Attachment_13_CPGM_7303.803.pdf

FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM GUIDANCE MANUAL

PROGRAM 7303.803

DATE OF ISSUANCE: PAGE 1

CHAPTER 03 - FOODBORNE BIOLOGICAL HAZARDS

SUBJECT: IMPLEMENTATION DATE

TBD

COMPLETION DATE

Domestic Food Safety

(FY 07-08)

This program has completed a Good Guidance Practices clearance by CFSAN’s ORP and OC/DFP/CPB in November 2006.

11/9/08

DATA REPORTING

PRODUCT CODES PRODUCT/ASSIGNMENT CODES

ALL HUMAN FOOD CODES

INSPECTION

03803 Foodborne Biological Hazards

04803 Chemical Contamination

09803 Food and Color Additives

USE APPROPRIATE PRODUCT

CODES SAMPLE COLLECTION AND ANALYSIS

03803B Filth

03803C Decomposition

03803D Microbiological

04803 Chemical Contamination

09803E Color Additives

09803F Food Additives

OTHER

21005 NLEA

NOTE: Material this is not releasable under the Freedom of Information Act (FIOA) has been redacted/deleted from this electronic version of the program.

Deletions are marked as follows: (#) denotes one or more words were deleted;

(&) denotes one or more paragraphs were deleted; and (%) denotes an entire attachment was deleted.

NOTE: The allergen guidance previously provided as Attachment F has been removed. At such time as new allergen program guidance is established, it will be in a separate program. All allergen work (“for cause” and other) sh ould continue to be reported under PAC 03803E.

FIELD REPORTS TO HEADQUARTERS

SUBMIT COMPLETED REPORTS TO:

A. Food and/ or Color Manufacturers Inspections

• Send copies of the entire Establishment Inspection Report (EIR) for only those inspections conducted at food additive manufacturers [Program and Project Structure (PPS) 09] which are classified as ‘Official Action Indicated (OAI)’ to:

CFSAN/ Compliance Programs Branch, HFS–636 5100 Paint Branch Parkway College Park, MD 20740-3835

DATE OF ISSUANCE: PAGE 2

EIR’s for color manufacturers should be submitted to CFSAN (at the above address). Documents may also be submitted via common carrier such as FedEx to CFSAN/Office of Cosmetics and Colors (OCAC) at the address below (this is not a post office mailing address):

CFSAN/ Office of Cosmetics and Colors (OCAC), HFS – 100

4300 River Road College Park, MD 20740-3835

PROGRAM ASSIGNMENT CODE REPORTING

• Do not report any coverage of domestic fish or fishery products under this Compliance Program. See Compliance Program 7303.842, “Domestic Fish and Fishery Products Inspection Program”. Use the appropriate PACs identified.

• Do not report any coverage of domestic cheese products for filth, decomposition, microbiological, phosphatase analysis or good manufacturing practices (GMP) inspections under this program. See Compliance Program 7303.037, “Domestic and Imported Cheese and Cheese Products Program”. Use the appropriate PACs identified.

NOTE: If cheese manufacturers are covered for incorrect application and storage of industrial/household chemicals and misuse of food/color additives, see Attachment B and C of this program. Resources for these areas will still be reported under the appropriate PACs listed in this Domestic Food Safety Compliance Program 7303.803.

• Do not report any coverage of Juice HACCP under this Compliance

Program. See Compliance Program 7303.847 “Juice HACCP Inspection Program” for coverage of Juice HACCP. Use the appropriate PACs identified. Juice beverages (less than 100% juice) are not subject to Juice HACCP regulations and therefore will continue to be inspected under this Domestic Food Safety compliance program (CP 7303.803). However, 100% juice, and juice beverages for which the juice portion is manufactured at the same location as the juice beverage are subject to Juice HACCP and will be covered entirely under the Juice HACCP compliance program (CP 7303.847).

All firms are currently subject to Juice HACCP and will be covered entirely under the Juice HACCP Compliance Program (CP 7303.847) for both HACCP and GMP violations.

• Refer to Compliance Program 7304.004, “Pesticides and Industrial

Chemicals in Domestic Foods” for coverage of pesticides incurred during farming/growing of raw and finished agricultural product.

In-plant misuse of chemicals, such as the problem of incorrect application and storage of industrial and household chemicals in food processing plants, warehouses, and transport vehicles, and coverage of food/color additives by the firm for all products, other than seafood and juice HACCP, are covered under this Domestic Food Safety Compliance Program 7303.803.

• See the following attachments for FACTS reporting requirements for sample collection and analysis:

DATE OF ISSUANCE: PAGE 3

Attachment A – Project 03 – Foodborne Biological Hazards Attachment B – Project 04 – Chemical Contaminants Attachment C – Project 09 – Food and Color Additives

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FORM FDA 2438 g (10/91)

PART I - BACKGROUND

This compliance program provides inspectional and analytical coverage of food products, in domestic commerce, for foodborne biological hazards, including unsanitary conditions (e.g., filth, and microbiological contamination), and decomposition, under Program and Project Structure (PPS) 03, adulteration with pesticides and industrial chemicals under PPS 04, and illegal use of color or food additives under PPS 09. This program also provides coverage of selected color manufacturers. A significant portion of the program's resources is devoted to inspections of firms producing products, which if abused, could be health hazards.

Inspectional and analytical resources for juice, cheese and seafood products are covered in the Juice HACCP Inspection Program (7303.847), Domestic and Imported Cheese and Cheese Products Program (CP 7303.037) and Domestic Fish and Fishery Products Inspection Program (CP 7303.842) programs, respectively.

Domestic coverage of pesticides in raw agricultural products incurred during farming/growing is provided in “Pesticides and Industrial Chemicals in Domestic Foods”, (CP 7304.004). This (Domestic Foods Safety) program covers the problem of incorrect application and storage of industrial and household chemicals in food processing plants, warehouses, and transport vehicles for all products except seafood and juice.

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FORM FDA 2438 g (10/91)

PART II – IMPLEMENTATION

OBJECTIVE

To conduct food safety inspections of domestic establishments involved in the production, storage, and distribution of food and to document any deficiencies that are observed.

