B08_-_ATTACHMENT_4_-_FERTILITY_CONTRO_VACCINCES.pdf

Standard Operating Procedures (SOPs) for Fertility Control Vaccines

SOPs listed below are for the purposes of this contract.

Vaccine Handling, Storage, and Disposal

Fertility control vaccines shall be handled, used, stored, and disposed of in accordance with directions on the EPA product registration label. If there is any doubt or perceived difference between those EPA label instructions and the instructions in the SOPs below, the contractor shall follow what is written on the EPA product label.

PZP ZonaStat-H vaccine antigen shall be stored frozen (below 32° F) until ready for use. Once defrosted the PZP ZonaStat-H vaccine expires after 24 hours. Keep frozen ZonaStat-H cold and frozen. If transportation away from a freezer takes longer than 8 hours, store unmixed PZP ZonaStat-H vaccine on dry ice in a cooler. When transporting thawed ZonaStat-H vaccine for use in the field, keep it stored in a cooler, with ice packs. In contrast, keep the Freunds adjuvant refrigerated at +36° F to +44° F, but not frozen, until it is ready to be mixed with the PZP antigen (see below). The frozen PZP antigen expires after two years. Unused ZonaStat-H vaccine that has been stored properly and is suitable for use at a later date shall be returned to the BLM. Unused ZonaStat-H that is no longer suitable for use at a later date shall be disposed of as medical waste according to Federal, State, and Local regulations.

Keep preloaded syringes of GonaCon-Equine in a refrigerator (36° F to 44° F) until ready for use. GonaCon-Equine vaccine must not be frozen. When in the field away from a refrigerator, keep preloaded GonaCon-Equine in a cooler on ice as long as possible prior to use. Store GonaCon-Equine vaccine under refrigeration (36° F to 45° F), or in a cooler with enough ice to keep it cool, but not frozen. Unused GonaCon-Equine that has been stored properly and is suitable for use at a later date shall be returned to the BLM. GonaCon-Equine that was not kept cool, or which was frozen, must be disposed of as medical waste according to applicable Federal, State, and/or Local regulations.

SOPs for Use; Common to All Vaccine Types:

Identification

Animals intended for treatment must be clearly, individually identifiable to allow for positive identification during subsequent management activities. For captured animals, marking for identification may be accomplished by marking each individual with a freeze mark on the hip or neck and a microchip in the nuchal ligament.

Safety

Safety for both humans and animals is the primary consideration in all elements of fertility control vaccine use. Administration of any vaccine must follow all safety guidance and label guidelines on applicable EPA labeling.

Care should be taken and sterile technique used during vaccine mixing, handling, and application to avoid contact of needles with any surface.

Injection Site

For hand-injection, delivery of the vaccine should be by intramuscular injection, while the animal is standing still, into the left or right side, above the imaginary line that connects the point of the hip (hook bone) and the point of the buttocks (pin bone): this is the hip / upper gluteal area.

Tracking of Treatments

1. Field applicators should record all pertinent data relating to identification of treated animals (this includes chip number, as well as freeze brand if the animal is marked) and date of treatment, lot number(s) of the vaccine, quantity of vaccine issued, the quantity used, the date of vaccination, side of animals that injections were given (left or right), disposition of any unused vaccine, the date disposed, the number of treated mares or jennies by HMA, field office, and State along with the microchip numbers and freeze-mark(s) applied by HMA. A summary narrative and data sheets will be forwarded to HQ- 261 annually (Reno, Nevada). A copy of the form and data sheets and any photos taken should be maintained at the field office.

2. BLM HQ-261 will maintain records sent from field offices, on the quantity and type of fertility control vaccine issued, the quantity used, disposition of any unused vaccine, the number of treated mares by HMA, field office, and State along with the freeze-mark(s) applied by HMA and date.

