As previously described, FDA has updated its Draft Guidance for Industry, #120, regarding the Veterinary Feed Directive Regulation.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

New Jersey bills S3551 and A5040 would require a vaccination schedule that is inconsistent with veterinary recommendations.

For example, the bills would require that “if the animal is a dog, [it] has received its first parvo and distemper vaccines and at least one booster, and the dog’s rabies inoculations are up to date.”

According to the American Animal Hospital Association (AAHA), and consistent with existing state laws “A single dose of rabies vaccine [should be administered] NOT EARLIER THAN 3 MO OF AGE.”  Earlier vaccination may be ineffective because of maternal immunity passed to the puppies.

AAHA also recommends vaccination against parvovirus and distemper virus beginning as early as 6 weeks of age, but booster shots should be administered at an interval of 2 to 4 wk until at least 16 wk of age.”  The bills would delay placement of an animal by requiring that it receive a booster before sale or adoption.   Since exposure to infectious diseases increases with the time each puppy or dog remains at a shelter or rescue facility, such a delay could increase, not decrease, the risk to animal health.

Rocky’s law would also require behavioral testing and reporting of historical behavioral abnormalities of animals before sale or adoption.  An animal’s behavior is an important factor for an owner  to consider and certainly any history of behavioral abnormalities, including aggression, should be recorded and reported.  Pets are often relinquished to a shelter or another home because of behavioral issues.  Equally important is the prevalence of dog bites in this country as reported by the AVMA.

Dog bites pose a serious health risk to our communities and society. More than 4.5 million people are bitten by dogs each year in the United States, and more than 800,000 receive medical attention for dog bites, according to the U.S. Centers for Disease Control (CDC). At least half of those bitten are children. Here are more dog bite facts:

Almost 1 in 5 people bitten by dogs require medical attention.

Children are by far the most common victims of dog bites and are far more likely to be severely injured.

Most dog bites affecting young children occur during everyday activities and while interacting with familiar dogs.

Senior citizens are the second most common dog bite victims.

Any dog can bite: big or small, male or female, young or old. Even the cuddliest, fuzziest, sweetest pet can bite if provoked. Remember, it is not a dog’s breed that determines whether it will bite, but rather the dog’s individual history and behavior.

There are several resources available for the evaluation of a dog’s temperament.

The American Veterinary Society of Animal Behavior (AVSAB), describes the importance of socialization of puppies by owners:

‘Puppies go through a sensitive period of socialization when they are uniquely prepared to benefit from exposure to social opportunities. From the time the owner adopts the puppy until 3 to 4 months of age, it is critical that the owner get the puppy out to meet other animals and people, and experience many different kinds of environments,’ said [former] AAVSAB president, Dr. E. Kathryn Meyer.

Unsocialized puppies may also fail to develop coping mechanisms and grow up into dogs that are unable to adapt to new situations. This can severely inhibit the dog’s quality of life as well as the owner’s enjoyment of the pet,

The American Kennel Club and the American Temperament Test Society, Inc. also have programs for testing dog behavior.

Once the pet leaves the pet shop, rescue or shelter, any subsequent behavior may have nothing to do with its care at these facilities.  Behavioral abnormalities, including aggression may have resulted from the care (or lack thereof) the animal had received from its owner.  The pet shop, rescue or shelter should not be liable for such subsequent behavior if there was no indication that the pet was predisposed to or had no history of such behavior.

These bills have promise, but require considerable amendments to protect animal health and welfare and the people and business who buy and sell them.

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.

The bill, if passed, would require an animal rescue organization facility, shelter and pound to “document the health, behavioral, and medical history of an animal prior to offering the animal for adoption.”

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 bill would also exempt animal rescue organization facilities, shelters and pounds from providing certain information by stating the information should be provided “to the extent possible.”  For example, the bill would require “[t]o the extent possible, an animal rescue organization facility, shelter, or pound shall determine and maintain records of the:

(1) date and place of birth of each animal placed in its care, and the actual or approximate age as established by a veterinarian, or the animal; [there is no reason a veterinarian cannot provide an approximate age, so this should be a requirement]

(2) sex, color markings, and other identifying information of the animal, including any tag, tattoo, collar number, or microchip information; [there is no reason why this information should not be required for every animal sold]

(3) name and address if the veterinarian last attending to the animal before the animal was placed in the animal rescue organization facility, shelter, or pound and any health, behavioral, or medical records that may be available from the veterinarian: [with the increasing incidence of the importation of highly contagious, infectious diseases through animal rescue organizations, this information should be required]

(4) name and address of the veterinarian attending to the animal while the animal is in the custody of the animal rescue organization facility, shelter, or pound, and the dates of the initial and any subsequent examinations of the animal; [there is no reason this information would not be available, and therefore it should always be provided]”

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.

The American Animal Hospital Association notes that every dog and cat “should receive year-round parasite control to prevent against heartworms, intestinal parasites, fleas, and when appropriate, ticks. Even if your pet spends most of his time indoors, he can still pick up diseases from these sneaky pests that can fly, crawl, or hitchhike on you to get inside your house. These bugs spread serious (even fatal, in the case of heartworms) diseases that are easily preventable with monthly medications.”

