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.

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.”


 

On July 7, 2016, the Senate passed a bill, An Act to Reauthorize and Amend the National Sea Grant College Program Act, and for Other Purposes (S. 764), through agreement to the House's amendment to S. 764, with further amendment. While the bill is being referred to as a genetically modified organism (GMO) labeling bill, there is no actual requirement to print GMO ingredients on labels. Instead, companies would be required to print information on the packaging (through text, a symbol such as a QR code, or an electronic link) directing consumers to a website or phone line for more information. The national bioengineered food disclosure standard includes a definition for "bioengineering": "a food - (A) that contains genetic material that has been modified through in vitro recombinant [DNA] techniques; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature," as well as specifics on how the new standard will be established through requirements and procedures. The new requirements and procedures include the following:

  • Prohibition of a food derived from an animal to be considered a bioengineered food solely because the animal consumed feed produced from, containing, or consisting of a bioengineered substance;
     
  • Determination of the amounts of a bioengineered substance that may be present in food for the food to be a bioengineered food;
     
  • Establishment of a process for requesting and granting a determination by the Secretary regarding other factors and conditions under which a food is considered a bioengineered food;
     
  • Provision of alternative reasonable disclosure options for food contained in small or very small packages; and
     
  • Requirements and procedures specific to small food manufacturers.

Subtitle F includes a section on federal preemption, which states that any state regulations on "labeling of whether a food (including food served in a restaurant or similar establishment) or seed [in interstate commerce] is genetically engineered ... or was developed or produced using genetic engineering," and also a section on exclusion from federal preemption -- that nothing in the subtitle, or in Subtitle E, "shall be construed to preempt any remedy created by a State or Federal statutory or common law right." The bill will allow producers with a U.S. Department of Agriculture "certified organic" designation to display an additional "non-GMO" label on their products. S. 764 is now back in the House and is expected to be taken up before Congress's seven week recess beginning July 15, 2016.


 

In less than two months, renewable fuel and biobased chemical companies that have successfully moved from research and development to commercialization will be required to respond to the U.S. Environmental Protection Agency's (EPA) Chemical Data Reporting (CDR) rule under the Toxic Substances Control Act (TSCA). This may come as a surprise to some biobased chemicals companies that are under the misperception that they are not regulated under TSCA. This is simply wrong. Unless otherwise regulated as a pesticide, food, food additive, drug, cosmetic, or nuclear material, biobased chemicals used for a commercial purpose, including fuels regulated under the Renewable Fuel Standard program, are subject to the rules and requirements under TSCA. Companies that do not comply are subject to enforcement actions and significant fines of up to $37,500 per violation, per day.

The reporting window for the 2016 CDR is June 1, 2016, to September 30, 2016. CDR reporting includes detailed information on volumes of chemicals produced, imported, used on site, and exported. It also requires information on amounts and functions for downstream uses in industrial, commercial and consumer applications. CDR reporting is further complicated with numerous potential exemptions that must be carefully analyzed for applicability. Bergeson & Campbell, P.C. (B&C®) is hosting an informational webinar on CDR reporting on May 3, 2016, from 1:00 p.m. - 2:00 p.m. (EDT). All impacted stakeholders are invited to participate, but companies new to the TSCA arena and CDR reporting are urged to attend.


 

As reported in last week's Update, EPA published its final rulemaking expanding the list of chemicals partially exemption from certain additional chemical data under the CDR. This action, which formally amended the list of chemicals that do not have to report the onerous downstream processing and use information under the CDR Form U, Part III, occurred because of the forward thinking actions of the Biobased and Renewable Products Advocacy Group (BRAG®). In October 2014, recognizing an advocacy opportunity to equalize what had been an uneven regulatory reporting field for biodiesel products, BRAG submitted a petition to EPA outlining the reasons why the six biodiesel chemicals listed below should be afforded reduced reporting requirements under the CDR:

  • Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (Chemical Abstracts Service (CAS) No. 67762-26-9);
     
  • Fatty acids, C16-18 and C-18 unsaturated, methyl esters (CAS No. 67762-38-3);
     
  • Fatty acids, canola oil, methyl esters (CAS No. 129828-16-6);
     
  • Fatty acids, corn oil, methyl esters (CAS No. 515152-40-6);
     
  • Fatty acids, tallow, methyl esters (CAS No. 61788-61-2); and
     
  • Soybean oil, methyl esters (CAS No. 67784-80-9).

