This document provides a summary of the National Agriculture Law Update presented at Tennessee College of Law's Agriculture Law & Policy Symposium on October 9, 2015. It discusses several key topics including the Veterinary Feed Directive which establishes new requirements for veterinary oversight of medically important antibiotics in animal feed. It also summarizes litigation over the definition of "waters of the United States" and lawsuits against Syngenta related to its genetically modified corn trait approval in China.
Ricky French: Championing Truth and Change in Midlothian
National Agriculture Law Update
1. National Agriculture Law Update
Tennessee College of Law’s Agriculture Law &
Policy Symposium
October 9, 2015
By Cari B. Rincker, Esq.
2. My Background
• Grew up on a beef cattle
farm in Central Illinois
• Education
– A.S. in Agriculture from
Lake Land College
– B.S. in Animal Science from
Texas A & M
– M.S. in Ruminant (Beef
Cattle) Nutrition from
University of Illinois
– J.D. from Pace Law School
(2007)
3. My Background
• Chair of the American Bar
Association, General Practice,
Solo & Small Firm Division’s
Agriculture Law Committee
• New York & Illinois Offices
• My food and agriculture client
base
– Farmers to ranchers
– Small to mid-size agri-business
– Food entrepreneurs
7. Definitions
Antibiotic
• Can inhibit the growth of bad bacteria that cause infections
and illness.
• Antibiotics belong to a class of drugs called “antimicrobials.”
Antimicrobial
• Any substance of natural, semisynthetic or synthetic origin
that kills or inhibits the growth of microorganisms but
causes little or no damage to the host.
• All antibiotics are antimicrobials, but not all antimicrobials
are antibiotics.
8. The Players
U.S. Department of Agriculture (“USDA”) regulates antibiotics in meat,
poultry, and eggs via two sub-agencies.
• Food Safety Inspection Service (“FSIS”) (Primarily)
• Agriculture Marketing Service (“AMS”)
• Animal and Plant Health Inspection Service (“APHIS”)
Food & Drug Administration is an agency of the Department of Health and
Human Services (“HHS”).
• FDA regulates food and drugs in livestock animals excluding meat, poultry, and eggs (regulated by
USDA).
• Center for Veterinary Medicine (“CVM”) is a sub-agency which oversees the safety and effectiveness
of animal drugs and the approval process.
Centers for Disease Control and Prevention (“CDC”) is also under the HHS
umbrella and safeguards health by monitoring antibiotic resistance.
• National Antimicrobial Residence Monitoring System (“NARMS”) is a sub-agency of the CDC
composed of the FDA, CDC, USDA’s FSIS.
9. Approval of Antibiotics
FDA Must Approve Antibiotics
• Federal Food, Drug, and Cosmetic
Act (“FFDCA” or “FDCA”) prohibits an
animal drug to be sold into interstate
commerce unless is has been
approved by an Approved New
Animal Drug Application (“NADA”).
• FDA does approve the use of
antibiotics in livestock and must
approve all antibiotics (for humans,
animals, and livestock). See 21 CFR §
530.
• This requirement still exists with VFD.
10. Background
Prior to 1996, FDA had 2 options
for distributing animal drugs:
• Over-the-Counter (“OTC”)
• Prescription (Rx)
Federal Food, Drug and Cosmetic
Act (“FDCA”) didn’t require
prescriptions for animal feeds.
• Viewed as being impractical because
feed mills would need to have a
pharmacist onsite to dispense
prescription drugs; thus feeds were OTC.
11. Background
Statutory
History
• In 1996, Congress enacted the Animal Drug
Availability Act (“ADAA”) to facilitate the approval
and marketing of new animal drugs and
medicated feeds.
• This law created a new regulatory category for
animal drugs used in animal feed – veterinary
feed directive (“VFD”) drugs.
• First VFD Rule by Food & Drug Administration
(“FDA”) was published in the Code of Federal
Regulations in 2000.
• The Second VFD Rule was published on June 3,
2015.
12. Background
Under ADAA, VFD drugs are
new animal drugs intended for
use in or on animal feed, which
are limited by an approved
application, conditionally
approved application or index
listing to use under professional
supervision of a licensed
veterinarian.
• VFD drug requires a VFD document by
licensed veterinarian who authorizes
the use.
13. Background
Currently there are a few VFD
drugs (mostly OTC).
• FDA received responses saying that the
VFD process was overly burdensome.
• FDA also received public comment
about public health, use of
antimicrobials/antibiotics in meat
producing animals, and concern for
antibiotic residence.
• New VFD “responded” to these
concerns.
14. Background
A VFD is a written statement issued by
a licensed veterinarian in the court of
the veterinarian’s professional practice
that orders the use of a VFD drug or
combination VFD drug in an animal feed.
•This authorizes the livestock producer to obtain
and use animal feed bearing or containing a VFD
drug or combination VFD drug to treat the
producer’s livestock in accordance with the
approved, conditionally approved application or
index.
