[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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