[Federal Register Volume 61, Number 173 (Thursday, September 5, 1996)]
[Rules and Regulations]
[Pages 46714-46716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-22606]
[[Page 46714]]
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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; Clarification
AGENCY: Food and Drug Administration, HHS.
ACTION: Clarification.
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SUMMARY: The Food and Drug Administration (FDA) is clarifying how it
intends to implement regulations that it issued in March 1996 that
require that, by January 1, 1998, certain standardized enriched grain
products be fortified with folic acid, with respect to foods to which
this substance is to be added or that include ingredients to which this
substance is to be added. Given that the U.S. Public Health Service
(PHS) has recommended that women of childbearing age consume at least
0.4 milligrams (mg) (400 micrograms (mcg)) of folic acid daily to
reduce their risk of having a pregnancy affected with spina bifida or
other neural tube defects, FDA encourages firms to initiate the
required fortification before the 1998 effective date of the
regulations. To facilitate initiation of fortification for firms who
elect to voluntarily fortify foods in a manner that is consistent with
the new folic acid fortification requirements, the agency is unlikely
to enforce the ingredient declaration and nutrition labeling
requirements of the Federal Food, Drug, and Cosmetic Act (the act) with
respect to this nutrient until after 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.
SUPPLEMENTARY INFORMATION:
I. Background
A. Folic Acid Requirements for Standardized Foods
In September 1992, PHS recommended that all women of childbearing
age in the United States consume 0.4 mg (400 mcg) of folic acid daily
to reduce their risk of having a pregnancy affected with spina bifida
or other neural tube defects (Ref. 2). In response to the PHS
recommendation, FDA issued regulations in the Federal Register of March
5, 1996 (61 FR 8781), that require that by January 1, 1998, certain
standardized enriched grain products be fortified with folic acid
(hereinafter referred to as the 1996 fortification final rule).
Affected foods are enriched bread, rolls, and buns (21 CFR 136.115);
enriched flour (21 CFR 137.165); enriched self-rising flour (21 CFR
137.185); enriched corn meals (21 CFR 137.260); enriched farina (21 CFR
137.305); enriched rice (21 CFR 137.350); enriched macaroni products
(21 CFR 139.115); enriched nonfat milk macaroni (21 CFR 139.122); and
enriched noodle products (21 CFR 139.155) and, by cross-reference, the
standards of identity for enriched bromated flour (21 CFR 137.160),
enriched vegetable macaroni products (21 CFR 139.135), and enriched
vegetable noodle products (21 CFR 139.165).
B. Effective Date
In the Federal Register of October 14, 1993 (58 FR 53305), FDA
published a proposed rule entitled ``Food Standards: Amendment of the
Standards of Identity for Enriched Grain Products to Require Addition
of Folic Acid'' (hereinafter referred to as the 1993 fortification
proposal). In the 1996 fortification final rule, FDA advised that many
comments had expressed concern over the statement in the 1993
fortification proposal that the final rule would become effective 1
year after publication. The comments addressed both manufacturing and
labeling issues. Comments explained that it would be difficult and
impractical to synchronize the addition of a folic acid-fortified
enriched cereal-grain product to a food with the availability of labels
for that food that have been revised to declare folic acid in the
ingredient statement and, where necessary, in the nutrition label.
These comments pointed out that enrichment nutrients are generally not
added to each product separately but are added, for example, to
thousands of pounds of flour at the flour mill. The flour is sold to
manufacturers as an ingredient, and this ingredient is used in many
different products. Thus, the comments asserted that, as a matter of
economic necessity, the enrichment of all products using the ingredient
occurs at the same time, regardless of the availability of new
labeling.
To resolve the problems of coordinating fortification with
labeling, comments requested an effective date for the fortification
requirement of 2 years or more from the date of publication of the
final rule adopting that requirement. Further, comments pointed out
that any less time to comply with the fortification requirement would
create economic burdens on firms because large inventories of labels
would have to be discarded. However, the comments did not provide data
concerning the extent of the economic burdens from discarded label
inventory. A few comments suggested that the agency permit folic acid
to be added to the product without requiring declaration in the
ingredient statement and the nutrition label.
In the preamble to the 1996 fortification final rule, FDA
acknowledged the significance of the logistical concerns regarding
label changes that must accompany the addition of folic acid to
enriched cereal-grain products and the resultant addition of folic acid
to the foods in which these products are used as ingredients. FDA
stated that it was persuaded that it should provide 2 years for
manufacturers to implement the label and formulation changes required
by the 1996 fortification final rule. The agency concluded that a 2-
year period should allow manufacturers time to exhaust current
packaging inventory and to add folic acid to the statement of
ingredients and nutrition label as other changes are made to update
package labeling. Furthermore, the agency pointed out that a 2-year
period is consistent with the amount of time given for implementation
of the requirements of the Nutrition Labeling and Education Act of 1990
(the 1990 amendments). Thus, the effective date of this final rule was
established as January 1, 1998.
