MIL-STD-3006C.PDF

NOT MEASUREMENT

SENSITIVE

MIL-STD-3006C

1 June 2008

SUPERCEDING

MIL-STD-3006A

7 June 2002

DEPARTMENT OF DEFENSE

STANDARD PRACTICE

SANITATION REQUIREMENTS

FOR FOOD ESTABLISHMENTS

AMSC N/A FSG 89GP

DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.

Downloaded from http://www.everyspec.com

FOREWORD

1. This standard is approved for use by all Departments and Agencies of the

Department of Defense (DOD).

2. The DOD is committed to the acquisition of food products produced, handled and stored in clean, sanitary food establishments in order to prevent the transmission of contaminants and foodborne disease to members of the Armed Forces. The requirements contained herein are based on available national food and drug regulatory requirements, industry and trade standards, and scientific guidelines published by various professional societies. These requirement documents are selectively applied herein to provide a scientific basis upon which to evaluate the safety of commercial food production purchased by the United States Armed Forces. This minimum set of standards can be augmented by the Major Command (MACOM) Veterinarian.

3. In keeping with DOD policy to use industry practices, the requirements for food establishments contained in this standard are based on industry standards applicable to the product identified in each appendix. While the appendices identify requirements selected from the appropriate industry standards, they do not contain all of the requirements from these standards. The requirements cited herein are not all-inclusive, verification during an audit may include other requirements from the cited document(s) at the discretion of the auditor.

4. This standard establishes the enforcement of Current Good Manufacturing Practices

(CGMPs) requirements, as provided in United States Code of Federal Regulations (CFR), Title 21, Part 110 as basic sanitation standards for food establishments requiring listing in the Worldwide Directory of Sanitarily Approved Food Establishments for Armed Forces Procurement. This standard also provides more detailed product specific requirements in the appendices.

5. This standard is applicable to all establishments supplying subsistence to DOD, whether in the Continental United States (CONUS) or outside the Continental United States (OCONUS). Detailed standards relating to specific types of food establishments are located in the appendices to this standard. This standard is also applicable to military owned/leased establishments where foods are stored (excluding retail operations), utilizing 21 CFR Part 110, General Requirements only. The auditing of military retail establishments is conducted utilizing the United States Food and Drug Administration (FDA) Food Code.

6. In OCONUS locations, the MACOM Veterinarian may supplement this document. This standard is not used to determine an establishment’s capabilities to comply with product specifications or other purchase requirements. In cases where CGMPs are provided for specific subsistence items (e.g., Low-acid canned foods), the specific requirements for that item will be applied in addition to those found in 21 CFR Part 110. Good Manufacturing Practice (CGMP) documents provided by industry and recognized by the FDA, the United States Department of Agriculture (USDA) or the United States Department of Commerce (USDC), may be used in conjunction with 21 CFR Part 110, with MACOM Veterinarian ii approval.

7. Comments, suggestions, or questions on this document should be addressed to the Director, DOD Veterinary Service Activity, Office of the Surgeon General/HQDA, 5109 Leesburg Pike, Falls Church, VA 22041-3258. Since contact information can change, you may want to verify the currency of this address information using the ASSIT Online database at http://assist.daps.dla.mil.

iii http://assist.daps.dla.mil/

CONTENTS

PARAGRAPH PAGE

FOREWORD.................................................................................................................................... ii

1. SCOPE

1.1 Scope

2. APPLICABLE DOCUMENTS

2.1 General

2.2 Government Documents

2.2.1 Handbook

2.2.2 Other Government publications

2.3 Order of Precedence

3. DEFINITIONS

3.1 General

3.2 Corrective Action Request (CAR)

3.3 Critical Finding

3.4 Directed Routine Sanitation Audit

3.5 Food Defense Finding

3.6 Food Defense Plan

3.7 Food Defense Program

3.8 Food Operational Risk Management (FORM)

3.9 Food Safety and Defense

3.10 Food Safety Program (FSP)

3.11 Imminent Health Hazard

3.12 Initial Sanitation Audit

3.13 Major Finding

3.14 Observation

3.15 Root Cause

3.16 Routine Sanitation Audit

3.17 Sanitation Audit

3.18 Sanitation Audit Rating

3.19 Sanitation Audit Report (SAR)

3.20 Special Sanitation Audit

3.21 Unacceptable Sanitation Audit Rating

3.22 Vulnerability

3.23 Water Potability Certificate

4. GENERAL REQUIREMENTS

4.1 Listing of Establishments

4.2 Appendices

4.3 Sanitation Audit

4.4 Laboratory Testing

4.5 Sanitation Audit Rating

iv

4.6 Corrective Action Request

5. DETAILED REQUIREMENTS

5.1 General

6. NOTES

6.1 Intended Use

6.2 Issue of DODISS

6.3 Tailoring Guidance

6.4 Audit Guidelines

6.5 Corrective Actions

6.6 Listing of Establishments

6.7 Subject Term (keyword) Listing

6.8 Changes from Previous Issue

GENERAL PROVISIONS

TABLE A-I

TABLE A-II

TABLE A-III

TABLE A-IV

TABLE A-V

TABLE A-VI

TABLE A-VII

BAKERY

MANUFACTURED CHEESE PRODUCTS

PASTEURIZED MILK PRODUCTS

SHELL EGGS

FROZEN DESSERTS

ICE

FISH AND FISHERY PRODUCTS

PASTEURIZED, REFRIGERATED JUICES

BOTTLED WATER

OFF POST CATERERS, CIVILIAN RESTAURANTS AND READY-TO-EAT

MANFACTURED PRODUCTS

SLAUGHTER AND FABRICATION OF MEAT PRODUCTS OCONUS

DRY DAIRY PRODUCTS

SLAUGHTER AND FABRICATION OF OF POULTRY PRODUCTS OCONUS

FRESH-CUT FRUITS AND VEGETABLES

MANUFACTURED EGG PRODUCTS

MUSHROOMS

v vi

VEGETABLE SPROUTS

LOW-ACID CANNED FOODS (LACF)

COOK/CHILL AND SOUS VIDE PROCESSING

FRESH FRUIT AND VEGETABLE SUPPLIERS (UNPROCESSED) IN OCONUS

AREAS

FOOD DEFENSE PROGRAM

1. SCOPE

1.1 Scope. This standard establishes sanitation and food defense requirements for establishments that produce, process, or store various types of food products before or after final acceptance by an element of the Department of Defense.

