FDA has continued to exercise its authority, via guidance documents, which FDA says, while not legally enforceable, represent the agencies current thinking on the topic.  To further the judicious use of medically important antimicrobial drugs in animals, the goal of Guidance #263 is to:

(1) Limit medically important antimicrobial drugs to uses in animals that are considered necessary for assuring animal health, and

(2) Limit medically important antimicrobial drugs to uses in animals that include veterinary oversight or consultation.

“FDA intends to work with affected drug sponsors to help them to voluntarily change the marketing status of their medically important antimicrobial new animal drug products from OTC to Rx.”

Certainly, animals benefit from examination, diagnosis and treatment plans from licensed veterinarians, but there are numerous veterinary deserts throughout the country in which access to licensed veterinarians can be difficult.

This occurs even in otherwise populated states, including New Jersey, where a recent proposed bill, A5117, would provide load redemption for certain eligible veterinarians who work at approved underserved sites for specified times.  As proposed,

The Secretary of Agriculture, in consultation with the New Jersey Horse Council, the New Jersey Association of Equine Practitioners, and the New Jersey Farm Bureau, shall annually establish a list of State designated veterinary underserved areas.

A veterinarian participating in the federally administered Veterinary Medicine Loan Repayment Program would not be eligible to participate in this NJ state program.

Additional hurdles that animal owners face, if in veterinary deserts, are the state veterinary practice acts which generally require veterinarians to be licensed in each state in which they are diagnosing and treating animals.  With a dearth of veterinarians serving rural areas, farmers and ranchers may experience additional hurdles to providing adequate care to their animals if they have to rely on state-licensed veterinarians.

In Guidance #263, FDA outlines the process for “sponsors of approved applications and abbreviated applications for new animal drugs containing medically important antimicrobials for use in non-food (companion), food-producing animals, or both, that are currently approved with over-the-counter marketing status . . . to facilitate voluntary changes to the approved conditions of use of these drugs to prescription marketing status.”

Entities responsible for animals covered by the AWA will be required to establish and implement contingency planning for emergency response by USDA, APHIS once a proposed rule is finally adopted (see Docket No. APHIS-2020-0101).

Specifically, the rule would require regulated entities to establish and implement contingency planning by 180 days after the final rule has been adopted, train relevant staff within 60 days of establishing those contingency plans, but would not require regulated entities to document training of relevant staff.

However, if there was ever a question about whether or not staff was adequately trained, it would be much easier to prove compliance by providing documentation of such training.

The agency has identified the following benefits of contingency planning:

First, contingency planning can prevent loss of animal life and any resulting undisposed carcasses that pose a threat to public health. Second, loss of valuable research resources and income can be mitigated with contingency planning. Third, having a contingency plan can reduce the time of recovery from disasters and thus provide cost savings to the affected businesses and organizations and allow for business continuity. Finally, required contingency planning will reassure the general public that facilities have measures in place to ensure the welfare of the animals in times of catastrophic and common emergencies.

Research facilities, dealers, exhibitors, intermediate handlers, and carriers will be required to develop, document, and follow an appropriate plan to provide for the humane handling, treatment, transportation, housing, and care of their animals in the event of an emergency or disaster (one which could reasonably be anticipated and expected to be detrimental to the good health and well-being of the animals in their possession). They may use APHIS Form 7093 or develop their own documents.

USDA, APHIS, AC has created an optional form that entities may use to develop and document a contingency plan. See Draft Form 7093.

The plan, as included in the Form, requires licenses/registrants to: (1) identify the common risks to the entities animals, including formerly identified hazards; (2) identify tasks necessary to address/respond to such risks/hazards; (3) identify the persons responsible for performing each task; and (4) identify details needed to perform each task.

These contingency plans will likely be scrutinized, especially if an entity subject to an incident is unable to protect its residents completely, despite having comprehensive contingency plans.  It is advisable that regulated entities consult with emergency preparedness officials familiar with the preparation of such plans, which are also intended to be evergreen.  The intention is that contingency plans form the framework to be used and amended as needed during implementation in an unfolding emergent event. Therefore, the plans must include the flexibility needed to be most effective during an adverse event and should not state or imply that they will be 100% effective.