PROGRAM MANAGEMENT INSTRUCTIONS

When appropriate:

• Have FDA laboratory personnel, such as microbiologists, chemists (chemical, food additive, etc. problems), and entomologists accompany investigators during complex inspections.

• Districts should coordinate inspectional operations with the appropriate Federal, State, and Local agencies.

A. Program Priorities and Resources Utilization

Resources shown in the ORA Workplan can be used to cover foodborne biological hazards and chemical contaminants (PPS 03, 04, and/ or 09) as described in the Attachments A, B, and C, of this program. When determining how this resource pool should be expended, use the priorities listed below. The core inspection is to be reported under PAC 03803, however, inspectional deficiencies observed or suspected, or necessary follow-up, in the areas of pesticide application or food and color additive usage should be reported under PAC 04803 or PAC 09803, respectively.

1) High-Risk Foods

For more information on identifiers of high risk foods refer to the high risk food instructions as updated at #

The term “High Risk Foods” is used to denote foods that may present hazards, which FDA believes, may present a high potential to cause harm from their consumption. The firms that produce high risk foods have priority for inspectional purposes. #

It is important to recognize that the number of establishments that FDA identifies associated with these foods will always be an estimate because: 1) food manufacturing business is subject to growth, mergers and/ or failure; 2) the Agency establishes new rules and further instructions to reduce foodborne hazards which may expand existing programs; and 3) as underlying scientific information improves to help target the source of the hazard, the number and types of firms applicable to the high risk definition will change.

A number of the “High Risk” firms and products, such as soft cheese, seafood, and juice are covered under other Compliance

TRANSMITTAL NO: PART II PAGE 2

FORM 2438 g (10/91)

Programs. These programs should be consulted prior to inspections.

NOTE: Dairy Plants on the Interstate Milk Shippers (IMS) list that meet the “High Risk Foods” definition will be inspected by a Regional Milk Specialist or identified for state contract inspections as directed under the Milk Safety Compliance Program (7318.003) #. For interstate milk producers listed in the Interstate Milk Shippers (IMS) list of Grade “A” milk and milk producers, refer to “Memorandum of Understanding with the National Conference of Interstate Milk Shippers” (formerly CPG 7158.01).

2) Firms classified “Official Action Indicated” (OAI), one or more times during the past three (3) years. Also consider coverage of firms with a “borderline” compliance profile over this time period, some of which may or may not have been classified as “OAI” during this period.

3) Nonfat Dry Milk Products

NOTE: Inspect ALL operating dried milk product manufacturers not inspected by USDA or not on the IMS List.

Refer to “Memorandum of Understanding between USDA/ AMS and FDA concerning Salmonella in Nonfat Dry Milk Products,” (formerly CPG 7155a.07) when considering coverage of nonfat milk producers. For interstate milk producers listed in the Interstate Milk Shippers (IMS) list of Grade “A” milk and milk producers, refer to “Memorandum of Understanding with the National Conference of Interstate Milk Shippers” (formerly CPG 7158.01). These documents can be obtained through the Federal Cooperative Agreements Manual, August 1996, which can be obtained through the Office of Regulatory Affairs (ORA), Office of Enforcement (OE), Division of Compliance Policy (HFC-230) at 301-827-0420.

Inspect firms participating in the USDA Salmonella Surveillance Program or Resident Inspection and Grading Program for problems other than Salmonella. Base the extent and frequency of surveillance on the firm’s past sanitation history and violative sample record (e.g., antibiotics, phosphatase, pesticides, etc.).

Inspections of plants processing non–grade “A” milk and milk products, specifically ice cream, frozen desserts, and dried milk should be emphasized (see IOM 538 – Other Government Inspection).

Plants targeted for coverage under this special emphasis should include:

• Milk processing plants that are NOT listed in the IMS list that receive or sell milk or milk product(s) interstate;

• Non – USDA inspected portions of USDA inspected plants;

Special Note: Any plant covered under a current special emphasis

FDA Compliance Program (e.g., Domestic and Imported Cheese and Cheese Products, the Milk Safety Program and Grade “A” IMS listed plants) should be specifically EXCLUDED from coverage under this special emphasis initiative.

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4) Firms covered by this program, other than warehouses, that do not fall under priority 1, 2 or 3, should be considered under the following criteria for coverage:

• Firms never inspected by the FDA or never inspected under the

Domestic Food Safety Program should be given precedence over firms previously inspected or inspected under this program and classified as “No Action Indicated” (NAI).

• Violative history of the overall industry.

NOTE: The violative history of the overall industry will be summarized and issued periodically to the field by the Center.

5) Do not routinely conduct surveillance inspections of firms that are designated as establishment type “warehouse” (W), only.

The Field will conduct follow–up inspections of warehouses that were classified “OAI” during the last inspection, or where intelligence indicates significant foodborne hazards.

B. Food Defense Measures and Food Registration

A Food Defense component should be included in all inspections conducted under this program. Reconciliation exams should also be covered (Please see IOM section 5.4.1.4.2)

C. Interaction with Other Programs FDA staff should refer to the on-line FDA Compliance Program Guidance Manual Master List for the latest issuance of all CFSAN programs at:#

1. Milk Safety Program, CP 7318.003

Consult with the Regional Milk Specialist to determine if a dairy plant is on the IMS list prior to identifying this plant for inspection. Only those areas of a milk processing plant that process Grade A listed products should be excluded from coverage under this special initiave. Under the IMS agreement, regulatory inspection and enforcement action are the responsibility of state agencies for Grade “A” products, which are IMS listed. Grade A products that are not covered by the IMS, or Non–Grade A products are appropriate for FDA coverage. See IOM section 5.4.9.3 “Grade A Dairy Plant Inspections” for additional information

The USDA has two voluntary inspection programs for dry milk plants; the Plant Inspection Program (PIP) and The Resident Inspection and Grading Program. If a firm is operating in compliance with either of these two programs they will appear on the USDA’s List of Dairy Plants Surveyed and approved for USDA Grading Service. Under MOUs with USDA (CPG #’s 7155a.01 and 7155a.07), FDA agrees not to (routinely) inspect dry milk product plants that are covered by one of the USDA inspection programs, or routinely sample dry milk for salmonella testing if the plant is operating under one of these two programs. See IOM section 3.2.1.5 #8 for additional information.

