Top 5 Legal Issues for Illinois Farmers in 2017
Macon Co. Farm Bureau
March 21, 2017
By Cari B. Rincker, Esq.
Who I Am• Grew up on a beef cattle
farm in Shelbyville, Illinois– Advanced degrees in animal
science• Past-Chair of the ABA,
General Practice, Solo & Small Firm Division’s Agriculture Law Committee
• Client bases ranges from farmers, food entrepreneurs to small to mid-size agri-businesses
Top 5 Legal Issues For Illinois Farmers
Veterinary Feed Directive
Syngenta Litigation
Waters of the United States (“WOTUS”)
Planning Against the Big D’s
More Than a Handshake
Veterinary Feed Directive
Timeline
This second VFD rule became effective on
October 1, 2015
December 2016 is the target for drug
sponsors to implement changes to
use conditions of products
January 1, 2017 target for switching OTC
drugs to VFD
Stakeholder Requirements
Veterinarians
Livestock Producers
Feed Distributors
Drug Manufacturers
Veterinary RequirementsMust be in compliance with the state’s veterinarian-client-patient relationship (“VCPR”) requirements pursuant to § 530.3(i)
If state doesn’t require a VCPR then FDA now requires that the VFD be issued within context of Federally defined VCPR, which requires:• Engage with livestock producer and assume responsibility for making
medical judgment about the animal’s health.• Have sufficient knowledge of the animal by virtue of examination and/or
visit the facility where the animal is managed to initiate a preliminary diagnosis.
• Provide for any necessary follow-up evaluation or care.
21 § CFR 558.6(b)
Veterinary Requirements
The veterinarian must also provide a written
veterinary feed directive (“VFD”).
The VFD must be in compliance with the
conditions for approved use, conditionally
approved use or indexed use under the ADAA.
21 CFR 558.6(a)
Veterinary Requirements
Extra-labeling Use is not permitted • I.e., Use of feed containing a VFD
drug in a manner other than as directed on the label is not permitted.
21 C.F.R. 558.6(a)
VFD Requirements
• Vet’s and livestock producer/client’s • Name• Address• Telephone number
• Premises at which the animals are located
• Date of VFD issuance• Species and production class of animals
to be fed the VFD feed
Required Informatio
n
VFD Requirements
VFD must include the name of the VFD drug • could be the generic name• can state that a substitution drug
is or isn’t allowed (optional info) • if substitution is allowed then the
feed distributor may choose to substitute if the generic VFD is part of an approved combination
21 CFR 558.6(b)
VFD Requirements
VFD must include an expiration date• The vet can write a date up to 6
months from the date the VFD is initiated.
• Duration determines the length of time the VFD is allowed to be fed to the animals as specified on the product label.
• If no expiration date then 6 mo. is the default
VFD RequirementsVFD Must Include
• Approximate/potential number of animals to be fed by the expiration date of the VFD on a premises• Also needs the expiration date
• Indication for which the VFD is issued • Drug level• Duration of use
• Note: Duration is different than expiration date• Withdrawal time• Special instructions/cautions• Number of reorders (refills) authorized – if permitted by the drug
approval
VFD Requirements
VFD Must Include
this Statement
• “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel) is not permitted.”
VFD Requirements
VFD must include:• An affirmation of
intent for combination VFD drugs
• Veterinarian’s electronic or written signature
Veterinary RequirementsAffirming Intent on the VFD
Choice 1: “This VFD only authorizes the use of the VFD drug(s) cited in this order and is not intended to authorize the use of such drugs in combination with any other animal drugs.”
Choice 2: “This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.” [List specifics ______________________ ______________________________________________________]
Choice 3: “This VFD authorizes the use of the VFD drug(s) cited in this order in any FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.”
VFD Requirements
VFD must include premises ID but may include more information of the animals • This is so someone can locate the animals,
if needed.• May include specific information, such as
the pen or description of where the animals are currently located.
