Federal Register, Volume 64 Issue 162 (Monday, August 23, 1999)

[Federal Register Volume 64, Number 162 (Monday, August 23, 1999)]
[Proposed Rules]
[Pages 45932-45937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21852]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 98P-0683]

Food Labeling: Health Claims; Soy Protein and Coronary Heart
Disease

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this
document as a reproposal of one provision of its proposed rule of
November 10, 1998, entitled ``Food Labeling: Health Claims; Soy Protein
and Coronary Heart Disease.'' In that proposal, FDA tentatively
indicated its intention to use a specific analytical method to measure
soy protein for assessing compliance. Comments on that proposal argued
that that method is inadequate for many products. FDA is therefore
proposing an alternative procedure that will rely on measurement of
total protein and require manufacturers, in certain circumstances, to
maintain records that document the amount of soy protein in products
and to make those records available to appropriate regulatory officials
for inspection and copying upon request.

DATES: Written comments by September 22, 1999. See section VI of this
document for the effective date of any final rule that may issue based
upon this proposal.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Submit written comments on the information collection
provisions to the Office of Information and Regulatory Affairs, OMB,
New Executive Office Bldg., 725 17th St. NW., Washington, DC 20503,
ATTN: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Susan M. Pilch, Center for Food Safety
and Applied Nutrition (HFS-465), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-205-4500.

SUPPLEMENTARY INFORMATION:

I. Background

On November 8, 1990, the President signed into law the Nutrition
Labeling and Education Act of 1990 (the 1990 amendments) (Public Law
101-535). This new law amended the Federal Food, Drug, and Cosmetic Act
(the act) in a number of important ways. One of the most notable
aspects of the 1990 amendments was that they provided procedures
whereby FDA is to regulate health claims on food labels and in food
labeling.
In the Federal Register of January 6, 1993 (58 FR 2478), FDA
issued a final rule that implemented the health claim provisions of the
act. In that final rule, FDA adopted Sec. 101.14 (21 CFR 101.14), which
sets out the rules for the authorization and use of health claims.
Additionally, FDA established in Sec. 101.70 (21 CFR 101.70) a process
for petitioning the agency to authorize health claims about a
substance-disease relationship (Sec. 101.70(a)) and sets out the types
of information that any such petition must include (Sec. 101.70(f)).
In the Federal Register of November 10, 1998 (63 FR 62977), FDA
proposed adding Sec. 101.82 to authorize the use, on food labels and in
food labeling, of health claims on the association between soy protein
and reduced risk of coronary heart disease (CHD) (the soy protein
proposed rule). FDA proposed this action in response to a petition
filed by Protein Technologies International, Inc. (the petitioner)
(Refs. 1 and 2). In the soy protein proposed rule, the agency presented
the rationale for a health claim on this substance-disease relationship
as provided for under the standard in section 403(r)(3)(B)(i) of the
act (21 U.S.C. 343(r)(3)(B)(i)) and Sec. 101.14(c) of FDA's
regulations. The agency tentatively concluded that, based on the
totality of publicly available scientific evidence, soy protein
included in a diet low in saturated fat and cholesterol may reduce the
risk of CHD. The soy protein proposed rule included qualifying criteria
for the purpose of identifying soy protein-containing foods eligible to
bear the proposed health claim and a proposed method for assessing
compliance with the qualifying criteria.
The petitioner requested that measurement of total soy isoflavones
be used as a marker for the content of soy protein in foods and as an
indicator of the effectiveness of soy protein products in reducing
blood cholesterol levels. As discussed in section III.C.5 of the soy
protein proposed rule (63 FR 62977 at 62987 to 62988), FDA found that
the petitioner's conclusions regarding the significance of soy
isoflavones with respect to the observed cholesterol-lowering effects
of soy protein were not supported by the available studies. Thus, in
section V.C. of the soy protein proposed rule (63 FR 62977 at 62992),
FDA found the petitioner's proposed methodology to assess isoflavones
was not suitable for assessing whether foods contain sufficient soy
protein to be eligible to bear the health claim. Accordingly, in
Sec. 101.82(c)(2)(ii)(B), FDA proposed to measure soy protein for
compliance purposes using the Association of Official Analytical
Chemists International (AOAC) official method of analysis No. 988.10.
This AOAC method is an enzyme-linked immunosorbent assay (ELISA) that
can detect soy protein in raw and heat-processed meat products. With
this assay, samples are compared to standard commercial soy protein and
appropriate blanks. The sample extraction procedure, which involves
preparation of an acetone powder, has been shown to be appropriate for
a complex food matrix (meat). FDA tentatively concluded that this assay
also should be suitable for other food matrices and requested comments
on the suitability of this method for assuring that foods bearing the
health claim contain qualifying levels of soy protein.

