
[Federal Register: February 25, 2008 (Volume 73, Number 37)]
[Rules and Regulations]               
[Page 9938-9947]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe08-3]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2008-P-0090] (formerly Docket No. 2006P-0393)

 
Food Labeling: Health Claims; Soluble Fiber From Certain Foods 
and Risk of Coronary Heart Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is amending the health 
claim regulation entitled ``Soluble fiber from certain foods and risk 
of coronary heart disease (CHD)'' to add barley betafiber as an 
additional eligible source of beta-glucan soluble fiber. Barley 
betafiber is the ethanol precipitated soluble fraction of cellulase and 
alpha-amylase hydrolyzed whole grain barley flour. FDA is taking this 
action in response to a health claim petition submitted by Cargill, 
Inc. FDA previously concluded that there was significant scientific 
agreement that a claim characterizing the relationship between beta-
glucan soluble fiber of certain whole oat and whole grain barley 
products and CHD risk is supported by the totality of publicly 
available scientific evidence. Based on the totality of publicly 
available scientific evidence, FDA now has concluded that in addition 
to certain whole oat and whole grain barley products, barley betafiber 
is also an appropriate source of beta-glucan soluble fiber. Therefore, 
FDA is amending the health claim regulation entitled ``Soluble fiber 
from certain foods and risk of CHD'' to include barley betafiber as 
another eligible source of beta-glucan soluble fiber.

DATES: This interim final rule is effective February 25, 2008. Submit 
written or electronic comments by May 12, 2008.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
P-0090 (formerly Docket No. 2006P-0393), by any of the following 
methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN

[[Page 9939]]

number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number(s), found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food 
Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450.

SUPPLEMENTARY INFORMATION:

I. Background

A. The Nutrition Labeling and Education Act of 1990

    The Nutrition Labeling and Education Act of 1990 (the 1990 
amendments) (Public Law 101-535) amended the Federal Food, Drug, and 
Cosmetic Act (the act) in a number of important ways. One aspect of the 
1990 amendments was that they clarified FDA's authority to regulate 
health claims on food labels and in food labeling.
    FDA (we) issued several new regulations in 1993 that implemented 
the health claim provisions of the 1990 amendments. Among these were 21 
CFR 101.14, Health claims: general requirements (58 FR 2478, January 6, 
1993) and Sec.  101.70 (21 CFR 101.70), Petitions for health claims (58 
FR 2478), which set out the general requirements for the authorization 
and use of health claims and established a process for petitioning the 
agency to authorize health claims about substance-disease relationships 
and set out the types of information that any such petition must 
include. These regulations became effective on May 8, 1993.
    When implementing the 1990 amendments, FDA also conducted a review 
of evidence for a relationship between dietary fiber and cardiovascular 
disease (CVD). Based on this review, the agency concluded that the 
available scientific evidence did not justify authorization of a health 
claim relating dietary fiber to reduced risk of CVD (58 FR 2552, 
January 6, 1993) (1993 dietary fiber and CVD health claim final rule). 
However, FDA did conclude there was significant scientific agreement 
that the totality of publicly available scientific evidence supported 
an association between types of foods that are low in saturated fat and 
cholesterol and that naturally are good sources of soluble dietary 
fiber (i.e., fruits, vegetables, and grain products) and reduced risk 
of CHD\1\. Therefore, FDA authorized a health claim about the 
relationship between diets low in saturated fat and cholesterol and 
high in vegetables, fruit, and grain products that contain soluble 
fiber and a reduced risk of CHD (21 CFR 101.77; 58 FR 2552 at 2572). In 
the 1993 dietary fiber and CVD health claim final rule, FDA commented 
that if a manufacturer could document with appropriate evidence that 
consumption of the type of soluble fiber in a particular food has the 
effect of lowering blood low density lipoprotein (LDL) cholesterol, and 
has no adverse effects on other heart disease risk factors (e.g., high 
density lipoprotein cholesterol), it should petition for authorization 
of a health claim specific for that particular dietary fiber-containing 
food (58 FR 2552 at 2567).
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    \1\ Cardiovascular disease means diseases of the heart and 
circulatory system. Coronary heart disease, one form of 
cardiovascular disease, refers to diseases of the heart muscle and 
supporting blood vessels.
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B. Soluble Fiber from Certain Foods and Risk of CHD Health Claim (21 
CFR 101.81)

    In 1995, FDA received a petition for a health claim on the 
relationship between oat bran and rolled oats and reduced risk of CHD. 
FDA concluded there was significant scientific agreement that the 
totality of publicly available scientific evidence supported the 
relationship between consumption of whole oat products and reduced risk 
of CHD. FDA further concluded that the type of soluble fiber found in 
whole oats, i.e., beta-glucan soluble fiber, is the component primarily 
responsible for the hypocholesterolemic effects associated with 
consumption of whole oat foods as part of a diet that is low in 
saturated fat and cholesterol (62 FR 3584 at 3597 and 3598, January 23, 
1997). As such, the final rule authorized a health claim relating the 
consumption of beta-glucan soluble fiber in whole oat foods, as part of 
a diet low in saturated fat and cholesterol, and reduced risk of CHD 
(the 1997 oat beta-glucan health claim final rule). The source of beta-
glucan soluble fiber in foods bearing this health claim had to be one 
of three eligible whole oat products; i.e., oat bran, rolled oats, or 
whole oat flour (see Sec.  101.81(c)(2)(ii)(A)). In the 1997 oat beta-
glucan health claim final rule, FDA anticipated the likelihood that 
other sources and types of soluble fibers could also affect blood lipid 
levels, and thus, may reduce heart disease risk (62 FR 3584 at 3587). 
At that time, FDA considered structuring the final rule as an umbrella 
regulation authorizing the use of a claim for ``soluble fiber from 
certain foods`` and risk of CHD. Such action would have allowed 
flexibility in expanding the claim to other specific food sources of 
soluble fiber when consumption of those foods has been demonstrated to 
help reduce the risk of heart disease. However, the agency concluded 
that it was premature to do so because FDA had not reviewed the 
totality of evidence on other, non-whole oat sources of soluble fiber 
(62 FR 3584 at 3588).
    The agency amended Sec.  101.81 (21 CFR 101.81), in response to a 
health claim petition to add a health claim relating soluble fiber from 
psyllium seed husk and CHD risk (63 FR 8103, February 18, 1998). At 
this time, FDA also modified the heading in Sec.  101.81 from ``* * * 
Soluble fiber from whole oats and risk of coronary heart disease'' to 
``* * * Soluble fiber from certain foods and risk of coronary heart 
disease (CHD)'' (63 FR 8103). FDA has also amended Sec.  101.81, in 
response to health claim petitions, to include oatrim, whole grain 
barley, and certain dry milled barley grain products as eligible 
sources of beta-glucan soluble fiber. In 2002, FDA amended Sec.  101.81 
to add oatrim, which is the soluble fraction of alpha-amylase 
hydrolyzed oat bran or whole oat flour, as an eligible source of beta-
glucan soluble fiber (67 FR 61733, October 2, 2002), and finally, FDA 
amended Sec.  101.81 to add whole grain barley and certain dry milled 
barley grain products as eligible sources of beta-glucan soluble fiber 
in 2005 (70 FR 76150, December 23, 2005).

