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.

By Lynn L. Bergeson

On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and environmental release) of certain genetically engineered (GE) organisms in response to advances in genetic engineering and APHIS’s understanding of the plant pest risk posed by GE organisms, thereby reducing the regulatory burden for developers of organisms that are unlikely to pose plant pest risks. For more information, please read the full memorandum here.

Tags: USDA, APHIS, SECURE, GE

 

By Lynn L. Bergeson

On May 15, 2020, U.S. Senators Cory Gardner (R-CO), Kirsten Gillibrand (D-NY), Ed Markey (D-MA), and Marco Rubio (R-FL) introduced the Bioeconomy Research and Development Act of 2020, creating a federal research initiative to ensure continued United States leadership in engineering biology. The National Engineering Biology Research and Development Initiative would focus on the advancement of societal well-being, national security, sustainability, and economic productivity and competitiveness. It would accomplish these goals through:

  • Advancement of areas of research at the intersection of biological, physical, chemical, data, and computational sciences;
  • Advancement of areas in biomanufacturing research;
  • Support of social and behavioral sciences and economics research that advances the field of engineering biology;
  • Improvement of the understanding of the engineering biology;
  • Support of risk research;
  • Development of novel tools and technologies to accelerate scientific understanding and technological innovation in engineering biology;
  • Expansion of the number of researchers, educators, and students with engineering biology training;
  • Acceleration of the translation and commercialization of engineering biology research and development by the private sector; and
  • Improvement of the interagency planning and coordination of federal government activities related to engineering biology.

According to Senator Rubio, the Bioeconomy Research and Development Act of 2020 has been endorsed by a number of leading research institutes, including the Biotechnology Innovation Organization (BIO), a Biobased and Renewable Products Advocacy Group (BRAG®) member.


 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On April 10, 2020, the European Commission (EC) announced the launch of its new online service that connects crop and food producers with biorefineries. This European Union (EU) project aims to address food waste by enabling crop producers, food processors, and agricultural cooperatives to sell their waste as feedstock for use by two biorefineries in Spain and Italy. The multi-feedstock biorefineries, designed by Agrimax, convert farming and food processing byproducts into compounds that can be used in biobased food packaging as well as in the biobased chemical and agricultural sectors. Agrimax is an EU-funded project focused on the development and demonstration of high-value products from crop and food-processing waste. Its work develops economically competitive routes to the commercialization of the products. The project is expected to end in September 2020; developers hope to make a positive impact in growth of the biobased and agricultural sectors.


 

The Acta Group (Acta®) announced today the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 Chemical Data Reporting (CDR) required by the U.S. Environmental Protection Agency (EPA). CDR Cross-Check utilizes the most recent CDR listing information publicly available provided by EPA (currently, 2016 lists) to identify whether all or some of a company’s inventory of chemical substances are subject to CDR under the Toxic Substances Control Act (TSCA) and, if so, at what reporting threshold. CDR Cross-Check will make CDR reporting easier.

CDR Cross-Check will identify whether chemicals are listed on the TSCA Inventory and, if so,

  • whether they are listed as active or inactive;
     
  • whether they were subject to specific TSCA regulatory actions in 2016;
     
  • whether they are exempt; and
     
  • what the 2020 reporting thresholds would be based on the 2016 data.

Sample CDR Cross-Check™ Report:

(Click image to enlarge.)

A CDR Cross-Check report prepared at this time will be extremely useful as a preliminary check in preparation for the 2020 CDR reporting. It will confirm regulatory statuses from the 2016 reporting cycle, so for those chemicals, users will know what the reporting threshold will be for 2020 and can determine now whether reporting is needed. It will also give users time to address potential issues well before the 2020 reports are due.

To access CDR Cross-Check, a customer will upload the list of chemicals to be evaluated by the CDR Cross-Check tool and pay the appropriate fee based on the number of chemicals to be evaluated. Fees are $3.00 (USD) per chemical for the first 750 chemicals plus $2.00 (USD) per chemical for additional chemicals over 750. The minimum fee is $400 (USD).

Acta anticipates that additional chemicals will be added to the regulatory lists in June 2020 that may result in lower reporting thresholds. The CDR Cross-Check will be updated at that time to include the new lists. Customers that have already used the CDR Cross-Check prior to the 2020 updates will receive a 50% discount for an updated list.

Visit the CDR Cross-Check website, https://cdr-cross-check.actagroup.com/, for more information and to order a CDR Cross-Check report.

More information on recent CDR developments is available in Acta’s March 19, 2020, memorandum “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

The Acta Group is a global scientific and regulatory consulting firm that assists companies with strategic commercialization planning and complex product registration and compliance matters in North America, South America, Europe, the Middle East, and Asia. Acta is the consulting affiliate of Washington, D.C., law firm Bergeson & Campbell, P.C.


 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

The international standards organization, ASTM International, is seeking additional task group members to further develop the current terminology standard in industrial biotechnology (E3072-19). ASTM International develops and publishes voluntary consensus technical standards for a wide range of materials, products, systems, and services. Its sub-committee, E62.91 for Terminology in Industrial Biotechnology, is responsible for suggesting new terms and definitions to be added to the current standard and for revising existing terms and definitions as needed. The meanings and explanations of the technical terms have been written for both non-expert and expert users and is updated annually to include editorially any terms approved in the committees of technical standards. This standard, however, does not purport to address all of the safety concerns, if any, associated with the use of biotechnology products, materials, systems, or services. Interested parties should contact the sub-committee chair, .(JavaScript must be enabled to view this email address), or the E62 staff manager, .(JavaScript must be enabled to view this email address), directly.


