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

 

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

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

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

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

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

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

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

 

HB 688, introduced on January 3, 2019, would

I. Makes changes to the definition of pet vendor and defines hobby breeder.

II. Establishes the companion animal welfare division in the department of agriculture, markets, and food.

III.  Establishes the animal transfer database in the department of agriculture, markets, and food.

IV. Creates a license for animal shelters and modifies the license for pet vendors.

V. Allows hobby breeders to register with the department of agriculture, markets, and food.

The bill would “REQUIRE” not “ALLOW” hobby breeders to register with the department, despite the language in the summary described above.

A “hobby breeder” means “A person who transfers animals for a fee and transfers 30 or fewer animals in a year.”  Notably, the term “animals” is not limited to dogs, cats, or other animals commonly owned as pets.

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

A hobby breeder registered under this subdivision shall:

I. Maintain in a clean and sanitary condition all premises, buildings, and other enclosures used in the business of dealing in live animals customarily used as household pets.

II. Submit premises, buildings, and other enclosures to scheduled inspections by department employees or local animal control, law enforcement, or health officials at reasonable times.

III.  Maintain, subject to inspection by the commissioner, his or her agent, local officials, law enforcement, or any member of the public, a proper record in which all live animals customarily used as household pets obtained or transferred shall be listed, including the breed, date the animal was obtained and transferred, and from whom the animal or bird was obtained and to whom the animal was transferred.  Such record shall also show the microchip, leg band, or tattoo number of each animal or bird, where applicable.  Animals that do not bear such identification shall be identified by recording markings, a physical description and any other information as the commissioner deems necessary to identify such animals.

IV. Keep records of all animals intended for transfer indicating identification, point of origin, and recipient, and shall submit said records to the commissioner upon request.

V. Provide a health certificate in accordance with RSA 437:10-d to the transferee.

VI. Shall not transfer animals to pet vendors.

VII.  Comply with such other rules as the commissioner may adopt to control disease.

The Fiscal Note, submitted with the bill as introduced, describes the expenditures required by New Hampshire related to the establishment of the Companion Animal Welfare Division within the Department of Agriculture, Markets and Foods, excluding expenses pertaining to operating the office which will house the new Division.  A wopping $3,896,000 are the estimated expenditures from 2020-2023.  The program is not expected to be operational until 2022.

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

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

Inspectors

(LG 18, Step 1)

8

 

$544,000 $560,000

Administrative Secretary

(LG 14, Step 1)

2 $122,000 $128,000

Administrator II

(LG 29, Step 1)

1 $94,000 $99,000

Technical Support Specialist VI

(LG 32, Step 1)

1 $104,000 $109,000

Veterinarian

(LG EE, Step 1)

1 $101,000 $107,000

Attorney III

(LG 30, Step 5)

1

 

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

 

The new Division has been purportedly modeled after the Animal Welfare Program in Maine.

However, there appear to be striking differences between the laws in Maine and those proposed in HB 688.  For example,  NH would require licensure of anyone who transfers as few as one animal for a fee.  In Maine, “a person may not advertise for sale, sell or exchange for value more than one cat or dog under the age of 6 months in a 12-month period unless that person has a valid animal shelter, kennel, breeding kennel or pet shop license or a valid vendor’s license issued under this section.”  MRS §4163 (emphasis added).

Maine also exempts hobby dog breeders from licensure as a kennel if they sell or exchange one litter of puppies within a 12-month period.  MRS §3907 (17).

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

S3366 (Senator Stack) and identical bill A3684 (Assemblywomen Chaparro and McKnight) recently introduced bills that would expand the requirements of notification to animal owners before their animals were tested for rabies virus.  Such measures could unreasonably delay testing that is required to ensure that other animals and humans were not exposed to rabies virus, a nearly 100% fatal virus.

Rabies testing requires extraction and testing of the brain, following euthanasia. The bill would also permit the owners the ability to request the return of the animal’s head following testing.  The bill would expose veterinarians, laboratory technicians and others-including the animal’s owner-to unnecessary and dangerous exposure to infectious, contagious disease if the current prohibition on the ban of the return of remains to veterinarians or animal owners is eliminated.