2. APPLICABLE DOCUMENTS

2.1 General. The documents listed in this section are specified in sections 3, 4, or 5 of this standard. This section does not include documents cited in other sections of this standard or recommended for additional information or as examples. While every effort has been made to ensure the completeness of this list, document users are cautioned that they must meet all specified requirements of documents cited in sections 3, 4, or 5 of this standard, whether or not they are listed.

2.2 Government Documents.

2.2.1 Handbook. The following handbook forms a part of this document to the extent specified herein. Unless otherwise specified, the issues of these documents are those cited in the solicitation or contract.

DEPARTMENT OF DEFENSE STANDARD

MIL-HDBK-3006C, Guidelines for Auditing Food Establishments.

(Copies of this document is available online at http://assist.daps.dla.mil/quicksearch/ or http://assist.daps.dla.mil or from the Standardization Document Order Desk, 700 Robbins Avenue, Building 4D, Philadelphia, PA 19111-5094.)

2.2.2 Other Government publications. The following other Government publications form a part of this document to the extent specified herein. Unless otherwise specified, the issues of these documents are those cited in the solicitation or contract.

MILITARY PUBLICATIONS

AR 40-657/NAVSUPINST 4355.4 /MCO P10110.31, Veterinary/Medical Food Inspection and Laboratory Service.

(Available from National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161; 1-800-553-6847; or download from web site: http://www.usapa.army.mil/.)

2.3 Order of Precedence. In the event of a conflict between the text of this document and the references cited herein, the text of this document takes precedence. Nothing in this document, however, supersedes applicable laws and regulations unless a specified exemption has been obtained.

http://assist.daps.dla.mil/quicksearch/ http://www.usapa.army.mil/

3. DEFINITIONS

3.1 General. The definitions and interpretations of terms found in 21 CFR Part 110 are applicable to this standard.

3.2 Corrective Action Request (CAR). A written request from the auditor to management addressing specific findings that require a response from management as to the root cause of the finding as well as the action(s) taken to correct and prevent recurrence of the finding(s).

3.3 Critical Finding. An imminent health hazard caused by a condition which presents a biological, chemical or physical food safety or food defense hazard that if not prevented, eliminated or reduced by a subsequent process, practice, step or procedure (hurdles); or that may cause food to be unsafe for consumption or otherwise adulterated.

3.4 Directed Routine Sanitation Audit. Conducted at the direction of the applicable MACOM Veterinarian within establishments listed in the Worldwide Directory when laboratory results indicate a need for further sanitation cognizance or other reasons. The focus of this audit is normally limited to the areas of concern.

3.5 Food Defense Finding. Any condition, practice, step or procedure noted relating to the risk of intentional food tampering or increased food vulnerability. Food Defense findings can occur at any stage during receipt, storage, processing, packaging, packing, warehousing or distribution.

3.6 Food Defense Plan. A written document or approach that uses established risk management procedures for preventing intentional food tampering and responding to threats or actual incidents of intentional tampering.

3.7 Food Defense Program. A program developed by an establishment to assess and mitigate the vulnerabilities within the food system or infrastructure to an attack from deliberate or intentional acts of food destruction, contamination or tampering.

3.8 Food Operational Risk Management (FORM). A simplified food safety and defense risk assessment process based on severity and frequency to prioritize risks, target resources and focus efforts on short-term accomplishments. The approach is similar to a Hazard Analysis Critical Control Point (HACCP) plan and used to minimize food safety and defense risks.

Components of FORM include: (1) Identify the hazards; 2) Assess the risk; 3) Analyze risk control measures; 4) Make control decisions; 5) Implement risk controls; and 6) Supervise and review. FORM provides for a more effective use of resources and can be used to improve food safety and defense. A HACCP plan supports, but does not substitute a FORM assessment.

3.9 Food Safety and Defense. A food is deemed safe when it has been prepared, packed, stored and distributed under sanitary conditions whereby it has not been rendered injurious to health. Food Defense is the implementation of programs or barriers that prevent or reduce the susceptibility and/or vulnerability of food systems to deliberate or intentional acts of destruction, contamination or tampering.

3.10 Food Safety Program (FSP). A written or practiced non-regulatory plan (similar to HACCP) that is implemented and practiced by establishment personnel and is designed to ensure the safe production of food. To differentiate mandatory (regulatory) HACCP from a voluntary program, this document makes reference to the Food Safety Program.

3.11 Imminent Health Hazard. A significant threat or danger to health that is considered to exist when there is evidence sufficient to show that a product, practice, circumstance, or event creates a situation that requires immediate correction or cessation of operation to prevent injury based on: (1) the number of potential injuries, and (2) the nature, severity, and duration of the anticipated injury.

3.12 Initial Sanitation Audit. A comprehensive evaluation of a commercial food establishment that determines the sanitary status for the first time. The Initial sanitation audit is triggered by a request to list a commercial establishment in the Worldwide Directory. This audit is used to approve or disapprove the establishment as a source for Armed Forces procurement.

Initial sanitation audits are a complete assessment of the facilities production procedures, and food safety and food defense control systems.

3.13 Major Finding. Condition, practice, step or procedure which in itself does not present a food defense or imminent health hazard yet has the potential to affect food safety or the product’s intended use due to loss or lack of verifiable control.

3.14 Observation. Condition, practice, step or procedure that is not in accordance with food safety and defense requirements, and does not meet the criteria of a Critical or Major finding.

