In 2014 and 2015, 26 nuisance lawsuits representing over 500 North Carolina residents were brought against Murphy-Brown, a subsidiary of Smithfield Foods, in North Carolina federal court.  The lawsuits involve 89 hog farms or “CAFOs” (Concentrated Animal Feeding Operations) in Eastern North Carolina.  Although Murphy-Brown owns some of the farms itself, in most instances, Murphy-Brown contracts with independent farm owners.  Under these arrangements, the hog farmers own the farm but Murphy-Brown owns the hogs and sets the operational rules.  The cases were consolidated in 2015 for pre-trial litigation.  The Court created five “Discovery Pool Cases” in which detailed discovery was taken and ordered two test trials, to be followed by monthly trials for the remaining cases.  In 2018, the trials began and four cases reached jury verdicts, all in favor of plaintiffs.

The lawsuits alleged that the odor and flies from the effluent spray process at the hog farms caused a nuisance to the surrounding property owners, and that tractor trailers travelled through the area at night, creating noise and lights that prevented sleep.  None of the lawsuits involved operational processes that broke any state or federal laws.  Three of the test cases, all before the same federal court judge, resulted in substantial jury awards totaling almost $550 million.  North Carolina’s punitive damages cap limiting punitive damages to three times compensatory damages or $250,000, whichever is larger, reduced the jury awards to $97.88 million.  A fourth lawsuit was decided by jury in December 2018 before a different federal judge.  That jury awarded $100,000 total in compensatory damages to all eight plaintiffs, but the judge ruled that plaintiffs failed to produce sufficient evidence of punitive damages.

When the lawsuits were filed, North Carolina had a Right to Farm Act, N.C. Gen. Stat. § 106-701 (2013), limiting the right to bring nuisance suits against agricultural farms.  It read in relevant part:

“When agricultural and forestry operation, etc., not constituted nuisance by changed conditions in or about the locality outside of the operation.

(a)         No agricultural or forestry operation or any of its appurtenances shall be or become a nuisance, private or public, by any changed conditions in or about the locality outside of the operation after the operation has been in operation for                         more than one year, when such operation was not a nuisance at the time the operation began.

(a1)       The provisions of subsection (a) of this section shall not apply when the plaintiff demonstrates that the agricultural or forestry operation has undergone a fundamental change.  A fundamental change to the operation does not include                              any of the following:

(1)  A change in ownership or size.

(2)  An interruption of farming for a period of no more than three years.

(3)  Participation in a government-sponsored agricultural program.

(4)  Employment of new technology.

(5)  A change in the type of agricultural or forestry product produced.  (a2)

The provisions of subsection (a) of this section shall not apply whenever a nuisance results from the negligent or improper operation of any agricultural or forestry operation or its appurtenances.”   106-701 (2013). The Act defines “agricultural operation” as “any facility for the production for commercial purposes of crops, livestock, poultry, livestock products, or poultry product.” § 106-701(b).

Further, in 2017, the legislature added a section that limited compensatory damages to the reduction in the fair market value of the plaintiff’s property caused by the nuisance, not to exceed the fair market value, for permanent nuisances, and to the diminution of the fair rental value of plaintiff’s property for temporary nuisances.  N.C. Gen. Stat. § 106-702(a) (2017).  The statute expressly did not prohibit or limit punitive damages.  § 106-702(d) (2017).

At summary judgment, the Court found that the Right to Farm Act only applies to agricultural operations that become a nuisance due to changed conditions in the locality outside the agricultural operation.  In re NC Swine Farm Nuisance Litigation, 2017 WL 5178038 at *5 (E.D.N.C. Nov. 8, 2017).  Because the plaintiffs had used their properties as residences well before the operations began at the subject hog farms, the Right to Farm Act was inapplicable as a matter of law.  Id. at *6.

