Veterinarians in New Jersey are hereby notified of amendments to existing regulations governing continuing veterinary educational requirements and supervision of veterinary students in training by state licensees.

First, continuing veterinary education (CVE) requirements have been amended to require one credit hour of CVE “in topics concerning prescription opioid drugs, including the risks and signs of opioid abuse, additional, and diversion,” beginning with the biennial renewal period beginning on June 30, 2019.  N.J.A.C. 13:44-4.10 (b)(3).

There was no discussion in the proposed rule — to which no comments were received — about the merits or intent of the proposed amendments.  Also unclear, is who would be qualified to provide such CVE, which presumably relates to addiction by humans – either veterinary clients diverting opioids prescribed for their pets, or veterinary staff.  Perhaps this is an example where, under the “One Health” banner, physicians could help educate veterinarian for the benefit of people and pets.  And notably, there will be a presentation on this topic at the NJVMA 2020 Veterinary Education Conference.

In the regulation there is also no discussion of or direction to veterinarians who may suspect opioid abuse, addiction or diversion in or from their clients (or staff for that matter).  Perhaps further amendments are needed to protect veterinarians if reporting such suspicious conduct in light of the overarching requirements for veterinarians to maintain confidentiality of veterinary medical records.

Another amendment receiving no public comment was adopted by the Division of Consumer Affairs, State Board of Veterinary Medical Examiners on October 30, 2019, effective on Feb. 3, 2020.  This amendment requires a veterinarian who is supervising a veterinary student in their practice to: (1) notify the veterinary board of the intent to supervise; (2) obtain certain information from the student’s veterinary school; (3) notify the patient’s owner that the student is not a licensee and maintain that information in the patient record.  See, N.J.A.C. 14:44-4.13.

With the increase in veterinary schools relying on training of veterinary students in private practices, veterinarians should understand what liabilities they be exposed to when agreeing to supervise veterinary students and other volunteers.  See, e.g., Wodohodsky v. Hall, 573 S.W.3d 645 (Mo. Ct. App. 2019), transfer denied (Mar. 29, 2019), reh’g and/or transfer denied (Mar. 29, 2019), transfer denied (June 4, 2019) (affirming verdict against veterinarian in action veterinary student brought “against veterinarian and farm operators for negligent supervision” in which student was hurt on the farm and the court found “sufficient evidence established the existence of a common law duty on the part of veterinarian to exercise ordinary care in supervising veterinary student.”)

Veterinarians should consult with an attorney and their insurance carrier about any potential exposure to liability.

In 2008, the Department of Justice (“the DOJ”), Civil Rights Division, published a Notice of Proposed Rulemaking seeking to amend the regulations which enforce the ADA’s prohibition of discrimination in public accommodations.[1] As part of the proposed changes, the DOJ wished to clarify the obligations of public accommodations regarding the use of service animals by persons with disabilities.[2]

According to the DOJ, the need for clarification was brought about by a large number of complaints from individuals with service animals concerned that covered entities were confused regarding the full scope of their duty to accommodate service animals.[3] Another concerning trend in need of correction was the growing use of wild, exotic, and untrained animals as supposed service animals.[4] In response to these concerns, the DOJ proposed defining “service animal” to include dogs and other “common domestic animals.”[5] The proposed rule specifically carved out of the definition “wild animals (including nonhuman primates born in captivity), reptiles, rabbits, farm animals (including horses, miniature horses, ponies, pigs, and goats), ferrets, amphibians, and rodents.”[6]

The DOJ explained this proposed change was necessary because of a growing concern among commentators who suggested that “limiting the number of allowable species would help stop erosion of the public’s trust, which results in reduced access for many individuals with disabilities despite the fact that they use trained service animals that adhere to high behavioral standards.”[7] In other words, an overly broad definition of service animal had resulted in public backlash with the practical effect of facilities turning away individuals with disabilities, which was the opposite intent of the ADA and its regulations.

