulation, and provides a sneak preview of what our legal, scientific, and regulatory professionals believe we are likely to see in the New Year. Our unique business platform and global team of highly skilled professionals are perfectly suited...

On December 18, 2017, the Food and Drug Administration (FDA) published a Federal Register notice announcing the availability of a draft guidance for industry entitled “Drug Products, Including Biological Products, That Contain Nanomaterials:  Guidance for Industry.”  According to the notice, FDA developed the guidance to provide industry with its current thinking for the development of human drug products, including those that are biological products, in which a nanomaterial is present...