Request for Comments on the Qualified Through Verification Program for the Fresh-Cut Produce Industry

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

[FV-96-328]

Request for Comments on the Qualified Through Verification

Program for the Fresh-Cut Produce Industry

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Notice, request for comment.

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SUMMARY: The Department of Agriculture (USDA) is seeking comment on the

``Qualified Through Verification'' Program (QTV). The program, which

began in January 1996, is a pilot program provided under the authority

of the Agricultural Marketing Act (AMA) of 1946, as amended. The

program provides for voluntary audit-based inspections for

wholesomeness and food safety. A new service was requested by

representatives of the fresh-cut produce industry that would address

wholesomeness in conjunction with food safety under Hazard Analysis

Critical Control Points (HACCP) criteria, and Food and Drug

Administration (FDA) current Good Manufacturing Practices (cGMPs).

Under a ``pilot program'', the Agricultural Marketing Service (AMS) has

found that QTV fosters a proactive approach by the production

facility's management for identifying process deficiencies during

production rather than after production is completed.

DATES: Comments must be received on or before November 3, 1998.

ADDRESSES: Interested persons are invited to submit written comments

concerning this notice. Comments must be sent in duplicate to the

Office of the Branch Chief, Processed Products Branch, Fruit and

Vegetable Programs, Agricultural Marketing Service, U.S. Department of

Agriculture, STOP 0247, P.O. Box 96456, Washington, DC. 20090-6456 or

e-mailed to [email protected]. Comments should note the

date and page number of this issue of the Federal Register and would be

made available for public inspection in the Office of the Branch Chief

during regular business hours at 1400 Independence Avenue, SW, Room

0709, South Building, Washington, DC 20250-0001.

FOR FURTHER INFORMATION CONTACT: Mr. James R. Rodeheaver, Branch Chief,

Processed Products Branch, Fruit and Vegetable Programs, Agricultural

Marketing Service, U.S. Department of Agriculture, STOP 0247, P.O. Box

96456, Washington, DC 20090-6456, Telephone (202) 720-4693.

SUPPLEMENTARY INFORMATION: This notice is requesting comments on the

QTV program which, since January 1996, has been a pilot program. This

service is performed under the Agricultural Marketing Act of 1946 (7

U.S.C. 1621-1627).

The QTV Program was developed in 1995 by AMS in response to a

request by the International Fresh-cut Produce Association (IFPA). A

notice was published in the Federal Register on December 20, 1996

announcing the program. AMS's QTV Program is a voluntary audit and

verification service using science-based techniques that helps maintain

public confidence in the wholesomeness of minimally processed fruits

and vegetables. Minimally processed fruits and vegetables are products

that have been freshly cut, washed, packaged, and maintained with

refrigeration. IFPA is one of the major trade associations that

represents the fresh-cut produce industry. As currently constituted,

QTV is directed only toward the fresh-cut produce industry. A producer

of bottled water has asked AMS to provide QTV services to them.

Although the Agency has declined the request, AMS would welcome input

regarding extending QTV to this or other products.

Since January 1996, AMS has offered the QTV pilot program as a

voluntary auditing and verification service. The program manual has

been revised twice (once in October 1997, with the most recent

revisions in July, 1998) based on the agency's experience.

QTV allows AMS to provide services that help food processors

develop food safety plans based on sound scientific and objective

techniques under HACCP. HACCP is widely viewed as an effective and

rational means of assuring food safety from harvest to consumption.

Under HACCP, safe production of food products is guided by identifying,

evaluating, and controlling food safety hazards.

Since 1985, the National Academy of Sciences has strongly endorsed

HACCP as the most effective and efficient means of ensuring the safety

of our food supply. Regulatory agencies such as FDA and the Food Safety

Inspection Service (FSIS) have required companies to implement HACCP

for seafood, (December 18, 1995 (60 FR 65096)), and meat and poultry,

(July 25, 1996 (61 FR 38805)). HACCP is currently being proposed to

regulate the fruit and vegetable juice industry, (April 24, 1998 (63 FR

20450 and 20486)). Currently, HACCP is not required for the fresh-cut

fruit and vegetable industry.

