[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Rules and Regulations]
[Pages 34212-34215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14035]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. FDA-2007-F-0390] (Formerly 2007F-0115)


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 a carbon dioxide 
laser for etching information on the surface of fresh, intact citrus 
fruit. This action is in response to a petition filed by Durand-
Wayland, Inc.

DATES: This rule is effective June 11, 2012. Submit either electronic 
or written objections and requests for a hearing by July 11, 2012. See 
section VIII of this document for information on the filing of 
objections.

ADDRESSES: You may submit either electronic or written objections and 
requests for a hearing, identified by Docket No. FDA-2007-F-0390, by 
any of the following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2007-F-0390 for this rulemaking. All objections 
received will be posted without change to http://www.regulations.gov, 
including any personal information provided. For detailed instructions 
on submitting objections, see section VIII. Objections in the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
objections received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Celeste Johnston, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1282.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of April 11, 2007 (72 
FR 18263), FDA announced that a food additive petition (FAP 7M4768) had 
been filed by Durand-Wayland, Inc., c/o Hyman, Phelps & McNamara, P.C., 
700 13th St. NW., suite 1200, Washington, DC 20005-5929. The petition 
proposed that the food additive regulations in part 179 (21 CFR part 
179) be amended to provide for the safe use of a carbon dioxide laser 
for etching information on food, excluding meat and poultry. The 
intended technical effect of the carbon dioxide laser is to etch 
information, such as the price look-up code printed on an adhesive 
label placed on the surface of individual, fresh produce items sold at 
retail, directly onto the surface of food. The carbon dioxide laser 
therefore obviates the need for an adhesive label.
    In a letter dated April 27, 2007, Hyman, Phelps & McNamara, P.C., 
informed FDA that Sunkist Growers, Inc., 14130 Riverside Dr., Sherman 
Oaks, CA 91423-2313, had joined Durand-Wayland, Inc., as co-petitioner 
of FAP 7M4768. The letter explained that Hyman, Phelps & McNamara would 
represent both petitioners with regard to FAP 7M4768.
    Subsequent to the filing of the petition, the petitioners amended 
the petition by requesting a response to the proposed use of the carbon 
dioxide laser for etching information on the skin of fresh, intact 
citrus fruit not intended for commercial juice production, while the 
other requests in the petition remained

[[Page 34213]]

under review. The petitioners submitted a letter dated September 1, 
2011, requesting withdrawal of all remaining uses of the petition other 
than to etch information on the skin of fresh, intact citrus fruit not 
intended for commercial juice production. On December 29, 2011, the 
petitioners communicated to FDA that, generally, citrus fruit intended 
solely for commercial juice production would not be laser etched, and 
that laser-etched citrus fruit would generally be intended for sale in 
the fresh market. However, certain circumstances (e.g., a cancelled 
order, expired shelf-life) could arise that would preclude laser-etched 
citrus fruit from being sold into the fresh market. In such 
circumstances, laser-etched citrus fruit could be sold for commercial 
juice production. To allow for this possibility, the petitioners 
requested that the proposed use not be limited to fruit not intended 
for nor used in commercial juice production. The petitioners assert 
that this use should be allowed because they contend there is no 
material difference between etched and non-etched citrus fruit. This 
final rule is a complete response to the petition.

II. Evaluation of Safety

    A source of radiation used to treat food meets the definition of 
``food additive'' under section 201(s) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 321(s)). While a source of 
radiation such as a carbon dioxide laser is not added to the food 
literally, the source is used to treat food and can affect the 
characteristics of the food.
    Under section 409(c)(3)(A) of the FD&C 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 21 CFR 170.3(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.``
    To fairly evaluate the safety of the carbon dioxide laser used to 
etch information on the skin of fresh, intact citrus fruit, the Agency 
must identify the various effects that may result from etching the 
fruit and assess whether any of these effects pose a public health 
concern. In doing so, FDA has determined that the two primary areas of 
possible public health concern are the potential chemical effects and 
the potential microbiological risk from etching the food. Each of these 
areas is discussed in detail within this document.