II. Petition and Grounds

A. The Petition

    Cargill, Inc. (petitioner), submitted a health claim petition to 
FDA on June 20, 2006, under section 403(r)(4) of the act (21 U.S.C. 
343(r)(4)). The petition requested that the agency expand the ``Soluble 
fiber from certain foods and risk of coronary heart disease health 
claim'' (Sec.  101.81) to include ``barley betafiber'' (described in 
section II.B of this document) as an eligible food ingredient source of 
beta-glucan soluble fiber in addition to the oat and whole grain and 
dry milled barley ingredients now listed (Ref. 1). On September 28, 
2006, the agency notified the petitioner that it had completed its 
initial review of the petition and that the petition was

[[Page 9940]]

being filed for further action in accordance with section 403(r)(4) of 
the act. If the agency does not act, by either denying the petition or 
issuing a proposed regulation to authorize the health claim, within 90 
days of the date of filing for further action, the petition is deemed 
to be denied unless an extension is mutually agreed upon by the agency 
and the petitioner (section 403(r)(4)(A)(i) of the act and Sec.  
101.70(j)(3)(iii)). The petitioner and FDA subsequently mutually agreed 
to extend the deadline for the agency's decision on the petition to 
March 6, 2008. The petitioner also requested that FDA issue an interim 
final rule by which labeling of foods that contain ``barley betafiber'' 
in appropriate amounts could bear the health claim prior to publication 
of a final rule.

B. Nature of the Substance

    The substance that is the subject of the oat/barley portion of 
current Sec.  101.81 is beta-glucan soluble fiber from the specific oat 
and barley food products listed in Sec.  101.81(c)(2)(ii)(A). Current 
Sec.  101.81(c)(2)(ii)(A) has been amended twice previously to list 
additional oat or barley food products as eligible sources (67 FR 61773 
and 70 FR 76150). Similar to these previous actions, FDA is now, in 
response to Cargill's health claim petition, amending Sec.  
101.81(c)(2)(ii)(A) to list barley betafiber as an eligible source of 
barley beta-glucan soluble fiber.
    The petition states that barley betafiber is a concentrated barley 
beta-glucan soluble fiber product derived from whole barley flour. The 
petitioner's description of the barley betafiber manufacturing process 
reflects information contained in the petitioner's patent entitled 
``Improved Dietary Fiber Containing Materials Comprising Low Molecular 
Weight Glucan'' (World Intellectual Property Organization, 
International Publication Number WO 2004/086878 A2) (Ref. 2) and a 
report of an expert panel on the generally recognized as safe (GRAS) 
status of barley betafiber commissioned by the petitioner (Ref. 3). The 
patent and the GRAS status report provide information on multiple 
variations of procedures for manufacturing concentrated barley beta-
glucan soluble fiber products; these procedures differ from the 
manufacturing procedures for producing the unique barley betafiber 
substance that is the subject of the petition. Further, the clinical 
trial reported in the petition tested two different barley beta-glucan 
soluble fiber concentrates--a high molecular weight concentrate and a 
low molecular weight concentrate. The petitioner specified that the 
barley betafiber product, which is the subject of the petition, is only 
the low molecular weight concentrate studied in the clinical trial 
(Ref. 4). FDA was not satisfied that the information in the petition 
was sufficiently specific in describing the manufacturing process for 
the unique barley betafiber product for which there is scientific 
evidence to permit a showing that the product is comparable in 
cholesterol-lowering ability to the other oat and barley food products 
listed in current Sec.  101.81(c)(2)(ii)(A). Discussion between the 
agency and the petitioner resulted in the description of the barley 
betafiber manufacturing process presented in the following paragraph 
and in final Sec.  101.81(c)(2)(ii)(A)(6) (Refs. 2 through 5).
    Barley betafiber is produced from an aqueous slurry of whole grain 
barley flour, starting with addition of an exogenous grain liquefying 
enzyme preparation with cellulase and alpha-amylase activity, derived 
from Bacillus amyloliquefaciens. The cellulase activity of the enzyme 
preparation acts on the beta-glucan soluble fiber in barley flour, 
since beta-glucan is a type of cellulose, and the alpha-amylase 
activity of the enzyme preparation acts on the starch in the barley 
flour. The temperature of the slurry is kept at or above the 
gelatinization temperature of the barley starch but below cellulase 
enzyme inactivation temperature; i.e., about 65[deg] C, for about 30 to 
60 minutes, to facilitate a partial hydrolysis of both the beta-glucan 
soluble fiber and starch. The pH of the slurry is kept in the range of 
about 5 to 7. When the cellulase enzymatic hydrolysis of barley flour 
has modified the beta-glucan soluble fiber to the desired extent, the 
cellulase activity of the enzyme preparation is heat inactivated. After 
the cellulase activity of the enzyme preparation has been deactivated, 
an exogenous thermo-stable amylolytic enzyme is added to the barley 
flour slurry for continued hydrolysis of starch molecules at the higher 
temperature. The slurry is held at the higher temperature until 
substantially all the starch has been hydrolyzed. A clear aqueous 
extract, which contains barley betafiber and the sugars and dextrins 
resulting from substantial hydrolysis of starch is then separated from 
insoluble material by centrifugation. Barley betafiber is precipitated 
from the aqueous extract supernatant with ethanol to separate it from 
other soluble components (i.e., substantially hydrolyzed starch, 
protein, lipids and other minor components) that remain suspended in 
the aqueous extract supernatant. The resultant barley betafiber 
precipitate is then dried and milled. The molecular weight range of 
barley betafiber produced by this procedure is 120 to 400 kilodaltons 
(Refs. 2, 3, and 5). The molecular weight range of barley betafiber is 
substantially reduced from that of native barley beta-glucan soluble 
fiber. The molecular weight range of native barley beta-glucan soluble 
fiber has been reported to range from about 500 to 3,330 kilodaltons 
depending upon the cultivars and applied extraction procedures, 
although lower molecular weight values of 80 to 300 kilodaltons have 
also been reported (Ref. 1). In final Sec.  101.81(c)(2)(ii)(A)(6), FDA 
defines barley betafiber by its manufacturing process, as follows 
``Barley betafiber. Barley betafiber is the ethanol precipitated 
soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain 
barley. Barley betafiber is produced by hydrolysis of whole grain 
barley flour, as defined in paragraph (c)(2)(ii)(A)(5) of this section, 
with a cellulase and alpha-amylase enzyme preparation, to produce a 
clear aqueous extract that contains mainly partially hydrolyzed beta-
glucan and substantially hydrolyzed starch. The soluble, partially 
hydrolyzed beta-glucan is separated from the insoluble material by 
centrifugation, and after removal of the insoluble material, the 
partially hydrolyzed beta-glucan soluble fiber is separated from the 
other soluble compounds by precipitation with ethanol. The product is 
then dried, milled and sifted. Barley betafiber shall have a beta-
glucan soluble fiber content of at least 70 percent on a dry weight 
basis.''