TRANSMITTAL NO: PART II PAGE 4

2. Domestic and Imported Cheese and Cheese Products Program, CP

7303.037. CP 7303.037 directs sampling of domestic and imported cheese for filth, decomposition, microbiological contamination and phosphatase, and good manufacturing practice (GMP) inspections of domestic cheese establishments.

NOTE: Coverage of domestic cheese establishments for incorrect application and storage of industrial/ household chemicals and misuse of food/ color additives will still be reported under the appropriate PACs listed in this Domestic Food Safety program.

3. Domestic and Import NLEA, Nutrient Sample Analysis and General

Food Labeling Program, CP 7321.005

Coverage of the NLEA and FALCPA is to be accomplished during ALL routine Domestic Food Safety inspections of firms that are manufacturing and/ or labeling or re-labeling food products at the site inspected.

4. Domestic Fish and Fishery Products Inspection Program, CP 7303.842

5. Pesticides and Industrial Chemicals in Domestic Foods, CP 7304.004

CP 7304.004 directs coverage of pesticides in domestic raw agricultural products incurred during farming/growing. The problem of incorrect application and storage of industrial and household chemicals in food processing plants, warehouses, and transport vehicles for all products except seafood and juice is covered under the Domestic Food Safety Program.

TRANSMITTAL NO: PART III/ IV PAGE 1

FORM FDA 2438g (10/91)

PART III – INSPECTIONAL AND PART IV - ANALYTICAL

To emphasize coverage of all relevant Program and Project Structure (PPS) areas during a food safety inspection, this program includes a separate Attachment for each project and analytical procedure not covered elsewhere.

Attachment A - PPS 03 - Foodborne Biological Hazards

Attachment B - PPS 04 - Chemical Contaminants

Attachment C - PPS 09 – Food Additives and Color Additives

Attachment D - Polymerase Chain Reaction (PCR) for Vibrio cholerae Enterotoxigenic Strains

Attachment E - Detection of Shigella by the Polymerase Chain Reaction (PCR)

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PART V – REGULATORY/ ADMINISTRATIVE STRATEGY

A. Regulatory/ Administrative Follow-up

This Compliance Program addresses various food adulterations under section 402 of the Act. Food misbranding is covered under the “Domestic and Import NLEA Nutrient Sample Analysis and General Food Labeling Program” (C.P. 7321.005). Refer to Part II, C. Interaction with Other Programs.

Foods contaminated with harmful microorganisms and adulterated under 402(a)(1) should be removed from commerce either through voluntary recalls by the responsible firm(s) or FDA civil legal actions, such as seizures or injunctions. Further instructions on recalls and model class I press releases for these situations can be accessed at http://www.fda.gov/opacom/7alerts.html and http://www.cfsan.fda.gov/~lrd/inspect.html. Foods adulterated under other sub-sections of 402 should be handled similarly; however, districts should determine appropriate regulatory strategy depending on the situation. Districts should also review the Foods, Color and Cosmetics Chapter 5 of the Compliance Policy Guides for FDA compliance policy of foods, http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/default.htm.

Food defense observations should not be listed on form FDA-483, Inspectional Observations, unless they constitute deviations from Current Good Manufacturing Practice.

Adverse findings from a reconciliation examination should be immediately relayed by telephone to FDA Emergency Operations (301-443-1240) and CFSAN Emergency Coordination and Response Staff (301-436-2700). The findings will be evaluated on a case-by-case basis.

Enforcement action recommendations should be submitted directly to Division of Enforcement via the “Compliance Management System” link located on Inside FDA’s IT Applications Page under CFSAN Applications # prior to issuance of any Warning Letter. Contact one of the Regulatory Contacts from the Domestic Branch for early discussion concerning seizures, injunctions, or prosecutions under this program:

• Donald Greaves at (301) 436-2057 or Donald.Greaves@FDA.HHS.GOV

• Dwayne Johnson at (301)436-1782 or Dwayne.Johnson@FDA.HHS.GOV

Districts are also encouraged to provide early alerts on potential legal action recommendations to the Branch Chief, Domestic Branch (HFS-607), William Correll at (301)436-1611 or by e-mail at William.Correll@FDA.HHS.GOV.

If a transport vehicle is shown to be the source of contamination, a Warning Letter may be considered. If further action is necessary, contact CFSAN/ Division of Enforcement/ Domestic Branch regulatory contacts identified in Part VI of this Compliance Program.

In reference to a carrier company and adulterated food, refer to CPG http://www.fda.gov/opacom/7alerts.html http://www.cfsan.fda.gov/%7Elrd/inspect.html http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/default.htm mailto:Donald.Greaves@FDA.HHS.GOV mailto:BCorrell@FDA.HHS.GOV

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7117.08 Foods, Rail Car Sanitation – Adulteration, section 545.300 at http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg545-300.html.

Refer, as necessary, samples showing non-certified colors or labeling violations to the home district of the color manufacturer.

When unsanitary conditions are encountered in a warehouse containing USDA-donated surplus foods, refer to FMD #126 (Sanitation Problems in Warehouses Storing USDA - Donated Surplus Foods) (http://www.fda.gov/ora/inspect_ref/fmd/fmd126.htm).

B. Compliance Achievements

Encourage responsible individuals to correct deficiencies during an inspection. Explain the significance of the observations. Verify corrections made during the inspection. Ask management to notify the district in writing of additional corrections they intend to take, including the time frame for completion of corrections. Report compliance achievements/ voluntary corrections into FACTS using the Compliance/Compliance Achievements screens after the corrections have been certified (i.e., by written format or physical observation of correction).

