[Federal Register Volume 61, Number 150 (Friday, August 2, 1996)]
[Rules and Regulations]
[Pages 40317-40320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19305]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 73 and 184
[Docket No. 93G-0017]
Direct Food Substances Affirmed as Generally Recognized as Safe;
Listing of Color Additives Exempt From Certification; Ferrous Lactate
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to affirm that ferrous lactate is generally recognized as
safe (GRAS) as a color fixative on ripe olives. The agency is adding
this use of ferrous lactate as a color fixative on ripe olives to the
other uses for ferrous lactate. The agency is also amending this
regulation to permit additional methods of synthesis for ferrous
lactate. This action is in response to a petition filed by Purac
America, Inc. The agency, on its own initiative, is also amending its
color additive regulations to provide for the safe use of ferrous
lactate for the coloring of ripe olives.
DATES: The amendments to Sec. 184.1311 (21 CFR 184.1311) will be
effective on August 2, 1996. New Sec. 73.165 will be effective on
September 4, 1996, except as to any provisions that may be stayed by
the filing of proper objections; written objections by September 3,
1996. The Director of the Office of the Federal Register approves the
incorporations by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51 of certain publications listed in Sec. 184.1311(b),
effective August 2, 1996; and in new Sec. 73.165(b) effective September
4, 1996.
ADDRESSES: Submit written objections to new Sec. 73.165 to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Robert L. Martin, Center for Food
Safety and Applied Nutrition (HFS-217), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3074.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with the procedures described in 21 CFR 170.35, Purac
America, Inc., c/o 700 13th St. NW., suite 1200, Washington, DC 20005,
submitted a petition (GRASP 3G0396) requesting that the regulations in
Sec. 184.1311 be amended to affirm that ferrous lactate is GRAS as a
color fixative in black olives.
FDA published a notice of filing of this petition in the Federal
Register of December 27, 1993 (58 FR 68437), and gave interested
parties an opportunity to submit comments to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm.
1-23, Rockville, MD 20857. Also, in this notice, FDA announced that, on
its own initiative, the agency would amend the color additive
regulations to provide for the safe use of ferrous lactate as a color
additive for the coloring of ripe olives. No comments were received in
response to this notice of filing.
Since the filing of this petition, the agency has come to recognize
that ferrous lactate is being used as a color fixative in ripe, rather
than black, olives. The Agricultural Marketing Service of the U. S.
Department of Agriculture defines ``ripe type'' olives as ``* * * those
which have been treated and oxidized in processing to produce a typical
dark brown to black color'' (7 CFR 52.3752(a)). Also, in 21 CFR 73.160,
the use of ferrous gluconate is approved for the coloring of ripe
olives. Ferrous lactate is a potential substitute for ferrous
gluconate. Therefore, to maintain consistency, the agency will refer to
ripe olives instead of black olives.
II. Standards for GRAS Affirmation
Under Sec. 170.30 (21 CFR 170.30), general recognition of safety
may be based only on the views of experts qualified by scientific
training and experience to evaluate the safety of substances added to
food. The basis of such views may be either: (1) Scientific procedures,
or (2) in the case of a substance used in food prior to January 1,
1958, experience based on common use in food (Sec. 170.30(a)). General
recognition of safety based upon scientific procedures requires the
same quantity and quality of scientific evidence as is required to
obtain approval of a food additive regulation and ordinarily is to be
based upon published studies, which may be corroborated by unpublished
studies and other data and information (Sec. 170.30(b)). General
recognition of safety through experience based on common use in food
prior to January 1, 1958, may be determined without the quantity or
quality of scientific procedures required for approval of a food
additive regulation but ordinarily is to be based upon generally
available data and information concerning the pre-1958 history of use
of the food ingredient (Sec. 170.30(c)). In its petition, Purac
America, Inc., relied on the scientific procedures that have been used
to support the regulated uses of ferrous lactate in Sec. 184.1311, and
on additional submitted published and unpublished data, to establish
that ferrous lactate is GRAS for use as a color fixative on ripe
olives.
III. Use, Estimated Exposure Levels, and Synthesis of Ferrous
Lactate
Ferrous lactate is currently affirmed as GRAS for use as a nutrient
supplement under Sec. 184.1311. Because ferrous lactate is used
interchangeably with several other iron salts that also may be used as
nutrient supplements, FDA considered the exposure to ferrous lactate
resulting from its use on ripe olives in relation to total exposure
from iron.
Based on information supplied in the petition, FDA has estimated
that the exposure to iron from the consumption of ferrous lactate-
treated olives would be no greater than 0.14 milligrams per person per
day (mg/person/day) (Ref. 1).
[[Page 40318]]
This represents a small contribution to the reference daily intake
(RDI) of 18 mg/day for iron (21 CFR 104.20(d)(3)). As ferrous lactate
can replace ferrous gluconate for coloring or fixing color in ripe
olives, no actual increase in exposure to iron is expected.
Lactic acid is GRAS (21 CFR 184.1061) and is a ubiquitous component
of the human body. FDA has estimated that exposure to lactate from the
petitioned use would not contribute significantly to the overall
dietary exposure to lactate (Ref. 1).