3.15 Root Cause. A true cause of a finding based on an in-depth investigation.

3.16 Routine Sanitation Audit. An evaluation to determine the current sanitary status and overall status of the sanitation and food defense program of an establishment listed in the Worldwide Directory. These audits result in the continued approval of the establishment or a notice to its management of the possibility of disapproval if the sanitary findings observed are not corrected in a reasonable amount of time, as determined by the MACOM Veterinarian.

Routine sanitation audits will be thorough enough, and at a frequency that allows the auditor to evaluate the current conditions of the establishment and associated operations. The in-plant assessment during Routine Sanitation Audits are normally performed in the same depth and complexity as Initial Sanitation Audits.

3.17 Sanitation Audit. An in-depth examination of an establishment’s policy and procedures to determine effectiveness and compliance as it applies to the protection of food.

Sanitation audits examine and evaluate the adequacy of an establishment's food safety, food defense, and other applicable control systems. Sanitation audits include Initial, Routine, Directed Routine, and Special audits.

3.18 Sanitation Audit Rating. A rating based upon the results of the sanitation audit, rated as either “Acceptable” or “Unacceptable”.

3.19 Sanitation Audit Report (SAR). A written record of the results from a sanitation audit.

3.20 Special Sanitation Audit. An evaluation to determine whether the establishment will remain an approved source for the procurement of subsistence for the Armed Forces. This audit is performed after an establishment has been rated "Unacceptable" after a Routine or Directed Routine sanitation audit, or the MACOM Veterinarian has reason to suspect products may be a threat to public health. The focus of this audit is normally limited to the findings found during a previous audit that was rated “Unacceptable”.

3.21 Unacceptable Sanitation Audit Rating. The rating given to an establishment that does not comply with the requirements of the sanitation audit. One Critical finding or more than three Major findings constitute an unacceptable audit rating. Observations alone will not result in an “Unacceptable" rating. The cumulative effect of multiple Observations indicating an out-of-control process may require an upgrade to a Major finding due to increased public health significance.

3.22 Vulnerability. A weakness in the design, implementation or operation of an asset or system that can be exploited by an adversary or disrupted by a natural hazard.

3.23 Water Potability Certificate. When an establishment uses water in food processing, or cleaning and sanitizing of food equipment, the establishment will provide a water potability certificate indicating the absence of coliforms. Water samples will be drawn from within the establishment on an annual basis and tested by an EPA certified or equivalent laboratory. If an establishment does not produce or handle unpackaged food, then a copy of the annual water certificate from the city water authority indicating compliance with the EPA Primary Drinking Water Standards will be available for review during the audit. Testing of chemical contaminants should be in full compliance with all provisions of EPA National Primary and Secondary Drinking Water Regulations (40 CFR parts 141 and 143).

4. GENERAL REQUIREMENTS

4.1 Listing of Establishments. Compliance with this standard is mandatory for listing of establishments in the Worldwide Directory of Sanitarily Approved Food Establishments for Armed Forces Procurement (see 6.6).

4.2 Appendices. The general requirements in the appendices contained herein shall apply to the appropriate food establishment.

4.3 Sanitation Audit. Compliance with the requirements of this standard and the applicable appendices shall be verified by an audit of the food establishment (see 6.4). The audit shall examine and evaluate the adequacy of an establishment's food safety, food defense, and other applicable control systems to include an examination of the methods used to receive, handle, process and store and transport food. The sanitation audit shall be performed in the presence of management or a designated representative. Results of the audit shall be documented.

4.4 Laboratory Testing. All food products in the establishment are subject to laboratory testing. If a product is selected for laboratory testing, the sanitation audit report will not be considered final until laboratory results are received.

4.5 Sanitation Audit Rating. A sanitation audit shall be rated either "Acceptable" or "Unacceptable". A Critical finding will result in an “Unacceptable” rating. More than three Major findings will result in an “Unacceptable” rating. It is possible to have multiple ‘unrelated’ findings with the same reference code listed (scored) separately. It is also possible to have multiple ‘related’ findings listed under the same score (i.e., Observation, Major, or Critical).

Observations will not result in an “Unacceptable” rating. The cumulative effect of multiple Observations indicating an out-of-control process may require an upgrade to one Major finding due to increased public health significance.

4.6 Corrective Action Request. Establishments receiving a Corrective Action Request (CAR) will provide feedback as to the root cause of the finding as well as the action(s) taken to correct and prevent recurrence of the finding(s) (See 6.5).

5. DETAILED REQUIREMENTS

5.1 General. The following appendices contain specific requirements related to the cited reference document, but are not intended to be all-inclusive.

APPENDIX A - General Requirements APPENDIX B - Bakery

APPENDIX C - Manufactured Cheese Products APPENDIX D - Pasteurized Milk Products APPENDIX E - Shell Eggs APPENDIX F - Frozen Desserts APPENDIX G - Ice APPENDIX H - Fish and Fishery Products APPENDIX J - Pasteurized, Refrigerated Juices APPENDIX K - Bottled Water APPENDIX L - Off Post Caterers, Civilian Restaurants, and Ready-to-Eat Manufactured Products

APPENDIX M - Slaughter and Fabrication of Meat Products OCONUS APPENDIX N - Dry Dairy Products

APPENDIX O - Slaughter and Fabrication of Poultry Products

OCONUS

APPENDIX P - Fresh-Cut Fruits and Vegetables APPENDIX Q - Manufactured Egg Products APPENDIX R - Mushrooms

APPENDIX S - Vegetable Sprouts APPENDIX T - Low-acid Canned Food (LACF) APPENDIX U - Cook/chill and Sous Vide Processing APPENDIX W - Fresh Fruit and Vegetable Suppliers (unprocessed) in OCONUS Areas APPENDIX Y - Food Defense Program

6. NOTES

6.1 Intended Use. This standard is intended to ensure that food products procured by DOD for use by Armed Forces personnel are safe.

