Over the last week I spoke to two families of very young children stricken by E. coli O111 after they both attended a small town Maine fair and petting zoo. One child was just released from the hospital after suffering from acute kidney failure and the other child was buried a week before from complications to exposure to the same toxic E. coli.

After every one of this tragedies, comes the praise of the value of the petting zoo and the small town fair – that somehow if we keep saying it, that the pain suffered by these families is somehow equal to the arguable benefits to the pubic of exposure to petting animals. True, we all yearn for the late summer days at the fair – the cotton candy, the blue ribbon animals and all the variety of deep fried foods – but, if the last decade is any indicator, the aspirational desire has come face to face with a pathogenic reality.

Much like when the President drags himself out before the press after another mass shooting, I too felt the inevitable feeling that we have seen this all before and will more likely see it again. And, a quick glance over that last dozen years shows just that:

Screen Shot 2015-10-16 at 6.24.42 PMFollowing the 2001 outbreaks, the CDC in Atlanta published, “Reducing the Risk for Transmission of Enteric Pathogens at Petting Zoos, Open Farms, Animal Exhibits, and Other Venues Where the Public Has Contact With Farm Animals” – 2001 CDC Recommendations:

  • Information should be provided. Persons providing public access to farm animals should inform visitors about the risk for transmission of enteric pathogens from farm animals to humans, and strategies for prevention of such transmission. This should include public information and training of facility staff. Visitors should be made aware that certain farm animals pose greater risk for transmitting enteric infections to humans than others. Such animals include calves and other young ruminant animals, young poultry, and ill animals. When possible, information should be provided before the visit.
  • Venues should be designed to minimize risk. Farm animal contact is not appropriate at food service establishments and infant care settings, and special care should be taken with school-aged children. At venues where farm animal contact is desired, layout should provide a separate area where humans and animals interact and an area where animals are not allowed. Food and beverages should be prepared, served, and consumed only in animal-free areas. Animal petting should occur only in the interaction area to facilitate close supervision and coaching of visitors. Clear separation methods such as double barriers should be present to prevent contact with animals and their environment other than in the interaction area.
  • Hand washing facilities should be adequate. Hand washing stations should be available to both the animal-free area and the interaction area. Running water, soap, and disposable towels should be available so that visitors can wash their hands immediately after contact with the animals. Hand washing facilities should be accessible, sufficient for the maximum anticipated attendance, and configured for use by children and adults. Children aged <5 years should wash their hands with adult supervision. Staff training and posted signs should emphasize the need to wash hands after touching animals or their environment, before eating, and on leaving the interaction area. Communal basins do not constitute adequate hand washing facilities. Where running water is not available, hand sanitizers may be better than using nothing. However, CDC makes no recommendations about the use of hand sanitizers because of a lack of independently verified studies of efficacy in this setting.
  • Hand-mouth activities (e.g., eating and drinking, smoking, and carrying toys and pacifiers) should not be permitted in interaction areas.
  • Persons at high risk for serious infections should observe heightened precaution. Everyone should handle farm animals as if the animals are colonized with human enteric pathogens. However, children aged <5 years, the elderly, pregnant women, and immunocompromised persons (e.g., those with HIV/AIDS) are at higher risk for serious infections. Such persons should weigh the risks for contact with farm animals. If allowed to have contact, children aged <5 years should be supervised closely by adults, with precautions strictly enforced.

However, not surprisingly, few fairs and petting zoos took the recommendations to heart and the outbreaks and illnesses continued.

Pennsylvania was somewhat of an exception. Following the same outbreak that moved the CDC to action the Pennsylvania enacted 3 Pa.C.S. § 2502 creating sanitation standards to minimize the risk of contracting a zoonotic disease at an animal exhibition:

(1) An operator shall promote public awareness of the risk of contracting a zoonotic disease at the animal exhibition and of the measures necessary to minimize the risk of contraction by posting appropriate notices at the animal exhibition.

(2) An adequate hand-cleansing facility for adults and children shall be conveniently located on the animal exhibition grounds. The operator shall post appropriate notices which designate the location of the hand-cleansing facility required by this paragraph and encourage the cleansing of hands after touching animals, using the restroom and before eating.

(3) A person may not bring an animal to an animal exhibition unless the person provides the operator with one of the following: (i) Except as provided under subparagraph (ii), a valid Pennsylvania health certificate or interstate certificate of veterinary inspection. (ii) A signed statement by the person attesting that a veterinary consultation relationship exists with regard to each animal to be exhibited, if a Pennsylvania health certificate or interstate certificate of veterinary is not specifically required under Chapter 23 (relating to domestic animals) and regulations promulgated under Chapter 23.

After yet another outbreak – this one in North Carolina, the North Carolina General Assembly passed G.S. 106-520.3A, also known as Aedin’s Law: G.S. § 106-520.3A. Animal exhibition regulation; permit required; civil penalties.

(a) Title. – This section may be referred to as “Aedin’s Law”. This section provides for the regulation of animal exhibitions as they may affect the public health and safety.

(b) Definitions. – As used in this section, unless the context clearly requires otherwise:

(1) “Animal” means only those animals that may transmit infectious diseases.

(2) “Animal exhibition” means any sanctioned agricultural fair where animals are displayed on the exhibition grounds for physical contact with humans.

(c) Permit Required. – No animal exhibition may be operated for use by the general public unless the owner or operator has obtained an operation permit issued by the Commissioner. The Commissioner may issue an operation permit only after physical inspection of the animal exhibition and a determination that the animal exhibition meets the requirements of this section and rules adopted pursuant to this section. The Commissioner may deny, suspend, or revoke a permit on the basis that the exhibition does not comply with this section or rules adopted pursuant to this section.

(d) Rules. – For the protection of the public health and safety, the Commissioner of Agriculture, with the advice and approval of the State Board of Agriculture, and in consultation with the Division of Public Health of the Department of Health and Human Services, shall adopt rules concerning the operation of and issuance of permits for animal exhibitions. The rules shall include requirements for:

(1) Education and signage to inform the public of health and safety issues.

(2) Animal areas.

(3) Animal care and management.

(4) Transition and nonanimal areas.

(5) Hand-washing facilities.

(6) Other requirements necessary for the protection of the public health and safety.

(e) Educational Outreach. – The Department shall continue its consultative and educational efforts to inform agricultural fair operators, exhibitors, agritourism business operators, and the general public about the health risks associated with diseases transmitted by physical contact with animals.

(f) Civil Penalty. – In addition to the denial, suspension, or revocation of an operation permit, the Commissioner may assess a civil penalty of not more than five thousand dollars ($5,000) against any person who violates a provision of this section or a rule adopted pursuant to this section. In determining the amount of the penalty, the Commissioner shall consider the degree and extent of harm caused by the violation.

A variety of regulations followed including:

SUBCHAPTER 52K – ANIMAL EXHIBITIONS SECTION .0300 – SIGNAGE

An animal contact exhibit shall provide visible signage at the entrance and exit of the exhibit to educate the public regarding:

(1) the fact that animal contact may pose a health risk;

(2) items that are prohibited in animal areas;

(3) the identity of high risk populations, including:

(a) the elderly;

(b) children under the age of six;

(c) women who are pregnant;

(d) people with an existing health condition; and

(4) the location of hand-washing stations.

SECTION .0400 – OPERATIONS AND STAFFING

(a) Animals and bedding shall be separated from the public with fencing to minimize the public’s contact with manure and bedding. This does not apply to:

(1) animal rides (including pony, camel, and elephant rides);

(2) milking booths; or

(3) the petting of an animal held or restrained outside of its housing area by an exhibit operator or patron as part of an educational or photographic opportunity where there is limited possibility of contact with manure and bedding.

(b) Fencing shall be at least 29 inches high. On the side(s) of the exhibit intended for public contact, the fencing shall have a solid board or panel at the bottom at least eight inches high to contain manure and bedding.

(c) Fencing may allow children to reach through or over to pet and feed animals.

NCAC 52K .0402 PROHIBITED ITEMS

In order to minimize hand to mouth contact, no pacifiers, baby bottles, drink cups, food, drink or smoking shall be allowed in animal contact exhibits.

NCAC 52K .0403 AGE REQUIREMENTS

Unsupervised children less than six years old shall not be permitted in animal contact areas.

NCAC 52K .0404 FEEDING OF ANIMALS

Only food provided by the animal contact exhibit may be fed to the animals. Animal food shall not be provided in containers that are human food items, such as ice cream cones.

NCAC 52K .0405 STAFFING; COMPLIANCE

An animal contact exhibit shall be staffed at all times of operation by at least one person who has the authority to ensure that the exhibit complies with this Subchapter. The owner, operator or person in charge of an animal contact exhibit shall be responsible for compliance with this Subchapter, and shall not knowingly permit violations by its employees, agents or patrons.

NCAC 52K .0406 SURFACES; EXHIBIT AREAS

(a) Surfaces in the animal contact exhibit that can be touched by both fair patrons and animals shall be made of impervious material, and shall be cleaned and disinfected daily and at any time visible contamination is present.

(b) All animal fencing, feed troughs, and open watering systems shall be disinfected prior to and at the end of each fair.

