Daily Rules, Proposed Rules, and Notices of the Federal Government
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
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
HACCP principles are designed to reduce the occurrence of foodborne illness risk factors through preventive controls. FDA has developed two technical assistance reference manuals that interpret and promote the application of HACCP principles to reduce the risk of foodborne illness in the operation of retail and food service establishments.
The responsibility and authority for regulating retail and food service establishments lie primarily with State and local governments. Officials in State, local, territorial, and tribal agencies inspect these food facilities, license establishments, issue permits, and enforce their State or local government's laws and regulations. FDA's Retail Food Protection Program provides assistance to the more than 3,000 State and local government agencies that regulate the retail food industry nationally. The primary objective of the Retail Food Protection Program is to prevent foodborne illness at the retail level of the food industry by directing activities toward promotion of effective State and local regulatory programs. FDA provides assistance to State, local, territorial, and tribal regulatory jurisdictions through multiple means including, but not limited to, training and technical assistance. Authority for providing such assistance is derived from section 311 of the Public Health Service Act (42 U.S.C. 243). In addition, FDA's mission under section 903(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(2)(A)) includes ensuring that foods are safe, wholesome, and sanitary, and section 903(b)(4) of the FD&C Act directs FDA to cooperate with food retailers, among others, in carrying out this part of its mission.
The first manual, entitled “Managing Food Safety: A Manual for the Voluntary Use of HACCP Principles for Operators of Food Service and Retail Establishments” (Operator's Manual) (available at
The second manual, entitled “Managing Food Safety: A Regulator's Manual for Applying HACCP Principles to Risk-based Retail and Food Service Inspections and Evaluating Voluntary Food Safety Management Systems” (Regulator's Manual) (available at
FDA developed the manuals as technical assistance reference resources for regulators and operators to help reduce the risk of foodborne illness. There is no Federal requirement that retail and food service establishments implement food safety management systems based on HACCP principles. State, local, territorial, and tribal regulatory authorities decide whether to require food safety management systems in the operation of retail and food service establishments. Regulators and operators will not submit information to FDA based on these manuals.
Regulators and retail and food service operators use the manuals as technical assistance reference resources. The Regulator's Manual contains information, recommendations and model documents for State, local, territorial, and tribal regulators who wish to develop practices for risk-based inspections of retail and food service establishments based on the application of HACCP principles. The Operator's Manual contains information, recommendations and model documents for operators of retail and food service establishments who wish to develop and/or validate the practices used in a food safety management system based on HACCP principles.
FDA estimates the burden of this collection of information as follows:
The number of operator recordkeepers estimated in column 2 of Table 1 is based on FDA's goal to have 50,000 (
The number of regulator recordkeepers estimated in column 2 of Table 1 is based on FDA's estimate that there are approximately 3,000 State, local, territorial, and tribal regulatory jurisdictions. Gathering and reviewing reference material to develop practices for risk-based inspections of retail and food service establishments based on HACCP principles is a one-time burden. We assume that those 3,000 regulatory jurisdictions have utilized FDA's technical assistance manuals to the degree that they chose to do so over the past 3 years and over the next 3 years will only need to reference these manuals on an as-needed basis. FDA estimates that, annually, approximately one half of the regulatory jurisdictions (1,500) will choose to reference FDA's information, recommendations or model documents.
The hours per record estimated in column 2 of Table 1 are based on FDA's experience with similar technical assistance materials offered by the Agency. FDA estimates that over the next 3 years regulators and operators will only need to reference these manuals on an as needed basis. We estimate that it will take an operator with a specific need for information approximately 12 minutes (0.2 hour) to gather and record the data from the manuals. We estimate that it will take a regulator with a specific need for information approximately 15 minutes (0.25 hour) to gather and record the data from the manuals.
The total recordkeeping burden of the technical assistance manuals is 5,375 hours, as shown in Table 1.