Thursday, January 19, 2017

Agricultural Law Weekly Review—January 19, 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:

Water: Supreme Court to Hear WOTUS Case
On January 13, 2017, the Supreme Court of the United States agreed to hear a petition regarding the proper venue for challenging the Environmental Protection Agency’s Waters of the United States rule (WOTUS) (National Association of Manufacturers v. Department of Defense, Docket No. 16-299).  According to the Court, the issue involves “whether the U.S. Court of Appeals for the 6th Circuit erred when it held that it has jurisdiction under…the Clean Water Act's judicial review provision…to decide petitions to review the waters-of-the-United-States rule, even though the rule does not ‘issu[e] or den[y] any permit’ but instead defines the waters that fall within Clean Water Act jurisdiction.”

COOL: USDA Proposes Provisions to Include Venison Meat
On January 13, 2017, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published notice in the Federal Register that the agency was proposing “to amend the country of origin labeling (COOL) regulation to add muscle cuts of venison and ground venison to mandatory COOL requirements” (82 FR 4198).  The comment period for the proposed rule closes March 14, 2017.

Quarantine: Pennsylvania Deer Tests Positive for Chronic Wasting Disease
On January 13, 2017, the Pennsylvania Department of Agriculture (PDA) announced that a deer harvested on a hunting preserve in Franklin County, has tested positive for Chronic Wasting Disease (CWD).  According to PDA, this is “the first new case [of CWD] in a captive deer farm since 2014.” The deer, which was harvested in November 2016, was “raised on a deer farm in Fulton County until it was sold to the Franklin County facility in August 2016.” PDA stated that both farms are currently under quarantine.

Trade: U.S. to Lift Ban on French Beef
On January 13, 2017, the European Commission (EC) issued a statement that the United States was removing a 19 year-old ban on the importation of beef from France.  According to EC, “[t]he American market has been closed to beef from the EU since January 1998, the date on which the United States introduced restrictions on the import of bovine, ovine and caprine meat following the Bovine Spongiform Encephalopathy (BSE) epidemic.”

Organic: USDA Proposes Rule for Organic Research, Promotion, and Information Order
On January 18, 2017, the United States Department of Agriculture (USDA) Agricultural Marketing Service (AMS) published notice in the Federal Register “invit[ing] comments on procedures for conducting a referendum to determine whether the issuance of a proposed Organic Research, Promotion, and Information Order is favored by certified organic producers, certified organic handlers, and importers of certified organic products” (82 FR 5438).  The comment period for the proposed rule closes March 20, 2017.

Medical Marijuana: PDH Publishes Amendments to Temporary Regulations  
On January 14, 2017, the Pennsylvania Department of Health (PDH) published notice in the Pennsylvania Bulletin regarding amendments to the temporary regulations under the Medical Marijuana Act relating to general provisions; and growers/processors (47 Pa.B. 199).  According to PDH, “Interested persons are invited to submit written comments, suggestions or objections regarding the amendments to the temporary regulations to John J. Collins, Office of Medical Marijuana, Department of Health, Room 628, Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120, (717) 787-4366, RA-DHMedMarijuana@pa.gov.”   

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Agricultural Law in the Spotlight—FSMA Regulatory Update

Written by Errin McCaulley – Research Assistant

On January 19, 2017 the Food and Drug Administration (FDA) announced the issuance of draft guidance titled Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations (FDA-2017-D-0175). Specifically, FDA has published this draft guidance to aid sprout operations comply with Subpart M (21 C.F.R. §§ 112.141-112.150) of the Produce Safety Rule. Interested parties wishing to comment upon this draft guidance may do so through https://www.regulations.gov/. Alternatively, written comments should be submitted to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should include reference to docket number FDA-2017-D-0175.

