Attachment_12.pdf

FOOD AND DRUG ADMINISTRATION

COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7303.803A

CHAPTER 03 - FOODBORNE BIOLOGICAL HAZARDS

SUBJECT:

DOMESTIC ACIDIFIED AND LOW-ACID CANNED FOODS

IMPLEMENTATION DATE

UPON RECEIPT

COMPLETION DATE

Continuing

DATA REPORTING

PRODUCT CODES PRODUCT/ ASSIGNMENT CODES (PAC)

INDUSTRY CODES:

USE APPRO

02-11, 13-41, 45-46, 50

PRIATE PRODUCT CODES

REPORT INSPECTIONS UNDER THE FOLLOWING

PACs:

03803A AF/LACF inspections

03803 Inspections of central distribution warehouses where unlabeled cans are shipped for labeling and casing; and follow-up inspections of AF/LACF products for filth.

71003E Inspections of LACF pet food (CVM) firms, Industry 72

ADD-ON INSPECTIONS

03842 Add-on domestic fish or fishery products for GMPs

03842H Add HACCP portion of Seafood inspection

21002 Medical food add-on inspections

21005 NLEA (Label Review)

21006 Infant formula add-on inspections

REPORT SAMPLE ANALYSIS UNDER THE

FOLLOWING PACs:

03803A AF/ LACF

Note: Material that is not releasable under the Freedom of Information Act (FOIA) 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.

FIELD REPORTS TO HEADQUARTERS

1DATE OF ISSUANCE:10/8/10 PAGE

FORM FDA 2438 (7/92)

PROGRAM 7303.803A

1. Compliance

Do not send copies of domestic Establishment Inspection Reports (EIRs) to the Center for Food Safety and Applied Nutrition (CFSAN) unless a compliance action is recommended. Submit all

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FORM FDA 2438g (10/91)

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FORM FDA 2438g (10/91) recommendations for compliance actions to CFSAN through Mission Accomplishments and Regulatory Compliance Services (MARCS) - Compliance Management System (CMS) and follow the procedures outlined in the Regulatory Procedures Manual (RPM), Chapter 4, Advisory Actions.

2. Inspectional

Send the following completed reports to:

CFSAN/Field Programs Branch (FPB), HFS-615

ATTENTION: DOMESTIC LACF MONITOR

5100 Paint Branch Parkway College Park, MD 20740-3835

{Reports should only be sent to CFSAN if they meet the criteria listed below}.

a. Entire EIR and information identified in PART III, A. 5.

Computer Controls, for review of retorting systems using microprocessors or computers to control and generate records of thermal processing or critical factors.

b. Entire EIR and any related materials for LACF inspections of any of the following technologies:

(1) Aseptically processed and packaged LACF products containing particulate food; e.g. clam chowder, chunky soups or stews, etc.

(2) Sterilization of aseptic packaging materials using media other than superheated steam, peroxyacetic acid/peracetic Acid or hydrogen peroxide;

(3) Digital thermometers in lieu of mercury-in-glass thermometers;

(4) Initial inspections of firms utilizing high pressure, microwave, pulsed light, ozone, pulsed electric fields, irradiation or technologies other than retorting used to process or aseptically package low acid canned food.

3. Training and Consulting

Better Process Control School Participation - See Part III, for further information.

Send completed reports to:

CFSAN/ Office of Food Safety

HFS-302

ATTENTION: BPCS Program Manager

FACTS - DATA REPORTING

See Part III and Part IV for complete instructions for reporting inspectional and analytical results.

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PART I - BACKGROUND

In 2007, the Agency responded to an extensive class I recall by a large LACF manufacturer due to the risk of botulinum toxin. The source of the contamination was determined to be a malfunctioning crateless retort system.

The firm involved was subsequently placed under Emergency Permit Control. As a follow-up to that inspection, a CFSAN issued survey assignment identified another firm with a large number of abnormal cans in their warehouse, serious control issues and positive C. botulinum laboratory findings. Inspectional findings identified malfunctioning equipment, a lack of control in the areas of container fill weights, can seam integrity problems, under processed product, product accountability, product coding, and inadequate heat distribution studies and heat penetration documentation.

This event and others have raised additional awareness about the safety of Acidified Foods (AF) and LACF products and the state of control in the AF/LACF industry. Inadequate evaluation of aging equipment, changing formulations and processes, and failure to execute GMPs could be industry wide problems. In addition, inadequate manufacturing, processing, or packing of thermally processed low-acid foods in hermetically sealed containers or acidified foods may result in the distribution in interstate commerce of processed foods that may be injurious to health. 21 CFR Parts 113 “Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers” and 21 CFR Parts 114 “Acidified Foods” describe requirements for manufacturing, processing and packing foods to prevent an environment conducive to the growth of Clostridium botulinum, whose toxin causes the potentially fatal food poisoning known as botulism. The absence of oxygen, low acidity, normal room temperatures and adequate moisture/nutrients favor growth and toxin production by these bacteria.

In addition to the other requirements, 21 CFR Part 108 “Emergency Permit Control” requires manufacturers of AF or LACF to register their processing plants, file their scheduled processes with FDA and to adhere to the mandatory requirements expressed in the Good Manufacturing Practices (GMPs).