Rabies is a dangerously pathogenic virus, for which extensive science-based public health laws have been development and implemented. Vaccination is the key to prevent unnecessary euthanasia and testing of those animals for which approved vaccines have been developed and approved. The routine vaccination of these species, including dogs and cats, must be performed by veterinarians in New Jersey for the animal to be considered adequately protected. Proper vaccination would eliminate the need for the potentially dangerous provisions proposed in these bills.

New Jersey State and Local Departments of Health and the New Jersey Department of Agriculture enforce the state and local laws governing the reporting and testing of animals  exposed or infected with rabies virus.

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

is an infectious disease caused by the rabies virus. Animals infected with rabies display strange behavior such as aggression, and signs of neurologic impairment including vocalization, circling, and paralysis.  People who are bitten by, or have had contact with saliva from an animal should notify the local health department (LHD) having jurisdiction where the animal is located and seek medical care.

See also N.J.S.A. 26:4-78 (“whenever a dog, cat, or other animal has been known or suspected to have been bitten by an animal known or suspected to be affected by rabies, the owner of the animal or any person with knowledge of the incident shall notify the local health department with jurisdiction where the animal is located.”).

After a report is received, “[t]he Health Officer shall then serve notice on the owner of the animal requiring euthanasia or confinement for up to 6 months and observation for the emergence of clinical signs of rabies.” (N.J.S.A 26:4-83).

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

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

Rabies testing, which requires animal euthanasia required extraction, submission and laboratory testing of at least two locations in the brain, preferably the brain stem and cerebellum.

According to the Center for Food Security & Public Health,

In animals, rabies prevention is based on vaccination and the avoidance of contact with infected animals (e.g., preventing pets from roaming, housing pet rabbits and rodents indoors) . . . Vaccination is recommended for dogs, cats and ferrets, to reduce human exposure as well as to protect the animal. Vaccination is recommended for dogs, cats and ferrets.

USDA has also licensed rabies vaccines for livestock in the United States, including horses, cattle and sheep.

 

 

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

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

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

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

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

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

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

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

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

Originally Posted: 25 Jan 2019 12:11 PM PST, republished with permission.

In most regions of the United States, dog overpopulation as an issue has been solved, and there are more potential owners than there are local pet dogs available. For example, many of the dogs that arrive in Northeastern shelters and rescues come from the southern United States, Puerto Rico, and sometimes even foreign countries.

Ending the dog surplus problem in some parts of the country is a challenge, due to a lack of clear records. To solve a problem, you have to be able to define it. Who is breeding these dogs? Who is surrendering them? Who is adopting them? And more and more, we’re having to ask where they coming from.

One thing we do know, is that fewer dogs are being bred in the United States while the practice of importing dogs from foreign countries for adoption is growing — and fast. So it is little surprise that the partial government shutdown has led to complaints from a group that brings 800+ dogs a year into the U.S., because they can no longer obtain the proper importation permits. This is just one organization of hundreds that are importing dogs in the Southwestern U.S., threatening the health of American dogs and flooding the dog marketplace.

This is why NAIA and our legislative partner, NAIA Trust are working so hard to find legislative solutions to this mushrooming problem.

Even though the government shutdown is currently over, concerns about the importation of dogs from other countries for sale/adoption in the United States remains a serious concern.  Such importation has already resulted in the introduction and spread of diseases infectious to humans and animals.

Virulent Newcastle disease (VND), formerly known as Exotic Newcastle Disease, and African Swine Fever outbreaks continue to impact poultry in California and hogs in China, respectively.  Notably, these diseases are largely not infectious to humans, but nevertheless are impacting farmers, ranchers, hobbyists, national and internal markets.

California has been trying to stamp out VND since last May.  Unfortunately, the outbreak, which initially infected only backyard breeders and owners, has since spread to some commercial flocks.  As reported by the California Department of Food and Agriculture (CDFA), “[s]ince May 2018, USDA/APHIS and CDFA employees have been working seven days a week in Southern California to eradicate virulent Newcastle disease in backyard birds, and to protect commercial facilities.”

