October 27, 2016

Zameer Qureshi, “The REACH Implementing Regulation on joint submission of data and data sharing: is it fair, transparent and non-discriminatory?,” Elements, the Magazine of Chemicals Northwest, Autumn, 2016.

Commission Implementing Regulation (EU) 2016/9 (Implementing Regulation) entered into force with retroactive effect on 26 January 2016, providing several new and important considerations and obligations for companies sharing data under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The Implementing Regulation aspires to: (1) provide useful clarity on data sharing and data compensation under REACH by providing detail on the “fair, transparent and...
October 24, 2016

Lynn L. Bergeson, “EPA Speeds Review of Chemicals,” Chemical Processing, October 24, 2016.

The U.S. Environmental Protection Agency (EPA) is continuing its brisk pace to be on target with implementing the new requirements of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (see “Grasp the Gravity of the New TSCA,” and “EPA Releases Q&As on New TSCA”). Congress has in its sights persistent, bioaccumulative, and toxic (PBT) chemicals — with the goal to reduce exposures to...
October 14, 2016

Charles M. Auer, Lynn L. Bergeson, “Role of ‘Conditions of Use’ Under Sections 5 and 6 of Amended Toxics Law,” BNA Daily Environment Report, October 14, 2016.

President Barack Obama signed into law amendments to the Toxic Substances Control Act on June 22. The amendments bring sweeping changes to the nation’s primary chemicals law. In this Bloomberg BNA Insights, Charles M. Auer and Lynn L. Bergeson look specifically at the role of ‘‘conditions of use’’ in Sections 5 and 6 under the amended law and other chemical exposure considerations....
September 30, 2016

Charles M. Auer, Lynn L. Bergeson, “Is The Section 5 Review Period Fixed Or Flexible In New TSCA?,” ABA Section of Environment, Energy, and Resources PCRRTK Newsletter, September, 2016.

 Among its other requirements and authorities, Section 5 of new TSCA generally requires that a company timely submit to EPA a notice of its intent to manufacture or process a new chemical or significant new use (NC/SNU). EPA is then required to conduct a review of the Section 5(a)(1) notice and make a determination on the NC/SNU and take required additional actions. Questions have been raised as to whether the review period is fixed and...
September 20, 2016

Lynn L. Bergeson, “EPA Releases Q&As on New TSCA,” Chemical Processing, September 20, 2016.

On September 2, 2016, the U.S. Environmental Protection Agency (EPA) released additional guidance on its implementation of the new Toxic Substances Control Act (TSCA) in the form of additional questions and answers (Q&As). This column explains the significance of this guidance. On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act, ushering in a significantly enhanced, and effective immediately, chemical management law. (See...
August 17, 2016

Lynn L. Bergeson, “Pollution Monitoring: New Tools Help Speed Compliance,” Chemical Processing, August 17, 2016.

The U.S. Environmental Protection Agency (EPA) has made much of its “Next Generation Compliance” initiative, created “to increase compliance with environmental regulations by using advances in pollutant monitoring and information technology combined with a focus on designing more effective regulations and permits to reduce pollution.” This involves more effective regulations and permits that include built-in compliance mechanisms, such as continuous monitoring for stationary sources;...
August 16, 2016

Charles M. Auer, “Old TSCA, New TSCA, and Chemical Testing,” BNA Daily Environment Report, August 16, 2016.

It is the author’s view that the central failing of old TSCA was its inability to produce the testing needed by EPA to assess and understand the hazards, exposures, and risks of existing chemicals. New TSCA makes important changes to the authority available to EPA to compel industry to generate the information needed by EPA to meet the purposes articulated under the new law. This paper briefly reviews the issues and problems that EPA encountered...
August 15, 2016

Lynn L. Bergeson, Charles M. Auer, “An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders,” Industrial Biotechnology, Volume 12, Issue 4, August 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act, P.L. 114-182, significantly amends the Toxic Substances Control Act (TSCA). The Act was signed into law by President Obama on June 22, 2016. The date of signature is both the date of enactment and of entry into force of amended TSCA. New TSCA fundamentally changes the U.S. Environmental Protection Agency’s (EPA) approach to evaluating and managing industrial chemicals, including genetically engineered microorganisms. The...
August 9, 2016

Kathleen M. Roberts, Richard E. Engler, Ph.D., Charles M. Auer, Lynn L. Bergeson, “An Analysis of Section 8 of the New Toxic Substances Control Act,” BNA Daily Environment Report, August 9, 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act significantly amends the Toxic Substances Control Act (TSCA), particularly with regard to Section 8 record keeping and reporting obligations. This article highlights a number of important changes and deadlines of which companies subject to TSCA should be aware....
July 12, 2016

Lynn L. Bergeson, “Grasp the Gravity of the New TSCA,” Chemical Processing, July 13, 2016.

