U.S. Department of Agriculture (USDA)

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.

A virulent form of Newcastle disease (vND), “a contagious and fatal viral disease affecting the respiratory, nervous and digestive systems of birds and poultry,” as described on USDA’s Virulent Newcastle Disease webpage has been confirmed in 93 cases in backyard exhibition chickens and turkeys by USDA since May 18, 2018.

The last outbreak of vND started in 2002 infecting 22 commercial premises and hundreds of backyard flocks, at a cost of over $180 million dollars to eradicate the outbreak, officially ending on March 26, 2003.  That outbreak, which started in California spread to four other states, but the majority of affected premises were in California.

Since May of this year, USDA has been regularly updating its stakeholders with information about the current outbreak, which to date, has not infected commercial poultry premises.

USDA reports that vND (previously called Exotic Newcastle Disease or END) “is one of the most infectious diseases of poultry in the world and is so deadly that many birds die without showing any signs of disease. A death rate of almost 100 percent can occur in unvaccinated poultry flocks. It can infect and cause death even in vaccinated birds.”

There are “three simple steps” USDA describes to prevent the disease from spreading to other flocks including:

Washing hands and scrubbing boots before and after entering an area with birds;

Cleaning and disinfecting tires and equipment before moving them off the property; and

Isolating any birds returning from shows for 30 days before placing them with the rest of the flock.

Bird owners are directed to contact state and federal animal health officials if their birds exhibit the following clinical signs:

Sudden death and increased death loss in flock

Sneezing, gasping for air, nasal discharge, coughing

Greenish, watery diarrhea

Decreased activity, tremors, drooping wings, twisting of head and neck, circling, complete stiffness

Swelling around the eyes and neck.

USDA also amended Veterinary Services Memorandum No. 800103 “Reissuance of Product Licenses for Autogenous Products and Guidance Concerning Restriction on the Production and Use of Veterinary Biologics,” seemingly related to concerns about the use of some virulent viruses in autogenous vaccines.

VS Memorandum 800.103 was signed on July 18, 2018, and cancels VS Memorandum 800.103 dated May 28, 2002. This memorandum provides guidance to licensees, permittees, and applicants concerning Animal and Plant Health Inspection Service’s restrictions on the production, importation, distribution, and use of autogenous biologics. This memorandum is effective immediately.

As described in Memorandum 800.103:  

APHIS restricts the importation and distribution of veterinary biologics from countries known to have exotic diseases, including, but not limited to, foot-and-mouth disease, rinderpest, highly pathogenic avian influenza, swine vesicular disease, Newcastle disease, African swine fever, and bovine spongiform encephalopathy if, in the opinion of APHIS, such products may endanger domestic animals, livestock, or poultry.

In addition, APHIS restricts the production and distribution of veterinary biologics, including, but not limited to, Brucella Abortus Vaccine, Vesicular Stomatitis Vaccine, and certain diagnostic products used in cooperative State/Federal/industry animal disease control and eradication programs, if it determines such products may interfere with disease surveillance and/or control and eradication efforts.

The instant amendments appear to be an attempt to prevent potentially virulent virus from inclusion in autogenous vaccines (a reasonable limitation).  Therefore, field isolates intended for inclusion in such products must be tested at an APHIS-approved laboratory before such use.

Hopefully, this outbreak will be resolved soon and without infecting more backyard or commercial-raised birds.

 

On June 4, the regulation titled “Thresholds for De Minimis Activity and Exemptions From Licensing Under the Animal Welfare Act” which purportedly implement[s] amendments to the Animal Welfare Act (AWA), was published by USDA-APHIS, effective on the date of publication.

The regulation expands some exemptions to the licensing requirements pursuant to the AWA.  There are some unintended consequences to these expansions that may be detrimental to certain animal owners.  For example, the ever-expanding pet store sourcing bans often limit sources to USDA-licensed dog breeders—if these professional breeders are not entirely excluded.  Many exempt breeders—those who own four or fewer breeding females—would prefer to be licensed so that they can sell to pet stores.  However, because the provision that permits an exempt breeder to apply for a voluntary license was previously deleted from the regulations, these breeders have cannot obtain an USDA license.

