Agricultural Law Weekly Review—March 2, 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:

WOTUS: President Signs Executive Order Reviewing “Waters of the United States” Rule

On February 28, 2017, President Donald J. Trump signed an Executive Order directing the Administrator of the Environmental Protection Agency (Administrator) and the Assistant Secretary of the Army for Civil Works (Assistant Secretary) to review the current federal waters of the United States rule (WOTUS).  Upon completion of this review, the Administrator and Assistant Secretary are to propose a rule either rescinding or revising the current rule.  For future WOTUS rulemaking, “the Administrator and Assistant Secretary shall consider interpreting the term ‘navigable waters,’ as defined in 33 U.S.C. 1362(7), in a manner consistent with the opinion of Justice Antonin Scalia in Rapanos v. United States, 547 U.S. 715 (2006).”

Food Labeling: Court Affirms Denial of Egg Carton Labeling

On February 27, 2017, the United States Court of Appeals for the Ninth Circuit affirmed a lower court ruling denying the mandatory labeling of egg-laying hen conditions on egg cartons (Compassion over Killing v. U.S. Food & Drug Administration, D.C. No. 3:13-cv-01385-VC).  The court held that the Food Safety and Inspection Service and the Agricultural Marketing Service lacked the authority to promulgate such mandatory labeling of shell eggs.  Additionally, the court held that the Federal Trade Commission reasonably denied the plaintiff’s request based on its discretion.  Finally, the court held that the Food & Drug Administration provided a reasonable explanation for denying the plaintiff’s request.

Animal Health: Pennsylvania Deer Tests Positive for Chronic Wasting Disease

On February 28, 2017, the Pennsylvania Department of Agriculture (PDA) announced that a captive Pennsylvania deer has tested positive for Chronic Wasting Disease (CWD).  According to PDA, the deer died on a Bedford County farm in January 2017 and was confirmed positive for CWD on February 10, 2017.  Pennsylvania Agriculture Secretary Russell C. Redding stated that “[w]hile CWD is no danger to public health and has never been associated as a human health concern, we will continue to work with deer farmers and sportsmen to protect the health of Pennsylvania’s deer.” The farm where the deer died is currently under quarantine.

AgLaw HotLinks:

• Farm Bill hearing focuses on dairy programs - DroversCTN
• USDA chief economist, Robert johansson, looks at U.S. agriculture - including farmland values, real farm income, etc. -  Farm Policy News
• Clemson University researchers will begin a 5 year study to help prevent citrus greening problem - AgriPulse
• “Illinois new raw milk rule gets first legislative tests” - FoodSafetyNews
• New U.N. Food & Ag Organization report notes environmental concerns with food production increases - AgriPulse
• American Dairy Coalition says some dairy producers worry about new immigration regulations - Brownfield
• Estimated payments per base acre for corn, soybeans, & wheat based on information provided by the National Agricultural Statistical Service - University of Illinois
• Food industry creates voluntary guidelines for standard labels to decrease food waste - DairyNetwork 
• USDA sees declining production in major US crops - AgriPulse
• By June, Tyson Foods says they will no longer use antibiotics in chicken - Brownfield
• The Feed a Bee program encourages planting wildflowers for honey bees, monarch butterflies, & other pollinators - AgriPulse
• Australian and U.S. farmers protest the use of the word “milk” with soy or almond drinks - SMH
• WTO denies Russia appeal over EU pork ban - MeatPoultry

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Connect with us on Facebook! Every week we will post the CASL Ledger which details all our publications and activities from the week.

Check out this week’s Agricultural Law In the Spotlight: Federal Court Rules against Application of Pennsylvania Equine Activity Immunity Act.

Stay informed with our monthly Agricultural Law Brief located here. 

Agricultural Law Weekly Review—December 15, 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:

GIPSA: USDA Announces Updated Farmer Fair Practices Rules

On December 14, 2016, the United States Department of Agriculture’s (USDA) Grain Inspection, Packers and Stockyards Administration (GIPSA) announced updated changes to the Farmer Fair Practices Rules.  According to USDA, the new regulations—contained in an interim final rule and two proposed rules—are intended to “level the playing field for farmers by proposing protections against the most egregious retaliatory practices harming chicken growers.” Relatedly, House Committee on Agricultural Chairman K. Michael Conaway (R-TX) issued a statement the he “will make it a priority to roll back these, and other midnight regulations from the Obama Administration, as soon as Congress returns in January.”  

