Federal Laws and Regulations

In a bulletin published on September 25, 2018, USDA announced “four overarching goals for advancing animal disease traceability to protect the long-term health, marketability and economic viability of the U.S. livestock industry.”

Advance the electronic sharing of data among federal and state animal health officials, veterinarians and industry; including sharing basic animal disease traceability data with the federal animal health events repository (AHER).

Use electronic ID tags for animals requiring individual identification in order to make the transmission of data more efficient;

Enhance the ability to track animals from birth to slaughter through a system that allows tracking data points to be connected; and

Elevate the discussion with States and industry to work toward a system where animal health certificates are electronically transmitted from private veterinarians to state animal health officials.

Animal disease traceability has been a long-term goal of state and federal officials, as well as farmers and ranchers interested in protecting their livestock from the spread of contagious, infectious diseases.

A State-Federal Working Group reviewed the existing program and potential future goals, the results of which are published in a Summary of Program Reviews and Proposed Directions, dated April 2018.

The working group expressed general concerns about, in part: (1) confidentiality and security of information systems; (2) producer liability based on disease transmission, and animal and human injury resulting from applying and reading identification tags; (3) cost; (4) lack of proportionality of scale for small compared to large producers; and (5) beef feeder cattle under versus over the age of 18 months; practicality of identifying livestock at birth premises; flexibility, among other issues.

There was particular concern over electronic ID (EID), related technology and costs:

  • “If radio frequency ID (RFID) is to be utilized, the establishment of standards, including one technology (low-frequency (LF) vs ultra-high frequency (UHF)) is critical. Most stakeholders supported a dual technology tag as an interim measure.
  • The infrastructure must be in place to support the transition to EID.
  • Cost remains the primary concern of producers and representatives from other sectors of the industry for both the reader infrastructure and tags; however, the use of EID would provide substantial savings due to the increased efficiency associated with the technology.
  • Availability and use of electronic forms, in particular, electronic ICVIs. Obtaining records electronically would decrease cost and improve the completeness and accuracy of the data. Additionally, retiring animal numbers at slaughter would be feasible, where it has been cost-prohibitive with visual-only tags.
  • A cost analysis on metal NUES tags to show the full cost of tags when working cattle to manually record ID numbers (labor, stress and shrink, injury, etc.), as well as their limitations relative to traceability, e.g., tag retirement, to more accurately illustrate the 14 costs of both visual-only and EID tags.
  • Proportionally higher implementation costs for smaller producers, who sell direct to consumers and believe their livestock are already highly traceable.”

USDA’s current goals build on its final rule adopted on January 9, 2013, “Traceability for Livestock Moving Interstate,” which requires cattle, bison, horses and other equine species, poultry, sheep and goats, swine, and captive cervids moving interstate to be officially identified and accompanied by an interstate certificate of veterinary inspection (ICVI) or other documentation, with limited exemptions.

The proposals from the Working, as published in the report, include:

  1. Maintain the policy that traceability regulations do not apply to interstate movements to a custom slaughter facility in accordance with Federal and State regulations for preparation of meat.
  2. Maintain the current population of livestock covered by the official ID requirements. The ADT rule will continue to include:
  • All dairy
  • Beef cattle > 18 months of age
  • All rodeo and exhibition cattle.
  1. Cattle should be identified to their birth premises , thus the official ID records must provide birth premises information for the animal. APHIS should revise Federal regulations to include interstate commerce and the appropriate authority – either USDA or State officials – should establish regulations that trigger official ID requirements at:
  • Change of ownership
  • First point of commingling
  • Interstate movement (may reflect no sale and no commingling).
  1. The United States must move toward an EID system for cattle with a target implementation date of January 1, 2023. A comprehensive plan is necessary to address the multitude of very complex issues related to the implementation of a fully integrated electronic system. A specialized industry-lead task force with government participation should develop the plan, with a focus on several key objectives (see report for specifics).
  2. APHIS and States must make the advancement of electronic records an immediate high priority. The enhancements recommended below would increase the ease of collecting data in a standardized format and subsequently provide access to accurate data in near real-time, greatly enhancing the effectiveness of U.S. traceability and disease control programs. (See report for specifics).
  3. Enhanced enforcement of existing regulations.
  4. APHIS should continue the efforts of the State/Federal Slaughter Plant Working Group to improve the rates of ID collection and correlation at slaughter.
  5. APHIS and States need to establish a partnership with industry that would enable utilization of private information systems for disease surveillance and response events. Ideally, establish a communication protocol between the private systems and an animal disease traceability portal that would allow producer data to be maintained in the private systems and made available to animal health officials only when needed for animal disease control and response. Producers would have the choice to maintain their data in a private or public system. APHIS and the States would continue to protect producer data held in their systems and use it only for disease response. (See report for additional details).
  6. Review and update existing exemptions for official identification requirements.
  7. Concerns about electronic ICVIs and other electronic movement records are a high priority . . . Stakeholders support consistent requirements; however, the State of destination should be responsible for determining the documents appropriate for collection and compliance of key traceability components for livestock arriving to that State.
  8. Address lack of uniformity of state importation regulations. 9 CFR Part 86 should provide the national standards for official ID and movement documentation. APHIS should continue revision of the regulations to increase standardization considering that eliminating various exemptions will lessen confusion and State differences.
  9. The working group feels there is value in considering a standard, or uniform, official eartag to increase awareness and understanding that it is unlawful to remove the tag. APHIS should conduct a study to determine the potential advantages and disadvantages of having one national ID eartag for cattle. The study should examine the merit a standardized tag might bring to ease of recognizing official tags and its effect on compliance. The study should also include cost comparisons of the use of numerous tag styles, sizes, etc. versus one standard, uniform tag. APHIS should review this information and, if having one uniform tag has significant advantages, publish the one tag concept for public comment through the Federal Register. The actual change, if pursued, would require rulemaking.
  10. The ability to maintain the identity of imported cattle is essential. As such, the working group recommends that APHIS allow the retagging of such animals with an official EID tag by revising the traceability regulation to define an “Import Tag” (with a specific range of AINs and tag color). For example, APHIS could reserve a range of 840 numbers starting with “8409” for use on these tags. To help distinguish “Import Tags” that have a panel component, the panel piece of the tag should include the text “Import”. This ID option would clearly identify animals tagged with an 840 Import Tag after importation to the United States; provide producers the option to use compatible EID technologies as preferred; and allows for re-tagging visual only tagged imported cattle with an 840 EID Import Tag (even if the visual only official tag of the exporting country is in the ear). Producers using UHF technology could use USDA approved UHF 840 tags or the USDA approved UHF NUES tags when the State Animal Health Official authorizes this option. The recordkeeping requirements for tagging imported animals would remain the same as currently written in 9 CFR Part 86 for retagging and adding a second official tag. The working group recommends that APHIS prohibit the use of visual only 840 tags in imported animals.
  11. Considerations related to official identification of beef feeders to include beef cattle under 18 18 month of age after additional analysis.

“Moving forward, USDA wants to continue to build on the current momentum around animal disease traceability, and will begin implementing these ADT goals starting in fiscal year 2019.”

State Departments of Emergency Management prepare and respond to natural disasters by implementing the orchestrated emergency response plans, which state, federal and non-profit partners help develop over the years. These plans, that also include responses to the intentional or accidental introduction of highly pathogenic zoonotic or strictly animal diseases, are considered ever-green and updated based on emerging technology and review of tabletop exercises.

For those farmers, ranchers, veterinarians, zoos, aquaria, equine facilities, animal shelters, pet stores, biomedical research facilities and companion animal owners in need of assistance following Hurricane Florence and then Hurricane Michael in the South East, I hope the following resources can be of assistance.

South Carolina

On October 8, 2018, South Carolina State Veterinarian Boyd H. Parr, DVM implemented “temporary exceptions to the regulations governing the importation and exportation of animals coming into and leaving South Carolina as a result of Hurricane Michael.  All animals moving under these exceptions are expected to return to their state of origin no later than 10/31/18 unless this order is extended or revised.”  The exceptions, set forth at the Clemson Livestock Poultry Health website, permit interstate movement without a Coggins test result form or Certificate of Veterinary Inspection.

A comprehensive list of resources are available on Clemson’s Emergency Preparedness, Response and Recovery website, including, for example, links to (1) Hurricane Guidance for Livestock Owners; (2) Disaster Plan for Horses; (3) Emergency Equine Stable Sites; Flooding Hay Request Form; (4) Animal/Agriculture Emergency Support Function (ESF)-17 Ag Damage Assessment Information Form; and (5) Business Continuity for Agriculture/Secure Food Supply Plans.

In the face of Hurricane Florence, South Carolina previously suspended certain motor vehicle requirements, including, “such federal rules and regulations, in conjunction with S.C. Code Ann. §§ 56-5-4010 et seq., which establish size, weight, and load requirements for South Carolina highways, for, in relevant part, “Persons and vehicles transporting livestock, poultry, food for livestock and poultry, and crops ready to be harvested.”

