[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