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

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

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

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

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

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

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

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...

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

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

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

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

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...

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

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

The June 24, 2015 Bloomberg BNA Daily Environment Report included quotes from Lynn L. Bergeson in the article “Bill to Update Toxic Substances Control Act Sails Through House by 398-1 Vote.” Lynn Bergeson, managing partner of Bergeson & Campbell P.C., told Bloomberg BNA in a June 23 e-mail that the changes in the bill prior to the House vote seemed to reflect the need for consensus more than anything. ‘‘EPA will be challenged to complete risk evaluations...

The House is scheduled to vote late today, June 23, 2015 (around 6:30 p.m. or 7:00 p.m.), on the TSCA Modernization Act of 2015 (H.R. 2576). The House Committee on Energy and Commerce issued a press release on June 22, 2015, noting that the bill “would bring much-needed reform to the decades-old Toxic Substances Control Act (TSCA), and is a true bipartisan breakthrough for the committee.” According to the press release, support “has poured in for this...

On June 10, 2015, and June 15, 2015, EPA held a webinar entitled “eDisclosure: EPA’s Plan to Modernize the Implementation of the Audit Policy and the Small Business Compliance Policy.” During the webinar, EPA set forth its plans to release in the fall 2015 a centralized online portal called eDisclosure to allow companies to submit self-disclosures electronically under EPA’s Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention of...

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...

B&C has prepared and serviced this press release based on information publicly available from EPA and ACS. We have no involvement in or knowledge of the award selection process. Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are deeply committed to supporting the development of greener, more sustainable chemical processes and products, and so we are pleased to help spread the news about a tremendous success story, featuring scientists from industry,...

The House Energy and Commerce Committee convened a markup session on June 2 and 3, 2015, to consider a slightly revised version of the TSCA Modernization Act of 2015 as H.R. 2576. As reported in our June 3, 2015, memorandum, the House Committee passed the marked up bill. The House Energy and Commerce Subcommittee on Environment and the Economy had considered and passed an earlier discussion draft version of the TSCA Modernization Act (TMA2 DD) in...

The June 11, 2015, Bloomberg BNA Daily Environment Report article “Scientists Sought for New Committee To Advise EPA Office on Risk, Other Issues,” included quotes from Lynn L. Bergeson about the addition of an advisory committee for Office of Pollution Prevention and Toxics (OPPT). “The new advisory committee offers a timely and excellent opportunity to provide input on critically important topics at the core of OPPT’s mission,” Lynn Bergeson, managing partner of...

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.”...

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)....

On June 2-3, 2015, the House Committee on Energy and Commerce held a markup hearing on the TSCA Modernization Act of 2015 (H.R. 2576). Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, formally introduced the bill on May 26, 2015. On June 2, 2015, the Committee heard opening statements only. Energy and Commerce Committee Vice Chair Marsha Blackburn (R-TN) made the first statement, noting the broad bipartisan support...

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 is a follow-up document to the February 9, 2015, “Enforcement Guidance for the Hazard Communication Standard’s (HCS) June 1, 2015 Effective Date” (Enforcement Guidance). The Interim Guidance offers clarity on a few specific...

The Acta Group (Acta®) is pleased to offer to ChemCon Asia 2015 attendees a complimentary 30-minute private session with Acta professionals and Acta’s South Korean-based affiliate, SHES Chemical Consulting (SHES), to answer questions relating to K-REACH, European Union REACH, TSCA, or other Asian chemical notification/regulation programs, as requested. This service is offered free of charge, provides an excellent opportunity to maximize your attendance at ChemCon, and is...

Lynn L. Bergeson was quoted in “Pick Your Poison,” an article in the Summer 2015 Washington Monthly discussing Toxic Substances Control Act (TSCA) modernization. In the absence of appropriate federal protections, states have stepped into the breach, promulgating their own rules. Under current TSCA regulations, unless and until the EPA regulates a chemical, states can issue their own limits. Those that have done so include California, New York, Vermont, Washington, Massachusetts,...

The May 27, 2015, Bloomberg BNA Daily Environment Report article “TSCA Modernization Act Introduced in House; Key Republicans, Democrats Back Legislation,” included quotes from the B&C analysis “TSCA Reform: Detailed Review of Representative Shimkus’ Second Discussion Draft of TSCA Reform Legislation.” Time remains to address pragmatic implementation concerns in the House’s “almost surgical” TSCA-reform bill as well as the more expansive Senate bill, the...

Bergeson & Campbell, P.C. (B&C®) is a proud supporter of the Sustainable Nanotechnology Organization (SNO) and we enthusiastically recommend that you consider joining and becoming part of the SNO family during the 2015 membership drive, running now through July 3, 2015. Lynn L. Bergeson, Managing Partner of B&C, has served on the Governance Board since SNO’s founding in 2012. SNO’s purpose is unique. It is the only organization devoted exclusively to...

