[Federal Register Volume 63, Number 143 (Monday, July 27, 1998)]
[Rules and Regulations]
[Pages 40010-40012]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20002]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 391 and 381
[Docket No. 98-030N]
Meat, Poultry, and Egg Products Labeling Review Process;
Elimination of Appointments With Label Courier/Expediting Firms
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice of procedural change; request for comments.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing a
procedural change for reviewing labeling submitted to the Labeling
Review Branch (LRB) of the Labeling and Compounds Review Division
(LCRD). The new procedure will eliminate routine, daily, time-set,
face-to-face appointments with label courier/expediting firms.
Elimination of the daily, face-to-face appointments will not change the
present system of labeling review and will not limit access to all LCRD
staff. The labeling review staff will continue to receive and approve
labels for meat, poultry, and egg products in a timely and orderly
manner. However, the procedural change will lead to a more effective
and efficient use of LRB staff time and enable staff to perform
labeling reviews and other duties concurrently.
DATES: The change in procedures for labeling review will be effective
September 10, 1998.
FOR FURTHER INFORMATION CONTACT: Mr. William J. Hudnall, Assistant
Deputy Administrator, Office of Policy, Planning and Evaluation;
telephone (202) 205-0495 or FAX (202) 401-1760.
SUPPLEMENTARY INFORMATION: FSIS has stated repeatedly its intent to
increase the proportional share of its resources that are devoted to
food safety. The Agency reorganization of 1996 reduced the number of
administrative support positions, eliminated several management levels,
improved supervisor-to-employee ratios, and restructured an expanded
front line inspection workforce to perform more effectively. The Agency
continues to seek ways to improve the efficiency with which it carries
out its consumer protection activities that are not related to food
safety. Therefore, FSIS is reviewing all operations in an effort to
achieve greater efficiency while improving the level of consumer
protection.
The Prior Label Approval System (PLAS) is conducted as part of the
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Agency's mandate to ensure that labeling for meat, poultry, and egg
products is truthful, not misleading, and in compliance with the
misbranding provisions of the Federal Meat Inspection Act, the Poultry
Products Inspection Act, the Egg Products Inspection Act, and
implementing regulations. FSIS streamlined the system in a final rule
issued on December 29, 1995, (60 FR 67444) that became effective July
1, 1996, by expanding the categories of products for which labeling can
be approved generically by industry. For example, the rule allows
Federal establishments to design and use labeling that conforms to the
regulatory requirements for meat, poultry, and egg products that have
standards of identity and composition defined in the regulations (9 CFR
319 and 381) or in the Food Standards and Labeling Policy Book. The
Agency also maintains a prior label approval system for reviewing and
approving sketches and temporary labeling for certain categories of
meat and poultry products that are not defined by standards of identity
and composition; products that are prepared using novel production
methods; products that are formulated with novel additives or
ingredients; or products whose labeling bears nutrition, health,
quality, or other types of claims.
The final rule on PLAS also indicated that the Agency would
implement a Generic Labeling Audit System (GLAS) to determine the
extent to which Federal establishments are applying labeling
regulations and policies in approving generic labeling, in compliance
with the regulations. The Agency is currently developing this audit
system. The prospective goals of PLAS include developing and
implementing GLAS simultaneously to conducting PLAS, and to devote more
time to devising a prior approval system that will be more consistent
with Hazard Analysis and Critical Control Point (HACCP) systems and the
labeling concepts of the future. The changes to PLAS and the
development of a generic labeling system are based on concepts that are
consistent with the Agency's effort to proportionally shift resources
to food safety and to afford processors flexibility in preparing and
modifying their labeling to fit their marketing needs.
Presently, labeling for meat, poultry, or egg products that
requires prior approval is submitted daily for review and approval to
the LCRD via regular mail; expedited mail and delivery services (such
as Federal Express); personal visits to the division by company and
trade representatives; and through the services provided by courier
firms/expediter services located in the Washington, DC area. Labeling
reviews for courier firms/expediter services are conducted during
routine, daily, time-set, face-to-face appointments with labeling
review staff during a 4-hour core time period each workday.
