Source: https://animallaw.foxrothschild.com/
Timestamp: 2019-04-19 10:28:55+00:00

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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.
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.
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.
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?
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?
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?
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?
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?
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.
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.
Does the State or Federal definition of a veterinarian-client-patient relationship (VPCR) apply?
What information should be included on the VFD to describe the “premises” at which the animals are located?
Can a VFD authorize either the approved pioneer or approved generic VFD drug(s)?
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?
What additional information is required on a VFD authorizing the use of a combination VFD drug?
What is the Distributor Notification Process?
How is an acknowledgment letter different from a distributor notification?
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?
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?
Are VFDs only required for food producing animals?
Is the listing of multiple premises on the VFD allowed? If so, is it mandatory or optional?
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?
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?
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?
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?
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?
I am a client that has multiple premises. Do I need to keep a copy of the VFD at each of those premises?
Pm a veterinarian and I also want to sell VFD feed. What do I have to do?
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?
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?
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?
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?
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?
Can a distributor distribute a VFD feed to a representative of the client (e.g., a family member, or employee)?
Can an acknowledgment letter be written to cover multiple shipments of VFD feed?
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?
What is needed in a distributor notification and can a distributor notification cover multiple locations?
What is needed in an acknowledgment letter and can an acknowledgment letter cover multiple locations between the distributors?
Do I need to hold VFD drugs or feed in a secure or locked area?
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?
I am a distributor with multiple locations. Can I fill a VFD from any of my locations?
I am a distributor with multiple locations. Do I need a VFD or acknowledgment letter to transfer VFD feed between my locations?
Can I provide a client with nutritionally different diets over the duration of use for a VFD?
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?
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?
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?
Can I manufacture VFD feed to have on hand before a client comes in with a VFD?
Do I have to use the same distributor to obtain all of the VFD feed on a VFD?
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?
Rocky’s Law, S3551 and its companion A5040, would require the mandatory registration of animal rescue organizations, as opposed to the current laws providing for voluntary registration. They would also would require all animal rescue organizations, pet shops, shelters and pounds to conduct and provide test results about the animal’s medical status and behavioral history to people purchasing* pets.
The expansion of existing pet shop requirements to animal rescue organizations and shelters is laudable, but some of the proposed requirements are medically unsound as written and others would result in unintended consequences. Also, some of the requirements for pet shops would still exceed those required for rescues and shelters, even though the potential risks are indistinguishable. Finally, penalties for behavioral conditions in pets that result in human harm, including death, do not recognize the owner’s responsibility and influence over the pet’s behavioral abnormalities that occur after purchase. Accordingly, some of the penalties for conditions resulting from the owner’s oversight of the animal and not the sellers are misplaced.
Some of these issues are identified herein—others will be discussed in subsequent blogs.
However, these requirements exclude animal rescue organizations and instead only apply to animal rescue organization facilities. While both entities sell pets to owners in the State, only those with a facility in the State would have to comply with the expanded requirements. Since risks from animal rescue organizations meet or exceed those with facilities in the State, the provisions should apply to all.
The bills would require a veterinarian to certify that the animal is “free” of parasites, but it would be more reasonable for a veterinarian to certify that she has performed an examination for internal and external parasites, and has treated the animal, if needed, based on the results of that examination.
Statements requiring a veterinarian to certify that the animal is free from “contagious hair loss” and “does not have feces free of disease, infection, and parasites” should be amended. For example, feces do not have diseases. Notably, there can be existing but subclinical infections that would not be evident during a physical examination even if certain testing were performed.
Also, feces contain germs, including bacteria that will be reported if cultured. As written, a veterinarian may be inclined to prescribe an antibiotic upon receipt of a positive culture, even in the absence of clinical signs of disease. The presence of bacteria in feces does not necessarily mean that the animal is diseased or infected. Such treatment is inconsistent with federal, state and medical policies to minimize unnecessary treatment with antibiotics that leads to antibiotic resistance. Further, the time required for bacterial and viral testing would unnecessarily delay sale or adoption.
Instead of trying to proscribe how veterinarians should perform examinations and diagnose illness, the sponsors should consider extending the warranty required for pet shops to animal rescue organizations, animal rescue organization facilities, and shelters.
Additional issues will be addressed in a subsequent blog.
*Purchasing and purchase should be considered the same as adopting and adoption.
North Carolina expands protections for its farmers under the Right to Farm Act.
In 2014 and 2015, 26 nuisance lawsuits representing over 500 North Carolina residents were brought against Murphy-Brown, a subsidiary of Smithfield Foods, in North Carolina federal court. The lawsuits involve 89 hog farms or “CAFOs” (Concentrated Animal Feeding Operations) in Eastern North Carolina. Although Murphy-Brown owns some of the farms itself, in most instances, Murphy-Brown contracts with independent farm owners. Under these arrangements, the hog farmers own the farm but Murphy-Brown owns the hogs and sets the operational rules. The cases were consolidated in 2015 for pre-trial litigation. The Court created five “Discovery Pool Cases” in which detailed discovery was taken and ordered two test trials, to be followed by monthly trials for the remaining cases. In 2018, the trials began and four cases reached jury verdicts, all in favor of plaintiffs.