A firm which does not comply with the mandatory provisions of 21 CFR Parts 108, 113 and 114 may be required to obtain an emergency permit as required in 21 CFR Part 108 Subpart B “ Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit” before introducing its products into interstate commerce.

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FORM FDA 2438 g 10/91)

10/8/10

PART II - IMPLEMENTATION

OBJECTIVES

A. To determine, by inspections and sample collections (and analyses), if domestic acidified and low-acid canned food manufacturers comply with 21 CFR, Parts 108 “Emergency Permit Control”, 21 CFR Part 113 “Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers”, 21 CFR Part 114 “Acidified Foods”, and other requirements of the Food, Drug, and Cosmetic (FD&C) Act.

B. To prevent the introduction of acidified and low-acid canned foods into interstate commerce which are manufactured under conditions that do not comply with these requirements.

NOTE: Foreign AF and LACF Manufacturers that ship to the United States are also required to comply with the mandatory provisions of 21 CFR, Parts 108 “Emergency Permit Control”, 21 CFR Part 113 “Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers”, 21 CFR Part 114 “Acidified Foods”, and other requirements of the FD&C Act. Use the same instructions in this Compliance Program when conducting both foreign and domestic inspections. *

PROGRAM MANAGEMENT INSTRUCTIONS

A. General Information

1. Because of the serious health hazards resulting from improperly processed AF/LACF and the occasional necessity for expert technical advice during an investigations and inspections, it is imperative that the Alert System procedures as defined in Attachment A be followed. During or IMMEDIATELY after an inspection in which significant deviations from the regulation are observed or where follow up to reports of product failures/recalls indicate a serious failure in a processing system or operating procedure, HFS-607 must be notified immediately, per Attachment A.

2. Pet or animal food should be covered under this program.

Appropriate PAC and Product Codes should be used for CVM products.

3. Be aware of firms using some new varieties of tomatoes for processing which could result in tomatoes and tomato products being subject to coverage as low-acid or acidified foods, i.e., tomatoes with natural pH equal to or greater than 4.7 (21 CFR 114.3(d)).

4. Naturally fermented products are not considered to be acidified foods. A naturally fermented product is one which:

a. has been salted or held in a brine solution; and

b. has been allowed to ferment for 1 or more weeks in containers;

and

c. the product has reached a pH of 4.6 or below at the end of the fermentation period without the use of any added acid.

NOTE: Some acids may be added before fermentation to control the

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PROGRAM

7303.803A fermentation

The growth of microorganisms and t responsible for the biochemical ch fermentation, including the loweri This is often referred to as lacti pickled cucumbers and cauliflower, heir enzymes in the product are anges that occur during food ng of the pH to 4.6 or below.

c acid fermentation. Sauerkraut, and certain dill pickles are examples of naturally fermented products.

Foods that purport to be fermented foods are low acid foods if they have a pH after fermentation that is greater than 4.6, are not refrigerated and have a water activity greater than 0.85. If the pH of a food that purports to be a fermented food is below 4.6 only because of its addition of acid, it is an acidified food and is subject to 21 CFR Part 114, unless the water activity is below 0.85 and/or the product is refrigerated.

If a fermented product is subjected to a washing process (to remove the old salt brine), check the pH after the wash. If the pH is above 4.6, it is a low-acid food and must either be refrigerated, acidified or thermally processed as a low-acid canned food, or given some other process to safely preserve it.

If questions arise as to whether the product is fermented, then it may be necessary to obtain a flow chart or document the flow of the fermentation process, and if necessary sample the product for water activity and pH. The firm should have pH history at each processing step.

5. Domestic AF and LACF inspections may be candidates for team inspections, especially as they relate to food processing and preservation, microbiological or electronic technologies.

6. CFSAN/Division of Field Program and Guidance/Field Programs Branch, HFS-615 will issue a printout on all domestic producers of AF/LACF.

The Districts can use this printout for scheduling inspections using the following priority coverage. It is anticipated that this printout will be issued in late August of each fiscal year.

7. For technical questions on this program, Investigators should contact CFSAN technical experts or DFI National Experts after concurrence with their District management.

B. Priority Coverage

Inspectional priority should be governed by the following considerations:

• All newly registered AF and/or LACF manufacturers should be inspected within six months of notification.

NOTE: Information on newly registered firms or changes to existing registrations will be handled with electronic mailing from the Center to the Director of Investigation Branch (DIB).

• All AF and/or LACF manufacturers operating under an Emergency

Permit or classified “Official Action Indicated” (OAI) should be inspected within 3 months of the firm being issued the Emergency Permit or within 3 months of the OAI inspection. Manufacturers

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FORM 2438 g (10/91) classified “Voluntary Action Indicated” (VAI) should be inspected within 12 months of the last inspection at the Districts discretion based on the type of violation.

• All AF and/or LACF manufacturers classified as “No Action Indicated” (NAI) should be inspected within 36 months of the last inspection.

• Prior to conducting inspections in firms that are subject to dual jurisdiction with USDA, contact the USDA/FSIS management contact in your district and invite their participation in the inspection.

• Local and/or state regulatory agencies that perform AF/LACF inspections at the facility should be contacted prior to the inspection, to determine if they have any information and concerns regarding processing conditions.

