All Published Articles

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 ozone layer. Asbestos, a mineral fiber widely used in insulation, caused lung cancer, especially in workers. Polybrominated biphenyls used as flame retardants were mistakenly mixed into animal feed and poisoned people and cattle in Michigan. Eating fish contaminated with mercury caused a severe neurological syndrome in adults as well as birth defects in Minamata, Japan. And the list went on.

Although society reaps enormous benefits from chemicals, there was little or no knowledge of the effects on health or the environment of the thousands of chemicals used and released into the  environment. There was not even a list of the chemicals made and used in America. The drumbeat of concerns contributed to a growing realization that environmental chemicals might cause major problems. People were suddenly aware that a man-made chemical environment of unknown dimensions literally surrounded them. Other studies pointed to the large gap in existing laws for dealing with these problems. During the 1970s, the groundswell of public concern resulted in legislative action.

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.

Lynn L. Bergeson, "EFSA Begins Public Consultation on Draft Guidance on the Preparation and Presentation of an Application for Authorization of a Novel Food," Nanotechnology Now, February 19, 2016.

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.

Lynn L. Bergeson, "Worthy of Consideration," Manufacturing Today, January 3, 2016.

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.

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 companies subject to OSHA enforcement.

Lynn L. Bergeson, "RAND Corporation Assesses NIOSH Nanotechnology Research Center," Nanotechnology Now, December 11, 2015.

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.

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.

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.

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 Act Section 5 because evidence did not support its claims that ECM Plastics would biodegrade plastics within nine months to five years. Significantly, FTC reverses part of the ALJ’s decision, finding that FTC counsel hadn’t met its burden in proving ECM made false, misleading, and material-implied biodegradable claims that ECM Plastics will completely biodegrade in a landfill within one year, a temporal period identified in the FTC Green Guides.

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 biology in the United States through the lens of different products. The case studies in the report look at synthetic organisms, synthetic chemicals, biopesticides, biomining products, and genetically modified plants, which are regulated by the Environmental Protection Agency, Food and Drug Administration and U.S. Department of Agriculture.

“Our report demonstrates the regulatory complexity innovators face in seeking to commercialize their products,” says Lynn Bergeson, lead author of the report and managing partner at Bergeson & Campbell PC. “The report offers some common-sense and easily implemented solutions to help federal agencies do their jobs more efficiently and offers suggestions for the regulated community to be more proactive in expanding the technological literacy of the agencies with jurisdictional oversight over their products.”

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 weeks later, EPA’s Office of Pollution Prevention and Toxics (OPPT) announced a project intended to support public dialog concerning the development and use of biotechnology by developing a new algae “how to” document for Toxic Substances Control Act Purposes, and to help jump start much needed public discourse around the topic of biotechnology in general.  Finally, OPPT also announced that it is updating its Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms. Each of these developments is important. This article discusses these initiatives, offers insights on why stakeholders should applaud these opportunities, and urges stakeholders to seize the moment and to engage vigorously in them.  

Lynn L. Bergeson, "White House Announces Nanotechnology-Inspired Grand Challenge for Future Computing," Nanotechnology Now, October 20, 2015.

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

Lynn L. Bergeson, "OECD Publishes 2013 Developments on the Safety of Manufactured Nanomaterials," Nanotechnology Now, October 19, 2015.

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.

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.

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 this rule when issued in final to review the proposal carefully, understand the reporting requirements, and prepare for the implications of EPA’s review of the forthcoming required information.

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.

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).

Ruth C. Downes-Norriss, Leslie S. MacDougall, "What is Happening with Chemical Regulation Outside of the European Union?," Elements, the Chemicals NorthWest Magazine, Autumn 2015.
Lynn L. Bergeson, "EC Scientific Committee Will Consider Safety of Nano Titanium Dioxide in Sunscreens and Personal Care Spray Products," Nanotechnology Now, September 15, 2015.

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.

Lynn L. Bergeson, "Belgium’s Nanomaterials Register Now Available," Nanotechnology Now, September 3, 2015.

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.

Lynn L. Bergeson, "New Compliance," Manufacturing Today, August 30, 2015.

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).

Lynn L. Bergeson, "EPA Continues Chemical Screening Tests," Chemical Processing, August 20, 2015.

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.

Lynn L. Bergeson, "FDA Issues Final Guidance on Use of Nanomaterials in Food for Animals," Nanotechnology Now, August 5, 2015.

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.

James V. Aidala, Jr., Charles M. Auer, Lynn R. Goldman, M.D., and James B. Gulliford, "Practical Advice for TSCA Reform: An Insider Perspective," The American Bar Association Section of Environment, Energy, and Resources Special Committee on TSCA Reform, August 2010.
Lynn L. Bergeson, "NGOs Challenge Nanosilva’s Conditional Registration," Nanotechnology Now, July 30, 2015.

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.

Charles M. Auer, James V. Aidala, Lynn L. Bergeson, "TSCA Reform Legislation and Its Workability: Thoughts on Steps to Help Ensure Successful Implementation at the Outset and Over Time," Bloomberg BNA Daily Environment Report, July 23, 2015.

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.

Lynn L. Bergeson, "White House Targets Biotechnology," Chemical Processing, July 16, 2015.

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 in 1986, the Coordinated Framework outlines a comprehensive federal regulatory policy for products of biotechnology. The memorandum could have significant implications for innovators in the biotechnology and synthetic biology commercial space.

Richard E. Engler, Ph.D., "The Impact of Toxic Substances Control Act Nomenclature on the Commercialization of Biobased Chemicals," AOCS Inform, July/August, 2015.

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 identity can impact commercialization.

Lynn L. Bergeson, "OSHA Clarifies GHS Compliance Efforts," Chemical Processing, June 16, 2015.

On May 29, 2015, the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) published the “Interim Enforcement Guidance for Hazard Communication 2012 (HCS 2012) June 1, 2015 Effective Date” (Interim Guidance). This supplements the February 9, 2015, “Enforcement Guidance for the Hazard Communication Standard’s (HCS) June 1, 2015 Effective Date” (Enforcement Guidance). The Interim Guidance clarifies specific points to manufacturers, importers, and distributors on OSHA’s HCS enforcement strategy.