15. Background
The final rule published in June 2015 on VFD
is the third of three core documents that the
FDA is using on its judicious use policy for
antibiotics.
Publication 1: Guidance for the Industry
(GFI) #209 “The Judicious Use of Medically
Important Antimicrobial Drugs in Food
Producing Animals”
Publication 2: GFI #213 “New Animal Drugs
and New Animal Drug Combination Products
Administered in or on Medicated Feed or
Drinking Water of Food-Producing Animals:
Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use Conditions
with GFI #209”
17. Veterinary Requirements
Must be in compliance with the state’s veterinarian-client-
patient relations (“VCPR”) requirements.
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)
18. 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)
19. 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)
21. Veterinary 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
Information
22. Veterinary Requirements
VFD must include the name
of the VFD drug.
• Could be the generic name.
• Can state that a substitution drug
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)
23. Veterinary 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.
24. Veterinary Requirements
VFD Must Include
• Approximate number of animals to be fed by the
expiration date of the VFD
• Indication for which the VFD is issued
• Drug level and duration of use
• Withdrawal time
• Special instructions/cautions
• Number of reorders (refills) authorized – if permitted
by the drug approval
26. Veterinary Requirements
VFD must include:
• An affirmation of
intent for
combination VFD
drugs
• Veterinarian’s
electronic or written
signature
27. Veterinary Requirements
VFD must include premises ID but
may include more information
about 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.
28. Veterinarian Requirements
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
29. Veterinary Requirements
Importantly, is not a
uniform rule for the
Veterinary Feed
Directive (“VFD”).
• Just needs to meet the
requirements promulgated in
the regulations.
• Advised that veterinarians
have an attorney review for
compliance.
30. Veterinarian Requirements
Copy 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 VFD
must keep original.
21 C.F.R. 558.6(a)
31. 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)
32. 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.
33. Feed Distributor Requirements
Shall only provide a VFD feed if the VFD
contains all the required information
and conforms to product approval.
Maintain records for 2 years.
• Keep copy in original form (hard copy v. original).
• Must be available for inspection and copying by
FDA upon request.
• Note that manufacturing records only need to be
kept for 1 year under 21 CFR Part 225 if
distributor also manufacturers.
21 CFR 558.6(c)
34. Feed Distributor Requirements
Provide one-time notifications
• To the FDA of the distribution of VFD feeds stating that
it intends to handle/distribute VFD drug-containing
medicated feeds.
• Acknowledgment of distribution limitations for VFD
fees that the purchasers will sell the VFD feeds only to
producers with valid VFD orders or to other distributors
for whom they have acknowledgement notices.
35. Feed Distributor Requirements
Notification must include:
• Distributor’s name and business address
• Distributor’s signature (or agent’s signature)
• Date the notification was signed
Must notify FDA within 30 days of any change in
ownership or business info.
• Must send notification to FDA, Center of Veterinary
Medicine, Division of Animal Feeds.
36. Feed Distributor Requirements
If the distributor is distributing the
VFD feed to another distributor, then
an acknowledgement letter must be
sent from the receiving distributor
under 21 CFR 558.3(b)(11) before
shipment of feed.
Consigner distributor
must retain copy of
acknowledgement
letter for 2 years.
37. Drug Manufacturers
All labeling and advertising for (combination) VFD drugs,
feeds containing (combination) VFD drugs must have the
following cautionary statement:
“Caution: Federal law restricts
medicated feed containing this
veterinary feed directive (VFD)
drug to use by or on the order
of a licensed veterinarian.”
21 CFR 558.6(a)
39. Effective Date Clarification
This second VFD rule becomes
effective on October 15, 2015 for
presently approved VFD drugs.
Effective for OTC drugs switching
to VFD status under GFI #213
when those drugs change status.
• Current target is January 1, 2017.
41. WOTUS Litigation
• Rapanos 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.
42. 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.
43. WOTUS Litigation
• Rapanos 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.
44. 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.
45. 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.
46. New Rule to Define WOTUS
Having 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].”
47. New Rule to Define WOTUS
• On August 28, 2015, the new 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
49. Syngenta Litigation
• In 2013, China refused to
accept shipment of corn that
contained Syngenta’s MIR
162 trait because the GMO
had not yet received a safety
certification due to
incomplete submission of
materials and statistics by
Syngenta.
50. 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.
51. 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 waiting for class certification.
Lawsuits by
Farmers
54. Vermont Litigation
In April 2014, the Vermont State Legislature passed a bill that
will go into effect in July 2016 that requires that all food sold
within Vermont be labeled stating that it contains GMOs.
• The law also prohibits manufacturers from advertising or labeling foods that
contain GMOs as “natural” or “all-natural.”
55. Vermont Litigation
Challenge to Vermont Law
• In June 2014, the Grocery Manufacturers
Association, the Snack Food Association, the
International Dairy Foods Association, and the
National Association of Manufacturers filed a
lawsuit in federal court in Vermont challenging the
constitutionality of Vermont’s law.