INTERACTION WITH OTHER PROGRAMS

A. Domestic Food Safety Program (7303.803)

Report inspections of central distribution warehouses where unlabeled containers (“brites”) are shipped for labeling and casing against PAC 03803. Cover container handling, equipment sanitation, and quality control procedures. If significant violations unrelated to the AF/LACF Program are revealed then a full inspection should be conducted in accordance with the Domestic Food Safety Program.

Consult the Domestic Food Safety Program concerning pesticides/chemical contaminants and food/color additives.

B. Domestic Fish and Fishery Products Inspection Program (7303.842)

The seafood Hazard Analysis and Critical Control Points (HACCP) regulations 21 CFR Part 123 “Fish and Fishery Products” became effective December 18, 1997. These regulations require, among other things, that all seafood be processed under a HACCP system. It is not necessary for a properly registered LACF processor of seafood to address controls for the hazard of Clostridium botulinum toxin in their HACCP plans when these are already addressed under LACF. However, the processor’s seafood HACCP plan must control other hazards associated with these canned seafood.

(e.g., the hazard of histamine toxin in canned tuna and other histamine forming species such as mackerel, sprats, anchovies, etc.) Investigators must complete the Seafood HACCP Inspection Report for the HACCP component of canned seafood inspections in addition to other required reports.

(See 7303.842 as appropriate). Attempt to "add-on" inspections of fishery product firms when conducting applicable LACF inspections.

Record both PAC 03803A and the applicable Domestic Seafood PAC as per CP (7303.842) when both types of inspections are conducted.

C. Medical Foods - Import and Domestic (7321.002)

Refer to the inspection schedule that is issued separately each year by CFSAN/DFPG. Where appropriate, include an LACF inspection. Record both PACs 03803A and 21002 when both types of inspections are conducted.

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D. Infant Formula Program – Import and Domestic (7321.006) Refer to the inspection schedule that is issued separately each year by CFSAN/DFPG.

Where appropriate, include an LACF inspection. Record both PACs 03803A and 21006 when both types of inspections are conducted.

E. Food Labeling Compliance Program (formerly NLEA and General Food

Labeling) Requirements - Domestic (7321.005).

The Food Labeling Compliance program reflects the current NLEA instructions. Report all resources expended for NLEA under PAC 21005.

Labeling issues regarding undeclared foods and allergens should be reported under this program accordingly.

F. Guidance For Use of pH Meters for Field Exams on Imported Acidified Food (ACF) Products and in Domestic Inspection at:

http://inside.fda.gov:9003/ProgramsInitiatives/FieldOperations/FieldGuida nce/default.htm

Refer to the field exam guide for instructions on conducting appropriate field exams in AF/LACF facilities.

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M 2438 g (10/91) 10/8/10

FOR

http://inside.fda.gov:9003/ProgramsInitiatives/FieldOperations/FieldGuidance/default.htm http://inside.fda.gov:9003/ProgramsInitiatives/FieldOperations/FieldGuidance/default.htm

PART III – INSPECTIONAL

See “Implementation Section” for “Interactions With Other Programs”.

A. INSPECTIONAL

1. Plant Registration/Scheduled Thermal Process Filing

As of June 2010 there is a new “exempt” category in the LACF Database to house products that have been reviewed by CFSAN and found to be exempt from filing. Products in this category do not file under 21 CFR 113 or 114 and therefore should not be included in inspectional activities under these regulations.

NOTE: Lack of Plant Registration and/or failure to file processes is reportable on the FDA-483, Inspectional Observations form.

Appropriate FDA-483 entries regarding failure to register and file include:

• Instances where the food is easily recognized as an acidified food or Low Acid Canned Food, and failure to register and file have occurred.

• Instances where the status of the food can be determined through contact with CFSAN, Supervisory, Compliance or ORA experts to be acidified or LACF prior to the conclusion of the inspection.

• Cases where the status of the food may have to be determined through laboratory analysis or evaluation of the formulation. The firm should be informed by the investigator that the food has been determined after review to be an acidified food and that the firm should register and file the scheduled process for that product.

• For lack of registration, investigators should site section 21 CFR 108 Subpart B. In addition to other requirements, this section provides authority for establishments that fail to register, file or improperly train personnel.

In any of the above mentioned events the firm should be informed that it is their responsibility to determine if the products they manufacture fall under the Acidified or Low-acid Canned Food regulations and file and register accordingly.

Use the Low-Acid Canned Food (LACF) On-Line Computer System at https://info1testtun.cfsan.fda.gov:8889/lacf/fda/default.cfm to:

• Determine whether the manufacturer has registered for a Food

Canning Establishment (FCE) number, TRANSMITTAL NO: PART III PAGE 1

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https://info1testtun.cfsan.fda.gov:8889/lacf/fda/default.cfm

• Determine whether a process(es) has been filed and accepted for the product(s), and/or

• Gain information about firm’s thermal process in preparation for the inspection.

Note: A copy of the form FDA-2541, Food Canning Establishment Registration, should be obtained prior to and included in the inspection report to ensure filing and registration. The Center’s LACF Registration Coordinator provides each DIB with a copy of form FDA-2541 for all the newly registered firms for their District. The DIB in return must provide the LACF Coordinator a copy of the form FDA-2541, indicating on each, the firm’s assigned FEI number.

