HACCP Plan Deer / Wild Game Processing

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HACCP Plan – Deer / Wild Game Processing

Documentation Of Proposed Variances and Justification

According to the 2009 FDA Food Code §8-103.11 (Documentation of Proposed Variance and Justification), before a variance from a requirement of the 2009 Food Code is approved, the information that shall be provided by the person requesting the variance includes:

(A)A statement of the proposed variance of the code requirement citing relevant code section numbers.

This establishment is requests a variance from the 2009 FDA Food Code §3-502.11 (F) (Variance Requirement)regarding custom processing animals that are for personal use as food and not for sale or service in a food establishment.

(B) An analysis of the rationale for how the potential public health hazards and nuisances addressed by the relevant code sections will be alternatively addressed by the proposal.

It has been well recognized by the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) that custom exempt and retail exempt establishments can process deer (i.e., venison) and/or other wild game under custom exemption. The custom preparation of venison/wild gamecarcasses, parts thereof, venison/wild gameor venison/wild game food products derived from the processing of any individual venison and/or from other wild game, delivered bythe owner thereof for such custompreparation, and transportation in commerce of such custom prepared articles,exclusively for use in the householdof such owner, by him and membersof his household and his nonpayingguests and employees.

This establishment controls the growth of potential pathogens during the production of raw, not ground venison/wild game and raw, ground venison/wild game by controlling the temperature of the raw products during processing.

It has been well recognized that the term “curing” in regards to meat and poultry products is the act of adding either the sodium or the potassium salt of nitrite. This establishment cures venison/wild game products during the production of processed venison/wild game products (e.g., cured venison, venison sausage, venison jerky, etc.). Nitrite serves a vital public health function: itblocks the growth of botulism-causing bacteria (Clostridium botulinum) and prevents spoilage. Nitrite also gives curedmeats their characteristic color and flavor. Inaddition, evidence indicates that nitrite can helpprevent the growth of Listeria monocytogenes, anenvironmental bacterium that can cause illness insome at-risk populations.

Because nitriteand nitrate, after being converted to nitric oxide, function by reacting chemically with the meat orpoultry myoglobin, the amounts of nitrite or nitrate permitted in the cure must be based on themeat block used in the formulation, notthe finished weight of the product. Excess nitrite or nitrate can be toxic. The amount of curing solution permitted in injected processes is also based on the green weight of the venison/wild game because FSIS believes that allthe curing agent used is taken up by the venison/wild game meat.

The limits vary among curing methods because the methods differ inthe efficiency with which the curing agent is brought in contact with the venison. This establishment utilizes regulated limits outlined in FSIS Directive 7620.3 (Processing Inspectors' Calculations Handbook - Revised 1995).

This establishment eliminates potential pathogens during the production of fully cooked, not shelf stable venison/wild game products and heat treated, shelf stable venison/wild game products by properly thermal processing and cooling venison/wild game products during processing.

This establishment does not practice “sous vide” production processes. Sous vide is French for “under vacuum” and describes a method of cooking in vacuum sealed plastic pouches at low temperatures for long times. Sous vide differs from conventional cooking methods in two fundamental ways: (i) the raw food is vacuum sealed in plastic pouches and (ii) the food is cooked using precisely controlled heating.

The vacuum packaging that is done within this facility is done to preserve the quality and food safety of the products produced. Vacuum packaging prevents moistureevaporative loss, prevents potential cross contamination problems, and inhibits off-flavors from oxidation.

This establishment has applied for a variance to process deer (i.e., venison) and/or otherwild game animals toproduce raw, not ground venison/wild gameproducts;raw, ground venison/wild gameproducts; fully cooked, not shelf stable venison/wild game products; and heat treated, shelf stable venison/wild game products. Although our products do not meet the criteria identified (i.e., water activity and pH), the products produced are not “potentially hazardous foods” because they are produced in accordance to typical manufacturing practices within the U.S. meat industry. Moreover, this document is our product assessment and contains detailed information of our production practices to ensure the safety of the products produced within this establishment.

(C) A HACCP plan if required as specified under ¶ 8-201.13(A) that includes the information specified under § 8-201.14 as it is relevant to the variance requested.

A HACCP plan for the custom processing of venison/wild game that are for personal use as food and not for sale or service is maintained by this establishment and is available to regulatory authorities upon request after a variance is granted by the regulatory authority.

