Most of you should already be aware of concerns about the spread of foreign animal disease, African Swine Fever (ASF), into the United States.  for those who need an update:

ASF has never been identified in the US, but it is coming closer, having been recently found in swine in the Dominican Republic and Haiti.

Since at least 2018, USDA has taken many steps to enhance education and surveillance and testing plans, including at least:

Federal Order: APHIS Suspends the Interstate Movement of Live Swine, Swine Germplasm, Swine Products, and Swine Byproducts from Puerto Rico and the U.S. Virgin Islands September 2021

Swine Hemorrhagic Fevers: African and Classical Swine Fever Integrated Surveillance Plan May 2019

A qualitative assessment of the likelihood of ASF virus entry to the United States. March 2019

A non-animal origin feed ingredient risk evaluation framework. March 2019

A literature review of non-animal origin feed ingredients and the transmission of viral pathogens of swine., March 2019

ASF Emerging Risk to Animal Health – Notice,  August 2018

Chinese Provinces Reporting ASF – Map, February 26, 2019

USDA-Industry ASF Surveillance and Response Points September 2018

USDA-Industry ASF Prevention Points September 2018.

Preparedness and response plans are available on USDA’s website.

USDA has partnered with State animal health officials, trade associations, and farmers and ranchers to implement its enhanced preparedness and response plans-a requirement for a successful outcome.

The most recent step has been a submission of a “dossier to the World Organisation for Animal Health (OIE) detailing the actions taken to finalize a new African Swine Fever (ASF) protection zone in Puerto Rico and the U.S. Virgin Islands.”  While ASF has not been diagnosed in Puerto Rico or the U.S. Virgin Islands, additional protective measures have been implemented to help prevent the entry of the disease to those jurisdictions.

All those involved in the raising and marketing of swine in the US should update their biosecurity protocols, working with trusted veterinary and industry partners, to protect livestock from exposure to this foreign animal disease.

The Center for Biological Diversity and the Natural Resources Defense Council submitted a petition for rule-making to the Secretary of the U.S. Department of Health and Human Services and the Centers for Disease Control and Prevention and submitted a similar petition to the Secretary of the U.S. Department of the Interior and the U.S. Fish and Wildlife Service to ban trade in wild mammals and birds to and from the U.S.

The petitions request prohibitions on the importation (and possibly exportation) of wildlife under a precautionary principle, to prevent the outbreak of another zoonotic disease that could result in a pandemic.  Despite the lack of evidence of an intermediary animal species that spread SARS-CoV-2 from bats to people, the petitions base their requests for prohibitions based, in part, on the spread of COVID-19.  The spread of COVID-19 has been largely based on spread from and between people, so reliance on this pathogen is misplaced.  In fact, except for spread on mink farms, believed to have started as a reverse zoonosis (spread from people to animals), AVMA and international and federal animal health officials have advised that animals are not a known source of the spread of SARS-CoV-2 to people.

The following quote from the petitions, citing to other sources, is devoid of evidence

‘1.7 million currently undiscovered viruses are thought to exist in mammal and avian hosts’ of which ‘631,000-827,000 could have the ability to infect humans.’

CDC Petition, at page 6 (citing IPBES (2020) Workshop Report on Biodiversity and Pandemics of the Intergovernmental Platform on Biodiversity and Ecosystem Services) (emphasis added).

If undiscovered, how can the number of these viruses be quantified or qualified?

The reliance on “One Health” and prohibitions on animal importation, ownership and use based on concerns about zoonotic diseases is not limited to these petitions.  Many animal rights organizations are relying on similar theories to advance their agendas.

Of course, there are a number of zoonotic diseases in wildlife residing in the United States.  The best method of housing to protect livestock from exposure to such potentially-infected wildlife, is to employ indoor housing with rigorous biosecurity controls.  Many animal rights organizations are opposed to those biosecure housing facilities, and instead, some have advanced proposals to prohibit the use of caging to house livestock, at least in the European Union.

Instead of overarching prohibitions, I propose that federal and state laws continue to permit importation and exportation of all animals, where such conduct is based on the identification of species and location-based risks and after implementations of reasonable and science-based testing where appropriate.

According to the USDA OIG Audit Report 33601-0003-23, previously available online, APHIS Animal Care (AC) had agreed that it would review barrier issues and may require reporting of escapes and attacks.  However, Audit Report 33601-0003-23, originally published on March 12, 2021, has been removed from the website, and is reportedly “undergoing a review pursuant to OIG’s Information Quality Guidelines. The report will be re-posted upon conclusion of OIG’s review.”

The requirements for exhibitors, in part, include requirements to “minimize possible harmful risks to animals and the public during public exhibition.” 9 C.F.R. § 2.131 (a)-(e). “Specifically, any animal must be handled to minimize the risk of harm to the animal and to the public, with sufficient distance and/or barriers between the animal and the general viewing public to assure the safety of animals and the public.” 9 C.F.R. § 213l (c)(l).

In 2010, OIG audited APHIS AC evaluated APHIS’ controls over the licensing of exhibitors of exotic animals and the agency’s efforts to safeguard both the animals and members of the public who visit exhibitor facilities. The audit found that

APHIS inspectors either did not identify safety-related deficiencies during inspections, or did not document the conditions and require corrective actions due to the lack of periodic onsite supervision . . . [and] recommended that APHIS issue clear regulations and guidance that define what constitutes a sufficient public barrier and require exhibitors to report all escapes and attacks involving dangerous animals to APHIS’ [animal care inspectors]. As part of Audit Report 33601-0003-23, OIG followed up on the recommendations from the June 2010 audit, with emphasis on the recommendations relating to public safety.

The recommendations and agency responses as previously published, are described, in part below.  Whether the current OIG review will result in amendments to the report will be determined upon final publication.

Recommendation 1:

Conduct a study to determine if there continues to be an issue with public barriers at licensed exhibitors with potentially dangerous animals. If the results indicate an issue, determine and implement the necessary corrective actions (i.e., new regulations, training, and/or guidance).

Agency Response to Recommendation 1:

APHIS agreed to conduct a study to determine if public barriers at licensed exhibitors create a potential hazard to people or animals.  “As part of this review, barriers will be measured for height and distance from primary enclosures and photographed; then submitted to the Animal Care species specialist team for assessment and evaluation.” Those studies will occur at the 19 facilities that OIG had included in its audit, but the identity of those facilities was not disclosed.

Recommendation 2:

Consult with the Office of General Counsel (OGC) to determine if APHIS has the authority under the AWA to require exhibitors to report animal escapes and/or attacks to APHIS. If APHIS does have the necessary authority, take action to ensure exhibitors report animal escapes and/or attacks to APHIS.

Agency Response to Recommendation 2:

The agency agreed to consult with the OGC and based on the legal determination of its authority, would promulgate regulations or provide guidance to stakeholders of its requirements to require certain reporting.

The remaining recommendations related to the agency’s internal procedures and frequency of inspection of licensed exhibitors.

More to come when the report is republished.

 

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).