[Federal Register Volume 64, Number 7 (Tuesday, January 12, 1999)]
[Rules and Regulations]
[Pages 1758-1761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-563]
[[Page 1758]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 172, 173, and 184
Foods and Drugs; Technical Amendments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendments.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations that incorporate by reference analytical methods in the
``Food Chemicals Codex'' 3d edition, by updating these references to
the 4th edition. Additionally, the agency is concomitantly updating the
incorporation by reference for specifications in six regulations that
incorporate by reference specification monographs in the ``Food
Chemicals Codex'' 3d edition, by updating these references to the 4th
edition. This action is being taken to meet the requirements for
incorporation by reference set forth in 1 CFR part 51.
DATES: The regulation is effective January 12, 1999. The Director of
the Office of the Federal Register approves the incorporation by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of
certain publications listed in Secs. 172.345(b), 172.665(d)(2),
172.723(b)(3), 173.310(c), 184.1007(b)(1), (b)(6), and (b)(7),
184.1257(b) and (b)(1), 184.1259(b)(3), 184.1282(b), 184.1293(b),
184.1530(b), 184.1699(b), 184.1979(b)(1) and (b)(2), 184.1979a(b)(1)
and (b)(2), 184.1979b(b)(1) and (b)(2), and 184.1979c(b)(1) and (b)(2)
(21 CFR 172.345(b), 172.665(d)(2), 172.723(b)(3), 173.310(c),
184.1007(b)(1), (b)(6), and (b)(7), 184.1257(b) and (b)(1),
184.1259(b)(3), 184.1282(b), 184.1293(b), 184.1530(b), 184.1699(b),
184.1979(b)(1) and (b)(2), 184.1979a(b)(1) and (b)(2), 184.1979b(b)(1)
and (b)(2), and 184.1979c(b)(1) and (b)(2)), effective January 12,
1999.
FOR FURTHER INFORMATION CONTACT: Martha D. Peiperl, Center for Food
Safety and Applied Nutrition (HFS-215), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3077.
SUPPLEMENTARY INFORMATION: FDA is amending its regulations in parts
172, 173, and 184 (21 CFR parts 172, 173, and 184) that incorporate by
reference analytical methods in the ``Food Chemicals Codex'' 3d
edition, by revising Secs. 172.665, 172.723, 173.310, 184.1007,
184.1257, 184.1259, 184.1979, 184.1979a, 184.1979b, and 184.1979c to
incorporate identical methods in the 4th edition of the ``Food
Chemicals Codex.'' Additionally, the agency is amending regulations in
parts 172 and 184 that incorporate by reference specification
monographs in the 3d edition of the ``Food Chemicals Codex,'' by
revising Secs. 172.345, 184.1257, 184.1282, 184.1293, 184.1530, and
184.1699 to incorporate identical specification monographs in the 4th
edition. 1 CFR part 51 requires filing and updating of material that
has been incorporated by reference in the CFR.
The agency is also taking this opportunity to amend the previous
regulations to: (1) Reflect a change in the address of the National
Academy Press and to add its Internet address; (2) reflect a change in
the name and address of the Association of Official Analytical Chemists
International (AOAC), as published as a technical amendment in the
Federal Register of March 24, 1998 (63 FR 14035), which updated this
reference in 21 CFR parts 101 through 169; and (3) revise sections in
part 184.
FDA has reviewed the food ingredient regulations that incorporate
by reference material in the ``Food Chemicals Codex.'' The edition of
the ``Food Chemicals Codex'' cited when many of these regulations were
established (3d edition) has been superseded by a subsequent edition
(4th edition). The agency has compared specification monographs and
methods in the 3d and 4th editions and found that no substantive
changes have been made to the material incorporated by reference into
the regulations amended in this document. The agency notes that in the
3d edition, reagents are often cited as test solutions (TS), without
giving the strength of the reagent in the specification monograph or
the analytical method. This requires the analyst to refer to the
section on TS in the back of the volume. In ``Food Chemical Codex'' 4th
edition, the TS reagent strengths are also given in the individual
specification monographs and analytical methods. This change is only
editorial in nature.