C. Review of Preliminary Requirements for a Health Claim

1. The Substance Is Associated With a Disease for Which the U.S. 
Population Is at Risk
    CHD continues to be a disease that has a large impact on mortality 
and morbidity in the general adult U.S. population. As explained in the 
existing beta-glucan soluble fiber health claim (Sec.  101.81(b)), FDA 
recognizes the CHD risk reduction benefit of certain foods that are 
sources of soluble dietary fiber resulting from effects on lowering 
blood total and LDL cholesterol. Although age-adjusted CHD mortality 
rates in the United States had been steadily decreasing since 
approximately 1960, recent evidence has suggested that the decline in 
CHD mortality has slowed (Ref. 6). Heart disease has been recognized as 
the leading cause of death in the United States for at least the last 
50 years (Ref. 6). Based on these facts,

[[Page 9941]]

FDA concludes that, as required in Sec.  101.14(b)(1), CHD is a disease 
for which the U.S. population is at risk.
2. The Substance Is a Food
    The substance of the health claim is beta-glucan soluble fiber from 
listed oat and barley sources. The petitioner requests an amendment to 
add barley betafiber to the list of eligible sources of beta-glucan 
soluble fiber. Barley betafiber is derived from whole barley flour. 
Barley flour is a commonly consumed human food and beta-glucan soluble 
fiber is a nutrient component of this food. Thus, the beta-glucan 
soluble fiber from barley betafiber, a processed whole barley flour 
product, is a ``substance'' as defined in Sec.  101.14(a)(2). Health 
claim general requirements provide that where a substance is to be 
consumed at ``other than decreased dietary levels,'' the substance must 
contribute taste, aroma, nutritive value, or any other technical effect 
as listed in 21 CFR 170.3(o), and must retain that attribute when 
consumed at levels necessary to justify the claim (Sec.  
101.14(b)(3)(i)). The level necessary to justify the claim is 0.75 g 
beta-glucan soluble fiber per serving. The term ``nutritive value'' is 
defined in Sec.  101.14(a)(3) as ``a value in sustaining human 
existence by such processes as promoting growth, replacing lost 
essential nutrients, or providing energy.'' The petitioner provided 
several examples of food categories (bars, beverages, bread, breakfast 
cereals, cookies, crackers, instant rice, pasta, muffins, salad 
dressings, snack chips, soups, tortillas and taco shells, vegetarian 
patties/crumbles, and reduced fat yogurt) in which barley betafiber 
could be used as an ingredient at a maximum level of 3 grams (g) beta-
glucan soluble fiber per serving. Beta-glucan soluble fiber at 0.75 to 
3 g per serving contributes nutritive value because it provides a 
source of calories and soluble fiber. In addition to its role as a 
source of beta-glucan soluble fiber, barley betafiber also has 
technical effects, including food applications as a thickener (e.g., 
soups), texturizer (e.g., snack foods), humectant (e.g., retain 
moisture of tortillas), or fat replacer (e.g., dressings for salads). 
Therefore, FDA concludes that the preliminary requirement of Sec.  
101.14(b)(3)(i) is satisfied.
3. The Substance Is Safe and Lawful
    Section 101.14(b)(3)(ii) requires that the substance be a food or a 
food ingredient or a component of a food ingredient whose use at the 
levels necessary to justify a claim has been demonstrated by the 
proponent of the claim, to FDA's satisfaction, to be safe and lawful 
under the applicable food safety provisions of the act. The petitioner 
asserts that the use of barley betafiber as a food ingredient is GRAS. 
The petitioner included in its health claim petition documentation of 
its 2003 GRAS self-determination for barley betafiber, which contains 
70 percent or more pure barley beta-glucan soluble fiber as evidence 
that barley betafiber meets the safe and lawful requirement (Ref. 3). 
FDA also received a notice informing FDA that the petitioner 
determined, through scientific procedures, that the use of barley 
betafiber is GRAS. FDA issued a letter (Ref. 7) in response to this 
notice stating that the agency had no questions at the time regarding 
petitioner's conclusions that barley betafiber is GRAS under the 
intended conditions of use.
    The 2003 Cargill GRAS self-determination stipulates that barley 
betafiber is obtained from food-grade whole grain barley flour by water 
extraction at elevated temperature, while starch is removed during the 
extraction process by treatment with enzymes that are GRAS for use in 
food manufacturing processes, specifically alpha-amylases from Bacillus 
licheniformis and B. amyloliquefaciens. The extracted barley betafiber 
is recovered by precipitation with denatured ethanol suitable for food 
production, and contains 70 percent or more beta-glucan, 2 to 12 
percent protein, and less than 3 percent of each sugars, lipids, and 
inorganic salts. The basis of the safety determination relies on the 
fact that barley betafiber contains only native components of barley 
and is formed by the action of applied food-grade enzymes, residues, or 
processing aids.
    In addition, barley is a traditional food with a long history of 
safe use, since at least 8,000 B.C. based on archeological discoveries 
(Ref. 3). In the Maghreb countries of Morocco, Algeria, Libya, and 
Tunisia, barley is used in a variety of traditional foods (bread, soup, 
porridge), resulting in an average intake of up to 172 g per person per 
day (Morocco). With this intake of barley, about 6 g per person per day 
of pure beta-glucan soluble fiber is consumed. The preparation of these 
traditional foods involves baking or boiling for longer periods of 
time, which ensures extraction of beta-glucan from its natural context 
(cell walls, complexes with proteoglycans). The physiological 
properties of beta-glucan as a dietary fiber may, therefore, be found 
in these traditional foods as is intended to be achieved with the 
addition to processed foods of barley beta-glucan concentrate.
    The intended uses of barley betafiber listed as a food ingredient 
stated in the 2003 Cargill GRAS self-determination include the 
following food categories: Bars, beverages, bread (whole grain and 
specialty), breakfast cereals (ready to eat and cooked), cookies 
(lite), crackers (reduced fat), instant rice, macaroni products, 
muffins (reduced fat), salad dressings (lite), snack chips (reduced 
fat), soups, tortillas and taco shells, vegetarian patties/crumbles, 
and reduced fat yogurt. The maximum incorporation rate for each of 
these food applications is 3 g beta-glucan soluble fiber from barley 
betafiber per serving.
    FDA concludes that the petitioners have satisfied the preliminary 
requirement of Sec.  101.14(b)(3)(ii) to demonstrate, to FDA's 
satisfaction, that the use of beta-glucan soluble fiber from barley 
betafiber at levels necessary to justify the health claim is safe and 
lawful under the applicable food safety provisions of the act. The 
agency has not made its own determination regarding the GRAS status of 
barley betafiber or beta-glucan soluble fiber from barley betafiber. 
Furthermore, the agency notes that a regulation to authorize a health 
claim for a substance should not be interpreted as affirmation that the 
substance is GRAS.

III. Review of Scientific Evidence of the Substance-Disease 
Relationship

A. Basis for Evaluating the Relationship Between Beta-Glucan Soluble 
Fiber from Barley Betafiber and CHD

    The types of data that FDA has recognized in previous CHD health 
claim evaluations as useful for assessing CHD risk reduction are: 
Coronary events (myocardial infarction, ischemia), cardiovascular 
death, atherosclerosis, high blood pressure, serum total cholesterol, 
and serum LDL cholesterol. FDA considers high blood pressure, serum 
total cholesterol, and serum LDL cholesterol levels to be the only 
currently validated surrogate measures for CHD risk (Ref. 8). Elevated 
levels of serum total and LDL cholesterol, a prerequisite for 
atherosclerotic disease, is a major modifiable risk factor in the 
development of CHD (Ref. 8). For these reasons, the agency based its 
original evaluation of the relationship between oat beta-glucan soluble 
fiber and CHD risk (62 FR 3584) and subsequent evaluations to add 
oatrim (67 FR 61773) and barley as eligible sources of beta-glucan 
soluble fiber (70 FR 76150) in the health claim, primarily on evidence 
for serum total and LDL cholesterol-lowering effects of beta-glucan 
soluble fiber containing food ingredients. As such, our evaluation of 
the evidence

