Professional Documents
Culture Documents
Issued in Washington, DC on Febuary 8, Procedures, effective at 0901 UTC on §§ 97.23, 97.25, 97.27, 97.29, 97.31,
2008. the dates specified, as follows: 97.33, 97.35 [Amended]
James J. Ballough, By amending: § 97.23 VOR, VOR/
Director, Flight Standards Service.
PART 97—STANDARD INSTRUMENT DME, VOR or TACAN, and VOR/DME
APPROACH PROCEDURES or TACAN; § 97.25 LOC, LOC/DME,
Adoption of the Amendment LDA, LDA/DME, SDF, SDF/DME;
■ 1. The authority citation for part 97
continues to read as follows: § 97.27 NDB, NDB/DME; § 97.29 ILS,
■ Accordingly, pursuant to the authority ILS/DME, ISMLS, MLS/DME, MLS/
delegated to me, Title 14, Code of Authority: 49 U.S.C. 106(g), 40103, 40106,
RNAV; § 97.31 RADAR SIAPs; § 97.33
Federal Regulations, Part 97, 14 CFR 40113, 40114, 40120, 44502, 44514, 44701,
44719, 44721–44722. RNAV SIAPs; and § 97.35 COPTER
part 97, is amended by amending SIAPs, identified as follows:
Standard Instrument Approach ■ 2. Part 97 is amended to read as
follows: Effective Upon Publication
01/31/08 ... VA DUBLIN ................................................. NEW RIVER VALLEY ........................... 8/3193 ILS RWY 6, AMDT 4
02/01/08 ... NE OMAHA ................................................. EPPLEY AIRFIELD ............................... 8/3311 ILS OR LOC RWY
32L, AMDT 1
02/01/08 ... OH DAYTON ............................................... DAYTON INTL ...................................... 8/3324 ILS OR LOC RWY
24R, AMDT 7
02/06/08 ... ME MILLINOCKET ...................................... MILLINOCKET MUNI ............................ 8/3814 LOC RWY 29, ORIG-
B
02/06/08 ... ME MILLINOCKET ...................................... MILLINOCKET MUNI ............................ 8/3815 VOR OR GPS-A,
AMDT 10A
02/06/08 ... ME MILLINOCKET ...................................... MILLINOCKET MUNI ............................ 8/3816 NDB OR GPS RWY
29, AMDT 3A
02/05/08 ... CO DENVER ............................................... DENVER INTL ...................................... 8/3609 ILS RWY 25, AMDT 2
02/01/08 ... IL CHICAGO .............................................. CHICAGO O’HARE INTL ...................... 8/3306 ILS OR LOC RWY
9R, AMDT 8
02/05/08 ... IL CHICAGO .............................................. CHICAGO O’HARE INTL ...................... 8/3591 ILS OR LOC RWY
4R, AMDT 6G
02/04/08 ... FL ORLANDO ............................................. EXECUTIVE .......................................... 8/3524 VOR/DME RWY 25,
AMDT 2A
02/04/08 ... FL ORLANDO ............................................. EXECUTIVE .......................................... 8/3525 RNAV (GPS) RWY
25, ORIG-A
02/04/08 ... FL ORLANDO ............................................. EXECUTIVE .......................................... 8/3526 LOC BC RWY 25,
AMDT 21A
[FR Doc. E8–2862 Filed 2–22–08; 8:45 am] grain barley flour. FDA is taking this 0090 (formerly Docket No. 2006P–0393),
BILLING CODE 4910–13–P action in response to a health claim by any of the following methods:
petition submitted by Cargill, Inc. FDA Electronic Submissions
previously concluded that there was Submit electronic comments in the
DEPARTMENT OF HEALTH AND significant scientific agreement that a following way:
HUMAN SERVICES claim characterizing the relationship • Federal eRulemaking Portal: http://
between beta-glucan soluble fiber of www.regulations.gov. Follow the
Food and Drug Administration certain whole oat and whole grain instructions for submitting comments.
barley products and CHD risk is Written Submissions
21 CFR Part 101 supported by the totality of publicly Submit written submissions in the
available scientific evidence. Based on following ways:
[Docket No. FDA–2008–P–0090] (formerly • FAX: 301–827–6870.
Docket No. 2006P–0393) the totality of publicly available
• Mail/Hand delivery/Courier [For
scientific evidence, FDA now has
Food Labeling: Health Claims; Soluble paper, disk, or CD–ROM submissions]:
concluded that in addition to certain
Fiber From Certain Foods and Risk of Division of Dockets Management (HFA–
whole oat and whole grain barley 305), Food and Drug Administration,
Coronary Heart Disease products, barley betafiber is also an 5630 Fishers Lane, rm. 1061, Rockville,
AGENCY: Food and Drug Administration, appropriate source of beta-glucan MD 20852.
HHS. soluble fiber. Therefore, FDA is To ensure more timely processing of
amending the health claim regulation comments, FDA is no longer accepting
ACTION: Interim final rule.
entitled ‘‘Soluble fiber from certain comments submitted to the agency by e-
SUMMARY: The Food and Drug foods and risk of CHD’’ to include mail. FDA encourages you to continue
Administration (FDA) is amending the barley betafiber as another eligible to submit electronic comments by using
health claim regulation entitled source of beta-glucan soluble fiber. the Federal eRulemaking Portal, as
‘‘Soluble fiber from certain foods and DATES: This interim final rule is described previously, in the ADDRESSES
risk of coronary heart disease (CHD)’’ to effective February 25, 2008. Submit portion of this document under
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add barley betafiber as an additional written or electronic comments by May Electronic Submissions.
eligible source of beta-glucan soluble 12, 2008. Instructions: All submissions received
fiber. Barley betafiber is the ethanol must include the agency name and
precipitated soluble fraction of cellulase ADDRESSES: You may submit comments, Docket No(s). and Regulatory
and alpha-amylase hydrolyzed whole identified by Docket No. FDA–2008–P– Information Number (RIN) (if a RIN
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Federal Register / Vol. 73, No. 37 / Monday, February 25, 2008 / Rules and Regulations 9939
number has been assigned) for this conclude there was significant scientific anticipated the likelihood that other
rulemaking. All comments received may agreement that the totality of publicly sources and types of soluble fibers could
be posted without change to http:// available scientific evidence supported also affect blood lipid levels, and thus,
www.regulations.gov, including any an association between types of foods may reduce heart disease risk (62 FR
personal information provided. For that are low in saturated fat and 3584 at 3587). At that time, FDA
additional information on submitting cholesterol and that naturally are good considered structuring the final rule as
comments, see the ‘‘Comments’’ heading sources of soluble dietary fiber (i.e., an umbrella regulation authorizing the
of the SUPPLEMENTARY INFORMATION fruits, vegetables, and grain products) use of a claim for ‘‘soluble fiber from
section of this document. and reduced risk of CHD1. Therefore, certain foods‘‘ and risk of CHD. Such
Docket: For access to the docket to FDA authorized a health claim about the action would have allowed flexibility in
read background documents or relationship between diets low in expanding the claim to other specific
comments received, go to http:// saturated fat and cholesterol and high in food sources of soluble fiber when
www.regulations.gov and insert the vegetables, fruit, and grain products that consumption of those foods has been
docket number(s), found in brackets in contain soluble fiber and a reduced risk demonstrated to help reduce the risk of
the heading of this document, into the of CHD (21 CFR 101.77; 58 FR 2552 at heart disease. However, the agency
‘‘Search’’ box and follow the prompts 2572). In the 1993 dietary fiber and CVD concluded that it was premature to do
and/or go to the Division of Dockets health claim final rule, FDA commented so because FDA had not reviewed the
Management, 5630 Fishers Lane, rm. that if a manufacturer could document totality of evidence on other, non-whole
1061, Rockville, MD 20852. with appropriate evidence that oat sources of soluble fiber (62 FR 3584
FOR FURTHER INFORMATION CONTACT: consumption of the type of soluble fiber at 3588).
