Agricultural Law Weekly Review—January 26, 2017

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:

Federal Regulations: President Issues Freeze on New and Pending Regulations

On January 20, 2017, Reince Priebus, Assistant to the President and Chief of Staff, issued a Memorandum on behalf of the President placing a freeze on any new or pending federal regulations.  First, the memorandum stated that no new regulations may be sent to the Office of the Federal Register (OFR) until an agency or department head appointed by the President reviews and approves the regulation.  Second, any regulation already sent to OFR, but not published in the Federal Register (FR), must be immediately withdrawn. Third, any regulations published in the FR, but which have not taken effect, will have their effective date delayed for 60 days from the date of the memorandum (January 20, 2017).

Genetically Engineered: USDA Proposes Changes to Biotechnology Regulations

On January 19, 2017, the United States Department of Agriculture (USDA) Animal and Plant Health Service (APHIS) published notice in the Federal Register that the agency is “revis[ing] its regulations regarding the importation, interstate movement, and environmental release of certain genetically engineered organisms” (82 FR 7008).  According to APHIS, the proposed revision is “in response to advances in genetic engineering and understanding of the plant pest and noxious weed risk posed by genetically engineered (GE) organisms, thereby reducing burden for regulated entities whose organisms pose no plant pest or noxious weed risks.” The comment period for the proposed rule closes May 19, 2017.

Plant Technology: FDA Requests Comment for Genome Editing of Plants Used for Human and Animal Food

On January 19, 2017, the United States Food and Drug Administration (FDA) published notice in the Federal Register announcing the “establishment of a docket to receive comments on the use of genome editing techniques to produce new plant varieties that are used for human or animal food” (82 FR 6564).  According to FDA, “[r]ecently, new technologies have emerged that are intended to alter the genomes of various organisms…[which] make it easier for plant developers to produce new plant varieties with targeted genetic modifications.” As a result, FDA seeks comment to help inform the agency’s thinking regarding foods derived from new plant varieties using these technologies.  The comment period closes April 19, 2017. 

International Trade: President Withdraws US from Tran-Pacific Partnership

On January 25, 2017, President Donald J. Trump published notice in the Federal Register of a Memorandum entitled: Withdrawal of the United States from the Trans-Pacific Partnership Negotiations and Agreement (82 FR 8497).  According to the Memorandum, the President directs the United States Trade Representative to withdraw the United States as a signatory to the Trans-Pacific Partnership (TPP) and to permanently withdraw the United States from TPP negotiations.

Labeling: Revision to Nutrition Facts Label for Meat and Poultry Products 

On January 19, 2017, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) published notice in the Federal Register of a proposed rule to amend the nutrition labeling requirements for meat and poultry products (82 FR 6732).  Included among FSIS’s proposed changes are a revision to the format and appearance of the Nutrition Facts label and an update to the list of nutrients that are required or permitted to be declared.  The comment period for the proposed rule closes March 20, 2017.

Dairy: Pennsylvania Milk Marketing Board Meeting Scheduled

On January 21, 2017, the Pennsylvania Milk Marketing Board (Board) published notice in the Pennsylvania Bulletin that the Board will conduct a public hearing for Milk Marketing Areas 1—6 on February 27, 2017, at 10 a.m. in Room 309, Agriculture Building, 2301 North Cameron Street, Harrisburg, PA (47 Pa.B. 396).  According to the notice, “[t]he purpose of the hearing is to receive testimony and exhibits concerning the level and duration of the Class I over-order premium to be effective April 1, 2017.”

