All Knowledge & Insights By Date

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 represents...

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., said the...

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 "Modernizing...

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 to how a firm...

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 remains...

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 report, said during...

The October 26, 2015, Inside EPA article, “TSCA Reform Legislation Could Smooth Path For New Biotechnologies,” included comments made by Lynn L. Bergeson at an event hosted by the Wilson Center’s Synthetic Biology Project (synbio). Pending legislation in Congress to reform the 40-year-old Toxic Substances Control Act (TSCA) could make it easier for EPA to assess the potential risks of new technologies, such as synthetic biology, and review requests to...

The pathway to market for new products utilizing synthetic biology can be difficult to navigate, posing a challenge for companies in their efforts to commercialize new ideas, while the novelty posed by some of these products can make it difficult for regulatory agencies to evaluate risks. This report from the Synthetic Biology Project,The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?, looks at the current regulatory oversight of synthetic biology in the United...

On October 20, 2015, the United States Federal Trade Commission (FTC) released a Final Order with a corresponding Opinion against ECM BioFilms, Inc. (ECM) stating that ECM made false and unsubstantiated environmental claims that its additives for plastics (ECM Plastics) would make treated plastics biodegrade in a landfill. The FTC Final Order and Opinion come two years after FTC issued an administrative complaint against ECM and ten months after an FTC Administrative Law...

The summer of 2015 was surprisingly busy in the industrial biotechnology policy and regulatory arenas with three important announcements regenerating lots of buzz.  On July 2, 2015, the White House Office of Science and Technology Policy, the Office of Management and Budget, the US Trade Representative, and the Council on Environmental Quality issued a memorandum directing EPA, FDA, and USDA to update and modernize the Coordinated Framework for the Regulation of Biotechnology.  A few...

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) hosted “Leveraging Synthetic Biology’s Promise and Managing Potential Risk,” a panel discussion featuring Lynn L. Bergeson, Sheryl Lindros Dolan, and Richard E. Engler, Ph.D., of B&C, and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincided with the release of “The DNA of the U.S. Regulatory...

George Washington University Milken Institute School of Public Health,George Washington University Law School,Environmental Law Institute, andBergeson & Campbell, P.C. Present: TSCA Reform Panel Summit: What's Happening Now, and What's Next? November 19, 201512:00 – 1:30 p.m. (EST)In-person and via Webcast Betting on passage by Congress of Toxic Substances Control Act (TSCA) reform is anything but a sure thing. While most remain optimistic, with each passing day the window of opportunity...

On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) hosted “Leveraging Synthetic Biology’s Promise and Managing Potential Risk,” a panel discussion featuring Lynn L. Bergeson, Sheryl Lindros Dolan, and Richard E. Engler, Ph.D., of B&C, and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincided with the release of “The DNA of the U.S. Regulatory...

On October 20, 2015, the White House announced a grand challenge to develop transformational computing capabilities by combining innovations in multiple scientific disciplines

The Organization for Economic Cooperation and Development (OECD) recently posted a new document in its Series on the Safety of Manufactured Nanomaterials, Developments on the Safety of Manufactured Nanomaterials: 2013.

Panel Discussion to Be Held Wednesday, October 15, 2015, from 12:00 p.m. - 2:00 p.m. (EDT) On October 15, 2015, the Woodrow Wilson International Center for Scholars (Wilson Center) will host "Leveraging Synthetic Biology's Promise and Managing Potential Risk," a panel discussion featuring Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincides with...

Panel Discussion to Be Held Wednesday, October 15, 2015, from 12:00 p.m. - 2:00 p.m. (EDT) On October 15, 2015, the Woodrow Wilson International Center for Scholars (Wilson Center) will host "Leveraging Synthetic Biology's Promise and Managing Potential Risk," a panel discussion featuring Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincides with...

On October 6, 2015, the White House Office of Science and Technology Policy (OSTP) issued a Request for Information (RFI) to solicit relevant data and information, including case studies that may assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (CF). The RFI will assist OSTP in clarifying the current roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and...

On September 28, 2015, the U.S. Environmental Protection Agency (EPA) announced revisions to its worker protection standard.  EPA states that these revisions are intended to “enhance the protections provided to agricultural workers, pesticide handlers, and other persons under the Worker Protection Standard (WPS) by strengthening elements of the existing regulation, such as training, notification, pesticide safety and hazard communication information, use of personal protective...

The July 31, 2015, Bloomberg BNA Daily Environment Report spoke with James V. Aidala regarding the progress of Toxic Substance Control Act (TSCA) modernization legislation. James Aidala, senior government affairs consultant with the law firm  Bergeson & Campbell P.C., said reaching an agreement on preemption is key. Aidala was associate assistant administrator of the EPA's Office of Prevention, Pesticides and Toxic Substances from 1993 to 2000, and previously worked in the...