If the LACF system is down, the District can consult its own registration files to verify registration. The same does not hold true for process filing. Refer below for further instructions.

This on-line computer system was implemented in the Field during Fiscal Year 2004. Personnel requiring access to this system will need to go to http://inside.fda.gov:9003/CFSAN/default.htm, then in the center of the page under “Title” choose “LACF”.

At this point you may request a new account by selecting the “Request Account” link on the LACF Login screen. The user will receive notification through FDA’s email services when CFSAN has completed the account activation. The account activation should occur within one day, if the request is made on a regular business day.

Complete instructions and definitions needed to use LACF online are available from the LACF Login Screen. Choose the Field Guide to print out a copy of this step by step guide.

In addition, FAQs are available from the Login Screen. If additional assistance is needed please contact the LACF Registration Coordinator listed in Part VI of this program.

a. If the FCE number is not available, to determine if a manufacturer has registered, go to the LACF database, in “Facility Section” select “search”. The file may be searched using any combination of the manufacturer’s name, street address, city, state/province, zip code/postal Code, and/or country. Firms must register by their actual processing plant name.

b. If the manufacturer is registered, to determine if the process has been filed for the product(s), container type(s), and container size(s), the following steps should be followed as appropriate.

• Select “Product Report” to determine if a process is on file for the product, container type and container size.

Search using the FCE and Submission ID (SID).

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http://inside.fda.gov:9003/CFSAN/default.htm

c. If the firm to be inspected has no processes filed or the product of concern is not listed and all the referenced items above have been checked, contact the LACF Registration Coordinator (HFS-303) for assistance at (301)436-2411. The Data Base is updated continuously.

d. If upon inspection, the firm has relocated, the manufacturer must notify CFSAN of the move and re-register and file process information for the new location. The District employee should notify the LACF Registration Coordinator in order to have the old FCE number put in an out of business status. In addition, if the Districts find that firms within their Official Establishment Inventory have a change in operational status that would affect their registration, the LACF Coordinator must be notified in order to update the LACF Database. The appropriate representative should submit an email to: LACF@fda.hhs.gov.

e. All forms, as well as the instruction book and regulations can be downloaded from CFSAN’s Internet at:

Security of Information Provided in the Low-Acid Canned Food On- Line Computer System

Due to the confidential information contained in the LACF Process File, special precautions must be taken to ensure security of the data generated from the system. The process filing facsimiles generated from this system must be handled with discretion, secured when not in use and destroyed in an appropriate manner when no longer needed, i.e.:

Only FDA employees and the firm being inspected can view their facsimiles and reports.

These reports may not be copied, except to be provided to the inspected firm if requested during the inspection. Follow FDA’s regulations and procedures regarding information disclosure when considering whether to disclose the information to a person outside FDA.

These reports may be placed in the Official Establishment Inventory jacket, in the section that is identified “not for public information or distribution” if they are to remain as part of the official file.

Reports generated in error or are no longer used by the District must be destroyed.

2. Inspections

To perform inspections under this program, Investigators must successfully complete the basic AF course to perform AF inspections and/or the basic LACF course to perform LACF inspections.

The investigator must be prepared during inspections of AF/LACF manufacturers

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to determine the firm’s compliance with the AF regulations, 21 CFR Part 114;

the LACF regulations, 21 CFR 113; Emergency Permit Control, 21 CFR 108; and GMP general standards regulation, 21 CFR Part 110.

Investigators should note that recent events such as confirmed botulism cases, Class I Recalls and serious investigational findings resulting in two firms being placed under Emergency Permit Control, have raised concerns about the safety of LACF products and the state of control in the industry. Problems identified included, malfunctioning equipment resulting in under processed product; a lack of control in the areas of container fill weights, can seam integrity, under processed product accountability and product coding; and inadequate heat distribution studies and heat penetration documentation. At one firm defective containers (swollen, buckled, and exploding cans) were routinely disposed of, or put on hold, without a determination of the severity or cause of the problem. In one case, problems were related in part to economic pressure from a new parent corporation to “cut corners”, resulting in poor equipment maintenance, poor labor- management relations, and complacency.

These findings have led to a reassessment of inspectional methods and focus during inspections of AF/LACF manufacturers. In the past a large part of the inspection focused on record review. The recent inspections have shown that in many cases records covering processing, can seam integrity and other operations, may not reveal problems that exist. An expanded, multiple angle inspectional method is more likely to reveal problems and deviations that exist at a firm.

This updated program stresses among other issues the following:

1) The need to perform Field exams, review of process deviation files and QC hold logs early in the inspection to identify possible problems and;

2) Investigation into whether equipment malfunctions, process deviations, or lack of an assessment of changes made to equipment, product and processes may have adversely affected the process/product safety.