II. Assessing Qualifying Amounts of Soy Protein in Foods

In response to the soy protein proposed rule, the agency received
approximately 130 letters, each containing one or more comments, from
consumers, consumer organizations,

[[Page 45933]]

professional organizations, government agencies, industry, trade
associations, health care professionals, and research scientists.
Several of the submissions included comments about the analytical
method that FDA had proposed to assess the qualifying levels of soy
protein. All of these comments disagreed with the proposed approach to
assessing compliance, and some suggested alternative approaches. The
agency is addressing only the comments about the analytical method and
compliance assessment in this document.

A. Comments on the Proposed Analytical Method

All of the comments on the proposed analytical method disagreed
with the use of AOAC official method of analysis No. 988.10 and
concluded that this ELISA method was unlikely to produce a reliable
measure of the soy protein content of foods in all cases. Several
comments noted that the method was designed and validated (Refs. 3 and
4) for the detection of soy protein in raw and cooked meat products.
They also noted that numerous factors affect the quantitative results
obtained and reported that published and unpublished data indicated
that the assay can usually only be considered semi-quantitative.
The comments pointed out several problems with the assay
including:
(1) Different soy protein sources and methods of processing
(defatted flours, isolates, concentrates, products subject to
hydrolysis or extrusion) can yield different response factors to the
immunoassay (Refs. 4 through 7).
(2) Heating the sample can induce loss of response (Ref. 5).
(3) Only a small number of matrices have been tested for
interference with soy protein quantitation. Although most of these were
relatively low (Refs. 4 and 5), other vegetable and cereal sources of
protein have the potential for considerable interference and need to be
tested.
(4) The collaborative study of the method in meat products
containing few or none of the potential interferents indicated a
between-laboratory variability of approximately 30 percent (Ref. 6).
One comment noted that the need to have available a sample of the
specific soy protein ingredient used in the product for calibration
(Ref. 7) in order to have a quantitative method posed difficulties in
the practical use of the assay. Because many foods contain more than
one soy protein ingredient that may be processed differently, use of
the assay would require manufacturers to maintain samples and product
specification sheets for possible later analysis. Another comment noted
the expense of validating the method for each soy protein source and
each product produced.
The agency is persuaded by these comments that AOAC official
method of analysis No. 988.10 is not an appropriate method for the
quantitation of soy protein in many of the products that may be
eligible to bear the health claim. Therefore, FDA will not be adopting
its use to assess compliance in the final rule.