Jillonne Kevala, Center for Food Safety in a particular food has the effect of The agency amended § 101.81 (21
and Applied Nutrition (HFS–830), Food lowering blood low density lipoprotein CFR 101.81), in response to a health
and Drug Administration, 5100 Paint (LDL) cholesterol, and has no adverse claim petition to add a health claim
Branch Pkwy., College Park, MD 20740– effects on other heart disease risk factors relating soluble fiber from psyllium seed
3835, 301–436–1450. (e.g., high density lipoprotein husk and CHD risk (63 FR 8103,
SUPPLEMENTARY INFORMATION: cholesterol), it should petition for February 18, 1998). At this time, FDA
authorization of a health claim specific also modified the heading in § 101.81
I. Background for that particular dietary fiber- from ‘‘* * * Soluble fiber from whole
A. The Nutrition Labeling and containing food (58 FR 2552 at 2567). oats and risk of coronary heart disease’’
Education Act of 1990 B. Soluble Fiber from Certain Foods and to ‘‘* * * Soluble fiber from certain
The Nutrition Labeling and Education Risk of CHD Health Claim (21 CFR foods and risk of coronary heart disease
Act of 1990 (the 1990 amendments) 101.81) (CHD)’’ (63 FR 8103). FDA has also
(Public Law 101–535) amended the amended § 101.81, in response to health
In 1995, FDA received a petition for claim petitions, to include oatrim,
Federal Food, Drug, and Cosmetic Act a health claim on the relationship
(the act) in a number of important ways. whole grain barley, and certain dry
between oat bran and rolled oats and milled barley grain products as eligible
One aspect of the 1990 amendments was reduced risk of CHD. FDA concluded
that they clarified FDA’s authority to sources of beta-glucan soluble fiber. In
there was significant scientific
regulate health claims on food labels 2002, FDA amended § 101.81 to add
agreement that the totality of publicly
and in food labeling. oatrim, which is the soluble fraction of
available scientific evidence supported
FDA (we) issued several new alpha-amylase hydrolyzed oat bran or
the relationship between consumption
regulations in 1993 that implemented whole oat flour, as an eligible source of
of whole oat products and reduced risk
the health claim provisions of the 1990 beta-glucan soluble fiber (67 FR 61733,
of CHD. FDA further concluded that the
amendments. Among these were 21 CFR October 2, 2002), and finally, FDA
type of soluble fiber found in whole
101.14, Health claims: general amended § 101.81 to add whole grain
oats, i.e., beta-glucan soluble fiber, is the
requirements (58 FR 2478, January 6, barley and certain dry milled barley
component primarily responsible for the
1993) and § 101.70 (21 CFR 101.70), grain products as eligible sources of
hypocholesterolemic effects associated
Petitions for health claims (58 FR 2478), with consumption of whole oat foods as beta-glucan soluble fiber in 2005 (70 FR
which set out the general requirements part of a diet that is low in saturated fat 76150, December 23, 2005).
for the authorization and use of health and cholesterol (62 FR 3584 at 3597 and II. Petition and Grounds
claims and established a process for 3598, January 23, 1997). As such, the
petitioning the agency to authorize final rule authorized a health claim A. The Petition
health claims about substance-disease relating the consumption of beta-glucan Cargill, Inc. (petitioner), submitted a
relationships and set out the types of soluble fiber in whole oat foods, as part health claim petition to FDA on June 20,
information that any such petition must of a diet low in saturated fat and 2006, under section 403(r)(4) of the act
include. These regulations became cholesterol, and reduced risk of CHD (21 U.S.C. 343(r)(4)). The petition
effective on May 8, 1993. (the 1997 oat beta-glucan health claim requested that the agency expand the
When implementing the 1990 final rule). The source of beta-glucan ‘‘Soluble fiber from certain foods and
amendments, FDA also conducted a soluble fiber in foods bearing this health risk of coronary heart disease health
review of evidence for a relationship claim had to be one of three eligible claim’’ (§ 101.81) to include ‘‘barley
between dietary fiber and whole oat products; i.e., oat bran, rolled betafiber’’ (described in section II.B of
cardiovascular disease (CVD). Based on oats, or whole oat flour (see this document) as an eligible food
this review, the agency concluded that § 101.81(c)(2)(ii)(A)). In the 1997 oat ingredient source of beta-glucan soluble
the available scientific evidence did not beta-glucan health claim final rule, FDA fiber in addition to the oat and whole
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justify authorization of a health claim grain and dry milled barley ingredients
relating dietary fiber to reduced risk of 1 Cardiovascular disease means diseases of the
now listed (Ref. 1). On September 28,
CVD (58 FR 2552, January 6, 1993) heart and circulatory system. Coronary heart 2006, the agency notified the petitioner
disease, one form of cardiovascular disease, refers
(1993 dietary fiber and CVD health to diseases of the heart muscle and supporting that it had completed its initial review
claim final rule). However, FDA did blood vessels. of the petition and that the petition was
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9940 Federal Register / Vol. 73, No. 37 / Monday, February 25, 2008 / Rules and Regulations
being filed for further action in that the barley betafiber product, which betafiber precipitate is then dried and
accordance with section 403(r)(4) of the is the subject of the petition, is only the milled. The molecular weight range of
act. If the agency does not act, by either low molecular weight concentrate barley betafiber produced by this
denying the petition or issuing a studied in the clinical trial (Ref. 4). FDA procedure is 120 to 400 kilodaltons
proposed regulation to authorize the was not satisfied that the information in (Refs. 2, 3, and 5). The molecular weight
health claim, within 90 days of the date the petition was sufficiently specific in range of barley betafiber is substantially
of filing for further action, the petition describing the manufacturing process reduced from that of native barley beta-
is deemed to be denied unless an for the unique barley betafiber product glucan soluble fiber. The molecular
extension is mutually agreed upon by for which there is scientific evidence to weight range of native barley beta-
the agency and the petitioner (section permit a showing that the product is glucan soluble fiber has been reported to
403(r)(4)(A)(i) of the act and comparable in cholesterol-lowering range from about 500 to 3,330
§ 101.70(j)(3)(iii)). The petitioner and ability to the other oat and barley food kilodaltons depending upon the
FDA subsequently mutually agreed to products listed in current cultivars and applied extraction
extend the deadline for the agency’s § 101.81(c)(2)(ii)(A). Discussion between procedures, although lower molecular
decision on the petition to March 6, the agency and the petitioner resulted in weight values of 80 to 300 kilodaltons
2008. The petitioner also requested that the description of the barley betafiber have also been reported (Ref. 1). In final
FDA issue an interim final rule by manufacturing process presented in the § 101.81(c)(2)(ii)(A)(6), FDA defines
which labeling of foods that contain following paragraph and in final barley betafiber by its manufacturing
‘‘barley betafiber’’ in appropriate § 101.81(c)(2)(ii)(A)(6) (Refs. 2 through process, as follows ‘‘Barley betafiber.
amounts could bear the health claim 5). Barley betafiber is the ethanol
prior to publication of a final rule. Barley betafiber is produced from an precipitated soluble fraction of cellulase
B. Nature of the Substance aqueous slurry of whole grain barley and alpha-amylase hydrolyzed whole
flour, starting with addition of an grain barley. Barley betafiber is
The substance that is the subject of produced by hydrolysis of whole grain
the oat/barley portion of current exogenous grain liquefying enzyme
preparation with cellulase and alpha- barley flour, as defined in paragraph
§ 101.81 is beta-glucan soluble fiber (c)(2)(ii)(A)(5) of this section, with a
from the specific oat and barley food amylase activity, derived from Bacillus
amyloliquefaciens. The cellulase cellulase and alpha-amylase enzyme
products listed in § 101.81(c)(2)(ii)(A). preparation, to produce a clear aqueous
Current § 101.81(c)(2)(ii)(A) has been activity of the enzyme preparation acts
on the beta-glucan soluble fiber in extract that contains mainly partially
amended twice previously to list hydrolyzed beta-glucan and
additional oat or barley food products as barley flour, since beta-glucan is a type
of cellulose, and the alpha-amylase substantially hydrolyzed starch. The
eligible sources (67 FR 61773 and 70 FR soluble, partially hydrolyzed beta-
76150). Similar to these previous activity of the enzyme preparation acts
on the starch in the barley flour. The glucan is separated from the insoluble
actions, FDA is now, in response to material by centrifugation, and after
Cargill’s health claim petition, temperature of the slurry is kept at or
above the gelatinization temperature of removal of the insoluble material, the
amending § 101.81(c)(2)(ii)(A) to list partially hydrolyzed beta-glucan soluble
barley betafiber as an eligible source of the barley starch but below cellulase
enzyme inactivation temperature; i.e., fiber is separated from the other soluble
barley beta-glucan soluble fiber.
