Can veterinarians comply with state and federal requirements for the Veterinary Client Patient Relationship and practice via telemedicine?

Nearly, if not all states, have some requirements regarding the establishment and maintenance of a veterinarian-client-patient relationships (VCPR) before the veterinarian can treat an animal owned by a client.  In New Jersey, for example, the regulations (not statute) defines the VCPR as

  1. i) The veterinarian has undertaken to make medical judgments regarding the health of an animal or animals, herd or flock being treated and the need for medical treatment;
  2. ii) The client has retained the services of the veterinarian;

iii) The veterinarian has sufficient knowledge of the animal or animals, herd or flock to initiate at least a general or preliminary diagnosis of the medical condition of the animal or animals, herd or flock;

  1. iv) The veterinarian is available for follow-up treatment; and
  2. v) The veterinarian maintains records on the animal or animals, herd or flock in accordance with N.J.A.C. 13:44-4.9.

N.J.A.C. 13:44-4.1 (b)(1).

FDA requires veterinarians issuing a Veterinary Feed Directive (VFD) (essentially a prescription for treatment of livestock and poultry) to:

(i) Be licensed to practice veterinary medicine; and

(ii) Be operating in the course of the veterinarian’s professional practice and in compliance with all applicable veterinary licensing and practice requirements, including issuing the VFD in the context of a veterinarian-client patient relationship (VCPR) as defined by the State. If applicable VCPR requirements as defined by such State do not include the key elements of a valid VCPR as defined in § 530.3(i) of this chapter, the veterinarian must issue the VFD in the context of a valid VCPR as defined in § 530.3(i) of this chapter.

21 CFR § 558.6(b)(1).

FDA has identified states that do not define the VCPR in the same way that FDA does, and has mandated that veterinarians writing VFD’s must comply with federal standards.  See FDA’s guidance.

Consider the continued contemporaneous evolution of three veterinary concerns regarding the proper care of livestock and poultry in the United States:

  1. The decreasing number of food animal veterinary practitioners, particularly in rural states;
  2. The state licensure requirements for each veterinarian practitioner; and
  3. The FDA requirements regarding the establishment of a VCPR prior to issuance of a VFD.

The decreasing number of food animal practitioners may have to be licensed in multiple states and be compliant with state and federal laws (which in the case of the VCPR may be inconsistent) to provide care to their patients, including medications pursuant to a VFD.  One viable solution to assist these veterinarians and the animals they treat, is telemedicine.  In many situations, veterinarians can comprehensively evaluate the needs of a herd or flock without visiting in person.  While there should be an initial in-person visit, veterinarians, like physicians, should be able to communicate, diagnose and prescribe for remote herds and flocks without a required in-person visit.  State licensing laws may have to be relaxed as a decreasing number of veterinarians engage in large anima/food animal practice.

Arizona has recently relaxed its laws, permitting out of state professionals moving to the state to engage in licensed practice without completing the previously required rigorous state licensing testing.  Historically, states have permitted limited consultation from out of state veterinarians.  Farmers and ranchers would certainly benefit if they could access veterinarians from other states that specialize in food animal medicine, without requiring a physical presence and in-person examination in each state.

Beef producers and packers have been required for years to “identify hazard points and critical points during beef slaughtering, which is a necessary first step toward developing a hazard analysis and critical control point system to control meat contamination by Escherichia coli O157:H7.”  See R. Guyon, et. al, Hazard Analysis of Escherichia coli O157:H7 Contamination during Beef Slaughtering in Calvados, France, J. Food Protection, Vol 64, No. 9, 2001, pp 1341-1345.  While protecting the health of employees and customers is of utmost importance, in addition to the development and implementation of robust HACCP plans that address the former, food producers can help protect themselves from the financial impact of an E. coli outbreak or similar contamination in food products by ensuring that agreements with suppliers, producers, and insurers includes a provision that expressly covers such a situation.  The following summary of a recent case provides guidance for others to use, to avoid similar outcomes.

In April 2011, beef from Meyer Natural Angus (“Meyer”), a Colorado natural beef producer, and processed by Greater Omaha Packing (“GOP”) allegedly tested positive for a dangerous strain of E. coli bacteria.  Meyer Natural Foods LLC v. Greater Omaha Packing Co., Inc. 302 Neb. 509 at *2 (Neb. 2019).

Meyer had a processing agreement with Greater Omaha Packing (“GOP”), pursuant to which GOP would slaughter, process, and fabricate Meyer’s cattle into various beef products.  Id.  The processing agreement also required GOP to maintain property insurance on Meyer property in its possession, with a total value of $1.8 million.  Id. at *5.  Further, Meyer had the option to reject “all products failing to meet the warranties and specifications” contained in the agreement and return said rejected products to GOP and charge GOP its out of pocket expenses of storing and reshipping any products properly rejected by Meyer.  Id. at *6.

