This presentation was created for the Lawline.com presentation titled "Lawyer's Guide to the Veterinary Feed Directive." The Lawline presentation will be on November 3, 2016 at 3:30pm ET. The recording of the lecture will subsequently be available via Lawline.com at https://www.lawline.com/faculty/cari-rincker. This presentation is broken up in two parts: (1) General Background discussing definitions, regulatory players and the legal framework, and (2) the Second VFD Rule promulgated in June 2015.

1. Lawyer’s Guide to the Veterinary
Feed Directive (“VFD”)
Lawline.com
November 3, 2016
By Cari B. Rincker, Esq.

2. Who I Am
• Grew up on a beef cattle
farm in 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
livestock producers & food
entrepreneurs to mid-size
agri-businesses

3. Overview
Background
• Definitions
• Players
• Regulatory Framework
(Second) Veterinary
Feed Directive
(“VFD”) Rule

4. Background

5. Definitions
Antibiotics Antimicrobials
Feed
Additives
Vaccines Hormones
Growth
Promotants

6. 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

7. Definitions
• Antibiotics can be administered as a feed additive
• Given to farm animals in feed to fulfill a specific need (e.g., vitamins,
minerals, fatty acids, and minerals)
Feed Additives
• Low-level antibiotics can be used as a growth promotant
Growth Promotant
• Ionophores can be a type of growth promotant
• Lipid-soluble molecule that transports ions across a cell membrane
Ionophores

8. Definitions
Hormones
• Hormones are
chemicals naturally
produced in the
body.
• In terms of livestock,
these include natural
estrogen,
progesterone,
testosterone, and
their synthetic
versions.
Vaccines
• Produces immunity
to a disease
• Can be administered
through needle
injections, by mouth,
or by aerosol
• Injection of a killed
or weakened
organism that
produces immunity
in the body against
that organism
Biologics
• All viruses, serums,
toxins, and
analogous products
of natural or
synthetic origin (e.g.,
vaccines, live
microorganisms)
intended for use in
the diagnosis,
treatment, or
prevention of
diseases of animals
Compare to antibiotics.
Consumers confuse these terms.

9. Definitions
Resistance
• Antibiotic resistance
occurs when an antibiotic
has lost its ability to
effectively control or kill
bacterial growth; in other
words, the bacteria are
"resistant" and continue
to multiply in the
presence of therapeutic
levels of an antibiotic.
Residues
• Traces of antibiotics in
feed, in some cases, as a
result of administering
antibiotics to livestock
used for meat and dairy.
There are maximum
antibiotic limits allowed in
food products (i.e.,
Maximum Residue Limits
or “MRLs”).
Commonly confused terms

10. Withdrawal Periods
• The animal’s body will eventually
metabolize the antibiotic and eliminate it
from its system. However, there are
withdrawal periods for the time in between
when the livestock was treated with
antibiotics and the time of harvest or
processing.
• This “withdrawal period” reduces any
concentration of the antibiotic that might
still be present in the animal’s body (and
thus in the milk, meat, or eggs).
• Withdrawal periods are set by the FDA and it
is different for each drug and species.

11. The Players
U.S. Department of Agriculture (“USDA”) regulates antibiotics in meat,
poultry, and eggs via three 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.

12. Role of USDA
FSIS
Pursuant to the Federal Meat Inspection Act
(“FMIA”), the Poultry Productions Inspection
Act (“PPIA”) and the Egg Products Inspection
Act (“EPIA”), FSIS is the USDA sub-agency that
oversees food labeling and whether meat or
poultry is misbranded.
Random Tests at USDA - Inspected Processing
Facilities
Violators are published with FSIS website
(“Residue Violation Information System”)
Penalties include jail time and fines
AMS
Sub-agency that certifies food as “organic”
under the National Organic Program (“NOP”)
APHIS
Manages the National Health Monitoring
System (“NAHMS”)
Conducts national studies on health and health
management of U.S. domestic livestock and
poultry populations

13. National Organic Program
• USDA-AMS regulates NOP
– There must not be any
administration of antibiotics
under any circumstances;
therefore, this could be viewed
“antibiotic free” label
regulation.
– If the animal gets sick in an
“organic” livestock operation
and organic approved methods
fail, the animal may receive
antibiotics, but then cannot be
labeled as “organic” anymore
under the NOP. See 7 CFR §
205.238(c)(7).

14. USDA-Regulated Marketing Claims
• All USDA label marketing claims
must be approved by FSIS to
determine if they are truthful and
not misleading.
– USDA’s FSIS is responsible for
labeling meat and poultry, liquid
eggs and cooked egg.
– Look for the “USDA Process
Verified” for this claim because the
shield means that this was verified.