Scope of Draft Guidance

Generally, Subpart M applies to operations engaged in the “growing, harvesting, packing and holding of all sprouts,” as those terms are defined in the Rule, not otherwise exempted from coverage. Subpart M does not, however, apply to sprouts that are grown in soil or non-soil substrates which are harvested above the soil or substrate line without roots. This draft guidance does not cover all other applicable requirements for sprout operations under the Produce Safety Rule, such as Subpart F (relating to biological soil amendments), but does include reference to key provisions which are supplemented by Subpart M. For example, Subpart M includes sprout-specific building, tools, and equipment standards (21 C.F.R. § 112.143(a)-(b)) that apply in addition to Subpart L’s buildings, tools, and equipment standards (21 C.F.R. § 112.122). The majority of this draft guidance is devoted to the various testing requirements under Subpart M relating to E. coli, Salmonella, Listeria, and L. monocytogenes. Lastly, this draft guidance includes advice regarding voluntary compliance with Subpart M for sprout operations that are otherwise exempted from coverage under the Produce Safety Rule.

Tuesday, January 17, 2017

Agricultural Law in the Spotlight – FSMA Regulatory Update

Written by M. Sean High—Staff Attorney

On January 17, 2017, the Center for Agricultural and Shale Law posted two new Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) guidance documents on the Center’s FSMA Library Guide.

The first document posted is entitled Guidance for Industry and FDA Staff: Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.  The resource contains nonbinding recommendations regarding FDA’s “voluntary program for the accreditation of third-party certification bodies, also known as auditors, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce.”  According to FDA, “[t]hese requirements will help ensure the competence and independence of the accreditation bodies and third-party certification bodies participating in the program.”

The second document posted is entitled Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods.  According to FDA, the draft guidance is intended for those subject to regulation 21 CFR part 117, entitled Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and for those “who manufacture, process, pack, or hold ready-to-eat (RTE) foods.” The document is not for implementation and is being distributed for comment purposes only. 

According to FDA the “guidance is not directed to processors of RTE foods that receive a listericidal control measure applied to the food in the final package, or applied to the food just prior to packaging in a system that adequately shields the product and food contact surfaces of the packaging from contamination from the food processing environment.” FDA stated that “the guidance also is not intended for food establishments that are not subject to part 117, such as farms.” 

The Center for Agricultural and Shale Law's FSMA Library Guide is intended to represent a collection of legal resources relating to FSMA and FDA food and safety regulations.  To view the FSMA Library Guide, please click here

Thursday, January 12, 2017

Agricultural Law Weekly Review—January 12, 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:

Government: PA Congressman Thompson Named Vice Chairman of House Agricultural Committee
On January 11, 2017, United States House Agricultural Committee Chairman K. Michael Conway (R-TX) issued a press release announcing new and returning Republican members serving on the House Agricultural Committee.  Included in Chairman Conway’s statement was an announcement that Glenn ‘GT’ Thompson (R-PA) would serve as Vice Chairman of the committee for the 115th Congress.  Previously, Thompson served three terms as Chairman of the House Agriculture Committee’s Subcommittee on Conservation and Forestry.

Food Policy: Report Calls for Reducing Milk in WIC Program
On January 5, 2017, the National Academies of Sciences, Engineering and Medicine (NASEM) issued a report regarding the Special Supplemental Nutrition Program for Women, Infants and Children (WIC).  The study was conducted as a result of a contractual agreement between NASEM and the United States Department of Agriculture's (USDA) Food and Nutrition Service (FNS).  According to the report summary, the study recommended reducing the amount of juice, milk, and peanut butter provided by the program.  Instead, the study recommended increasing the provision of vegetables, fruits, seafood, and whole grains.  Additionally, the study suggested that milk could be replaced with yogurt and soy beverages. 

GMOs: Federal Appeals Court Allows Class Action to Continue
On January 3, 2017, the United States Court of Appeals for the Ninth Circuit ruled that a class action against ConAgra Foods labeling of Wesson-brand cooking oil could continue.  The class action in question alleges that labels on Wesson-brand cooking oils stating “100% Natural” were false and misleading because the products were made from genetically modified organisms (GMOs).  The plaintiffs claim that because of this action “ConAgra has violated state consumer protection statutes, breached express and implied warranties, and been unjustly enriched.”   

Pesticides: EPA Releases Final Rule on Tetraconazole
On January 10, 2017, the Environmental Protection Agency (EPA) published notice in the Federal Register of a final rule establishing tolerances for residues of tetraconazole in or on vegetable, fruiting (Crop Group 8-10) ,and cucurbit (Crop Group 9) (82 FR 2900).  Additionally, the final rule “revises the tolerance for residues on beet, sugar, root; beet, sugar, dried pulp; and beet, sugar molasses.”  The regulation is effective January 10, 2017.