B. Alternatives for Assessing Compliance

Some comments urged that FDA consider use of other validated ELISA
methods. One published variation on the ELISA procedure (Ref. 8), like
the method that FDA had initially proposed, has been validated only in
meat products. Other ELISA assay techniques described in a comment were
reported to be proprietary. Without validation data on such procedures,
FDA is not proposing their use.
Several of the comments urged FDA to work collaboratively with
other interested parties to develop an analytical method to quantify
soy protein in various foods. FDA agrees that having a reliable,
accurate analytical method is the ideal means to verify compliance. The
agency intends to pursue development of an analytical method for soy
protein and would be open to a collaborative effort with industry
similar to that undertaken to develop a methodology to measure folate.
However, FDA's resources are limited. Moreover, the complicated nature
of the analytical problem may take several years to solve. (The agency
notes that it took FDA and the industry over 10 years to develop a
highly specific antibody for use in the analysis of free folic acid, a
task that was relatively simple compared to developing a methodology to
measure soy protein in all foods.) Development of a universally
applicable analytical method, or multiple methods applicable to
different foods or soy protein sources, to measure soy protein in foods
is not likely to provide a timely, practical method to assess
compliance. Accordingly, the agency is not prepared to authorize use of
a soy protein health claim based on use of analytical methodology that
does not now exist. Should, however, suitable analytical methodology
for soy protein be developed and validated, the agency would propose to
amend its regulation to provide for use of such method or methods for
compliance verification.
Several comments suggested alternative approaches to measure soy
protein. These alternatives involved either calculations based on
manufacturers' records or a combination of analysis of total protein
content and calculations based on manufacturers' records. One comment
noted that some of the soy-based foods that may be eligible to bear the
health claim are products whose protein content is derived solely from
whole soybeans or from soy protein ingredients such as soy flour,
concentrates, or isolates. For such products, the amount of soy protein
present is represented by the total protein content, for which an
appropriate AOAC method as specified in Sec. 101.9(c)(7) (21 CFR
101.9(c)(7)) is available. For other products that contain protein
sources other than soy, the soy protein content would represent a
calculable fraction of the total protein content. This comment noted
that, based on the known amount of protein per gram of a soy ingredient
(soy flour, concentrate, or isolate), one can calculate the quantity of
soy protein in a final food product based on the known ratio of added
soy products multiplied by the measured protein content. Another
comment suggested that an alternative approach could consist of
measurement of total protein content followed by calculation, through
recipes, of soy protein content based on the ratio of soy protein to
total protein in the food. The ratio of soy protein ingredients to
total protein ingredients could be determined by reference to nutrient
data bases, recipes, purchase orders for ingredients, or other
reasonable bases. This comment further noted that the methodology and
records that provide appropriate documentation for the calculations
required should be available at the food manufacturer's facility or
other site for review by FDA investigators. One comment endorsed the
outlined approach of employing appropriate record keeping under FDA
inspection for assessing compliance. Another comment recommended the
use of manufacturing records for tracking both the presence and amount
of soy protein in products bearing the soy protein health claim. It
further suggested use of such records would provide an accurate and
practical method to determine the quantity of soy protein in a food.
One comment supported a procedure whereby manufacturers would monitor
the level of soy protein addition via batch recordkeeping that the
agency would be able to inspect. Another comment recommended that those
companies making the claim be responsible for

[[Page 45934]]

tracking systems based on formulations and usage.
These comments have persuaded the agency that it should propose an
alternative approach for quantifying soy protein in foods until such
time as a suitable analytical method for soy protein is available. The
agency is persuaded that a procedure employing measurement of total
protein and, for some products, calculation of the soy protein content
based on information contained in manufacturers' records is an accurate
and practical method for assuring that products bearing the proposed
health claim meet the requirement for the qualifying level of soy
protein. FDA is, therefore, revising proposed Sec. 101.82(c)(2)(ii)(B)
to provide for this alternative approach for compliance assessment.
Under this proposed approach, FDA will measure total protein in a
product by an appropriate method of analysis as given in the ``Official
Methods of Analysis of the AOAC International,'' as described at
Sec. 101.9(c)(7). If the protein content per reference amount
customarily consumed (RACC) fails to meet the qualifying level of soy
protein for eligibility to bear the health claim, the product would not
be in compliance with Sec. 101.82 and would be misbranded under section
403(a) of the act. If the protein content per RACC equals or exceeds
the qualifying level of soy protein and the food contains no sources of
protein other than soy, the product would be in compliance with
Sec. 101.82. If the protein content per RACC equals or exceeds the
qualifying level of soy protein and the food contains a source or
sources of protein in addition to soy, then FDA will require that it
have access to manufacturers' records to calculate the contribution of
soy protein to the total protein content as the means to establish
compliance.

