[Federal Register Volume 61, Number 159 (Thursday, August 15, 1996)]
[Rules and Regulations]
[Pages 42381-42383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20853]


-----------------------------------------------------------------------


DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 179

[Docket No. 94F-0125]


Irradiation in the Production, Processing, and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of a source of high 
intensity pulsed light to control microorganisms on the surface of 
food. This action is in response to a food additive petition filed by 
Foodco Corp. (now known as PurePulse Technologies, Inc.).

DATES: Effective August 15, 1996; written objections and requests for a 
hearing by September 16, 1996.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Patricia A. Hansen, -Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., -Washington, DC 20204, 202-418-3093.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    -In a notice published in the Federal Register of May 2, 1994 (59 
FR 22673), FDA announced that a food additive petition (FAP 4M4417) had 
been filed by Foodco Corp., 8888 Balboa Ave., San Diego, CA 92123, 
proposing that the food additive regulations be amended to provide for 
the safe use of a source of high intensity pulsed light to control 
microorganisms on the surface of food. (Since the publication of the 
notice of filing, Foodco Corp. has changed its

[[Page 42382]]

name to PurePulse Technologies Inc., (PurePulse).)

II. Evaluation of Safety

    Under the proposed conditions of use, foods would be exposed to 
broadband radiation (wavelengths covering the range 200 to 1,100 
nanometers (nm)) that is emitted as high intensity pulses (flashes) by 
xenon flashlamps. This wavelength range covers the entire ``visible'' 
region of the spectrum (that range of wavelengths that is capable of 
being perceived by the human eye), as well as limited portions of the 
ultraviolet (UV) and infrared (IR) regions. Use of the proposed sources 
of radiation results in exposure of the surfaces of treated foods to 
short pulses of high intensity light. The proposed pulsed light 
treatment does not involve the use of a source of ionizing radiation.
    -The proposed pulsed light treatment is intended to reduce the 
numbers of microorganisms (bacteria, yeasts, and molds) on the surfaces 
of treated foods. PurePulse did not propose restricting the types of 
foods that would be treated with pulsed light. The agency has evaluated 
the safety of the proposed pulsed light treatment assuming that all 
types of foods could potentially be treated with pulsed light, while 
recognizing that, in actual practice, not all types are likely to be so 
treated.
    -In assessing the safety of foods treated with radiation, including 
pulsed light, the agency considers changes in chemical composition of 
the food that may be induced by the proposed treatment, including any 
potential changes in nutrient levels. The agency also considers 
potential differences in the microbial populations found on treated 
versus untreated foods.
    PurePulse submitted data and information regarding the nature and 
extent of photochemical change expected to occur in foods treated with 
the proposed high intensity pulsed light treatment. PurePulse also 
submitted data regarding the nature and extent of the changes in 
microbial populations on the surfaces of a representative variety of 
foods treated with pulsed light under the proposed conditions of use.
    Having evaluated the data in the petition and other relevant 
material in its files, the agency finds that treated foods will not 
sustain significant reduction in nutrients and, thus, will retain their 
nutritional qualities (Ref. 1). FDA also finds that the types and 
amounts of photoproducts that might be produced and subsequently 
consumed, are not of any toxicological significance (Refs. 2 and 3).
    From a microbiological standpoint, the agency concludes that the 
proposed treatment is effective in reducing the numbers of 
microorganisms on the surface of treated foods and that treated foods 
will be at least as safe, from a microbiological standpoint, as 
untreated foods that are currently marketed (Refs. 4 and 5).

III. Conclusions

    -FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that the 
proposed use of a source of high intensity pulsed light is safe, that 
the additive will achieve its intended technical effect, and that 
therefore, the regulations in 21 CFR part 179 should be amended as set 
forth below.
    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.

IV. Environmental Impact

    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.

V. Objections

    Any person who will be adversely affected by this regulation may at 
any time on or before September 16, 1996, 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 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.

VI. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.

    1. Memorandum from S. Carberry, Chemistry Review Branch, to P. 
Hansen, Biotechnology Policy Branch, dated February 1, 1995.
    2. Memorandum from S. Carberry, Chemistry Review Branch, to P. 
Hansen, Biotechnology Policy Branch, dated May 17, 1994.
    3. Memorandum from A. Chang, Additives Evaluation Branch #1, to 
P. Hansen, Division of Product Policy, dated June 28, 1994.
    4. Memorandum from J. Madden, Strategic Manager for 
Microbiology, to P. Hansen and G. Pauli, Division of Product Policy, 
dated August 9, 1994.
    5. Memorandum from J. Madden, Strategic Manager for 
Microbiology, to P. Hansen, dated June 15, 1995.

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: Secs. 201, 402, 403, 409, 703, 704 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343, 348, 373, 
374).

    2. New Sec. 179.41 is added to subpart B to read as follows:


[[Page 42383]]




Sec. 179.41   Pulsed light for the treatment of food.

    Pulsed light may be safely used for treatment of foods under the 
following conditions:
    (a) The radiation sources consist of xenon flashlamps designed to 
emit broadband radiation consisting of wavelengths covering the range 
of 200 to 1,100 nanometers (nm), and operated so that the pulse 
duration is no longer than 2 milliseconds (msec);
    (b) The treatment is used for surface microorganism control;
    (c) Foods treated with pulsed light shall receive the minimum 
treatment reasonably required to accomplish the intended technical 
effect; and
    (d) The total cumulative treatment shall not exceed 12.0 Joules/
square centimeter (J/cm2.)

    Dated: July 30, 1996.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 96-20853 Filed 8-14-96; 8:45 am]
BILLING CODE 4160-01-F