The lawsuits alleged that the odor and flies from the effluent spray process at the hog farms caused a nuisance to the surrounding property owners, and that tractor trailers travelled through the area at night, creating noise and lights that prevented sleep. None of the lawsuits involved operational processes that broke any state or federal laws. Three of the test cases, all before the same federal court judge, resulted in substantial jury awards totaling almost $550 million. North Carolina’s punitive damages cap limiting punitive damages to three times compensatory damages or $250,000, whichever is larger, reduced the jury awards to $97.88 million. A fourth lawsuit was decided by jury in December 2018 before a different federal judge. That jury awarded $100,000 total in compensatory damages to all eight plaintiffs, but the judge ruled that plaintiffs failed to produce sufficient evidence of punitive damages.
“When agricultural and forestry operation, etc., not constituted nuisance by changed conditions in or about the locality outside of the operation.
(a) No agricultural or forestry operation or any of its appurtenances shall be or become a nuisance, private or public, by any changed conditions in or about the locality outside of the operation after the operation has been in operation for more than one year, when such operation was not a nuisance at the time the operation began.
(1) A change in ownership or size.
(2) An interruption of farming for a period of no more than three years.
(3) Participation in a government-sponsored agricultural program.
(4) Employment of new technology.
The provisions of subsection (a) of this section shall not apply whenever a nuisance results from the negligent or improper operation of any agricultural or forestry operation or its appurtenances.” 106-701 (2013). The Act defines “agricultural operation” as “any facility for the production for commercial purposes of crops, livestock, poultry, livestock products, or poultry product.” § 106-701(b).
Further, in 2017, the legislature added a section that limited compensatory damages to the reduction in the fair market value of the plaintiff’s property caused by the nuisance, not to exceed the fair market value, for permanent nuisances, and to the diminution of the fair rental value of plaintiff’s property for temporary nuisances. N.C. Gen. Stat. § 106-702(a) (2017). The statute expressly did not prohibit or limit punitive damages. § 106-702(d) (2017).
At summary judgment, the Court found that the Right to Farm Act only applies to agricultural operations that become a nuisance due to changed conditions in the locality outside the agricultural operation. In re NC Swine Farm Nuisance Litigation, 2017 WL 5178038 at *5 (E.D.N.C. Nov. 8, 2017). Because the plaintiffs had used their properties as residences well before the operations began at the subject hog farms, the Right to Farm Act was inapplicable as a matter of law. Id. at *6.
“Right to farm defense; nuisance actions.
(1) The plaintiff is a legal possessor of the real property affected by the conditions alleged to be a nuisance.
(2) The real property affected by the conditions alleged to be a nuisance is located within one half-mile of the source of the activity or structure alleged to be a nuisance.
(3) The action is filed within one year of the establishment of the agricultural or forestry operation or within one year of the operation undergoing a fundamental change.” N.C. Gen. Stat. § 106-701 (2018).
“A plaintiff may not recover punitive damages for a private nuisance action where the alleged nuisance emanated from an agricultural or forestry operation that has not been subject to a criminal conviction or a civil enforcement action taken by a State or federal environmental regulatory agency pursuant to a notice of violation for the conduct alleged to be the source of the nuisance within the three years prior to the first act on which the nuisance action is based.” 106-702(a1) (2018).
The amended statute is a significant victory for the agricultural industry in North Carolina. The 2018 amendments substantially limit the availability of punitive damages, change the focus from the surrounding locality to the operation itself by eliminating the changed conditions language, thereby making it more difficult for pre-existing neighbors to bring suit, and removing the exception for nuisances caused by negligence or improper operation. In combination with the 2017 amendments limiting compensatory damages to fair market value of the harmed property, there is little financial incentive to bring suit. The likely result is that we will see fewer nuisance lawsuits against the agricultural industry in the future.
These cases are all pending on appeal, and this post may be updated accordingly.
Guest post from NAIA: Three Cheers for the Supremes!
Republished with permission. Originally posted on Feb 20, 2019.
I. Makes changes to the definition of pet vendor and defines hobby breeder.
II. Establishes the companion animal welfare division in the department of agriculture, markets, and food.
III. Establishes the animal transfer database in the department of agriculture, markets, and food.
IV. Creates a license for animal shelters and modifies the license for pet vendors.
V. Allows hobby breeders to register with the department of agriculture, markets, and food.
The bill would “REQUIRE” not “ALLOW” hobby breeders to register with the department, despite the language in the summary described above.
A “hobby breeder” means “A person who transfers animals for a fee and transfers 30 or fewer animals in a year.” Notably, the term “animals” is not limited to dogs, cats, or other animals commonly owned as pets.