Representatives of courier firms/expediter services submit labeling
for meat, poultry, or egg products for processors who choose to use
their services. Each courier firm has a designated time period in a day
to have its labeling reviewed by members of the Labeling Review Branch.
During these time periods, courier firms could meet with up to four
FSIS staff members in 1-hour intervals. FSIS believes that operating in
this manner is no longer consistent with the efforts to better use
personnel resources. The following factors compel the need to alter the
current process:
An increase in the submission of labeling with complex
technical issues has occurred. Greater concentration and more time are
needed by the labeling review staff to evaluate labeling that reflects
new initiatives within the industry. The current process of reviewing,
approving, or rejecting labeling during daily, face-to-face labeling
reviews does not allow this time.
Greater time is needed to research labeling policy issues,
such as use of the novel additives not currently approved for use in
meat, poultry, or egg products; chemical analysis reviews; variations
in nutrition labeling claims; and labeling with animal production
claims. Such comprehensive reviews require interaction among the
division staff, and with other parts of the Agency, other Federal
Agencies, and experts outside FSIS. However, daily appointments with
courier firms have taken precedence over the other duties of the staff.
Therefore, the effective use of labeling review staff time is
restricted because half of the workday of the labeling review staff is
devoted to the structured allotment of time for courier service.
Maintaining a fixed, daily schedule of face-to-face
labeling reviews is no longer critical because the immediacy of the
need for an on-the-spot labeling approval provided by someone on the
labeling review staff has diminished. Before the December 1995 final
rule on PLAS took effect, the division was responsible for approving
essentially all labeling in both sketch and final form. However,
effective July 1, 1996, this requirement changed. Of the labeling that
must be submitted for prior approval now, only sketch labeling needs to
be submitted. The industry need not submit such labeling in final form.
This has shifted the issue of the timeliness of the approvals of final
labeling to meet industry's marketing needs to one controlled by
industry.
Given the diminished need for immediate, on-the-spot
approval of labeling by labeling review staff, continuing the existing
procedure is unfair to companies choosing to mail their labeling to the
division or have company employees deliver it for them for review in
person. Currently, labeling submitted by mail or submitted personally
by processors is not given time for review that is equal to that given
to labeling submitted by labeling courier firms/expediter services
during face-to-face reviews. It is necessary that staff time be more
equitably arranged to review labeling that is mailed to the branch or
division or delivered by processors themselves by individuals
representing meat, poultry, or egg processors. This can only be done by
eliminating face-to-face reviews.
The division will continue to review and approve labeling in a
timely and efficient manner and accommodate representatives of industry
and other representatives who wish to meet with staff members for
consultation on any issues relating to labeling, standards, or
ingredients. Labeling approvals will be handled on a first-come, first-
served basis, as they are delivered to the LCRD, including expedited
labeling, labeling mailed directly to the division, and labeling
delivered in person by representatives of the industry. As needed,
representatives of industry and other representatives will have the
opportunity to arrange appointments with division staff on a time-
available basis to discuss novel product and ingredient issues and
appeals, and to receive regulatory guidance. The LRB will continue, to
the extent possible, to accommodate emergency situations regarding
labeling approvals on a case-by-case basis. The Agency believes this
procedural change will result in a more productive use of LCRD staffing
resources, and most importantly, improve the quality of meat, poultry,
and egg products labeling.
It is the Agency's intent to implement the policy described in this
notice 45 days from the date it is published. However, the Agency is
interested in receiving substantive comments within 30 days of
publication on how it can better implement the procedural changes
contained in the notice.
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Done at Washington DC, on: July 14, 1998.
Thomas J. Billy,
Administrator.
[FR Doc. 98-20002 Filed 7-24-98; 8:45 am]
BILLING CODE 3410-DM-P