In response to the Court’s findings and the large jury awards, North Carolina’s legislature acted swiftly and decisively in amending the statute in June 2018.  The preamble to the amended statute states that “frivolous nuisance lawsuits threaten the very existence of farming in North Carolina” and “following the 1979 enactment, at least three succeeding General Assemblies in 1992, 2013, and 2017 tried to perfect a statutory framework that broadly fosters a cooperative relationship between farms and forestry operations and their neighbors across North Carolina.”  However, “recently a federal trial court incorrectly and narrowly interpreted the North Carolina Right to Farm Act in a way that contradicts the intent of the General Assembly and effectively renders the Act toothless in offering meaningful protection to long-established North Carolina farms and forestry operations.”  It further states that “regrettably, the General Assembly is again forced to make plain its intent that existing farms and forestry operations in North Carolina that are operating in good faith be shielded from nuisance lawsuits long after the operations become established.”  Governor Cooper vetoed the amended statute, and the Senate overrode his veto in a 37-9 vote.  The day after the override, the House voted 74-45 in favor of the bill.  The Right to Farm Act now reads, in pertinent part:

“Right to farm defense; nuisance actions.

(a)         No nuisance action may be filed against an agricultural or forestry operation unless all of the following apply:

(1) The plaintiff is a legal possessor of the real property affected by the conditions alleged to be a nuisance.

(2)  The real property affected by the conditions alleged to be a nuisance is located within one half-mile of the source of the activity or structure alleged to be a nuisance.

(3)  The action is filed within one year of the establishment of the agricultural or forestry operation or within one year of the operation undergoing a fundamental change.”  N.C. Gen. Stat. § 106-701 (2018).

The definition of fundamental change remains the same.  The language regarding changed conditions is eliminated.  It also deleted the language permitting punitive damages, and instead added an express provision prohibiting punitive damages in private nuisance suits except in very limited circumstances:

“A plaintiff may not recover punitive damages for a private nuisance action where the alleged nuisance emanated from an agricultural or forestry operation that has not been subject to a criminal conviction or a civil enforcement action taken by a State or federal environmental regulatory agency pursuant to a notice of violation for the conduct alleged to be the source of the nuisance within the three years prior to the first act on which the nuisance action is based.”  106-702(a1) (2018).

The amended statute is a significant victory for the agricultural industry in North Carolina.  The 2018 amendments substantially limit the availability of punitive damages, change the focus from the surrounding locality to the operation itself by eliminating the changed conditions language, thereby making it more difficult for pre-existing neighbors to bring suit, and removing the exception for nuisances caused by negligence or improper operation.  In combination with the 2017 amendments limiting compensatory damages to fair market value of the harmed property, there is little financial incentive to bring suit.  The likely result is that we will see fewer nuisance lawsuits against the agricultural industry in the future.

These cases are all pending on appeal, and this post may be updated accordingly.

 

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

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

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

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

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

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

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

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

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

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

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

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

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

The National Pork Producers Council reported

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

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

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

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

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

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

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

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

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

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

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

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

Specifically, as of the effective date:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

To date, 46 comments are posted.

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

On October 30, 2018 FDA announced “the Plant and Animal Biotechnology Innovation Action Plan to outline the key priorities the agency will pursue to support innovation in plant and animal biotechnology while advancing the agency’s public health mission.”

The overall goal of the action plan is to ensure the safety of plant and animal products of biotechnology while avoiding unnecessary barriers to future innovation.

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

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

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

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

The project end date is April 14, 2019.

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

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

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

More to come about all these programs.

The Food Animal Residue Avoidance Databank (FARAD) recently provided guidance to small ruminant producers and their veterinarians in an article titled “Extralabel drug use (ELDU) in small ruminants” in JAVMA, Vol 253, No. 8, Oct. 15, 2018, pp 1001-1009.

FARAD is a university-based national program that serves as the primary source for scientifically-based recommendations regarding safe withdrawal intervals of drugs and chemicals in food-producing animals. As such, FARAD is a key resource for protection of our nation’s food supply, including meat, milk and eggs, against accidental contamination of animal-derived foods with violative residues of drugs, pesticides or other agents that could compromise food safety.”

FARAD regularly provides guidance to the food animal producing industry and veterinarians regarding “the use of therapeutic drugs, pesticides and other agents that improve overall animal health and promote safe, efficient and humane production practices.”

