All Knowledge & Insights By Date

On February 16, 2016, the U.S. Occupational Safety and Health Administration (OSHA) released for public comment its “Guidance on Data Evaluation for Weight of Evidence Determination.” The document aims to help employers consider all available information when classifying hazardous chemicals for labeling and safety data sheet (SDS) completion purposes. Because of the critical importance of satisfying these regulatory obligations correctly, understanding the Guidance is essential.

The European Food Safety Authority (EFSA) has begun a public consultation on its draft guidance on the preparation and presentation of an application for authorization of a novel food.

House Bill Would Delete International Regulatory Provisions From Clean Air Act: Stating that "this assault on our Constitution and states' rights must be stopped," Representative Scott Perry (R-PA) on February 11, 2016, introduced a bill that would deny the U.S. Environmental Protection Agency (EPA) "the ability to bypass Congress and take control of every states' energy program." The Energy Sovereignty Act (H.R. 4544) seeks to do so by eliminating Section 115 of the Clean Air Act (CAA)....

On January 25, 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) announced the adoption of final regulations (Regulations) related to the development and maintenance of a website to "provide information to the public regarding exposures to listed chemicals for which warnings are being provided" under Proposition 65 (Prop 65). Final Statement of Reasons (FSOR) at 11. OEHHA states that its intent with these Regulations is to "increase the availability of...

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Oscar Hernandez, Ph.D. has joined our teams as Senior Regulatory Chemist. Dr. Hernandez is the former Director of the Risk Assessment Division (RAD) in the U.S. Environmental Protection Agency's (EPA) Office of Pollution Prevention and Toxics (OPPT), where he managed a multi-disciplinary science group that provided expert scientific support in the areas of hazard and risk assessment of chemicals...

According to a Federal Register notice published on February 5, 2016, 81 Fed. Reg. 6225, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) announced 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 notice identifies "reasonable...

On January 21, 2016, the American National Standards Institute (ANSI) hosted a presentation on enforcement under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation. The topics covered included "Enforcement -- the Actors and the Activities"; "[the European Chemicals Agency (ECHA) Forum for Exchange of Information on Enforcement (ECHA Forum)]'s Role and Initiatives"; "Enforcement Targeted to Importers"; and "Enforcement of [Substances of...

On January 7, 2016, the U.S. Environmental Protection Agency (EPA) announced in the Federal Register the beginning of a 45-day comment period on the peer review draft of the Guidelines for Human Exposure Assessment (draft Guidelines). According to EPA, the draft Guidelines benefit from over two decades of experience with assessments conducted by EPA programs under their respective authorities and constraints, as well as from input from external panels, including the...

On February 1, 2016, the White House Office of Science and Technology Policy (OSTP) announced the dates and locations for the second and third public engagement sessions that will discuss the July 2, 2015, memorandum entitled "Modernizing the Regulatory System for Biotechnology Products." The second public meeting will be held on March 9, 2016, at the U.S. Environmental Protection Agency's (EPA) Region 6 office at 1445 Ross Avenue in Dallas, Texas. The third public meeting will be held...

The December 2015 issue of Nature Biotechnology included comments by Richard E. Engler, Ph.D. on keeping biotech rules current with scientific progress in the article “A face-lift for biotech rules begins.” To stay up to date with technology, Richard Engler, a senior chemist at the environmental law firm Bergeson & Campbell in Washington, DC, suggested that technology stewards be embedded in each of the relevant federal agencies. Their role would be to monitor...

Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Susan M. Kirsch has joined our teams as Government Affairs Advisor. Ms. Kirsch brings substantial regulatory and technical policy expertise at the local, state, and federal levels, with experience at the New York State Department of Environmental Conservation, the U.S. Department of Justice, Environmental and Natural Resource Division, and most recently the Association of Clean Water...

On January 4, 2016, the U.S. Food and Drug Administration (FDA) issued a final rule amending its food additive regulations to no longer allow the use of three specific perfluoroalkyl ethyl-containing food contact substances (FCS) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods. All three of the FCSs contain extended perfluorinated alkyl chains greater than or equal to eight carbons in length and as such are long-chain perfluorinated...

Click here for a PDF version of the memorandum. Even if Toxic Substances Control Act (TSCA) legislation is not enacted, 2016 will be a momentous year. As the curtain closes on eight years of the Obama Administration, there are a number of items expected to be among the "legacy" issues in the chemical and pesticide regulation space. Enhanced protections for farmworkers, more protective assessment policies, and a re-energized toxic chemical assessment program are among the short list of notable...

In October, the U.S. Environmental Protection Agency (EPA) announced proposed changes to its regulations under the Resource Conservation and Recovery Act (RCRA) regarding the export and import for recovery operations of hazardous wastes from and into the United States.

