[Federal Register Volume 59, Number 72 (Thursday, April 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8979]


[[Page Unknown]]

[Federal Register: April 14, 1994]


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 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