[Federal Register Volume 61, Number 44 (Tuesday, March 5, 1996)]
[Rules and Regulations]
[Pages 8781-8797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5014]



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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
standards of identity for several enriched grain products and, by 
cross-reference, the standards of identity for enriched bromated flour, 
enriched vegetable macaroni, and enriched vegetable noodle products, to 
require the addition of folic acid. The agency is requiring that these 
products be fortified with folic acid at levels ranging from 0.43 
milligrams (mg) to 1.4 mg per pound (mg/lb) or 95 micrograms 
(g) to 309 g/100 grams (g), of product. These values 
are based on a fortification level of 140 g/100 g (0.635 mg/
lb) of the cereal grain product. This action is being taken to help 
women of childbearing age to reduce their risk of having a pregnancy 
affected with spina bifida or other neural tube defects (NTD's) and to 
comply with the recommendation of the U.S. Public Health Service (PHS) 
that they consume at least 0.4 mg (400 g) of folic acid daily. 
This action also responds to a citizen petition submitted by Glenn 
Scott.
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.

SUPPLEMENTARY INFORMATION:

I. Background

    Recent estimates state that there are approximately 4,000 
pregnancies each year, including 2,500 live births, that are affected 
by spina bifida and other neural tube defects. In September 1992, PHS 
recommended that all women of childbearing age in the United States 
consume 0.4 mg (400 g) of folic acid daily to reduce their 
risk of having a pregnancy affected with spina bifida or other NTD's 
(Ref. 1). Furthermore, PHS identified several possible approaches by 
which folate intake by the target population could be increased. These 
approaches included: (1) Improvement of dietary habits, (2) 
fortification of the U.S. food supply, and (3) daily use of folic acid 
supplements by women throughout their childbearing years. However, the 
PHS recommendation cautioned against daily intakes of folate above 1 
mg. A recognized adverse effect of high intakes of folate is a masking 
of the anemia of vitamin B12 deficiency, allowing the neurologic damage 
to progress untreated. PHS noted that care should be taken to keep 
total folate consumption at less than 1 mg (1,000 g)/day, 
except under the supervision of a physician (Ref. 1).
    Following publication of the PHS recommendation, FDA convened a 
Folic Acid Subcommittee from its Food Advisory Committee (hereinafter 
referred to as the Folic Acid Subcommittee) to consider some of the 
issues raised by the recommendation. After consideration debate, the 
Folic Acid Subcommittee identified several approaches that might assist 
women of childbearing age to increase their daily folate intake. These 
approaches included: (1) Development of a fortification program such 
that 90 percent of women of childbearing age could receive at least 400 
g per day from all sources, while preventing 

[[Page 8782]]
excessively high folate intakes by nontarget groups; (2) appropriate 
labeling of foods, including dietary supplements; and (3) 
implementation of an educational program directed primarily at women of 
childbearing age that emphasizes the importance of folate intake before 
pregnancy, and continuing into early pregnancy and its potential effect 
on reducing the incidence of NTD's. (For a detailed discussion of the 
issues and concerns raised by the Folic Acid Subcommittee please refer 
to the Health Claims proposed rule (58 FR 23254 at 23256) and the final 
rule authorizing a health claim about the relationship between folate 
and neural tube defects (hereinafter referred to as the claims final 
rule) published elsewhere in this issue of the Federal Register.)
    After considering the suggestions of PHS and the Folic Acid 
Subcommittee, FDA tentatively concluded that development and 
implementation of a fortification program for the addition of folic 
acid to the food supply could be an effective part of an overall plan 
to increase the folate intake of women of childbearing age to assist 
them in reducing their risk of having a NTD-affected pregnancy. Food 
fortification, as noted by the Folic Acid Subcommittee and expert 
speakers who testified before the Folic Acid Subcommittee, has the 
advantage of reaching a great number of women in the target population 
before conception and during early pregnancy. It also has the advantage 
of providing folic acid in a continuous and passive manner and, thus, 
represents a potentially effective means for improving the folate 
nutriture of women throughout their childbearing years. However, 
fortification must be controlled to ensure that daily intake of folate 
by the target population, as well as by the general population, is no 
more than 1 mg.
    The issues raised by a fortification program were highlighted for 
the agency in the Federal Register of October 14, 1993 (58 FR 53254), 
in a document entitled ``Food Labeling: Health Claims and Label 
Statements; Folate and Neural Tube Defects,'' (hereinafter referred to 
as the folic acid health claims proposal) when it proposed to authorize 
a health claim about the relationship between folate and the risk of 
neural tube birth defects on the labels or in the labeling of foods and 
dietary supplements. In the folic acid health claims proposal (58 FR 
53254 at 53270), FDA acknowledged that authorizing a health claim on 
folate and NTD's would create the likelihood that manufacturers would 
fortify their products with folic acid so that they could qualify to 
bear the claim, thereby increasing the possibility of uncontrolled 
fortification of the food supply. Consequently, FDA said that any 
fortification program that it adopted must be consistent with a safe 
range of intake for all population groups and yet be capable of 
maximizing the folate intakes of the target population within this safe 
range.
    The options that FDA considered for providing folic acid to women 
of childbearing age through food fortification included the addition of 
folic acid to cereal-grain products, fruit juices, and dairy products. 
In weighing these options, FDA considered the effects of the inclusion 
of folic acid in breakfast cereals and in dietary supplements. The 
agency's decision to factor the amount of folic acid supplied by 
breakfast cereals and supplements in its estimates of the effects of 
fortification is fully discussed in the folic acid health claims 
proposal (58 FR 53254 at 53276).
    In determining the appropriate levels of fortification with folic 
acid, the agency used the U.S. Department of Agriculture's (USDA's) 
1987 to 1988 national food consumption data (Ref. 2) to estimate the 
daily intake of folate for the target population, as well as for the 
general population, with fortification at different levels for cereal-
grain products, dairy products, and juices. The agency estimated the 
effects of fortification using three values: 70, 140, and 350 
g of folic acid/100 g of cereal- grain product. As discussed 
in the folic acid health claims proposal, the value of 70 g/
100 g (0.317 g/lb) is the amount recommended in 1974 by the 
Food and Nutrition Board, National Research Council, National Academy 
of Sciences, and would restore the folate lost in the milling of 
cereal-grain products (Ref. 3). The value of 140 g/100 g is 
twice that amount, and 350 g/100 g is five times that amount.
    FDA's analysis showed that when fortification included fruit juices 
and dairy products in addition to cereal-grain products, ready-to-eat 
breakfast cereals, and dietary supplements, intakes by consumers in 
some nontarget groups exceeded 1 mg/day even at the lowest level of 
fortification. However, when fortification is limited to cereal-grain 
products at levels of 70 g/100 g or 140 g/100 g, 
estimates of daily intakes remained below 1 mg/100 g. At fortification 
levels of 350 g/100 g, FDA estimated the daily intake to reach 
levels of 1,220 g/day, which exceeds the recommended safe 
upper limit.
    The agency also estimated the daily intake of folate for consumers 
who follow Federal government dietary guidance, such as the U.S. 
Dietary Guidelines and the DHHS/USDA Food Guide Pyramid, and consume 
cereal-grain products fortified with folic acid, to determine whether 
these consumers will have daily intakes in excess of the recommended 
safe upper limit of 1 mg/day.
    These estimates showed that consumers who followed even the low-end 
of recommendations from the USDA Food Guide Pyramid could, without 
supplement use, easily consume 420 g or more of folate per day 
from cereal-grain products fortified with 70 g/100 g. Further, 
such consumers' daily intake could triple if such products were 
fortified with 350 g folic acid/100 g.
    As a result of its analysis of fortification of several cereal-
grain, dairy, and juice products, FDA tentatively determined that 
fortification should be limited to cereal-grain products and not 
extended to dairy products and fruit juices. The agency noted that 
intakes by very large segments of the general population could reach 
several milligrams per day if all of these foods were fortified with 
folic acid.
    The agency also tentatively decided that the appropriate 
fortification level for cereal-grain products was 140 g/100 g. 
Based on the results of its analysis, FDA determined that fortification 
of cereal-grain products with 140 g/100 g, along with 
fortification of ready-to-eat breakfast cereals up to 100 g/
serving and dietary supplements up to 400 g per unit or per 
serving, would provide increased intakes of folate for women in their 
childbearing years, while keeping daily intakes for the nontarget 
population within the recommended safe upper limit of approximately 1 
mg/day. The agency noted that even with supplement use, 95th percentile 
intakes by adults 51+ years of age could reach 840 to 860 g/
day if these enriched cereal-grain products are fortified with 140 
g/100 g. While the agency recognized that this level 
approached the recommended safe upper limit and did not take into 
account likely underreporting biases regarding food intakes and 
underestimation of folate content of foods, it tentatively concluded 
that fortification of cereal-grain products with 140 g/100 g 
folic acid was the most appropriate fortification level of the three 
levels analyzed.
    In addition to estimating daily intakes of folate at the levels 
cited above, FDA reviewed the existing food additive regulation 
Sec. 172.345 (21 CFR 172.345) governing the use of folic acid to 
determine whether the regulation was adequate to ensure that addition 
of folic acid to foods would be consistent with 

[[Page 8783]]
the fortification proposals discussed above. As a result of its review, 
FDA recognized that the existing regulation lacked the guidance 
necessary for manufacturers to decide which foods are appropriate for 
fortification, and the levels at which folic acid can be added. More 
importantly, FDA realized that the regulation would not have limited 
the addition of folic acid to enriched cereal-grain products, breakfast 
cereals, and dietary supplements. In fact, the regulation as written 
would have permitted folic acid addition to virtually any food.
    Thus, in the same issue of the Federal Register that the agency 
proposed to authorize a health claim about the relationship of folate 
and NTD's (58 FR 53254 at 53270), it published a proposal entitled 
``Food Additives Permitted for Direct Addition to Food for Human 
Consumption, Folic Acid (Folacin)'' (58 FR 53312) (hereinafter referred 
to as the food additives proposal) to amend the food additive 
regulation to restrict the addition of folic acid to specific foods. In 
that document, FDA proposed, among other things, to establish a 
limitation on the addition of folic acid to breakfast cereals of 100 
g folic acid per serving, to retain current limitations (i.e., 
400 g/daily) on the use of folic acid in dietary supplements, 
and to permit the addition of folic acid to foods as authorized by the 
standards of identity. The agency tentatively concluded that such 
action was necessary to establish safe conditions of use for folic acid 
in the food supply and still assist the target population, women of 
childbearing age, to achieve the goal recommended by PHS that they 
consume at least 400 g of folate per day.
    Also, in the October 14, 1993, issue of the Federal Register, FDA 
published a proposal entitled ``Food Standards: Amendment of the 
Standards of Identity for Enriched Grain Products to Require Addition 
of Folic Acid,'' (58 FR 53305) (hereinafter referred to as the 
standards of identity proposal) to amend the following standards of 
identity to require the addition of folic acid at a fortification level 
of 140 g/100 g: enriched bread, rolls, and buns (Sec. 136.115 
(21 CFR 136.115)); enriched flour (Sec. 137.165 (21 CFR 137.165)); 
enriched self-rising flour (Sec. 137.185 (21 CFR 137.185)); enriched 
corn grits (Sec. 137.235 (21 CFR 137.235)); enriched corn meals 
(Sec. 137.260 (21 CFR 137.260)); enriched farina (Sec. 137.305 (21 CFR 
137.305)); enriched rice (Sec. 137.350 (21 CFR 137.350)); enriched 
macaroni products (Sec. 139.115 (21 CFR 139.115)); enriched nonfat milk 
macaroni products (Sec. 139.122 (21 CFR 139.122)); and enriched noodle 
products (Sec. 139.155 (21 CFR 139.155)) and, by cross-reference, the 
standards of identity for enriched bromated flour (Sec. 137.160 (21 CFR 
137.160)), enriched vegetable macaroni products (Sec. 139.135 (21 CFR 
139.135)), and enriched vegetable noodle products (Sec. 139.165 (21 CFR 
139.165)).
    FDA received approximately 170 letters in response to its proposal 
to amend the standards of identity for enriched cereal-grain products 
to require folic acid fortification at 140 g/100 g. Each 
letter contained one or more comments. The letters were from a wide 
range of sources, including individual members of FDA's Folic Acid 
Subcommittee and Food Advisory Committee, Federal and State Government 
agencies, a foreign government, health care organizations, academia, 
consumer organizations, medical professionals, consumers, industry, and 
industry trade associations. Some comments supported various provisions 
of the proposal. Other comments suggested modifications, revisions, or 
revocations of various provisions of the proposal. Some comments raised 
concerns that were more germane to issues discussed in the folic acid 
health claims and food additive proposals. These comments were 
forwarded to the appropriate dockets for response. Some comments raised 
issues that were outside the scope of this rulemaking and will not be 
addressed in this final rule. A summary of the relevant comments, the 
agency's responses to the comments, and a complete discussion of the 
agency's conclusions with respect to the fortification of enriched 
cereal-grain products follow.