This analysis reviews the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697) as passed by the Senate on December 17, 2015, and compares it to the previous version of S. 697 (identified as Lautenberg2 in this analysis), passed by the Senate Environment and Public Works (EPW) Committee in June 2015. This review also briefly compares S. 697 to H.R. 2576, the [Toxic Substances Control Act (TSCA)] Modernization Act of 2015, which passed the House of Representatives on...

On December 16, 2015, the House Appropriations Committee released the Consolidated Appropriations Act, 2016. The 2,009-page bill includes full appropriations legislation and funding for the 12 annual appropriations bills through the end of fiscal year (FY) 2016. The bill would reauthorize the Land and Water Conservation Fund (LWCF), which expired on September 30, 2015. This reauthorization is likely what prompted Senator Richard Burr (R-NC) to inform Senate Majority Leader Mitch...

On October 1, 2015, the U.S. Occupational Safety and Health Administration (OSHA) released a revised Field Operations Manual (FOM), Directive Number CPL 02-00-159, available here. The FOM aims to “provide OSHA offices, State Plan programs and federal agencies with policy and procedures concerning the enforcement of occupational safety and health standards.” Because OSHA can impose higher penalties as a result of the Bipartisan Budget Act of 2015, the document is a must-read for...

On November 23, 2015, the U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) issued a Letter of Interpretation (LOI) on labeling packages for import and export. The LOI discusses labeling scenarios and details OSHA's interpretation of the Hazard Communication Standard (HCS 2012) requirements for those scenarios. Background On May 26, 2012, OSHA issued a final rule modifying its HCS to conform to the United Nations' Globally Harmonized System of...

The December 14, 2015, Chemical Watch article “TSCA Bill Could Have 'Huge' Impact On Downstream Users,” included quotes from Lynn L. Bergeson on possible results of TSCA Reform. Changes to the chemical inventory as proposed in the US Senate Toxic Substances Control Act (TSCA) reform would have a “huge” impact on downstream users, according to Lynn Bergeson, owner of Bergeson & Campbell, PC.  Bill S697 proposes to reset the TSCA Inventory of Chemical Substances to...

On November 27, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) took two actions: (1) it withdrew its proposed rule issued on January 16, 2015, that would have repealed and replaced the existing Article 6 regulations regarding the all-important "clear and reasonable warnings" requirements under Proposition 65 (Prop 65); and (2) it replaced it with a new proposed rule that will repeal and replace the Prop 65 Article 6 regulations (Proposed Rule), posted with an...

On November 27, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) took two actions: (1) it withdrew its proposed rule issued on January 16, 2015, that would have repealed and replaced the existing Article 6 regulations regarding the all-important "clear and reasonable warnings" requirements under Proposition 65 (Prop 65); and (2) it replaced it with a new proposed rule that will repeal and replace the Prop 65 Article 6 regulations (Proposed Rule), posted with an...

On December 11, 2015, Chemical Watch, quoted Lynn Bergeson in the article “Senate TSCA Bill More Aligned With EPA Principles, Says Denison.” Lynn Bergeson, managing partner of Bergeson & Campbell, said it is possible that the Senate will approve S-697 before Congress adjourns in mid-December. “Until it emerges from the Senate we can’t have any further action on the bill,” she added.

The National Institute for Occupational Safety and Health (NIOSH) posted a RAND Corporation (RAND) report entitled Nanomaterial Safety in the Workplace: Pilot Project for Assessing the Impact of the NIOSH Nanotechnology Research Center.

EPA Launches eDisclosure Portal: On December 9, 2015, the U.S. Environmental Protection Agency (EPA) announced that it is modernizing implementation of its self-disclosure policies by creating a centralized web-based ''eDisclosure'' portal to receive and automatically process self-disclosed civil violations of environmental law. 80 Fed. Reg. 76476. Under the automated eDisclosure system, "large and small businesses will quickly be able to get some of their more routine types of disclosures...

The December 9, 2015, Daily Environment Report article “Evolving Chemical Issues Drive Change at Law Firms” included an interview with Lynn Bergeson and Heidi Lewis on how Bergeson & Campbell, P.C., has changed in the 10 years since REACH became law.  REACH became law in 2006 in the European Union, Iceland, Liechtenstein and Norway. Since then, Bergeson & Campbell PC has seen “tremendous growth” said Heidi Brown Lewis, director of marketing for the firm. “We've...

