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.”  

Agricultural Law Weekly Review—May 26, 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:

Labeling: FDA Revises Nutritional Labels

On May 20, 2016, the Food and Drug Administration (FDA) issued an unpublished notice in the Federal Register regarding revisions to the regulations governing nutritional and supplemental facts labels (2016-11867).  According to the pre-publication final rule, the amendment “updates the list of nutrients that are required or permitted to be declared; provides updated Daily Reference Values and Reference Daily Intake values that are based on current dietary recommendations from consensus reports; amends requirements for foods represented or purported to be specifically for children under the age of 4 years and pregnant and lactating women and establishes nutrient reference values specifically for these population subgroups; and revises the format and appearance of the Nutrition Facts label.” The final rule is scheduled for publication on May 27, 2016, and becomes effective on July 26, 2016.

Labor: DOL Finalizes “White Collar” Overtime Regulations

On May 23, 2016, the Department of Labor (DOL) Wage and Hour Division published notice in the Federal Register of a final rule revising “regulations under the FLSA [Federal Labor Standards Act] implementing the exemption from minimum wage and overtime pay for executive, administrative, professional, outside sales, and computer employees” (81 FR 32391).  Commonly known as the “EAP” or “white collar” exemptions, DOL’s final rule increases the current annual salary threshold for the exemption from $23,660 ($455/week) to $47,476 ($913/week).  The new regulations become effective December 1, 2016.

GE Food: Canada Approves AquaAdvantage Salmon for Livestock Feed

On May 19, 2016, the Canadian Food Inspection Agency (CFIA) issued Decision Document DD2016-117 regarding the approval of the genetically engineered AquaAdvantage Salmon for use as livestock feed.  According to CIFA, the “feed ingredients derived from this animal with a novel trait does not present livestock feed safety or nutrition concerns when compared to feeds derived from salmon currently permitted to be used as livestock feed in Canada.” As a result, as of May 19, 20016, feed ingredients derived from AquaAdvantage Salmon are authorized for use in livestock feeds in Canada.

Transportation: Proposed PA Legislation Assigns Gross Weight for Milk Hauling

On May 23, 2016, Pennsylvania governor Tom Wolf was presented with legislation that would amend Title 75 (Vehicles) of the Pennsylvania Consolidated Statutes (SB 1108).  Under the proposed legislation, vehicles “hauling milk to or from a manufacturer…may be permitted by the department and local authorities to move upon highways within their respective jurisdictions 24 hours a day, seven days a week, except during inclement weather as defined in department regulations, if the gross weight does not exceed 95,000 pounds and the weight of any nonsteering axle does not exceed 21,000 pounds.”

Equine: Clarifying Legislation Introduced for PA Breeding Fund

On May 23, 2016, Pennsylvania House Representative John A. Lawrence introduced House Bill 923 which is “legislation to clarify language in the recently passed Administrative Code regarding the eligibility of thoroughbreds receiving payments from the Pennsylvania Breeding Fund, a restricted account within the State Racing Fund that provides incentive awards for winning Pennsylvania born/bred thoroughbred race horses.” Accordingly, the proposed legislation was referred to the House Agricultural and Rural Affairs Committee.

Agricultural Law Weekly Review: February 19, 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:

GE Crops: APHIS Publishes Notice of Intent to Deregulate Monsanto GE Maize 

On February 17, 2016, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) published notice in the Federal Register regarding Monsanto Co.’s request to deregulate genetically engineered (GE) maize designated as event MON 87419.  According to the published notice, “APHIS has determined that maize designated as event MON 87419 is unlikely to pose a plant pest risk” and as a result, APHIS has made “a preliminary determination of nonregulated status of maize designated as event MON 87419.” Comments on the published notice will be received for 30 days from the date of publishing in the Federal Register. 

Raw Milk:  FDA Announces Reevaluation of Testing of Raw Milk Cheese 

On February 8, 2016, the United States Food and Drug Administration (FDA) issued a press release announcing that FDA will reevaluate the testing of raw milk cheese for non-toxigenic E. coli.  The press release stated that FDA was responding to concerns raised by cheese makers “suggesting that the FDA is applying safety criteria that may, in effect, limit the production of raw milk cheese without demonstrably benefiting public health.” According to the press release, FDA “will continue to inspect cheese-making facilities and test for pathogens in domestic and imported cheese but, in the meantime, FDA is in the process of pausing its testing program for non-toxigenic E. coli in cheese.”

Labeling: Court Affirms Federal Authority over Meat and Poultry Labeling 

On February 12, 2016, the United States Court of Appeals for the Ninth Circuit affirmed a lower court ruling that California was barred from “enforcement of California’s statutory prohibition against nonfunctional slack fill (i.e., empty space between a product and its packaging that serves none of a list of specified purposes)…as applied to meat and poultry products” (Case No. 13-16893).  The Court held that “California’s nonfunctional slack fill provisions…are expressly preempted by the Federal Meat Inspection Act (“FMIA”) and the Poultry Products Inspection Act (“PPIA”)” and that “Congress intended to allow meat and poultry packaging to be subject to less specific regulation than other types of product packaging.”