(c) Contact animal exhibits shall be held on impervious surfaces whenever feasible.

(d) Impervious exhibit areas shall be cleaned and disinfected at the end of the fair.

(e) Exhibit areas that are not impervious shall be cleaned of all manure at the end of the fair and shall not be used for human activities for at least six months after cleaning.

NCAC 52K .0407 WASTE DISPOSAL

The fair shall designate a manure disposal area and shall control wastewater runoff. The animal contact exhibit shall have a designated area for temporary storage of animal waste and shall not transport such waste through areas occupied by fair patrons. Manure disposal and storage areas shall be inaccessible to the public, unless waste is bagged and placed in a closeable dumpster.

NCAC 52K .0501 HAND-WASHING STATIONS

(a) Hand-washing stations with soap, running water, paper towels and disposal containers shall be located within 10 feet of the exit of an animal contact exhibit, wherever feasible.

(b) Hand-washing stations suitable for small children shall be available in the same area as the stations in Paragraph (a) of this Rule.

(c) Signage shall be provided to direct patrons to hand-washing stations.

(d) In order to promote hand-washing with soap and water, dispensers for waterless hand sanitizing lotions, gels or hand wipes shall not be provided in the transition or exhibit area. Such dispensers may be placed at the entrance of milking booths to reduce the potential for introduction of disease to the exhibit animals.

NCAC 52K .0502 FOOD AND DRINK

Food and beverages for human consumption shall not be sold, prepared, served, or consumed in transition areas.

SECTION .0600 – ANIMAL KEEPING, CERTIFICATIONS AND EXHIBITION – NCAC 52K .0601 HEALTH CERTIFICATE; VACCINATIONS

(a) An official health certificate as defined in 02 NCAC 52B .0202, a rabies vaccination certificate (when applicable), and any other documentation required by 02 NCAC 52B for species or state of origin, shall accompany all animals contained in a public contact setting.

(b) An animal for which there is an approved rabies vaccine, but which is too young to receive rabies vaccination, is prohibited from animal contact exhibits unless proof of rabies vaccination, within the preceding 12 months, of the mother is provided.

(c) Initial rabies vaccination shall be administered at least 30 days prior to the event. Subsequent vaccinations for livestock shall be no more than one year prior to the event and may be within 30 days of the event if proof of previous vaccination is provided. Dogs and cats shall be in compliance with the North Carolina rabies law, G.S. 130A, Article 6, Part 6.

(d) If no licensed rabies vaccine exists for a particular species (such as rabbits, goats, llamas, and camels), no vaccination is required.

NCAC 52K .0602 DAILY MONITORING

Animals shall be monitored daily by exhibit personnel for signs of illness. Animals that exhibit signs of illness shall be removed from public contact immediately.

NCAC 52K .0603 HIGH RISK ANIMALS

Animals that pose a high disease risk to humans, as determined by the State Veterinarian or his representative, shall not be allowed in animal contact exhibits.

NCAC 52K .0604 BIRTHING ANIMALS

No near-birth or birthing sheep, cattle or goats and no sheep, cattle or goats that have given birth within the previous two weeks shall be allowed in animal contact exhibits.

Although these were comprehensive regulations, Aedin’s Law, did not prevent another outbreak in 2012. Now the North Carolina State Fair will likely proceed without a petting zoo at all. In part because, the petting zoo venue is almost uninsurable do to the risk of yet another outbreak.

Washington took up the cause next in passing WAC 246-100-192. Animals in public settings — Measures to prevent human disease.

(1) The purpose of this rule is to protect the public from diseases transmitted to humans from animals in public settings.

(2) The definitions in this subsection apply throughout this section unless the context clearly requires otherwise:

(a) “Animal exhibitor” means a person with a valid class C certification as an exhibitor under the Animal Welfare Act, 7 U.S.C. 2131-2159.

(b) “Animal venue operator” means a person furnishing a setting where public contact with animals is encouraged such as a petting zoo, county fair, or horse or pony rides.

(c) “Immunocompromised” means having the immune system impaired or weakened as by drugs or illness.

(d) “Person” means any individual, corporation, company, association, society, firm, partnership, joint stock company, or governmental agency; or the authorized agents of these entities.

(3) Animal venue operators shall:

(a) Provide an accessible hand-washing station or alternative hand sanitizing method approved by the local health officer;

(b) Post a prominent sign in a simple and easy to understand format for visitors to see before they enter the animal exhibit area which warns that:

(i) Animals can carry germs that can make people sick, even animals that appear healthy;

(ii) Eating, drinking, or putting things in a person’s mouth in animal areas could cause illness;

(iii) Older adults, pregnant women, immunocompromised people, and young children are more likely to become ill from contact with animals;

(iv) Young children and individuals with intellectual disabilities should be supervised in animal exhibit areas; and

(v) Strollers, baby bottles, pacifiers, and children’s toys are not recommended in animal exhibit areas.

(c) Post a prominent sign at each exit of the animal exhibit area reminding visitors to wash their hands.

(4) To meet the requirements of subsections (3)(b) and (c) of this section, animal venue operators may use materials provided by the department and available at www.doh.wa.gov.

(5) Animal exhibitors and other persons legally responsible for animals in public settings shall:

(a) Observe animals daily for signs of illness;

(b) Prevent public contact with sick animals;

(c) As applicable, comply with WAC 246-100-197, Rabies — Measures to prevent human disease;

(d) As applicable, comply with WAC 246-100-201, Psittacosis — Measures to prevent human disease; and

(e) Comply with, and have in their possession, any local, state, or federally required documents allowing the exhibition of animals in public settings.

(6) Animal venue operators, animal exhibitors, other persons legally responsible for animals in public settings, and veterinarians shall cooperate with local health officer investigations and control measures for zoonotic disease.

Yet, despite Washington’s rules, another outbreak occurred in 2015, not directly related to a petting zoo, but at a venue where animals had been and no measures to clean up or protect children occurred.

Over the last several years, many of the top veterinarians have been consistently tried to keep county fairs and petting zoos in business while at the same time protecting visitors – especially young children. Yearly for the last decade they have published a “Compendium of Measures to Prevent Disease Associated with Animals in Public Settings.” The most recent National Association of State Public Health Veterinarians Animal Contact Compendium Committee 2013:

Venue operators should take the following steps:

  • Become familiar with and implement the recommendations in this compendium.
  • Consult with veterinarians, state and local agencies, and cooperative extension personnel on implementation of the recommendations.
  • Become knowledgeable about the risks for disease and injury associated with animals and be able to explain risk-reduction measures to staff members and visitors.
  • Be aware that direct contact with some animals is inappropriate in public settings, and this should be evaluated separately for different audiences.
  • Develop or obtain training and educational materials and train staff members.
  • Ensure that visitors receive educational messages before they enter the exhibit, including information that animals can cause injuries or carry organisms that can cause serious illness.
  • Provide information in a simple and easy-to-under- stand format that is age and language appropriate.
  • Provide information in multiple formats (e.g., signs, stickers, handouts, and verbal information) and languages.
  • Provide information to persons arranging school field trips or classroom exhibits so that they can educate participants and parents before the visit.

Venue staff members should take the following steps:

  • Become knowledgeable about the risks for disease and injury associated with animals and be able to explain risk-reduction recommendations to visitors.
  • Ensure that visitors receive educational messages regarding risks and prevention measures.
  • Encourage compliance by the public with risk- reduction recommendations, especially compliance with hand-washing procedures as visitors exit animal areas.

Recommendations for nonanimal areas are as follows:

  • Do not permit animals, except for service animals, in nonanimal areas.
  • Store, prepare, serve, or consume food and beverages only in nonanimal areas.
  • Provide hand-washing facilities and display hand- washing signs where food or beverages are served.
  • Entrance transition areas should be designed to facilitate education.
  • Post signs or otherwise notify visitors that they are entering an animal area and that there are risks associated with animal contact.
  • Instruct visitors not to eat, drink, smoke, and place their hands in their mouth, or use bottles or pacifiers while in the animal area.
  • Establish storage or holding areas for strollers and related items (e.g., wagons and diaper bags).
  • Control visitor traffic to prevent overcrowding.
  • Exit transition areas should be designed to facilitate hand washing.
  • Post signs or otherwise instruct visitors to wash their hands when leaving the animal area.
  • Provide accessible hand-washing stations for all visitors, including children and persons with disabilities. Position venue staff members near exits to encourage compliance with proper hand washing.

