[Federal Register Volume 66, Number 45 (Wednesday, March 7, 2001)]
[Rules and Regulations]
[Pages 13652-13653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5511]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 00F-0812]


Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Dimethyl Dicarbonate

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 a more descriptive term, in place 
of ``inhibitor of yeast,'' for the safe use of dimethyl dicarbonate 
(DMDC). The more descriptive term is ``microbial control agent.'' This 
document also involves adding related limitations to our regulations on 
dimethyl dicarbonate. This action is in response to a petition filed by 
Bayer Co.

DATES: This rule is effective March 7, 2001. Submit written objections 
and requests for a hearing by April 6, 2001.

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: Martha D. Peiperl, Center for Food 
Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3077.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of March 7, 2000 (65 
FR 12014), FDA announced that a food additive petition (FAP 0A4718) had 
been filed by Bayer Co., c/o McKenna & Cuneo LLP, 1900 K St. NW., 
Washington, DC 20006-1108. The petition proposed to amend the food 
additive regulations in Sec. 172.133 Dimethyl dicarbonate (21 CFR 
172.133) both to provide for the safe use of DMDC in noncarbonated 
juice beverages containing up to and including 100 percent juice and to 
provide for a more descriptive term in place of ``inhibitor of yeast,'' 
for the safe use of DMDC.
    In a notice published in the Federal Register of September 27, 2000 
(65 FR 58091), FDA announced that it was amending the filing notice of 
March 7, 2000, to clarify that the proposed amendment to provide for a 
more descriptive term in place of ``inhibitor of yeast,'' for the safe 
use of DMDC will also involve adding related limitations to 
Sec. 172.133. In the September 27, 2000, notice, FDA also announced 
that the petitioner's additional request, to amend the food additive 
regulations to provide for the safe use of DMDC in noncarbonated juice 
beverages containing up to and including 100 percent juice, was 
converted to a food-contact substance notice (FCN 0035) (21 U.S.C. 
348(h)(5)). Subsequently, this request was withdrawn from the petition 
as of the effective date of FCN 0035 (June 9, 2000).
    DMDC is currently listed in Sec. 172.133 for use as a yeast 
inhibitor in wine, dealcoholized wine, and low alcohol wine (53 FR 
41325, October 21, 1988; and 58 FR 6088, January 26, 1993); in ready-
to-drink teas (59 FR 5317, February 4, 1994); in carbonated or 
noncarbonated, nonjuice-containing flavored or unflavored beverages 
containing added electrolytes (61 FR 26786, May 29, 1996); and in 
carbonated, dilute beverages containing juice, fruit flavor, or both, 
with juice content not to exceed 50 percent (61 FR 26786, May 29, 
1996). In addition, there is an effective notification for the use of 
DMDC as a microbial control agent in noncarbonated juice beverages 
containing up to and including 100 percent juice (FCN 0035, June 9, 
2000).

II. Evaluation of Safety

    DMDC is used in the beverage industry for supplemental microbial 
control in beverages during the final stages of filling. It is added to 
beverages, whose viable microorganism load was previously reduced by 
other technologies, immediately prior to bottling, canning, or other 
forms of final packaging. To ensure its safe use, the agency set the 
maximum amount of DMDC that may be added to food at 250 parts per 
million (ppm). DMDC is currently approved under Sec. 172.133(b)(1) and 
(b)(2) as an inhibitor of yeast in various beverages under normal 
circumstances of bottling or canning where the viable yeast count has 
been reduced to 500 per milliliter (mL) or less by current good 
manufacturing practices. DMDC is also approved under Sec. 172.133(b)(3) 
and (b)(4) as an inhibitor of yeast in additional beverages. During its 
review of the subject petition, FDA found that restrictions given in 
paragraphs (b)(1) and (b)(2) were inadvertently omitted from paragraphs 
(b)(3) and (b)(4).
    Bayer Co. petitioned the agency to change the term ``inhibitor of 
yeast'' to ``microbial control agent'' to better describe the actual 
functional effect of DMDC (at levels up to 250 ppm) in beverages during 
the final stages of filling. In support of the more descriptive term 
``microbial control agent,'' the petitioner provided studies of the 
effect of DMDC (at levels up to 250 ppm) on various yeast strains and 
on Escherichia coli 0157:H7 in several noncarbonated juice beverages.
    In its review of the proposed use of the term ``microbial control 
agent,'' the agency evaluated the information submitted with FAP 
0A4718, as well as previously submitted information. FDA has determined 
that DMDC is effective in microbial control for beverages under normal 
circumstances of bottling, canning, and other forms of final packaging 
where the viable microorganism load has been reduced to 500 
microorganisms/mL or less by current technologies.

[[Page 13653]]

III. Conclusion

    FDA has evaluated the data in the petition and other relevant 
material. Based on this information, the agency concludes that: (1) The 
proposed renaming of the use of the additive is appropriate provided 
that related limitations are added to Sec. 172.133, (2) the uses of the 
additive specified in this section remain safe, (3) the additive will 
achieve its intended technical effect, and therefore, (4) the 
regulations in Sec. 172.133 should be amended as set forth in this 
document.
    The agency is also taking this opportunity to correct an 
inadvertent error in and to make editorial changes to Sec. 172.133 in 
response to the ongoing initiative regarding plain language in 
government writing.
    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 determined subsequent to the amended filing notice of 
this petition that the categorical exclusion in 21 CFR 25.30(i) is no 
longer appropriate. The agency is relying instead on the categorical 
exclusion in 21 CFR 25.32(k) for this action. Because this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment, neither an environmental assessment 
nor an environmental impact statement is required.

V. Paperwork Reduction Act 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VI. Objections

    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (address above) 
written objections by April 6, 2001. 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 are to be submitted and are to 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 172

    Food additives, Reporting and recordkeeping requirements.
    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 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

    1. The authority citation for 21 CFR part 172 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
    2. Section 172.133 is amended by redesignating paragraph (c)(2) as 
paragraph (c)(3), by adding a new paragraph (c)(2), and by revising 
newly redesignated paragraph (c)(3) and paragraph (b), to read as 
follows:


Sec. 172.133  Dimethyl dicarbonate.

* * * * *
    (b) The additive is used or intended for use as a microbial control 
agent in the following beverages under normal circumstances of 
bottling, canning, or other forms of final packaging, where the viable 
microbial load has been reduced to 500 microorganisms per milliliter or 
less by current good manufacturing practices such as heat treatment, 
filtration, or other technologies prior to the use of dimethyl 
dicarbonate:
    (1) In wine, dealcoholized wine, and low alcohol wine in an amount 
not to exceed 200 parts per million.
    (2) In ready-to-drink teas in an amount not to exceed 250 parts per 
million.
    (3) In carbonated or noncarbonated, nonjuice-containing (less than 
or equal to 1 percent juice), flavored or unflavored beverages 
containing added electrolytes (5-20 milliequivalents/liter sodium ion 
(Na+) and 3-7 milliequivalents/liter potassium ion (K+)) in an amount 
not to exceed 250 parts per million.
    (4) In carbonated, dilute beverages containing juice, fruit flavor, 
or both, with juice content not to exceed 50 percent, in an amount not 
to exceed 250 parts per million.
    (c) * * *
    (2) The intended use of the additive.
    (3) Adequate directions for use to ensure compliance with this 
section.

    Dated: February 20, 2001.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 01-5511 Filed 3-6-01; 8:45 am]
BILLING CODE 4160-01-F