USDA notes that the “four or fewer exemption” has been in place since 2004 (addressing a comment related to licensure of small exotic and wild animal owners), there was no discussion about the growing impact to dog “hobby” breeders, perhaps because no one submitted a relevant comment.  (There was a comment that permitting these breeders to go unlicensed created a loophole, but USDA “made no changes in response to that comment”).

If these breeders were to try to use third party certifiers to prove to the public that it complies with or exceeds standards required pursuant to the AWA, the reliance on such certification may be questioned based on USDA’s recent announcement that it “will not establish new criteria for recognizing third-party inspection and certification programs when determining the Agency’s own inspection frequency under the Animal Welfare Act (AWA).”

USDA explained:

In this case, APHIS found the vast majority of the comments we received to not be in favor of establishing new criteria for recognizing third party inspection and certification programs.  Stakeholders on all sides of the issue expressed concern about APHIS’ ability to maintain responsibility for inspections and AWA compliance should third-party inspections be taken into account when determining APHIS inspection frequencies.

APHIS will continue to use its current risk-based inspection system to determine the frequency of inspections, and will continue to promote compliance with the AWA by conducting quality inspections, offering voluntary compliance support and learning opportunities, and taking enforcement action, as appropriate.

Still, no one should be surprised if activists use USDA’s decision to support their unsubstantiated position that certain third party certifications are meaningless.

While it is understandable that USDA has adopted this rule to “allow . . . APHIS to focus its limited resources on situations that pose a higher risk to animal welfare and public safety” I hope that these exemptions do not create additional hardships for animal owners, breeders, and exhibitors.  More to follow in PART TWO.

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.

 

 

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.

 

Genetic testing in human and animal medicine has been used for some time, and shows great promise, when used judiciously.  For example, genotyping the avian influenza virus and other pathogens has helped animal and human health officials understand the spread of pathogens so that measures can be implemented to prevent or mitigate such spread.

As reported by Greg Cima, “[f]aster, cheaper genome sequencing is helping public health researchers identify the risks of drug resistance and medical treatment failure . . . The sequences also may help federal investigators find outbreak sources, by geographic location and species, as well as guide vaccine and antimicrobial development.”  Finding risks in a flood of genetic data, JAVMAnews Issues, Aug. 1, 2016. .

According to Dr. Jerold Bell, a small animal practitioner and adjunct professor at the Tufts University Cummings School of Veterinary Medicine, “[c]ompanies are using diagnostics to determine what breeds exist in a mixed-breed dog . . . Some companies take it one step further and also tests for genes controlling body conformation and known disease-causing mutations.”  M.S, Filippo, Genetic testing for pets quickly catching up to its human counterpart, AVMA press release, 8/8/2016.

Diagnostic test results are rarely dispositive, and the reliability of the results can be influenced by many factors, including, but not limited to: sample collection; quality control and quality assurance of test reagents; method and proficiency of testing; and interpretation of test results.  Even tests performed by USDA-APHIS-approved laboratories that are part of the National Animal Health Laboratory Network, using reference materials and proficiency tests produced at the National Veterinary Services Laboratory that are accredited to international standards, must be interpreted by knowledgeable clinicians.

As a large animal veterinarian, when I received laboratory results from state or private laboratories that did not seem consistent with my patient’s clinical signs, I would consult with the laboratory director and other officials to discuss those inconsistencies.  Sometimes, additional testing was warranted.  In some cases, the final results were never definitive.

As the Director, Division of Animal Health, New Jersey Department of Agriculture I was responsible for the oversight of the only animal health diagnostic laboratory in the State, and for interpreting laboratory results related to regulated and reportable diseases.  That analysis started with the laboratory test results, and where the results appeared inconsistent with the clinical signs of the tested animal, an in depth review of the testing process from sample collection to results ensued.