FSMA: FDA Publishes Guidance for Voluntary Third-Party Certification

On December 6, 2016, the United States Food and Drug Administration (FDA) published notice in the Federal Register “announcing the availability of a guidance for industry and FDA staff entitled ‘Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards’” (81 FR 88099).  The guidance contains non-binding “FDA recommendations on third-party certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA program required by the FDA Food Safety Modernization Act (FSMA).”

Litigation: Court Rules FDA did not Negligently Issue Salmonella Warning

On December 2, 2016, the United States Court of Appeals for the Fourth Circuit upheld a district court ruling that the United States Food and Drug Administration’s (FDA) did not negligently issue a 2008 warning that certain types of raw red tomatoes were likely contamination with Salmonella Saintpaul (Seaside Farm, Inc., v. United States of America, 2016 WL 7030629).  According to the court, shortly after the warning was issued, it was determined that the outbreak did not result from tomatoes, but from jalapeño and serrano peppers imported from Mexico.  The plaintiff, Seaside Farms, alleged that FDA’s warning was negligent and devalued its tomato crop by $15,036,293.95.  The court determined that the warning properly fell within the discretionary function exception of the Federal Tort Claims Act and that the district court “ruling was essential to protect FDA’s vital role in safeguarding the public food supply.”

SNAP: USDA Announces Final Rule for Retail Establishments

On December 8, 2016, the United States Department of Agriculture (USDA) Food and Nutrition Service (FNS) issued a news release announcing a final rule entitled Enhancing Retailer Standards in the Supplemental Nutrition Assistance Program (SNAP).  According to FNS, the final rule amends the SNAP retailer eligibility criteria to require that authorized SNAP retail food establishments must “offer a larger inventory and variety of healthy food options.” Additionally, FNS stated that the final rule provides changes to the definition of the term “accessory food” so as to “ensure that stores are not able to participate in SNAP by selling primarily snack foods.”

Class Action: Post Holdings Announces Settlement of Egg Price-Fixing Claims

On December 8, 2016, Post Holdings announced that the company has agreed to pay $75 million to settle claims, asserted by direct purchasers of shell eggs against Michael Foods, Inc., for allegedly conspiring to inflate egg prices (In re Processed Egg Products Antitrust Litigation, Case Number  2:08-md-02002).  Filed in the Eastern District of Pennsylvania in 2008, the litigation predates Post Holdings acquisition of Michael Foods in 2014.  According to Post Holdings, “the terms of the settlement must be formally documented and are subject to approval by the court following notice to all class members.”

Industrial Hemp: 2017 Pilot Program Parameters Announced

On December 10, 2016, the Pennsylvania Department of Agriculture (PDA) published notice in the Pennsylvania Bulletin announcing the Industrial Hemp Research Pilot Program parameters for 2017 (46 Pa.B. 7668).  The parameters outline the requirements necessary for 2017 Industrial Hemp Research Pilot Program permit applications.  According to PDA, all applications must be submitted to the department by January 6, 2017.

Fruit Production: Pennsylvania Terminates Apple Marketing Program

On December 10, 2016, the Pennsylvania Department of Agriculture (PDA) published notice in the Pennsylvania Bulletin that the Pennsylvania Apple Marketing Program will be terminated on May 26, 2017 (46 Pa.B. 7677).  From October 17—31, 2016, a referendum was held among eligible producers to determine if a majority wished the Program to continue for an additional 5 years.  According to the notice, the eligible producers voted 56% to 44% against continuation of the program. 

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

Recent AgLaw HotLinks include:

• Top food safety prosecutor continues accountability approach - FoodSafetyNews
• Animal protein analyst talks about avian influenza worries - Brownfield
• “Big data in ag continues to expand” - Feedstuffs
• “Class action over Syngenta corn moves forward” - AgriPulse
• Fewer family farms, more million-dollar farms says the USDA - Brownfield
• Water infrastructure legislation reduces EPA regulatory requirements - Brownfield
• Drastic measures taken to prevent bird flu spread in Asia and Europe - Meatingplace
• “USDA announces farmer fair practices rules” - USDA.gov
• “Weather radar helps researchers track bird flu” - Meatingplace
• While most farmers are 55 years old or more, young farmers still have big impact on farming operations - Brownfield 

Connect with us on Facebook! Every week we will post the Friday Recap which details all our publications and activities from the week.

