UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE FSIS Requirements associated with Slaughter of Immunologically Castrated “Barrows” 10/04/12 1

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE What is IMPROVEST®? IMPROVEST® is the brand name of an FDA/CVM approved biological protein compound used to immunologically “castrate” young boars n Alternative to surgical castration n 10/04/12 2

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE What is IMPROVEST®? Inhibits the development of the male reproductive organs and natural hormones n Has a temporary effect n Approved in 63 countries including EU, Japan, Canada and China n 10/04/12 3

IMPROVEST® is approved for use in 63 countries Global product names include: Improvac, Vivax, Innosure <2005 2 countries: § Australia (1998) § New Zealand (1998) 10/04/12 2005 -08 21 countries: § Argentina § Brazil § Chile § Colombia § Costa Rica § Ecuador § El Salvador § Guatemala § Honduras § Korea § Mexico § Nicaragua § Panama § Peru § Philippines § Russia § South Africa § Switzerland § Thailand § Venezuela § Vietnam 2009 31 countries: § Austria § Belgium § Bulgaria § Cyprus § Czech Republic § Denmark § Estonia § Finland § France § Germany § Greece § Hungary § Iceland § Ireland § Italy § Latvia § Liechtenstein § Lithuania § Luxembourg § Malaysia § Malta § NL § Norway § Poland § Portugal § Romania § Slovakia § Slovenia § Spain § Sweden § UK 2010 2011 4 countries: § Japan § Croatia § China § Uruguay 5 country § US § Canada § Ukraine § Serbia § Dominican Republic • The manufacturer of IMPROVEST® is not aware of any trade restrictions world-wide (consulted with USMEF) 4

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE How does IMPROVEST® work? n Uses the pig’s natural immune system to control development of reproductive organs and limit the production of other substances that can create odor in pork meat. 10/04/12 5

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE What is IMPROVEST®? Food Safe - Zero withdrawal period n 2 Dose Treatment Regimen n “Restricted Use” Only n Available by veterinary prescription only n 10/04/12 6

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Slaughter Interval n The most recent FDA approval of IMPROVEST stipulates it is intended for slaughter no earlier than 3 weeks and no later than 10 weeks after receipt of the second dose of IMPROVEST. 10/04/12 7

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE FSIS Requirements Associated with Slaughter of IMPROVEST® “Barrows” 10/04/12 8

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE How does use of IMPROVEST® impact meat inspection? AMS treats Immunologically Castrated Boars as “Barrows” n Requires Presentation of IMPROVEST® Declaration Certificate to IPP n “Certified” Lots are segregated from and differentiated from “uncertified” boars or stags. n 10/04/12 9

IMPROVEST® Classified as Barrows USDA Classification – Guidance to Industry – May 25, 2011 10/04/12 “Intact male swine receiving IMPROVEST as per FDAapproved label instructions and before sexual maturity would be considered barrows at the time of slaughter. Therefore, packers would report them as barrows under Livestock Mandatory Reporting. The definition of a barrow (7 CFR 59. 200) is ‘a neutered male swine, with the neutering performed before the swine reached sexual maturity. ’ Further, any product from these swine would be considered product from a barrow. ” 10

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE How does use of IMPROVEST® impact meat inspection? n NOTE: It is only the accompaniment of the “IMPROVEST® Declaration Certificate” that enables IMPROVEST® Boars to be treated as “Barrows”. 10/04/12 11

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE The IMPROVEST Certificate: United States n n n Provides assurance that intact male pigs were effectively administered IMPROVEST® and that all on farm protocols and quality assurance inspections occurred. Intact male swine receiving IMPROVEST® with the accompanying certificate are defined by USDA-AMS as barrows and any product from these swine is considered product from a barrow. The IMPROVEST® Declaration Certificate that accompanies each load of market swine will make additional scrutiny of secondary sexual organs of Immunocastrated (IC) barrows on post mortem unnecessary. 10/04/12 12

SA MP LE UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE 10/04/12 13

10/04/12 MP Canada SA The IMPROVEST® Declaration Certificate: LE UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE 14

