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.

Helms Amendment Would Exempt Rats, Mice and Birds from Animal Welfare Act

Yesterday the U.S. Senate approved an amendment to a major farm bill that would exempt rats, mice and birds from the Animal Welfare Act. The amendment was introduced by Sen. Jesse Helms (R-North Carolina) and would overturn a successful legal victory by the Humane Society of the United States to have those animals included under the Animal Welfare Act.

Although the Animal Welfare Act did not specifically exempt rats, mice and birds, the U.S. Department of Agriculture never applied the law to those animals which together constitute 95 percent of animals used for medical research.

HSUS and other animal rights groups sued the USDA in 1990 arguing that it had no legal basis for exempting rats, mice and birds. After the USDA lost a court ruling on that matter, it reached an agreement with HSUS in which the USDA promised to draft regulations covering the formerly exempted species. Under the proposed rule changes, researchers would have to more thoroughly justify research involving such animals and demonstrate that they are not repeating previous research.

This change has been opposed by the medical research community on the grounds that it will create an expensive nightmare of forms that will not enhance the welfare of research animals but will increase the costs and hence slow the pace of medical research with animals.

Helms’ amendment specifically exempts rodents and birds used in medical research from USDA oversight.

HSUS vice president Michael Stephens accused Helms of not caring enough about research animals. He told the Associated Press,

Just because Senator Helms doesn’t care about birds, mice and rats doesn’t mean they shouldn’t have legal protections. This is an issue that concerns millions of animals used in research. No one doubts that they can feel pain.

Helms’ amendment passed on a voice vote in the Senate without debate, and the farm bill itself passed the Senate. Now a House-Senate conference committee will meet to reconcile the different farm bills passed by each chamber of Congress. If the amendment remains in the final version of the bill that emerges from that conference committee, it will become law as long as George W. Bush decides not to veto the farm bill (which would be highly unlikely).

Source:

Helms denies protections for rodents in lab experiments. The Associated Press, February 14, 2002.

HSUS vs. the First Amendment

One of the few things I agree with the Humane Society of the United States about is that cockfighting is cruel and should be outlawed. Unfortunately, as they typically do, even in this matter the HSUS resorts to tactics that are simply wrong and ultimately leave the supporters of cockfighting look like the victims (leave it to HSUS to make cock fighters look sympathetic).

In this case the HSUS actually wants the editors of two Arkansas-based cockfighting magazines, The Feathered Warrior and The Gamecock to be prosecuted for doing nothing more than publishing their respective magazines.

HSUS’ Wayne Pacelle told the Associated Press that the two magazines should be prosecuted under a provision of the Animal Welfare Act which makes it illegal to use the mail to promote “an animal fighting venture except as performed outside the limits of the States of the United States.”

If that is indeed what the Animal Welfare Act says then it is almost certainly unconstitutional given that cockfighting is still legal in Oklahoma, Louisiana and New Mexico. In fact, I suspect the statute would be ruled unconstitutional even if it were promoting cockfights in states where the practice is illegal (Pacelle might want to brush up on his First Amendment law — if promoting illegal acts could be outlawed, many animal rights activists would wind up in jail).

Like the attempted ban on transporting chickens across state lines, this is just another example of HSUS and others being unable to muster enough support to outlaw cockfighting in the three states that still allow the practice. With that avenue cut off, HSUS attempts to limit the rights of people outside those states who are not directly involved in cockfighting but cover it in their magazines or sell supplies to those who are involved in cockfighting.

Source:

Humane Society trying to shut down Arkansas cockfighting magazines. The Associated Press, August 8, 2001.

Cockfighting and Animal Welfare

The “sport” of cockfighting remains legal
in only three states – Louisiana, Oklahoma and New Mexico — but is causing
a widespread controversy following the introduction of a bill by Senator
(and veterinarian) Wayne Allard (R-Colorado) that would ban the interstate
sale of chickens for cockfighting purposes. Both of Louisiana’s senators,
John Breaux and Mary Landrieu, oppose the bill based largely on a states’
rights argument (the individual states should be left to decide whether
or not cockfighting remains legal rather than the federal government).

For his part Allard says he
is only trying to close a loophole in the Animal Welfare Act. The AWA
prohibits the interstate transportation of fighting dogs but is silent
about fighting birds. “The senator doesn’t want to tell the people
of Louisiana what to do,” Allard’s spokesman Sean Conway told the
New Orleans Times-Picayune, “but you’ve got breeders shipping
roosters all over (the country), not just to Louisiana, and law enforcement
people are having a heck of a time cracking down.”

Of course numerous animal
rights groups have endorsed the proposed new law. What has surprised
me is the level of support for cockfighting among otherwise level headed
animal welfare advocates. A completely unscientific poll conducted
on my this site asked people, “Should cockfighting be banned?” Of the
396 people who responded, 131 agreed that it should be banned while 265
said no, cockfighting should not be banned. In discussing this result,
it quickly became apparent that the support of cockfighting was actually
a rather rigid opposition to animal rights groups.

The argument seems
to be that if animal rights groups support it, it must be a bad idea.
Giving any ground to the animal rights movement or conceding that cockfighting
might be abusive would be giving PETA and other groups a victory that
can be ill-afforded, according to proponents of this view.

In my opinion this is a self-defeating
position wrought with numerous problems. First, it gives way too much
credence to the animal rights groups. Whether or not a particular use
of an animals is justifiable should be based on evaluating it from an
animal welfare position rather than on what animal rights groups and
activists think about it. Inevitably animal welfare and animal rights
advocates will occasionally arrive at the same position for different
reasons. Discarding animal welfare views simply because they happen to
coincide with the animal rights position on occasion is neither wise nor
prudent.

Second, it is an obviously
hypocritical position. Nobody is going to (or even should) believe animal
welfare advocates when they claim to want to minimize the suffering of
laboratory animals or animals raised in an agricultural setting if those
same advocates then turn a blind eye to something such as cockfighting.
Where is the consistency in that position?

In fact cockfighting seems
to violate all of the precepts of a reasonable animal welfare philosophy
and should be banned. Cockfighting is not a case of a necessary human
use of animals that simply needs to be regulated so as to minimize suffering.
The whole point of cockfighting is to introduce suffering under a semi-controlled
environment for the visceral thrill of a gathered crowd or for the thrill
of wagering on the often deadly contest. Human beings may need to cause
pain and suffering to animals as an unfortunate side effect of some other
legitimate use, but to cause pain and suffering as an end in itself is
the antithesis of animal welfare.

The Associated Press recently
ran a story about Cesar Cerda, a 26-year-old California resident, who received
what is believed to be the longest prison sentence ever handed down for cruelty to animals. Cerda was sentenced to 7 years in jail for training
dogs to fight each other to the death. As the AP described Cerda, “[he]
earned up to $5,000 a month from gamblers who watched the animals fight
in a bloodstained pit.” Prosecutor Brian Myers described how “he
took these dogs to the brink of death and then nursed them back to health
so they could fight again.” Because of their training, all of the
dogs seized from Cerda had to be euthanized.

The sentence may have been
a bit long, but the principle behind the ban on animal fighting seems
immensely sound to this writer. These animals are being used to study
medical problems or raised for food or even used for their fur. They’re
being trained to fight for the sheer enjoyment that other people get from
watching them fighting.