56. Vermont Litigation
• Challenge to Vermont Law
– The lawsuit claims that the Vermont GMO labeling law
is:
• Unconstitutional under the First Amendment
• Unconstitutional under the Commerce Clause
• Preempted by the Federal Food, Drug, and Cosmetic Act
(“FFDCA”), the Nutritional Labeling and Education Act
(“NLEA”), the Federal Meat Inspection Act (“FMIA”), and the
Poultry Products Inspection Act (“PPIA”)
– The lawsuit also claims that the ban on “natural”
labeling is unconstitutional under the First
Amendment and Commerce Clause as well.
57. Vermont Litigation
• On April 27, 2015, US District Court in
Vermont issued a decision that mostly favored
the State of Vermont and those in favor of
labeling GMO-containing foods.
– First Amendment Claim
– Commerce Clause Claim
– Supremacy Clause Claim
– “Natural” Labeling Prohibition
58. Vermont Litigation
Second Circuit Appeal
• On June 24, 2015, the Grocery
Manufacturers Association
and other plaintiffs appealed
the decision of the District
Court in the Court of Appeals
for the Second Circuit arguing
that the District Court erred in
concluding that the labeling
mandate was constitutional
and in failing to grant an
injunction.
• Oral argument was on Oct. 8,
2015.
59. GMO Labeling Legislation
Federal GMO Labeling Bill
• In July of 2015, the U.S. House of Representatives passed a bill that would
block any mandatory labeling of food with genetically modified organisms,
including pre-empting Vermont’s state law that goes into effect in 2016.
• The U.S. Senate has yet to vote on the bill.
60. Conditional GMO State Law
Connecticut
• In June of 2013, Connecticut
became the first state to
mandate labeling of foods that
contained GMO ingredients.
• Section 3 of the Bill states that
this law only goes into effect if
four other states also enact
mandatory labeling of foods
containing GMOs that are
consistent with Connecticut’s
statute.
Maine
• In January 2014, Maine
enacted a GMO labeling food
statute that requires at least
five other states to enact
similar legislation or states
that total a population of 20
million people.
61. Country of Origin Labeling
• Food products covered by
the law are:
– Muscle cut and ground
meats (beef, veal, pork,
lamb, goat, & chicken)
– Wild and farm-raised fish
and shellfish
– Fresh and frozen fruits and
vegetables
– Peanuts, pecans, and
macadamia nuts
– Ginseng
62. Country of Origin Labeling
In October 2014, the World Trade Organization
ruled in favor of Canada and Mexico in a
dispute over COOL on meat.
• The WTO stated that these rules unfairly discriminate
against meat imports and give advantage to domestic
meat products.
• However, the WTO Compliance Panel did state that the
labels provide U.S. consumers with information regarding
source of meat therefore dismissing Canada and Mexico’s
claim that the labels did not serve their intended purpose.
63. Country of Origin Labeling
After the October 2014 ruling, the United
States appealed the WTO decision, which
was rejected by the WTO in May 2015.
In June 2015 following the WTO ruling,
the U.S. House of Representatives passed
a bill to repeal COOL for beef, pork, and
chicken in order to avoid possibly $3.6
billion in tariffs imposed by Canada and
Mexico in retaliation. Will likely face
opposition in the Senate.
65. Food Safety
• Raw Milk
• Peanut Corporation
of America Trial
• Food Safety
Modernization Act
66. Food Safety
• Raw Milk
– The federal law prohibits
dairies from distributing
raw milk across state lines
in final packaging, i.e.
ready for consumption.
• It may only be distributed
across state lines if it is going
to be pasteurized or used to
make aged cheese.
67. Food Safety
• Raw Milk
– The sale of raw milk is
completely prohibited in
18 States.
• Alabama, Delaware,
Florida, Georgia, Hawaii,
Indiana, Iowa, Louisiana,
Maryland, Michigan,
Montana, New Jersey,
North Carolina, North
Dakota, Ohio, Virginia,
West Virginia, Wyoming
68. Food Safety
• Raw Milk
– 17 states restrict sale of
raw milk only to the
farm where milk is
produced along with
specific labeling.
• Alaska, Arkansas,
Colorado, Illinois, Kansas,
Kentucky, Massachusetts,
Maine, Missouri,
Mississippi, Nebraska,
New York, Oregon,
Oklahoma, Tennessee,
TEXAS, Wisconsin
69. Food Safety
• Raw Milk
– 16 states allow sale of raw
milk at retail stores
separate from farms where
milk was produced with
appropriate labeling.
• Arizona, California,
Connecticut, Idaho, Maine,
Missouri, New Hampshire,
New Mexico, Nevada,
Oregon, Pennsylvania, South
Carolina, South Dakota,
Utah, Vermont, Washington
70. Food Safety
Litigation
with Raw
Milk
Organic Pastures
v. U.S. Food and
Drug
Administration
In 2012, the U.S.’s largest raw
milk dairy sued the FDA for
failure to respond to petition by
Organic Pasture to have law
changed banning sale of raw
milk across state lines.