Lynn L. Bergeson, "OECD Finds Standard Test Guidelines for Normal Chemical Substances Are in Most Part Suitable for Nanomaterials," Nanotechnology Now, June 9, 2015.

The Organization for Economic Cooperation and Development (OECD) issued a June 9, 2015, press release entitled "OECD chemical studies show way forward for nanomaterial safety."

Lynn L. Bergeson, "EPA Promulgates SNUR for Graphene Nanoplatelets," Nanotechnology Now, June 5, 2015.

On June 5, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNUR) for 22 chemical substances that were the subject of premanufacture notices (PMN), including graphene nanoplatelets having a predominant thickness of 1-10 layers with lateral dimension predominantly less than 2 microns (PMN Number P-14-763).

Lynn L. Bergeson, "EPA Conditionally Registers Nanosilver Pesticide Product," Nanotechnology Now, May 26, 2015.

On May 19, 2015, the U.S. Environmental Protection Agency (EPA) announced that it issued a conditional registration for a nanosilver-containing antimicrobial pesticide product named "NSPW-L30SS," or "Nanosilva."

Richard E. Engler, Ph.D., "Thought Leadership: The Toxic Substances Control Act and the Bioeconomy: Part 3, Call to Action," Biofuels Digest, May 18, 2015.

In the second installment of this series, I wrote about how the Toxic Substances Control Act (TSCA) regulates products across a manufacturing process, from feedstock to product. In this last installment, I present options for updating TSCA and the related implementing regulations to put novel, biobased chemistry on an even footing with incumbent products and processes that were grandfathered in as part of the original TSCA Inventory. The key is to find a way to level the field without compromising the U. S. Environmental Protection Agency’s (EPA) mission and authority to protect human health and the environment.

Lynn L. Bergeson, "TSCA Reform May Be Closer Than You Think," Chemical Processing, May 18, 2015.

On April 28, 2015, the Senate Committee on Environment and Public Works held a hearing to consider the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697). Since then, S. 697 has gained additional backing from both Republicans and Democrats. These events are important because they demonstrate significant bipartisan support for reform of the Toxic Substances Control Act (TSCA), and suggest TSCA reform actually may be in our future.

Lynn L. Bergeson, "Nano Community Members Can Benefit From Membership In The Sustainable Nanotechnology Organization," Nanotechnology Now, May 12, 2015.

Membership in the Sustainable Nanotechnology Organization (SNO) offers a number of benefits to members of the nano community. SNO's purpose is to provide a professional society forum to advance knowledge in all aspects of sustainable nanotechnology, including both applications and implications.

Richard E. Engler, Ph.D., "Thought Leadership: The Toxic Substances Control Act and the Bioeconomy: Part 2, Reportable Substances across the Manufacturing Process," Biofuels Digest, May 1, 2015.

In the first installment of this series, I wrote about how the Toxic Substances Control Act (TSCA) regulates products. In this article, we will look across a manufacturing process. TSCA applies to chemical substances that are used for purposes other than food, food additives, animal feed, cosmetics, drugs, tobacco and tobacco products, pesticides, munitions, and nuclear source materials. Biobased chemicals, that is, chemicals made from lignocellulose or other biomass, are finding markets in food and cosmetic markets, but much of the recent innovation focuses on biobased fuels and commodity chemicals. For these final products, TSCA applies. Chemical products must be listed on the TSCA Inventory of Chemical Substances (the Inventory) or be eligible for an exemption. If the product is not listed on the Inventory, the manufacturer must file a premanufacture notification 90 days before manufacturing (or importing) that substance or qualify for an appropriate exemption.

Lynn L. Bergeson, "NIOSH Announces Publication of Paper from Industrywide Study on Carbon Nanotube and Nanofiber Exposure," Nanotechnology Now, May 1, 2015.

On April 27, 2015, the National Institute for Occupational Safety and Health (NIOSH) announced publication of "Carbon Nanotube and Nanofiber Exposure Assessments: An Analysis of 14 Site Visits" in Annals of Occupational Hygiene.  The paper is the second report from NIOSH's Industrywide Study. According to NIOSH, the findings illustrate which tasks have the highest exposures, trends in exposure, nature and character of materials involved, effectiveness of controls when used, and continued refinement of the methods used to evaluate exposure of this high-priority class of nanomaterials.

Richard E. Engler, Ph.D., "The Toxic Substances Control Act and the Bioeconomy: Part 1, The Impact of Nomenclature on the Commercialization of Biobased Chemicals," Biofuels Digest, April 26, 2015.

Bioeconomy companies recognize that their products are subject to a variety of federal chemical regulations, especially if they sell food, food additives, cosmetics, or other products regulated by the U.S. Food and Drug Administration (FDA). Unfortunately, companies may not recognize all the ways that the U.S. Environmental Protection Agency (EPA) regulates bioproducts, perhaps because of the understandable focus on the Clean Air Act (CAA) and the various programs under that authority: Renewable Fuel Standard, fuel additive registration, or other CAA submissions. TSCA also applies to bioproducts used in industrial, commercial, and most consumer products, including fuels. TSCA reporting requirements are in addition to, and separate from, CAA reporting.

Lynn L. Bergson, "ECETOC Nano Task Force Proposes Decision-Making Framework for the Grouping and Testing of Nanomaterials," Nanotechnology Now, April 23, 2015.

The European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Nano Task Force published an article in Regulatory Toxicology and Pharmacology entitled "A decision-making framework for the grouping and testing of nanomaterials (DF4nanoGrouping)."

Gyöngyi (Pearl) Németh, M.Sc., Leslie S. MacDougall, "The Next Step for REACH: Lessons Learned and Tips for Success Regarding Authorisation," Elements, The Chemicals NorthWest Magazine, Spring, 2015.

As all chemical companies doing business in the European Union (EU) should know, the "A" in REACH stands for Authorisation, the last of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) processes to be implemented since the regulation entered into force in 2008. This article reviews the path to Authorisation and reports on key developments shared during the "Lessons Learnt on Applications for Authorisation" ECHA conference held 11 February, 2015. 

