WSR 98-11-010

PREPROPOSAL STATEMENT OF INQUIRY

DEPARTMENT OF AGRICULTURE

[Filed May 11, 1998, 8:50 a.m.]



Subject of Possible Rule Making: Revisions to chapter 16-86 WAC, Brucellosis, tuberculosis and scrapie in sheep and goats, pilot rule.

Statutes Authorizing the Agency to Adopt Rules on this Subject: RCW 16.36.040.

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: A pilot rule project to allow veterinarians to vaccinate female cattle older than twelve months of age (mature) with RB-51 brucella vaccine. This will be of economic benefit to cattle producers and will maintain the brucellosis immunity level of the collective state herd.

Other Federal and State Agencies that Regulate this Subject and the Process Coordinating the Rule with These Agencies: United States Department of Agriculture biologics license all biologics. Present labeling allows adult vaccination with permission of state authorities.

Process for Developing New Rule: Pilot rule making, a pilot project with volunteer veterinarians will be instituted by June 1, 1998, and end November 1, 1998, to evaluate changing vaccination rules in chapter 16-86 WAC to allow mature brucellosis vaccination.



Briefing Memo - Brucellosis Vaccine Pilot Rules



Attached to this memo is a copy of proposed changes to Washington Administrative Code (WAC) 16-86 which will constitute pilot rules for a pilot rule-making project which will begin June 1, 1998 and end November 30, l998. Additional changes to chapter 16-86 WAC which are not part of the pilot rule project will be submitted to the register at the end of the project. Volunteer veterinarians and public livestock markets are needed to participate in a pilot rule project pertaining to RB-51 brucellosis vaccination for the duration of the project. At that time the pilot project will be evaluated with regards to whether the rules should be made permanent rules.

Pilot rule making is the development of methods for measuring and testing the feasibility of complying with or administering new rules or amendments through the use of volunteer groups. In this case volunteer veterinarians and livestock markets may comply with the pilot project rules between the designated dates of the pilot project rather than the present vaccination rules as presented in chapter 16-86 WAC. Such veterinarians or livestock markets must submit the attached agreement on their clinic letterhead agreeing to the instructions for vaccinating female cattle older than twelve months of age and submitting the required reports and surveys.

The following criteria for mature vaccination by volunteer veterinarians and livestock markets will be in place during the pilot project:

a. Nonpregnant female cattle may be vaccinated at ages exceeding the calfhood vaccination ages of 4 to 12 months with RB-51 brucellosis vaccine.

b. The mature dosage is a 2cc dose containing approximately 1 billion organisms. This is 1/10 of the calfhood dose. The calfhood 2cc dose contains 10 to 34 billion organisms. Special vials of diluent for making the final dilution must be obtained from the manufacturer. 18 cc of diluent added to 2 cc of calfhood concentration will give ten doses (2cc per dose) of mature dose vaccine. Calfhood doses must not be given to mature animals.

c. For the duration of the pilot project we are asking that a blood sample for brucellosis testing be submitted for each mature vaccinate. Veterinarians may vaccinate the animal prior to getting laboratory results but we need to try to identify animals which may have lost their identity as a vaccinate (tattoo has faded and orange eartag lost).

d. Identify pregnant animals and do not vaccinate such animals until after they calve. We are suggesting within 45 days of calving. There is no milk withhold time for the vaccine but the withhold from slaughter is still three weeks so [to] be sure animals on their way to slaughter within that time are not vaccinated with RB-51 vaccine.

e. Tattoo in the right ear with M, V shield, and 8 for the duration of the pilot project. The eight stands for the last digit of 1998.

f. Place the regular orange vaccination tag and a plain (silver color) identification tag in the right ear. The double tagging in the right ear will help to visually identify mature vaccinates without reading ear tattoos. Enter both tag numbers on the vaccination report.

g. Submit vaccination reports within ten days to the office of the state veterinarian. Attach a copy of part 4 or pink copy of the Brucellosis Test Record to show that blood was drawn for brucellosis testing. However, be sure to send the rest of the test record and blood to the laboratory, not to the state veterinarian's office.

h. Report monthly any unusual or untoward occurrences with the use of RB-51 vaccine on mature animals.

i. Complete a critique survey at the end of the pilot project.



implementation plan for pilot rules

Chapter 16-86 WAC



1. When and how may affected veterinary practices volunteer to be part of the pilot project? Veterinarians or veterinary practices may volunteer by filling out application information on their letterhead and forwarding the information to the office of the state veterinarian any time after the distribution of the information packets. Volunteers will be accepted into the project any time from the time the application information is distributed until the end of the project.

2. How may volunteer veterinarians or veterinary practices terminate from the project? Any volunteer may terminate from the pilot project by sending a letter of resignation to the office of the state veterinarian.

3. When and how will affected parties be notified?

a. A packet of information will be sent to all large animal practices during the last week of April 1998.

b. All known cattle practices will be visited personally by area veterinarians in the month of May 1998.

c. A news release will be issued in the first week of May l998.

d. A CR-101 and briefing memo including the pilot rules and implementation plan will be entered for publication in the Washington State Register.

4. What are the estimated dates and locations of informational meetings with volunteers? Initial meetings will be setup by the area veterinarians during the month of May 1998 to brief local groups of veterinarians in their areas on the details of the program.

During the months of June and July 1998, the state veterinarian and assistant state veterinarian will arrange local Veterinary Medical Association meetings to answer questions on the progress of the pilot program in its initial stages.