Lawsuit v.
Claravale Farm
Company
In April 2015, a Santa Cruz, CA
resident commenced a lawsuit
against Claravale Farm Company
after he became ill with
Campylobacter bacteria from
drinking tainted raw milk that
led back to Claravale’s dairy.
71. Food Safety
• Peanut Corporation of
America Trial
– In 2008, a salmonella
outbreak traced back to
peanut butter
manufactured by the
Peanut Corporation of
America, which killed
nine people and
sickened 714 across 46
states.
72. Food Safety
• Peanut Corporation of
America Trial
– In September 2014, after
a seven week jury trial,
the former CEO of Peanut
Corporation of America,
Stewart Parnell, and his
brother, Michael Parnell,
were found guilty of 76
counts linked to
intentionally shipping out
salmonella contaminated
peanuts
73. Food Safety
• Peanut Corporation of
America Trial
– In September 2015,
Steward Parnell was
sentenced to 28 years in
prison for knowingly
shipping out deadly food.
– Michael Parnell was given
a 20 year sentence, while
Mary Wilkerson, the
plant’s quality assurance
manager, was sentenced
to five years.
74. Food Safety
Food Safety Modernization Act (“FSMA”
pronounced “Fiz-ma”)
• FSMA was signed into law on January 4, 2011 with
purpose of overhauling the United States’ safety
oversight system.
• FSMA requires facilities that produce and sell food
to be registered and it provides regulations for
facilities to ensure food is processed and sold
safely.
75. Food Safety
FSMA
• Analysis of hazards and risk-based preventative controls
• FSMA creates a food safety plan that “food facilities” follow
for identification of hazards in food and preventative controls
to ensure hazards are treated properly.
• FSMA also provides for oversight and management of the
preventative controls requiring that processes to kill
pathogens are monitored with appropriate temperatures
being carefully monitored.
• FSMA requires that a plan be in place for disposing of foods
that are discovered to contain hazardous pathogens.
76. Food Safety
Primary
Producing Farm
“Operation under one management in one general,
but not necessarily contiguous, location devoted to
the growing of crops, the harvesting of crops, the
raising of animals (including seafood), or any
combination of these activities”
This also includes farms that can pack
or hold raw agricultural commodities,
such as fresh produce, and some
manufacturing/processing activities
such as dehydrating grapes for raisins.
Secondary
Activities Farm
An operation not located on the Primary Producing
Farm that is devoted to harvesting, packing, and/or
holding raw agricultural commodities.
Allows facilities that are not
specifically on a farm to qualify under
the farm label and not be subject to
preventative controls.
Definition of “Farm” (exempt)
78. Overview of “Ag Gag” Laws
“Ag gag” refers to anti-whistleblower laws that restrict
employees from taking photographs or videos illustrating
alleged cruelty to animals, food safety issues, and/or poor
working conditions, during the farming process and/or restrict
people such as activists and undercover journalists from
obtaining illegal access (commonly through job application
fraud) onto agricultural operations for this same purpose.
79. Other Existing “Ag Gag” Laws
Kansas
North
Dakota
Montana Iowa Missouri Utah Arkansas
80. Idaho’s “Ag Gag” Law
• In 2012, an animal welfare
group released graphic video
that was taken while
undercover of workers at an
Idaho dairy allegedly
mistreating cows.
• In response to this video, the
Idaho Dairymen’s Association
drafted legislation to
criminalize undercover
investigations in the future,
which the Idaho governor
signed into law in 2014.
81. Idaho’s “Ag Gag” Law
• The law provides that a person commits the
crime of interference with agricultural
production if the person knowingly:
– “Enters an agricultural facility that is not open to
the public and, without the facility owner’s
express consent or pursuant to judicial process or
statutory authorization, makes audio or video
recordings of the conduct of an agricultural
production facility’s operations.”
82. Idaho’s “Ag Gag” Law
This led animal activist groups to file suit against the
state challenging this law for violation of free
speech.
In August 2015, U.S. District Court Judge in Idaho
found that Idaho’s Ag Gag Law was unconstitutional
for criminalizing certain types of speech.
• As of September 2015, the Idaho Attorney General is awaiting
Judge Winmill’s formal order striking down the law before
deciding whether or not to appeal the decision.
84. Cannabis Law/ Medical Marijuana
• Federal Law
– Producing,
distributing, and
possessing marijuana
for any purposes if
illegal under federal
law
– The federal
government does not
recognize an
exception for medical
uses for marijuana
85. Cannabis Law/ Medical Marijuana
• Federal Law
– In August 2013, the U.S.
Department of Justice
announced an update to
their marijuana
enforcement policy,
stating that while
marijuana remains illegal
federally, the USDOJ
expects states that make
marijuana legal to enforce
its laws properly and the
USDOJ maintains right to
challenge the laws of the
states at any time if it
feels necessary.