Lynn L. Bergeson, "SCENIHR Identifies Use Of Nanomaterials For Medical Imaging And Drug Delivery And Graphene Nanomaterials As Emerging Issues," Nanotechnology Now, April 13, 2015.

On April 9, 2015, the European Commission (EC) Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) posted a Position Statement on emerging and newly identified health risks to be drawn to the attention of the European Commission. 

Lynn L. Bergeson, "EPA Eyes Nanoscale Materials," Chemical Processing, April 13, 2015.

On April 6, 2015, the U.S. Environmental Protection Agency (EPA) proposed a Toxic Substances Control Act (TSCA) Section 8(a) rule concerning reporting and recordkeeping requirements for certain chemical substances when manufactured (including imported) or processed at the nanoscale. 

Lynn L. Bergeson, "EPA Proposes Significant New Use Rule for Certain Nonylphenol and Nonylphenol Ethoxylates," Environmental Quality Management, Spring 2015.
On October 1, 2014, the US Environmental Protection Agency (EPA) proposed a Significant New Use Rule (SNUR) under the Toxic Substances Control Act (TSCA) for certain related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE) (Federal Register [Fed. Reg.], 2014). For 13 NPs and NPEs, the EPA would designate any use as a “significant new use,” and for two additional NPs, the EPA would designate that any use other than use as an intermediate or use as an epoxy cure catalyst would constitute a "significant new use" (Fed. Reg., 2014, p. 59186). For a variety of reasons, which are discussed next, the proposed rule is interesting and significant. The EPA has already agreed to extend the comment period to mid-January in response to several industry-trade groups’ requests for more time.
Lynn L. Bergeson, Carla N. Hutton, "FDA’s Final and Draft Nanotechnology Guidance Documents: No Big Surprises," Nanotechnology Law & Business, Spring 2015.
On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidance documents and one draft guidance document that FDA believes will provide greater regulatory clarity for industry and other stakeholders on the use of nanotechnology in FDA-regulated products. In this article, Lynn Bergeson and Carla N. Hutton review the recent guidance and highlight important considerations.
Lynn L. Bergeson, "Comments Due July 6 On Proposed Reporting And Recordkeeping Requirements For Nanoscale Materials," Nanotechnology Now, April 6, 2015.

The U.S. Environmental Protection Agency's (EPA) 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 was published in the April 6, 2015, Federal Register. 

Lynn L. Bergeson, "New Technologies and an Old Law: Renewable Chemicals Invite Challenges under TSCA," Natural Resources & Environment Volume 29, Number 4, Spring 2015.

The resurgence of chemical production derived from renewable feedstocks reflects the new business imperatives of which chemical product manufacturers are all keenly aware: produce greener chemicals and reduce carbon footprints. Careful review of the Toxic Substances Control Act (TSCA), a law enacted almost forty years ago during the heyday of petroleum-derived chemical production, suggests that more can be done now to promote the commercialization of renewable chemicals to achieve these imperatives. This article describes renewable chemicals, provides a brief overview of TSCA, discusses key TSCA challenges as applied to them, and suggests actions to ensure TSCA’s implementation now and potential future TSCA revisions to facilitate the commercialization of renewable chemicals. 

Lynn L. Bergeson, "USDA NOP Releases New Policy Memo on Nanotechnology," Nanotechnology Now, March 30, 2015.
The U.S. Department of Agriculture (USDA) National Organic Program (NOP) issued on March 24, 2015, a policy memorandum clarifying the status of nanotechnology in organic production and handling under the USDA organic regulations.
Lynn L. Bergeson, "EPA Issues Response to ICTA Petition Regarding Nanosilver," Nanotechnology Now, March 25, 2015.
Almost seven years ago, the International Center for Technology Assessment (ICTA) filed a petition for rulemaking requesting that the U.S. Environmental Protection Agency (EPA) regulate products containing nanosilver as pesticides and for related other forms of relief. On March 19, 2015, EPA responded to the petition.
Lynn L. Bergeson, "French Agency Publishes Opinion on Silver Nano Particles," Nanotechnology Now, March 24, 2015.
The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) published on March 10, 2015, an Opinion concerning exposure to silver nanoparticles that "stresses the research that has been carried out to examine the potential health and environmental effects of silver nanoparticles but notes that this is still insufficient to allow the health risks to be assessed."
Lynn L. Bergeson, "OSHA Publishes HCS Compliance Guide," Chemical Processing, March 17, 2015.
On Feb. 9, 2015, the U.S. Occupational Safety and Health Administration (OSHA) published the Enforcement Guidance for the Hazard Communication Standard (HCS) effective June 1, 2015. The Guidance offers important insights into OSHA’s HCS enforcement strategy with regard to mixtures, and is therefore a must-read for stakeholders if they wish to be in the best possible position to avoid enforcement consequences for non-compliance with the HCS.
Lynn L. Bergeson, "EPA Eyes Perfluorinated Chemicals," Chemical Processing, February 11, 2015.

Between the late 1990s and early 2000s, the EPA identified potential issues presented by PFOS, a perfluorinated acid. Data showed PFOS to be present in low levels in humans and wildlife worldwide, and that PFOS appeared to be highly persistent. At the time, PFOS was used in industrial and consumer applications, including soil and stain repellant sprays, fire-fighting foams and semiconductor manufacture. Between 2000 and 2002, 3M Company, the principal domestic manufacturer of PFOS, voluntarily phased the chemical out of production. Working with industry, the EPA followed this action with a series of SNURs that were effectively intended to limit uses for which alternatives were not available. Several years later, similar concerns were raised with regard to PFOA, other LCPFACs, and other chemicals known as fluorinated telomers that potentially could degrade to PFOA in the environment. The EPA worked with the manufacturers and users of these chemicals to understand the risks and encourage development of alternatives. These efforts yielded the 2010/2015 PFOA Stewardship Program through which industry made and delivered on a series of commitments that, over time, made the current proposed SNUR possible. 

Lynn L. Bergeson, "EPA Promulgates SNUR for Polymer of Terephthalic Acid and Ethyl Benzene with Multi-Walled Carbon Nanotube (Generic)," Nanotechnology Now, February 3, 2015.