The public reacted strongly to this proposed change with a stalwart defense of one category of animals specifically marked for exclusion from the definition of service animals. While commentators acknowledged the wisdom of excluding primates, reptiles, and other concerning animals, a strong case was made for inclusion of miniature horses as service animals.[8] One commentator pointed out that miniature horses had “proven to be very effective and well-received by the public both domestically and abroad in Europe.”[9] The American Association of the Deaf-Blind opined that miniature horses served “not only as seeing eye guides but as support for balance problems. For these deaf-blind people, guide dogs are not strong enough to give them something to hang on to when they stumble, wobble, or lose their balance.”[10] The Disability Rights Education and Defense fund likewise noted, “Miniature horses have been used as service animals by the disability community for some time, particularly the blind community. Miniature horses are able to be trained to do work or perform tasks for people with disabilities, can be housebroken, and are a viable option for those who are allergic to dogs or who would like a service animal with a longer lifespan.”[11] The Washington State Human Rights Commission argued that miniature horses “should also be allowed for those with balance issues or allergies to dogs.”[12] One commentator told the story of his blind friend who experienced deep grief from the loss of two guide dogs to old age. The commentator’s friend subsequently decided to train a miniature horse due to their long life expectancy and found she had received, what she called, “A Guide for Life.”[13]

The DOJ was ultimately convinced by these and other commenters into recognizing properly trained, appropriately sized, miniature horses as service animals in their final rule announced on September 15, 2010.[14] The DOJ stated the following points contributed to their decision:

  1. Proven Effective. Miniature horses already had a long history providing assistance to persons with disabilities.
  2. Allergies. Miniature horses constituted a viable alternatives to dogs for individuals with dog allergies.
  3. Religious Concerns. Miniature horses could service those whose religious beliefs preclude the use of dogs.[15]
  4. Longer Life/Strength. A strong factor in favor of miniature horses is their longer life span and strength in comparison to dogs. Specifically, miniature horses can provide service for more than 25 years while dogs can provide service for approximately seven years, and, because of their strength, miniature horses can provide services that dogs cannot provide. Accordingly, use of miniature horses reduces the cost involved to retire, replace, and train replacement service animals.
  5. Training Methods. Similar to dogs, miniature horses can be trained through behavioral reinforcement to be “housebroken.”
  6. Variety of Services. The rulemakers noted miniature horses are not one specific breed, but are derived from several breeds, with distinct characteristics that produce animals suited to a variety of service animal work. The horses generally range in height from 24 inches to 34 inches measured to the withers, or shoulders, and generally weigh between 70 and 100 pounds. These characteristics are similar to those of large breed dogs, such as Labrador Retrievers, Great Danes, and Mastiffs. According to information provided by an organization that trains service horses, miniature horses can be trained to provide a wide array of services to their handlers, primarily guiding individuals who are blind or have low vision, pulling wheelchairs, providing stability and balance for individuals with disabilities that impair the ability to walk, and supplying leverage that enables a person with a mobility disability to get up after a fall. According to one commenter, miniature horses are particularly effective for large stature individuals. The animal can be trained to stand (and in some cases, lie down) at the handler’s feet in venues where space is at a premium, such as assembly areas or inside some vehicles that provide public transportation. Some individuals with disabilities have even traveled by train and have flown commercially with their miniature horses.[16]

These points, in contrast to the lack of utility of other animals proposed exclusion, lifted miniature horses out of disfavor and into recognition as viable service animals. The example of the miniature horse highlights the important role public commentators serve in the rulemaking process.

[1] Nondiscrimination on the Basis of Disability by Public Accommodations and in Commercial Facilities, 73 FR 34508-01, (June 17, 2008)

[2] Id. at 34516.

[3] Id. at 34515.

[4] Id. at 34516.

[5] Id. at 34520.

[6] Id. at 34521.

