[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]
BILLING CODE 4160-01-F