On February 2, 2015, the U.S. Environmental Protection Agency (EPA) promulgated through a direct final rule significant new use rules (SNURs) for 27 chemical substances that were the subject of premanufacture notices (PMNs). The substances include polymer of terephthalic acid and ethyl benzene with multi-walled carbon nanotube (generic) (PMN Number P-13-573), which is subject to a Toxic Substances Control Act (TSCA) Section 5(e) consent order.  

Lynn L. Bergeson, "Canada Begins Review of SNAc Orders and Notices for Nanomaterials," Nanotechnology Now, February 2, 2015.

On January 28, 2015, Environment Canada announced that, with Health Canada, it has initiated a review of significant new activity (SNAc) orders and notices currently in place under the Canadian Environmental Protection Act (CEPA). See http://www.chemicalsubstanceschimiques.gc.ca/plan/approach-approche/snac-nac/index-eng.php#a2 According to Environment Canada, since publication of the first SNAc in 2001, policies and practices have evolved, particularly with respect to the nature and scope of SNAcs, as well as the wording used to identify "significant new activities." 

Lynn L. Bergeson, "Switzerland Announces Continuation of Action Plan for Synthetic Nanomaterials," Nanotechnology Now, January 23, 2015.

The Federal Office of Public Health (FOPH) announced on December 17, 2014, that the Federal Council decided to continue the action plan for synthetic nanomaterials until 2019. See http://www.bag.admin.ch/nanotechnologie/12167/?lang=en The objectives of the action plan include:

  • Development of regulatory framework conditions for the responsible handling of synthetic nanomaterials;
  • Creation of scientific and methodical conditions aimed at identifying and preventing potential harmful effects of synthetic nanomaterials on health and the environment;
  • Promotion of the public dialogue about opportunities and risks of nanotechnology; and
  • Better utilization of existing tools for the development and rollout of sustainable nanotechnology applications.

 

Lynn L. Bergeson, "Nine Hazardous Chemicals Go On Watch List To Prevent Their Import," Chemical Processing, January 20, 2015.

On December 29, 2014, the U.S. Environmental Protection Agency (EPA) published a final rule signaling renewed interest in asserting Toxic Substances Control Act (TSCA) jurisdiction over finished goods. The final rule adds nine benzidine-based chemical substances to the existing significant new use rule (SNUR) on these substances, and, with respect to both the newly added and previously-listed substances, makes inapplicable the exemption relating to persons that import or process the substances as part of an article. 

Lynn L. Bergeson, "Canada’s New Substances Program Publishes Risk Assessment Summary for Multi-Wall Carbon Nanotubes," Nanotechnology Now, January 15, 2015.

Canada announced on January 9, 2015, that the New Substances Program has published six new risk assessment summaries for chemicals and polymers, including a summary for multi-wall carbon nanotubes. See http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=4BCC7425-1 Environment Canada and Health Canada conduct risk assessments on new substances. These assessments include consideration of information on physical and chemical properties, hazards, uses, and exposure to determine whether a substance is or may become harmful to human health or environment as set out in Section 64 of the Canadian Environmental Protection Act, 1999 (CEPA 1999), and, if harm is suspected, to introduce any appropriate or required control measures.

Lynn L. Bergeson, "EPA’s New, Final Work Plan Assessments And What They Mean To You," Environmental Quality Management, December 22, 2014.

The United States Environmental Protection Agency (EPA) released on June 25, 2014, and on August 28, 2014, final risk assessments for targeted uses of four Toxic Substances Control Act (TSCA) Work Plan chemicals. The June Assessment consists of certain uses of trichloroethylene (TCE), and the assessments released in August are for uses of methylene chloride or dichloromethane (DCM), antimony trioxide (ATO), and 1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylcyclopenta-[γ]-2-benzopyran (HHCB). The much anticipated release of these assessments marks a real milestone for the EPA's Office of Chemical Safety and Pollution Prevention (OCSPP), and the EPA is to be commended for its significant efforts in completing these assessments relatively quickly.  

Lynn L. Bergeson, "EP ENVI Committee Proposes Moratorium on the Use of Nanomaterials in Food," Nanotechnology Now, December 1, 2014.

“On November 24, 2014, the European Parliament (EP) Committee on Environment, Public Health and Food Safety (ENVI) considered draft legislation concerning novel foods. See http://www.europarl.europa.eu/news/en/news-room/content/20141125IPR80424/html/Novel-foods-MEPs-call-for-moratorium-on-nano-foods-and-labelling-of-cloned-meat. The Committee amended the draft legislation, proposing a moratorium on the use of nanomaterials in food based on the precautionary principle. The Committee approved the amended draft legislation by a vote of 57-4, with two abstentions. EP Member James Nicholson (ECR, UK), who is steering the legislation through the EP, stated that he was not completely satisfied with the vote. ”

Lynn L. Bergeson, "EPA Proposes SNUR For Nonylphenols And Nonylphenol Ethoxylates," ABA Pesticides, Chemical Regulation, and Right-to-Know Committee Newsletter, December 2014.

On October 1, 2014, the U.S. Environmental Protection Agency (EPA) proposed a Significant New Use Rule (SNUR) for 15 related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE). For 13 NPs and NPEs, EPA would designate any use as a "significant new use," and for two additional NPs, EPA would designate that any use other than use as an intermediate or use as an epoxy cure catalyst would constitute a “significant new use.” Persons subject to the SNURs would be required to notify EPA at least 90 days before they manufacture (including import) or process any of these 15 chemical substances for a significant new use.  The full ABA PCRRTK Newsletter is available online . 

Lynn L. Bergeson, "New Wastewater Treatment Guidelines," Pollution Engineering, December 1, 2014.

"On September 16, 2014, EPA released its Final 2012 Effluent Guidelines Program Plan (Final 2012 Plan) and the Preliminary 2014 Effluent Guidelines Program Plan (Preliminary 2014 Plan) under the Clean Water Act (CWA). These are important plans as they telegraph EPA’s plans for developing effluent guidelines for targeted industries. This article discusses EPA’s current plans."

Lynn L. Bergeson, "EP Committee Study on Legislative Areas of the TTIP Addresses Nanomaterials," Nanotechnology Now, November 18, 2014.