If you have concerns about the proposed rule, you should submit comments on or before August 24, 2021, by either of the following methods:

  1. Federal eRulemaking Portal: Go to www.regulations.gov. Enter APHIS-2020-0101 in the Search field.
  2. Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2020-0101, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

Missouri Bill HB 574,  approved by the Governor on June 10, 2021, effective on August 28, 2021, “prohibits the inspection of certain grounds or facilities in Missouri to enforce the laws of a state other than Missouri,” more specifically,

This bill specifies that the Missouri Department of Agriculture, Department of Natural Resources, the United States Department of Agriculture, the county sheriff and any other federal or Missouri state agency with statutory or regulatory authority have exclusive authority to inspect the grounds or facilities in Missouri used for the production of eggs, milk or other dairy products, or raising of livestock. Unless requested by the owner of the facility, no other entity may inspect the grounds or facilities to enforce or carry out the laws or administrative rules of the state or that of another state.

Notably, this would still allow the owner of a facility to provide an out of state entity permission to inspect their facility, if they, for example, wanted to be able to sell certain agricultural products into another state that requires inspection (e.g., California Prop 12 requirements).

This should help protect agricultural facilities in the State from unauthorized seizures by animal rights organizations, but may not be protective if local law enforcement engages such entities to assist in alleged animal cruelty investigations pursuant to valid search warrants.  The law further provides,

No testimony or evidence offered regarding conditions or events at the described facilities by anyone other than those authorized may be admissible in any criminal prosecution unless the testimony is offered by someone who is authorized by the owner to be present at the facility or grounds, a person who entered pursuant to a valid search warrant, or a person who observed the condition or event from public land or private land owned or rented by such person.

Whether this law will be challenged by animal rights organizations, some of whom opposed the bill remains to be seen.  The opponents stated that “[t]hose who oppose the bill say that the portion of the bill limiting evidence is too strict and would not allow whistle blowers to testify even if they are on the property under proper pretenses.”  It is unclear what those “proper pretenses” would be, since, as the law specifies, only “evidence gained inspecting a facility without proper authority could not be used in court.”  (Double-negative in original text).

Proposed New Jersey Assembly Bill A5715 (the “Rescue Animal Disclosure Act” or the “Bill”) which would provide for the regulation of animal rescue organizations and facilities (“Animal Rescue”) in New Jersey, was introduced in May, with no sister bill to date in the Senate.

The Bill would require the Animal Rescue to provide consumers with an animal’s medical and behavioral history and permit the return of an animal within 21 days of adoption, under certain conditions.  Those requirements are somewhat similar to provisions in the Pet Purchase Protection Act (“Act”) which govern pet shops. However, the Bill expressly exempts Animal Rescues from the provisions of the Act.

Notably, the Bill protects consumers by requiring the Animal Rescue to provide consumers with “a copy of the records, statements, reports, and other information required,” including any veterinary reports. The Bill permits an animal to be returned to the Animal Rescue if “the person adopting the animal cannot care for the animal because of the animal’s behavioral temperament or any other reason that would prevent the person from properly caring for the animal.”  If an animal is returned, the Animal Rescue “shall request that a person returning an animal provide an anonymous statement describing the reason the animal is being returned, as well as a copy of any veterinarian reports that have been provided to the person.”

These records must be provided to any subsequent adopter with notification that the animal might be unfit for sale and that it would be advisable for the consumer to have the animal examined by a veterinarian.  Such notification allows consumers to have important information about a pet before the adoption is finalized and the ability to return the pet as previously described.

In addition, the Bill also amends section 6. of P.L. 2011, c.142, which permitted but did not require registration of Animal Rescues with the Department of Health (“DHS”).  If adopted, the Bill would make it mandatory for every animal rescue organization and facility to register with the DHS.

In addition, the Bill establishes that animal rescue organization facilities can only charge “reasonable fees” for adoptions and may never outright sell animals.

Some legal questions that concern us are the following:

Who will determine what a “reasonable fee” is?