[7] Id. at 34516

[8] Nondiscrimination on the Basis of Disability by Public Accommodations and in Commercial Facilities, 75 FR 56236-01 (September 15, 2010) (“Commenters asserted that certain species of animals (e.g., reptiles) cannot be trained to do work or perform tasks, so these animals would not be covered.”)

[9] DOJ-CRT-2008-0015-0906 (Steven Jacquez).

[10] DOJ-CRT-2008-0015-2670 (American Association of the Deaf-Blind).

[11] DOJ-CRT-2008-0015-2753 (Disability Rights Education and Defense Fund).

[12] DOJ-CRT-2008-0015-2693 (Washington State Human Rights Commission).

[13] DOJ-CRT-2008-0015-1752 (D. Vaughn).

[14] Nondiscrimination on the Basis of Disability by Public Accommodations and in Commercial Facilities, 75 FR 56272 (September 15, 2010).

[15] https://www.huffpost.com/entry/whats-up-with-muslims-and_b_1144819

[16] Id.

I was honored to join colleagues and clients at the 2020 Aviation Symposium the Firm sponsored in Tysons Corner from February 4 through February 6, 2020.

Symposium topics included:

  • What about the Lion Air and Ethiopian Airlines accidents should concern you?
  • An update on emotional support and service animals
  • Structuring and conducting an effective emergency drill
  • Working with first responders
  • A decade of evolution in the Federal Family Assistance Plan
  • The changing faces of the NTSB and FAA
  • The effect of FAA reorganizations on oversight, monitoring and surveillance
  • Recent developments involving disruptive passengers
  • The C-Suite and Crises: Managing the message and handling bad news, internally and externally.

I addressed the increasingly problematic issues involving the identification of legitimate service animals in the face of the increasing designation of their pets as emotional support animals, during the session titled “Disruptive/Disgruntled Passengers, Miniature Horses, Emotional Support Parakeets and Other Issues.”

The U.S. Department of Transportation has recently published proposed amendments to the regulation of service animals on flights.

As reported by DOT, the regulations would:

Define a service animal as a dog that is individually trained to do work or perform tasks for the benefit of a person with a disability;

No longer consider an emotional support animal to be a service animal;

Consider a psychiatric service animal to be a service animal and require the same training and treatment of psychiatric service animals as other service animals;

Allow airlines to require forms developed by DOT attesting to a service animal’s good behavior, certifying the service animal’s good health, and if taking a long flight attesting that the service animal has the ability to either not relieve itself, or can relieve itself in a sanitary manner;

Allow airlines to require passengers with a disability who are traveling with a service animal to check-in at the airport one hour prior to the travel time required for the general public to ensure sufficient time to process the service animal documentation and observe the animal;

Require airlines to promptly check-in passengers with service animals who are subject to an advanced check-in process;

Allow airlines to limit the number of service animals traveling with a single passenger with a disability to two service animals;

Allow airlines to require a service animal to fit within its handler’s foot space on the aircraft;

Continue to allow airlines to require that service animals be harnessed, leashed, tethered, or otherwise under the control of its handler;

Continue to allow airlines to refuse transportation to service animals that exhibit aggressive behavior and that pose a direct threat to the health or safety of others; and

Continue to prohibit airlines from refusing to transport a service animal solely on the basis of breed.

It would appear that miniature horses would not be permitted on flights as service animals, which is inconsistent with the American for Disability Act.  As explained in a blog to be published shortly, “A Brief History of Miniature Horses and the ADA,” those individuals who rely on mini-horses are likely to object to their exclusion from flights.  I would caution, however, whether any miniature horse could safely exist a plane during an emergent landing, for example when egress on a plane’s emergency chute/slide is required.  As any horse owner or veterinarian knows, horses do not sit down.  If a horse cannot safely exist a plane in an emergency, perhaps that is a sufficient reason to prohibit it from flying in the first place.