Georgia

In Georgia, the Department of Agriculture has a Hurricane Response Center available on its website that also provides links to relevant information, including tips for those impacted by the storm.  Guidance is available related to livestock, pets, food, fuel, crops and other important information, such as:

0/12/2018 Commissioner Black Gets First Glimpse of Hurricane Michael’s Damage

10/12/2018 Disaster Assistance Discovery Tool

10/11/2018 Hurricane Michael Devastates Georgia’s Agricultural Industry

10/10/2018 Disaster Assistance Fact Sheet

10/10/2018 Press Release: Georgia Department of Agriculture Responds to Threat of Hurricane Michael

10/10/2018 Hurricane Michael: Animal Interstate Movement Requirements for Entry into Georgia from Florida are Temporarily Suspended UPDATED!

10/09/2018 Georgia National Fair Press Release: Fair Closed Wednesday October 10th, 2018

10/09/2018 Governor Nathan Deal declared a state of emergency for 92 counties in Georgia

Resources for Animal Food Producers in Flooded Areas of Gulf Coast

Like South Carolina, Georgia  and Florida temporarily suspended their interstate importation requirements for the transportation of animals.

Florida

Florida, with its long history of exemplary emergency preparedness and response, continues to implement those plans, including “[s]upporting pet-friendly shelters, agricultural producers, and local communities with various needs for supplies, transportation and staffing.”

North Carolina

The North Carolina Department of Agriculture & Consumer Services, N.C. State University Cooperative Extension and N.C. Cattlemen’s Association issued a warning on Sept. 22, 2018 to its constituents that “an individual was offering operational recovery assistance to producers with the claim that he had been authorized by the South Carolina state government. A background check on this individual proved this to be false.”

We are asking that if you are contacted by organizations or individuals that you do not know and you have a concern about their legitimacy, to please get the name of the individual/team, phone numbers, emails, license plate numbers, etc. and share that with your county Emergency Management Services.

USDA

A long-time partner with state departments of agriculture in emergency response, USDA provides resources and information on its website.  Its role  is “to provide food, emergency housing, community, as well as farmer and rancher assistance to individuals and small businesses affected by severe storms and flooding . . . [and] to work with states affected by severe storms and flooding regarding requests for various assistance, waivers and flexibilities in administering federal nutrition assistance programs.”  USDA also provides link to FEMA’s app for shelter and related information, as well as disaster assistance programs for farmers.

FDA

FDA, concerned about contamination of crops from floodwaters, provides relevant guidance on its website, “Crops Harvested from Flooded Fields Intended for Animal Food: Questions and Answers.”  In some cases, and with specific FDA approval, crops intended for human consumption can be used for animal feed.

The FDA will work with producers to consider requests to recondition an adulterated crop into animal food on a case-by-case basis. FDA’s compliance guide (CPG 675.200) provides a step-by-step process for reconditioning requests.

AVMA

The AVMA helps veterinarian impacted by disasters and provides emergency preparedness guidance on its website.

Hopefully, everyone impacted by these recent storms will find these and other resources helpful as they rebuild their properties, care for their animals, and recover.

As part of its Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings—just released—FDA announced that it plans to shift from “educating” food animal veterinarians and producers about the 2016 Veterinary Feed Directive (VFD) to “ensuring compliance with the . . . regulation to further ensure the safety of animal and human health.”  In other words, producers, veterinarians, and VFD medicated feed distributors (e.g., feed mills, retailers) should expect enhanced enforcement by FDA inspectors.

Those regulated should keep in mind that FDA inspectors will “examine VFD orders, requirements for the parties involved, and recordkeeping” during inspections.

FDA’s overall plans include three broad-based goals:

  1. Align antimicrobial drug product use with the principles of antimicrobial stewardship;

  2. Foster stewardship of antimicrobials in veterinary settings; and

  3. Enhance monitoring of antimicrobial resistance and antimicrobial drug use in animals.

While described as a One Health initiative, FDA’s plans favor the preservation of medically important antibiotics for humans over animals, particularly food animals.  Also, while acknowledging that it does not regulate either veterinary medicine or farming activities, FDA has set forth plans that appear to attempt to extend their regulatory reach, through proposed expansion of inspection and testing of animals, including food animals, companion animals, animal feed, farm-raised seafood and retail meat.

FDA also plans on bringing the 5% of antimicrobials still available over the counter under veterinary oversight, including, for example intramammary treatment to prevent or treat mastitis.  Not only will this increase costs to producers (which will be passed along to consumers), but according to the AVMA, many farmers and ranchers in rural communities do not have access to adequate veterinary care because of veterinary shortages “in more than 180 rural communities across the country.”

Certainly, the issue of antimicrobial resistance is important.  However, the emphasis by some government officials and legislators too often focuses on limiting use of antibiotics important to maintain the health of animals.  And the collection and reporting of antibiotic use and test results are used by activists to eliminate the use of animals for food completely.

