Evaporated Milk; Amendment of the Standard of Identity

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 131

[Docket No. 91P-0090]

Evaporated Milk; Amendment of the Standard of Identity

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the

standard of identity for evaporated milk by revising the minimum

milkfat and total milk solids content requirements and establishing a

minimum milk solids-not-fat content requirement. This action is in

response to a petition filed by the American Dairy Products Institute

(ADPI) and will promote honesty and fair dealing in the interest of

consumers.

DATES: Effective June 13, 1994, written objections and requests for a

hearing by May 16, 1994.

ADDRESSES: Submit written objections to the Dockets Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION: Nannie H. Rainey, Center for Food Safety and

Applied Nutrition (HFS-158), Food and Drug Administration, 200 C St.

SW., Washington, DC 20204, 202-205-5099.

SUPPLEMENTARY INFORMATION:

I. The Proposal

In the Federal Register of July 22, 1992 (57 FR 32470), FDA

published a proposal, based on a petition from ADPI, 130 North Franklin

St., Chicago, IL 60606, to amend the standard of identity for

evaporated milk (21 CFR 131.130) to: (1) Reduce the minimum milkfat

content requirement from 7.5 percent to 6.5 percent by weight; (2)

reduce the minimum total milk solids content requirement from 25

percent to 23 percent by weight; and (3) add a minimum milk solids-not-

fat content requirement of 16.5 percent by weight. Interested persons

were given until September 21, 1992, to submit comments.

II. Comments

The agency received seven responses, each containing one or more

comments, from a consumer, a trade association, and several

manufacturers. Six letters supported, and one opposed, the proposal. A

summary of the opposing comments and the agency's responses follow.

1. The comment contended that the solids content of fluid milk

(producers' milk) has probably increased over the last 20 years, and

that the proposed reduction in the minimum required milkfat and total

milk solids content of evaporated milk is inconsistent with the intent

of the standard of identity for evaporated milk, as well as the intent

of the subsequent amendments, that the milkfat and milk solids-not-fat

contents be reasonably related to those of the milk used in the

manufacture of evaporated milk.

The agency disagrees with the comment. According to data supplied

by the U.S. Department of Agriculture (USDA) (Ref. 1), the composition

of producers' milk has remained fairly constant through the 1970's and

the 1980's. These data show that the yearly average milkfat content for

all producers' milk, before standardization for beverage purposes,

during the period 1970 to 1991 (Ref. 1) ranged between 3.64 percent and

3.68 percent, with an overall average of 3.66 percent.

The agency does not agree that the change in compositional

requirements is inconsistent with the intent of the evaporated milk

standard. Throughout the history of the evaporated milk standard, the

labeling of evaporated milk products and the instructional materials

pertaining to the use of the food supplied to consumers by food

manufacturers, trade associations, and USDA (Ref. 2), as well as policy

statements by FDA, have described the food as a 2 to 1 concentrate of

milk. Instructions on the label or in labeling of evaporated milk

frequently show that the food is to be diluted with an equivalent

portion of water for use in preparation of beverages made using the

food. In addition, recipes for other foods often state that a can of

evaporated milk may be diluted with a can of water for use in recipes

calling for the addition of milk (Ref. 2).

The standard of identity for milk in Sec. 131.110 (21 CFR 131.110)

defines minimum compositional requirements for the food of not less

than 3.25 percent of milkfat and not less than 8.25 percent of milk

solids not fat. The minimum compositional requirements for evaporated

milk that FDA is adopting in this final rule (i.e., not less than 6.5

percent of milkfat, 16.5 percent of milk solids not fat, and 23 percent

total milk solids) correspond to a twofold concentration of

standardized milk and, thus, are directly related to those of milk.

Because the change in compositional requirements accurately reflects

the general understanding that evaporated milk is a twofold concentrate

of milk, the agency finds that the change in the evaporated milk

standard is consistent with the intent of the standard and, therefore,

is revising the standard as proposed.

2. The comment disagreed that the test results that ADPI submitted

from a monadic (i.e., single-product evaluation) in-home use test were

a reliable indication of real consumer preferences. The comment stated

that monadic ratings are not accepted by organizations such as the

National Advertising Division of the Better Business Bureau to support

product comparative claims.

FDA acknowledges the comment's concern that ADPI's in-home use

test was not a conclusive demonstration that consumers preferred the

lower fat, lower solids evaporated milk over the traditional

standardized evaporated milk. However, ADPI submitted information in

its petition on a total of three industry research tests on consumer

perceptions of traditional standardized evaporated milk compared to

evaporated milk manufactured to conform to the parameters for which

ADPI had petitioned. The monadic in-home use test was only one of these

tests. In the other two tests, each participant was able to evaluate

both products.