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE What useful information should IPP take from this presentation? n n IPP need the IMPROVEST® Declaration Certificate to classify boars as “barrows”. IPP will learn how to differentiate: n n n IMPROVEST® “barrows” from all other male swine (boars, stags, or unidentified intact male swine). “boar taint” from external carcass contamination FSIS Regulations regarding “odors” 10/04/12 15

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Comparison of Intact Boars, Surgically Castrated Barrows, and IMPROVEST® “Barrows” on Ante Mortem 10/04/12 16

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Surgically castrated barrows 10/04/12 17

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE IMPROVEST® market hogs 10/04/12 18

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE VS. IMPROVEST® market hogs Intact boar 10/04/12 19

Boars and Stags n IPP can quickly verify for the presence of boars and stags in a pen of market hogs when performing ante mortem. n It is expected IMPROVEST® barrows will appear and behave similar to barrows and gilts. 10/04/12 20

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Visual Comparison of Barrows, IMPROVEST® Barrows and Boars on the Rail 10/04/12 21

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE IMPROVEST® Barrow Boars vs. 10/04/12 22

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Visual Comparisons of the Male Reproductive Organs of Barrows, IMPROVEST® “Barrows” and Intact Boars 10/04/12 23

Basic Male Swine Reproductive Anatomy 10/04/12 24

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Comparison of Swine Testes Intact Boar 10/04/12 vs. Immunocastrated 25

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Comparison of Swine Testes IMPROVEST® Barrows vs. Boar boar 10/04/12 26

Comparison of Male Swine Reproductive Tracts IMPROVEST® Barrow Boar 10/04/12 27

Bulbourethral glands Boar Barrow IMPROVEST® 10/04/12 28

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE IMPROVEST® BOAR 10/04/12 BOAR 29

Comparison of Swine Reproductive Tracts (Skrlep et al. 2010) 10/04/12 30

Barrow Reproductive Tract Bulbourethral gland (Cowpers) Seminal Vesicles Penis 10/04/12 31

IMPROVEST® Barrow Reproductive Tract Residual Testicles Bulbourethral gland (Cowpers) Seminal Vesicles Penis 10/04/12 32

Mature Boar Reproductive Tract Normal Testicles Bulbourethral gland (Cowpers) Seminal Vesicles Penis 10/04/12 33

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE 10/04/12 34

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Biological Variation among IMPROVEST® Barrows and Boars 10/04/12 35

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Biological Variability n n n Within each population (e. g. treated vs. untreated), there is natural variability best evaluated by statistical means. As a result, it is not meaningful to make assessments on only secondary sex organs (seminal vesicles, bulbourethral glands) of individual animals as an indicator of overall effectiveness of immunocastration. IPP are to rely on their routine inspection procedures and presentation of the IMPROVEST® Declaration Certificate. 10/04/12 36

Biological Variation in Male Swine Reproductive Tract Organs Seminal Vesicles 10/04/12 Example of Biological Variation That May Be Seen at Harvest 37

Testicle Size Variation § Testicle size of IC barrows will vary based on 1. Inherent genetic variation 2. Temperature of environment (testicles descend from body in warmer temperatures) 3. Age and maturation of the animal when the second immunization is administered which slow/stops further development of testicles. (Dunshea et al. 2001. J. Anim. Sci. , 79: 25242535. Example of variation in scrotum size from immunocastrated barrows 38

Testicle Size Variation n n Presentation of testicles in the pan for inspection, when intended for edible food, should not be scrutinized for size as an indicator of effective immunocastration Biological variation and age of animal at second dose will dictate testicle size at harvest Boar 10/04/12 Immunocastrated Barrows Example variation of testicles from Immunocastrated barrows 39

Seminal Vesicles (SV) n Pale colored seminal vesicles with minimal secretions are both indicative of non-functional sexual organs Boar 10/04/12 Immunocastrated Barrow 40

Variation in Color and Size of Seminal Vesicles Immunocastrated Barrows 10/04/12 41