On April 25, 2011, Meyer delivered 1600 head of cattle to GOP for slaughter and processing.  After processing, GOP sealed and delivered the beef to Meyer.  Id. at *2.  While on “hold” for testing prior to delivery to stores, 17.5% of the beef tested returned presumptively positive for E. coliId.  Meyer immediately recalled the trucks with the contaminated beef, and sent the beef either to the cooker to be sold at a reduced charge or to a landfill because it was unsafe for human consumption.  Id. at *3.

After the contamination, Meyer sued GOP claiming that GOP was responsible for contaminating the beef and alleging breach of contract, breach of warranty, breach of an indemnity obligation, failure to obtain insurance, and breach of the guarantee.  Meyer moved for partial summary judgment for failure to obtain and maintain property insurance on the value of Meyer’s beef.  The district court denied Meyer’s motion because it found that GOP had a property insurance policy that provided coverage for any non-owned personal property in GOP’s care, custody, and control that GOP “agreed, prior to loss, to insure.”  Id. at *5.  Thus, GOP complied with its contractual obligations.  The district court also granted summary judgment to GOP on Meyer’s remaining claims because Meyer failed to return the rejected products to GOP, as required by the processing agreement.  Meyer appealed.

In March of this year, the Nebraska Supreme Court issued its opinion upholding the district court’s decisions.  On appeal, Meyer argued that the insurance policy’s exclusion of coverage for damage resulting from E. coli constituted a breach of the contractual requirement between Meyer and GOP that GOP maintain property insurance on Meyer’s property in its possession.  Id. at *4.  Nebraska’s Supreme Court concluded that the processing agreement did not contain any language regarding the inclusion of E. coli coverage or the prohibition of exclusions contained within the insurance policy.  Id. at *5.  Thus, GOP did not breach its contract with Meyer by maintaining a policy that excluded coverage for E. coli contamination.  Id.  Nebraska’s Supreme Court also upheld the district court’s conclusion that Meyer was not entitled to damages for GOP’s breach because it failed to return the rejected products to GOP.  Meyer could have avoided the loss caused by GOP’s breach by doing soId. at *6-7.

Meyer also argued that GOP breached its express warranty that the meat it processed would “not be adulterated or misbranded” by contaminating it with E. coli.  Id. at *7.  The Nebraska Supreme Court agreed that GOP breached its express warranty by adulterating the beef with E. coli, but because Meyer failed to return the beef to GOP for full credit as provided for by the processing agreement, it was not entitled to recoveryId. at *8-9.

Lastly, the court rejected Meyer’s negligence claim because there was no evidence presented that demonstrated that GOP was negligent on the days on which GOP fabricated Meyer’s cattle.  Id. at *9.

Takeaways: Review your agreements with third party vendors and ensure that you are requiring those vendors to maintain insurance policies that actually cover the main risks in your business, and be sure to follow the remedies required in your agreements when a breach occurs.

Stayed tuned for more analysis on the court’s conclusion regarding adulterating.

I was recently a panelist at the 2019 annual meeting of the New Jersey State Bar Association discussing legal issues about how to share pets after divorce.  As pets become increasingly important in many households in the United States, their disposition after divorce has become the subject of legal disputes during divorce.  Analysis of the economics related to pet ownership should be used as a tool to help inform adjudicators decide where the beloved pet should reside to insure they are properly cared for.

In the US, 67% of the estimated 84.9 million households reportedly owned a pet, according the 2019-2010 National Pet Owners Survey (“the Survey”), conducted by the American Pet Products Association (“APPA”).  In the 2017-2018 Survey, APPA reported 89.7 million dogs and 94.2 million cats reside in US households, and if you add less traditional pets, like poultry, reptiles and also include horses, the total approaches 400 million.  Americans spent nearly $67 billion dollars on their dogs and cats in 2016, including over $30 billion for veterinary care, supplies and medication, $28.23 billion for food, and $5.76 billion for pet services like grooming and boarding (an area expected to continue to expand).  APPA 2017-2018 National Pet Owners Survey.

At the same time, improvements in veterinary medicine have resulted in the increased life expectancy of pets.  Geriatric pets develop many of the same problems seen in older people, such as cancer, heart disease, metabolic disorders (e.g., kidney disease, liver disease, diabetes), osteoarthritis and senility. Virtually any treatment available to humans is also available to animals, but the cost of that care can be significant. If divorcing parties are bickering over pet ownership, the willingness of each to provide and pay for reasonable veterinary care for the rest of the pet’s life, can help inform the adjudicator when deciding “pet custody” issues.