II. Comments and Agency Response

A. Fortification

    1. The majority of comments recognized the need to assist women of 
childbearing age to increase their daily intake of folate to reduce 
their risk of an NTD-affected pregnancy. Many of these comments agreed 
with the PHS' and Folic Acid Subcommittee's recommendations that 
fortification of the food supply is an appropriate approach to achieve 
this goal. Several comments, however, opposed the use of fortification 
as a mechanism to address this need. Some of the comments opposed 
fortification because of uncertainties in the efficacy data. These 
comments stated that the available data do not indicate what minimum 
level of folate is needed to effect a significant reduction in NTD's, 
and they argued that, therefore, the decision to fortify is premature. 
These comments suggested that the agency wait until additional studies 
have been completed that better define the minimum level of folate 
needed to be effective or that identify other alternatives that would 
be effective in increasing the daily folate intake of the target 
population.
    While FDA recognizes that there is some uncertainty in the 
literature as to the optimal intake of folate required to reduce the 
risk of NTD's, PHS, in examining the data from the available human 
studies, found the evidence sufficiently consistent to make its 
recommendation that all women capable of becoming pregnant should 
consume 400 g folic acid daily. This target intake goal 
represents the best scientific judgment based on available data. It has 
also been supported by the Folic Acid Subcommittee.
    Furthermore, PHS, the Folic Acid Subcommittee, as well as other 
medical experts, recommended food fortification as part of an overall 
program to improve the folate intake of women of childbearing age. This 
recommendation is based on the fact that 50 percent of pregnancies are 
unplanned, and that a large segment of women in the target group will 
not use folic acid supplements daily. Thus, a passive means of ensuring 
that these women have adequate folate intake is important. The comments 
that opposed fortification did not submit any data in support of their 
position. Thus, the agency has no basis to reject the recommendations 
of PHS and the Folic Acid Subcommittee to develop a folate 
fortification program to assist women of childbearing age in consuming 
at least 400 g/day.
    Although the agency is aware that there are several ongoing studies 
on the relationship between folate and NTD's, it has not been persuaded 
by the comments to wait until additional studies have been completed to 
determine what minimum level of folate intake is likely to be 
effective. The agency has confidence in the data that suggest that at 
intake levels of 400 g/day, the incidence of NTD's can be 
reduced. Thus, the agency concludes that it would not be in the best 
interest of women in the target group to wait until these studies are 
completed and reviewed before implementing a program to assist them in 
increasing their daily intake of folate.
    The evidence that is available supports the position that the 
consumption of folate plays an important role in reducing the risk of 
neural tube birth defects. Weighing this evidence and recognizing that 
the majority of women in the target population do not consume the 
levels of 

[[Page 8784]]
folic acid recommended to reduce the risk of neural tube birth defects 
(Ref. 1), the agency concludes that it is appropriate to implement a 
fortification program at this time.
    Further, the agency is concerned that without the limitations that 
it is adopting in this final rule, and in the final rule entitled 
``Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Folic Acid (Folacin)'' (hereinafter referred to as the 
food additives final rule) which is published elsewhere in this issue 
of the Federal Register, to control the addition of folic acid to the 
food supply, the authorization of the health claim about folate and 
NTD's may encourage overfortification of the U.S. food supply and 
increase the risk of overconsumption of folate. Because the current 
food additive regulation does not limit or specify the types of foods 
that can be fortified with folic acid, approval of the claim, without 
any other action by the agency, could encourage manufacturers to 
fortify a variety of foods to qualify the food for a health claim. 
Consequently, without proper control over the types of foods that can 
be fortified with folic acid, overfortification could result.
    The amendment to the standards of identity for enriched cereal-
grain products to require the addition of folic acid at specific levels 
will help to ensure that the addition of folic acid to the food supply 
is done in a safe, rational, and reasonable manner because it will 
limit the number of foods that can be fortified and limit the level of 
fortification. The levels of fortification established in this final 
rule, coupled with the provisions governing addition of folic acid to 
nonstandardized foods established in the food additives final rule, 
will meet the goal of increasing folate intake among women of 
childbearing age while keeping the daily consumption of folate below 
the safe upper limit of 1 mg/day.
    2. Comments that opposed fortification asserted that consumers 
believe that fortification as proposed denies freedom of choice and 
control over daily folate intake and is, therefore, viewed as an 
attempt to medicate people without obtaining informed consent. These 
comments further asserted that fortification, as proposed, subjects 
them to the risk of overconsumption. As an alternative, these comments 
suggested that the effort to increase dietary folate intake in the 
target population focus on the use of dietary supplements because the 
amount of intake can be better controlled. They suggested that FDA work 
with other public health service agencies to establish policy 
initiatives equivalent to those used by the food and dietary supplement 
industries to market their products.
    The agency disagrees with these comments. The agency is providing 
for fortification with folic acid only in the standards of identity for 
enriched cereal-grain products. Unenriched cereal-grain products 
without folic acid will continue to be available. Consumers will be 
able to select foods made with the unenriched version of the product if 
they wish to avoid folic acid. Furthermore, the estimated daily intakes 
that will result from the level of fortification established in this 
final rule are well below the level of folic acid traditionally used to 
treat persons with folate deficiency. Therapeutic dosages of folic acid 
used for treatment of folate deficiency are generally in the range of 1 
to 5 mg/day and are administered under the supervision of a physician. 
Therefore, the comments that suggest that fortification of enriched 
cereal-grain products is an attempt to medicate the U.S. population 
simply have no basis in fact.
    Furthermore, the intakes that are likely to result from the level 
of fortification established in this final rule do not present a health 
concern to the general population, especially in conjunction with the 
provisions of the food additive final rule published elsewhere in this 
issue of the Federal Register. FDA has projected the total daily intake 
of folate that is likely to result from the levels of fortification 
that FDA is requiring and determined that it is well within the safe 
upper limit of intake. Moreover, cereal-grain products have a long 
history of being vehicles for improving the nutrient intake of the U.S. 
population. FDA requires the addition of niacin, thiamin, and 
riboflavin in the standards of identity for enriched cereal-grain 
products to improve the daily intake of these nutrients. Fortification 
of these products was instrumental in reducing the prevalence of 
diseases related to insufficient intake of these vitamins.
    In response to the comments that suggested that FDA rely on the use 
of dietary supplements to increase daily folate intake, the agency 
notes that in requiring the fortification of enriched cereal-grain 
products, it is not discounting the use of dietary supplements to 
assist women in the target group to increase their daily folate intake. 
In fact, the agency included the use of dietary supplements in its 
estimates to determine the appropriate level for fortification of 
enriched cereal-grain products. However, the agency is not confident 
that the use of dietary supplements alone will be sufficient to reach 
the target population when folate intake is critical (i.e., before and 
during the first 6 weeks of pregnancy).
    During the first 6 weeks of pregnancy many women are not even aware 
that they are pregnant and would likely not be under the care of a 
physician. Thus, as stated in several comments, there would be no 
reason to expect the many women who do not normally take supplements 
daily to be motivated to change this behavior. Therefore, supplement 
use cannot be relied on as the sole source for increasing dietary 
folate intake. As discussed above, the use of fortification of cereal-
grain products has the advantage of providing folic acid in a 
continuous and passive manner and, therefore, should be an effective 
means for improving the folate nutriture of women in their childbearing 
years.
    3. A few comments opposed to fortification suggested that, as an 
alternative, FDA encourage women in the target group to increase their 
daily folate intake by increasing consumption of foods that naturally 
contain high levels of folate such as blackeye peas.
    While FDA finds merit in the comments' suggestion to encourage 
women in the target group to increase their daily folate intake by 
increasing their consumption of foods naturally high in folate, the 
agency is not persuaded that such action makes food fortification 
unnecessary. The dietary guidance suggested by the comment can be used 
in conjunction with food fortification, as part of a program designed 
to help women in the target group to increase their daily folate 
consumption. A health claim about the relationship between folate and 
NTD's on a food that qualifies to bear the claim will contribute to 
such a program, regardless of whether the food naturally qualifies to 
bear the claim or qualifies on the basis of its fortification level. In 
addition, foods that naturally contain folate and qualify to bear a 
health or nutrient content claim are likely to be highlighted as a 
source of this nutrient. Such claims will encourage women in the target 
group to select these foods as a part of their diet.
    Most significantly, however, given the value of adequate folate 
intake by women of childbearing age and given the value of a program 
that allows women to obtain adequate folate by simply consuming such 
staples as bread and rolls, FDA sees no reason not to require 
fortification of such foods, even though foods exist that are naturally 
high in folate.
    4. Some comments opposed to fortification opined that fortification 


[[Page 8785]]
would not assure physicians and health care professionals that their 
patients are obtaining adequate amounts of folate from the food supply 
because the bioavailability of folate in foods is 25 to 75 percent 
depending on the food.
    As discussed in the folic acid health claims proposal, FDA 
considered several issues in developing its options for fortification. 
With respect to issues of bioavailability, FDA concluded that 
bioavailability cannot be meaningfully factored into fortification 
scenarios because issues of bioavailability are very complex, and no 
systematic data are available on many of the factors that affect 
bioavailability. Consequently, the estimates developed by FDA focused 
more on consumption patterns of various staple foods, and their 
availability and use in the U.S. food supply, than on the 
bioavailability of folic acid from a specific food.
    The comment did not provide information to persuade the agency that 
the complexity associated with bioavailability would significantly 
reduce the effectiveness of food fortification as part of an overall 
effort to improve folate nutriture among women in the target group.
    5. Two comments recommended revising the proposal to require the 
addition of vitamin B12 in a one-to-one ratio with folic acid. The 
comments contended that doing so will not only prevent vitamin B12 
deficiency, but it will also prevent the masking effect that may be 
caused with high consumption of folate. One comment urged FDA to design 
research that will determine the safety and effectiveness of fortifying 
the food supply with vitamin B12 along with folic acid because 
such fortification could eliminate the adverse effect of folate on 
vitamin B12 deficiency.
    The agency is not persuaded that the approach suggested by these 
comments addresses all of the safety concerns relating to persons with 
vitamin B12 deficiencies. As fully discussed in the food additives 
final rule, FDA rejects this recommendation because the available data 
do not establish that requiring the addition of vitamin B12 
whenever folic acid is added will eliminate the safety concerns 
relating to persons with vitamin B12 deficiencies that arise 
because of deficiencies in intrinsic factor (pernicious anemia) or 
other B12-related deficiencies.
    6. Two comments opposed to fortification stated that FDA should 
take the same position with respect to folic acid fortification that it 
did when it decided not to fortify foods with iron in the 1970's 
because of the concern about iron storage diseases.
    While the agency acknowledges that it considered taking a similar 
approach to increase the amount of iron provided by the diet when it 
proposed to double the amount of iron added to enriched cereal-grain 
products, the agency did not finalize that proposal because of 
significant safety concerns regarding the risk of iron storage 
diseases. Rather, the agency retained the existing level of iron 
fortification for cereal-grain products. The agency does not have 
similar safety concerns about the level of folic acid fortification 
that it is requiring in this final rule because it has concluded, based 
on a safety review (as fully discussed in the food additives proposal 
and final rule), that this required level is safe and will not result 
in overconsumption of folate.

