Agricultural Law Weekly Review—August 18, 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:

Food Safety: USDA Announces Preliminary Deregulation of GE Apple

On August 12, 2016, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) published notice in the Federal Register that the agency has reached a preliminary decision to extend deregulation to a genetically engineered line of apples known as Arctic® Fuji (81 FR 53396).  Developed by the company Okanagan Specialty Fruits Inc., Arctic® Fuji has been engineered to resist enzymatic browning.  The comment period for extending deregulation closes September 12, 2016.

Industrial Hemp: Notice Published for Federal Statement of Principles

On August 12, 2016, the United States Department of Agriculture (USDA), the United States Drug Enforcement Administration (DEA), and the United States Food and Drug Administration (FDA) published notice in the Federal Register that the three agencies have “developed a Statement of Principles on Industrial Hemp to inform the public how Federal law applies to activities associated with industrial hemp that is grown and cultivated in accordance with Section 7606 of the Agricultural Act of 2014” (81FR 53395).  According to the Federal Register notice, because the “Statement of Principles does not establish any binding legal requirements…[i]t is, therefore, exempt from notice and comment rulemaking requirements under the Administrative Procedure Act pursuant to 5 U.S.C. 553(b).”

Food Safety: FDA Issues Final Rule for Substances Generally Recognized as Safe

On August 17, 2016, the United States Food and Drug Administration (FDA) published notice in the Federal Register of a final rule amending the regulations regarding “when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)” due to the substance “being generally recognized as safe (GRAS) under the conditions of its intended use” (81 FR 54959).  Additionally, FDA stated that the agency was amending the “regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure.  The final rule comment period closes on October 17, 2016.  The final rule becomes effective on October 17, 2016. 

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Pesticide Regulation: Court Orders EPA to take Final Action

On August 12, 2016, the United States Court of Appeals for the Ninth Circuit denied a United States Environmental Protection Agency (EPA) request for an “additional six month extension to take final action on its proposed revocation rule and its final response to Pesticide Action Network North America and Natural Resources Defense Council’s (collectively, “PANNA”) 2007 administrative petition.” According to the Court, EPA has delayed taking action for nine years and has received previous court extensions.  As a result, the Court stated that it will not grant any further extensions and instead ordered EPA to take final action by March 31, 2017. 

Dairy Order: USDA Reduces Number of Dairy Board Importer Members

On August 12, 2016, the United States Department of Agriculture (USDA) Agricultural marketing Service (AMS) published notice in the Federal Register of a final rule amending the Dairy Promotion and Research Order so as to reduce the number of National Dairy Promotion and Research Board (Dairy Board) importer members from 2 members to 1 member (81 FR 53245).  According to the final rule, the number of domestic Dairy Board members will remain at thirty-six.  The final rule became effective on August 12, 2016.

Avian Influenza: USDA Amends NPIP and Low Pathogenic Indemnity Regulations

On August 12, 2016, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) published notice in the Federal Register of a final rule “[a]mending the National Poultry Improvement Plan (NPIP), its auxiliary provisions, and the indemnity regulations for the control of H5 and H7 low pathogenic avian influenza (81 FR 53247).  According to USDA the final rule “clarifyi[es] who may participate in the NPIP, amend[s] participation requirements, amend[s] definitions for poultry and breeding stock, amend[s] the approval process for new diagnostic tests, and amend[s] slaughter plant inspection and laboratory inspection and testing requirements.” The final rule becomes effective September 12, 2016.

Mergers and Acquisitions: Sen. Grassley Sends Letter to DOJ and FTC Regarding Proposed Biotech and Seed Transactions

On August 17, 2016, Senate Judiciary Committee Chairman Charles Grassley (R-IA) issued a letter to Renata Hesse, Principal Deputy Assistant Attorney General, Antitrust Division, United States Department of Justice (DOJ) (which is reviewing the proposed merger between Dow Chemical Corp. and DuPont Co.) and Edith Ramirez, Chairwoman, Federal Trade Commission (FTC) (which is reviewing the proposed acquisition of Syngenta AG by China National Chemical Corp.).  According to Sen. Grassley, “[b]ecause of the complex nature of [the agricultural] industry it is important that these transactions not be viewed in isolation.” As a result, Sen. Grassley stated that DOJ and FTC should “collaborate” in their reviews, and where “appropriate solicit ‘input from the Department of Agriculture.”  

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).  

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