The human-animal bond is a well-recognized and powerful phenomenon, which makes decisions about “pet custody” particularly emotion-ridden.  While divorcing parties may allege that the pet would be better off with one party, pets will often be just as happy with either party.  In addition to the medical and economic considerations described above, if “custody” is shared, the parties should agree to provide consistent food, housing, and exercise to avoid disruptions that could result in medical or behavioral abnormalities (of the pet).  A board-certified veterinary behaviorist should examine any pet if there are concerns about behavioral issues—before or after divorce.  Since veterinarians have a statutory, professional and ethical duty to the pet owner, ownership issues must be resolved even if custody is shared, to ensure that the veterinarian obtains informed consent before any treatment is provided.

Rabies is a nearly 100% fatal disease when unvaccinated animals and humans are exposed.  As previously discussed the risk of exposure to rabies from dogs imported from other countries, especially from Egypt, has increased exponentially resulting from the shift from pets purchased from USDA licensed or exempt breeders in to the unregulated sales of pets increasingly imported from other countries.

On May 10, 2019, the Centers for Disease Control and Prevention, though publication in the Federal Register, announced that

effective immediately, it is temporarily suspending the importation of dogs from Egypt. This includes dogs originating in Egypt that are imported from third-party countries if the dogs have been present in those countries for less than six months. CDC is taking this action in response to an increase of imported cases of rabies in dogs from Egypt. This action is needed to prevent the reintroduction of canine rabies virus variant (CRVV), which has been eliminated from the United States. This suspension will remain in place until appropriate veterinary controls have been established in Egypt to prevent the export of rabid dogs. CDC will coordinate with other federal agencies and entities as necessary to implement this action.

As, rabies, which can infect any mammal, is typically fatal once clinical signs appear.  There are various forms of rabies, and the United States has been free of the canine variant (although other variants exist in the US) since 2007.  According to the CDC “the canine variant  is responsible for 98% of the estimated 59,000 human rabies deaths worldwide each year (WHO, 2004 [Page 116]).”

CDC initiated its temporary importation ban based on the following incidents resulting from importation of rabid dogs to the US from Egypt:

  1. Importation of one rabies-infected of 26 imported dogs from Egypt on January 29, 2019, imported from a Kansas-based rescue organization into the Kansas City area. The dogs had been “placed into foster care or adopted in the Kansas City metro area of Kansas and Missouri.”
  2. In December 2017, one of four dogs, imported to JFK from Egypt by an animal rescue group, was diagnosed with the canine variant of rabies, infected before departure from Egypt.
  3. In May, 2015 one of 35 dogs and cats, imported into New York from Egypt, was diagnosed with rabies after euthanization. Animals from this shipment were transported to five states, and multiple humans and animals were exposed to the rabies virus.

CD  justified its ban because,

[t]he United States was declared CRVV free in 2007. The importation of just one dog infected with CRVV risks the re-introduction of the virus into the United States. CRVV has been highly successful at adapting to new host species, particularly wildlife. Importation of even one CRVV-infected dog could result in transmission to humans, transmission to other dogs, transmission to wildlife, and of particular concern, could result in sustained transmission in a susceptible animal population, thereby threatening our entire rabies public health infrastructure.

Rabies is just one of many zoonotic diseases that has been imported along with “rescues” from other countries.  Animal and public health remains at risk until animal health importation regulations are applied to shelter and rescue organizations in the same way they are applied to professionally and purposely bred pets regulated by USDA.

On October 30, 2018, the U.S. Food and Drug Administration “announced the Plant and Animal Biotechnology Innovation Action Plan to outline the key priorities the agency will pursue to support innovation in plant and animal biotechnology while advancing the agency’s public health mission. The overall goal of the action plan is to ensure the safety of plant and animal products of biotechnology while avoiding unnecessary barriers to future innovation.” See  https://www.fda.gov/animal-veterinary/cvm-updates/fda-announces-plant-and-animal-biotechnology-innovation-action-plan.

Both Acting FDA Commissioner Sharpless and FDA Chief Counsel Amin both emphasized the importance of this plan in their remarks at the Annual Conference of the Food and Drug Law Institute held in Washington, D.C. on May 2-3, 2019.

As explained in the action plan, sister agencies—FDA, USDA and EPA—each federal governmental agencies with regulatory authority over animal biotechnology (the plant issues are important but excluded for purposes of this blog) have worked in a coordinated fashion to “began to modernize the regulatory framework for biotechnology products to ensure the preparedness of federal regulatory agencies for future products of biotechnology.”

Among other initiatives, FDA has begun the process of “review[ing] the science behind genome editing in animals, the promising uses of this technology in animals, the potential risks, and information about CVM’s risk-based approach to the oversight of intentional genomic alterations to animals.”