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Thursday, January 5, 2017

Agricultural Law Weekly Review—January 5, 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:

International Trade: Public Hearing Scheduled on EU Beef Import Ban
On December 28, 2016, the Office of the United States Trade Representative (USTR) published notice in the Federal Register of a public hearing to discuss the possible reinstatement of trade actions against the European Union (EU) for bans on beef importation (81 FR 95724).  According to the notice, currently “[t]he EU bans the import of beef and beef products produced from animals to which any of six hormones have been administered for growth-promotion purposes.” The announced meeting is scheduled to take place before the Section 301 Committee, in Washington D.C., on February 15, 2017.

Raw Milk: PDA Issues Warning about Contaminated Cheese
On December 29, 2016, the Pennsylvania Department of Agriculture (PDA) issued a consumer warning regarding certain batches of raw milk cheese produced by Stone Meadow Farm in Centre County.  According to PDA, samples taken from the dairy by department inspectors tested positive for the bacteria Staphylococcus Aureus.  PDA stated that “[n]o illnesses have been reported that could be associated with the cheeses, which were sold between October 2016 and mid-December 2016.”

Labeling: FDA Extends Comment Period for Labeling of the Term “Healthy”
On December 30, 2016, the United States Food and Drug Administration (FDA) published notice in the Federal Register that the agency is extending the comment period regarding the use of the term “healthy” in the labeling of human food products (81 FR 96404).  Previously, the comment period was scheduled to close on January 26, 2017.  As a result of the FDA action, the comment period has been extended an additional 90 days until April 26, 2017.

Labeling: FDA Clarifies Compliance Date for Nutritional Labeling of Menu Items
On December 30, 2016, the United States Food and Drug Administration (FDA) published notice in Federal Register of a final rule clarifying the compliance date for the labeling of certain nutritional information for menu items in certain restaurants and retail food establishments (81 FR 96364).  According to FDA, previous notice stated that enforcement of the labeling regulation would begin on May 5, 2017, but no formal change had been made to the compliance date through rulemaking.  With the most recent notice, FDA formally confirmed that the compliance date for the menu regulation is also May 5, 2017.

Farm Succession: USDA to Offer Early Termination Opportunity for Certain CRP lands
On December 29, 2016, the United States Department of Agriculture (USDA) announced that beginning January 9, 2017 the department “will offer an early termination opportunity for certain Conservation Reserve Program (CRP) contracts, making it easier to transfer property to the next generation of farmers and ranchers, including family members.”  According to USDA, “[t] he land that is eligible for the early termination is among the least environmentally sensitive land enrolled in CRP.” USDA stated, that “[n]ormally if a landowner terminates a CRP contract early, they are required to repay all previous payments plus interest.” Under the new policy, however, repayment is waived “if the land is transferred to a beginning farmer or rancher through a sale or lease with an option to buy.”

International Trade: U.S. Wins Dispute Regarding Indonesia Trade Barriers to Agricultural Products
On December 22, 2016, the Office of the United States Trade Representative (USTR) announced that “a World Trade Organization (WTO) dispute settlement panel has found in favor of the United States’ challenge to Indonesia’s wide-ranging restrictions and prohibitions on horticultural products, animals, and animal products.” According to USTR, “[t]he United States, working closely with New Zealand as co-complainant, filed this dispute to address trade barriers in Indonesia that restrict the importation of American fruits and vegetables (such as apples, grapes, and potatoes), animal products (such as beef and poultry), and other agricultural products.” USTR stated that “[t]he WTO Panel agreed with the United States on 18 out of 18 claims that Indonesia is applying import restrictions and prohibitions that are inconsistent with WTO rules.”

Animal Drugs: FDA Amends Regulation for Animal Drugs Used in Animal Feed
On December 27, 2016, the United States Food and Drug Administration (FDA) published notice in the Federal Register that the agency “is amending the animal drug regulations to reflect approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed” (81 FR94991).  FDA stated, that where applicable, the agency “is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications.”