about 65° C, for about 30 to 60 minutes, compounds by precipitation with
The petition states that barley
to facilitate a partial hydrolysis of both ethanol. The product is then dried,
betafiber is a concentrated barley beta-
glucan soluble fiber product derived the beta-glucan soluble fiber and starch. milled and sifted. Barley betafiber shall
from whole barley flour. The The pH of the slurry is kept in the range have a beta-glucan soluble fiber content
petitioner’s description of the barley of about 5 to 7. When the cellulase of at least 70 percent on a dry weight
betafiber manufacturing process reflects enzymatic hydrolysis of barley flour has basis.’’
information contained in the modified the beta-glucan soluble fiber to C. Review of Preliminary Requirements
petitioner’s patent entitled ‘‘Improved the desired extent, the cellulase activity for a Health Claim
Dietary Fiber Containing Materials of the enzyme preparation is heat
Comprising Low Molecular Weight inactivated. After the cellulase activity 1. The Substance Is Associated With a
Glucan’’ (World Intellectual Property of the enzyme preparation has been Disease for Which the U.S. Population
Organization, International Publication deactivated, an exogenous thermo-stable Is at Risk
Number WO 2004/086878 A2) (Ref. 2) amylolytic enzyme is added to the CHD continues to be a disease that
and a report of an expert panel on the barley flour slurry for continued has a large impact on mortality and
generally recognized as safe (GRAS) hydrolysis of starch molecules at the morbidity in the general adult U.S.
status of barley betafiber commissioned higher temperature. The slurry is held at population. As explained in the existing
by the petitioner (Ref. 3). The patent and the higher temperature until beta-glucan soluble fiber health claim
the GRAS status report provide substantially all the starch has been (§ 101.81(b)), FDA recognizes the CHD
information on multiple variations of hydrolyzed. A clear aqueous extract, risk reduction benefit of certain foods
procedures for manufacturing which contains barley betafiber and the that are sources of soluble dietary fiber
concentrated barley beta-glucan soluble sugars and dextrins resulting from resulting from effects on lowering blood
fiber products; these procedures differ substantial hydrolysis of starch is then total and LDL cholesterol. Although age-
from the manufacturing procedures for separated from insoluble material by adjusted CHD mortality rates in the
producing the unique barley betafiber centrifugation. Barley betafiber is United States had been steadily
substance that is the subject of the precipitated from the aqueous extract decreasing since approximately 1960,
petition. Further, the clinical trial supernatant with ethanol to separate it recent evidence has suggested that the
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reported in the petition tested two from other soluble components (i.e., decline in CHD mortality has slowed
different barley beta-glucan soluble fiber substantially hydrolyzed starch, protein, (Ref. 6). Heart disease has been
concentrates—a high molecular weight lipids and other minor components) that recognized as the leading cause of death
concentrate and a low molecular weight remain suspended in the aqueous in the United States for at least the last
concentrate. The petitioner specified extract supernatant. The resultant barley 50 years (Ref. 6). Based on these facts,
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Federal Register / Vol. 73, No. 37 / Monday, February 25, 2008 / Rules and Regulations 9941
FDA concludes that, as required in claim, to FDA’s satisfaction, to be safe The intended uses of barley betafiber
§ 101.14(b)(1), CHD is a disease for and lawful under the applicable food listed as a food ingredient stated in the
which the U.S. population is at risk. safety provisions of the act. The 2003 Cargill GRAS self-determination
petitioner asserts that the use of barley include the following food categories:
2. The Substance Is a Food
betafiber as a food ingredient is GRAS. Bars, beverages, bread (whole grain and
The substance of the health claim is The petitioner included in its health specialty), breakfast cereals (ready to eat
beta-glucan soluble fiber from listed oat claim petition documentation of its and cooked), cookies (lite), crackers
and barley sources. The petitioner 2003 GRAS self-determination for barley (reduced fat), instant rice, macaroni
requests an amendment to add barley betafiber, which contains 70 percent or products, muffins (reduced fat), salad
betafiber to the list of eligible sources of more pure barley beta-glucan soluble dressings (lite), snack chips (reduced
beta-glucan soluble fiber. Barley fiber as evidence that barley betafiber fat), soups, tortillas and taco shells,
betafiber is derived from whole barley meets the safe and lawful requirement vegetarian patties/crumbles, and
flour. Barley flour is a commonly (Ref. 3). FDA also received a notice reduced fat yogurt. The maximum
consumed human food and beta-glucan informing FDA that the petitioner incorporation rate for each of these food
soluble fiber is a nutrient component of determined, through scientific applications is 3 g beta-glucan soluble
this food. Thus, the beta-glucan soluble procedures, that the use of barley fiber from barley betafiber per serving.
fiber from barley betafiber, a processed betafiber is GRAS. FDA issued a letter FDA concludes that the petitioners
whole barley flour product, is a (Ref. 7) in response to this notice stating have satisfied the preliminary
‘‘substance’’ as defined in § 101.14(a)(2). that the agency had no questions at the requirement of § 101.14(b)(3)(ii) to
Health claim general requirements time regarding petitioner’s conclusions demonstrate, to FDA’s satisfaction, that
provide that where a substance is to be that barley betafiber is GRAS under the the use of beta-glucan soluble fiber from
consumed at ‘‘other than decreased intended conditions of use. barley betafiber at levels necessary to
dietary levels,’’ the substance must The 2003 Cargill GRAS self- justify the health claim is safe and
contribute taste, aroma, nutritive value, determination stipulates that barley lawful under the applicable food safety
or any other technical effect as listed in betafiber is obtained from food-grade provisions of the act. The agency has
21 CFR 170.3(o), and must retain that whole grain barley flour by water not made its own determination
attribute when consumed at levels extraction at elevated temperature, regarding the GRAS status of barley
necessary to justify the claim while starch is removed during the betafiber or beta-glucan soluble fiber
(§ 101.14(b)(3)(i)). The level necessary to extraction process by treatment with from barley betafiber. Furthermore, the
justify the claim is 0.75 g beta-glucan enzymes that are GRAS for use in food agency notes that a regulation to
soluble fiber per serving. The term manufacturing processes, specifically authorize a health claim for a substance
‘‘nutritive value’’ is defined in alpha-amylases from Bacillus should not be interpreted as affirmation
§ 101.14(a)(3) as ‘‘a value in sustaining licheniformis and B. amyloliquefaciens. that the substance is GRAS.
human existence by such processes as The extracted barley betafiber is
promoting growth, replacing lost recovered by precipitation with III. Review of Scientific Evidence of the
essential nutrients, or providing denatured ethanol suitable for food Substance-Disease Relationship
energy.’’ The petitioner provided several production, and contains 70 percent or A. Basis for Evaluating the Relationship
examples of food categories (bars, more beta-glucan, 2 to 12 percent Between Beta-Glucan Soluble Fiber from
beverages, bread, breakfast cereals, protein, and less than 3 percent of each Barley Betafiber and CHD
cookies, crackers, instant rice, pasta, sugars, lipids, and inorganic salts. The
muffins, salad dressings, snack chips, basis of the safety determination relies The types of data that FDA has
soups, tortillas and taco shells, on the fact that barley betafiber contains recognized in previous CHD health
vegetarian patties/crumbles, and only native components of barley and is claim evaluations as useful for assessing
reduced fat yogurt) in which barley formed by the action of applied food- CHD risk reduction are: Coronary events
betafiber could be used as an ingredient grade enzymes, residues, or processing (myocardial infarction, ischemia),
at a maximum level of 3 grams (g) beta- aids. cardiovascular death, atherosclerosis,
glucan soluble fiber per serving. Beta- In addition, barley is a traditional high blood pressure, serum total
glucan soluble fiber at 0.75 to 3 g per food with a long history of safe use, cholesterol, and serum LDL cholesterol.
