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

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