[Federal Register Volume 59, Number 230 (Thursday, December 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29521]


[[Page Unknown]]

[Federal Register: December 1, 1994]


                                                   VOL. 59, NO. 230

                                         Thursday, December 1, 1994

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 184

[Docket No. 93P-0024]

 

Diacetyl Tartaric Acid Esters of Mono- and Diglycerides; Revision 
of Common or Usual Name

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to revise 
its regulations to recognize the acronym ``DATEM'' as the alternate 
common or usual name of diacetyl tartaric acid esters of mono- and 
diglycerides. This proposal is in response to a citizen petition 
submitted by Grindsted Products Co.

DATES: Written comments by January 30, 1995. The agency proposes that 
any final rule that may be issued based on this proposal shall become 
effective on the date of publication of the final rule in the Federal 
Register.

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

FOR FURTHER INFORMATION CONTACT: Gerad L. McCowin, Office of Food 
Labeling (HFS-151), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, 202-205-4561.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of February 21, 1989 (54 FR 7401), FDA 
published a final rule to affirm that diacetyl tartaric acid esters of 
mono- and diglycerides (Sec. 184.1101 (21 CFR 184.1101)) are generally 
recognized as safe (GRAS) for use as direct human food ingredients 
(Docket No. 78N-0349). FDA initiated the rulemaking that resulted in 
the February 21, 1989, final rule by publishing a proposal in the 
Federal Register of February 8, 1983 (48 FR 5751).
    In the Federal Register of March 31, 1989 (54 FR 13168), FDA 
published a notice that corrected its response to a comment that was 
included in the February 21, 1989, final rule. In that notice, the 
agency stated that the final rule had been inadvertently published 
while FDA was still considering a submission that claimed that 
``DATEM'' was an appropriate acronym for diacetyl tartaric acid esters 
of mono- and diglycerides. FDA stated that it had completed its 
evaluation of this claim and had concluded that ``the use of the term 
`DATEM' in conjunction with the ingredient name for diacetyl tartaric 
acid esters of mono- and diglycerides on food labels would be 
appropriate'' (see Sec. 184.1101(e)). The agency went on to state that 
``[P]ublic exposure over a period of time could lead to eventual 
acceptance of the acronym as an alternate common or usual name for this 
ingredient.'' The agency has not received any submissions subsequent to 
publication of the March 1989 correction notice that were opposed to 
the use of the term ``DATEM.''

II. Petition and Statement of Grounds

    Grindsted Products Co., 201 Industrial Pkwy., P.O. Box 26, 
Industrial Airport, KS 66031, submitted a citizen petition, dated 
January 21, 1993 (Docket No. 93P-0024), that requests that FDA amend 
Sec. 184.1101 to recognize the acronym ``DATEM'' as an alternate common 
or usual name for the GRAS food ingredient diacetyl tartaric acid 
esters of mono- and diglycerides, and to permit the use of ``DATEM'' on 
food labels to denote the use of these tartaric acid esters as 
components of processed foods.
    In support of the action requested in its citizen petition, 
Grindsted Products Co. presented the following in its statement of 
grounds:
    Diacetyl tartaric acid esters of mono- and diglycerides are 
common components of baked goods and other foods and have been used 
in these applications for more than forty years. From its earliest 
use in foods, this compound has been referred to in the scientific 
community by its acronym, ``DATEM.'' * * *
    The parenthetical listing of ``DATEM'' has been used since the 
publication of the above regulation in 1989. During that time, it 
has appeared on the labels of a majority of products produced using 
the tartaric acid esters. Many ``DATEM''-labeled products are 
distributed nationally and are consumed by the public on a daily 
basis.
    It is also important to note that the use of this alternate name 
will not, in any way, impede the public's ability to obtain 
information about substances used to produce processed foods. The 
term ``DATEM'' has been used in scientific literature for over 15 
years, and was used extensively by scientists and in food trade 
literature prior to FDA's 1989 affirmation of DATEM's GRAS status. * 
* *
    According to the petition, the most common use of diacetyl tartaric 
acid esters of mono- and diglycerides is as a dough conditioner in 
baked goods. The petition claims that, each year, labels of over 250 
million loaves of bread bear the parenthetical listing of the acronym 
``DATEM.'' Additionally, the petition claims that over 100 million 
units of refrigerated ready-to-bake dough products are produced 
annually using the ``DATEM'' parenthetical listing. Grindsted Products 
Co. included labels of products that contain diacetyl tartaric acid 
esters of mono- and diglycerides as exhibits to the petition.
    The petitioner also conducted a literature search based solely on 
the term ``DATEM,'' and it identified 15 articles published in the 
scientific literature between 1970 and 1993 that contained a reference 
to ``DATEM.'' The petitioner concluded that the use of ``DATEM'' as an 
alternate common or usual name for diacetyl tartaric acid esters of 
mono- and diglycerides on food labeling will not inhibit public 
identification of this common food component.