serving contributes nutritive value since at least 8,000 B.C. based on FDA considers high blood pressure,
because it provides a source of calories archeological discoveries (Ref. 3). In the serum total cholesterol, and serum LDL
and soluble fiber. In addition to its role Maghreb countries of Morocco, Algeria, cholesterol levels to be the only
as a source of beta-glucan soluble fiber, Libya, and Tunisia, barley is used in a currently validated surrogate measures
barley betafiber also has technical variety of traditional foods (bread, soup, for CHD risk (Ref. 8). Elevated levels of
effects, including food applications as a porridge), resulting in an average intake serum total and LDL cholesterol, a
thickener (e.g., soups), texturizer (e.g., of up to 172 g per person per day prerequisite for atherosclerotic disease,
snack foods), humectant (e.g., retain (Morocco). With this intake of barley, is a major modifiable risk factor in the
moisture of tortillas), or fat replacer about 6 g per person per day of pure development of CHD (Ref. 8). For these
(e.g., dressings for salads). Therefore, beta-glucan soluble fiber is consumed. reasons, the agency based its original
FDA concludes that the preliminary The preparation of these traditional evaluation of the relationship between
requirement of § 101.14(b)(3)(i) is foods involves baking or boiling for oat beta-glucan soluble fiber and CHD
satisfied. longer periods of time, which ensures risk (62 FR 3584) and subsequent
extraction of beta-glucan from its evaluations to add oatrim (67 FR 61773)
3. The Substance Is Safe and Lawful natural context (cell walls, complexes and barley as eligible sources of beta-
Section 101.14(b)(3)(ii) requires that with proteoglycans). The physiological glucan soluble fiber (70 FR 76150) in the
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the substance be a food or a food properties of beta-glucan as a dietary health claim, primarily on evidence for
ingredient or a component of a food fiber may, therefore, be found in these serum total and LDL cholesterol-
ingredient whose use at the levels traditional foods as is intended to be lowering effects of beta-glucan soluble
necessary to justify a claim has been achieved with the addition to processed fiber containing food ingredients. As
demonstrated by the proponent of the foods of barley beta-glucan concentrate. such, our evaluation of the evidence
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9942 Federal Register / Vol. 73, No. 37 / Monday, February 25, 2008 / Rules and Regulations
supporting the petitioned request to CHD. FDA’s review of the evidence to hydrolysis step, thus producing a
extend the eligible barley sources to support the petitioned amendment of concentrated source of barley beta-
include barley betafiber (as described in the health claim regulation entitled glucan soluble fiber with a molecular
section II.B of this preamble), focused ‘‘Soluble fiber from certain foods and weight similar to that of the endogenous
on evidence from human randomized risk of CHD’’ was conducted consistent beta-glucan soluble fiber in barley grain
controlled trials of the effects of with FDA published guidance on from which it was derived.
consuming beta-glucan soluble fiber significant scientific agreement in the Following a 4-week run-in period to
from barley betafiber on blood lipids. review of health claims (Ref. 9) and adjust to the low saturated/trans fat diet,
This focus is consistent with existing focused on evidence from intervention the subjects were randomly assigned to
§ 101.81 in which FDA concluded that studies. one of five treatment groups: placebo
there is significant scientific agreement control, 3 g per day barley betafiber, 5
B. Assessment of Intervention Studies g per day barley betafiber, 3 g per day
that the relationship between CHD risk
and consumption of beta-glucan soluble This petition identified one relevant HMW beta-glucan extract, and 5 g per
fiber from certain oat and barley food human randomized controlled trial of day HMW beta-glucan extract. Subjects
ingredients is mediated primarily by the how consumption of beta-glucan soluble consumed the test foods daily for 6
effect of the beta-glucan soluble fiber on fiber from barley betafiber affects heart weeks. Consumption of 3 or 5 g beta-
serum lipids. disease risk and serum lipid levels. A glucan per day from barley betafiber
summary of this trial was included in significantly lowered serum total
FDA’s determination of significant the petition and subsequently published cholesterol levels (6.0 percent and 9.9
scientific agreement that the totality of in a peer reviewed scientific journal percent, respectively) relative to the
publicly available scientific evidence (Ref. 4). FDA also evaluated reported placebo control group. Consumption of
supports the relationship between beta- results from randomized controlled 3 or 5 g beta-glucan per day from the
glucan soluble fiber from certain oat and trials of other types of beta-glucan HMW barley beta-glucan extract also
barley foods and CHD risk is concentrates, extracts, and gums (Refs. significantly lowered serum total
documented in rulemaking for § 101.81. 10 through 19). cholesterol (7.0 percent and 11.2
When issuing the 1997 oat beta-glucan The study reported in Keenan et al. percent, respectively) relative to the
health claim final rule, the agency 2007 (Ref. 4) investigated the effects of placebo control group. Serum LDL
concluded that the beta-glucan soluble consuming concentrated barley beta- cholesterol levels were significantly
fiber component of oat products plays a glucan soluble fiber-enriched foods decreased in all active treatment groups.
significant role in the relationship (fruit drink and corn flakes) on blood At the end of the 5-week intervention
between whole grain oats and the risk lipids in hypercholesterolemic men and period, the mean serum LDL cholesterol
of CHD based, in part, on evidence that women. The study was conducted as a level of the 3 g per day beta-glucan from
there is a dose response between the randomized, double-blind, placebo- barley betafiber group was 10 mg/dL
level of beta-glucan soluble fiber from controlled, parallel arm study of five lower than the mean serum LDL
whole oats and the level of reduction in groups with 30 to 32 subjects per group. cholesterol level of the placebo control
serum LDL cholesterol, and evidence The study included a total of 155 group, representing a 7.5 percent
that intakes at or above 3 g per day were hypercholesterolemic adult subjects, reduction in LDL cholesterol relative to
more effective in lowering serum lipids between 25 and 73 years of age, with the placebo control group. The
than lower intake levels (62 FR 3584 at baseline serum LDL cholesterol levels reduction in mean serum LDL
3585). In the 2002 and 2005 between 140 and 190 milligrams per cholesterol for the 5 g per day beta-
amendments to the health claim to add deciliter (mg/dL). The subjects were glucan from barley betafiber group
oatrim and whole grain and dry milled instructed to follow a diet low in relative to the placebo control group
barley products, respectively, as eligible saturated and trans fatty acids (less than was 16 mg/dL or 12 percent. The
sources of beta-glucan soluble fiber, the 10 percent kilocalories (kcals) per day) reduction in mean serum LDL
agency considered evidence that beta- and to consume three servings of the cholesterol for the 3 g per day HMW
glucan soluble fiber from those sources concentrated barley beta-glucan soluble beta-glucan group was 12 mg/dL or 8
had comparable cholesterol-lowering fiber-enriched test foods per day, one percent relative to the placebo control
effects to that from the sources serving with each of three major meals. group. For the 5 g per day HMW beta-
previously listed in § 101.81(c)(2)(ii)(A) The concentrated barley beta-glucan glucan group, the reduction in mean
as further support for FDA’s previous soluble fiber-enriched test foods were LDL cholesterol was 19 mg/dL or 13
determination that there is significant formulated to provide either 3 or 5 g of percent relative to the placebo control
scientific agreement that a relationship beta-glucan soluble fiber per day; a group. There were no statistically
exists between consumption of certain placebo version of the test foods without significant differences between barley
beta-glucan soluble fiber sources and added barley beta-glucan extracts was betafiber and the HMW barley beta-
reduced risk of CHD (67 FR 61773 at also used. Two concentrated barley glucan extract groups, or between 3 g
61779 and 70 FR 76150 at 76155). beta-glucan soluble fiber products were per day or 5 g per day beta-glucan
Similarly, FDA considers that scientific used; one is the barley betafiber groups, in the magnitude of the
evidence to establish that the produced from the manufacturing cholesterol lowering effects.
cholesterol-lowering effects of beta- process described in section II.B of this The magnitude of cholesterol-
glucan soluble fiber from barley preamble, and was described in the lowering reported by Keenan et al. (Ref.
