U.S. Cattlemen’s Association (USCA) submitted a Petition for Rule Making to USDA Food Safety and Inspection Service (FSIS) on Feb. 9, 2018 requesting “that FSIS exclude products not derived directly from animals raised and slaughtered from the definition of ‘beef’ and ‘meat.’”

Harvard Law School Animal Law and Policy Clinic (Harvard) submitted a Petition for Rule Making to FSIS on Jun 9, 2020 requesting “that FSIS adopt a labeling approach for ‘cell-based’ meat and poultry products that respects First Amendment commercial speech protections.”

FSIS issued its responses to these petitions, dated September 16, 2021. FSIS intends to address the issues raised in USCA’s petition related to labeling of products using animal cell culture technology through the advance notice of proposed rulemaking (ANPR) the agency published on September 3, 2021.  That ANPR solicits “comments and information regarding the labeling of meat and poultry products made using cultured cells derived from animals under FSIS jurisdiction [which] FSIS will use . . .to inform future regulatory requirements for the labeling of such food products.”

FSIS denied USCA’s request to add the terms “meat” and/or “beef” to the agency’s Policy Book, and clarified that FSIS does not have the “jurisdiction to regulate the labeling of products derived from sources that are not amenable to the FMIA or PPIA, such as plant-based products.”

FSIS also encouraged Harvard to submit comments to the ANPR which the agency expects to “expand FSIS’ understanding of cell-based products and help inform future rulemaking to establish labeling requirements and will help inform FSIS’ approach to the issues you raised in your petition.”

For those with information to help inform FSIS’ policy and regulations, there is a 60-day period for comment on the ANPR, which is available at the FSIS website.

In June 2021, the USDA Office of Inspector General published its report, Animal Care Program Oversight of Dog Breeders, evaluating Animal and Plant Health Inspection Service’s (“APHIS”) controls to ensure compliance with the Animal Welfare Act (“AWA”) and following up on the agency actions in response to a previous 2010 audit.

While this audit focused on the agencies oversight of dog breeders, the three recommendations the agency agreed to comply with, will impact all AWA licensees and registrants.  Those recommendations include:

Recommendation 1.  APHIS should ensure the data reliability and security issues with ACIS do not persist in SalesForce and eFile.

Recommendation 2.  Develop and implement guidance, policies, and procedures to ensure a consistent response to complaints and to ensure the response is sufficiently documented.

Recommendation 3.  Provide inspectors training on the process of responding to complaints, documenting actions taken, and the reason for those actions.

Regarding Recommendation 1.  Anyone who has used USDA’s Animal Care database has been frustrated about its inaccessibility at times, and lack of reliability, so, to the extent the database is publicly available, it should be reliable and functional.

Regarding Recommendation 2 and Recommendation 3, all registrants and licensees may have cause for concern about the agencies processes of responding to complaints, because of the weaponization of APHIS AC enforcement of the AWA by animal rights activists.  Those activists characterize citations on inspection reports as violations of the AWA.  They are not.  However, those entities file complaints with APHIS AC claiming that the registrants/licensees must be fined the maximum fine because they have violated the AWA.  Citations are not determinations that a facility has violated the AWA.  However, now the agency appears to be establishing additional protocols following receipt of complaints.

Should such protocols be subject to APA mandated rule promulgation and response before implementation?

If the process falls short of what is considered acceptable by activists, the agency should expect legal consequences.

If the process falls short of what is considered acceptable by licensees/registrants, the agency might expect legal consequences.

What is clear is that any such challenge diverts agency funding from actually enforcing the AWA to defending its policies and procedures.

Recently, the Eight Circuit upheld one of two challenged provisions of Iowa’s Agricultural Production Facility Fraud statute.  The Access Provision passed constitutional muster against allegations that the statute violated the First Amendment free speech clause—but the employment provision did not.

The Eight Circuit affirmed in part and reversed in part the United States District Court for the Southern District of Iowa’s grant of summary judgment for plaintiff organizations “alleging that Iowa statute criminalizing agricultural production facility fraud, which prohibited accessing such a facility by false pretenses and making false statements as part of employment application to to a facility, violated the First Amendment free speech clause.”  See Animal Legal Defense Fund v. Reynolds, 8 F.4th 781 (8th Cir. 2021).

