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

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URL: https://www.frixlaw.com/law-library/documents/fr%3A98-23903

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** September 4, 1998
- **Citation:** 63 FR 47220

## Text

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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-23903. Public record. Not legal advice.