[Federal Register Volume 62, Number 36 (Monday, February 24, 1997)]
[Rules and Regulations]
[Pages 8163-8166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4365]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 131 and 133
[Docket Nos. 95P-0125, 95P-0250, 95P-0261, and 95P-0293]
Lowfat and Skim Milk Products, Lowfat Cottage Cheese: Revocation
of Standards of Identity
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; response to objection and denial of the request for
a hearing; confirmation of effective date.
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SUMMARY: The Food and Drug Administration (FDA) is responding to
objections and is denying the requests that it received for a hearing
on the final rule removing the standards of identity for lowfat milk
and skim milk as well as those for other lower-fat dairy products.
After reviewing the objections to the final rule, the agency has
concluded that the objections do not raise issues of material fact that
justify granting a hearing. Therefore, FDA is confirming the effective
date for the final rule. The final rule was based, in part, on
petitions filed jointly by the Milk Industry Foundation and the Center
for Science in the Public Interest and on a petition filed by the
American Dairy Products Institute. This action is also part of the
agency's ongoing review of existing regulations under President
Clinton's Regulatory Reinvention Initiative.
DATES: Effective date confirmed: January 1, 1998. This rule is
applicable to all products initially introduced or initially delivered
for introduction into interstate commerce on or after this date.
Compliance may begin on November 20, 1996. Any labels or labeling that
require revision as a result of this revocation shall comply no later
than January 1, 1998.
FOR FURTHER INFORMATION CONTACT: Michelle A. Smith, 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. Background--The Final Regulation
In the Federal Register of November 20, 1996 (61 FR 58991), FDA
issued a final rule entitled ``Lowfat and Skim Milk Products, Lowfat
and Nonfat Yogurt Products, Lowfat Cottage Cheese: Revocation of
Standards of Identity; Food Labeling, Nutrient Content Claims For Fat,
Fatty Acids and Cholesterol Content of Food'' which removed the
standards of identity for the following lower-fat dairy products:
Sweetened condensed skimmed milk (21 CFR 131.122), lowfat dry milk (21
CFR 131.123), evaporated skimmed milk (21 CFR 131.132), lowfat milk (21
CFR 131.135), acidified lowfat milk (21 CFR 131.136), cultured lowfat
milk (21 CFR 131.138), skim milk (21 CFR 131.143), acidified skim milk
(21 CFR 131.144), cultured skim milk (21 CFR 131.146), sour half-and-
half (21 CFR 131.185), acidified sour half-and-half (21 CFR 131.187),
and lowfat cottage cheese (21 CFR 133.131) (the November 1996 final
rule). The final regulation also amended the standard of identity for
dry cream in 21 CFR 131.149 by removing the reference to 21 CFR 131.135
(the lowfat milk standard). FDA announced that it was deferring action,
for 120 days, on its proposal to remove the standards of identity for
lowfat and nonfat yogurt (21 CFR 131.203 and 131.206). Further, the
final rule amended the nutrient content claims regulations for fat,
fatty acids, and cholesterol content to provide for ``skim'' as a
synonym for ``nonfat'' when used in labeling milk products.
Interested persons had until December 20, 1996, to file written
objections to the revisions in parts 131 and 133 (21 CFR parts 131 and
133) or to request a hearing on the specific provisions to which there
were objections. FDA received one letter, from Mid-America Dairymen,
Inc., Associated Milk Producers, Inc., and Swiss Valley Farms
(hereinafter referred to as ``Mid-America'' or ``the objector'')
containing objections to portions of the November 1996 final rule and
requests for a hearing on those objections. Under section 701(e) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(e)), FDA
has carefully considered the objections and requests for a hearing, and
other responses. The specific objections and the agency's conclusions
follow.
II. Standards for Granting a Hearing
Section 701(e) of the act provides that, within 30 days after
publication of an order relating to standards of identity for dairy
products, any person adversely affected by such an order may file
objections, specifying with particularity the provisions of the order
``deemed objectionable, stating the grounds therefor,'' and requesting
a public hearing based upon such objections. FDA may deny a hearing
request if the objections to the regulation do not raise genuine and
substantial issues of fact that can be resolved at a hearing (Community
Nutrition Institute v. Young, 773 F.2d 1356, 1364 (D.C. Cir. 1985),
cert. denied, 475 U.S. 1123 (1986)). Specific criteria for determining
whether a request for a hearing is justified are set forth in 21 CFR
12.24(b).
A party seeking a hearing is required to meet a ``threshold burden
of tendering evidence suggesting the need for a hearing.'' (See Costle
v. Pacific Legal Foundation, 445 U.S. 198, 214-215 (1980) reh. den.,
445 U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning,
Inc., 412 U.S. 609, 620-621 (1973).) If a hearing request fails to
identify any factual evidence
[[Page 8164]]
that would be the subject of a hearing, there is no point in holding
one.
