**SUPPORTING STATEMENT**

**IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD**

**OMB Control No. 0910-0549**

**A. Justification**

1\. **Necessity for the Information Collection**

Under section 409(a) of the Federal Food, Drug, and Cosmetic Act (the
act), the use of a food additive is deemed unsafe unless it conforms to
the terms of a regulation prescribing its use, or to an exemption for
investigational use, or in the case of a food additive that is a food
contact substance, there is in effect a regulation prescribing the
conditions under which such additive may be safely used or a
notification that is effective. In response to a petition that is
submitted under section 409 of the act to establish that a food additive
is safe, the agency may either (1) by order establish a regulation
(whether or not in accord with that proposed by the petitioner)
prescribing, with respect to one or more proposed uses of the food
additive involved, the conditions under which such additive may be
safely used (including, but not limited to, specifications as to the
particular food or classes of food in or on which such additive may be
used, the maximum quantity which may be used or permitted to remain in
or on such food, the manner in which such additive may be added to or
used in or on such food, **and any directions or other labeling or
packaging requirements for such additive deemed necessary to assure the
safety of such use**), and shall notify the petitioner of such order and
the reasons for such action; or (2) by order deny the petition and
notify the petitioner of such order and of the reasons for such action.

In a notice published in the Federal Register of November 18, 1993 (58
FR 60860), FDA announced that a food additive petition (FAP 3M4399) had
been filed by Science Applications International Corp. The petition
proposed that the food additive regulations in §179.21 [Sources of
radiation used for inspection of food, for inspection of packaged food,
and for controlling food processing]{.underline} (21 CFR 179.21) be
amended to provide for the safe use of a source of fast (high energy)
neutrons to inspect cargo containers that may contain food. A source of
radiation used for the purpose of inspection of foods meets the
definition of a food additive under section 201(s) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s)). Under section
409(c)(3)(A) of the act (21 U.S.C. 348(c)(3)(A)), a food additive cannot
be approved for a particular use unless a fair evaluation of the data
available to FDA establishes that the additive is safe for that use.
FDA's food additive regulations in §173(i) (21 CFR 173(i)) define safe
as "a reasonable certainty in the minds of competent scientists that the
substance is not harmful under the intended conditions of use."

FDA concludes that to assure safe use of this source of radiation, the
amendment to 21 CFR 179.21 requires that the label of the neutron source
bear a statement of the minimum and maximum energy of neutrons emitted
by the neutron source. In addition, the label or accompanying labeling
shall bear adequate directions for safe use and a statement that no food
shall be exposed to a radiation source so as to receive a dose in excess
of 0.01 gray (Gy). The agency believes that these labeling requirement
do not impose an additional burden to the manufacturer(s) of the
equipment producing this source of radiation because such labeling would
ordinarily be provided by these manufacturers for the safe operation of
the equipment.

OMB granted emergency approval for this collection of information so
that implementation of the neutron inspection technology would not be
delayed upon publication of the final rule since the use of this
technology is in the interest of national security. The final rule in
response to FAP 3M4399 published on December 21, 2004 (69 FR 76401).
(See attachments - 21CFR 179.21 and link to the final rule
<http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-27868.pdf>.)

> The Food and Drug Administration requests an extension of OMB approval
> for the information collection requirements contained in the
> following:
>
> **21 CFR 179.21(a)(5), (b)(1)(iv), and (b)(2)(v), as amended -
> Disclosure to a third party**

These amendments to §179.21 require certain information on the labeling
of permitted neutron sources used for inspecting cargo containers that
may contain food.

2\. **Uses of the Information**

The information is used by the operator of the source of radiation in
the inspection of cargo containers that may contain food. The required
labeling provides the information necessary to enable the operator of
the equipment to use the equipment safely and in conformance with all
applicable FDA regulations.

3\. **Use of Improved Information Technology**

The regulations in 21 CFR 179.21 do 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 are
free to use whatever forms of information technology may best assist
them in developing the required information.

4\. **Efforts to Avoid Duplication and Unavailability of Similar
Information**

There is no duplication because of the clear Congressional authority
given to FDA with regard to promulgation of regulations pertaining to
food additives.

5\. **Methods to Minimize Burden on Small Businesses**

The information that is being required on the label is the minimum
information for complying with the provisions of the act. Furthermore,
the information that FDA requires to be included on the label or
accompany the label is information that is normally provided by
manufacturers of this type of equipment, including a small business, as
a normal course of doing business.

