[Federal Register Volume 61, Number 151 (Monday, August 5, 1996)]
[Rules and Regulations]
[Page 40513]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19803]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES-

Food and Drug Administration

21 CFR Parts 136, 137, and 139

[Docket No. 91N-100S]
RIN 0910-AA19


Food Standards: Amendment of Standards of Identity for Enriched 
Grain Products to Require Addition of Folic Acid; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule that appeared in the Federal Register of March 5, 1996 (61 FR 
8781). The final rule amended the standards of identity for several 
enriched cereal-grain products and by cross-reference, the standards of 
identity for enriched bromated flour, enriched vegetable macaroni, and 
enriched vegetable noodle products, to require fortification of those 
cereal grain products with folic acid. The document was published with 
some errors. This document corrects those errors.

EFFECTIVE DATE: January 1, 1998.

FOR FURTHER INFORMATION CONTACT: Felicia B. Satchell, Center for Food 
Safety and Applied Nutrition (HFS-158), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-5099.

    In FR Doc. No. 96-5014, appearing on page 8781 in the Federal 
Register of Tuesday, March 5, 1996, the following corrections are made:
    1. On page 8781, in the third column, under the ``SUPPLEMENTARY 
INFORMATION'' caption, in the second paragraph, in the eighth line, 
``consideration'' is corrected to read ``considerable''.
    2. On page 8782, in the first column, in the fourteenth line, 
``Health Claims'' is corrected to read ``folic acid health claims''; 
and beginning on the same line ``58 FR 23254 at 23256'' is corrected to 
read ``58 FR 53254 at 53256''; and in the nineteenth line,``the 
claims'' is corrected to read ``the folic acid health claims''.
    3. On page 8783, in the first column, in the first full paragraph, 
in the second line from the bottom, ``folate'' is corrected to read 
``folic acid''.
    4. On page 8786, in the first column, in the first full paragraph, 
in the seventh line, the word ``direct'' is inserted after the word 
``include'', and in the same page, in the third full paragraph, the 
last sentence in parenthesis is deleted.
    5. On page 8788, in the third column, in the second full paragraph, 
in the fifth line, the word ``raises'' is removed and is reinserted in 
the sixth line, after the word ``request''.
    6. On page 8794, in the third column, in the fifth full paragraph, 
in the ninth line, the last sentence is corrected to read:
    The cost of the required label changes will vary with the 
compliance period. The estimated cost of the required label changes 
in the proposed rule was based on a compliance period of 1 year. 
However, this final rule changes the compliance period from 1 year 
to 2 years. This increase in the compliance period reduces the 
estimated cost of required label changes to $11 million. The cost of 
adding the required folic acid and the cost of testing are recurring 
costs that are not significantly affected by the change in the 
compliance period. Thus, the total one-time cost of relabeling these 
products is estimated to be $11 million and the recurring costs are 
estimated to be $6.5 million. These costs are extremely small 
relative to the estimated health benefits of this final rule.
    7. On page 8795, in the first column, before ``B. Benefits'', the 
following paragraph is added:
    ``Total Costs. If fortification were to be at 70 /100 g, 
quantified costs for allowing 2 years for compliance are now estimated 
to be $16 million. If fortification were to be at 350 g/100 g, 
quantified costs for allowing 2 years for compliance are now estimated 
to be $23.5 million. Again, FDA has declined to quantify the costs of 
neurologic effects due to masking of anemia of vitamin B12 
deficiency.''
    8. On page 8795, in the second column, under section 2.a, in the 
sixth line ``10 to 50 percent of'' is removed; on the same page, in the 
third column, under ``C. Conclusion'', in the second paragraph, in the 
third line ``$27 million'' is corrected to read ``$17.5 million''; in 
the same paragraph, beginning in the thirteenth line, ``should be 
approximately 25 percent of the first year cost'' is corrected to read 
``is estimated to be approximately $7 million''; and in the third 
paragraph, in the second line, ``$27 million'' is corrected to read 
``$17.5 million''.

    Dated: July 25, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-19803 Filed 8-2-96; 8:45 am]
BILLING CODE 4160-01-F