86. Cannabis Law/ Medical Marijuana
• Medical marijuana is legal in
23 states and Washington
D.C. as of July 2015.
– Alaska, Arizona, California,
Colorado, Connecticut,
Delaware, District of
Columbia, Hawaii, Illinois,
Maine, Maryland,
Massachusetts, Michigan,
Minnesota, Montana,
Nevada, New Hampshire,
New Jersey, New Mexico,
New York, Oregon, Rhode
Island, Vermont, Washington
87. Cannabis Law/ Medical Marijuana
• As of September 25,
2015, Pennsylvania
and Ohio have
pending legislation
regarding legalization
of medical marijuana.
88. Cannabis Law/ Medical Marijuana
• Legislation has failed in
17 states in 2015.
– Alabama, Florida, Georgia,
Indiana, Iowa, Kansas,
Kentucky, Mississippi,
Missouri, Nebraska, North
Carolina, North Dakota,
South Carolina, Tennessee,
Texas, Utah, and West
Virginia
90. Farm Bill
Major Farm Policy Changes
in the 2014 Farm Bill
• Repeals Direct Payments
and limits producers to risk
management tools that
offer protection when they
suffer significant losses.
• Limits on payments are
reduced, eligibility rules are
tightened, and means tests
were more streamlined.
91. Farm Bill
Major Farm Policy
Changes in the 2014
Farm Bill
• Added a “sodsaver
provision” to the
Federal Crop
Insurance Program
• Reform to dairy
policy
92. Farm Bill
Major Farm Policy
Changes in the 2014
Farm Bill
• Voluntary, margin
protecting program
• Livestock disaster
assistance
• Training and Access to
Capital
93. Farm Bill
Changes with the
Supplemental Nutrition
Assurance Program (“SNAP”)
(f/k/a “Food Stamps”)
• Eliminates “heat-and-eat” loophole.
• Establishes 10-state pilot program to
engage able-bodied adults in
mandatory work programs.
• Prohibits USDA from engaging in
SNAP recruitment activities and
advertising SNAP on TV, radio,
billboards, & through foreign
governments.
94. Farm Bill
SNAP Changes
• Ensures illegal immigrants, lottery
winners, traditional college
students, & the deceased do not
receive SNAP benefits.
• Ensures SNAP recipients are not
receiving benefits across multiple
states.
• Prevents abuse such as water
dumping to exchange bottles for
cash.
• Demands outcomes from existing
employment and training programs.
95. Farm Bill
SNAP Changes
• Eliminates medical marijuana as
an allowable medical expense.
• Institutes pilot investigation
program to battle retailer fraud
and crackdown on trafficking
through data mining, terminal ID,
and other measures.
• Increases access to local, tribal,
Kosher, and Halal foods in food
assistance programs.
96. Farm Bill
SNAP Changes
• Provides grants to eligible
nonprofit organizations to
improve community access to
food through development of
innovative projects, such as
school garden programs and
urban greenhouse initiatives.
• Increases assistance for food
banks.
97. Questions on Being an Agriculture Lawyer
• Fridays with Cari
Skype Calls
– First Friday of the
month at 2pm ET
– RSVP to
cari@rinckerlaw.com
– No charge
98. I Wrote a Book
Cari B. Rincker & Patrick B.
Dillon, “Field Manual: Legal
Guide for New York Farmers
& Food Entrepreneurs”
(2013)
Available at
http://www.amazon.com/Fi
eld-Manual-Legal-Farmers-
Entrepreneurs/dp/1484965
191
99. Please Stay in Touch
• Send Me Snail Mail: 535 Fifth Avenue, 4th Floor,
New York, NY 10017
• Call Me: (212) 427-2049 (office)
• Email Me: cari@rinckerlaw.com
• Visit My Website: www.rinckerlaw.com
• Read My Food, Farm & Family Law Blog:
www.rinckerlaw.com/blog
• Tweet Me: @CariRincker @RinckerLaw
• Facebook Me: www.facebook.com/rinckerlaw
• Link to Me:
http://www.linkedin.com/in/caririncker
Editor's Notes
Overtime, FDA did not feel like this created the necessary safeguards
Needed more control than OTC status
FDA started to become concerned about preventing the potential for the development of bacterial resistance to antimicrobial drugs administered through medicated feeds
ADAA – help facilitate the approval and marketing of new animal drugs and medicated feeds
FDA started getting some backlash stating that VFD was overly burdensome
In response, the FDA published several documents inviting public comment of VFD
Publication 1 – This was published around April 2012. It set forth FDA’s framework for instituting several key measures for ensuring the judicious use of medically important antimicrobial drugs in livestock. It included the possible elimination of feed and water use of medicated feeds and bringing all remaining.
Publication 2 – Published in December 2013; Outlined a detailed process and timeline for implementing the measures identified in GFI #209. This document discussed the transition of over-the-counter antimicrobial drugs to VFD marketing status.
