[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

[[Page 40011]]

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