[Federal Register: September 14, 2005 (Volume 70, Number 177)]
[Page 54390-54391]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0349]

Agency Information Collection Activities: Proposed Collection; 
Comment Request; Food and Drug Administration Survey of Current 
Manufacturing Practices in the Food Industry

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish a notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on a proposed survey of current manufacturing 
practices in the food industry. The purpose of the proposed survey is 
to improve FDA's understanding of current food industry manufacturing 
practices. The information will be used to assess what impact, if any, 
new manufacturing requirements would make on the food industry.

DATES: Submit written or electronic comments on the collection of 
information by November 14, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

FDA Survey of Current Manufacturing Practices in the Food Industry

    The authority for FDA to collect the information derives from the 
FDA Commissioner's authority, as specified in section 903(d)(2) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)).
    FDA's regulations in part 110 of Title 21 of the Code of Federal 
Regulations (21 CFR part 110) describe the methods, equipment, 
facilities and controls for producing processed food, hereafter 
referred to as food CGMPs. As the minimum sanitary and processing 
requirements for producing safe and wholesome food, CGMPs are an 
important part of regulatory control of the nation's food supply. FDA 
believes that it is necessary to revisit and modernize the food CGMPs. 
Since the food CGMPs were last revised in 1986, there have been 
significant changes in food production technology and important 
advances in the understanding of foodborne illnesses. Accordingly, the 
agency will rigorously assess the impacts of any modernization policies 
on food facilities. To assess the impacts of the modernization policy, 
information is needed to help understand baseline or current industry 
practice. At present, however, FDA lacks baseline information on the 
nature of current manufacturing practices that would serve as part of a 
regulatory impact analysis.
    FDA plans to conduct an Internet survey of all domestic FDA-
registered facilities that primarily manufacture or process food and 
all foreign FDA-registered facilities that primarily manufacture or 
process food, which are located in those countries that are the largest 
food exporters to the United States: Japan, Canada, China, France, 
Italy and Mexico. The Internet survey will be supplemented by extended 
case study interviews with selected respondents from the survey. The 
survey and extended case studies will solicit detailed information 
about six key topics relevant to the food CGMPs modernization effort: 
employee training, sanitation and personal hygiene, allergen controls, 
process controls, post-production processing, and recordkeeping. 
Additionally, FDA will collect information on establishment 
characteristics, such as facility size and industry, which are expected 
to correlate with the presence or absence of various manufacturing 
practices, such as electronic recordkeeping, ongoing employee training 
in food safety, and product-to-label conformance procedures. The case 
study interviews will provide qualitative, in-depth information about 
various factors that influence decisions to implement these types of 
manufacturing practices, as well as about the circumstances that 
underlie the cost and effectiveness of such programs. The survey will 
be sent to every FDA-registered facility in the United States, Japan, 
Canada, China, France, Italy and Mexico that primarily manufactures or 
processes food products and that included an e-mail address with their 
registration. Participation will be voluntary and the respondent 
identifiers that would permit an association of specific responses to 
specific respondents will not be accessible to FDA.
    The proposed Internet survey will collect the information from 
respondents electronically. With a custom-designed online survey 
system, responses will be entered directly into a computer database, 
eliminating the need for additional coding and data entry operations. 
Also, the system will ensure that conditional questions are asked in 
proper order, freeing the

[[Page 54391]]

respondent from the need to keep track of the question order and skip 
patterns. The data quality will also be higher because the instrument 
will contain built-in edits, prompts, and data validation features.
    The Internet survey method was selected due to the following 
considerations: (1) E-mail addresses of the respondents are available 
from the FDA Food Facility Registration database and are continuously 
validated by FDA; (2) the Internet survey method is the least costly to 
the agency when compared with other modes of collection and generates 
the timeliest responses; (3) the Internet survey will impose a 
relatively modest reporting burden on small entities; and (4) the 
Internet survey method is the only feasible method by which FDA may 
survey foreign facilities that export food products to the United 
    The Internet survey includes a pledge of confidentiality regarding 
the contractor's use of the data provided by the respondents. All data 
will be collected and compiled by Eastern Research Group, Inc. (ERG), 
an independent consulting firm contracted by FDA. ERG will provide FDA 
personnel with data compiled in the course of the study. In keeping 
with longstanding FDA practice, however, ERG will not provide FDA with 
identifiers that would permit the association of specific responses 
with a given respondent. Under its contract with FDA, ERG is precluded 
from releasing to the public any study data or findings without FDA's 
prior approval.
    The key information to be collected includes responses to questions 
about the following: (1) Training procedures and practices for food 
production managers, production supervisors, quality control personnel, 
sanitation and cleaning supervisors and production line employees on 
the topics of food safety, basic cleaning, sanitizing, sanitation, 
personal hygiene, specific product and equipment training and allergen 
control; (2) pest control and sanitation procedures and practices for 
food contact surfaces, non-food contact surfaces, production areas and 
warehouses; (3) allergen control procedures and practices for soybean 
or soybean-based ingredients, peanuts or peanut-based ingredients, 
finfish and crustacea, tree nuts, milk and other diary products, eggs, 
and wheat or wheat-based products; (4) process controls, including 
written procedures for handling incoming raw materials, approving 
vendors, the calibration of operating equipment, pathogen control, and 
a Hazard Analysis and Critical Control Point system; (5) recordkeeping 
practices; (6) the primary operation characteristics conducted at the 
facility, such as the type of food manufactured or processed for human 
consumption; and (7) fresh produce and ready to eat packing practice 
and post harvest operations.
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                 Annual Frequency      Total Annual
                 Activity                   No. of Respondents     per Response          Responses        Hours per Response           Total Hours
Domestic Facilities
Screener                                               10,241                   1              10,241              .67                              683
Completed Survey                                       15,361                   1              15,361              .75                           11,520
Total Domestic Facilties                    ..................  ..................  ..................  ......................                   36,355
Foreign Facilities
Screener                                               17,565                   1              17,565              .67                            1,171
Completed Survey                                       17,565                   1              17,565              .75                           13,174
Total Foreign Facilities                    ..................  ..................  ..................  ......................                   14,345
Total                                       ..................  ..................  ..................  ......................                   50,700
\1\There are no capital costs or maintenance and operating costs associated with this collection of information.

    These estimates are based on FDA's registration database and FDA 
and the contractor's experience with previous surveys. The respondents 
are divided into two groups: domestic and foreign. We estimate the 
number of domestic facilities at 45,747 based on information in the 
registration database. However, we do not expect that all of these 
firms will participate in the survey. It is possible that the database 
will contain wrong e-mail addresses or out-of-business facilities, 
which we estimate will reduce the number of respondents by 20 percent, 
or 9,149. We estimate that an additional 22 percent, or 10,972, will 
simply not respond to the survey. Therefore, the number of domestic 
facilities expected to participate in the survey is 25,602. Among the 
54,806 foreign facilities in the registration database, 4,620 are 
expected to be out of business or have wrong e-mail addresses (or about 
8 percent), and 15, 056 (or about 27 percent) are not expected to 
respond at all. Therefore, it is expected that 35,130 foreign 
facilities will respond.
    Prior to the administration of the survey, the agency plans to 
conduct a pretest of the final survey to identify and resolve potential 
problems. The pretest will be conducted with nine participants.

    Dated: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18164 Filed 9-13-05; 8:45 am]