Tag: USDA

BRAG Biobased Products Blog

USDA Requests Input On HBIIP

On January 16, 2020, the U.S. Department of Agriculture (USDA) announced the issuance of a Request for Information (RFI) to assist with the creation of its new program called Higher Blends Infrastructure Incentive Program (HBIIP). A 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. Requesting feedback from all interested parties, this RFI solicits 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. With an approaching deadline for comment submissions by January 30, 2020, thus far, only three parties have submitted comments to USDA.

DOE Announces Launch Of The 2020 Tibbetts Awards Program

On January 21, 2020, the U.S. Department of Energy’s (DOE) Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Programs Office announced the launch of the U.S. Small Business Administration’s (SBA) Tibbetts Awards. The Tibbetts Awards recognize companies, organizations, and individuals exemplifying the best of the best in the SBIR and STTR programs. Named after the founder of the SBIR program, Roland Tibbetts, the awards also help DOE to document the economic, technical, and societal benefits from SBIR/STTR funding. Nominees can consist of an individual, a company, or an organization that promotes the mission and goals of the SBIR/STTR programs. The mission and goals include:

  • Stimulation of technological innovation;
  • Work with small businesses to meet federal development needs;
  • Encouragement of diverse participation in innovation and entrepreneurship;
  • Increase of private sector commercialization of innovations derived research and development (R&D); and
  • Foster technology transfer through cooperative R&D between small businesses and research institutions.

Nominations are open through February 21, 2020, and can be submitted via this website.

EU Funds Project To Develop Biobased Ropes For Aquaculture

On January 17, 2020, the European Union (EU) announced a new innovative project called BIOGEARS that will be funded under the European Maritime and Fisheries Fund (EMFF). The project focuses on the development of biobased gear solutions for the creation of an eco-friendly offshore aquaculture sector using a multitrophic approach and new biobased value chains. With the aim to address the gap of biobased ropes for offshore aquaculture, which is currently manufactured with 100 percent non-recyclable plastics, BIOGEARS will create a biobased value chain under the EU Bioeconomy Strategy framework. The European Bioeconomy Strategy aims to accelerate the deployment of a sustainable and circular European bioeconomy to maximize its contribution towards the 2030 Agenda and its Sustainable Development Goals (SDG), as well as the Paris Agreement. With the goal of increasing aquaculture marketable products, BIOGEARS uses an Integrated Multi-Trophic Aquaculture (IMTA) approach by integrating seaweed with mussel production. The BIOGEARS project’s intention is to develop biobased ropes that are tough, durable, and fit-for-purpose while still able to biodegrade in shorter time and managed by local composting facilities.

As part of the project, all project partners will participate in a BLUE LAB to enhance cooperation and enable tracking of innovation of the new biobased materials developed. Project coordinator, Leire Arantzamendi, expressed her hopes of boosting more eco-friendly mussel and seaweed production stating that BIOGEARS “will generate three rope prototypes with a highly reduced carbon footprint along the value chain.” The project will focus on the Atlantic Basin.

©2020 Bergeson & Campbell, P.C.

For more developments in the Biotech sphere, see the National Law Review Biotech, Food & Drug law section.

New Joint Website on Agricultural Biotechnology Products Launched by EPA, USDA, and FDA

On January 9, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) announced the launch of a new website created in coordination with the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) that provides information about actions the federal government is taking to oversee the development of agricultural biotechnology products.  This “one-stop-shop” website was created under the direction of Executive Order (EO) “Modernizing the Regulatory Framework for Agricultural Biotechnology Products.”

EPA regulates biotechnology-based pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and residues from such pesticides under the Federal Food, Drug and Cosmetic Act (FFDCA).  EPA also regulates under the Toxic Substances Control Act (TSCA) certain new microorganisms that are not subject to regulation under other statutes.  USDA regulates certain new biotechnology products under the Plant Protection Act (PPA), including agricultural crops that have been modified to be resistant to conventional pesticides.  FDA regulates the safety of human and animal foods produced using biotechnology, including genetically modified agricultural crops and animals, and the safety of drugs and human biologics produced with biotechnology, under the FFDCA.

