[Federal Register Volume 59, Number 49 (Monday, March 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5824]


[[Page Unknown]]

[Federal Register: March 14, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94N-0007]

 

Revision of the Food Chemicals Codex Policy on Arsenic 
Specifications; Opportunity for Public Comment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the revised Food Chemicals Codex 
policy on arsenic specifications. This new policy was recently approved 
by the National Academy of Sciences/Institute of Medicine (NAS/IOM) 
Committee on Food Chemicals Codex (the committee). This revised policy 
is intended to be implemented in the fourth edition of the Food 
Chemicals Codex, scheduled for release in early 1996.

DATES: Written comments and information by May 27, 1994. The committee 
advises that comments not received by this date cannot be considered 
for the fourth edition but will be considered for a later edition or 
supplement.

ADDRESSES: Submit written comments and information to the NAS/IOM 
Committee on Food Chemicals Codex, National Academy of Sciences, 2101 
Constitution Ave. NW., Washington, DC 20418.

FOR FURTHER INFORMATION CONTACT:
     Fatima N. Johnson, Committee on Food Chemicals Codex, Food and 
Nutrition Board, National Academy of Sciences, 2101 Constitution Ave. 
NW., Washington, DC 20418, 202-334-2580, or
    Paul M. Kuznesof, Center for Food Safety and Applied Nutrition 
(HFS-247), Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, 202-254-9537.

SUPPLEMENTARY INFORMATION: FDA provides research contracts to NAS/IOM 
to support the preparation of the Food Chemicals Codex, a compendium of 
specifications for substances used as food ingredients. In the Federal 
Register of July 15, 1993 (58 FR 38129), FDA announced an opportunity 
for public comment on the committee's revised policy on lead and heavy 
metals.
    FDA now gives notice that the committee is soliciting comments and 
information on a revised policy on arsenic specifications and its 
proposed implementation. The revised policy is intended for 
implementation in the fourth edition of the Food Chemicals Codex, which 
is scheduled for release in early 1996. FDA emphasizes, however, that 
it will not consider adopting new Food Chemicals Codex monographs and 
monograph revisions until the public has had ample opportunity to 
comment on them. The opportunity for public comment on new and revised 
monographs will be announced in a notice published in the Federal 
Register.
    The committee regards the safety of properly used food chemicals as 
one of its goals. This means that Food Chemicals Codex specifications 
will respond to advances in new manufacturing methods, analytical 
techniques, toxicology, and safety issues. At the same time, where 
possible, the committee will reduce unnecessary burdens on 
manufacturers and users of food ingredients. Currently, most monographs 
for Food Chemicals Codex substances include an arsenic limit that 
requires testing to ensure compliance. The committee believes that 
arsenic is no longer a contemporary concern in many Food Chemicals 
Codex substances for the following reasons: (1) The use of arsenic-
containing materials in agriculture and manufacturing has declined 
sharply and registrations for many arsenic-containing pesticides have 
been revoked; (2) the heavy metals limit for many Food Chemicals Codex 
substances has been significantly reduced. Because arsenic is one of 
the nine elements detected as a heavy metal, the test indirectly 
provides a safety net in those rare cases where arsenic is present; and 
(3) arsenic has not been associated with or detected in most Food 
Chemicals Codex substances with a long history of use. Therefore, the 
committee believes that the inclusion of arsenic limits in Food 
Chemicals Codex monographs should not be routine, but that inclusion of 
such limits should be considered on an ``as needed'' basis. The 
committee has adopted the following general policy:
    The general policy for arsenic specifications in Food Chemicals 
Codex monographs is that an arsenic specification be included in the 
requirements only when there is specific reason to believe that 
arsenic constitutes a significant portion of the heavy metals limit.
    To implement this policy in the fourth edition, the committee 
proposes deleting the arsenic specification from all current 
monographs, except for the following substances where the arsenic 
specification will be retained.
    1. The top 25 high-volume usage ingredients, based on the 1987 NAS/
NRC Food Additives Survey:
Calcium carbonate
Calcium oxide
Caramel color
Citric acid
Coconut oil
Corn oil
Corn syrup
Corn syrup solids (glucose syrup, dried)
Cottonseed oil
Cottonseed oil, partially hydrogenated
Dextrose
Diatomaceous earth
D-sorbitol
Food starch, modified
High fructose corn syrup
Lactose
Mono- and diglycerides
Sodium bicarbonate
Sodium chloride
Sodium hydroxide
Soybean oil
Soybean oil, hydrogenated
Sucrose
Sucrose, liquid
Whey
    2. Ingredients that are obtained from natural sources, such as gums 
and mineral phosphates, including:
Acacia gum
Agar
Alginic acid
Ammonium alginate
Ammonium phosphate, dibasic
Ammonium phosphate, monobasic
Calcium alginate
Calcium phosphate, monobasic
Calcium phosphate, dibasic
Calcium phosphate, tribasic
Calcium pyrophosphate
Carrageenan
Gellan gum
Ground limestone
Guar gum
Gum ghatti
Kaolin
Karaya gum
Konjac flour
Locust (Carob) bean gum
Pectin
Perlite
Potassium alginate
Potassium phosphate, dibasic
Potassium phosphate, monobasic
Potassium phosphate, tribasic
Potassium polymetaphosphate
Potassium pyrophosphate
Potassium tripolyphosphate
Silicon dioxide
Sodium alginate
Sodium aluminum phosphate, acidic
Sodium aluminum phosphate, basic
Sodium metaphosphate, insoluble
Sodium phosphate, dibasic
Sodium phosphate, monobasic
Sodium phosphate, tribasic
Sodium polyphosphates, glassy
Sodium pyrophosphate
Sodium trimetaphosphate
Sodium tripolyphosphate
Talc
Titanium dioxide
Xanthan gum
    3. Ingredients where information and/or data exist to support the 
inclusion of an arsenic specification.
    The committee requests data and information from all interested 
parties suggesting other Food Chemicals Codex monographs that, for 
safety reasons, should retain the arsenic specification.
    Two copies of written comments and information regarding this 
notice are to be submitted to NAS (address above). Comments may also be 
submitted electronically to the Food Chemicals Codex bulletin board, 
202-334-1738, or transmitted by facsimile, 202-334-2316. Each 
submission should include the statement that it is in response to this 
Federal Register notice. NAS will forward a copy of each comment, 
submitted either electronically or in writing, to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, to be placed under Docket No. 
94N-0007 for public review.

    Dated: March 3, 1994.
 L. Robert Lake,
 Acting Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-5824 Filed 3-14-94; 8:45 am]
BILLING CODE 4160-01-F