The Organization for Economic Cooperation and Development (OECD) posted a new publication in its Series on the Safety of Manufactured Nanomaterials, Preliminary Guidance Notes on Nanomaterials: Interspecies Variability Factors in Human Health Risk Assessment.

California's Department of Toxic Substances Control (DTSC) released for comment its Draft Stage 1 Alternatives Analysis Guide (Draft AA Guide). Under the Safer Consumer Products Regulations (SCPR), responsible entities (generally, manufacturers) must perform an AA for the listed Chemical of Concern (COC) and Priority Product (PP) combination to determine how best to limit potential exposures or the level of potential adverse public health and environmental impacts posed by the COC in...

On April 6, 2015, the United States Environmental Protection Agency (EPA) proposed an important rule under Section 8(a) of the Toxic Substances Control Act (TSCA) concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. This article from the Fall, 2015, issue of Environmental Quality Management assists stakeholders in the nanoscale chemical substance area who will be directly impacted by...

The Federal Trade Commission (FTC) announced in a September 14, 2015, press release, "FTC Sends Warning Letters about Green Certification Seals," that it sent warning letters to five providers of environmental certification seals and 32 businesses using those seals, "alerting them to the agency's concerns that the seals could be considered deceptive and may not comply with the FTC's environmental marketing guidelines." FTC states that environmental certification seals are intended to help...

The National Nanotechnology Initiative (NNI) announced on September 17, 2015, that the National Science Foundation (NSF) will provide a total of $81 million over five years to support 16 sites and a coordinating office as part of a new National Nanotechnology Coordinated Infrastructure (NNCI).

On August 31, 2015, the U.S. Environmental Protection Agency (EPA) proposed an important rule under the Resource Conservation and Recovery Act (RCRA) that would ease the standards for healthcare facilities that dispose of hazardous waste pharmaceuticals. The proposal is of interest to all participants in the pharmaceutical value chain, from manufacturers to health care providers to end users. This column explains why.

The U.S. Environmental Protection Agency (EPA) released on September 17, 2015, a signed final significant new use rule (SNUR) for hexabromocyclododecane or 1,2,5,6,9,10-hexabromocyclododecane (HBCD). Under the final rule, persons who intend to manufacture (including import) or process HBCD for use in consumer textiles (other than for use in motor vehicles) must notify EPA at least 90 days before commencing that activity. EPA notes that in this SNUR, the exemption for persons importing or...

On September 14, 2015, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted a request from the EC for a scientific opinion on titanium dioxide (nano) as a UV-filter in sunscreens and personal care spray products.

On September 2, 2015, the U.S. Department of Health and Human Services' (HHS) Agency for Toxic Substances and Disease Registry (ATSDR), in accordance with guidelines developed by ATSDR and the U.S. Environmental Protection Agency (EPA), issued a proposed Toxicological Profile for Perfluoroalkyls for review and comment that included updated toxicological profiles for 13 perfluorinated chemicals, including two well-studied perfluorinated chemicals, perfluorooctane sulfonic acid (PFOS)...

A September 3, 2015, Inside EPA article regarding EPA’s efforts to improve how it reviews companies’ proposals to develop synthetic biology products, and specifically biotech algae, featured quotes from Bergeson & Campbell, P.C.: In a recent memo to clients, the law firm Bergeson & Campbell calls the announcement of the algae guide update "hugely important for the industrial biotechnology communities," adding that "EPA's announcement suggests a broader Agency initiative is...

This week, Belgium's Federal Public Service for Health, Food Chain Safety and Environment created an online portal for companies to register nanomaterials they put on the market.

On July 20, 2015, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) issued OSHA Directive Number CPL 02-02-079. The Directive is intended to establish “policies and procedures to ensure uniform enforcement of the Hazard Communication standard” (HCS 2012).

The U.S. Environmental Protection Agency (EPA) published a notice in the August 25, 2015, Federal Register announcing a public meeting on September 30, 2015, to receive public input and comments on EPA's data needs to support risk assessments of biotechnology products subject to oversight under the Toxic Substances Control Act (TSCA) that make use of genetically engineered algae and cyanobacteria. The notice states that the workshop will inform an update to an EPA...

The release of the first Tier 1 assessments in the Endocrine Disruptor Screening Program (EDSP) by the U.S. Environmental Protection Agency (EPA) on June 30, 2015, is a significant benchmark in the program since the original List 1 test orders were issued in October 2009. This column explains why.

On August 4, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance document entitled "Guidance for Industry: Use of Nanomaterials in Food for Animals." The Guidance is intended to assist industry and other stakeholders in identifying potential issues related to safety or regulatory status of food for animals containing nanomaterials or otherwise involving the application of nanotechnology.