Recommendations for animal areas are as follows:

  • Do not allow consumption of food and beverages in these areas.
  • Do not allow toys, pacifiers, spill-proof cups, baby bottles, strollers, or similar items to enter the area.
  • Prohibit smoking and other tobacco product use.
  • Supervise children closely to discourage hand-to- mouth activities (e.g., nail biting and thumb sucking), contact with manure, and contact with soiled bedding. Children should not be allowed to sit or play on the ground in animal areas. If hands become soiled, supervise hand washing immediately.
  • Ensure that regular animal feed and water are not accessible to the public.
  • Allow the public to feed animals only if contact with animals is controlled (e.g., with barriers).
  • Do not provide animal feed in containers that can be eaten by humans (e.g., ice cream cones) to decrease the risk of children eating food that has come into contact with animals.
  • Promptly remove manure and soiled animal bedding from these areas.
  • Assign trained staff members to encourage appropriate human-animal interactions, identify and reduce potential risks for patrons, and process reports of injuries and exposures.
  • Store animal waste and specific tools for waste removal (e.g., shovels and pitchforks) in designated areas that are restricted from public access.
  • Avoid transporting manure and soiled bedding through nonanimal areas or transition areas. If this is unavoidable, take precautions to prevent spillage.
  • Where feasible, disinfect the area (e.g., flooring and railings) at least once daily.
  • Provide adequate ventilation both for animals and humans.
  • Minimize the use of animal areas for public activities (e.g., weddings and dances).
  • If areas previously used for animals must be used for public events, they should be cleaned and disinfected, particularly if food and beverages are served.

Honestly, like guns, petting zoos are not going to be banned, and perhaps they should not. Perhaps being in touch with the small town fair is an important part of our heritage. However, trying to stay in touch with our inner rural lifestyle needs to pay attention to the pathogens of the day. If we want petting zoos we need rules to deal with these bugs that are far more deadly that many that plagued our great grandparents. If we want to protect children and save petting animals, we do need “A Petting Zoo Preservation Act.”

Frankly, simply adopting and enforcing the 2013 National Association of State Public Health Veterinarians Compendium would likely get us to a point where the inevitable outbreak perhaps fades further into the distance.  Look for a Model Act coming to you in the next month with a few additions like animal vaccinations and testing before they are allowed at the fair.

Colton-Guay-myles-Herschaft-main-300x200One death and one child still with hemolytic uremic syndrome (HUS).

The 2015 Oxford County Fair that was held in mid-September will be remembered for the death of one child and the severe illness to another due to infections with E. coli O111. The common exposure to the two children was the same petting zoo.

The investigation is ongoing, but what has appeared thus far indicates a venue that followed few of the warnings and recommendations from decades of prior outbreaks that had sickened thousands. As more information comes out over the next week on what the Fair did and did not do to prevent these families’ tragedies, the fair should be judged from health official recommended since 2001.

“Reducing the Risk for Transmission of Enteric Pathogens at Petting Zoos, Open Farms, Animal Exhibits, and Other Venues Where the Public Has Contact With Farm Animals” – 2001 CDC Recommendations:

  • Information should be provided. Persons providing public access to farm animals should inform visitors about the risk for transmission of enteric pathogens from farm animals to humans, and strategies for prevention of such transmission. This should include public information and training of facility staff. Visitors should be made aware that certain farm animals pose greater risk for transmitting enteric infections to humans than others. Such animals include calves and other young ruminant animals, young poultry, and ill animals. When possible, information should be provided before the visit.
  • Venues should be designed to minimize risk. Farm animal contact is not appropriate at food service establishments and infant care settings, and special care should be taken with school-aged children. At venues where farm animal contact is desired, layout should provide a separate area where humans and animals interact and an area where animals are not allowed. Food and beverages should be prepared, served, and consumed only in animal-free areas. Animal petting should occur only in the interaction area to facilitate close supervision and coaching of visitors. Clear separation methods such as double barriers should be present to prevent contact with animals and their environment other than in the interaction area.
  • Hand washing facilities should be adequate. Hand washing stations should be available to both the animal-free area and the interaction area. Running water, soap, and disposable towels should be available so that visitors can wash their hands immediately after contact with the animals. Hand washing facilities should be accessible, sufficient for the maximum anticipated attendance, and configured for use by children and adults. Children aged <5 years should wash their hands with adult supervision. Staff training and posted signs should emphasize the need to wash hands after touching animals or their environment, before eating, and on leaving the interaction area. Communal basins do not constitute adequate hand washing facilities. Where running water is not available, hand sanitizers may be better than using nothing. However, CDC makes no recommendations about the use of hand sanitizers because of a lack of independently verified studies of efficacy in this setting.
  • Hand-mouth activities (e.g., eating and drinking, smoking, and carrying toys and pacifiers) should not be permitted in interaction areas.
  • Persons at high risk for serious infections should observe heightened precaution. Everyone should handle farm animals as if the animals are colonized with human enteric pathogens. However, children aged <5 years, the elderly, pregnant women, and immunocompromised persons (e.g., those with HIV/AIDS) are at higher risk for serious infections. Such persons should weigh the risks for contact with farm animals. If allowed to have contact, children aged <5 years should be supervised closely by adults, with precautions strictly enforced.

“Compendium of Measures to Prevent Disease Associated with Animals in Public Settings, 2013” – National Association of State Public Health Veterinarians Animal Contact Compendium Committee 2013:

Venue operators should take the following steps:

  • Become familiar with and implement the recommendations in this compendium.
  • Consult with veterinarians, state and local agencies, and cooperative extension personnel on implementation of the recommendations.
  • Become knowledgeable about the risks for disease and injury associated with animals and be able to explain risk-reduction measures to staff members and visitors.
  • Be aware that direct contact with some animals is inappropriate in public settings, and this should be evaluated separately for different audiences.
  • Develop or obtain training and educational materials and train staff members.
  • Ensure that visitors receive educational messages before they enter the exhibit, including information that animals can cause injuries or carry organ- isms that can cause serious illness.
  • Provide information in a simple and easy-to-under- stand format that is age and language appropriate.
  • Provide information in multiple formats (e.g., signs, stickers, handouts, and verbal information) and languages.
  • Provide information to persons arranging school field trips or classroom exhibits so that they can educate participants and parents before the visit.

Venue staff members should take the following steps:

  • Become knowledgeable about the risks for dis- ease and injury associated with animals and be able to explain risk-reduction recommendations to visitors.
  • Ensure that visitors receive educational messages regarding risks and prevention measures.
  • Encourage compliance by the public with risk- reduction recommendations, especially compliance with hand-washing procedures as visitors exit animal areas.

Recommendations for nonanimal areas are as follows:

  • Do not permit animals, except for service animals, in nonanimal areas.
  • Store, prepare, serve, or consume food and beverages only in nonanimal areas.
  • Provide hand-washing facilities and display hand- washing signs where food or beverages are served.
  • Entrance transition areas should be designed to facilitate education.
  • Post signs or otherwise notify visitors that they are entering an animal area and that there are risks associated with animal contact.
  • Instruct visitors not to eat, drink, smoke, and place their hands in their mouth, or use bottles or pacifiers while in the animal area.
  • Establish storage or holding areas for strollers and related items (e.g., wagons and diaper bags).
  • Control visitor traffic to prevent overcrowding.
  • Exit transition areas should be designed to facilitate hand washing.
  • Post signs or otherwise instruct visitors to wash their hands when leaving the animal area.
  • Provide accessible hand-washing stations for all visitors, including children and persons with disabilities. Position venue staff members near exits to encourage compliance with proper hand washing.

Recommendations for animal areas are as follows:

  • Do not allow consumption of food and beverages in these areas.
  • Do not allow toys, pacifiers, spill-proof cups, baby bottles, strollers, or similar items to enter the area.
  • Prohibit smoking and other tobacco product use.
  • Supervise children closely to discourage hand-to- mouth activities (e.g., nail biting and thumb sucking), contact with manure, and contact with soiled bedding. Children should not be allowed to sit or play on the ground in animal areas. If hands become soiled, supervise hand washing immediately.
  • Ensure that regular animal feed and water are not accessible to the public.
  • Allow the public to feed animals only if contact with animals is controlled (e.g., with barriers).
  • Do not provide animal feed in containers that can be eaten by humans (e.g., ice cream cones) to decrease the risk of children eating food that has come into contact with animals.
  • Promptly remove manure and soiled animal bedding from these areas.
  • Assign trained staff members to encourage appropriate human-animal interactions, identify and reduce potential risks for patrons, and process reports of injuries and exposures.
  • Store animal waste and specific tools for waste removal (e.g., shovels and pitchforks) in designated areas that are restricted from public access.
  • Avoid transporting manure and soiled bedding through nonanimal areas or transition areas. If this is unavoidable, take precautions to prevent spillage.
  • Where feasible, disinfect the area (e.g., flooring and railings) at least once daily.
  • Provide adequate ventilation both for animals and humans.
  • Minimize the use of animal areas for public activities (e.g., weddings and dances).
  • If areas previously used for animals must be used for public events, they should be cleaned and disinfected, particularly if food and beverages are served.

A view from the Courtroom:

Under premises liability law, the entity or entities responsible for managing an animal exhibition have a duty of care to those it invites onto the premises. This duty includes the responsibility to adequately reduce risks the entity is or should be aware of. The duty also carries a responsibility to warn fairgoers of risks present at the exhibition.

The principles of negligence also revolve around the risks to fairgoers that animal exhibitors know of or reasonably should know of. To successfully bring a negligence claim, a sickened person would need to show that the actions of an animal exhibitor fell below a reasonable standard of care in the operation of the exhibit. Failing to implement the well-established recommendations of the CDC and NASPHV constitutes falling below that standard of care.