C. Federal/ State Relations

Contracts exist with many states to inspect food establishments. This program is incorporated by reference in these contracts as further instructions in conducting sanitation inspections. Some states may also inspect firms where there are greater risks as identified in this program. State inspection assignments should follow the priorities in this program and should be coordinated with the districts selection of firms for FDA inspections. The selection of Dairy Firms should be coordinated with the Regional Milk Specialist.

http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg545-300.html http://www.fda.gov/ora/inspect_ref/fmd/fmd126.htm

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PART VI – ATTACHMENTS, REFERENCES AND PROGRAM CONTACTS

A. ATTACHMENTS

1. Attachment A – Project 03 – Foodborne Biological Hazards

2. Attachment B – Project 04 – Chemical Contaminants

3. Attachment C – Project 09 – Food Additives and Color Additives

4. Attachment D – Polymerase Chain Reaction (PCR) for V. cholerae

Enterotoxigenic Strains

5. Attachment E – Detection of Shigella by PCR

B. REFERENCES

Refer to the on-line FDA Compliance Program Guidance Manual Master List for FDA Staff for the latest issuance of all CFSAN programs @ #

FDA Investigations Operations Manual, most current issue, http://www.fda.gov/ora/inspect_ref/IOM/default.htm

“FDA’s Catalog of Information Materials for the Food and Cosmetics Industries” is available from CFSAN/ Office of Constituent Operations/ Industry Activities Staff, HFS–565, (301) 436–1727.

DFI Inspections Guides, available hard copy from DFI, 301-827-5639, or #

Compliance Policy Guides, http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/default.htm

C. PROGRAM CONTACTS

General: Monali Yajnik, Office of Compliance, Division of Field Programs, Compliance Programs Branch, HFS–636, (301) 436– 1616, Fax: (301) 436–2657, Monali.Yajnik@FDA.HHS.GOV

Center Filth Analysis: Michael McLaughlin (Acting), Office of Plant and Dairy Foods, Division of Natural Products, Micro-analytical Branch, HFS–345, (301) 436–1958, Michael.Mclaughlin@FDA.HHS.GOV

Center Phosphatase Analysis: George C. Ziobro, Office of Plant and Dairy Foods, Division of Natural Products, Micro-analytical Branch, HFS–315, (301) 436–1965, George.Ziobro@FDA.HHS.GOV

Center Microbiological Analysis: Keith Lampel, Office of Plant and Dairy Foods, Division of Microbiological Studies, HFS–515,

(301) 436–2007, Fax: (301) 436–2644, Keith.Lampel@FDA.HHS.GOV

CFSAN Methods Contact: Peter Feng (E. coli O157:H7), Office of Plant and Dairy Foods, Microbiology Methods Research Branch, HFS-515, and

(301) 436–1650, Peter.Feng@FDA.HHS.GOV http://www.fda.gov/ora/inspect_ref/IOM/default.htm mailto:George.Ziobro@FDA.HHS.GOV mailto:Keith.Lampel@FDA.HHS.GOV mailto:Peter.Feng@FDA.HHS.GOV

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Wallace Andrews (Salmonella), Office of Plant and Dairy Foods, Microbiology Methods Research Branch, HFS–515,

(301) 436–2008, Wallace.Andrews@FDA.HHS.GOV

Reginald Bennett, (Staphylococcus) Office of Plant and Dairy Foods, Division of Microbiological Studies, HFS–515, (301) 436–2009, Fax: (301) 436–2644, Keith.Lampel@FDA.HHS.GOV

Keith Lampel (Shigella), Office of Plant and Dairy Foods, Division of Microbiological Studies, HFS–515,

(301) 436–2007, Fax: (301) 436–2644, Keith.Lampel@FDA.HHS.GOV

Mahendra Kothary (V. cholerae), Office of Science, HFS–237, (301) 827-8616, Mahendra.Kothary@FDA.HHS.GOV

William L. Payne (ETEC and V. Cholerae PCR), Office of Science, HFS–237,

(301) 827-8623, William.Payne@FDA.HHS.GOV

Anthony Hitchins (Listeria), Office of Plant and Dairy Foods, Microbiology Methods Branch, HFS–516, (301) 436- 1649, Anthony.Hitchins@FDA.HHS.GOV

Center Chemical Contaminants Analysis:

Steve Capar, Office of Plant and Dairy Foods and Beverages, Division of Pesticides and Industrial Chemicals, HFS–335, (301) 436–2003, Steve.Capar@FDA.HHS.GOV

Center Food Additives Analysis: Gregory Diachenko, Office of Food Additive Safety, Division of Chemistry Research and Environmental Review, HFS–245, (301) 436–2387, Gregory.Diachenko@FDA.HHS.GOV

Center Color Additives Analysis: Alan Scher, Office of Cosmetics and Colors, Division of Science and Applied Technology, Color Technology Branch, HFS–126, (301) 436-1139, Alan.Scher@FDA.HHS.GOV

Regulatory: Donald Greaves, OC/ DB, HFS–607, (301) 436–2057, Donald.Greaves@FDA.HHS.GOV

Dwayne Johnson, OC/ DB, HFS-607, (301) 436-1782, Dwayne.Johnson@FDA.HHS.GOV

Investigations: Barbara Marcelletti, Division of Field Investigations, Investigations Branch, HFC–132, (301) 827–5635, mailto:Wandrews@CFSAN.FDA.GOV mailto:Keith.Lampel@FDA.HHS.GOV mailto:Keith.Lampel@FDA.HHS.GOV mailto:Mahendra.Kothary@FDA.HHS.GOV mailto:William.Payne@FDA.HHS.GOV mailto:Anthony.Hitchins@FDA.HHS.GOV mailto:Steve.Capar@FDA.HHS.GOV mailto:Gregory.Diachenko@FDA.HHS.GOV mailto:Alan.Scher@FDA.HHS.GOV mailto:Donald.Greaves@FDA.HHS.GOV mailto:DJohnson@CFSAN.FDA.GOV

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Barbara.Marcelletti@ORA.FDA.GOV

ORA Analytical Contacts (Microbiology):

Marsha Hayden, Division of Field Science, HFC-141, (301) 827-1039, Marsha.Hayden@ora.fda.gov

Lydia Rosas-Marty, Division of Field Science, HFC-141, (301) 827-6624, Lydia.Rosas-Marty@ora.fda.gov

Carl Sciacchitano, Division of Field Science, HFC-141, (301) 827-1028, Carl.Sciacchitano@ora.fda.gov

