SKIP TO CONTENT
On November 12, 2015, the U.S. Food and Drug Administration (FDA) requested comment on the use of the term "natural" in the labeling of human food products. The notice states that it is establishing "a docket to receive information and comments on the use of the term 'natural' in the labeling of human food products, including foods that are genetically engineered or contain ingredients produced through the use of genetic engineering." FDA states that this action is a result of three...
November 11, 2015
TSCA: New Requirements for Submitting Section 5 Notices Take Effect in January 2016
The U.S. Environmental Protection Agency (EPA) recently reminded stakeholders that new requirements for submitting Toxic Substances Control Act (TSCA) Section 5 notices and support documents will take effect on January 19, 2016. EPA issued a direct final rule on July 20, 2015, amending the TSCA Section 5 electronic reporting regulations. Submitters will be required to use the new Chemical Safety and Pesticide Programs (CSPP) data flow, referred to as the new version of the...
November 10, 2015
Lynn L. Bergeson Quoted Extensively In BNA Daily Environment Report Article “Nanomaterials Said to Illustrate Need for TSCA Reform”
The November 10, 2015, BNA Daily Environment Report article "Nanomaterials Said to Illustrate Need for TSCA Reform" included comments from Lynn L. Bergeson and the NanoBusiness Commercialization Association (NanoBCA) on the importance of TSCA reform for nanomaterials. […]Lynn Bergeson, managing partner of Bergeson & Campbell P.C., said the EPA could have used the authority the House and Senate [TSCA modernization] bills would give the agency to order...
November 9, 2015
Australia Implementing Reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
As most recently reported in The Acta Group's (ACTA®) October 28, 2015, Global Regulatory Update, the Australian government is implementing reforms to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS). According to an item in the October 6, 2015, issue of The NICNAS Bulletin, the September 2015 implementation plan outlines opportunities for community and industry consultation; timing of legislative and information technology (IT)...
November 6, 2015
Inside EPA Includes Comments From Richard E. Engler, Ph.D. In Article “Agencies Receive Conflicting Comments On Update Of Biotech Reviews”
On November 6, 2015, Inside EPA included comments made by Richard E. Engler, Ph. D. at a public meeting held by EPA, USDA, and FDA to update the federal coordinated framework for how the three agencies regulate biotechnology. […]Industry officials, meanwhile, emphasized biotechnology's growing importance in food production and cautioned that over-regulation will stifle innovation. Officials with Dupont and the law firm Bergeson & Campbell, P.C., which...
November 2, 2015
BNA Daily Environment Report Article “New Authority Not Expected for Biotech Framework Update,” Quotes Richard E. Engler, Ph.D.
The November 2, 2015, BNA Daily Environment Report article, “New Authority Not Expected for Biotech Framework Update,” included comments made by Richard E. Engler, Ph.D. at the “Modernizing the Regulatory System for Biotechnology Products” public meeting held by FDA, USDA, and EPA. […DuPont global director of corporate regulatory affairs Terry] Medley and Richard Engler, a senior chemist working for Bergeson & Campbell P.C.,...
November 1, 2015
Public Meeting Announced To Discuss Modernizing The Regulatory System For Biotechnology Products Memorandum
On October 30, 2015, a public meeting was held to discuss Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology and Developing a Long-Term Strategy for the Regulation of the Products of Biotechnology (Framework). FDA's role in responding to the July 2015 memorandum issued by OSTP, the Office of Management and Budget (OMB), the U.S. Trade Representative (USTR), and the Council on Environmental Quality (CEQ) entitled...
November 9, 20151:00 - 4:00 p.m. (EST)In-person and via Webcast Although the June 1, 2015, implementation date for hazard classification, label and Safety Data Sheet (SDS) development, and packaging has passed, industry still struggles to comply with the new requirements. Many chemical manufacturers do not understand how to reclassify their hazardous chemicals, develop the appropriate labels and SDSs, or demonstrate "due diligence" to inspectors. Significant confusion remains as...
October 27, 2015
Lynn L. Bergeson Quoted in BNA Daily Environment Report Article “Uncertain Regulatory Path Costs Biotech Companies”
Lynn L. Bergeson was quoted in the October 15, 2015, BNA Daily Environment Report article “Uncertain Regulatory Path Costs Biotech Companies” about the recent Wilson Center report “The DNA of the U.S. Regulatory System: Are We Getting it Right for Synthetic Biology?”: Getting regulatory approval for products made with synthetic biology techniques is a daunting process, Lynn Bergeson, managing partner of Bergeson & Campbell P.C., and co-author of the...
October 27, 2015
Bergeson & Campbell P.C. TSCA Reform Webinar Quoted in BNA Daily Environment Report
The September 29, 2015, BNA Daily Environment Report article “States Urge Further Changes in TSCA-Reform Bill,” included comments made by Lynn L. Bergeson in a Bergeson & Campbell webinar. Lynn Bergeson, managing partner of Bergeson & Campbell PC, discussed state pre-emption during a Sept. 24 webinar her law firm held on TSCA-reform legislation before the House and Senate. Her firm specializes in laws and regulations addressing chemicals. “State pre-emption...