6\. **Consequences if Data Were Collected Less Frequently**

Failure of a firm to comply with the requirements for providing the
information on the labels or labeling of its neutron sources may result
in those products being adulterated under section 402 of the act.
Additionally, failure to comply with these requirements may result in
food becoming adulterated and the firm subject to enforcement action.

7\. **Special Circumstances**

> Not applicable

8\. **Outside Consultation**

On (insert date), FDA published a 60 day notice soliciting comments for
the collection of information (see attachment). No comments were
received.

**9. Payment or Gifts**

This information collection does not provide for payment or gifts to
respondents.

**10. Confidentiality**

Information that is trade secret or confidential is subject to FDA\'s
regulations on the release of

information, 21 CFR Part 20.

**11. Sensitive Questions**

> This information collection does not involve any questions of a
> sensitive nature.

**12. Respondent Hour Burden and Annualized Burden Hour Costs
Estimates**

 

Burden Hours.

 

FDA estimates the total annual burden for this collection will be
insignificant because the reporting requirement reflects customary
business practice.  FDA is aware of only one company that produces
inspection technology based on high energy neutron sources.  Based on
discussions with an industry representative, the burden hours estimated
for this collection of information are as follows:

(a) The total annual burden estimated for this collection is 1 hour.

+----------+---------+--------+--------+-------+------------+---------+
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| Table 1. |         |        |        |       |            |         |
| > \--    |         |        |        |       |            |         |
| > E      |         |        |        |       |            |         |
| stimated |         |        |        |       |            |         |
| > Annual |         |        |        |       |            |         |
| > R      |         |        |        |       |            |         |
| eporting |         |        |        |       |            |         |
| > B      |         |        |        |       |            |         |
| urden^1^ |         |        |        |       |            |         |
+----------+---------+--------+--------+-------+------------+---------+
| 21 CFR   | No. of  | Annual | Total  | Hours | Total      | Total   |
| Section  | Resp    | Fre    | Annual | per   | Operating  | Hours   |
|          | ondents | quency | Res    | Res   | and        |         |
|          |         | per    | ponses | ponse | M          |         |
|          |         | Re     |        |       | aintenance |         |
|          |         | sponse |        |       | Costs      |         |
+----------+---------+--------+--------+-------+------------+---------+
| 21 CFR   |  1      | 1      | 1      | 1     | \$100      | 1       |
| 179.2    |         |        |        |       |            |         |
| 1(a)(5), |         |        |        |       |            |         |
| (b)      |         |        |        |       |            |         |
| (1)(iv), |         |        |        |       |            |         |
| and      |         |        |        |       |            |         |
| (        |         |        |        |       |            |         |
| b)(2)(v) |         |        |        |       |            |         |
+----------+---------+--------+--------+-------+------------+---------+

> ^1^(Footnote) There are no capital costs associated with this
> collection of information.
>
>  

**13.  Annual Cost Burden to Respondent**

 

The operating and maintenance cost associated with this collection is
\$100 for preparation of labels.

>  

**14. Cost to the Federal Government**

> FDA has the authority to inspect firms who manufacture sources of
> radiation used for inspecting containers that may contain food as part
> of its routine establishment inspection activities, even in the
> absence of the labeling requirement in 21 CFR 179.21(a)(5),
> (b)(1)(iv), and (b)(2)(v). FDA would devote approximately \<1 hour per
> inspection to the inspection of labeling compliance. If FDA were to
> inspect the manufacturers of neutron sources once each year, FDA would
> spend less than one hour per year on this requirement resulting in
> essentially no cost to the government. In practice, FDA normally does
> not inspect manufacturers of this type of equipment because of limited
> resources and the low risk to public health.

15\. **Changes or Adjustments in Burden**

> There are no changes.

**16. Statistical Analysis, Publication Plans, and Schedule**

> Not applicable

**17. Approval Not to Display Expiration Dates**

There are no reasons why display of the expiration date for OMB approval
of the information collection would be inappropriate.

**18. Exception to Certification Statement**

No exceptions to the certification statement identified in Item 19 of
the instructions for completing OMB Form 83-I have been identified.

**B.** **Collections of Information Employing Statistical Methods**

There are no plans to publish the information collected under the
provisions of this regulation for statistical use. The collection of
information required under the provisions of this proposed regulation
does not employ statistical methods.