The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

On February 21, 2017, USDA announced in the Federal Register that the comment period for the Designation of Product Categories for Federal Procurement proposed rule had been extended.  The proposed rule aims to amend the Guidelines for Designating Biobased Products for Federal Procurement to add 12 product categories composed of intermediate ingredient and feedstock materials and to propose a minimum biobased content for each category.  In addition to the product categories and biobased content, USDA is seeking comments on appropriate performance standards for each product category, the positive environmental and human health attributes of biobased products within the proposed categories, and how small businesses may be affected by the proposed rule.  Comments are now due by April 13, 2017.


 

Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Charles M. Auer, Senior Regulatory and Policy Advisor with B&C, have published “An Analysis of TSCA Reform Provisions Pertinent to Industrial Biotechnology Stakeholders,” in Industrial Biotechnology. This article discusses how the “New [Toxic Substances Control Act (TSCA)] fundamentally changes the U.S. Environmental Protection Agency's (EPA) approach to evaluating and managing industrial chemicals, including genetically engineered microorganisms. The body of changes, the careful balancing of countless competing needs and interests, and artful drafting yield a statute that has been greatly strengthened and addresses virtually all of the deficiencies that have impeded TSCA's effectiveness over the years.  The changes are consequential, and stakeholders in the industrial biotechnology community could be greatly impacted by them, depending upon how EPA interprets and discharges its new authorities. This article highlights key changes of which stakeholders should be aware, sets forth the law's schedule by which EPA is to implement the changes, and identifies opportunities for stakeholders to engage in rulemaking or other activities to help influence the implementation process to ensure that it is firmly rooted in a clear understanding of the science, and of the risks and benefits offered by products of industrial biotechnology.”


 

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology. The 2017 Update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products. Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the 2017 Update offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.” Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.” More information is available in Bergeson & Campbell, P.C.’s (B&C®) memorandum White House Announces Release of Final Update to the Coordinated Framework for the Regulation of Biotechnology.


 

By Lynn L. Bergeson and Carla N. Hutton

On January 4, 2017, the White House announced the release of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology (2017 Update).  The Update to the Coordinated Framework provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) with respect to regulating biotechnology products.  Together with the National Strategy for Modernizing the Regulatory System for Biotechnology Products, published in September 2016, the Update to the Coordinated Framework offers a “complete picture of a robust and flexible regulatory structure that provides appropriate oversight for all products of modern biotechnology.”  Within that regulatory structure, the federal agencies “maintain high standards that, based on the best available science, protect health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory practices.”  To help product developers and the public understand what the regulatory pathway for products might look like, the 2017 Update presents information about agency roles and responsibilities in several forms, including:

  • Graphics that illustrate agency-specific overviews of regulatory roles;
  • Case studies that demonstrate how a product developer might navigate the regulatory framework; and
  • A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.

In its blog item, “Increasing the Transparency, Coordination, and Predictability of the Biotechnology Regulatory System,” the Obama Administration acknowledges that while the 2017 Update represents “remarkable progress by the EPA, FDA, and USDA to modernize the regulatory system for biotechnology products, much work remains.”  EPA, FDA, and USDA will consider the comments submitted in response to the proposed 2017 Update and information gathered during the three public engagement sessions hosted by EPA, FDA, and USDA to inform ongoing and future agency activities.  In addition, the agencies commissioned an independent study by the National Academy of Sciences (NAS) on future biotechnology products.  When completed, the agencies will consider the study’s findings, as well as the comments.  More information on the Update to the Coordinated Framework will be available in our forthcoming memorandum, which will be available on our website under the key phrase biobased products, biotechnology.


 

Lynn L. Bergeson was quoted in the December 28, 2016, Bloomberg BNA Daily Environment Report story "Biobased Chemical, Fuel Makers Seek Parity For Their Products Under Trump" (subscription required):

Biobased chemical and fuel manufacturers want their products to be treated equally with their fossil fuel-based counterparts under the incoming administration's policies.

[...]  Lynn Bergeson, managing partner of the Washington D.C.-based Bergeson & Campbell, P.C., which manages the Biobased and Renewable Products Advocacy Group (BRAG), said Pruitt’s alignment with the fossil fuel industry does not necessarily telegraph a lack of support for biobased chemicals.

