Ag Law Weekly Review - October 31, 2019

Written by: 

Brook Duer —Staff Attorney

Audry Thompson—Research Assistant

           

The following information is an update of recent local, state, national, and international legal developments relevant to agriculture:

Industrial Hemp/Cannabis: USDA Releases Interim Final Rule for Domestic Hemp Production

On October 29, 2019, USDA publicly announced and released the text of its interim regulations governing domestic hemp production.  The interim final rule implements Section 10113 of the 2018 Farm Bill and various new sections of the Agricultural Marketing Act of 1946, which it amended. Once published in the Federal Register, the rule will be immediately effective and expire after two years.  In the meantime, there will be a 60-day comment period and thereafter USDA anticipates issuing its final rule.  The rule adds new part 990 (“Domestic Hemp Production”) to 7 CFR. As stated in the 2018 Farm Bill, states wishing to have primary authority over hemp production must have a USDA-approved hemp production plan. Subpart B of new part 990 outlines the mandatory components and the approval and amendment processes for a state plan, as well as containing material provisions of interest regarding acreage reporting to states and FSA, grower data sharing with USDA, hemp sampling and THC testing, disposal of “hot” plants, and annual inspections.  In the absence of a USDA-approved plan, Subpart C governs hemp production through the application and issuance a USDA-issued hemp producer license and its compliance requirements.  Subpart E contains a provision stating that no state may prohibit the transportation of hemp or hemp products through their state if legally produced under federal law.  The interim final rule does not address import/export of seed or plant material or extracts, nor does it address seed certification. Those issues remain unchanged as presently regulated.

WOTUS:  Lawsuits Challenge Repeal of 2015 WOTUS Rule 

After the October 22, 2019, EPA repeal of the 2015 WOTUS Rule and simultaneous reinstitution of the pre-existing WOTUS regulatory framework dating to the 1980s, immediate legal action was taken by at least two interest groups to challenge that action. 

• On October 22, 2019, the New Mexico Cattle Growers’ Association filed a lawsuit in New Mexico federal court claiming the reinstitution of the old regulatory framework was unconstitutional.  New Mexico Cattle Growers' Association v. U.S. Environmental Protection Agency et al., 1:19-cv-00988. The suit alleges, among other things, that: (a) the result of EPA’s action is an unconstitutional delegation of legislative authority to an agency; (b) the term “navigable waters” should be declared void for vagueness; (c) the former interpretation and application of navigable waters was already rejected by the U.S. Supreme Court in the 2006 Rapanos v. U.S. case. 
• On October 23, 2019, a collection of environmental groups filed a lawsuit in South Carolina federal court alleging that the repeal and reinstitution of the old rule violated the Administrative Procedure Act, and interpretative caselaw, in multiple ways and should be invalidated. South Carolina Coastal Conservation League, et al. v. U.S. Environmental Protection Agency, et al., 2:19-cv-03006. 

EPA’s repeal becomes effective December 23, 2019, and thus far no federal court has entertained or granted an injunction preventing the repeal from taking effect. 

Pesticides: EPA Proposes New Rule on Pesticide Application Exclusion Zone Requirements

On October 24, 2019, the U.S. Environmental Protection Agency (EPA) announced a proposed rule to be published in the Federal Register revising the Application Exclusion Zone (AEZ) requirements of the Worker Protection Standard (WPS).  The AEZ refers to the area around an on-going pesticide application that acts as a buffer zone to prevent unnecessary human contact with the pesticide.  According to EPA, the proposed changes would limit an AEZ to the boundaries of a farmer’s own property, provide exemptions for immediate family members, simplify criteria for determining whether a 100-foot or a 25-foot AEZ should apply, and clarifies when to resume an application that has been suspended due to human entry into the AEZ.  In the announcement and proposed rule, EPA points out that persons outside a farm’s boundaries are still protected by the existing rule’s “do not contact” provisions prohibiting pesticide contact with all known persons, within or outside property lines.  Once published, a 90-day comment period will commence.    

Food Labeling: FDA States Enforcement Stance on New Nutrition Facts Labeling

On October 23, 2019, food manufacturers received information from the U.S. Food and Drug Administration (FDA) regarding enforcement of the long-pending required amendment of  Nutrition and Supplement Facts Labeling (81 FR 33741) set to take effect for large manufacturers (total sales in excess of $10 million) on January 1, 2020.  In response to a September 30, 2019 letter from the Food & Beverage Issue Alliance (“Alliance”) requesting, among other things, a “six-month period of enforcement discretion,” FDA revised the compliance language on its webpage devoted to the new labeling to read: “During the first 6 months following the January 1, 2020, compliance date, FDA plans to work cooperatively with manufacturers to meet the new Nutrition Facts label requirements and will not focus on enforcement actions regarding these requirements during that time.”