Labor: Class Action Brought Against Meat Processor over Employment of Illegal Workers 

On February 16, 2016, a class action lawsuit was filed in the United States District Court for the Northern District of India on behalf of hourly-paid production workers at the Indiana Packers Company’s (IPC) meat processing facility (Case No. 4:16-cv-00015-JD-JEM).  The class action lawsuit was brought pursuant to the Racketeer Influenced and Corrupt Organizations Act (RICO) and alleged that IPC engaged in “a scheme to employ vast numbers of illegal immigrants at the plant [in an effort] to depress wages.” According to the filed complaint, IPC carried out its “scheme” by knowingly hiring illegal workers and making false attestations on I-9 Forms that the illegal workers were authorized for employment in the United States.

SNAP: USDA Proposes Rule to Require Healthier Choices 

On February 17, 2016, the United States Department of Agriculture (USDA) published a proposed rule in the Federal Register “to make changes to the Supplemental Nutrition Assistance Program (SNAP) regulations pertaining to the eligibility of SNAP retail food stores.”  According to the proposed rule, SNAP-authorized retailer food stores will be required to stock a wide variety of healthy foods so that SNAP program recipients will be provided with increased access to healthy food options.  Comments on the proposed rule will be received for 60 days from the date of publishing in the Federal Register.

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.”

USDA Requires Permitting of Genetically Engineered Wheat

Written by M. Sean High – Staff Attorney

On December 11, 2015, the United States Department of Agriculture Animal and Plant Health Inspection Service (USDA-APHIS) announced that beginning January 1, 2016, all field trials of regulated genetically engineered (GE) wheat must be conducted under USDA’s permitting process.  Prior to the announcement, field trials of GE wheat had been conducted under USDA’s less stringent notification process.  USDA-APHIS stated that “recent unauthorized releases of GE wheat and findings have led USDA-APHIS to the conclusion that U.S. agriculture would benefit from the increased oversight provided by the Permit process.”

Accordingto USDA-APHIS, during 2013-2014, two separate incidents of unauthorized GE wheat were discovered in Oregon and Montana.  The Oregon GE wheat field trial had never been authorized at the discovered site and authorization for the discovered Montana GE wheat field trial site had expired 10 years prior.  USDA-APHIS voiced concern that these detections “had great potential to disrupt wheat markets globally” and that some U.S. trading partners have imposed “risk mitigation measures to imports of U.S. wheat in response to [the Oregon] incident.”

USDA-APHIS stated that “[u]sing permits for field trials of GE wheat provides an additional level of safeguarding based on, and consistent with the technology of wheat.” Furthermore, the agency exclaimed that “[b]ringing GE wheat under permit enables APHIS to create and enforce permit conditions that minimize the likelihood that the regulated GE wheat will spread or persist in the environment.” Importantly, USDA-APHIS noted that through the more stringent permitting process, international trading partners will be reassured “that the U.S. is committed to being the world’s reliable supplier of grain.”   

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. 

Grocers Launch Alternative to GMO Labeling

Written by M. Sean High - Staff Attorney

On December 2, 2015, the Grocery Manufacturers Association (GMA) announced the launching of a technology initiative designed to provide consumers with detailed product information via the internet.  According to GMA, the new technology, known as SmartLable, has been created as a result of a collaboration of manufacturers and retailers, and will allow consumers the ability to receive detailed information on products ranging from food, beverage, pet care, personal care, as well as household items. 

The way SmartLabel works is that a product included in the system will have its own online “landing page” that provides detailed information about that product.  Information to be provided will include “nutritional information, ingredients, allergens, third-party certifications, social compliance programs, usage instructions, advisories and safe handling instructions and company/brand information along with other pertinent information about the product.”

To access the SmartLabel information regarding a particular product, consumers can scan the product with their smartphone, visit a participating company’s website, or simply type the product name into an online search engine such as Google, Yahoo, or Bing.  Eventually, a SmartLabel app is to be released.  For consumers that lack a smartphone or access to the internet, GMA stated that many retailers will assist shoppers “via their customer service desks in stores.”

According to GMA, “[m]ore than 30 of the nation’s major food, beverage and consumer products companies already are committed to using SmartLabel to provide detailed information about their products.” Significantly, GMA stated that SmartLabel will begin at the end of 2015 and that 30,000 products are projected to be included in the system by 2017.  Furthermore, GMA anticipates that within five years, 80% of all related products will be available for review through the SmartLabel system.

GMA board chairman J.P Bilbrey (who is also chairman, president, and CEO of The Hershey Company) stated, that “[p]eople’s relationship with food has changed dramatically and consumers now want to know more about their food” and that SmatLabel “is what real food transparency is about.” To that end, GMA asserted that by the end of 2017, SmartLabel will identify “whether 20,000 food products do, may or do not contain ingredients sourced form genetically engineered (GE) crops, commonly known as GMOs.” GMA further opined that the number of identified food products “could triple once a uniform national standard is set for GMOs.”

Finally, GMA declared that the results of a recent nationwide survey conducted by the Benson Strategy Group, indicating that 75% of consumers would likely use SmartLabel, serves to demonstrate “that the program will meet a consumer desire for more product information.”  

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).