Virulent Newcastle disease (VND), formerly known as Exotic Newcastle Disease, is a serious, highly contagious viral disease that can affect poultry and other birds. In rare cases, humans that have exposure to infected birds may get eye inflammation or mild fever-like symptoms. These signs generally resolve without treatment, however, medical care should be sought if symptoms persist. Infection is easily prevented by using standard personal protective equipment. Virulent Newcastle disease is not a food safety concern. No human cases of Newcastle disease have ever occurred from eating poultry products. Properly cooked poultry products are safe to eat.

This is not CDFA’s first rodeo with VND.  From 2002-2003, VND outbreaks in back yard flocks and commercial poultry operations in Southern California, Arizona, Nevada and Texas “led to the depopulation of 3.16 million birds at a cost of $161 million” before the outbreak was successfully eradicated.

Since the current VND outbreak has persisted, despite a robust state and federal response, the California State Veterinarian has announced the following additional draconian measures in an attempt to contain this outbreak:

Due to progression and duration of a virulent Newcastle Disease (VND) outbreak in parts of Southern California, the State Veterinarian has ordered mandatory euthanasia of birds in neighborhoods in Compton (Los Angeles County), Muscoy (San Bernardino County), Mira Loma/Jurupa Valley (Riverside County)       Perris (Riverside County).

Unfortunately, even if birds and flocks have previously tested negative but now fall within a designated mandatory euthanasia area, the birds must be euthanized. USDA/CDFA staff will contact affected bird owners.

While this action is difficult for all involved, it MUST be done to eradicate VND. Otherwise, the disease will continue to spread and kill additional flocks.

When depopulation of flocks is mandated to contain such a devastating outbreak it is very difficult on animal owners as well as the animal health officials involved.

Parallel measures have seemingly been deployed in China, where African Swine Fever was first confirmed in more than 50 cases since August 2018.

According to USDA, African Swine Fever was “first described in the 1920s in Kenya, is a highly contagious hemorrhagic disease of wild and domestic suids with extremely high morbidity and mortality rates. ASF is a notifiable disease with the World Organization for Animal Health (OIE) due to its ability to spread rapidly and cause severe illness. ASF does not pose a risk to public health.”

Similar to concerns about the spread of Foot and Mouth Disease virus in the UK in 2001—considered the most contagious virus affecting animals—ASF can be spread by people or equipment not properly decontaminated.  Because of such concerns, the USDA and U.S. pork producers and related associations have provided information to producers about how to protect their animals against accidental exposure.

ASF has reportedly “infected 100 farms across China since August 2018, spreading faster than in any other country to date.”  

The National Pork Producers Council reported

On August 3, 2018, China reported their first case of ASF. By August 23, 2018 there were four outbreaks reported, and more are suspected. The outbreaks are in areas of China with large pig populations. APHIS, CBP and all other agencies with relevant authority are monitoring movements of people and goods from these areas to guard against an ASF outbreak in the United States. ASF does not infect people or other animals, and there are no food safety implications.

USDA has posted several guidance documents regarding its response to the ASF outbreak, available here.

A list of tasks intended to prevent the importation of infected or contaminated products, include the following precautionary measures:

APHIS import restrictions prohibit the entry of untreated animal products, including meat and meat products, from countries or regions considered affected with certain diseases. Fresh/frozen pork is prohibited from regions affected with FMD, CSF, SVD, or ASF, while meat that has been cooked is allowed under APHIS regulations.

Swine casings that originate from ASF positive countries/regions are prohibited entry into the US under APHIS regulations.

APHIS acted to deny entry of Chinese origin swine casings in transit when ASF was found in China.

A comprehensive list is available at usda-industry-prevention-points.pdf.

Bill A-4840 in the New Jersey Assembly, as currently drafted would interfere with the veterinarian-client-patient relationship and a pet owners ability to determine the proper care for their pets, and would provide animals greater access to free legal representation than people accused of criminal animal cruelty misdemeanors in the State.  It should not be passed unless amended.