Section 184.1311(a) describes ferrous lactate as a greenish-white
powder prepared by reacting calcium lactate or sodium lactate with
ferrous sulfate or by direct reaction of lactic acid with iron filings.
The petitioner described two additional methods for preparing ferrous
lactate: (1) Reaction of ferrous chloride with sodium lactate and (2)
reaction of ferrous sulfate with ammonium lactate.
The petitioner also submitted a draft copy of specifications for
ferrous lactate that has been incorporated into the 4th edition of the
Food Chemicals Codex recently published by the National Academy of
Sciences. The agency has reviewed these additional methods of synthesis
and specifications for ferrous lactate and has concluded that they are
acceptable (Ref. 1).
IV. Safety
FDA discussed the safety of ferrous lactate in a proposal that
published in the Federal Register on April 21, 1987 (52 FR 13086). As
noted above, ferrous lactate is affirmed as GRAS for use as a nutrient
in food under Sec. 184.1311. Ferrous lactate is also recognized as a
coloring adjunct and nutrient by the Food and Agriculture Organization/
World Health Organization and the Joint Expert Committee on Food
Additives. Ferrous lactate is listed as a color retention agent in the
Registry of Food Additives of the European Communities. Ferrous lactate
is also listed by the Spanish Ministry of Health for color fixation of
black olives. The petitioner has relied primarily on the above data to
support its proposed use of ferrous lactate as a color fixative for
ripe olives.
FDA has considered the information in the petition, along with
other available information, concerning ferrous lactate and other iron
salts and has concluded that ferrous lactate is safe for use as a color
fixative for ripe olives (Ref. 2). This determination is based on the
fact that lactate is a normal constituent of food and a normal
intermediary metabolite in humans. Ferrous salts are present in many
foods, particularly meats and poultry and are used as nutrients in food
processing. The exposure to iron from the consumption of ferrous
lactate-treated olives represents only a small contribution to the RDI
of 18 mg/day for iron.
V. Conclusions on Use of Ferrous Lactate as a Color Fixative on
Ripe Olives
FDA has evaluated all of the available information on ferrous
lactate. Based on its review, the agency concludes that the data are
adequate to demonstrate the safety of ferrous lactate for the
petitioned use. Therefore, the agency concludes, based upon scientific
procedures, that ferrous lactate is GRAS for use as a color fixative on
ripe olives at levels consistent with current good manufacturing
practice. The agency is therefore amending Sec. 184.1311 to provide for
this use.
The agency is also amending Sec. 184.1311 to provide for the
additional methods of synthesis for ferrous lactate that were discussed
above. Additionally, the agency is amending Sec. 184.1311 to require
that the ingredient meets the specifications listed in the Food
Chemicals Codex. In the existing GRAS regulation for food use of
ferrous lactate (Sec. 184.1311), the agency indicated that it was
developing specifications for ferrous lactate in cooperation with the
National Academy of Sciences. The agency, as noted above, has reviewed
the specifications for ferrous lactate that published in the 4th
edition of the Food Chemicals Codex and has found them acceptable.
Therefore, the agency is amending Sec. 184.1311 to require that ferrous
lactate meet the specifications in the Food Chemicals Codex, 4th
edition, pages 154 and 155.
VI. Use of Ferrous Lactate as a Color Additive
In the document announcing the filing of Purac America, Inc.'s,
GRAS affirmation petition for ferrous lactate, FDA proposed, on its own
initiative, to amend the color additive regulations in part 73 (21 CFR
part 73) to provide for the safe use of ferrous lactate as a color
additive for the coloring of ripe olives. The agency undertook this
action because of questions as to whether ferrous lactate, when used
for the petitioned purpose, is functioning as a color fixative or as a
color additive. Section 721(b)(4) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 379e(b)(4), provides that ``* * * a
color additive shall be deemed to be suitable and safe for the purpose
of listing under this subsection for use generally in or on food, while
there is in effect a published finding of the Secretary declaring such
substance exempt from the term `food additive' because of its being
generally recognized by qualified experts as safe for its intended use,
as provided in section 201(s).'' Therefore, to eliminate any questions
with respect to the use of ferrous lactate on ripe olives, the agency
proposed to amend part 73 to provide for the safe use of ferrous
lactate for the coloring of ripe olives.
Having concluded that ferrous lactate is GRAS for use as a color
fixative on ripe olives, the agency is amending part 73 to provide for
the use of ferrous lactate as a color additive for the coloring of ripe
olives.
The agency has also determined that the Food Chemicals Codex
specifications for ferrous lactate are acceptable for the color
additive use of ferrous lactate in coloring ripe olives, and in the
regulation, the agency is requiring that the substance conform to these
specifications. Section 721(c) of the act provides that GRAS substances
when listed as color additives are exempt from certification.
Therefore, ferrous lactate, when used as a color additive for coloring
ripe olives, is exempt from certification.
In accordance with Sec. 71.15 (21 CFR 71.15), 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. 71.15, the agency will
delete from the documents any materials that are not available for
public disclosure before making the documents available for inspection.
