Dying for Better Warning Labels: The Short and Lonely Life of the Laboratory Research Dog

In Kazuo Ishiguro’s 2005 novel, Never Let Me Go (made into a movie in 2010), children at an isolated English boarding school do not have parents but rather "guardians," people who continually encourage them to remain healthy. Three students learn that this emphasis on health is not for their own good, but because they have a special function. They are clones created for only one purpose, to produce healthy organs for people who need to replace parts of their bodies. After the organs of these clones have been harvested, they will die, a step referred to as "completion." The school and the students come from a novelist’s imagination, but for laboratory animals such a world is not fictional. 

As Lynda Birke wrote in a 2012 article in Body & Society, the “edifice of what we call scientific, medical, knowledge is built upon animal corpses.” Dogs have been specifically bred for laboratory experimentation as commercial products for over a hundred years (Asdal 2008), but this segment of the canine breeding industry, unlike all other dog breeders, strives to remain as inconspicuous to the general public as possible. The scientists who perform research on animals also avoid describing how those animals were used in their experiments, perhaps 45% of the time do not indicate how the animals were killed, and frequently do not even acknowledge that the animals in fact died (Smith et al. 2005). One seminal analysis of animal research papers found that of 98 papers describing “procedures which must have involved the death of the animals involved,” only 44 of the papers mentioned that the animals in the experiments had died (Smith et al. 1997). In 2019 there were about 65,000 dogs in U.S. laboratories and about 18,000 dogs in EU laboratories.

Killing Snails and Slugs

Laboratory Research Dog (courtesy Peta)

When I go through the Federal Register every morning, I look for certain topics, including terrorism financing and anti-money laundering regulation, as well as references to dogs, wolves, and other terms relevant to interests of mine.  Many, perhaps most, of the federal government releases that refer to dogs are of only passing interest, including items about drugs that are being approved for veterinary use with dogs, food additives that are being found safe for use in dog food, or sometimes not safe, and occasionally references to pesticides and other chemicals that may put dogs at risk if ingested.  Such references are usually brief, often contained only in tables that summarize research findings, and rarely draw my attention.  These findings sometimes mean that dogs were used in experiments, that is, that dogs were laboratory animals being given food or undergoing procedures to see what the effects of administering a chemical might be. 

Somewhere in the back of my mind, when I encounter such references, is an image of a dog in a cage in a sterile room, looking at other dogs in cages, none ever having any name beyond  numbers on their cages, perhaps allowed a brief period of exercise each day in a small room with a concrete floor and windows too high to look out, perhaps not even allowed to play with other dogs if companionship might violate somebody’s requirements for the research being conducted on them, often maimed or killed in the interest of science and human welfare, autopsied with organs weighed and then biopsied to establish variance from a control population (which may also be killed, but here it is sometimes possible to use legacy statistics from other laboratories), and finally disposed of as laboratory waste rather than given any dignity in a burial or individual cremation.    

Recently I saw a document that gave more information than is usually available, more than I really wanted to know because it forced me think about what the animals’ lives were like, something I try not to think about, until I can’t avoid it.  The Federal Register for March 4, 2015, contained a release of the Environmental Protection Agency that provided tolerances for residues of metaldehyde in parts per million (ppm) on certain commodities including ginseng (0.25 ppm), pea and bean (succulent shelled, subgroup 6B, 0.20 ppm), vegetable, foliage of legume (except soybean, 1.5 ppm), clover (forage and hay, each 0.60 ppm).  Metaldehyde is a molluscicide that is used by growers and gardeners to kill snails and slugs and the EPA was doing some fine tuning to its regulation (40 CFR 180.522) on how much can be present in certain food items for human and animal consumption, such as for cattle that are slaughtered for meat markets.

Metaldehyde (National Center for Biotechnology Information)

This Federal Register release was almost certainly of no interest to anyone outside of a relatively small set of farming and agricultural production facilities, and of only slightly more interest to manufacturers of metaldehyde.  Known more technically as 2,4,6,8-tetramethyl-1,3,5,7-tetroxocane, metaldehyde is sold, according to the National Center for Biotechnology Information, under at least 65 trade names, including Antimilice, Ariotox, Blitzem (in Australia), Cekumeta, Deadline, Defender (in Australia), Halizan, Limatox, Limeol, Meta, Metason, Mifaslug, Namekil, Slug Fest Colloidel 25, and Slugit. A UC Davis website concerning pests in gardens and landscapes states that this is the most common snail and slug bait product available, but adds the following warning:

[M]etaldehyde baits are particularly poisonous to dogs and cats, and the pelleted form is especially attractive to dogs. Don’t use metaldehyde snail baits where children and pets could encounter them. Metaldehyde baits containing 4% active ingredient are more effective than those containing only 2%; however, they also are more toxic to dogs and wildlife. Avoid getting metaldehyde bait on plants, especially vegetables.

The entry in the Federal Register came about because a research group at Rutgers University, the IR-4 Project, had recommended in 2013 that tolerance levels for metaldehyde on certain crops be established, and recommended changes to tolerance levels previously set by the EPA for certain other crops.  This is a case where a university research program was filling in certain gaps in industrial research that would not be cost-effective for chemical manufacturers to conduct.  The crops with new tolerance levels included ginseng, certain peas, beans, and tomatoes, forage clover and hay

The EPA’s release effectively finalized some of the proposals previously made by IR-4.

Toxicological Profile

The March 4 Federal Register release contained the following sentences in the description of the toxicological profile of metaldehyde:

The principal toxic effects for metaldehyde are clinical signs of neurotoxicity, as well as changes in the liver and testes/prostate following repeated oral dosing. The dog is the most sensitive species for neurotoxic effects. Nervous system effects observed in the subchronic and chronic oral toxicity studies include: Ataxia and tremors; twitching; salivation; emesis; rapid respiration in dogs and maternal rats; and limb paralysis, spinal cord necrosis, and hemorrhage in maternal rats. Liver effects include increased liver weight, increased incidence of liver lesions (hepatocellular necrosis, hepatocellular hypertrophy and inflammation), and an increased incidence of hepatocellular adenomas in female rats and in both sexes of mice. In dogs, atrophy of the testes and prostate was observed following subchronic and chronic exposure.

Summary of Toxicological Doses and Endpoints for Metaldehyde Use in Human Health Risk Assessment (EPA 2013)

Things like liver weights and prostate size could not have been precisely determined without killing the dogs and extracting their organs.  This got me wondering where the information on metaldehyde’s effects came from, but the EPA gave no citation to support its short description.  In 2013, however, in an earlier release setting limits on residues for metaldehyde on various commodities (78 Fed. Reg. 70864, November 27, 2013), the EPA again did not name the original studies on toxicity of metaldehyde, but did include a table of “toxicological doses and endpoints for metaldehyde for use in human health risk assessment.”  Note that although the table is intended to provide a human health risk assessment, the recommendations for limits are based, as indicated in the fourth column, on a “chronic dog oral toxicity study.”  Some acronyms need defining: 

NOAEL = no-observed-adverse-effect-level

LOAEL = lowest-observed-adverse-effect-level

LOC = level of concern

MOE = margin of exposure

UF = uncertainty factor

UF_A = uncertainty factor extrapolated from the study on dogs to humans because humans, of course, are not available to be put in cages and administered poisons to undertake such tests.  UF_H = potential variation among humans, i.e., once the dosage limit is extrapolated from dogs to humans, how much variation in that estimate there might be in the human population. 

RID = reference dogs

The 2013 release added some detail to the information about the dog studies on which the various limits for metaldehyde were determined, stating that clinical “signs (ataxia, tremors, twitching, salivation) in the chronic dog study, which occurred within the first week of explosure and persisted through week 19 (other signs included lateral position, reduced mobility, convulsions, and vocalization in one female, and agitation in another).” Thus, some of the dogs had been given doses of metaldehyde over at least 19 weeks, almost five months, and one female dog protested her unfair lot by barking while another may have begun to lose her mind. 