There are other concerns about the DOT proposed rule, including what appears to be discriminatory requirements for disabled passengers that seemingly conflict with the intent, if not the language of the ADA, to prohibit such discrimination.

That said, the intent to limit the abuse of false claims that a pet is a service or emotional support animals are overdue, and hopefully the regulation can be further amended as needed to comply with provisions enacted to benefit those with disabilities under the ADA.

Last month, I listened to a podcast interviewing the owner of Straight Arrow, the parent company that produces Mane and Tail and Cowboy Magic products. As a lifelong horse owner (including several grey horses that love mud), I cannot remember a time when I did not have a Mane and Tail and/or Cowboy Magic product in my tack room. The interview took place after the podcasters toured the Cowboy Magic manufacturing facility, which, according to the podcast interview, is a state of the art facility which adheres to strict quality assurances. When listening to the details of how their products are manufactured, I realized that many animal owners may not know what regulatory standards apply to the manufacturing of pet grooming products.

According to the FDA, the “animal counterpart of a cosmetic is commonly referred to as a ‘grooming aid.’” See FDA, Animal Products FDA Regulates, available at https://www.fda.gov/animal-veterinary/resources-you/animal-products-fda-regulates (hereinafter, “FDA Guidelines”). The FDA is only empowered to regulate cosmetics that pertain to human use:

The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.

21 U.S.C. § 321(i). Therefore standard animal grooming products do not fall within the control of the FDA. See FDA Guidelines. However, if animal grooming products are also made for human use, if the products are intended for any therapeutic purpose, or if the products are intended to affect the structure or function of the animal, they are subject to FDA regulation as a new animal drug. Id. Thus, a product like Mane and Tail, which is marketed for human use as well as animal use, is subject to FDA regulations.

A “new animal drug” is “any drug intended for use in animals other than man, including any drug intended for use in animal feed” but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggested in the labeling of the drug. See 21 U.S.C. § 321(v); see also FDA, New Animal Drug Applications, available at https://www.fda.gov/animal-veterinary/development-approval-process/new-animal-drug-applications. New animal drugs may not be sold until they are approved or conditionally approved by the FDA’s Center for Veterinary Medicine.

Thus, the answer as to what standards apply to the production of animal grooming products is, like most things in the law: it depends. A pet shampoo that merely claims to make the fur soft and shiny is unlikely to be subject to FDA regulations, whereas a shampoo that claims to prevent anemia or illness caused by fleas or ticks would be subject to FDA regulations and EPA regulations (governing all pet pesticide treatments). Of course, pet grooming products must still comply with packaging and labeling requirements governed by FTC and state consumer protection laws, and any claims about the efficacy of the product must be substantiated by competent and reliable scientific evidence.

We are available if you need advice related to any animal products you are manufacturing, distributing or selling.

Here is a glimpse into what happened at the tail end (ha!) of the 2018-2019 New Jersey Legislative Session.

Homes for Animal Heroes

The Homes for Animal Heroes bill, S 2826, made it over the final hurdle on the last day of this legislative session in New Jersey, passing 75-0 in the Assembly on January 13, 2020.  It had previously passed in the Senate so is now headed to the Governor’s desk.

The bill will require an institution of higher education, and research institutions that contract with colleges and universities to use cats and dogs for educational, research, or scientific purposes to provide such animals for adoption, when the cat or dog is no longer needed for educational, research, or scientific purposes, after determining that the health of the cat or dog renders it suitable for adoption.

While this is the practice of these research institutions in the State and much of the country, this law codifies this practice.

As reported in a press release published on Insider NJ,

‘New Jersey’s biomedical research community, including our nationally-renowned research universities and partners within the state’s life sciences companies, are pleased to see the Legislature recognize the importance of ensuring permanent homes for retired research animals – our animal heroes,’ said Tom Leach, executive director of the New Jersey Association for Biomedical Research. ‘We thank Assemblywoman Vainieri Huttle and the late Senator Anthony R. Bucco for their leadership in sponsoring this important legislation and working with all stakeholders to ensure we continue to find forever homes with the best interests of the animals in mind.’