 

By Lynn L. Bergeson

The European Commission (EC) will host a webinar on biobased products developed from fast pyrolysis oil, where four companies will present their work. A technology that can convert a wide range of biomass into clean and uniform bio-oil that is easy to transport and store, fast pyrolysis has mostly focused, thus far, on the use of pyrolysis oil for energy purposes. According to EC, the Horizon 2020 project called Bio4Products, however, has recently developed a technology to divide pyrolysis oil into multiple fractions that could be used for material applications. In its webinar, EC will showcase some of the latest results from companies using this technology. Part of a series of webinars called From Biomass to Biobased Products, the webinar will be on February 20, 2020, at 5:00 a.m. (EST). Interested parties may register for the webinar here.


 

By Lynn L. Bergeson

The New York State Department of Environmental Conservation (NYSDEC) will hold a public meeting on February 24, 2020, at 1 p.m. (EST) in Albany, New York, “to discuss amendments to the household cleansing product rules that are being considered for adoption.” According to NYSDEC, amendments include specifying what information must be reported about covered products and their ingredients, how information should be shared with NYSDEC for the public record, the type of studies that must be reported, and how confidential business information (CBI) should be handled. NYSDEC states that during the meeting, it “is looking for input on disclosure of nonfunctional ingredients, issues around confidential information, how to disclose when a product’s formulation temporarily changes, and any other regulatory concerns.” Registration is required to attend the meeting. NYSDEC notes that it “will hold a formal public comment period at a later date once it officially proposes the regulations.”

As reported in Bergeson & Campbell, P.C.’s (B&C®) September 4, 2019, blog item, on August 27, 2019, the State of New York Supreme Court invalidated the Household Cleansing Product Information Disclosure Program (Disclosure Program). Information related to NYSDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer cleaning products to disclose information regarding the ingredients in those products is available here. The court found that the Disclosure Program was established in violation of the State Administrative Procedure Act (SAPA) and the New York State Constitution. In making this finding, the court held that the Program was a “rule” as argued by Petitioners and not “guidance” for which adherence to SAPA was not required, as argued by NYSDEC. A more detailed analysis and commentary are available in our August 30, 2019, memorandum, “NY Department of Environmental Conservation Household Cleansing Product Information Disclosure Program Ruled ‘Null and Void.’


 

By Lynn L. Bergeson

Pennsylvania State University’s (Penn State) Huck Institutes of the Life Sciences’ Center of Excellence in Industrial Biotechnology (CoEIB) is now offering a new round of IMPACT Seed Grants to support interdisciplinary research, curricular development, or educational activities in the broad area of industrial biotechnology. These areas include but are not limited to: biopharmaceutical manufacturing, food biotechnology, and production of biobased chemicals. According to Penn State’s announcement, project proposals of up to $25,000 per project will be available. Favorable consideration will be given to grant proposals that: (1) leverage the capabilities in the CSL Behring Fermentation Facility; (2) provide matching funds to support new industry-funded collaborations; and (3) support graduate/undergraduate students in industrial biotechnology research or educational activities. The CSL Behring Fermentation Facility is a biotechnology pilot plant capable of research- and pilot-scale production of microbial cells, recombinant proteins, and other microbial products over a wide range of controlled conditions. Proposals should be submitted to CoEIB on or prior to 5:00 p.m. (EST) on February 7, 2020.


 

By Lynn L. Bergeson

On January 1, 2020, U.S. President Donald Trump released a statement recognizing the beginning of National Biotechnology Month and the country’s “enormous potential” of biotechnology to improve lives in the United States and around the globe. Highlighting the benefits of biotechnology in different sectors, President Trump states that for every one job in biotechnology, nearly two other jobs are created in various sectors in the rural United States. In his statement, the President assures Americans that his policies to encourage innovation and drive job growth will continue:

As we mark the start of National Biotechnology Month and a new decade of American ingenuity, we recognize the importance of American leadership in maintaining science- and risk-based review and regulation of biotechnology products, promoting and safeguarding critical biotechnology infrastructure and data, and preparing the next generation of biotechnology scientists, engineers, and innovators. Together, we can ensure this booming, innovative industry continues to foster economic growth and American innovation.


 

By Lynn L. Bergeson

On January 9, 2020, also in recognition of National Biotechnology Month, the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and the U.S. Environmental Protection Agency (EPA) announced the launch of a unified website for biotechnology regulation. Streamlining information about the three agencies in charge of overseeing agriculture biotechnology products, this website comes, in part, to fulfill President Trump’s Executive Order (EO) on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The unified website also describes the federal review process for certain biotechnology products and allows users to submit questions to USDA, FDA, and/or EPA. Aiming to improve customer service to innovators and developers, the three agencies also wish to assure Americans about the safe use of biotechnology innovations. According to USDA Secretary of Agriculture, Sonny Purdue, all Americans deserve transparency and science-based regulations that foster innovation, conserve resources, and protect public health. BRAG will supplement this notice with more information next week.


 
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