I. Maintain in a clean and sanitary condition all premises, buildings, and other enclosures used in the business of dealing in live animals customarily used as household pets.
II. Submit premises, buildings, and other enclosures to scheduled inspections by department employees or local animal control, law enforcement, or health officials at reasonable times.
III. Maintain, subject to inspection by the commissioner, his or her agent, local officials, law enforcement, or any member of the public, a proper record in which all live animals customarily used as household pets obtained or transferred shall be listed, including the breed, date the animal was obtained and transferred, and from whom the animal or bird was obtained and to whom the animal was transferred. Such record shall also show the microchip, leg band, or tattoo number of each animal or bird, where applicable. Animals that do not bear such identification shall be identified by recording markings, a physical description and any other information as the commissioner deems necessary to identify such animals.
IV. Keep records of all animals intended for transfer indicating identification, point of origin, and recipient, and shall submit said records to the commissioner upon request.
V. Provide a health certificate in accordance with RSA 437:10-d to the transferee.
VI. Shall not transfer animals to pet vendors.
VII. Comply with such other rules as the commissioner may adopt to control disease.
The Fiscal Note, submitted with the bill as introduced, describes the expenditures required by New Hampshire related to the establishment of the Companion Animal Welfare Division within the Department of Agriculture, Markets and Foods, excluding expenses pertaining to operating the office which will house the new Division. A wopping $3,896,000 are the estimated expenditures from 2020-2023. The program is not expected to be operational until 2022.
The new Division has been purportedly modeled after the Animal Welfare Program in Maine.
However, there appear to be striking differences between the laws in Maine and those proposed in HB 688. For example, NH would require licensure of anyone who transfers as few as one animal for a fee. In Maine, “a person may not advertise for sale, sell or exchange for value more than one cat or dog under the age of 6 months in a 12-month period unless that person has a valid animal shelter, kennel, breeding kennel or pet shop license or a valid vendor’s license issued under this section.” MRS §4163 (emphasis added).
Maine also exempts hobby dog breeders from licensure as a kennel if they sell or exchange one litter of puppies within a 12-month period. MRS §3907 (17).
S3366 (Senator Stack) and identical bill A3684 (Assemblywomen Chaparro and McKnight) recently introduced bills that would expand the requirements of notification to animal owners before their animals were tested for rabies virus. Such measures could unreasonably delay testing that is required to ensure that other animals and humans were not exposed to rabies virus, a nearly 100% fatal virus.
Rabies testing requires extraction and testing of the brain, following euthanasia. The bill would also permit the owners the ability to request the return of the animal’s head following testing. The bill would expose veterinarians, laboratory technicians and others-including the animal’s owner-to unnecessary and dangerous exposure to infectious, contagious disease if the current prohibition on the ban of the return of remains to veterinarians or animal owners is eliminated.
Rabies is a dangerously pathogenic virus, for which extensive science-based public health laws have been development and implemented. Vaccination is the key to prevent unnecessary euthanasia and testing of those animals for which approved vaccines have been developed and approved. The routine vaccination of these species, including dogs and cats, must be performed by veterinarians in New Jersey for the animal to be considered adequately protected. Proper vaccination would eliminate the need for the potentially dangerous provisions proposed in these bills.
New Jersey State and Local Departments of Health and the New Jersey Department of Agriculture enforce the state and local laws governing the reporting and testing of animals exposed or infected with rabies virus.
is an infectious disease caused by the rabies virus. Animals infected with rabies display strange behavior such as aggression, and signs of neurologic impairment including vocalization, circling, and paralysis. People who are bitten by, or have had contact with saliva from an animal should notify the local health department (LHD) having jurisdiction where the animal is located and seek medical care.
See also N.J.S.A. 26:4-78 (“whenever a dog, cat, or other animal has been known or suspected to have been bitten by an animal known or suspected to be affected by rabies, the owner of the animal or any person with knowledge of the incident shall notify the local health department with jurisdiction where the animal is located.”).
After a report is received, “[t]he Health Officer shall then serve notice on the owner of the animal requiring euthanasia or confinement for up to 6 months and observation for the emergence of clinical signs of rabies.” (N.J.S.A 26:4-83).
Rabies testing, which requires animal euthanasia required extraction, submission and laboratory testing of at least two locations in the brain, preferably the brain stem and cerebellum.
In animals, rabies prevention is based on vaccination and the avoidance of contact with infected animals (e.g., preventing pets from roaming, housing pet rabbits and rodents indoors) . . . Vaccination is recommended for dogs, cats and ferrets, to reduce human exposure as well as to protect the animal. Vaccination is recommended for dogs, cats and ferrets.
USDA has also licensed rabies vaccines for livestock in the United States, including horses, cattle and sheep.

References: § 530
 § 106
 § 106
 § 106
 § 106

V. 

V. 
 §4163
 §3907