FDA established

the Veterinary Innovation Program (VIP), to provide intensive assistance, both technical and programmatic, for developers seeking FDA approval of intentionally altered genomic DNA in animals and animal cells, tissues, and cell- or tissue-based products that provide a benefit to human health, animal health, animal well-being (e.g. husbandry improvements), or food production.

 

USDA explains its role in biotechnology by first defining the term “biotechnology to mean the use of recombinant DNA technology, or genetic engineering (GE) to modify living organisms. APHIS regulates certain GE organisms that may pose a risk to plant or animal health. In addition, APHIS participates in programs that use biotechnology to identify and control plant and animal pests.”

USDA regulates: 1) the importation and exportation of genetically engineered animals and animal products; 2) veterinary biologic that are developed using genetically engineered organisms; and 3)  research facilities used for certain vertebrate animals, including vertebrate animals that are genetically engineered.

“EPA regulates pesticides created through biotechnology as a part of its regulatory jurisdiction over all pesticides marketed and used in the United States.

States may also regulate these evolving industries.

As always, it will be important that laws are based on sound scientific principles that advance and protect the health and well-being of animals, people and the environment in which we live.

I attended the Annual Conference of the Food and Drug Law Institute held in Washington, D.C. on May 2-3, 2019, a truly informative and well-orchestrated conference that included sessions discussing all manner of issues facing industries and attorneys representing their interests from medicines, medical devices, food, cosmetics, tobacco, cannabis, including topics I found most compelling for my practice—animal drugs and animal-related innovations.

Norman E. ‘Ned’ Sharpless, MD, Acting Commissioner of Food and Drugs – Food and Drug Administration and FDA Chief Counsel, Stacy Cline Amin gave remarks at the conference respectively available here and here.

In Dr. Sharpless’ remarks, the first made in his new role, he included issues facing animal populations, including the promising field of genomic alteration and the role of FDA’s Center of Veterinary Medicine in ensuring “that the genetic modification is safe to the animal, that it does what it’s supposed to do, and, if in a food-producing animal, that it is safe to eat.”

Chief Counsel Amin also addressed innovations related to genome-edited animals [and plants].  She also discussed the impact of the Department of Justice’s “Brand Memo” which limits the use of agency guidance documents in affirmative civil enforcement cases.  As stated therein,

[o]n November 16, 2017, the Attorney General issued a memorandum (“Guidance Policy”) prohibiting Department components from issuing guidance documents that effectively bind the public without undergoing the notice-and-comment rulemaking process. Under the Guidance Policy, the Department may not issue guidance documents that purport to create rights or obligations binding on persons or entities outside the Executive Branch (including state, local, and tribal governments), or to create binding standards by which the Department will determine compliance with existing statutory or regulatory requirements.

The Guidance Policy also prohibits the Department from using its guidance documents to coerce regulated parties into taking any action or refraining from taking any action beyond what is required by the terms of the applicable statute or lawful regulation.

This memo may help circumvent deference by courts under Chevron, to agency interpretation of laws set forth in guidance documents.

As stated in the memo,

effective immediately for affirmative civil enforcement (“ACE”) cases, the Department may not use its enforcement authority to effectively convert agency guidance documents into binding rules.

Likewise, Department litigators may not use noncompliance with guidance documents as a basis for proving violations of applicable law in ACE cases.

More to come on the information provided at this conference for animal, food, drug, and cosmetic law practitioners.

Oregon HB 2804 was soundly defeated after hearing testimony from dog enthusiasts and veterinarians in a dogged effort by Patti Strand and the National Animal Interest Alliance (NAIA) to educate the legislators about the harm to people, animals and businesses that would result if the bill became law.

NAIA, founded in 1991, is a national animal welfare organization headquartered in Portland that was “created to provide fact-based answers to complex and controversial issues regarding animals.”

Oral and written testimony submitted by NAIA, the Responsible Dog Breeders Association of Oregon, veterinarians and others provided the legislators with critical information about why the bill should be defeated.

Some of the reasons provided below, are also applicable throughout the country, where, unfortunately, legislators were influenced by activists advancing a false narrative about the care dogs receive by professional dog breeders and pet shops.

As NAIA stated:

Dog overpopulation – a century-long animal welfare problem – has been solved in the Pacific Northwest with the result that there are no longer enough locally-bred dogs to meet demand.  As a result, shelters and rescues have created ‘humane relocation’ programs, which import thousands of dogs into their nonprofit organizations, sustain their operations and increase their adoptions. In many cases these shelters and rescues have become de facto pet stores while retaining their former image as charities that care for local pets.