During these inspections it is important to focus on the occurrence of unusual events that may have affected the delivery of the process or introduced post-process contamination. They may include potential for the filler to overfill cans; risk of incipient spoilage if the line is down for several hours;

reduction of the products internal temperature; increased risk of can damage during jams; and overcooling causing can seams to remain wet and increase the risk of leaker spoilage. In cases where process deviations result in “still cooks” of a lot in a continuous agitating retort, unprocessed cans in the in-feed track should be properly accounted for and reprocessed or destroyed. The disposition of these unprocessed cans should be documented. Because a firm may file numerous alternate processes, not all unusual events may be documented in a deviation file. QC hold logs may also identify unusual occurrences.

Objectives of the inspection include:

To assure that the firm's Process Authority has had an active role in temperature distribution and heat penetration studies, and deviation evaluation.

To observe the retort processing line while in operation and to look for possible malfunctions.

To review maintenance records (for each system) for changes to equipment or process, and any corresponding evaluation records (i.e. temperature distribution studies).

To review formulation/filling method changes and any corresponding

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evaluation records.

To evaluate the firm’s the containers.

To review the firm’s w procedures/documentati container integrity testing and the integrity of ater quality and cooling water sanitation on.

To conduct field exams of warehouse product and sample collections of suspect product.

To determine how the firm identifies, handles and assesses spoiled product/abnormal cans, including finished product in storage.

It is important to be fully prepared before initiating the inspection, to use critical thinking skills and be flexible and open-minded in your approach. A team approach should be considered for these inspections, dividing the workload into process evaluation and field exam/sampling duties. Lead CSOs should be experienced investigators who routinely conduct LACF inspections, and have attended the FDA AF or LACF training course where the concepts of retort design, vent size/configuration and drain location are covered. When necessary and feasible, an experienced Lab analyst should also be included on a team inspection to evaluate the firms can seam teardown and evaluation procedures.

Inspections should occur when the firm is operating (which may require some advance planning) and should include observations of retort processing lines while in operation, to look for possible malfunctions. (This may involve the inspection team being at the firm for early or late shifts and overtime.)

Inspections should be thorough and include use of reporting forms 3511. The forms have been updated to capture critical information during the inspection that is essential to determining an establishment’s state of control.

Investigators should document full details in the EIR and on the appropriate forms. NOTE: FDA-3511 forms were created to ensure complete inspectional coverage. Use FDA Form 3511 and the appropriate Retort Reporting Form (FDA Forms 3511a-i) as a guide to the conduct of the inspection.

Report all AF/LACF inspections using the following forms, as appropriate. The Forms are available on ORA’s forms site at http://www.fda.gov/opacom/morechoices/fdaforms/ora.html. The forms are in PDF format and can be electronically completed after downloading. The report forms are as follows:

a. FDA Form 3511 FDA LACF Inspection Report

b. FDA Form 3511 a–i Retort Reporting Forms - see below, as appropriate

c. FDA Form 3511-2 Acidified Food Inspection Report

d. FDA Form 3511-3 Aseptic Food Inspection Report (currently under final review). It will be available on the forms site upon completion.

Retort Reporting forms:

3511a Processing in Steam in Still Retorts 3511a-1 Processing in Steam in Crateless Retorts 3511b Processing in Water in Still Retorts 3511c Processing in Steam in Continuous Agitating Retorts 3511d Processing in Steam in Discontinuous Agitating Retorts 3511e Processing in Water in Discontinuous Agitating Retorts 3511f Processing in Steam in Hydrostatic Retorts 3511g Processing in Cascading/Spray Water Retort

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http://www.fda.gov/opacom/morechoices/fdaforms/ora.html

3511h Processing in Steam-Air Retorts 3511i Processing in Other Unique Retort Systems

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a. Inspection preparation

• Determine firm status: e.g., initial, routine, compliance follow-up, etc. Contact appropriate individuals as required prior to the inspection for guidance e.g., compliance officer, other investigators, national and program experts via district management as needed.

• Review previous inspection reports.

• Review references such as “Guide to Inspection of…” as listed below in the “Reference” section.

• Obtain equipment and all required forms (482, 482a, 482b, 3511, etc.).

• Investigators should choose a product and production line that represents one of the most difficult to control.

b. Inspectional Approach

At the on-set of the inspection look for unusual events and defective product:

• Review deviation files and QC Hold logs

• Visually examine the firm’s warehouse stock

• Examine QC hold areas, determine why lots are on hold and document lot numbers. These areas may also be called “distressed goods”, “morgue”, “quarantine”, etc.

• Examine product for signs of leaking, swollen, and damaged containers or containers with any abnormalities.

• Examine off-site storage areas concurrent with other areas if more than one FDA Investigator is on-site.

• Determine if lots are on hold and why.

c. Field Exams

Field examination of warehouse stock is stressed. Any of these issues would prompt field exams:

• Visual observation of warehoused product that shows a significant amount of abnormal containers (greater than 1%)and the firm has not conducted a spoilage diagnosis to determine the cause of the spoilage and if the lot is safe for distribution.

• Record review and/or observation of processing equipment and unexpected events such as excessive delays resulting from frequent stoppages in the production line that could cause or contribute to incipient spoilage and under processing.