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.”...

On May 12, 2015, Representative John Shimkus (R-IL), Chair of the House Energy and Commerce Subcommittee on Environment and the Economy, released a new (second) draft of the TSCA Modernization Act of 2015 (TMA2 DD). In April, Shimkus released an initial discussion draft of the TSCA Modernization Act of 2015 (TMA1); our memorandum on TMA1 is available online. In the previous Congress, Shimkus introduced first a discussion draft of the Chemicals in Commerce Act (CICA1), and then a...

The U.S. Occupational Safety and Health Administration’s (OSHA) Hazard Communication Standard (HCS) deadline of June 1, 2015, is fast approaching. Below is a brief summary of what is at stake, and what needs to be in place by the deadline. On March 26, 2012, OSHA issued a final rule modifying its HCS to conform to the United Nations’ Globally Harmonized System of Classification and Labeling of Chemicals (GHS), Revision 3. In the final rule, OSHA drastically...

Lynn L. Bergeson has once again been awarded a Band 1 ranking, the highest attainable, among Washington, D.C. environmental lawyers by Chambers USA Guide 2015. This is Ms. Bergeson’s tenth consecutive year of being ranked by Chambers USA as one of the best lawyers in America. In the commentary accompanying her 2015 ranking, Chambers asserts “Lynn Bergeson of Bergeson & Campbell PC has developed an enviable reputation in the chemical regulation area and frequently advises on...

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...

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....

On May 8, 2015, in El Comite Para El Bienestar De Earlimart v. EPA, a Panel of the U.S. Court of Appeals for the Ninth Circuit denied a petition for review filed by several groups that the court describes as “community organizations” who challenged the U.S. Environmental Protection Agency’s (EPA) 2012 approval of California State Implementation Plan (SIP) elements under the Clean Air Act (CAA), including its related approval of certain fumigant regulations.  This challenge was...

On May 14, 2015, the House Energy and Commerce Subcommittee on Environment and the Economy held a markup of a revised discussion draft of the TSCA Modernization Act of 2015, prepared by Subcommittee Chair John Shimkus (R-IL) and released on May 12, 2015. The May 12, 2015, press release announcing the revised discussion draft and markup emphasizes the bipartisan nature of the bill, which is supported by Shimkus, Subcommittee Ranking Member Paul Tonko (D-NY), Committee Chair...

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....

Background A new version of the Frank R. Lautenberg Chemical Safety for the 21st Century Act was considered for markup by the Senate Environment and Public Works (EPW) Committee on April 28, 2015. The revised version, which we identify here as Lautenberg2, includes changes that appear to be intended to address issues and concerns identified by Senators with the previous version of the bill (Lautenberg1). Our review of Lautenberg1 is available online. We reviewed the key changes...

DOT Inspector General To Audit PHMSA Progress In Meeting Congressional Mandates: On May 5, 2015, U.S. Department of Transportation (DOT) announced that its Inspector General (IG) has launched an audit of DOT’s Pipeline and Hazardous Materials Safety Administration (PHMSA) at the request of Representative Peter DeFazio (D-OR), Ranking Member of the House Transportation and Infrastructure Committee. In its announcement of the audit, the IG’s office stated that DeFazio is...

FDA Announces GUDID Public Website: On May 4, 2015, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced that the data submitted to the Global Unique Device Identification Database (GUDID) are now publicly available. The website, in partnership with the National Library of Medicine, is part of the phase-in for the Unique Device Identification compliance timeline and offers anyone access to search or download information submitted for...

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...

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...

The April 30, 2015, Bloomberg BNA Daily Environment Report discussed correspondence between the U.S. Environmental Protection Agency (EPA) and its inspector general over the value of pesticide inspections.  The article quoted James V. Aidala. Tempest in a Teapot Jim Aidala, a senior consultant at the firm  Bergeson  and Campbell and the former head of what is now the EPA’s Office of Chemical Safety and Pollution Prevention, described the disagreement as a...

On April 28, 2015, the Senate Committee on Environment and Public Works held a hearing to consider several bills, including the Frank R. Lautenberg Chemical Safety for the 21st Century Act (S. 697). Prior to the hearing, on April 27, 2015, Senators Tom Udall (D-NM), Sheldon Whitehouse (D-RI), Jeff Merkley (D-OR), and Cory Booker (D-NJ) announced a bipartisan compromise agreement intended to strengthen protections under S. 697, while expanding states’ authority. During...

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...

Earlier this month, the U.S. Environmental Protection Agency (EPA) published in the Federal Register its long-awaited 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 (see our memoranda EPA Proposes Reporting and Recordkeeping Requirements for Nanoscale Materials and EPA Opens Docket for Proposed TSCA Section 8(a) Rule for...

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).”...