[[Page 9942]]

supporting the petitioned request to extend the eligible barley sources 
to include barley betafiber (as described in section II.B of this 
preamble), focused on evidence from human randomized controlled trials 
of the effects of consuming beta-glucan soluble fiber from barley 
betafiber on blood lipids. This focus is consistent with existing Sec.  
101.81 in which FDA concluded that there is significant scientific 
agreement that the relationship between CHD risk and consumption of 
beta-glucan soluble fiber from certain oat and barley food ingredients 
is mediated primarily by the effect of the beta-glucan soluble fiber on 
serum lipids.
    FDA's determination of significant scientific agreement that the 
totality of publicly available scientific evidence supports the 
relationship between beta-glucan soluble fiber from certain oat and 
barley foods and CHD risk is documented in rulemaking for Sec.  101.81. 
When issuing the 1997 oat beta-glucan health claim final rule, the 
agency concluded that the beta-glucan soluble fiber component of oat 
products plays a significant role in the relationship between whole 
grain oats and the risk of CHD based, in part, on evidence that there 
is a dose response between the level of beta-glucan soluble fiber from 
whole oats and the level of reduction in serum LDL cholesterol, and 
evidence that intakes at or above 3 g per day were more effective in 
lowering serum lipids than lower intake levels (62 FR 3584 at 3585). In 
the 2002 and 2005 amendments to the health claim to add oatrim and 
whole grain and dry milled barley products, respectively, as eligible 
sources of beta-glucan soluble fiber, the agency considered evidence 
that beta-glucan soluble fiber from those sources had comparable 
cholesterol-lowering effects to that from the sources previously listed 
in Sec.  101.81(c)(2)(ii)(A) as further support for FDA's previous 
determination that there is significant scientific agreement that a 
relationship exists between consumption of certain beta-glucan soluble 
fiber sources and reduced risk of CHD (67 FR 61773 at 61779 and 70 FR 
76150 at 76155). Similarly, FDA considers that scientific evidence to 
establish that the cholesterol-lowering effects of beta-glucan soluble 
fiber from barley betafiber are comparable to the effects of beta-
glucan soluble fiber from the oat/barley products in current Sec.  
101.81(c)(2)(ii)(A) builds on the substantial base of scientific 
evidence that already establishes significant scientific agreement for 
the association between consumption of the oat/barley products now 
listed and reduced risk of CHD. FDA's review of the evidence to support 
the petitioned amendment of the health claim regulation entitled 
``Soluble fiber from certain foods and risk of CHD'' was conducted 
consistent with FDA published guidance on significant scientific 
agreement in the review of health claims (Ref. 9) and focused on 
evidence from intervention studies.

B. Assessment of Intervention Studies

    This petition identified one relevant human randomized controlled 
trial of how consumption of beta-glucan soluble fiber from barley 
betafiber affects heart disease risk and serum lipid levels. A summary 
of this trial was included in the petition and subsequently published 
in a peer reviewed scientific journal (Ref. 4). FDA also evaluated 
reported results from randomized controlled trials of other types of 
beta-glucan concentrates, extracts, and gums (Refs. 10 through 19).
    The study reported in Keenan et al. 2007 (Ref. 4) investigated the 
effects of consuming concentrated barley beta-glucan soluble fiber-
enriched foods (fruit drink and corn flakes) on blood lipids in 
hypercholesterolemic men and women. The study was conducted as a 
randomized, double-blind, placebo-controlled, parallel arm study of 
five groups with 30 to 32 subjects per group. The study included a 
total of 155 hypercholesterolemic adult subjects, between 25 and 73 
years of age, with baseline serum LDL cholesterol levels between 140 
and 190 milligrams per deciliter (mg/dL). The subjects were instructed 
to follow a diet low in saturated and trans fatty acids (less than 10 
percent kilocalories (kcals) per day) and to consume three servings of 
the concentrated barley beta-glucan soluble fiber-enriched test foods 
per day, one serving with each of three major meals. The concentrated 
barley beta-glucan soluble fiber-enriched test foods were formulated to 
provide either 3 or 5 g of beta-glucan soluble fiber per day; a placebo 
version of the test foods without added barley beta-glucan extracts was 
also used. Two concentrated barley beta-glucan soluble fiber products 
were used; one is the barley betafiber produced from the manufacturing 
process described in section II.B of this preamble, and was described 
in the study report as a low molecular weight (LMW) extract; the other 
concentrated barley beta-glucan soluble fiber product of the study was 
described as a high molecular weight (HMW) beta-glucan extract. The HMW 
barley beta-glucan extract was processed in a fashion similar to that 
for barley betafiber but omitted the cellulase enzymatic hydrolysis 
step, thus producing a concentrated source of barley beta-glucan 
soluble fiber with a molecular weight similar to that of the endogenous 
beta-glucan soluble fiber in barley grain from which it was derived.
    Following a 4-week run-in period to adjust to the low saturated/
trans fat diet, the subjects were randomly assigned to one of five 
treatment groups: placebo control, 3 g per day barley betafiber, 5 g 
per day barley betafiber, 3 g per day HMW beta-glucan extract, and 5 g 
per day HMW beta-glucan extract. Subjects consumed the test foods daily 
for 6 weeks. Consumption of 3 or 5 g beta-glucan per day from barley 
betafiber significantly lowered serum total cholesterol levels (6.0 
percent and 9.9 percent, respectively) relative to the placebo control 
group. Consumption of 3 or 5 g beta-glucan per day from the HMW barley 
beta-glucan extract also significantly lowered serum total cholesterol 
(7.0 percent and 11.2 percent, respectively) relative to the placebo 
control group. Serum LDL cholesterol levels were significantly 
decreased in all active treatment groups. At the end of the 5-week 
intervention period, the mean serum LDL cholesterol level of the 3 g 
per day beta-glucan from barley betafiber group was 10 mg/dL lower than 
the mean serum LDL cholesterol level of the placebo control group, 
representing a 7.5 percent reduction in LDL cholesterol relative to the 
placebo control group. The reduction in mean serum LDL cholesterol for 
the 5 g per day beta-glucan from barley betafiber group relative to the 
placebo control group was 16 mg/dL or 12 percent. The reduction in mean 
serum LDL cholesterol for the 3 g per day HMW beta-glucan group was 12 
mg/dL or 8 percent relative to the placebo control group. For the 5 g 
per day HMW beta-glucan group, the reduction in mean LDL cholesterol 
was 19 mg/dL or 13 percent relative to the placebo control group. There 
were no statistically significant differences between barley betafiber 
and the HMW barley beta-glucan extract groups, or between 3 g per day 
or 5 g per day beta-glucan groups, in the magnitude of the cholesterol 
lowering effects.
    The magnitude of cholesterol-lowering reported by Keenan et al. 
(Ref. 4) for 3 and 5 g per day beta-glucan from barley betafiber is 
consistent with the magnitude of cholesterol-lowering observed with 
similar barley beta-glucan soluble fiber intake levels consumed as dry 
milled barley foods (70 FR 76150 at 76153). The randomized controlled 
trials with dry milled barley foods that FDA considered when previously

