U.S. Department of Agriculture (USDA)

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.”

 

 

Since its passage in the Senate, there has not been much action with the Assembly version of S63.

However, as recently reported by Andrew George on njbiz.com

“Lesniak says he’s planning to amend the bill” to address concerns of pet store owners and their sources, including “eliminating the grandfathering portion of the measure and lifting the restriction on new pet stores to only source from kennels, shelters or animal rescues.”

However, there is no new version of the bill with these amendments to review.

Even with these amendments, the bill and the existing law, impermissibly bans sales to pet stores from licensed breeders who have not been finally determined to have violated the Animal Welfare Act (AWA).

The Pet Protection Act bans sales to pet stores from licensed pet dealer who:

  • has been cited on a USDA inspection report for a direct violation of the federal AWA or corresponding regulations during the two-year period prior to purchase;
  • has been cited on a USDA inspection report during the two-year period prior to the purchase by the pet store for three or more indirect violations of the Awa or corresponding regulations.
  • is cited on the two most recent USDA inspection reports prior to the purchase of the animal by the pet shop for no-access violations.

As recently discussed in Pet Stores Under Attack, only an USDA Administrative Law Judge can make a determination that a licensee has violated the AWA. A noncompliant item on an inspection report does not constitute a violation of the act.

Individual pet stores and customers can (and should) review USDA reports and determine, on a case-by-case basis, whether to purchase from particular breeders.

S63, the year-old amendments to the PPPA and similar ordinances will not (and have not) affected any actual puppy mills, because, as defined by USDA’s OIG, these facilities are large commercial unlicensed breeders. Banning sales from hobby breeders, exempt from USDA licensure because these breeders provide humane care to their dogs, will not affect puppy mills.

The interstate pet market has been targeted for decades by NGO’s intent on eliminating purposely-bred pets and replacing them with randomly-sourced and irresponsibly-bred pets sold through rescue and shelter channels. According to the Humane Society of the United States (HSUS) more than “140 jurisdictions nationwide” have recently passed pet store sourcing limitations or bans, with 35 local bans passed in the first five months of 2016 alone.  The patchwork of ordinances affecting retail pet stores and their sources are decimating the interstate pet market and create an impermissible obstacle to the mechanisms USDA has adopted to enforce the Animal Welfare Act (AWA).  These ordinances, therefore, violate the Supremacy Clause and are preempted by the AWA.

 

There are two ways a local jurisdiction can adopt laws governing the pet market without running afoul of the Supremacy Clause.

  1. Local jurisdictions may require pet dealers, including Class B licensees and USDA exempt breeders to be licensed and comply with standards in addition to those prescribed in 7 U.S.C. § 2143(a)(8)(1); or
  2. Local jurisdiction may protect their citizens against dangerous animals, infectious diseases, or other hazards to public health.

The pet store sourcing bans do neither. The sourcing bans do not require additional humane standards of care by market participants—they simply ban sales from certain (licensed) sources in favor of unlicensed, randomly sourced pets, without regard to any requirements relating to animal care or welfare. The sourcing bans are also unrelated to public health or safety concerns that would be defensible under police powers.  Banning sales of puppies from licensed or exempt sources and limiting or favoring sales from rescue channels does not protect local consumers from health or safety risks—in fact, it increases the risk of importation of infectious diseases and parasites.

 

These sourcing bans are a significant hindrance to the mechanism Congress established in the AWA to ensure that animals in interstate commerce are treated humanely. The interstate pet market includes breeders, wholesalers, and retailers.  Some of these entities, like retail pet stores that sell face-to-face or breeders with four or fewer breeding females are exempt from licensure under the AWA, but they are nevertheless part of the interstate market.  The public lacks an understanding of the depth and breathe of the interstate pet market, and the comprehensive licensing scheme USDA has deployed to enforce the AWA.

 

A state law is preempted if it “‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Int’l Paper Co. v. Ouellette, 479 U.S. 481, 492 (1987).  The Supreme Court’s obstacle preemption analysis in Geir is instructive here. The Court found that a state law that would have required manufacturers of all Honda Accord and similar cars to specifically install airbags which the Court held “would have stood ‘as an obstacle to the accomplishment and execution of’ the important means-related federal objectives” set forth in the National Traffic and Motor Vehicle Safety Act, and was therefore preempted. Geir v. Am. Honda Motor Co., Inc., 529 U.S. 861, 881 (2000).

 

Here, Congress and USDA, through the AWA, identifies specific classes of licenses and requires pet dealers to qualify for and maintain humane standards of care to be federally licensed, unless they have specifically exempted certain breeders from licensure because they already provide such care. By banning sales from these entities without regard to the care they provide their animals, the sourcing bans interfere with this specific method Congress has established.