Publication of this document constitutes final action on these
changes under the Administrative Procedure Act (5 U.S.C. 553). Notice
and public procedure are unnecessary because FDA is merely updating
incorporations by reference that involve nonsubstantive changes.
List of Subjects
21 CFR Part 172
Food additives, Incorporation by reference, Reporting and
recordkeeping requirements.
21 CFR Part 173
Food additives, Incorporation by reference.
21 CFR Part 184
Food ingredients, Incorporation by reference.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR parts 172, 173, and 184 are amended as follows:
PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION
1. The authority citation for 21 CFR part 172 continues to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.
2. Section 172.345 is amended by revising paragraph (b) to read as
follows:
Sec. 172.345 Folic acid (folacin).
* * * * *
(b) Folic acid meets the specifications of the ``Food Chemicals
Codex,'' 4th ed. (1996), pp. 157-158, 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, Box 285, 2101
Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://
www.nap.edu''), or may be examined at the Center for Food Safety and
Applied Nutrition's Library, Food and Drug Administration, 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.
* * * * *
3. Section 172.665 is amended by revising paragraph (d)(2) to read
as follows:
Sec. 172.665 Gellan gum.
* * * * *
(d) * * *
(2) Residual isopropyl alcohol (IPA) not to exceed 0.075 percent as
determined by the procedure described in the Xanthan Gum monograph, the
``Food Chemicals Codex,'' 4th ed. (1996), pp. 437-438, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51.
[[Page 1759]]
Copies are available from the National Academy Press, Box 285, 2101
Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://
www.nap.edu''), or may be examined at the Center for Food Safety and
Applied Nutrition's Library, Food and Drug Administration, 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.
* * * * *
4. Section 172.723 is amended by revising paragraph (b)(3) to read
as follows:
Sec. 172.723 Epoxidized soybean oil.
* * * * *
(b) * * *
(3) The heavy metals (as Pb) content cannot be more than 10 parts
per million, as determined by the ``Heavy Metals Test,'' of the ``Food
Chemicals Codex,'' 4th ed. (1996), pp. 760-761, Method II (with a 2-
gram sample and 20 microgram of lead ion in the control), 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, Box 285,
2101 Constitution Ave. NW., Washington, DC 20055 (Internet address
``http://www.nap.edu''), or may be examined at the Center for Food
Safety and Applied Nutrition's Library, Food and Drug Administration,
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.
* * * * *
PART 173--SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR
HUMAN CONSUMPTION
5. The authority citation for 21 CFR part 173 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348.
6. Section 173.310 is amended in the table in paragraph (c) in the
entry for ``Sodium carboxymethylcellulose'' to read as follows:
Sec. 173.310 Boiler water additives.
* * * * *
(c) * * *
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Substances Limitations
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* * * *
* * *
Sodium carboxymethylcellulose...... Contains not less than 95 percent
sodium carboxymethylcellulose on a
dry-weight basis, with maximum
substitution of 0.9
carboxymethylcellulose groups per
anhydroglucose unit, and with a
minimum viscosity of 15
centipoises for 2 percent by
weight aqueous solution at 25 C;
by the method prescribed in the
``Food Chemicals Codex,'' 4th ed.
(1996), pp. 744-745, 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, Box 285, 2101
Constitution Ave. NW., Washington,
DC 20055 (Internet address ``http:/
/www.nap.edu''), or may be
examined at the Center for Food
Safety and Applied Nutrition's
Library, Food and Drug
Administration, 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.
* * * *
* * *
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* * * * *
PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED
AS SAFE
7. The authority citation for 21 CFR part 184 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 371.
8. Section 184.1007 is amended by revising paragraphs (b)(1),
(b)(6), and (b)(7) to read as follows:
Sec. 184.1007 Aconitic acid.
* * * * *
(b) * * *
(1) Assay. Not less than 98.0 percent of
C3H3(COOH)3, using the ``Food
Chemicals Codex,'' 4th ed. (1996), pp. 102-103, test for citric acid,
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51, and a molecular weight of 174.11. Copies of the
material incorporated by reference are available from the National
Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC
20055 (Internet address ``http://www.nap.edu''), or may be examined at
the Center for Food Safety and Applied Nutrition's Library, Food and
Drug Administration, 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.