6.2 Issue of DODISS. When this standard is used in acquisition of products, the applicable issue of the DODISS must be cited in the solicitation.

6.3 Tailoring Guidance. To ensure proper application of this standard, invitations for bids, requests for proposals, and contractual statements of work should tailor the requirements in section 5 of this standard to exclude any unnecessary requirements. For example, if the requirement applies to a bakery establishment, only the requirements contained in this standard and in the bakery appendix should be mandated.

6.4 Audit Guidelines. The Government will perform audits of contractors’ premises based on guidelines contained in MIL-HDBK-3006C, Guidelines for Auditing Food Establishments. Copies of this document is available online at http://assist.daps.dla.mil/quicksearch/ or http://assist.daps.dla.mil or from the Standardization Document Order Desk, 700 Robbins Avenue, Building 4D, Philadelphia, PA 19111-5094.

6.5 Corrective Actions. Follow the guidelines in MIL-HDBK-3006C for establishments that receive Corrective Action Requests.

6.6 Listing of Establishments. Establishments in compliance with this standard may be listed in the Worldwide Directory of Sanitarily Approved Food Establishments for Armed Forces Procurement (http://www.veterinaryservice.army.mil/). Requests for listing in the Directory should be directed to the appropriate procurement agency. Information related to its use should be directed to the appropriate MACOM Veterinarian.

6.7 Subject Term (keyword) Listing.

Sanitation Audit Report Corrective Action Request Auditing Personnel Initial Audit Routine Audit Special Audit Directed Routine Sanitation Audit Methodology

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Laboratory Audit Recommendation for Deletion Request for Removal Food Safety Food Defense Worldwide Directory

6.8 Changes from Previous Issue. Marginal notations are not used in this revision to identify changes with respect to the previous issue due to the extent of the changes.

APPENDIX A

GENERAL PROVISIONS

A.1 SCOPE

A.1.1 Scope. This appendix establishes the general sanitation requirements for auditing food processing and food warehousing establishments. This appendix is a mandatory part of this standard. The information contained herein is intended for compliance.

A.2 APPLICABLE DOCUMENTS

A.2.1 General. The Government and non-Government publications listed in this particular section are applicable to this appendix. However, this particular section does not include: (1) documents cited in other sections of this standard; (2) documents recommended for additional information; or (3) documents recommended as examples. While every effort has been made to ensure the completeness of the publication lists in this particular section, users are cautioned that all other specified documents {(1) through (3) above} cited in this appendix still apply, whether they are listed below or not.

A.2.2 Other Government documents and publications. The following other Government documents and publications form a part of this document to the extent specified herein. Unless otherwise specified, the issues of these documents are those cited in the solicitation or contract.

CODEX ALIMENTARIUS

Recommended International Code of Practice, General Principles of Food Hygiene. CAC/RCP 1-1969, (Current Revision).

(Available online at: http://www.codexalimentarius.net/web/index_en.jsp.)

CODE OF FEDERAL REGULATIONS (CFR)

Title 21, Part 110 (Updated annually in April).

(Application for copies should be addressed to Superintendent of Public Documents, U.

S. Government Printing Office, Washington, DC 20402-0001, or online at:

http://www.gpoaccess.gov/cfr/index.html.)

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Food, Drug and Cosmetic Act, 1938, as amended Public Law (PL) 107- 188.

(Application for copies should be addressed to Superintendent of Public Documents, U. S. Government Printing Office, Washington, DC 20402-0001, or online at http://www.fda.gov or http://www.gpoaccess.gov/.)

Downloaded from http://www.everyspec.com http://www.codexalimentarius.net/web/index_en.jsp http://www.gpoaccess.gov/cfr/index.html http://www.fda.gov/ http://www.gpoaccess.gov/

U.S. DEPARTMENT OF AGRICULTURE, FOOD SAFETY AND INSPECTION

SERVICE

The National Advisory Committee on Microbiological Criteria for Foods (NACMCF), “Requisite Scientific parameters for Establishing the Equivalence of Alternative Methods of Pasteurization”, Aug 2004.

(Available on-line at:

http://www.fsis.usda.gov/ophs/nacmcf/2004/nacmcf_pasteurization_082704.pdf.)

A.2.3 Non-Government publications. The following documents form a part of this document to the extent specified herein. Unless otherwise specified, the issues of these documents are those cited in the solicitation or contract.

AIB INTERNATIONAL (AIB)

The AIB Guide to Food Security.

(Application for copies should be addressed to the AIB International, 1213 Bakers Way, P.O.

Box 3999, Manhattan, KS 66505-3999: Available on-line at: http://www.aibonline.org/.)

A.3 DEFINITIONS

The definitions in section 3 of this standard apply to this appendix.

A.4 GENERAL REQUIREMENTS

This section is not applicable to this appendix.

A.5 DETAILED REQUIREMENTS

A.5.1 General. The requirements in Tables A-I through A-VII shall be as specified in the individual Tables, but are not intended to be all-inclusive. The requirements herein relate to personnel safety and cleanliness, building and facilities, equipment and utensils, raw materials and operations, defect action levels, hazard analysis (HACCP)/food safety program (FSP) and the food defense program to ensure the adequacy and safety of food products.

http://www.fsis.usda.gov/ophs/nacmcf/2004/nacmcf_pasteurization_082704.pdf http://www.aibonline.org/

TABLE A-I.