C. FDA Inspection of Records

FDA is proposing a method to assess compliance for products that
bear the proposed soy protein health claim that would require records
inspection in some instances.
When Congress enacted the 1990 amendments, it sought to ensure
that the rules pertaining to health and nutrient content claims would
be enforceable (see H. Rept. 538, 101st Cong., 2d sess. 8, 9 (1990)).
Health and nutrient content claims are intended to make the consumer
aware of the nutritional attributes of the labeled food. Because these
claims are meant to help consumers maintain healthful dietary
practices, it is of the utmost importance that they accurately reflect
the nutritional composition of the labeled food. (See 136 Congressional
Record, H 12953, October 26, 1990, statement of house floor managers:
``There is a great potential for defrauding consumers if food is sold
that contains inaccurate or unsupportable health claims.'')
Under section 701(a) of the act (21 U.S.C. 371(a)), the agency may
issue regulations for the efficient enforcement of the act. Courts have
recognized that FDA may impose recordkeeping requirements where they
effectuate the act's goals. (See Toilet Goods Association v. Gardner,
387 U.S. 158, 163-64 (1967); and National Confectioners Association v.
Califano, 569 F.2d 690, 693 & n.9 (D.C. Cir. 1978).) The agency has
required that records be maintained and made available for inspection
by FDA employees in a number of situations. (See, e.g., 21 CFR
108.25(g) and 114.100 (acidified foods); 108.35(h) and 113.100 (thermal
processing of low-acid foods); 129.80(h) (bottled drinking water);
172.320 (amino acids); 176.170 (components of paper and paperboard in
contact with aqueous and fatty foods); and 179.25(e) (food
irradiation).)
In addition, on a number of occasions, FDA has determined that
adequate enforcement of labeling rules would be possible only if the
agency can review the information that a manufacturer has developed to
support the statements on its food labels. For example, in the final
rule on serving sizes (58 FR 2229 at 2271, January 6, 1993), FDA
provided that manufacturers of aerated foods could substitute a volume-
based measure for a weight-based reference amount as the basis for
determining a product's serving size. Under the regulation
(Sec. 101.12(e)(21 CFR 101.12 (e)), manufacturers who choose this
approach must make available to the agency upon request certain
information, including a detailed protocol and records of all data used
to arrive at the density-adjusted reference amount (58 FR 2272). In the
nutrient content claims final rule (Sec. 101.13(j)(1)(ii)(A)), FDA also
imposed a records requirement on firms that use a broad-based reference
nutrient value for claims such as ``light'' (58 FR 2302 at 2365,
January 6, 1993). In the Federal Register of February 2, 1996 (63 FR
3885), FDA proposed to extend record inspection requirements, in
certain circumstances, to records that support the use of certain
health claims and nutrient content claims. In that proposed rule, the
agency specifically identified concerns about claims that are based on
information about a food that is available only to the food
manufacturer and without which the agency would be unable to evaluate
the truthfulness of the claim (63 FR 3885 at 3887). In that proposed
rule, the agency also discussed in detail its legal authority to issue
regulations for the efficient enforcement of the act, including
regulations that require that access to certain records be provided to
the agency (63 FR 3885 at 3888 to 3889).
In the absence of an accurate and reliable analytical method for
the quantitation of soy protein, when soy is not the only source of
protein in a food, only the manufacturer will have the information
required to determine the amount of soy protein per RACC. Therefore,
FDA has tentatively concluded that the proposed requirements, which
would cover only the proposed soy protein health claim, are necessary
for the efficient enforcement of the act. Ensuring the accuracy of
claims was an overriding concern of Congress in passing the 1990
amendments. Congress envisioned that, under the act as amended, ``only
truthful claims may be made on foods'' (136 Congressional Record H
12953, October 26, 1990, statement of Representative Waxman).
A manufacturer who places a health or nutrient content claim in
food labeling must have knowledge that the food qualifies to bear the
claim. Congress expected that manufacturers would have to ascertain the
nutritional attributes of their food products, through laboratory
analysis or otherwise, in order to label those products properly. FDA
has stated previously that a food manufacturer is responsible for the
accuracy of its food labels (58 FR 2079 at 2163 and 2165). Indeed, a
claim in food labeling that calls the consumer's attention to the
food's nutritional characteristics is a representation that the
manufacturer has evidence that the food meets the requirements for the
claim. Thus, making a claim without such a basis would be misleading,
in violation of section 403(a) of the act.
FDA, therefore, proposes to require that, in some cases,
manufacturers who choose to place a soy protein health claim on the
food label or in labeling may do so only if they maintain the
information on which the claim is based and make it available for
inspection and copying to appropriate regulatory officials upon
request. Failure to meet the requirements by maintaining appropriate
records and complying with an agency request to examine those records
will be a violation of section 403(r) of the act, misbranding the food
bearing the claim.
Compliance with the proposed regulation should not entail the
creation