Applying complicated decisions from Supreme Court jurisprudence, the Court agreed with the State arguing that the Access Provision of the statute “which provides that a person is guilty of agricultural production facility fraud if he ‘obtains access to an agricultural production facility by false pretenses’ . . . is consistent with the first Amendment because it prohibits exclusive lies associated with a legally cognizable harm—namely, trespass to private property.”  Id., at 785-786.

However, the Court upheld the district court’s ruling that the Employment Provision is unconstitutional on its dace under the First Amendment, because that provision “provides that a person commits an offense if he ‘makes a false statement or representation as part of an application or agreement to be employed at an agricultural production facility, if he ‘knows the statement to be false, and makes the statement with an intent to commit an act authorized by the owner of the agricultural production facility, knowing that the act is not authorized.”’  Id., at 786-787.

The Court stated that a less restrictive means to prevent the State’s compelling interest in preventing false statements to secure offers of employments could be to proscribe only false statements that are material to a hiring decision, but could not amend the statute accordingly.  Perhaps the legislature could introduce such an amendment to rehabilitate this law.

One panelist concurred with the Court holding, but another concurred in part and dissented in part, and would have upheld the two challenged provisions a constitutional.

It will be interesting to see the next legal steps.

Jasmine
Jasmine sleeping by my desk-she could not get any closer to me while I worked

She was not my child or husband or even my best friend, but she was my beloved dog.  A golden retriever through and through, who dropped whatever she was doing whenever we walked through the door, grabbing her toy/sock/our favorite shoe/whatever and presented it to us as her way of welcoming us home.

That along with her infamous vocal greeting- grunt which reminded us of Chewbacca from Star Wars.

For those who have had the privilege of owning a dog, you know of all the joy they can bring.  Like many who were able to work from home for the last year +, Jasmine was thrilled to be able to be by my side.  Now I won’t have to worry about her separation anxiety as we anticipate going back to life as we knew it.  I only have to worry about our loss – life without Jasmine.

But even now, when the loss is so raw, I am so grateful for the time we had together.  Such is the joy and heartbreak of owning a dog.  A lifelong companion, whose life is much shorter than ours.

I am not the first or last to pay tribute to a beloved dog.  The following is the memorialized closing argument in a 1869-1870 lawsuit, Old Drum – Burden vs. Hornsby, avenging the death of a beloved dog who killed a neighbor’s sheep.

“Gentlemen of the Jury, the best friend a man has in the world may turn against him and become his enemy. His son or daughter that he has reared with loving care may prove ungrateful. Those who are nearest and dearest to us, those whom we trust with our happiness and our good name, may become traitors to their faith. The money that a man has, he may lose. It flies away from him, perhaps when he needs it the most. A man’s reputation may be sacrificed in a moment of ill-considered action. The people who are prone to fall on their knees to do us honor when success is with us may be the first to throw the stone of malice when failure settles its cloud upon our heads. The one absolutely unselfish friend that man can have in this selfish world, the one that never deserts him and the one that never proves ungrateful or treacherous is his dog.

Gentleman of the Jury, a man’s dog stands by him in prosperity and in poverty, in health and in sickness. He will sleep on the cold ground, where the wintry winds blow and the snow drives fiercely, if only he may be near his master’s side. He will kiss the hand that has no food to offer, he will lick the wounds and the sores that come in encounters with the roughness of the world. He guards the sleep of his pauper master as if he were a prince. When all other friends desert he remains.

When riches take wings and reputation fall to pieces, he is as constant in his love as the sun in its journey through the heavens. If fortune drives the master forth an outcast in the world, friendless and homeless, the faithful dog asks no higher privilege than that of accompanying him to guard against danger, to fight against his enemies, and when the last scene of all comes, and death takes the master in its embrace and his body is laid away in the cold ground, no matter if all other friends pursue their way, there by his graveside will the noble dog be found, his head between his paws, his eyes sad but open in alert watchfulness, faithful and true even to death.”

Jasmine, we will miss you.

 

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.