[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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