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Thursday, December 22, 2016

Agricultural Law Weekly Review—December 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:

Chesapeake Bay: Study finds many PA Farmers have Voluntarily Implemented Water Quality Practices
On December 15, 2016, the Penn State College of Agricultural Sciences announced the results of a new research study that found that “[m]any Pennsylvania farmers in the Chesapeake Bay watershed have voluntarily implemented, at their own expense, practices aimed at improving water quality.” Based largely on a survey response from nearly 7,000 Pennsylvania farmers, the information collected was verified through 700 randomly selected farm visits conducted by Penn State Extension staff members. According to the announcement, the study assists in documenting the voluntary best management practices used by farmers in the Chesapeake Bay watershed that have not been “adequately captured and reported for credit.”

Food Law: Court Dismisses Lawsuit against Philadelphia Soda Tax
On December 19, 2016, the Court of Common Pleas of Philadelphia County First Judicial District of Trial Division-Civil dismissed a lawsuit seeking to invalidate Philadelphia’s recently enacted 1.5% tax on sugar sweetened beverages (Lora Jean Williams, et. al., v. City of Philadelphia, et. al., Control Number 16100940).  The court rejected the plaintiff’s argument that because sugary drinks are already taxed at the state level, and Pennsylvania law prevents duplicate taxes, the tax violated the uniformity clause of the state’s constitution.  As a result of the ruling, the tax is scheduled to go into effect January 1, 2017.  

Medical Marijuana: PA Announces Application Dates for Medical Marijuana Program
On December 21, 2016, Pennsylvania Department of Health (PDH) issued a press release announcing the Medical Marijuana Program permit application dates for growers, processors, and dispensaries.  According to PDH, permit applications will be made available beginning January 17, 2017, and will be accepted from February 20, 2017 until March 20, 2017.  PDH stated that there will 12 permits issued for growers/processors and 27 permits issued for dispensaries.

Water: President Signs Drought Relief into Law
On December 16, 2016, President Obama signed into law the Water Infrastructure Improvements for the Nation Act (S.612).  The law, which is intended “[t]o provide for improvements to the rivers and harbors of the United States, to provide for the conservation and development of water and related resources” contains drought relief provisions applicable to the agricultural industry. 

FSMA: FDA Publishes Updated Training Strategy
On December 21, 2016, the United States Food and Drug Administration (FDA) announced an update to the agency’s Strategy for Food Safety Modernization Act (FSMA) training.  According to FDA, the published update “reflect[s] the progress the progress that has been made in the past year” regarding the implementation of FSMA. 

Trade: U.S. Announces Enforcement Action against China for Rice, Wheat, and Corn
On December 21, 2016, the Office of the United States Trade Representative (USTR) announced that “the Obama Administration [has] launched a new trade enforcement action against the People’s Republic of China at the World Trade Organization (WTO) concerning China’s administration of tariff-rate quotas (TRQs) for rice, wheat, and corn.” According to USTR, China’s government excessively administers price supports for rice, wheat, and corn and that these actions are a breach of “WTO commitments and undermines American farm exports.”

Fees: PDA Announces Fees for Certificates of Free Sale
On December 17, 2016, the Pennsylvania Department of Agriculture (PDA) published notice in the Pennsylvania Bulletin regarding the fees the department will charge persons for the issuance of Certificates of Free Sale (46 Pa.B. 7832).  According to PDA, “[a] Certificate of Free Sale is a formal, official attestation from the Department, confirming that specified Commonwealth-produced food offered for entry into another country complies with applicable laws for distribution of that food in domestic commerce.” Additionally, “[a] Certificate of Free Sale might also address the process or system by which a food is produced.”

Labeling: USDA Encourages “Best if Used By” date label
On December 14, 2016, the United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) announced new guidance “encouraging food manufacturers and retailers that apply product dating to use a ‘Best if Used By’ date label.” With the exception of infant formula, Federal regulations do not require product dating.  Nevertheless, “[f]ood manufacturers frequently use a variety of phrases, such as ‘Sell-by’ and ‘Use-by’ on product labels to describe quality dates on a voluntary basis.” To eliminate consumer confusion, “FSIS is changing its guidance to recommend the use of ‘Best if Used By’ because research shows that this phrase is easily understood by consumers as an indicator of quality, rather than safety.”

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Thursday, December 15, 2016

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 jalapeƱo 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. 

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