Testing of some food products, albeit for other purposes, resulted in the conviction of the owners and operators of the Decoster Egg Farms for “introducing eggs into interstate commerce that had been adulterated with Salmonella enteritidis,” even though the government admitted that it had not identified any personnel, including the defendants who knew that the eggs were contaminated.  United States v. Decoster, 828 F.3d 626 (8th Cir. 2016) (Beam, J., dissenting).

Keep in mind that preventing Salmonella enteriditis was the basis for the adoption of enlarged cage requirements for hens in California despite evidence that such measures do not decrease the prevalence of the bacteria.  Furthermore, California and Massachusetts have imposed their regulations on producers in other states—an impermissible extraterritorial regulation in violation of dormant commerce clause, which has been challenged.  State of Missouri, et al. v. State of California, No. 22O148 (2017); State of Indiana, et al. v. Commonwealth of Mass., No. 22O149 (201

An interesting study about ordinances governing backyard poultry ownership in Colorado was recently published, titled “A Method for Guarding Animal Welfare and Public Health: Tracking the Rise of Backyard Poultry Ordinances” (the “Report”).

The Report “tracks the development of municipal ordinances, with attention to provisions for animal health and welfare and significant concerns for public health.”

Public and animal health officials, as well as large commercial poultry operations, have been concerned about the spread of infectious, contagious diseases, such as avian influenza virus from small backyard flocks where owners are unaware of and not familiar with the typical biosecurity measures that are generally recommended in animal agriculture.

USDA has published a number of guidance documents for people interested in raising poultry for their personal consumption of eggs.

In “Biosecurity for Birds,” USDA explains:

Raising backyard poultry is a growing trend across the United States. It is very important for all backyard poultry owners to know the signs of two deadly poultry diseases, as well as the basic ‘biosecurity’ steps you can take to protect your birds. APHIS runs the Biosecurity for Birds campaign to help raise awareness among backyard, hobby and pet bird owners.

On the other hand, animal rights activists often blame commercial agriculture for the spread of avian influenza.  See, e.g., An HSUS Report: Human Health Implications of Intensive Poultry Production and Avian Influenza, and Avian Influenza Just One Marker of Sickness in Industrial Agriculture .

The fact is that avian influenza is most often spread from wildlife to privately owned domestic flocks, regardless of the size of the flock.  Therefore, for animal and public health concerns, statutes and regulations̶̶-federal, state, or local-should provide for the health and welfare of laying hens as well as ensuring quality standards for eggs.

Federal and state laws govern standards of egg quality relating to the prevention of contamination with Salmonella.  As the Report discusses:

The federal regulations include requirements related to egg handling and storage prior to point of purchase by consumers, as well as testing for Salmonella on farms that have more than 3000 hens and implementation of biosecurity programs on those farms to control egg safety risks. For poultry meat safety, USDA inspects live birds and carcasses at federally inspected slaughter plants (i.e., plants that process meat for export or interstate commerce) to ensure that they are free of disease, and also evaluates conditions at those plants to ensure that they are sanitary and following ‘good commercial practices.’

However, as the Report states, local ordinances that permit ownership of backyard poultry usually do not include provisions related to either the health or safety of the hens.

[B]ackyard birds may pose significant risks to the general public. The outbreak of highly pathogenic avian influenza (HPAI, H5N1) in Egypt offers a shocking example. The majority (107/112) of Egypt’s clinically confirmed HPAI cases of human infection from 2006 to 2009 are linked to close contact with diseased backyard birds resulting in 36 deaths and human-to-human spread. In addition, the 2002 California outbreak of Exotic Newcastle Disease (END) originated in backyard flocks. The outbreak spread into commercial operations and resulted in depopulation of over 3 million birds, costing taxpayers $161 million. (citations omitted).

The Report, analyzing backyard poultry ordinances in Colorado, found, in part:

  1. The most common guidelines for poultry ordinances pertain to housing design and placement, the sex of birds, and total number of birds allowed, including specific space requirements for birds, in come cases.
  2. Ordinances commonly required housing to be predator resistant, easily cleaned, and maintained regularly to prevent the development of pests, rodents, or odors that would cause nuisances.
  3. In urban locations, the number of birds permitted was often limited to between 4 and 6 birds per lot.
  4. Ventilation requirements were often not included in ordinances.
  5. Roosters were commonly prohibited.

Notably, the Report stated that “[r]egulations pertaining directly to animal health and welfare were rare.”

The Report concluded that ordinances should include these provisions.