• Inadequate maintenance of seaming equipment combined with evidence of loose seams and poor quality cooling water

• Products which have had changes in formulation/fill, with no evaluation of scheduled process by a Process Authority

• Product manufactured on equipment which has been modified or received maintenance (changing functional parameters) with no subsequent temperature distribution studies by a Process Authority

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• LACF Products with pH of 4.7 – 5.4 held at ambient temperatures

• “Not for Cause” flat can sampling of green beans, peas and beets should be discussed with CFSAN Enforcement Contact, prior to initiation.

Note: If any observations noted during review of the maintenance records have the potential to affect the proper processing of products on the retort line, the investigator must conduct a field examination of two production lots immediately prior to the maintenance and two production lots immediately after the maintenance, based on availability of products in storage at the facility.

If your findings indicate abnormal product may have been distributed contact the CFSAN Enforcement Contact to determine if the observations noted warrant additional field examination to be performed at consignees.

Note: For detailed information on Field Exams refer to the guidance document “Requests for Additional pH Meters and Updated Guidance for Their Use” and the Investigations Operations Manual (IOM) Sample Chart 2, “SAMPLING SCHEDULE FOR CANNED AND ACIDIFIED FOODS” located at http://www.fda.gov/ICECI/Inspections/IOM/ucm127460.htm

d. Scheduled Process

• Determine the Process Authorities credentials (knowledge, training, and experience, etc.).

• Determine if the Process Authority is actively involved in conducting temperature distribution studies, heat penetration studies and evaluating process deviations.

• Determine if product or process changes have occurred since the most recent inspection and if so, determine whether the Process Authority has evaluated the scheduled process in relationship to these changes. Focus as necessary on the following when investigation reveals that major changes have been made in the process or product:

Major changes include:

Change in product formulation Change in ingredient specification Ingredient substitutions Change in product form or cut Change in processing and filler equipment Change in blending procedure Change in processing methods (e.g., still to agitating, etc.)

Change in container types (e.g., metal to semi-rigid, traditional can to self heating can, etc.

Addition of new product lines, etc.

• If the scheduled process(es)have changed, Investigators should determine if the changes were reviewed by the firm’s Process Authority. Investigators should determine whether old processes have been canceled and new processes filed. Describe and

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FORM 2438 g (10/91) http://inside.fda.gov:9003/ProgramsInitiatives/FieldOperations/FieldGuidance/default.htm http://inside.fda.gov:9003/ProgramsInitiatives/FieldOperations/FieldGuidance/default.htm document full extent of changes using FDA Form 3511.

e. Delivery of the Scheduled Process

• Determine if the retorts, retort control systems, container filling and handling equipment, and venting conditions have remained the same since the last inspection.

If no changes, a general visual inspection of the equipment to identify gross deviations from the regulations is sufficient.

If the retort system and/or other critical equipment have changed significantly, describe and document the full extent of changes using the appropriate Retort Reporting Form (FDA Forms 3511a-i) or FDA Form 3511 as necessary.

If significant deviations (e.g., broken MIG, etc.) are noted during the visual inspection, describe and document full extent of deviations using appropriate Retort Reporting Form (FDA Forms 3511a-i) or FDA Form 3511 as necessary.

Change in equipment could change parameters and scheduled process requiring review by the Process Authority

f. Documentation of Process Delivery

• Determine that records to document delivery of the scheduled process and control of critical factors are being created and maintained.

• Conduct a random audit of the records to determine that the scheduled process is being delivered and that critical factors are under control.

• If an audit reveals deviations from the scheduled process or lack of control of critical factors, audit the separate process deviation log or file. If the deviation log or file indicates improper handling of deviations, describe and document firm’s failure to comply in complete detail using FDA Form 3511.

g. Process Controls and Concerns

• The following are some process concerns which may not be evident by normal record review, but have proved to be problematic during past inspections. Be sure to focus on the occurrence of unusual events that may affect processing.

Failure to contact Process Authority when a change warrants notification which may result in changes to processing parameters

Failure to recognize and correct process deviations Inadequate corrective steps taken to address deviations Inadequate delivery of scheduled process

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Overfilling of containers Risk of incipient spoilage due to processing delays Reduction of products internal temperature Container damage Overcooling Loose can seams Inadequate container closure Inadequate vacuum Low initial temperatures Low brine fill temperatures Excessive headspace Product codes not synchronized with the retort time clock, missing or not complete

Timing delays Inadequate equilibrium pH

h. Container Integrity

• Document whether or not the firm is conducting appropriate visual and destructive tests to assess if the container seaming operation is adequate.

• Interview employees that evaluate or inspect seams and/or closures of AF/LACF products. Determine if these employees have had adequate training.

• Audit container examination records to ensure container seams or seals are within specifications.

• Audit container handling equipment and procedures (tracks, conveyors, crates, etc.) to ensure the container closing operation is not compromised.

• Determine how the firm handles, investigates and documents abnormal containers.

• Is finished product exposed to elevated temperatures during storage or shipment that could cause thermophilic growth and spoilage?

• Determine if the firm’s containers are protected from post processing contamination.

• Determine if container closures are examined and if results are recorded.

i. Water Supply

• Recent inspections have shown container cooling water sanitation to be a problematic area. Below are areas to examine.

Determine the source of the firm’s water supply.

If non-municipal, examine well design, maintenance and records.

If pre-treated, determine by what method.

Determine if the water is disinfected, the method used

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and how it is monitored.