The website, The Unified Website for Biotechnology Regulation, describes the federal review process for biotechnology products, outline’s each agency’s role in regulating biotechnology products, and allows users to submit questions to the three agencies.  EPA Administrator Andrew Wheeler states that the new website “will help provide regulatory certainty and clarity to our nation’s farmers and producers by bringing together information on the full suite of actions the Trump Administration is taking to safely reduce unnecessary regulations and break down barriers for these biotechnology products in the marketplace.”

Commentary

In recent years, a number of Non-Governmental Organizations (NGO) have raised concerns regarding the risks from products that have been genetically modified using biotechnology, including agricultural crops that have been genetically modified to improve pesticide or disease resistance, and agricultural animals that have been genetically modified to enhance food production.  In some instances, farmers have also expressed concern that crops with novel traits may exchange genetic information with other plant strains or species.  Implicit in all of this criticism is a presumption that the agencies with regulatory jurisdiction over these novel organisms have not adequately prevented or mitigated the risks associated with biotechnology.

In contrast, proponents of biotechnology have complained that regulatory requirements imposed by the responsible agencies have stifled useful innovation and have requested relief from regulatory requirements that they contend have impeded or slowed introduction of new products of agricultural biotechnology.  The Executive Order that underlies the new website seeks to streamline the administrative process for introducing novel agricultural products without increasing potential risks of biotechnology.

Additional information on how EPA regulates biotechnology products is available here.

©2020 Bergeson & Campbell, P.C.

For more on biotech, see the National Law Review Biotech, Food & Drug lawpage.

Senate Introduces Bill to Formalize Joint Framework for Regulating Cell-Cultured Meat Products

Producers of cell-cultured meat – synthetic meat products derived from animal cell cultures that are intended to simulate the taste, appearance, and texture of traditional animal products – may soon receive regulatory direction from Congress. On December 16, 2019, Senators Mike Enzi (WY) and Jon Tester (MT) introduced legislation to codify a joint agreement between the U.S. Food & Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) regulating the development and sale of cell-cultured meat products. The legislation aims to address ongoing uncertainty over which federal agency should regulate the cell culture development process, and would assign authority to USDA to establish appropriate label terms for cell-cultured meat products. The bill arrives even as a number of states have recently acted to prohibit cell-cultured meat products from being labeled as “meat” – and are now facing lawsuits in federal court.

Cell-cultured meat, also called lab-grown meat or “clean meat,” is grown in a sterile laboratory environment. The cell cultures are drawn from either a live or slaughtered animal and grown in a complex multi-step process.[1] They are differentiated and matured to simulate traditional meat products while avoiding many of the environmental impacts associated with traditional animal husbandry. Technology advocates state that cell-cultured meat reduces feed costs, crop footprints, greenhouse gas emissions, and water consumption.

But cell-cultured meat products have not yet been able to offer these benefits at scale, owing in part to high costs currently associated with development and production. Regulatory uncertainty has also created challenges, as regulators have grappled over which federal agency should have primary oversight over the cell-cultured meat production process: while USDA regulates and inspects meat and poultry, FDA generally regulates all other food products to ensure that they are safe for human consumption and labeled accurately. This longstanding framework has prompted a challenging question for regulators and stakeholders alike: should cell-cultured meat products be regulated by USDA under its authority over traditional meat and poultry products, or by FDA, which has historically regulated the types of food manufacturing facilities and laboratories where cell-cultured meat will be grown and produced?

The agencies have already offered their commitment to work together. In November 2018, USDA and FDA issued a press release articulating a joint framework for robust collaboration, wherein FDA would oversee the stages of production from cell collection to differentiation, while USDA would regulate all subsequent processing, packing, and labeling of the products.[2] The agencies formalized their joint agreement in March 2018.

Responding to concerns from livestock industry groups and other stakeholders, a number of states (including Arkansas, Louisiana, Missouri, Mississippi, and Wyoming) subsequently passed laws to prohibit certain animal-derived food products from being labeled as “meat” or a “meat food product.” Several of those laws were subsequently challenged in lawsuits brought by public interest groups.

In the wake of these legal challenges, Senators Enzi and Tester introduced the “Food Safety Modernization for Innovative Technologies Act” (Senate Bill 3053) on December 16.[3] The bill draws from the Joint Agreement and aims to clarify that FDA will oversee the initial cell collection, proliferation, and culturing processes while transferring regulatory oversight of the harvested cells to USDA for regulation related to further processing and packaging. Significantly, the bill provides USDA with exclusive authority over labeling requirements for cell-cultured meat products derived from cell lines of livestock or poultry and assigns USDA with responsibility for establishing “appropriate nomenclature” for these product labels. The bill also requires the FDA and USDA to share information and collaborate during cell differentiation and harvesting. As of this date, the bill has been referred to the Committee on Agriculture, Nutrition, and Forestry and has yet to face a vote.