The principles of HACCP, as provided by the National Advisory

Committee on the Microbiological Criteria for Foods (NACMCF) adopted

November 1989 and amended in 1992 and 1997 are:

Principle 1: Conduct a hazard analysis.

Principle 2: Determine critical control points.

Principle 3: Establish critical limits.

Principle 4: Establish monitoring procedures.

Principle 5: Establish corrective actions.

Principle 6: Establish verification procedures.

Principle 7: Establish record-keeping and documentation procedures.

Hazards may be microbiological, chemical, or physical. HACCP uses

preventive measures and predetermined corrective actions at specific

points in the production process identified as critical control points

based on a comprehensive hazard analysis of the food being produced. As

defined by the NACMCF, a critical control point is a step in a process

at which control can be applied and is essential to prevent or

eliminate a food safety hazard or reduce it to an acceptable level.

In addition to the Agency's experience from present audit based

programs, AMS processed fruit and vegetable inspectors verify that food

processing facilities where AMS has contracted to perform in-plant

product certification are conforming to FDA cGMP's and are handling

adulterated products in accordance with FDA requirements.

[[Page 47221]]

QTV is not a mandatory or regulatory program like other HACCP based

programs established or proposed by FDA and FSIS. Participation in QTV

does not relieve a facility of its responsibilities with respect to FDA

or other food safety regulators. AMS believes that participation in QTV

will help firms comply with food safety regulations.

A company that is interested in the QTV pilot program begins by

requesting the Agency to perform a program presentation and conduct a

plant survey of the company's facilities. At the meeting, AMS seeks

commitment to the QTV concept from senior management and recommends

HACCP-based training for key plant personnel. Also, any deficiencies in

the facility or staff training identified by AMS during the QTV

approval process must be addressed satisfactorily before the plant can

enter the program.

A QTV plan is developed by a company, then submitted to AMS for

review. The QTV plan is then evaluated based on the criteria for the

program. When a company submits its draft QTV plan to AMS for review,

AMS considers the submission as the firm's application for QTV

certification for the facility covered by the plan. The Agency reviews

QTV plans in the order in which they are received. Draft QTV plans are

generally reviewed within 30 days. Later drafts, if revisions to the

QTV plan are necessary, are usually reviewed within two weeks. A

company's progress in the QTV Program is based on the speed with which

a firm has revised its QTV plan and completed any necessary training or

facility modifications.

The QTV plan includes:

(Note: A more detailed list of technical terms and definitions can

be found in the QTV Program Manual, entitled ` ``Qualified Through

Verification'' Program for the Fresh-Cut Produce Industry''; the QTV

Program Manual is available on the USDA website at http://

www.ams.usda.gov/fv/qtv.htm or by contacting the Processed Products

Branch Chief, at the address given above. Interested parties are

invited to submit comments on the QTV Program Manual to the same

address.)

1. Organizational Chart and Narrative: A diagram identifying the

personnel responsible for developing and implementing the QTV plan; a

narrative describing the duties of the identified personnel specific to

QTV and HACCP requirements.

2. Description of Product and Labels: A list of all major groups of

finished processed fruit and vegetable products that are to be covered

under the QTV Program. The description includes but is not limited to

product mixes, package sizes, ingredients, and shelf-life. Examples of

the primary package labels are to be included in this section of the

plan.

3. Process Flow Charts and Process Flow Narrative: The flow

chart(s) illustrates the operational steps involved with a product or

similar products with designations of critical control points and

control points. The process flow narrative is a description of each

operational step involved with a product or similar products with

designations of critical control points and control points.

4. Hazard Analysis: This is an evaluation of all the potential

hazards that can be associated with the products produced in the

facility as well as in the growing, harvesting, transporting and

storing of these products. This evaluation is used to determine which

hazards must be addressed in the HACCP plan. A thorough hazard analysis

is the most important step towards developing an effective HACCP plan

for QTV. It requires extensive review by the company HACCP team and, if

additional expertise is needed, outside experts.