Metaldehyde Dog Experiments

The U.S. Environmental Protection Agency publishes a manual, Recognition and Management of Pesticide Poisonings (Roberts and Reigart 2013), which gives sources that were not provided by the agency in its Federal Register releases.  Prior to 1986 there had only been two metaldehyde pharmacology studies, both of which used mice, that had found (1) a significant decrease in the brain concentration of γ-aminobutyric acid, (2) and increase in monoamine oxidase activity, and (3) a significant decrease in brain levals of noradrenaline, 5-hydroxytryptamine, and 5-hydroxyindoleacetic acid.  The LD50 for rats (the dosage level that would kill 50% of a population of test animals) was determined to be between 420 and 690 mg/kg (milligrams per kilogram of body weight). 

Then in 1986, Booze and Oehme used dogs instead of rats. They chose 15 “healthy mixed-breed male dogs” weighing between 8 and 19 kilograms (18 and 42 pounds), from six months to two years old.  Using young dogs is preferred so that measures such as organ weight and damage can largely exclude effects of aging. The animals came from Kansas State University’s Animal Resources Facility (renamed the Comparative Medicine Group in 2009).  Dogs were “housed individually in large metabolism cages, two to a room.”  (Metabolism, or metabolic cages, have themselves been the subject of research.  Sabchuk et al. (2012) found that “dogs kept in metabolic cages eliminate drier feces and spend more time inactive than those kept in kennels.” The dogs in this study also slept more in cages than kennels.) 

The dogs were given dry dog food and free access to water.  Eight dogs were orally dosed with 600 mg of metaldehyde (or 600 mg of acetaldehyde) per kg of body weight. An arterial catheter was surgically placed in the left carotid artery under anesthesia, “and brought to the surface on the left side of the neck, where it was kept in place by a Velcro-fastened enclosure.”  Dogs were dosed at 8 a.m., with blood samples obtained after 15 minutes, 45 minutes, and then hourly for 12 hours after the dose was administered.  Urine samples were collected in a stainless steel pan under the cage until the drugs were no longer detected.

Tremors were graded into four categories: none, slight, moderate, severe; respiration as normal, panting, or labored; salivation as normal, increased, or thick; coordination as normal or abnormal; hyperesthesia (increased sensitivity to stimulation) as absent or present; vomiting as absent or present; and diarrhea as absent or present.  One dog had tonic-clinic convulsions, profuse and thick salivation, hyperesthesia, and ataxia, and died 4.5 hours after dosing.  The remaining dogs appeared normal a day after dosing.  The clinical signs occurred in the following numbers of the eight dogs dosed with metaldehyde:

Slight tremors	8
Moderate tremors	3
Severe tremors	2
Ataxia	4
Hyperesthesia	4
Increased salivation	2
Death	1

The authors concluded that the LD50 of metaldehyde for dogs is greater than 600 milligrams per kilogram of the dog’s body weight, refining a previous estimate of the same authors (1985), based on poisoning cases, of between 100 and 1,000 mg/kg of body weight.

More recent dog research on metaldehyde was conducted in England.  A 1996 British government report by the Department of Environment, Food and Rural Affairs, Pesticides Safety Directorate, describes an unpublished German study (Neumann 1980) using smaller doses of metaldehyde (20, 60, or 90 mg/kg body weight/day) where there were “no clinical or ophthalmological signs of toxicity and no deaths” over six months of dosing.  The research also found that “clinical chemistry, haematology and urinalysis were unaffected by treatment.”  All of which makes the study sound relatively harmless to the dogs except for the observation that “post-mortem organ weights were not affected by the treatment.”  The animals were killed at the end of the study to verify internal effects resulting from the administration of the pesticide.   The NOEL level (no observed effect level) for metaldehyde, from this study was determined to be 20 mg/kg body weight/ day.  It is on the basis of this finding that some of the minimum levels of metaldehyde in agricultural products were established. 

Laboratory Animal Welfare Act

The fate of laboratory dogs is all quite legal, of course, though Congress has taken occasional interest in laboratory animals, often because of stories disturbing to the public about escaped pets that ended up as subjects in research facilities (National Research Council 2009).  This generally happens in states that permit pounds to sell pets, usually after a short period, to research facilities as an alternative to euthanizing them.  (The connections between pounds and research facilities could itself be an extensive study.) 

Number of Animals Covered by AWA Used in Research 2001-2007 (NRC 2009)

The number of animals over a seven-year period from 2001 to 2007 that were used as research subjects is indicated in a table provided in the NRC’s 2009 report, taking statistics from an earlier USDA report.  Fortunately, sporadic statistics for later years indicate that the number of dogs used in experiments continues to decline.   

Section 13 of the Animal Welfare Act of 1966 (PL 89-544, August 24, 1966) provides that the Secretary of Agriculture is to “establish and promulgate standards to govern the humane handling, care, treatment, and transportation of animals by dealers and research facilities.”  Standards are to include requirements on “housing, feeding, watering, sanitation, ventilation, shelter from extremes of weather and temperature, separation by species, and adequate veterinary care.” 

Under 9 CFR 3.7, which concerns the humane handling, care, treatment, and transportation of dogs and cats by “dealers, exhibitors, and research facilities,” specifies that if “a dog is housed, held, or maintained at a facility without sensory contact with another dog, it must be provided with positive physical contact with humans at least daily.” Thus, the research facility has a choice between giving dogs contact with each other or contact with people. 

The National Research Council of the National Academies publishes a Guide for the Care and Use of Laboratory Animals (8^th ed. 2011), which accepts that dogs, cats, rabbits, and other animals benefit from “positive human interaction.”  Dogs are singled out as regards human attention: “Dogs can be given additional opportunities for activity by being walked on a leash, having access to a run, or being moved into areas for social contact, play, or exploration.” 

Cage Height Table (NRC 2011)

Dogs have an advantage over most experimental species, according to the NRC’s Guide, in that they can be “trained, through use of positive reinforcement techniques, to cooperate with research procedures or remain immobile for brief periods.”   (See also Meunier 2006.) Dogs, because they are “noisy animals,” should be housed away from where research is being done.  When possible, they should be given “manipulable toys.” However, their noisiness, according to the Guide, makes them useful in research where pain thresholds are being measured.  (See, e.g., Devitt et al. 2005; Holton et al. 1998.)

Dogs have the disadvantage of needing more space in cages that cats and rabbits, so the fact that dogs are used less extensively than some other species is not wholly due to the reluctance of researchers to use animals that their children might think of as pets.  Cage size also determines why certain breeds, such as beagles, are more common in research settings (Andersen 1970). 

Various organization, including Peta and the Humane Society, have launched campaigns to improve the lot of laboratory animals, in some cases attempting to force the USDA’s Animal & Plant Inspection Service to investigate complaints about how some laboratories care for animals on which they are experimenting.  Of course, this goes only to the more superficial trappings of what happens to these animals, insuring that cages are cleaned, vermin are removed from the environment, wounds are treated, etc.  The fact that there is often a horror to the overall fate of these animals is not something that the present law or rules will do anything to alleviate.

Sociological Research on Researchers Who Use Dogs in Lethal Experiments

Lynda Birke of the University of Chester, already quoted, must be read if one wants to delve into the nether world of the use of animals in biomedical research. In a 2012 paper she gets as close to the core of anyone I have read as to why we find the use of animals in experiments to be acceptable:

We inherit a long history of cultural beliefs that animals, unlike humans, do not have souls/consciousness, and that other species cannot perceive pain or perceive it less than we do. Thus we can justify producing sick animals as models, and we can accept probing into their bodies in the search for understanding what bodies do. Indeed, it is precisely because of that history of human exceptionalism that probing into animals’ living bodies in pursuit of knowledge becomes acceptable. Animal bodies, whether alive or dead, thus stand in for human ones, representing our diseases – so much so, that lab animals can be said to represent our salvation from the terror of our own mortality.

Arnold Arluke of Northeastern University, who has also studied how researchers relate to laboratory animals and is a sometime collaborator with Birke, notes (Arluke 1988) that researchers often prefer to avoid eye contact with the dogs on which they experiment. 

