[Federal Register Volume 64, Number 177 (Tuesday, September 14, 1999)]
[Notices]
[Pages 49812-49814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23811]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0572]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request; Collection of Letters of Interest and Food
Safety Data in a Voluntary Pilot Program Using HACCP Principles for
Retail Food Operations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by
October 14, 1999.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
Collection of Letters of Interest and Food Safety Data in a
Voluntary Pilot Program Using HACCP Principles for Retail Food
Operations
Section 402 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 342) enables FDA to regulate the safety of foods in
interstate commerce. In addition, under authority granted in the Public
Health Service Act (the PHS Act) (42 U.S.C. 241, 243, and 264), the
agency engages in a range of activities intended to ensure the safety
of the nation's food supply, from regulating food when it can be a
vector of disease to assisting, and cooperating with, the States to
ensure effective State and local food safety programs. FDA endeavors to
assist the more than 3,000 Federal, tribal, State, and local regulatory
agencies that have primary responsibility for monitoring retail food
establishments to ensure that consumers are protected.
FDA is proposing to collect information, through a voluntary pilot
program, on how hazard analysis critical control points (HACCP)
principles might be implemented in the retail food industry. The pilot
program is designed to provide insight into the problems, costs, and
benefits of developing and implementing HACCP principles for food
service, retail food stores, and other retail food establishments, in
order to improve and provide direct guidance to both the retail
industry and regulatory authorities for the implementation of HACCP
principles in the retail food sector. FDA will select candidates with a
goal of ensuring that the participants in the program cross the
spectrum of retail activities, have a range of scientific capabilities,
have facilities of varying sizes, and have a range of HACCP experience.
FDA has been approached by State and local governments to provide
guidance for applying HACCP principles at retail; therefore, the agency
intends to collect information through the pilot program to develop and
enhance guidance. The agency intends to make a summary of the results
of the retail pilot program publicly available.
The agency will request retail food establishments and regulatory
agencies interested in participating in the pilot program to send to
FDA a letter of interest. Letters from regulatory agencies need only
state an interest in participating. FDA requests that the letters of
interest from retail food establishments describe their menu, the
location and size of their facility, the type of techniques they use to
prepare their products, and the extent to which, and how, they employ
HACCP; identify area government officials with whom they have worked to
implement or reinforce the system; identify which State, local, and/or
tribal government officials they would like to work with in the pilot
program; and identify trade associations they would like to work with
in the pilot. FDA will review the letters of interest from retail
applicants and identify a limited number of individual establishments
that represent a broad spectrum of the retail food industry and that,
in the judgment of the agency, are best suited to participate in the
pilot program. The retail pilot participants will maintain a food
safety program based upon HACCP principles for the duration of the
pilot. FDA will study the information and data the pilot participants
use to maintain their food safety programs.
In the Federal Register of July 30, 1998 (63 FR 40716), the agency
requested comments on the proposed collection of information. The
agency received one comment from a trade association that represents
one segment of the retail food industry. The comment recommended that
FDA not pursue the pilot program as currently planned. Instead, the
comments suggested that the agency solicit industry and academic input
into the development of a ``new, more inclusive'' HACCP pilot program.
The comment's recommendation was based on several concerns.
[[Page 49813]]
First, the comment expressed concern that a mandatory information
collection regulation may mark the end of cooperative industry
development of HACCP programs.
The voluntary retail HACCP pilot program is neither mandatory, nor
is it a regulation. The purpose of the pilot program is to enhance
understanding and implementation of HACCP principles through
cooperation among industry, FDA, and participating State and local
regulatory authorities. Any participant may leave the program at any
time. The agency hopes that the pilot will promote rather than curtail
the cooperative efforts toward building HACCP into retail. The agency
agrees with the statement in the comment that ``There are many problems
to overcome before HACCP can be fully implemented in the retail
industry and clearly cooperation and inclusion will provide the answers
to those problems.'' This is exactly why industry is being invited to
participate; the agency recognizes that industry involvement is
critical to furthering a cooperative relationship.
Second, the comment expressed concern about the disclosure of
proprietary information and cautioned that access to voluntary HACCP
plans, including records and customer complaints, must be restricted.
The comment also stressed that the records must remain the property of
the establishment.
The information collected at individual establishments will be held
as proprietary, and contracts are to be signed by all parties involved
limiting the use of the proprietary information. The agency intends to
review the systems implemented by the retail establishment, including
records, in order to document how the system works, but the records
will remain the property of the establishment. After the pilot, the
data collected at individual establishments will be generalized, and a
collective retail HACCP pilot report will be publicly disseminated. The
names and locations of the participating firms will be held as
proprietary unless authorized for release by the participant.
Third, the comment raised several issues relating to consultation,
participation, and fairness. The comment expressed concern that FDA is
duplicating efforts by the restaurant industry and asserted that FDA
has not consulted with developers of existing HACCP programs or
evaluated these ongoing programs. The comment also charged that FDA
intends to exclude universities and trade associations from direct
participation in the pilot to prevent them from having input into any
final recommendations resulting from the pilot. More generally, the
comment expressed the view that FDA lacks the knowledge and detachment
to select participants in the pilot on an objective basis.
The agency believes these concerns are unfounded. FDA intends to
build on retail industry efforts through the retail HACCP pilot program
by studying ongoing HACCP systems and documenting activities used by
the retail industry to fully implement a HACCP system. During the
design of the program, industry representatives shared their views on
how an effective pilot program should proceed and provided feedback and
guidance on this effort of collecting information. This information was
used in designing the retail HACCP pilot program.