The Frank R. Lautenberg Chemical Safety for the 21st Century Act makes seismic changes in domestic industrial chemical management. If you think the extensive revisions to the Toxic Substances Control Act (TSCA) enacted on June 22, 2016, don’t impact your business, think again. TSCA reform affects virtually every domestic business sector involving chemicals and manufactured goods containing chemicals, and will continue to do so for years to come....
July 11, 2016

Lynn L. Bergeson, “EC Denies 2014 Petition Seeking EU-Wide Ban on Nanoparticles,” Nanotechnology Now, July 12, 2016.

On June 29, 2016, the European Commission (EC) provided a notice to the European Parliament regarding its response to a 2014 petition calling for a European Union (EU)-wide ban on microplastics and nanoparticles. The petition summary states: “Nanoparticles are so small that they penetrate cells effortlessly and can damage them, causing cancer. Because the precautionary principle applies in the EU, the petitioner urges a ban on these small particles as soon as possible.”...
July 5, 2016

Lynn L. Bergeson, “CRS Prepares “Policy Primer” on Nanotechnology,” Nanotechnology Now, July 6, 2016.

The Congressional Research Service (CRS) prepared a June 28, 2016, report, Nanotechnology: A Policy Primer. The report provides an overview of federal research and development (R&D) in nanotechnology, U.S. competitiveness in the field, environmental, health, and safety (EHS) concerns, nanomanufacturing, and public understanding of and attitudes toward nanotechnology. According to the report, while more than 60 nations established similar programs after the launch of the National...
June 28, 2016

Emma L. Jackson, Louise C. Boardall, Zameer Qureshi, “Top Questions for Substance Information Exchange Forum (SIEF) Participation,” Elements, the Magazine of Chemicals Northwest, Summer, 2016.

The global chemicals industry has been presented with significant, often unfamiliar, challenges by the concept and functioning of SIEFs under REACH.  Through years of experience in SIEF participation on our clients’ behalf, Acta has identified the following questions to consider when participating in a SIEF....
June 15, 2016

Lynn L. Bergeson, “In-House Counsel Beware: TSCA Reform Impacts Everyone,” Law360, June 15, 2016 .

In-house counsel unfamiliar with the tsunami-like changes in domestic chemical management headed our way soon may wish to read this article. If you think for a second that the extensive revisions to the Toxic Substances Control Act (TSCA) expected to be enacted imminently do not impact your legal practice or your client’s business operations, think again. TSCA reform impacts virtually every business sector in the United States, and will continue to do so for years...
June 7, 2016

Lynn L. Bergeson, “Mexico Begins Public Consultation on Draft Nanotechnology Standards,” Nanotechnology Now, June 7, 2016.

On May 3, 3016, Mexico’s Ministry of Economy published a notice beginning a public consultation on two draft nanotechnology standards. ISO/TS 80004-5:2011 lists terms and definitions related to the interface between nanomaterials and biology. It is intended to facilitate communications between scientists, engineers, technologists, designers, manufacturers, regulators, non-governmental organizations (NGO), consumer organizations, members of the public, and others....
June 1, 2016

Lynn L. Bergeson, “Proposed Harmonized Classification and Labeling Would Apply to Nanosized Titanium Dioxide,” Nanotechnology Now, June 1, 2016.

On May 31, 2016, the European Chemicals Agency (ECHA) began a public consultation on a harmonized classification and labeling (CLH) proposal submitted by France for titanium dioxide. The CLH report states: “Based on available evidence and information in the registration dossier (e.g. mechanism of carcinogenicity, characterization of the particles), the proposed scope for the Annex VI entry is: ‘Titanium dioxide in all phases and phase combinations; particles in all...
June 1, 2016

Lynn L. Bergeson, “EPA Seeks to Revise Risk Management Program,” Chemical Processing, June 1, 2016.