Pesticides: EU Approves Ban of Another Neonicotinoid Harmful to Pollinators  

On October 22, 2019, the majority of European Union (EU) countries approved the proposal of the European Commission not to extend approval of the use of the pesticide thiacloprid after its current approval expires on April 30, 2020.  Thiacloprid is a neonicotinoid sold by Bayer CropScience under the brand name Biscaya, and has been linked to harm to pollinators.  A July 2019 EU notification to the World Trade Organization of the impending action also states that harmful effects on human health and groundwater cannot be ruled out.  According to Bloomberg News, Bayer CropScience submitted a letter to EPA in 2013 voluntarily canceling all its thiacloprid product registrations in the United States.  This is the fourth neonicotinoid to be banned for outdoor use in the EU. Thiacloprid use increased as a replacement for three previously banned neonicotinoids. Use of one remaining neonicotinoid, acetamiprid, is authorized in the EU but is characterized as relatively low toxicity.  

Farm Bill:  USDA, DOE Collaborate on Rural Energy Technology Development 

On October 25, 2019, U.S. Department of Agriculture (USDA) and U.S. Department of Energy (DOE) announced the execution of a memorandum of understanding (MOU) pursuant to Section 6501 of the 2018 Farm Bill to collaboratively promote investment in rural energy infrastructure and the development of energy-related technologies and manufacturing in rural and agricultural communities. An interagency working group is to be established to implement the MOU’s terms and prepare a yearly report of actions and projects.  This MOU results from the 2017 establishment of, and resulting report from, the Task Force on Agriculture and Rural Prosperity, which recommended the development of all sources of energy including renewable sources to bolster rural prosperity. 

From National Ag Law Experts:

Tiffany Dowell Lashmet, Livestock and Community Property (October 28, 2019) 

Brigit Rollins, Protecting the Nest: Court Upholds Protections for Sage Grouse (October 24, 2019)

Penn State Research:

Katie Bohn, One Avocado A Day Helps Lower 'Bad' Cholesterol For Heart Healthy Benefits (October 28, 2019)

Behrend Students Discover Invasive Shrimp Species in Lake Erie (October 22, 2019)

Pennsylvania Department of Agriculture:

“Wolf Administration Announces $500,000 Available to Improve Elementary School Access to Healthy, Local Foods” (October 24, 2019)

Pennsylvania Executive Agencies—Actions and Notices:

Department of Agriculture

“Program Requirements for the Agriculture and Youth Organization Grant Program” (October 26, 2019)

Department of Environmental Protection

“2020 Environmental Education Grants; Notice of Availability” (October 26, 2019)

“The Clean Streams Law and the Federal Clean Water Act: Applications for National Pollutant Discharge Elimination System (NPDES) Permits and Water Quality Management (WQM) Permits” (October 26, 2019)

“National Oceanic and Atmospheric Administration Performance Evaluation of the Pennsylvania Coastal Resources Management Program; Public Meeting and Availability of Public Comment Period” (October 26, 2019)

State Conservation Commission

“Action on Odor Management Plans for Concentrated Animal Operations and Concentrated Animal Feeding Operations and Volunteers Complying with the Commonwealth's Facility Odor Management Program” (October 26, 2019)

Susquehanna River Basin Commission

“Grandfathering Registration Notice” (October 26, 2019)

“Projects Approved for Consumptive Uses of Water” (October 26, 2019)

Pennsylvania Legislature

H.B.1085 “An Act repealing the act of June 22, 1935 (P.L.414, No.182), known as the State Personal Property Tax Act” Presented to Governor (October 29, 2019)

S.B.147 “An Act amending Title 34 (Game) of the Pennsylvania Consolidated Statutes, in Pennsylvania Game Commission, further providing for accountability; and, in hunting and furtaking, further providing for hunting on Sunday prohibited and for trespass on private property while hunting and providing for hunting on Sunday without written permission,” Re-reported as Committed (October 29, 2019)

House Agriculture and Rural Affairs Committee

H.B.918 “An Act repealing the act of May 20, 1857 (P.L.617, No.658), entitled ‘An act making an Appropriation from the State Treasury, in aid of the Farmers' High School,’” Committee Vote—Report Bill as Amended (October 23, 2019)

H.B.1223 “An Act providing for the creation of keystone opportunity dairy zones to facilitate the economic development of Pennsylvania's dairy industry; authorizing expenditures; providing tax exemptions, tax deductions, tax abatements and tax credits; creating additional obligations of the Commonwealth and local governmental units; and prescribing powers and duties of certain State and local departments, agencies and officials,” Committee Vote—Report Bill as Amended (October 23, 2019)

H.B.1224 “An Act amending the act of April 28, 1937 (P.L.417, No.105), known as the Milk Marketing Law, in purpose, short title and definitions, further providing for definitions and construction; in general powers of the board, providing for coordination with Department of Revenue; and, in prices of milk, further providing for cooperatives,” Committee Vote—Report Bill as Committed (October 23, 2019)

H.B.1775 “An Act amending the act of May 15, 1945 (P.L.547, No.217), known as the Conservation District Law, providing for legislative report,” Committee Vote—Report Bill as Amended (October 23, 2019)

Federal Executive Agencies—Actions and Notices:

Agricultural Marketing Service

“National Organic Program; Amendments to the National List of Allowed and Prohibited Substances per April 2018 NOSB Recommendations (Crops and Handling),” Final Rule (October 23, 2019)