[[Page 9943]]

amending the health claim to add dry milled barley had reported mean 
serum LDL cholesterol reductions of between 10 and 19 mg/dL from barley 
beta-glucan intake levels of 3 to 8 g per day. Based on evidence from 
the randomized controlled trials of dry milled barley ingredients which 
FDA relied upon when adding barley products to the health claim, the 
data for barley betafiber from Keenan et al. are consistent with the 
expected magnitude of cholesterol-lowering from consumption of the 
barley products listed in current Sec.  101.81(c)(2)(ii)(A)(5).
    Clinical trial evidence of oat/barley beta-glucan extracts other 
than barley betafiber indicate that not all oat/barley beta-glucan 
extracts affect serum total and LDL cholesterol levels as consistently 
as does consumption of the intact oat and barley grain from which they 
have been extracted (Refs. 10 through 19). This indicates that some 
extraction processes negatively affect whatever characteristics of 
beta-glucan soluble fiber in whole grain oats and barley that are 
responsible for the cholesterol-lowering effect. Accordingly, data from 
trials of beta-glucan extracts and concentrates other than barley 
betafiber support FDA's previous position (62 FR 3584 at 3587) that oat 
and barley products will be added to the health claim as eligible 
sources of beta-glucan soluble fiber only on a case-by-case basis when 
FDA is presented with adequate supporting evidence.
    Evidence from the randomized controlled trial reported by Keenan et 
al. (Ref. 4) indicates that beta-glucan soluble fiber from barley 
betafiber, prepared as described in section II of this preamble, is 
comparable to beta-glucan soluble fiber from the oat and barley sources 
now included in current Sec.  101.81 in regard to cholesterol-lowering 
properties. Evidence from randomized controlled trials of other oat or 
barley beta-glucan extracts indicate that some forms of processing of 
oat and barley grain to extract or concentrate beta-glucan can 
negatively affect whatever properties of oat and barley beta-glucan are 
responsible for the cholesterol-lowering effect. Therefore, results 
from Keenan et al. can not be extrapolated to beta-glucan extracts 
other than the specific products tested in the trial. Results from the 
Keenan et al. trial also demonstrate that the serum cholesterol-
lowering effects were comparable for beta-glucan soluble fiber from 
barley betafiber (i.e., the LMW product in the Keenan et al. trial) and 
for the barley beta-glucan extract that was not subjected to beta-
glucan hydrolysis (the HMW product in the Keenan et al. trial) (Ref. 
4). This evidence demonstrates that the cholesterol-lowering ability of 
beta-glucan soluble fiber in barley betafiber is not affected by the 
process used in the manufacture of barley betafiber to reduce the 
molecular weight of the barley betafiber product.

IV. Decision to Amend the Health Claim

    Available evidence demonstrates that foods enriched with beta-
glucan soluble fiber from barley betafiber at levels sufficient to 
provide at least 3 g beta-glucan soluble fiber per day are effective in 
lowering serum LDL-cholesterol levels, which may reduce the risk of 
CHD. As noted previously, when issuing the 1997 oat beta-glucan health 
claim final rule the agency concluded that the beta-glucan soluble 
fiber component of oat products plays a significant role in the 
relationship between whole grain oats and the risk of CHD based, in 
part, on evidence that there is a dose response between the level of 
beta-glucan soluble fiber from whole oats and the level of reduction in 
serum LDL cholesterol, and evidence that intakes at or above 3 g per 
day were more effective in lowering serum lipids than lower intake 
levels (62 FR 3584 at 3585). The clinical trial results reported by 
Keenan et al. (Ref. 4) demonstrating the cholesterol-lowering effect of 
consuming beta-glucan soluble fiber from barley betafiber are 
consistent in magnitude with what would be expected based on the oat 
beta-glucan soluble fiber/cholesterol-lowering dose-response evidence, 
which was cited in the 1997 oat beta-glucan health claim final rule, 
and cholesterol-lowering effect of consuming beta-glucan soluble fiber 
from dry milled barley grain ingredients (70 FR 76150 at 76155). Thus, 
FDA concludes that the cholesterol-lowering effect of beta-glucan 
soluble fiber from barley betafiber is comparable to that of beta-
glucan soluble fiber from whole grain oat and dry milled barley sources 
currently listed in Sec.  101.81(c)(2)(ii)(A). FDA also concludes that 
the scientific evidence supports a minimum daily effective intake of 
beta-glucan soluble fiber from barley betafiber the same as that which 
was previously found for whole oat and dry milled barley sources of 
beta-glucan soluble fiber, i.e., 3 g per day. Therefore, FDA is 
amending Sec.  101.81, by adding Sec.  101.81(c)(2)(ii)(A)(6) to list 
barley betafiber as an eligible source of beta-glucan soluble fiber. 
Consistent with current Sec.  101.81(c)(2)(i)(G)(1), the source of the 
3 g or more per day of beta-glucan soluble fiber may be from whole oats 
or barley, including the barley betafiber source, or a combination of 
oats and barley eligible sources. In addition, consistent with the 
description of other oat and barley products listed in current Sec.  
101.81, amended Sec.  101.81 will specify barley betafiber by the 
method of production as described in section II.B of this preamble. The 
agency is satisfied that the description of the method for producing 
barley betafiber appropriately characterizes the barley product being 
added to the regulation. Further, barley beta-glucan can be measured by 
the same quantitative analytical method as is currently specified in 
Sec.  101.81(c)(2)(ii)(A) for the determination of oat beta-glucan and 
barley beta-glucan from whole grain barley and dry milled barley 
products. Based on the totality of the publicly available scientific 
evidence, FDA concludes there is significant scientific agreement, 
among experts qualified by scientific training and experience, for a 
claim about the relationship between certain beta-glucan soluble fiber 
sources and reduced risk of CHD. Thus, FDA is amending Sec.  
101.81(c)(2)(ii)(A) to include barley betafiber derived from whole 
barley flour, prepared as described in section II.B of this document, 
as an additional source of beta-glucan soluble fiber.
    The requirement in Sec.  101.81(c)(2)(iii)(A) states that a food 
bearing the claim on its label include one of the ingredients listed 
within Sec.  101.81(c)(2)(ii)(A) and that the ingredient provide at 
least 0.75 gram of beta-glucan soluble fiber per reference amount 
customarily consumed (RACC) of the food product. This level is based on 
the minimum daily effective intake of beta-glucan soluble fiber from 
barley betafiber and is the same as that which was previously found for 
whole oat and dry milled barley sources of beta-glucan soluble fiber, 
i.e., 3 g per day. FDA arrived at a value of 0.75 gram beta-glucan 
soluble fiber per RACC based on a standard assumption that the daily 
dietary intake is divided over four eating occasions per day (three 
meals and a snack) (62 FR 3584 at 3592). Thus, adding barley betafiber 
as an additional eligible source of beta-glucan soluble fiber will 
further increase the type and number of qualifying food products and 
make it easier for consumers to select barley and oat products at four 
eating occasions per day. Thus, FDA is retaining under the ``Nature of 
the food eligible to bear the claim'' section of the codified text of 
this interim final rule, the criterion that foods eligible to bear the 
claim contain at least 0.75 gram of soluble fiber (Sec.  
101.81(c)(2)(iii)(A)(2)).
    There is strong consistent scientific evidence that diets high in 
saturated fat

