[Federal Register Volume 59, Number 49 (Monday, March 14, 1994)]
[Unknown Section]
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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