Stay informed with our monthly Agricultural Law Brief located here. 

Agricultural Law Weekly Review—September 22, 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:

Legal Settlement: Syngenta Agrees to Pay $1.2 M. for Selling Misbranded Pesticides

On September 16, 2016, the United States Environmental Protection Agency (EPA) issued a press release stating that the agency has reached a settlement agreement with Syngenta Crop Protection, LLC (Syngenta) for allegedly violating the Federal Insecticide, Fungicide, and Rodenticide Act through the repackaging, selling and distribution of unregistered and misbranded pesticides. As a result of the settlement agreement, Syngenta will pay $766,508 in civil penalties and spend $436,990 to implement an environmental compliance promotion Supplemental Environmental Project.

FSMA: PA Announces $6.3 M. to Implement Produce Safety Rule

On September 19, 2016, Pennsylvania Governor Tom Wolf issued a press release announcing that the Commonwealth has received a $6.3 million Federal grant to assistance Pennsylvania produce growers in meeting requirements enacted under the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA).  According to the press release, “The funding, spread across five years, gives the [Pennsylvania Department of Agriculture] resources to implement a produce safety system, develop and provide education and outreach, and to develop programs to address the specific and unique needs of the growers in Pennsylvania’s farming communities.”

GIPSA: Amendment Regarding Electronic Transactions Clears House Ag Committee

On September 14, 2016, the United States House Agriculture Committee passed H.R. 5883 which would amend the Packers & Stockyards Act (GIPSA) “to expand the definition of ‘marketing agency’ to include any person engaged in the business of buying or selling livestock in commerce through online, video, or other electronic methods on a commission or other fee basis when handling or providing a means to handle receivables or proceeds from the sale of that livestock.” Additionally, according to the Bill Summary, H.R. 5883 would also amend GIPSA “to specif[y] that funds for purchasing livestock may be transferred to the account of the seller by electronic funds transfer or any other expeditious method that the Department of Agriculture determines to be appropriate.” Subsequently, on September 20, 2016, H.R. 5883 was placed on the Union Calendar, Calendar No. 601.

HPAI: FSIS Issues Directive Regarding Poultry Slaughterhouse Inspection

On September 21, 2016, the United States Department of Agriculture (USDA) Food Safety and Inspection Service released a directive regarding how “inspection program personnel (IPP) at official poultry slaughter establishments [are] to conduct enhanced inspection for domestic poultry in the event of a Highly Pathogenic Avian Influenza (HPAI) outbreak or an agro terrorism incident that involves HPAI viruses” (6020.1 Rev. 1).  According to FSIS, the new directive updates FSIS Directive 6020.1 regarding: (1) current notification procedures and enhanced inspection documentation; and (2) instructions for IPP assigned to establishments under the New Poultry Inspection System (NPIS).

FSMA: FDA Announces Effective Date for Definition of Qualified Auditor for Two Final Rules

On September 19, 2016, the United States Food and Drug Administration (FDA) published notice in the Federal Register announcing the effective date regarding the definition of a qualified auditor in the following FDA Food Safety and Modernization Act final rules: (1) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis; and (2) Risk-Based Preventive Controls for Food for Animals; Definition of Qualified Auditor (81FR 64060).  Accordingly, the definition for each final rule became effective September 19, 2016. 

Pesticides: EPA's Announces Draft Human Health and Ecological Risk Assessments

On September 19, 2016, the United States Environmental Protection Agency (EPA) published notice in the Federal Register announcing “the availability of EPA's draft human health and ecological risk assessments for the registration review of carfentrazone-ethyl, copper compounds, mineral acids, spinosad, and spinetoram and opens a public comment period on these documents” (81 FR 64149).  According to the published notice, “EPA's periodic review of pesticide registrations is intended to ensure that each pesticide…can perform its intended function without unreasonable adverse effects on human health or the environment.” The comment period regarding the draft human health and ecological risk assessments closes November 18, 2016.