If an Animal Rescue cannot sell an animal, who is the owner of that animal?  Custody and ownership are increasingly complicated and oft disputed issues amongst pet owners.

Stay tuned for updates regarding this and similar legislation. Anyone seeking additional guidance can contact us directly for assistance.

 

The primary author, Andrew Regan is a Fox Rothschild 2021 summer associate.

The Ninth Circuit’s recent holding[1] that “the ADA prohibits certification requirements for qualifying service dogs” is a timely reminder for all persons using service animals that certification of a service animal’s task-performing ability by a third party is prohibited under the Americans with Disabilities Act (ADA) for qualification as a service animal. The underlying logic of the Ninth Circuit’s holding may further extend to the U.S. Department of Transportation (“DOT”)’s December 2020 final rule (“Traveling by Air with Service Animals”),[2] which recently updated the definition of “service animal” under the Air Carrier Access Act (ACAA). As summer travel continues to increase, many airline passengers with service animals may encounter the DOT’s updated regulations for the first time, and legal challenges between such passengers and airline carriers may result.

Although the DOT’s updated definition of service animal does not perfectly mirror the Department of Justice (DOJ)’s definition[3] implementing the ADA in all respects, both the DOT and DOJ similarly define a service animal as a dog “that is individually trained to do work or perform tasks for the benefit of a qualified individual with a disability, including a physical, sensory, psychiatric, intellectual, or other mental disability.” However, primarily due to safety concerns related to the close confinement of passengers and crewmembers aboard airplanes, the DOT final rule allows for additional service animal-related requirements by airline carriers under the ACAA beyond those permitted by DOJ service animal regulations related to public accommodations under the ADA.[4]

Importantly, while the DOT’s December 2020 final rule allows an airline carrier to require that passengers traveling with service animals provide advance attestation of their service animal’s task-performing ability, the DOT rule specifically notes that “the rule does not require service animal users to incur the cost of training by third party schools or organizations; service animal users are free to train their own dogs to perform a task for function for them.” Similarly, the Ninth Circuit’s recent holding was specifically premised, in part, on the DOJ’s refusal to impose any third-party certification requirement on service animals under the ADA.[5] The Ninth Circuit emphasized that the DOJ definition of a service animal doesn’t specify “by whom the dog must be trained.”[6] In fact, the Ninth Circuit further found that the DOJ’s regulatory commentary “confirms that persons with disabilities need not secure formal training and may self-train their animals.”[7]  The administrative commentary accompanying the DOT’s December 2020 rule includes similar reasoning.

Although the DOT has authorized airline carriers to require additional attestations by service animal owners prior to travel with their service animals on planes, these additional requirements likely do not extend to a requirement for third-party certification of a service animal’s abilities. As air travel continues to increase, passengers with service animals will continue to encounter new airline carrier operating procedures following the DOT’s December 2020 final rule. The Ninth Circuit’s recent decision in L.M. v. Del Almo is a timely judicial interpretation of the DOJ’s interpretation of the ADA; similar judicial reasoning may well apply to the DOT’s December 2020 revisions interpreting the ACAA.

Jonathan Madara is a Fox Rothschild 2021 summer associate.

 

[1] C.L. v. Del Amo Animal Hospital, 992 F.3d 901, 910 (9th Cir. 2021).

[2] Traveling by Air with Service Animals, 85 Fed. Reg. 79742 (Dec. 10, 2020) (to be codified at 14 C.F.R. pt. 382).

[3] 28 C.F.R. §§ 35.104, 36.104.

[4] For a detailed discussion of the December 2020 DOT final rule, please see our December 10, 2020 Animal Law Update (https://animallaw.foxrothschild.com/2020/12/10/emotional-support-animals-are-considered-pets-not-service-animals-by-us-department-of-transportation/).

[5] Del Amo, 992 F.3d at 910-13.

[6] Id. at 911.

[7] Id. at 912.

 

FDA recently published Guidance #263 titled, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter,” which builds on earlier provided guidance to limit medically important drugs in food-producing animals. (Guidance #209 and Guidance #213).