“Reorganization and Transfer of Regulations; Correction,” Final Rule (October 23, 2019)

Animal and Plant Health Inspection Service

“Concurrence with OIE Risk Designations for Bovine Spongiform Encephalopathy,” Notice (October 25, 2019) 

“Request for Revision to and Extension of Approval of an Information Collection; Introduction of Organisms and Products Altered or Produced Through Genetic Engineering,” Notice (October 25, 2019)

Delaware River Basin Commission

“Notice of Public Hearing and Business Meeting; November 13 and December 11, 2019,”  Notice (October 29, 2019)

Environmental Protection Agency

“Thirty-Sixth Update of the Federal Agency Hazardous Waste Compliance Docket,” Notice (October 28, 2019)

“Renewable Fuel Standard Program: Standards for 2020 and Biomass-Based Diesel Volume for 2021, and Response to the Remand of the 2016 Standards; Supplemental Notice of Proposed Rulemaking,” Proposed Rule (October 28, 2019)

“Receipt of a Pesticide Petition Filed for Residues of Pesticide Chemicals in or on Various Commodities (September 2019),” Proposed Rule (October 28, 2019)

“Mandipropamid; Pesticide Tolerances,” Final Rule (October 28, 2019)

“Pesticide Product Registration; Receipt of Applications for New Uses (September 2019),” Notice (October 25, 2019)

“Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registrations and Amend Registrations To Terminate Certain Uses,” Notice (October 25, 2019)

“Sulfoxaflor; Pesticide Tolerances,” Final Rule (October 25, 2019)

“Pesticide Product Registration; Receipt of Applications for New Active Ingredients (September 2019),” Notice (October 25, 2019)

“Pesticide Program Dialogue Committee (PPDC); Notice of Charter Renewal,” Notice (October 25, 2019)

“Fenbuconazole; Pesticide Tolerances,” Final Rule (October 25, 2019)

“Proposed Reissuance of NPDES General Permit for Concentrated Animal Feeding Operations Located in Idaho,” Notice (October 23, 2019)

Fish and Wildlife Service

“Federal Fish and Wildlife Permit Applications and Reports-Migratory Birds,” Notice (October 28, 2019)

“Migratory Bird Harvest Information Program and Migratory Bird Surveys,” Notice (October 24, 2019)

“Endangered and Threatened Wildlife and Plants; Removal of the Interior Least Tern From the Federal List of Endangered and Threatened Wildlife,” Proposed Rule (October 24, 2019)

“Endangered Species; Receipt of Recovery and Interstate Commerce Permit Applications,” Notice (October 23, 2019)

Food and Drug Administration

“Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size,” Final Rule (October 28, 2019)

Food and Nutrition Service

“Supplemental Nutrition Assistance Program: State Agency Options for Standard Utility Allowances and Self-Employment Income,” Notice (October 25, 2019)

Food Safety and Inspection Service

“Changes to the Salmonella Verification Testing Program: Proposed Performance Standards for Salmonella in Raw Ground Beef and Beef Manufacturing Trimmings and Related Agency Verification Procedures,” Notice (October 28, 2019)

Partnerships and Public Engagement Office

“Advisory Committee on Beginning Farmers and Ranchers,” Notice (October 25, 2019)

U.S. House Agriculture Committee Actions: 

H.R.4885 “To amend Public Law 87-788 (commonly known as the McIntire-Stennis Cooperative Forestry Act; 16 U.S.C. 582a-7) to provide for equal treatment of the District of Columbia with respect to funds made available under that Act,” Introduced; Referred to House Committee on Agriculture (October 28, 2019)             

H.R.4881 “To amend the Federal Food, Drug, and Cosmetic Act to ensure that consumers can make informed decisions in choosing between meat products such as beef and imitation meat products, and for other purposes,” Introduced; Referred to Committee on Energy and Commerce and Committee on Agriculture (October 28, 2019)

H.R.4874 “To amend the Department of Agriculture Reorganization Act of 1994 to establish the Rural Innovation and Partnership Administration and to amend the Consolidated Farm and Rural Development Act to establish the Rural Future Partnership Fund to invest in the rural areas of the United States to achieve their preferred future while maximizing their contribution to the well-being of the United States, and for other purposes,” Introduced; Referred to Committee on Agriculture, Committee on Financial Services, and Energy and Commerce (October 28, 2019)

S.2107 “Protecting America's Food and Agriculture Act of 2019,” Referred to Committee on Homeland Security and Committee on Agriculture (October 28, 2019)

H.R.4820 “To amend the Department of Agriculture Reorganization Act of 1994 to provide assistance to manage farmer and rancher stress and for the mental health of individuals in rural areas, and for other purposes,” Introduced; Referred to House Committee on Agriculture (October 23, 2019)

H.R.4816 “To amend the Commodity Exchange Act to modify provisions relating to whistleblower incentives and protection, and for other purposes,” Introduced; Referred to Committee on Agriculture and Committee on Oversight and Reform (October 23, 2019)