With regard to selection of participants, the design and intent of
the pilot is inclusive, not exclusionary. The pilot seeks to include
establishments that represent a broad spectrum of retail activities,
geographic locations, sizes, and levels of experience with HACCP. Since
each participant has the right, within the limits of the law, to
control access to its proprietary information, each participant has the
right to invite entities such as State, local, and tribal regulatory
agencies, universities, and trade associations to work with it during
the pilot, and it also has the right not to work with any such entities
(although participants will, of course continue to be subject to
applicable food safety laws and regulations in all jurisdictions during
the pilot).
FDA will involve the pilot participants in the summary of results
and formation of conclusions at the end of the pilot program, and will
make the summary report publicly available. The pilot is designed to
encourage voluntary evolution of retail HACCP plans with the
involvement of all stakeholders: Government, industry, academia, and
trade associations.
Fourth, the comment expressed doubts about the need for the pilot
program. The comment stated that the retail food industry has used
HACCP for many years with great success. According to the comment, FDA
should remain only an evaluator of the success of HACCP programs, and
should not attempt to institute or mandate such programs.
FDA disagrees with the comment. The PHS Act provides that the
agency shall assist States and political subdivisions in the prevention
and suppression of communicable diseases, and with respect to other
public health matters, shall cooperate with and aid State and local
authorities in the enforcement of their health regulations, and shall
advise the States on matters relating to the preservation and
improvement of the public health. FDA is also entrusted with regulating
food safety under the act. Therefore, the agency is responsible for
carrying out these functions and intends to do so. The retail HACCP
pilot program is one of many elements necessary to enable FDA to
perform these statutory responsibilities.
Fifth, the comment expressed concern about the recordkeeping
burdens that the retail HACCP pilot program would create for
participants. The comment asserted that massive recordkeeping paperwork
for the hundreds of items on restaurant menus would be required. The
comment expressed hope that the pilot does not move to apply a single,
``one-size-fits-all'' FDA recordkeeping system.
The agency is seeking information through the pilot program on the
amount and extent of recordkeeping that retail establishments have
determined necessary to effectively implement and manage their HACCP
systems. To be part of the voluntary pilot, the only recordkeeping
requirement is a letter to FDA expressing interest to participate in
the pilot program. The agency will not determine the amount or type of
records needed during the pilot; rather, each industry participant will
determine the amount and type of records it needs to effectively verify
that its system is working. Thus, the pilot program will not create an
undue burden and will not impose a single recordkeeping system on all
establishments.
The comment also expressed the belief that FDA's burden estimate
did not account for all the time that would be required by the smallest
participants in this program to learn about and institute a HACCP
program. The comment further stated that FDA has not shown a
willingness to encourage or assist vital small restaurant operator
participation in this pilot.
The agency will select candidates with a goal of ensuring that the
participants in the program cross the spectrum of retail activities,
have a range of scientific capabilities, have facilities of varying
sizes, and have a range of HACCP experience. The pilot program will
encompass the challenges unique to the retail environment, such as
multiple menu items, size of the facility, and employee turnover. The
agency intends to work with establishments with preexisting HACCP
programs and those establishments intending to start designing their
HACCP systems. The agency is seeking information that will document the
costs and time necessary for developing and implementing a HACCP
system.
[[Page 49814]]
FDA will also provide guidance and counseling upon request to those
participating establishments that are in the process of developing
HACCP systems, although the agency will not write HACCP plans.
Finally, the comment expressed concern that agencies could make use
of prior establishment records as the basis for enforcement action.
In order to deal with this concern, the agency intends to provide
clear direction to the pilot site teams to separate HACCP activities,
such as the establishment's performance of corrective action, from
system failures when risk factors are uncontrolled and enforcement
action may be necessary. FDA has initiated and intends to further train
the pilot site teams on how to evaluate a HACCP system and identify
items that are important. The establishment has the primary
responsibility to ensure the food is safe by fully implementing its
HACCP system, and the pilot site teams will evaluate the effectiveness
of that program.
FDA estimates the burdens of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden \1\
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Annual
Activity No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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Letters of interest from State/ 50 1 50 1 50
local/tribal authorities \2\
Letters from interested retail 50 1 50 1 50
firms \2\
Total 100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One time activity.
Table 2.--Estimated Annual Recordkeeping Burden \1\
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Annual
Activity No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Record
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Plan development 40 1 40 100 4,000
Plan implementation documents 40 7,000 280,000 .05 14,000
Implementation review 40 4 160 4 640
Total 18,640
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
These estimates are based on FDA's experience with other pilot
programs and on comments received through the Conference for Food
Protection, public meetings, and through retail industry advice. This
information was utilized to design the pilot program with the least
amount of burden to the retail industry.
Because only one letter of interest need be submitted per
prospective participant in the pilot, submitting the letter will create
only a minimal one time burden. Once the pilot program begins, FDA
estimates that the burden of collecting and maintaining food safety
information based upon HACCP principles will vary considerably across
the wide spectrum of retail activities and establishments, the types,
and numbers of products involved, and the nature of the equipment or
instruments required by the retail establishment for monitoring. The
recordkeeping burden to each retail participant would involve
maintaining a food safety plan based upon HACCP principles, generating
the necessary records to implement that plan, and checking the records
to verify implementation. Those participants who do not already have a
HACCP plan in place would also have to develop such a plan.
Since the publication of the July 1998 Federal Register notice
seeking comment on the pilot program, FDA has learned from
conversations with potential participants that approximately 20 percent
of these potential participants are already using HACCP plans in the
normal course of their business activities. The PRA regulations (5 CFR
1320.3(b)(2)) provide that the time, effort, and financial resources
that would be incurred by persons in the normal course of usual and
customary activities are excluded from the burden of a collection of
information. Therefore, the agency has revised its estimates to reflect
the fact that the pilot program would impose no additional
recordkeeping burden on the establishments that are already using
HACCP.
Dated: September 8, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-23811 Filed 9-13-99; 8:45 am]
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