 

Despite the fact that the sourcing bans do not require more rigorous standards of care than required in the AWA and by the USDA, NGO’s have succeeded in convincing legislators and the public that these sourcing bans are needed because the standards of care enforced by USDA do not provide “humane” standards of care, and even if they did, that USDA has “allegedly” proven it is unable to enforce those standards. While local jurisdictions may require standards of care that exceed those mandated by the AWA (which they have not done), they cannot redefine what qualifies as “humane standards of care.”  Congress has not amended the AWA to strip USDA of its authority or declare the standards deficient even though it has had ample opportunity to do so.

 

Further, the national patchwork of sourcing bans conflict with each other and the AWA and is precisely the situation the Supremacy Clause was established to avoid. See, e.g., Darling v. Mobil Oil Corp., 864 F.2d 981, 984 (2d Cir. 1989) (establishing a “single, uniform set of rules to regulate the grounds for termination and nonrenewal and eliminate the uneven patchwork of rules governing franchise relationships which differ from State to State.”) (internal quotation omitted); Paneccasio v. Unisource Worldwide, Inc., 532 F.3d 101, 113 (2d Cir. 2008) (rejecting “a patchwork scheme of regulation [that] would introduce considerable inefficiencies”) (internal quotation omitted).  If such laws are not enjoined they will cumulatively render the federal law superfluous to the local sales bans or, at best, be subject to a labyrinthine patchwork of local regulation.

 

For example, pet stores in many localities, like Albuquerque, N.M., are not permitted to sell dogs or cats. Albuquerque, N.M. City Ordinance§ 9-2-3-12.  In Sunrise, Florida pet stores can only purchase from shelters, rescues, or “hobby breeders” who are limited to producing one litter per year per breeding dog (male or female). Maryeli’s Lovely Pets, Inc. v. City of Sunrise, 2015 U.S. Dist. LEXIS 98451, at *2-*3 (S.D.Fl. June 24, 2015).  In Cook County, Illinois “a ‘pet shop operator’ may only sell animals obtained from a breeder that (among other requirements) holds a USDA class ‘A’ license and ‘owns or possesses no more than 5 female dogs, cats or rabbits capable of reproduction in any 12-month period.” Mo. Pet Breeders Ass’n v. Cnty of Cook, No. 14-06930, 2015 WL 2448332, at *1 (N.D.Ill. May 21, 2015), appeal docketed, No. 15-2895 (7th Cir. Sept. 3, 2015).  In New York City, pet stores can only purchase from Class A breeders—pet stores are expressly prohibited from purchasing from Class B dealers.

 

To support these allegations, the NGO’s: (1) raise the specter that pet stores’ sources are puppy mills based only on noncompliant citations on USDA’s inspection reports which they misrepresent as violations of the AWA; and (2) claim USDA fails to properly enforce the AWA as determined by USDA’s Office of the Inspector General’s 2010 report, “Inspections of Problematic Breeders.” NGO’s also mischaracterize brokers and distributors as “evil middlemen,” despite the fact that federal law permits intermediaries to participate in the interstate commerce of pets, by establishing a separate classification for these market participants (Class B license).  All these conclusions are based on NGO “investigations” even though no one other than USDA is authorized to inspect USDA licensees or reclassify Class B licensees or USDA exempt breeders as pet dealers who provide inhumane care.

 

States and local governments may create and enforce their own laws and regulations to protect animals, which may exceed the AWA standards, but they cannot adopt laws with the intent and effect to exclude legitimate, licensed or exempt pet dealers from selling healthy, domestic (not wild or inherently dangerous) pets to pet stores, as the AWA has contemplated and permitted. Laws can be adopted to prohibit the sales of all pets or particular types of pets (like ferrets) if they are considered dangerous or even too expensive for local governments to regulate, but this is not what the sourcing bans have done.

 

The effect of these sourcing bans since their initial adoption in 2006 has resulted in a quantitative effect on the entire pet industry, resulting in 3,488 fewer Class A licensees and 1478 fewer Class B licensees nationwide—a 75% and 85% drop respectively. Imagine the impact to biomedical research if similar ordinances were passed that banned continued research based on noncompliant items on USDA inspection reports and NGO’s contention that animal use in research is inhumane?  For example, New Jersey’s pet sourcing bans prohibit sales to pet stores from a licensee who has been cited on a USDA inspection report for: (1) a direct violation of the AWA during the prior 2 years; (2) 3 or more indirect violations of the AWA during the prior 2 years; or (3) a no-access violation of the AWA on the 2 most recent inspection reports.  Despite the fact that the licensees have not been “finally determined” to have violated the AWA, pet stores may not purchase from these licensees.  If similar restrictions were applied to biomedical research facilities, most research involving animal testing would cease.