Based on this extensive background and understanding of testing, I am concerned about the inappropriate use of certain genetic tests to refute the pedigree registration status of purebred dogs.  As several courts have held, genetic testing is currently not dispositive of pedigree registration status.  See, e.g., Sandra Shines v. Furry Babies Stratford Square, Inc., No. 13-3592, slip op. at 9 (Ill. 18th Jud. Cir. Jan. 22, 2014) (finding DNA test results unreliable to support plaintiff’s claim that the cocker spaniel in dispute was a mixed breed).

Mars Veterinary, a business unit of Mars Petcare that sells a DNA genetic test called Wisdom Panel® warns that the test is not “intended to be used in any judicial proceedings” and further suggests that “[i]f questions arise as to a purebred dog’s pedigree and breed ancestry, parentage testing through the AKC is the appropriate course of action. For this evaluation, the documented sire and/or dam are examined to ensure they were the genetic contributors to the dog in question. If they are confirmed as the parents, their pedigree (and breed) is conferred onto the puppy.”  See Wisdom Panel® Terms and Conditions.

The purebred status of dogs is based on documentation confirming each dog’s lineage, required by the relevant breed canine breed registries—not the results of DNA testing.  Similarly, ancestry DNA testing in humans could not be used to nullify the citizen status of a third-generation U.S. citizen, no matter what their genetic makeup reveals.

The proper use of genetic testing is reflected in AVMA’s new policy on “Inherited Disorders in Responsible Breeding of Companion Animals” which “supports research in genetic and inherited disorders to better educate the profession and breeders on identifying and minimizing inherited disorders in companion animal breeding programs.”  K. Burns, AVMA passes policy on responsible pet breeding, JAVMAnews, Feb. 15, 2017.

Undoubtedly, genetic testing will be used as a increasingly important tool for pathogen tracking, disease control purposes, to help guide responsible dog breeders and to help identify the genetic make-up of mixed breed dogs, with unknown pedigree.

 

After a whirlwind of comments and criticisms, USDA has updated its statement regarding the abrupt deactivation of its Animal Care Search Tool, available here https://content.govdelivery.com/accounts/USDAAPHIS/bulletins/185b051.

Similar to statements published on interested parties’ websites, USDA confirmed that this decision was based on internal discussions and review that predated the new administration.

In 2016, well before the change of Administration, APHIS decided to make adjustments to the posting of regulatory records.

USDA noted that the deactivation resulted not only based on guidance from the Department of Justice (see Department of Justice Guide to the Freedom of Information Act and Overview of the Privacy Act), that provides a comprehensive review of litigation related to FOIA and the Privacy Act, but that their action was also related to litigation “APHIS is currently involved in . . . concerning, among other issues, information posted on the agency’s website.”

USDA/APHIS did not identify which litigation it referenced in its updated statement.

Like USDA, many federal agencies struggle to balance transparency with personal and business protections required by federal law.

 Recently, PETA (largely) lost it’s lawsuit against HHS, alleging that the Centers for Disease Control and Prevention had impermissibly withheld information pursuant to PETA’s FOIA request “seeking records submitted by importers of nonhuman primates . . . to CDC pursuant to certain agency regulations.”   People for the Ethical Treatment of Animals v. United States Department of Health and Human Services, No. 15-cv-309, slip op. (D.D.C. January 5, 2017).

In the final Order, the Court granted Defendant’s Corrected Motion for Relief under Fed. R. Civ. P. 60(b) holding:

“The four categories of information the Court previously held qualified for protection pursuant to FOIA Exemption 4 with respect to the records of seven objecting importers—quantity of animals imported, the descriptions of crates used in shipments, the names of the companies that export the animals, and the names of the airline carriers that transport the animals—also qualify for such protection with respect to the records of Central State Primate (‘CSP’), Dallas Zoo Management (‘DZM’), and SBNL USA (‘SNBL’). It is further ORDERED that Plaintiff’s [52] Cross-Motion for Relief under Fed. R. Civ. P. 60(b) is GRANTED-IN-PART and DENIED-IN-PART. Plaintiff’s motion is GRANTED in that information regarding the quantity of animals imported and the descriptions of crates used in shipments on the records of Worldwide Primates, Inc. (‘WWP’) and Primate Products Inc. (‘PPI’) does not qualify for protection pursuant to FOIA Exemption 4. Plaintiff’s motion is DENIED in all other respects.  Id., slip op. (D.D.C. Feb. 6, 2017).”