III. Evaluation of the Safety of the Petitioned Use of a Carbon Dioxide 
Laser

A. Background on Carbon Dioxide Laser Etching System

    The low energy carbon dioxide laser that is the subject of this 
petition emits an infrared pulsed light with a wavelength of 10.6 
micrometers ([mu]m). The infrared energy produced by the carbon dioxide 
laser is non-ionizing and falls within the infrared energy spectrum 
that is commonly used for food processing, such as cooking, toasting, 
and grilling. The carbon dioxide laser beam is integrated with a dot-
matrix type printer head that etches information by removing the 
pigmented top layer from the surface of food and revealing a 
contrasting sublayer. The etching penetrates the food to an average 
depth of 50 [mu]m, which is about the first two to three epidermal cell 
layers of the food's surface.
    To limit the etching depth (i.e., how far the laser penetrates the 
fruit) and the total surface area of the fruit that is etched, the 
petitioners have specified the maximum energy per laser etched area to 
be 9.8 x 10-3 joules per square centimeter (J/cm\2\) and a 
maximum total surface area of fruit etched by the laser to be 0.122 
cm\2\. The petitioners have also proposed a limit on the total energy 
to which the citrus fruit is exposed from the use of the carbon dioxide 
laser to be 1.5 x 10-3 J. Studies that evaluated the 
chemical and microbiological effects of the carbon dioxide laser on 
fresh produce, which are discussed in section III.B and III.C of this 
document, were consistent with these limits. To ensure that the use of 
the carbon dioxide laser for etching information on citrus fruit is 
safe, FDA is specifying these limits as conditions of safe use in the 
resulting regulation.

B. Potential for Chemical Effects in Food

    One of the issues considered by FDA in evaluating the safety of a 
carbon dioxide laser used to etch information on the skin of fresh, 
intact citrus fruit is the potential formation of chemical products in 
the fruit generated by the laser etching process. To determine whether 
the use of a food additive is safe, FDA typically considers the 
chemical identity and amount of the additive that will be ingested 
compared to what is known regarding its toxicity. In the case of 
substances added directly to food, the Agency estimates the amount of 
the additive that will be ingested from the proposed use levels of the 
additive in particular foods and the consumption patterns of those 
foods. Information about the chemical structure of an additive, an 
assessment of the likely consumption of the additive, and information 
regarding the toxicity of the additive, forms the basis for evaluating 
its safety. Similarly, for the petitioned use of the carbon dioxide 
laser for etching the skin of fresh, intact citrus fruit, the Agency 
considered the potential exposure to new chemical substances that may 
be generated in the laser-etched fruit in evaluating its toxicological 
safety.
    To demonstrate the safety of the laser etching process, the 
petitioners provided a study that compared the chemical effects in 
tomatoes, potatoes, and apples exposed to the carbon dioxide laser 
etching system to those cooked with infrared heat. The study included 
chemical analyses that showed that use of the carbon dioxide laser to 
etch information on foods does not generate any new chemical substances 
that are not also typically generated by conventional cooking. Although 
this study was not conducted specifically on citrus fruit, the results 
are relevant for evaluating the potential chemical effects in fruits 
and vegetables exposed to laser etching in general, and therefore, 
support a determination that the proposed use of a laser to etch the 
skin of fresh, intact citrus fruit is safe.
    Furthermore, the dietary exposure to any substances generated in 
the citrus fruit by the laser etching process is expected to be 
negligible due to the insignificant amount of substances formed, the 
very small portion of the surface area of the citrus fruit that is 
etched (0.122 cm\2\), and the fact that the skin of citrus fruit is 
normally not consumed (Refs. 1 and 2). Based on this information, FDA 
concludes that any chemical effects generated by the laser etching 
process leading to the formation of products in the fruit are of no 
toxicological concern (Ref. 3).