Both bases for liability on the part of animal exhibitors-premises liability and negligence-carry with them a burden of education on the part of the exhibitor. Because the law holds people to a standard of what they reasonably should know, ignorance of the risks involved is not an effective defense. The law thus provides no impetus to stray from the course of action that is best for both customers and exhibitors in the first place-recognizing the risk and taking steps to reduce it.

Screen-Shot-2015-10-11-at-4.35.51-PM-300x216In 1992 in response to a growing risk of pathogenic E. coli being linked to hamburger being cooked to the 140 degrees then suggested by the FDA Food Code, the State of Washington Department of Health increased the recommended temperature to 155 degrees – the only state to do so.  Officials disseminated the new temperature to all restaurants in the state and the corporate headquarters of nationwide restaurant chains – that included San Diego, California based Jack-in-the-Box.

Jack-in-the-Box ignored the Department of Health recommendation and the result was over 700 with E. coli O157:H7, including dozens with acute kidney failure and the deaths of four children.

During the resulting litigation it was uncovered that corporate officials at Jack-in-the-Box knew about the recommendations but ignored it. It cost them over $100,000,000.

Now, over twenty-two years later a smaller E. coli O157:H7 outbreak at Vermont’s Worthy Burger has been linked to a dozen illnesses and undercooked, E. coli tainted burgers.

According to press reports, Worthy Burger was closed for five days starting September 17, switched several food vendors, and made other changes. Vermont State officials also advised Worthy Burger that hamburgers be cooked to 155 degrees for at least 15 seconds to ensure any potential pathogens are cooked out.

rare.hamburger-300x200Sound familiar?

After the closure when asked by the press if Worthy Burger was cooking hamburgers to 155 degrees, Jason Merrill, the executive chef, said, “Our customers are telling us what temperature they’d like their hamburger.” Worthy Burger continued to cook hamburgers rare and medium-rare at customers’ request.

After Worthy Burger reopened on September 22 another customer became ill with E. coli O157:H7. This new illness led Worthy Burger to reconsider its practices in regards to rare burgers. Jason Merrill confirmed that Worthy Burger, which used to advertise its signature burger as locally sourced, grass fed and as “pink in the middle,” is now thoroughly cooking all of its burgers, according to press reports.

“We’re not doing rare burgers,” Merrill said. “What’s happening right now, we’re cooking our burgers all the way through to the USDA-recommended temperature of 155 degrees.”

Hey, Jason Merrill – brilliant idea – just a bit late.

Marler-and-Parnell-at-congressional-hearing-406x260A week ago last Monday, I was sitting in a bar in the Boston airport across the gate from my delayed flight (I would eventually get home a day late) monitoring tweets and texts for the outcome of the sentencing of Stewart Parnell, his brother Michael Parnell, and their “food safety” director Mary Wilkerson, which was occurring in a federal courtroom in Georgia.

I had flown to Boston the evening before for a 15-minute hearing in federal court that Monday (before the same judge who heard the Boston Bomber case) on an E. coli O157:H7 death case involving a young boy. Although I would not have missed that hearing, my thoughts were in part a thousand miles south thinking of my clients who were testifying in favor of long sentences against the people made infamous when, faced with Salmonella in their product, wrote such memorable emails as: “Just ship it,” “Turn them loose,” and “Costing us huge $$$$$.”

Stewart Parnell — the point person for the Salmonella outbreak that sickened more than 700 people and killed at least nine — and I have never spoken, although I was only a few chairs away when he “took the Fifth” before a packed congressional hearing in 2009. I sued him personally and his company, the Peanut Corporation of America (PCA), and watched while PCA was pushed into bankruptcy. I, along with my clients, advocated for years for the prosecution of Stewart Parnell and others for the injuries and deaths and the recall of nearly 4,000 different kinds of food products. The loss of those nine people was certainly incalculable. Some put the economic loss for this one food poisoning event at more than $500,000,000.

OK, back to the airport bar in Boston. Sometime after 5 p.m. Eastern, my text pinged: “28 years for Stew” from someone in the courtroom. Then came: “20 for Bro and 5 for Mary.”

For the above reasons, the 28 years in prison that U.S. District Court Judge W. Louis Sands sentenced Stewart Parnell to seems reasonable. Honestly, I never really knew what to expect, but it felt like justice had been served. Remember, Stewart Parnell was facing more than 70 felony counts for “knowingly” shipping adulterated product into the stream of commerce, as well as mail fraud, wire fraud and obstruction of justice. He could have received 803 years behind bars.

Stewart Parnell and his fellow conspirators are fortunately the exception and not the rule in the foodborne illness outbreaks in which I have been involved over the past 22 years. Certainly, over the past decades some decision-makers came close to the edge of knowingly shipping a tainted product, but most avoided knowledge by failing to inspect or test, thereby creating “plausible deniability.” And, I imagine they were a bit better at not putting things in writing.

I think all would agree that if someone knowingly ships tainted product, jail time is clearly warranted. Let’s just hope as a society that these types of decisions (and even those that come close) never occur again. I am optimistic that simple morality guides most people — with some encouragement by the U.S. Attorney and the Honorable Judge Sands.

As I said to the first reporter who reached me in that Boston airport bar: “This sentence is going to send a stiff, cold wind through boardrooms across the U.S.” I believe that. During the years that it took to get Stewart Parnell charged, tried, convicted and sentenced (hopefully the appeals will be short and unsuccessful), I have been asked to speak around the world on the topic of criminal liability in food cases. What happened to Stewart Parnell, and arguably more important, to his managers and employees, is now on the radar screen of food producers around the world — and that is a good thing.

People in the food business are now very much aware of the no-longer-quiet criminal provisions in the 1938 Federal Food, Drug and Cosmetic Act — both felony and misdemeanor sections. Not only is that because of the PCA felony case, but also in other outbreaks, where knowledge of contamination was not shown and only misdemeanors charged, prosecutions are happening. A simple fact is that there have been more prosecutions in the past five years for misdemeanor violations (punishable with up to a year in jail and a $250,000 fine per charge) than in the other two decades of my practice.

As my plane finally pulled up to the gate, I told another reporter: “I’d rather Stewart Parnell never go to jail, and that the outbreak had never happened.” I believe that, too. It is sad that Stewart Parnell will likely spend the rest of his life in jail. It is terrible that nine people died and hundreds were sickened due to his greed. The outbreak was a tragedy, and Stewart Parnell is a tragic figure.

In the end, criminalizing food production is not the answer. A sentence like Stewart Parnell’s and more misdemeanor prosecutions certainly have the attention of executives and managers. However, I think we all can agree that avoiding the cause is a far better result for consumers, the companies and employees.

Perhaps what happened in a South Georgia courtroom on Sept. 21, 2015, will be another reason to make the investment in government and industry to help avoid another life sentence — either by the consumer or by the manufacturer.

Screen Shot 2015-09-16 at 9.50.32 AM“If that’s not criminal behavior, I don’t know what is.”

Sitting on a plane heading home to Seattle, I am still a bit stunned by the sentenced carried out yesterday in a Federal Courtroom in Georgia.

I was looking for the first time I raised the issue of prosecuting Stewart Parnell. I found it in a blog post from January 2009, shortly after the announcement of the outbreak and the recall and during the time when I was being briefly considered for a food safety position in the Obama Administration. Here is the post from the past:

While the Washington Post pondered if I would actually move from Seattle to Washington DC, yet another food recall was happening in the other – actual states.  Here is a “round-up” of a few choice quotes:

Minneapolis Star-Tribune

Bill Marler, a Seattle attorney who has been suing food makers for years on behalf of people who get sick, said he’s never seen a company accused of shipping products that tested positive for a foodborne pathogen. “It’s insane,” he said. “You have to ask, what are these people thinking when the product is going into institutional settings with kids and older people? It’s just unconscionable.”

New York Times

The report from the inspection, first posted on the Internet by Bill Marler, a lawyer, cites 12 instances in 2007 and 2008 in which the company’s own tests of its product found contamination by salmonella.

Burlington Free Press

After obtaining a damning FDA report on PCA and posting it on his Web site, www.marlerblog.com, Marler added demands for unspecified punitive damages to the Meunier lawsuit. “We do not allege punitive damages in most cases. Just the most egregious,” Marler wrote on his blog Wednesday. “In fifteen years of litigating food cases, this is one of the worst examples of corporate responsibility I have ever seen.”

ABC Evening News

“If this doesn’t rise to a criminal level I don’t know what does,” food safety attorney Bill Marler told ABC News on Wednesday. Marler is suing the company on behalf of one consumer. Marler’s current advice? “I would think twice right now about giving a peanut butter product of any kind to someone under the age of 5 or over the age of 70.”

The FDA inspections also documented unsanitary conditions at the plant, including cockroaches, mold and leaking roofs. “This is one of the worst inspection reports I’ve seen in 15 years of practice,” Marler said.

As numbers climb higher, people like Marler are questioning the government’s ability to keep food safe as products make their way through a complex supply chain from farms to grocery store shelves to kitchen pantries. Today Marler said it’s key for the government to step up its efforts and require “across-the-board bacterial and viral testing on all ready-to-eat products. The reality is that, frankly, U.S. companies do a marvelous job at poisoning our own citizens,” Marler said. “Our focus on imported products are frankly misplaced given the fact that most food-borne illness outbreaks that occur in the United States are caused by homegrown companies.”

