0186 SS Part A 2015

Irradiation in the Production, Processing and Handling of Food
OMB Control No. 0910-0186
SUPPORTING STATEMENT
A. Justification
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 by the Food and Drug
Administration (FDA) under the food additive premarket approval provisions. 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 us 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.).
We request OMB approval for the following information collection requirements:
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 our inspectors to assess compliance with the
regulation that establishes limits within which radiation may be safely used to treat food. We
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.

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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.
We estimate 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
We estimate 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. We aid small businesses in complying with our requirements through our Regional
Small Business Representatives and through our scientific and administrative staffs. We have
provided a Small Business Guide on our 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, we 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 us 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), we published a 60-day notice for public comment in the
Federal Register of March 31, 2015 (80 FR 17055). One comment was received but did not
respond to any of the four information collection topics solicited and is therefore not addressed by
the agency.
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9. Explanation of Any Payment or Gift to Respondents
We do not provide any payments or gifts to respondents.
10. Assurance of Confidentiality Provided to Respondents
Confidential commercial information is protected from disclosure under the Freedom of
Information Act (FOIA) under sections 552(a) and (b) (5 U.S.C. 552(a) and (b)), and by part 20 of
our regulations (21 CFR part 20). To the extent 21 CFR 20.64 applies, we will honor the
confidentiality of any data in investigation records compiled for law enforcement purposes.
11. Justification for Sensitive Questions
This information collection does not involve any questions that are of a personally sensitive nature.
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
We estimate the burden of this collection of information as follows:
Table 1.--Estimated Annual Recordkeeping Burden1
21 CFR
Section
179.25(e),
large
processors
179.25(e),
small
processors
Total
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No. of
Recordkeepers

No. of Records per
Recordkeeper
300

Total
Annual
Records
1,200

Average Burden
per
Recordkeeping
1

4

4

30

120

1

Total
Hours
1,200

120

1,320

There are no capital costs or operating and maintenance costs associated with this collection of information.

We base our estimate of burden for the recordkeeping provisions of § 179.25(e) on our experience
regulating the safe use of radiation as a direct food additive. The number of firms who process food
using irradiation is extremely limited. We estimate that there are four 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. We estimate 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) four facilities devoting 100 percent of their business
to food irradiation (4 x 300 hours = 1,200 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).
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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 subject to review by
the Office of Management and Budget under the Paperwork Reduction Act.
12b. Annualized Cost Burden Estimate
The cost of the recordkeeping requirement to irradiation facilities is minimized because the
recordkeeping requirement reflects customary business practice. We estimate that the cost for the
retention and disclosure of records for food products under this regulation would equal
approximately $37,356. Factoring in that this is customary business practice, we estimate 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 WashingtonBaltimore in 2015, which is $14.15 per hour. Total annual burden hours (1,320) multiplied by
$14.15 per hour equals $18,678. To account for overhead, this cost is increased by 100 percent,
making the total estimated burden hour cost to the respondents $37,356.
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
Our review of the retained records would generally occur as part of our routine establishment
inspection activities. We would devote approximately 5 hours per inspection to the inspection of
records. We estimate the annualized cost to the Federal government for the review of records
retained by a firm to be $435.20 per review. In this calculation of cost, we estimate the hourly cost
for review and evaluation at a base GS-13, step 1 salary of $43.52 per hour. Five hours multiplied
by $43.52 per hour equals $217.60. To account for overhead, this cost is increased by 100 percent,
making the total annualized cost to the Federal government $435.20 per review.
15. Explanation for Program Changes or Adjustments
This is an approval request in which the annual number of recordkeepers in IC#1 increased. The
annual number of recordkeepers increased from 3 to 4 with a corresponding increase in annual
hours from 900 to 1,200 (an increase of 300). We attribute the increase to industry growth and are
characterizing the increase as an adjustment.
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.

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18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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