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.

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 the lawsuits were filed, North Carolina had a Right to Farm Act, N.C. Gen. Stat. § 106-701 (2013), limiting the right to bring nuisance suits against agricultural farms.  It read in relevant part:

“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.

(a1)       The provisions of subsection (a) of this section shall not apply when the plaintiff demonstrates that the agricultural or forestry operation has undergone a fundamental change.  A fundamental change to the operation does not include                              any of the following:

(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.

(5)  A change in the type of agricultural or forestry product produced.  (a2)

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.

In response to the Court’s findings and the large jury awards, North Carolina’s legislature acted swiftly and decisively in amending the statute in June 2018.  The preamble to the amended statute states that “frivolous nuisance lawsuits threaten the very existence of farming in North Carolina” and “following the 1979 enactment, at least three succeeding General Assemblies in 1992, 2013, and 2017 tried to perfect a statutory framework that broadly fosters a cooperative relationship between farms and forestry operations and their neighbors across North Carolina.”  However, “recently a federal trial court incorrectly and narrowly interpreted the North Carolina Right to Farm Act in a way that contradicts the intent of the General Assembly and effectively renders the Act toothless in offering meaningful protection to long-established North Carolina farms and forestry operations.”  It further states that “regrettably, the General Assembly is again forced to make plain its intent that existing farms and forestry operations in North Carolina that are operating in good faith be shielded from nuisance lawsuits long after the operations become established.”  Governor Cooper vetoed the amended statute, and the Senate overrode his veto in a 37-9 vote.  The day after the override, the House voted 74-45 in favor of the bill.  The Right to Farm Act now reads, in pertinent part:

“Right to farm defense; nuisance actions.

(a)         No nuisance action may be filed against an agricultural or forestry operation unless all of the following apply:

(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).

The definition of fundamental change remains the same.  The language regarding changed conditions is eliminated.  It also deleted the language permitting punitive damages, and instead added an express provision prohibiting punitive damages in private nuisance suits except in very limited circumstances:

“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.

 

Republished with permission.  Originally posted on Feb 20, 2019.

 

Here’s some good news! Supreme Court says constitutional protection against excessive fines applies to state actions:

“For good reason, the protection against excessive fines has been a constant shield throughout Anglo-American history: Exorbitant tolls undermine other constitutional liberties,” Ginsburg wrote. “Excessive fines can be used, for example, to retaliate against or chill the speech of political enemies. . . . Even absent a political motive, fines may be employed in a measure out of accord with the penal goals of retribution and deterrence.”

As a cherry on top, this was a unanimous ruling, too. But how does this relate to animal issues?

For over 30 years we have watched private nonprofit humane societies armed with state police powers seize animals – primarily dogs – under color of law, with very mixed results. There are definitely cases of horrendous neglect and abuse where animals must be removed from their current environment to protect and save their lives.

However, we have also observed animal confiscations that appeared to be little more than media events designed to provide a poster child opportunity for a humane society’s current legislative or fundraising campaign. We have seen seized animals that were portrayed by the shelter as being at death’s door when seized but made available for adoption within days of confiscation.

Decades ago, when dog overpopulation was still a problem in most parts of the country, the primary role of humane societies was to house and rehabilitate stray, neglected, owner relinquished and abused animals, and rehome them. But in the modern era, many shelters serve primarily as a major source of pets in their communities, often importing animals from different states and even foreign countries to maintain a steady supply of adoptable dogs. Confiscating pets in this environment is highly questionable and creates the perception of a serious conflict of interest. In addition, NAIA believes that nonprofit organizations should never be granted police powers, and that animal confiscations should only be carried out by duly appointed law enforcement personnel operating under proper legal justification, not by employees of a private nonprofit operating under the mission statement of their organization.

Three cheers for the Supremes and this decision. This applies to seizure of property that is used in engaging in criminal activity and, since dogs and other animals are defined as property, we expect that state legislatures will address their laws to align with this Supreme Court decision.

 

HB 688, introduced on January 3, 2019, would

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.

At least some of the requirements for “hobby breeders” appear to be draconian and overly burdensome.  See, e.g., inspection and record keeping requirements:

A hobby breeder registered under this subdivision shall:

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 projected number, type and cost of new positions needed for the new Division includes:

Position Number of Positions FY 2022 Salary and Benefit Costs FY 2023 Salary and Benefit Costs

Inspectors

(LG 18, Step 1)

8

 

$544,000 $560,000

Administrative Secretary

(LG 14, Step 1)

2 $122,000 $128,000

Administrator II

(LG 29, Step 1)

1 $94,000 $99,000

Technical Support Specialist VI

(LG 32, Step 1)

1 $104,000 $109,000

Veterinarian

(LG EE, Step 1)

1 $101,000 $107,000

Attorney III

(LG 30, Step 5)

1

 

$111,000 $113,000
Hearing Officer Contractor 0.5 $37,000 $37,000
Total  14.5  $1,224,000 $1,266.000

 

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).

