Irradiation in the Production, Processing and Handling of Food
SUPPORTING STATEMENT
1. Circumstances
Making the Collection of Information Necessary
Under
sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 321(s) and 348), food irradiation is
subject to regulation under the food additive premarket approval
provisions of the FD&C Act. The regulations providing for uses
of irradiation in the production, processing, and handling of food
are found in part 179 (21 CFR part 179). To ensure safe use of a
radiation source, § 179.21(b)(1) requires that the label of
sources bear appropriate and accurate information identifying the
source of radiation and the maximum (or minimum and maximum) energy
of radiation emitted by X-ray tube sources. Section 179.21(b)(2)
requires that the label or accompanying labeling bear adequate
directions for installation and use and a statement supplied by FDA
that indicates maximum dose of radiation allowed. Section 179.26(c)
requires that the label or accompanying labeling bear a logo and a
radiation disclosure statement. Section 179.25(e) requires that food
processors who treat food with radiation make and retain, for 1 year
past the expected shelf life of the products up to a maximum of 3
years, specified records relating to the irradiation process (e.g.,
the food treated, lot identification, scheduled process, etc.).
The Food and Drug Administration requests continued OMB approval for the information collection requirements contained in the following citations:
21 CFR 179.21(a)(5), 179.21(b)(1), 179.21(b)(2), and 179.26(c) – Third Party Disclosure
Requires labeling of a radiation source to ensure safe use.
21 CFR 179.25(e) - Recordkeeping
Requires maintenance of records in irradiation treatment of foods.
2. Purpose
and Use of the Information Collection
The
records required by § 179.25(e) are used by FDA inspectors to
assess compliance with the regulation that establishes limits within
which radiation may be safely used to treat food. The agency cannot
ensure safe use without a method to assess compliance with the dose
limits, and there are no practicable methods for analyzing most foods
to determine whether they have been treated with ionizing radiation
and are within the limitations set forth in part 179. Records
inspection is the only way to determine whether firms are complying
with the regulations for treatment of foods with ionizing radiation.
The labeling of a radiation source required by §§
179.21(b)(1), 179.21(b)(2), and 179.26(c) assists the agency in
ensuring safe use.
Description
of Respondents: The
respondents are businesses engaged in the irradiation of food.
Respondents are from the private sector (for-profit businesses).
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. Food processors are free to use whatever forms of information technology may best assist them in retaining the appropriate records and making them available to regulatory officials.
The agency estimates that close to one-hundred percent (100%) of the records will be maintained electronically in the next three years.
4. Efforts
to Identify Duplication and Use of Similar Information
There
is no duplication at the federal level because no other federal
agency requires food processors to retain these records or label
radiation sources.
5. Impact
on Small Businesses or Other Small Entities
FDA
estimates that ten percent (10%) of respondents are small businesses.
A limited number of firms process food using irradiation. The
recordkeeping and labeling requirements are no more burdensome for
small businesses than for large businesses, and such records would
ordinarily be kept by these food processors for their own use as a
matter of good management procedures. Consumer Safety Officers in
the Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition, at FDA are available by telephone to answer any
questions about recordkeeping requirements. FDA
aids small businesses in complying with its requirements through the
agency’s Regional Small Business Representatives and through
the scientific and administrative staffs within the agency. FDA has
provided a Small Business Guide on the agency’s website at
http://www.fda.gov/oc/industry/.
6. Consequences
of Collecting the Information Less Frequently
Data
collection occurs occasionally. If
the recordkeeping requirements were not met by the food processor,
FDA would, in most cases, be unable to verify that the food has been
processed in accordance with applicable regulations.
7. Special
Circumstances
Relating to the
Guidelines of 5 CFR 1320.5
None
of the requirements are inconsistent with 5 CFR 1320.5(d)(2). 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.
8. Comments
in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency
In
accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for
public comment in the Federal Register of May 17, 2012 (77 FR 29352).
The agency did not receive any responsive comments within the scope
of the four collection of information topics during the 60-day
response period.
12. Estimates of Annualized Burden Hours and Costs
Description of Respondents: The respondents are businesses engaged in the irradiation of food. Respondents are from the private sector (for-profit businesses).
12a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection of information as follows:
Table 1.--Estimated Annual Recordkeeping Burden1 |
|||||
21 CFR Section |
No. of Record-keepers |
No. of Records per Recordkeeper |
Total Annual Records |
Average Burden per Recordkeeping |
Total Hours |
179.25(e), large processors |
3 |
300 |
900 |
1 |
900 |
179.25(e), small processors |
4 |
30 |
120 |
1 |
120 |
Total |
|
|
|
|
1,020 |
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA
bases its estimate of burden for the recordkeeping provisions of §
179.25(e) on the agency’s experience regulating the safe use of
radiation as a direct food additive. The number of firms who process
food using irradiation is extremely limited. FDA estimates that
there are three irradiation plants whose business is devoted
primarily (i.e., approximately 100 percent) to irradiation of food
and other agricultural products. Four other firms also irradiate
small quantities of food. FDA estimates that this irradiation
accounts for no more than 10 percent of the business for each of
these firms. Therefore, the average estimated burden is based on:
(1) three facilities devoting 100 percent of their business to food
irradiation (3 x 300 hours = 900 hours for recordkeeping annually);
and (2) four facilities devoting 10 percent of their business to food
irradiation (4 x 30 hours = 120 hours for recordkeeping annually).
No burden has been estimated for the labeling requirements in §§ 179.21(b)(1) and (b)(2) and 179.26(c) because the information to be disclosed is information that has been supplied by FDA. Under 5 CFR 1320.3(c)(2), the public disclosure of information originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the public is not a collection of information.
12b. Annualized Cost Burden Estimate
The cost of the recordkeeping requirement to irradiation facilities is minimized because the recordkeeping requirement reflects customary business practice. FDA estimates that the cost for the retention and disclosure of records for food products under this regulation would equal approximately $28,294.80. Factoring in that this is customary business practice, FDA estimates that the average hourly wage for an employee to retain the records and make them available to regulatory officials would be equivalent to a GS-3/Step 3 level in the locality pay area of Washington-Baltimore in 2012, which is $13.87 per hour. Total annual burden hours (1,020) multiplied by $13.87 per hour equals $14,147.40. To account for overhead, this cost is increased by 100 percent, making the total estimated burden hour cost to the respondents $28,294.80.
13. Estimates
of Other Total Annual Cost Burden to Respondents and Record Keepers
There are no capital, start-up, operating, or maintenance costs associated with this collection.
14. Annualized
Cost to Federal
Government
FDA’s
review of the retained records would generally occur as part of its
routine establishment inspection activities. FDA would devote
approximately 5 hours per inspection to the inspection of records.
FDA estimates the annualized cost to the Federal Government for the
review of records retained by a firm to be $416.50 per review. In
this calculation of cost, FDA estimates the hourly cost for review
and evaluation at a base GS-13, step 1 salary of $42.66 per hour.
Five hours multiplied by $42.66 per hour equals $213.30. To account
for overhead, this cost is increased by 100 percent, making the total
annualized cost to the Federal Government $426.60 per review.
15. Explanation
for Program Changes or Adjustments
The
hour burden is unchanged.
16. Plans for Tabulation and Publication and Project Time Schedule
There
are no plans to publish data from this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
We
are not seeking approval to not display the expiration date for OMB
approval of the information collection.
18. Exceptions
to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
| File Type | application/msword |
| File Title | Supporting Statement for |
| Author | Joanna Capezzuto |
| Last Modified By | dhc |
| File Modified | 2012-07-18 |
| File Created | 2012-07-17 |