FDA has reviewed the studies that ADPI submitted (Ref. 3). The

agency concludes that there was sufficient evidence to support ADPI's

claim that consumers were unable to distinguish between the

standardized evaporated milk and evaporated milk manufactured to

conform to the petitioned parameters. Taken individually, the studies

did not provide overwhelming data, but the combined weight of the three

studies has convinced the agency that consumers' perceptions of the two

products were not significantly different. Each test was performed

under different circumstances (i.e., employing different evaluation

techniques) and used a different representative sample of consumers.

The studies examined a wide variety of possible consumer uses of

evaporated milk in realistic, everyday situations. Additionally, these

were separate studies employing within-subjects and between-subjects

designs that came to identical conclusions. Based on all of the

evidence in the petition, the agency finds that it can conclude that

consumers are unable to discriminate between standardized evaporated

milk and the evaporated milk manufactured to conform to the suggested

parameters.

3. The comment stated that the overwhelming use of evaporated milk

is in recipes, and that it was not aware of anyone reconstituting

evaporated milk for beverage use in the United States. The comment

questioned whether consumers consider evaporated milk to be a 2:1

concentrate of fluid milk, and whether the amendment would make

reconstitution for beverage use more convenient.

The agency agrees that evaporated milk is used primarily as an

ingredient of other foods. FDA notes that evaporated milk may be used

in recipes, as manufactured, or in reconstituted form as a direct

replacement for milk. Another significant use of evaporated milk is in

coffee and tea (Ref. 4). Although the common consumption of

reconstituted evaporated milk as a beverage is decreasing (Refs. 5 and

6), evaporated milk does replace fluid milk for beverage purposes in

individual households as a result of commercial purchases, as well as

through the USDA commodity distribution program; in institutions; and

by participants in the USDA Supplemental Food Program for Women,

Infants, and Children (Ref. 4). In fact, one comment from a consumer

stated that he and his family have used evaporated milk regularly in

food recipes, in coffee, and in the preparation of beverage milk.

Evaporated milk has been touted as a 2:1 concentration of milk for

many years (Ref. 7). A 2:1 concentrate is easier for consumers to

reconstitute than a 2.3:1 concentrate because it is in whole units. In

addition, as noted above, a 2:1 concentrate, when diluted, results in a

product whose composition is the same as that for beverage milk.

Therefore, FDA concludes that providing for a 2:1 concentrate of milk

under the standard of identity for evaporated milk is in the best

interest of consumers, and that the concerns raised by the comment are

without merit.

4. The comment argued that a change in the standard of identity

for evaporated milk is unnecessary because consumers that want a lower

fat, lower cholesterol evaporated milk can purchase evaporated lowfat

milk or evaporated skimmed milk.

FDA notes that consumers may continue to purchase evaporated

lowfat milk or evaporated skimmed milk. However, comments from a

manufacturer of evaporated milk that were submitted in support of the

proposal stated that many of its customers have expressed an interest

in lower fat and lower calorie foods, and that the amendment would

afford it (the commenting manufacturer) the opportunity to meet the

demands of this segment of the public. Furthermore, the fat reduction,

although modest, is consistent with ``The Surgeon General's Report on

Nutrition and Health'' (Ref. 8) and the National Academy of Sciences'

report on ``Diet and Health, Implications for Reducing Chronic Disease

Risk'' (Ref. 9), which recommend that consumers reduce their

consumption of fats and cholesterol. Therefore, FDA finds that the

amended standard will benefit consumers.

FDA also notes that the nutritional benefit is only one of several

bases that support the amended standard. Therefore, FDA concludes that

the argument raised by the comment is without merit.

5. The comment noted that the proposed reduction in the minimum

required milkfat content and milk solids content in evaporated milk

would make the U.S. standard of identity for evaporated milk

inconsistent with the International Codex standard for evaporated milk.

FDA acknowledges that the amended standard is not identical to the

International Codex standard for evaporated milk. The Codex standard

requires that evaporated milk contain not less than 7.5 percent of

milkfat and not less than 25 percent of total milk solids. Because the

new requirements in the standard that FDA is adopting will establish

lower values for minimum milkfat and minimum total milk solids content

than those of the Codex standard for evaporated milk, products

complying with the Codex standard will meet FDA's standard of identity.

U.S. exporters of evaporated milk may need to reformulate their

products if they are to be shipped to countries that require that the

food comply with the minimum requirements of the Codex standard, but

this fact provides no basis for not making the proposed change in the

standard.

Accordingly, after consideration of all comments, the agency is

amending the standard of identity for evaporated milk in

Sec. 131.130(a) by reducing the minimum milkfat content requirement

from 7.5 percent to 6.5 percent by weight, reducing the minimum total

milk solids content requirement from 25 percent to 23 percent by

weight, and establishing a minimum milk solids-not-fat content

requirement of 16.5 percent by weight. FDA concludes that the

amendments will promote honesty and fair dealing in the interest of

consumers.