Equine Stabling Tax Exempt

Another animal-related bill that made it through the legislative process, A1045 “clarifies the sales tax collection responsibilities of horse-boarding businesses in New Jersey by providing an exemption from tax for the lease or rental of certain stable stalls and charges for horse boarding and certain other related services.”

The bill provides that boarding, stabling, keeping, and feeding horses and other domestic equids are non-taxable services.

Proposed Bill on Animal Use in Cosmetic Testing

A bill just introduced on January 9, 2020, S4348 would prohibit the sale of cosmetic products that have been tested on animals.  Like similar bills passed in other states, this bill includes numerous exemptions, if:

(1)   The animal test is required by a federal or State regulatory authority and:

(a)   the ingredient that requires an animal test is in wide use and cannot be replaced by another ingredient,

(b)   a specific human health problem is associated with the ingredient and the need to conduct an animal test on the ingredient is justified and supported by a research protocol, and

(c)   there is no non-animal test that is accepted by the relevant federal or State regulatory authority as a means to gather the relevant data;

(2)   The animal test is conducted to comply with a requirement of a foreign regulatory authority, if no evidence derived from the test is relied upon to substantiate the safety of the cosmetic pursuant to federal or State regulations; or

(3)   The animal test is conducted on a product or ingredient subject to the requirements of chapter V of the federal “Food, Drug, and Cosmetic Act,” 21 U.S.C. s.351 et seq.

[and]

to cosmetics that were sold in the State or tested on animals prior to January 1, 2020, even if the cosmetic is manufactured after that date.

Like the bills known as “Moose’s Law” and “Desmond’s Law” previously discussed, S4348 will likely be re-introduced in the 2020-2021 Legislative Session.

 

 

Instead of amending Moose’s law to remove untenable, unreasonable provisions, last discussed here, the bill was amended to to provide that persons charged with “animal cruelty offenses,” a presumption against being admitted into a pretrial intervention program.  As described in the statement to S861, “[a] pretrial intervention program is a program that provides defendants, generally first-time offenders, with opportunities for alternatives to the traditional criminal justice process of ordinary prosecution.”

Once again, the bill fails to differentiate egregious acts of animal cruelty for which such a provision might be reasonable to apply, from other alleged violations of the animal cruelty statute.  Such a provision appears to conflict with current state and federal measures of criminal justice reform.

With no reliable available database to track animal cruelty cases, which in New Jersey are often adjudicated in municipal courts, it is impossible to prove that those with lower socio-economic status are more frequently defendants in these cases.  However, it is not unreasonable to assume that such persons, if accused, would not have the resources to retain an attorney to provide a vigorous defense or minimize their liability.

The amendment to N.J.S.2C:43-12 reads as follows, in relevant part

     2C:43-12.   Supervisory Treatment–Pretrial Intervention.

  1. Public policy. The purpose of N.J.S.2C:43-12 through N.J.S.2C:43-22 is to effectuate a Statewide program of Pretrial Intervention.  It is the policy of the State of New Jersey that supervisory treatment should ordinarily be limited to persons who have not previously been convicted of any criminal offense under the laws of New Jersey, or under any criminal law of the United States, or any other state when supervisory treatment would:

(1)   Provide applicants, on an equal basis, with opportunities to avoid ordinary prosecution by receiving early rehabilitative services or supervision, when such services or supervision can reasonably be expected to deter future criminal behavior by an applicant, and when there is apparent causal connection between the offense charged and the rehabilitative or supervisory need, without which cause both the alleged offense and the need to prosecute might not have occurred; or

(2)   Provide an alternative to prosecution for applicants who might be harmed by the imposition of criminal sanctions as presently administered, when such an alternative can be expected to serve as sufficient sanction to deter criminal conduct; or

(3)   Provide a mechanism for permitting the least burdensome form of prosecution possible for defendants charged with “victimless” offenses, other than defendants who were public officers or employees charged with offenses that involved or touched their office or employment; or

(4)   Provide assistance to criminal calendars in order to focus expenditure of criminal justice resources on matters involving serious criminality and severe correctional problems; or

(5)   Provide deterrence of future criminal or disorderly behavior by an applicant in a program of supervisory treatment.