* * * * *
(6) Readily carbonizable substances. Passes the test for citric
acid of the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 102-103,
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. The availability of this incorporation by reference
is given in paragraph (b)(1) of this section.
(7) Residue on ignition. Not more than 0.1 percent as determined by
the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 102-103, test for
citric acid, which is incorporated by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation
by reference is given in paragraph (b)(1) of this section.
* * * * *
9. Section 184.1257 is amended by revising the introductory text of
paragraph (b) and by revising paragraph (b)(1) to read as follows:
Sec. 184.1257 Clove and its derivatives.
* * * * *
(b) Clove bud oil, clove leaf oil, clove stem oil, and eugenol meet
the specifications of the ``Food Chemicals Codex,'' 4th ed. (1996), pp.
104-105, 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, Box 285, 2101 Constitution Ave. NW., Washington, DC
20055 (Internet address ``http://www.nap.edu''), or may be examined at
the Center for Food Safety and Applied Nutrition's Library, Food
[[Page 1760]]
and Drug Administration, 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. As determined by analytical methods in the ``Food
Chemicals Codex,'' clove oleoresin or other natural extractives (other
than clove oils) meet the ``Food Chemicals Codex'' specifications for
clove (clove bud) oil and the following modifications:
(1) The assay for phenols, as eugenol, by the ``Food Chemicals
Codex'' test, 4th ed. (pp. 104-105), or the volatile oils content by
the ``Food Chemicals Codex'' test, 4th ed. (pp. 104-105) should conform
to the representation of the vendor;
* * * * *
10. Section 184.1259 is amended by revising paragraph (b)(3) to
read as follows:
Sec. 184.1259 Cocoa butter substitute.
* * * * *
(b) * * *
(3) Heavy metals (as lead), not more than 10 milligrams per
kilogram, as determined by the Heavy Metals Test of the ``Food
Chemicals Codex,'' 4th ed. (1996), pp. 760-761, 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, Box 285, 2101
Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://
www.nap.edu''), or may be examined at the Center for Food Safety and
Applied Nutrition's Library, Food and Drug Administration, 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.
* * * * *
11. Section 184.1282 is amended by revising paragraph (b) to read
as follows:
Sec. 184.1282 Dill and its derivatives.
* * * * * *
(b) Dill oils meet the description and specifications of the ``Food
Chemicals Codex,'' 4th ed. (1996), pp. 122-123, 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, Box 285, 2101
Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://
www.nap.edu''), or may be examined at the Center for Food Safety and
Applied Nutrition's Library, Food and Drug Administration, 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.
* * * * *
12. Section 184.1293 is amended by revising paragraph (b) to read
as follows:
Sec. 184.1293 Ethyl alcohol.
* * * * *
(b) The ingredient meets the specifications of the ``Food Chemicals
Codex,'' 4th ed. (1996), p. 136, 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, Box 285, 2101 Constitution Ave. NW.,
Washington, DC 20055 (Internet address ``http://www.nap.edu''), or may
be examined at the Center for Food Safety and Applied Nutrition's
Library, Food and Drug Administration, 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.
* * * * *
13. Section 184.1530 is amended by revising paragraph (b) to read
as follows:
Sec. 184.1530 Niacin.
* * * * *
(b) The ingredient meets the specifications of the ``Food Chemicals
Codex,'' 4th ed. (1996), p. 264, 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, Box 285, 2101 Constitution Ave. NW.,
Washington, DC 20055 (Internet address ``http://www.nap.edu''), or may
be examined at the Center for Food Safety and Applied Nutrition's
Library, Food and Drug Administration, 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.
* * * * *
14. Section 184.1699 is amended by revising paragraph (b) to read
as follows:
Sec. 184.1699 Oil of rue.
* * * * *
(b) Oil of rue meets the specifications of the ``Food Chemicals
Codex,'' 4th ed. (1996), pp. 342-343, 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, Box 285, 2101
Constitution Ave. NW., Washington, DC 20055 (Internet address ``http://
www.nap.edu''), or may be examined at the Center for Food Safety and
Applied Nutrition's Library, Food and Drug Administration, 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.
