[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