VII. Environmental Effect
The agency has carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
VIII. Economic Effects of GRAS Affirmation
FDA has examined the economic implications of this final rule
affirming that the use of ferrous lactate is GRAS as a color fixative
on ripe olives and of amending Sec. 184.1311 to permit
[[Page 40319]]
additional methods of synthesis for ferrous lactate 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). The Regulatory Flexibility Act
requires analyzing options for regulatory relief for small businesses.
FDA finds that this final rule is not a significant regulatory
action as defined by Executive Order 12866. The compliance costs to
firms are zero because no current activity is prohibited by affirming
the GRAS status of ferrous lactate as a color fixative for ripe olives,
or by amending the regulations to permit additional methods of
synthesis for ferrous lactate. Because this final rule will not
increase the health risks faced by consumers, total health costs are
also zero. Potential benefits include the ability to use additional
methods to synthesize ferrous lactate and any resources saved by
eliminating the need to prepare further petitions to affirm the GRAS
status of this substance.
Affirming that ferrous lactate is GRAS as a color fixative for ripe
olives under conditions of current good manufacturing practice and
permitting additional methods of synthesis for ferrous lactate will
expand the formulation possibilities for food manufacturers, including
small businesses. Therefore, in accordance with the Regulatory
Flexibility Act, FDA has also determined that this rule will have a
positive impact on small businesses.
IX. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Memoranda from Chemistry Review Branch, HFS-247, to Direct
Additives Branch, HFS-217, dated December 19, 1994, July 28, 1995,
and November 21, 1995.
2. Memorandum from Additives Evaluation Branch no. 1, HFS-226,
to Direct Additives Branch, HFS-217, dated September 9, 1993.
X. Objections to Sec. 73.165
Any person who will be adversely affected by new Sec. 73.165 may at
any time on or before September 3, 1996, file with the Dockets
Management Branch (address above) written objections thereto. 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 shall be
submitted and shall 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. FDA will publish
notice of the objections that the agency has received or lack thereof
in the Federal Register.
List of Subjects
21 CFR Part 73
Color additives, Cosmetics, Drugs, Medical devices.
21 CFR Part 184
Food ingredients.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drug and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR parts 73 and 184 are amended as follows:
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
1. The authority citation for 21 CFR part 73 continues to read as
follows:
Authority: Secs. 201, 401, 402, 403, 409, 501, 502, 505, 601,
602, 701, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e).
2. New Sec. 73.165 is added to subpart A to read as follows:
Sec. 73.165 Ferrous lactate.
(a) Identity. The color additive ferrous lactate is the ferrous
lactate defined in Sec. 184.1311 of this chapter.
(b) Specifications. Ferrous lactate shall meet the specifications
given in the Food Chemicals Codex, 4th ed. (1996), pp. 154 to 155,
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Copies are available from the National Academy
Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be
examined at the Center for Food Safety and Applied Nutrition's Library,
200 C St. SW., rm. 3321, Washington, DC, or at the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
(c) Uses and restrictions. Ferrous lactate may be safely used in
amounts consistent with good manufacturing practice for the coloring of
ripe olives.
(d) Labeling. The label of the color additive shall conform to the
requirements of Sec. 70.25 of this chapter.
(e) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health, and
therefore batches thereof are exempt from the certification
requirements of section 721(c) of the Federal Food, Drug, and Cosmetic
Act (the act).
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
AS SAFE
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
3. Section 184.1311 is amended by revising paragraphs (a), (b), and
(c) to read as follows:
Sec. 184.1311 Ferrous lactate.
(a) Ferrous lactate (iron (II) lactate, C6H10FeO6,
CAS Reg. No. 5905-52-2) in the trihydrate form is a greenish-white
powder or crystalline mass. It is prepared by reacting calcium lactate
or sodium lactate with ferrous sulfate, direct reaction of lactic acid
with iron filings, reaction of ferrous chloride with sodium lactate, or
reaction of ferrous sulfate with ammonium lactate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 4th ed. (1996), pp. 154 to 155, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
are available from the National Academy Press, 2101 Constitution Ave.
NW., Washington, DC 20418, or may be examined at the Center for Food
Safety and Applied Nutrition's library, 200 C St. SW., rm. 3321,
Washington, DC, or at the Office of the Federal Register, 800 North
Capitol St. NW., suite 700, Washington, DC.
(c) In accordance with Sec. 184.1(b)(1), the ingredient is used in
food as a nutrient supplement as defined in
[[Page 40320]]
Sec. 170.3(o)(20) of this chapter and as a color fixative for ripe
olives, with no other limitation other than current good manufacturing
practice. The ingredient may also be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) (21 U.S.C. 350a(g)) or with regulations promulgated under
section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)).
* * * * *
Dated: July 19, 1996.
Janice F. Oliver,
Deputy Director for Systems and Support, Center for Food Safety and
Applied Nutrition.
[FR Doc. 96-19305 Filed 8-1-96; 8:45 am]
BILLING CODE 4160-01-F