[1] See Alan Sachs & Sarah Kettenmann, A Burger by Any Other Name, 15 SciTech Lawyer 19 (Winter 2019).

[2] U.S. Dept Agric., Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the Regulation of Cell-Cultured Food Products from Cell Lines of Livestock and Poultry, Release No. 0248.18, Nov 16, 2018, available at https://www.usda.gov/media/press-releases/2018/11/16/statement-usda-secretary-perdue-and-fda-commissioner-gottlieb.

[3] Food Safety Modernization for Innovative Technologies Act, S. 3053, 116th Cong. (2019).

© 2019 Beveridge & Diamond PC

For more on Cell-Cultured Meat, please see the Biotech, Food and Drug Law section of the National Law Review.

Lapse in Government Funding Continues to Affect FDA, USDA

As previously covered on this blog, without either a fiscal year 2019 appropriation or a Continuing Resolution, a partial government shutdown, which began on December 22, 2018, has continued to impact both the U.S. Department of Agriculture and the U.S. Food and Drug Administration. As of the time of this blog’s publication, the government has been partially shut down for over 20 days.

Most recently, in a Twitter thread, FDA Commissioner Scott Gottlieb noted that the agency stopped a limited number of domestic food inspections because of the shutdown, but the agency is, “taking steps to expand the scope of food safety surveillance inspections we’re doing during the shutdown to make sure we continue inspecting high risk food facilities.” Several commodities are deemed “high risk” and include: seafood, soft cheeses, fresh fruits and vegetables, spices, shell eggs, infant formula and medical foods. Gottlieb noted that the mechanism to expand the domestic inspections will be in place beginning the week of January 14.

As for the USDA, Senator Debbie Stabenow submitted a letter to the Secretary of Agriculture on January 9 requesting information on the impact that the shutdown is having on the agency, including the delay in implementing the recently-passed Farm Bill. As of the time of this publication, the Secretary has yet to respond. USDA put out a press release at the end of 2018 regarding activities that would be affected by the shutdown, but the department has not updated it since that time.

 

© 2019 Keller and Heckman LLP.
This post was contributed by Food and Drug Law at Keller and Heckman.
For more legal news on the Food and Drug Administration check out the National Law Review’s Biotech Food and Drug Type of law page.

GM Labeling Update: Ingredient Disclosure Debate

  • As previously reported on this blog, legislation requiring labeling of genetically modified (GM) foods and food ingredients was signed into law on July 29, 2016.  This law directs the U.S. Department of Agriculture (USDA) to develop regulations and standards to create mandatory disclosure requirements for bio-engineered foods by July 2018. On June 28, 2017, USDA’s Agricultural Marketing Service (AMS) posted a list of 30 questions to obtain stakeholder input to facilitate the drafting of mandatory disclosure requirements to implement the National Bioengineered Food Disclosure Law. One of those questions is:
    • “Will AMS require disclosure for food that contains highly refined products, such as oils or sugars derived from bioengineered crops?”
  • USDA has not yet posted the comments it has received, which were due by August 25, 2017; however, several organizations have posted the comments they submitted in response to the questions. Among the organizations supporting disclosure were the Grocery Manufacturers Assn. (GMA), the International Dairy Foods Assn. (IDFA)and the Consumers Union. Noting that excluding highly refined ingredients (HRI) from the scope of the mandatory disclosure standard would result in roughly 80% fewer products being subject to the disclosure requirements under the federal law, GMA wrote, “A clear, simple, and consistent mandatory disclosure standard that includes HRI will assist manufacturers in educating consumers about biotechnology as a safe and beneficial method of plant breeding.”
  • In contrast, the Information Technology & Innovation Foundation (ITIF) and The Biotechnology Innovation Organization (BIO) are opposed to mandatory disclosure of HRI. ITIF suggested that some refined products do not contain residual DNA sequences and that “[t]here are not analytical methods that would allow such products to be identified as coming from ‘GM’ plants or animals vs. others.”
  • While USDA develops mandatory disclosure requirements for bio-engineered foods, a number of class action laws suit have been filed suggesting that products containing GM ingredients are falsely labeled as natural. For example, last week, the U.S. Supreme Court refused to hear a bid by Conagra Brands Inc. to avoid a class-action lawsuit concerning cooking oil labeled 100% natural that contains GM ingredients (see S. News). And earlier this month, Frito-Lay North America agreed to not make any non-GMO claims on certain products “unless the claim is certified by an independent third-party certification organization”(see Food Navigator).
  • We will continue to monitor developments on the National Bioengineered Food Disclosure Standard and report them to you here.
This post was written by the Food and Drug Law at Keller and Heckman of Keller and Heckman LLP., © 2017
For more Biotech, Food & Drug legal analysis, go to The National Law Review