[O]ur study indicates that there are fewer guidelines for the health and welfare of backyard poultry than their commercial counterparts. Regulation is important in disease prevention. Fragmented oversight of animal welfare and health creates policy blind spots critical to shared human and animal health.

I concur.

You have likely heard about the recent attempt by an individual to board a flight with a peacock who purportedly served as an emotional support animal.  See, e.g., “Woman denied emotional support peacock on United Flight.

United has published current rules regarding Psychiatric/Therapeutic/Emotional Support Animal Authorization on its website, which indicates that changes to the current requirements will be forthcoming:

Pursuant to the Department of Transportation (DOT) guidance for the carriage of service animals, United requires a passenger with a qualified disability traveling with a psychiatric/therapeutic/emotional support type animal to obtain documentation from their medical/mental health professional.

This form is only valid for travel between now and February 28, 2018; additional documentation will be required for travel on or after March 1, 2018.

Other documentation may be required for travel entering or exiting an international location.

United requires service animals to be “properly harnessed for the duration of the flight. Small animals may remain in the passenger’s lap during the flight. If a carrier will be used, it must meet the USDA guidelines and fit under the aircraft seat.”

Notably, the airline also states that animals “must be trained to behave appropriately in a public setting. Animals found not to have been trained to behave will only be accepted in accordance with United’s current pet policies or may be denied boarding.” (Emphasis in original).

 

There is additional information on United Airlines’ Service animals webpage:

Beginning March 1, 2018, United will require additional documentation for customers traveling with an emotional support animal. Currently, customers must provide 48 hours’ notice to the Accessibility Desk and a letter from a licensed medical/mental health professional. For travel on or after March 1, customers will need to also provide a veterinary health form documenting the health and vaccination records for the animal as well as confirming that the animal has appropriate behavioral training.

Additional information and forms will be available soon, so please continue to check united.com if you have upcoming travel with an emotional support animal. The process for trained service animals is currently not changing.

We have published several blogs about legal requirements and provisions governing the use of service and emotional support animals.  Individuals with legitimate disabilities may be disadvantaged by those who want to travel with their pets but have no legitimate disability or emotional disorder.  Since specific certification is not required for service or emotional support animals, but a plethora of websites offer registration, vests and identification cards provided for a fee and based on the honor system, it is easy for people to fake it.

The U.S. Department of Transportation has published a comprehensive “Service Animal Definition Matrix—Air Carrier Access Act vs. Americans with Disabilities Act,” dated July 1, 2016, that includes helpful definitions, questions and answers summarizing information about:

  1. The Air Carrier Access Act (ACAA) and 14 CFR Part 382;
  2. DOJ’s interpretation of Americans With Disabilities Act (ADA);
  3. FRA’s interpretation of Americans With Disabilities Act (ADA) 49 CFR 37.3;
  4. FTA’s interpretation of Americans with Disabilities Act (ADA) 49 CFR 37.3, 37.167(d); and
  5. HUD’s FHAct and/or Section 504.

In addition to definitions based on the above-mentioned categories, helpful questions and answers are included in the matrix, including, for example:

  1. Should disability mitigation training for the animal be required as a condition of access?
  2. Should public access training for the animal be required as a condition of access?
  3. Should the rule designate eligible species and, if so, what species should be allowed? Should the rule allow certain species to travel as service animals subject to certain restrictions (such as remaining contained during flight)?
  4. What requirements should the rule impose to prevent fraud in the documentation process.

This matrix, while not legal advice, should be helpful to airline and other carriers considering whether to amend their policies regarding travel with emotional support animals.

It may be worth considering policies to permit pet owners to purchase seats for certain pets, with reasonable requirements for health and behavior, since it is likely that many people would pay for these tickets, if available.

On Wednesday, November 15, 2017, Las Vegas City Council voted to enact “Bill No. 2017-40 – which repeals a formerly adopted ordinance which prohibits pet shops from selling or disposing of dogs, cats or potbellied pigs other than those obtained from an animal care facility or nonprofit animal rescue organization.”

As both the American Kennel Club (AKC) and Pet Industry Joint Advisory Council (PIJAC) stated in written testimony, the misrepresentations about the puppies sold at pet stores harms puppies, breeders, pet stores and consumers by removing a highly regulated source of healthy puppies for people desiring a lifelong pet with specific behavioral and physical characteristics they prefer for their families.

As PIJAC explained:

Even as we have worked to raise standards of care, PIJAC has battled misconceptions about the quality of pet store animals and the sources of such animals. The unsubstantiated assertion that pet store animals generally come from substandard breeding facilities is commonly used as a smoke screen to obscure the fact that the overwhelming majority of pet owners who choose to purchase from pet stores bring home a happy, healthy pet and remain highly satisfied with their pet store experience.