As explained in Guidance #263,

This plan builds upon the important steps the Center for Veterinary Medicine (CVM) has already taken to support the judicious use of antimicrobials in animals, and is driven by the concept that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control, or prevention of specific diseases.

FDA wants to extend veterinary oversight for medically important antimicrobial drugs implemented for use in food-producing animals, to all animals, instead of those currently available over-the-counter.

FDA believes that requiring oversight by veterinarians should provide more judicious use of antimicrobials in all animals, since the following factors are considered by veterinarians prescribing such drugs to animal patients:

The decision by the veterinarian to use a specific approved drug is generally based on multiple factors , such as the mode of antibacterial action, drug distribution in specific tissues, the duration of effective drug levels at the site of infection, past treatment outcomes, local burden of illness information, and concurrent animal health issues. Other important factors veterinarians consider when determining the appropriateness of a given antimicrobial use include whether: (1) there is evidence of effectiveness, (2) such use is consistent with accepted veterinary practice, (3) the use is linked to a specific etiologic agent, (4) the use is appropriately targeted to animals with or at risk of developing a specific disease, and (5) no reasonable alternatives for intervention exist. FDA believes that veterinarians are uniquely qualified to make these decisions and to determine appropriately timed administration of the antimicrobial to treat, control, or prevent disease in animals.

FDA proposes a voluntary 2-year time frame for drug sponsors to submit revised labeling for approval and has published a list of affected drugs on its website.  Guidance #263 includes instructions for such submission.

Anyone seeking additional guidance can contact us or FDA directly for assistance.

As reported in the Washington Post on June 19, 2021, the Centers for Disease Control and Prevention has launched a “multistate investigation after imported rescue dog tests positive for rabies variant twice eradicated in U.S.”

This is the fourth case of a dog imported from a country with a high rabies risk later determined to have been infected with the canine variant of rabies virus, which was eradicated from the U.S. in the 1970s.  This form of the rabies virus transmits easily between dogs and has reportedly resulted in “59,000 human deaths a year-mostly in Africa and Asia.”

The facts reported by the Washington Post include:

  • The infected dog was a puppy “imported from Azerbaijan by a[n undisclosed] rescue group”;
  • The puppy was imported with 32 other dogs and one cat, arriving in Chicago on June 10, 2021;
  • The other 33 animals were sent to eight (8) other states, including: California, Illinois, Indiana, Michigan, New Jersey, New York, Ohio and Pennsylvania;
  • At least 12 people were reportedly exposed to the rabies-infected puppy;
  • An undisclosed number of other animals were also exposed and are presumably in quarantine; and
  • The cost of the federal public health investigation is estimated between $215,000 and $509,000.

As previously reported, CDC recently announced a temporary ban on the importation of dogs from 113 countries, deemed high-risk for rabies, with limited pre-approved exceptions.  Importations of dogs for adoption or resale would not be permitted.  Notably Azerbaijan is one of the listed high-risk countries.

What should you do to protect your shelter, rescue, family and pets?  Keep in mind that rabies infection is nearly 100% fatal, especially if not diagnosed quickly.  Infected animals are usually euthanized out of an abundance of caution.  Exposed animals are quarantined for periods of time depending on their vaccination status.  Exposed people can be effectively treated if treatment is provided quickly.

  1. Make sure all your pets are properly vaccinated;
  2. Have all pets examined by your veterinarian when you adopt/purchase them, and then at least annually thereafter;
  3. Do not adopt or foster animals unless you have sufficient proof of the source of those animals, preferably from birth, and proof of veterinary examination and vaccination (keep in mind that at least in some cases of dogs imported from high-risk rabies countries, they arrived with fraudulent importation documents); and
  4. Shelters and rescues should impose strict quarantine procedures and should require complete medical and behavioral histories for incoming animals.

CDC announced that it will prohibit the entry of dogs into the United States from the countries listed below beginning on July 14, 2021 unless CDC provides advance written approval to bring in a dog from one of these high-risk countries.

Effective July 14, 2021, CDC is temporarily suspending the importation of dogs from countries classified by CDC as high risk for dog rabies AND countries NOT at high risk for dog rabies if the dogs have been in high-risk countries during the previous 6 months.