[[Page 9944]]

and cholesterol are associated with elevated serum total and LDL 
cholesterol, and that elevated serum cholesterol levels are a major 
modifiable risk factor for CHD. Expert groups recommend lowering 
dietary saturated fat and cholesterol as a primary lifestyle change for 
reducing heart disease risk (Ref. 8). Comments to the 1997 oat beta-
glucan health claim final rule expressed concern that a CHD risk claim 
that does not include a reference to a low saturated fat, low 
cholesterol diet may mislead consumers into thinking that the single 
food, e.g., oat products, would appear to be a ``magic bullet'' (62 FR 
3584 at 3594). Further, based on the scientific evidence, the role of 
soluble fiber from whole oats in the diet is generally recognized as 
being of smaller magnitude in reducing CHD risk compared to consumption 
of a low saturated fat, low cholesterol diet. When issuing the 1997 oat 
beta-glucan health claim final rule, FDA concluded that although 
selection of foods with soluble fiber from whole oats is a useful 
adjunct to selection of diets low in saturated fat and cholesterol, in 
reducing CHD risk, it would not be in the best interest of public 
health nor consistent with the scientific evidence to imply that 
selecting diets with soluble fiber from whole oats is a substitute for 
consuming diets low in saturated fat and cholesterol (id.). Therefore, 
FDA required in the 1997 oat beta-glucan health claim final rule that 
the health claim statement include the phrase ``diets that are low in 
saturated fat and cholesterol and that include soluble fiber from * * 
*'' (Sec.  101.81(c)(2)(i)(A)). FDA reiterated this position and 
extended it to soluble fiber from listed barley products when the 
agency amended Sec.  101.81 to add whole grain barley and certain dry 
milled barley products as eligible sources of beta-glucan soluble fiber 
in 2005 (70 FR 76150 at 76156).
    Beta-glucan soluble fiber from barley betafiber functions 
comparably to beta-glucan soluble fiber from the listed oat and barley 
sources in current Sec.  101.81(c)(2)(ii)(A) in its effect on reducing 
LDL and total cholesterol. Barley betafiber, as a source of beta-glucan 
soluble fiber, is a useful adjunct to selection of diets low in 
saturated fat and cholesterol to reduce CHD risk. Thus, the agency is 
requiring that the beta-glucan soluble fiber from barley betafiber 
health claim be subject to the requirements in Sec.  
101.81(c)(2)(i)(A). Including a reference to a low saturated fat, low 
cholesterol diet in the health claim will enable the public to 
understand the relative significance of the information in the context 
of a total daily diet (21 U.S.C. 343(r)(3)(A)(iii)).

V. Description of Amendments to the Soluble Fiber from Certain Foods 
and Risk of Coronary Heart Disease Health Claim Regulation

A. Nature of the Substance; Eligible Sources of Soluble Fiber

    Section 101.81(c)(2)(ii) (nature of the substance) lists the types 
and sources of soluble fiber that have been demonstrated to FDA's 
satisfaction to have a relationship to a reduced risk of CHD. Section 
101.81(c)(2)(ii)(A) lists beta-glucan soluble fiber from whole oat and 
barley sources, along with specifying an AOAC INTERNATIONAL method of 
analysis for beta-glucan soluble fibe, which will be used by FDA for 
verifying compliance. Section 101.81(c)(2)(ii)(A)(1) through 
(c)(2)(ii)(A)(5) identifies the whole oat and barley products that are 
eligible sources of beta-glucan, i.e., oat bran, rolled oats, whole oat 
flour, oatrim, whole grain barley, and dry milled barley.
    FDA is amending Sec.  101.81(c)(2)(ii)(A) by adding Sec.  
101.81(c)(2)(ii)(A)(6), which would specify barley betafiber as being 
the ethanol isolated, soluble fraction of cellulase and alpha-amylase 
hydrolyzed whole grain barley flour, with a beta-glucan content of at 
least 70 percent on a dry weight basis (dwb). Thus, Sec.  
101.81(c)(2)(ii)(A)(6) will read as follows ``Barley betafiber. Barley 
betafiber is the ethanol precipitated soluble fraction of cellulase and 
alpha-amylase hydrolyzed whole grain barley. Barley betafiber is 
produced by hydrolysis of whole grain barley flour, as defined in 
paragraph (c)(2)(ii)(A)(5) of this section, with a cellulase and alpha-
amylase enzyme preparation, to produce a clear aqueous extract that 
contains mainly partially hydrolyzed beta-glucan and substantially 
hydrolyzed starch. The soluble, partially hydrolyzed beta-glucan is 
separated from the insoluble material by centrifugation, and after 
removal of the insoluble material, the partially hydrolyzed beta-glucan 
soluble fiber is separated from the other soluble compounds by 
precipitation with ethanol. The product is then dried, milled and 
sifted. Barley betafiber shall have a beta-glucan soluble fiber content 
of at least 70 percent on a dry weight basis.''

B. Nature of the Food Eligible to Bear the Claim

    Section 101.81(c)(2)(iii)(A)(2) (nature of the food) currently 
states ``The food containing the oatrim from paragraph (c)(2)(ii)(A)(4) 
of this section shall contain at least 0.75 g of beta-glucan soluble 
fiber per reference amount customarily consumed of the food product;''
    Because FDA is amending Sec.  101.81 to add barley betafiber, FDA 
is amending Sec.  101.81(c)(2)(iii)(A)(2) as follows ``The food 
containing the oatrim from paragraph (c)(2)(ii)(A)(4) of this section 
or the barley betafiber from paragraph (c)(2)(ii)(A)(6) of this section 
shall contain at least 0.75 g of beta-glucan soluble fiber per 
reference amount customarily consumed of the food product;''

C. Other Requirements

    All other requirements in Sec.  101.81(c)(1) through (c)(2)(i) and 
the optional information in Sec.  101.81(d) will apply to the use of 
the health claim authorized in Sec.  101.81 for barley betafiber-
containing products.

D. Model Health Claims

    This interim final rule to amend existing Sec.  101.81(c)(2) does 
not affect the model health claims specified in paragraph (e) of Sec.  
101.81. Thus, the model health claims in Sec.  101.81(e) apply to a 
claim about beta-glucan soluble fiber from barley betafiber and a 
reduced risk of CHD.

VI. Analysis of Impacts

    FDA has examined the impacts of this interim final rule under 
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). 
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 agency believes that 
this interim final rule is not a significant regulatory action as 
defined by the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this interim final rule concerns voluntary 
claims, the agency certifies that the interim final rule will not have 
a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that

[[Page 9945]]

includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $127 million, using the most current (2006) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
interim final rule to result in any 1-year expenditure that would meet 
or exceed this amount.
    FDA has identified the following three options regarding this 
petition: (1) Deny the petition; (2) authorize the petition (add only 
barley betafiber to the ``Soluble fiber from certain foods and risk of 
coronary heart disease health claim`` in Sec.  101.81 (the soluble 
fiber and CHD health claim)); or (3) add barley betafiber to the 
soluble fiber-CHD health claim and also expand the scope of the claim 
to include all sources of soluble fiber. FDA concludes that authorizing 
the petition by adding barley betafiber to the soluble fiber and CHD 
health claim is the best option of those identified.
Option One: Deny the Petition
    FDA can only define costs and benefits relative to a baseline. FDA 
usually selects the option of taking no action as the baseline because 
it helps readers identify the costs and benefits of actions that change 
the status quo. In this case, denying the petition would correspond to 
taking no action because it would imply no change in the soluble fiber 
and CHD health claim and thus the continuation of the status quo. By 
definition, the baseline itself has no costs or benefits. This does not 
mean that we ignore the costs and benefits of the baseline. Instead, it 
means that FDA expresses the costs and benefits of the baseline in how 
it calculates the costs and benefits of the other regulatory options.
Option Two: Authorize the Petition (Add Only Barley Betafiber to the 
Soluble Fiber and CHD Health Claim)
    This option would allow producers who use barley betafiber to use 
the soluble fiber and CHD health claim on their product labels under 
certain conditions. Producers would only choose to change product 
labels or reformulate products if they believe that the benefits that 
they will derive from doing so are at least as great as the costs of 
making those changes. FDA has reviewed the data supplied in the 
petition and concludes that the claim is truthful and not misleading. 
If this interim final rule is finalized without change, FDA can be sure 
that to whatever extent producers use the claim, consumers will be in a 
better position, assuming that more information that is truthful and 
not misleading is always better for consumers. Based on this, FDA can 
conclude that adding barley betafiber to the soluble fiber and CHD 
health claim is better for social welfare than denying the petition.
Option Three: Add Barley Betafiber to the Soluble Fiber and CHD Health 
Claim and Also Expand the Scope of the Claim to Include All Sources of 
Soluble Fiber
    This option would allow producers who use barley betafiber and all 
other sources of soluble fiber to use the soluble fiber and CHD health 
claim on their product labels under certain conditions rather than just 
listing specific sources of soluble fiber. Similar to option two, 
producers would only choose to change product labels or reformulate 
products if they believed that the benefits that they will derive from 
doing so are at least as great as the costs of making those changes. In 
addition, this option would reduce the future burden on manufacturers 
of petitioning FDA to use the soluble fiber and CHD health claim for 
additional sources of soluble fiber, and it would also reduce the 
agency's burden of evaluating each petition for each individual source 
of soluble fiber. However, by expanding the use of the claim to all 
sources of soluble fiber without reviewing the scientific data on each 
source, FDA would not be able to verify that the claim was being used 
under circumstances where it is truthful and not misleading to 
consumers. If the expanded claim was used on a product that did not 
reduce the risk of CHD, then the expanded claim could actually result 
in an increase in CHD. This would happen if consumers were misled into 
thinking that they were reducing their risk of CHD by consuming a 
product that actually did not reduce the risk of CHD. As a result, they 
might not take other beneficial steps that would decrease their risk of 
CHD.
    FDA cannot conclude that the cost savings of option three outweigh 
the increased risk of a false or misleading claim being made under the 
expanded claim. Therefore FDA cannot conclude that option three is 
better for social welfare than option two. Moreover, the agency 
believes that expanding the soluble fiber and CHD health claim to all 
sources of soluble fiber without reviewing the scientific data 
supporting such a claim of CHD risk reduction for each individual 
source of fiber would be a failure to carry out our statutory 
responsibility under section 403(r)(3)(B) of the act to issue health 
claim regulations only when the agency determines that there is 
significant scientific agreement that the claim is supported by the 
totality of publicly available scientific evidence.