H.R.4813 “To prohibit large platform utilities from being a financial institution or being affiliated with a person that is a financial institution, and for other purposes,” Introduced; Referred to Committee on Financial Services and Committee on Agriculture (October 23, 2019)

H.R.4642 “Community Broadband Mapping Act,” Referred to Subcommittee on Commodity Exchanges, Energy, and Credit (October 22, 2019)

U.S. Senate Agriculture, Nutrition, And Forestry Committee Actions: 

S.2692 “A bill to amend the Richard B. Russell National School Lunch Act to improve direct certification, and for other purposes,” Introduced (October 24, 2019)

S.2695 “A bill to authorize the Secretary of Agriculture to provide for the defense of United States agriculture and food through the National Bio and Agro-Defense Facility, and for other purposes,” Introduced (October 24, 2019)

S.2704 “A bill to amend the Department of Agriculture Reorganization Act of 1994 to establish the Rural Innovation and Partnership Administration and to amend the Consolidated Farm and Rural Development Act to establish the Rural Future Partnership Fund to invest in the rural areas of the United States to achieve their preferred future while maximizing their contribution to the well-being of the United States, and for other purposes,” Introduced (October 24, 2019)

Follow us on Twitter at PSU Ag & Shale Law (@AgShaleLaw) to receive AgLaw HotLinks:

“Map Shows How Food Gets from Farms to Your Home” (October 27, 2019)

“Sunday Hunting Bill Moves on in Pennsylvania Legislature” (October 25, 2019)

“Study Shows Risk of ASF Entered U.S. Has Doubled” (October 25, 2019) 

“Harnessing the Power of Data to Improve Agricultural Policy and Conservation Outcomes” (2019)

“Northeast Dairy Co-op to Dock Farmers for Overproduction” (October 24, 2019) 

“PepsiCo Leaning In on Sustainability Goals: ‘Companies Like Us No Longer Have a Choice’” (October 23, 2019) 

“NIFA Grants Help Fund Farmer Stress Network” (October 22, 2019)

“FDA Proposes Animal Antibiotics Go Behind the Counter” (October 22, 2019) 

“USDA Launches Economic Development Hubs” (October 22, 2019) 

“Rural & Ag Groups Reaffirm Opposition to STELAR” (October 22, 2019) 

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Agricultural Law Weekly Review: February 5, 2016

Written by M. Sean High – Staff Attorney

The following information is an update of recent, local, state, national, and international legal developments relevant to agriculture:

Litigation: PA Federal Judges Certifies Class Action against Egg Producers

On February 2, 2016, United States District Judge Gene E.K. Pratter of the United States District Court for the Eastern District of Pennsylvania granted a motion to certify a class action in a case involving an alleged conspiracy by the nation’s leading egg producers to inflate prices by limiting the supply of eggs (Case No. 08-md-2002).  Appointed as class representatives are T.K. Ribbing’s Family Restaurant, LLC; John A. Lisciandro d/b/a Lisciandro’s Restaurant; Eby-Brown Company; and Karetas Foods, Inc.

Labeling: FDA Bans Importation of GE Salmon

On January 29, 2016, the United States Food and Drug Administration (FDA) announced that the department will “not allow the introduction or delivery for introduction into interstate commerce of any food that contains genetically engineered salmon, until FDA publishes final labeling guidelines for informing consumers of such content (Import Alert 99-40).” The alert did not provide a timetable for the completion of the final labeling guidelines.

Biotechnology: New Monsanto Biotech Soybean Now Available

On February 3, 2016, Monsanto announced that the company had received import approval from China for Roundup Ready 2 Xtend soybeans. The Roundup Ready 2 Xtend soybeans are genetically modified to be tolerant to both glyphosate and dicamba herbicides, and as a result China’s import approval, will now be made “available in the United States and Canada in time for the 2016 season.”

International: China Seeks to Modernize Farm Policy

On February 4, 2016, the International Center for Trade and Sustainable Development reported that China appears to be shifting its agricultural industry towards a modern, market-base system.  Specifically, according to the report, there appears to be a movement towards “the reform of the maize purchasing and storage system, [to] reflect market supply and demand in corn prices.” Additionally, the report stated that “[w]hile the timing and specifics of the new approach remain unclear…Beijing was believed to favour making compensation payments to farmers when prices fell short of a target price, instead of purchasing stocks to support prices when these fell below a pre-established floor.”

Research: USDA Awards over $30 Million for Research Projects

On February 3, 2016, the United States Department of Agriculture (USDA) announced that the department had awarded “$30.1 million in competitive grants to fund 80 research projects to improve food safety, reduce antibiotic resistance in food, and increase the resilience of plants in the face of climate change.”  According to USDA Secretary Tom Vilsack, the research funding was necessary because “[i]n the face of diminishing land and water resources and increasingly variable climatic conditions, food production must increase to meet the demands of [a] world population projected to pass 9 billion by 2050.”

Regulatory Update: FDA Approves Genetically Engineered Chicken

Written by M. Sean High – Staff Attorney

On December 8, 2015, the U.S. Food and Drug Administration (FDA) approved a genetically engineered (GE) chicken designed to produce eggs to be used in the manufacturing of a drug intended to treat the human enzyme disease lysosomal acid lipase deficiency (LAL-D).