AgLaw HotLinks: 

• USDA’s country-of-origin labeling to be amended to include venison - Meatingplace
• Lab-grown meat decreases risk of animal disease/other contaminants and is humane - FoodSafetyNews
• A deer at a private PA hunting preserve found to have chronic wasting disease - LancasterOnline
• “Consumer inflation up; food prices unchanged” - Meatingplace
• FDA releases draft rules regarding animals with genome engineering - Nature
• “Rural America matters to all Americans” - TheConversation
• EPA nominee assured senators he would enforce Chesapeake Bay cleanup agreement - LancasterOnline
• “Farm lending activity slows” - FeedStuffs
• Business Benchmark on Farm Animal Welfare releases annual report on animal welfare - MeatPoultry
• Agribusinesses and farm groups ask to take part in NAFTA renegotiations - AgriPulse
• “Rules for Safe Food for Canadians Act reach final review phase” - FoodSafetyNews

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Stay informed with our monthly Agricultural Law Brief located here.

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 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.

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).  

Organic Advocacy Group Sues USDA

Written by Stephen Kenney

On August 25, 2015, the Center for Food Safety (CFS) filed suit against the USDA Animal and Plant Health Inspection Service (APHIS) for violating the Freedom of Information Act (FOIA).  CFS sought records from APHIS related to the proposed Plant Protection Act Regulations.  CFS requested in its complaint that the court order APHIS to disclose all the non-exempt records that CFS requested. CFS is a non-profit entity that advocates for and promotes organic and similar types of agriculture production.  APHIS is tasked with regulating genetically engineered organisms which it does under the Plant Protection Act.

CFS alleged in the complaint that APHIS has routinely violated FOIA when CFS has requested information regarding APHIS’s oversight of GE crops.  In addition to the disclosure of the requested documents, CFS seeks a court declaration that APHIS has a pattern of failing to timely respond to CFS’s FOIA requests and to order APHIS to make amendments to its FOIA Handbooks and procedures to ensure compliance with FOIA in the future.

APHIS published its proposed updated GE crop regulations in 2008.  The proposal was officially withdrawn on March 4, 2015.  CFS made a FOIA request about the decision when the group first learned that APHIS was planning to withdraw the proposed updated GE regulations in December 2014.  Nine months later, CFS had not received any records from APHIS.  CFS claimed that this is not an isolated incident and that it has made dozens of FOIA requests to APHIS regarding the regulation of GE crops since 2002.  CFS further claimed that APHIS had failed to respond timely to twenty-nine of those claims.  

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 

Energy and Commerce Committee Holds Hearing on GMO Labeling Bill

On June 18, 2015, the United States House of Representatives Energy and Commerce Subcommittee on Health held a hearing on House Bill 1599, regarding the implementation of a national framework for the labeling of foods containing genetically-modified organisms (GMOs).

House Bill 1599 would create a voluntary labeling standard for foods containing GMOs. The bill would require USDA certification for a product to be labeled as non-GMO as well as requiring FDA safety approval for new genetically engineered traits in crops and products. The bill would also preempt any individual state laws regarding GMO labeling, such as Vermont’s mandatory labeling law.

Testimony was heard from both proponents and opponents of the bill. One proponent of House Bill 1599 stated that a national framework would protect farmers and agricultural cooperatives from a “hodgepodge of rules” that would be “unworkable.” Another testified that compliance with Vermont’s law is “really a nightmare” for manufacturers, requiring either product reformulation or creation of a separate line of product labeling for the state.  One proponent even testified that GMO labeling is meaningless, as all food products have been altered from their original state, stating that “it is a process, not a product.”

One opponent of the bill stated that the lack of a new safety approval process through the FDA leaves safety determinations in the hands of companies.  Another opponent testified that by preempting state laws, the bill interferes with the role of states “as laboratories of democracy to develop novel…experiments without risk to the rest of the country.”

To watch the full hearing, click here.

Written by Tyler R. Etter- Research Assistant

June 19, 2015

Kauai Limits Use of Pesticides on Genetically Modified Crops

Legislators on the Hawaiian island of Kauai approved have approved a bill that would restrict the use of pesticides by companies developing genetically modified crops on the island.  The Kauai County Council voted 6-to-1 to pass the bill on October 16^th after a hearing that lasted a day and a half.