The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP). See http://www.europarl.europa.eu/thinktank/en/document.html?reference=IPOL_STU(2014)536293. The study analyzes the main differences between European Union (EU) and U.S. legislation in eight areas: human medicines and medical devices; cosmetics; food and nutrition; sanitary and phyto-sanitary; nanomaterials; cloning; raw materials and energy; and motor vehicles. 

Lynn L. Bergeson, "EPA Proposes New Rule for Toxic Chemicals," Chemical Processing, November 5, 2014.

On October 1, 2014, the U.S. Environmental Protection Agency (EPA) proposed a significant new use rule (SNUR) for 15 related chemical substances commonly known as nonylphenols (NP) and nonylphenol ethoxylates (NPE). These substances are recognized as persistent and toxic in the environment. This article discusses this important move.

Lynn L. Bergeson, "Evolving Global Chemical Management Programs and Why They Matter," Trends, the ABA Section of Environment, Energy, and Resources Newsletter, November 2014.

Chemicals play a central role in our personal and professional lives. As consumers, we focus keenly on the chemicals in the products we use and with which we come into contact. Globalization and the emergence worldwide of sophisticated chemical management programs invite complex legal, commercial, and scientific challenges. These challenges extend far beyond compliance questions that, by comparison, seem now nostalgically straightforward. Understanding these programs and their evolution can only help inform our judgment as lawyers, consultants, and educated consumers.

Lynn L. Bergeson, "EPA Assessing Utility of Toxic Substances Control Act to Obtain Information on Hydraulic Fracturing," Environmental Quality Management, Fall 2014.

The United States Environmental Protection Agency (EPA) published in the May 19, 2014, Federal Register an advance notice of proposed rulemaking (ANPR) to seek comment on the information that should be reported or disclosed for hydraulic fracturing chemical substances and mixtures and the mechanism for obtaining this information. According to EPA, this mechanism could be regulatory (under Sections 8(a) and/or 8(d) of the Toxic Substances Control Act (TSCA)), voluntary, or a combination of both. It could include best management practices, third-party certification and collection, and incentives for disclosure of information.
 

Lynn L. Bergeson, "Harmonizing DOT HMR International Standards," Pollution Engineering, October 5, 2014.

On Aug. 25, 2014, the U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) issued a proposed rule seeking to harmonize the hazardous materials regulations (HMR) with international regulations and standards. The rule would revise proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations and vessel stowage requirements.

Lynn L. Bergeson, Charles M. Auer, Oscar Hernandez, "Creative Adaptation: Enhancing Oversight of Synthetic Biology Under the Toxic Substances Control Act," Industrial Biotechnology, October 2014.

Synthetic biology is delivering on its promise as an emerging scientific field in providing society with effective new sustainable products in diverse areas including renewable energy, contamination remediation, and medical applications, among others. As is the case with any rapidly evolving technology, the pace of technological innovation challenges regulators’ ability to identify and address adequately the substantial uncertainties they confront when discharging their legal obligations under controlling laws to ensure human and environmental safety. This article provides a brief description of synthetic biology, discusses the current domestic regulatory framework that governs the regulation of products of synthetic biology, and focuses narrowly on options and opportunities the US Environmental Protection Agency (EPA), innovators in the area of synthetic biology, and the Toxic Substances Control Act (TSCA)-regulated community at large may wish to consider to enhance TSCA’s core adaptive capacity to identify and address potential health and environmental risk implications posed by the commercialization of products of synthetic biology.

Lynn L. Bergeson, "EPA Considers Revisions to RMP Regulations," Pollution Engineering, October 1, 2014.

On July 31, 2014, EPA published a Request for Information (RFI) seeking information and data on potential revisions to its Clean Air Act (CAA) Risk Management Program (RMP) regulations and related programs. In the RFI, EPA asks for information on specific regulatory elements and on Occupational Safety and Health Administration (OSHA) Process Safety Management (PSM) approaches, the public and environmental health and safety risks they address, and the costs and burdens they may impose. This column explains why this RFI is critically important to the RMP and PSM programs and thus to Pollution Engineering readers.

Lynn L. Bergeson, "Canada Eyes Hazardous Products Regulation," Chemical Processing, September 23, 2014.

On August 9, 2014, Canada published a proposal for adopting the Globally Harmonized System for Classification and Labeling of Chemicals (GHS). GHS compliance is a big issue for just about all manufacturers, and understanding the approach of our neighbor to the north is important. This column summarizes the highlights.

Lynn L. Bergeson, "NNI and NASA Co-Sponsor Technical Interchange Meeting on Carbon Nanotubes," Nanotechnology Now, September 8, 2014.

The National Nanotechnology Coordination Office (NNCO) announced in the September 8, 2014, Federal Register that it will hold a technical interchange meeting entitled "Realizing the Promise of Carbon Nanotubes -- Challenges, Opportunities and the Pathway to Commercialization" on September 15, 2014. See http://nano.gov/2014CNTTechInterchange The meeting is sponsored by the National Nanotechnology Initiative (NNI) and co-sponsored by the National Aeronautics and Space Administration (NASA). According to the notice, the objectives of the meeting are to identify, discuss, and report the technical barriers preventing the production of carbon nanotube-based materials with electrical and mechanical properties approaching theoretical values, and to explore ways to overcome these barriers.

Lynn L. Bergeson, "EPA’s Air Office Recommends Lowering Ozone NAAQS," Pollution Engineering CoffeHaus Blog, September 8, 2014.

The EPA's Office of Air Quality Planning and Standards (OAQPS) has concluded that there is adequate evidence for lowering the existing National Ambient Air Quality Standard (NAAQS) for ozone (O3) from 75 parts per billion to between 70 ppb and 60 ppb. The recommendation is found in a 600 page long Policy Assessment for the Review of the Ozone National Ambient Air Quality Standards, issued on Aug. 29, 2014.

Lynn L. Bergeson, "Misleading Recycled Content Claims are Criminal," Pollution Engineering, September 1, 2014.

