[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) * * *

 
------------------------------------------------------------------------
             Substances                          Limitations
------------------------------------------------------------------------
  *                    *                    *                    *
                   *                    *                    *
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.
  *                    *                    *                    *
                   *                    *                    *
------------------------------------------------------------------------

 * * * * *

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