The purpose of its latest digest, as stated, “was to provide US veterinarians guidance regarding ELDU in small ruminants. The lack of FDA-approved drugs for sheep and goats frequently necessitates ELDU in those species. When the FDA approves a drug for use in a particular species, it establishes a tolerance or that drug in the various tissues or products (eg, milk or eggs) of that species that might be consumed by people. When a drug not labeled for use in a small ruminant is administered in an extralabel manner, there is a zero tolerance for residues of the parent drug or its metabolites in the edible tissues or products of treated animals, and detection of the parent drug or metabolites in any product marketed for human consumption is considered a violation and subject to regulatory action. Given the lack of tolerance and pharmacokinetic and tissue depletion data for many drugs administered in an extralabel manner to small ruminants, extended meat and milk WDIs are generally required to ensure that drug residues are undetectable. Veterinarians need to be cognizant of the requirements for legal ELDU in food-animal species to safeguard the human food supply while continuing to promote the health and welfare of small ruminants.”

As a former owner of a veterinary large animal practice in which 50% of my patients were small ruminants (goats, sheep, alpaca and llama), it was imperative to be able to prescribe or administer drugs in an extralabel manner to provide humane care and prevent animal suffering.

Extralabel use means actual use or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes, but is not limited to, use in species not listed in the labeling, use for indications (disease or other conditions) not listed in the labeling, use at dosage levels, frequencies, or routes of administration other than those stated in the labeling, and deviation from the labeled withdrawal time based on these different uses.  21 CFR 530.3.

Some of these uses have included medications added to commercial feeds, that are now governed under the Veterinary Feed Directive that FDA enforces for use in major, but not minor species.

According to guidance from FDA, “many commercial medical feeds that require a VFD are not approved for use in minor species,” defined by FDA as all species other than cattle, horses, swine, chickens, turkeys, dogs, and cats.  Compliance Policy Guide Sec. 615.115 Extralabel Use of Medicated Feeds for Minor Species.  A veterinarian may consider ELDU of medicated feed in minor species if:

There are no approved treatment options available;

The health of the animals is threatened; and

Failure to treat the animals would result in suffering or death.

The veterinarian must provide a written recommendation that includes the medical rationale for ELDU of medicated feed.

Before a veterinarian can provide such professional guidance, a valid veterinarian-client-patient relationship (VCPR) must exist.  While state laws govern the practice of veterinary medicine, including such relationships, FDA has inserted itself in the equation by identifying which states do not require the elements of a VCPR that FDA considers sufficient for the purposes of enforcing its Veterinary Feed Directive and other federal laws.

These multilayered state and federal laws can be difficult for veterinarians and small ruminant producers to decipher—hence the necessity of FARAD and other agencies to provide more specific guidance.

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.

Typically, animal diseases have a seasonal presence.  For example, avian influenza, like other influenza viruses prefer cold damp conditions.  On the other hand, viruses transmitted by mosquitoes (arboviruses), including Equine Encephalitis virus and West Nile virus , are diagnosed when the mosquito population has peaked, often in in mid-late summer and early fall.

In addition to the seasonal prevalence of arboviruses in the United States, USDA APHIS has been tracking and reporting on an outbreak of Virulent Newcastle Disease (vND) in California, first identified in May 18, 2018.

USDA has confirmed 156 cases of vND in California, 102 in San Bernardino County, 22 in Riverside County, 31 in Los Angeles County and 1 in Ventura County.

To date the virus has been confirmed predominately in backyard exhibition chickens.  Backyard mixed species birds, backyard hobby turkeys and one live bird market have also been infected.  Virus has not been identified in commercial flocks to date, and state and federal animal health officials are emphasizing the importance of implementing enhances biosecurity practices to prevent additional transmission to other premises.  The last confirmed case was reported on October 4, 2018.

Across the globe, African Swine Fever, a highly contagious hemorrhagic disease of wild and domestic suids, has been spreading in Asia and across Europe.

As reported by USDA, China first reported the outbreak on August 3, 2018, “on a domestic swine farm in Shenyang, Liaoning Province with an onset date of August 1.”  This disease, like other highly pathogenic diseases of livestock and poultry are reportable to the World Animal Health Organization (“OIE”).

In addition to China, since the beginning of 2018, ASF has been reported in the following countries: Hungary, Romania, Moldova, Poland, Czech Repulic, Belgium, Russia, Latvia, Poland, Ukraine and Chad, as reported by OIE.