A laboratory that transported conscious dogs kept them in a private hallway outside the laboratory until moments before an experiment was to get under way. Another laboratory, which had no such hallway, would turn the dogs' cages to face a wall and sometimes drape surgical sheets over the cages as well.

Laboratory Research Beagle (courtesy Peta)

Arluke reports that laboratory technicians often prefer purpose-bred dogs—dogs that have never known anything but cages in breeding facilities and experimental environments—because these dogs are less likely to behave like pets, to extend a paw for contact, to whine, to sit on command, in other words to behave like an animal that should be cared for.  Shapiro (1989) concludes that researchers attempt to view an animal they are dealing with not as an individual, not even as a member of a species, but rather as an organic process, a biological organism, a physiological system, or, as Birke (2012) says, “a specific local accomplishment of the organization of laboratories and their associated infrastructure.”  She elaborates:

Once lab animals are thus perceived, it becomes more difficult to see them in the same way as ‘naturalistic’ animals elsewhere. They are different: they would not exist were it not for the demands of experimental science. As such, we can learn to justify intrusion into their bodies for a putative greater good, and we can learn (if somewhat ambivalently) to see their bodies as sums of parts.

As someone who once did research to determine if intertidal crabs could orient toward the nearest shore by the position of the sun or, at night, the moon, I am aware of how easily the objective of the research, and its importance to the advancement of science (or at least to one’s career), can become an excuse for ignoring the effects of the experiments on the animal subjects that are producing the raw data.  Yet it sometimes moves to the macabre, and must make us question our humanity, as with a technician described by Arluke (1988) who amused his colleagues by addressing a dog he was about to anesthetize by saying to it, “Okay Fido, let’s boogie!”

Birke (2012) also notes that because of an animal’s species-specific biology, its ability to stand in for humans and provide relevant conclusions may often be questionable.  This, of course, opens up yet another issue that could fill volumes.  

 

Rehoming Laboratory Dogs 

Efforts are increasing to rehome laboratory dogs‒i.e., to put them up for adoption‒if they are lucky enough not to have been used in an experiment with a terminal protocol. This trend raises the obvious question of how well dogs that have lived a portion of their lives in laboratory cages will adapt to a home environment, a question that has become a research topic for some behaviorists and psychologists (Doring et al. 2017a, 2017b; Skidmore and Roe 2020; Lopresti-Goodman and Bensmiller 2022). These studies generally concluded that laboratory dogs could be given to private owners successfully.  To call this "rehoming" rather misses the fact that most of the dogs had, prior to being taken from research facilities, no home in the conventional sense for most pets. 

 

The studies generally demonstrated that former laboratory dogs have the resiliency necessary to fit into the lives of the families that adopted them, and were on some measures perhaps better pets than most dogs without similar experiences in that they were less likely to chase cats and birds or roll in their feces. They tended to be more fearful of strangers, however, and to react more to sudden and loud noises. Despite being more fearful of strangers, they were less likely to be aggressive towards strangers. Beagles that are aggressive towards strangers, however, may be poor candidates for rehoming and may remain in shelters indefinitely, creating an overall bias in the samples of rehomed dogs. 

 

Beagles adopted from laboratories were generally more anxious and fearful, and showed more separation anxiety, than beagles that had not had the same experience, and these effects could last for up to four years and, in some cases, even longer. While experimenters generally knew little about the nature of the experiments that were performed on rehomed dogs, there were indications that some dogs could be appropriately diagnosed as having canine post-traumatic stress disorder (CPTSD), a phenomenon that has been reported in military working dogs. Dogs used in disease research and toxicity testing often undergo painful and distressing procedures that could put them at risk for CPTSD.

Conclusion

If it could be shown that some research directed towards human health requires validation through experiments on medium-sized mammals (National Research Council 2009 accepts that this is the case), and admitting that some core element of our humanity requires that we not use members of our own species as research subjects, then insisting that dogs not be used while pigs or rabbits can be used seems arbitrary, as if we must heed the advice of the Chick-fil-A cows and EAT MOR CHIKIN.  Birke et al. (2006) cite one scientist who did not have a problem experimenting on certain species, but could not see working with dogs, cats, or monkeys. 

Yet perhaps there should be a social contract in the human-canine relationship, as if the fact their varied and complex assistance to us throughout the long history of their domestication creates an obligation on us to excuse them from the more horrific burdens of domesticated status.  Even if this is accepted, however, it does not prove that we move onto a moral high ground if we insist that dogs not be used in painful and fatal experiments yet accept that pigs can be. 

Scientists should indicate in published research when and how animals are used, and when they are killed for experimental purposes.  Federal and state agencies relying on such research for setting standards should at least refer to the research, in the Federal Register or elsewhere, when indicating the justification for a standard being set. Steps should be taken to lift the veil of secrecy that has been built to protect the industry that produces animals for research.  Efforts by various groups, such as the Humane Society, to find out about conditions of laboratory animals often require filing of Freedom of Information Act requests with the USDA and other inspection services.  Such reports should be publicly available, without advocates having to figure out where information and statistics may have been hidden by government bureaucracies to avoid the possibility of public outrage.  

Finally, although efforts should continue to be made to regulate the transfer of animals from pounds and general dealer markets into research markets, the use of purpose-bred dogs by laboratories should not create a façade that allows us to ignore the horror faced by such dogs just because they were never pets or around other dogs that were to become pets. Purpose-bred dogs are as horrifying as purpose-bred people. Like the children in Ishiguro’s novel, such dogs have only one purpose, and often one fate, and many, in the few short years they are allowed to live, will never be able to stand tall enough to look out to any other world. We cannot absolve ourselves, even if we can justify our research.   

Additional Notes: For a discussion of "compassion fatigue" among individuals who care for laboratory animals, see an article in Science written by David Grimm, "Suffering in Silence: Caring for research animals can take a severe mental toll. Is anyone listening?" The EPA continues to adjust its metaldehyde regulations, though it is not clear that any additional dog experiments have been conducted in doing so. 81 Fed. Reg. 71633 (October 18, 2016). 

This blog was written by John Ensminger and L.E. Papet.

Sources:

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31. Shapiro, K.J. (1989).  The Death of the Animal: Ontological Vulnerability.  Between the Species, 5, 183-193.
32. Skidmore, T., and Roe, E. (2020). A Semi-Structured Questionnaire Survey of Laboratory Animal Rehoming across 41 UK Animal Research Facilities. PLoS One 15(6), e0234922.
    
33. Smith, J.A., Birke, L., and Sadler, D. (1997). Reporting Animal Use in Scientific Papers.  Laboratory Animals, 31(4), 312-317.
34. Smith, A., Munthe, A.C., and Strengehagen, K. (2005).  Reporting the Results of Animal Experiments: An Analysis of 160 Articles Published in 2004.  Berlin: Fifth World Congress on Alternatives & Animal Use in the Life Sciences.
35. Steenbergen, V.M. (2004).  Taking the Bait: Metaldehyde Toxicosis.  Veterinary Technician.

GAO Chides TSA for Failure to Place Bomb Dogs at Airport Checkpoints

A report of the Government Accountability Office published February 17, 2016, summarizes recommendations the GAO has made since 2003 concerning the Transportation Security Administration's security-related technology acquisitions (GAO-16-276).  The GAO report contains the following chart, which indicates that TSA has failed to implement a total of seven GAO recommendations, two from 2004, one from 2012, one from 2013, and three from 2014.  

