[Federal Register Volume 64, Number 237 (Friday, December 10, 1999)]
[Rules and Regulations]
[Pages 69190-69191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 94F-0455]


Irradiation in the Production, Processing, and Handling of Food

AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of X-radiation, 
produced by operation of X-ray tubes at energy levels of 500 kilovolt 
peak or lower, to inspect food. This action is in response to a 
petition filed by American Science and Engineering, Inc.

DATES: This regulation is effective December 10, 1999; written 
objections and request for a hearing by January 10, 2000.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Felicia Binion Williams, Center for 
Food Safety and Applied Nutrition (HFS-206), Food and Drug 
Administration, 200 C St. SW., Washington, DC 20204, 202-418-3122.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of January 13, 1995 (60 FR 3249), FDA announced that a food 
additive petition (FAP 5M4438) had been filed by American Science and 
Engineering, Inc., 829 Middlesex Turnpike, Billerica, MA 01821, 
formerly 40 Erie St., Cambridge, MA 02139-4286. The petitioner proposed 
that the food additive regulations in Sec. 179.21 Sources of radiation 
used for inspection of food, for inspection of packaged food, and for 
controlling food processing (21 CFR 179.21), be amended to provide for 
the safe use of X-radiation, produced by operation of X-ray tubes at 
energy levels of 500,000 electron volts (500 keV) or lower, to inspect 
cargo containers that may contain food. The current regulation limits 
the operation of X-ray tubes to energy levels of 300,000 electron volts 
(300 keV) peak or lower.
    FDA has evaluated the data and information in the petition and 
other relevant material, and notes that information in the petition 
establishes that an extension of the upper limit on the energy level is 
necessary in order to be able to inspect large cargo containers using 
X-ray tubes. The data and information available to the agency establish 
that the maximum absorbed dose expected as a result of the petitioned 
use of X-radiation is 50 micrograys. This level of absorption is well 
below 10 grays, a level established as safe, by prior agency reviews.
    The agency concludes that the proposed use of X-radiation, produced 
by operation of X-ray tubes at energy levels of 500 keV or lower, to 
inspect food, is safe and that the conditions listed in Sec. 179.21 
should be amended as set forth below. In addition, FDA is making a 
minor editorial change in the wording of the regulation to reflect the 
fact that operating voltage of the X-ray source should be described as 
a voltage, rather than an energy level. This change is more technically 
accurate and does not change the requirements of the current 
regulation.
    In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that FDA considered and relied upon in reaching its 
decision to approve the petition are available for inspection at the 
Center for Food Safety and Applied Nutrition by appointment with the 
information contact person listed above. As provided in Sec. 171.1(h), 
the agency will delete from the documents any materials that are not 
available for public disclosure before making the documents available 
for inspection.
    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.
    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    Any person who will be adversely affected by this regulation may at 
any time on or before January 10, 2000, file with the Dockets 
Management Branch (address above) written objections thereto. Each 
objection shall be separately numbered, and each numbered objection 
shall specify with particularity the provisions of the regulation to 
which objection is made and the grounds for the objection. Each 
numbered objection on which a hearing is requested shall specifically 
so state. Failure to request a hearing for any

[[Page 69191]]

particular objection shall constitute a waiver of the right to a 
hearing on that objection. Each numbered objection for which a hearing 
is requested shall include a detailed description and analysis of the 
specific factual information intended to be presented in support of the 
objection in the event that a hearing is held. Failure to include such 
a description and analysis for any particular objection shall 
constitute a waiver of the right to a hearing on the objection. Three 
copies of all documents shall be submitted and shall be identified with 
the docket number found in brackets in the heading of this document. 
Any objections received in response to the regulation may be seen in 
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

List of Subjects in 21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation 
protection, Reporting and recordkeeping requirements, Signs and 
symbols.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 179 is amended as follows:

PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF 
FOOD

    1. The authority citation for 21 CFR part 179 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.

    2. Section 179.21(a)(1) is revised to read as follows:


Sec. 179.21  Sources of radiation used for inspection of food, for 
inspection of packaged food, and for controlling food processing.

* * * * *
    (a) * * *
    (1) X-ray tubes producing X-radiation from operation of the tube 
source at a voltage of 500 kilovolt peak or lower.
* * * * *

    Dated: November 26, 1999.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 99-32001 Filed 12-9-99; 8:45 am]
BILLING CODE 4160-01-F