LAL-D is a rare (and potentially fatal) disease that causes the build-up of fats within the tissue cells of multiple organs including the heart, liver, and spleen.  According to the pharmaceutical manufacturer Alexion Pharmaceuticals Inc. (Alexion), when LAL-D is present in infant patients (known as Wolman disease) there is currently a nearly 90% mortality rate; when LAL-D is present in pediatric and adult patients (known as cholesteryl ester storage disease) “with a clinical biopsy assessment, nearly 50% progress to fibrosis, cirrhosis, or liver transplant within 3 years of symptom onset.” Consequently, Alexion sought FDA approval for Kanuma, the company’s enzyme replacement therapy drug designed to combat LAL-D. 

Under Alexion’s manufacturing of Kanuma, GE chickens are raised so as to “produce a recombinant form of human lysosomal acid lipase (rhLAL) protein in their egg whites.” In turn, the rhLAL egg whites are to be purified and refined into the LAL-D fighting drug Kanuma.

FDA stated that the GE chickens and their eggs do not pose a human health risk because neither will be permitted to enter the food supply.  Importantly, FDA noted that their approval will “not cause a significant impact on the environment, because the chickens are raised in highly secure facilities. 

Vermont Farm Agrees to Settlement with DOJ Regarding Tainted Animals Sold for Human Consumption

M. Sean High – Staff Attorney

One day after the Department of Justice (DOJ) filed a complaint for permanent injunction to prevent a Vermont dairy farm’s use of unauthorized animal drugs in animals sold for human consumption, the parties filed an agreed upon settlement.

On December 7, 2015, on behalf of the United States of America, DOJ filed a complaint in the United States District Court for the District of Vermont requesting a permanent injunction against Correia Farm Limited Partnership for allegedly violating the Federal Food, Drug, and Cosmetic Act (FDCA) by administering unapproved new animal drugs which resulted in unsafe drug residue levels in animals slaughtered for human consumption.   

On December 8, 2015, the parties filed a settlement consent decree for permanent injunction.  As part of the settlement, Correia Farm Limited Partnership agreed to a heightened level of Federal Drug Administration (FDA) oversight and scrutiny of their operation and to cease operations until the implementation of FDA approved “record-keeping and operational protocols designed to ensure consumer safety.” Significantly, Correia Farm Limited Partnership agreed not to resume food production (excluding milk) until an FDA determination that the operation’s manufacturing practices have come into compliance with the law.  

The agreed upon consent decree for permanent injunction now awaits judicial approval from the U.S. District Court for the District of Vermont.

Sugar Companies and Corn Refiners Settle Lawsuit

Written by M. Sean High - Staff Attorney

On November 20, 2015, less than one month into a trial that pitted sugar companies against corn refiners, parties announced a settlement had been reached.  The lawsuit in question involved the advertisement of various health claims relating to high fructose corn syrup.  According to the parties, the terms of the settlement agreement are confidential.

In 2011, sugar companies brought suit against the Corn Refiners Association for using advertisements that referred to high fructose corn syrup as “corn sugar” and “natural.” Furthermore, the sugar companies disputed those advertisements that claimed high fructose corn syrup was “nutritionally the same as table sugar.”

According to the sugar companies, sugar and high fructose corn syrup are distinct products and any advertisement to the contrary is false and misleading.  The sugar companies claimed that this false advertisement resulted in damages in excess of $1.1 billion.  Relatedly,  in 2012, the Food and Drug Administration issued a ruling denying the Corn Refiners Association petition to use “corn sugar” as an alternate name for high fructose corn syrup.

In a joint statement announcing the settlement agreement, the parties expressed that they will “continue their commitments to practices that encourage safe and healthful use of their products, including moderation in the consumption of table sugar, high fructose corn syrup and other sweeteners.”

FDA Refuses to Mandate GMO Labeling

Written by Stephen Kenney

On November 19, 2015, the Food and Drug Administration (FDA) refused to consider labeling of biotechnology foods.  The decision came via the denial of a petition filed by the Center for Food Safety.  The Center for Food Safety is a non-profit public interest and environmental advocacy organization.

The Center for Food Safety requested that FDA “require that foods that are genetically engineered organisms, or contain ingredients derived from genetically engineered organisms – collectively referred to as ‘Foods derived from GE sources’ be labeled under the Federal Food, Drug, and Cosmetic Act (FD&C Act).”  The letter asserted that FDA was required to mandate labeling under FD&C Act.

FDA did not find sufficient evidence in the petition to give the agency reason to deviate from its current policy of not mandating labeling.  The petition did not convince the FDA that genetically engineered plants as a class “differ from foods derived from non-GE plant varieties in any meaningful or uniform way, or that as a class, such foods present any different or greater safety concerns than foods developed by traditional plant breeding.”   FDA emphasized that GE breeding and traditional plant breeding are not radically different and both fall under the umbrella term of “genetic modification.”  Ultimately the FDA said that it is the final food product that is regulated not the process by which it is produced.  According to FDA, the final product from the genetic engineering process is not different in terms of safety from the traditional plants.