B. Covered Products

    7. Some comments stated that dietary consumption studies indicate 
that women of reproductive age are less likely than other groups to 
consume enriched cereal-grain products that conform to a standard of 
identity, and that, therefore, the use of such foods as a vehicle for 
folic acid fortification would not significantly affect the risk of 
NTD's. These comments argued that, instead, fortifying these foods will 
only increase the amount of daily folate intake among the nontarget 
groups.
    In selecting cereal-grain products as vehicles for fortification, 
the agency started with the basic principle that fortification of 
staple products that are commonly consumed in significant amounts by 
virtually all members of the target population is most likely to result 
in increased intakes of a specific nutrient by the target population. 
Although the agency recognizes that current survey data suggest that 
consumption of enriched grain products may be somewhat lower in the 
target population than in other groups, these foods still are reported 
to be consumed on a daily basis by more than 90 percent of women of 
childbearing age (Ref. 4). In addition, data show that the difference 
between target and nontarget populations in consumption of other foods 
considered as fortification vehicles, such as dairy products and 
juices, is even greater (Ref. 4). Therefore, the other foods would be 
no more appropriate as fortification vehicles for maximizing folate 
intake by the target group, and yet maintaining safe consumption by 
nontarget groups, than cereal-grain products.
    The agency notes that cereal-grain products were recommended by the 
Food and Nutrition Board in its 1974 report on food fortification as 
fortification vehicles because of the patterns of consumption of these 
foods. In addition, enriched cereal-grain products have a long history 
of being successful vehicles for improving the nutriture of the U.S. 
population and for reducing the risk of nutrient deficiency diseases. 
Thus, the agency concludes that enriched cereal-grain products are an 
appropriate vehicle to increase daily folate intake among women of 
childbearing age. In fact, the estimates that FDA developed in 
evaluating options for folic acid fortification demonstrate that the 
addition of folic acid to enriched cereal-grain products, coupled with 
the addition of this nutrient to breakfast cereals and dietary 
supplements, will help to significantly increase the daily folate 
intake of women in the target group (see Table 7 of 58 FR 53254 at 
53295)).
    Furthermore, increasing awareness of the role of folate in reducing 
the risk of neural tube birth defects through the use of health claims 
and other educational initiatives should encourage women in the target 
group to increase their daily folate intake by consuming folate 
containing foods, including enriched cereal-grain products. Consumption 
of cereal-grain products is also likely to be influenced by current 
dietary guidelines that promote increased consumption of these foods.
    8. Other comments requested that FDA permit the addition of folic 
acid to other cereal-grain products such as whole grain flours, breads, 
cereals, macaroni products, rice, and grits and not just the enriched 
cereal-grain foods that conform to a standard of identity. The comments 
argued that without these products being fortified, consumers may be 
encouraged to eat enriched refined grains instead of their whole grain 
counterparts and consequently follow dietary patterns that are 
inconsistent with current dietary guidelines to eat whole grain 
products.
    FDA did not propose to provide for the addition of folic acid to 
whole grains or products from whole grains because, traditionally, 
these products are not enriched. Whole grain wheat products naturally 
contain higher levels of the B vitamins, including folate, because the 
germ and bran layer are not removed when the wheat kernel is processed. 
FDA's standards of identity for cracked wheat, crushed wheat, and whole 
wheat flour, in Secs. 137.190, 137.195, and 137.200, respectively, 
state that the proportions of the natural constituents of such wheat, 
other than the moisture, remain unaltered by the manufacturing process. 
In establishing the standards of identity for the enriched cereal-grain 
products, the agency's initial goal was to 

[[Page 8786]]
restore thiamin, niacin, and riboflavin, nutrients that are removed 
when the bran layer and germ are removed during the processing of 
wheat. Subsequently, the agency required the addition of iron to the 
enriched grain and also provided for the optional addition of other 
nutrients, such as calcium and vitamin D.
    The estimates that the agency has relied on in selecting a 
fortification level of 140 g/100 g considered only 
fortification of breakfast cereals, dietary supplements, and 
standardized enriched cereal grain products and did not include 
fortification of other nonstandardized or unenriched standardized 
cereal-grain products. Consequently, including such foods in the 
fortification program could result in a daily intake of folate that is 
above the safe upper limit of 1 mg/day. Thus, the agency is not 
persuaded by the comment that other cereal-grain products should be 
fortified with folic acid.
    With regard to the concern raised in the comment that fortification 
of enriched cereal grain products may encourage consumers to choose 
these products over their whole grain counterparts, the comment did not 
provide any support for its concern. The decision to fortify enriched 
cereal grain products at the level of 140 g/100 g is based on 
current dietary consumption patterns. The agency is not persuaded by 
the comments that the addition of folic acid will significantly change 
consumption patterns of the target population. There is no evidence 
that women will suddenly start consuming enriched products instead of 
whole grain foods. In fact, one reason the agency has decided to 
require the fortification of enriched cereal-grain products is to 
enable women of childbearing age to significantly increase their daily 
folate intake without changing their dietary habits. Finally, the 
agency notes that while current dietary recommendations do encourage 
increased consumption of whole grain foods, they also encourage 
consumption of all cereal-grain products.
    9. One comment expressed concern that the agency's tentative 
decision to fortify cereal-grain products was unfair to the cereal-
grain industry because it singled out one segment of industry to 
address a health concern. (The agency notes that the comment was not 
submitted by a member of the cereal grains industry.)
    As discussed in the folic acid health claims proposal, FDA 
considered several options that included fortification of dairy 
products and juices before concluding that the most appropriate option 
was to limit fortification to enriched cereal-grain products. Aside 
from the fact that these products have a long history of successful use 
as vehicles for increasing nutrient intake among U.S. consumers, 
consumption data and other relevant information reviewed by the agency 
show that these products are consumed routinely on a daily basis by 90 
percent of women in the target group. Furthermore, some comments 
submitted to the docket by representatives of the cereal grains 
industry stated that, generally, these products can be easily fortified 
with folic acid. Therefore, FDA concludes that the enriched cereal-
grain products are the appropriate foods for fortification, and that 
fortification of these products is not unfair to the industry.

C. Fortification Level

    10. In the standards of identity proposal, FDA requested comments 
on whether the proposed fortification levels discussed for enriched 
cereal-grain products were appropriate. Comments responding to this 
issue were varied. Some comments that supported fortification of 
cereal-grain products stated that the proposed levels were too low to 
have any appreciable effect on reducing the risk of NTD's in the target 
population. One of these comments urged the agency to revise its 
proposal and require fortification at levels of at least 210 
g/100 g. However, the majority of these comments recommended 
that FDA require fortification of folic acid within the range of 250 to 
350 g/100 g. In support of their position, these comments 
contended that this range was well within limits for safety and should 
not mask the effects of vitamin B12 deficiency. One comment 
further argued that at a fortification level of 350 g/100 g, 
95 percent of persons in the nontarget population would not consume 
more than 1 mg per day. One comment recommended 400 g/100 g 
for cereal-grain products. This comment argued that fortification of 
enriched cereal-grain products should be at the same level as dietary 
supplements.
    However, supplemental comments submitted by a majority of the 
organizations supporting a higher fortification level, stated that 
implementing fortification at a level of at least 140 g/100 g 
will constitute a critically important step forward for the health of 
American children. Some of these comments further stated that 
fortification with at least 140 g/100 g will be the most 
efficient and cost-effective approach to ensuring that women of 
childbearing age consume the level of folic acid recommended to reduce 
the risk of having a neural tube defect affected pregnancy.
    The agency agrees with the latter comments. As discussed in the 
folic acid health claims proposal (58 FR 53254 at 53279), fortification 
of cereal-grain products at 140 g/100 g will produce a 
significant increase in daily folate intake, even for women who make 
food choices from the ``low'' range of the USDA Food Guide Pyramid and 
consume only 5 servings/day of cereal-grain products and 1 bowl of 
cereal containing a minimum of 100 g of folic acid. From these 
sources alone, these women will consume about 320 g of folic 
acid. Addition of a serving or two of vegetables, or of a serving of 
fruit, will provide them with a folate intake above 500 g/day. 
Thus, fortification of cereal-grain products at 140 g/100 g is 
an important step in assisting women of childbearing age achieve the 
PHS recommendation of consuming 400 g.
    However, if cereal-grain products were fortified at 350 g/
100 g, and the dietary choices indicated above were made, a ``low'' 
consumer would obtain 610 g folic acid daily from these 
sources alone. Thus, at a fortification level of 350 g/100 g a 
``high'' consumer could reach intakes of folic acid of more than 1 mg/
day from bread, noodle, rice, and pasta products alone. Additional 
consumption of breakfast cereals, fruits, vegetables, and a dietary 
supplement by ``high'' consumers could result in daily intakes of 
folate of about 2.5 mg/day, a level significantly above the safe upper 
limit of daily intake of 1 mg.
    The comments supporting fortification of enriched cereal-grain 
products at levels above 140 g/100 g did not provide any 
information to the agency that it had not considered in developing its 
proposed rules. Nor did the comments offer alternative fortification 
schemes that would allow addition of folic acid to enriched cereal-
grain products at levels exceeding 140 g/100 g yet limit the 
daily intake of folate to levels that are within the safe upper limit 
of 1 mg/day. Consequently, FDA disagrees with those comments that 
suggested that enriched cereal-grain products be fortified at levels of 
at least 210 g/100 g. There simply is no evidence in the 
record that such a fortification program would keep folate intakes 
within the safe upper limit.
    Accordingly, as proposed, the agency is requiring the addition of 
folic acid to enriched cereal grain products at a fortification level 
of 140 g/100 g. FDA concludes that 140 g/100 g is the 
maximum level of fortification of enriched cereal-grain products that 
would be safe for all groups. 

[[Page 8787]]

    Nonetheless, as the agency states in the final rule on the use of 
folic acid as a food additive, which is published elsewhere in this 
issue of the Federal Register, given the nature of the support for 
higher folic acid fortification levels in the comments, if evidence 
becomes available to support that there is a reasonable certainty of no 
harm at folate intakes above 1 mg/day, FDA would be willing to 
reconsider the fortification levels that it is adopting and to consider 
raising those levels.
    11. Other comments opposed fortification at the proposed level of 
140 g/100 g on the grounds that it is too high. These comments 
asserted that such fortification may increase the risk of consuming 
folate at levels in excess of the safe upper limit of 1 mg/day in a 
substantial portion of the general population. Some of these comments 
suggested that FDA consider the lower fortification level of 70 
g/100 g in conjunction with an educational campaign that could 
still be effective in reducing the risk of NTD's yet not pose the risk 
of daily consumption of folate in excess of 1 mg/day.
    In support of their position, some of these comments noted that the 
Food and Nutrition Board recommended the fortification of cereal-grain 
products at 70 g/100 g to restore folate lost in the milling 
of cereal-grain products. Another comment supporting fortification at 
the restoration level contended that such action would permit 
additional restorations of nonstandardized foods such as breakfast 
cereals. One comment from a foreign government questioned FDA's 
decision to require folic acid fortification of all enriched cereal-
grain products when the data do not clearly establish the effectiveness 
and safety of the proposed intervention program. However, the comment 
suggested support of the Food and Nutrition Board's 1974 proposal for 
cereal grain fortification, i.e., fortification with folic acid at 70 
g/100 g.
    In the standards of identity proposal, FDA tentatively concluded 
that fortification of cereal-grain products with 140 g/100 g 
folic acid was the most appropriate fortification level of the three 
levels analyzed to ensure that folate intakes by the target population 
would increase. The comments have not persuaded the agency that a 
fortification level of 70 g/100 g could be as effective in 
assisting women in the target population to achieve the PHS recommended 
daily intake of 400 g. In fact, at a fortification level of 70 
g/100 g, the estimated daily folate intake by ``low'' 
consumers among women of childbearing age is not likely to reach the 
PHS recommended levels of 400 g/day without changes in their 
food selection practices (see Table 4 of 58 FR 53254 at 53292). While 
the agency must ensure that the use of folic acid in the food supply is 
safe, it must also provide as great an opportunity as is prudent and 
rational for all women of childbearing age to increase their intake to 
the recommended level. The agency concludes that a level of 140 
g/100 g is the most appropriate fortification level for 
enriched cereal-grain products because, based on the results of its 
estimated daily intakes, fortification at this level will provide daily 
intakes for the nontarget population that remain within the recommended 
safe upper limit of 1 mg/day, while providing increased intakes of 
folate for women in their childbearing years (see Table 7 of 58 FR 
53254 at 53295).
    The agency notes, however, that it has reconsidered its proposed 
fortification level for breakfast cereals. As fully discussed in the 
food additives final rule, published elsewhere in this issue of the 
Federal Register, FDA is permitting breakfast cereals to contain up to 
400 g of folic acid per serving. As explained in that 
document, the estimates for total daily folate intake that FDA 
presented in the folic acid health claims proposal were based on the 
assumption that all breakfast cereals were fortified at 400 g/
serving. Based on those estimates, daily folate intake for certain 
groups in the nontarget population could exceed the recommended safe 
upper limit of 1 mg/day. Currently, however, only about 3 to 6 percent 
of breakfast cereals fortify at 400 g/serving. The agency has 
found no reason to expect that this percentage will change and, 
therefore, considers it unlikely that daily folate intake in the 
nontarget population will exceed 1 mg with the fortification program 
adopted in this final rule and in the food additives final rule.