This suspension applies whether dogs are hand-carried, checked in as passenger baggage, or transported as cargo on flights to the United States. These rules apply to all dogs, including puppies, service animals, and emotional support dogs. These rules also apply whether you are (1) just visiting the United States with your dog, (2) importing dogs into the United States, or (3) traveling out of the United States and returning with your dog after a temporary visit, such as a vacation or holiday, or for visiting friends and relatives. If you do not follow CDC’s rules, your dog will not be allowed to enter the United States and will be returned to the country of departure at your expense. Airlines and US Customs and Border Protection (CBP) will verify dogs’ country of departure. Airlines will deny boarding and CBP will deny entry into the United States for any dog that has been in a high-risk country in the previous 6 months that does not have a valid CDC Dog Import Permit.

A “CDC Dog Import Permit” can be obtained online and must be submitted to CDC at least six (6) weeks prior to importation, and approval is not guaranteed.

The agency identified eligible and ineligible potential importers of dogs from the list of high-risk countries:

The following categories of importers are eligible to request a permit to import a dog into the United States:

  • A US government employee with permanent change of station or temporary duty orders;
  • A US citizen or lawful US resident relocating to the United States, such as for employment or education; or
  • An owner of a service dog that is trained to assist a person with a disability.
  • In accordance with US Department of Transportation regulations at 14 CFR part 382, emotional support animals, comfort animals, companionship animals, and service animals in training are not considered service animals.
  • Importers wishing to import dogs for science, education, or exhibition, as these terms are defined in 42 CFR 71.50, or for bona fide law enforcement.

CDC Dog Import Permits will NOT be issued for:

  • Dogs intended for other purposes, such as adoption, resale, or transfer of ownership.

  • Dogs that will accompany owners on short-term travel to and from high-risk countries. (This is a change from the Egypt dog suspension policy.)

Notably, the temporary suspension of dogs imported from Egypt, implemented on May 10, 2019, after three cases of rabid dog importation were diagnosed, continues.

This will undoubtedly have an impact on those animal rescue organizations who import dogs from overseas for adoption in the U.S.

CDC identified the following as high-risk countries/states:

  1. Algeria
  2. Angola
  3. Benin
  4. Botswana
  5. Burkina Faso
  6. Burundi
  7. Cameroon
  8. Central African Republic
  9. Chad
  10. Comoros
  11. Côte D’Ivoire (Ivory Coast)
  12. Democratic Republic of the Congo
  13. Djibouti
  14. Egypt (Temporary importation suspension of dogs from Egypt until further notice)
  15. Equatorial Guinea
  16. Eritrea
  17. Eswatini (Swaziland)
  18. Ethiopia
  19. Gabon
  20. Gambia
  21. Ghana
  22. Guinea
  23. Guinea-Bissau
  24. Kenya
  25. Lesotho
  26. Liberia
  27. Libya
  28. Madagascar
  29. Malawi
  30. Mali
  31. Mauritania
  32. Morocco
  33. Mozambique
  34. Namibia
  35. Niger
  36. Nigeria
  37. Republic of the Congo
  38. Rwanda
  39. Sao Tome
  40. Principe
  41. Senegal
  42. Sierra Leone
  43. Somalia
  44. South Africa
  45. South Sudan
  46. Sudan
  47. Tanzania
  48. Zanzibar
  49. Togo
  50. Tunisia
  51. Uganda
  52. Western Sahara
  53. Zambia
  54. Zimbabwe
  55. Belize
  56. Bolivia
  57. Brazil
  58. Colombia
  59. Cuba
  60. Dominican Republic
  61. Ecuador
  62. El Salvador
  63. Guatemala
  64. Guyana
  65. Haiti
  66. Honduras
  67. Nicaragua
  68. Peru
  69. Suriname
  70. Afghanistan
  71. Armenia
  72. Azerbaijan
  73. Bangladesh
  74. Belarus
  75. Bhutan
  76. Brunei
  77. Cambodia
  78. China (excluding Hong Kong and Taiwan)
  79. Georgia
  80. India
  81. Indonesia
  82. Iran
  83. Iraq
  84. Jordan
  85. Kazakhstan
  86. Kuwait
  87. Kyrgyzstan
  88. Laos
  89. Lebanon
  90. Malaysia
  91. Moldova
  92. Mongolia
  93. Myanmar (Burma)
  94. Nepal
  95. North Korea
  96. Oman
  97. Pakistan
  98. Philippines
  99. Qatar
  100. Russia
  101. Saudi Arabia
  102. Sri Lanka
  103. Syria
  104. Tajikistan
  105. Thailand
  106. Timor-Leste (East Timor)
  107. Turkey
  108. Turkmenistan
  109. Ukraine
  110. United Arab Emirates
  111. Uzbekistan
  112. Vietnam
  113. Yemen

