USDA Proposes Regulation Requiring Researchers to File Detailed Medical Records

The U.S. Department of Agriculture’s Animal and Planet Health Inspection Service (APHIS) is proposing to require medical researchers to file detailed medical records related to research animals as part of its enforcement of the Animal Welfare Act.

In announcing the proposed changes, APHIS contends that,

While maintenance of medical records is implied through our requirements for adequate veterinary care, the regulations do not specifically stipulate the maintenance of medical records as one of the elements in a program of adequate veterinary care. Medical records are an essential part of any program of adequate veterinary care. Adequate veterinary care can only be provided to animals if an accurate medical history is maintained on the animals to provide communication among all personnel involved in providing care. In addition, medical records provide a basis for APHIS inspectors to assess a veterinary care program and ensure that animals receive adequate veterinary care.

Therefore, we propose to add new Sec. Sec. 2.33(b)(6) and 2.40(b)(6) to the regulations to include the maintenance of legible medical records as an additional element of the program of adequate veterinary care required by the regulations. To ensure that medical records include, at a minimum, information such as the vaccination history, surgical history, and any known drug sensitivities of the animals, we would specify that each medical record must include: (1) The identity of the animal (with the exception that routine husbandry, such as vaccinations, preventive medical procedures, or treatments, performed on all animals in a group (or herd) may be kept on a single record); (2) the date, description of the problem, pertinent history, observations, examination findings, test results, and plan for treatment and care with a tentative diagnosis and a prognosis, when appropriate; (3) the type and chronology of treatment procedures performed, the context of the problem to which the treatment procedures pertain, and the identification of the medication used, the date given, dosage, route of administration, frequency, and duration of treatment; (4) the names of all vaccines administered and the dates of vaccination; and (5) the dates and results of all screening, routine, or other required or recommended tests.

Not surprisingly, animal rights groups think this proposed regulation is a great idea, while groups representing medical researchers are generally opposed to the change.

Michael Stephens, vice president for animal research at the Humane Society of the United States, told The Scientist,

This is something that is long overdue, and we view the USDA as simply closing up a loophole. It will be a little easier for us to investigate whether adequate veterinary care is being provided. This is another element of accountability by the research community to demonstrate that they are indeed taking medical care of these animals.

Similarly PETA’s Mary Beth Sweetland — who is a direct beneficiary of animal research that resulted in insulin treatment for diabetes — had this to say to The Scientist,

USDA has realized how shoddy the record keeping on animal health really is. The USDA shouldn’t even have to intercede in this, but they do because these research facilities are not, of their own volition, going to keep proper records. It’s a matter of laziness and not caring.

That, of course, is a typical PETA lie. In fact, in proposing the new regulation APHIS itself notes that 75 percent of regulated research facilities are already in compliance voluntarily with the proposed new regulation. The Scientist reported that APHILS senior veterinarian medical officer Jerry DePoyster was unable to give an explanation of what motivated the proposed regulation.

But if this is something that most research facilities already do, why oppose making it required? Because, researcher groups argue, the new regulation would add an additional layer of detailed record keeping that would be expensive to comply with while providing little new additional information to help APHIS ensure compliance with the Animal Welfare Act.

In a letter to APHIS opposing the regulation, Federation of American Societies for Experimental Biology president Steve Teitelbaum argues that the level of detail required by APHIS is unrealistic and that the proposals interfere with the ability of attending veterinarians to use their professional judgment in treating animals,

FASEB strongly believes that adequate veterinary care, which includes maintenance of animal health records, is an important component of laboratory animal care. In fact, the Animal Care Resource Guide?s Policy #3 currently requires that adequate records be kept. Our principal concern with the proposed amendment is that it creates burdensome paperwork that will not ultimately benefit the health of research animals. We agree with the American Physiological Society (APS) and the National Association for Biomedical Research (NABR) that the content of animal medical records is best left to the discretion of the attending veterinarian, in accordance with standard veterinary practice.

Medical records, whether for animals or humans, serve to document the history of illness and medical care for that individual. The proposed amendment attempts to transform animal medical records into ?a means of communication concerning the care being provided to animals? and ?a basis for the [APHIS] to better asses the veterinary care programs of research facilities.? While well intentioned, the level of detail required to accomplish these new goals is unrealistic for a research environment. In addition, no matter how detailed, medical records are only a small part of veterinary care, and can only play a limited role in aiding APHIS inspectors to evaluate programs based upon accepted standards of laboratory animal care.

More specifically, we wish to concur with APS and NABR in their comments regarding Section 2.33, particularly in reference to requiring a ?prognosis? for individual animals, which is inappropriate in a research setting, as well as to those provisions that clearly infringe on the professional judgment of the attending veterinarian ((b)(6)(iii)). Moreover, we agree that there exists no sound scientific means by which to evaluate drug-sensitivities in animals, and that all language referring to such should be removed from the background material.

Similarly American Physiological Society president John A. Williams sent a letter to APHIS regarding the proposed regulations on June 2 that read, in part,

While agreeing with the need for animal health records, the APS objects to the level of detail APHIS proposes to include in the AWA regulations. Prescriptive regulatory detail is inappropriate because this rule touches upon an area that rightfully falls within the scope of the professional judgment of the attending veterinarian. Most attending veterinarians in research facilities have been specially trained to manage health problems that may arise in a research setting. APHIS does not claim animal welfare in research facilities has been jeopardized due to poor record keeping. Nevertheless, it proposes to require an expansive system of animal health records and has seriously underestimated the amount of time that will be needed and the volume of paperwork that will be generated to implement it. Moreover, some of the information APHIS proposes to require is superfluous in the context of providing adequate veterinary care in a research environment.

. . .

The proposed rule goes well beyond the health records requirements of existing Policy #3, which states that animal health records ?are meant to convey necessary information to all people involved in an animal?s care.? The proposed rule appropriately states that records should ?serve as a basis for reviewing the medical history and planning veterinary care and provide a mechanism of communication for matters of animal health, behavior, and well being.? It goes on to say, ?Medical records document the animal?s illness, veterinary care and treatment and serve as a basis for review, study, and evaluation of veterinary care provided by the facility.? (Emphasis added.) This added rationale creates a problem because it leads USDA to propose adding record-keeping requirements that exceed what would generally be accepted as necessary in a research setting. These requirements will not ?ensure that animals receive adequate veterinary care.? Rather, they will compel attending veterinarians to order more diagnostic tests and devote more time to writing medical records in anticipation of APHIS audits of their treatment decisions.

According to The Scientist, it will be about a year before a final decision is made on this proposed regulation. The proposed regulation can be found in its entirety here.

Source:

Groups attack USDA animal plan. Obaid Siddiqui, The Scientist, June 13, 2003.

APS Opposes Expanded Animal Records Rule. John Williams, American Physiological Society, June 2, 2003.

APHIS Proposal from the Federal Regster. APHIS, April 11, 2003.

Letter to APHIS. Steven Teitelbaum, Federation of American Societies for Experimental Biology, June 4, 2003.

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