While HB 688 would help the state regulate the transfer of animals through animal rescue organizations, it’s required licensure of all hobby breeders appears to be overreaching and likely not necessary to obtain the laudible goals of “put[ting] the humane treatment of animals on par with the existing mission priorities of the Department . . .”

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.

Confirmed or suspect cases must be immediately reported to the relevant local health department.  Rabies, as described by NJDOH,

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).

Guidance from the State’s Public Health and Environmental Laboratories (PHEL), responsible for rabies testing, prohibits specimens submitted for rabies testing to be returned to veterinarians or animal animals UNDER ANY CIRCUMSTANCES.  See Preparation of Specimens for Submission (emphasis in original.)

According to the CDC, “[r]abies is a preventable viral disease of mammals most often transmitted through the bite of a rabid animal.”

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.

According to the Center for Food Security & Public Health,

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.

 

 

Arizona bill HB 2329,  a bill titled “pet dealers: purchaser remedies” includes a repeal of Section 44-1799.11 of the Arizona Revised Statutes in the last line of the bill.  That section has nothing to do with purchaser remedies but everything to do with the regulation of pet dealers in Arizona.  Specifically, 44-1799.11 states

The regulation of pet dealers is a matter of statewide concern. A city, town or county may enact or enforce an ordinance to enforce section 44-1799.10 against a pet store or pet dealer. Any local law, rule, regulation or ordinance that imposes requirements on pet dealers that exceed the requirements of section 44-1799.10 or penalties prescribed by section 44-1799.08 is preempted. Any local law, rule, regulation or ordinance may not directly or indirectly prohibit or be applied to prohibit the sale of dogs or cats by a pet store or pet dealer, expressly or in effect, based on the source from which the animal is obtained if obtained in compliance with section 44-1799.10.

The statute was enacted following the adoption of an ordinance in Phoenix which banned pet stores from selling dogs or cats purchased from commercial breeders.  See Puppies ‘N Love v. City of Phoenix, 283 F.Supp.3d 815 (D. Ariz. 2017), appeal dismissed 2017 WL 7726037.  The “intervening Arizona state legislation that allowed pet stores to sell dogs and cats obtained from commercial breeders that met certain requirements, which preempted a charter city ordinance that banned pet stores from selling dogs or cats supplied by commercial breeders, required a vacatur of summary judgment granted in favor of city and nonprofit group on the constitutionality and validity of the ordinance, despite claims that pet store operator persuaded Arizona to pass the statute, that operator was required to show equitable entitlement to vacatur, and that public interest favored a denial of vacatur.”

There is nothing in HB 2329 revealing the repeal, other than the one-liner at the end of the bill.  Unless someone knows statutory citations, there would be no public notice that the repeal of statutory preemption was a major objective of this bill .  Therefore, those who would be impacted but such a repeal are now on notice.

There are also serious concerns about the proposed substantive amendments related to purchaser remedies:

  1. The bill would permit a purchaser to show by a preponderance of the evidence that an animal had an illness, injury, defect or congenital or hereditary condition when the purchase took possession of the animal.  This amendment is unnecessary because the law already provides for a purchaser’s remedies upon the presentation of a veterinarian’s written opinion of an illness, injury or defect to the pet store within a prescribed number of days.  With limited exceptions Arizona prohibits anyone except a licensed veterinarian from diagnosing or prognosticating “any animal condition, disease, deformity, defect, wound or injury . . .”  Ariz. Rev. Stat. Ann. § 32-2231.

Additionally, a “preponderance of the evidence” standard is a legal standard, and one which a pet store would not be able to determine. Therefore this additional provision is unnecessary and would create ambiguities that would not benefit anyone.

  1. Several amendments eliminate requirements that provide objective evidence of proof of diagnosed illness or conditions. An amendment to Section B (6) would make “findings of the examination or necropsy, including laboratory results or copies of laboratory reports” optional.  Veterinary medicine is a sophisticated medical practice wherein diagnosis of infectious diseases or congenital defects are confirmed by laboratory testing, including necropsy results.  To permit an exclusion of such objective support of a clinical diagnosis is neither sound science, nor good public policy.
  2. The bill would permit the purchaser to receive reimbursement for reasonable veterinary fees for diagnosis and treatment without restriction instead of the existing limit of “an amount not more than the original purchase price of the animal.” The cost of medical treatment varies considerably between practices, and can grossly exceed the original purchase price of the animal.  Other states limit reimbursements to two times the purchase price.  See, e.g., N.J.S.A. 56:8-95 (i)(4).
  3. The bill would permit a purchaser to receive reimbursement for the death of a pet within sixty days of the time of purchase. The current limitation is fifteen days.  The bill would permit such reimbursement in the absence of a necropsy.  The incubation period of most infectious diseases is less than fifteen days.  While complications during treatment could result in death after fifteen days, many other variables would have to be considered, making it difficult or impossible to determine a cause of death without a necropsy.  Therefore, objective laboratory diagnostic tests, including necropsies, should be required, particularly if extending the time period for reimbursement as proposed herein.

Finally, since the vast majority of pets are currently obtained from animal rescue organizations or animal shelters, similar remedies should be required of these facilities.