Subpart A – Personnel REQUIREMENTS as specified in:

Good Manufacturing Practices, CFR Title 21, Part 110

C

M

O

ITEM REQUIREMENT

A1

Adequate disease control measures are practiced. Employees that are ill or otherwise suspected of carrying a communicable disease are excluded from processing or reassigned to other duties where they are not in contact with food, equipment or utensils. (21 CFR 110.10(a))

A2 Employees are wearing suitable clothing. (21 CFR 110.10(b))

A3 Employees are maintaining adequate cleanliness. (21 CFR 110.10(b))

A4 Employees are washing hands thoroughly after each absence from the workstation and at any other time the hands may have become soiled or contaminated. (21 CFR 110.10(b))

A5 Employees working in the processing area are free from unsecured jewelry or other objects. (21 CFR 110.10(b))

A6 Employees are using proper gloves and maintaining them in an intact, clean, and sanitary condition. (21 CFR 110.10(b))

A7 Employees are wearing effective hair or beard restraints. (21 CFR 110.10(b))

A8 Employees' personal belongings are being properly stored. (21 CFR 110.10(b))

A9

Employees are not eating food, chewing gum, drinking beverages or using tobacco where food or single-service articles are exposed or where equipment and utensils are washed or could become contaminated. (21 CFR 110.10(b))

A10 Precautions are taken to protect food, equipment and packaging materials from being contaminated by employees. (21 CFR 110.10(b))

A11

Employees are trained in food safety and handling and have clearly assigned responsibilities, and are supervised. Supervisors shall be trained to a level of competency that will ensure the production of clean and safe food. (21 CFR 110.10(9)(c) and (d))

*C-Critical, **M-Major, ***O-Observation

TABLE A-II.

Subpart B - Buildings and facilities REQUIREMENTS as specified in:

M

O

ITEM REQUIREMENT

B1 Grounds are maintained in a condition that will protect against product or establishment contamination or foster the harborage of pests. (21 CFR 110.20 (a))

B2

Buildings and structure are suitable in size, construction, and design to facilitate maintenance and sanitary operations to include food contact surfaces and food packaging materials. Potential for contamination reduced by effective separation of operations in which contamination is likely to occur. (21 CFR 110.20(b))

B3

Buildings (to include floors, walls, and ceilings) fixtures (to include those that allow dripping and condensation), utensils, and other physical facilities of the plant are maintained in a sanitary condition and in good repair. (21 CFR 110.20(b)) and (21 CFR 110.35(a))

B4 Adequate protection against glass breakage over exposed foods, processing equipment and containers is provided. (21 CFR 110.20(b)(5), (6) and (7))

B5 Adequate lighting, ventilation, and screening shall be provided. (21

CFR 110.20)

B6 Substances used for cleaning, sanitizing and pest control are safe, adequate, used IAW instructions; and are properly marked and stored. (21 CFR 110.35(b)) and (21 CFR 110.35 (d)(5))

B7 Adequate measures are taken to exclude pests from processing and storage areas and to protect against contamination of foods by pests, and/or pesticides. (21 CFR 110.35(c))

B8

Food contact surfaces and non-food contact surfaces are adequately cleaned and sanitized as frequently as necessary. Food contact surfaces, non-food contact surfaces of equipment and single service articles are properly protected against contamination. (21 CFR 110.35(d) and (e))

B9

The water supply is sufficient and from a sanitary source. Water potability checked not less than annually by samples selected from within the plant. (21 CFR 110.37(a)) (Not applicable for warehouses that do not process food.)

B10 The plumbing is adequate in size and is adequately installed and maintained. (21 CFR 110.37(b))

TABLE A-II – Continued.

Subpart B - Buildings and facilities REQUIREMENTS as specified in:

M

O

ITEM REQUIREMENT

B11 Sewage is adequately disposed. (21 CFR 110.37(c))

B12 Adequate toilet facilities are provided for employees and are sanitarily maintained, in good repair, and do not open directly into food processing areas. (21 CFR 110.37(d))

B13 Adequate hand-washing facilities are provided at convenient locations.

(21 CFR 110.37(e))

B14

Rubbish and offal shall be conveyed, stored and disposed of so as to minimize the development of odor or presence of a food safety hazard and minimizes the potential for becoming an attractant or harborage for pests. (21 CFR 110.37(f))

TABLE A-III.

Subpart C - Equipment and utensils REQUIREMENTS as specified in:

M

O

ITEM REQUIREMENT

C1 All pieces of equipment and utensils are adequately designed so as to be cleanable and are properly maintained and cleaned as often as necessary. (21 CFR 110.40(a))

C2 Food contact surfaces are corrosion resistant, made of nontoxic materials and shall be maintained to prevent contamination of food from any source. (21 CFR 110.40(a))

C3 Equipment lubrication does not contaminate the product; only food grade lubricants are used in the food zone. (21 CFR 110.40(a))

C4 Seams on food-contact surfaces are smoothly bonded or maintained so as to minimize the growth of microorganisms. (21 CFR 110.40(b))

C5 Surfaces of equipment, other than food contact surfaces, maintained in the food handling area, are constructed so they can be kept in a clean condition. (21 CFR 110.40(c))

C6 Holding, conveying and manufacturing systems are designed and constructed so that they can be maintained in an appropriate sanitary condition. (21 CFR 110.40(d))

C7 Adequate indicating thermometers, temperature-measuring devices, temperature-recording devices, and temperature controls are in place.

(21 CFR 110.40(f))

C8 Compressed air or other gases that are mechanically introduced into food or used to clean food-contact surfaces are free of indirect food additives (e.g., condensate, oil or unfiltered air). (21 CFR 110.40(g))

C9 Installed thermometers or temperature recording devices are required for freezers and cold storage areas that hold food capable of supporting microbial growth. (21 CFR 110.40(e))

C10 Instruments and controls for recording temperature(s), pH, acidity, water activity or other processing controls shall be accurate (calibrated) and properly maintained. (21 CFR 110.40(f))

TABLE A-IV.

