Tag: USDA

USDA To Declare Salmonella An Adulterant in Some Raw Poultry

  • On August 1, the USDA’s FSIS announced that it will declare Salmonella an adulterant in breaded and stuffed raw chicken products. Breaded and stuffed raw chicken products will be considered adulterated when they exceed 1 colony forming unit (CFU) of Salmonella per gram. Products that exceed the limit would be subject to regulatory action. FSIS believes the limit of 1 CFU/gram will significantly reduce the risk of illness from consuming such products.
  • Breaded and stuffed raw chicken products have been associated with up to 14 food safety outbreaks and approximately 200 illnesses since 1998. The products at issue are those found in the freezer section and that appear to be cooked, but are only heat-treated to set the batter or breading; the products contain raw poultry. FSIS has found that continual efforts to improve product labeling have not reduced consumer illnesses.
  • FSIS is expected to publish a notice in the Federal Register in the fall and will be seeking public comments on whether a different standard for adulteration (i.e., zero tolerance or one based on specific serotypes) would be more appropriate, an implementation plan, and a verification testing program.
  • This announcement is part of FSIS’ effort to reduce Salmonella illnesses associated with poultry. In October 2021, USDA announced that it was reevaluating its Salmonella control strategy. USDA plans to present a proposed framework for a new comprehensive strategy to reduce Salmonella illnesses attributable to poultry in October and convene a public meeting to discuss in November.

Article By The Food and Drug Law Practice Group at Keller and Heckman LLP

For more biotech, food, and drug legal news, click here to visit the National Law Review.

© 2022 Keller and Heckman LLP

Intellectual Property Consolidation in the Agriculture Industry

Ever since agencies around the world such as the USPTO, USDA, and Union for the Protection of New Varieties of Plants (UPOV) have started recognizing and enforcing intellectual property rights relating to plants, there has been a slow yet massive consolidation in global seed markets.  This article discusses a brief history of how intellectual property rights and lax antitrust enforcement in the seed industry created one of the largest industry consolidations and how the current Administration seems to be taking steps in the right direction.

Intellectual Property in the Agriculture Industry

In 1930, the United States began granting plant patents and the USPTO issued the first plant patent in 1931 for a rose.  The UPOV is an international organization that was founded in 1961 to acknowledge and make available exclusive property rights for breeders of new plant varieties in all member states to the UPOV Convention. The U.S. Plant Variety Protection Act (PVPA) was enacted by Congress in 1970 to encourage the development of new varieties and to make them available to the public.  The Plant Variety Protection Act established in the Department of Agriculture an office to be known as the Plant Variety Protection Office.  These regulations are all very important for the protection and continued innovation of certain varieties of crops and plants.  However, when genetically modified seeds were introduced in 1996, seed companies began to take advantage of these protections and began to invest heavily in amassing as many seed-related IP rights as they could.  As these companies have merged and acquired smaller businesses, they remove competition from the industry, harming farmers, families, and consumers.

There are many ways that companies protect intellectual property in the agricultural industry.  For example, companies file for utility patents to protect a wide variety of plant-related inventions, such as breeding methods, plant-based chemicals, plant parts, and plant products. Plant patents are unique to the United States and provide protection to any distinct and new variety of plant that has been asexually reproduced, other than a tuber-propagated plant or a plant found in an uncultivated state.  Plant Variety Protection certificates, which are similar to plant patents, provide certain exclusive rights to breeders of any new, distinct, uniform, and stable sexually or asexually reproduced or tuber-propagated plant varieties.  Other rights, known as Breeders’ Rights, exist in other countries outside the United States and are very similar to the Plant Variety Protection regulations.  These protections generally last for 20 years from the date of filing and, according to the World Intellectual Property Organization, the patent owner has the right to decide who may – or may not – use the patented invention for the period in which the invention is protected.

The Key Players in the Agriculture Industry

Monsanto was a multinational agricultural biotechnology corporation founded in 1901 and based in the United States.  In 1970, Monsanto scientist John Franz discovered that glyphosate was an herbicide and quickly patented it as such.  In 1974, Monsanto brought the patented glyphosate herbicide to the market using the tradename “Roundup.”  In 1996, Monsanto created the first genetically engineered (GE), glyphosate-resistant crop, causing Roundup-resistant soybeans to be planted commercially throughout the United States.  By 1998, glyphosate-resistant corn was available on the market, and Monsanto became the largest supplier of these new GE, “Roundup-Ready” seeds.  This was such a breakthrough in the agriculture industry that in 2003, Roundup-Ready seeds accounted for about 90% of the genetically modified seeds planted around the globe.