[[Page 45935]]

of any new information or the compilation of any special records.
Rather, the proposed recordkeeping requirement would obligate
manufacturers to keep and provide FDA with information that they should
already possess. Adequate records may consist of results of appropriate
combinations of direct product analyses, data base values, recipe
calculations, and purchase orders.
The agency anticipates that manufacturers may have concerns about
the confidentiality of the information inspected by the agency under
this proposal. Manufacturers should be assured that FDA does not and
would not release information that would provide a competitive
advantage to another manufacturer (Sec. 20.61 (21 CFR 20.61)). For
example, if a company's records that support the validity of the use of
the soy protein health claim in a food's labeling contain confidential
information describing product formulation, manufacturing processes, or
unique testing methods, the agency would protect this information from
public disclosure (Sec. 20.61). (See also 5 U.S.C. 552(b)(4), 18 U.S.C.
1905, and 45 CFR 5.65.)
The agency notes that, if it does not proceed with this proposal
to require access to records to verify the amount of soy protein in
foods whose labeling bears a soy protein health claim, it is prepared
to authorize use of the claim only on foods whose sole source of
protein is from soy. However FDA ultimately proceeds, the agency would
propose to amend its regulation to provide for compliance verification
based on one or more validated analytical methodologies that are
effective in all foods, should such a methodology or methodologies be
developed.

III. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(11) 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.

IV. Analysis of Impacts

In the analysis of the soy protein proposed rule, FDA examined the
rule's effects under Executive Order 12866 and the Regulatory
Flexibility Act (5 U.S.C. 601-612). The agency found that the soy
protein proposed rule was not a significant regulatory action under the
Executive Order, and that it would not have a significant economic
impact on a substantial number of small entities. This proposed
modification of the method of assessing compliance does not change
those conclusions.
In the following analysis, the agency discusses the benefits and
costs associated with the proposed modification and three regulatory
alternatives. The four options considered are:
1. Take no action (do not modify proposed method of assessing
compliance in the soy protein proposed rule).
2. Modify proposed method of assessing compliance in the soy
protein proposed rule as proposed in this document.
3. Use manufacturing records for all products as the method of
assessing compliance.
4. Authorize use of the soy protein health claim only on foods
whose sole source of protein is from soy.

A. Option One: Take no action (do not modify method of assessing
compliance in the soy protein proposed rule)
Taking no action would not affect the actual costs or benefits of
the soy protein proposed rule.

