[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