Oregon Humane Society alone imported 3,944 dogs in 2017, (72% of their total intake), which is more dogs than all 8 of Oregon’s pet stores combined sell in a year.

Dogs imported by Oregon shelters and rescues for adoption to Oregon consumers come from as far away China, So. Korea and Mexico, countries where the standards of veterinary medicine are often far below those of the US. Many of these dogs carry diseases and parasites that can hurt our pets and people.

Statistics about the movement of dogs and other animals through shelters and rescues throughout the country have been collected by NAIA in its Shelter Database, available on its website.

NAIA and its founder and chair, Patti Strand, remain a valuable resource to those interested in learning the truth about many animal welfare issues, and helping to educate legislators and the public they serve.

As previously described, FDA has updated its Draft Guidance for Industry, #120, regarding the Veterinary Feed Directive Regulation.

The intersection of federal and state law impacted by this regulation is interesting.

Specifically, what is the impact to a veterinarian when the Veterinarian-Client-Patient relationship as defined by the relevant state law (governing that veterinarian’s license) conflicts with or is otherwise different from FDA’s definition?

FDA has revised its guidance regarding this issue, quoted here.  See #120, at page 12.

In those States that require a VCPR that includes the key elements of the Federally-defined VCPR in order for a veterinarian to issue a VFD, the veterinarian issuing the VFD must be operating within the context of a VCPR as that term is defined by the State. In all other cases, the veterinarian must be operating within the context of a valid VCPR as defined by FDA in 21 CFR 530.3(i). (21 CFR 558.6(b)(1)(ii)). FDA considers States with VCPR definitions that at least address the concepts that the veterinarian (1) engage with the client to assume responsibility for making clinical judgments about patient health, (2) have sufficient knowledge of the patient by virtue of patient examination and/or visits to the facility where patient is managed, and (3) provide for any necessary follow-up evaluation or care to include the key elements of the Federally-defined VCPR as set forth in 21 CFR 530.3(i).

In States where the veterinary practice requirements do not require that a VFD be issued within the context of a State-defined VCPR that includes the key elements of a valid VCPR as defined in Federal regulations at 21 CFR 530.3(i), FDA is requiring that the VFD be issued within the context of a Federally-defined valid VCPR as defined at 21 CFR § 530.3(i). (21 CFR 558.6(b)(1)(ii)).

FDA has worked with State regulatory authorities to verify whether their State has VCPR requirements in place that apply to the issuance of a VFD and include the key elements of the Federally-defined VCPR. FDA has compiled a list of states that require a VCPR that includes the key elements of the Federally-defined VCPR in order for a veterinarian to issue a VFD. This list is available online and the list will be updated periodically as FDA receives and verifies information from States if they change their VCPR definition or its applicability.

Veterinarians can review whether FDA believes a state-defined VCPR is consistent with its definition by visiting the FDA’s website FDA titled “Does the State or Federal VCPR Definition Apply to a Lawful VFD in my State?

The FDA webpage, last updated on 03/04/2019, lists the following states in which FDA has determined that the federal definition of VCPR, not the state definition, controls: Alabama, Alaska, Arkansas, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Kansas, Maryland, Massachusetts, Michigan, Montana, New Jersey, New York, Pennsylvania, Rhode Island, South Dakota, Vermont, Washington, and Wisconsin.

In those states, if a veterinarian who prescribes medication pursuant the VFD, does not fulfill the requirements of a VCPR as defined by FDA, s/he may be found to be in violation of these federal regulations, even if complying with the state-defined VCPR.  An outstanding question is whether and to what extent that state’s veterinary medical board may take punitive action against the veterinarian based on the alleged federal violation.  And if so, how that would impact that licensee’s veterinary licenses in sister states, if licensed in more than one state.

Veterinarians may be required to affirmatively disclose federal charges and/or findings, depending on the nature of such violations, whether civil or criminal.  For example in New Jersey, initial and renewal applicants must answer the following questions.

  1. Have you ever been summoned; arrested; taken into custody; indicted; tried; charged with; admitted into pre-trial intervention (P.T.I.); or pled guilty to any violation of law, ordinance, felony, misdemeanor or disorderly persons offense, in New Jersey, any other state, the District of Columbia or in any other jurisdiction? (Parking or speeding violations need not be disclosed, but motor vehicle violations such as driving while impaired or intoxicated must be.)
  2. Have you ever been convicted of any crime or offense under any circumstances? This includes, but is not limited to, a plea of guilty, non vult, nolo contendere, no contest, or a finding of guilt by a judge or jury.
  3. Have you ever been disciplined or denied a license or certificate to practice veterinary medicine or any other professional license in New Jersey, any other state, the District of Columbia or in any other jurisdiction?
  4. Have you ever had a professional license or certificate of any type suspended, revoked or surrendered in New Jersey, any other state, the District of Columbia or in any other jurisdiction?
  5. Has any action (including the assessment of fines or other penalties) ever been taken against your professional practice by any agency or certification board in New Jersey, any other state, the District of Columbia or in any other jurisdiction?
  6. Have you ever been named as a defendant in any litigation related to the practice of veterinary medicine or other professional practice in New Jersey, any other state, the District of Columbia or in any other jurisdiction?
  7. Are you aware of any investigation pending against a professional license or certificate issued to you by any professional board in New Jersey, any other state, the District of Columbia or in any other jurisdiction?
  8. Are there any criminal charges now pending against you in New Jersey, any other state, the District of Columbia or in any other jurisdiction?