VII. Environmental Impact

    The agency has determined under 21 CFR 25.32(p) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    FDA concludes that the labeling provisions of this interim final 
rule are not subject to review by the Office of Management and Budget 
because they do not constitute a ``collection of information'' under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the 
food labeling health claim on the association between consumption of 
barley betafiber beta-glucan soluble fiber and CHD risk is a ``public 
disclosure of information originally supplied by the Federal Government 
to the recipient for the purpose of disclosure to the public'' (see 5 
CFR 1320.3(c)(2)).

IX. Federalism

    FDA has analyzed this interim final rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the rule has a preemptive effect on State law. Section 4(a) of the 
Executive order requires agencies to ``construe * * * a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an 
express preemption provision. Section 403A(a)(5) of the act provides 
that ``* * * no State or political subdivision of a State may directly 
or indirectly establish under any authority or continue in effect as to 
any food in interstate commerce--* * * any requirement respecting any 
claim of the type described in section 403(r)(1) of the act made in the 
label or labeling of food that is not identical to the requirement of 
section 403(r). * * *''
    Currently, this provision operates to preempt States from imposing 
health claim labeling requirements concerning beta-glucan soluble fiber 
from barley betafiber and reduced risk of CHD because no such 
requirement had been

[[Page 9946]]

imposed by FDA under section 403(r) of the act. This interim final 
rule, if finalized without change, would amend existing food labeling 
regulations to add barley betafiber as an eligible source of beta-
glucan soluble fiber to the authorized health claim for soluble fiber 
from certain foods and risk of CHD. Although this rule would have a 
preemptive effect in that it would preclude States from issuing any 
health claim labeling requirements for beta-glucan soluble fiber from 
barley betafiber and a reduced risk of CHD that are not identical to 
those that would be required by this interim final rule, this 
preemptive effect is consistent with what Congress set forth in section 
403A of the act. Section 403A(a)(5) of the act displaces both State 
legislative requirements and State common law duties. (Medtronic v. 
Lohr, 518 U.S. 470, 503 (1996) (Breyer, J., concurring in part and 
concurring in judgment); id. at 510 (O'Connor, J., joined by Rehnquist, 
C.J., Scalia, J., and Thomas, J., concurring in part and dissenting in 
part); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 521 (1992) 
(plurality opinion); id. at 548-49 (Scalia, J., joined by Thomas, J., 
concurring in judgment in part and dissenting in part).
    FDA believes that the preemptive effect of this interim final rule, 
if finalized without change, is consistent with Executive Order 13132. 
Section 4(e) of the Executive order provides that ``when an agency 
proposes to act through adjudication or rulemaking to preempt State 
law, the agency shall provide all affected State and local officials 
notice and an opportunity for appropriate participation in the 
proceedings.'' FDA provided the States with an opportunity for 
appropriate participation in this rulemaking on December 12, 2007, when 
FDA's Division of Federal and State Relations provided notice via fax 
and email transmission to State health commissioners, State agriculture 
commissioners, food program directors, and drug program directors as 
well as FDA field personnel of FDA's intent to amend the health claim 
regulation authorizing health claims for soluble fiber from certain 
foods and risk of CHD (Sec.  101.81). It advised the States of FDA's 
possible action and encouraged the States and local governments to 
review the petition and to provide any comments to the docket (Docket 
No. 2006P-0393), until January 12, 2008. FDA received no comments in 
response to the notice. FDA is also providing an opportunity for State 
and local officials to comment on this interim final rule.
    In conclusion, the agency has determined that the preemptive 
effects of this interim final rule are consistent with Executive Order 
13132.

X. Issuance of an Interim Final Rule and Immediate Effective Date

    FDA is issuing this rule as an interim final rule, effective 
immediately, with an opportunity for public comment. Section 403(r)(7) 
of the act authorizes us to make proposed regulations issued under 
section 403(r) of the act effective upon publication pending 
consideration of public comment and publication of a final regulation, 
if the agency determines that such action is necessary for public 
health reasons. This authority enables us to act promptly on petitions 
that provide for information that is necessary to: (1) Enable consumers 
to develop and maintain healthy dietary practices, (2) enable consumers 
to be informed promptly and effectively of important new knowledge 
regarding nutritional and health benefits of food, or (3) ensure that 
scientifically sound nutritional and health information is provided to 
consumers as soon as possible. Proposed regulations made effective upon 
publication under this authority are deemed to be final agency action 
for purposes of judicial review. The legislative history indicates that 
such regulations should be issued as interim final rules (H. Conf. 
Rept. No. 105-399, at 98 (1997)).
    We are satisfied that all three of the criteria in section 
403(r)(7)(A) of the act have been met for the amendment to the soluble 
fiber from certain foods and risk of CHD health claim to list barley 
betafiber as eligible source of beta-glucan soluble fiber. This health 
claim amendment will help enable consumers to develop and maintain 
healthy dietary practices. The health claim will also provide consumers 
with important knowledge regarding the effects of beta-glucan soluble 
fiber in reducing the risk of, and will provide consumers with 
scientifically sound information on the benefits of foods containing 
beta-glucan soluble fiber from barley betafiber. Therefore, we are 
using the authority given to us in section 403(r)(7)(A) of the act to 
issue an interim final rule authorizing a health claim for soluble 
fiber from barley betafiber and CHD, effective immediately.
    FDA invites public comment on this interim final rule. The agency 
will consider modifications to this interim final rule based on 
comments made during the comment period. Interested persons may submit 
to the Division of Dockets Management, in any of the ways noted in the 
ADDRESSES section at the beginning of this document, comments regarding 
this interim final rule by (see DATES). Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.
    This regulation is effective upon publication in the Federal 
Register. The agency will address comments and confirm or amend the 
interim final rule in a final rule.