Scientific American

“It’s inconceivable that the FDA or the state of Georgia allowed a plant like this to operate,” says Seattle personal-injury attorney Bill Marler, who sued PCA in federal court in Albany, Ga., last week on behalf of a 7-year-old boy who got sick after eating salmonella-tainted peanut butter. “This company … got positive tests and shipped it in any event. If that’s not criminal behavior, I don’t know what is.”

peanut-butter-and-jellyIn 2009 President Obama was quoted:

“At a bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter,” the president said.

“That’s what Sasha eats for lunch,” Obama said, referring to his 7-year-old daughter. “Probably three times a week. I don’t want to worry about whether she’s going to get sick as a consequence of eating her lunch.”

This coming Monday Stewart Parnell, the former owner of Peanut Corp. of America, Michael Parnell, who is Stewart Parnell’s brother and a former supervisor and Mary Wilkerson, a former quality-assurance manager will face justice after being convicted by a jury of from one to over 70 felony charges. Daniel Kilgore, plant manager and Samuel Lightsey, a onetime plant operator pled guilty earlier and testified against the three who went to trial. They too will be sentenced – likely at a later date.

In 1938 Congress passed the Federal Food, Drug, and Cosmetic Act (FDCA) in reaction to growing public food safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles, including food, from entering interstate commerce.

Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health. Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability.

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both. The key here is an intentional act.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.

Screen Shot 2015-09-16 at 9.50.32 AMHere are five cases involving foodborne illness outbreaks where prosecutors have brought criminal charges:

  • In 2012 Eric Jensen, age 37, and Ryan Jensen, age 33, brothers who owned and operated Jensen Farms, a fourth generation cantaloupe operation, located in Colorado, presented themselves to U.S. marshals in Denver and were taken into custody on federal charges brought by the U.S. Attorney’s Office with the Food and Drug Administration – Office of Criminal Investigation. According to the six-count indictment, Eric and Ryan Jensen unknowingly introduced adulterated (Listeria-tainted) cantaloupe into interstate commerce. The indictment further stated that the cantaloupe was prepared, packed and held under conditions, which rendered it injurious to health.  The outbreak sickened over 147, killing over 33 in 28 states in the fall of 2011.  The Jensen’s faced up to six years in jail and $1,500,000 in fines each. The eventually pleaded guilty and were sentenced to five years probation.
  • In 2013, Austin “Jack” DeCoster and his son, Peter DeCoster, both faced charges stemming from a Salmonella outbreak caused by their Iowa egg farms in 2010.  The Salmonella outbreak ran from May 1 to November 30, 2010, and prompted the recall of more than a half-billion eggs. And, while there were 1,939 confirmed infections, statistical models used to account for Salmonella illnesses in the U.S. suggested that the eggs might have sickened more than 62,000 people. The family business, known as Quality Egg LLC, pleaded guilty in 2015 to a federal felony count of bribing a USDA egg inspector and to two misdemeanors of unknowingly introducing adulterated food into interstate commerce. As part of the plea agreement, Quality Egg paid a $6.8-million fine and the DeCosters $100,000 each, for a total of $7 million.  Both DeCosters were sentenced to three months in jail. They are appealing the jail sentence.
  • In 2015 ConAgra Foods agreed to plead guilty and pay $11.2 million in connection with the shipment of Salmonella contaminated peanut butter linked to a 2006 through 2007 nationwide outbreak of that sickened over 700. ConAgra signed a plea agreement admitting that it unknowingly introduced Peter Pan and private label peanut butter contaminated with Salmonella into interstate commerce during the 2006 through 2007 outbreak.
  • In 2014 former Peanut Corporation of America owner Stewart Parnell, his brother and one-time peanut broker, Michael Parnell, and Mary Wilkerson, former quality control manager at the company’s Blakely, Georgia, plant, faced a federal jury in Albany, Georgia. The 12-member jury found Stewart Parnell guilty on 67 federal felony counts, Michael Parnell was found guilty on 30 counts, and Wilkerson was found guilty of one of the two counts of obstruction of justice charged against her. Two other PCA employees earlier pleaded guilty. The felony charges of introducing adulterated food into interstate commerce, “with the intent to defraud or mislead,” stemmed from a 2008 to 2009 Salmonella outbreak that sickened 714 and left nine dead. All defendants will be sentenced in July of this year. Stewart and Michael are facing decades in jail.
  • In 1998 in what was the first criminal conviction in a large-scale food-poisoning outbreak, Odwalla Inc. pleaded guilty to violating Federal food safety laws and agreed to pay a $1.5 million fine for selling tainted apple juice that killed a 16-month-old girl and sickened 70 other people in several states in 1996. Odwalla, based in Half Moon Bay, California pleaded guilty to 16 counts of unknowingly delivering ”adulterated food products for introduction into interstate commerce” in the October 1996 outbreak, in which a batch of its juice infected with the toxic bacteria E. coli O157:H7 sickened people in Colorado, California, Washington and Canada. Fourteen children developed a life-threatening disease (hemolytic uremic syndrome -HUS) that ravages kidneys. At the time, the $1.5 million penalty was the largest criminal penalty in a food poisoning case.  Odwalla also was on court-supervised probation for five years, meaning that it had to submit a detailed plan to the food and drug agency demonstrating its food safety precautions and that any subsequent violations could have resulted in more serious charges.

And, here are some where no charges have been brought – at least as of yet:

  • 2015 Andrew & Williamson Salmonella Outbreak: As of September 15, 2015, a total of 418 people infected with the outbreak strains of Salmonella Poona have been reported from 31 states. The number of ill people reported from each state is as follows: Alaska (10), Arizona (72), Arkansas (6), California (89), Colorado (16), Hawaii (1), Idaho (14), Illinois (6), Indiana (2), Kansas (1), Kentucky (1), Louisiana (4), Minnesota (20), Missouri (8), Montana (13), Nebraska (2), Nevada (9), New Mexico (22), New York (4), North Dakota (2), Ohio (2), Oklahoma (10), Oregon (8), Pennsylvania (2), South Carolina (8), Texas (20), Utah (37), Virginia (1), Washington (15), Wisconsin (9), and Wyoming (4). On September 4, 2015, Andrew & Williamson Fresh Produce voluntarily recalled all cucumbers sold under the “Limited Edition” brand label during the period from August 1, 2015 through September 3, 2015.
  • 2013 Glass Onion E. coli Outbreak: A total of 33 persons infected with the outbreak strain of E. coli O157:H7 were reported from four states. The number of ill persons identified in each state was as follows: Arizona (1), California (28), Texas (1), and Washington (3). 32% of ill persons were hospitalized. Two ill persons developed hemolytic uremic syndrome (HUS), and no deaths were reported. Epidemiologic and traceback investigations conducted by local, state, and federal officials indicated that consumption of two ready-to-eat salads, Field Fresh Chopped Salad with Grilled Chicken and Mexicali Salad with Chili Lime Chicken, produced by Glass Onion Catering and sold at grocery store locations, was the likely source of this outbreak of E. coli O157:H7 infections. On November 10, 2013, Glass Onion Catering recalled numerous ready-to-eat salads and sandwich wrap products that may be contaminated with E. coli O157:H7.
  • 2013 Townsend Farms/Costco Hepatitis A Outbreak: A total of 165 people were confirmed to have become ill from hepatitis A linked to pomegranate arils contained in ‘Townsend Farms Organic Antioxidant Blend’ in 10 states: Arizona (23), California (79), Colorado (28), Hawaii (8), New Hampshire (1), New Jersey (1), New Mexico (11), Nevada (6), Utah (3), and Wisconsin (2). The major outbreak strain of hepatitis A virus, belonging to genotype 1B, was found in clinical specimens of 117 people in nine states. This genotype is rarely seen in the Americas but circulates in North Africa and the Middle East. This genotype was identified in a 2013 outbreak of hepatitis A virus infections in Europe linked to frozen berries and a 2012 outbreak in British Columbia related to a frozen berry blend with pomegranate seeds from Egypt.
  • 2014 Bidart Brothers Listeria Apple Outbreak: A total of 35 people infected with the outbreak strains of Listeria monocytogenes were reported from 12 states: Arizona (5), California (3), Colorado (1), Minnesota (4), Missouri (5), Nevada (1), New Mexico (6), North Carolina (1), Texas (4), Utah (1), Washington (1), and Wisconsin (3). Of these, 34 people were hospitalized. Listeriosis contributed to at least three of the seven deaths reported. Eleven illnesses were pregnancy-related (occurred in a pregnant woman or her newborn infant), with one illness resulting in a fetal loss. Three invasive illnesses (meningitis) were among otherwise healthy children aged 5–15 years. On January 6, 2015, Bidart Bros. of Bakersfield, California, recalled Granny Smith and Gala apples because environmental testing revealed contamination with Listeria monocytogenes at the firm’s apple-packing facility.
  • 2015 Blue Bell Ice Cream Listeria Outbreak: A total of 10 people with Listeriosis related to this outbreak were reported from 4 states: Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). All ill people were hospitalized. Three deaths were reported from Kansas (3). On April 21, CDC reported that whole genome sequencing confirmed that the people from Arizona (1) and Oklahoma (1) were part of the outbreak, bringing the total case count to 10. On May 7, 2015, FDA released the findings from recent inspections at the Blue Bell production facilities that found significant food safety violations.