Atin Datta (PFGE) , Division of Field Science, HFC-141, (301) 827-1030, Atin.Datta@ora.fda.gov

ORA Analytical Contact (Filth): Helen Jones, Division of Field Science, HFC-141, (301) 827-1233, Helen.Jones@ora.fda.gov mailto:Barbara.Marcelletti@ORA.FDA.GOV mailto:MHayden@ora.fda.gov mailto:Lydia.Rosas-Marty@ora.fda.gov mailto:Carl.Sciacchitano@ora.fda.gov mailto:Atin.Datta@ora.fda.gov mailto:HJones@ora.fda.gov

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FORM FDA 2438b (2/95)

PART VII – CENTER RESPONSIBILITIES

PROGRAM EVALUATIONS

The Director, Office of Plant and Dairy Foods (OPDF) has the responsibility to prepare periodic formal evaluations of this compliance program. (%)

ATTACHMENT A

DOMESTIC FOOD SAFETY PROGRAM

PROJECT 03 – FOODBORNE BIOLOGICAL HAZARDS

OBJECTIVE

To emphasize coverage of all relevant Program and Project Structure

(PPS) areas during a food safety inspection. This attachment covers filth, decomposition and microbiological contamination.

FACTS REPORTING REQUIREMENTS:

• Report resources utilized for filth, decomposition, microbiological contamination into the FACTS as appropriate using the following Program Assignment Codes (PAC) and Problem Area Flags (PAF). Use the appropriate secondary PAF when needed:

PAC PAF Problem Area Sub-PAF PAF Description 03803B (Filth)

FIL ANI

ART

BIR

EXH

FOR

OTH

Animal Filth Arthropod Filth Bird Filth Filth Exhibit Foreign material Other, Not Listed, Identify in Remarks

03803C (Decomp)

FIL DEC

EXH

GEO

HMC

MAC

YEA

OTH

Decomposition Filth Exhibit Geotrichum Mold Howard Mold Count Macroscopic Mold Yeast Other, Not Listed, Identify in Remarks

03803D (Micro)

MIC MIC

PHOS

ANT

SAL

ABR

Microbiological analysis (included rapid test kits for micro analysis) Phosphatase analysis Salmonella serotyping Antibiotic resistance testing

• Refer to page 2, Program Assignment Code Reporting, of this Compliance Program for more information regarding reporting requirements.

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B. Inspectional Instructions:

1. Inspectional

A top priority of the Agency is to decrease foodborne illness caused by microbial contamination. Use the following as directions for conducting inspections of firms manufacturing products susceptible to microbial contamination.

• Care should be taken during the inspection to fully identify sources of and possible routes of contamination to the product.

For example, report the number of flies and times when they were on the product, open doors or damaged screens providing the flies a route to a toilet or to the outside, and the specific distances to animal feces, garbage or decaying animals. If a swab is taken of a floor drain, report if any flies that landed on that drain or splash from that drain go to the finished food or food contact surfaces. In addition, depending on the nature of the adulteration, in–line bacteriological sampling may be indicated, For further instructions on conducting inspections involving microbial contamination, refer to the current edition of the Investigations Operations Manual (IOM) (http://www.fda.gov/ora/inspect_ref/iom/), Sections 5.4.7.2, “Inspectional Guidance for Firms Producing Products Susceptible to Contamination with Non – Pathogenic or Pathogenic Microorganisms”, and 4.3.7.7, “Products Susceptible to Contamination with Pathogenic Microorganisms” for sampling instructions.

• Product(s) covered should be selected based on health risk and seriousness of objectionable conditions observed. However, within reason, the investigator should select as many products as necessary to establish the firm’s overall compliance picture.

• Cover railcars or trucks that are off–loading or being loaded to insure food products are shipped in compliance. When the condition of a transport vehicle may lead to food contamination, attempt to dissuade the shipper from using it. If unsuccessful notify the destination District so they may follow–up. See PART V Regulatory/ Administrative Strategy of the “Domestic Food Safety Compliance Program” for more information.

For firms that receive, via tanker trucks, product components such as liquid egg-, dairy-, soy-, corn - or sugar- syrup based products (e.g., products that can support microbial growth), and are producing food products that are susceptible to microbial contamination that would not normally be cooked or prepared in a manner that would be lethal to harmful microorganisms [Category I and II foods of IOM “Sample Schedule Chart 1” {IOM Chapter 4}, check to see that controls are in effect to prevent contamination of the finished products. These controls would consist of microbial testing or heat-treating to affect a 5-log kill of the incoming product component(s) or of the finished product(s), use of dedicated tankers for incoming food components, etc. If such controls are not in place, collect samples of the incoming and/ or finished product for pathogens causing foodborne illness testing.

• Conduct follow–up inspections for all positive findings of

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pathogenic microorganisms in a processed food product.

Before beginning a follow-up inspection, the District should discuss plans for the inspection with CFSAN/ Division of Enforcement to ensure that evidence/samples obtained will support further regulatory action. Depending on the nature of the adulteration, in–line bacteriological sampling may be indicated.

In addition to analyzing in–line and finished product samples for the specific microorganisms whose association with the firm’s product generated the inspection, the product should also be analyzed for microorganism such as E. coli, which could be an indicator of the plant’s potentially unsanitary condition(s), and Staphylococcus aureus, which could be an indicator of possible temperature abuse of products made by hand.

• Follow-up activities associated with “import for export” articles are to be conducted during domestic inspections when the inspection is conducted at a manufacturer’s facility where an imported article is being further processed or incorporated into a product intended for exportation. Refer to the Regulatory Procedures Manual, Chapter 9, Import for Export, Follow-up section. See IOM section 5.1.1.14.

2. Sample Collection

Detailed instructions for sample collection, including collection technique, aseptic sampling, field examination, selective sampling, in-line sampling and sampling of products susceptible to contamination with pathogenic organisms is contained in IOM Subchapter 4.3. See also IOM sample schedule chart 1 and applicable DFI Inspectional Guidance Documents, # for applicable sample size. If you are unsure of the proper sample size, call your servicing laboratory listed in the current ORA Field Workplan, Appendix III, “Servicing Laboratories”.