According to the 2009 FDA Food Code §8-201.14 (Contents of a HACCP Plan), a food establishment is required under 2009 FDA Food Code § 8-201.13 to have a HACCP plan. The HACCP plan and specifications shall indicate:

(A) A categorization of the types of potentially hazardous foods (time/temperature control for safety foods) that are specified in the menu such as soups and sauces, salads, and bulk, solid foods such as meat roasts, or of other foods that are specified by the regulatory authority.

Within the establishment’s HACCP plan, this information is found within the section titled “Categorization Of Products.”

(B) A flow diagram by specific food or category type identifying critical control points.

Within the establishment’s HACCP plan, this information is found within the section titled “Process Flow Diagram.” The critical control point (CCP) has been identified within the process flow diagram.

(1)Ingredients, materials, and equipment used in the preparation of that food.

Within the establishment’s HACCP plan, the listing of ingredients is found within the section titled “Product Ingredient List.” All ingredients come from approved manufacturing sources and are appropriate to use for meat and food. All materials (e.g., netting, casings, etc.) come from approved manufacturing source and are appropriate to use for meat and food. All equipment used by this establishment follows Title 9 of the Code of Federal Regulations (CFR) § 416.3 (equipment and utensils) (a) that states “equipment and utensils used forprocessing or otherwise handling edibleproduct or ingredients must be of suchmaterial and construction to facilitatethorough cleaning and to ensure thattheir use will not cause the adulterationof product during processing, handling, or storage. Equipment and utensilsmust be maintained in sanitarycondition so as not to adulterate product.”

(2)Formulations or recipes that delineate methods and procedural control measures that address the food safety concerns involved.

Within the establishment’s HACCP plan, the listing of formulations, processing procedures, and smokehouse schedules (i.e., thermal processing) are maintained by this establishment and are available to regulatory authorities upon request after a variance is granted by the regulatory authority. The establishment’s product formulations, processing procedures, smokehouse schedule, etc. are trade secret and include confidential information pursuant to 5 U.S.C 552(b)(4). No part of this information (including the HACCP plan) may be reproduced, stored in a retrieval systemor transmitted in any form or by any means without the written permission of this establishment.

(C)Food employee and supervisory training plan that addresses the food safety issues of concern

Within this establishment, any employee that is assigned to the processing of deer and/or otherwild game animals to produce raw, not ground venison/wild gameproducts;raw, ground venison/wild gameproducts; fully cooked, not shelf stable venison/wild game products; and heat treated, shelf stable venison/wild game products; has been properly trained on proper food safety production practices to ensure the production of safe food.

(D)A statement of standard operating procedures for the plan under consideration.

(1)Each critical control point.

Within the establishment’s HACCP plan, this information is found within the section titled “Process Flow Diagram.” The critical control point (CCP) has been identified within the process flow diagram. Further description of the critical control point is outlined within the document titled “Hazard Analysis and Identification of the Critical Control Points.”

(2)The critical limits for each critical control point.

Within the establishment’s HACCP plan, this information is found within the section titled “Identifying Critical Limits, Monitoring and Corrective Action.”

(3) The method and frequency for monitoring and controlling each critical control point by the food employee designated by the person in charge.

Within the establishment’s HACCP plan, this information is found within the section titled “Identifying Critical Limits, Monitoring and Corrective Action.”

(4) The method and frequency for the person in chargeto routinely verify that the food employee is following standard operating procedures and monitoring critical control point.

Within the establishment’s HACCP plan, this information is found within the section titled “Identifying Critical Limits, Monitoring and Corrective Action.”

(5) Action to be taken by the person in chargeif the critical limits for each critical control point are not met.

Within the establishment’s HACCP plan, this information is found within the section titled “Identifying Critical Limits, Monitoring and Corrective Action.”

(6) Records to be maintained by the person in chargeto demonstrate that the HACCP plan is properly operated and managed.

Within the establishment’s HACCP plan, this information is found within the section titled “Recordkeeping and Verification Procedures.” This establishment also documents the critical control point/critical control limit on a specific HACCP forms.

(E) Additional scientific data or other information, as required by the regulatory authority, supportingthe determination that food safety is not compromised by the proposal.

Within the establishment’s HACCP plan, this informationis found within the section titled “Supporting Documentation.” The supporting documentation is used to prove that the implemented HACCP plan, specifically the critical control point and the critical limits, will ensure the production of safe food.

Date: ______Approved by: ______