D. Optional Versus Mandatory

    Because of the increased health risk to persons with vitamin B 
12 deficiency caused by increased levels of folate intake, FDA 
solicited comments in the standards of identity proposal on whether the 
addition of folic acid to enriched cereal-grain products should be 
required as proposed or made optional.
    12. A few comments fully supported the agency's proposal to require 
folic acid addition to the enriched cereal-grain products. These 
comments contended that required addition of folic acid was an 
appropriate means of increasing the daily folate intake of women in the 
target population. However, the majority of the comments that responded 
to this issue stated that fortification should be voluntary. The 
comments cited varied reasons in support of their position. Some 
comments stated that the addition of folic acid to enriched cereal-
grain products should be optional pending further evidence that the 
benefits outweigh the risk of masking vitamin B12 deficiency. 
These comments contended that mandatory fortification of a wide variety 
of common products may create difficulty for people wishing to avoid 
folic acid. Furthermore, the comments asserted that FDA failed to 
establish why mandatory fortification would be necessary given that 
under current regulations voluntary fortification of standardized foods 
with folic acid is prohibited.
    Other comments recommended optional fortification so that millers 
will not have to change their enrichment premixes for the general flour 
supply, thereby minimizing the costs associated with fortification, 
i.e., label changes, analytical testing, and inventory and supply 
coordination, especially for products exported to countries that do not 
permit folic acid fortification. The comments also stated that 
voluntary fortification would facilitate compliance with the various 
State enrichment laws.
    A few comments opposed to mandatory fortification stated that FDA 
failed to offer information as to why voluntary fortification would not 
be sufficient to accomplish the public health goal of decreasing the 
incidence of pregnancies with neural tube birth defects. The comments 
urged FDA to establish a voluntary fortification program for enriched 
cereal-grain products and to reassess the need for a mandatory 
fortification in several years. One of these comments acknowledged, 
however, that it is difficult to predict the extent of voluntary 
fortification.
    A small number of comments supported voluntary fortification for 
only the enriched noodle and macaroni products. The comments contended 
that voluntary compliance is consistent with FDA's current standards of 
identity for enriched noodle and macaroni products with regard to 
vitamin D, calcium, and wheat germ.
    The agency does not agree with the comments that argued that the 
fortification of enriched cereal-grain products should be voluntary. In 
accepting the PHS' and Folic Acid Subcommittee's recommendation to 
include fortification as part of an overall plan to increase the folate 
nutriture of women of childbearing age, FDA has concluded that in order 
for a fortification program to be effective, 

[[Page 8788]]
fortification must be mandatory for the enriched cereal-grain products. 
FDA is concerned that if it made fortification voluntary, and voluntary 
fortification were not widespread, there would be only a negligible 
increase in the daily folate intake of the target group, and the intent 
of this rulemaking would have been defeated. FDA finds that there is a 
public health need for women in their childbearing years to have 
adequate folate intake, and that the only way that it can ensure that 
they will have such an intake is through mandatory fortification.
    FDA has traditionally used mandatory fortification to restore 
nutrients lost during the processing of cereal grains and thereby to 
address the need for reducing the risk of certain vitamin deficiency-
related problems. The comments have not persuaded the agency that the 
same basic approach should not be applied in this case, where low 
folate intake represents a risk factor for a neural tube defect-
affected pregnancy. USDA consumption data show that 90 percent of women 
of childbearing age consume cereal-grain products. Thus, mandatory 
fortification of cereal grains will, as stated above, increase folate 
intake among the target group, without requiring significant change in 
dietary patterns. Consequently, mandatory fortification of enriched 
cereal grains will help to ensure that the daily intake among the 
target group will reach the PHS recommended level of 400 g. 
Voluntary fortification does not offer the same likelihood that folate 
intake will result in intakes that approach the PHS recommendation 
because the decision to fortify with folic acid will be at the 
discretion of individual manufacturers. Therefore, voluntary 
fortification will not adequately address the need for increased folate 
intake among women of childbearing age.
    FDA derived the fortification levels established in this final rule 
based in part on a safe upper limit of 1 mg folate/day. The agency has 
concluded that mandatory fortification of the enriched cereal-grain 
products at the levels provided in this final rule is not likely to 
increase the risk of ``masking'' anemia in vitamin B12 deficient 
persons. Thus, the fortification program that FDA is adopting will help 
to ensure that the amount of folate that people in all groups of the 
population can reasonably be expected to consume will not exceed 1 mg/
day. As discussed in the food additives final rule, the agency has 
examined the available data on the levels of folate that may mask 
anemia of vitamin B12 deficiency and concluded that a daily intake 
of up to 1 mg of folate is safe.
    In response to concerns raised by millers regarding label changes, 
analytical testing, and inventory and supply coordination, FDA 
recognizes that manufacturers will need ample time to implement the 
changes required by this amendment of the standards of identity. As 
discussed below in the effective date section, FDA is permitting 
manufacturers time to coordinate any necessary changes that need to be 
made throughout the chain of food production to comply with the 
requirements established in this final rule as well as with the 
requirements set out in part 101 (21 CFR part 101).
    The agency notes that manufacturers will continue to have the 
option of using unenriched cereal-grain products as ingredients in 
foods and to add enrichment nutrients to those products as they choose. 
Several comments from industry representatives raised a concern that 
the provisions in the food additive proposal would not permit addition 
of folic acid at the bakery site. To the contrary, as discussed in the 
food additives final rule, FDA will permit addition of folic acid at 
the bakery site as long as it is in compliance with the governing 
standard of identity. Consequently, manufacturers will have the same 
option of adding folic acid as they have with other enrichment 
nutrients when preparing foods that are made with unenriched cereal-
grain ingredients. The agency notes, however, that any products 
marketed as a standardized enriched cereal-grain product will have to 
contain folic acid at the levels established in this final rule, and 
that these requirements preempt state enrichment requirements that are 
not identical (see section 403(a) of the act (21 U.S.C. 343(a))).
    With regard to exported products, the agency recognizes that 
manufacturers may be required to maintain separate inventories for 
foreign and domestic sales. While FDA recognizes the importance of 
reducing trade barriers, its first obligation is to protect and promote 
the health of U.S. consumers. In that regard, the agency concludes 
that, because the fortification program adopted in this final rule is 
necessary to significantly reduce the incidence of neural tube defect 
affected pregnancies, it would not constitute an illegal trade barrier.

E. Other Issues

    13. One comment from a consumer interest group recommended that if 
research and monitoring does not establish in the next 2 years that the 
risk of increasing folate intakes is significant for persons affected 
with vitamin B12 deficiency or any folate-related diseases, then 
FDA should increase the fortification levels in grain products or other 
foods and require that upper safe limits be disclosed in higher dose 
products. This comment urged FDA to initiate a rulemaking to restore 
refined grain products with most of the vitamins and minerals that are 
removed during milling as recommended by the Food and Nutrition Board 
in 1974. The comment stated its belief that such an approach would 
raise few safety concerns and would not be costly because manufacturers 
are already equipped to add nutrients to food.
    FDA cannot at this time commit to increasing the levels of folic 
acid that may be added to food within the next several years. However, 
as stated above, should data become available that demonstrate that 
modifications need to be made to improve the effectiveness of the 
intervention program, and evidence be developed that the safe upper 
limit can be raised, FDA will decide what action is necessary. The 
agency notes, however, that the action it is taking in this rulemaking 
will more than compensate for the amount of folate lost during the 
milling process.
    As for the comment's request that FDA initiate rulemaking to 
restore to refined grain products other vitamins and minerals that are 
removed during milling raises, the agency notes that the request issues 
outside the scope of this rulemaking. Therefore, no action on this 
request is appropriate at this time.
    14. Several comments raised concern regarding the impact of the 
proposed regulation on foreign trade. One comment from a foreign trade 
association urged FDA to delay finalizing the proposed regulation to 
provide the International Harmonization Working Groups the opportunity 
to review the proposal and recommend a strategy that would serve public 
health goals, while achieving the spirit and intent of the North 
American Free Trade Agreement (NAFTA). Another comment stated that the 
extra costs and inherent inefficiencies of separate production runs 
could preclude some manufacturers from the export marketplace.
    Other comments stated that the lack of consistent requirements for 
folic acid fortification between major trading partners, e.g., the 
United States and Canada, would create problems in cross-border trade 
and could result in higher costs for both U.S. and foreign consumers. 
Furthermore, these comments asserted that inconsistent requirements 
could reduce the competitiveness of domestic 

[[Page 8789]]
manufacturers who export their products. Thus, the comments urged FDA 
to resolve the issue of exporting folic acid enriched products to 
foreign countries by working with foreign governments to permit export 
of folic acid-enriched food.
    FDA recognizes that the provisions it is adopting in this final 
rule may be inconsistent with the fortification policies of other 
countries. However, as discussed above, the agency finds that the 
action that it is taking in this final rule is necessary to adequately 
protect the public health of U.S. consumers. FDA will continue to work 
with officials in other countries, particularly parties to NAFTA, to 
find ways to reduce barriers to cross-border trading of cereal-grain 
products and other foods.

F. Specific Standards of Identity

    In this document, the agency is providing for the addition of folic 
acid at the level of 140 g/100 g to the individual enriched 
cereal-grain products that are the subject of standards of identity. 
The agency described indepth the method that it used in arriving at the 
levels of addition for folic acid in the specific standards of identity 
in the standards of identity proposal. FDA will not describe that 
method again in this document except to the extent that clarification 
is warranted in response to specific comments. For a complete 
discussion of the basis on which FDA established the enrichment levels 
for the subject standards of identity, the agency refers interested 
persons to the standards of identity proposal (58 FR 53305 at 53307 to 
53309).
1. Bakery and Wheat Flour Products
    15. One comment, while supportive of the proposal to fortify 
cereal-grain products, suggested that a range of levels be permitted 
for addition of folic acid to all enriched cereal-grain products 
because of the inherent variation in the addition of the vitamins, the 
distribution of the vitamins in a food, and the analytical methodology. 
The comment suggested that FDA permit the addition of folic acid within 
a range of 24 to 35 percent over the amount established for each 
individual standard. For example, the comment suggested that the 
proposed amount of 0.7 mg/lb for enriched flour should be revised to 
0.7 to 0.91 mg/lb. The comment argued that this scheme is the same as 
that used for enrichment in the macaroni and noodle standards and is 
needed for the same reasons that it is provided for in those standards.
    FDA does not agree that it is necessary to provide for a range in 
the level of folic acid used in the production of all enriched cereal-
grain products. Providing for a single level, with provision for 
reasonable overages within the limits of current good manufacturing 
practice (CGMP), has worked well with the other nutrients (thiamin, 
niacin, riboflavin, and iron) required to be added to enrich bread, 
rolls, and buns and various flour products. The provision for 
``reasonable overages'' in the standards for enriched bread, rolls, and 
buns (Sec. 136.115(a)(3)) and enriched flour (Sec. 137.165(c)) provides 
manufacturers with flexibility to ensure that required levels for the 
added nutrients will be met, and that these levels will be maintained 
throughout the shelf life of the food under customary conditions of 
distribution and storage. While FDA is not establishing a specific 
upper limit for folic acid addition, the agency advises that reasonable 
variations for overages of folic acid will be assessed on the same 
basis as that for the other added nutrients in these foods. Those 
reasonable variations are based on a number of factors, including the 
technology of nutrient addition, the possibility of nutrient 
deterioration, the firms' quality control procedures, and appreciation 
by the manufacturer of these factors.
    FDA acknowledges that some of the standards for enriched cereal-
grain products that are the subject of this final rule specify the 
levels of added nutrient (thiamin, riboflavin, and iron) in terms of 
ranges, and FDA has continued this approach with respect to the 
addition of folic acid in those products. In addition, the agency notes 
that it received a petition (Docket No. 94P-0413/CP 1) subsequent to 
the issuance of the folic acid health claims proposal to amend the 
standards for enriched macaroni and noodle products to provide for 
nutrient addition in terms of a single level with provision for 
reasonable overages. However, FDA is not making the change to a single 
enrichment level in those standards at this time because, while it has 
reached a final decision on folic acid fortification, it has not had an 
opportunity to fully analyze the petition. FDA is not aware of any 
reason why it should delay action in the present rulemaking while it 
analyzes the petition. Thus, until such time as the agency rules on the 
petition, the standards in question will continue to provide for 
nutrient addition in terms of ranges.
    The ranges established in those standards provide a measure of 
flexibility in selecting the target level when nutrients are added to 
foods that consist of large particles such as farina or rice, or for 
preparations (e.g., semolina or other ingredients) used for 
manufacturing enriched macaroni or noodle products. The nutrients, 
which usually are in the form of a fine powder, have a tendency to 
settle out and to make uniform blends with the cereal grains more 
difficult to achieve. In such instances, manufacturers, depending on 
their application process, may select target levels at the upper end of 
the range to ensure that the minimum levels established for the 
nutrients will be met. Thus, to enable manufacturers to adhere to 
procedures that will deliver the minimum level of nutrients required by 
the standards and to compensate for variables in the processing 
operations, the agency is continuing to provide for nutrient additions 
in terms of ranges for the other enriched foods as set forth below.
    FDA also notes that the regulations for nutrition labeling in 
Sec. 101.9(g)(4)(i) require that added nutrients be present in the food 
at levels that are at least equal to the amount declared on the label. 
In addition, Sec. 101.9(g)(6) provides for reasonable overages within 
the limits of CGMP. Thus, the manufacturer bears the responsibility of 
ensuring that not only will the requirements for added nutrients in the 
respective standards of identity be met, but also that the content of 
any added nutrient is accurately declared in nutrition labeling. 
Therefore, consumers should receive the stated quantity of each added 
nutrient whether the standard provides for the added nutrient in terms 
of a single level or a range.
    a. Enriched flour. No specific comments were received on the 
fortification of enriched flour with folic acid. Thus, as proposed, FDA 
is requiring that enriched flour contain 0.7 mg/lb of folic acid. FDA 
derived this value by adding the fortification level of 0.635 mg/lb to 
the Food and Nutrition Board's folate value of unfortified flour of 
0.076 mg/lb, which yields 0.711 mg/lb. The agency rounded this value to 
0.7 mg/lb. Accordingly, based on this calculation, FDA is amending the 
standards of identity for enriched flour (Sec. 137.165) and enriched 
self-rising flour (Sec. 137.185), and, by cross-reference, enriched 
bromated flour (Sec. 137.160), to require that these foods contain 0.7 
mg/lb of folic acid.
    b. Enriched bread, rolls, and buns. FDA is amending the standards 
of identity for enriched bread, rolls, and buns in Sec. 136.115 to 
require that these foods contain 0.43 mg/lb of folic acid. This rate of 
fortification is proportionally consistent with the fortification rate 
for the B vitamins (thiamin, riboflavin, and niacin) when 