betafiber are comparable to the effects of study report as a low molecular weight 4) for 3 and 5 g per day beta-glucan from
beta-glucan soluble fiber from the oat/ (LMW) extract; the other concentrated barley betafiber is consistent with the
barley products in current barley beta-glucan soluble fiber product magnitude of cholesterol-lowering
§ 101.81(c)(2)(ii)(A) builds on the of the study was described as a high observed with similar barley beta-glucan
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substantial base of scientific evidence molecular weight (HMW) beta-glucan soluble fiber intake levels consumed as
that already establishes significant extract. The HMW barley beta-glucan dry milled barley foods (70 FR 76150 at
scientific agreement for the association extract was processed in a fashion 76153). The randomized controlled
between consumption of the oat/barley similar to that for barley betafiber but trials with dry milled barley foods that
products now listed and reduced risk of omitted the cellulase enzymatic FDA considered when previously
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Federal Register / Vol. 73, No. 37 / Monday, February 25, 2008 / Rules and Regulations 9943
amending the health claim to add dry Keenan et al. trial) (Ref. 4). This source, or a combination of oats and
milled barley had reported mean serum evidence demonstrates that the barley eligible sources. In addition,
LDL cholesterol reductions of between cholesterol-lowering ability of beta- consistent with the description of other
10 and 19 mg/dL from barley beta- glucan soluble fiber in barley betafiber oat and barley products listed in current
glucan intake levels of 3 to 8 g per day. is not affected by the process used in the § 101.81, amended § 101.81 will specify
Based on evidence from the randomized manufacture of barley betafiber to barley betafiber by the method of
controlled trials of dry milled barley reduce the molecular weight of the production as described in section II.B
ingredients which FDA relied upon barley betafiber product. of this preamble. The agency is satisfied
when adding barley products to the that the description of the method for
IV. Decision to Amend the Health Claim
health claim, the data for barley producing barley betafiber appropriately
betafiber from Keenan et al. are Available evidence demonstrates that characterizes the barley product being
consistent with the expected magnitude foods enriched with beta-glucan soluble added to the regulation. Further, barley
of cholesterol-lowering from fiber from barley betafiber at levels beta-glucan can be measured by the
consumption of the barley products sufficient to provide at least 3 g beta- same quantitative analytical method as
listed in current § 101.81(c)(2)(ii)(A)(5). glucan soluble fiber per day are effective is currently specified in
Clinical trial evidence of oat/barley in lowering serum LDL-cholesterol § 101.81(c)(2)(ii)(A) for the
beta-glucan extracts other than barley levels, which may reduce the risk of determination of oat beta-glucan and
betafiber indicate that not all oat/barley CHD. As noted previously, when issuing barley beta-glucan from whole grain
beta-glucan extracts affect serum total the 1997 oat beta-glucan health claim barley and dry milled barley products.
and LDL cholesterol levels as final rule the agency concluded that the Based on the totality of the publicly
consistently as does consumption of the beta-glucan soluble fiber component of available scientific evidence, FDA
intact oat and barley grain from which oat products plays a significant role in concludes there is significant scientific
they have been extracted (Refs. 10 the relationship between whole grain agreement, among experts qualified by
through 19). This indicates that some oats and the risk of CHD based, in part, scientific training and experience, for a
extraction processes negatively affect on evidence that there is a dose claim about the relationship between
whatever characteristics of beta-glucan response between the level of beta- certain beta-glucan soluble fiber sources
soluble fiber in whole grain oats and glucan soluble fiber from whole oats and reduced risk of CHD. Thus, FDA is
barley that are responsible for the and the level of reduction in serum LDL amending § 101.81(c)(2)(ii)(A) to
cholesterol-lowering effect. cholesterol, and evidence that intakes at include barley betafiber derived from
Accordingly, data from trials of beta- or above 3 g per day were more effective whole barley flour, prepared as
glucan extracts and concentrates other in lowering serum lipids than lower described in section II.B of this
than barley betafiber support FDA’s intake levels (62 FR 3584 at 3585). The document, as an additional source of
previous position (62 FR 3584 at 3587) clinical trial results reported by Keenan beta-glucan soluble fiber.
that oat and barley products will be et al. (Ref. 4) demonstrating the The requirement in
added to the health claim as eligible cholesterol-lowering effect of § 101.81(c)(2)(iii)(A) states that a food
sources of beta-glucan soluble fiber only consuming beta-glucan soluble fiber bearing the claim on its label include
on a case-by-case basis when FDA is from barley betafiber are consistent in one of the ingredients listed within
presented with adequate supporting magnitude with what would be § 101.81(c)(2)(ii)(A) and that the
evidence. expected based on the oat beta-glucan ingredient provide at least 0.75 gram of
Evidence from the randomized soluble fiber/cholesterol-lowering dose- beta-glucan soluble fiber per reference
controlled trial reported by Keenan et al. response evidence, which was cited in amount customarily consumed (RACC)
(Ref. 4) indicates that beta-glucan the 1997 oat beta-glucan health claim of the food product. This level is based
soluble fiber from barley betafiber, final rule, and cholesterol-lowering on the minimum daily effective intake
prepared as described in section II of effect of consuming beta-glucan soluble of beta-glucan soluble fiber from barley
this preamble, is comparable to beta- fiber from dry milled barley grain betafiber and is the same as that which
glucan soluble fiber from the oat and ingredients (70 FR 76150 at 76155). was previously found for whole oat and
barley sources now included in current Thus, FDA concludes that the dry milled barley sources of beta-glucan
§ 101.81 in regard to cholesterol- cholesterol-lowering effect of beta- soluble fiber, i.e., 3 g per day. FDA
lowering properties. Evidence from glucan soluble fiber from barley arrived at a value of 0.75 gram beta-
randomized controlled trials of other oat betafiber is comparable to that of beta- glucan soluble fiber per RACC based on
or barley beta-glucan extracts indicate glucan soluble fiber from whole grain a standard assumption that the daily
that some forms of processing of oat and oat and dry milled barley sources dietary intake is divided over four
barley grain to extract or concentrate currently listed in § 101.81(c)(2)(ii)(A). eating occasions per day (three meals
beta-glucan can negatively affect FDA also concludes that the scientific and a snack) (62 FR 3584 at 3592). Thus,
whatever properties of oat and barley evidence supports a minimum daily adding barley betafiber as an additional
beta-glucan are responsible for the effective intake of beta-glucan soluble eligible source of beta-glucan soluble
cholesterol-lowering effect. Therefore, fiber from barley betafiber the same as fiber will further increase the type and
results from Keenan et al. can not be that which was previously found for number of qualifying food products and
extrapolated to beta-glucan extracts whole oat and dry milled barley sources make it easier for consumers to select
other than the specific products tested of beta-glucan soluble fiber, i.e., 3 g per barley and oat products at four eating
in the trial. Results from the Keenan et day. Therefore, FDA is amending occasions per day. Thus, FDA is
al. trial also demonstrate that the serum § 101.81, by adding retaining under the ‘‘Nature of the food
cholesterol-lowering effects were § 101.81(c)(2)(ii)(A)(6) to list barley eligible to bear the claim’’ section of the
comparable for beta-glucan soluble fiber betafiber as an eligible source of beta- codified text of this interim final rule,
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from barley betafiber (i.e., the LMW glucan soluble fiber. Consistent with the criterion that foods eligible to bear
product in the Keenan et al. trial) and current § 101.81(c)(2)(i)(G)(1), the source the claim contain at least 0.75 gram of
for the barley beta-glucan extract that of the 3 g or more per day of beta-glucan soluble fiber (§ 101.81(c)(2)(iii)(A)(2)).
was not subjected to beta-glucan soluble fiber may be from whole oats or There is strong consistent scientific
hydrolysis (the HMW product in the barley, including the barley betafiber evidence that diets high in saturated fat
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9944 Federal Register / Vol. 73, No. 37 / Monday, February 25, 2008 / Rules and Regulations
and cholesterol are associated with the information in the context of a total contain at least 0.75 g of beta-glucan
elevated serum total and LDL daily diet (21 U.S.C. 343(r)(3)(A)(iii)). soluble fiber per reference amount
cholesterol, and that elevated serum customarily consumed of the food
V. Description of Amendments to the
cholesterol levels are a major modifiable product;’’
Soluble Fiber from Certain Foods and Because FDA is amending § 101.81 to
risk factor for CHD. Expert groups
Risk of Coronary Heart Disease Health add barley betafiber, FDA is amending
recommend lowering dietary saturated
Claim Regulation § 101.81(c)(2)(iii)(A)(2) as follows ‘‘The
fat and cholesterol as a primary lifestyle
change for reducing heart disease risk A. Nature of the Substance; Eligible food containing the oatrim from
(Ref. 8). Comments to the 1997 oat beta- Sources of Soluble Fiber paragraph (c)(2)(ii)(A)(4) of this section
glucan health claim final rule expressed Section 101.81(c)(2)(ii) (nature of the or the barley betafiber from paragraph
concern that a CHD risk claim that does substance) lists the types and sources of (c)(2)(ii)(A)(6) of this section shall
not include a reference to a low soluble fiber that have been contain at least 0.75 g of beta-glucan
saturated fat, low cholesterol diet may demonstrated to FDA’s satisfaction to soluble fiber per reference amount
mislead consumers into thinking that have a relationship to a reduced risk of customarily consumed of the food
the single food, e.g., oat products, would CHD. Section 101.81(c)(2)(ii)(A) lists product;’’
appear to be a ‘‘magic bullet’’ (62 FR beta-glucan soluble fiber from whole oat C. Other Requirements
3584 at 3594). Further, based on the and barley sources, along with
scientific evidence, the role of soluble All other requirements in
specifying an AOAC INTERNATIONAL § 101.81(c)(1) through (c)(2)(i) and the
fiber from whole oats in the diet is method of analysis for beta-glucan
generally recognized as being of smaller optional information in § 101.81(d) will
soluble fibe, which will be used by FDA apply to the use of the health claim
magnitude in reducing CHD risk for verifying compliance. Section
compared to consumption of a low authorized in § 101.81 for barley
101.81(c)(2)(ii)(A)(1) through betafiber-containing products.