C. Potential for Microbiological Risk in Food

    The petitioners submitted data from a controlled study that 
evaluated whether the petitioned use of the carbon dioxide laser for 
etching information on the skin of fresh, intact citrus fruit increased 
the microbiological risk from changes to the surface of laser-etched 
fruit compared to fruit that had not been laser etched. The study 
assessed the ability of Salmonella bacteria to infiltrate, survive, or 
grow on the surface of fresh Valencia oranges in the area that was 
etched by the carbon dioxide laser under the proposed conditions of 
use. Salmonella bacteria were inoculated on the surface of oranges 
under typical conditions of commercial storage of fresh oranges. The 
study utilized Salmonella because

[[Page 34214]]

it is a human pathogen commonly associated with fresh produce 
contamination. Valencia oranges were used in the study because they are 
a fresh citrus fruit and, compared to other types of citrus fruit, have 
a higher hydrogen-ion concentration (pH) that is more advantageous for 
Salmonella growth.
    According to the study's results, the recovery of viable Salmonella 
bacteria from the oranges after etching by the carbon dioxide laser and 
subsequent storage for 29 days was comparable to the recovery of 
Salmonella from control oranges that were not etched by the carbon 
dioxide laser. The amount of viable Salmonella bacteria decreased with 
storage time and followed a similar pattern of decline over the 
duration of storage under all treatment conditions. The study also 
evaluated the presence of viable Salmonella in the juice portion of 
inoculated and etched oranges. Salmonella was not detected in the juice 
portion of any sound, decay-free oranges that had been etched by the 
laser.
    FDA evaluated the results of the study and concluded that 
Salmonella bacteria present on orange surfaces prior to etching by the 
carbon dioxide laser, and that contaminate orange surfaces after laser 
etching, do not infiltrate, survive, or grow during subsequent storage 
to a level that presents a potential public health hazard significantly 
greater than the survival or growth of Salmonella bacteria on oranges 
that are not etched by the carbon dioxide laser (Ref. 4).
    As stated earlier, on December 29, 2011, the petitioners requested 
that the proposed use not be limited to citrus fruit not intended for 
nor used in commercial juice production because certain circumstances, 
such as a cancelled order or expired shelf-life, may arise that would 
preclude citrus fruit that is already laser etched from being sold in 
the fresh market, but such fruit could still be sold for commercial 
juice production. In these circumstances, the preferred alternative 
would be to use the laser-etched citrus fruit for commercial juice 
production. FDA concludes that no additional safety data or analysis is 
necessary because the evidence submitted by the petitioners has 
established that there is no material difference between etched and 
non-etched citrus fruit. Specifically, the Salmonella study results 
provided by the petitioners demonstrated the microbiological 
similarities between the untreated and laser-etched oranges, and the 
results from the same study showed no detection of Salmonella in the 
juice portion of laser-etched oranges. In addition, juice processors 
are required to comply with the Hazard Analysis and Critical Control 
Point regulation for juice (part 120 (21 CFR part 120)) (the juice 
HACCP regulation). Specifically, Sec.  120.24(a) (21 CFR 120.24(a)) 
requires juice processors to include in their HACCP plans control 
measures that will consistently produce, at a minimum, a 5-log 
reduction in the pertinent microorganism, which is the most resistant 
microorganism of public health significance that is likely to occur in 
the juice. Juice processors must achieve the 5-log reduction through 
treatments applied directly to the juice, except that citrus juice 
processors may use treatments applied to the surface of the fruit, 
provided that the 5-log reduction process begins after culling and 
cleaning as defined in Sec.  120.3(a) and (f), and the reduction is 
accomplished within a single production facility (Sec.  120.24(b)). FDA 
concludes that laser-etched citrus fruit, which has been otherwise 
cleaned and culled in accordance with the requirements of part 120, can 
be eligible to be used to make citrus juice where treatments applied 
only to the surface of the fruits are used to achieve the 5-log 
pathogen reduction control measure. In addition, Sec.  120.11(b) 
requires the juice processor to validate that the HACCP plan, including 
any processes used to achieve the 5-log pathogen reduction requirements 
of Sec.  120.24, is adequate to control food hazards that are 
reasonably likely to occur. If validation reveals that the HACCP plan 
is no longer adequate to achieve the 5-log pathogen reduction and 
otherwise meet the requirements of part 120, the juice processor must 
modify the HACCP plan immediately. Based on the data submitted by the 
petitioners demonstrating that there is no material difference between 
etched and non-etched citrus fruit, and the additional controls for the 
growth of pertinent microorganisms provided by the juice HACCP 
regulation, FDA has no safety concerns regarding the possible use of 
laser-etched citrus fruit for commercial juice production, and this use 
is not excluded from the scope of the final rule.

