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

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,

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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

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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

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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

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\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