saturated fat, low cholesterol diet. When (c)(2)(ii)(A)(5) identifies the whole oat
issuing the 1997 oat beta-glucan health and barley products that are eligible D. Model Health Claims
claim final rule, FDA concluded that sources of beta-glucan, i.e., oat bran, This interim final rule to amend
although selection of foods with soluble rolled oats, whole oat flour, oatrim, existing § 101.81(c)(2) does not affect
fiber from whole oats is a useful adjunct whole grain barley, and dry milled the model health claims specified in
to selection of diets low in saturated fat barley. paragraph (e) of § 101.81. Thus, the
and cholesterol, in reducing CHD risk, FDA is amending § 101.81(c)(2)(ii)(A) model health claims in § 101.81(e) apply
it would not be in the best interest of by adding § 101.81(c)(2)(ii)(A)(6), which to a claim about beta-glucan soluble
public health nor consistent with the would specify barley betafiber as being fiber from barley betafiber and a
scientific evidence to imply that the ethanol isolated, soluble fraction of reduced risk of CHD.
selecting diets with soluble fiber from cellulase and alpha-amylase hydrolyzed
whole oats is a substitute for consuming whole grain barley flour, with a beta- VI. Analysis of Impacts
diets low in saturated fat and glucan content of at least 70 percent on FDA has examined the impacts of this
cholesterol (id.). Therefore, FDA a dry weight basis (dwb). Thus, interim final rule under Executive Order
required in the 1997 oat beta-glucan § 101.81(c)(2)(ii)(A)(6) will read as 12866 and the Regulatory Flexibility Act
health claim final rule that the health follows ‘‘Barley betafiber. Barley (5 U.S.C. 601–612), and the Unfunded
claim statement include the phrase betafiber is the ethanol precipitated Mandates Reform Act of 1995 (Public
‘‘diets that are low in saturated fat and soluble fraction of cellulase and alpha- Law 104–4). Executive Order 12866
cholesterol and that include soluble amylase hydrolyzed whole grain barley. directs agencies to assess all costs and
fiber from * * *’’ (§ 101.81(c)(2)(i)(A)). Barley betafiber is produced by benefits of available regulatory
FDA reiterated this position and hydrolysis of whole grain barley flour, alternatives and, when regulation is
extended it to soluble fiber from listed as defined in paragraph (c)(2)(ii)(A)(5) of necessary, to select regulatory
barley products when the agency this section, with a cellulase and alpha- approaches that maximize net benefits
amended § 101.81 to add whole grain amylase enzyme preparation, to produce (including potential economic,
barley and certain dry milled barley a clear aqueous extract that contains environmental, public health and safety,
products as eligible sources of beta- mainly partially hydrolyzed beta-glucan and other advantages; distributive
glucan soluble fiber in 2005 (70 FR and substantially hydrolyzed starch. impacts; and equity). The agency
76150 at 76156). The soluble, partially hydrolyzed beta- believes that this interim final rule is
Beta-glucan soluble fiber from barley glucan is separated from the insoluble not a significant regulatory action as
betafiber functions comparably to beta- material by centrifugation, and after defined by the Executive order.
glucan soluble fiber from the listed oat removal of the insoluble material, the The Regulatory Flexibility Act
and barley sources in current partially hydrolyzed beta-glucan soluble requires agencies to analyze regulatory
§ 101.81(c)(2)(ii)(A) in its effect on fiber is separated from the other soluble options that would minimize any
reducing LDL and total cholesterol. compounds by precipitation with significant impact of a rule on small
Barley betafiber, as a source of beta- ethanol. The product is then dried, entities. Because this interim final rule
glucan soluble fiber, is a useful adjunct milled and sifted. Barley betafiber shall concerns voluntary claims, the agency
to selection of diets low in saturated fat have a beta-glucan soluble fiber content certifies that the interim final rule will
and cholesterol to reduce CHD risk. of at least 70 percent on a dry weight not have a significant economic impact
Thus, the agency is requiring that the basis.’’ on a substantial number of small
beta-glucan soluble fiber from barley entities.
betafiber health claim be subject to the B. Nature of the Food Eligible to Bear Section 202(a) of the Unfunded
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Federal Register / Vol. 73, No. 37 / Monday, February 25, 2008 / Rules and Regulations 9945
includes any Federal mandate that may position, assuming that more regulations only when the agency
result in the expenditure by State, local, information that is truthful and not determines that there is significant
and tribal governments, in the aggregate, misleading is always better for scientific agreement that the claim is
or by the private sector, of $100,000,000 consumers. Based on this, FDA can supported by the totality of publicly
or more (adjusted annually for inflation) conclude that adding barley betafiber to available scientific evidence.
in any one year.’’ The current threshold the soluble fiber and CHD health claim
VII. Environmental Impact
after adjustment for inflation is $127 is better for social welfare than denying
million, using the most current (2006) the petition. The agency has determined under 21
Implicit Price Deflator for the Gross Option Three: Add Barley Betafiber to CFR 25.32(p) that this action is of a type
Domestic Product. FDA does not expect the Soluble Fiber and CHD Health that does not individually or
this interim final rule to result in any 1- Claim and Also Expand the Scope of the cumulatively have a significant effect on
year expenditure that would meet or Claim to Include All Sources of Soluble the human environment. Therefore,
exceed this amount. Fiber neither an environmental assessment
FDA has identified the following This option would allow producers nor an environmental impact statement
three options regarding this petition: (1) who use barley betafiber and all other is required.
Deny the petition; (2) authorize the sources of soluble fiber to use the
VIII. Paperwork Reduction Act of 1995
petition (add only barley betafiber to the soluble fiber and CHD health claim on
‘‘Soluble fiber from certain foods and their product labels under certain FDA concludes that the labeling
risk of coronary heart disease health conditions rather than just listing provisions of this interim final rule are
claim‘‘ in § 101.81 (the soluble fiber and specific sources of soluble fiber. Similar not subject to review by the Office of
CHD health claim)); or (3) add barley to option two, producers would only Management and Budget because they
betafiber to the soluble fiber-CHD health choose to change product labels or do not constitute a ‘‘collection of
claim and also expand the scope of the reformulate products if they believed information’’ under the Paperwork
claim to include all sources of soluble that the benefits that they will derive Reduction Act of 1995 (44 U.S.C. 3501–
fiber. FDA concludes that authorizing from doing so are at least as great as the 3520). Rather, the food labeling health
the petition by adding barley betafiber costs of making those changes. In claim on the association between
to the soluble fiber and CHD health addition, this option would reduce the consumption of barley betafiber beta-
claim is the best option of those future burden on manufacturers of glucan soluble fiber and CHD risk is a
identified. petitioning FDA to use the soluble fiber ‘‘public disclosure of information
Option One: Deny the Petition and CHD health claim for additional originally supplied by the Federal
FDA can only define costs and sources of soluble fiber, and it would Government to the recipient for the
benefits relative to a baseline. FDA also reduce the agency’s burden of purpose of disclosure to the public’’ (see
usually selects the option of taking no evaluating each petition for each 5 CFR 1320.3(c)(2)).
