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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Agricultural Law Weekly Review—April 21, 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:

Medical Marijuana: Pennsylvania Establishes Medical Marijuana Program

On April 17, 2016, Pennsylvania Governor Tom Wolf signed into law the establishment of the Commonwealth’s medical marijuana program (Act 16).  Under the enacted legislation, only persons holding a permit from the Department of Health of the Commonwealth (the Department) may grow or process medical marijuana.  Accordingly, the Department is only authorized to issue 25 permits throughout the entire state and must charge each permit holder a $10,000 permit application fee, a $200,000 permit fee, and a $10,000 yearly permit renewal fee.

Legislation: Committee Approves Agricultural Appropriations Bill

On April 19, 2016, United States House of Representatives Committee on Appropriations approved the Fiscal Year 2017 Agriculture Appropriations Bill (the Bill).  Of note, approval of the Bill included amendments that: 1) prevent the slaughter of horses for human consumption; 2) delay a new rule by USDA to change the requirements for approved SNAP retailers; and 3) prevent a Grain Inspection, Packers and Stockyards Administration regulation that would place restrictions on poultry, beef and pork marketing arrangements.

Dairy Production: USDA Updates Margin Protection Program for Dairy

On April 13, 2016, the United States Department of Agriculture Commodity Credit Corporation published notice in the Federal Register “amend[ing] the regulations for the Margin Protection Program for Dairy (MPP-Dairy) to allow dairy operations to update their production history when a son, daughter, grandchild, or spouse of a child or grandchild of a current producer participating in the MPP-Dairy program joins the operation” (81 FR 21699).  Additionally, the final “rule provides for a later due date for the payment of the entire premium and clarifies that dairy operations that purchase buy-up coverage on less than 90 percent of their production history will also receive catastrophic coverage on the balance, up to 90 percent of the production history.” The final rule became effective April 13, 2016.

Fruit Importation: APHIS Reopens Comment Period Regarding European Apples and Pears

On April 15, 2016, the United States Department of Agriculture animal and Plant Health Inspection Service published notice in the Federal Register that the agency was “reopening the comment period for our proposed rule that would amend the regulations to allow the importation of fresh apple and pear fruit from certain countries in the European Union into the continental United States, provided that the fruit is produced in accordance with a systems approach, as an alternative to importation under the current preclearance program” (81 FR 22203).  The proposed rule in question was originally published in the Federal Register January 20, 2016 (81 FR 3033).  The reopened comment period for the proposed rule closes May 5, 2016.

Marketing Order: USDA Adopts Final Rule on Tart Cherries

On April 18, 2016, the United States Department of Agriculture Agricultural Marketing Service published notice in the Federal Register that the agency was “adopting, as a final rule, without change an interim rule implementing a recommendation from the Cherry Industry Administrative Board (Board) that revised the exemption provisions under the marketing order for tart cherries grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin” (81 FR 22511).  Accordingly, “[t]he interim rule changed the number of years that new market development and market expansion projects are eligible for handler diversion credit from one year to three years…[and] revised the composition of the subcommittee which reviews exemption requests.” The effective date for the affirmation of the interim rule as final rule was April 19, 2016.

Animal Drugs: FDA Publishes Final Rule for New Animal Drugs

On April, 18, 2016, the Department of Health and Human Services Food and Drug and Administration (FDA) published notice in the Federal Register of a final rule “amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016” (81 FR 22520).  According to the final rule, “FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.” The final rule became effective April 18, 2016.

FSMA: OSHA Publishes Final Rule for Employee Protection

On April 18, 2016, the United States Department of Labor Occupational Safety and Health Administration published notice in the Federal Register “provid[ing] the final text of regulations governing the employee protection (retaliation or whistleblower) provision found at section 402 of the FDA Food Safety Modernization Act (FSMA)” (81 FR 22530). The final rule became effective April 18, 2016.