Admittedly, I have been a booster for increased food crime prosecutions – both misdemeanor and felony. In all the cases above where prosecutions happened, I have helped prosecutors understand the science behind the outbreaks and explained to them the devastation suffered by the victims and families.

Yet, looking at the above outbreaks together, I find it a bit hard to parse out why some have been targeted – OK, perhaps the Parnell prosecution is a bit easier because it was so clearly intentional – and some have not, or at least not yet.

Honestly, what are the differences in prosecuting the Jensens, DeCosters and ConAgra and leaving the others – so far – unmolested by section 402(a)(4) of the FDCA? Is it the number of sick, the number of dead? Is it the economic consequences? What really are the criteria, or, should it simply be left to the discretion of the prosecutor as to who or what feels the sting of the criminal justice system?

It is time for prosecutors to set forth clear guidelines for who is prosecuted and who is not. People (and corporations if you do not quite agree with some who do not see the difference) should know what the rules are and how they are going to be enforced and that they will be enforced consistently and fairly.

0In the spring of 2007, I was asked to testify before the U.S. House of Representative’s Energy and Commerce Committee, which was the committee tasked with modernizing our food safety system. From those hearings, which stretched from 2007 to 2009, came the Food Safety Modernization Act (FSMA). On the Senate side of the hill, work was also being done, but with much less fanfare, on its version of the sweeping new legislation.

My testimony, which only lasted for about 15 minutes with questions, was part of a hearing entitled, “A Diminished Capacity: Can the FDA Assure the Safety and Security of the Nation’s Food Supply?” My pitch was pretty straightforward — modernize our food safety system and deny me the opportunity to sue food companies on behalf of my clients. The politicians and the audience seemed to relish the idea of “putting me out of business.”

After me came a table full of CEOs whose companies had caused some of the larger foodborne illness outbreaks in the preceding years. Producers of lettuce, pot pies, beans and chili sauce were forced to stand and swear under oath to tell the truth. Their army of lawyers was right behind them to help them avoid making any statements that might haunt them later.

As I watched these CEOs squirm under questioning, it was clear that all of them wished they were anywhere in the world other than where they were now sitting. As many of them stumbled though the grilling by both Democrats and Republicans on the committee, something was becoming painfully clear to all: It was past time to set aside the hollow arguments against regulation and seek a responsible solution to reduce the 48 million cases of foodborne illness in the U.S. each year (with an estimated cost to consumers of more than $15 billion).

It was also clear to all in attendance that the cost to business from outbreaks and recalls was negatively impacting profits. Just months before, all spinach grown in the U.S. was recalled after 205 people were sickened and five died from spinach that came from one California farm. Spinach sales tanked and have never quite returned. Then there was the peanut recall, prompted by more than 700 illnesses and nine deaths. That one ended up causing more than 4,000 products to be recalled and peanut sales to plummet, at an estimated cost of nearly $500 million.

It was amazing to see CEOs, who may have previously thought that “government was the problem,” admit that it was past time to enact comprehensive food safety legislation to allow for thoughtful hazard analysis of the food supply – both domestic and imported. Being hauled in front of a congressional committee, realizing the burden on the consumers, or feeling the hit to their company’s bottom line may have awakened them to a newfound desire for a partnership between business, government and consumers.

With this partnership – especially between some consumer groups and the food industry – the outlines of FSMA began to emerge. The primary guiding principle was to apply the rigors of Hazard Analysis and Critical Control Points to the 80 percent of the food supply regulated by the U.S. Food and Drug Administration (FDA). The other principle – more of a reality – was that FDA would probably never have sufficient resources to hire enough inspectors to oversee all these changes, and therefore the burden would fall on the CEOs and their board bosses to ultimately make sure that the food they produce was safe.

FDA was tasked with creating new regulations – in consultation with both industry and consumers – to set standards for testing, water quality, and other good manufacturing practices. These new regulations have been slow to roll out since the passage of FSMA in 2010, but they are coming and will ultimately set the ground rules for what FDA will expect from food production, both here and abroad.

FDA also was given – although not necessarily wanted – mandatory recall authority. Although still not frequently used, it is an “arrow in the quiver,” along with mandatory registration, mandatory reporting and increased product testing, all of which adds a bit of muscle to an agency without the necessary resources for enough inspections.

A CEO and his or her board can see the new FSMA rules and regulations as a burden, but I expect most to see them as opportunities to avoid the problems and costs of the past. Playing by the rules, although far from perfect, provides the opportunity to avoid problems and prevent outbreaks and recalls and the attendant costs.

I would be remiss if I didn’t mention one final reason why the CEO and board need to pay attention to FSMA. That would be these two words: “criminal sanctions.” What is clear, and will become even clearer on Sept. 21 when former Peanut Corporation of America CEO Stewart Parnell of Salmonella outbreak fame could be sentenced to spend the rest of his life in prison, is that FDA is likely using the criminal sections of the Federal Food Drug and Cosmetic Act to focus attention on those who produce our food. There have been more criminal prosecutions in the past five years of food company managers than in the prior two decades combined. Hefty fines and jail time do have a way of focusing one’s attention.

In my view, a CEO and board embracing FSMA makes sense. Playing by the rules and not poisoning customers is good for business. It is a good thing not to alienate your customer base with foodborne illness symptoms, such as diarrhea and vomiting, or perhaps worse. It is a good thing to avoid the recall costs and other attendant losses, including your personal freedom.

prison-cellIs it time for prosecutors to set forth clear guidelines for who is prosecuted and who is not?

A few weeks ago I was quoted in an article entitled “Will Blue Bell face criminal charges after ice cream recall?”

Bill Marler, a food safety lawyer who has represented victims in many of those cases, says Justice’s recent activity is especially notable because in many of the cases, company executives didn’t know they were shipping out tainted food, but they were hit with criminal charges anyway. “It’s been very much of a sea change,” Marler said. “Once you start down this road you have to decide whether you are going to do it all the time or selectively.”

So, when to prosecute and when to not? What are the criteria, if any, that the Justice Department now uses to decide to prosecute? For those that are prosecuted, does the punishment fit the crime? And, what happens when similar “crimes” are not prosecuted at all?

First, for a bit(e) of background history.

In 1938 Congress passed the Federal Food, Drug, and Cosmetic Act (FDCA) in reaction to growing public food safety demands.  The primary goal of the Act was to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles, including food, from entering interstate commerce.

Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance, which may render it injurious to health. Chapter III of the Act addresses prohibited acts, subjecting violators to both civil and criminal liability.

Felony violations include adulterating or misbranding a food, drug, or device, and putting an adulterated or misbranded food, drug, or device into interstate commerce.  Any person who commits a prohibited act violates the FDCA.  A person committing a prohibited act “with the intent to defraud or mislead” is guilty of a felony punishable by years in jail and millions in fines or both. The key here is an intentional act.

A misdemeanor conviction under the FDCA, unlike a felony conviction, does not require proof of fraudulent intent, or even of knowing or willful conduct.  Rather, a person may be convicted if he or she held a position of responsibility or authority in a firm such that the person could have prevented the violation.  Convictions under the misdemeanor provisions are punishable by not more than one year or fined not more than $250,000, or both.

Here are four recent cases where prosecutors brought criminal charges:

  • In 2012 Eric Jensen, age 37, and Ryan Jensen, age 33, brothers who owned and operated Jensen Farms, a fourth generation cantaloupe operation, located in Colorado, presented themselves to U.S. marshals in Denver and were taken into custody on federal charges brought by the U.S. Attorney’s Office with the Food and Drug Administration – Office of Criminal Investigation. According to the six-count indictment, Eric and Ryan Jensen unknowingly introduced adulterated (Listeria-tainted) cantaloupe into interstate commerce. The indictment further stated that the cantaloupe was prepared, packed and held under conditions, which rendered it injurious to health.  The outbreak sickened over 147, killing over 33 in 28 states in the fall of 2011.  The Jensen’s faced up to six years in jail and $1,500,000 in fines each. The eventually pleaded guilty and were sentenced to five years probation.
  • In 2013, Austin “Jack” DeCoster and his son, Peter DeCoster, both faced charges stemming from a Salmonellaoutbreak caused by their Iowa egg farms in 2010.  The Salmonella outbreak ran from May 1 to November 30, 2010, and prompted the recall of more than a half-billion eggs. And, while there were 1,939 confirmed infections, statistical models used to account for Salmonella illnesses in the U.S. suggested that the eggs might have sickened more than 62,000 people. The family business, known as Quality Egg LLC, pleaded guilty in 2015 to a federal felony count of bribing a USDA egg inspector and to two misdemeanors of unknowingly introducing adulterated food into interstate commerce. As part of the plea agreement, Quality Egg paid a $6.8-million fine and the DeCosters $100,000 each, for a total of $7 million.  Both DeCosters were sentenced to three months in jail. They are appealing the jail sentence.
  • In 2015 ConAgra Foods agreed to plead guilty and pay $11.2 million in connection with the shipment of Salmonella contaminated peanut butter linked to a 2006 through 2007 nationwide outbreak of that sickened over 700. ConAgra signed a plea agreement admitting that it unknowingly introduced Peter Pan and private label peanut butter contaminated with Salmonella into interstate commerce during the 2006 through 2007 outbreak.
  • In 2014 former Peanut Corporation of America owner Stewart Parnell, his brother and one-time peanut broker, Michael Parnell, and Mary Wilkerson, former quality control manager at the company’s Blakely, Georgia, plant, faced a federal jury in Albany, Georgia. The 12-member jury found Stewart Parnell guilty on 67 federal felony counts, Michael Parnell was found guilty on 30 counts, and Wilkerson was found guilty of one of the two counts of obstruction of justice charged against her. Two other PCA employees earlier pleaded guilty. The felony charges of introducing adulterated food into interstate commerce, “with the intent to defraud or mislead,” stemmed from a 2008 to 2009 Salmonella outbreak that sickened 714 and left nine dead. All defendants will be sentenced in July of this year. Stewart and Michael are facing decades in jail.