B. Option Two: Modify proposed method of assessing compliance in the
soy protein proposed rule as proposed in this document
The specification of the method that FDA will use to determine the
level of soy protein in products does not lead to additional compliance
costs. Use of the proposed soy protein health claim is voluntary;
manufacturers choosing to make the claim must determine the level of
soy protein in their products, but need not use the same method that
FDA proposes to use.
As discussed in section II.B. of this document, some comments on
the soy protein proposed rule suggested alternative methods that FDA
could use to determine the level of soy protein in products bearing the
proposed claim. Having considered these comments, FDA is proposing to
modify proposed Sec. 101.82(c)(2)(ii)(B) to provide that FDA will
establish the level of soy protein by analyzing the total protein
content of a product by an appropriate method of analysis as given in
the ``Official Methods of Analysis of the AOAC International'' as
described in Sec. 101.9(c)(7). If the product contains sources of
protein in addition to soy, the agency will establish the level by
using manufacturers' records to calculate the contribution of soy
protein to the total protein content.
1. Costs
The proposed modification may reduce the cost to FDA of
determining the level of soy protein in some products. This cost is a
social cost in the sense that FDA operating funds are derived from
public tax revenues. Because this cost is not a compliance cost,
reducing it will not affect the compliance costs of the rule but it may
increase the net benefits--the costs of implementing a voluntary
program must be subtracted from the benefits of that program in order
to arrive at net benefits.
As discussed in section II.A. of this document, some of the
comments on the method of compliance in the soy protein proposed rule
indicated that its use would be costly for some manufacturers. This
proposed modification will reduce these distributive effects of the soy
protein proposed rule, and so eliminate the equity issue raised in
those comments.
2. Benefits
As discussed in section II.A. of this document, some of the
comments on the soy protein proposed rule argued that the method for
assessing compliance set forth in that proposal is not appropriate for
the quantitation of soy protein in many of the products that may be
eligible to bear the health claim. Use of that method would therefore
reduce the information value of the health claim. This proposed
modification would increase the information value of the health claim
by increasing the accuracy of the statement concerning the level of soy
protein in particular products.
The proposed modification might also reduce the benefits of the
soy protein proposed rule if the requirement that FDA have access to
records under the modified method were to discourage use of the
proposed health claim and reduce the number of products bearing the
claim. In some comments, firms indicated that the agency should use
records to assess compliance, so the agency believes that many firms
would still be prepared to use the claim on their food products. Most
firms probably already keep the relevant records for business purposes,
including: (1) Product recipes and formulations in order to make
consistent products, (2) nutrient analyses or databases in order to
comply with the required Nutrition Facts panel, and (3) purchase orders
for normal business purposes. Therefore, the agency does not believe
that the proposed modification will significantly reduce the benefits
of the proposed health claim. FDA requests comments on whether, and the
extent to which, the proposed modification would discourage use of the
claim.

C. Option Three: Use manufacturing records for all products as the
method of assessing compliance

[[Page 45936]]

As discussed in section II.B. of this document, FDA believes that
there is no validated analytical method currently available that the
agency could use instead of the analytical method proposed in the soy
protein proposed rule. However, some comments on the soy protein
proposed rule recommended that FDA use manufacturing records for all
products, not merely for those products that contain protein from
sources other than soy.
1. Costs
Using manufacturing records in all cases would generate higher
costs for FDA than using the proposed modified method for products that
have only one source of protein. It would cost more to use
manufacturing records to determine the level of soy protein in products
whose only source of protein is soy than it would cost to determine the
level of soy protein in those products by using only an appropriate
analytical method.
2. Benefits
Using manufacturing records in all cases may reduce the benefits
of the soy protein proposed rule more than the proposed modified
method, if more manufacturers would be discouraged from using the claim
because they would be required to provide FDA with access to their
records.