A. Filth/ Unsanitary Conditions

• Collect raw materials, in-line samples, and finished product samples if contaminated raw materials were believed used.

• Do not sample finished products to support contamination in the finished product if inspectional evidence indicates little likelihood of detecting this contamination in the finished product. Instead, collect physical samples of contaminated raw material(s) and/or exhibits with documentation that the finished product moves interstate. Fully document the use of these contaminated raw materials in the manufacture of a specific lot or lots of finished products.

The Center will consider cases based solely on detailed observations, photographs, etc., which would convince the ordinary consumer that a condition or practice is filthy). Obtain physical samples of raw materials, in-process sub-samples, and other items such as filth exhibits showing routes of contamination to clearly show that conditions of manufacture or storage are such that there is a reasonable possibility that contamination may have occurred.

Obtain swab samples (i.e., environmental) of surfaces that are likely to come in contact with food if there is a suspicion that

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they might contaminate the food with pathogenic organisms such as Listeria monocytogenes.

B. Microbiological

• Collect samples for microbiological analyses only if:

1) The firm has a previous history of microbiological contamination (e.g., follow – up to illness or injury, complaint, recalled/ seized product, previous inspectional history, etc.)

or

2) Sampling is conducted “for cause” during an inspection

(e.g., inspectional observations warrants collection for microbiological analyses).

• General Information

Pay particular attention to the presence of potential vectors of microorganisms. Some of these vectors would be flies, roaches, and other filth insects. Also document the source of filth such as the presence of cats and dogs and their feces. Document unsanitary conditions outside of the plant.

• Nonpathogenic Microorganisms

See the appropriate Sections of the IOM, Chapter 4 and # for sampling instructions. If a CPG does not exist and there is no reason to suspect contamination with pathogens, consider regular filth cases if conditions indicate abuse of susceptible products/raw materials. Include observation concerning organoleptically detectable filth or decomposition and time/ temperature parameters. Refer to IOM (Section 4.3.9) and (http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/default.html) for specific information regarding filth and specific commodities.

• Pathogenic Microorganisms

See the current edition of the IOM, Chapter 4 for sampling instructions and # for sample size. For Salmonella, see IOM “Sample Schedule Chart 1” {IOM Chapter 4}. If unsure of sample size, call your servicing laboratory.

• Animal Drug Residue

When inspecting firms that produce dry milk products (including dry whey, a by-product of cheese manufacturing), determine if the firm tests for animal drug residue. Review the firm’s procedure to assure proper operation of analytical equipment, both mechanical and biological, used in the analysis. If the firm tests for animal drug residue, review the quality control records. (Antibiotic contamination may be seasonal because the heaviest usage in animals occurs in late winter and spring.) If animal drug residue is being found or testing is not performed on every lot, collect a sample.

http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/default.html

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Sample size: # retail units of at least 120 grams (4oz.) each if the sample is being analyzed for animal drug residue only. If the sample is also being analyzed for phosphatase, collect # retail units of at least 120 grams each in triplicate. If it is necessary to sample from bulk, use aseptic sampling techniques.

• Phosphatase

Pasteurization of milk products destroys organisms that cause serious diseases (tuberculosis, Q fever, etc.) and inactivates the enzyme phosphatase. Measurement of phosphatase activity indicates that some or all of the milk used may not have been properly pasteurized. Phosphatase testing is to be performed only on fluid milk, dried milk products, ice cream and cheese – not on any cultured dairy products.

Sample size: as directed under “Animal Drug Residue”

3. Sample Submission

Refer to the current ORA Field Workplan, Appendix III, “Servicing Laboratories”, for field servicing laboratories.

C. Analytical Instructions

Conduct and confirm analyses in field laboratories. Some confirmations or speciations must be performed at Headquarters. Use the methodology, special instruction or sample preparation cited below as necessary for each type of analysis.

1. Filth, Mold and Foreign Objects: Microscopic and Macroscopic

Methodology: AOAC, 17th Ed. or most current Ed., Chapter 16

Extraneous Materials: Isolation

JAOAC {Interim Official First Action Methods}

Macroanalytical Procedures Manual (MPM), FDA Technical Bulletin, No. 5

Laboratory Information Bulletins (LIBs)

Comments: For Identification (as needed) submit to CFSAN’s Division of Natural Products, Microanalytical Branch, HFS–345, Douglas L. Park, (301) 436–2401

2. Decomposition

Methodology: Organoleptic; AOAC, 17th Ed. or most current Ed., for chemical indices; mold counts, etc.

Field Laboratories: Refer to the current ORA Field Workplan, Appendix III, “Servicing Laboratories”.

Comments: Consult ORO/DFS, HFS–140 for servicing laboratories, if necessary

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3. Microbiology

Methodology: Bacteriological Analytical Manual (BAM), 8th Ed., Revision A, 1998 or most current Ed.

(http://www.cfsan.fda.gov/~ebam/bam-toc.html);

AOAC, 17th Ed. or most current Ed., Chapter 17 “Microbiological Methods”.

Comments: Final identification (if needed) submit to CFSAN/ Office of Plant, Dairy Foods and Beverages/ Division of Microbiological Studies, HFS-515. Reginald Bennett at (301) 436 - 2009

• E. coli and coliform detection [See Ch. 4, eBAM Section I)

(http://www.cfsan.fda.gov/~ebam/bam-toc.html)].

Alternatively, LST MUG method (Ch. 4, eBAM Section II) may be used to examine for coliforms when both E. coli and coliform analysis are required in chilled and frozen foods ONLY and exclusive of bivalve molluscan shellfish. The presumptive test for coliforms can be performed in conjunction with the test for E. coli by preparing tubes of LST – MUG medium with gas tubes (i.e., using the LST MUG for both E. coli and coliform determination).

• Enterotoxigenic E. coli (ETEC), Gene Probe

Do not perform ETEC analysis unless E. coli is greater than or equal to 10,000 / gram.

Method: eBAM, Ch. 24, “Identification of Foodborne Bacterial Pathogens by Gene Probe”, “Enterotoxigenic E. coli”, (http://www.cfsan.fda.gov/~ebam/bam-toc.html)

PRL-SW will provide radioactive probes for ETEC. The laboratory contact is Michael Kawalek at 949-608-3505.