Final rule- effective as of October 1, 20015
If vet doesn’t know if the state has a VCPR then FDA is publishing a list soon
(1) Extra-label drug use (“ELDU”) occurs when a drug in an animal is used in a manner that is not in accordance with the approved labeling. This can mean using a drug in a species for which it is not labeled, at a different dosage rate, frequency or route of administration, for diseases other than those on the label, or with a different withdrawal time than that listed.
(2) Only a veterinarian can make the necessary determination to use a drug in an extra-label manner. See American Veterinary Medical Association, “Animal Medicinal Drug Use Clarification Act (AMDUCA”) available at https://www.avma.org/KB/Resources/Reference/Pages/AMDUCA.aspx (last visited May 31, 2015). See also 21 CFR § 530 and 21 CFR § 530.41 (list of drugs that are prohibited for extra-label use in animals).
(3) For example, if a livestock animal is really sick, a veterinarian might allow for an antibiotic to be administered at a level that exceeds the dosage allowed on the label.
(4) This is done only in rare instances. Veterinarians are reluctant to ever treat an animal extra-label.
(5) If a livestock producer exceeds the dosage of the antibiotic without an extra-label prescription then he/she is in “violation” – if caught then this producer will be added to violators list. See American Veterinary Medical Association’s “Extralabeling Drug Use and AMDUCA: FAQ” available at https://www.avma.org/KB/Resources/FAQs/Pages/ELDU-and-AMDUCA-FAQs.aspx (last visited June 11, 2015).
Substitution information is OPTIONAL
There were a lot of requests for FDA to change the record keeping requirement to 1 year- kept it at 2 years
Furthermore, a mere “hydrological connection” is not sufficient to qualify a wetland as covered by the CWA; it must have a “continuous surface connection” with a water of the United States that makes it “difficult to determine where the ‘water’ ends and the ‘wetland’ begins.”
The Plot Thickens…
•
c. This new rule basically defines WOTUS to include virtually any wet area – even a rain-fed temporary pool – that is close to any other body of water with a physical connection to a navigable waterway.
d. Where in the past the EPA would have to do a case-by-case analysis to determine which waters fell under their regulation, now every water is essentially under federal regulation and a case-by-case analysis is required to determine which waters are exempt from the new definition.
MIR 162- insect resistence
a. Cargill v. Syngenta: In September of 2014, Cargill Grain & Oilseed Supply Chain North America sued Syngenta for financial damages due to China’s refusal of corn containing Syngenta’s MIR 162 trait. Their lawsuit is based on the fact that Syngenta “broadly [commercialized] a new product before receiving approval from a key export market like China.”
b. Trans Coastal v. Syngenta: Trans Coastal Supply Co, a major exporter of livestock feed products, sued Syngenta for more than $41 million because of Syngenta’s failure to receive approval from China for MIR 162
These lawsuits include farmers who did and did not use Syngenta seeds to grow their corn because China’s rejection of corn had an effect on the market as a whole regardless of the type of seed used to grow corn.
Many of the federal lawsuits were consolidated into one in the federal court in Kansas where Syngenta moved to dismiss the case in June, 2015. A hearing on the motion occurred in August. A ruling has not been made yet but is expected in September.
The decision on the motion to dismiss will determine the next steps, including the certification of a class, requests for discovery, and possible settlements.
b. First Amendment Claim: Plaintiffs alleged that the law requiring GMO labeling of food violated the First Amendment against unlawfully-compelled speech.
i. The Court held that strict scrutiny was not warranted in this case, rather a “reasonable relationship” test should be applied and under that standard there was not enough proof to issue a preliminary injunction.
ii. The Court held that unless Vermont’s legislative findings proved unfounded for a permanent injunction, the state had demonstrated a reasonable relationship between the state’s interest and the GMO-labeling mandate.
c. Commerce Clause Claim: Plaintiffs argued that Vermont’s GMO-labeling requirement would put an undue burden on interstate commerce creating mismatched laws amongst states.
i. The Court dismissed this claim because there are currently no other states with conflicting labeling laws.
d. Supremacy Clause Claim: Plaintiffs argued that the labeling requirements for GMO containing food was preempted by the FFDCA, NLEA, FMIA, and PPIA.
i. The Court held that FFDCA and NLEA did not preempt this type of labeling.
ii. However, the Court agreed with Plaintiffs that the FMIA and PPIA expressly preempt state standards for labeling that differ from federal standards. Therefore, processed and packaged foods that are subject to USDA inspections do not have to comply with Vermont’s GMO-labeling requirement.
e. “Natural” Labeling Prohibition Claims: Plaintiffs argued that the prohibition on “natural” and “all-natural” labeling of foods containing GMOs was against the First Amendment.
i. The Court agreed stating that under the intermediate scrutiny test Vermont failed to demonstrate a substantial state interest in prohibiting these words on food labels.
ii. The Court also held that this prohibition also violated the Commerce Clause to the extent that it attempted to regulate advertising that occurred outside of Vermont.
iii. Although the judge agreed with Plaintiffs on these claims, a preliminary injunction was not issued due to lack of proof of irreparable harm on part of Plaintiffs.