III. Economic Impact

FDA has examined the economic implications of this final rule to

amend the standard of identity for evaporated milk in 21 CFR part 131

as required by Executive Order (E.O.) 12866 and the Regulatory

Flexibility Act (Pub. L. 96-354). E.O. 12866 directs agencies to assess

all costs and benefits of available regulatory alternatives and, when

regulation is necessary, to select regulatory approaches that maximize

net benefits (including potential economic, environmental, public

health, and safety effects; distributive impacts; and equity). The

Regulatory Flexibility Act requires that the agency analyze options for

regulatory relief for small businesses.

On July 22, 1992, FDA analyzed the economic impact of the

requirements that the agency is adopting under the previous E.O. 12291

and found that they would not have a significant impact on small

business. The agency noted in the proposed rule that manufacturers may

continue to process evaporated milks using current formulations. Thus,

no changes are required in formulations unless manufacturers wish to

reformulate their products. In the proposal, the agency tentatively

concluded that the regulation would have zero costs associated with it.

FDA has received no information or comments that would alter the

tentative finding that it set out in the proposed rule that there is no

substantive economic issue in this rulemaking.

Thus, the agency finds that this final rule is not a significant

regulatory action as defined in E.O. 12866. In compliance with the

Regulatory Flexibility Act, the agency certifies that the final rule

will not have a significant impact on a substantial number of small

businesses.

IV. Environmental Impact

The agency has determined under 21 CFR 25.24(b)(1) 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.

V. Objections

Any person who will be adversely affected by this regulation may

at any time on or before May 16, 1994, file with the Dockets Management

Branch (address above) written objections thereto. Each objection shall

be separately numbered, and each numbered objection shall specify with

particularity the provisions of the regulation to which objection is

made and the grounds for the objection. Each numbered objection on

which a hearing is requested shall specifically so state. Failure to

request a hearing for any particular objection shall constitute a

waiver of the right to a hearing on that objection. Each numbered

objection for which a hearing is requested shall include a detailed

description and analysis of the specific factual information intended

to be presented in support of the objection in the event that a hearing

is held. Failure to include such a description and analysis for any

particular objection shall constitute a waiver of the right to a

hearing on the objection. Three copies of all documents shall be

submitted and shall be identified with the docket number found in

brackets in the heading of this document. Any objections received in

response to the regulation may be seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday through Friday.

VI. 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. Rourke, J., Dairy Division , U.S. Department of Agriculture,

facsimile of Summary Data on Milkfat Content of Producers' Milk,

1970 through 1991, to Shellee A. Davis, February 17, 1993.

2. Leighton, R. J., and R. F. Mann, letter to Fred R. Shank,

FDA, May 4, 1993.

3. Heaton, A. W., FDA Division of Consumer Studies, memorandum

to Shellee A. Davis, November 6, 1992.

4. Clark, W. S., letter to Dockets Management Branch, February,

25, 1992.

5. USDA Summary Data from the Nationwide Food Consumption

Survey/Individual, 1977-1978.

6. USDA Summary Data from the Nationwide Food Consumption

Survey/Individual, 1987-1988.

7. Jenness, R., and S. Patton, ``Principles of Dairy

Chemistry,'' p. 325, John Wiley & Sons, Inc., New York, NY, 1959.

8. U.S. Department of Health and Human Services, Public Health

Service, ``The Surgeon General's Report on Nutrition and Health,''

DHHS (PHS) Publication No. 88-50210 (GPO Stock No. 017-001-00465-1),

pp. 9-11, U.S. Government Printing Office, Washington, DC, 1988.

9. Committee on Diet and Health, Food and Nutrition Board,

Commission on Life Sciences, National Research Council, National

Academy of Sciences, Executive Summary from ``Diet and Health,

Implications for Reducing Chronic Disease Risk,'' National Academy

Press, Washington, DC, 1989.

List of Subjects in 21 CFR Part 131

Cream, Food grades and standards, Milk, Yogurt.

Therefore, under the Federal Food, Drug, and Cosmetic Act and

under authority delegated to the Commissioner of Food and Drugs, 21 CFR

part 131 is amended as follows:

PART 131--MILK AND CREAM

1. The authority citation for 21 CFR part 131 is revised to read

as follows:

Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371,

379e).

2. Section 131.130 is amended by revising paragraph (a) to read as

follows:

Sec. 131.130 Evaporated milk.

(a) Description. Evaporated milk is the liquid food obtained by

partial removal of water only from milk. It contains not less than 6.5

percent by weight of milkfat, not less than 16.5 percent by weight of

milk solids not fat, and not less than 23 percent by weight of total

milk solids. Evaporated milk contains added vitamin D as prescribed by

paragraph (b) of this section. It is homogenized. It is sealed in a

container and so processed by heat, either before or after sealing, as

to prevent spoilage.

* * * * *

Dated: April 8, 1994.

Michael R. Taylor,

Deputy Commissioner for Policy.

[FR Doc. 94-8979 Filed 4-11-94; 12:13 pm]

BILLING CODE 4160-01-F