Draft Final Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables; Availability; Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft final guidance document entitled “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-Cut Fruits and Vegetables” (the draft final fresh-cut guidance). This document complements FDA's Current Good Manufacturing Practice (CGMP) requirements for foods by providing specific guidance on the processing of fresh-cut produce. The draft final fresh-cut guidance and the CGMP regulations are intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers and retail establishments in a ready-to-eat form. FDA also is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

DATES:

Submit written or electronic comments on the guidance at any time. Fax written comments on the collection of information by April 12, 2007.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. Submit written requests for single copies of the draft final guidance entitled: “Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh-Cut Fruits and Vegetables” to the Center for Food Safety and Applied Nutrition, Office of Plant and Dairy Foods (HFS-306), 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1400 or FAX: 301-436-2651. Include a self-addressed adhesive label to assist that office in processing your request.

Submit written comments on the draft final guidance, identified with Docket No. 2006D-0079, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments . See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. A copy of the draft final guidance is available for public examination in the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain the draft final guidance at http://www.cfsan.fda.gov/~dms/guidance.html .

FOR FURTHER INFORMATION CONTACT:

With regard to the information collection: Jonna Capezzuto, Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.

With regard to the draft final guidance document: Amy Green, Center for Food Safety and Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2025 or FAX: 301-436-2651, e-mail: amy.green@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Fresh-cut fruits and vegetables are minimally processed fruits and vegetables that have been altered in form by peeling, slicing, chopping, shredding, coring, or trimming, with or without washing or other treatment, prior to being packaged for use by the consumer or a retail establishment. The methods by which produce is grown, harvested, and processed may contribute to its contamination with pathogens and, consequently, the role of the produce in transmitting foodborne illness. Factors such as the high degree of handling and mixing of the product, the release of cellular fluids during cutting or chopping, the high moisture content of the product, the absence of a step lethal to pathogens, and the potential for temperature abuse in the processing, storage, transport, and retail display all enhance the potential for pathogens to survive and grow in fresh-cut produce.

With this notice, FDA is announcing the availability of the draft final fresh-cut guidance. The draft final fresh-cut guidance is intended to assist processors in minimizing microbial food safety hazards common to the processing of most fresh-cut fruits and vegetables sold to consumers in a ready-to-eat form. The draft final guidance was revised based on public comments. This draft final guidance represents FDA's current thinking on the microbiological hazards presented by most fresh-cut fruits and vegetables and the recommended control measures for such hazards in the processing of such produce. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if such approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance (see FOR FURTHER INFORMATION CONTACT).

II. Paperwork Reduction Act of 1995

This draft final guidance contains information collection provisions that are subject to review by the OMB under the PRA (44 U.S.C 3501-3520 ). Under the PRA, Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, in the Federal Register of March 6, 2006 (71 FR 11209), FDA gave interested persons 60 days to comment on the information collection provisions in the draft guidance. FDA received a number of comments on the draft guidance but received no comments regarding the information collection provisions.

After publishing the 60-day notice requesting public comment, section 3507 of the PRA (44 U.S.C. 3507) requires Federal agencies to submit the proposed collection to OMB for review and clearance. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. FDA will not finalize this guidance unless and until OMB approves the collection of information. If the collection is approved, FDA will publish a notice in the Federal Register announcing that the guidance is final and providing an OMB control number.

Draft Final Guidance for Industry: Guide to Minimize Food Safety Hazards for Fresh-Cut Fruits and Vegetables

Description: The Federal Food, Drug, and Cosmetic Act (the act) prohibits the distribution of adulterated food in interstate commerce (21 U.S.C. 331 and 342). In response to the increased consumption of fresh-cut fruits and vegetables and the potential for foodborne illness associated with these products, FDA recognizes the need for guidance specific to the processing of fresh-cut fruits and vegetables. Accordingly, FDA encourages fresh-cut produce processors to adopt the general recommendations in the guidance and to tailor practices to their individual operations.

FDA's draft final fresh-cut guidance represents the agency's recommendations to industry based on the current state of science. Following the recommendations set forth in the fresh-cut guidance is the choice of each individual fresh-cut operation, plant, or processor. FDA estimates the burden of this guidance on industry by assuming that those in the fresh-cut industry who do not currently follow the recommendations put forth in the guidance will find it of value to do so. Therefore, the estimates of the burden associated with the issuance of this guidance represent the upper bound estimate of burden, the burden if every fresh-cut plant, processor, or operation that does not follow the recommendations of the guidance should choose to do so.

A. Industry Profile

Estimates of the paperwork burden to the fresh-cut industry that may result from the publication of FDA's draft final fresh-cut guidance are based on information from FDA's relationship with a fresh-cut processor who has developed and maintained these programs and information from a fresh-cut produce industry trade association. Because of the small number of fresh-cut processors, the agency is able to extrapolate data from industry programs to calculate the total estimated upper bound burdens that may result from the issuance of this draft final fresh-cut guidance (see table 1 of this document).