XI. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

XII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site address, but FDA is not responsible for 
any subsequent changes to the Web site after this document publishes in 
the Federal Register.)
    1. Cargill, Inc., ``Petition for Health Claim--Barley Betafiber 
and Coronary Heart Disease,'' (Docket 2006P-0393 CP1), June 20, 
2006.
    2. Cargill, Inc., ''Petition for Health Claim--Barley Betafiber 
and Coronary Heart Disease,'' Appendix 4, (Docket 2006P-0393), June 
20, 2006.
    3. Cargill, Inc., ``Petition for Health Claim--Barley Betafiber 
and Coronary Heart Disease,'' Appendix 1, (Docket 2006P-0393), June 
20, 2006.
    4. Keenan, J.M., Goulson, M., Shamliyan, T., et al., ''The 
Effects of Concentrated Barley Beta-Glucan on Blood Lipids in a 
Population of Hypercholesterolaemic Men and Women,'' British Journal 
of Nutrition, 97:1162-1168, 2007.
    5. E-mail from Lore Kolberg, Cargill, Inc., to Jillonne Kevala, 
FDA, August 28, 2006.
    6. Cooper, R., Cutler, J., Desvigne-Nickens, P., et al., 
``Trends and Disparities in Coronary Heart Disease, Stroke, and 
Other Cardiovascular Diseases in the United States: Findings of the 
National Conference on

[[Page 9947]]

Cardiovascular Disease Prevention,'' Circulation, 102:3137-3147, 
2000.
    7. Agency Response Letter to Generally Recognized as Safe Notice 
No. GRN 000207, FDA, Center for Food Safety and Applied Nutrition, 
Office of Food Additive Safety, December 19, 2006.
    8. National Heart, Lung, and Blood Institute; National 
Cholesterol Education Program Expert Panel on Detection, Evaluation, 
and Treatment of High Blood Pressure in Adults (Adult Treatment 
Panel III), Third Report of the NCEP Adult Treatment Panel III, 
Executive Summary, Bethesda (MD): National Institutes of Health, 
National Heart, Lung and Blood Institute, (www.nhlbi.nih.gov/
guidelines/cholesterol/atp_iii.htm), May 2001.
    9. Guidance for Industry: Significant Scientific Agreement in 
the Review of Health Claims for Conventional Foods and Dietary 
Supplements, Rockville, MD: U.S. Food and Drug Administration; 
December 1999, Available from: http://www.cfsan.fda.gov/~dms/
ssaguide.html.
    10. Bi[ouml]rklund, M., vanRees, A., Mensink, R.P., et al., 
``Changes in Serum Lipids and Postprandial Glucose and Insulin 
Concentrations After Consumption of Beverages with [beta]-Glucans 
from Oats or Barley: A Randomized Dose-Controlled Trial,'' European 
Journal of Clinical Nutrition, 59:1272-1281, 2005.
    11. Keogh, G.F., Cooper, G.J.S., Mulvey, T.B., et al., 
``Randomized Controlled Crossover Study of the Effect of a Highly 
[beta]-Glucan-Enriched Barley on Cardiovascular Disease Risk Factors 
in Mildly Hypercholesterolemic Men,'' American Journal of Clinical 
Nutrition, 78:711-718, 2003.
    12. Kerckhoffs, D.A.J.M., Hornstra, G., and R.P. Mensink, 
``Cholesterol-Lowering Effect of [beta]-Glucan from Oat Bran in 
Mildly Hypercholesterolemic Subjects May Decrease When [beta]-Glucan 
is Incorporated Into Bread and Cookies,'' American Journal of 
Clinical Nutrition, 78:221-227, 2003.
    13. Lovegrove, J.A., Clohessy, A., Milon, H., et al, ``Modest 
Doses of [beta]-Glucan Do Not Reduce Concentrations of Potentially 
Atherogenic Lipoproteins,'' American Journal of Clinical Nutrition, 
72:49-55, 2000.
    14. Naumann, E., vanRees, A.B., [Ouml]nning, G., et al., 
``[beta]-Glucan Incorporated Into a Fruit Drink Effectively Lowers 
Serum LDL-Cholesterol Concentrations,'' American Journal of Clinical 
Nutrition, 83:601-605, 2006.
    15. Pick, M.E., Hawrysh, Z.J., Gee, M.I., et al., ``Oat Bran 
Concentrate Bread Products Improve Long-Term Control of Diabetes: A 
Pilot Study,'' Journal of the American Dietetic Association, 
96:1254-1261, 1996.
    16. Beer, M.U., Arrigoni, E., and R. Amado, ``Effects of Oat Gum 
on Blood Cholesterol Levels in Healthy Young Men,'' European Journal 
of Clinical Nutrition, 49:517-522, 1995.
    17. Braaten, J.T., Wood, P.J., Scott, F.W., et al., ``Oat 
[beta]-Glucan Reduces Blood Cholesterol Concentration in 
Hypercholesterolemic Subjects,'' European Journal of Clinical 
Nutrition, 48:465-474, 1994.
    18. Pomeroy, S., Tupper, R., Cehun-Anders, and P. Nestel, ``Oat 
[beta]-Glucan Lowers Total and LDL-Cholesterol,'' Australian Journal 
of Nutrition and Dietetics, 58:51-55, 2001.
    19. T[ouml]rr[ouml]nen, R., Kansanen, L., Uusitupa, M., et al., 
``Effects of an Oat Bran Concentrate on Serum Lipids in Free-Living 
Men with Mild to Moderate Hypercholesterolemia,'' European Journal 
of Clinical Nutrition, 46:621-627, 1992.

List of Subjects in 21 CFR Part 101

    Food labeling, Nutrition, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended as follows:

PART 101--FOOD LABELING

0
1. The authority citation for 21 CFR part 101 continues to read as 
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342, 
343, 348, 371; 42 U.S.C. 243, 264, 271.

0
2. Section 101.81 is amended by adding paragraph (c)(2)(ii)(A)(6) and 
by revising paragraph (c)(2)(iii)(A)(2) to read as follows:


Sec.  101.81  Health claims: Soluble fiber from certain foods and risk 
of coronary heart disease (CHD).

* * * * *
    (c) * * *
    (2) * * *
    (ii) * * *
    (A) * * *
    (6) Barley betafiber. Barley betafiber is the ethanol precipitated 
soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain 
barley. Barley betafiber is produced by hydrolysis of whole grain 
barley flour, as defined in paragraph (c)(2)(ii)(A)(5) of this section, 
with a cellulase and alpha-amylase enzyme preparation, to produce a 
clear aqueous extract that contains mainly partially hydrolyzed beta-
glucan and substantially hydrolyzed starch. The soluble, partially 
hydrolyzed beta-glucan is separated from the insoluble material by 
centrifugation, and after removal of the insoluble material, the 
partially hydrolyzed beta-glucan soluble fiber is separated from the 
other soluble compounds by precipitation with ethanol. The product is 
then dried, milled and sifted. Barley betafiber shall have a beta-
glucan soluble fiber content of at least 70 percent on a dry weight 
basis.
* * * * *
    (iii) * * *
    (A) * * *
    (2) The food containing the oatrim from paragraph (c)(2)(ii)(A)(4) 
of this section or the barley betafiber from paragraph (c)(2)(ii)(A)(6) 
of this section shall contain at least 0.75 g of beta-glucan soluble 
fiber per reference amount customarily consumed of the food product; or
* * * * *

    Dated: February 15, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-3418 Filed 2-22-08; 8:45 am]

BILLING CODE 4160-01-S
