Regulatory Analysis FOR

Proposed Amendments to

Rules and Regulations Pertaining to Epidemic

and Communicable Disease Control, 6 CCR 1009-1,

Regulation 8

Adopted by the Executive Director of the Colorado Department of Public Health and Environment
on
January 19, 2010

1.A description of the classes of persons who will be affected by the proposed rule, including classes that will bear the costs of the proposed rule and classes that will benefit from the proposed rule. The classes of persons who will bear the costs of the proposed rule changes are veterinary staff, as this group will need to fill out the rabies vaccination waiver form and include the form within the medical records of their patient. The Colorado Department of Public Health & Environment (CDPHE) will bear the cost of providing a “Exemption from Rabies Vaccination Form.” These changes may also benefit citizens of the state by preventing adverse events in dogs and cats that have medical conditions considered as contraindications for vaccination.

2.To the extent practicable, a description of the probable quantitative and qualitative impact of the proposed rule, economic or otherwise, upon affected classes of persons. The estimated increased workload and cost to veterinary staff related to the proposed rule changes is minimal. The estimated workload for veterinary staff is taking a few minutes of time to explain to the animal owner the purpose of the waiver form, and the cost would be only for paper and printing of the one page form. CDPHE would bear the minimal cost of providing the “Exemption from Rabies Vaccination Form,” by posting such form on the CDPHE webpage, and disseminating the location of this form via the email distribution list of the Colorado Veterinary Medical Association (CVMA). If this proposed rule is implemented, reactions to vaccination in pets with medical contraindication and resulting hospitalization of a small number of dogs and cats may be avoided, thus saving some pet owners the cost of such veterinary care. Medical contraindications for rabies vaccination are rare but may include immune mediated hemolytic anemia in dogs and recurrent vaccine associated feline sarcomas. The efficacy of rabies vaccine is high, with vaccine failure rarely reported in domestic animals. Adverse event rates associated with animal rabies vaccines are considered to low to moderate, with low to moderate severity. There is no evidence in peer-reviewed, scientific literature demonstrating that rabies vaccine causes more adverse events than other core vaccines for dogs and cats. To provide information on the incidence of adverse events associated with common vaccination for dogs and cats, in one study, “2,560 vaccine associated adverse events (VAAES) were associated with administration of 1,258,712 doses of vaccine to 496,189 cats (51.6 VAAEs/10,000 cats vaccinated).” “No localized reactions recorded in the 30-day period were subsequently diagnosed as neoplasia when followed for 1 to 2 years.”1 Another study, a retrospective cohort study of dogs vaccinated at 360 veterinary hospitals was conducted by “searching electronic records for possible VAAEs (nonspecific vaccine reaction, allergic reaction, urticaria, or anaphylaxis) diagnosed within 3 days of vaccine administration”. Only “4,678 adverse events (38.2/10,000 dogs vaccinated) were associated with administration of 3,439,576 doses of vaccine to 1,226,159 dogs.” 2

3.The probable costs to the agency and to any other agency of the implementation and enforcement of the proposed rule and any anticipated effect on state revenues. There are no costs of the proposed rule modifications to any agency beyond those described above. As stated in the proposed Regulation 8 D, CDPHE would have the authority to review veterinary medical records to investigate complaints of misuse of the waiver process by veterinarians who may be reported as signing waiver forms when no legitimate medical contraindication is present. After such review, the case can be referred to the Colorado State Board of Veterinary Medicine. The State Board of Veterinary Medicine has agreed to review such complaints because such behavior would violate the standards of practice for a veterinarian. There are no anticipated effects of the rule modifications on state revenues.

4.A comparison of the probable costs and benefits of the proposed rule to the probable costs and benefits of inaction. The creation of a process for waiver of rabies vaccination requirement for dogs and cats may benefit citizens of the state by prevention of adverse events to vaccination that could lead to hospitalization of their pet. Costs of inaction also include the time for local animal control and public health officials to continue to address questions from veterinarians and pet owners related to C.R.S. § 25-4-607 if no waiver rule were established.

5. A determination of whether there are less costly methods or less intrusive methods for achieving the purpose of the proposed rule. No alternative methods are available to achieve the purposes of the proposed rule.

6.A description of any alternative methods for achieving the purpose of the proposed rule that were seriously considered by the agency and the reasons why they were rejected in favor of the proposed rule. No alternative methods for achieving the purpose of the proposed rules were considered because C.R.S. 25-4-607, (3) (a) states: “[t]he executive director of the health department shall enact rules allowing for the exemption of an animal from a rabies vaccination due to the medical condition of the animal.”

7. To the extent practicable, a quantification of the data used in the analysis; the analysis must take into account both short-term and long-term consequences. In answers to questions #1 and #2 above, analysis of quantitative data was not feasible for this issue.

References:

1. J Am Vet Med Assoc. 2007 Jul 1;231(1):94-100.

Adverse events after vaccine administration in cats: 2,560 cases (2002-2005).

Moore GE, DeSantis-Kerr AC, Guptill LF, Glickman NW, Lewis HB, Glickman LT.

Department of Comparative Pathobiology, School of Veterinary Medicine, Purdue University, West Lafayette, IN 47907-2027, USA.

2. J Am Vet Med Assoc. 2005 Oct 1;227(7):1102-8.

Adverse events diagnosed within three days of vaccine administration in dogs.

Moore GE, Guptill LF, Ward MP, Glickman NW, Faunt KK, Lewis HB, Glickman LT.

Department of Veterinary Pathobiology, School of Veterinary Medicine, Purdue University, West Lafayette, IN 47907-2027, USA.

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