EPA quickly concurred with BRAG's view and issued a direct final rule to add the listed chemicals to the partial reporting list in January 2015. Unfortunately, due to one adverse comment submitted, which did not provide information pertinent to EPA's planned actions, the listing process under the direct final rule was halted. Instead, EPA had to proceed with a proposed rulemaking under the Administrative Procedures Act, a significantly more time and resource consuming approach. At that time, BRAG members were very concerned that EPA may not complete the rulemaking process to add the biodiesel chemicals to the partial reporting exemption list in time for the 2016 reporting cycle.

Knowing the industry's concerns with the upcoming reporting cycle, EPA staff worked diligently to issue the proposed rulemaking in July 2015. No adverse comments were submitted, and the final rulemaking was issued six months later, which is lightening fast action within a regulatory context.

While BRAG members took the initiative to request the partial reporting exemption and worked with EPA to ensure the listing occurred, any company that manufactures or imports the listed biodiesel products can take advantage of the listing. Thus, for the 2016 reporting cycle, companies that produce or import the above-listed six biodiesel chemicals do not have to report the following information elements for the exempted chemicals:

  • Top ten combinations of industrial process, industrial sector, and industrial functions;
     
  • Production or importation volumes associated with each combination;
     
  • Number of industrial sites using the chemical within each combination;
     
  • Number of workers potentially exposed within each combination;
     
  • Top ten consumer and/or commercial downstream applications;
     
  • Indication of whether reported consumer or commercial categories result in products intended for children;
     
  • Production or importation volumes associated with each reported consumer or commercial category;
     
  • Maximum concentration within each reported consumer or commercial category; and
     
  • Number of workers potentially exposed within each reported consumer or commercial category.

Per EPA's estimate, companies that utilize this reporting exemption will save 65.63 hours or almost 1.5 weeks of staff time, per report. Companies that produce more than one of the listed chemicals or have more than one reporting site will save even more.


 

On March 29, 2016, the U.S. Environmental Protection Agency (EPA) published the Partial Exemption of Certain Chemical Substances from Reporting Additional Chemical Data final rule in the Federal Register. This final rule amends the list of chemical substances that are partially exempt from additional reporting requirements under the Chemical Data Reporting (CDR) rule. The rule applies to six biodiesel chemicals that are very similar to petroleum based biodiesel chemicals that are already on the exempt list. EPA determined that CDR processing and use information for these chemical substances is of low current interest and, while the chemical substances can be removed from the exempt list in the future, manufacturers are now exempt from submitting processing and use information for:

  • Fatty acids, C14-18 and C16-18 unsaturated, methyl esters (Chemical Abstracts Service (CAS) No. 67762-26-9);
     
  • Fatty acids, C16-18 and C-18 unsaturated, methyl esters (CAS No. 67762-38-3);
     
  • Fatty acids, canola oil, methyl esters (CAS No.129828-16-6);
     
  • Fatty acids, corn oil, methyl esters (CAS No. 515152-40-6);
     
  • Fatty acids, tallow, methyl esters (CAS No. 61788-61-2); and
     
  • Soybean oil, methyl esters (CAS No. 67784-80-9).

This exemption was created after the Biobased and Renewable Advocacy Group (BRAG®) petitioned EPA in 2014 to create an equivalent exemption for six biodiesel versions of petroleum based chemicals that were already exempt from submitting processing and use information under the CDR rule.


 
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