The U.S. Environmental Protection Agency (EPA) has posted a document concerning its development of a project intended to support public dialog concerning the development and use of biotechnology.  EPA has oversight responsibility for the production and use of intergeneric cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches.  EPA’s recently posted document, US Environmental Protection Agency Biotechnology Algae Project, states...

The July 31, 2015, Bloomberg BNA Daily Environment Report spoke with Lynn L. Bergeson regarding EPA’s plans to develop updated guidance for companies making chemicals with genetically engineered microorganisms under the Toxic Substances Control Act (TSCA). “EPA's posting of the synbio algae project is hugely important for the industrial biotechnology and synthetic biology communities,” Lynn  Bergeson, managing partner of Bergeson  & Campbell P.C., told Bloomberg BNA...

On July 27, 2015, two petitions for review of the U.S. Environmental Protection Agency's (EPA) second conditional registration of a nanosilver pesticide product were filed in the U.S. Court of Appeals for the Ninth Circuit.

On July 20, 2015, the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) issued OSHA Directive Number CPL 02-02-079. The Directive is intended to establish "policies and procedures to ensure uniform enforcement of the Hazard Communication standard" (HCS 2012). The Directive repeals previous instructions CPL 02-02-038 and CPL 02-02-039. It also cancels both enforcement memorandums effective February 9, 2015, and May 29, 2015, respectively. For more...

Competing proposals are working their way through the House and Senate to amend the Toxic Substances Control Act, the nation’s primary law for managing chemicals in commerce. In this article, former senior Environmental Protection Agency officials Charles Auer and James Aidala and attorney Lynn Bergeson discuss making the bill clearer and how congressional direction can be provided on what EPA is to do with certain new provisions to implement them in the first years of any amended TSCA.

With little fanfare, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of Biotechnology. Last updated in 1992 and first rolled out...

The release of the first Tier 1 assessments in the Endocrine Disruptor Screening Program (EDSP) by the U.S. Environmental Protection Agency (EPA) on June 30, 2015, is a significant benchmark in the program since the original List 1 test orders were initially issued in October 2009. Fifteen of the original 67 List 1 chemicals were subsequently cancelled or discontinued by the respective pesticide registrants. The intended purpose of the Tier 1 screening was to identify potential...

On June 23, 2015, the House passed the TSCA Modernization Act of 2015 (H.R. 2576) by a vote of 398-1. The House Committee on Energy and Commerce issued a press release on June 22, 2015, noting that the bill "would bring much-needed reform to the decades-old Toxic Substances Control Act (TSCA), and is a true bipartisan breakthrough for the committee." According to the press release, support "has poured in for this bill as it works to improve the protection of human health and...

With little fanfare or advanced notice to the general public, on July 2, 2015, the White House Office of Science and Technology Policy (OSTP), the Office of Management and Budget (OMB), the U.S. Trade Representative, and the Council on Environmental Quality issued a memorandum directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the Coordinated Framework for the Regulation of...

After over a year of review and revision, on June 25, 2015, the Chinese Ministry of Environmental Protection Solid Waste and Chemical Management Center (MEP-SCC) published the "Guidance for New Chemical Substance Notification and Registration (Draft)" (Guidance) for public comment. The deadline to submit comments to MEP-SCC regarding the Guidance is July 31, 2015. Comments should be submitted to MEP-SCC via e-mail (guidance@mepscc.cn). In addition, MEP-SCC will hold a meeting to explain the...

Imagine receiving a certified letter from the US Environmental Protection Agency (EPA) announcing that it plans to conduct an audit of your company’s facility in two weeks. The audit will focus on your company’s compliance obligations as a chemical manufacturer under the Toxic Substances Control Act (TSCA). Would you be prepared or are you unsure of what TSCA is and whether it applies to you? This article explains how TSCA applies to biobased chemicals and how nomenclature and chemical...

The American Bar Association (ABA) Section of Environment, Energy, and Resources' Young Lawyers Division presented a fascinating webinar on June 23, 2015, on the key areas of alignment and non-alignment between the European Union's (EU) and the United States' approach to chemical management by exploring the EU's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation and the Toxic Substances Control Act (TSCA).  The webinar was moderated by Lynn L....

On June 11, 2015, the U.S. Environmental Protection Agency (EPA) held a meeting on its Toxic Substances Control Act (TSCA) Section 8(a) proposed rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale. Jeff Morris, Deputy Director for Programs, Office of Pollution Prevention and Toxics (OPPT), and Jim Alwood, OPPT Chemical Control Division, provided further insight into EPA's goals, directives, and...