USDA reported that it met with the swine industry on September 5, 2018 “to discuss protections USDA has in place to prevent the introduction of African Swine Fever (ASF) to the United States as well as activities to enhance those protections.”

USDA provided a summary of recommended enhancement activities-“USDA industry prevention points.

To prevent the introduction of this virus to the United States, USDA has: scheduled biweekly calls for updates and discussion; will review state authorized waste feeding of swine to determine whether inspection of licensed facilities should be enhanced; reviewed the importation of potentially infected meat, casing, and feed; asked Custom and Border Protection to “target its inspections of passengers and cargo coming from ASF positive regions.”

According to a report by Rabobank, African Swine Fever Shifts Global Protein Picture,

These disruptions could open export opportunities for U.S., Canadian and Brazilian pork producers, including initial panic buying. However, Rabobank explained, the potential spread of the disease throughout Asia and/or Europe also poses a great risk to North American and South American producers.

The Division of Animal Health has proposed amendments to the regulation governing laboratory services provided by the State Animal Health Diagnostic Laboratory, available on its website as published in the New Jersey Register on September 4, 2018 (50 N.J.R. 1919).

The amendments would increase fees charged for animal disease diagnostic and testing services offered in the state of the art laboratory which replaced the long outdated facility previously located on the second floor in downtown Trenton.  The prior location made it impossible to perform certain diagnostic testing, such as necropsies on large animals.

The regulation would add 30 new tests and provide for molecular testing and referring services to other laboratories when required.  Some of the new tests pertain to bacterial isolation and identification and animals that are not domestic livestock.

Others would “facilitate the most economic and accurate diagnosis of clinical conditions by grouping tests. If done individually, the total cost to perform these tests would be more. Amendments are proposed in equine neurologic tests due to changes in the disease (West Nile, which is now endemic), increased knowledge of epidemiology (Western equine encephalitis), and unavailability of certain reagents for HI and IgG tests.”

The Division has proposed amendments to N.J.A.C. 2:10-2 to codify “the longstanding policy of not returning animal remains of any kinds due to the risks of disease transmission to the general community.”  New section 2:10-2.2 “would allow for submitters or animal owners to direct remains be disposed of to a licensed crematorium upon written request prior to the start of a necropsy.”

One of the most important amendments involves the protection of test results and related information (e.g., animal owner, animal identification, animal location) which reasonably protects the privacy of animal owners.  This longstanding policy should be codified.  The Division has identified a number of reasons to support this amendment, including: (1) laboratory reports are generally applicable only to the submitter; (2) reports include details of a private nature; (3) laboratory services are provided to livestock and other animal owners, veterinarians, and other submitters who pay for those services, which should remain private: (4) veterinary clients expect their information to remain private; (5) veterinarians are required to maintain the confidentiality of veterinary records  with few exceptions; (6) animal owners and veterinarians could circumvent disclosure of private information by using private or out of state laboratories which would decrease the State’s ability to identify and control disease; and (7) if tests are performed in other laboratories, interstate or international animal movement restrictions could be imposed without review by State animal health officials that might not be necessary or reasonable.

Comments to the proposed amendments are accepted until November 3, 2018.

Fees collected by the Division are not swept into the State coffers, but are instead “held separate and apart from all other funds of the State in a non-lapsing fund for annual appropriation to assure the provision of continuous support for the needed laboratory services.”

The New Jersey Department of Agriculture (NJDA), through its Division of Animal Health (DAH), operates the New Jersey Animal Health Diagnostic Laboratory (AHDL).

The AHDL provides diagnostic testing services to support disease control programs, health management, and productivity of livestock, equine, poultry, fish, and wildlife. The AHDL serves New Jersey’s companion animal owners by providing fast, accurate, convenient, and cost effective services to diagnose diseases in dogs, cats, exotics, and other pets. The AHDL serves as an expert veterinary diagnostic resource to state agencies, federal agencies, veterinarians, clinics, animal organizations, and universities.

Dr. Amar Patil, DVM, MS, PhD, DACVM is the Laboratory Director and the Assistant Director Division of Animal Health.

Dr. Manoel Tamassia, DVM, MS, PhD Dipl. Is the current Division Director and State Veterinarian, a position I previously held for nearly a decade.

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