GAO Recommendations on TSA Acquisitions 2003-2015

Most of the unimplemented recommendations have nothing to do with dogs, but two that were made in 2013 concerned explosive detection dogs for passenger screening.  One recommendation was that TSA should determine the effectiveness of dogs in passenger screening.  The GAO had stated in two prior reports (GAO-13-239 and GAO-14-695T) that passenger screening canines sometimes misidentified which individuals were actually carrying explosives at airports.  This was discussed in several prior blogs (February 18, 2013; January 22, 2015) and the GAO even released a video clip (scroll down in blog of January 22, 2015) of one of its tests showing a dog passing by a decoy carrying an explosive odor and alerting to an innocent passenger walking through a terminal.  Despite this obvious problem, the GAO now says that TSA has appropriately determined the effectiveness of TSA-deployed canines.  It would be useful for the public's peace of mind to know what changed in the last few years to lead the GAO to place its stamp of approval on TSA canines, but we may have to wait a long time for any significant information about this.

The other recommendation that was made in 2013, but which has not been fully implemented according to the GAO, concerns the location of passenger-screening canines throughout airports.  The 2013 report had much to say about this, but the 2016 report only indicates that passenger-screening dogs are not being used at checkpoints. Again, the current report provides little detail on the present level of this deficiency.  If TSA is resisting the idea of deploying dogs at checkpoints, this may have more to do with concerns that clogged checkpoints would become even more clogged with dogs present.  A highly publicized letter from Miguel Southwell, General Manager of the Hartsfield-Jackson Atlanta International Airport to Peter Neffenger, TSA Administrator, states that if TSA cannot speed up checkpoint screening, the Atlanta airport may replace TSA screeners with private contractors.  How this might affect canine operations throughout the airport is not clear, but TSA may not want to signal at this time that it will add more steps to the checkpoint process.  Rather than re-analyzing the issues regarding TSA canine deployments with such little information to go on, I have chosen to add a brief discussion to the Update Notes in the prior blog posted February 18, 2013. 

Labor Department Proposes Service-Animal Rules for Job-Training Agencies and Programs

Additional Notes:  In December, the Department of Labor finalized the regulations discussed in this blog (81 Fed. Reg. 87130, December 2, 2016).  Several commenters to the proposal issued in January had recommended that miniature horses should be included in the service-animal definition, or given the kind of provisional status they have received from the Department of Justice.  In the preamble to the final rules as just issued, the Department states:

An advocacy organization recommended that the definition of “service animal” be expanded to include emotional support animals to be consistent with language in the Pennsylvania Human Relations Act and the Federal Fair Housing Act. Another advocacy organization suggested that CRC eliminate or explain the differences between CRC’s and DOJ’s language regarding emotional support and the exclusion of miniature horses as service animals. Similarly, a state-based organization serving individuals with developmental disabilities recommended that the definition of “service animal” be revised to include miniature horses. The commenter noted that, even though current ADA requirements recognize dogs only as service animals, it also permits the use of a miniature horse as a service animal in certain circumstances.

The references in this paragraph are to the State of Michigan's Developmental Disabilities Council and Psychiatric Service Dog Partners. To such suggestions, the Department now says:

In the interest of uniformity, our definition of a service animal under section 38.4(fff) is limited to dogs, consistent with the Department of Justice's 2010 ADA Title regulations. While another section of the DOJ Title II regulations sets out standards for the reasonable modificaiton of policies, and procedures to permit miniature horses to be utilized in certain circumstances and under specific criteria, this is different from including miniature horses in the definition of "service animal."

Uniformity, however, would be to include such a separate provision. The Department also rejected the idea that emotional support animals should be included in the service-animal definition. This, however, could not be said to be a surprise because the Department had demonstrated no interest in broadening the DOJ definition.

As I noted in the original blog below, the most important question was whether these rules might become a model for more significant enforcement areas delegated to the Department of Labor. Though that is still possible, the demonstrated aversion of the incoming administration to regulations in general, as well as the visible contempt of the president-elect towards those with disabilities, make it unlikely that these provisions will have broader significance for some years.

The original blog follows.  

The Department of Labor has shown little inclination to issue regulations regarding service animals. In the entire of Title 29 of the Code of Federal Regulations there is only one reference to a service animal and one to a guide dog, and both are in explanatory texts rather than in the regulations themselves. Thus, in describing mitigating measures that should not be taken into account in determining whether an impairment substantially limits a major life activity, the explanatory language to 29 CFR 1630.2(j)(1)(vi), gives a service animal as an example of a mitigating measure not to be taken into account.  In other words, blindness substantially limits a major life activity even if a guide dog allows the individual with a disability to function more close to normal, and deafness severely limits a major life activity even if a hearing dog allows the dog’s owner to respond to sounds in his or her environment.  Eyeglasses and contact lenses are an exception to this logic, so that if a person with vision impairment can function normally with glasses, he or she may not be categorized as having an impairment that substantially limits a major life activity. 

The reference to a guide dog in Title 29 comes only a few pages away and concerns 29 CFR 1630.2(o), a section that gives a number of definitions, including one for “reasonable accommodation.” The explanatory language states that it “would be a reasonable accommodation for an employer to permit an individual who is blind to use a guide dog at work, even though the employer would not be required to provide a guide dog for the employee.” Thus, whether an employee should be able to have a service animal in a workplace is a matter that requires a reasonable accommodation analysis.  

Workforce Innovation and Opportunity Act

This dearth of regulatory attention to service animals by the Department of Labor has changed dramatically with the issuance of proposed regulations that would implement the Workforce Innovation and Opportunity Act (PL 113-128, abbreviated "WIOA"), signed into law by President Obama on July 22, 2014. This Act was designed to provide federal funds for workers to learn new skills to enable them to compete for jobs in growth sectors of the 21^st century economy.  The Act prohibits agencies receiving federal funds for this purpose from discriminating on the basis of race, color, religion, sex, national origin, age, disability, or political affiliation or belief. Section 3(25) of the Act defines “an individual with a disability” as “an individual with a disability as defined in section 3 of the Americans with Disabilities Act of 1990 (42 U.S.C. 12102).”  The proposed rules, published in the Federal Register on January 26, are open for comment until March 28, 2016.  (Department of Labor, Implementation of the Nondiscrimination and Equal Opportunity Provisions of the Workforce Innovation and Opportunity Act, RIN 1291-AA36.  81 Fed. Reg. 4494, January 26, 2016)

The anti-discrimination provisions apply to recipients of federal funds provided under the Act.  A recipient is defined under proposed 29 CFR 38.4(zz) as an entity that receives assistance either directly or indirectly, such as a state or any of the following entities:

(1) State-level agencies that administer, or are financed in whole or in part with, WIOA Title I funds;

(2) State Workforce Agencies;

(3) State and local Workforce Investment Boards;

(4) LWIA [Local Workplace Investment Area] grant recipients;

(5) One-Stop operators;

(6) Service providers, including eligible training providers;

(7) On-the-Job Training (OJT) employers;

(8) Job Corps contractors and center operators;

(9) Job Corps national training contractors;

(10) Outreach and admissions agencies, including Job Corps contractors that perform these functions;

(11) Placement agencies, including Job Corps contractors that perform these functions;

(12) Other National Program recipients.

Thus, programs and activities that receive federal financial assistance under the Act cannot discriminate against participants with disabilities who use service animals. As to why DOL decided to deal with service animals in these proposed regulations, DOL says that the “Department’s discussions with recipients’ EO [Equal Opportunity] Officers demonstrate that there has been some confusion on the part of recipients as to what constitutes a service animal and what constitutes a pet.” 

Service Animals under New DOL Regulations

The regulations now proposed for 29 CFR Part 38 would replace final regulations published in July 2015 that were in question and answer form but which brought complaints from recipient agencies that found the format confusing and difficult to navigate.  Those regulations did not mention service animals.

Given that many covered entities are state-level agencies, it is not surprising that DOL has now chosen to rely on the DOJ service-animal regulations that apply to state and local governments.  There are differences between the service-animal rules of the two Departments, however, the major ones being (1) the inclusion of a provision on the presence of service animals in food preparation areas in the DOL rules, and (2) the absence of any mention by DOL of miniature horses as a category that, while not formally labeled service animals by DOJ, are at least provisionally covered by similar access provisions.  Those differences are highlighted in the table below, with the proposed rules of the Department of Labor on the left and the final rules of the Department of Justice on the right. 