The GMA brief argues that under both the Zauderer and Central Hudson standards the labeling requirement fails because it does not serve a substantial state interest. GMA argues this labeling is “nothing more that consumer-curious interest … gussied up with the thinnest of justifications” because it merely relies on consumer curiosity to justify it rather than addressing the concerns that GMO-derived foods raise, such as public health, food safety, and environmental impact. The consumer-curiosity justification was found to not be enough to meet standard of substantial state interest in Amestoy.
In regards to the failure to grant a preliminary injunction, GMA argues that without an injunction GMA members will be required to make “vast structural changes to their inventory, production, and distribution systems,” the costs of which will not be able to be recouped if GMA is successful in its litigation. GMA also argues that without an injunction there will be reputational harms to GMA members because they will have to warn Vermont consumers that their products are somehow different from those sold in other states and from other non-labeled products.
In Vermont’s response brief, filed August 24, 2015, the Defendants argue that the public debate surrounding genetic engineering does not trigger intermediate scrutiny under Central Hudson because there are no “controversial” statements required by the labeling requirement to invoke the Central Hudson standard. They argue that there is no controversy regarding the statement that is required on GMO containing foods.
Additionally, the Defendants argue that the District Court erred in deciding that prohibiting “natural” label on GMO food is an unconstitutional suppression of free speech because the legislature considered studies showing that consumers believe that a “natural” labeling on food means the absence of GMO foods and therefore the state is within its constitutional right to forbid misleading labeling on food.
Amicus Brief in Support of Vermont
In August 2015, Connecticut, Maine, Maryland, Massachusetts, Hawaii, Illinois, New Hampshire, and Washington all signed an amicus brief in support of Vermont’s GMO-labeling bill.
Additionally, the following associations also filed amicus briefs in support of the bill: Public Citizen, Inc., Consumer Union of United States, Inc., Vermont Business for Social Responsibility, and Ben & Jerry’s Homemade, Inc., along with many others.
Amicus Brief in Support of Grocery Manufacturers Association
In July 2015, Chamber of Commerce of the United States, Agricultural and Commodity Trade Associations, American Chemistry Council, and Washington Legal Foundation amongst others filed amicus briefs in support of GMA. Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985)
Central Hudson Gas & Elec. Corp. v. Pub. Serv. Comm’n of New York, 447 U.S. 557 (1980)
c. On June 4, 2015, Canada requested authorization from the WTO to suspend the application of certain tariff concessions for the United States for burdening of WTO free trade laws. The United States objected to the level of which the tariff concessions would be suspended and the matter was referred to arbitration under Article 22 of the Dispute Settlement Understanding.
d. The Canadian government has claimed that requiring COOL on meat has cost them a combined loss of $900 million as of 2014 and has threatened to place tariffs on U.S. meat products, as well as wine, potatoes, and orange juice if COOL stays in place
Raw milk is milk from cows, sheep, or goats that has not been pasteurized to kill harmful bacteria.
Since the milk has not been treated, it may contain bacteria, E.coli, parasites, and viruses. According to the CDC, raw milk may cause diarrhea, stomach cramping, and vomiting, and more serious issues such as kidney failure, paralysis, chronic disorders, and even death.
Many proponents of raw milk, such as Mark McAfee, CEO of Fresno, California based Organic Pastures, the nation’s largest raw-milk dairy, claim that drinking raw milk and cure allergies and asthma. However, the CDC has stated that there are no health benefits associated with drinking raw milk that cannot be obtained from drinking pasteurized milk.
Prohibited completely: Alabama, Delaware, Florida, Georgia, Hawaii, Indiana, Iowa, Louisiana, Maryland, Michigan, Montana, New Jersey, North Carolina, North Dakota, Ohio, Virginia, West Virginia, Wyoming
Alaska, Arkansas, Colorado, ILLINOIS, Kansas, Kentucky, Massachusetts, Maine, Missouri, Mississippi, Nebraska, NEW YORK, Oregon, Oklahoma, TENNESSEE (Allows sales through herd leasing programs such as cowshares and goatshares), TEXAS, Wisconsin
Arizona, California, CONNECTICUT, Idaho, Maine, Missouri (only to farmers markets, not stores), New Hampshire, New Mexico, Nevada, Oregon (only goat milk), Pennsylvania, South Carolina, South Dakota (only to farmers markets, not stores), Utah (retail store must be owned by farm), Vermont, Washington
Organic Pastures
The FDA responded to the petition and denied it stating that the petition does not state grounds for changing the current law nor does it show that changing the law is in the best interest of the public
As for enforcement of this rule, the FDA states: “With respect to the interstate sale and distribution of raw milk, the FDA has never taken, nor does it intend to take, enforcement action against an individual who purchased and transported raw milk across state lines solely for his or her own personal consumption.