FDA did acknowledge that consumer’s may have an interest in labeling GMO foods, but that consumer interest alone “does not provide a sufficient basis to require labeling disclosing whether a food has been produced with or without the use of such genetic engineering.”  According to FDA, without sufficient basis, the agency could not compel manufacturers to label their products.  

FDA Releases New Voluntary Labeling Guidance for GE Food

Written by Tyler R. Etter

On November 19, the Food and Drug Administration (FDA) released two new guidance documents for genetically engineered (GE) plants and animals for use as food. One document is the finalized guidance on labeling food to indicate if food has or has not been derived from GE plants. The other document is draft guidance on voluntary labeling indicating if food has or has not been derived from GE Atlantic salmon.

The first document, pertaining to plant-derived food products, is meant to assist food and feed manufacturers that wish to apply labels to their products. The FDA’s primary concern is that any label is truthful and not misleading. For foods that do not use GE derived foods, labeling such include a statement in a context that clearly refers to bioengineering, such as “Not bioengineered” or “Not genetically engineered”, among other possibilities. Foods that are derived from GE products must have statements such as “Genetically engineered” or similar declarations. The FDA does not encourage the use of “GMO” or “genetic modification” as such claims are very broad, and encompass a wide variety of alterations, including natural breeding methods.

The second document, pertaining to food derived from GE Atlantic salmon, was released in conjunction with the approval of AquAdvantage Salmon, a GE Salmon from AquaBounty Technologies. The guidance recommends labeling standards similar to the GE plant guidance, with clear context for the labeling directly stating an association or lack thereof with bioengineering.

The new guidance documents are merely recommendations, and are not binding on the FDA or the public. The commenting period on both documents opens on November 24, 2015, and closes after 60 days. Comment for the plant guidance can be made here, and comment for the GE Salmon guidance can be made here.

FDA Issues New Food Safety Rules

Written by Katharine Richter

On November 13, 2015, the United States Food and Drug Administration (FDA) finalized new rules updating the bipartisan Food Safety Modernization Act (FSMA).  The new rules will “establish enforceable safety standards for produces farms and make importers accountable for verifying that imported food meets U.S. safety standards.”  A rule was also established that created third-party certification bodies which will perform food safety audits in foreign food facilities.

The three rules released are “referred to as the Produce Safety rule, the Foreign Supplier Verification Programs rule, and the Accredited Third-Party Certification rule.”  The stream of recent foodborne illnesses that have occurred over the last few years highlighted to the FDA the need for updates to food safety rules.

The Produce Safety rule “establishes science-based standards for growing, harvesting, packing, and holding produce” which are designed to minimize risk of illness when consuming contaminated produce.  The Foreign Supplier Verification Programs rule requires food importers in the U.S. that have received imported foreign foods, that these foods are meeting U.S. safety standards and meet the same standards of food safety as domestic farms.  The importers are required to conduct various verification activities.  The Accredited Third-Party Certification creates a program where “third-party certification bodies…conduct food safety audits and to certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.”

FDA Approves Genetically Engineered Salmon

Written by Stephen Kenney

On Thursday November 19^th, U.S. health regulators decided that AquAdvantage salmon is as safe to eat as any non-genetically engineered (GE) Atlantic salmon.  This approval was the first such approval for an animal whose DNA had been scientifically modified.  The FDA also will not require companies to label the genetically modified food.

AquAdvantage Salmon is a product of AquaBountyTechnologies.  The AquAdvantage Salmon are Atlantic salmon that reach market size more quickly than non-GE farm-raised Atlantic Salmon.  AquaBounty claims that the salmon can grow to market size in half the time required for conventional salmon.  The genetically modified fish is an Atlantic salmon with a Pacific salmon gene for faster growth and a gene from the eel-like ocean pout that promotes year round growth.

Five years ago, the U.S. Food and Drug Administration (FDA) first began the evaluation of GE salmon.  The Salmon can only be raised in land-based hatchery tanks in two specific facilities that are located in Canada and Panama.  The FDA ultimately approved the safety of the fish because the data demonstrated that the “inserted genes remained stable over several generations of fish, that food from the GE salmon is safe to eat by humans and animals, that the genetic engineering is safe for the fish, and the salmon meets the sponsor’s (AquaBounty) claim about faster growth.”  The FDA also assessed the environmental impacts of the fish and found that there would not be a significant impact on the environment because of the containment measures that will be put into place at the hatcheries.  The agency also found that there is not a risk of the fish reproducing with wild fish because the GE fish are sterile.

Activist groups and grocers are not convinced that the GE fish is a safe alternative.  Activist groups are concerned that the genetically modified food may pose a risk to the environment or public health.  Kroger, a national grocery chain, said that it has “no intention of sourcing or selling genetically engineered salmon.”  Trader Joe's and Whole Foods Market Inc. also do not intend to carry the modified fish.