USDA Announces $15.1 Million In Grants For Bioenergy and Bioproducts

On July 20, 2017, the U.S. Department of Agriculture’s (USDA) National Institute of Food and Agriculture (NIFA) awarded 34 grants totaling $15.1 million for research on renewable energy, biobased products, and agroecosystems.  The grants, which are funded through the agency’s Agriculture and Food Research Initiative (AFRI), are expected to help develop the next generation of renewable energy, bioproducts, and biomaterials; protect the ecosystems that support agriculture; and improve the agricultural systems and processes that help feed the nation.

The following institutions were awarded grants for projects focused on cover crop systems for biofuel production:

  • USDA Agricultural Research Service (ARS) received $494,000 for the development of lupin, cereal rye, and carinata winter cover crops for biomass in the southern coastal plain;
  • Purdue University received $498,000 for the development of cover cropping for the development of sustainable co-production of bioenergy, food, feed (BFF) and ecosystem services (ES);
  • Iowa State University of Science and Technology received $498,378 for the development of perennial cover crop systems for maize grain and biomass production;
  • Louisiana State University Agricultural Center received $387,000 to study the feedstock production potential of energy cane-sweet sorghum rotation with a winter cover crop system; and
  • University of Nebraska received $500,000 to assess innovative strategies to maximize cover crop yields for biofuel across a precipitation gradient.​​​

The following institutions were awarded grants for projects focused on the socioeconomic implications and public policy challenges of bioenergy and bioproducts market development and expansion:

  • Auburn University received $499,886 to identify the economic barriers to biomass production, to evaluate the effectiveness of the Biomass Crop Assistance Program (BCAP) in stimulating biomass market expansion, and to explore the economic and ecosystem service implications of biomass production;
  • Colorado State University received $499,000 to produce a unified atlas of marginal lands in the U.S., and provide insight on the costs, potential environmental benefits, and overall practical likelihood of using those lands for biomass feedstock production;
  • Purdue University received $492,099 to develop a dynamic theoretical model on rejuvenating coal-power plants with biomass;
  • Iowa State University of Science and Technology received $499,622 to provide an integrated model-based assessment of the socioeconomic, policy, and market implications of sustainable bioenergy derived from cellulosic biomass; and
  • University of Missouri received $498,441 to evaluate impacts on forest resources surrounding power plants using woody biomass, assess economic impacts of wood biopower systems, and quantify tradeoffs between cost, carbon reductions, and renewable energy generation obtained by the increased use of wood biopower.

More information on the grants is available at the NIFA website.

This post was written by Lauren M. Graham, Ph.D. of Bergeson & Campbell, P.C.

Read more legal analysis at the National Law Review.

Full Senate Set to Confirm Sonny Perdue as Agriculture Secretary

USDA Agriculture Sonny PerdueIt has been nearly 14 weeks since President Donald Trump nominated Sonny Perdue, former two-term governor of Georgia, to lead the U.S. Department of Agriculture (USDA). His long wait for formal confirmation is likely to come to an end this week. The Senate is scheduled to hold a confirmation vote late Monday afternoon, where Perdue is expected to receive bipartisan support.