action as the baseline because it helps individual source of soluble fiber. IX. Federalism
readers identify the costs and benefits of However, by expanding the use of the
actions that change the status quo. In claim to all sources of soluble fiber FDA has analyzed this interim final
this case, denying the petition would without reviewing the scientific data on rule in accordance with the principles
correspond to taking no action because each source, FDA would not be able to set forth in Executive Order 13132. FDA
it would imply no change in the soluble verify that the claim was being used has determined that the rule has a
fiber and CHD health claim and thus the under circumstances where it is truthful preemptive effect on State law. Section
continuation of the status quo. By and not misleading to consumers. If the 4(a) of the Executive order requires
definition, the baseline itself has no expanded claim was used on a product agencies to ‘‘construe * * * a Federal
costs or benefits. This does not mean that did not reduce the risk of CHD, statute to preempt State law only where
that we ignore the costs and benefits of then the expanded claim could actually the statute contains an express
the baseline. Instead, it means that FDA result in an increase in CHD. This preemption provision or there is some
expresses the costs and benefits of the would happen if consumers were other clear evidence that the Congress
baseline in how it calculates the costs misled into thinking that they were intended preemption of State law, or
and benefits of the other regulatory reducing their risk of CHD by where the exercise of State authority
options. consuming a product that actually did conflicts with the exercise of Federal
Option Two: Authorize the Petition not reduce the risk of CHD. As a result, authority under the Federal statute.’’
(Add Only Barley Betafiber to the they might not take other beneficial Section 403A of the act (21 U.S.C. 343–
Soluble Fiber and CHD Health Claim) steps that would decrease their risk of 1) is an express preemption provision.
This option would allow producers CHD. Section 403A(a)(5) of the act provides
who use barley betafiber to use the FDA cannot conclude that the cost that ‘‘* * * no State or political
soluble fiber and CHD health claim on savings of option three outweigh the subdivision of a State may directly or
their product labels under certain increased risk of a false or misleading indirectly establish under any authority
conditions. Producers would only claim being made under the expanded or continue in effect as to any food in
choose to change product labels or claim. Therefore FDA cannot conclude interstate commerce—* * * any
reformulate products if they believe that that option three is better for social requirement respecting any claim of the
the benefits that they will derive from welfare than option two. Moreover, the type described in section 403(r)(1) of the
doing so are at least as great as the costs agency believes that expanding the act made in the label or labeling of food
of making those changes. FDA has soluble fiber and CHD health claim to that is not identical to the requirement
reviewed the data supplied in the all sources of soluble fiber without of section 403(r). * * *’’
petition and concludes that the claim is reviewing the scientific data supporting Currently, this provision operates to
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truthful and not misleading. If this such a claim of CHD risk reduction for preempt States from imposing health
interim final rule is finalized without each individual source of fiber would be claim labeling requirements concerning
change, FDA can be sure that to a failure to carry out our statutory beta-glucan soluble fiber from barley
whatever extent producers use the responsibility under section 403(r)(3)(B) betafiber and reduced risk of CHD
claim, consumers will be in a better of the act to issue health claim because no such requirement had been
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9946 Federal Register / Vol. 73, No. 37 / Monday, February 25, 2008 / Rules and Regulations
imposed by FDA under section 403(r) of of this interim final rule are consistent identified with the docket number
the act. This interim final rule, if with Executive Order 13132. found in brackets in the heading of this
finalized without change, would amend document. Received comments may be
X. Issuance of an Interim Final Rule
existing food labeling regulations to add seen in the Dockets Management Branch
and Immediate Effective Date
barley betafiber as an eligible source of between 9 a.m. and 4 p.m., Monday
beta-glucan soluble fiber to the FDA is issuing this rule as an interim through Friday.
authorized health claim for soluble fiber final rule, effective immediately, with This regulation is effective upon
from certain foods and risk of CHD. an opportunity for public comment. publication in the Federal Register. The
Although this rule would have a Section 403(r)(7) of the act authorizes us agency will address comments and
preemptive effect in that it would to make proposed regulations issued confirm or amend the interim final rule
preclude States from issuing any health under section 403(r) of the act effective in a final rule.
claim labeling requirements for beta- upon publication pending consideration
glucan soluble fiber from barley of public comment and publication of a XI. Comments
betafiber and a reduced risk of CHD that final regulation, if the agency Interested persons may submit to the
are not identical to those that would be determines that such action is necessary Division of Dockets Management (see
required by this interim final rule, this for public health reasons. This authority ADDRESSES) written or electronic
preemptive effect is consistent with enables us to act promptly on petitions comments regarding this document.
what Congress set forth in section 403A that provide for information that is Submit a single copy of electronic
of the act. Section 403A(a)(5) of the act necessary to: (1) Enable consumers to comments or two paper copies of any
displaces both State legislative develop and maintain healthy dietary mailed comments, except that
requirements and State common law practices, (2) enable consumers to be individuals may submit one paper copy.
duties. (Medtronic v. Lohr, 518 U.S. 470, informed promptly and effectively of Comments are to be identified with the
503 (1996) (Breyer, J., concurring in part important new knowledge regarding docket number found in brackets in the
and concurring in judgment); id. at 510 nutritional and health benefits of food, heading of this document. Received
(O’Connor, J., joined by Rehnquist, C.J., or (3) ensure that scientifically sound comments may be seen in the Division
Scalia, J., and Thomas, J., concurring in nutritional and health information is of Dockets Management between 9 a.m.
part and dissenting in part); Cipollone v. provided to consumers as soon as and 4 p.m., Monday through Friday.
Liggett Group, Inc., 505 U.S. 504, 521 possible. Proposed regulations made Please note that on January 15, 2008,
(1992) (plurality opinion); id. at 548–49 effective upon publication under this the FDA Web site transitioned to the
(Scalia, J., joined by Thomas, J., authority are deemed to be final agency Federal Dockets Management System
concurring in judgment in part and action for purposes of judicial review. (FDMS). FDMS is a Government-wide,
dissenting in part). The legislative history indicates that electronic docket management system.
FDA believes that the preemptive such regulations should be issued as Electronic submissions will be accepted
effect of this interim final rule, if interim final rules (H. Conf. Rept. No. by FDA through FDMS only.
finalized without change, is consistent 105–399, at 98 (1997)).
with Executive Order 13132. Section We are satisfied that all three of the XII. References
4(e) of the Executive order provides that criteria in section 403(r)(7)(A) of the act The following references have been
‘‘when an agency proposes to act have been met for the amendment to the placed on display in the Division of
through adjudication or rulemaking to soluble fiber from certain foods and risk Dockets Management (see ADDRESSES)
preempt State law, the agency shall of CHD health claim to list barley and may be seen by interested persons
provide all affected State and local betafiber as eligible source of beta- between 9 a.m. and 4 p.m., Monday
officials notice and an opportunity for glucan soluble fiber. This health claim through Friday. (FDA has verified the
appropriate participation in the amendment will help enable consumers Web site address, but FDA is not
proceedings.’’ FDA provided the States to develop and maintain healthy dietary responsible for any subsequent changes
with an opportunity for appropriate practices. The health claim will also to the Web site after this document
participation in this rulemaking on provide consumers with important publishes in the Federal Register.)
December 12, 2007, when FDA’s knowledge regarding the effects of beta- 1. Cargill, Inc., ‘‘Petition for Health
Division of Federal and State Relations glucan soluble fiber in reducing the risk Claim—Barley Betafiber and Coronary Heart
provided notice via fax and email of, and will provide consumers with Disease,’’ (Docket 2006P–0393 CP1), June 20,
transmission to State health scientifically sound information on the 2006.
commissioners, State agriculture benefits of foods containing beta-glucan 2. Cargill, Inc., ’’Petition for Health
commissioners, food program directors, soluble fiber from barley betafiber. Claim—Barley Betafiber and Coronary Heart
Therefore, we are using the authority Disease,’’ Appendix 4, (Docket 2006P–0393),
and drug program directors as well as
given to us in section 403(r)(7)(A) of the June 20, 2006.
FDA field personnel of FDA’s intent to 3. Cargill, Inc., ‘‘Petition for Health
amend the health claim regulation act to issue an interim final rule Claim—Barley Betafiber and Coronary Heart
authorizing health claims for soluble authorizing a health claim for soluble Disease,’’ Appendix 1, (Docket 2006P–0393),
fiber from certain foods and risk of CHD fiber from barley betafiber and CHD, June 20, 2006.