Yet, ‘‘certain inferences flow from that alignment, none of which are especially good news for the biobased community,’’ Bergeson said.

The Biobased and Renewable Products Advocacy Group (BRAG) is the leader in TSCA compliance issues for the biobased chemical industry. Working together within BRAG the industry is pursuing reasonable, equitable regulations now and in the future.  Companies or persons interested in becoming a member or needing more information on BRAG membership, should contact BRAG executive director Kathleen M. Roberts

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On October 18, 2016, the Biotechnology Innovation Organization (BIO) sent a letter to Congressional Leadership, the Senate Finance Committee Chairs, and the House Ways and Means Committee Chairs calling for the extension of expiring renewable energy tax credits.  The Second Generation Biofuel Producer Tax Credit, the Special Depreciation Allowance for Second Generation Biofuel Plant Property, the Biodiesel and Renewable Diesel Fuels Credit, and the Alternative Fuel Vehicle Refueling Property are set to expire at the end of 2016, with BIO urging congress for multi-year extensions.  Brent Erickson, Executive Vice President of the Industrial and Environmental section at BIO, stated “[a]dvanced biofuel tax credits drive innovation while leveling the playing field for U.S. companies in the international marketplace.  These tax credits foster American-born technology innovations and help keep them here at home.”  BIO continued to defend the biofuels incentives by outlining the $184.5 billion in economic output and 852,056 jobs that are created annually by the biofuels industry.  A long term extension of biofuel tax credits will increase the ability to raise capital, allowing advanced biofuel production to continue expanding.


 

On September 22, 2016,  Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology (Update to the Coordinated Framework) was published in the  Federal Register . This proposed update provides a comprehensive summary of the roles and responsibilities of the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S. Department of Agriculture (USDA) with respect to the regulation of biotechnology products. More information about what this means for the future of biotechnology and the biotechnology industry is available in the Bergeson & Campbell, P.C. (B&C®) memorandum "Biotechnology: White House Releases Proposed Update to the Coordinated Framework and National Strategy for Modernizing the Regulatory System for Biotechnology Products." Comments are due by  November 1, 2016 , at  5:00 p.m. (EDT).


 

On September 16, 2016, the White House posted a blog item, "Building on 30 Years of Experience to Prepare for the Future of Biotechnology" and released two documents intended to modernize federal regulation of biotechnology products. In July 2015, the White House directed the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to develop a long-term strategy to ensure that the system is prepared for the future products of biotechnology, and commission an expert analysis of the future landscape of biotechnology products to support this effort. The proposed Update to the Coordinated Framework updates the 1986 Coordinated Framework for the Regulation of Biotechnology and provides a comprehensive summary of the roles and responsibilities of EPA, FDA, and USDA with respect to the regulation of biotechnology products. The National Strategy for Modernizing the Regulatory System for Biotechnology Products (National Strategy) sets forth a long-term strategy intended to ensure that the federal regulatory system is equipped to assess efficiently the risks, if any, of the future products of biotechnology. The Update to the Coordinated Framework is now available for comments per the Federal Register notice. Comments will be due by November 1, 2016, at 5:00 p.m. (EDT). Read the full memorandum on the Bergeson & Campbell P.C. (B&C®) website.


 

Tuesday, September 27, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time

Register Today

Three months have passed since Toxic Substances Control Act (TSCA) reform was enacted, and now implementation trends are starting to take shape. Rather than waiting to see what TSCA reform's impact on your business might be, take control of your approach to "new" TSCA with the information and insight shared in "The New TSCA: What You Need To Know" webinar series presented by Chemical Watch and B&C.

Webinar 4 will cover:

  • Section 6(h) -- Chemicals That Are Persistent, Bioaccumulative, and Toxic (PBT);
     
  • Section 18 -- State-Federal Relationship and Preemption;
     
  • Section 19 -- Judicial Review; and
     
  • Section 26 -- Fees.