Perdue easily secured the Senate Agriculture Committee’s support at its business meeting on March 30 by a 19-1 vote; Sen. Kirsten Gillibrand (D-NY) voiced her opposition to his nomination and Sen. David Perdue (R-GA) – cousin of Sonny Perdue – declined to participate because of their close connection. Senator Gillibrand requested her opposition be recorded, noting her disapproval of how certain Supplemental Nutrition Assistance Program (SNAP) issues in the State of Georgia were handled by then-Governor Perdue. However, Sonny Perdue is one of President Trump’s more uncontroversial Cabinet choices, and he notably boasts the support of the top Democrat on the Senate Agriculture Committee, Ranking Member Debbie Stabenow (D-MI), who has made clear her support for the Senate to swiftly confirm Perdue for the top USDA spot.

A formal swearing-in ceremony for Perdue, likely to be held later this week, will officially recognize Perdue as the 31st Secretary of Agriculture.

This Week’s Legislative Activities:

  • On Monday, April 24, the Senate will hold a vote on confirmation of the nomination of Sonny Perdue to be Secretary of Agriculture.

ARTICLE BY Natasha Eckard Hammond of Squire Patton Boggs (US) LLP

© Copyright 2017 Squire Patton Boggs (US) LLP

USDA Releases Report On Lifecycle Greenhouse Gas Balance Of Ethanol

greenhouse gasOn January 12, 2017, USDA released a report on the lifecycle greenhouse gas (GHG) balance of corn ethanol, titled “A Life-Cycle Analysis of the Greenhouse Gas Emissions of Corn-Based Ethanol.”  The study reviewed industry and farm sector performance over the past decade and found that in the United States corn-based ethanol generates 43 percent less GHG emissions than gasoline.  Compared to previous studies, the lifecycle GHG benefits were greater due to improvements in corn production efficiency, conservation practices, and ethanol production technologies.  The report also presented two projected GHG emissions profiles for corn ethanol in 2022, with one assuming a continuation of observable trends and the other analyzing additional improvements that could further reduce the GHG emissions.

ARTICLE BY Lauren M. Graham, Ph.D. of Bergeson & Campbell, P.C.

©2017 Bergeson & Campbell, P.C.

Biomass Research And Development Initiative Provides Seven Projects With Up To $10 Million In Funding

On May 9, 2016, the U.S. Department of Energy (DOE), the U.S. Department of Agriculture (USDA), and the National Institute of Food and Agriculture (NIFA) announced the recipients of up to $10 million in funding through the Biomass Research and Development Initiative (BRDI). BRDI is a joint program through DOE and USDA that helps develop sustainable sources of biomass and increase the availability of biobased fuels and products. DOE selected two of the grant winners to receive between $1 million and $2 million: the Ohio State University (OSU) project is “Biomass Gasification for Chemicals Production Using Chemical Looping Techniques,” and the Massachusetts Institute of Technology (MIT) project is “Improving Tolerance of Yeast to Lignocellulose-derived Feedstocks and Products.”

USDA then selected five grant winners to receive a total of $7.3 million in funding:

  • University of California-Riverside, to convert poplar to ethanol and polyurethane via pretreatment and lignin polymer synthesis;

  • University of Montana, to quantify ecological and economic opportunities of various forest types and to quantify benefits of replacing fossil fuel with forest-based bioenergy;

  • North Carolina Biotechnology Center, to optimize production of educational resources on biomass sorghum production in the Mid-Atlantic region;

  • Dartmouth College, to overcome the lignocellulosic recalcitrance barrier; and

  • State University of New York College of Environmental Science and Forestry, to provide life cycle understanding for the production of willow and forest biomass to mitigate investment risk.

Article By Kathleen M. Roberts of Bergeson & Campbell, P.C.

©2016 Bergeson & Campbell, P.C.

USDA (U.S. Department of Agriculture) Finalizes Import Regulations for “Mad Cow Disease”

Varnum LLP

 

In November, the USDA announced a final rule that will align the Agency’s import regulations for bovine spongiform encephalopathy (BSE or “mad cow disease”)with international standards. According to a USDA November news release, the final regulation will allow for the safe trade of bovines and bovine product, while still protecting the U.S. from the introduction of BSE.

Michigan Senator Debbie Stabenow praised the new rule by stating, “I applaud USDA’s actions to make sure that American’s beef producers have access to new export markets…This effort is crucial to breaking down other countries’ unfounded trade barriers, and re-opening trade markets that are closed to U.S. beef. American agriculture has long set the gold standard food production. [These] actions will ensure U.S. beef producers can operate on a more level playing field and help grow our agriculture economy.”

 

Article by:

Aaron M. Phelps

Of:

Varnum LLP