SUPPORTING STATEMENT
RECORDKEEPING AND RECORDS
ACCESS REQUIREMENTS FOR FOOD FACILITIES
1. Circumstances
Making the Collection of Information Necessary
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) added section 414 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive, distribute, transport, or import food in the United States establish and maintain records identifying the immediate previous sources and immediate subsequent recipients of food. Sections 1.326 through 1.363 (21 CFR 1.326 through 1.363) of FDA's regulations set forth the requirements for recordkeeping and records access. The requirement to establish and maintain records improves FDA's ability to respond to, and further contain, threats of serious adverse health consequences or death to humans or animals from accidental or deliberate contamination of food.
We request the extension of OMB approval for the following collection of information requirements:
21 CFR 1.337 -- Recordkeeping
Requires respondents to establish and maintain records to identify the immediate previous sources of food.
21 CFR 1.345 -- Recordkeeping
Requires respondents to establish and maintain records to identify the immediate subsequent recipients of food.
21 CFR 1.352 -- Recordkeeping
Requires respondents to establish and maintain records for each food they transport in the United States.
2. Purpose
and Use of the Information Collection
Information
maintained under these regulations will help FDA to identify and
locate quickly food that might be affected by deliberate or
accidental contamination and to inform the appropriate individuals
and food facilities of specific terrorist threats. FDA's regulations
require that records for non-transporters include the name and full
contact information of sources, recipients, and transporters, an
adequate description of the food including the quantity and
packaging, and the receipt and shipping dates (§§ 1.337 and
1.345). Required records for transporters include the names of
consignor and consignee, points of origin and destination, date of
shipment, number of packages, description of freight, route of
movement and name of each carrier participating in the
transportation, and transfer points through which shipment moved (§
1.352). Existing records may be used if they contain all of the
required information and are retained for the required time period.
3. Use
of Improved Information Technology and Burden Reduction
The
regulation does not specifically prescribe the use of automated,
electronic, mechanical, or other technological techniques or other
forms of information technology as necessary for use by firms.
Companies may opt to use whatever forms of information technology may
best assist them in retaining the appropriate records and making them
available to regulatory officials.
4. Efforts
to Identify Duplication and Use of Similar Information
To the best of our knowledge, no other federal government agency is engaged in the collection of this information. There can be no duplicative collection of this information because the information maintained in fulfilling the statutory requirements for recordkeeping under section 414 of the act is unique to each firm and its customers and suppliers. Moreover, the regulation states that,
The regulations in this
subpart do not require duplication of existing records if those
records contain all of the information required by this subpart. If a
covered person keeps records of all of the information as required by
this subpart to comply with other Federal, State, or local
regulations, or for any other reason, then those records may be used
to meet these requirements. Moreover, persons do not have to keep all
of the information required by this rule in one set of records. If
they have records containing some of the required information, they
may keep those existing records and keep, either separately or in a
combined form, any new information required by this rule. There is no
obligation to create an entirely new record or compilation of records
containing both existing and new information, even if the records
containing some of the required information were not created at the
time the food was received or released. (21 CFR 1.330)
5. Impact
on Small Businesses or Other Small Entities
The recordkeeping requirements of these regulations are mandated by section 414 of the act and there is no statutory exception for small businesses. However, FDA staggered the dates by which very small, small, and large sized firms were required to comply with the rule. Very small firms were given 24 months to comply, small firms were given 18 months, while large firms were given 12 months In addition, FDA has Small Business Representatives who help small businesses whose products are regulated by FDA.
6. Consequences
of Collecting the Information Less Frequently
Pursuant to the act and the implementing regulations, a record is established for each transaction involving food at the time the transaction occurs. The information cannot be collected less frequently. If the collection is not conducted or is conducted less frequently, persons that manufacture, process, pack, hold, receive, distribute, transport, or import food in the United States would not be in compliance with section 414 of the act. If the required records are not maintained, FDA may not be able to identify and locate quickly food that might be affected by deliberate or accidental contamination or to inform the appropriate individuals and food facilities of specific terrorist threats.
7. Special Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
The recordkeeping regulations that are the basis for this collection of information generally do not require submission of information to FDA. FDA may inspect the records by invoking the access provisions of § 1.361, which require that FDA have “a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.” Thus, this collection of information does not involve more than quarterly submission of information to the agency, written responses to the agency in less than 30 days, submission of more than an original and 2 copies, retention of records for more than three years, the use of statistical methods, pledges of confidentiality by FDA not supported by authority established in statute or regulation, or require the disclosure of trade secrets or other confidential information. The collection fully complies with 5 CFR 1320.5(d)(2).
8. Comments
in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency
Description of Respondents: Persons that manufacture, process, pack, hold, receive, distribute, transport, or import food in the United States are required to establish and maintain records, including persons that engage in both interstate and intrastate commerce.
FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Recordkeeping Burden1 |
|||||
21 CFR Section |
No. of Record- keepers |
Annual Frequency per Record-keeping |
Total Annual Records |
Hours per Record |
Total Hours |
1.337, 1.345, and 1.352 (records maintenance) |
379,493 |
1 |
379,493 |
13.228 |
5,020,000 |
1.337, 1.345, and 1.352 (learning for new firms) |
18,975 |
1 |
18,975 |
4.790 |
90,890 |
Total |
5,110,890 |
||||
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
This estimate is based on FDA's estimate of the number of facilities affected by the final rule entitled “Establishment and Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002,” published in the Federal Register of December 9, 2004 (69 FR 71562 at 71630). With regard to records maintenance, FDA estimates that approximately 379,493 facilities will spend 13.228 hours collecting, recording, and checking for accuracy of the limited amount of additional information required by the regulations, for a total of 5,020,000 hours annually. In addition, FDA estimates that new firms entering the affected businesses will incur a burden from learning the regulatory requirements and understanding the records required for compliance. In this regard, the agency estimates the number of new firms entering the affected businesses to be five percent (5%) of 379,493, or 18,975 firms. Thus, FDA estimates that approximately 18,975 facilities will spend 4.790 hours learning about the recordkeeping and records access requirements, for a total of 90,890 hours annually. Therefore, the total annual recordkeeping burden is estimated to be 5,110,890 hours.
Estimated Annualized Cost for the Burden Hours
FDA estimates that the average hourly wage of the recordkeepers is $15 per hour. The overall estimated cost incurred is $76,663,350 (5,110,890 burden hours X $15/hr = $76,663,350).
13. Estimates
of Other Total Annual Cost Burden to Respondents and Record
Keepers
There
are no capital costs or operating and maintenance costs associated
with this collection of information.
14. Annualized
Cost to Federal
Government
There
are no annual costs to the Federal government associated with this
collection of
information.
15. Explanation
for Program Changes or Adjustments
The decrease of 248,110 burden hours is due primarily to a reduction in the estimated hours per record.
16. Plans for Tabulation and Publication and Project Time Schedule
The
information from this collection will not be published.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
There are no reasons why display of the expiration date for OMB approval of the information collection would be inappropriate.
18. Exceptions
to Certification for Paperwork Reduction Act Submissions
FDA has not identified any exceptions to the certification statement identified in Item 19 of the instructions for completing OMB Form 83-I.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | Jonna Capezzuto |
| File Modified | 2008-01-23 |
| File Created | 2008-01-23 |