Subpart E - Raw materials and operations REQUIREMENTS as specified in:

Federal Food, Drug and Cosmetic Act, 1938 (the Act)

C

M

O

ITEM REQUIREMENT

E1

Raw materials and other ingredients are inspected at receipt, are purchased from an approved supplier, and are clean, and suitable for processing. Compliance verified by any effective means including supplier guarantee or certification. Raw materials are properly handled at all times to protect from contamination and adulteration. (21 CFR 110.80(a))

E2 Manufacturing operations are conducted under conditions and controls necessary to minimize the potential growth of microorganisms or contamination of foods. (21 CFR 110.80(b))

E3

Foods are maintained under conditions during warehousing and distribution that will protect the food item and its container against physical, chemical, and microbial contamination as well as against deterioration. (21 CFR 110.93) and (21 CFR 110.80(b))

E4

Chemical, microbial, or extraneous-material testing procedures are used where necessary to identify sanitation failures or possible food contamination. Test results must meet the applicable requirements. (21 CFR 110.80(b))

E5

Methods to exclude physical contaminants are established and monitored (e.g., metal detection, visual screening, sieves, or other suitable effective means IAW best industry practices). (21 CFR 110.80(b))

E6

Process controls are adequate to ensure known public health risk(s) associated with the food being processed have been addressed in accordance with current good manufacturing practices to prevent contamination and to prevent the food from being considered adulterated within the meaning of the act. (21 CFR 110.80(b)) and (the Act)

E7

When ice is used in contact with food, it shall be made from water that is of adequate sanitary quality and shall only be used if it has been manufactured in accordance with good manufacturing practices as outlined in this part. (21 CFR 110.80(b)(16))

E8 Food manufacturing areas and equipment used for manufacturing human food should not be used to manufacture nonhuman food-grade animal feed or inedible products. (21 CFR 110.80(b)(17))

TABLE A-IV – Continued.

Subpart E - Raw materials and operations REQUIREMENTS as specified in:

M

O

ITEM REQUIREMENT

E9

Ingredients that are known allergens (e.g., eggs, milk, fish, soy, peanuts, tree nuts, crustacea and wheat) are stored, segregated, handled and processed to prevent the inadvertent contamination of non-allergen food products, shared food contact surfaces storage areas and packaging. (21 CFR 110.80) and (21 CFR 110.5)

E10 Packaging materials are safe and suitable for use in contact with food.

(21 CFR 110.80(b)(13)(iii))

E11 Food will not be prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. (21 CFR 110.5(a))

TABLE A-V.

Subpart G - Defect actions levels REQUIREMENTS as specified in:

Federal Food, Drug and Cosmetic Act, 1938 (the Act)

C

M

O

ITEM REQUIREMENT

G1 Ingredients purchased and foods produced are in compliance with applicable defect action levels. (21 CFR 110.110(a))

G2

Compliance with defect action levels does not excuse violation of the requirements of the act that food not be prepared, packed or held under unsanitary conditions or meet current good manufacturing practices.

(21 CFR 110.110(c)) and (the Act)

G3 Mixing of food exceeding maximum defect action levels with a lot of complying food (dilution of defect) is prohibited. (21 CFR 110.110(d))

TABLE A-VI.

Subpart H - Hazard analysis (HACCP)/Food safety program (FSP)

REQUIREMENTS as specified in:

CODEX Alimentarius National Advisory Committee of the Microbiological Criteria of Foods

(NACMCF)

Good Manufacturing Practices, CFR Title 21, Part 110

C

M

O

ITEM REQUIREMENT

H1 Hazard analysis is performed for ingredients, formulated product, and all production steps. (CODEX Alimentarius and NACMCF)

H2 A HACCP or Food Safety Plan (FSP) is developed and a plan is written and implemented and validated for each product produced with identified hazards. (CODEX Alimentarius and NACMCF)

H3

HACCP or FSP plan includes prerequisite programs, flow diagram, hazard analysis, critical control point summary, critical limits, monitoring procedures, corrective action plans, verification procedures and record keeping system. (CODEX Alimentarius and NACMCF)

H4 Corrective action plan is followed and deviant product segregated.

(CODEX Alimentarius and NACMCF)

H5 Corrective actions and product disposition results are fully documented. (CODEX Alimentarius and NACMCF)

H6 Records include all required information. (CODEX Alimentarius and

NACMCF)

H7 Records are reviewed, signed and dated as required. (CODEX Alimentarius and NACMCF)

H8 Records are retained as required (per reference standard) and are available and subject to public disclosure limitations. (CODEX Alimentarius and NACMCF)

H9 Internal reviews are performed as required. (CODEX Alimentarius and

NACMCF)

H10 A trained individual performs verification activities when a process change is made and when the HACCP or FSP plan is modified.

(CODEX Alimentarius and NACMCF)

H11 Prerequisite programs are performed and documented with sufficient frequency to ensure compliance with CGMPs. (21 CFR 110)

TABLE A-VII.

Subpart J – Food defense program REQUIREMENTS as specified in:

The AIB Guide to Food Safety (AIB)

M

O

ITEM REQUIREMENT

J1 A Food Defense program exists and is fully implemented. (AIB, Section 1.0)

J2 The outside grounds and roof are adequately safeguarded. (AIB, Section 2.0)

J3 Employee and visitor programs adequately address food defense policies. (AIB, Section 3.0)

J4 Material receiving system provides appropriate food defense measures.

(AIB, Section 4.0)

J5 Establishment operations provide appropriate food defense measures.

(AIB, Section 5.0)

J6 Finished goods storage/shipping system provides appropriate food defense measures. (AIB, Section 6.0)

APPENDIX B

BAKERY

B.1 SCOPE

B.1.1 Scope. This appendix establishes the food safety and related requirements for bakery establishments. This appendix is a mandatory part of this standard. The information contained herein is intended for compliance.

B.2 APPLICABLE DOCUMENTS

B.2.1 General. The Government and non-Government publications listed in this particular section are applicable to this appendix. However, this particular section does not include: (1) documents cited in other sections of this standard; (2) documents recommended for additional information; or (3) documents recommended as examples. While every effort has been made to ensure the completeness of the publication lists in this particular section, users are cautioned that all other specified documents {(1) through (3) above} cited in this appendix still apply, whether they are listed below or not.