On March 14, 2016, the U.S. Environmental Protection Agency (EPA) proposed much-anticipated amendments to the Risk Management Program (RMP) regulations. This column summarizes the proposed amendments and industry’s response to them. The genesis of the proposal is President Obama’s Executive Order (EO) 13650, which was issued in the aftermath of the catastrophic explosion that occurred in April 2013 that claimed 15 lives in West, Texas. The EO requires various federal agencies to develop...
May 10, 2016

Lynn L. Bergeson, “Australia Addresses Nanomaterials in Third NICNAS Reforms Consultation Paper,” Nanotechnology Now, May 10, 2016.

On April 29, 2016, Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS) published the third consultation paper on its reform initiative. See https://www.nicnas.gov.au/about-nicnas/nicnas-reforms/consultation-paper-3 and https://www.nicnas.gov.au/about-nicnas/nicnas-reforms Under the reforms, the requirements to establish that a new chemical can be classified as being not hazardous to human health or the environment, and therefore falls in...
May 4, 2016

Lynn L. Bergeson, “NNCO Accepting Registrations for SME and NanoEHS Webinars,” Nanotechnology Now, May 4, 2016.

On May 11, 2016, the National Nanotechnology Coordination Office (NNCO) will hold a webinar for small- and medium-sized enterprises (SME) that will focus on the experiences, successes, and challenges for SMEs working in nanotechnology and on issues of interest to the business community. See http://www.nano.gov/node/160  The National Science Foundation’s Center for High-rate Nanomanufacturing, at Northeastern University’s College of Engineering in Boston, will host the...
April 28, 2016

Lynn L. Bergeson, “Registration Now Open for 2016 U.S.-EU: Bridging NanoEHS Research Efforts Joint Workshop,” Nanotechnology Now, April 28, 2016.

Registration is now open for the June 6-7, 2016, U.S.-European Union (EU) “Bridging NanoEHS Research Efforts” joint workshop. See https://docs.google.com/forms/d/1-wZatJVQ3b9LSx9rrJeeEZqFO-8DZVs-80txK-9DBmQ/viewform and http://us-eu.org/2016%20-us-eu-nanoehs-workshop/ The workshop will bring together the U.S.-EU Communities of Research (COR), which serve as a platform for U.S. and EU scientists to share information on nanotechnology environmental, health, and...
April 21, 2016

Lynn L. Bergeson, “SNWG Submits Comments on NIOSH Draft CIB on Silver Nanomaterials,” Nanotechnology Now, April 21, 2016.

On April 18, 2016, the Silver Nanotechnology Working Group (SNWG) submitted comments on the National Institute for Occupational Safety and Health’s (NIOSH) draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. See https://www.regulations.gov/#!documentDetail;D=CDC-2016-0001-0017 and https://www.regulations.gov/#!documentDetail;D=CDC-2016-0001-0002 The draft Current Intelligence Bulletin (CIB) includes a review and...
April 15, 2016

Lynn L. Bergeson, “OSHA Revises Silica Standards,” Chemical Processing, April 15, 2016.

On March 25, 2016, the U.S. Occupational Safety and Health Administration (OSHA) issued its long-awaited revised standards for occupational exposure to respirable crystalline silica (81 Fed. Reg. 16286). OSHA issued two separate standards — one for general industry and maritime, and the other for the construction industry — to tailor requirements to the unique circumstances found in these sectors. The rule impacts more than 2.3-million American workers across a wide spectrum of industries,...
April 5, 2016

Lynn L. Bergeson, “TSCA Reform: Is It Still in Our Future?,” Industrial Biotechnology, April 5, 2016.

Toxic Substances Control Act (TSCA) reform has been a “work in progress” for years. House and Senate passage in 2015 of substantive TSCA reform measures considerably improved the odds that Congress would enact TSCA-reform legislation in 2016. Recent events suggest otherwise, however, and as of this writing in mid-March the fate of TSCA reform remains decidedly uncertain. Momentum has dissipated as a dithering House has been slow to engage with Senate counterparts to reconcile the...
April 1, 2016

Susan M. Kirsch, “Pesticides and NPDES: Increased Environmental Protection, or Just More Paperwork?,” ABA SEER Pesticides, Chemical Regulation, and Right-To-Know Committee Newsletter, April, 2016.

On January 26, 2016, the U.S. Environmental Protection Agency (EPA) published a draft National Pollutant Discharge Elimination System (NPDES) pesticide general permit (PGP) for public comment. The publication marks the first reissuance of the PGP since its inception in 2011. The Sixth Circuit’s decision in National Cotton Council v. EPA, F.3d 927 (6th Cir. 2009), which vacated EPA’s 2007 rule exempting pesticides from NPDES permitting, required EPA to issue the PGP. In October 2011, EPA...
March 24, 2016

Lynn L. Bergeson, “ECHA Announces New Approach on Hazard Assessment for Nanoforms,” Nanotechnology Now, March 24th, 2016.