5. What is the beginning date of the pilot rules? June 1, 1998.

6. What are the reporting dates by volunteers?

a. Vaccination reports must be filed with the office of the state veterinarian within 10 days of vaccinating mature female bovines. A copy of the brucellosis test submission record, VS 4-33, should be submitted with the vaccination record. The vaccination record should show that a pregnancy examination was performed prior to vaccination.

b. Unusual or untoward occurrences encountered with the use of the vaccine to vaccinate mature bovine females must be filed with the office of the state veterinarian for each month by the 10th of the following month.

c. Final critique forms must be filed by December 15, 1998, following the end of the pilot program on November 30, 1998.

d. Any abortions of mature vaccinates must be reported to the office of the state veterinarian the next working day after the veterinarian has knowledge of the abortion.

7. What is the completion date of the pilot rules? November 30, 1998.

8. What is the final report date on the collected information and evaluation of the feasibility of the rule? December 31, 1998.

9. When will volunteers and affected parties be notified on the results of the final report? As soon as possible after December 31, 1998, and before the hearing date on January 18, 1999.

10. What is the anticipated filing date of the CR-102 proposed rules? If preliminary review of the collected information and the final report warrants, the CR-102 will be filed on December 16, 1998.



PILOT RULE MAKING - CHAPTER 16-86 WAC

BRUCELLOSIS, TUBERCULOSIS, AND SCRAPIE IN CATTLE, GOATS AND SHEEP



I. Stakeholders

Cattle and Mixed Practice Large Animal Veterinarians

Dairy Farmers

Beef Farmers

Livestock Markets

Livestock Dealers

Organizations representing the listed groups.

Input from the stakeholder groups has been nearly unanimous in asking for the proposed rule changes since brucellosis vaccine RB-51 was conditionally licensed by USDA effective March 1, 1996.



II. Report on other state and federal jurisdictions (Document A)



There are no other Washington state or local entities that regulate brucellosis vaccination activities.

The federal rules on vaccination do not require brucellosis vaccination in brucellosis free states. Washington has held free status since 1988. The Washington cattle industries wish to maintain a high level of immunity within their herds regardless of the status of the rest of the country. Brucellosis in the Yellowstone bison and elk herd will be a threat to Washington cattle long after the country is free of the disease in cattle herds. Chapter 16.36 WAC as amended in 1998 allows animal health rules to be more restrictive than federal rules.

The proposal by Washington state to allow vaccination above 12 months of age with the adult dose of RB-51 brucellosis vaccine was presented to most of the state veterinarians from the western states at the Western States Livestock Health Association in March 1998 at Denver, Colorado. Response to the proposal presented to them by both Washington and Oregon state veterinarians was primarily positive. South Dakota did have reservations based on the fact that the country's livestock will soon be free. Why then extend the amount of vaccination, which is being done. Should we not rather reduce the vaccination level rather than facilitating it? The northwest states of Oregon, Idaho and Washington all agreed that the industries of those states would not reduce the level of vaccination for many years after the country is shown to be free of the disease. In the mean time we need to reduce the waste of good nonvaccinated animals being sent to slaughter just because they cannot be vaccinated.



plan for measuring and testing pilot rule

Chapter 16-86 WAC - Brucellosis Vaccination Sections



Methods for measuring and testing feasibility of complying with or administering the rule:

1. When will the pilot rules be implemented? June 1, 1998, to continue to November 30, 1998.

2. What will be measured to determine the effectiveness of the rule?

a. The number of mature vaccinations administered during the pilot program.

b. The number of abnormal reactions reported in vaccinated animals.

c. The number of mature vaccinates sold or resold at public livestock markets.

d. Comments from neighboring states concerning the acceptance of such vaccinates into their states.

3. How will the effectiveness or feasibility of rule be measured? By the number of anticipated or unanticipated problems with the mature vaccination and the exemption of pregnant animals until 45 days post parturition. Problems should decrease with each succeeding month of the project. Some shake down problems are expected early on in the pilot program until all veterinarian volunteers thoroughly understand the procedures.

4. Volunteers will be required to make the following timely reports:

a. File with the state veterinarian's office VS Form 4-26 "Brucellosis Vaccination Record" within ten days of vaccinating mature animals.

b. File monthly with the state veterinarian's office a written report of any unusual or untoward occurrences encountered with use of RB-51 mature vaccine on uninfected mature cattle.

c. Submit a final critique form at the end of the pilot program evaluating the use of RB-51 vaccine in this manner.

d. Any abortions reported in animals inadvertently vaccinated when pregnant must be reported immediately to the state veterinarian and will be handled as a possible case of human exposure to a virulent brucellosis organism.

5. How will the small business requirements for pilot rule making (RCW 34.05.313(4)) be met? It is anticipated that approximately 100 small businesses could be affected by the pilot rule. It is a good assumption that the majority of those businesses will volunteer to participate in the pilot program. It is anticipated that there will be only one business affected that would have over fifty employees (the WSU, School of Veterinary Medicine). Very few would have up to twenty-six employees. The majority of the volunteers will be in the category of zero to ten employees.

6. When will the final report be prepared and written? The final report will be prepared and written by December 31, 1998.

Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Dr. Robert W. Mead, State Veterinarian, Washington State Department of Agriculture Food Safety, Animal Health Division, P.O. Box 42577, Olympia, WA 98504-2577, (360) 902-1878, FAX (360) 902-2087, e-mail rmead@agr.wa.gov.

May 8, 1998

Candace Jacobs

Assistant Director

Legislature Code Reviser

Register

Washington State Code Reviser's Office