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The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Applications (NURA) program is offering a free three-session training series on replacing the traditional two-year bioassay with a more effective, human-relevant carcinogenicity assessment. In “Tomorrow’s Data Today: Sunsetting the 2-year Carcinogenicity Assay,” toxicologists, risk assessors, and scientists will hear directly from other experts on the current progress among working...

In a move that some may not have seen coming, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on December 29, 2022, as part of the Omnibus Appropriations Act. The MoCRA significantly strengthens the U.S. Food and Drug Administration (FDA) authority over cosmetic products. Key impacts are summarized below. Background On April 16, 2021, the Performance Enhancement Reform Act was introduced to the House of Representatives by Representative Gerald E. Connolly (D-VA)....

Click here for a PDF brochure of the memorandum. Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to offer you our Forecast 2023, our seasoned team’s collective take on what to expect regarding global industrial, agricultural, and biocidal chemical initiatives in the New Year. We have worked hard to offer our best-informed judgment on the trends...

By Lynn L. Bergeson and Carla N. Hutton   As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) published two...

October 26, 202212:00 p.m. - 1:00 p.m. (EDT) The U.S. Food and Drug Administration (FDA) reports that 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) in part to address this significant public health issue. FSMA is a comprehensive law intended to shift the focus of foodborne illness management from responding to outbreaks to...

By Lynn L. Bergeson and Carla N. Hutton   As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” The White House hosted a Summit on Biotechnology and Biomanufacturing on September 14, 2022. According to the White House fact sheet on the summit, federal...

Download transcript. This week, I welcomed back to the studio Karin F. Baron, Senior Regulatory Consultant at B&C and our consulting affiliate, The Acta Group. Karin and I discuss the U.S. Food and Drug Administration’s (FDA) initiative called the New Era of Smarter Food Safety. The goal of this initiative is to diminish the number of foodborne illness, which, surprisingly, has not diminished since the Food Safety Modernization Act was enacted 11 years ago. We discuss FDA’s...

October 26, 202212:00 p.m. - 1:00 p.m. (EDT)Register Now  The U.S. Food and Drug Administration (FDA) reports that 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) in part to address this significant public health issue. FSMA is a comprehensive law intended to shift the focus of foodborne illness management from responding to...

The U.S. Food and Drug Administration (FDA) will hold the “FDA NanoDay Symposium 2022” on October 11, 2022. The symposium will address the following topics: An overview and discussion of the recent “Guidance for Industry: Drug Products, Including Biological Products, that Contain Nanomaterials.” More information on the guidance is available in our April 24, 2022, blog item; A contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products; A...

On September 7, 2022, the Environmental Defense Fund (EDF) held a webinar to introduce a cumulative risk assessment (CRA) framework that takes into account multiple exposures to chemical and non-chemical stressors. Sarah Vogel, Senior Vice President for Health at EDF, moderated the webinar. According to Vogel, for decades, environmental justice leaders have documented disproportionate chemical exposures to disadvantaged communities. These chemical and social stressors (e.g., racism and...

On August 23, 2022, Chemical Watch quoted the Bergeson & Campbell, P.C. (B&C®) memoradum "EPA Will Discontinue Use of Exposure Modeling Thresholds When Assessing Health and Environmental Risks of New Chemicals," regarding the U.S. Environmental Protection Agency's (EPA) plan to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under the Toxic Substances Control Act (TSCA) New Chemicals Program. Law...

On August 19, 2021, the U.S. Environmental Protection Agency (EPA) announced a collaborative agreement with Unilever to explore better ways to assess chemical risks associated with consumer products. According to EPA, this agreement builds on prior cooperation between EPA and Unilever regarding New Approach Methods (NAM), “which are a promising alternative to conventional toxicity testing that are intended to reduce reliance on the use of animals.” EPA states that the collaboration...

The National Academies of Sciences, Engineering, and Medicine (NASEM) released on August 9, 2022, a report entitled Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health. NASEM was tasked by Congress and funded by the U.S. Environmental Protection Agency (EPA) to undertake a consensus study of the potential risk of ultraviolet (UV) filters on already threatened aquatic environments and the potential...

On July 20, 2022, the Food and Drug Administration (FDA) published a request for information (RFI) to obtain data and information on the use of fluorinated polyethylene for food contact applications. 87 Fed. Reg. 43274. FDA states that it is seeking scientific data and information on current food contact uses of fluorinated polyethylene, consumer dietary exposure that may result from those uses, and the safety of certain per- and polyfluoroalkyl substances (PFAS) that may migrate from...

The U.S.  Food and Drug Administration (FDA) announced on April 22, 2022, the availability of a final guidance for industry entitled “Drug Products, Including Biological Products, that Contain Nanomaterials.” 87 Fed. Reg. 24169. FDA states that the guidance applies to human drug products, including those that are biological products, in which a nanomaterial is present in the finished dosage form. The guidance discusses both general principles and specific considerations for developing drug...

On April 5, 2022, Chemical Watch quoted Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), regarding the U.S. Environmental Protection Agency’s (EPA) recent policy interpretation on the fluorination of high-density polyethylene (HDPE) containers. [‌I]n some respects, there has been little surprise at the agency’s view that the generation of certain PFASs during the fluorination of polyolefins – including polyethylene – is an...

Environment and Climate Change Canada (ECCC) announced on February 9, 2022, that the government introduced in the Senate the Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5), intended to modernize the Canadian Environmental Protection Act, 1999 (CEPA) and make related amendments to the Food and Drugs Act (FDA). The bill was initially introduced in the 43rd Parliament in April 2021 as Bill C-28, but it was not considered due to the federal election...

The National Nanotechnology Initiative (NNI) will hold a webinar on “What We Know about NanoEHS: Building International Bridges” on March 1, 2022. NNI states that it has supported the emergence of an international community of collaborative researchers on the environmental, health, and safety aspects of nanomaterials (nanoEHS). According to NNI, “[b]y advancing tools, methods, and standards for robust health and safety evaluation, these cooperative efforts have furthered the safe and...

The U.S. Food and Drug Administration (FDA) issued a proposed rule on January 26, 2022, to amend procedures for determining when a food contact substance notification (FCN) is no longer effective. 87 Fed. Reg. 3949. FDA states that the proposed rule would allow industry and FDA more flexibility in responding to new information on the safety and use of food contact substances. The amendments aim to create administration mechanisms to improve the program’s overall efficiency. Comments are...

Click here for a PDF brochure of the memorandum. Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to offer you our Forecast 2022. The extraordinary diversity and complexity of global industrial, agricultural, and biocidal chemical initiatives in which our clients engage are reflected in the detailed summary that follows, prepared by the legal,...