Food Groups Petition for FDA Rule Change for Breaker Eggs

Written by Katharine Richter

On September 29, 2015, The National Chicken Council (NCC), Grocery Manufacturers Association (GMA), and Association for Dressings and Sauces (ADS) wrote a petition to the Food and Drug Administration (FDA) asking “to amend the Final Rule on Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation, published July 9, 2009 [74 FR 33030].”

The rule requires that any eggs being sent to breaking facilities, which will eventually be pasteurized, must be “kept at 45 degrees F within 36 hours after being laid.”  The NCC originally challenged the rule when it was being proposed in 2010 because the FDA never explained the additional health benefits from requiring the refrigeration and the petition argues there is “no additional food safety value.”  The refrigeration requirements effectively made broiler hatcheries dispose of all excess eggs, which the NCC estimated was around 365 million eggs last year.  Prior to the rule, broiler hatcheries could sell excess eggs they had due to fluctuating market demands.  The excess eggs were sold as “breaker eggs” (eggs broken and sold in liquid form).  With the enactment of the rule, the broiler farms could not sell the excess eggs because they failed to meet the refrigeration requirements.

The petition comes at a time when egg prices have “more than doubled in the period following the HPAI outbreak.”  Many companies have felt the price increase.  The petition states that, “Industry experts estimate that the price of a dozen breaker eggs rose dramatically from 63 cents in late April to $2.15 in early June.”  The petition argues changing the rule to either make breaker eggs exempt from the refrigeration requirement or increasing the refrigeration requirement to 120 hours after being laid, would help meet market demands and stop the need to import eggs from other countries.

Study Uses GE Plants to Eliminate E. coli in Food Products

 Written by Katharine Richter

On September 8, 2015, The Proceedings of the National Academy of Sciences published a study online titled, “Broad and efficient control of major foodborne pathogenic strains of Escherichia coli by mixture of plant-produced colicins.”  The study advocates that colicins, which are nonantibiotic antimicrobial proteins that “kill or inhibit the growth of other competing E. coli strains,” could be used to effectively mitigate the risk of E. coli in meat and produce.

The study states E. Coli. “is one of the leading cause of bacterial enteric infections worldwide, cause ~100,000 illnesses, 3,000 hospitalizations, and 90 deaths annually in the United States alone.”  According to the study, the only effective method currently to eliminate E. coli in meat and produce is to use thermal inactiviation, but the cost of using this method is it negatively affects both the taste and quality of the food. 

The study results show that using a spray mixture of colicins from plants that have been genetically modified and are able to “demonstrate very high levels of colicin expression,” such as tobacco and edible plants such as spinach, drastically reduced E. coli bacteria on meat.   

If the plant-produced colicins spray mixture is to be used for commercial use in the U.S., it will need to be approved by the Food and Drug Administration (FDA) as generally recognized as safe (GRAS).  

FDA Issues Nutrition Labeling Draft Guidance For Restaurants

Written By Katharine Richter

On September 11, 2015, the Food and Drug Administration (FDA) released a draft guidance titled “A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11).”

According to the draft guidance document, “section 4205 of the Patient Protection and Affordable Care Act amended 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343 (q)(5)(H)) to require that restaurants and similar retail food establishments . . . provide calorie information for standard menu items.”

The guide was issued to assist restaurants in complying with the final rule published by the FDA December 1, 2014, which requires standard menu items to have the nutrition content labeled.  According to the guidance document, “the rule is codified at Title 21 of the Code of Federal Regulations at § 101.11 (21 CFR § 101.11).”  The rule applies to restaurants and similar retail establishments that have 20 or more locations operating under the same name with similar menu items.  This includes bakeries but will not include food trucks, schools, prisons, trains, and a few other exceptions mentioned in the draft guidance.

The guidance document describes what is defined as a ‘covered establishment’ under the act and the expected nutritional labeling requirements and how to implement the changes.  The draft offers nonbinding recommendations and the FDA is accepting comments to better clarify sections that may still contain ambiguities and questions.

Food Group Seeks Continued Use of Artificial Trans Fats

On August 5, 2015, the Grocery Manufacturers Association (GMA) petitioned the United States Food and Drug Administration (FDA) to allow the continued use of partially hydrogenated oils (PHOs) for food products in specific low-levels.

The petition comes as a response to the FDAs June 16, 2015 regulatory change of PHO, removing it from the designation of “generally recognized as safe” (GRAS) for use in human food, to making PHO a food additive.  Under the food additive designation, each product containing any level of PHOs would need to be petitioned and approved by the FDA.  The FDA is giving manufacturers three years to phase out the ingredient, by June 18, 2018, or to petition the FDA for approval. 

In the submitted petition, GMA states that low-level use of PHOs meet the requirements for "GRAS” foods and that low-level use of PHOs is as safe as naturally occurring trans fats which are in beef, milk and other dairy products.  According to the petition, trans fat can make up 1.5% of an individual’s caloric intake without affecting cholesterol levels. 

If the FDA were to approve the low-level use of PHOs as “GRAS,” any product below the recommended levels would not be required to submit a petition and obtain approval by the FDA.