The Federal Trade Commission (FTC) has stepped up its enforcement initiatives and recently settled two cases with companies that market plastic lumber and related products. FTC alleged that these companies misled consumers in violation of Section 5 of the FTC Act in their marketing materials regarding the environmental attributes of their products.

Lynn L. Bergeson, "Australia Pesticides and Veterinary Medicines Authority Will Hold Nanotechnology Regulation Symposium," Nanotechnology Now, August 26, 2014.

The Australian Pesticides and Veterinary Medicines Authority (APVMA) will host a nanotechnology regulation symposium on October 28, 2014. See http://apvma.gov.au/node/11191 APVMA states that it "has worked over many years to progressively develop a regulatory framework for nanoscale agvet chemicals and chemical products." APVMA intends the symposium to provide industry and regulators with an opportunity for dialogue on the future regulation of nanopesticides and veterinary nanomedicines.

Lynn L. Bergeson, Meglena Mihova, "Nanomaterials and Public Disclosure: Are European Nano Product Registries the Answer?," Natural Resources & Environment, Volume 29, Number 1, Summer 2014.

Nano product registries in Europe are the newest twist to satiating the public’s relentless “right to know.” Nominally intended to prevent hazards, facilitate monitoring, and promote consumer choice, nano product registries also risk stigmatizing nano products, diverting limited government and private resources, and potentially creating commercial barriers to a promising technology. This article in the American Bar Association’s Natural Resources & Environment magazine focuses on efforts of multiple European countries that are presently at varying stages of establishing product registries to keep track of nanomaterials and the products that contain them. After outlining the stated purposes of these registries and explaining how they operate, the article explores whether they are achieving their stated goals or inadvertently inviting unintended consequences.

Lynn L. Bergeson, "DOT Eyes Safe Transport of Crude Oil," Chemical Processing, August 14, 2014.

On August 1, 2014, the Pipeline and Hazardous Materials Safety Administration (PHMSA), which falls under the U.S. Department of Transportation (DOT), published an important proposed rule intended to improve the safety of transportation of large quantities of flammable materials by rail — particularly crude oil and ethanol. The proposal responds to several catastrophic railcar derailments, all involving crude oil and resulting in fatalities. The DOT also issued on the same day a companion Advance Notice of Proposed Rulemaking (ANPR).

Lynn L. Bergeson, "EPA Approves Petition for Exemption," Chemical Processing, July 22, 2014.

On June 19, 2014, the U.S. Environmental Protection Agency (EPA) issued a direct final rule exempting manufacturers of three chemical substances from certain reporting-process-and-use information requirements under the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) rule for those compounds. This column discusses the rule and the potential value of public petitioning.

Lynn L. Bergeson, "DOT’s Emergency Order Limits Crude Transport," Pollution Engineering, July 1, 2014.

The growing number of rail mishaps involving oil is attracting much press attention and now regulatory attention as well. On May 7, 2014, the U.S. Department of Transportation (DOT) issued an emergency order requiring all railroads operating trains containing bulk quantities of UN 1267, petroleum crude oil, Class 3 that either originates or is sourced from the Bakken formation in the Williston Basin (Bakken crude oil) to notify State Emergency Response Commissions (SERC) about the operation of these trains through their states. This article discusses this important topic.

Lynn L. Bergeson, "EPA Proposes Rule to Cut Greenhouse Gas Emissions," Pollution Engineering, July 1, 2014.

On June 2, 2014, the U.S. Environmental Protection Agency (EPA) issued an ambitious and likely contentious rule to diminish significantly the United States’ contribution to greenhouse gases (GHG). The rule is proposed under the authority of the Clean Air Act (CAA) and takes direct aim at the coal industry by requiring a 30 percent reduction in carbon dioxide (CO2) emissions from existing fossil fuel-fired power plants by 2030, using 2005 as the baseline year. This column summarizes key aspects of the rule and its implications for Pollution Engineering readers.

Lynn L. Bergeson, "FDA Issues Final and Draft Nanotechnology Guidances," Nanotechnology Now, June 24, 2014.

On June 24, 2014, the U.S. Food and Drug Administration (FDA) issued three final guidances and one draft guidance that it intends to provide "greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products." See http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm402499.htm. One final guidance addresses FDA's overall approach for all products that it regulates, while the two additional final guidances and the new draft guidance provide specific guidance for the areas of foods, cosmetics, and food for animals, respectively.

Lynn L. Bergeson, Timothy D. Backstrom, "EPA Issues Stop Sales Order for Unregistered Food Containers Containing Nanosilver: What Are the Implications?," Nanotechnology Law & Business, Volume 11, Issue 3, 2014.

On March 19, 2014, the U.S. Environmental Protection Agency (EPA) issued an administrative order to Pathway Investment Corp. (Pathway) of Englewood, New Jersey, to stop the sale of plastic food storage containers that are not registered with EPA, in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). According to a press release issued on March 31, 2014, by EPA concerning the stop sale order, the Company’s Kinetic Go Green Premium Food Storage Containers and Kinetic Smartwist Series Containers contain “nanosilver” as an active ingredient, and the Company markets other products as containing nanosilver, which the Company claims helps reduce the growth of mold, fungus, and bacteria. EPA notes that such claims can be made only for products that have been properly tested and are registered under FIFRA. EPA states that, in addition to the order sent to Pathway, it also issued warning letters to Amazon, Sears, Walmart, and other large retailers directing them not to sell these food storage containers. This enforcement action put nanosilver in the public spotlight, and not in a good way. This article summarizes recent regulatory developments pertinent to nanosilver, and discusses the recent EPA enforcement action to explain what the case means, and what it does not mean.

Lynn L. Bergeson, "House Releases Discussion Draft of TSCA Reform Legislation," Environmental Quality Management, Summer 2014.

Reform of the Toxic Substances Control Act (TSCA) may be a little closer to reality since Rep. John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released on February 27, 2014, a much anticipated discussion draft that would update TSCA. The Chemicals in Commerce Act (CICA) keys off of Senate Bill (S.) 1009, the Chemical Safety Improvement Act (CSIA), which was introduced on May 22, 2013, by late Sen. Frank R. Lautenberg (D-NJ) and Sen. David Vitter (R-LA). Under Shimkus’s leadership, the Subcommittee has held five hearings that reviewed core sections of Title I of TSCA and the proposed Senate amendments to those sections. This column provides an overview of the discussion draft of the new, not-yet-numbered House bill, the CICA, and compares its key provisions with the Senate’s approach to TSCA reform under S. 1009.

