[Federal Register Volume 63, Number 172 (Friday, September 4, 1998)]
[Notices]
[Pages 47220-47224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23903]


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 Notices
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
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  Federal Register / Vol. 63, No. 172 / Friday, September 4, 1998 / 
Notices  

[[Page 47220]]


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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.

BILLING CODE 3410-02-P

[[Page 47223]]

[GRAPHIC] [TIFF OMITTED] TN04SE98.000



BILLING CODE 3410-02-C
    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]
BILLING CODE 3410-02-P