Department of Labor	Department of Justice
29 CFR 38.4 Definitions. *** (fff) Service animal means any dog that is individually trained to do work or perform tasks for the benefit of an individual with a disability, including a physical, sensory, psychiatric, intellectual, or other mental disability. Other species of animals, whether wild or domestic, trained or untrained, are not service animals for the purposes of this definition. The work or tasks performed by a service animal must be directly related to the individual’s disability. Examples of work or tasks include, but are not limited to, assisting individuals who are blind or have low vision with navigation and other tasks, alerting individuals who are deaf or hard of hearing to the presence of people or sounds, providing non-violent protection or rescue work, pulling a wheelchair, assisting an individual during a seizure, alerting individuals to the presence of allergens, retrieving items such as medicine or the telephone, providing physical support and assistance with balance and stability to individuals with mobility disabilities, and helping persons with psychiatric and neurological disabilities by preventing or interrupting impulsive or destructive behaviors. The crime deterrent effects of an animal’s presence and the provision of emotional support, well-being, comfort, or companionship, without more, do not constitute work or tasks for the purposes of this definition.	28 CFR 35.104 Definitions. *** Service animal means any dog that is individually trained to do work or perform tasks for the benefit of an individual with a disability, including a physical, sensory, psychiatric, intellectual, or other mental disability. Other species of animals, whether wild or domestic, trained or untrained, are not service animals for the purposes of this definition. The work or tasks performed by a service animal must be directly related to the individual's disability. Examples of work or tasks include, but are not limited to, assisting individuals who are blind or have low vision with navigation and other tasks, alerting individuals who are deaf or hard of hearing to the presence of people or sounds, providing non-violent protection or rescue work, pulling a wheelchair, assisting an individual during a seizure, alerting individuals to the presence of allergens, retrieving items such as medicine or the telephone, providing physical support and assistance with balance and stability to individuals with mobility disabilities, and helping persons with psychiatric and neurological disabilities by preventing or interrupting impulsive or destructive behaviors. The crime deterrent effects of an animal's presence and the provision of emotional support, well-being, comfort, or companionship do not constitute work or tasks for the purposes of this definition.
29 CFR 38.16 Service animals.  (a) General. Generally, a recipient shall modify its policies, practices, or procedures to permit the use of a service animal by an individual with a disability. (b) Exceptions. A recipient may ask an individual with a disability to remove a service animal from the premises if— (1) The animal is out of control and the animal’s handler does not take effective action to control it; or (2) The animal is not housebroken. (c) If an animal is properly excluded. If a recipient properly excludes a service animal under paragraph (b) of this section, the recipient must give the individual with a disability the opportunity to participate in the WIOA Title I-financially assisted service, program, or activity without having the service animal on the premises. (d) Animal under handler’s control. A service animal must be under the control of its handler. A service animal must have a harness, leash, or other tether, unless either the handler is unable because of a disability to use a harness, leash, or other tether, or the use of a harness, leash, or other tether would interfere with the service animal’s safe, effective performance of work or tasks, in which case the service animal must be otherwise under the handler’s control (e.g., voice control, signals, or other effective means). (e) Care or supervision. A recipient is not responsible for the care or supervision of a service animal. (f) Inquiries. A recipient must not ask about the nature or extent of a person’s disability, but may make two inquiries to determine whether an animal qualifies as a service animal. A recipient may ask if the animal is required because of a disability and what work or task the animal has been trained to perform. A recipient must not require documentation, such as proof that the animal has been certified, trained, or licensed as a service animal. Generally, a recipient may not make these inquiries about a service animal when it is readily apparent that an animal is trained to do work or perform tasks for an individual with a disability (e.g., the dog is observed guiding an individual who is blind or has low vision, pulling a person’s wheelchair, or providing assistance with stability or balance to an individual with an observable mobility disability). (g) Access to areas of a recipient’s facilities. (1) In general. Individuals with disabilities must be permitted to be accompanied by their service animals in all areas of a recipient’s facilities where members of the public, participants in services, programs or activities, beneficiaries, registrants, applicants, eligible applicants/registrants, applicants for employment and employees, or invitees, as relevant, are allowed to go. (2) Use of service animals in food preparation areas. An employee, applicant or beneficiary with a disability who needs to use a service animal in a food preparation area must be allowed to do so unless the employer recipient, after an individualized assessment, can demonstrate, that the presence of the service animal presents a direct threat to health or safety that cannot be eliminated or reduced by a reasonable accommodation to the employee, applicant or beneficiary. (h) Surcharges. A recipient must not ask or require an individual with a disability to pay a surcharge because of his or her service animal, even if people accompanied by pets are required to pay fees, or to comply with other requirements generally not applicable to people without pets. If a recipient normally charges individuals for the damage they cause, an individual with a disability may be charged for damage caused by his or her service animal.	28 CFR 35.136  Modifications in policies, practices or procedures. (a) General. Generally, a public entity shall modify its policies, practices, or procedures to permit the use of a service animal by an individual with a disability. (b) Exceptions. A public entity may ask an individual with a disability to remove a service animal from the premises if— (1) The animal is out of control and the animal's handler does not take effective action to control it; or (2) The animal is not housebroken. (c) If an animal is properly excluded. If a public entity properly excludes a service animal under §35.136(b), it shall give the individual with a disability the opportunity to participate in the service, program, or activity without having the service animal on the premises. (d) Animal under handler's control. A service animal shall be under the control of its handler. A service animal shall have a harness, leash, or other tether, unless either the handler is unable because of a disability to use a harness, leash, or other tether, or the use of a harness, leash, or other tether would interfere with the service animal's safe, effective performance of work or tasks, in which case the service animal must be otherwise under the handler's control (e.g., voice control, signals, or other effective means). (e) Care or supervision. A public entity is not responsible for the care or supervision of a service animal. (f) Inquiries. A public entity shall not ask about the nature or extent of a person's disability, but may make two inquiries to determine whether an animal qualifies as a service animal. A public entity may ask if the animal is required because of a disability and what work or task the animal has been trained to perform. A public entity shall not require documentation, such as proof that the animal has been certified, trained, or licensed as a service animal. Generally, a public entity may not make these inquiries about a service animal when it is readily apparent that an animal is trained to do work or perform tasks for an individual with a disability (e.g., the dog is observed guiding an individual who is blind or has low vision, pulling a person's wheelchair, or providing assistance with stability or balance to an individual with an observable mobility disability). (g) Access to areas of a public entity. Individuals with disabilities shall be permitted to be accompanied by their service animals in all areas of a public entity's facilities where members of the public, participants in services, programs or activities, or invitees, as relevant, are allowed to go. (h) Surcharges. A public entity shall not ask or require an individual with a disability to pay a surcharge, even if people accompanied by pets are required to pay fees, or to comply with other requirements generally not applicable to people without pets. If a public entity normally charges individuals for the damage they cause, an individual with a disability may be charged for damage caused by his or her service animal. (i) Miniature horses. (1) Reasonable modifications. A public entity shall make reasonable modifications in policies, practices, or procedures to permit the use of a miniature horse by an individual with a disability if the miniature horse has been individually trained to do work or perform tasks for the benefit of the individual with a disability. (2) Assessment factors. In determining whether reasonable modifications in policies, practices, or procedures can be made to allow a miniature horse into a specific facility, a public entity shall consider— (i) The type, size, and weight of the miniature horse and whether the facility can accommodate these features; (ii) Whether the handler has sufficient control of the miniature horse; (iii) Whether the miniature horse is housebroken; and (iv) Whether the miniature horse's presence in a specific facility compromises legitimate safety requirements that are necessary for safe operation. (3) Other requirements. Paragraphs 35.136(c) through (h) of this section, which apply to service animals, shall also apply to miniature horses.