The Animal Welfare Act was amended by the 2014 Farm Bill to provide “the Secretary of Agriculture with the authority to determine that animal dealers and exhibitors are not required to obtain a license under the Act  . . . if the size of the business conducting AWA-related activities is determined to be de minimis by the Secretary.”

USDA has proposed regulations that define de minimis and “has determined that de minimis businesses  . . .  are capable of providing adequate care and treatment of the animals involved in regulated business activities.”

USDA proposes that :

“[d]ealers and exhibitors operating at or below the thresholds determined for their particular AWA-related business activity would be exempted from Federal licensing requirements established under the Act and regulations. Our proposed actions would amend the regulations to be consistent with the Act while continuing to ensure the humane care and treatment of animals covered under the AWA.”

USDA performed a “Regulatory Impact & Analysis Initial Regulatory Flexibility Analysis” regarding its proposed regulations, finding that:

“this proposed rule would relieve regulatory responsibilities for some currently licensed entities and reduce the cost of business for those entities [and] [t]hose currently licensed exhibitors and dealers . . . would no longer be subject to licensing, animal identification, and recordkeeping requirements.”

USDA’s summarized the economic impact of its rule:

“The cost of a license for the smallest entities is between $40 and $85 annually. Identification tags for dogs and cats cost from $1.12 to $2.50 each. Other covered animals can be identified by a label attached to the primary enclosure containing a description of the animals in the enclosure at negligible cost.  We estimate that the average currently licensed entity potentially affected by this proposal spends about 10 hours annually to comply with the licensing paperwork and recordkeeping requirements.  All of the currently licensed entities that would be considered de minimis under this proposal would benefit from reduced costs for licensing, identification and recordkeeping. “

“We estimate that there may be as many as 212 currently licensed exhibitors who would no longer need to be licensed under the proposed rule. There are 133 currently licensed exhibitors with 4 or fewer animals that would therefore be considered de minimis under this proposal.  There are also 79 currently licensed exhibitors with 5 to 8 animals.  At least some of the licensees in this latter group exhibit any or all of their animals for no more than 30 days per calendar year, and would therefore be considered de minimis as seasonal exhibitors under this proposal.  We estimate that the cost savings for all these entities could total about $41,400 annually.”

Comments to USDA’s regulation will be accepted until November 2, 2016.

Animal agriculture, like other animal-related industries, is a constantly evolving enterprise, informed by results from scientific studies focused on the best methods to raise livestock so as to minimize animal discomfort and disease.

With increasing concerns about the impacts on antibiotic resistance resulting from the use of antibiotics in livestock, methods to keep livestock healthy without relying on antibiotics has become the focus of scientific research.

Hence, the ability to modify animal genes to protect them from disease infection has been an area of increased interested.

Genus, a world-leading animal genetics company, recently announced “the discovery of the first pig resistant to Porcine Respiratory and Reproductive Syndrome virus (‘PRRSv’)[1] in collaboration with the University of Missouri. An exclusive global license has been signed enabling Genus to develop and commercialise the technology.”

As reported on USDA’s website[2]

PRRSV is the etiologic agent of PRRS, an economically devastating, pandemic disease of swine that is typically characterized by reproductive failure in breeding herds and respiratory problems and growth retardation in growing pigs.  Two PRRS outbreaks were first reported in the late 1980s in North America and central Europe.  The disease is now found in most pig-producing countries and affects the swine industry and food safety worldwide, causing enormous economic losses each year.  In the US, the annual loss due to PRRS is estimated to exceed $500 million.  Over the last decade, this genetic/antigenic diversity of PRRSV has expanded continuously and rapidly, highlighting the dynamic nature of PRRSV evolution and epidemiology.

Using gene editing technology, Genus and its subsidiary the Pig Improvement Company (PIC) reportedly made “small changes . . . to inactivate a single gene from the pigs that produces a protein, known as CD163, [which] the PRRS virus requires for infection to occur.”

The results allow the production of PRRSv resistant pigs.

As described on Genus’ website:

“Using precise gene editing, the University of Missouri was able to breed pigs that do not produce a specific protein necessary for the virus to spread in the animals.  The early stage studies conducted by the University demonstrate these PRRSv resistant pigs, when exposed to the virus, do not get sick and continue to gain weight normally.  Genus will continue to develop this technology, and we expect it will be at least five years until PRRS resistant animals are available to farmers.”

Since there is no cure for PRRSV and the disease results in “the suffering or death of millions of pigs and piglets each year,” this type of innovative advance in science is considered a breakthrough.

[1] While antibiotics are not effective in treating viruses like PRRSV, such infections are often accompanied by secondary bacterial infections which are susceptible to targeted antibiotic treatment.

[2] This information is from Utah State University’s submission to USDA’s Current Research Information System (CRIS).