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

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

[[Page 46716]]

$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