15. USDA-Marketing Claim
• “No Antibiotics Used” requires the producer to submit
food formulations, pharmaceutical invoices, or other
appropriate documentation verifying that animals have
received antibiotics by any means.
– They also must provide how they care for and treat sick animals.
– In order to use this marketing claim, the animals must have
never been treated with antibiotics.
• Variations include:
– No Added Antibiotics
– No Antibiotics Added
– No Antibiotics Administered
– Raised without antibiotics-for meat and poultry only

16. Role of FDA
Meat
• Withdrawal
periods
• Dosage
Poultry
• Antibiotic
labels
Eggs
• Use of
antibiotics on
livestock
USDA regulates eggs,
poultry and meat with
antibiotics
FDA regulates most other
issues

17. Role of CDC
• National Antimicrobial Residence Monitoring System (“NARMS”) is
a sub-agency of the CDC.
– Players: Composed of the FDA, CDC, USDA’s FSIS
– Purposes: Its primary purpose is to track antibiotic residence in the
United States. The primary objectives of the NARMS program are to:
• Monitor trends in antimicrobial resistance among foodborne bacteria from
humans, retail meats, and animals;
• Disseminate timely information on antimicrobial resistance to promote
interventions that reduce resistance among foodborne bacteria;
• Conduct research to better understand the emergence, persistence, and
spread of antimicrobial resistance; and
• Assist the FDA in making decisions related to the approval of safe and
effective antimicrobial drugs for animals.

18. 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.

19. Background
Prior to 1996, FDA had 2 options
for distributing animal drugs:
•Over-the-Counter (“OFC”)
•Prescription (Rx)
Federal Food, Drug and Cosmetic
Act (“FDCA”) didn’t require
prescriptions for animal feeds.
•Medicated feeds were OTC
•Viewed as being impractical because feed
mills would need to have a pharmacist
onsite to dispense prescription drugs; thus
feeds were OTC.

20. 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 fees.
• 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

21. 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.
• Although a similar concept, VFD drugs are not
prescription (Rx) drugs

22. Background
A VFD is a written statement issued by
a licensed veterinarian in the court of a
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.

23. Background
Before the Second VFD Rule,
there were few VFD Drugs
• 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.

24. Background
The final rule 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: Guidance for the
Industry 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”

25. Background
• Published around April 2012
• Described the overall policy direction.
• This publication focused on 2 key
principles:
• Limit use of medically important
antimicropial drugs in food-producing
animals to those uses (1) considered
necessary for assuring animal health and
(2) that include veterinary oversight or
consultation
Publication 1:
Guidance for the
Industry (GFI)
#209 “The
Judicious Use of
Medically
Important
Antimicrobial
Drugs in Food
Producing
Animals”

26. Background
•Published in December 2013
•Outlined a detailed process and timeline for implementing the
measures identified in GFI #209.
•This document discussed the transition of OTC antimicrobial
drugs to VFD marketing status.
•This publication noted that December 2016 was the target for
drug sponsors to implement changes to use conditions of
“medically important” antimicrobials in food and water to:
•(1) voluntarily withdraw approved production uses such as
“increased rate of weight gain” or feed efficiency and
•(2) after the label changes these production uses will no
longer be legal; however, therapeutic uses are to be retained
for treatment, control and prevention indications.
Publication 2: Guidance
for the Industry 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”

27. Background
• A key principle noted in this publication was to
include a veterinarian in the decision-making
process.
• It doesn’t require direct veterinarian involvement
in the drug administration but it does require use
to be authorized by a licensed veterinarian in the
context of a Veterinarian Client Patient
Relationship (“VCPR”).
• This includes water soluable products to Rx
(“medicated drinking water”) and products used
in or on feed to VFD (“medicated feed”)
Publication 2: Guidance
for the Industry 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”

28. Background
VFD – final rule
published in the Federal
Register on June 3, 2015
Builds off of GFI #213
(“Publication 2”)
Provides for a phased
enforcement of the
implementation of the
rule as OTC become VFD
FDA focusing now on
stakeholder education
• Veterinarians
• Livestock producers
• Feed mill distributors

29. Background – Effective Date
First VFD Rule
(December 8,
2000) was in
effect until
October 1,
2015
Second VFD
Rule (June 2,
2015) went
into effect
after October
1, 2015

30. Background
What drugs are
affected? (Look
for 2 things)
Those that are
considered
“medically
important” AND
Administered in feed
or drinking water
• i.e., injectables, boluses
and other dosage forms
are not affected
(GFI # 213)

31. Background
So what are
“medically important”
antimicrobials?
• GFI #213 (Publication #2) defined
“medically important” to include all
antimicrobial drugs/drug classes that
are listed in Appendix A of FDA’s
Guidance #152
• Put simply, it includes all antimicrobial
drugs that are considered important by
the FDA for therapeutic uses