B.2.2 Other Government publications. The following other Government publications form a part of this document to the extent specified herein. Unless otherwise specified, the

CFR Title 21, Part 110.

(Application for copies should be addressed to Superintendent of Public Documents, U.S.

Government Printing Office, Washington, DC 20402-0001, or online at:

http://www.gpoaccess.gov/cfr/index.html.)

B.2.3 Non-Government publications. The following documents form a part of this document to the extent specified herein. Unless otherwise specified, the issues of these documents are those cited in the solicitation or contract.

BAKING INDUSTRY SANITATION STANDARDS COMMITTEE (BISSC)

Sanitation Standards for the Design and Construction of Bakery Equipment and Machinery.

(Application for copies should be addressed to the AIB International P.O. Box 3999, Manhattan, KS 66502-3999, http://www.bissc.org/.)

B.3 DEFINITIONS

B.3.1 Definitions. The definitions in section 3 of this standard apply to this appendix.

Downloaded from http://www.everyspec.com http://www.gpoaccess.gov/cfr/index.html http://www.bissc.org/

B.4 GENERAL REQUIREMENTS

See Appendix A requirements in Tables A-I through A-VII.

B.5 DETAILED REQUIREMENTS

B.5.1 General. The requirements in Table B-I shall be as specified in the Table, but are not intended to be all-inclusive.

TABLE B-I.

PARAGRAPH

Bakery REQUIREMENTS as specified in:

Baking Industry Sanitation Standards Committee (BISSC) CFR Title 21, Part 110

E9

Ingredients that are known allergens (eggs, milk, soybeans, peanuts, tree nuts, and wheat) are stored, segregated, handled and processed to prevent the inadvertent contamination of non-allergen food products, shared food contact surfaces storage areas and packaging. (21 CFR 110.80 and 110.5)

C8

Air or other gases mechanically introduced into the product or product zone shall be filtered or washed to remove particles 5 microns or larger, and shall not contain oil, water and other liquids, unless such materials are specifically required as an operational procedure. (BISSC 3.1.19)

C1 Equipment other than that on solid bases attached to the floor shall provide a floor clearance of at least 6 inches (150mm) or shall be accessible for cleaning. (BISSC 3.2.6)

C3 Where lubrication is required, the design and construction shall be such that the lubricant cannot leak, drip or be forced into the product zone. (BISSC 3.2.9)

C1 Conveyors which are an integral part of the equipment and which carry the product through a filling, icing or glazing application shall be readily removable or appropriately fitted for in-place cleaning. (BISSC 4.5.1.8)

E2 Potable water inlet lines shall terminate not less than 1 inch (25mm) or twice the inlet pipe diameter, whichever is greater, above the overflow level of the bowl. (BISSC 4.6.1.14)

C6 Drip and/or catch pans used to collect spillage or drips are readily accessible or readily removable. (BISSC 4.7.2.1, 4.7.2.1.7, 4.7.2.1.12, 4.7.2.1.22, and 4.7.2.1.23)

C6 Liquid ingredient inlet pipes, valves and fittings are of sanitary take-apart type, unless designed for in-place cleaning, and are pitched for self-draining, back to the point where the line is continuously filled. (BISSC 4.6.1.13)

C1, E5 Vents on equipment for handling and storing dry ingredients are protected against entry of foreign material, and are provided with readily removable filters to exclude particles of 5 microns or larger. (BISSC 4.1.1.3)

C5, C6

Screw conveyor housings are hinged or removable so that the area around the helical flights can be cleaned from the outside. Sufficient clearance is provided between the bottom of the screw housing and the floor to permit sufficient exposure of the screw for cleaning. The screw housings are dust-tight and readily accessible. (BISSC 4.1.1.10)

C4, C6

Straight run surfaces of pneumatic conveyors, valves and rotary feeders are smooth and readily accessible or removable, except that piping, tubing, valves or feeders which are self-purging are exempt from the requirements for accessibility. (BISSC 4.1.3.1)

TABLE B-I – Continued.

C8 The air supply for blowers or compressors is filtered to exclude particles of 5 microns or larger. (BISSC 4.1.3.4)

E5 Sifter screens shall be minimum mesh to allow passage of product. (BISSC 4.1.4.5)

C6, C8 Separate conveying air systems are provided before and after an atmospheric sifter in the system. (BISSC 4.1.4.1)

C1, C6 A removable flexible connection is provided between the inlet to the hopper and the product delivery equipment. (BISSC 4.1.5.1)

C1, C3, E2 Bearings are outside the product zone and are sealed or self-lubricated; and design and construction are such that lubricant cannot leak, drip or be forced into the product zone.

(BISSC 3.1.13)

C1 Flexible tubing is transparent or translucent. Nozzles are readily removable. (BISSC 4.5.1.3)

C1, C6 Pumps, valves, pipe fittings, including those used to insert thermometers and pressure gauge bulbs, are of the sanitary take-apart type and are readily accessible or removable.

(BISSC 4.18.2.3)

C1, C2 Stationary mixer bowls drain completely. Close-coupled sanitary drain valves which are accessible or removable are provided. (BISSC 4.6.2.11)

C2, E2 Proofing cloths are smooth, except they may be of absorbent material, but are readily removable for laundering. An extra set of proofing cloths are provided. (BISSC 4.16.1.1)

C1, C6 Pumping, piping, valves and fittings used to dispense or convey frying fats, batter, glaze, icing, jellies and fillings are of sanitary take-apart type at least equal to 3A standards, and are accessible for inspection and cleaning. (BISSC 4.16.1.16)

C1, C6 The icing and/or glazing reservoir return is readily accessible and self-draining.

(BISSC 4.31.1.2)

APPENDIX C

MANUFACTURED CHEESE PRODUCTS

C.1 SCOPE

C.1.1 Scope. This appendix establishes the food safety and related requirements for manufactured cheese establishments. This appendix is a mandatory part of this standard. The information contained herein is intended for compliance.