The burden to industry of developing and maintaining the activities recommended in FDA's draft final fresh-cut guidance will vary considerably among fresh-cut processors, depending on the type and number of products involved, the sophistication of the equipment or instruments (e.g., those that automatically monitor and record food safety controls), and the type of controls monitored under any individual preventive control program, such as critical control points (CCPs) monitored under a hazard analysis and critical control point (HACCP) program.

Currently, the fresh-cut trade association estimates that there are 250 fresh-cut plants in operation in the United States. While most of the recent growth in the fresh-cut industry has been due to mergers between already existing firms, there are approximately 50 fresh-cut plants that did not exist in 2001. This implies that about 10 new firms are entering the fresh-cut industry each year. Many of the existing firms in the fresh-cut industry already make use of CGMP-related, recall, HACCP, and other activities. FDA estimates that the burden of this draft final fresh-cut guidance will fall on both existing and new firms entering the industry who may follow the recommendations in the guidance.

B. SOPs and SSOPs

Two general recommendations in this draft final guidance are for operators to develop and implement both a written standard operating procedures (SOPs) plan and a written sanitary standard operation procedures (SSOPs) plan. SOPs describe in writing the performance of the day-to-day operations of a processing plant. Examples of activities that would fall under SOPs would be developing written specifications for agricultural inputs, ingredients, and packaging materials; production steps for the processing and packaging operations; instructions for packaging and storage activities; and procedures for equipment maintenance, calibration, and replacement and facility maintenance and upkeep; and maintaining SOP records on product processing and distribution activities.

SSOPs provide written instructions or procedures for sanitary practices developed for each specific sanitation activity in and around the facility. Sanitation activities include procedures for cleaning equipment, food-contact surfaces and plant facilities; chemical use and storage; cleaning equipment maintenance, use, and storage; pest control; and maintaining SSOP records for the activities. From communication with the fresh-cut industry, we know that existing fresh-cut processors already have developed SOPs and SSOPs. We therefore consider the development of SOPs and SSOPs to be “usual and customary” for manufacturers and processors in the fresh-cut industry (see 5 CFR 1320.3(b)(2)). Thus, we do not calculate this burden for existing firms or new firms entering this industry.

FDA recommends that facilities not only develop but also maintain SOPs and SSOPs. Implementation and maintenance of SOPs and SSOPs include maintaining daily records for each of the firm's operational days for the following activities: Inspection of incoming ingredients, such as the fresh produce and packaging material; facility and production sanitation inspections; equipment maintenance, sanitation, and visual safety inspections; equipment calibration, e.g., checking pH meters; facility and premises pest control audits; temperature controls during processing and in storage areas; and audits of ingredients, food contact surfaces, and equipment for microbiological contamination.

Of the 250 fresh-cut processors, the fresh-cut trade association estimates that well over half have SOP and SSOP maintenance programs in place. Therefore, for purposes of estimating the annual recordkeeping burden for SOP and SSOP maintenance programs, the agency assumed that 40 percent of the existing processors, or 100 firms, and the 10 new firms do not have SOP and SSOP maintenance programs in place. FDA estimates the recordkeeping burden for SOP and SSOP maintenance programs by assuming that these 110 firms will choose to implement such a maintenance strategy as a result of the recommendations in this draft final fresh-cut guidance document, when finalized.

A typical fresh-cut processing plant operates about 255 days per year. For an 8-hour shift, assuming the ingredients are received twice during that time, under the recommendations in the draft final guidance, there would be about 13 records kept (2 for inspecting incoming ingredients; 2 for inspecting the facility and production areas once every 4 hours; 3 records for equipment (maintenance, sanitation, and visual inspections for defects); one for calibrating equipment; 2 temperature recording audits (1 time for each of the 2 processing runs); and 3 microbiological audits (ingredients, food contact surfaces, and equipment)). Therefore, the annual frequency of recordkeeping for SOPs and SSOPs is calculated to be 3,315 times (255 x 13) per year per firm; 110 firms will be performing these activities to generate a total 364,650 records (3,315 x 110) annually, assuming all firms choose to follow the recommendations on keeping records.

The total time to record observations for SOP and SSOP maintenance is estimated to take 4 minutes or 0.067 hours per record, and the number of records maintained is 364,650. Therefore, the total annual burden in hours for 110 processors to maintain their SOP and SSOP records is approximately 24,432 hours. The maintenance burden for these 110 firms, along with the annual maintenance burden of audits or testing, is estimated in row 1 of table 1 of this document. Again, these figures assume that all firms choose to follow the recommendations on recording observations.