The agency noted, however, that compliance with the requirements
established in this final rule could begin immediately, provided that
the label accurately reflects that folic acid has been added to the
product. FDA explained that it would not permit folic acid
fortification without label declaration because, traditionally, it has
not permitted manufacturers who change their formulas by adding or
deleting ingredients to use labels that do not reflect this fact.
Furthermore, the agency believed that it was establishing an effective
date that would provide manufacturers ample time to ensure that
products enriched with folic acid are labeled in compliance with the
regulations. The agency also reminded manufacturers that it considered
stickers an acceptable means to correct labels.
C. Problems With Folate Labeling
After the March 1996 regulations requiring that standardized
enriched
[[Page 46715]]
grain foods be fortified with folic acid were issued, the National
Pasta Association (NPA) submitted a request (Ref. 1) that, at least
until January 1, 2000, the agency permit folic acid addition to
products without requiring declaration in the ingredient statement. NPA
stated that such flexibility was urgently needed because, without it,
manufacturers of all affected standardized enriched grain foods would
suffer tremendous financial losses.
More specifically, NPA stated that pasta manufacturers would lose
millions of dollars of label inventory. NPA advised that the logistical
problems regarding label changes that must accompany folic acid
fortification were not fully resolved by the agency's extension of the
effective date until 1998 or by the agency's explicit permission for
using stickering to correct ingredient lists on labels. NPA explained
that the industry still faces high costs from labels that must be
discarded, because coordinating folic acid fortification with labeling
changes is a monumental task. NPA stated that once folic acid is added
to a raw material that serves as an ingredient in food, all products
using that material will include the substance, but it is not possible
to change all labels for such products at the same time. Furthermore,
because firms must regularly replenish label supplies, NPA stated that,
without the requested labeling flexibility, firms would face losing the
same level of label inventory, regardless of when the regulations take
effect. NPA stated that its members had advised that about 5,000 pasta
products would have label inventories costing more than $27 million
that would have to be discarded when the regulations take effect.
In addition, NPA advised that using stickering to correct
ingredient lists on labels would not resolve logistical problems
regarding label changes because many companies would have to purchase
special machines for stickering. A machine would have to be purchased
for each packaging line, and pasta manufacturers typically have
multiple packaging lines. NPA stated that each machine would cost about
$10,000. In addition to these costs, NPA stated that production
problems would be created by stickering. NPA explained that it is
generally not practicable to cover the ingredient statement on pasta
packaged in a folding carton because of the high speed of the cartoners
and the manner in which the cartons are oriented as they move through
the packaging line. Stickers would have to be applied to cartons before
they enter the packaging line with significant loss of packaging
efficiency. Production could be drastically reduced.
NPA explained that stickering would also not be practicable on
pasta packaged in bags because stickers cannot be affixed to the
package film without making the film significantly thicker. A thicker
film could not be wound tightly on the packaging spool. Also, the
stickers would not move smoothly through the forming tubes on the
baggers. If manufacturers tried to sticker the bags after filling, they
could not reliably cover existing ingredient information, given the
speed of the packaging line and the fact that the bags are neither flat
nor consistently oriented after they are filled.
Furthermore, NPA asked whether the effective date ultimately
designated for fortification of standardized enriched grain products
would apply to products labeled on or after that date or to products
introduced into interstate commerce on or after that date. NPA
suggested that the agency should adopt the former approach for
consistency with the effective date established in the 1990 amendments,
ease of enforcement, equity between small and large manufacturers, and
maximization of cost savings derived from a delayed effective date.
II. The Agency's Position
Given the more specific information that was provided by NPA
regarding folic acid label changes, the logistical problems with these
changes, and the costs associated with label inventories that would
have to be discarded, FDA has reviewed its position regarding the
effective date of these regulations. FDA recognizes that its allowance,
without label flexibility, of nearly 2 years for compliance with the
fortification requirements did not resolve significant problems
associated with formulation and label changes, and that there are
significant reasons for flexibility in label declaration of folate
content, at least pending the effective date of the regulations
requiring fortification. These reasons are listed as follows:
(1) Among firms that add folic acid to their foods themselves
(e.g., flour manufacturers), the raw material is commonly fortified in
large batches, and the fortified material is then used in numerous
products. Because each product requires at least one label (e.g., often
a firm will pack one product for several companies, each of which uses
a different label), numerous labels will have to be corrected once
fortification begins. If all these labels have to be changed at once,
existing label inventories would have to be discarded. Even if it were
possible to change all (perhaps hundreds) labels at once, firms would
logically postpone fortification as long as possible to allow for
depletion of label inventory.