Comparison of Male Swine Reproductive Tract Organs n 1. 2. 3. 4. The normal variation within boars and IC barrows seen during post mortem harvest are affected by: Age at injection, Genetics, Nutrition, and Environmental conditions effect Example of Biological Variation That May Be Seen at Harvest 10/04/12 42

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Discussion of Regulatory Requirements Relative to Carcass Presentation, Carcass Contamination and Odors 10/04/12 43

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE IMPROVEST® Swine Testes n n n Testes from IMPROVEST® barrows may be saved as “edible”. Testes are subject to inspection requirements in 9 CFR 310. 2. Testes may be presented with the viscera or may be batch collected and are subject to reinspection by IPP per 318. 2. 10/04/12 44

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE USDA FSIS Regulations Sec. 310. 7 Removal of spermatic cords, pizzles and preputial diverticuli. Spermatic cords and pizzles shall be removed from all carcasses. Preputial diverticuli shall be removed from hog carcasses. 10/04/12 45

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Pizzle and Prepuce Removal 10/04/12 46

Preputial Diverticulum 10/04/12 47

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Preputial Diverticuli Preputial diverticuli contain decomposing epithelial cells, urine, and bacteria. If opened, the contents of the preputial diverticuli have a strong odor and have the appearance of swine fecal material. n Such localized contamination must be removed from the carcass surface. n Such odor must be distinguished from “boar taint” most prominent in fat tissues. n 10/04/12 48

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE USDA FSIS Regulations Sec. 311. 37 Odors, foreign and urine. (a) Carcasses which give off a pronounced odor of medicinal, chemical, or other foreign substance shall be condemned. (b) Carcasses which give off a pronounced urine odor shall be condemned. (c) Carcasses, organs, or parts affected by odor to a lesser degree than as described in paragraphs (a) and (b) of this section and in which the odor can be removed by trimming or chilling may be passed for human food, after removal of affected parts or dissipation of the condition. 10/04/12 49

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Boar Taint “Boar Aroma” Sexual Odor 10/04/12 50

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Boar Taint n n n Term associated with an unpleasant aroma or taste in cooked pork from some mature male swine. Swine typically reach puberty at 5 -6 months – when market hogs (butcher hogs) typically are sent to slaughter Domestic swine reach sexual maturity at 8 -9 months. The more mature the swine, the more likely “boar taint” is likely to be detected. 10/04/12 51

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Boar Taint Androstenone and skatole are the major contributing compounds to boar taint in pork. (Patterson, 1968, Bonneau et. al. , 2000) n Caused by accumulation of androstenone (from testicles of pubertal and especially mature swine) and skatole ( a by-product from tryptophan metabolism in large intestine). n 10/04/12 52

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Boar Taint n Generally accepted threshold values for detecting boar aroma: (Godt et. al. , 1996; Bonneau, 1998) n androstenone > 1. 0 ug/g (or 1000 ng/g) n skatole >0. 20 ug/g (or 200 ng/g) n Presence of boar taint is variable among pigs and can have differing levels of intensity. (Xue & Dial, 1997) n Gilts can also have boar taint compounds. 10/04/12 53

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE USDA FSIS Regulations Sec. 311. 20 Sexual odor of swine. (a) Carcasses of swine which give off a pronounced sexual odor shall be condemned. (b) The meat of swine carcasses which give off a sexual odor less than pronounced may be passed for use in comminuted cooked meat food product or for rendering. Otherwise it shall be condemned. 10/04/12 54

Sensory Panel Testing used to Evaluate for Evidence of Boar Taint* 10/04/12 55

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Sensory Panel n Some segments of the human population are more apt to detect such odors. * n Consumers have varied abilities to detect boar aroma. (Xue & Dial, 1997) n “Boar taint” is not a food safety issue – it is simply a preference or acceptability issue for consumers 10/04/12 56

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Acknowledgement and Disclaimer 10/04/12 n Images within this presentation were provided courtesy of Pfizer, Inc. n USDA FSIS does not endorse any commercial products. 57

UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE Questions? Contact PDD at 1 -800 -233 -3935 OR Submit questions to ask. FSIS: http: //askfsis. custhelp. com/ 10/04/12 58