D. Option 4: Authorize use of the soy protein health claim only on
foods whose sole source of protein is from soy
As stated in section II.C. of this document, if FDA does not
proceed with the proposed modified method to verify the amount of soy
protein in some foods using records, it is prepared instead to
authorize use of the claim only on foods whose sole source of protein
is from soy. Under this option, fewer products would be able to make
claims under the soy protein proposed rule. The costs and benefits of
the rule would therefore be less than under the modification proposed
in this rule.

V. Paperwork Reduction Act of 1995

This proposed rule contains information collection requirements
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995. A description of these
requirements is given below with an estimate of the annual
recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information; including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques or other forms of information
technology.
Title: Record Retention Requirements for the Soy Protein/CHD
Health Claim
Description: Section 403(r) of the act requires that food bearing
a health claim authorized by regulation on a petition to the agency be
labeled in compliance with that regulation issued by FDA. In the soy
protein proposed rule (63 FR 62977 at 62994), FDA stated its tentative
conclusion that the labeling requirements proposed for soy protein are
not subject to review by OMB because they do not constitute a
``collection of information'' under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). Rather, the proposed food labeling health claim
on the association between soy protein and reduced risk of CHD would be
a ``public disclosure of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the
public'' (5 CFR 1320.3(c)(2)). The regulation set forth in this
proposed rule would authorize the use in food labeling of a health
claim about the relationship between soy protein and CHD. This proposal
would also require that a manufacturer of a product bearing the
proposed soy protein health claim whose product contains non-soy
sources of protein retain all the records that permit the calculation
of the ratio of soy protein to other sources of protein in the food.
The manufacturer of such a food product would be required to make those
records available for review and copying by appropriate regulatory
officials upon request and during site visits.
Description of Respondents: Businesses or others for-profit.

Table 1.--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
101.82(c)(2)(ii)(B) 25 1 25 1 25
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operation and maintenance costs associated with this collection of
information.

FDA believes that the records that a manufacturer would retain
would be records that a prudent business would obtain and retain as a
normal part of doing business. The requirements contained in this
proposal would require only a minimal burden, no more than one hour per
response, from respondents.
In compliance with 44 U.S.C. 3507(d), the agency has submitted the
information collection requirements of the proposed rule to OMB for
review. Interested persons are requested to send comments regarding
information collection by September 22, 1999 to the Office of
Information and Regulatory Affairs, OMB (address above), ATTN: Desk
Officer for FDA.

VI. Proposed Effective Date

FDA is proposing to make these regulations effective upon
publication in the Federal Register of a final rule based upon this
proposal.

VII. Comments

Interested persons may, on or before September 22, 1999, submit to
the Dockets Management Branch (address above) written comments
regarding this proposal. Two copies of any comments are to be
submitted, except that individuals may submit one 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 office above
between 9 a.m. and 4 p.m., Monday through Friday.
This proposed rule is not a ``technical regulation'' as defined in
19 U.S.C. 2576b(7) because it is not mandatory that a soy protein
health claim be placed on the label or in the labeling of qualifying
foods. Therefore, the

[[Page 45937]]

requirement for a 75-day comment period for a proposed technical
regulation found in Executive Order 12889, ``Implementation of the
North American Free Trade Agreement,'' does not apply to this proposed
rule. In addition, this proposal addresses only the narrow issue of the
method FDA will use to verify that foods bearing a soy protein health
claim contain the required amount of soy protein. Moreover, under
section 403(r)(4)(A)(i) of the act, if the agency issues a proposed
regulation on a health claim petition, the agency is to complete the
rulemaking within 540 days of the date the agency receives the petition
(see also Sec. 101.70(j)(4)(ii)). Therefore, FDA finds that there is
good cause under 21 CFR 10.40(b)(2) to provide 30 days, rather than 60
days, for public comment on this proposed rule.