5. Critical Control Point (CCP) Narrative and Worksheet: The

worksheet is a description of the following information for each CCP.

(a) Location of the Critical Control Point

(b) Hazard(s) to be controlled at Critical Control Point

(c) Preventive Measures

(d) Critical Limits

(e) Monitoring Procedures

(f) Corrective Actions

(g) Records

(h) Verification

6. Record Keeping: Record keeping is a method of documenting and

filing information relevant to HACCP and the QTV plan. These records

must be identified and easily accessible for review by AMS auditors.

7. Verification Procedures: These procedures describe methods the

company will use daily, monthly, and annually, to determine the overall

effectiveness of its QTV plan.

8. Sanitation Standard Operating Procedures (SSOPs): SSOPs are a

comprehensive description of the company's program to ensure sanitation

compliance. These procedures include listing equipment and structures

to be cleaned and/or sanitized, and the sanitation schedule for each.

SSOPs should also identify the types of chemicals used, where and how

they are stored, materials and methods used, who will perform the

cleaning operations, and who will verify that the cleaning was done

properly.

9. Consumer Complaints: There must be an established procedure for

handling, addressing, and recording consumer complaints.

10. Recall Procedures: This is a method of positively identifying,

locating, and retrieving products that have left the facility.

11. Microbiological Testing Program and Corrective Procedures: The

microbiological testing program describes the procedures employed by

the applicant to ensure that the product and sanitation techniques

comply with regulations. This includes testing for specific

microorganisms in incoming product, environmental testing of the

facility (equipment, drains, etc.), and finished product testing. The

QTV plan must specify the corrective procedures that will be undertaken

if specific microorganisms are found during testing that could result

in product contamination.

12. Additional Elements as Described in the QTV Program Manual:

These include a pest control program, standard operating procedures,

standard testing procedures, an employee training program, and a

product coding system.

Once AMS has determined that a firm's QTV plan meets QTV

requirements, the company must then implement the AMS-accepted plan for

a minimum of 30 days to demonstrate that it can fulfill its plan's

requirements. After the 30-day period and when requested by the plant,

AMS will perform the validation audit. This is a complete review by AMS

QTV auditors of the company's QTV plan in operation. The auditors will

follow the Systems Audit Checklist (which may be found in the QTV

Program Manual).

The validation audit includes a review of the facility's production

records, interviews with employees at CCP's, observation of employee

food handling practices during each shift, observation of cleaning and

sanitizing of equipment before and during production, review of the

microbiological testing program, and review of the employee training

program. The plant will be accepted into the QTV Program if a minimum

of a Level IV rating is obtained based on the results of the validation

audit. A Level IV rating indicates that the facility is following its

QTV plan, that the plan is effective, and that the facility qualifies

for unannounced AMS QTV audits once it enters a contract for service

with AMS.

AMS and the company will then enter into a contract for AMS service

which includes periodic unannounced Systems Audits. The company agrees

under the contract to conform to the

[[Page 47222]]

Regulations Governing Inspection and Certification of Processed Fruits

and Vegetables and Related Products (7 CFR 52.1 through 52.83) and

instructions covering inspection and certification. The company also

agrees to the following:

Records--Maintain and make available for review by AMS all records

required by the QTV plan including, but not limited to, hazard

analysis, preventive measures, CCP and critical limit documentation,

monitoring records of preventive measures associated with CCP's,

corrective action reports, and verification records, including consumer

complaints relevant to the QTV plan.

Samples--Provide reasonable quantities of product samples while

participating in the QTV Program at no cost to the Government.

Surety--At the discretion of AMS, furnish an acceptable surety,

effective prior to the date of the first Systems Audit, guaranteeing

payment for the services to be rendered in an amount sufficient to

cover estimated billings for a period of three months in the form of a

properly executed surety bond or advance payment.