Requirements are in place for process for making foods, food allergen controls, sanitation controls, and recall plans for food that is found to be hazardous.
These processes in place have been verified through scientific evidence; they are effective in controlling identified hazards.
Secondary –
Example: operation in which nuts are hulled and dehydrated by an operation not located at the orchard before going to a processing plant.
1. There are only a handful of states that have “ag gag” laws; however, there is a lot of variation right now among those states. The laws range from creating criminal sanctions against the employee making the recording to criminal actions for distributing the recording after they have been made.
2. States vary on what is and what is not an offense. Most existing laws may directly restrict unauthorized recordings at animal facilities or focus on gaining employment under false pretenses. In some versions of the statute, undercover video/photographer takers must submit unedited versions of the recordings to law enforcement authorities.
3. This statute provides that a person found guilty of the crime of interference with agricultural production “shall be guilty of a misdemeanor and shall be punished by a term of imprisonment of not more than one (1) year or by a fine not in excess of five thousand dollars ($5,000), or by both such fine and imprisonment
In his decision, Judge Winmill wrote: “Although the State may not agree with the message certain groups seek to convey about Idaho's agricultural production facilities, such as releasing secretly recorded videos of animal abuse to the Internet and calling for boycotts, it cannot deny such groups equal protection of the laws in their exercise of their right to free speech.
a. The August 2013 memo from the USDOJ stated that its enforcement of marijuana laws would be prioritized to eight specific categories:
i. Preventing the distribution of marijuana to minors;
ii. revenue from the sale of marijuana from going to criminal enterprises, gangs and cartels;
iii. the diversion of marijuana from states where it is legal under state law in some form to other states;
iv. state-authorized marijuana activity from being used as a cover or pretext for the trafficking of other illegal drugs or other illegal activity;
v. violence and the use of firearms in the cultivation and distribution of marijuana;
vi. drugged driving and the exacerbation of other adverse public health consequences associated with marijuana use;
vii. growing of marijuana on public lands and the attendant public safety and environmental dangers posed by marijuana production on public lands;
viii. preventing marijuana possession or use on federal property.
New York – July 2014
Each state has specific regulations in place for those who operate medical marijuana dispensaries.
Applicable taxes
Product safety
Any deviation from it would subject users to state prosecution and subject marijuana establishments to lose their license to operate.
Elimination of Direct Payments, Counter-Cyclical Payments, the Average Crop Revenue Election Program, and the Supplemental Revenue Assistance Payments Program is expected to create $18.4 billion in savings.
Any person or entity with an annual gross income (“AGI”) of $900k or more will be ineligible for payments from farm subsidiary programs, which are now capped at $125k per person including marketing loans.
The “sodsaver provision” increases individual accountability by reducing farm program benefits to farmers producing on newly broken lands therefore these farmers are doing so at their own risk rather than that of taxpayers.
Reform to dairy policy
Replaces Dairy Product Price Support Program and Milk Income Loss Contract Programs with new programs.
Dairy Margin Insurance Program: Protects producer margins equal to the difference between the all-milk price and a national feed cost
For small and medium sized farms, lower premium margin. Protection is offered on first 4 million pounds of marketed milk (the annual production of approximately 200 cows).
Diary Production Purchasing Program: gives USDA flexibility to purchase dairy products when margins fall below $4, and those products will be donated to organizations like food banks, soup kitchens, and homeless shelters.
New voluntary, margin protecting program without government-mandated supply controls.
Farmers may choose to participate in either Agricultural Risk Coverage (“ARC”) or Price Loss Coverage (“PLC”) Programs. ARC covers losses at either the individual farm level or at the country level. PLC provides payments when the price of a crop drops below a reference price.
Livestock disaster assistance
Provides assistance to livestock producers who have experienced grazing losses due to drought.
Continues assistance for natural disasters that destroy grazing lands, honey bees, farm fish, orchard trees, and nursery trees.
Training and access to capital for small businesses and beginning farmers and ranchers
Beginning Farmer and Rancher Individual Development Accounts Pilot Program: authorizes matching-funds for savings accounts specifically to be used for farming-related expenses for beginning farmers and ranchers.
Pilot Program Authority: gives USDA authority to create pilot programs in Farm Loan Programs exclusively targeted to particular regions, agriculture sectors, and populations like beginner farmers.
1. Eliminates “heat-and-eat” loophole.
a. Will stop states from issuing extremely low Low Income Home Energy Assistance Program (“LIHEAP”) benefits to qualify households to receive Standard Utility Allowances for sole purpose of increasing SNAP benefits.
2. Establishes 10-state pilot program to engage able-bodied adults in mandatory work programs.
a. This program eliminates many of the barriers to employment, such as lack of childcare or transportation.
The Emergency Food Assistance Program (“TEFAP”): helps supplement the diets of low-income individuals by providing emergency food and nutrition assistance and provides additional funding to help meet immediate needs of food banks.
Note that my outline goes into more detail