The December 1, 2015, Bloomberg BNA Daily Environment Report article “Swedish Agency Proposes Nanomaterials Reporting” included quotes from Lynn L. Bergeson. The proposal is not unexpected, said Lynn Bergeson, managing partner of the law firm Bergeson & Campbell P.C., which has tracked policies for nanomaterials for more than a decade. Sweden's National Action Plan, issued Oct. 8, 2013, recommended the creation of an inventory of products on the market that contain...

"TSCA Reform: What’s Happening Now, and What’s Next?" Request Recording and slides from “TSCA Reform Panel Summit: What’s Happening Now, and What’s Next?”  Program informational flyer George Washington University (GWU) Milken Institute School of Public Health, GWU Law School, Environmental Law Institute, Arnold & Porter LLP, and Bergeson & Campbell, P.C. Present:  TSCA Reform Panel Summit: What's Happening Now, and What's Next? Thursday, November 19, 2015,...

Biotechnology is an area of growing domestic and international importance to the manufacturing sector, and this summer the federal government announced several important biotechnology initiatives of which stakeholders should be aware. This article from the Winter, 2015, issue of Environmental Quality Management explains each initiative, and outlines why stakeholders are encouraged to engage in each one.

A November 30, 2015 story in Bloomberg BNA Daily Environment Report on the federal approach to regulating bioengineered products and comments submitted by nearly a thousand organizations and individuals on the Coordinated Framework for the Regulation of Biotechnology, featured commentary from B&C: Bergeson & Campbell PC, a law firm that represents companies working with emerging technologies, supported the efforts to update the framework but described structural...

B&C Managing Partner and Product Stewardship Society Board Member Lynn L. Bergeson’s presentation "Legal and Stewardship Issues Associated with EPDs and HPDs" was featured in the society’s Full Circle Blog:  “Regardless of what the law requires, disclosure is fast becoming a commercial imperative, especially for companies wanting to establish themselves as ‘green,’ said Lynn Bergeson, managing partner, Bergeson & Campbell, PC, during a session at...

The November 25, 2015, Bloomberg BNA Daily Environment Report quoted Bergeson & Campbell, P.C., in the article “Diverse Parties Say Federal Biotech Rules Confusing.” Bergeson & Campbell PC, a law firm that represents companies working with emerging technologies, supported the efforts to update the framework but described structural problems that may thwart the White House's intentions. The regulatory infrastructure is ill-suited to address synthetic biology—a new form of...

EPA Seeks To Vacate Enlist Duo Herbicide FIFRA Registration: On November 24, 2015, in the U.S. Court of Appeals for the Ninth Circuit, Case No. 14-7335, the U.S. Environmental Protection Agency (EPA) filed a motion to vacate voluntarily and remand its registration of Dow AgroSciences LLC's (DowAgro) Enlist Duo herbicide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The motion for vacatur is unusual and noteworthy to all pesticide registrants. The case commenced in...

On November 24, 2015, Inside EPA published the article “TSCA Bill Faces Implementation Hurdles Despite Potential For Senate Vote.”  Jim V. Aidala was quoted discussing a possible implementation timeline if the TSCA Reform bill was passed. Former EPA toxics official Jim Aidala, now with the law firm Bergeson & Campbell, at the ELI event identified some of the time frames on rulemakings, new definitions, and administrative fees as potential "early implementation hurdles"...

On November 19, 2015, the U.S. Food and Drug Administration (FDA) announced it had approved AquaBounty Technologies' application for the genetically engineered (GE) salmon (AquAdvantage Salmon), the first time FDA has approved a GE animal. FDA regulates GE animals under the new animal drug requirements through the Center for Veterinary Medicine in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA states in the news release that it "thoroughly...

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According to an item in the U.S. Environmental Protection Agency's (EPA) Fall 2015 Regulatory Agenda, EPA intends to promulgate a final Toxic Substances Control Act (TSCA) Section 8(a) rule in October 2016 concerning reporting and recordkeeping requirements for certain chemical substances when they are manufactured or processed at the nanoscale.

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...

The November 17, 2015, Chemical Watch article “Leading Republican Senators Pledge To ‘Rein In’ US EPA,” included a quote from Lynn L. Bergeson on a possible outcome of Republicans taking control of the Senate. “Given Senator Inhofe’s strong views on EPA, it would not surprise me if he took direct aim at many EPA initiatives, starting with, but by no means ending with, climate change,” said Lynn Bergeson of the law firm Bergeson & Campbell, which specialises in...

On October 20, 2015, the U.S. Federal Trade Commission (FTC) released a “Final Order and Opinion” against ECM BioFilms, Inc., 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 opinion come two years after FTC issued an administrative complaint against ECM and ten months after an FTC Administrative Law Judge (ALJ) issued an Initial Decision finding ECM violated FTC Act...

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 electronic...

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 the...

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) system...

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...