Payment--Pay by check, draft, or money order drawn to the order of

USDA for the service covered herein on or before the due date specified

on the bill.

Plant Access--The applicant is responsible for granting permission

for AMS to enter plant premises to perform Systems Audits at any time.

AMS agrees to perform the following:

Systems Audits--Provide objective third-party verification of the

applicant's QTV plan.

Verification--Review, evaluate, and verify the effectiveness of the

processor's adherence to the QTV plan through on-site inspections,

evaluation of production processes identified in the plan, evaluation

of product samples, audit of plant records and interviews with plant

employees.

Sanitation--Perform sanitation inspections and report to company

management any sanitation deficiency which may result in an

unsatisfactory rating or cause product contamination.

Sample--Randomly draw and evaluate official samples to verify the

effectiveness of the applicant's QTV plan and determine if end items

comply with applicable specifications.

Formulation--Verify product formulation. Audit reports and records

to determine if documentation of components and quantities used are

accurate and complete.

Calibration--Verify procedures used to calibrate scales and

measuring devices. Packaging and Labeling--Verify that product

packaging and labeling are in compliance with the applicable

specifications in the QTV plan.

Record Keeping--Review records associated with and identified in

the QTV plan to determine adherence to the plan.

Exit Interview--Discuss and report the results and observations

with the firm after each QTV Systems Audit, providing verification

reports, sharing data and sample results as necessary, allowing for

voluntary follow-up and corrective action, where appropriate. Provide

written notification in the event any violative condition is found.

Report--Issue a report to plant management on Systems Audits and

evaluations.

Confidentiality--To the extent permitted by law, consider and treat

any trade secrets or confidential information as proprietary and

confidential and further to consider any QTV records and related

information provided to AMS, because of the company's participation in

the QTV Program, as information that is voluntarily submitted to the

Agency.

Charges--Bill the applicant for Systems Audits on an hourly basis

in accordance with the applicable sections of the Regulations.

Systems Audits shall continue until the company has suspended

service, withdrawn, been debarred, or the agreement is terminated by:

Mutual consent--either party giving the other party 30 days advance

written notice specifying the date of suspension or termination;

A written notice by AMS if the applicant fails to honor any invoice

for fees within 60 days after date of receipt;

Bankruptcy of the applicant or closing out of business, or change

in controlling ownership of the firm;

AMS at any time, acting pursuant to any applicable law, rule, or

regulation, debarring the applicant from receiving any further benefits

of the service; or

Non-performance by the applicant such that the applicant no longer

satisfies the requirements for participation in the QTV Program.

Following validation and the signing of the QTV contract, AMS will

conduct unannounced audits at scheduled intervals as set forth in the

QTV Program Manual. The company may revise its QTV plan at any time,

subject to AMS review and approval.

Whenever an AMS auditor identifies a current Good Manufacturing

Practice violation under QTV, whether during the Validation Audit or

subsequent unannounced Systems Audits, the auditor will first notify

the processor. The processor is responsible for taking proper and

effective corrective action. The extent of any subsequent actions by

AMS, will depend upon the nature of the audit finding and the adequacy

of a processor's response.

Traditionally, shields are used by AMS for marketing as an

identifying mark of a program service in its voluntary programs. The

shields shown in Figures 1 and 2 can be used by facilities that have

been successfully validated and have entered into a QTV contract. The

processor's name and address or assigned plant number identifies the

facility as approved for the QTV plan.

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AMS welcomes comments on how to improve the design or wording for

the shield, whether to provide for an official QTV shield at all, or

whether the use of an approved official QTV mark should in some way be

limited. The Agency is aware of differing views on the use and design

of the QTV mark.

Two types of marks are available under the program for use by a

validated company. One shield, Figure 1, includes a QTV facility number

within the shield and can be used by a company with only one facility.

A company under the same name with multiple facilities can use either

Figure 1 or the non-numbered QTV shield provided the QTV facility

number is also included on the label in close proximity to the shield

in Figure 2. Each plant successfully operating under an approved QTV

plan has a separate QTV identifying number. These approved

identification marks may only be used on products specified in the QTV

plan.