[[Page 8790]]
enriched flour is used in making these foods. For example, the levels 
of thiamin, riboflavin, and niacin in enriched flour (Sec. 137.165) are 
2.9, 1.8, and 24.0 mg/lb, respectively, and in enriched bread 
(Sec. 136.115) are 1.8, 1.1, and 15.0 mg/lb, resulting in a ratio of 
approximately 1.62 to 1. In the case of the level of folic acid, the 
level for enriched flour is 0.7 mg/lb compared to 0.43 mg/lb for bread, 
resulting in a ratio 1.63 to 1. The levels of enrichment specified for 
the B vitamins and folic acid content are slightly lower in enriched 
bread products than in enriched flour to allow the bread products to be 
made from the standardized enriched flour without further 
fortification.
    c. Enriched farina. In the standards of identity proposal, FDA 
proposed to establish a fortification level for folic acid in enriched 
farina (Sec. 137.305) on the same basis as that for enriched wheat 
flour, i.e., 1 lb of the food would contain not less than 0.7 mg of 
folic acid.
    One comment disagreed with the agency's rationale and argued that 
enriched farina is a different product than enriched wheat flour and 
therefore should not be fortified at the same level as enriched wheat 
flour. The comment asserted that farina is used differently than flour. 
For example, according to the comment, farina is often used as an 
ingredient in the less expensive pastas to replace the more expensive 
semolina. The comment pointed out that farina is also eaten as a hot 
cereal, and that precooked breakfast cereals are fortified with folic 
acid. The comment did not offer an alternative fortification level or 
data on which an alternative level could be based.
    Because both wheat flour and farina are made from the endosperm of 
wheat, that portion of the wheat kernel that remains after the bran 
layer and germ have been removed, and because it is the bran layer and 
germ that contain most of the B vitamins, including the naturally 
occurring folate, the amount of B vitamins lost during processing would 
be similar in both foods. Therefore, the agency finds that it is 
reasonable to fortify both flour and farina on the same basic level of 
140 g/100 g.
    However, FDA acknowledges that enriched farina and enriched flour 
may serve different functions. Farina is often used as a substitute for 
a flour-containing food, e.g., as a hot cereal at breakfast, with or 
without other cereal-grain products being consumed at that meal, and it 
may be used in other foods such as pasta. However, the agency finds no 
basis to change the fortification level based on these possible end 
uses of the products because these uses are governed by other 
regulations. For example, when farina is used as an ingredient in the 
manufacture of precooked or instant breakfast cereal products, the 
level of enrichment is governed by the food additive regulation in 
Sec. 172.345. That regulation provides that such ready-to-eat cereals 
may be enriched with folic acid up to 100 percent of the daily value 
per serving (i.e., 400 g/serving). Neither this final rule nor 
the food additive final rule published elsewhere in this issue of the 
Federal Register, would affect the continued addition of folic acid to 
the precooked or ready-to-eat breakfast cereals that are manufactured 
with farina.
    With respect to pasta products, the agency notes that the standard 
of identity for enriched macaroni and noodle products provides for the 
use of farina as an ingredient. However, the agency is not persuaded 
that it should adjust the fortification level for farina based on this 
possible use of this food. In cases where farina is used as an 
ingredient in an enriched macaroni or noodle product, the manufacturer 
has the option of adding enrichment nutrients to the farina at the 
flour mill or at the manufacturing facility to meet the requirements of 
the standard of identity for enriched macaroni or noodle products.
    One comment pointed out that farina is not washed before cooking as 
had been noted in the proposal, and, thus, washing should not be a 
factor in determining appropriate fortification levels.
    The agency acknowledges that current farina product labels do not 
suggest that enriched farina products need to be rinsed before cooking. 
Thus, with current technology, rinsing of the enriched farina product 
would not be a factor in deciding on an appropriate value for vitamin 
and mineral addition to farina. However, the agency notes that the 
proposed upper limit was not based solely on the fact that the product 
may be rinsed but also on the fact that it may be diluted when prepared 
in other recipes. The comment did not offer data to persuade the agency 
to deviate from the proposed upper limit of folic acid addition. Thus, 
as proposed, the agency is amending the standard of identity for 
enriched farina to provide for an upper limit for folic acid addition 
(0.87 mg/lb) that is approximately 25 percent higher than the minimum 
of 0.7 mg/lb as it has done for the other B vitamins (thiamin, 
riboflavin, and niacin) that are required to be present in enriched 
farina.
2. Corn and Rice Products
    a. Enriched corn grits. No specific comments were received 
regarding the addition of folic acid to enriched corn grits. Thus, as 
proposed, FDA is amending Sec. 137.235 to require fortification of 
enriched corn grits with the same level of folic acid as that 
established for enriched wheat flour products, such that each pound of 
the food would contain at least 0.7 mg of folic acid. FDA is also 
establishing the proposed upper limit for folic acid fortification of 
1.0 mg/lb, which is approximately 50 percent higher than the minimum of 
0.7 mg/lb, as it has done for the other B vitamins (thiamin, 
riboflavin, and niacin) that are required to be present in enriched 
corn grits.
    The agency notes that it published a proposed rule in the Federal 
Register of October 13, 1995 (60 FR 53480), that would revoke the 
standard of identity for enriched corn grits. If comments to the 
proposal support revocation of this standard of identity, the 
provisions set forth in this final rule for enriched corn grits will 
also be revoked. FDA believes, however, that enriched corn grits is a 
widely consumed food that is likely to be eaten by women in need of 
additional sources of folate. Therefore, should FDA revoke this 
standard of identity, the agency is prepared to amend Sec. 172.345, the 
food additive regulation on folic acid, to include fortified grits to 
the list of nonstandardized foods to which folic acid may be added.
    b. Enriched corn meals. No specific comments were received 
regarding the enrichment of corn meal products with folic acid. Thus, 
as proposed, FDA is amending the standard of identity in Sec. 137.260 
to provide for a minimum folic acid level that is consistent with that 
established for enriched flour, such that each pound of the food 
contains 0.7 mg. Because corn meal products may be used as substitutes 
for wheat flour products, the agency believes, as discussed in the 
standards of identity proposal (58 FR 53305 at 53308), that consumers 
expect to be able to obtain the same levels of nutrients from enriched 
corn meals as from enriched wheat flour. FDA is also establishing an 
upper limit for folic acid addition (i.e., 1.0 mg/lb which is 
approximately 50 percent higher than the minimum fortification level), 
as has been done for the added B vitamins. The upper limit on the other 
B vitamins is intended to prohibit addition of excessive amounts of the 
nutrient and to ensure uniformity in composition of corn meals. FDA 
finds that, for the same reasons, an upper 