• If the VFD is intended to authorize the use of a VFD feed in a group of animals that are located at more than one physical location, then the VFD can specify more than one pen so long as the feed is supplied by a single feed distributor.
Optional VFD Information
VFD may provide the following additional information:
• Approximate age/weight range of the animals
• Any other information the veterinarian deems appropriate to identify the animals specified in the VFD
Veterinary Requirements
Please note that the VFD no longer requires the veterinarian to state the amount of feed to be fed to the animals
• Instead, the burden is on the distributor to determine the proper amount of feed to manufacture and distribute to the producer
Veterinary Requirements
Importantly, is not a required VFD Form• Guidance for the Industry
(“GFI”) #233 lists several recommended common formats for the VFD
• Veterinarian can create his/her own VFD form but should have it reviewed by an attorney for compliance
Veterinarian RequirementsCopy of the VFD must go to the client (producer) and feed distributor• Can be delivered hard-copy, facsimile or
electronic (e.g., email)• Transmitted to the distributor and client
gets copy
Must maintain VFD records for 2 years
• Must retain original VFD • Other segments can keep copies but the
veterinarian must keep original
21 C.F.R. 558.6(a)
Producer Requirements
Feed animal feed containing a VFD drug only to animals based upon a duly issued VFD from a licensed veterinarian
Maintain all VFD records for 2 years
• Keep copy in original form (hard copy v. original)
• Must be available for inspection and copying by FDA upon request
21 CFR 558.6(a)
Producer Requirements
Prohibited from feeding a VFD after an expiration date• The expiration defines the period
of time for which the authorization to provide an animal feed containing a VFD drug is lawful.
• Expiration date specifies the last day the VFD feed can be fed to a group of animals.
Producer Requirements
Veterinary Feed Directive Issuance
VFD should
state the expiration
date
Feed DeliveryMedicated feed being delivered
in different
increments
FeedingExpiration
Date
21 CFR 558.6(a)
Note: Was the duration prescribed different than the expiration date?
Syngenta Litigation
Syngenta Litigation
• In 2013, China refused to accept shipment of corn that contained Syngenta’s MIR 162 trait found in Veptera and Duracade because the GMO had not yet received a safety certification due to incomplete submission of materials and statistics by Syngenta.
Syngenta Litigation• China rejected 887,000 tonnes of
US corn shipments due to the presence of MIR 162 trait.
• This loss of China as a trade partner caused a decrease in demand in the United States for corn.– This arguably caused a decrease in
the market price of all U.S. corn, regardless of its variety and who the corn seed was bought from.
– Allegedly causing more than $1 billion in losses for US farmers.
Syngenta Litigation
• Cargill v. Syngenta• Trans Coastal v. Syngenta
Lawsuits by
Companies
• U.S. farmers have also filed a class action lawsuit against Syngenta in federal courts in 11 states – consolidated into Kansas case and class certified.
Lawsuits by
Farmers
Class Certification
• Federal court certified 9 classes, including a nationwide producer class– Any producer who priced corn for sale after November
18, 2013 and who did not purchase Viptera or Duracade corn seed.
– Any person falling within this definition is automatically included in the lawsuit as a class member.
• Eligible producers should have been notified and have until April 1, 2017 to “opt out” of the class – No action to “opt in”
Are You In or Are You Out?
• Represented by named counsel • No control over settlement; no costs to the producer
Remaining in Class
Action
• Producer won’t share any in of the $$ recovery• May go to court and file his or her own individual claim
against Syngenta• Own lawyer• Own decision about settlement• Own costs
Opting Out
Waters of the United States (“WOTUS”)
WOTUS LitigationRapanos v. United States, 547 U.S. 715 (2006)• Facts: John Rapanos sought to fill in
three wetland areas on his property in order to build a shopping mall. He was warned by Michigan Department of Environmental Quality that the area was federally protected land, which he ignored along with a cease-and-desist order from the U.S. Environmental Protection Agency, which resulted in a civil suit against him by the United States.