32. Background:
Affected Antimicrobials Administered via Feed
Antimicrobial Class Specific Drugs Approved for Use in Feed
Aminoglycosides Apramycin, Hypgromycin B, Neomyscin, Streptomyscin
Diaminophyrimidines Ormetoprim
Lincosamides Lincomycin
Macrolides Erythromycin, Oleandomycin, Tylosin
Penicillins Penicillin
Streptogramins Virginiamycin
Sulfas Sulfadimethoxine, Sulfamerazine, Sulfamethazine,
Sulfaquinoxaline
Tetracycline Chlortetracycline, Oxytetracycline
See FDA “Medically Important
Antimicrobials in Animal Agriculture” at 15

33. Background:
Affected Antimicrobials Administered via Water
Antimicrobial Class Specific Drugs Approved for Use in Water
Aminoglycosides Apramycin, Gentamicin, Neomyscin, Spectinomycin,
Streptomyscin
Diaminophyrimidines NONE
Lincosamides Lincomycin
Macrolides Erythromycin, Oleandomycin, Tylosin
Penicillins Penicillin
Streptogramins NONE
Sulfas Sulfachlorophyrazine, Sulfachlorpyridazine,
Sulfadimethozine, Sulfamerazine, Sulfamethazine,
Sulfaquinoxaline
Tetracycline Chlortetracycline, Oxytetracycline, Tetracycline
See FDA “Medically Important
Antimicrobials in Animal Agriculture” at 16

34. Background
What drugs
aren’t affected?
• Antimicrobials that are already VFD
• Avilamycin, florfenicol, tilmicosin
• Rx Tylosin
• Antimicrobials that are not “medically important”
• Ionophores (e.g., monensin, lasalocid)
• Bacitracin (e.g., bacitracin zinc)
• Bambermycins
• Carbodox
• Non-antimicrobial drugs
• Anthelmentics
• Beta agonists
• Coccidiostats
See FDA “Medically Important
Antimicrobials in Animal Agriculture” at 17

35. Background
Feed-use drugs are assigned to one of two
categories
•Category I – Drugs having the lowest potential for
residues
•Category II- Drugs having the highest potential for
residues
•VFD drugs are no longer automatically Category II
This category determines whether a facility
needs to be licensed to handle the drug in
the Type A form

36. Veterinary Feed Directive (VFD)

37. Stakeholder Requirements
Veterinarians
Livestock Producers
Feed Distributors
Drug Manufacturers

38. Veterinary Requirements
Must 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)

39. 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)

40. 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)

41. Veterinary Requirements
VFD
Information
Required
information
Optional
information

42. 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

43. Veterinary 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)

44. 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.
• If no expiration date then 6 mo. is
the default

45. Veterinary Requirements
VFD 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

46. Veterinary Requirements
Note that expiration date and the duration of use are
2 different concepts
Few examples:
• Avilamycin has an expiration date of 90 days but should only be
used for 21 days
• Florfenicol for swine has an expiration date of 90 days but has a
typical duration of only 5 days
• Tilmicosin for cattle has an expiration date of 45 days but typically
prescribed for 14 days

47. Veterinary 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.”

48. Veterinary Requirements
VFD must include:
• An affirmation of
intent for
combination VFD
drugs
• Veterinarian’s
electronic or written
signature

49. Veterinary Requirements
Affirming
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.”

50. Veterinary 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.

51. 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

52. 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

53. 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

54. 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 the
veterinarian must keep original
21 C.F.R. 558.6(a)

55. 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)

56. 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.

57. Producer Requirements
Veterinary Feed Directive Issuance
VFD
should
state the
expiration
date
Feed Delivery
Medicated
feed being
delivered
in different
increments
Feeding
Expiration
Date
21 CFR 558.6(a)
Note: Was the duration prescribed different
than the expiration date?

58. Who is a Feed “Distributor”?
Any person who distributes
a medicated feed containing
a VFD drug to either:
• Another distributor or
• Client-recipient of VFD
(livestock producer).

59. 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)

60. 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

61. 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

62. 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.

63. 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)

64. Drug Manufacturers
Substitution of Drugs
• If the VFD doesn’t specify that a generic
version may be substituted then the then the
manufacturer may use an approved generic
VFD drug to manufacture the VFD feed
• However, the manufacturer may not substitute
a generic VFD drug for a pioneer VFD drug in a
combination VFD feed if the generic VFD drug is
not part of an approved combination VFD drug

65. FDA Enforcement
General
surveillance
and for-
cause
inspection
assignments

66. 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

67. 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

68. Oh, P.S. – 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 , Kindle + iBooks

69. Please Stay in Touch
New York Office:
535 Fifth Avenue, 4th Floor
New York, NY 10017
(212) 427-2049
cari@rinckerlaw.com
www.rinckerlaw.com
Illinois Office:
301 N. Neil Street, Suite 400
Champaign, IL 61820
Twitter: @CariRincker @RinckerLaw
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