A bill in New Jersey that would have interfered with rabies testing of domestic companion animals has been amended to remove the potentially dangerous and unneeded obstacles to timely testing.

The bill, A1219, requires notification to a pet owner from a health official or veterinarian before an animal is prepared for rabies testing or submitted to a qualified laboratory for such testing.  That notification, both verbally and in writing, must include:

 (1) the necessity of the rabies testing and the reasons therefor;

(2) the rabies testing protocol to be followed;

(3) the protocol to be followed with regard to the handling of the  animal’s body;

(4) the protocol to be followed with regard to the disposal of the animal’s body or its return to the owner; and

(5) the protocol of decapitation.

These requirements only apply if the owner of the animal is known.

The owner must then “release the animal to the health official or veterinarian, as applicable, for the rabies testing” and sign an acknowledgement that the owner has been duly notified.

Which begs the question – what happens if the owner refuses to release the animal for testing or refuses to sign the form?  The only remedy for failure for an owner to comply resides in a different statute, also amended in this bill.

That provision provides liability (a fine) for any person who violates the laws that authorizes local boards of health to protect residents against communicable diseases, including rabies.

So, the only amendment to existing law that would result if this bill is enacted, is a requirement for a verbal and written notification to an animal owner, if known, about why a rabies test is required and how it will be conducted.

If such notification would help pet owners cope if their pet had to be tested, as determined by health officials, that would be a good result.

A better result would be for all pet owners to make sure that their pets are properly vaccinated against rabies—a nearly 100% fatal disease.

The Fourth edition of the “Guide for the Care and Use of Agricultural Animals in Research and Teaching,” published by the American Dairy Science Association®, American society of Animal Science and Poultry Science Association, is now available on line.

Scientists at a large number of universities contributed to the revisions of the Third edition, resulting in the current version.

For those unfamiliar with the “Ag Guide,” guidance is provided in the following chapters:

Chapter 1: Institutional Policies

Chapter 2: Agricultural Animal Health Care

Chapter 3: Husbandry, Housing, and Biosecurity

Chapter 4: Environmental Enrichment

Chapter 5: Animal Handling and Transport

Chapter 6: Beef Cattle

Chapter 7: Dairy Cattle

Chapter 8: Horses

Chapter 9: Swine

Chapter 10: Domestic Sheep and Goats

Chapter 11: Meat-Type Poultry

Chapter 12: Egg-Type Poultry

Chapter 13: Waterfowl

The species-specific chapters include guidance for:  Facilities and Environment, Feed and Water, Husbandry, Standard Agricultural Practices, Environmental Enrichment, Handling and Transport, Special Considerations, and Slaughter and Euthanasia.

Current guidance for Beef cattle castration is that “[c]astration is least stressful when performed at or shortly after birth . . . [-] [a]n increasing body of still-limited literature indicates that it is best to castrate calves as young as possible.”  Ag Guide at p. 85.  Similarly, if not working with naturally polled cattle, disbudding is the preferred method, which must be performed before the formation of horn buds.

The Canadian Veterinary Medical Association recommends that disbudding be performed within the first month of life (CVMA, 2016). In the United Kingdom, disbudding with a hot iron is preferred to dehorning and it is advised that this should be performed before cattle reach the age of 2 mo.

Id.  Similar guidance is provided for procedures performed on other agricultural species.  As appropriate, the Ag Guide differentiates between animals raised for food and fiber production and those raised and used in animal research.