As with many industries, the agriculture industry has those companies that are at the top and those that are not.  The agriculture industry’s “Big Six” companies—Monsanto, DuPont, Syngenta, Dow, Bayer, and BASF—turned into the “Big Four”—ChemChina, Corteva, Bayer, and BASF— after a series of mergers and acquisitions that took place in the last decade with very little oversight from some of the antitrust authorities in the United States and around the world.  As a result of these mergers, the “Big Four” companies now control around 60% of the proprietary seed in the world market.

The Consolidation of the Seed Industry

Dr. Phil Howard from Michigan State University discussed the tremendous consolidation of the commercial seed industry in one of his first publications, 2009’s Visualizing Consolidation in the Global Seed Industry: 1996-2008.  Dr. Howard describes how the hybrid-seed corn industry of 1930, the enforcement of patent-like protections, and especially the commercialization of fully patent-protected transgenic, genetically engineered seeds in the mid-late 1990s triggered a wave of consolidation in the agricultural industry.  To make matters worse, when these companies consolidated and amassed massive intellectual property portfolios, it was not uncommon for seed rights to be bundled with other inputs to protect profits in other, agrochemical divisions.  For example, as Dr. Howard details in Visualizing Consolidation, in order to use Monsanto’s herbicide-tolerant transgenic seed, farmers are required to also use Monsanto’s proprietary glyphosate herbicide, rather than a generic herbicide.  Essentially, if you were buying Roundup-Ready seed, you were buying Roundup herbicide, and if you were using Roundup herbicide, it was probably a good idea to buy Roundup-Ready seed.  This type of competitive business practice is one that eventually creates a multitude of problems for smaller, independent businesses, breeders, and farmers.

Antitrust and Anti-Competition in America

Antitrust laws are not a new concept in American society.  Antitrust laws are statutes and regulations that are designed to promote the overall competition in the market by promoting free, open, and competitive markets.  Congress passed the first antitrust law in 1890 when it wrote the Sherman Act, which made it illegal for companies to enter into agreements to compete with one another, resulting in price fixing and monopoly power.  Several years later, in 1914, Congress passed the Clayton Act and Federal Trade Commission Act to protect American consumers by giving the Federal Trade Commission (FTC) and the Department of Justice (DOJ) the authority to oversee and review mergers and acquisitions that are likely to stifle competition.  Under the Hart-Scott-Rodino Act, the FTC and DOJ review most of the proposed transactions that affect commerce in the United States and either agency can take legal action to block deals that it believes would “substantially lessen competition.”

While these laws are all beneficial in theory, their implementation in the agricultural industry has been lacking to say the least.  According to a study in 2018, Bayer alone is estimated to control 35% of corn seed, 28% of soybean seed, and 70% of cottonseed in the global market!  Even more alarming may be the USDA’s 2014 report citing concerns that glyphosate-resistant crops have become ubiquitous with American agriculture with 93% of soybeans, 85% of corn, and 82% of cotton planted being genetically modified to be glyphosate-resistant.  The herbicides that are used to combat the weeds surrounding the crops, in many cases, are supplied by the same company that provides the seeds.

Promoting Competition in the Agriculture Industry

It has been almost a century since the first antitrust laws were enacted, and yet the problem of corporate consolidations remains in many industries across America.  On July 9, 2021, the Biden Administration signed an executive order aimed to promote competition within various industries in the United States.  The order includes 72 initiatives by more than a dozen federal agencies to promptly tackle some of the most pressing competition problems across our economy.  According to the Administration, this order is a “whole-of-government” approach to drive down prices for consumers, increase wages for workers, and facilitate innovation. This was a major step in the right direction to weaken the power that major businesses have obtained as a result of corporate consolidation in industries like healthcare, technology, transportation, and especially agriculture.

This Executive Order also established the White House Competition Council to drive forward the Administration’s whole-of-government effort to promote competition.  On September 10, 2021, the Competition Council held its inaugural meeting to discuss promoting pro-competitive policies and new ways of delivering concrete benefits to America’s consumers, workers, farmers, and small businesses.  During the meeting, the heads of the Department of Health and Human Services, the Department of Transportation, the Department of Justice, the United States Department of Agriculture, and the Federal Trade Commission briefed the council members on their efforts to implement the directives of the Executive Order.