SOPs for Liquid PZP vaccine (ZonaStat-H)

ZonaStat-H vaccine (Science and Conservation Center, Billings, MT) would be administered through hand-injection by trained BLM personnel or collaborating partners only. Until the day of its use, ZonaStat-H PZP antigen must be kept frozen.

A dose of vaccine includes antigen, and liquid adjuvant, mixed together into an emulsion.

Animals that have never been treated with a PZP vaccine would receive 0.5 cc of PZP antigen (ZonaStat-H), emulsified with 0.5 cc of Freund’s Modified Adjuvant (FMA). Animals identified for re-treatment receive 0.5 cc of the PZP antigen (ZonaStat-H) emulsified with 0.5 cc of Freund’s Incomplete Adjuvant (FIA).

Hand-injection of liquid PZP vaccine would be by intramuscular injection into the gluteal muscles while the animal is restrained in a working chute. The vaccine would be injected into the left or right hind quarters of the animal, above the imaginary line that connects the point of the hip (hook bone) and the point of the buttocks (pin bone).

For Hand-injection, delivery of the vaccine would be by intramuscular injection into the left or right buttocks and thigh muscles (gluteals, biceps femoris) while the animal is standing still. In most cases, the left side will be more accessible and should be used.

SOPs for application of PZP-22 pelleted vaccine

PZP-22 pelleted vaccine treatment would be administered only by trained BLM personnel or designated partners. The pellets are intended to release PZP over time.

A treatment of PZP-22 is comprised of two separate injections: (1) a liquid dose of PZP vaccine (equivalent to one dose of ZonaStat-H; this includes PZP antigen and either Freund’s Modified Adjuvant for animals that have never been treated before, or Freund’s Incomplete Adjuvant for animals that have been treated before) is administered using an 18-gauge needle by hand injection; and (2) the pellets are preloaded into a 14-gauge needle. For animals constrained in a working chute, these are delivered using a modified syringe and jabstick to inject the pellets into the gluteal muscles of the animals being returned to the range. Until the day of its use, the antigen portion of PZP-22 must be kept frozen until it is mixed with adjuvant.

Delivery of PZP-22 treatment would only be by intramuscular injection into the gluteal muscles while the animal is restrained in a working chute. The primer would consist of 0.5 cc of liquid PZP emulsified with 0.5 cc of adjuvant. Animals that have never been treated with a PZP vaccine would receive 0.5 cc of PZP vaccine emulsified with 0.5 cc of Freund’s Modified Adjuvant (FMA). Animals identified for re-treatment receive 0.5 cc of the PZP vaccine emulsified with 0.5 cc of Freund’s Incomplete Adjuvant (FIA). The jabstick syringe with PZP vaccine pellets would be loaded into the jabstick for the second injection. With each injection, the liquid or pellets would be injected into the left or right hind quarters of the animal, above the imaginary line that connects the point of the hip (hook bone) and the point of the buttocks (pin bone).

SOPs for GonaCon-Equine Vaccine Treatments

GonaCon-Equine vaccine (USDA Pocatello Storage Depot, Pocatello, ID; Spay First!, Inc., Oklahoma City, OK) is distributed as preloaded doses (2 mL) in labeled syringes. Upon receipt, the vaccine should be kept refrigerated (36° F to 44° F) until use. Do not freeze GonaCon- Equine. The vaccine has a 6-month shelf-life from the time of production and the expiration date will be noted on each syringe that is provided.

For initial and booster treatments, mares receive the full dose of GonaCon-Equine that is loaded in a 2.0 ml syringe (i.e., about 1.8mL or more of vaccine).

Administering GonaCon Vaccine by Hand-Injection

For hand-injection, delivery of the vaccine would be by intramuscular injection, while the animal is standing still, into the left or right side, above the imaginary line that connects the point of the hip (hook bone) and the point of the buttocks (pin bone): this is the hip / upper gluteal area.

After a time period as directed by the COR, a booster vaccine may be administered after the first injection to improve efficacy of the product over subsequent years.