C. Recall and Traceback

We recommend that fresh-cut processors establish and maintain written traceback procedures to respond to food safety hazard problems when they arise and establish and maintain a written contingency plan for use in initiating and effecting a recall. In order to facilitate tracebacks and recalls, we recommend that processors establish a program that documents and tracks fresh-cut products back to the source of their raw ingredients, and keep records of product identity and specifications, the product in inventory, and where, when, to whom, and how much of the product is shipped.

Traceback programs are used for those times when a food safety problem has been identified or a product has been implicated in a foodborne illness outbreak. The burden to develop a traceback program is a one-time activity estimated to take approximately 20 hours. Firms in the industry may choose to begin a traceback program after this guidance is made available. The total annual estimated burden for this activity for the 250 existing fresh cut firms and the 10 new businesses expected to enter the industry annually is 5,200 hours. The burden estimate of developing a traceback program is shown in row 2 of table 1 of this document.

Traceback program adjustments or revisions may, or may not, be needed annually. Firms may test their traceback programs yearly to see if adjustments are needed to maintain traceback capabilities. Evaluating and updating traceback programs is estimated to take 40 hours to complete. The annual burden of maintaining a traceback program is estimated for the 250 existing firms in the industry plus the 10 firms new to the industry that may decide to implement this type of program. Assuming that each firm completes this exercise once a year, the total maintenance burden of traceback programs is 10,400 hours yearly. This burden estimate is shown in row 3 of table 1 of this document.

This draft final fresh-cut guidance refers to previously approved collections of information found in FDA regulations. The recommendations in this document regarding establishing and maintaining a recall plan, as provided in 21 CFR 7.59, have been approved under OMB control number 0910-0249. Therefore, FDA is not calculating a new paperwork burden for recall plans.

D. Preventative Control Program

When properly designed and maintained by the establishment's personnel, a preventive control program is a valuable program for managing the safety of food products. A common preventive control program used by the fresh-cut industry is a HACCP system. A HACCP system allows managers to assess the inherent risks and identify hazards attributable to a product or a process, and then determine the necessary steps to control the hazards. Monitoring and verification steps, which include recordkeeping, are included in the HACCP system to ensure that potential risks are controlled. We use HACCP as an example of a preventive control program that a firm may choose based on the recommendations in the draft final guidance to estimate the burden of developing, implementing, and reviewing a preventive control program.

FDA estimated the paperwork burden of developing and implementing a HACCP plan based on a plan with two CCPs. The number of CCPs may vary depending on how the processor chooses to identify the CCPs for a particular operation. Of the estimated 250 fresh-cut processors, the fresh-cut industry estimates that approximately 50 percent of the firms already have HACCP plans in place. Therefore, assuming that the remaining fresh-cut processors voluntarily decide to develop a HACCP plan, 125 existing firms plus the 10 new firms, will develop a HACCP plan.

Developing a HACCP plan is a one-time activity that is estimated to take 100 hours based on a trained HACCP team working on the plan full time. The HACCP team identifies the CCPs and measures needed to control them, and then identifies the approach needed to verify the effectiveness of the controls. During this plan development period, the firm chooses the records to be kept and information and observations to be recorded. This is a one-time process during the first year. Therefore, the total time for 135 processors to develop their individual HACCP plans is approximately 13,500 hours. This one-time burden is shown in row 4 of table 1 of this document.

After the HACCP plan is developed, the frequency for recordkeeping for implementing or maintaining daily records is estimated to be 510 records per year. (This is based on a firm choosing to maintain daily records for 2 CCPs for one 8-hour shift per day for each of the estimated 255 operational days per year.) The total time to record observations for the CCPs was estimated to take 4 minutes or 0.067 hours per record. Therefore, the total annual records kept by the 135 firms choosing to implement the HACCP plan is 68,850, and the “Total Hours” required are 4,613. This annual burden is shown in row 5 of table 1 of this document.

After the HACCP plan has been developed and implemented, we recommend that the plan is reviewed regularly to ensure that it is working properly. Fresh-cut processors are estimated to review their HACCP plans four times per year (once per quarter). Assuming that it takes each of the 135 firms 4 hours per review each quarter, the total burden of this activity, for firms that choose to review their plans annually, is 2,160 hours per year. This annual burden is shown in row 6 of table 1 of this document.

FDA estimates the burden of the collection of information described in the previous paragraphs as follows:

Summing the “Total Hours” column, the estimated one-time recordkeeping burden for firms that choose to follow the recommendations is 18,700 hours; the annual burden for firms, existing and new, is estimated to be 41,605 hours.

III. Comments

Interested persons may submit written or electronic comments to the Division of Dockets Management (see ADDRESSES) regarding this guidance document at any time. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The draft final guidance and received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

Persons with access to the Internet may obtain the draft final guidance document at http://www.cfsan.fda.gov/~dms/guidance.html .