Determine water analysis and the frequency conducted Determine if the water used is re-circulating or single pass.

Free chlorine kills bacterial cells and spores more rapidly as the pH decreases from pH 7.0. Above pH 7.0, the antimicrobial effect diminishes rapidly. Plant cooling water should have a pH between 6.5 and 8.5.

Below pH 6.5, the water is highly corrosive and may degrade equipment; above pH 8.5, the antimicrobial effect is negligible.

Chlorine and chlorine compounds are the most commonly used water sanitizers. Bromine may be used and sometimes in combination with chlorine. Determine how the firm provides for a measurable residual of sanitizer and frequency of residual sanitizer testing on container cooling water.

Container cooling water should be breakpoint chlorinated such that there is a measurable amount of free chlorine, ideally 2-7 ppm.

Determine if there are problems that would lead to the water being contaminated.

Municipal water can vary greatly in microbiological quality. The most common source of water system contamination is due to line breaks with infiltration of soil bacteria. Check points in the distribution system farthest from the treatment plant.

Bacterial spores are 10 to 1000 times more resistant to chlorine inactivation than are their corresponding vegetative cells. A contact time of 30 minutes is generally accepted as being an adequate amount of contact time for the inactivation of spores in cooling water at a specified chlorine level provided chlorine levels are adequate.

Note: If the quality of the firm’s containers and the source cooling water quality are suspect, contamination may be introduced in the container during cooling. In such cases be prepared to trace water lines and collect water samples.

Samples must be collected aseptically and analyzed within 24 hours of collections. See IOM Chapter 4 for instructions on collecting water samples and sodium thiosulfate usage.

For more information regarding inspectional coverage of water supply in AF and LACF see “Reference” section below.

j. Equipment

• A thorough review of the firm’s equipment condition, maintenance and related documents should be performed.

Determine when the last major overhaul or maintenance was performed on firm equipment.

Determine if the firm conducts a retort survey after a major overhaul or after maintenance is performed on critical equipment which helps ensure compliance with

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the regulations.

Determine how often temperature distribution studies are conducted on retorts, who evaluates the data, what procedures are used, and if there is documentation such as a retort diagram and parameters used to validate the test.

Does the Process Authority conduct heat distribution tests on one or all retorts?

Determine if the boiler(s) supply sufficient steam to the retorts and if the header pipe supplies steam to the retorts especially when more than one retort is being vented simultaneously.

Determine if the Process Authority is advised when additions/revisions to the retort or boiler configuration occur. Determine if contact with the Process Authority has been documented.

Review maintenance records to determine if the equipment is adequate to ensure that the scheduled process is delivered. Focus on maintenance of equipment used to measure critical factors such as scales, thermometers, gauges, and consistency meters or devices; replacement of equipment found to be out of specifications; and modification of any equipment critical to controlling time/temperature parameters of the firm’s scheduled process.

Determine if proper calibration procedures are used to assure the accuracy of MIGs used on retorts.

Determine if the firm’s thermometers are accurate (dial or MIG).

Determine if the firm has pH meters and if they are used properly.

Determine what type of changes have been made since the temperature/heat distribution study was last done.

Many small plumbing changes can have an overall significant cumulate impact on the process delivery.

k. General

• Determine if appropriate plant personnel have been to a

Better Process Control School (BPCS).

• Document whether or not the firm has a recall plan on file.

• Complete a review of the firm’s consumer complaint file.

Focus on reports of spoilage, swollen containers, inadequate pH, etc., frequency of such reports and action taken if any.

3. References:

For more information on the inspection of acidified food and low-acid canned foods refer to:

21 CFR Parts 108, 113, 114; at http://www.fda.gov/Food/FoodSafety/Product- SpecificInformation/AcidifiedLow-AcidCannedFoods/Regulations/default.htm.

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2438 g 10/8/10

FORM (10/91)

http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/Regulations/default.htm http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/AcidifiedLow-AcidCannedFoods/Regulations/default.htm

• Form FDA 482a – Written Demand for Records. Refer to the FDA GUIDE TO INSPECTIONS OF LOW ACID CANNED FOOD MANUFACTURERS, Part 1 – Administrative Procedures/ Scheduled Processes, for specific guidance of use.

• Form FDA 482b – Written Request for Information. Refer to the FDA GUIDE TO INSPECTIONS OF LOW ACID CANNED FOOD MANUFACTURERS, Part 1 – Administrative Procedures/ Scheduled Processes, for specific guidance of use.

• FDA GUIDE TO INSPECTIONS OF LOW ACID CANNED FOOD

MANUFACTURERS, Part 1- Administrative Procedures/Scheduled Processes, at http://www.fda.gov/ICECI/Inspections/InspectionGuides/u cm074992.htm

MANUFACTURERS, Part 2 - Process/Procedures, at cm074995.htm

MANUFACTURERS, Part 3 – Containers/Closures, at cm074999.htm

• FDA GUIDE TO INSPECTIONS OF ACIDIFIED FOOD

MANUFACTURERS, at cm075003.htm

• FDA GUIDE TO THE INSPECTION OF ASEPTIC PROCESSING AND

PACKAGING FOR THE FOOD INDUSTRY, at cm074946.htm

• FDA GUIDE TO THE INSPECTIONS OF COMPUTERIZED SYSTEMS IN

THE FOOD PROCESSING INDUSTRY, at cm074871.htm

• Better Processing Schools Manual; contact CFSAN

Technical Expert.