IV. Conclusion

    Based on the data and studies submitted in the petition and other 
relevant information in the Agency's files, FDA concludes that the 
proposed use of a carbon dioxide laser for etching information on the 
surface of fresh, intact citrus fruit is safe under the conditions 
proposed in this petition. Therefore, the food additive regulations 
should be amended as set forth in this document.

V. Public Disclosure

    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 (see FOR FURTHER INFORMATION CONTACT). 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.

VI. Environmental Impact

    The Agency has previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 7M4768 (72 FR 
18263). No new information or comments have been received that would 
affect the Agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.

VII. Paperwork Reduction Act of 1995

    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.

VIII. Objections

    Any person who will be adversely affected by this regulation may 
file with the Division of Dockets Management (see ADDRESSES) either 
electronic or written objections by (see DATES). 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. It is only necessary to send one set of 
documents. Identify documents 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 Division of Dockets Management

[[Page 34215]]

between 9 a.m. and 4 p.m., Monday through Friday.

IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    FDA's review of this petition was limited to section 409 of the 
FD&C Act. This final rule is not a statement regarding compliance with 
other sections of the FD&C Act. For example, the Food and Drug 
Administration Amendments Act of 2007, which was signed into law on 
September 27, 2007, amended the FD&C Act to, among other things, add 
section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)). Section 301(ll) of 
the FD&C Act prohibits the introduction or delivery for introduction 
into interstate commerce of any food that contains a drug approved 
under section 505 of the FD&C Act (21 U.S.C. 355), a biological product 
licensed under section 351 of the Public Health Service Act (42 U.S.C. 
262), or a drug or biological product for which substantial clinical 
investigations have been instituted and their existence has been made 
public, unless one of the exceptions in section 301(ll)(1) to (ll)(4) 
of the FD&C Act applies. In its review of this petition, FDA did not 
consider whether section 301(ll) of the FD&C Act or any of its 
exemptions apply to the laser-etching source. Accordingly, this final 
rule should not be construed to be a statement that a food that has 
been laser etched, if introduced or delivered for introduction into 
interstate commerce, would not violate section 301(ll) of the FD&C Act. 
Furthermore, this language is included in all food additive final rules 
and therefore should not be construed to be a statement of the 
likelihood that section 301(ll) of the FD&C Act applies.

X. References

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

1. Memorandum from Lee, Chemistry Review Group, Division of Petition 
Review, to Johnston, Regulatory Group II, Division of Petition 
Review, May 16, 2007.
2. Memorandum from Lee, Chemistry Review Group, Division of Petition 
Review, to Johnston, Regulatory Group II, Division of Petition 
Review, November 19, 2008.
3. Memorandum from Khan, Toxicology Team, Division of Petition 
Review, to Johnston, Regulatory Group II, Division of Petition 
Review, April 20, 2010.
4. Memorandum from Losikoff, Division of Seafood Safety, and 
Mahovic, Produce Safety Staff, to Johnston, Regulatory Group II, 
Division of Petition Review, August 15, 2011.

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, 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.


0
2. Section 179.43 is added to subpart B to read as follows:


Sec.  179.43  Carbon dioxide laser for etching food.

    Carbon dioxide laser light may be safely used for etching 
information on the surface of food under the following conditions:
    (a) The radiation source consists of a carbon dioxide laser 
designed to emit pulsed infrared radiation with a wavelength of 10.6 
micrometers such that the maximum energy output of the laser does not 
exceed 9.8 x 10-3 joules per square centimeter (J/cm\2\);
    (b) The carbon dioxide laser shall be used only for etching 
information on the skin of fresh, intact citrus fruit, providing the 
fruit has been adequately washed and waxed prior to laser etching, and 
the etched area is immediately rewaxed after treatment; and
    (c) The maximum total energy to which the etched citrus fruit is 
exposed from the use of the carbon dioxide laser shall not exceed 1.5 x 
10-3 J, and the maximum total etched surface area of the 
citrus fruit shall not exceed 0.122 cm\2\.

    Dated: June 5, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14035 Filed 6-8-12; 8:45 am]
BILLING CODE 4160-01-P