As to why DOL added a provision regarding service animals in food preparation areas, it is perhaps worth noting that the EEOC has a webpage, “How to Comply with the Americans with Disabilities Act: A Guide for Restaurants and Other Food Service Employees.” This webpage does not define “service animal” but does refer to an ADA website for further information on service animals, as well as cross-referencing to service-animal provisions in the Food Code, a document discussed here in a prior blog.  Placing the burden of establishing a reason to exclude a service animal from a food preparation area on the recipient of funds, rather than on the individual using the animal, is appropriate and, if DOL is considering expanding its service-animal provisions to other areas where it has regulatory authority, it is to be hoped that this approach will remain consistent.

The lack of  any mention of miniature horses, either in the text of the regulations or in the preamble, is more puzzling.  Whether this is due to reasons similar to those given by the Veterans Administration in declining to allow miniature horses in VA facilities, as discussed here when those rules were finalized last August, or is rather explained by a total lack of agency experience with miniature horses, is unclear. It is to be hoped that those advocating the use of miniature horses as service animals will sooner rather than later find an effective lobbying voice and begin commenting on regulatory ignorance of their existence. 

Conclusion

It might be hoped that DOL’s willingness to follow DOJ’s lead on service animal issues will soon extend beyond just the recipients of federal funds under a single program.  Two footnotes in the regulatory release give pause to such speculation, however.  Both footnotes state that the “EEOC has not addressed whether or not this definition [i.e., the definition of “service animal” in proposed 29 CFR 38.4 in the table above] would apply to employers and employment agencies covered under Title I of the ADA or Section 501 of the Rehabilitation Act.”  While these footnotes acknowledge a deficit in regulatory coverage, they may not imply that this deficit will be addressed any time soon but rather may be intended to emphasize that no extension of the current proposal regarding service animals to other areas under DOL's purview is to be anticipated.

FDA Food Production Rules Grant Access to Guard and Pest-Detection Dogs, but Why Are Guide Dogs the Only Service Animals Allowed into Some Buildings and Facilities?

The Food and Drug Administration has thousands of pages of regulations regarding the growing and manufacturing of food for human consumption, among which are rules about animal waste, which is a concern because of the possibility that, if found in human food, such waste can cause disease (Salmonella, E. Coli, Cryptosporidium, etc.). Two new sets of rules issued in September, concerning food manufacturing procedures, and November, concerning fruits and vegetables, add nearly five hundred pages to the total, and raise certain access issues as to specially trained canines that will be discussed here (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, 80 Fed. Reg. 55908, September 17, 2015; Standards for the Growing Harvesting, Packing, and Holding of Produce for Human Consumption, RIN 0910-AG35, 80 Fed. Reg. 74354, November 27, 2015).

General  FDA Policies on Reducing Animal Contamination Risks

In order to reduce the threat of contamination as much as possible, animals are generally prohibited to the extent practical from being in environments where food is grown, harvested, stored, processed, packaged, and otherwise altered before reaching retail outlets. Not all animals can be excluded, however. Grazing animals may be on farms where plants are being grown for human food. Livestock herding and guarding dogs may have to protect these grazing animals from predators. Guard dogs may be needed to protect buildings where food is processed and stored.  Pest-detection dogs may be needed to identify and eliminate various pests and infestations both in fields and pastures and inside of structures. Farm pets may run through fields and barns. Individuals with disabilities may work in food-producing environments and may require the assistance of service dogs. 

The FDA regulations in Title 21 of the Code of Federal Regulations recognize all these types of animals, except service dogs. Rather, the regulations recognize guide dogs only, most probably a legacy of that period where the only dogs with access greater than pets under disability law were guide dogs for the blind and visually impaired. The earliest references to guide dogs in FDA regulations date from 1986, before the 1991 regulations under the Americans with Disabilities Act fleshed out access provisions for service animals. The reason the FDA has not taken service animals into consideration is probably administrative inertia in continuing to use the first rule (21 CFR 110.35) as a template for later rules.  Also, apparently in none of the subsequent regulatory proposals did anyone with a service animal comment on the restrictive language, nor that I can find did any service animal organization submit comments. I must acknowledge that I also failed to notice when proposals only mentioning guide dogs, not service animals, were published in the Federal Register in 2013. It is too late to submit comments on the proposals as they have been made final, but, fortunately, there is a way to raise the issue outside of the regulatory process. 

The concept of service animals is not, however, foreign to the FDA as the 2013 Food Code, a document issued jointly by the FDA, the Centers for Disease Control and Prevention (CDC), and the Food Safety and Inspection Service of the U.S. Department of Agriculture (USDA), uses the term multiple times. 

Locations with Animal Access Restrictions under FDA Regulations

Before discussing the various types of dogs that may be present in agricultural and food production operations, it might be helpful to list general locations where specific types of dogs and other animals are permitted. This table generally moves from the more confined locations (buildings and manufacturing plants) to more open locations (water sources, growing areas, and farms). As is evident in the table, and further explained below, the more restricted areas are generally only supposed to be open to certain dogs with specialized training and skills, while more open areas such as fields and farmyards are accepted as inevitably having more types of animals, even grazing and wild animals, under less or no control.   

Locations Where FDA Rules Specify Limitations on Animal Access
Location/type of food	Animals allowed (dogs)	Provision/effective date
Buildings and facilities used in manufacturing, packing, or holding human food (Part 110)	Guard and guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials.	21 CFR 110.35 Pest control (removed after 9/17/2018, but effectively replaced by 21 CFR 117.35 on 11/16/2015; this replaces a non-binding provision with a binding provision.)
Physical plant and grounds used in manufacturing, packaging, labeling, or holding operations for dietary supplements  (Part 111)	Guard or guide dogs are allowed in some areas of your physical plant if the presence of the dogs will not result in contamination of components, dietary supplements, or contact surfaces.	21 CFR 111.15, effective since 2007.
Fully-enclosed buildings used in growing, harvesting, packing and holding of produce (fruits and vegetables) for human consumption (Part 112)	Domesticated animals must be excluded from fully-enclosed buildings where covered produce, food contact surfaces, or food-packing material is exposed, unless such animals can be separated from such activities in the fully-enclosed building by “location, time or partition.”  However: “Guard or guide dogs may be allowed in some areas of a fully enclosed building if the presence of the dogs is unlikely to result in contamination of produce, food contact surfaces, or food-packing materials.”	21 CFR 112.127, effective 1/26/2016, with different compliance dates depending on the size of the business (an income determination).
Areas of a plant used for manufacturing of human food (Part 117)	… Guard, guide, or pest-detecting dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials.	21 CFR 117.35, effective 11/16/2015 (as noted above replacing non-binding provision of Part 110 with binding provision in Part 117).
Water sources, water distribution system, and pooling of water used in growing, harvesting, packing and holding of produce (fruits and vegetables) for human consumption (Part 112)	Water sources must be kept free of domesticated animals.	21 CFR 112.42, effective 1/26/2016.
Areas, including growing areas where” there is a reasonable probability that grazing animals, working animals, or animal intrusion will contaminate” produce (fruit and vegetables) (Part 112)	Grower must evaluate whether produce can be harvested without reasonable likelihood of contamination. Working animal is defined broadly to include “dogs, cats, or chickens” used to deter pests in growing areas, as wells as “guard dogs used to keep other animals out of fields.”  This would seem to include livestock guarding dogs used to deter predators.	21 CFR 112.83, effective 1/26/2016.

Guide, Guard, and Pest-Detecting Dogs

A rule added to 21 CFR Part 110 (Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food) in 1986 (51 Fed. Reg. 22475, June 19, 1986) contained a provision on pest control (21 CFR 110.35) that included the sentence: “Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials.”  The wording of this sentence has continued to the present, though the provision will now be moved to new 21 CFR 117.35, where it will be modified to add a reference to “pest-detecting dogs.” (There will be a nearly two-year interval where both provisions will technically be effective because of staggered effective dates, though because of the identical language, this will present no additional burden.)

Guide dogs are also mentioned in 21 CFR Part 111 (Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements), at 21 CFR 111.15, which includes a sentence which differs from that in 21 CFR 110.35 only by the italicized words:

Guard or guide dogs are allowed in some areas of your physical plant if the presence of the dogs will not result in contamination of components, dietary supplements, or contact surfaces.