Register Online

Speakers:

  • Moderator -- Lynn L. Bergeson, Managing Partner, B&C;
     
  • Charles M. Auer, Senior Regulatory and Policy Advisor, B&C, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA);
     
  • Richard E. Engler, Ph.D., Senior Chemist, B&C, former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program;
     
  • Lisa R. Burchi, Of Counsel, B&C; and
     
  • Sheryl Lindros Dolan, Senior Regulatory Consultant, B&C.

Additional Webinars in "The New TSCA: What You Need To Know" Series:

  • Webinar 1: Overview and Summary of Major Changes: What to Expect and When to Expect It, presented June 13, 2016.
     
  • Webinar 2: Impacts on New Chemical Programs, presented July 14, 2016.
     
  • Webinar 3: Inventory, CDR, and CBI (Sections 8 & 14), presented September 12, 2016.
     
    • For a copy of any of these webinar recordings, click here.

Read B&C's TSCA blog for the latest news and analysis regarding TSCA reform, implementation, and related legal and administrative developments.


 

By Lynn L. Bergeson and Margaret R. Graham

On September 16, 2016, the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA), in collaboration with the White House, released two documents that will update the Coordinated Framework for the Regulation of Biotechnology (Coordinated Framework) that was first rolled out by the White House Office of Science and Technology Policy (OSTP) in 1986 and updated in 1992.  The White House states that this is “an important step to ensure public confidence in the regulatory system for biotechnology products and to improve the transparency, predictability, coordination, and, ultimately, efficiency of that system.”  The documents released are:

The Update document is intended to help product developers and the public understand what the regulatory pathway for products might look like.  The White House states that the Update document presents information about agency roles and responsibilities in several forms, including:

  • Graphics that illustrate agency-specific overviews of regulatory roles;
  • Case studies that demonstrate how a product developer might navigate the regulatory framework, and;
  • A comprehensive table that summarizes the current responsibilities and the relevant coordination across EPA, FDA, and USDA for the regulatory oversight of an array of biotechnology product areas.

The White House is seeking public comment on this proposed Update.  The comment deadline will be 40 days from the date of publication in the Federal Register.

The Strategy document, which the White House states “sets forth a vision for ensuring that the Federal regulatory system is equipped to assess efficiently the risks, if any, associated with future products of biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens,” also details many existing activities at EPA, FDA, and USDA; new activities that have been instigated by the memorandum on “Modernizing the Regulatory System for Biotechnology Products,” which directed EPA, FDA, and USDA to update the Coordinated Framework; and key commitments that these three agencies will keep going forward to continue the modernization process.  These commitments are:

  • EPA, FDA, and USDA will review existing communication tools and, as appropriate, may revise existing or develop new user-friendly sources of regulatory information for product developers and the general public.
  • EPA, FDA, and USDA are emphasizing their commitments to interagency communication and collaboration in order to make timely decisions on regulatory jurisdiction for biotechnology products and to optimize the review and use of scientific data for regulatory assessments.
  • EPA and FDA intend to clarify their respective approaches for oversight of products developed using genome editing techniques, including, for example, pesticidal products at EPA and genetically engineered animals at FDA.
  • EPA, FDA, and USDA will continue to examine their regulatory structures with the goal of clarifying how the U.S. Federal Government will regulate genetically engineered insects in an integrated and coordinated fashion to cover the full range of potential products.
  • EPA, FDA, and USDA commit to reporting annually, for at least the next five years, on specific steps that they are taking to implement the Strategy, as well as any additional actions being taken to improve the transparency, predictability, and efficiency of biotechnology regulation and the coordination among the regulatory agencies.
  • EPA, FDA, and USDA will continue to provide leadership in international fora to promote scientific competency, understanding of the U.S. regulatory approach, and regulatory compatibility worldwide for biotechnology products.
  • EPA, FDA, and USDA commissioned a study by the National Academy of Sciences, entitled “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.”  This report is still forthcoming.

On Tuesday, September 20, 2016, at 2:00 p.m. (EDT), OSTP, EPA, FDA, and USDA will be participating in a conference call on the White House’s efforts in regards to the above.  More information regarding registration for the call and submitting questions is available online.

More information concerning the Coordinated Framework, the memorandum on “Modernizing the Regulatory System for Biotechnology Products,” and other current biotechnology issues are available in our memoranda on our website under the key phrase “Biobased Products, Biotechnology.”


 
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