Eggs: Final Rule Regarding Voluntary Grading of Shell Eggs

On September 16, 2016, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published notice in the Federal Register of a final rule “amend[ing] the Regulations Governing the Voluntary Grading of Shell Eggs to clarify the definition of ‘condition’ and revise the prerequisite requirement for shell eggs eligible for voluntary USDA grading and certification” (81 FR 63675).  This final rule is effective September 16, 2016.

Animal Welfare: USDA Extends Comment Period for Horse Protection Regulations

On September 16, 2016, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) issued a press release announcing that the agency is extending by 30 days the comment period on the proposed rule that would amend APHIS’ Horse Protection Act (HPA) regulations.  As a result interested stakeholders may now submit comments until October 26, 2016.  According to the press release, under the proposed rule APHIS would: (1) assume responsibility for training, screening and licensing horse inspectors; and (2) prohibit the use of all action devices, pads, and foreign substances at horse shows, exhibitions, sales, and auctions. 

Agricultural Law Weekly Review—July 28, 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 Security: President Signs Global Food Security Act

On July 20, 2016, President Obama signed into law S.1252, the Global Food Security Act of 2016, which “requires the President to develop and implement a Global Food Security Strategy to promote global food security, resilience, and nutrition.” According to the enacted legislation, the President is required to submit the strategy to Congress by October 1, 2016.

Checkoff Programs: USDA Issues Proposed Changes to Soybean and Beef Programs

On July 15, 2016, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published notice in the Federal Register of a proposed rule that would amend both the soybean and beef checkoff programs so as to allow producers “to request, under certain circumstances, that their assessments paid to a State board or council authorized under their respective statutes, be redirected to the national program” (81 FR 45984).  The comment period for the proposed rule ends September 13, 2016.

GMOs: EU Commission Announces Approval of Three Biotech Soybeans

On July 22, 2016, the European Commission issued a press release announcing the approval of three varieties of genetically modified soybeans (soybean MON 87708 x MON 89788, soybean MON 87705 x MON 89788 and soybean FG 72) for both food and feed uses in the European Union.  The European Commission did state, however, that the decision to approve the genetically soybeans does not extend to cultivation.

Food Safety: UK Reports Measures Improve Egg Safety

On July 25, 2016, the Food Standards Agency (FSA) of the United Kingdom Advisory Committee on the Microbiological Safety of Food (ACMSF) issued a report regarding the “microbiological risk from shell eggs and their products’.” According to the report, since 2001, microbiological risk from Salmonella in UK hen shell eggs has been significantly reduced due to the “Lion Code quality assurance scheme, which comprises a suite of measures including: vaccination for Salmonella Enteritidis and Typhimurium, a cool chain from farm to retail outlets, enhanced testing for Salmonella, improved farm hygiene, effective rodent control, independent auditing, date stamping on each individual egg and traceability.” As a result, the report stated that UK shell eggs produced under the Lion Code may safely be consumed raw by “vulnerable groups” such as pregnant women, the young, and the elderly.

Agricultural Law Weekly Review—April 7, 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:

Right to Farm:  Commonwealth Court Upholds Trial Court Ruling against Mulching Operation

On April 7, 2016, the Commonwealth Court of Pennsylvania issued an unreported decision upholding a trial court decision finding that a Tinicum, Pennsylvania mulching operation was not protected by the Pennsylvania Municipalities Planning Code (MPC) or the Pennsylvania Right to Farm Act (RTF) (Tinicum Twp. v. Nowicki, 2016 WL 1276158).  As a result, the Commonwealth Court upheld the trial court ruling that the mulching operation was in violation of a preliminary injunction and in contempt for violating the injunction.  Significantly, the Commonwealth Court held that the trial court did not abuse its discretion in determining that the mulching operation was not an agricultural operation protected by MPC or RTF because: 1) the vast majority of the raw materials used for the mulching operation were brought in from off-site sources; and 2) the resulting mulch was not used onsite, but instead was delivered for use off-site.   