Lynn L. Bergeson, "Notice Concerning Nanoscale Materials Remains in EPA’s Regulatory Agenda," Nanotechnology Now, June 5, 2014.

On May 23, 2014, the U.S. Environmental Protection Agency (EPA) posted its 2014 Regulatory Agenda, which still includes RIN 2070-AJ54, "Nanoscale Materials; Chemical Substances When Manufactured, Imported, or Processed as Nanoscale Materials; Reporting and Recordkeeping Requirements; Significant New Use Rule." See http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201404&RIN=2070-AJ54.

Lynn L. Bergeson, "EPA and Corps of Engineers Propose New Rule Governing Clean Water Act Jurisdiction," Pollution Engineering, June 2, 2014.

In late March, EPA and Army Corps of Engineers (Corps) proposed a rule that would dramatically revise and expand the reach of the Clean Water Act’s (CWA) jurisdiction. Unquestionably, determining the scope of the CWA’s jurisdiction, particularly over streams and tributaries, has become confusing and complex following several Supreme Court decisions and various EPA interpretations issued in response to these decisions over the years. For nearly a decade, Congress, state and local officials, industry, agriculture, environmental groups and the public have asked for a rulemaking to provide clarity. The proposal is already generating much controversy and should invite significant comments.

Lisa M. Campbell, James V. Aidala, Susan Hunter Youngren, "EPA Guidance on Pesticide Drift Will Affect Product Registrations," CPDA Quarterly, June, 2014.

How to address and manage potential risks posed by pesticide “drift” -- the unintentional movement of some level of pesticide outside of the intended area of application -- has long been a challenging, complex regulatory policy issue. It is difficult to dispute that when applying a pesticide product some small amount may, in some circumstances, move off-site. In other words: “drift happens.” The issue quickly becomes whether, from a risk management perspective, the amount of off-site movement matters. That question is, in turn, heavily dependent on factors specific to the pesticide application at issue, such as the nature of the specific pesticide (e.g., its volatility), the application method used (e.g., aerial or ground application), and climatic conditions. Because many such factors must be considered, the U.S. Environmental Protection Agency (EPA) has found it challenging to devise a “drift policy” or define generally what, if any, level of potential drift is acceptable. This article explores the current situation.

Kathleen M. Roberts, "How to Make Friends and Win EPA Approvals: tips for biobased chemicals," Biofuels Digest, May 28, 2014.

In last week’s Special Report on Scale-up in Industrial Biotechnology, the Digest noted that a consistent lesson shared by leading biotech heavyweights at the BIO World Congress scale-up session is to “avoid an afterthought approach to regulatory compliance.” As luck and good scheduling would have it, after lunch on the same day, savvy conference-goers got up-close-and-personal with two senior U.S. Environmental Protection Agency (EPA) regulators and a seasoned company executive involved with biobased chemicals at a session titled “Commercializing Renewable Chemicals and Biobased Products: The Importance of Successfully and Efficiently Navigating the Regulatory Process.” This article highlights the top tips for gaining EPA regulatory approval shared by EPA’s Dr. Tracy Williamson and Dr. David Widawsky at the session.

Lynn L. Bergeson, "Spotlight Shines on Plant Safety," Chemical Processing, May 22, 2014.

Chemical plant safety is once again in the limelight due to some high profile and very public catastrophes. On January 3, 2014, a federal working group created by the Obama administration’s Executive Order (EO) 13650 issued a set of preliminary options intended to improve chemical plant safety and security. This is a priority topic commanding considerable attention and readers should be aware of and engaged in these developments. This column explains why.

Lynn L. Bergeson, "Chemical Safety and Drinking Water Protection Act," Pollution Engineering, May 20, 2014.

The tragic spill of a chemical into the Elk River in West Virginia that occurred on Jan. 9, 2014, has spurred the development of new legislation. On Jan. 27, 2014, Senators Joe Manchin (D-W.V.), Barbara Boxer (D-Calif.), Chair of the Environment and Public Works Committee, and Jay Rockefeller (D-W.V.) introduced the Chemical Safety and Drinking Water Protection Act of 2014. The regrettable spill and the mismanagement of the spill’s consequences by federal and state regulators reads like a case summary of mistakes to avoid when managing a crisis of epic proportions. The legislation that may emerge from this tragedy could prevent similar events in the future.

Lynn L. Bergeson, "European NGOs Publish Position Paper on the Regulation of Nanomaterials," Nanotechnology Now, May 7, 2014.

The European Chemicals Agency (ECHA) Biocidal Products Committee (BPC) adopted an opinion on April 10, 2014, concerning HeiQ AGS-20 (AGS-20). See http://echa.europa.eu/documents/10162/21680461/bpc_opinion_heiq_ags-20_en.pdf.

Lynn L. Bergeson, "TSCA Reform: Do It Now, Or It May Never Be Done," ELI Forum, May/June, 2014.

Whatever window of opportunity exists to reform the Toxic Substances Control Act is closing. This is not only because the mid-term elections are fast approaching, or that there are too few legislative days left this session, or even that Congress is polarized and achieving passage of complicated chemical legislation seems intuitively beyond reach. It is also because of the emergence of international and state chemical management frameworks. This article is from the Environmental Law Institute’s May/June 2014 issue of ELI Forum titled “TSCA Redux: Rejuvenating a Timeworn Statute.” The publication features articles from authors representing a variety of viewpoints on the issue including Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C.; Richard A. Denison, Lead Scientist, Environmental Defense Fund; Kathy Kinsey, Deputy Secretary for Regulatory Programs and Operations, Maryland Department of the Environment; Ann R. Klee, Vice President, Environment, Health & Safety, General Electric; John Shimkus, Chair, House Environment & the Economy Subcommittee; and Tom Udall, Chair, Senate Subcommittee on Superfund, Toxics, and Environmental Health. Visit www.eli.org for more information.