[[Page 8791]]
limit on the addition of folic acid of 1.0 mg/lb is necessary.
    c. Enriched rice. The folic acid content of rice varies from 0.008 
mg/100 g (0.036 mg/lb) for white rice to 0.020 mg/100 g (0.090 mg/lb) 
for brown rice (Ref. 7). FDA proposed to amend the standard of identity 
for enriched rice to provide for the addition of not less than 0.7 mg 
and not more than 1.4 mg of folic acid per pound (58 FR 53305 at 
53312). The agency also noted in the standards of identity proposal 
that rice in the United States may be enriched by addition of a powder 
mixture containing the added nutrients or by use of a rice premix 
consisting of rice kernels coated with a concentrated nutrient mix. 
When the powder enrichment procedure is used, the label of the package 
generally bears a statement that the rice should not be rinsed before 
or drained after cooking, in accordance with Sec. 137.350(c), to ensure 
that the rice retains the added nutrients. However, the agency stated, 
there is no assurance that these instructions are being followed. In 
the case of the rice premix, a special coating is applied to the rice 
kernels, so that the added nutrients will not be washed off if the 
product is rinsed before cooking. Rice coated with the premix is 
blended with unenriched rice such that the finished enriched rice 
product will contain the required minimum levels of added nutrients. 
The agency stated that the proposed range would provide flexibility in 
the production of the enriched rice and ensure that the food, when 
prepared for consumption, will contain the required minimum levels of 
nutrients.
    16. According to comments on the standards of identity proposal, 
most enriched rice produced in this country is manufactured using the 
powder procedure to add nutrients. A comment stated that some rice 
processors are very concerned about the addition of an enrichment 
powder mix containing folic acid because folic acid could result in off 
colors, taste, and aromas in the enriched rice. The comment maintained 
that firms fear that consumers may reject the enriched rice product if 
it does not possess the usual white color. It further stated that 
processors needed additional time to conduct research on the addition 
of folic acid to rice.
    While FDA acknowledges that the provision in the enriched rice 
standard for the addition of riboflavin has been stayed because of 
objections from the industry stating that riboflavin addition results 
in a yellow discoloration being imparted to the rice that is 
unacceptable to consumers (23 FR 1170, February 25, 1958), the agency 
has not received any information from rice processors that demonstrates 
that addition of folic acid to rice will result in off colors, taste, 
or aromas in the enriched rice product. Thus, as proposed, the agency 
is amending the standard of identity for enriched rice (Sec. 137.350) 
to include a range for the folic acid fortification level, 0.7 mg/lb to 
1.4 mg/lb, with the lower limit being consistent with the folic acid 
fortification level for enriched wheat flour. FDA concludes that use of 
the same minimum level of fortification is appropriate because it is 
consistent with the Food and Nutrition Board's recommendation that the 
same restoration level be used for wheat flour, corn products, and rice 
(although the Food and Nutrition Board only recommended addition at 
restoration levels). FDA is also establishing an upper limit for folic 
acid fortification of enriched rice of 1.4 mg/lb, as it has done with 
other enrichment nutrients added to rice. As discussed in the standards 
of identity proposal (58 FR 53305 at 53309), the upper level is based 
on the way that rice is fortified in this country.
    The agency recognizes that manufacturers will need time to 
experiment with the addition of folic acid to their products. FDA is 
providing approximately 2 years from the publication date of this final 
rule to allow manufacturers to test their ability to comply with the 
new requirements and to make appropriate label changes.
    17. One comment stated that, because the powder-enriched rice 
suffers substantial nutrient loss when it is washed (as rice is by many 
consumers), it is unlikely that folate intakes will increase as much as 
FDA estimates. The comment suggested that the agency should, 
consequently, increase the fortification level.
    FDA disagrees with the comment. For those consumers who wish to 
consume ``enriched'' rice, the agency has provided requirements in the 
standard of identity for enriched rice to ensure delivery of the 
required nutrients. Section 137.350(c) requires that enrichment 
nutrients be present in the rice in such form and at such levels that 
if the enriched rice is washed, it contains not less than 85 percent of 
the minimum quantities of the nutrients required to be present in the 
enriched rice. If they are not present in such form or at such levels 
to comply with these minimum requirements, the label of the enriched 
rice must bear the statement ``to retain vitamins do not rinse before 
or drain after cooking'' immediately following the name of the food. In 
addition, the label cannot bear cooking directions that call for 
washing or draining the enriched rice. In the case of precooked 
enriched rice, the package must be labeled with directions for 
preparation that, if followed, will avoid washing away or draining off 
enrichment ingredients.
    As discussed above, FDA is providing for addition of folic acid at 
the level of 140 g/100 g of the enriched cereal-grain 
products. The agency has concluded that this fortification level is 
necessary to help ensure that the total consumption level will not 
exceed the recommended daily consumption level of 1 mg (or 1,000 
g). To minimize the potential losses in enrichment nutrients 
in rice, the agency had provided for a range in the levels, with an 
upper limit that is twice that of the minimum level required to be 
present in the rice. Thus, rice processors who use the powder-
enrichment procedure, where nutrient losses would be expected to be 
greater, will be able to use a level of enrichment nutrients that makes 
it likely that consumers will receive the minimum levels of nutrients 
required to be in the food.
3. Macaroni and Noodle Products
    The standards of identity for enriched macaroni products 
(Sec. 139.115), enriched nonfat milk macaroni products (Sec. 139.122), 
and enriched noodle products (Sec. 139.155), and the cross- referenced 
standards of identity for enriched vegetable macaroni products 
(Sec. 139.135) and enriched vegetable noodle products (Sec. 139.165), 
provide for significantly higher levels of nutrient addition than the 
related flour standards of identity because these products are usually 
cooked in a large amount of water that is usually discarded after 
cooking and before consumption of the macaroni and noodle products.
    18. One comment asserted that because of the preparation process 
for macaroni and noodle products, vitamin retention data are absolutely 
essential before any level of enrichment can be discussed. Thus, the 
comment recommended that FDA delay implementation of folic acid 
fortification of cereal-grain products until more concrete information 
is available on vitamin retention with cooking.
    FDA is not delaying the implementation of folic acid fortification, 
as suggested by the comment, because of the need to increase the folic 
acid levels in the diets of women of childbearing age. The agency 
recognizes that there will be losses in the content of water soluble 
vitamins when the enriched macaroni and enriched noodle products are 
cooked in water, and that water is drained from the foods before 
consumption (Ref. 8). The agency also 

[[Page 8792]]
acknowledges that data on retention of the vitamins (thiamin, niacin, 
and riboflavin) required to be added to enrich these foods are limited, 
and that it is difficult to make inferences as to the retention of 
added folic acid when folic acid enriched products are cooked in water, 
and the water is discarded. However, there are some data to suggest 
that the retention rates are similar.
    According to a study conducted by Ranhortra, et al. (Ref. 8), on 
the retention rates of the thiamin, niacin, and riboflavin in three 
enriched pasta products (spaghetti, noodles, and macaroni), at least 50 
percent (75 to 77 percent on average) of the added nutrients was 
retained after cooking in water and draining. This study looked at the 
retention of the naturally occurring folate in the pasta products, 
before and after cooking, and found that the retention rate was 77 to 
79 percent. Based on this data, FDA does not expect that the retention 
rate of folic acid in these products would be significantly different 
from the retention rates of the other B vitamins.
    FDA recognizes that, as with other grain products, manufacturers 
will need to conduct research on the most effective means of adding 
folic acid and of ensuring that the added folic acid will be available 
in the finished food. Such studies will need to focus on not only the 
method of adding the nutrient but also on the stability of the vitamin 
during usual conditions of distribution and storage. The agency notes 
that similar studies were required when FDA established requirements 
for the addition of the other B vitamins to enriched cereal-grain 
products. In addition to studies, it may be necessary for manufacturers 
to develop label instructions on how the product should be prepared, 
e.g., instructions on limiting the amount of water to be used in its 
preparation or cooking time, and on whether the cooked food can be 
rinsed without loss of nutrients before serving, to ensure maximum 
retention of folic acid and the added water soluble nutrients.
    FDA is requiring the addition of folic acid to macaroni and noodle 
products in the same proportion as it is requiring such addition to 
enriched flour, except that the required level (expressed in terms of a 
range) will be approximately 25 percent higher for macaroni and noodle 
products than the required level of folic acid that is to be added to 
flour. This 25-percent increment is consistent with the requirements 
for the other added nutrients (thiamin, riboflavin, niacin, and iron) 
in the enriched macaroni and noodle products standards, compared to 
those in the standards of identity for flour products.
    Accordingly, as proposed, FDA is requiring that the enriched 
macaroni and noodle products contain from 0.9 to 1.2 mg/lb of folic 
acid.

G. Effective Date

    19. Many comments expressed concern over the statement in the 
standards of identity proposal that the final rule would become 
effective 1 year after publication. The comments stated that it would 
be difficult and impractical to synchronize the addition to a food of a 
folic acid-fortified enriched cereal- grain product with the 
availability of revised labels for that food that declare folic acid in 
the ingredient statement. These comments pointed out that enrichment 
nutrients are generally not added to each separately labeled product 
but are added to thousands of pounds of flour at the flour mill, the 
flour is sold to other manufacturers as an ingredient, and then this 
ingredient is used in many different products. Thus, the comments 
asserted that as a matter of economic necessity, the enrichment of all 
these products occurs at the same time, regardless of the availability 
of new labeling. One comment recommended that FDA establish an 
effective date of at least 2 years from the date of publication of the 
final rule. The comment asserted that a 2-year period would allow 
adequate time to incorporate changes on labels of slower moving 
products as well as products with higher retail turn rates. Thus, the 
comment continued, existing packaging inventory could be used, thereby 
reducing the cost impact of the regulation. Another comment suggested a 
``phase-in'' period of at least 3 years or, in the alternative, an 
effective date consistent with the next uniform effective date, 
whichever is later. In support of the suggestion, the comment asserted 
that a ``phase-in'' period would allow label changes to take place 
concurrent with the folic acid addition on a product-by-product basis. 
In addition, the comment contended, such action would allow 
manufacturers to exhaust their current label inventory and reduce the 
economic impact of the regulation. Moreover, the comment continued, 
additional time is needed for analytical testing for declaration of 
folic acid in nutrition labeling.
    FDA acknowledges the concerns raised in these comments regarding 
label changes that must accompany the addition of folic acid to 
enriched cereal-grain products and to foods in which these products are 
used as ingredients. FDA is persuaded by the concerns raised in the 
comments to establish an effective date that will provide manufacturers 
with time to implement the label and formulation changes required by 
the amendments established in this final rule. The agency agrees with 
the comment that suggested that FDA establish an effective date of at 
least 2 years from the date of publication of the final rule. A 2-year 
period would allow manufacturers time to exhaust current packaging 
inventory, add folic acid to their statement of ingredients and the 
nutrition facts panel as other changes are made to update package 
labeling, and subsequently ensure that packaging is available that 
accurately reflects the addition of folic acid to their products. 
Furthermore, the agency points out that a 2-year period is consistent 
with the amount of time given for implementation of the Nutrition 
Labeling and Education Act (NLEA) requirements. Thus, the effective 
date of this final rule will be January 1, 1998. The agency notes, 
however, that compliance with the requirements established in this 
final rule may begin immediately, provided that the label accurately 
reflects that folic acid has been added to the product. Furthermore, 
the agency will not object to the use of stickers to bring a product 
label into compliance with the ingredient labeling and nutrition 
labeling provisions. The agency notes, however, that unless the 
standardized food bears a claim about folate, the declaration of folate 
in the nutrition label is voluntary.
    20. A few comments that raised concern about label changes that 
must accompany the addition of folic acid suggested that the agency 
permit folic acid to be added to the product without requiring 
declaration in the ingredient statement. One comment contended that 
there was no safety issue regarding folic acid that would require its 
declaration on the label.
    Traditionally, the agency has not permitted manufacturers who 
change their formulas by adding or deleting ingredients to use 
noncompliant labels. Furthermore, as discussed in response to the 
previous comment, the agency is establishing an effective date in this 
final rule that will provide industry ample time to ensure that 
products enriched with folic acid are labeled in compliance with the 
regulations.
    In response to the argument that the addition of folic acid need 
not be declared because it does not raise a safety issue, the agency 
advises that the act requires that all foods fabricated from two or 
more ingredients declare each of its ingredients by common or usual 
name in a list of ingredients. This 

[[Page 8793]]
requirement applies without regard to whether there is a safety issue 
regarding the food. Consequently, the agency has not been persuaded by 
the comments to permit the addition of folic acid to foods without also 
requiring that folic acid be declared in ingredient labeling.

III. Economic Impact

    FDA has examined the impacts of this final rule to require the 
addition of folic acid to enriched cereal-grain products that conform 
to a standard of identity as required by Executive Order 12866 and the 
Regulatory Flexibility Act. Executive Order 12866 directs agencies to 
assess all costs and benefits of available regulatory alternatives and, 
when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety, and other advantages; distributive impacts; 
and equity). The Regulatory Flexibility Act (Pub. L. 96-654) requires 
the analysis of options for regulatory relief for small businesses. FDA 
finds that this final rule is not a significant regulatory action as 
defined by Executive Order 12866. In compliance with the Regulatory 
Flexibility Act, the agency certifies that this final rule will not 
have a significant impact on a substantial number of small businesses.
    On October 14, 1993 (58 FR 53305 at 53309), FDA published an 
economic impact analysis of the proposed requirements under the 
previous Executive Order (E.O. 12291). In the analysis, the agency 
evaluated the following regulatory options:
    1. Improve dietary practices among women of childbearing age.
    2. Require fortification with folic acid at 140 g/100 g.
    3. Require fortification with folic acid at: (a) A lower level, 
specifically 70 g/100 g; or (b) a higher level, specifically 
350 g/100 g.
    In response to the standards of identity proposal, the agency 
received several comments that provided information that has altered 
its economic impact analysis. Costs and benefits for each of the 
regulatory options are examined below.