PETA has appealed this decision.

In a stunning turn of events, USDA has deactivated it’s Animal Care Search Tool, as indicated on its website:

Animal Care Search Tool-DEACTIVATED
Animal Care Search Tool-DEACTIVATED.

USDA inspection reports of licensees pursuant to the Animal Welfare Act, among other data, were previously available on this search engine.

The following alert is provided when clicking on the link (now deactivated):

If the law requiring such disclosure is not specific about where the pet store must obtain the inspection reports, then the pet stores may have to obtain those documents from their sources.  Certainly, they will be unable to obtain the reports quickly through a FOIA request (unless that process has drastically changed).  Even if obtainable through FOIA, it seems likely that the breeder’s personal information, required by many laws, will be redacted by USDA.

It will be incredibly interesting and insightful to hear more about the legal basis USDA relied upon to protect this personal information under the Privacy Act and other laws, as mentioned in the alert.

It seems likely that USDA will be explaining this in court when this policy is undoubtedly challenged.  See some of their thinking at their Q&A on their website.

Without access to USDA inspection reports, animal activists, intent on closing pet stores and eliminating dog breeding, will be unable to misrepresent the meaning of non-compliant citations on those reports, as they have consistently done to convince legislators to ban sales of pets based on mere citations.  Such citations do not mean that licensees have violated the AWA.  As described in USDA’s alert, inspection reports and other legal proceedings that have not received final adjudication are no longer available.  Hopefully, this will help ensure that licensees are provided with due process of the law that the Constitution and justice requires before their businesses are effectively shuttered.

I had the opportunity to present an “Animal Law Update” on October 21, 2016 at the New Jersey Association for Biomedical Research’s 23rd Annual IACUC Conference – the region’s premier training conference for professionals in laboratory animal research field.  Among this year’s 110 participants were key institution decision makers, Animal Care and Use Committee members, lab animal veterinarians, animal welfare compliance specialists and other lab animal research team members from the pharmaceutical industry, contract research organizations, academic research institutions, and government officials from USDA and NIH.

 

During my presentation I discussed the legal issues affecting animal-related industries, including the biomedical research community and analyzed activist activities that can help the research community predict, prepare for, and defend against such challenges.   I was also re-elected to the Board of Directors of the New Jersey Association for Biomedical Research during the annual meeting, held at the beginning of this conference.

 

Dr. William Stokes, Assistant Director, Animal Welfare Operations, USDA, APHIS, Animal Care provided an informative USDA Regulatory Update and Insights.  Dr. Stokes shared USDA Animal Care’s “5-year Strategic Plan” including the mission and vision of the agency, also available on its website:

New to the agency is the introduction of the term “critical noncompliant items” (“NCI’s) which includes all “direct noncompliant items” and certain “indirect noncompliant items.”  Dr. Stokes explained that this term was not really new, and had been used in practical effect, by the agency for a long time.

Dr. Stokes also provided important data from USDA’s inspections authorized by the Animal Welfare Act including:

  • There were over 10,000 unannounced inspections in FY16 of research facilities, breeders, dealers, exhibitors, transporters and intermediate handlers;
  • There were about 1350 inspections of the 1050 registered research facilities;
  • 76% of these inspections had no NCI’s;
  • Of the 561 NCI’s in research facilities, 38% of those were related to activities and conduct of Institutional Animal Care and Use Committees, and specifically related to the semi-annual reports that are required by the AWA.

Dr. Stokes  informed the attendees about the updated public search engine that serves as the database for USDA licensees and related inspection reports, known as the Animal Care Information System (ACIS3).  USDA  sent a bulletin on  09/22/2016 to stakeholders titled “New Terms Will Appear on USDA Inspection Reports.” As Dr. Stokes explained, there are two new terms that will appear on reports and in search results:

  • Focused inspections
  • Critical noncompliant items.

Dr. Stokes ended his presentation reminding all attendees that the goal of USDA and its licensees is to “optimize welfare.”