Wednesday, December 9, 2015

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.

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