A. Costs

Cost estimates are revised first for fortification at 140 g/
100 g followed by the cost estimates for fortification at 70 
g/100 g and 350 g/100 g.
    1. Require Fortification With Folic Acid at 140 g/100 g
    Costs of fortifying with folic acid at 140 g/100 g include 
health costs and reformulation costs.
    a. Health costs. Potential health costs of this regulatory option 
include the costs of neurologic disease associated with masking of the 
anemia of vitamin B12 deficiency. Several studies have found that 
folic acid can mask the anemia of vitamin B12 deficiency at levels 
as low as 250 g/day. Although there is no scientific consensus 
on the percentage of diagnoses of vitamin B12 deficiency anemia 
that would be complicated by folate intake at this level, the agency 
has determined that adverse health effects are not significant until 
folate intake reaches 1 mg/day. In the proposal, FDA tentatively 
concluded that the 140 g/100 g level for fortification of 
enriched cereal grain products was the most appropriate level based on 
a regulation that would have required that fortification of all 
breakfast cereals be limited to 100 g folic acid/serving. This 
limitation was proposed under a separate food additive regulation 
published elsewhere in the same Federal Register (58 FR 53312). With 
this option, 140 g/100 g, FDA preliminarily concluded that 
intake of persons in the target and nontarget populations would remain 
below 1 mg/day.
    Comments submitted in response to the proposal to limit breakfast 
cereals to 100 g folic acid/serving persuaded the agency to 
allow breakfast cereals to continue to contain up to 400 g 
folic acid/serving. If all breakfast cereals were fortified at the 
level of 400 g/serving, some high end consumers could consume 
more than 1 mg folate/day. However, most cereals currently are 
fortified at a level of 100 g/serving (25 percent of the 
reference daily intake (RDI)) and only an estimated 5 percent of 
breakfast cereals fortify at a level of 400 g (100 percent of 
the RDI).
    Further, it is unlikely that manufacturers of breakfast cereals 
will increase the folic acid level in cereals from 100 g/
serving to 400 g/serving. Since most breakfast cereals that 
contain at least 40 g/serving (10 percent of the RDI) of folic 
acid can now make health claims (if all other criteria are met), 
manufacturers have no incentive to reformulate from 100 g to 
400 g per serving and incur reformulation costs.
    There are a number of confounding uncertainties that make it 
difficult to estimate the potential health costs of folic acid 
fortification of enriched grain products (Ref. 9). These include:
    1. Current intakes estimated from food consumption survey data may 
underestimate actual intakes due to underreporting of food intake;
    2. The folate content of foods may be underestimated due to 
methodologic difficulties;
    3. Good data on the distribution of dietary supplement intake are 
not available;
    4. Estimates of masking of anemia (with subsequent progression of 
neurologic symptoms) based on enumerating only those associated with 
pernicious anemia would underestimate potential adverse effects because 
all vitamin B12 deficiencies may lead to neurologic problems; and
    5. It is difficult to predict effects of changes in dietary 
patterns that occur simultaneously with, but independently of, this 
regulation. Such changes may be the result of educational efforts by 
various organizations, physicians, and health care providers or in 
response to health claims.
    The last factor is particularly problematic. Recent surveys have 
shown a growing awareness of the value of increased folate intake among 
both the population as a whole and, specifically, among women of 
childbearing age. From 1994 to 1995, awareness of the problems 
associated with insufficient folic acid intake grew from 28 to 44 
percent among women of all ages (Ref. 10). As awareness grows, it is 
likely that folic acid intake will increase in the target group. In 
addition, new label claims allowed by the final rule for health claims 
on the association between folate intake and a reduced risk of NTD's 
are also expected to increase folic acid intake among women of 
childbearing age. However, the survey mentioned above also showed that 
such awareness is strongly positively correlated with education, so 
that these messages may not reach less well- educated women in the 
population.
    In the folic acid health claims proposal, FDA tentatively found 
that there were several nontarget groups whose intake levels of folate 
may approach 1 mg/day (intakes > 800 g/day) with a level of 
140 g/day and use of dietary supplements. These include 
individuals in groups including children 4 through 10 years of age and 
males 11 through 18, 19 through 50, and 51+ years of age. Individuals 
at risk of pernicious anemia include both males and females over 51 and 
Hispanic females ages 40 and above. The largest group at potential risk 
includes males over 51 who take dietary supplements. In order to be at 
risk of potential adverse effects from consuming greater than 1 mg 
folate/day individuals must: (1) Consume an excessive amount of folic 
acid through some combination of supplements containing folic acid and 
consumption of fortified enriched grain products and other products 
containing folic acid; and (2) have low vitamin B12 status or have 
vitamin B12 deficiency. 

[[Page 8794]]
Because of the difficulties mentioned above, it is not possible to 
estimate the number of people in the high risk subgroup who fit all of 
these categories.
    However, one such attempt has been made between the time of the 
standards of identity proposal and this final rule. In this analysis, 
Romano et. al. made the following assumptions:
    1. The annual incidence of pernicious anemia is 9.5 to 16.7 per 
100,000 persons (based on two European population-based studies);
    2. With low level fortification, 5 to 10 percent of these patients 
would receive enough folic acid to mask the anemia of vitamin B12 
deficiency; and
    3. Between ``24 and 26 percent of patients with pernicious anemias 
whose anemias respond to folic acid develop neurologic signs'' (Ref. 
11).
    Based on these assumptions, the authors estimated that 
approximately 500 people per year would develop neurologic disease as a 
result of low level folic acid fortification. Other authors contend 
that this estimate may considerably understate the number of cases 
(Ref. 12). On the other hand, one uncertainty not acknowledged by this 
analysis is that this rule may create a market for cereal-grain 
products that are not ``enriched.'' A nonstandardized cereal-grain 
product could be produced that was not labeled as being enriched with 
folate (although it could have other vitamins and minerals added and be 
labeled to reflect this fact) and could be marketed to people at risk 
of vitamin B12 deficiency. If such a market developed, and at-risk 
persons were encouraged to consume products not enriched with folic 
acid, this problem might be reduced. In addition, sale to high risk 
subgroups of nonstandardized products such as whole wheat breads 
(mentioned earlier in this preamble) which do not need to be enriched, 
may increase as a result of this rule.
    Another uncertainty that would reduce the number of cases of masked 
anemia, mentioned by one comment, is the percentage of cases of 
B12 deficiency that could be discovered with routine population 
screening. If such tests were performed proactively, B12 
deficiencies might be identified before neurologic symptoms developed.
    In addition, it is not clear whether the European population-based 
studies that reported the annual incidence of diagnosed pernicious 
anemia are relevant to the U.S. population. Some population groups in 
the United States (e.g., African-American women) appear to experience 
an earlier age-at-onset of pernicious anemia than occurs with 
pernicious anemia in Northern European countries, which are 
predominantly Caucasian populations.
    Although not able to estimate an absolute number, FDA has 
calculated a cost per case of neurologic symptoms resulting from 
masking of the anemia of pernicious anemia so that a break-even point 
may be calculated at which point benefits would equal the costs. The 
cost-per-illness will be calculated using the sum of medical costs and 
the cost of lost utility. The majority of medical costs, which include 
costs for physicians, other hospital services, and drugs, are normally 
paid by insurance such that estimates based on willingness-to-pay to 
avoid death would not be likely to be included. Other utility losses, 
including death, pain and suffering, immobility, and lost productivity 
associated with morbidity, are calculated as a function of the 
willingness- to-pay (WTP) to avoid death. Thus, for example, each day 
of morbidity is a day spent in less than perfect health engendering 
some utility loss. That is, each day of illnesses is somewhere between 
a day of full utility, 1, and death, 0. Because WTP to avoid death does 
not include the medical expenditures mentioned above, these costs are 
calculated separately.
    The expected utility loss estimates were calculated in the 
preliminary economic impact analysis (the PRIA) in the standards of 
identity proposal. The most common symptoms of a delay in the diagnosis 
of vitamin B12 deficiency are permanent paresthesia (numbness or 
tingling) in the hands or feet and ataxia (inability to coordinate 
voluntary muscular movements).
    In the standards of identity proposal, FDA estimated the cost per 
case to be approximately $538,000 (Ref. 13). This estimate was 
calculated using weighted probabilities of a mild (95 percent) and a 
severe case (5 percent) and the value of expected utility loss per case 
of neurologic disability. For each state, mild and severe, a health 
status value was calculated that related the state to a day of 
``perfect health''. Thus, a person with a mild case of neurologic 
disability is calculated to enjoy only 70 percent of the utility per 
day as that of a person in a perfectly healthy state. For a more severe 
case it would be approximately 50 percent (Ref. 14). Using the likely 
duration of each illness, the utility loss from a severe neurologic 
disability was found to be equivalent to a loss of 5.56 perfect-health 
years. From the value of a perfect health year, $138,889 (Ref. 14), the 
value of expected utility loss per case of mild neurologic disability 
was estimated to be $525,598. The utility loss due to severe neurologic 
disability was estimated in a similar fashion to be $772,598 per case. 
The weighted value (based on likelihood of a mild versus severe case) 
of a case of masked pernicious anemia leading to permanent adverse 
health effects was calculated as the weighted mean: (0.95  x  525,598) 
+ (0.05  x  772,598) = $537,948.
    In addition to utility costs, hospital costs of neurologic effects 
due to pernicious anemia have been estimated by Romano et al. (Ref. 
11). In this study, each neurologic case requires hospitalization once 
for an average duration of 16 days at $867/day. After factoring in 
physician services and other direct and indirect costs, the total 
direct outlay cost of neurologic disease as a result of folic acid 
fortification was estimated to be $33,000 per case (Ref. 11). Total 
costs per case are thus calculated to be $570,000.
    However, as mentioned in Romano et al., the cost estimate may be 
too high because these estimates assume that all neurologic disease 
would be severe, and mild cases may not require hospitalization (Ref. 
11). In addition, this estimate may be too high if there were routine 
population wide screening for vitamin B12 deficiency, although 
this is not currently occurring nor is it likely to be instituted. At 
the same time, however, the estimate may be too low if a case leads to 
later complications or to the need for lifelong skilled nursing care 
(Ref. 11).
    These costs, lost utility and hospital costs, are not annual costs. 
Once someone has experienced permanent adverse health effects from 
masked pernicious anemia, that person ought not to be included in the 
costs estimated for subsequent years, since the discounted value of 
their permanent adverse health effects has already been calculated and 
attributed to the first year. Any costs in subsequent years would 
involve only those entering the at-risk age pool.
    b. Other health costs. FDA is aware of the potential for other 
health problems resulting from increased long-term intakes of folic 
acid but has no data with which to quantify these costs.
    c. Reformulation costs. Reformulation costs associated with this 
option were estimated in the proposal to be $27 million for the first 
year. The cost of adding the required folic acid is approximately $4 
million per year. The cost of testing was estimated to be about $2.5 
million per year and the cost of the required label changes $20 
million. FDA will use these costs for this final rule as no comments 
were received on this part of the analysis.
    In addition, some countries, such as Canada, do not allow folic 
acid fortification of these products. Thus, this option would require 
that separate 

[[Page 8795]]
production runs be made for fortified products exported, to and 
imported from, these countries. This requirement may preclude some 
manufacturers from the export market. None of the comments provided 
information that would assist in determining the costs of having 
different international requirements.
2. Costs of Requiring Fortification With Folic Acid at Either 70 
g/100 g or 350 g/100 g
    The total cost of the option to fortify at 70 g/100 g in 
the first year was estimated in the proposal to be $25 million plus the 
cost of separate production runs for these products exported to and 
imported from certain foreign countries. For the option of fortifying 
with folic acid at 350 g/100 g, the PRIA estimated a cost of 
$1.88 billion annually.
    With the latter option, the folate intake of some consumers at risk 
of vitamin B12 deficiency (including pernicious anemia) would be 
raised to levels exceeding 1 mg per day. One comment to the proposal 
said that the estimated health costs of fortifying at this (higher) 
level were unrealistically high as FDA had failed to take into account 
that each subsequent year should only account for new cases (Ref. 11). 
Because of the problems with estimating numbers of people who will 
become ill at either level, FDA will not quantify these costs.
    Reformulation costs. In the proposal, the cost of the folic acid 
required to fortify at 350 g/100 g was estimated to be 
approximately $10 million per year. The cost of testing was estimated 
to be $2.5 million and the cost of the required label changes was 
estimated to be $20 million.