The reality is that almost all pet store puppies originate from USDA licensed breeders who are regularly inspected and found to comply with appropriate care standards. By contrast, many of the dogs and cats from other sources, including rogue Internet operators, private sales, shelters and rescues, did not come from licensed breeders.

AKC stated:

An important part of ensuring the success of a pet with a new owner is to ensure that it is an appropriate fit with the owner’s lifestyle. Treasured pets may be obtained from a variety of sources, including breeders, pet stores, rescues, and local shelters.

Under the current law, families in Las Vegas have lost an important source for choosing a quality pet that is the best fit for their lifestyle and circumstances.

There is no credible evidence that puppies purchased from pet stores originate from “puppy mills,” large commercial substandard breeding facilities, or that pet store puppies contribute to shelter populations-misrepresentations that form the bases for pet store sourcing bans.

Las Vegas City Council repealed the pet store sourcing ban. Hopefully, other communities will follow suit.

On a related note, Circuit Judge Hamilton dissented from the majority opinion in a constitutional challenge to a pet store ban in Chicago (Park Pet Shop, Inc. v. City of Chicago, 872 F. 3d 495 (7th Cir. 2017) “[o]n two points critical to the federal Commerce Clause claim.”

First, the Supreme Court itself has not yet confined the balancing test under Pike v. Bruce Church, Inc., 397 U.S. 137 (1970), as narrowly as my colleagues suggest. The majority writes that Pike balancing comes into play ‘only when the law discriminates against interstate commerce in practical application.’ Ante at 502 (emphasis in original), citing National Paint & Coatings Ass’n v. City of Chicago, 45 F.3d 1124, 1131 (7th Cir. 1995) . . . . The majority would apply Pike only when the challenged law gives ‘local firms any competitive advantage over those located elsewhere’ . . . The Supreme Court’s more recent discussions of Pike, since we decided National Paint in 1995, are difficult to reconcile with this approach. For example, the Court has explained that federal courts ‘generally leave the courtroom door open to plaintiffs invoking the rule in Pike, that even nondiscriminatory burdens on commerce may be struck down on a showing that those burdens clearly outweigh the benefits of a state or local practice.’

 

Judge Hamilton also found that “the majority errs by applying a stringent version of Iqbal and Twombly to find that plaintiffs have not plausibly alleged sufficiently burdensome effects on interstate commerce.”

 

Judge Hamilton found that the complaint had sufficiently alleged plausible impacts that the pet store sourcing ban would result in the alleged harms, concluding,

I don’t know whether the plaintiffs in this case could ultimately meet the demands of the Pike balancing test. They should be permitted to try, though, particularly now that the ordinance has taken effect and evidence of actual effects should be available. I would reverse the dismissal for failure to state a claim and remand for further proceedings.

 

 

The “PUPPERS” Act, H.R. 3197, a bill that would prohibit the use of canines in biomedical research at the Veterans Administration by eliminating required funding, is misguided and, if enacted, would be harmful to both humans and animals.

Esteemed scientific associations (listed below) wrote to Congressional representatives, in opposition to H.R. 3197, explaining that while scientists embrace efforts to reduce the number of animals needed in research and to replace animals when possible, animal models are still required before drugs or devices are sufficiently proven to be both safe and efficacious for their intended use.  While the number of dogs involved in biomedical research has been reduced, their contribution remains critical in finding cures for certain diseases and disorders, like the previously incurable and fatal genetic disorder affecting skeletal muscles in both humans and dogs, called Myotubular Myopathy (MTM), recently described here.

Canines are currently playing a vital role in the moonshot to end cancer, aging and Alzheimer’s, heart disease, diabetes, and most recently the first FDA-approved artificial pancreas was brought to fruition because of work at the VA. Additionally, 22 of the 25 most prescribed medications were brought to patients’ bedsides thanks to research with canines.

Quote from letter to Congressional representatives from:

  • American Academy of Neurology (AAN);
  • American Association for Laboratory Animal Science (AALAS);
  • American College of Neuropsychopharmacology (ACNP) ;
  • American Neurological Association (ANA);
  • American Society of Laboratory Animal Practitioners (ASLAP);
  • American Society for Pharmacology & Experimental Therapeutics (ASPET);
  • American Thoracic Society (ATS);
  • Americans for Medical Progress (AMP);
  • Associated Medical Schools of New York (AMSNY);
  • Association for Research in Vision and Ophthalmology (ARVO);
  • Association of American Medical Colleges (AAMC);
  • Association of American Universities (AAU);
  • Association of American Veterinary Medical Colleges (AAVMC);
  • Association of Public and Land-grant Universities (APLU);
  • Baylor College of Medicine California Biomedical Research Association (CBRA);
  • Coalition for the Life Sciences The College on Problems of Drug Dependence, Inc. Comparative Biosciences, Inc. Council On Governmental Relations (COGR);
  • Federation of American Societies for Experimental Biology (FASEB);
  • IACUC 101 Series Massachusetts Society for Medical Research (MSMR);
  • Michigan Society for Medical Research (MISMR);
  • National Animal Interest Alliance (NAIA) National Association for Biomedical Research (NABR);
  • National Association of Veterans’ Research & Education Foundations (NAVREF);
  • New Jersey Association for Biomedical Research (NJABR);
  • North Carolina Association for Biomedical Research (NCABR)
  • Northwest Association for Biomedical Research (NWABR);
  • Oregon Health & Science University (OHSU);
  • Pennsylvania Society for Biomedical Research (PSBR);
  • RxGen SNBL USA, Ltd. Society for Neuroscience (SfN);
  • Society for the Study of Reproduction (SSR);
  • States United for Biomedical Research (SUBR);
  • Texas Society for Biomedical Research (TSBR); and
  • University of California, Los Angeles University of Illinois Urbana-Champaign Washington University in St. Louis.

Our ability to study and find cures for many human and animal diseases and disorders would not have been obtainable without studies involving animals, including the following medical achievements:

  • the cardiac pacemaker;
  • the first liver transplant;
  • nicotine patch;
  • the discovery of insulin;
  • vaccinations against canine distemper, parvovirus, rabies, coronavirus, leptospirosis, Lyme disease, measles, and hepatitis;
  • prevention of canine intestinal parasitic diseases, fleas, ticks, mites and mange.

Like the entities listed above I look forward to a time when biomedical research does not involve animal testing, but we currently are not knowledgeable or scientifically advanced enough to entirely replace animals with other models.

Therefore, federally proposed bills, including H.R. 3197 and a similar amendment offered by Rep. Dave Brat (R-VA) to the Defense, Military Construction, Veterans Affairs, Legislative Branch, and Energy and Water Development National Security Appropriations Act, 2018, if adopted, would only serve to harm both human and animal health, and should therefore be opposed.

 

FDA’s recent announcement that it is “withdrawing draft Guidance for Industry (GFI) #230, ‘Compounding Animal Drugs from Bulk Drug Substances’” reminded me that pet owners can become confused about what type of medications are available for treating their pets.  For example, while serving on the New Jersey State Board of Veterinary Medicine, I recall a fair number of consumer complaints that alleged that a veterinarian provided substandard medical care because the medication prescribed to a pet was labeled “for human use only.”  Consumers therefore concluded that the medication harmed their pet.

However, the fact that medication is not specifically approved for use in animals does not mean that it would necessarily be harmful to those animals.

In fact, the use of an approved drug in a manner that is different than stated on the label, has been a fundamental tool used in veterinary medicine since drugs were first labeled.  This “extralabel” drug use was memorialized by Congress in the Animal Medicinal Drug Clarification Act of 1994 (AMDUCA).  See AVMA’s description of AMDUCA.

As AVMA describes on it’s website, “Compounding: FAQ for Veterinarians,” “compounding for animal patients . . . [is] a subpart of  [the] Extralabel Drug Use (ELDU) Rules.”

The ability to use approved drugs in species, for treatments, or at dosages, frequencies, or routes of administration that are not included on the label, is a tool that veterinarians use on a daily basis.  Since obtaining drug approvals for all uses in all types of animal species is cost-prohibitive, the only way some animals can be treated is through the use of drugs in an extra-labeled fashion.

When used properly and pursuant to the standard of care in veterinary medicine, such use should be considered legal.

While FDA has stated that “[c]urrent law does not permit compounding of animal drugs from bulk drug substances,” whether, and to what extent FDA governs compounding in the veterinary space has been the subject of legal debate.

However, FDA’s withdrawal of its guidance document related to compounding animal drugs from bulk substances creates even more confusion and uncertainty for the regulated community.  The now withdrawn guidance document,  Guidance #230, had set forth the situations in which FDA had indicated that it would not take regulatory action against a pharmacy or veterinarian when “an animal drug compounded from bulk substances may be an appropriate treatment option.”

Now, instead of finalizing the draft guidance based on comments received, “FDA intends to publish the new draft in early 2018 for public comment.”

So, the regulated community will be without guidance for a short period of time.

Hopefully FDA’s new guidance will continue to permit compounding from bulk substances when needed to provide adequate medical care for animals in need thereof.