* * * * *
15. Section 184.1979 is amended by revising the introductory text
of paragraph (b)(1), by revising paragraph (b)(2), and by removing
footnote numbers ``1'' and ``2'' to read as follows:
Sec. 184.1979 Whey.
* * * * *
(b) * * *
(1) The analysis of whey, concentrated whey, and dry (dried) whey,
on a dry product basis, based on analytical methods in the referenced
sections of ``Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th ed. (1980), which is incorporated
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is
given in paragraphs (b)(1)(i) through (b)(1)(vii) of this section.
Copies may be obtained from the Association of Official Analytical
Chemists International, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877-2504, or may be examined at the Center for Food
Safety and Applied Nutrition's Library, Food and Drug Administration,
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.
* * * * *
(2) Limits of impurities are: Heavy metals (as lead). Not more than
10 parts per million (0.001 percent) as determined by the method
described in the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 760-761,
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, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055
(Internet address ``http://www.nap.edu''), or may be examined at the
Center for Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 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.
* * * * *
16. Section 184.1979a is amended by revising the introductory text
of paragraph (b)(1), by revising paragraph (b)(2), and by removing
footnote numbers ``1'' and ``2'' to read as follows:
Sec. 184.1979a Reduced lactose whey.
* * * * *
(b) * * *
[[Page 1761]]
(1) The analysis of reduced lactose whey, on a dry product basis,
based on analytical methods in the referenced sections of ``Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th ed. (1980), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is given in
paragraphs (b)(1)(i) through (b)(1)(vii) of this section. Copies may be
obtained from the Association of Official Analytical Chemists
International, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877-2504, or may be examined at the Center for Food Safety and
Applied Nutrition's Library, Food and Drug Administration, 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.
* * * * *
(2) Limits of impurities are: Heavy metals (as lead). Not more than
10 parts per million (0.001 percent), as determined by the method
described in the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 760-761,
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, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055
(Internet address ``http://www.nap.edu''), or may be examined at the
Center for Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 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.
* * * * *
17. Section 184.1979b is amended by revising the introductory text
of paragraph (b)(1), by revising paragraph (b)(2), and by removing
footnote number ``1'' to read as follows:
Sec. 184.1979b Reduced minerals whey.
* * * * *
(b) * * *
(1) The analysis of reduced minerals whey, on a dry product basis,
based on analytical methods in the referenced sections of ``Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th ed. (1980), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is given in
paragraphs (b)(1)(i) through (b)(1)(vii) of this section. Copies may be
obtained from the Association of Official Analytical Chemists
International, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877-2504, or may be examined at the Center for Food Safety and
Applied Nutrition's Library, Food and Drug Administration, 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.
* * * * *
(2) Limits of impurities are: Heavy metals (as lead). Not more than
10 parts per million (0.001 percent), as determined by the method
described in the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 760-761,
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, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055
(Internet address ``http://www.nap.edu''), or may be examined at the
Center for Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 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.
* * * * *
18. Section 184.1979c is amended by revising the introductory text
of paragraph (b)(1), by revising paragraph (b)(2), and by removing
footnote numbers ``1'' and ``2'' to read as follows:
Sec. 184.1979c Whey protein concentrate.
* * * * *
(b) * * *
(1) The analysis of whey protein concentrate, on a dry product
basis, based on analytical methods in the referenced sections of
``Official Methods of Analysis of the Association of Official
Analytical Chemists,'' 13th ed. (1980), which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, is
given in paragraphs (b)(1)(i) through (b)(1)(vii) of this section.
Copies may be obtained from the Association of Official Analytical
Chemists International, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877-2504, or may be examined at the Center for Food
Safety and Applied Nutrition's Library, Food and Drug Administration,
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.
* * * * *
(2) Limits of impurities are: Heavy metals (as lead). Not more than
10 parts per million (0.001 percent), as determined by the method
described in the ``Food Chemicals Codex,'' 4th ed. (1996), pp. 760-761,
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, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055
(Internet address ``http://www.nap.edu''), or may be examined at the
Center for Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 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.
* * * * *
Dated: December 7, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center
for Food Safety and Applied Nutrition.
[FR Doc. 99-563 Filed 1-11-99; 8:45 am]
BILLING CODE 4160-01-F