B. Benefits

1. Require Fortification with Folic Acid at 140 g/100 g
    The primary benefit of this option is a reduction in the number of 
infants born with NTD's each year. In addition, a possible benefit will 
be a reduction in cardiovascular diseases from intake of increased 
folate. However, there is still tremendous uncertainty with respect to 
the latter effect (for a more complete discussion, see folic acid food 
additive document published elsewhere in this Federal Register).
    Based on a synthesis of information from several studies, including 
those which used multivitamins containing folic acid at a daily dose 
level of  0.4 mg, it was inferred that folic acid alone at 
levels of 0.4 mg per day will reduce the risk of NTD's. This conclusion 
was based on two studies, one from a high risk population (Hungary) 
with a small number of subjects that was found to be 100 percent 
effective and another from a study that showed zero risk reduction in a 
low prevalence population (California and Illinois). From these 
studies, the PHS estimated a reduction of 50 percent of the number of 
NTD's in the United States. Other studies evaluated by PHS varied in 
their results. A possible explanation for the lack of effectiveness was 
that studies were conducted in populations with a low prevalence of 
NTD's which may not have had a folate-related subset of NTD's.
    In a study by Shaw et al., the reduction in NTD risk associated 
with folate intake is consistent with other studies, but the reduced 
risk was found to be specific to particular subsets of the population, 
primarily non-Hispanic women and women whose education did not exceed 
high school (Ref. 15). For Hispanic women, the risk reduction was 
approximately 10 percent. In a study by Romano et. al., the 50 percent 
estimate of reduced risk of NTD's was used with literature-based 
sensitivity limits of 67 percent (Ref. 16) and 20 percent (Refs. 11 and 
17).
    In the proposal, FDA estimated that under the 140 g/100 g 
option, 116 NTD's per year would be prevented (50 percent reduction). 
Initiation of this option was also estimated to prevent an additional 
25 infant deaths each year. Total benefits of this option were 
estimated to be between $651 and $788 million per year.
    There is no consensus on the dose-response relationship between 
folate intake and the reduction in risk of NTD's. However, using a 
lower bound of 10 percent and an upper bound of a 50 percent reduction 
in NTD's, the estimated reductions in total cases would be between 25 
(5 deaths) and 125 (27 deaths) resulting in quantified benefits ranging 
from $220 to $700 million.
2. Require Fortification with Folic Acid at 70 g/100 g and 350 
g/100 g
    a. 70 g/100 g. The benefit of requiring fortification of 
these products at 70 g/100 g was estimated in the proposal to 
be between $326 and $394 million. Using the sensitivity limits 
mentioned above, 10 to 50 percent of the estimated benefits would range 
from $110 to $346 million.
    b. 350 g/100 g. The benefit of requiring fortification of 
these products at 350 g/100 g is estimated to be between $550 
million and $1.4 billion. This option is the only option that would 
generate significant health costs.

C. Conclusion

    In accordance with Executive Order 12866, the agency has analyzed 
the economic effects of this final rule and has determined that this 
rule, if issued, will not be an economically significant rule as 
defined by that order.
    The cost of this final rule in the first year is estimated to be 
approximately $27 million which includes the cost of relabeling, 
testing, and fortification. In addition, there may be some health costs 
associated with neurologic symptoms resulting from masking the anemia 
of vitamin B12 deficiency as well as the cost of separate 
production runs for products exported to and imported from certain 
foreign countries. The cost of the proposed action in each year after 
the first year should be approximately 25 percent of the first year 
cost. The benefits are estimated to be between $220 and $700 million 
per year. Using a value of $570,000 per case of masked pernicious 
anemia resulting in neurologic damage, the break-even number of these 
cases at which costs would equal benefits would fall between 386 and 
1,228.
    Although reformulation costs of this option are approximately $27 
million, the cost per firm is expected to be very small. Therefore, in 
accordance with the Regulatory Flexibility Act, FDA has determined that 
this rule will not have an adverse impact on a substantial number of 
small businesses.

IV. Environmental Impact

    The agency has carefully considered the potential environmental 
effects of this action. FDA has concluded that the action will not have 
a significant impact on the human environment, and that an 
environmental impact statement is not required. The agency's finding of 
no significant impact and the evidence supporting that finding, 
contained in an environmental assessment, may be seen in the Dockets 
Management Branch (address above) between 9 a.m. and 4 p.m., Monday 
through Friday.

V. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) 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. USDA, Nationwide Food Consumption Survey/Individual Intake-
1987-1988, accession no. PB90-504044, National 

[[Page 8796]]
Technical Information Service, Springfield, VA, 1990.
    3. Food and Nutrition Board, National Research Council, National 
Academy of Sciences, Proposed Fortification Policy for Cereal-Grain 
Products, Washington, DC, 36 pp., 1974.
    4. Nationwide Food Consumption Survey, Continuing Survey of Food 
Intakes by Individuals: Women 19-50 Years Old and Their Children 1-5 
years, 1 day, 1985; United States Department of Agriculture, 
Hyattsville, MD; NFCS, CSFII, Report No. 85-1, 1985.
    5. Subcommittee on Food Technology, Committee on Food 
Protection, Food and Nutrition Board, National Research Council, 
National Academy of Sciences, Proceedings of a Workshop on 
Technology of Fortification of Cereal-Grain Products, Washington, 
DC, May 16-17, 1977.
    6. USDA Handbook 8-20: Composition of Foods, Cereal Grains, and 
Pasta, Raw Processed, Prepared. Rev., October 1989.
    7. Hoffpauer, D.W., ``Rice Enrichment for Today,'' Cereal Foods 
World, vol. 37, No. 10, pp. 757-759, 1992.
    8. Ranhortra, G.S., J.A. Gelroth, F.A. Novak, and R.H. Matthews, 
``Retention of Selected B Vitamins in Cooked Pasta Products,'' 
Cereal Chemistry, vol. 60, No. 6, pp. 476-477, 1985.
    9. Crane, N. et al., ``Evaluating Food Fortification Options: 
General Principles Revisited with Folic Acid,'' American Journal of 
Public Health, vol. 85, No. 5, pp. 660- 666, 1995.
    10. FDA, Health and Diet Survey, 1994 and 1995.
    11. Romano, P.S. et al., ``Folic Acid Fortification of Grain: An 
Economic Analysis,'' American Journal of Public Health, vol. 85, No. 
5, pp. 667-676, 1995.
    12. Perez-Escamilla, R., ``Folic Acid Fortification for the 
Prevention of Neural Tube Defects: Consensus Needed on Potential 
Adverse Effects,'' American Journal of Public Health, vol. 85, No. 
11, pp. 1587-1588, 1995.
    13. Healton, E.B., D.G. Savage, J.C. Brust, T.J. Garett, J. 
Lindenbaum, ``Neurologic Aspects of Cobalamin Deficiency,'' 
Medicine, vol. 7, No. 4, pp. 229-245, 1991.
    14. Research Triangle Institute, ``Quality of Well-Being Scale 
in Estimating the Value of Consumers' Loss from Food Violating the 
FD&C Act,'' vol. II, Final Report, 1988.
    15. Shaw, G.M. et al., ``Periconceptional Vitamin Use, Dietary 
Folate and the Occurrence of Neural Tube Defects,'' Epidemiology 
Resources Inc., 1995.
    16. MRC Vitamin Study Research Group, ``Prevention of Neural 
Tube Birth Defects: Results of the Medical Research Council Vitamin 
Study,'' Lancet, vol. 338, pp. 131- 137, 1991.
    17. Mills, J.L., G.G. Rhoads, J.L. Simpson, G.C. Cunningham, 
M.R. Conley, M.R. Lassman, M.E. Walden, D.R. Depp, H.J. Hoffman, 
``The Absence of a Relation Between the Periconceptional Use of 
Vitamins and Neural-tube Defects,'' New England Journal of Medicine, 
321:430-435, 1989.

List of Subjects

21 CFR Part 136

    Bakery products, Food grades and standards.

21 CFR Part 137

    Cereals (food), Food grades and standards.

21 CFR Part 139

    Food grades and standards.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR parts 136, 137, and 139 are amended as follows:

PART 136--BAKERY PRODUCTS

    1. The authority citation for 21 CFR part 136 continues to read as 
follows:

    Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 
379e).

    2. Section 136.115 is amended by revising paragraph (a)(1) to read 
as follows:


Sec. 136.115  Enriched bread, rolls, and buns.

    (a) * * *
    (1) Each such food contains in each pound 1.8 milligrams of 
thiamin, 1.1 milligrams of riboflavin, 15 milligrams of niacin, 0.43 
milligrams of folic acid, and 12.5 milligrams of iron.
* * * * *

PART 137--CEREAL FLOURS AND RELATED PRODUCTS

    3. The authority citation for 21 CFR part 137 continues to read as 
follows:

    Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 
379e).

    4. Section 137.165 is amended by revising paragraph (a) to read as 
follows:


Sec. 137.165  Enriched flour.

* * * * *
    (a) It contains in each pound 2.9 milligrams of thiamin, 1.8 
milligrams of riboflavin, 24 milligrams of niacin, 0.7 milligrams of 
folic acid, and 20 milligrams of iron.
* * * * *
    5. Section 137.185 is amended by revising paragraph (a) to read as 
follows:


Sec. 137.185  Enriched self-rising flour.

* * * * *
    (a) It contains in each pound 2.9 milligrams of thiamin, 1.8 
milligrams of riboflavin, 24 milligrams of niacin, 0.7 milligrams of 
folic acid, and 20 milligrams of iron.
* * * * *
    6. Section 137.235 is amended by revising paragraph (a)(1) to read 
as follows:


Sec. 137.235  Enriched corn grits.

    (a) * * *
    (1) It contains in each pound not less than 2.0 milligrams (mg) and 
not more than 3.0 mg of thiamin, not less than 1.2 mg and not more than 
1.8 mg of riboflavin, not less than 16 mg and not more than 24 mg of 
niacin or niacinamide, not less than 0.7 mg and not more than 1.0 mg of 
folic acid, and not less than 13 mg and not more than 26 mg of iron 
(Fe);
* * * * *
    7. Section 137.260 is amended by revising paragraph (a)(1) to read 
as follows:


Sec. 137.260  Enriched corn meals.

    (a) * * *
    (1) It contains in each pound not less than 2.0 milligrams (mg) and 
not more than 3.0 mg of thiamin, not less than 1.2 mg and not more than 
1.8 mg of riboflavin, not less than 16 mg and not more than 24 mg of 
niacin or niacinamide, not less than 0.7 mg and not more than 1.0 mg of 
folic acid, and not less than 13 mg and not more than 26 mg of iron 
(Fe);
* * * * *
    8. Section 137.305 is amended by revising paragraph (a)(1) to read 
as follows:


Sec. 137.305  Enriched farina.

    (a) * * *
    (1) It contains in each pound not less than 2.0 milligrams (mg) and 
not more than 2.5 mg of thiamin, not less than 1.2 mg and not more than 
1.5 mg of riboflavin, not less than 16.0 mg and not more than 20.0 mg 
of niacin or niacinamide, not less than 0.7 mg and not more than 0.87 
mg of folic acid, and not less than 13.0 mg of iron (Fe).
* * * * *
    9. Section 137.350 is amended by revising paragraph (a)(1) to read 
as follows:


Sec. 137.350  Enriched rice.

    (a) * * *
    (1) Not less than 2.0 milligrams (mg) and not more than 4.0 mg of 
thiamin, not less than 1.2 mg and not more than 2.4 mg of riboflavin, 
not less than 16 mg and not more than 32 mg of niacin or niacinamide, 
not less than 0.7 mg and not more than 1.4 mg of folic acid, and not 
less than 13 mg and not more than 26 mg of iron (Fe).
* * * * * 

[[Page 8797]]


PART 139--MACARONI AND NOODLE PRODUCTS

    10. The authority citation for 21 CFR part 139 continues to read as 
follows:

    Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 
379e).

    11. Section 139.115 is amended by revising paragraph (a)(1) to read 
as follows:


Sec. 139.115  Enriched macaroni products.

    (a) * * *
    (1) Each such food contains in each pound not less than 4.0 
milligrams (mg) and not more than 5.0 mg of thiamin, not less than 1.7 
mg and not more than 2.2 mg of riboflavin, not less than 27 mg and not 
more than 34 mg of niacin or niacinamide, not less than 0.9 mg and not 
more than 1.2 mg of folic acid, and not less than 13 mg and not more 
than 16.5 mg of iron (Fe);
* * * * *
    12. Section 139.122 is amended by revising the first sentence of 
paragraph (a)(3) to read as follows:


Sec. 139.122  Enriched nonfat milk macaroni products.

    (a) * * *
    (3) Each such food contains in each pound not less than 4.0 
milligrams (mg) and not more than 5.0 mg of thiamin, not less than 1.7 
mg and not more than 2.2 mg of riboflavin, not less than 27 mg and not 
more than 34 mg of niacin or niacinamide, not less than 0.9 mg and not 
more than 1.2 mg of folic acid, and not less than 13 mg and not more 
than 16.5 mg of iron (Fe). * * *
* * * * *
    13. Section 139.155 is amended by revising paragraph (a)(1) to read 
as follows:


Sec. 139.155  Enriched noodle products.

    (a) * * *
    (1) Each such food contains in each pound not less than 4 
milligrams (mg) and not more than 5 mg of thiamin, not less than 1.7 mg 
and not more than 2.2 mg of riboflavin, not less than 27 mg and not 
more than 34 mg of niacin or niacinamide, not less than 0.9 mg and not 
more than 1.2 mg of folic acid, and not less than 13 mg and not more 
than 16.5 mg of iron (Fe);
* * * * *
    Dated: February 26, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-5014 Filed 2-29-96; 12:03 pm]
BILLING CODE 4160-01-P