Because of these possible impacts to their licenses, veterinarians should make every effort to comply with the governing law when prescribing medications via the VFD.

FDA recently released an edited version of its previously released guidance on the Veterinary Feed Directive Regulation fashioned as questions and answers.  (See Guidance #120).

Some of the edited and added Q&A will be discussed in future blogs, but the list of the edited and newly added questions, delineated in the table of contents, is reproduced here for those veterinarians impacted (which includes any veterinarian who issues a VFD for the use of a VFD drug in a medicated feed, regardless of whether the approved use is for a food producing or non-food producing animal.

  1. Edited questions:
  2. Does the State or Federal definition of a veterinarian-client-patient relationship (VPCR) apply?
  3. What information should be included on the VFD to describe the “premises” at which the animals are located?
  4. Can a VFD authorize either the approved pioneer or approved generic VFD drug(s)?
  5. In cases where a VFD drug is approved for use at multiple drug levels, or for use in a range of drug levels, would one or multiple VFD orders have to be issued to cover such drug uses?
  6. What additional information is required on a VFD authorizing the use of a combination VFD drug?
  7. Can I write a VFD for an OTC drug?
  8. How do I authorize or limit the use of a VFD drug that is approved to be used in combination with OTC drugs?
  9. How do I cancel my VFD?
  10. Can I make my own VFD form to authorize the use of a VFD drug?
  11. What is the Distributor Notification Process?
  12. What is an acknowledgment letter?
  13. How is an acknowledgment letter different from a distributor notification?
  14. If a VFD authorizes the use of a drug(s) that is not approved as a VFD drug or combination VFD drug, can a distributor fill the VFD?
  15. Can I have my veterinarian write a VFD to authorize the use of a medicated feed that is not approved for the use I’m intending (i.e., Extralabel use)?
  16. Newly added questions:
  17. If I am a university researcher and I want to perform research on a drug in medicated feed, do I need a VFD to obtain the medicated feed?
  18. Are VFDs only required for food producing animals?
  19. Is the listing of multiple premises on the VFD allowed? If so, is it mandatory or optional?
  20. Some VFD drugs are approved at a set dose (e.g., mg/head/day), but different drug levels in the feed may be necessary to accomplish that dose over the course of treatment. How should I reflect this on the VFD?
  21. Some approvals for use of VFD drugs in feed specify a body weight as part of the indication. When the approval includes body weight as part of the indication, does the VFD need to include estimated body weight of the animals?

 