And, here are four where no charges have been brought – at least as of yet:

  • Glass Onion coli Outbreak: A total of 33 persons infected with the outbreak strain of E. coli O157:H7 were reported from four states. The number of ill persons identified in each state was as follows: Arizona (1), California (28), Texas (1), and Washington (3). 32% of ill persons were hospitalized. Two ill persons developed hemolytic uremic syndrome (HUS), and no deaths were reported. Epidemiologic and traceback investigations conducted by local, state, and federal officials indicated that consumption of two ready-to-eat salads, Field Fresh Chopped Salad with Grilled Chicken and Mexicali Salad with Chili Lime Chicken, produced by Glass Onion Catering and sold at grocery store locations, was the likely source of this outbreak of E. coli O157:H7 infections. On November 10, 2013, Glass Onion Catering recalled numerous ready-to-eat salads and sandwich wrap products that may be contaminated with E. coli O157:H7.
  • 2013 Townsend Farms/Costco Hepatitis A Outbreak: A total of 165 people were confirmed to have become ill from hepatitis A linked to pomegranate arils contained in ‘Townsend Farms Organic Antioxidant Blend’ in 10 states: Arizona (23), California (79), Colorado (28), Hawaii (8), New Hampshire (1), New Jersey (1), New Mexico (11), Nevada (6), Utah (3), and Wisconsin (2). The major outbreak strain of hepatitis A virus, belonging to genotype 1B, was found in clinical specimens of 117 people in nine states. This genotype is rarely seen in the Americas but circulates in North Africa and the Middle East. This genotype was identified in a 2013 outbreak of hepatitis A virus infections in Europe linked to frozen berries and a 2012 outbreak in British Columbia related to a frozen berry blend with pomegranate seeds from Egypt.
  • 2014 Bidart Brothers Listeria Apple Outbreak: A total of 35 people infected with the outbreak strains of Listeria monocytogenes were reported from 12 states: Arizona (5), California (3), Colorado (1), Minnesota (4), Missouri (5), Nevada (1), New Mexico (6), North Carolina (1), Texas (4), Utah (1), Washington (1), and Wisconsin (3). Of these, 34 people were hospitalized. Listeriosis contributed to at least three of the seven deaths reported. Eleven illnesses were pregnancy-related (occurred in a pregnant woman or her newborn infant), with one illness resulting in a fetal loss. Three invasive illnesses (meningitis) were among otherwise healthy children aged 5–15 years. On January 6, 2015, Bidart Bros. of Bakersfield, California, recalled Granny Smith and Gala apples because environmental testing revealed contamination with Listeria monocytogenes at the firm’s apple-packing facility.
  • 2015 Blue Bell Ice Cream Listeria Outbreak: A total of 10 people with Listeriosis related to this outbreak were reported from 4 states: Arizona (1), Kansas (5), Oklahoma (1), and Texas (3). All ill people were hospitalized. Three deaths were reported from Kansas (3). On April 21, CDC reported that whole genome sequencing confirmed that the people from Arizona (1) and Oklahoma (1) were part of the outbreak, bringing the total case count to 10. On May 7, 2015, FDA released the findings from recent inspections at the Blue Bell production facilities that found significant food safety violations.

Admittedly, I have been a booster for increased food crime prosecutions – both misdemeanor and felony. In all the four cases above where prosecutions happened, I have helped prosecutors understand the science behind the outbreaks and explained to them the devastation suffered by the victims and families.

Yet, looking at the above eight outbreaks together, I find it a bit hard to parse out why some have been targeted – OK, perhaps the Parnell prosecution is a bit easier because it was so clearly intentional – and some have not, or at least not yet.

Honestly, what are the differences in prosecuting the Jensens, DeCosters and ConAgra and leaving the others – so far – unmolested by section 402(a)(4) of the FDCA? Is it the number of sick, the number of dead? Is it the economic consequences? What really are the criteria, or, should it simply be left to the discretion of the prosecutor as to who or what feels the sting of the criminal justice system?

It is time for prosecutors to set forth clear guidelines for who is prosecuted and who is not. People (and corporations if you do not quite agree with some who do not see the difference) should know what the rules are and how they are going to be enforced and that they will be enforced consistently and fairly.

Livestock exhibitions, petting zoos, county and state fairs, frankly any “farm experience,” are “as American as apple pie.”

Unfortunately, these same places have been the source of large outbreaks of zoonotic diseases over the last decades. And, just as unfortunately, despite the severe illnesses and a death attributed to these activities, little seems to be learned from outbreak to outbreak despite previously existing standards for safer exhibition of animals being encoded more forcefully into law. After each outbreak it is hoped that future exhibitors will, one hopes, heed the calls previously issued by the Centers for Disease Control and Prevention (CDC) and by veterinarians: to take steps to reduce the likelihood of zoonotic-disease transmission to animal exhibition patrons – and to young children in particular.

Now we see another one. During April’s Milk Maker’s Fest at the Washington Fairgrounds at least 25 were sickened by E. coli O157:H7 with 10 hospitalized and six developing hemolytic uremic syndrome (HUS). The cause of this outbreak is clearly set forth in recommendations for future event organizers:

  • Evaluate and update plans for cleaning and disinfection before, during, and after events, particularly surfaces with high levels of hand contact (such as seats, door or fence handles, and hand railings).
  • Evaluate and update measures to restrict access to areas more likely to be contaminated with animal manure.
  • Ensure access to hand washing facilities with soap, running water, and disposable towels.
  • Display signs and use other reminders to attendees to wash hands when leaving animal areas.
  • Store, prepare, or serve food and beverages only in non-animal areas.

Screen Shot 2015-06-04 at 9.42.10 AMSeeing this I feel a bit frustrated since I gave a speech 10 years ago to the Washington State Fair Association about the risks of animal contact in these types of settings and recommendation on how to avoid outbreaks.

The risk of transmission in exhibition settings of zoonotic diseases in general and E. coli O157:H7 in particular is not – or should not be – news. A survey as far back as 2003 of the literature, including CDC’s Morbidity and Mortality Weekly Report (MMWR), revealed at least 23 outbreaks of zoonotic disease, including illnesses from E. coli O157:H7, associated with animal exhibitions in the United Kingdom and the United States. These prior outbreaks included an E. coli O157:H7 outbreak associated with a county fair in Medina, Ohio, in August, 2000; two E. coli O157:H7 outbreaks in Pennsylvania in 2000 and 2001 associated with farm animals; 92 E. coli O157:H7 cases associated with the Wyandot County Fair in Ohio in September 2001; and the largest E. coli O157:H7 outbreak in Oregon history at the Lane County Fair in September 2002. And, over the last decade there is not a year that has gone by that many other outbreaks have left hundreds and hundreds sickened.

In addition, research has shown that E. coli O157:H7 is prevalent even among the prize livestock exhibited at agricultural fairs. A 2003 study on the prevalence of E. coli O157: H7 in livestock at 29 county and three large state agricultural fairs in the United States found that E. coli O157:H7 could be isolated from 13.8 percent of beef cattle, 5.9 percent of dairy cattle, 3.6 percent of pigs, 5.2 percent of sheep, and 2.8 percent of goats. Over 7 percent of pest-fly pools also tested positive for E. coli O157:H7.

