94-5824. Revision of the Food Chemicals Codex Policy on Arsenic Specifications; Opportunity for Public Comment  

  • [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
    
    
    

Document Information

Published:
03/14/1994
Department:
Food and Drug Administration
Entry Type:
Uncategorized Document
Action:
Notice.
Document Number:
94-5824
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.
Pages:
0-0 (1 pages)
Docket Numbers:
Federal Register: March 14, 1994, Docket No. 94N-0007