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.

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.