  1. (1)  Admission of an applicant into a program of supervisory treatment shall be measured according to the applicant’s amenability to correction, responsiveness to rehabilitation and the nature of the offense.

(2)   There shall be a presumption against admission into a program of supervisory treatment for:

(a)   a defendant who was a public officer or employee whose offense involved or touched upon his public office or employment; [and]

(b)   a defendant charged with any crime or offense involving domestic violence, as defined in subsection a. of section 3 of P.L.1991, c.261 (C.2C:25-19) if the defendant committed the crime or offense while subject to a temporary or permanent restraining order issued pursuant to the provisions of the “Prevention of Domestic Violence Act of 1991,” P.L.1991, c.261 (C.2C:25-17 et al.) or if the crime or offense charged involved violence or the threat of violence.  For purposes of this subparagraph, a crime or offense involves violence or the threat of violence if the victim sustains serious or significant bodily injury as defined in subsection b. or d. of N.J.S.2C:11-1, or the actor is armed with and uses a deadly weapon or threatens by word or gesture to use a deadly weapon as defined in subsection c. of N.J.S.2C:11-1, or threatens to inflict serious or significant bodily injury ; and

(c) a defendant charged with a criminal animal cruelty offense, as defined in section 1 of P.L.    , c.    (C.          ) (pending before the Legislature as this bill) .

On November 25, 2019, FDA posted 15 warning letters from the Center for Food Safety and Applied Nutrition (CFSAN) or the Center for Drug Evaluation and Research (CDER) stating that certain products containing CBD were illegally labeled as dietary supplements and in many cases were also: unapproved new drugs, misbranded drugs, adulterated human foods, and in some cases were also unapproved new animal drugs and adulterated animal foods.

FDA explains its position about its regulation of CBD containing products in the letters which is also included on this webpage.

FDA has stated that CBD-containing products cannot be sold as Dietary Supplements because they do

not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff).  FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.  There is an exception if the substance was ‘marketed as’ a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.

As FDA has previously warned, it appears to be focusing on products that are advertised (by label and/or on websites) “for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or [are] intended to affect the structure or any function of the body” of a human or animal.  FDA considers these products to be unapproved new drugs or unapproved new animal drugs pursuant to section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act), 21 U.S.C. 321(g)(1), stating, that the products intended for use by people:

are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are ‘new drugs’ under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

There are similar allegations for products intended for use in animals.

FDA considers the human products to be misbranded drugs, pursuant to section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), which requires labeling that includes adequate directions for use of drugs labeling of drugs “under which a layperson can use a drug safely and for the purposes for which it is intended.”  (See also, 21 CFR 201.5.).

FDA also warns against the use human and animal products as human or animal food.  FDA has concluded that section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll) prohibits the introduction into interstate commerce any food to which CBD has been added and no exception exists since CBD was not marketed in food before relevant drugs approvals.  FDA also concludes that CBD does not qualify as a food additive or GRAS and has not received premarket approvals.

FDA invites those warned to provide evidence that would call into question FDA’s positions on these topics.

Until those positions change, and/or FDA is successfully legally challenged, CBD products should be carefully labeled and advertised to avoid warnings or worse.

Direct Action Everywhere practices what it calls “Open Rescue” which involves criminal trespass and stealing animals raised by farmers, ranchers and breeders, and believes such conduct should be legal because they are opposed to raising animals for food and biomedical research.

