[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]



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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

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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