WOTUS Litigation
Rapanos v. United States, 547 U.S. 715 (2006)
• Argument: Rapanos argued that the Clean Water Act gives government jurisdiction to regulate only traditionally navigable water, while the government argued that Rapanos’s lands were covered by the CWA as “adjacent wetlands.” The District Court upheld the government interpretation of the Act.
WOTUS LitigationRapanos v. United States, 547 U.S. 715 (2006)• Appeal: The case was
appealed to the Supreme Court of the United States where in a 5 to 4 opinion the Supreme Court held that: the definitional term “waters of the United States” can only refer to “relatively permanent, standing or flowing bodies of water,” not “occasional,” “intermittent,” or “ephemeral” flows.
New Rule to Define WOTUS
• The rule, published on June 29, 2015 and becoming effective on August 28, 2015, identifies six types of waters that are categorically within federal jurisdiction and two categories of water for which a case-by-case determination is required.
New Rule to Define WOTUS
Case-by-case analysis is required if the water in question is either:• a member of a series of named
formations such as prairie potholes, Carolina and Delmarva Bays, pocosins, western vernal pools in California, or Texas coastal prairie wetlands; or
• a water body that, due to its location within a certain distance from a high tide or high water mark of a jurisdictional water, has a “significant nexus” to that water.
New Rule to Define WOTUSHaving a significant nexus means “that a water, including wetlands, either alone or in combination with other similarly situated waters in the region, significantly affects the chemical, physical, or biological integrity of [waters used in interstate or foreign commerce, interstate waters, and the territorial seas].”
New Rule to Define WOTUS
• On August 28, 2015, the WOTUS Rule went into effect in all states except 13, where a federal district court in North Dakota granted a preliminary injunction blocking the implementation of the new rule.
• The 13 states (Alaska, Arizona, Arkansas, Colorado, Idaho, Missouri, Montana, Nebraska, Nevada, New Mexico, North Dakota, South Dakota, and Wyoming) claimed that the new WOTUS rule is a threat to state sovereignty because it asserts federal jurisdiction over wetlands and waters that should be subject to state government control.
Temporary
Injunction of
WOTUS Rule
Trump’s Executive Order
• In February 2017, President Trump signed an executive order directing the EPA to reconsider WOTUS– It does not repeal the rule– It may be years before we
know the result of this reconsideration
Planning Against the Big D’sDeath
Debt
Destruction
Divorce
Disability
DeathEstate Planning• Last Will and Testament• Advanced Directives
• Power of Attorney• Medical Power of Attorney/ Living Will
• Trusts
Succession Planning• Business Planning?• Shifting Management/ Training • Operations Manual
Estate and succession planning mediation?
DestructionWhen is the last time you did an insurance review?• Have your activities changed? (e.g., agritourism, roadside food
stand)• Comprehensive Farmowners Insurance Policy• Commercial Insurance Policy• Food product liability insurance• Cyber insurance
Umbrella policies• They don’t fill in holes- they are more like a top hat in your
current coverage!
Divorce
Prenups are not taboo• Divorce can heavily impact family farms
Go about divorce the right way• Consider Alternative Dispute
Resolution
More Than a Handshake
• Land• Livestock• Fam Machinery
Purchase Agreements
• Farm Lease• Bull/Boar/Horse Leases• Farm Machinery Leases• Grazing Leases
Leases
Specialized Contracts
Custom Feeding
Arrangements
Stocker Cattle
Contracts
Embryo Transfer
Contracts
Non-Disclosure
Agreements
Partnership Agreements• A partnership arises when
two or more people agree to share profits and losses in a business
• Types of partnerships:– General Partnership– Limited Partnership– Limited Liability Partnership
Please Stay in [email protected]
Illinois Office:301 N. Neil Street, Suite 400Champaign, IL 61820(217) 531-2179
Twitter: @CariRincker @RinckerLawwww.facebook.com/rinckerlaw http://www.linkedin.com/in/caririnckerSnapchat + Periscope: CariRincker IG: @CariRincker + @RinckerLawYouTube: /CariRincker
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