Lynn L. Bergeson, "Chemical Compliance: California Calls for Changes to Prop 65," Chemical Processing, April 10, 2014.

On March 7, 2014, the California Office of Environmental Health Hazard Assessment (OEHHA) released a proposal for a draft regulation amending Proposition 65 regulations. The proposal seeks changes to the warning requirements to include more detailed information, including the names of the chemicals covered by individual warnings, the ways that individuals are exposed to these chemicals, and how individuals can avoid or reduce their exposure to these chemicals. This column explains this proposal and its significance.

Lynn L. Bergeson, "Electronic Hazardous Waste Manifests Rules Issued," Pollution Engineering, April 1, 2014.

On Feb. 7, 2014, EPA issued a final rule under the Resource Conservation and Recovery Act authorizing the use of electronic hazardous waste manifests. The final rule will have immediate implications for virtually all domestic manufacturers of hazardous waste. This column explains why.

Lynn L. Bergeson, "ECHA Report Includes Recommendations for Exposure Assessment and Risk Characterization of Nanomaterials under REACH," Nanotechnology Now, March 28, 2014.

On March 26, 2014, SAFENANO announced that the European Chemicals Agency (ECHA) published a report entitled Human health and environmental exposure assessment and risk characterization of nanomaterials: Best practice for REACH registrants.

Lynn L. Bergeson, "Chemical Plant Safety," Pollution Engineering, March 24, 2014.

On Jan. 3, 2014, a federal working group created by Executive Order 13650 issued a set of preliminary options intended to improve chemical plant security. This is a hot topic likely to command considerable attention in the New Year.

Ruth C. Downes-Norris, Leslie S. MacDougall, Gyöngyi (Pearl) Németh, M.Sc., "Think REACH Does Not Apply to Your Company? Are You Certain? Read On," Elements, The Chemicals NorthWest Magazine, Spring, 2014.

According to the study, Impact of REACH on SMEs in the Netherlands, commissioned by the Dutch Ministry for Infrastructure and the Environment, 23% of SMEs belonging to the chemical industry are not aware that they do, in fact, have obligations under REACH. A company does not need to be an SME, however, to have the false impression that it has no obligations under REACH. This article outlines frequent misconceptions regarding REACH obligations and provides guidance to help confirm whether companies have responsibilities under REACH.

Lynn L. Bergeson, "America Competes Reauthorization Act Would Reauthorize NNI," Nanotechnology Now, March 20, 2014.

On March 7, 2014, the Organization for Economic Cooperation and Development (OECD) posted a report entitled Ecotoxicology and Environmental Fate of Manufactured Nanomaterials: Test Guidelines, which provides a report of the discussion and recommendations from the January 2013 expert meeting on ecotoxicology and environmental fate.

Lynn L. Bergeson, "Brave New World: California Finalizes Safer Consumer Products Regulations," Environmental Quality Management, Spring 2014.

It is official. California’s Office of Administrative Law (OAL) approved the California Department of Toxic Substances Control (DTSC) Safer Consumer Products regulations, and the program went into effect on October 1, 2013. The regulations mark the much-anticipated regulatory implementation of California’s Green Chemistry Initiative. The regulations and final statement of reasons are available at http://www.dtsc.ca.gov/SCPRegulations.cfm. This new program is a true game-changer, and it will have profound national and international business, regulatory, and commercial implications for consumer product manufacturers and others for the reasons noted in this Washington Watch article. 

Lynn L. Bergeson, "Toxic Substance Control Act Reform Nears," Chemical Processing, March 18, 2014.

Reform of the Toxic Substances Control Act (TSCA) is a little closer to happening since Representative John Shimkus (R-IL), chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released on February 27, 2014, a discussion draft updating the TSCA. The Chemicals in Commerce Act (CICA) keys off S. 1009, the Chemical Safety Improvement Act (CSIA), which was introduced last May by the late Senator Frank R. Lautenberg (D-NJ) and Senator David Vitter (R-LA). This column highlights provisions in the discussion draft.

Lynn L. Bergeson, "OECD Issues Expert Meeting Report on Ecotoxicology and Environmental Fate of Manufactured Nanomaterials," Nanotechnology Now, March 7, 2014.

On March 7, 2014, the Organization for Economic Cooperation and Development (OECD) posted a report entitled Ecotoxicology and Environmental Fate of Manufactured Nanomaterials: Test Guidelines, which provides a report of the discussion and recommendations from the January 2013 expert meeting on ecotoxicology and environmental fate.

Andrew R. Bourne, Lara A. Hall, Lisa R. Burchi, "EU Biocidal Products Regulation and Its Impact on Industry: A Practical Briefing," Bloomberg BNA Daily Environment Reporter, February 26, 2014.

The European Union Biocidal Products Regulation dramatically changes the way biocidal active substances and biocidal products are regulated under European law. This new regulatory system is subtly different from those in other jurisdictions and EU neighboring countries, and fundamentally redefines biocidal products and treated articles. Companies exporting to the EU as a component of their global business must ensure that their supply chains and product designs are compliant with the regulation. This article presents a snapshot of existing industry norms and anticipates how these standard practices will be affected by the regulation.

Lynn L. Bergeson, "EPA Targets Flame Retardants DecaBDE and BPA," Chemical Processing, February 13, 2014.

On January 29, 2014, the U.S. Environmental Protection Agency (EPA) released two final Alternatives Assessment Reports for the flame retardant decabromodiphenyl ether (DecaBDE) and bisphenol A (BPA) in thermal paper. The EPA’s Design for the Environment (DfE) program developed the assessments, which profile the environmental and human health hazards for DecaBDE, BPA, and their alternatives. This article explains why these assessments are important.

Lynn L. Bergeson, "EPA Promulgates Final SNURs for Multi-Walled Carbon Nanotubes and Infused Carbon Nanostructures," Nanotechnology Now, February 12, 2014.

On February 12, 2014, the U.S. Environmental Protection Agency (EPA) issued, through a direct final rule, significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 35 chemical substances that were the subject of premanufacture notices (PMN). The 35 substances include four identified as multi-walled carbon nanotubes (generic) that were the subject of a December 3, 2012, TSCA Section 5(e) consent order.

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