III. The Proposal

    FDA recognizes that food manufacturers have been declaring 
``DATEM'' in parentheses in the ingredient statement following the 
required name, diacetyl tartaric acid esters of mono- and diglycerides, 
for approximately 5 years. The agency agrees with the petitioner that 
because both terms have been consistently used together on products 
marketed in the United States, American consumers purchasing bakery 
products and other similar products containing diacetyl tartaric acid 
esters of mono- and diglycerides have had an opportunity to become 
familiar with ``DATEM.''
    The agency also recognizes, based upon the reference search and 
copies of articles supplied with the petition, that both scientific and 
trade journals have used ``DATEM'' in referring to diacetyl tartaric 
acid esters of mono- and diglycerides.
    Thus, based on the petition's showing that the public has been 
exposed to the acronym ``DATEM'' for approximately 5 years, FDA 
tentatively concludes that such exposure has been adequate to allow 
consumers to recognize the term and to understand its meaning. The 
agency's tentative decision is consistent with its decision in adopting 
``canola'' as the alternate common or usual name for low erucic acid 
rapeseed oil (see 53 FR 36067, September 16, 1988; and 53 FR 52681, 
December 29, 1988). In that rulemaking, FDA found, after a period of 
joint declaration of approximately the same length as the period during 
which DATEM and diacetyl tartaric acid esters of mono- and diglycerides 
have been declared together, that ``there has been sufficient exposure 
to the term `canola oil' to allow the American consumer to recognize 
and understand the term.''
    Based on the information and tentative findings discussed above, 
FDA is proposing to revise paragraphs (a) and (e) of Sec. 184.1101 on 
diacetyl tartaric acid esters of mono- and diglycerides to provide for 
the use of the acronym ``DATEM'' in food labeling as the alternate 
common or usual name of this ingredient.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(9) and (a)(11) that 
this action is of a type that does not individually or cumulatively 
have a significant effect on the human environment. Therefore, neither 
an environmental assessment nor an environmental impact statement is 
required.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety effects; 
distributive impacts; and equity).
    According to Executive Order 12866, a regulatory action is 
economically significant if it meets any one of a number of specified 
conditions, including having an annual effect on the economy of $100 
million or adversely affecting in a material way a sector of the 
economy, competition, or jobs. A regulation is considered significant 
under Executive Order 12866 if it raises novel legal or policy issues. 
The Regulatory Flexibility Act requires analyzing options for 
regulatory relief for small businesses.
    There are no compliance costs associated with this proposed rule 
because this proposed rule will not prohibit any current activity. 
Under this proposal, the use of the acronym ``DATEM'' as the alternate 
common or usual name of the substance diacetyl tartaric acid esters of 
mono- and diglycerides is optional. Food manufacturers may continue to 
use the longer chemical common or usual name in food labeling 
applications. In addition, this proposal will not generate costs for 
consumers because consumers have had an opportunity to become familiar 
with the use of the term ``DATEM'' and because this term is used in 
scientific and trade journals. The benefit of the proposed rule is the 
ability of manufacturers to use the term ``DATEM'' in place of the 
longer chemical common or usual name in food labeling applications.
    Based on these considerations, FDA finds that this proposed rule is 
not an economically significant regulatory action, as defined in 
Executive Order 12866. In addition, and in compliance with the 
Regulatory Flexibility Act, FDA certifies that this proposed rule will 
not have a significant impact on a substantial number of small 
businesses. Finally, this proposal raises no novel legal or policy 
issues. Therefore, FDA finds that this proposed rule is not a 
significant regulatory action as defined by Executive Order 12866.

VI. Comments

    Interested persons may, on or before January 30, 1995, submit to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 184

    Food ingredients.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
the authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 184 be amended as follows:

PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

    1. The authority citation for 21 CFR part 184 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 384, 371).

    2. Section 184.1101 is amended by revising paragraphs (a) and (e) 
to read as follows:


Sec. 184.1101  Diacetyl Tartaric Acid Esters of Mono- and Diglycerides.

    (a) Diacetyl tartaric acid esters of mono- and diglycerides, also 
known as DATEM, are composed of mixed esters of glycerin in which one 
or more of the hydroxyl groups of glycerin has been esterified by 
diacetyl tartaric acid and by fatty acids. The ingredient is prepared 
by the reaction of diacetyl tartaric anhydride with mono- and 
diglycerides that are derived from edible sources.
* * * * *
    (e) Labeling: The acronym ``DATEM'' may be used as the alternate 
common or usual name for the ingredient diacetyl tartaric acid esters 
of mono- and diglycerides.

    Dated: November 22, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-29521 Filed 11-30-94; 8:45 am]
BILLING CODE 4160-01-F