Written by Katharine Richter - Research Assistant

August 6, 2015

Raw Milk Update: FDA Releases Risk Assessment of Cheese Produced from Raw Milk

On July 31, 2015, the Food and Drug Administration, in conjunction with Health Canada, released a risk assessment for soft-ripened cheeses produced from raw milk. The assessment was focused on the risk of contracting listeriosis by consuming the products.

Listeriosis is caused by Listeria monocytogenes, a pathogen that is frequently found in agricultural and food processing environments. Listeriosis generally affects the digestive tract, but can also spread to other parts of the body, known as “invasive listeriosis”. Those most at-risk for the disease are the elderly, pregnant women, children, and individuals with compromised immune systems.

In the risk assessment, the risk of contracting listeriosis was conducted on a per-serving basis of a Camembert-like soft-ripened cheese, with a comparison between the use of pasteurized and non-pasteurized milks in the production of the cheese. The assessment also focused on different production methods, such as the aging period and intervention techniques to reduce the risk of contracting listeriosis. The current standard is a 60-day aging period, but the FDA is considering the benefits of a performance standard in its place.

The risk assessment had already received criticism during the draft phase in 2013. Both U.S. and French cheese associations have called the assessment flawed, and are concerned that the assessment will cast doubt on all cheeses produced from raw milk, including hard cheese.

The FDA is currently requesting additional comments and data as a response to the assessment. The full risk assessment can be read here.

Written by Tyler R. Etter- Research Assistant
August 3, 2015

FDA Comment Period Opens for Proposed Added Sugar Labeling

On July 27, 2015, the Food and Drug Administration (FDA) opened the comment period for a proposed rule update that would require Nutrition Facts labels to include percent daily value (% DV) for added sugars.

The FDA, on their webpage, claim adding the information to the label will allow consumers to make more informed choices.  According to FDA, “Americans get 16 percent of their total calories from added sugars.”  Following recommendations from the 2015 Dietary Guidelines for Americans and other expert groups such as the American Heart Association, the FDA wants to encourage Americans to cut down on added sugars because they provide “no additional nutrient value” and cause individuals to “eat less nutrient rich foods.” 

In a study conducted by the FDA to see how the proposed labeling would affect consumers, the majority of participants were able to correctly identify the amount of sugars in a serving when it included an added sugars declaration.  When there was a high amount of added sugar, high amount being dependent on the food, there was a trend towards having “more negative judgments on the product’s healthfulness.” 

The Sugar Association on their online blog commented on the proposed rule as being “based on the limited and weak scientific evidence found in the 2015 Dietary Guidelines report.”  The association declared they plan to oppose the proposal.

Written by Katharine Richter - Research Assistant

July 27, 2014

Senate Committee on Appropriations Approves GE Salmon Labeling

On July 16, 2015, the Senate Committee on Appropriations approved the Fiscal Year 2016 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill. The bill received bipartisan support, which would appropriate $148.3 billion for agricultural and rural development, as well as food safety, public health, and nutrition programs.

The bill covers a wide variety of issues, but one amendment to the bill may prove to be very controversial. Senator Lisa Murkowski (R-AK) introduced an amendment to the bill that would require the FDA to spend “not less than $150,000…to implement a requirement that the labeling of genetically engineered salmon offered for sale to consumers indicate that such salmon is genetically engineered…” Sen. Murkowski assured her colleagues that the labeling would not set precedent for the labeling of bioengineered crops, claiming “[c]orn doesn’t swim from one field to the next…Fish move. Fish escape.”

Although the bill passed with a vote of 28-2, it is important to note that Sen. Murkowski’s amendment was unanimously accepted. A press release summarizing the highlights of the bill can be read here. The full text of the bill can be found here.

Written by Tyler R. Etter- Research Assistant
July 17, 2015

Executive Memorandum Issued Ordering Modernization of Biotechnology Regulations

  On July 2, 2015, the White House issued an executive memorandum directed towards the FDA, EPA, and USDA, requiring modernization of their biotechnology regulations.

  The order states the existing regulations adequately protect health and safety, but there are “…in some cases, unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of timeframes for review, and other processes…”  These uncertainties have created difficulties for both small and mid-sized companies as well as the public to understand the regulatory process and food safety.  The memorandums objective is to ensure public confidence and prevent “unnecessary barriers to future innovation and competitiveness by improving transparency, coordination, predictability, and efficiency of the regulation of biotechnology products…”  

  The memorandum requires an updated federal Coordinated Framework for the Regulation of Biotechnology (CF) within a year of the memorandum issue date.  The CF provides the outline for the federal regulatory policy that ensures the safety of biotechnology products.  Updating the CF could clarify each agency’s role in biotechnology regulation as well as create a long-term strategy to ensure inadequacies in the current system are addressed.

  The group responsible for updating the CF will be a “new Biotechnology Working Group under the Emerging Technologies Interagency Policy Coordination Committee (ETIPC).”  The Working Group will have representatives from the Executive Office of the President, EPA, FDA, and the USDA.    Further, the EPA, FDA, and USDA are required to have an external, independent analysis of “the future landscape of biotechnology” every five years in order to make informed policy decisions due to biotechnology products and processes rapid changes.

Written by Katharine Richter - Research Assistant

July 3, 2015