0186 ss final for OMB

United States Food and Drug Administration
Irradiation in the Production, Processing and Handling of Food
OMB Control No. 0910-0186
SUPPORTING STATEMENT Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports agency regulations. 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, us or
we) 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.).
The regulations impose recordkeeping requirements whereby records are subject to FDA
inspection. We therefore request approval for the information collection requirements in
21 CFR 179: Irradiation in the Production, Processing and Handling of Food.
2. Purpose and Use of the Information Collection
The recordkeeping required under 21 CFR 179 is 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. Respondents to the information collection 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. We estimate all (100%) records will be maintained
electronically.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. We are mandated under the FD&C
Act to fulfill this public health responsibility.
5. Impact on Small Businesses or Other Small Entities
We estimate ten percent (10%) of respondents are small businesses. A limited number of
firms process food using irradiation, however we do not believe the information collection
is unduly burdensome on small entities. We also believe the recordkeeping and labeling
requirements would ordinarily be kept by respondents (food processors) for their own use
as a good management practice. In addition, 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 the recordkeeping requirements found in 21
CFR Part 179. Finally, FDA aids small businesses in complying with our requirements
through our Regional Small Business Representatives and through our scientific and
administrative staffs. We also provide 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 are not met by the
respondents to the information collection, FDA is unable to verify that food has been
processed in accordance with applicable public health safety 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), FDA published a 60-day notice for public comment
in the Federal Register of January 26, 2018 (83 FR 3734). No comments were received.
9. Explanation of Any Payment or Gift to Respondents
FDA does not provide any payments or gifts to respondents.

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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
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

No. of
Recordkeepers

No. of
Records per
Recordkeeper

179.25(e),
large processors
179.25(e),
small processors
Total

4

300

4

30

1

Total
Annual
Records

Average
Burden per
Recordkeeping

Total
Hours

1,200

1

1,200

120

1

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).
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

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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 $39,864. Assuming 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 Washington- Baltimore in 2018, which is $15.10 per hour. Total annual
burden hours (1,320) multiplied by $15.10 per hour equals $19,932. To account for
overhead, this cost is increased by 100 percent, making the total estimated burden hour
cost to the respondents $39,864.
Activity
Records Retention

Total Burden
Hours
1,320

Hourly Wage Rate
Total Respondent
(including overhead)
Costs
$30.20
$39,864

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital Costs
There are no capital, start-up, operating, or maintenance costs associated with this
collection of information.
14. Annualized Cost to the Federal Government
FDA review of the retained records occurs as part of its routine inspection program. We
expend 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 $464.60 per review. In this calculation of cost, we estimate the hourly cost for review
and evaluation at a base GS-13, step 1 wage in the locality pay area of WashingtonBaltimore in 2018 of $46.46 per hour. Five hours multiplied by $46.46 per hour equals
$232.30. To account for overhead, this cost is increased by 100 percent, making the total
annualized cost to the Federal government $464.60 per review.
15. Explanation for Program Changes or Adjustments
We retain the currently approved burden for the information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
There are no plans to publish data from this information collection.

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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.

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