The bill, as proposed states,

In any criminal court proceeding pursuant to R.S.4:22-17 et seq. or pursuant to P.L.2015, c.85 (C.2C:33-31), or any other criminal proceeding that affects the welfare or care of a cat or dog, the court may order, upon its own initiative or upon request of a party or counsel for a party, that a separate advocate be appointed to represent the best interests of the animal.  If a court orders an advocate to be appointed, the advocate shall be appointed from a list provided to the court by the Administrative Director of the Courts.  A decision by the court denying a request to appoint a separate advocate to represent the best interests of the animal shall not be subject to appeal.  A-4840 (emphasis added).

The “separate advocate . . . appointed to represent the best interests of the animal” would be in a similar legal position as a guardian ad litem appointed by the court, upon request, to represent the best interests of a child or incapacitated adult.

As the American Veterinary Medical Association’s position on guardianship of animals states, such changes in terminology and its effect would not protect animals, but would instead be harmful.

The American Veterinary Medical Association promotes the optimal health and welfare of animals.  Further, the AVMA recognizes the role of responsible owners in providing for their animals’ care.  Any change in terminology describing the relationship between animals and owners, including ‘guardian,’ does not strengthen this relationship and may, in fact, harm it.  Such changes in terminology may adversely affect the ability of society to obtain and deliver animal services and, ultimately, result in animal suffering.

When a similar bill was introduced in the Connecticut legislature, the Connecticut Veterinary Medical Association opposed the bill on similar grounds.  Before it was passed, it was amended to permit an animal advocate to represent the interest of justice, not the animal in certain criminal proceedings.

Animal cruelty is never acceptable, but the rights of animals to legal representation in court should not exceed the rights afforded to those accused of such acts.  If animals are to receive the benefit of legal representation, so too should the accused.  Since many animal cruelty offenses are considered non-indictable offenses, a defendant would not have access to a public defender, and would instead have to pay for legal representations.  If animals in these cases would be represented by attorneys appointed by the State or worse, from animal rights organizations, a gross misapplication of justice would result.

Even more concerning, is the escalation of the rights of animals as similar to the rights of children or incapacitated adults requiring representation by guardians ad litem.  The escalation of animal rights to those provided to humans, should be a concern to all except those who believe animals and humans should be afforded the same legal rights and that animal ownership is unconscionable and unethical.

Therefore, the bill should be amended to include representation of the accused in the same manner that the interests of the animals would be represented and should limit appointment of an advocate only by the court, and not upon the request of a party or counsel for a party.

NOTE: The Senate companion bill is S-3322.  A-4840 is scheduled for the Assembly Judiciary Committee on January 24.

The National Organic Program (NOP) is the regulatory program administered by USDA’s Agricultural Marketing Services agency that implements the Organic Foods Production Act of 1990, subsequently amended and its related regulations.

In addition to other activities, AMS manages the National List of Allowed and Prohibited Substances used on certified organic premises, which it recently amended.  See 83 FR 66559-01, 2018 WL 6788997 (F.R.) Dec, 27, 2018.

As published, the rule, effective on January 28, 2019:

changes the use restrictions for seventeen substances allowed for organic production or handling on the National List. This rule also adds sixteen new substances on the National List to be allowed in organic production or handling. In addition, this final rule lists the botanical pesticide, rotenone, as a prohibited substance in organic crop production. This final rule removes ivermectin as an allowed parasiticide for use in organic livestock production and amends our regulations to allow the use of parasiticides in fiber bearing animals. Finally, this rule inserts corrections of instructions and regulation text as listed in the proposed rule.

Three new substances, hypochlorous acid, magnesium oxide, and squid byproducts have been added as synthetic substances allowed for use in organic crop production.  7 CFR § 205.601

Specifically, as of the effective date:

  • Hypochlorous acid will be allowed for use as an algicide, disinfectant, and sanitizer.
  • Magnesium oxide will be allowed for use in controlling the viscosity of a clay suspension agent for humates.
  • Social soil testing an alternative verifiable methods, such as tissue testing when approved by the certifying agent, will be the only method for demonstrating a soil micronutrient deficiency.
  • Squid byproducts rom food waste processing only will be an allowed substance for use in organic crop production.
  • Rotenone will be added as a nonsynthetic substances prohibited for use in organic crop production.
  • Activated charcoal, calcium borogluconate, calcium propionate, hypochlorous acid, kaolin pectin, mineral oil, nutritive supplements—injectable vitamins, trace minerals and electrolytes, propylene glycol, acidified sodium chlorite, and zinc sulfate will be permitted as synthetic substances allowed for use in organic livestock production.