(§ 101.81). It advised the States of FDA’s effective immediately. 4. Keenan, J.M., Goulson, M., Shamliyan,
possible action and encouraged the FDA invites public comment on this T., et al., ’’The Effects of Concentrated Barley
States and local governments to review interim final rule. The agency will Beta-Glucan on Blood Lipids in a Population
the petition and to provide any consider modifications to this interim of Hypercholesterolaemic Men and Women,’’
comments to the docket (Docket No. final rule based on comments made British Journal of Nutrition, 97:1162–1168,
during the comment period. Interested 2007.
2006P–0393), until January 12, 2008.
persons may submit to the Division of 5. E-mail from Lore Kolberg, Cargill, Inc.,
FDA received no comments in response
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Federal Register / Vol. 73, No. 37 / Monday, February 25, 2008 / Rules and Regulations 9947
Cardiovascular Disease Prevention,’’ Total and LDL-Cholesterol,’’ Australian shall contain at least 0.75 g of beta-
Circulation, 102:3137–3147, 2000. Journal of Nutrition and Dietetics, 58:51–55, glucan soluble fiber per reference
7. Agency Response Letter to Generally 2001. amount customarily consumed of the
Recognized as Safe Notice No. GRN 000207, 19. Törrönen, R., Kansanen, L., Uusitupa, food product; or
FDA, Center for Food Safety and Applied M., et al., ‘‘Effects of an Oat Bran Concentrate
Nutrition, Office of Food Additive Safety, on Serum Lipids in Free-Living Men with * * * * *
December 19, 2006. Mild to Moderate Hypercholesterolemia,’’ Dated: February 15, 2008.
8. National Heart, Lung, and Blood European Journal of Clinical Nutrition, Jeffrey Shuren,
Institute; National Cholesterol Education 46:621–627, 1992.
Program Expert Panel on Detection, Assistant Commissioner for Policy.
Evaluation, and Treatment of High Blood List of Subjects in 21 CFR Part 101 [FR Doc. E8–3418 Filed 2–22–08; 8:45 am]
Pressure in Adults (Adult Treatment Panel Food labeling, Nutrition, Reporting BILLING CODE 4160–01–S
III), Third Report of the NCEP Adult and recordkeeping requirements.
Treatment Panel III, Executive Summary,
Bethesda (MD): National Institutes of Health, ■ Therefore, under the Federal Food,
National Heart, Lung and Blood Institute, Drug, and Cosmetic Act and under DEPARTMENT OF JUSTICE
(www.nhlbi.nih.gov/guidelines/cholesterol/ authority delegated to the Commissioner
atp_iii.htm), May 2001. of Food and Drugs, 21 CFR part 101 is 28 CFR Part 16
9. Guidance for Industry: Significant amended as follows: [CPCLO Order No.: 001–2008]
Scientific Agreement in the Review of Health
Claims for Conventional Foods and Dietary PART 101—FOOD LABELING Privacy Act of 1974; System of
Supplements, Rockville, MD: U.S. Food and
Drug Administration; December 1999,
Records
■ 1. The authority citation for 21 CFR
Available from: http://www.cfsan.fda.gov/ part 101 continues to read as follows: AGENCY: Federal Bureau of
~dms/ssaguide.html. Investigation, Department of Justice.
10. Biörklund, M., vanRees, A., Mensink, Authority: 15 U.S.C. 1453, 1454, 1455; 21
R.P., et al., ‘‘Changes in Serum Lipids and U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. ACTION: Final rule.
Postprandial Glucose and Insulin 243, 264, 271.
Concentrations After Consumption of ■ 2. Section 101.81 is amended by SUMMARY: The Federal Bureau of
Beverages with b-Glucans from Oats or adding paragraph (c)(2)(ii)(A)(6) and by Investigation (FBI), a component agency
Barley: A Randomized Dose-Controlled revising paragraph (c)(2)(iii)(A)(2) to of the Department of Justice (DOJ), is
Trial,’’ European Journal of Clinical read as follows: issuing a final rule exempting a new
Nutrition, 59:1272–1281, 2005. Privacy Act system of records, the Law
11. Keogh, G.F., Cooper, G.J.S., Mulvey, § 101.81 Health claims: Soluble fiber from Enforcement National Data Exchange.
T.B., et al., ‘‘Randomized Controlled certain foods and risk of coronary heart The FBI published a system of records
Crossover Study of the Effect of a Highly b- disease (CHD). notice for N–DEx and a proposed rule
Glucan-Enriched Barley on Cardiovascular * * * * *
Disease Risk Factors in Mildly
implementing these exemptions on
(c) * * * October 4, 2007. The listed exemptions
Hypercholesterolemic Men,’’ American
(2) * * * are necessary to avoid interference with
Journal of Clinical Nutrition, 78:711–718,
2003.
(ii) * * * the law enforcement functions and
12. Kerckhoffs, D.A.J.M., Hornstra, G., and (A) * * * responsibilities of the FBI. This
R.P. Mensink, ‘‘Cholesterol-Lowering Effect (6) Barley betafiber. Barley betafiber is document addresses public comments
of b-Glucan from Oat Bran in Mildly the ethanol precipitated soluble fraction on the proposed rule.
Hypercholesterolemic Subjects May Decrease of cellulase and alpha-amylase
hydrolyzed whole grain barley. Barley DATES: This final rule is effective
When b-Glucan is Incorporated Into Bread
and Cookies,’’ American Journal of Clinical betafiber is produced by hydrolysis of February 25, 2008.
Nutrition, 78:221–227, 2003. whole grain barley flour, as defined in FOR FURTHER INFORMATION CONTACT:
13. Lovegrove, J.A., Clohessy, A., Milon, paragraph (c)(2)(ii)(A)(5) of this section, Kirsten J. Moncada, Director, Office of
H., et al, ‘‘Modest Doses of b-Glucan Do Not with a cellulase and alpha-amylase Privacy and Civil Liberties, 950
Reduce Concentrations of Potentially Pennsylvania Avenue, NW.,
Atherogenic Lipoproteins,’’ American
enzyme preparation, to produce a clear
aqueous extract that contains mainly Washington, DC 20530, or facsimile
Journal of Clinical Nutrition, 72:49–55, 2000.
14. Naumann, E., vanRees, A.B., Önning, partially hydrolyzed beta-glucan and 202–616–9627.
G., et al., ‘‘b-Glucan Incorporated Into a Fruit substantially hydrolyzed starch. The SUPPLEMENTARY INFORMATION:
Drink Effectively Lowers Serum LDL- soluble, partially hydrolyzed beta- On October 4, 2007, the FBI issued a
Cholesterol Concentrations,’’ American glucan is separated from the insoluble system of records notice at 72 FR 56793,
Journal of Clinical Nutrition, 83:601–605, material by centrifugation, and after for a new Privacy Act records system,
2006. removal of the insoluble material, the JUSTICE/FBI–020, the Law Enforcement
15. Pick, M.E., Hawrysh, Z.J., Gee, M.I., et partially hydrolyzed beta-glucan soluble National Data Exchange (N–DEx), and a
al., ‘‘Oat Bran Concentrate Bread Products
Improve Long-Term Control of Diabetes: A
fiber is separated from the other soluble notice of proposed rulemaking, at 72 FR
Pilot Study,’’ Journal of the American compounds by precipitation with 56704, to exempt it from subsections
Dietetic Association, 96:1254–1261, 1996. ethanol. The product is then dried, (c)(3) and (4); (d)(1), (2), (3), and (4);
16. Beer, M.U., Arrigoni, E., and R. Amado, milled and sifted. Barley betafiber shall (e)(1), (2), (3), (5), and (8); and (g) of the
‘‘Effects of Oat Gum on Blood Cholesterol have a beta-glucan soluble fiber content Privacy Act. The FBI explained that the
Levels in Healthy Young Men,’’ European of at least 70 percent on a dry weight exemptions were necessary in order to
Journal of Clinical Nutrition, 49:517–522, basis. avoid interference with the FBI’s law
1995. enforcement functions and
17. Braaten, J.T., Wood, P.J., Scott, F.W., et
* * * * *
(iii) * * * responsibilities.
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