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 and Ligia Duarte Botelho, M.A.

On April 17, 2020, U.S. Department of Agriculture (USDA) Secretary, Sonny Perdue, announced $19 billion to farmers and ranchers as part of its COVID-19 relief program. Aimed at providing critical support in maintaining the integrity of the U.S. food supply chain and ensuring that every American has access to the food needed, the funds will be used not only to directly support farmers and ranchers, but also for USDA purchase and distribution. The latter goal means that USDA will partner with regional and local distributors affected by the closure of businesses to purchase $3 billion in fresh produce, dairy, and meat. The distributors will then provide boxes of fresh food supplied to food banks and other non-profits serving Americans in need. The one element not mentioned in the use of the relief funds, however, was assistance for biofuel producers who are bearing the impact of decrease in consumption.

In early April, 15 U.S. Senators had submitted a bipartisan letter to Secretary Perdue, requesting the use of its authority to assist the biofuels industry’s economic circumstances brought by the COVID-19 pandemic. Highlighting the negative impacts of the pandemic on farmers and producers who are suffering from the impact of the decrease in consumption, the letter asked that USDA consider the allocation of additional funds to assist the biofuels industry sector. Assistance would be helpful in the format of reimbursements for feedstocks and additional relief funds to the Higher-Blends Infrastructure Incentive Program to drive future biofuel demand. At the time, the 15 signatories of the letter seemed hopeful of receiving the aid requested and much needed. It seems as though USDA’s focus, however, is not geared toward addressing the biofuel industry’s request. According to an article, Secretary Perdue addressed this issue by stating that it is not within his authority to extend the aid to energy production and that USDA does not have a fundamental way to help the biofuels sector.


 

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

On April 9, 2020, the U.S. Department of Agriculture (USDA) published a report titled “Agricultural Biotechnology Annual,” which argues that under any scenario, the United Kingdom’s (U.K.) separation from the EU (Brexit) is unlikely to change policy or trade in genetically engineered (GE) industries. According to the report prepared by USDA’s Jennifer Wilson, given the fact that the EU is the U.K.’s trading partner and has been for many years, the U.K. will retain much of the EU’s food laws in the short to medium term. Although Brexit could potentially change the agricultural biotechnology policy arena, it is not clear yet whether the U.K. will deviate from the European Court of Justice ruling on New Plant Breeding Techniques. Overall, according to Wilson’s summary, it seems that senior U.K. politicians favor simple genome editing techniques. In addition, it would be unlikely that large multinational seed technology companies would invest in commercialization of a GE crop that could only be marketed in the U.K., which is part of the reason that the current landscape for the cultivation and importation of GE products is not expected to change.

Tags: USDA, GE, Brexit

 

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

On April 6, 2020, 15 United States Senators submitted a bipartisan letter to the U.S. Department of Agriculture (USDA) Secretary, Sonny Perdue, requesting the use of its authority to assist the biofuels industry’s economic circumstances brought by the COVID-19 pandemic. Highlighting the negative impacts of the pandemic on farmers and producers who will bear the impact of the decrease in consumption, in the letter, the Senators have also taken the opportunity to criticize the U.S. Environmental Protection Agency (EPA) for failing to implement the Renewable Fuel Standard (RFS). Specifically, the letter states that EPA has failed “to implement the RFS in accordance with the law, including its issuance of illegal small refinery waivers and enforcement of ethanol blending requirements.” The lack of proper implementation of RFS combined with the COVID-19 crisis, according to the Senators, further negatively impact the rural communities and employment rates in their respective home states.

Given these circumstances, the 15 signatories of the letter ask that USDA considers the allocation of additional funds provided to the Commodity Credit Corporation (CCC) by the Coronavirus Aid, Relief, and Economic Stabilization (CARES) Act to assist the biofuels industry sector. Assistance would be helpful in the format of reimbursements for feedstocks and additional CCC funds to the Higher-Blends Infrastructure Incentive Program to drive future biofuel demand. Although, Secretary Purdue has not yet responded to the aforementioned request, the biofuels industry is hopeful.