• Various Publications available from GMA which if not available in your district can be purchased at http://www.gmabrands.com/index.cfm, including:

AOAC Classification of Can Defect Poster NFPA Bulletins 26-L & 30L (Thermal Processes-Low

Acid in Metal Containers).

NFPA Bulletin # 43-L Validated Guidelines for

Automated Control

• Reference: Attachment B, “Expanded LACF Establishment Inspection”, May 2008, on CFSAN’s (#)

TR ANSMITTAL NO: PART III PAGE 13

DATE OF ISSUANCE:

FOR

10/8/10 M 2438 g (10/91) http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm103536.htm http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm103536.htm http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074992.htm http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074992.htm http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074995.htm http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074995.htm http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm075003.htm http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm075003.htm http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074871.htm http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074871.htm http://www.gmabrands.com/index.cfm

● “Requests for Additional pH Meters and Updated Guidance for Their Use DFI Memorandum issued 12/5/08 (#)

● Low Acid Canned Foods Webinar, May 2008: Please request through DHRD because this document is no longer posted on the intranet.

• ORAU Classroom Training

Basic Low Acid Canned Food, FD103

Advanced Low Acid Canned Food, FD3003

Acidified Foods, FD202

Aseptic Processing for Food, FD405

Canned Seam Analysis, LB221

• ORAU On-line Courses

FD6040 - Food Microbiological Control 7A: Control by Thermal Processing (MIC08)

FD6042 - Food Microbiological Control 7C:Control by Retorting (MIC10)

• DFI Bulletins: Note – 2 proposed DFI bulletins have been written by Brian Hendrickson, DFI Technical Expert and sent to CFSAN for review and concurrence – (1) Venting & Operating Procedures For Continuous Agitating Retorts Processing in Steam, and (2) Heat Distribution

vs. Temperature Distribution in Seam Retorts & Retorts Operating with Overpressure. After review and final concurrence by CFSAN, these bulletins should be distributed to the Field and referenced in this section of the compliance program.

4. Determination of Acidified Food

Acidified Foods are covered under 21 CFR Part 114.

NOTE: Appropriate FDA 483 entries regarding failure to register and file include:

• Instances where the food is easily recognized as an acidified food, (e.g., fresh pack peppers) and failure to register and file has occurred.

• Instances where the status of the food can be determined through contact with CFSAN, Supervisory, Compliance or ORA experts to be AF or LACF prior to conclusion of the inspection.

• Cases where the status of the food may have to be

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determined through laboratory analysis or evaluation of the formulation. The firm should be informed that the food has been determined after review to be an acidified food and that the firm should register and file the scheduled process for that product.

In any of the above mentioned events the firm should be informed that it is their responsibility to determine if the products they manufacture fall under the Acidified or Low-acid Canned Food regulations and file and register accordingly.

To determine whether the small amounts of low-acid ingredient(s) result in a significant pH difference, obtain:

a. Quantitative formulation (obtain quantitative information using the same units of measurement or percentages). When determining the quantitative amounts of low acid ingredients, do not count sugar, salt or water. Do count powders such as onion powder, garlic powder, etc., as these ingredients can absorb acid and affect the finished equilibrium pH. If the investigator is unable to determine with certainty the status of the food product, then in addition to quantitative formulation, samples of all raw materials should be collected along with finished product. Enough raw materials should be collected to allow the formulation to be recreated in the lab, in the same proportion as the commercial product.*

b. The pH of each ingredient in the quantitative formulation if feasible OR other evidence that determines whether ingredients being used are acid or low-acid components (i.e., raw chopped vegetables used as ingredient(s)).

c. Complete description of the formulation process (how ingredients are processed and formulated together).

d. The pH of the acid(s) and/or acid food(s)ingredients mixed together in the same proportion in which the acid(s)and/or acid food(s) ingredients appear in the product formulation. Relate these samples to the equilibrium pH of the finished product to determine if there is a significant shift in pH.

e. The pH (minimum of six units of finished product when obtaining information to determine if product is an acidified food).

Obtain information from the firm, if available, or through sampling and testing with a calibrated pH meter. Finished products collected to determine pH by an FDA laboratory for the purpose of supporting regulatory action should be collected per IOM chapter 4 “Sample Schedule Chart 2” found at http://www.fda.gov/ICECI/Inspections/IOM/ucm127460.htm.

f. Alternatively, watch the firm determine the regulatory status of their own products – acidified or acid foods. This includes their quantification of ingredients – both low acid and acid/acid food ingredients to determine if the low acid food ingredients constitute “small amounts” and the pH testing of acid/acid food ingredients and finished product to determine if there is a significant shift in pH. Note – the firm should test a minimum of 6 jars of finished product. Collect the data

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and submit with the EIR. If the firm determines through their own testing that a product is an acidified food and they have not registered and/or filed a scheduled process, consider citing the firm for their failure to register and/or file.

Submit the information to CFSAN Enforcement Contacts for review to determine if there is a…