Activated charcoal and the other permitted substances in the last bullet point are important medical tools that provide medical relief to animals raised for food.

The rule also revises the list of approved and prohibited treatments for parasite control in food animals and fur-bearing animals.

The regulations permit the use of some parasiticides that can be used in organic livestock production when the following conditions exist:

(1) Emergency treatment for dairy and breeder stock only when preventive measures have failed; (2) a parasiticide withdrawal period before milk or milk products from treated animals can be sold as organic; and (3) a prohibition on use in breeder stock during the last third of gestation or during lactation if progeny will be sold as organic.

Ivermectin, a highly effective parasiticide, has been removed from permitted use in organic livestock production.

The use of some medications, such as xylazine—a historically safe and effective medication for sedation, anesthesia, muscle relaxation, and analgesia in animals, has been restricted to use “by or on the lawful written or oral order of a licensed veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug Administration regulations. Also, for use under 7 CFR part 205, paragraph (a)(30 also includes the following requirements:

(i) Use by or on the lawful written order of a licensed veterinarian;

(ii) A meat withdrawal period of at least 8 days after administering to livestock intended for slaughter; and a milk discard period of at least 4 days after administering to dairy animals.

Zinc sulfate, an effective treatment for use as a footbath for control of foot rot in livestock, primarily dairy cattle, sheep and goats, will be permitted.

In summary, animals raised under the organic certification will largely benefit by the amendments to USDA’s national list of allowed and prohibited substances.

Some happenings at USDA and FDA that may impact your business are noteworthy.

On November 16, 2018 FDA released for public comment “proposed research to validate an alternative approach for bioequivalence studies for certain animal drugs.”

Bioequivalence studies are required before drugs are approved by FDA (for humans or animals) as safe and efficacious.

The proposed study will measure the bioequivalence of the approved antiparasitic drugs ivermectin and praziquantel by in vitro dissolution compared to blood levels that indicate how the drug is dissolving in the body (also known as blood-level pharmacokinetics), with the goal of validating these laboratory-based alternative (i.e., surrogate) endpoints. Ivermectin is used in dogs to treat heartworm, a potentially fatal infection. Praziquantel treats tapeworms, an internal parasite that lives primarily in the gastrointestinal tract but can form cysts in liver and other organs.

Comments to the proposed white paper, Alternative Methods for Evaluating Locally Acting, Nonsystemically Absorbed Drugs in Canine Disintegrating or Chewable, Single Layer Combination Drug Products, are available here.

To date, 46 comments are posted.

Recently the Secretary of the Department of Veterans Affairs expressed continued support for the use of dogs in certain research, without which significant gains in medical care for people and pets would not be possible.

On October 30, 2018 FDA 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.

Titled, the “Veterinary Innovation Program (VIP)” the program is designed to “guide sponsors [of certain veterinary products] through the regulatory process . . .”

Some of these innovations involve genome editing in animals, and exciting new frontier that will benefit humans and animals alike.

As reported by USDA Research, Education & Economics Information System a project titled “Improvement of Dairy animal Well-Being By Genetic Dehorning,” sponsored by the National Institute of Food and Agriculture “will evaluate gene-editing as a means for genetically dehorning cattle without crossbreeding in three steps.”

First we will introduce the polled genetics into dairy cattle by gene-editing and determine if it has the same effect as crossbreeding. Second, we will determine if there are any unintended effects on the animals; and third, we will evaluate the feasibility of deploying this technology in a variety of breeds to enable broad acceptance and rearing of genetically dehorned cattle.

The project end date is April 14, 2019.

Finally, as United States Cattlemen’s Association recently announced, USDA and FDA “will jointly oversee the regulation of cell-cultured food products from cell lines of livestock and poultry.”

FDA will oversee cell collection, cell banks, and cell growth and differentiation. A transition from FDA to USDA oversight will occur during the cell harvest stage. USDA will then oversee the production and labeling of food products derived from the cells of livestock and poultry.