C.2 APPLICABLE DOCUMENTS

C.2.1 General. The Government and non-Government publications listed in this particular section are applicable to this appendix. However, this particular section does not include: (1) documents cited in other sections of this standard; (2) documents recommended for additional information; or (3) documents recommended as examples. While every effort has been made to ensure the completeness of the publication lists in this particular section, users are cautioned that all other specified documents {(1) through (3) above} cited in this appendix still apply, whether they are listed below or not.

C.2.2 Other Government publications. The following other Government publications form a part of this document to the extent specified herein. Unless otherwise specified, the issues of these documents are those cited in the solicitation or contract.

ARMY REGULATION

AR 40-657, Veterinary/Medical Food Inspection and Laboratory Service.

(Available on Line at: http://www.army.mil/usapa/epubs/pdf/r40_657.pdf.)

CFR Title 7, Part 58.

CFR Title 21, Parts 133, and 173.

Government Printing Office, Washington, DC 20402-0001, or online at:

U.S. Public Health Service (USPHS)/Food and Drug Administration (FDA) Pasteurized Milk Ordinance (PMO).

http://www.army.mil/usapa/epubs/pdf/r40_657.pdf

(Application for copies should be addressed to: US Department of Health and Human Services, US Food and Drug Administration, Milk Safety Branch, HFS-626, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740-3835.)

C.3 DEFINITIONS

C.3.1 Definitions. The definitions in section 3 of this standard apply to this appendix.

C.4 GENERAL REQUIREMENTS

See Appendix A requirements in Tables A-I through A-VII.

C.5 DETAILED REQUIREMENTS

C.5.1 General. The requirements in Table C-I shall be as specified in the Table, but are not intended to be all-inclusive.

TABLE C-I.

Manufactured cheese products REQUIREMENTS as specified in:

CFR Title 7, Part 58 CFR Title 21, Parts 133 and 173

USPHS/FDA Pasteurized Milk Ordinance (PMO) AR 40-657, Veterinary/Medical Food Inspection and Laboratory Service

E1 Milk originates from farms that meet the requirements or intent of the PMO and herds that meet the animal health requirements as specified in Section 8 (Animal Health) of the PMO or equivalent program as determined by the MACOM Veterinarian in overseas areas. (PMO, Sec. 8)

E1, E4 Cheese not aged for NLT 60 days at NLT 35° F is made from milk in which every particle has been pasteurized. (7 CFR 58.439)

B2, B3 Building and facilities are maintained for laboratory, starter rooms, grading rooms, etc.

(7 CFR 58.126)

C1,C5, C6 All CIP systems, weighing and receiving tanks comply with 3-A accepted practices.

(7 CFR 58.128)

C7, C8, C10

If applicable, all can washers; associated water and steam lines are equipped and maintained for proper temperature and pressure controls. Steam pressure is not less than 80 lbs and the final rinse is an automatically controlled system, and does not exceed 140º F (60° C). (7 CFR 58.128 (c))

E1, E4, H6, H8

Raw milk conforms to basic quality and classification specifications of

58.132 - 133 and is tested at the frequencies required, and records are maintained.

(7 CFR 58.134 – 139)

E2, E6, C5, C6

Receiving, holding, and processing of milk and cream and the manufacturing, handling, packaging, storing, and delivery of dairy products is in accordance with 7 CFR Part 58.

H6, H8 Records are maintained for all required tests and analyses. (7 CFR 58.148)

C1, C5 Sanitary seal assemblies are removable on all agitators, pumps, and vats, and are inspected at regular intervals and kept clean. (7 CFR 58.146 (a))

B3, C1, E4, H6

Packaging room atmosphere is practically free from mold and verified in accordance with 7 CFR Part 58.151.

E1 Salt is free flowing, white, refined sodium chloride, and meets the requirements of 7 CFR Part 58.

E1 Color additives shall be approved by U.S. FDA. (7 CFR 58.329, and 58.719)

B2, B5, H6 A separate starter room or properly designed starter tanks with satisfactory air movement is provided. The air supply is filtered to 90% efficiency in accordance with ASHRAE Synthetic Dust Arrestance Test. (7 CFR 58.406)

TABLE C-I – Continued.

E4, H6 Mold counts for make rooms are not more than 15 colonies per plate/15 minutes.

(7 CFR 58.407)

B2, B3 Brine room is separately constructed and maintained with minimum corrosion. (7

CFR 58.408)

B2, E3 Adequate shelving, air circulation, temperature and humidity control is provided and maintained in drying rooms. (7 CFR 58.409)

B2, E2 Separate rooms are provided for packaging and boxing; maintained at proper temperature to prevent sweating prior to paraffining. (7 CFR 58.410)

E1 Bulk cheese for cutting, shredding, slicing or re-packaging must be manufactured in an approved establishment. (AR 40-657, Chapter 2-15)

B2 Separate rooms are provided for preparation of bulk cheese to be cut and wrapped into smaller packages. Air movement is outward moving. (7 CFR 58.413)

C6, C7 Bulk starter vats are equipped with tight fitting lids and have adequate temperature controls and indicating/recording devices. (7 CFR 58.414)

C1, C2, C3

Vats, tanks, and drain tables are constructed of 16-gauge steel or equally corrosion resistant metal, properly pitched, welded, and fitted with sanitary outlets and valves for maintenance of heat to the lines. Auto curd makers, cyclone separators, conveying systems, and curd fillers are properly constructed and maintained. (7 CFR 58.416)

C1 Mechanical agitators, shields, shafts, hubs, blades, forks, and stirrers are in accordance with 3-A Accepted Standards. (7 CFR 58.417)

C1, C8 Automatic salters meet the specific requirements (salting method, design, and steam quality) of 7 CFR 58.418.

C1, C2, C3 All hand utensils, knives, racks,…