Industrial Hemp: Bill Passes House Unanimously

On April 6, 2016, the Pennsylvania House of Representatives voted 187-0 to pass legislation that would legalize the growth and cultivation of industrial hemp for research purposes.  Co-sponsored by Representatives Russ Diamond (R-Lebanon) and Marty Flynn (D-Lackawanna), House Bill 967 (HB 967) is similar in language to Senate Bill 50 (SB 50), which on March 16, 2016, unanimously passed the Pennsylvania Senate (see previous Penn State Agricultural Law Blog article).  HB 967 now moves to the Senate for concurrence with SB 50. 

Food Safety:  FDA Finalizes Rule for Food Transportation

On April 6, 2016, as part of the Food Safety and Modernization Act (FSMA), the Federal Drug Administration (FDA) published the final rule for Sanitary Transportation of Human and Animal Food (81 FR 20091).  According to FDA, the final rule “establish[es] requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport.” The new requirements established under the final rule are scheduled to become effective June 6, 2016. 

Avian Influenza: USGS Study Finds Alaska Likely Entry Point for Virus

On April 5, 2016, the United States Geological Survey (USGS) announced the results of a study indicating “that western Alaska remains a hot spot for avian influenza to enter North America.” According to USGS, the report finds “that while no highly pathogenic avian influenza viruses have been found in Alaska, the state remains an important area to monitor due to migratory bird flyways from North America and Eurasia that overlap the region.”

Animal Welfare: Walmart and Sam’s Club to Transition to Cage-Free Eggs

On April 5, 2016, Walmart U.S. and Sam’s Club U.S.announced plans “to transition to a 100 percent cage-free egg supply chain by 2025.”  According to the press release, all shell egg suppliers will be required “to be certified and fully compliant with United Egg Producers (UEP) Animal Husbandry Guidelines or equivalent standard.” Additionally, the press release stated that suppliers will be challenged “to use selective breeding practices, innovation and best management practices to improve the health and welfare of laying hens.” 

SNAP: Comment Period Extended for Proposed Rule on Retail Standards

On April 5, 2016, the Department of Agriculture Food and Nutrition Service published notice in the Federal Register that the agency was extending “the comment period and respond[ing] to questions posed by commenters about certain aspects of a proposed rule pertaining to the eligibility of Supplemental Nutrition Assistance Program (SNAP) retail food stores that was published in the Federal Register on February 17, 2016” (81 FR19500).  According to the notice, the extended comment period will close May 18, 2016. 

Dairy: USDA AMS Proposes Rule to Modify National Dairy Promotion and Research Board

On April 1, 2016, the United States Department of Agriculture Agricultural Marketing Service published a proposed rule in the Federal Register amending the Dairy Promotion and Research Order (81 FR 18802).  According to the proposed rule, “the proposal would modify the number of National Dairy Promotion and Research Board importer members. The total number of domestic Dairy Board members would remain the same at 36 and the total number of importer members would be reduced from 2 to 1.” The time for comment on the proposed rule ends May 2, 2016. 

HPAI Update: New HPAI Indemnity Payment Rule becomes Effective

Written by M. Sean High – Staff Attorney

On February 9, 2016, the United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) published in the Federal Register an interim rule amending the regulations governing the payment of indemnity claims for highly pathogenic avian influenza (HPAI) (81 FR 6745).  The new regulations became effective upon the interim rule’s February 9, 2016 publication in the Federal Register.

The February 9, 2016 interim rule amends the previous HPAI indemnity regulations in three ways: 1) APHIS is allowed to split indemnity payments between poultry/egg owners and contractors; 2) existing policy is clarified through language providing for indemnity payments for eggs destroyed as a result of HPAI; and 3) poultry/egg owners and contractors of large facilities must each provide statements that prior to the detection of HPAI in their facility, they had in place, and were following, a biosecurity plan.

By way of authority, APHIS administers HPAI indemnity payments under 9 CFR 53.  Prior to the February 9, 2016 interim rule, 9 CFR 53 allowed indemnity payments for the costs of purchase, destruction, and disposal of animals and materials required to be destroyed due to HPAI contamination or exposure, but did not specify that an indemnity payment could be divided between a poultry/egg owner and a contractor.

Relatedly, a similar problem previously existed regarding Low Pathogenic Avian Influenza (LPAI).  In 2002, after an LPAI outbreak in Virginia, 9 CFR 56, which governs APHIS LPAI indemnity payments, was amended to allow indemnity payments to both animal owners and contractors (9 CFR 56.8).

