Federal/EPA Regulatory Policy

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.

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 published a five-year PGP, which expires on October 31, 2016. Additionally, all states with delegated NPDES program authority developed and issued state versions of the PGP.

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, "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.

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, "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, "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.

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, "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 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, "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, "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, "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, "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, "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.

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, "What Can We Expect From EPA in 2014?," Chemical Processing, January 20, 2014.

This “Compliance Advisor” column outlines thoughts on what might be headed our way in 2014 from the Office of Chemical Safety and Pollution Prevention (OCSPP) of the U.S. Environmental Protection Agency (EPA). Beyond the election-driven rhetoric, demands of the discrete issues that routinely come before program management will drive the EPA. An added and complicating concern may be the impact on these and all issues of continued budget cuts that challenge the EPA's ability to operate as it has in the past; even the simple ability to process approvals or conduct public meetings about non-controversial matters have become more difficult.

Lynn L. Bergeson, "EPA Targets Significant New Use Rule-Regulating Articles," Chemical Processing, November 15, 2013.

The U.S. Environmental Protection Agency (EPA) issued in October 2013 a final rule amending a significant new use rule (SNUR) for perfluoroalkyl sulfonate (PFAS) chemical substances. The rule is receiving praise because it narrowly and precisely targets the scope of the “articles” (finished products) subject to the SNUR requirements.

Lynn L. Bergeson, "New Executive Order Issued to Improve Safety at Chemical Manufacturing Facilities," Pollution Engineering, October 1, 2013.

On Aug. 1, 2013, President Barack Obama issued Executive Order (EO) 13650, ordering federal agencies to review safety rules at chemical facilities in response to the April explosion at the West Fertilizer Co., in West, Texas. The order, Improving Chemical Facility Safety and Security, seeks to close gaps in the regulation of facilities that the government believes contributed to the fatal accident. Here is a summary of that order.

James V. Aidala, "Neonicotinoids: EPA’s New Get-Tough Measures," Law360, September 25, 2013.

Throughout 2013, the issue of the contribution of pesticide use to the decline in honeybee colony health, known as colony collapse disorder (CCD), has been increasingly controversial. Of particular concern is the role that a particular class of pesticides, known as neonicotinoids, may play in CCD. While EPA generally maintains its view that pesticides, including the neonicotinoids, are one of many factors in contributing to CCD, in July 2013, it took steps to control more stringently the foliar use of neonicotinoid pesticides, including the ones affected by the EU suspension. EPA's most recent "get tough" approach is a new labeling requirement issued Aug. 15, 2013, and available online, and it holds some additional implications. This article reviews U.S. and European regulatory developments and offers commentary on how new restrictions will affect users and applicators of neonicotinoids.

Lynn L. Bergeson, co-author, "A Multi-Stakeholder Perspective on the Use of Alternative Test Strategies for Nanomaterial Safety Assessment," ACS Nano, August 7, 2013.

This article presents the results of a January 2013 workshop convened at the California NanoSystems Institute of the University of California, Los Angeles (UCLA) and hosted by the University of California Center for the Environmental Implications of Nanotechnology, as well as the UCLA Center for Nanobiology and Predictive Toxicology. Using carbon nanotubes as a case study, national and international leaders from government, industry, and academia discussed the utility of alternative test strategies (ATS) for decision-making analyses of engineered nanomaterials (ENM). After discussions, participants generated a short list of generally shared viewpoints, including a general view that ATS approaches for ENMs can significantly benefit chemical safety analysis. The article is available for purchase online.

Lynn L. Bergeson, "EPA Wipes Away Rule; Reusable and Disposable Solvent-contaminated Wipes Get Exclusion," Chemical Processing, August 7, 2013.

As one of the U.S. Environmental Protection Agency (EPA) Administrator Gina McCarthy’s first official acts, on July 23, 2013, the Administrator signed a final rule easing the requirements under the Resource Conservation and Recovery Act (RCRA) for solvent-contaminated rags and wipes. The rule has been long in the making and much anticipated.

Lynn L. Bergeson, Kathleen M. Roberts, and Heidi B. Lewis, "Why BRAG Before You Go to Market? The Biobased and Renewable Products Advocacy Group (BRAG) Helps Companies Commercialize Their Products," Industrial Biotechnology, August 2013.

Renewable chemicals are emerging at a fast pace, paving the way for new, innovative, and sustainable biobased products. The renewable chemicals’ market is estimated to reach $83.4 billion by 2018 in applications ranging from transportation and agriculture to textiles and cosmetics. In addition to all the elements great companies need to succeed -- a great product, a great brand, inspiring leadership, and vision -- biobased product companies need to understand how the U.S. Environmental Protection Agency (EPA) occupies a virtual seat at their management table, whether or not they know it.

Lynn L. Bergeson, "The Chemical Safety Improvement Act," Pollution Engineering, August 1, 2013.

Senators David Vitter (R-LA) and the late Frank Lautenberg (D-NJ) introduced S. 1009, the Chemical Safety Improvement Act (CSIA), in May 2013. The CSIA provides a new approach to Toxic Substances Control Act (TSCA) reform that, to date, has met with broad stakeholder approval. Highlights of the draft bill are below.

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