• Enterohemorrhagic E coli (E coli O157:H7, EHEC) – Individual Sub– samples.

Remove 25g from a sub–sample then add 225ml of EHEC Enrichment Broth (EEB) and place into a sterile blender. Blend (10,000 – 12,000 rpm for 60 seconds at a minimum). Include positive and negative controls. See eBAM, Ch. 4A Section M and N (http://www.cfsan.fda.gov/~ebam/bam-toc.html) http://www.cfsan.fda.gov/%7Eebam/bam-toc.html http://www.cfsan.fda.gov/%7Eebam/bam-toc.html http://www.cfsan.fda.gov/%7Eebam/bam-toc.html

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Incubate with vigorous shaking for 24h (i.e., 130–140rpm on an orbital shaker at 37°C. Proceed with the method as described in eBAM, Ch. 4A Section O http://www.cfsan.fda.gov/~ebam/bam-toc.html).

Positive E. coli O157:H7

Submit E. coli 0157:H7 isolates for Pulse Field Gel Electrophoresis (PFGE) assay to respective servicing laboratories.

• Shigella

PCR primers and the positive control will be supplied to each District. Contact Keith Lampel, CFSAN’s scientific contact for Shigella at (301) 827-8617 for primers and positive control.

Shigella will be done on a composite basis (i.e., 2 composites per sample). Each composite for Shigella analysis will consist of 250mL.

Prepare each composite by removing 50mL from each of five (5) sub– sample rinses into a sterile beaker/flask and mix thoroughly.

Remove 100mL (of each composite) and place it into centrifuge tubes and spin at 2000rpm for 3 minutes to pellet plant material. Then follow methodology as outlined in Attachment E, “Detection of Shigella by Polymerase Chain Reaction”.

This method is to be used as presumptive evidence and confirmation for the presence of Shigella. Retain the PCR products in the event that DNA sequencing is required. In this case, send the remaining PCR product to Keith Lampel, the CFSAN Scientific contact for Shigella.

• Listeria

General Method

BAM 8th Ed., Revision A, or most current Ed., Ch. 10 “Listeria monocytogenes”, pages 141 – 151 and Ch. 11, “Serodiagnosis of Listeria monocytogenes”, pages 153 – 160 (http://www.cfsan.fda.gov/~ebam/bam-toc.html).

SAFETY PRECAUTIONS: Media preparation for L. monocytogenes directs the use of cycloheximide, which is an extremely toxic chemical, and acriflavine, which is a powerful mutagen (use caution).

Since the L. monocytogenes method gives the option of using α-naphthol, do not use α-naphthylamine. All analysts should take extreme safety precautions when handling these chemicals (e.g., weigh in a containment hood free of drafts; wear gloves and face masks). Those

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laboratories with pesticide capabilities should take additional precautions against possible contamination, as cycloheximide is a fungicide.

Compositing/ Sample Preparation Instructions

Listeria analysis will be done on ready–to–eat food products that require none or minimal processing (no adequate kill step by the preparer).

The analysis will be conducted on composite basis ONLY (e.g., analyze two (2) composites per sample).

This includes all follow–up samples collected based on an initial positive finding (if appropriate).

Use the following procedure for preparing each composite:

6-subs/ sample – Remove 83.3g from each of three (3) sub-samples. Each composite size is 250g.

10-subs/ sample – Remove 50g from each of five (5) sub-samples. Each composite size is 250g.

Once the two composites have been prepared, remove 25mL or g from each composite for analysis. Mix the 25mL or g with 225mL Listeria enrichment broth.

Incubate the enrichment broth (EB) mixture for a total of 48hrs at 30°C. Proceed with the method in the BAM 8th Ed., Revision A, or most current Ed. Ch. 10, page 10.04, section D “Isolation Procedure” (http://www.cfsan.fda.gov/~ebam/bam-toc.html).

NOTE: IF THE SAMPLE IS TO BE ANALYZED FOR BOTH LISTERIA AND

SALMONELLA THEN COMPOSITE SUB-SAMPLES FOR SALMONELLA AS

OUTLINED IN BAM 8TH ED., REVISION A, OR MOST CURRRENT ED.

CHAPTER 1, PAGE 3, THEN RANDOMLY SELECT TEN (10) SUB-

SAMPLES FROM THE ORIGINAL SAMPLE TO PREPARE THE TWO

COMPOSITES FOR LISTERIA ANALYSIS AS OUTLINED ABOVE.

Isolation and Identification: BAM 8th Ed., Revision A, or most current Ed. Ch. 10 and 11 (http://www.cfsan.fda.gov/~ebam/bam-toc.html). Additionally, Rapid Test Kits mentioned in the July 9, 1998 memo, “Guidance for the Use of Listeria Rapid Methods for Food Microbiology”, may be used #. If the laboratory does not have a copy of the memo, they should request a copy from the Division of Field Science, HFC–140.

Enumeration

Perform using the cultural method.

Cultural Enumeration Method: This can be readily accomplished by the enumeration method in the current version of BAM 8th Ed., Revision A or most current Ed., Ch. 10, (http://www.cfsan.fda.gov/~ebam/bam-10.html). The Simultaneous Detection and Enumeration method is strongly recommended. Note:

http://www.cfsan.fda.gov/%7Eebam/bam-toc.html http://www.cfsan.fda.gov/%7Eebam/bam-toc.html http://www.cfsan.fda.gov/%7Eebam/bam-10.html

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Use of BCM or ALOA media is preferred to use of Oxford and other esculin media because the former are more specific for L.

monocytogenes. [Contact: A.D. Hitchins, CFSAN at (301) 436- 1649]

Positive Listeria

Submit Listeria isolates for Pulse Field Gel Electrophoresis (PFGE) assay to respective servicing laboratories.

Salmonella

Isolation and Identification

Refer to the BAM online, October 2001, Ch. 5, Salmonella (http://www.cfsan.fda.gov/~ebam/bam-5.html). Additionally, Rapid Test Kits mentioned in the April 24, 1998 memo, “Guidance for the Use of Rapid Methods for Food Microbiology”, may be used. If the laboratory does not have a copy of this memo, it should be requested from the Division of Field Science, HFC–140.