 

 

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

On March 4, 2020, the U.S. Food and Drug Administration (FDA), in collaboration with EPA and the U.S. Department of Agriculture (USDA), launched a new initiative called “Feed Your Mind” to help consumers better understand genetically engineered (GE) foods. Consisting of science-based information, the initiative’s features include a wide range of resources designed to teach consumers, health care professionals, and students about what a genetically modified organism (GMO) is, how GMOs are created and grown, the types of crops that can be GE, and to address questions about the health and safety of GMOs. “Feed Your Mind” also includes an explanation of how GMOs are regulated in the United States. Materials available through the initiative include new web content, videos, graphics, fact sheets, and stories, which include historical information on GMOs in agriculture. The initiative is launching in phases, and FDA expects that more resources will become available later in 2020 and 2021, including professional learning series for dietitians and a supplemental science curriculum for high schools. According to the three agencies, the materials available are based on extensive formative research after input from stakeholders and experts in biotechnology, education, and communications.

Tags: FDA, USDA, GE

 

By Lynn L. Bergeson

On March 4, 2020, USDA announced that it is now accepting comments on its technical guidelines and science-based methods to quantify greenhouse gas (GHG) sources and sinks from the agriculture and forest sectors at the entity-scale. USDA intends to update the technical guidelines based on newly available data and methodologies within the next three years. Interested parties must submit comments on or prior to April 20, 2020.

Tags: USDA, GHG

 

By Lynn L. Bergeson

On February 3, 2020, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published a notice requesting comments and feedback on its draft instructions on testing methods under the National Bioengineered Food Disclosure Standard (Standard). According to the Standard, which became effective in 2019, with a mandatory compliance date of January 1, 2022, foods that do not contain bioengineered (BE) material do not require label disclosure. USDA’s definition of BE food (7 CFR 66.1) states that food does not contain modified genetic material if the genetic material is not detectable. Therefore, detectability testing for BE materials in foods plays a key role for stakeholders to determine labeling compliance. Given its importance, USDA AMS has drafted instructions on acceptable testing methodology to be used to satisfy the requirement that the food does not contain detectable BE material. Detectability testing must meet the following standard:

  • Laboratory quality assurance must ensure the validity and reliability of test results;
     
  • Analytical method selection, validation, and verification must ensure that the testing method used is appropriate and that the laboratory can successfully perform the testing;
     
  • The demonstration of testing validity must ensure consistent, accurate analytical performance; and
     
  • Method performance specifications must ensure that analytical tests are sufficiently sensitive for the purposes of the detectability requirements of this part.

Comments on USDA AMS’s draft instructions must be submitted on or prior to March 4, 2020.

Tags: USDA, BE

 

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

On January 30, 2020, the National Biodiesel Board (NBB) submitted comments to USDA in response to its request for information (RFI) on the Higher Blends Infrastructure Incentive Program (HBIIP). A new USDA Rural Development project, HBIIP is designed to expand the availability of domestic ethanol and biodiesel by incentivizing the expansion of sales of renewable fuels. USDA’s RFI solicited information on options for fuel ethanol and biodiesel infrastructure, innovation, products, technology, and data derived from all HBIIP processes and/or science that drive economic growth, promote health, and increase public benefit. A total of 56 comments were submitted in response to USDA’s RFI. NBB’s comments included a request for USDA to focus the program on opportunities that would invest in facilitating the greatest additional volumes of biodiesel (including bioheat and sustainable aviation fuel) to enter the marketplace. NBB also calls for direct investment in infrastructure instead of federal funding that incentivizes sales. According to NBB, infrastructure investments should include heated storage tanks, transfer stations, large-scale national retail chains, increased rail capabilities to move and store biodiesel, and pipeline terminals to blend biodiesel. Urging USDA to make HBIIP a multi-year program, NBB Vice President of Federal Affairs, Kurt Kovarik, expresses NBB’s optimism that HBIIP will facilitate biodiesel industry growth.


 

By Lynn L. Bergeson

On January 27, 2020, the U.S. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) announced that it is accepting comments on its proposed revisions to regulations implemented under the Federal Seed Act (FSA). The proposed rule includes revisions to seed labeling, testing, and certification requirements, including new eligibility standards and the recognition of current breeding techniques. Revised FSA regulations would add certain seed species to the lists of covered kinds of seed and update the lists to reflect current scientific nomenclature. In addition, the proposed revisions would update regulations related to seed quality, germination and purity standards, and acceptable seed testing methods. AMS’s aim is to align FSA regulations with current industry practices, harmonize FSA testing methods and industry standards, and clarify confusing or contradictory language in the existing regulations. As a result of these revisions, AMS expects that trade burden associated with interstate seed commerce would be reduced, encouraging compliance with state and federal laws. Comments on the proposed rule must be submitted on or prior to March 27, 2020.

Tags: USDA

 
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