Now, because of the February 9, 2016 interim rule, the formula used in 9 CFR 56.8 for dividing LPAI indemnity payments between animal owners and contractors has been incorporated to apply to HPAI (9 CFR 53.11).  As a result, APHIS may now pay a contractor indemnity for their losses associated with HPAI.  Accordingly, after indemnity is paid to a contractor (based on the 9 CFR 53.11 formula), the poultry/egg owner is then eligible to receive the remaining indemnity balance.

Prior to the February 9, 2016 interim rule, as a matter of policy, APHIS included eggs under the general term “materials” for purposes of indemnity payments.  Seeking to provide clarity on the matter, 9 CFR 53 now specifically makes reference to eggs and provides direction for the appraisal value of eggs destroyed due to HPAI (9 CFR 53.3(e)).

Finally, the February 9, 2016 interim rule now requires that for indemnity payment eligibility, both poultry/egg owners and contractors must provide APHIS with a statement that at the time HPAI was detected in their facility, they had in place, and were following, a biosecurity plan.  As a result, barring an exemption, indemnity claims will be denied without these statements (9 CFR 53.10(g)).

Under 9 CFR 53.10(g), only large poultry operations must comply with the biosecurity requirement.  Accordingly, poultry facilities are exempted from issuing the biosecurity statements if the operation is: 1) a commercial table egg facility with fewer than 75,000 birds; 2) a facility that raises for release upland game birds and has fewer than 25,000 upland game birds annually; 3) a facility that raises for release water fowl and has fewer than 25,000 water fowl birds annually; 4) a broiler facility that raises fewer than 100,000 broilers annually; or 5) a meat turkey facility that raises fewer than 30,000 turkeys annually. 

APHIS has stated that the purpose of the February 9, 2016 interim rule was “to solidify policies surrounding the payment of indemnity and further strengthen biosecurity adherence at poultry operations.” The comment period on the interim rule ends April 11, 2016.  

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.”

Food Policy Update: Federal 2015-2020 Dietary Guidelines Endorse Lean Meats, Lean Poultry, and Eggs

Written by M. Sean High - Staff Attorney

On January 7, 2016, the Federal Government released the 2015-2020 Dietary Guidelines for Americans, 8th Edition.  Published every five years for public health officials, the Federal Dietary Guidelines are produced in a joint effort between the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA).  

According to the 2015-202 Dietary Guidelines for Americans:

The main purpose of the Dietary Guidelines is to inform the development of Federal food, nutrition, and health policies and programs. The primary audiences are policymakers, as well as nutrition and health professionals, not the general public. The Dietary Guidelines is a critical tool for professionals to help Americans make healthy choices in their daily lives to help prevent chronic disease and enjoy a healthy diet. It serves as the evidence-based foundation for nutrition education materials that are developed by the Federal Government for the public.

While the Dietary Guidelines are not legally binding regulations, they are extremely influential in determining what food is made available through Federal food programs such as the school lunch program.  Just as important, the Dietary Guidelines can have a significant effect on consumer perceptions and often sway food purchasing decisions.  

Of significance to the agricultural industry, the 2015-2020 Dietary Guidelines for Americans stated that “[f]or those who eat animal products, the recommendation for the protein foods subgroup of meats, poultry, and eggs can be met by consuming a variety of lean meats, lean poultry, and eggs.”

On January 7, 2016, the National Cattleman’s Beef Association issued a press release praising “HHS Secretary Sylvia Burwell and USDA Secretary Tom Vilsack for ensuring the final recommendations were based on the latest nutrition evidence available.”  The press release quoted Texas cattle producer and physician Dr. Richard Thorpe who expressed his appreciation that the guidelines were based on the latest nutrition science.  Dr. Thorpe stated that “[n]umerous studies have shown positive benefits of lean beef in the diet, and I commonly encourage my patients to include beef in their diet to help them maintain a healthy weight and get the nutrients they need to be physically active.”

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. 

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.