(2) For firms that do not themselves perform all folic acid
fortification of the ingredients in the products they manufacture, the
logistics of coordinating label changes with fortification are even
more complicated. These firms have little or no control over when the
fortification of ingredients with folic acid is to begin. Suppliers of
ingredients that are to be fortified with folic acid are likely to
initiate fortification at different times. In many, if not most,
situations, firms may be advised of the fortification only through the
ingredient list that comes from the supplier. Firms will thus have
significant difficulty anticipating when label stocks that do not list
folic acid as an ingredient will have to be depleted. Firms also will
have difficulty anticipating how far in advance of the 1998 effective
date new label stocks will be needed. Thus, many firms will likely
incur costs associated with discarding label stocks. Also, where
suppliers fortify early, some firms may not have new label stocks that
appropriately reflect the composition of their food.
(3) Where firms purchase an enriched ingredient from multiple
suppliers, planning for depletion of old label stock and for acquiring
new label stock will present particular problems. Some ingredient
shipments may be fortified with folic acid, others may not.
Consequently, such firms will be faced with having to switch back and
forth between old and new label stocks. Where enriched ingredient
shipments are pooled into an automatic bulk handling system, folic
acid-enriched and non-folic acid-enriched ingredients will be
commingled. The commingled ingredient may not conform to fortification
requirements, and both old and new label stocks may be inappropriate as
a result.
(4) NPA has presented logical reasons why stickering will not
provide a practicable way to correct lists of ingredients and nutrient
declarations on old labels because of adverse impact on manufacturing
productivity.
(5) NPA has provided data concerning the extent of the economic
burden from discarded label inventory in the pasta industry. For that
industry, the costs appear to be substantial. Pasta manufacturers are
not likely to be the only firms affected by the problems associated
with the folic acid label changes and the logistical problems and costs
associated with these changes. Thus, costs from discarded label
inventory may be much higher than the
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$27 million that NPA estimated. Such costs will surely be passed on to
consumers.
Although NPA has demonstrated that significant problems will be
presented by the transition to fortification of enriched grains with
folic acid, it has not explained why the effective date should be
changed from January 1, 1998, to January 1, 2000. If firms have
flexibility to use existing label stocks that do not have folic acid
ingredient labeling until January 1, 1998, most of the cost burdens on
these firms should be eliminated. The only continuing concern would be
if label suppliers could not meet the demand for new labels by January
1, 1998. However, neither NPA nor the comments on the 1993
fortification proposal indicated that large numbers of firms would be
faced with such a situation. To the contrary, the agency knows of no
reason why most firms cannot acquire new label stocks by that date.
On May 23, 1996, the March of Dimes wrote to FDA that the desire to
begin to fortify early was widespread in the industry, but that many
firms were not doing so because fortifying their foods would mean that
they could not use up existing label stocks (Ref. 3). The March of
Dimes suggested that if the agency provided flexibility in the use of
label supplies, it would make it more likely that firms would proceed
with folic acid fortification at an earlier date, thereby helping to
reduce a woman's risk of having a pregnancy affected with spina bifida
or other neural tube defects.
Given this significant benefit from folic acid fortification and
the significant difficulties in label modification as folic acid is
being phased into enriched grain products, FDA advises that, until the
amendments to the standards of identity for enriched grain products are
effective on January 1, 1998, it is unlikely to take regulatory action
against enriched grain products, or products that contain enriched
grain products, because the ingredient list in the labeling of such
foods fails to include folic acid, or because the nutrition label fails
to accurately declare the level of folate, unless folate claims are
made for the product. If folate claims are made FDA will expect the
food to comply fully with all applicable labeling requirements.
With respect to NPA's request for clarification of the
applicability of the effective date, FDA advises that the January 1,
1998, effective date for fortification of standardized enriched grain
products applies to the date such products are initially introduced
into interstate commerce. FDA does not agree with the NPA suggestion
that the effective date should be tied to the date that products are
labeled. The agency has for many years used the date of initial
introduction into interstate commerce as the effective date for
compliance with regulations. Using the date of initial introduction
into interstate commerce is a more efficient enforcement approach
because this date is easier to determine (e.g., from shipping
documents) than the date the food was labeled (from manufacturers'
records). Even though the effective date established by the 1990
amendments was the date on which the label was applied to the food,
there is no indication in that law or its legislative history that
Congress intended that provision to change FDA's approach to effective
dates for other labeling requirements from the one the agency has
traditionally used.
III. References
The following references have been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Centers for Disease Control and Prevention, ``Recommendations
for the Use of Folic Acid to Reduce the Number of Cases of Spina
Bifida and Other Neural Tube Defects,'' in Morbidity and Mortality
Weekly Reports, 41, 1-7, 1992.
2. Kinnaird, Jula J., letter to F. Edward Scarbrough, April 18,
1996.
3. Howse, Jennifer L., letter to Secretary Donna Shalala, May
23, 1996.
Dated: August 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-22606 Filed 9-04-96; 8:45 am]
BILLING CODE 4160-01-F