Against this backdrop, the CDC published recommendations for reducing the risk that enteric pathogens will be transmitted at petting zoos, open farms, and animal exhibits. The most updated version of these recommendations can be found on CDC’s MMWR Web site. These recommendations arise out of several documented outbreaks in which enteric pathogens were passed to humans in such settings. Draft recommendations were published in MMWR on April 20, 2001; readers were invited to submit comments and suggestions; and the final recommendations were posted on the Internet on October 26, 2001. The recommendations encapsulated on the CDC Web site and in MMWR were created by the National Association of State Public Health Veterinarians (NASPHN). Many of the recommendations are common sense and most, if not all were likely ignored by those involved with the Milk Maker’s Fest:

Venue operators should take the following steps:

  • Become familiar with and implement the recommendations in this compendium.
  • Consult with veterinarians, state and local agencies, and cooperative extension personnel on implementation of the recommendations.
  • Become knowledgeable about the risks for disease and injury associated with animals and be able to explain risk-reduction measures to staff members and visitors.
  • Be aware that direct contact with some animals is inappropriate in public settings, and this should be evaluated separately for different audiences.
  • Develop or obtain training and educational materials and train staff members.
  • Ensure that visitors receive educational messages before they enter the exhibit, including information that animals can cause injuries or carry organ- isms that can cause serious illness.
  • Provide information in a simple and easy-to-under- stand format that is age and language appropriate.
  • Provide information in multiple formats (eg, signs, stickers, handouts, and verbal information) and languages.
  • Provide information to persons arranging school field trips or classroom exhibits so that they can educate participants and parents before the visit.

Venue staff members should take the following steps:

  • Become knowledgeable about the risks for dis- ease and injury associated with animals and be able to explain risk-reduction recommendations to visitors.
  • Ensure that visitors receive educational messages regarding risks and prevention measures.
  • Encourage compliance by the public with risk- reduction recommendations, especially compliance with hand-washing procedures as visitors exit animal areas.

Recommendations for nonanimal areas are as follows:

  • Do not permit animals, except for service animals, in nonanimal areas.
  • Store, prepare, serve, or consume food and beverages only in nonanimal areas.
  • Provide hand-washing facilities and display hand- washing signs where food or beverages are served.
  • Entrance transition areas should be designed to facilitate education.
  • Post signs or otherwise notify visitors that they are entering an animal area and that there are risks associated with animal contact.
  • Instruct visitors not to eat, drink, smoke, and place their hands in their mouth, or use bottles or pacifiers while in the animal area.
  • Establish storage or holding areas for strollers and related items (eg, wagons and diaper bags).
  • Control visitor traffic to prevent overcrowding.
  • Exit transition areas should be designed to facilitate hand washing.
  • Post signs or otherwise instruct visitors to wash their hands when leaving the animal area.
  • Provide accessible hand-washing stations for all visitors, including children and persons with disabilities. Position venue staff members near exits to encourage compliance with proper hand washing.

Recommendations for animal areas are as follows:

  • Do not allow consumption of food and beverages in these areas.
  • Do not allow toys, pacifiers, spill-proof cups, baby bottles, strollers, or similar items to enter the area.
  • Prohibit smoking and other tobacco product use.
  • Supervise children closely to discourage hand-to- mouth activities (eg, nail biting and thumb sucking), contact with manure, and contact with soiled bedding. Children should not be allowed to sit or play on the ground in animal areas. If hands become soiled, supervise hand washing immediately.
  • Ensure that regular animal feed and water are not accessible to the public.
  • Allow the public to feed animals only if contact with animals is controlled (eg, with barriers).
  • Do not provide animal feed in containers that can be eaten by humans (eg, ice cream cones) to decrease the risk of children eating food that has come into contact with animals.
  • Promptly remove manure and soiled animal bedding from these areas.
  • Assign trained staff members to encourage appropriate human-animal interactions, identify and reduce potential risks for patrons, and process reports of injuries and exposures.
  • Store animal waste and specific tools for waste removal (eg, shovels and pitchforks) in designated areas that are restricted from public access.
  • Avoid transporting manure and soiled bedding through nonanimal areas or transition areas. If this is unavoidable, take precautions to prevent spillage.
  • Where feasible, disinfect the area (eg, flooring and railings) at least once daily.
  • Provide adequate ventilation both for animals and humans.
  • Minimize the use of animal areas for public activities (eg, weddings and dances). • If areas previously used for animals must be used for public events, they should be cleaned and disinfected, particularly if food and beverages are served.

In addition, the Pennsylvania legislature enacted a law mandating standards for animal exhibition sanitation. The Pennsylvania law requires animal exhibit operators to “promote public awareness of the risk of contracting a zoonotic disease” by posting notices. The law further requires adequate hand-cleansing facilities and prohibits the exhibition of any animal not properly cared for by a veterinarian.

Thus, even before the outbreaks in North Carolina and Florida in the fall and winter of 2004-2005, the risk of disease transmission and the means of reducing that risk were well known. This common knowledge forms the basis of legal liability for both the private and governmental entities that operate animal exhibitions. While laws vary from state to state, the liability of these entities to those sickened through exposure to animals on site would be based in the premises of both liability and negligence.

Under premises liability law, the entity or entities responsible for managing an animal exhibition have a duty of care to those it invites onto the premises. This duty includes the responsibility to adequately reduce risks the entity is or should be aware of. The duty also carries a responsibility to warn fairgoers of risks present at the exhibition.

The principles of negligence also revolve around the risks to fairgoers that animal exhibitors know of or reasonably should know of. To successfully bring a negligence claim, a sickened person would need to show that the actions of an animal exhibitor fell below a reasonable standard of care in the operation of the exhibit. Failing to implement the well-established recommendations of the CDC and NASPHV constitutes falling below that standard of care.

Both bases for liability on the part of animal exhibitors-premises liability and negligence-carry with them a burden of education on the part of the exhibitor. Because the law holds people to a standard of what they reasonably should know, ignorance of the risks involved is not an effective defense. The law thus provides no impetus to stray from the course of action that is best for both customers and exhibitors in the first place-recognizing the risk and taking steps to reduce it.

Following the E. coli O157:H7 outbreak in North Carolina, the Terry Sanford Institute of Public Policy at Duke University contracted with the North Carolina Department of Health and Human Services to develop recommendations on regulating petting zoos. The researchers concluded:

In response to the largest outbreak of Escherichia coli (E. coli) in North Carolina history, we recommend that the North Carolina Department of Health and Human Services (DHHS) issue guidelines and pursue legislation that will control public contact with animals, inform the public of risks related to animal contact, provide transition areas, regulate animal care, and license petting zoos.

The North Carolina Legislature subsequently adopted “Aedin’s Law,” named after a young child who was severely injured in the outbreak. According to the preamble of the bill, the child was hospitalized for 36 days and will suffer lifelong injury from complications of HUS. Aedin’s Law requires that animal exhibitors acquire a public permit. The bill further requires the North Carolina State Board of Agriculture to adopt regulations in line with those of the Duke University study and CDC.

There are benefits to continuing the tradition of animal exhibits – it is a recreational and educational link to our country’s ongoing agricultural heritage. Slowly heeding the hard lessons learned, private, public, and legal forces are at work to reduce the risks associated with this pastime. Animal exhibitors are unwise to view these changes as a threat, or those working for change as enemies. Likewise, it is shortsighted to resist the recommendations and guidelines offered to make the animal exhibits safer. The long-term existence of animal exhibits to the public cannot be assured in an environment that permits the possibility of large-scale, life-threatening disease outbreaks like those that occurred in North Carolina and Florida. And, the best way to keep the lawyers out of it is to keep the children safe.

References

  1. See E. coli O157:H7 outbreak in Whatcom County, Washington Final Investigation Summary – http://wa-whatcomcounty.civicplus.com/CivicSend/ViewMessage/Message?id=5760
  1. See http://www.fair-safety.com/fair-outbreaks.htm
  1. E. Keen, T.E. Wittum, J.R. Dunn, J.L. Bono, and M.E. Fontenot. 2003. “Occurrence of STEC O157, O111, and O26 in Livestock at Agricultural Fairs in the United States,” Proc. 5th Int. Symp. on Shiga Toxin-Producing Escherichia coli Infections, Edinburgh, UK 22 (2003) – http://www.ars.usda.gov/research/publications/Publications.htm?seq_no_115=144426
  1. National Association of State Public Health Veterinarians, Inc. (NASPHV). “Compendium of Measures to Prevent Disease Associated with Animals in Public Settings – http://nasphv.org/documentsCompendiumAnimals.html
  1. CDC, “Notice to Readers: Availability of Final Recommendations on Reducing the Risk for Transmission of Enteric Pathogens at Petting Zoos, Open Farms, Animal Exhibits, and Other Venues,” 50 MMWR Weekly, 928 (October 25, 2001) – http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5042a6.htm
  1. Outbreak Response and Surveillance Unit, Recommendations: Farm Animal Contact, (Atlanta, CDC September 2002) – http://www.cdc.gov/foodborneoutbreaks/publication/recomm_farm_animal.htm
  1. See 3 Pa. C.S. [section]2501 et seq
  1. Dustyn Baker, Tugba Gurcanlar, Emily Hildebrand, Matthew Perault, & Kuang-zhen Wu, “E. coli Outbreak Creates Need for Government Regulation” (Terry Sanford Institute of Public Policy May 2005) – http://www.fair-safety.com/ecoli-public-policy.pdf
  1. See N.C. S. L. 2005-191
  1. Marler speech to Washington State Fair Association 2005 – http://www.slideshare.net/marlerclark/2005-washington-fair-assoc