VIII. References

The following references have been placed on display in the
Dockets Management Branch (address above) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Protein Technologies International, Inc., ``Health Claim
Petition,'' May 4, 1998 [CP1, vol. 1-3]
2. Protein Technologies International, Inc., ``Addendum to
Health Claim Petition,'' August 10, 1998 [CP1, vol. 4]
3. Crimes, A. A., F. J. Bailey, and C. H. S. Hitchcock,
``Determination of Foreign Proteins in Meat Products,'' Analytical
Proceedings, 18:164-166, 1981.
4. Hitchcock, C. H. S., F. J. Bailey, A. A. Crimes, D. A. G.
Dean, and P. J. Davis, ``Determination of Soya Proteins in Food
Using an Enzyme-linked Immunosorbent Assay Procedure,'' Journal of
the Science of Food and Agriculture, 32:157-165, 1981.
5. Griffith, N. M., M. J. Billington, A. A. Crimes, and C. H.
S. Hitchcock, ``An Assessment of Commercially Available Reagents for
an Enzyme-linked Immunosorbent Assay (ELIZA) of Soy Protein in Meat
Products,'' Journal of the Science of Food and Agriculture, 35:1255-
1260, 1984.
6. Olsman, W. J., S. Dobbelaero, and C. H. S. Hitchcock, ``The
Performance of an SDS-PAGE and ELISA Method for the Quantitative
Analysis of Soya Protein in Meat Products, an International
Collaborative Study,'' Journal of the Science of Food and
Agriculture, 36:499-507, 1985.
7. McNeal, F. E., ``Semiquantitative Enzyme-linked
Immunosorbent Assay of Soy Protein in Meat Products: Summary of
Collaborative Study,'' Journal of the Association of Official
Analytical Chemists, 71(2):443, 1988.
8. Yasumoto, K, M. Sudo, and T. Suzuki, ``Quantitation of Soya
Protein by Enzyme-linked Immunosorbent Assay of its Characteristic
Protein,'' Journal of the Science of Food and Agriculture, 50:377-
389, 1990.

List of Subjects in 21 CFR Part 101

Food labeling, Incorporation by reference, Nutrition, Reporting
and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and
under authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:

PART 101--FOOD LABELING

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.
2. In Sec. 101.82, as proposed to be added at 63 FR 62977 at
62997, November 10, 1998, revise paragraph (c)(2)(ii)(B) to read as
follows:

Sec. 101.82 Health claims: Soy protein and risk of coronary heart
disease (CHD).

* * * * *
(c) * * *
(2) * * *
(ii) * * *
(B) FDA will assess qualifying levels of soy protein in the
following fashion: FDA will measure total protein content by the
appropriate method of analysis given in the ``Official Methods of
Analysis of the AOAC International,'' as described at 21 CFR
101.9(c)(7). Interested persons can obtain copies of the ``Official
Methods of Analysis of the AOAC International'' from the Association of
Official Analytical Chemists, 481 North Frederick Ave., suite 500,
Gaithersburg, MD 20877-2504, or may examine copies at the Center for
Food Safety and Applied Nutrition's Library, 200 C St. SW., rm. 3321,
Washington, DC, or at the Office of the Federal Register, 800 North
Capitol St. NW., suite 700, Washington, DC. For products that contain
no sources of protein other than soy, FDA will consider the amount of
soy protein as equivalent to the total protein content. For products
that contain a source or sources of protein in addition to soy, FDA
will, using the measurement of total protein content, calculate the soy
protein content based on the ratio of soy protein ingredients to total
protein ingredients in the product. FDA will base its calculation of
the ratio of soy protein ingredients to total protein ingredients on
manufacturers' information such as nutrient data bases or analyses,
recipes or formulations, purchase orders for ingredients, or other
reasonable bases. Manufacturers must maintain records that permit such
calculations for as long as the products are marketed. Manufacturers
must make these records available for authorized inspection and copying
by appropriate regulatory officials and manufacturers must submit these
records to those regulatory officials upon request.
* * * * *

Dated: August 16, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-21852 Filed 8-19-99; 10:15 am]
BILLING CODE 4160-01-F