Speciation

If the sample is positive for Salmonella, prepare slants and provide hard copy information requested under BAM online, Ch. 5, section E – 11, “Submission of cultures for serotyping” (http://www.cfsan.fda.gov/~ebam/bam-toc.html). Send to Denver Laboratory (DEN) or designated lab by Division of Field Science (DFS) for speciation. Laboratories should submit appropriate form when sending isolates for Salmonella speciation.

Salmonella Positive Isolates

ARL will submit one (1) positive Salmonella isolate of each somatic group recovered from each sub-sample to Denver District Laboratory’s (DEN-LAB) microbiology laboratory for antibiotic sensitivity assay. Isolates, which were found to be multi-drug resistant, will be shipped to Regional ORA lab for PFGE analysis.

Prepare cultures for shipment according to requirements for shipment of etiological agents. Submit cultures on brain heart infusion (BHI) agar slants in screw – cap tubes (13mm x 100mm) with caps securely tightened. Label each tube with the sample and sub-sample numbers. Submit copies of the collection report and analytical worksheets. Place the cultures in a culture container with an official FDA seal. Place the accompanying record inside the shipping carton but not within the officially sealed culture container. Label the secondary shipping container according the service needed (see below). Send the container by the most rapid means available. Maintain duplicate cultures for all cases, which are under consideration for legal action.

Microbiology Field laboratories should follow the following instruction in sending Salmonella isolates for serotyping (for epidemiological purposes):

http://www.cfsan.fda.gov/%7Eebam/bam-5.html

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Isolates from NRL, WEAC, SRL and ARL will be serotyped in ARL:

Arkansas Regional Laboratory 3900 NCTR Road Building 26 Jefferson, AR 72029

Attention: Gwendolyn Anderson Tel# 870-543-4621 Fax# 870-543-4041

Isolates from SAN, PRL-NW, PRL-SW and DEN will be serotyped in

DEN:

Denver District Laboratory 6th Ave & Kipling St,DFC, DFC Building 20 Denver, CO 80225-0087 Attention: Doris Farmer Tel# 303-236-9604 Fax# 303-236-9675

ARL submit Salmonella isolates for antibiotic sensitivity assays to:

FDA/ ORA/ DEN

ATTN: Connie Kiessling 6th Ave & Kipling St,DFC, Building 20, ENT-10 Denver, CO 80225-0087

Submit Salmonella isolates for Pulse Field Gel Electrophoresis (PFGE) assay to respective servicing laboratories.

• Staphylococcal Enterotoxin

General

Perform enterotoxin testing if:

1. Product abuse (e.g. temperature, outbreaks, etc.) is suspected or

2. Instructed by Compliance Program or Field Assignment to analyze the sample for Staphylococcus.

If viable Staphylococcus sp. colonies are observed by:

• most probable number (MPN) when performed as directed per BAM Chapter 12

• (http://www.cfsan.fda.gov/~ebam/bam- 12.html)where the results are >11,000 and http://www.cfsan.fda.gov/%7Eebam/bam-12.html http://www.cfsan.fda.gov/%7Eebam/bam-12.html

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• direct plate counts when performed as directed per BAM chapter 2 (http://www.cfsan.fda.gov/~ebam/bam- 2.html)indicates a level of 10,000/ gram

Enterotoxin Analysis:

Follow the methodology outlined in BAM 8th Ed., Revision A, 1998 or most current Ed., Ch. 13, “Staphylococcal Enterotoxins” (http://www.cfsan.fda.gov/~ebam/bam-toc.html), beginning on page 13.01.

The laboratory will individually test each sub-sample using the TECRATM ELISA with proper procedures followed accordingly.

NOTE: Under no circumstances should positive TECRATM ELISA results be conveyed to a regulated firm or consumer without confirmation. The TECRATM ELISA is intended as a screening method only.

NOTE: The total contents of each subsample should be retained until the original analyses are completed to ensure that a sufficient amount of product is available for subsequent additional and confirmation tests, if necessary.

TECRATM ELISA Test Results

1. Negative result - the laboratory need not conduct further analysis for enterotoxin. The sample is considered “negative” and no other regulatory or follow-up action is warranted.

2. Positive result – the laboratory should analyze the original sample using the VIDAS method for confirmation refer to BAM 8th Ed., Revision A, 1998 or most current Ed., Ch. 13A, “Staphylococcal Enterotoxins: Micro-slide Double Diffusion and ELISA Based Methods”(i.e., VIDAS)”. See (http://www.cfsan.fda.gov/~ebam/bam-toc.html)

NOTE: If the District or Regional Laboratory cannot perform the

VIDAS, contact Reginald Bennett, HFS–516 at (301) 436–2009 to arrange for shipment of portions of the actual sub-samples to CFSAN for confirmation.

TECRATM ELISA and the VIDAS Tests Results

1. When the TECRATM ELISA and the VIDAS Tests are positive, the following should be sent to CFSAN for re-confirmation analysis:

(a) The remaining portion of the original TECRATM ELISA positive tested extract(s)

(b) The remaining portion of the positive tested extract(s) from the VIDAS System

(c) “all” of the remaining reserves portion of the http://www.cfsan.fda.gov/%7Eebam/bam-2.html http://www.cfsan.fda.gov/%7Eebam/bam-2.html

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positive subsample(s)

(d) a copy of the analytical worksheets

(e) a copy of the collection report to

FDA/ CFSAN/ Microbiology Methods Research Branch Attention: Reginald Bennett, HFS-516

College Park, MD 20740.

NOTE: Please notify the Division Director at 301.436.2007 that the sample is being sent to CFSAN for confirmation analyses.

If additional information concerning sample preparation, handling or shipping to CFSAN is needed contact Reginald Bennett at 301.436.2009.

The Microbiology Methods Research Branch will perform confirmation analyses on the extract and reserve subsample(s) as appropriate and provide sample(s) to Dr. A. Rasooly for SDS-PAGE immunoblot analyses as indicated.

Districts should wait for Center confirmation before…