  1. If a VFD is written to allow VFD drugs to be used in feed in combination with OTC drugs using the affirmation statements, do the withdrawal time, special instructions, and cautionary statements need to include both drugs, or just the VFD drug?
  2. I am a distributor/client who receives electronic VFDs and paper VFDs from veterinarians or clients. I would like to store these VFDs as electronic PDFs to meet the VFD regulation for retention. Can I archive required records in a standard electronic file format such as PDF, XML, or SGML?
  3. If a staff veterinarian writes a VFD for a company-owned feedmill, for company animals, does the company need to retain one or three copies of the VFD?
  4. I am a client that has multiple premises. Do I need to keep a copy of the VFD at each of those premises?
  5. Can I authorize a feed through pesticide to be used in a VFD feed? If so, how do I do that?
  6. If the VFD has expired for a batch of feed, can I reissue a VFD to use the remaining feed?
  7. Pm a veterinarian and I also want to sell VFD feed. What do I have to do?
  8. If I’m licensed in one State, can I write a VFD for animals located in another State? What if I have a temporary license in the State where the animals are located?
  9. If a VFD label has a duration range in which a VFD can be fed (e.g., 21-42 days), and I authorize the use of the VFD for the full 42 days, can the client decide when to stop feeding the VFD feed after the minimum provided in the range?
  10. What if the label for the VFD drug uses the dosage (e.g., mg/head/day) instead of the level of the drug (e.g., g/ton) in the feed? Can I just include the dosage on the VFD?
  11. Can I assign an extended withdrawal to a VFD medication even though the producer will be using the VFD feed as labeled (i.e., no Extralabel use)?
  12. Can I work with a feed distributor, nutritionist, or other animal health professionals in order to write a VFD?
  13. My client will have multiple groups of animals moving through their farm during the time period the VFD covers. Can I write the VFD to include the successive groups of animals that will be on the farm during the time period?
  14. Some drug labels have different wording for the duration of use. For example, some say feed for X days and some say feed up to X days. How should I fill out the duration of use on the VFD?
  15. Our veterinary clinic has multiple veterinarians. Can any of our veterinarians write a VFD for any of our clients?
  16. My client wants to use the VFD to receive a Type B medicated feed. Do I fill out the VFD with the Type B information?
  17. My client has minor species. I would like to write a VFD for a therapeutic use of a medicated feed, but there is not an approval for this species What should I do?
  18. Do I need to have a laboratory confirmation of disease prior to writing a VFD?
  19. If a veterinarian makes a mistake on a VFD and wants to go back and make corrections to the VFD rather than fill out a new VFD, can the veterinarian do that?
  20. My client has requested a new VFD to replace the former VFD that will soon expire. Can I fill out the new VFD ahead of time and date it to begin when the previous VFD expires?
  21. Who is a distributor?
  22. Am I considered a distributor if I manufacture feed in my feed mill and deliver it to animals that I own, but are kept in a barn that is not mine and raised by a contract grower?
  23. Can a distributor distribute a VFD feed to a representative of the client (e.g., a family member, or employee)?
  24. Can an acknowledgment letter be written to cover multiple shipments of VFD feed?
  25. I manufacture a VFD feed and ship a VFD feed to a farmer, but the sales transaction is handled through a dealer who does not physically take possession of or distribute the VFD feed. What are my responsibilities and what are the dealer’s responsibilities?
  26. What is needed in a distributor notification and can a distributor notification cover multiple locations?
  27. What is needed in an acknowledgment letter and can an acknowledgment letter cover multiple locations between the distributors?
  28. Do I need to hold VFD drugs or feed in a secure or locked area?
  29. Do I have to repackage VFD feed into smaller amounts if the client does not need all of the VFD feed in a bag? If I don’t repackage, will I be responsible for keeping track of the extra amount the client has on hand?
  30. I am a distributor with multiple locations. Can I fill a VFD from any of my locations?
  31. I am a distributor with multiple locations. Do I need a VFD or acknowledgment letter to transfer VFD feed between my locations?
  32. Can I provide a client with nutritionally different diets over the duration of use for a VFD?
  33. The client wants to purchase a Type B medicated feed under the VFD. If I distribute a Type B medicated feed, what are my responsibilities and what are the animal producer’s responsibilities?
  34. I want to distribute a Type A medicated article to a client. Do I need a VFD from the client? Are there additional requirements for distributing Type A medicated articles?
  35. Now that the VFD has the approximate number of animals instead of the amount of feed, what are my responsibilities as a distributor to make sure that the client is not receiving too much feed under the VFD? Will the FDA take enforcement action against me if a client over-orders or misuses a VFD feed?
  36. Can I manufacture VFD feed to have on hand before a client comes in with a VFD?
  37. Do I have to use the same distributor to obtain all of the VFD feed on a VFD?
  38. What do I do if I need to treat animals for a specific duration (e.g , 30 days) but need to receive the VFD feed from two separate mills? For example, because of the animals’ growth stage and needs, one mill will provide the ration for animals during the first 20 days of the VFD’s duration and another mill will provide the ration for animals during the last 10 days of the VFD’s duration
  39. I feed my animals several different rations based on their nutritional needs during each growth stage. I have a VFD with a duration of use that will encompass several of these growth stages. Can my feed mill provide me VFD feed with different formulations over the duration of the VFD?
  40. I have a VFD that authorizes me to feed my animals for 5 days as indicated on the drug approval. What happens if the animals get sick again? Can I use the same VFD to get additional VFD feed and feed the animals again for 5 days? Can the veterinarian write the VFD to allow me to use the VFD feed for more than one 5-day period prior to the 6-month expiration date?
  41. I am currently feeding my animals a VFD feed under a valid VFD. I would like to transfer ownership of my animals. May I do that?
  42. Does the VFD feed authorized by a VFD need to be shipped in one load, or can it be delivered in multiple loads?
  43. My animals are in the United States, but I receive my feed from Canada. Can I get a VFD feed from Canada and if so what are the requirements?
  44. The veterinarian used an affirmation statement to indicate that I can feed the VFD feed in combination with an over-the-counter (OTC) drug. Is it okay for me to feed the VFD drug alone?
  45. I want to get a Type A medicated article and manufacture my own feed. What are the requirements?
  46. When I purchase a Type A medicated article to create an authorized Type C VFD feed, where does the copy of the VFD intended for the distributor go?
  47. I have 4 months remaining on my VFD and I would like to get my VFD feed from a different distributor. Can I ask my veterinarian to cancel the first VFD and issue a new VFD to the second distributor?
  48. I am a client. Do I need to keep any records describing my use of the VFD feed in addition to keeping the VFD?