There is no additional charge for use of the QTV shield. Firms may

use the shield in their advertising and promotion. This activity must

not, however, suggest that products bearing the shield are safer than

others or otherwise misrepresent the QTV shield.

QTV facilities that fail to meet acceptable QTV audit levels will

be dropped from the pilot program. Products from such facilities may

not then bear the QTV shield and the facility must destroy such labels.

AMS verifies that the facility has ceased its use of the approved mark.

Unauthorized use of the mark may violate the AMA of 1946 and/or the

Perishable Agricultural Commodities Act of 1930 (PACA), as amended (7

U.S.C. 499a-499s). Violators may be subject to fines and/or

imprisonment, civil penalties, loss of USDA grading and certification,

or suspension or revocation of their PACA license.

AMS maintains a copy of a plant's QTV plan and AMS, QTV auditors

examine but do not normally, copy or remove from the facility any plant

documents during systems audit. QTV plans in AMS's possession remain

the property of the company and will be treated as privileged or

confidential. AMS will maintain as confidential, QTV related records

and plans to the extent permitted by law.

Beyond the costs of AMS audits, the overall cost of participation

in QTV will vary depending on a company's facility and staff

preparation. The frequency of AMS audits, and hence the Agency's

charges for its services, will vary based on a firm's performance as

determined by the periodic QTV audits. After validation, all firms

begin at Level IV, which requires an unannounced QTV audit every two

weeks. Under the original QTV Program requirements dated October 1995,

a firm which demonstrates exemplary performance during all audits could

advance from Level IV to Level I (which requires the least frequent

auditing) in approximately nine months, or seven audits, significantly

reducing their audit costs. Firms which perform well will reduce their

audit costs since the frequency of AMS unannounced audits decreases

when a firm is able to progress from Level IV to Levels III, II, and

ultimately to Level I. Level I had required an unannounced audit every

six months, but the Agency has adjusted the minimum audit rate to once

every three months in the current revision dated July 1998. Under the

new revision, a company can advance from Level IV to Level I in seven

months or five audits.

Fees for the program would be provided for in the regulations under

Sec. 52.51(a). The QTV Program is funded entirely through user fees.

The fee currently charged for QTV services under the pilot program is

$41.00 per hour (see 7 CFR 52.42). This fee is charged for the time

required by AMS personnel to travel to and from an audit site, do the

audit, and perform associated administrative activities. Currently, the

door-to-door cost for a typical eight-hour QTV Systems Audit, based on

recently completed QTV Systems Audits by two auditors, has averaged

between $1700.00 and $2000.00. As the QTV Program continues and AMS

knows more precisely the program costs, it will make any necessary fee

rate adjustments. Costs for analytical work regularly performed by a

firm or an outside provider to support a firm's QTV Program is the

firm's responsibility.

There are approximately 300 to 400 fresh-cut processors according

to IFPA estimates. This estimate does not include an unknown number of

restaurants, produce wholesalers, or retailers that may process fruits

and vegetables for salads or other purposes. There are currently seven

plants participating in Systems Audits under the program. These plants

include small to large-size processors.

AMS has identified a need for participation from the private sector

in training, consulting, and microbiological testing for QTV Program

applicants. Several private laboratories have taken the initiative to

provide these services and are currently working jointly with AMS in

training and QTV plan development for several applicants. This

cooperation has proven beneficial to all parties.

AMS invites comments on the program, use of the shield,

requirements of the program, and quality versus food safety issues.

This notice has a 60-day comment period. All interested parties

will have an opportunity to express their views. Once the comment

period has closed, AMS will review and consider all comments before

making further decisions about the QTV Program.

[[Page 47224]]

Dated: August 28, 1998.

Enrique E. Figueroa,

Administrator, Agricultural Marketing Service.

[FR Doc. 98-23903 Filed 9-3-98; 8:45 am]

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