Farmland Preservation: 32 New PA Farms Added to Protected List

On April 15, 2016, the Pennsylvania Department of Agriculture (PDA) issued a press release announcing that “an additional 1,792 acres on 32 farms in 14 counties were safeguarded through the state’s nation-leading farmland preservation program.”  According to PDA: “[s]ince the program began in 1988, federal, state, county and local governments have invested more than $1.3 billion to preserve 520,619 acres on 4,951 farms in 57 counties for future agricultural production.”  

Vermont Farm Agrees to Settlement with DOJ Regarding Tainted Animals Sold for Human Consumption

M. Sean High – Staff Attorney

One day after the Department of Justice (DOJ) filed a complaint for permanent injunction to prevent a Vermont dairy farm’s use of unauthorized animal drugs in animals sold for human consumption, the parties filed an agreed upon settlement.

On December 7, 2015, on behalf of the United States of America, DOJ filed a complaint in the United States District Court for the District of Vermont requesting a permanent injunction against Correia Farm Limited Partnership for allegedly violating the Federal Food, Drug, and Cosmetic Act (FDCA) by administering unapproved new animal drugs which resulted in unsafe drug residue levels in animals slaughtered for human consumption.   

On December 8, 2015, the parties filed a settlement consent decree for permanent injunction.  As part of the settlement, Correia Farm Limited Partnership agreed to a heightened level of Federal Drug Administration (FDA) oversight and scrutiny of their operation and to cease operations until the implementation of FDA approved “record-keeping and operational protocols designed to ensure consumer safety.” Significantly, Correia Farm Limited Partnership agreed not to resume food production (excluding milk) until an FDA determination that the operation’s manufacturing practices have come into compliance with the law.  

The agreed upon consent decree for permanent injunction now awaits judicial approval from the U.S. District Court for the District of Vermont.

FDA Publishes Final Rule on Veterinary Feed Directive

On June 3, 2015, the Food and Drug Administration (FDA) published the final rule for the Veterinary Feed Directive (VFD). The VFD places the use of antimicrobial drugs in or on the feed of food-producing animals (VFD drugs) under veterinary oversight. The rule is part of a broader effort on the part of the FDA to eliminate antimicrobial drug use in a productive capacity, such as promoting animal growth.

The final rule outlines the authorization process of VFD drug use and provides veterinarians with a national framework regarding the authorization of drug use for specific animal health purposes.  VFD drugs can be issued only in the context of a veterinarian-client-patient-relationship (VCPR). The rule provides the key elements that constitute the relationship.

The final rule also requires that veterinarians follow the state-defined requirements for a VCPR. The FDA will defer to the state’s judgment regarding conduct standards for veterinarians so long as the state meets the federal VCPR. In the event that a state fails to meet the standard, the FDA will require veterinarians to adhere to the federal standard.

The FDA will begin enforcement of the VFD final rule in December of 2016 to allow adequate time for industry to adjust to the new regulations. The full text of the final rule can be found here. For the outline of the FDA’s “current thinking” on industry compliance for the final rule, see the draft guidance available here.

Written by Tyler R. Etter- Research Assistant
June 15, 2015

FDA Revokes Approval of Three Arsenic-Based Animal Drugs

On September 30, the Food and Drug Administration withdrew approvals for three of four animal drugs that contain arsenic. The revocation came after the companies that market the products asked the FDA to withdraw their approval. The FDA denied a Citizen Petition to remove the four arsenic-based animal drugs from the market because the issue became moot after the sponsoring companies requested the removal of three of the drugs in question. The FDA is in the process of completing several scientific studies to help the agency better understand the potential concerns related to the safety of arsenic-based drugs. After these studies, the FDA states that it will initiate proceedings to withdraw the approval of the only remaining arsenic-based animal drug on the market, nitarsone, if there are grounds for its removal.

The arsenic-based drugs that were removed are:
 -  Roxarsone
 -  Arsanilic acid
-  Carbarsone

For more information, please see the FDA Citizen Petition Response.

Written by Sarah L. Doyle - Research Assistant

The Agricultural Law Resource and Reference Center

@PSUAgLawCenter

October 3, 2013