The difference, of course, is that Part 111 deals only with manufacturing practice regarding dietary supplements.  This provision was proposed in 2003 (60 Fed. Reg. 12158, March 13, 2003) and finalized in 2007 (72 Fed. Reg. 34752, June 25, 2007), well within the modern era of ADA regulation, but no service dog user or organization commented on the restrictive reference to guide dogs only.  The “physical plant” includes the “building, structure, or parts thereof, used for or in connection with the manufacturing, processing, packing, or holding of human food” (80 Fed. Reg. 55938, September 17, 2015; 21 CFR 117.3).

New Part 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, added in 2015 (80 Fed. Reg. 74357, November 27, 2015; proposed 2013), also mentions guide dogs along with guard dogs. Under 21 CFR 112.127:

(a) You must take reasonable precautions to prevent contamination of covered produce, food contact surfaces, and food-packing materials in fully-enclosed buildings with known or reasonably foreseeable hazards from domesticated animals by:

(1) Excluding domesticated animals from fully-enclosed buildings where covered produce, food contact surfaces, or food-packing material is exposed; or

(2) Separating domesticated animals in a fully enclosed building from an area where a covered activity is conducted on covered produce by location, time, or partition.

(b) Guard or guide dogs may be allowed in some areas of a fully enclosed building if the presence of the dogs is unlikely to result in contamination of produce, food contact surfaces, or food-packing materials.  (emphasis added)

Because the provision is not merely a manufacturing provision, but also covers the growing and harvesting of produce within an agricultural operation, the precautions that must be taken include taking such steps as are reasonable with regard to animals such as livestock, which might contaminate areas where produce (fruit and vegetables) are being grown or harvested. Thus, putting up a fence to keep cattle out of a corn field might be expected.   

As mentioned in the first paragraph under this heading, some of Part 110 is being moved to new Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, and new 21 CFR 117.35 will continue the guard and guide dog reference for manufacturing of food (except for Part 111, concerning dietary supplements), with the addition of “pest-detecting dogs.”  There appears no logical reason why pest-detection dogs were not added to the parallel provisions mentioning guard and guide dogs in Parts 111 and 112. 

Working Animals

Under new 21 CFR Part 112, references to “working animals” can include dogs.  Subpart I of Part 112 concerns domesticated and wild animals, and 21 CFR 112.83(a) states: 

You must take the steps set forth in paragraph (b) of this section if under the circumstances there is a reasonable probability that grazing animals, working animals, or animal intrusion will contaminate covered produce. 

There are additional references to working animals in 21 CFR 112.32 stating that hygienic practices require avoiding contact with animals other than working animals and requiring steps to minimize the likelihood of contamination from contact with working animals including washing hands after contact.

“Working animal” is not defined in the regulations but the preamble describes this category as including “horses, dogs, cats, and chickens” (80 Fed. Reg. 74481), and another passage refers to “using dogs, cats, or chickens to deter pests in growing areas…” and “using guard dogs to keep other animals out of fields” (80 Fed. Reg.  74480-1). This would seem to be broad enough to include livestock guarding dogs, and should probably include livestock herding dogs. Yet another passage in the preamble distinguishes working animals from “grazing animals” (80 Fed. Reg. 74370).

Domesticated Animals

Yet another term found in the regulations just finalized that can include dogs is “domesticated animal.” This term also is not formally defined, though the preamble contains a parenthetical to the term “domesticated animals (such as livestock, working animals, and pets)…” (80 Fed. Reg. 74478).  (It is probably not too much of a stretch to argue that since the parenthetical does not mention guide or guard dogs, these also fit within the category of working animal.)  New 21 CFR 112.42 requires keeping water sources “free of … domesticated animals, and other possible sources of contamination of covered produce to the extent practicable….” 

Specifically as to pets, the FDA states:

You are permitted to have cats or dogs on your covered farm, provided that … you (1) adequately control their excreta and litter and (2) maintain a system for control of their excreta and litter. These measures are necessary to prevent contamination of covered produce, food-contact surfaces, areas used for a covered activity, agricultural water sources, and agricultural water distribution systems with waste from your cats or dogs.  (80 Fed. Reg. 74495; see also new 21 CFR 112.134.) 

Thus, a covered farm, one that grows food and produce for human consumption, need  not exclude its own pets, but might want to restrict visitors from brining in large numbers of pets. 

Why Were Service Animals Not Considered by the FDA?

None of the commenters on the 2013 proposals mentioned service dogs or service animals.  In contrast, the Pennsylvania Vegetable Growers Association (comment of Brian Campbell, President) noted that “dogs are sometimes used to control animal intrusions into fields…,” an observation which the drafters of the regulations adapted in the preamble.  Dr. Richard Bonanno, President of the Massachusetts Farm Bureau Federation, noted the need for the “intermittent presence of service animals, such as dogs to scare away wildlife or geese that may eat weeds….” George Greig, Secretary of the Pennsylvania Department of Agriculture noted that dogs and cats are used “for pest control and/or keeping other animals out of fields and outbuildings.” Thus, pest-detection dogs were recognized in the final rules, but service animals were not. 

It may be that if the issue of a non-guide service dog ever arises in a food production context, the relevant authorities will consider that such service dogs are to be treated the same way as guide dogs.  A personal communication with someone who has worked in agricultural settings has confirmed that this has been the case in her experience, and the references to service animals in the Food Code, discussed next, would certainly support such an argument. Nevertheless, in an email communication with an official of the FDA, the official suggested that the service animals would be in the same category as domesticated animals, i.e., in no better position for access than grazing animals. 

2013 Food Code

As stated at the beginning, the 2013 Food Code (“Code”) issued by three agencies, including the FDA and the CDC, both inside the Department of Health and Human Services, and the Food Safety and Inspection Service inside the USDA, makes numerous references to service animals.  The Code (p. 20) defines a service animals as “an animal such as a guide dog, signal dog, or other animal individually trained to provide assistance to an individual with a disability.” Employees are to “clean their hands and exposed portions of their arms” after “caring for or handling SERVICE ANIMALS or aquatic animals….” (2-301.14, p. 47).  Service animals controlled by a  “disabled EMPLOYEE or PERSON” may be in “areas that are not used for FOOD preparation and that are usually open for customers, such as dining and sales areas … if a health or safety HAZARD will not result from the presence or activities of the SERVICE ANIMAL.”  The following general statement is made (p. 537) regarding food employees with service animals:

Decisions regarding a food employee or applicant with a disability who needs to use a service animal should be made on a case-by-case basis. An employer must comply with health and safety requirements, but is obligated to consider whether there is a reasonable accommodation that can be made.

For additional information, the Code lists a number of releases of the Department of Justice regarding service animals, as well as the ADA website. It is clear that some officials inside the FDA are familiar with service animals, though perhaps the use of the more modern term in the Code is to be credited to one of the other agencies involved.   

Telling the FDA about a Service Animal

There is one way that service dog users can bring this issue to the FDA’s attention, should they wish.  The FDA has a system, the FDA Technical Assistance Network, which has an icon, “Submit Inquiry,” where a question may be posed to the FDA and which will, I am assured, be directed to the correct official inside of the agency. Those who have service animals who may be affected by these rules should consider sending a comment to this effect, along with any questions about the reach of the rules, through this mechanism.  I submitted the following comment by this means:

Although it is too late to submit formal comments regarding the recent Food and Drug Administration rules that discuss various types of trained dogs, pets, and other animals in food production environments (21 CFR 112.127; 21 CFR 117.35), I should like to note that the FDA’s regulatory limitation of service animals to guide dogs is contrary to recent legal developments regarding animals that are used by people with various types of disabilities other than blindness and vision impairment, and is also more limiting than the positions of the FDA itself as contained in the 2013 Food Code. 