The European Chemicals Agency (ECHA) announced on March 23, 2016, a new publication co-authored with the Dutch National Institute for Public Health and the Environment (RIVM) and Joint Research Center (JRC) that illustrates how to use data for different nanoforms within the same substance registration....
March 2, 2016

Lynn L. Bergeson, “OECD Publishes Reports on Physical-Chemical Properties and Categorization of Nanomaterials,” Nanotechnology Now, March 2, 2016.

The Organization for Economic Cooperation and Development (OECD) recently published the following reports: Physical-chemical properties of nanomaterials- Evaluation of methods applied in the OECD-WPMN testing programme and categorisation of manufactured nanomaterials workshop report. ...
March 1, 2016

Lynn L. Bergeson, “The EPA Proposes Changes to RCRA Hazardous Waste Export and Import Regulations,” Environmental Quality Management, Spring, 2016.

Prompted by a 2013 Commission for Environmental Cooperation (CEC) report on hazardous waste exports from the United States (CEC, 2013) and changes to the 2001 Organisation for Economic Cooperation and Development’s (OECD) Council Decision for waste exports and imports, the United States  Environmental Protection Agency (EPA) announced on October 19, 2015, proposed changes to its regulations under the Resource Conversation and Recovery Act (RCRA) regarding the export and import of...
March 1, 2016

Charles M. Auer, Frank D. Kover, James V. Aidala, Mark Greenwood, “Toxic Substances: A Half Century of Progress,” Protecting the Environment: A Half Century of Progress, EPA Alumni Association, March 1, 2016.

PUBLIC CONCERNS LEAD TO CHEMICAL LAW In the 1960s and early to mid-1970s, new reports of chemicals causing cancer appeared in the press or on TV almost every month. Polychlorinated biphenyls (PCBs), used in electrical transformers for over 40 years, were being found in fish and environmental samples from around the country. Other chemicals, including those not thought to be harmful, caused serious health or environmental effects. Chlorofluorocarbons (CFCs) were depleting the earth’s protective...
February 23, 2016

Lynn L. Bergeson, “Compliance: OSHA Offers Weight-of-Evidence Guidance,” Chemical Processing, February 23, 2016.

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....
December 16, 2015

Lynn L. Bergeson, “OSHA Issues New Field Operations Manual,” Chemical Processing, December 16, 2015.

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...
December 1, 2015

Lynn L. Bergeson, “Biotechnology: A Lot is Going On,” Environmental Quality Management, Winter, 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....
November 20, 2015

Lynn L. Bergeson, “EPA Intends to Promulgate Final TSCA 8(a) Rule in October 2016,” Nanotechnology Now, November 20, 2015.

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....
November 17, 2015

Lynn L. Bergeson, “FTC Targets Biodegradable Materials,” Chemical Processing, November 17, 2015.

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...
October 25, 2015

L. Bergeson, B. Auerbach, L. Campbell, T. Backstrom, S. Dolan, J. Vergnes, R. Engler, J. Bultena, K. Baron, C. Auer, “The DNA of the U.S. Regulatory System: Are We Getting It Right for Synthetic Biology?,” Woodrow Wilson International Center for Scholars Synthetic Biology Project Report, October 15, 2015.

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...
October 21, 2015

Lynn L. Bergeson, “Industrial Biotechnology: Coordinated Framework Make-Over and Lots More,” Industrial Biotechnology, Vol. 11 No. 5, October 2015.

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...
October 2, 2015

Lynn L. Bergeson, “OECD Posts Preliminary Guidance Notes on Nanomaterials Concerning Interspecies Variability Factors in Human Health Risk Assessment,” Nanotechnology Now, October 2, 2015.

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....
October 1, 2015

Lynn L. Bergeson, “EPA Proposes Significant Reporting and Recordkeeping Requirements for Nanoscale Materials,” Environmental Quality Management, Fall, 2015.

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...
September 23, 2015

Lynn L. Bergeson, “NSF Will Provide $81 Million to Support New NNCI,” Nanotechnology Now, September 23, 2015.

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)....
September 23, 2015

Lynn L. Bergeson, “Hazardous Waste Rules Get a Rethink,” Chemical Processing, September 23, 2015.

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....