The animals rights group has worked with councilpersons in California to introduce resolutions that support, if not applaud such conduct, as the Right to Rescue, and call for leniency for several members facing criminal charges and potential imprisonment.

The animal rights group reported on its website that the

Berkeley City Council became the first legislative body in history (that we are aware of) to support the #RightToRescue.

On December 10, 2019, the City Council voted for a version of the original resolution submitted, with floor amendments, recorded on the video of the meeting.  DxE is expected to use the resolution to support its position that its members may enter animal facilities if they believe animals are not being humanely treated.   The resolution describes unlawful conduct as laudatory acts to save animals from mistreatment.

148 activists have been arrested in Sonoma County while trying to document the conditions of commercial animal operations and rescue nonhuman animals therein from thirst, starvation, injury, and illness . . .

NOW THEREFORE, BE IT RESOLVED by the Council of the City of Berkeley that the Mayor and City Council hereby declare that the 21 individuals being prosecuted in Sonoma County were acting under penal code 597 (e) to provide domestic animals with sufficient food and water and attempting to expose the abuses of nonhuman animals in commercial animal operations.

BE IT FURTHER RESOLVED that the Mayor and City Council encourage the Sonoma County District Attorney to dismiss such prosecution or exercise leniency, and to devote the resources that could be saved from these actions to instead investigate and prosecute potential violations of the law in commercial animal operations in Sonoma County.

If such unlawful conduct were to become accepted by the mainstream and offenders were not properly punished, animal enterprises will be in great jeopardy.

Instead, perhaps these offenses should be considered violations pursuant to the Animal Enterprise Terrorism Act.

A disturbing new trend has been developing on Facebook: raffling off animals. For example, a well-bred registered Quarter Horse yearling was recently offered for sale through a raffle on a local North Carolina equestrian page. The seller offered 100 spots, each selling for $40. Bidders paid the seller directly through PayPal for a slot, and when all of the slots were filled and paid in full, the seller held a random drawing and a winner was announced. The winner got herself a yearling for $40 and the seller pocketed $4,000 for a horse she struggled to sell through traditional avenues at a lower price.

Does this new sales trend seem too good to be true? It is. In most instances, it violates Facebook and PayPal rules, as well as state gambling laws. It also implicates tax issues and raises animal health concerns.

A raffle is a form of gambling. Most states regulate raffles and online gambling. For example, in North Carolina, where I practice, a “raffle” is defined as “a game in which the prize is won by random drawing of the name or number of one or more persons purchasing chances.” N.C. Gen. Stat. § 14-309.15(b).

North Carolina permits only non-profit organizations and government agencies to hold raffles, and those raffles are subject to certain restrictions. N.C. Gen. Stat. § 14-309.15(a). Any person who conducts an impermissible raffle is guilty of a Class 2 misdemeanor. Id. Thus, unless you are a non-profit organization or a government entity, raffling off your animal online is most likely illegal in North Carolina.

Further, because the IRS considers a raffle to be a form of lottery or gambling, there may be reporting requirements and tax withholding requirements. See IRS, Tax-Exempt Organizations and Raffle Prizes – Reporting Requirements and Federal Income Tax Withholding, Notice 1340 (March 2005), available at https://www.irs.gov/pub/irs-tege/notice_1340.pdf.

Both Facebook and PayPal also have rules regarding raffles. Facebook’s guidelines state that “Pages, Groups, and Events must not facilitate or promote online gambling, online real money, games of skill, or online lotteries without our prior written permission.” See Facebook Policies available at https://www.facebook.com/policies/pages_groups_events/. Raffles are not permitted on personal Facebook timelines. Id. PayPal also requires pre-approval to accept payment for activities involving “gambling, gaming, and/or any other activity with an entry fee and a prize.” See PayPal’s Acceptable Use Policy, available at https://www.paypal.com/va/webapps/mpp/ua/acceptableuse-full. PayPal also prohibits the use of its services for activities that violate any law, statute, ordinance or regulation. Id.