In this connection, I believe that, in future revisions of 21 CFR 111.15, 112.127, and 117.35 (the latter replacing 21 CFR 110.35), the FDA should replace the term “guide dog” with “service animal.” Should it be deemed appropriate to define the term “service animal,” I suggest that the definition provided by the Department of Justice in 28 CFR 36.104 be used: “Service animal means any dog that is individually trained to do work or perform tasks for the benefit of an individual with a disability, including a physical, sensory, psychiatric, intellectual, or other mental disability.” The 2013 Food Code (6-501.115, p. 536) refers to 28 CFR 36.104 as the source of that document’s definition of service animal (though using a now outdated version of the Title 28 provision).  In this connection it is perhaps also worth noting that the Department of Justice recognizes that miniature horses have been trained to perform functions similar to those provided by guide dogs and therefore are allowed similar access to public accommodations (see 28 CFR 36.302(c)(9)). I accept that miniature horses would involve considerations that apply to certain grazing animals in the FDA regulations.    

Thank you for considering these observations.... 

The only response I have received so far was an unsigned email to my "FCIC Inquiry" advising me to submit my comments to "your local or state health department." This was either computer-generated (or at least mindlessly generated) as no state or local health department would have the authority to consider, much less correct, negligent drafting of federal regulations.  It must be hoped that, if more comments along the lines of what I have submitted are received, the issue will begin to be addressed by some higher intelligence inside the FDA. 

Conclusion

The actual level of inspection of farms and food-production facilities has dramatically decreased under the Obama administration according to experts in the area. (See, for example, Joe Ferguson, “Retired USDA Inspectors Share Concerns about HIMP Project,” Food Safety News, November 16, 2015; Tony Corbo, “USDA Continues to Deceive on Meat Inspections,” Food & Water Watch, April 17, 2014.)  So, admittedly, the chance that an inspector might actually raise an issue with regard to a non-guide service dog in an agricultural setting is not very likely.

The FDA is to be praised for taking pest-detection dogs into consideration with regard to manufacturing plants (Part 117), and should probably expand their usage to fully-enclosed buildings (Part 112) and manufacturing plants for dietary supplements (Part 111).  References to guide dogs should be expanded to service dogs, as it is as likely that people with disabilities other than vision impairments are working in the food industry.  Where dogs may be in fields and around grazing animals, references to guard dogs should clarify that in some of these environments the dogs might be livestock herding and protection dogs.  Since there are no open regulatory projects on which comments are still being received, such modifications may have to wait, but those interested in these issues should take advantage of the portal within the FDA Technical Assistance Network. 

Thanks to Sarah Bell for bringing to my attention the fact that under the Obama administration food inspection personnel have been reduced considerably, all but eliminating an important safety threshold on the food we eat. Thanks also to Veronica Morris, Brad Morris, and Chanda Hagen for suggestions and information regarding service animals used in agricultural settings. Thanks to Emma Ertinger of the National Sustainable Agricultural Coalition for information concerning FSMA rules and FDA procedures.

© John Ensminger 2015

FDA Access Rules Regarding Dogs and Other Animals in Food Production Environments (Comprehensive Table of CFR Title 21 References)
Dog or animal category	CFR section	Relevant regulatory text	Status/Notes
Guard dog (note reference under “working animal” below to using “guard dogs to keep other animals out of fields” (80 FR 74481))	(see 21 CFR 100.35(c) and 21 CFR 100.15(d) below)
Guide dog	Part 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food Subpart B—Buildings and Facilities 21 CFR 110.35 Sanitary operations… (c) Pest control.	… Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials.	51 FR 22475, June 19, 1986; amended 54 FR 24892, June 12, 1989; Part 110 removed and reserved, effective September 17, 2018 (80 FR 56144, September 17, 2015); FDA is re-establishing “certain non-binding provisions of part 110 in part 117 as binding provisions.” (80 FR 55939)
	Part 111-Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements Subpart C—Physical Plant and Grounds 21 CFR 111.15 What sanitation requirements apply to your physical plant and grounds? … (d). Pest control.	(1) …  Guard or guide dogs are allowed in some areas of your physical plant if the presence of the dogs will not result in contamination of components, dietary supplements, or contact surfaces….	Proposed March 13, 2003, 68 Fed. Reg. 12158; finalized June 25, 2007, 72 Fed. Reg. 34752.
	Part 112—Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Subpart L—Equipment, Tools, Buildings, and Sanitation 21 CFR 112.127 What requirements apply regarding domesticated animals in and around a fully-enclosed building?	(a) You must take reasonable precautions to prevent contamination of covered produce, food contact surfaces, and food-packing materials in fully-enclosed buildings with known or reasonably foreseeable hazards from domesticated animals by: (1) Excluding domesticated animals from fully-enclosed buildings where covered produce, food contact surfaces, or food-packing material is exposed; or (2) Separating domesticated animals in a fully=enclosed building from an area where a covered activity is conducted on covered produce by location, time, or partition. (b) Guard or guide dogs may be allowed in some areas of a fully enclosed building if the presence of the dogs is unlikely to result in contamination of produce, food contact surfaces, or food-packing materials.	Effective January 26, 2016 (80 FR 74357, 74528, November 27, 2015; proposed 78 Fed. Reg. 3504, January 16, 2013), but different compliance dates depending on the size of the business (an income determination).
	Part 117—Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Subpart B—Current Good Manufacturing Practices 21 CFR 117.35 Sanitary operations … (c) Pest control.	… Guard, guide, or pest-detecting dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials.	Effective November 16, 2015 (80 FR 56131, September 17, 2015); note that there appear to be dates where both the requirements of Part 110 and Part 117 apply, though the identity of language makes this irrelevant.
Pest-detecting dog	(see 21 CFR 117.35 above)
Domesticated animals (which can include “livestock, working animals, and pets” (80 FR 74478); the absence of reference to guide dogs here suggests that in this connection at least a guide dog is a working animal)	(see 21 CFR 112.127 above) Subpart E—Agricultural Water 21 CFR 112.42 What requirements apply to my agricultural water sources, water distribution system, and pooling of water?	(c) You must adequately maintain all agricultural water sources to the extent they are under your control (such as wells). Such maintenance includes regularly inspecting each source to identify any conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces; correcting any significant deficiencies (e.g., repairs to well cap, well casing, sanitary seals, piping tanks and treatment equipment, and control of cross-connections); and keeping the source free of debris, trash, domesticated animals, and other possible sources of contamination of covered produce to the extent practicable and appropriate under the circumstances.
	21 CFR 112.134  What must I do to control animal excreta and litter from domesticated animals that are under my control?	(a) If you have domesticated animals, to prevent contamination of covered produce, food contact surfaces, areas used for a covered activity, agricultural water sources, or agricultural water distribution systems with animal waste, you must: (1) Adequately control their excreta and litter; and (2) Maintain a system for control of animal excreta and litter. (b) [Reserved]
Working animal (which can include “horses, dogs, cats, and chickens” (80 FR 74481, November 27, 2015); distinguished from “grazing animals” (80 FR 74370, 74481); “using dogs, cats, or chickens to deter pests in growing areas, or prevent farms from using guard dogs to keep other animals out of fields” (80 FR 74480-1); “working animals such as horses used for tilling and harvest activities and transporting produce” (80 FR 74480))	Part 112—Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Subpart I—Domesticated and Wild Animals 21 CFR 112.83 What requirements apply regarding grazing animals, working animals, and animal intrusion?	(a) You must take the steps set forth in paragraph (b) of this section if under the circumstances there is a reasonable probability that grazing animals, working animals, or animal intrusion will contaminate covered produce.  (b) You must: (1) Assess the relevant areas used for a covered activity for evidence of potential contamination of covered produce as needed during the growing season (based on your covered produce; your practices and conditions; and your observations and experience); and (2) If significant evidence of potential contamination is found (such as observation of animals, animal excreta or crop destruction), you must evaluate whether the covered produce can be harvested in accordance with the requirements of § 112.112 and take measures reasonably necessary during growing to assist you later during harvest when you must identify, and not harvest, covered produce that is reasonably likely to be contaminated with a known or reasonably foreseeable hazard.	See notes on 21 CFR 112.127 above.