More to come on this soon.

 

As part of its activities Wildlife Services (WS) provides assistance to private and public entities, including tribes and other governmental agencies, when requested to develop programs in cooperation with “land and animal management agencies to reduce damage [caused by animals] effectively and efficiently in accordance with applicable federal, state and local laws and Memorandums of Understanding . . . between WS and other agencies.”  See Environmental Assessment, Mammal Damage Management in the State of New Jersey.

The agency explains the complexity of issues it addresses in these assessments:

Human/animal conflict issues are complicated by the wide range of public responses to animals and animal damage. What may be unacceptable damage to one person may be a normal cost of living with nature to someone else. The relationship in American culture of values and damage can be summarized in this way: Animals have either positive or negative values, depending on varying human perspectives and circumstances (Decker and Goff 1987). Animals are generally regarded as providing economic, recreational and aesthetic benefits, and the mere knowledge that animals exist is a positive benefit to many people. However, the activities of some animals may result in economic losses to agriculture and damage to property. Sensitivity to varying perspectives and values is required to manage the balance between human and animal needs. In addressing conflicts, managers must consider not only the needs of those directly affected by damage but a range of environmental, sociocultural and economic considerations as well.

The assessments include comprehensive data collected by the agency in cooperation with other local, state and federal agencies, described in the LIST OF TABLES:

Table 1.1 – WS’ technical assistance projects conducted in New Jersey, FY 2012 – FY 2016

Table 1.2 – NJDFW technical assistance calls conducted in New Jersey, CY 2014 – CY 2016

Table 1.3 – Mammal species WS received requests for assistance from FY 2012 – 2016 and the resource type affected by those species

Table 1.4 – Animal diseases that pose potential human health and safety risks through transmission to humans (Davidson 2006; Miller et al. 2013; Conover and Vail 2015).

Table 1.5 – Mammal species reported struck by civilian aircraft in New Jersey from 1/1/1990 – 4/30/2016

Table 1.6 – Wildlife diseases with mammalian hosts that pose threats to livestock in the United States (modified from (Miller et al. 2013)).

Table 3.1 – Number of beavers addressed in New Jersey from 2012 to 2016.

Table 3.2 – Number of eastern cottontails addressed in New Jersey from 2012 to 2016.

Table 3.3 – Number of coyotes addressed in New Jersey from 2012 to 2016.

Table 3.4 – Number of white-tailed deer addressed in New Jersey from 2012 to 2016.

Table 3.5 – Number of gray fox addressed in New Jersey from 2012 to 2016.

Table 3.6 – Number of red fox addressed in New Jersey from 2012 to 2016.

Table 3.7 – Number of muskrats addressed in New Jersey from 2012 to 2016.

Table 3.8 – Number of opossums addressed in New Jersey from 2012 to 2016.

Table 3.9 – Number of raccoons addressed in New Jersey from 2012 to 2016.

Table 3.10 – Number of striped skunks addressed in New Jersey from 2012 to 2016.

Table 3.11 – Number of feral swine addressed in New Jersey from 2012 to 2016.

Table 3.12 – Number of woodchucks addressed in New Jersey from 2012 to 2016.

Table 3.13 – Number of feral/free-ranging cats and dogs addressed in New Jersey from 2012 to 2016.

WS has recently provided similar assessments for other states.  See, e.g., “Mammal Damage Management in the State of New Hampshire,” and “Mammal Damage Management in the State of Maine.”

Clearly, each assessment is tailored for the issues in each specific state or location and sets forth a series of recommendations and method available to attempt to resolve location-specific identified issues.  For example, WS includes specific recommendations for beaver dam breaching/removal and a programmatic biological opinion related to Canada lynx and Atlantic salmon in New Hampshire.

A list of federally threatened and endangered species is also included in each report.

The assessments are available for review and comment on WS’ website.

“WS only conducts mammal damage management after receiving a request for assistance. Before initiating mammal damage activities, a Memorandum of Understanding, cooperative service agreement, or other comparable document must be signed between WS and the cooperating entity which lists all the methods the property owner or manager will allow to be used on property they own and/or manage.”

The agency expects to receive requests for assistance in the future related to damage or threats from black bear, beaver, white-tailed deer, feral cats and a number of other species.