Of course, there are also concerns about where your animal may end up when raffled off. Someone who bought a horse for $40 is far less likely to invest in maintaining its health and well-being than someone who bought the horse for $4,000. Thus, before you decide to list your horse for sale through a raffle drawing, ask yourself if that’s the best decision you can make for the animal. At the very least, check your local state gambling laws to make sure it’s even legal and be sure to comply with the online platform’s raffle requirements.

Contact us for questions relating to the sale of your animals, including help drafting sales and lease agreements.

Without clear statutory authority, FDA has proposed to expand its legal authority over veterinarians and veterinary compounding pharmacies in its newly released “Revised Draft Guidance on Compounding Animal Drugs from Bulk Drug Substances,” (#256) as announced on November 19, 2019.

FDA continues to describe the use of certain compounded medications for animals as violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which it will not enforce under certain prescribed circumstances.

As stated in Guidance #256

The policies described in this document aim to protect human and animal health by limiting the use of animal drugs compounded from bulk drug substances primarily to situations in which a veterinarian is acting within a valid veterinarian client-patient relationship (VCPR) 3 and there is no medically appropriate drug that is FDA approved, conditionally approved, or on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (indexed) to treat the animal.

While FDA states that the “FD&C Act does not generally distinguish between compounding animal drugs from bulk drug substances and other methods of animal drug manufacturing . . . [t]he law permits compounding of animal drugs [only] when the source of the active ingredient is a finished FDA-approved drug, and not a bulk drug substance.”  (Emphasis added).

FDA proposed certain labeling and adverse reporting requirements for drugs compounded pursuant to patient-specific prescriptions for nonfood-producing animals, drugs compounded for office stock for nonfood producing animals, and drugs compounded for use as antidotes for food-producing animals.  Veterinarians administering or dispensing antidotes used for food-producing animals must also provide scientifically-based withdrawal times.

Also, without statutory authority, FDA requests input from the purportedly regulated community about a “List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals or Antidotes for Food-Producing Animals.

The proposed list includes:

DOGS, CATS, HORSES

Apomorphine hydrochloride – Indication: For the induction of emesis in dogs. Dosage form: 6.25 mg subconjunctival tablets, 3.125-6.25 mg/ml subconjunctival solution, and 2.5 mg/ml injectable solution.

Cisapride – Indication: For management of gastrointestinal disorders in cats, including: general constipation and constipation from megacolon. Dosage form: 2.5 and 5 mg oral tablets or capsules, and 5-10 mg/ml oral suspension.

Dipyrone – Indication: For the treatment of severe, acute fever in Shar-Pei dogs and Shar-Pei mixed breed dogs suffering from Shar-Pei fever. Dosage form: 250 and 500 mg/ml injectable solution.

Guaifenesin – Indication: For muscle relaxation in the horse during anesthetic induction and/or surgery. Dosage form: 50 g soluble powder to be reconstituted into a solution for IV infusion with the addition of 500 ml (10%) or 1000 ml (5%) sterile diluent.

Metronidazole benzoate – Indication: For the treatment of feline inflammatory bowel disease in cats. Dosage form: 80 mg/ml suspension.

Miconazole nitrate – Indication: For treatment of fungal keratitis in horses. Dosage form: 1% or 2% miconazole nitrate ophthalmic solution or ophthalmic ointment.

Potassium bromide – Indication: For initiation of treatment for seizures in dogs. Dosage form: 250 mg/ml oral solution.

Tacrolimus – Indication: For treatment of dogs with keratoconjunctivitis sicca (KCS) that is non-responsive to cyclosporine. Dosage form: 0.01– 0.03% tacrolimus ophthalmic drops.

NON FOOD-PRODUCING MINOR SPECIES

Awaiting nominations

FOOD-PRODUCING SPECIES

Awaiting nominations

Interested parties should submit nominations for additional bulk drug substances as described in the #256 Appendix.