USCA noted that their pending petition for rule making to define “beef” and “meat” remains outstanding and should be addressed to ensure truth in labeling for consumers.

More to come about all these programs.

In a prior blog I discussed proposed amendments to Oregon’s animal cruelty statute that would provide for statutory standing to any plaintiff who files a complaint against any animal owner for alleged violations of the state’s animal cruelty statute.  Below, are summaries of several Oregon cases litigated pursuant to the current or in effect at that time.

In State v. Branstetter, 45 P.3d 137 (Or. Ct. App. 2002) review denied 54 P.3d 1042, 334 Or. 632, a horse and donkey owner was charged with 12 counts of animal neglect in the first degree, which was a Class A misdemeanor.  Id., at 138 (citing ORS 167.330).  Defendants’ animals were seized and were cared for by the pioneer Humane society of Umatilla County, who filed a petition for the animals before Defendant’s trial.  The Court ordered the forfeiture of animals if Defendant did not post a $2,700 bond within 72 hours, which he failed to do.

After being acquitted on all counts, Defendant filed an appeal with the following issue.

“Was defendant denied constitutional due process and right to a remedy as a consequence of the forfeiture statute that did not provide for setting aside the forfeiture(s) subsequent to the acquittal(s)?”  Id.

The Court denied the appeal, “reject[ing] defendant’s due process and remedies clause arguments without discussion.”  The Court also rejected Defendant’s that “any forfeiture to cover the costs of his animals’ care during the pendency of the criminal prosecution violates the excessive fines provisions of Article I, section 16, of the Oregon Constitution, and the Eighth Amendment to the United States Constitution.”  Id., at 139.

In Stirton v. Trump, 121 P.3d 714 (Or. Ct. App. 2005), a dog owner, charged with 31 counts of animal neglect in the second degree and the county impounded the 31 dogs, and a justice of the peace ordered forfeiture of the dogs following a petition filed by the impounding county.  The County Circuit Court, hearing a petition for a writ of review filed by the Defendant over jurisdictional matters, entered judgment awarding the county the cost of boarding the 31 dogs and dismissing Defendant’s petition.

On appeal, the Court affirmed the trial court’s holding that the justice of the peace court had subject matter jurisdiction, but reversed the award, finding that the county was not a party to the petition.

In State v. Marsh, 66 P.3d 541 (Or. Ct. App. 2003), the Court limited the amount in restitution the defendant must pay to the care of providing for only the ten animals he was convicted of neglecting, and not for the 69 animals that were seized from his property.

In City of Lebanon v. Milburn (2017) 398 P.3d 486 (Or. Ct. App. 2017), the Court, on appeal, rejected the City’s argument that the forfeiture of Defendant’s dog in this case was irreversible, even after the Defendant had been acquitted of criminal charges of animal cruelty.  The Court’s holding in this case, is notable:

The issue on appeal turns on whether the circuit court erred in ordering the city to return defendant’s property upon acquittal after the municipal court had ordered the property forfeited under ORS 167.350 as part of defendant’s sentence.  A court is permitted to order forfeiture, but it is contingent upon a court having determined that defendant is guilty of the offense charged. ORS 167.350(1).  Necessarily, we have recognized that ‘[t]here can be no sentence, probation or other sanction after an acquittal’ . . . We have characterized a forfeiture that is part of sentencing under ORS 167.350 as a punitive forfeiture . . . In this case, although the forfeiture was authorized under ORS 167.350 as part of the sentence in municipal court, defendant cannot continue to be subject to a punitive sanction after she has been acquitted. An acquittal is an acquittal. That outcome necessarily implicates the forfeiture that is part of the judgment in municipal court . . . Because defendant was acquitted in the circuit court, property taken from her as a result of the municipal court judgment must be returned.  Id., at 487-488 (citations omitted).

Based on these cases, Oregon already has sufficient state laws to protect animals from owners who fail to care for them humanely, such that the proposed amendment discussed here, that would permit anyone, to file a civil suit against an animal owner because of public policy concerns, is unnecessary.  Such an amendment would lead to a flood of lawsuits filed by plaintiffs who object to the use of animals in agriculture, biomedical research, breeding and other animal-related businesses.