Meat, Poultry, and Egg Products Labeling Review Process; Elimination of Appointments With Label Courier/Expediting Firms

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