The Challenge of Facing the Consolidated Agriculture Industry

According to an October 20, 2021 report by Thomson Reuters, Tom Vilsack, the U.S. Secretary of Agriculture, said that the Biden Administration plans to take a hard look at the consolidation of the seed industry and figure out “why it’s structured the way it’s structured” and “whether these long patents make sense.”  The White House Competition Council is certainly faced with a difficult challenge to parse through both anti-competition law and intellectual property law.  For centuries these bodies of law have caused great debate.  One body of law restricts monopolization wherein the later grants monopolistic opportunities.

There is no doubt that any changes to the current seed industry scene would shake things up.  But what exactly would that look like?  Are we going to see the “Big-4” morph into another, new identity?  Are changes to the patent law system likely?  Whatever happens, the agriculture industry will likely pay close attention to the actions of the White House Competition Council over the next couple months.

Article By Reinier R. Smit of Summa PLLC

Copyright 2021 Summa PLLC All Rights Reserved

USDA Certified Organic Ciders: One of a Kind?

Anheuser-Busch introduced its Michelob Ultra Organic Seltzer last month, advertising the beverage as the “First-of-its-kind organic option to the hard seltzer category,” “First USDA-certified organic seltzer,” “First National USDA Certified Organic Hard Seltzer,” and “First-ever national USDA certified organic hard seltzer.” Anheuser-Busch even aired commercials during the nationally televised, highly viewed NFL Division Championship games, along with the Super Bowl that took place on Sunday, February 7. But now the question before an Oregon Court is whether these advertisements imply that it is the first and only kind in the country.

USDA Certified Organic Ciders

Suzie’s Brewery Company brews and packages Organic Hard Seltzer in Pendleton, Oregon. Suzie’s Brewery first launched its product line in July 2020 after obtaining its national organic certification from the USDA’s National Organic Program in June 2020. This program grants businesses the right to display the “USDA Organic” seal on their products should the business meet specific national standards. It also allows certified businesses to represent in advertising that their products have received national USDA organic certification. While most alcoholic beverages are regulated by the Federal Tax and Trade Bureau (“TTB”), and sugar fermented seltzers by the Food and Drug Administration (“FDA”), the USDA governs any food or beverage products that bear the “organic” label.

On February 2, 2021, Suzie’s Brewery sued Anheuser-Busch for false advertising and filed a motion for a temporary restraining order that would keep it from airing ads that Suzie’s Brewery claims are false. “Suzie’s Seltzer also has a national USDA organic certification, and was available on the market well before ULTRA Seltzer,” argued the attorney for Suzie’s Brewery, “In addition, there are several other hard seltzer brands on the market that have USDA organic certification.” Suzie’s Brewery further claims multiple consumers and product distributors contacted them regarding the Michelob Ultra Organic Seltzer advertisements, confused about it being the “first” or “only” USDA Organic certified seltzer. Others questioned the veracity of Suzie’s Brewery and their seltzers being USDA Certified organic, since Anheuser-Busch had claimed to be the “only” one on the market.

One of a Kind?

“Using the bully-pulpit its massive national advertising budget allows, Anheuser-Busch has premiered a new false and misleading advertising campaign aimed at convincing health-conscious drinkers that its new organic hard seltzer is a unique, one-of-a-kind product. To be clear, it is not,” Suzie’s Brewery stated, “and Anheuser-Busch will continue to pursue its strategy of unfairly squeezing out its smaller competitors in the organic hard seltzer market (like Suzie’s Brewery) unless this court puts a stop to its misconduct.”

On February 9, 2021, Judge Michael H. Simon of the United States District Court for the District of Oregon granted the temporary restraining order requiring Anheuser-Busch to immediately stop falsely claiming that its product – Michelob ULTRA Organic Hard Seltzer – is the only or first national USDA certified organic hard seltzer on the market. “It is false for Anheuser-Busch to say this,” the judge said, “because Suzie’s Organic Hard Seltzer is certified organic under the USDA’s National Organic Program and was certified under the national program before Michelob Ultra was.” This temporary restraining order will remain in effect until June 2, 2021, when Judge Simon is scheduled to rule on a motion for preliminary injunction filed by Suzie’s Brewery.

©2020 Norris McLaughlin P.A., All Rights Reserved
For more, visit the NLR Corporate & Business Organizations section.

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