McDonald’s Plans To Go Cage-Free

Written by Katharine Richter

On September 9, 2015, according to a McDonald’s press release, the company stated in ten years all eggs used by the company in the United States and Canada will be laid by cage-free chickens.  This goal will affect 16,000 restaurants in U.S. and Canada.  According to the press release, “McDonald’s USA purchases approximately two billion eggs and McDonald’s Canada purchases 120 million eggs…”  McDonald’s U.S. President, Mike Andres, stated that the decision comes from customers who are “increasingly interested in knowing more about their food” and also enforcing emphasis on food quality.

The Humane Society of the United States, in a press release, announced it applauded McDonald’s decision and were “optimistic that the switch can occur even quicker” than the proposed ten years.  After McDonald’s announcement, the Massachusetts Society for the Prevention of Cruelty to Animals, in coalition with numerous other groups, proposed a ballot initiative that would “curb extreme confinement and lifelong immobilization of animals at industrial-style factory farms.”  The goal is for the proposal to be included on the 2016 statewide ballot but it will need 90,000 signatures to qualify.

Not all groups are applauding the announcement by McDonald's.  Ken Klippen, president of the National Association of Egg Farmers, wrote an open letter to McDonald's.  In the letter he comments on how McDonald’s has ignored science and cage-free chickens will not bring better quality eggs, nor a safer, less stressful environment for chickens.  Other major agricultural groups have commented with concerns on McDonald’s decision and the proposed ballot initiative, such as rising costs for consumers and farmers and diminution of choice in animal living configurations.

Jail Times for Egg Crimes

Written by Stephen Kenney
On June 3, 2014, Austin “Jack” DeCoster and Peter DeCoster pled guilty in Federal Court to their connection with the “distribution of adulterated eggs in interstate commerce.”  The father and son officially pled guilty to one count of bribery of a public official, one count of introducing a misbranded food into interstate commerce with intent to defraud, and one count of introducing adulterated food into interstate commerce.  They were charged after it was found that a nationwide Salmonella outbreak was linked to their Iowa based company, Quality Egg LLC.  The U.S. Centers for Disease Control and Prevention (CDC) estimated that nearly 2,000 people were sickened by the outbreak that was linked to the company’s eggs. They were sentenced three months in jail and one year of supervised probation along with fines.

The government’s memorandum regarding sentencing noted that Quality Egg had disregarded safety standards and practices for years and had misled major customers, including Walmart, about the LLC’s food safety practices.  On April 13, 2015, U.S. District Court Judge Mark W. Bennett sentenced the father and son to three months in prison and one year of probation. 

The family and LLC paid $7 million in fines in April, but are appealing the prison sentence.  The appeal will be heard by the Eighth Circuit U.S. Court of Appeals in St. Louis.  The Department of Justice filed a 60 pagebrief on September 18, 2015, in support of the prison sentences.  The brief states that Quality Egg was “producing SE positive eggs” at a rate of contamination “approximately 39 times higher than the current national incidence rate.”  The barn facilities were also found to be extremely contaminated with “63 percent of the wash water, feed samples, feed ingredients and pullet houses showing widespread SE contamination.” 

The DeCosters argue that incarceration would be unconstitutional because neither man had any knowledge of the violations.  They argue that the sentences would be based on “strict liability” which would violate the Due Process Clause and the Eighth Amendment of the Constitution.  The Eighth Amendment prohibits the government from imposing cruel and unusual punishments. 

General Mills Announces Commitment to Cage-Free Eggs in U.S.

On July 7, 2015, General Mills (GM) released an updated global policy on animal welfare that contained an announcement that the company will seek to use only cage-free eggs in U.S. production. The company already only uses free-range eggs for Haagen-Dazs ice cream in Europe.

Unlike organic product labeling which requires USDA certification, cage-free eggs are considered to be a voluntary label, meaning there is no requirement for disclosure. The USDA, however, does have a definition of cage-free eggs, and any claim or label “must be truthful and not misleading,” with verification performed by the USDA’s Food Safety Inspection Service.

GM joins companies such as Starbucks, Kellogg, Nestle, Dunkin’ Donuts, and Walmart in this commitment. There has been no announcement regarding when the company would like to complete the transition, but GM did state that given the recent disruption in the U.S. egg supply due to avian influenza, the company will work with suppliers to establish “a reasonable timeline toward this commitment.”

The full policy can be read here.

Written by Tyler R. Etter
July 9, 2015