The island has become a popular place for growing new varieties of corn and other genetically modified crops for the production of seeds due to its warm weather allowing for three corn harvests a year.  DuPont Pioneer, Sygenta, Dow, and BASF all grow corn on the island.

The bill would establish no-spray zones around schools, medical facilities, homes, public roads, and waterways.  It would also require seed companies to disclose which pesticides they use.  The original bill would have also limited genetically modified crop planting, but those provisions were eventually removed from the bill after seed companies argued that the original bill would have forced them off the island.  Seed companies also threatened to challenge the original bill in court.

The text of the original bill can be found here.  The New York Times article reporting the bill approval can be found here.

Written by Alyssa Looney – Research Assistant

The Agricultural Law Resource and Reference Center

@PSUAgLawCenter

October 25, 2013

The Oregon State Legislature Passes a Bill that Prohibits Counties from Regulating Genetically Engineered Crops

S.B. 863 declares that “regulation of agricultural seed, flower seed, nursery seed and vegetable seed and products of agricultural seed, flower seed, nursery seed and vegetable seed be reserved to the state,” preventing local governments from adopting any of their own GE policies. 

Senate Bill 863 has been passed by the senate and the house but is still waiting to be signed into law by Oregon’s Governor. Governor John Kitzhaber has stated that before he signs the bill into law he wants state officials to map locations of GE crops.  In addition, he wants to implement buffer zones between GE crops and organic crops in the state by 2015. 

To view Senate Bill 863 and additional general information about the bill click here.

To track the continuing activity of the bill click here. 

Written by Joseph Negaard - Research Assistant

The Agricultural Law Resource and Reference Center

@PSUAgLawCenter

October 8, 2013

USDA Grants Non-Regulated Status to GE Soybean

On August 16, the USDA Animal Plant Health Inspection Service (APHIS) announced its decision to grant non-regulated status to a genetically modified soybean engineered by Bayer CropScience. The soybean, FG72, is resistant to glyphosate and isoxaflutole, both herbicides that are registered for use on corn.

APHIS, the Environmental Protection Agency (EPA) and the Food and Drug Administration (FDA) have regulatory authority over GE organisms. APHIS has the authority to regulate the introduction of certain GE organisms and products under the Plant Protection Act and 7 CFR § 340, but a person may petition APHIS to have a regulated article de-regulated by showing under § 340.6 that the regulated item is unlikely to present a greater plant pest risk than the unmodified organism. To achieve non-regulation status, APHIS must then determine that the GE organism is unlikely to pose a plant pest risk through thorough analysis. In addition, the EPA has the authority to regulate pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 7 U.S.C. 136. Through testing, the EPA determines if the pesticide will cause unreasonable adverse effects on humans, the environment, and non-target species. EPA also sets tolerances for residues of pesticides remaining on food and feed products. Lastly, the FDA regulates GE organisms under the Federal Food Drug and Cosmetic Act (FFDCA) 21 U.S.C. 301. FDA implements voluntary consultations to ensure that food safety issues are resolved before commercial distribution so developers are in compliance with Federal food safety laws prior to marketing.

Bayer petitioned APHIS that FG72 did not pose a plant pest risk in 2009. After considering several environmental, production, socioeconomic and human and animal health issues, as well as public comments, numerous alternatives and cumulative impacts, APHIS granted the non-regulated status to FG72. The FDA concluded in July of 2012 that FG72 is not materially different than comparative soybeans now grown, marketed, and consumed in the U.S. Isoxaflutole is still under review by the EPA, but tolerance of isoxaflutole residues has already been established by final rule in the Federal Register.

For more information about APHIS’s analysis, please visit its website on the Draft Environmental Analysis of FG72.

 

Written by Sarah L. Doyle - Research Assistant

The Agricultural Law Resource and Reference Center

@PSUAgLawCenter

August 26, 2013