 

As USDA had previously suggested, it just posted a new version of the searchable database that had been dismantled this past February.  Access to the new version is available here.

Many animal rights organizations and animal-trade organizations had expressed outrage or concern when USDA initially dismantled its database.  The current version may not effectuate changes to those positions, since much of the information about individual licensees (compared to licensed businesses) appears to be redacted.

Also, it seems as if license numbers are not available for individuals, but it could be I need to more carefully review the instructions for searching the new database to find that information.

It is a given, that those clamoring for this data will be hard at work deciphering what is and what is not available.

For those pet stores and dealers in towns, cities and states that are required to provide inspection reports to sell puppies, it seems as if the only way to provide such documents from breeders licensed as individuals is to obtain the reports directly from those breeders.

The recent horrific attacks in Syria reminded me of the concerns following 9/11 about potential attacks on livestock and poultry.  Those concerns rose to the highest echelon in our government and others, exemplified by the first International Symposium on Agroterrorism, held in Kansas City, Missouri on May 5, 2005.

I attended that meeting and was awestruck by the opening video-a poignant memorial to the farmers and others involved in agriculture from across the country, highlighting their back-breaking work that feeds and clothes everyone in the United States, and much of the world.  I would love to see that video again-if anyone has a link, please share.

FBI Director Robert S. Mueller, III greeted the attendees, describing the unique challenges involved in distinguishing intentional acts of agroterrorism from natural disease outbreaks:

This distinction is important. If a car bomb explodes outside of a building, we know the attack was intentional. But if a cow contracts Foot and Mouth Disease or a soybean plant exhibits rust, it can be difficult, if not impossible, to determine whether the attack was intentional or occurred naturally.

Director Mueller highlighted the federal, state and local public-private efforts then recently adopted and deployed to investigate a potential threat:

Several months ago, the State Department received an anonymous tip that an unknown individual had threatened to introduce a virus to a large pig farm in Kansas. The State Department passed this information to the Secret Service, which notified one of its agents in Kansas. This agent was part of the FBI’s local Joint Terrorism Task Force. Together, we got the investigative ball rolling.

We coordinated with a local veterinarian, the USDA, and the FDA to assess the threat. Working with INS and local law enforcement, we found this man and questioned him. As it turns out, he had recently returned from South Africa, and it was possible that he could have transported a virus with him.

In the end, this investigation turned out to be a poison pen letter. The man we questioned had no intention of spreading a damaging virus. But because of our established networks, we were able to quickly assess the threat and move to prevent any attack.

In 2008, the FBI, Department of Justice and USDA published the “Criminal Handbook for Agroterrorism,” which “represent[ed] a joint effort of the Federal Bureau of Investigation, Counterterrorism Division; the Food and Drug Administration, Office of Criminal Investigations; the Food and Drug Administration, Center for Food Safety and Applied Nutrition; the Department of Homeland Security; and the U.S. Department of Agriculture, Office of the Inspector General.”

The handbook was considered important since “[a]n attack against the food or agriculture sector . . . requires a high level of cooperation . . .  to identify . . . the threat, prevent . . .the spread of the disease or further contamination of a food product, prevent . . . public panic, and apprehend . . . those responsible. Lack of mutual awareness and understanding, as well as the absence of established communication procedures, could hinder the effectiveness of joint law enforcement investigations. Due to the continued likelihood of attacks against the U.S. food and agriculture sector, the effective use of all resources during an incident will be critical to ensure an efficient and appropriate response.”

Protecting the food supply in this country remains a priority of the FBI, according to Mollie Halpern (not a relative), explaining:

One way the FBI ensures the safety of the nation’s food from farm to fork is through agroterrorism workshops. Our 56 field offices across the country host these workshops, which bring together the public and private sector—such as farmers, law enforcement, federal regulatory agencies, and academia. Supervisory Special Agent Kelly Decker says outreach, liaising, and awareness are the best defenses against agroterrorism.

USDA has continued its efforts to protect the nation’s food supply.  The Office of Inspector General at USDA published a report in March 2017, “Agroterrorism Prevention, Detection, and Response

“to evaluate if USDA’s [Office of Homeland Security and Emergency Coordination’s] OHSEC had developed and communicated effective plans and procedures to prevent, detect, and respond to agroterrorism threats.”

The OIG recommended:

Development and implementation of written processes to effectively oversea USDA’s agroterrorism prevention, detection, and response activities;

Development and implementation of a comprehensive process to track USDA’s compliance with Homeland Security Presidential Directive (HSPD)-9; and

Improvement of the process used to create the Sector Specific Plan (SSP).

The recommendations were largely accepted and will hopefully be completed before they are needed.