A hearing request must not only contain evidence, but that evidence
should raise a material issue of fact concerning which a meaningful
hearing might be held (Pineapple Growers v. FDA, 673 F.2d 1083, 1085
(9th Cir. 1982)). Where the issues raised in the objection are, even if
true, legally insufficient to alter the decision, the agency need not
grant a hearing (Dyestuffs and Chemicals, Inc., v. Flemming, 271 F.2d
281 (8th Cir. 1959) cert. denied, 362 U.S. 911 (1960)). A hearing is
justified only if the objections are made in good faith, and if they
``draw into question in a material way the underpinnings of the
regulation at issue'' (Pactra Industries v. CPSC, 555 F.2d 677 (9th
Cir. 1977)). Finally, courts have uniformly recognized that a hearing
need not be held to resolve questions of law or policy. (See Citizens
for Allegan County, Inc., v. FPC, 414 F.2d 1125 (D.C. Cir. 1969); Sun
Oil Co. v. FPC, 256 F.2d 233, 240 (5th Cir.) cert. denied, 358 U.S. 872
(1958).)
In sum, a hearing request should present sufficient credible
evidence to raise a material issue of fact, and the evidence must be
adequate to resolve the issue as requested and to justify the action
requested.
III. Objections and Requests for a Hearing
1. The first objection was about the removal of the standards of
identity for lowfat milk (21 CFR 131.135) and skim milk (21 CFR
131.143). In the November 1996 final rule, FDA removed the standards of
identity for lower-fat dairy products, including the standards for
lowfat milk and skim milk, so that these products would be subject to
the requirements in 21 CFR 130.10 (the general standard). FDA concluded
that the final regulation will provide for consistency in the
nomenclature and labeling of most nutritionally modified dairy products
and other foods bearing ``lowfat'' and ``nonfat'' claims; promote
honesty and fair dealing in the interest of consumers; increase
flexibility for manufacturers of lower-fat dairy products; and increase
product choices available to consumers.
Mid-America objected to the removal of the standards for lowfat and
skim milk stating that those standards were issued because the
Commissioner of Food and Drugs (the Commissioner) found that they would
promote honesty and fair dealing in the interest of consumers. In
support of this objection, Mid-America cited section 401 of the act (21
U.S.C. 341) which provides:
Whenever in the judgment of the Secretary such action will
promote honesty and fair dealing in the interest of consumers, he
shall promulgate regulations fixing and establishing for any food,
under its common or usual name so far as practicable, a reasonable
definition and standard of identity.
Mid-America also included by reference ``all of the factual findings
made by the Commissioner when the lowfat and skim milk standards were
promulgated.''
In further support of the objection, Mid-America maintained that
new nutrition and other labeling requirements do not obviate the need
for standards of identity for lowfat milk and skim milk. Mid-America
acknowledged that some of the rationale in the preamble to the November
1996 final rule may be sound for products other than lowfat milk and
skim milk, because of the new labeling requirements. However, according
to Mid-America, these new requirements cannot be interpreted to mean
that removing the standards for lowfat milk and skim milk will be in
the interest of consumers because the standards were issued to promote
honesty and fair dealing in the interest of consumers.
Mid-America did not specify to which new labeling requirements it
was referring. FDA assumes the reference is to the January 6, 1993,
final rules implementing the Nutrition Labeling and Education Act of
1990 (the 1990 amendments). These final rules included new requirements
for nutrition labeling, uniform definitions for nutrient content claims
and health claims, and more complete ingredient declaration,
particularly for standardized foods. Further, the objection did not
identify the foods to which it was referring in saying that the new
nutrition labeling regulations may justify removal of the standards of
identity in part 131 or 133, nor did it offer any reason for treating
lowfat milk and skim milk differently from other lower-fat dairy
products with respect to the new nutrition labeling requirements. Thus,
this part of the objection does not present any substantive evidence in
support of the objection.
In addition, Mid-America included by reference all the ``factual
findings'' made by the Commissioner in establishing the standards for
lowfat and skim milk. The objection's premise appears to be that if
those findings justified issuance of the standards of identity, they
must now preclude removal of the standards. However, an evidentiary
hearing was not held when the standards were originally issued, and,
therefore, there were no formal findings of fact.
FDA assumes that by referring to ``factual findings,'' without any
more specific references, Mid-America may have intended to include by
reference all conclusions reached by the agency during the course of
the rulemaking that resulted in the standards for lowfat milk and skim
milk. This rulemaking spanned 14 years, however, and Mid-America has
provided no specific information to help the agency focus its attention
on any factual evidence or legal arguments that Mid-America might
present at a hearing. Consequently, it is difficult for the agency to
determine the specific issues to which the objection refers.
Nonetheless, FDA has carefully reviewed the record of the rulemaking
that resulted in the standards for lowfat milk and skim milk to see
whether there were any findings or conclusions that were in conflict
with the agency's determination in the November 1996 final rule to
revoke these standards and to replace them with the general standard.
Most of the objections to the original final rule issuing standards
for lowfat and skim milk (38 FR 27924, October 10, 1973) (the 1973
final rule), as discussed in a notice in the Federal Register of
December 5, 1974 (39 FR 42351), have no bearing here. For example, FDA
received objections to the requirement in the 1973 final rule that milk
be pasteurized. Other objections concerned the failure of the standards
for fluid milks to provide for fortification with minerals and vitamins
other than vitamins A and D.
The only issue that the agency found that could be even partially
related to Mid-America's objection was one over whether FDA should have
provided for the use of stabilizers and emulsifiers, and the basis for
limiting the permitted amounts of these substances, in lowfat milk and
skim milk. The 1973 final rule establishing standards of identity for
lowfat milk and skim milk provided for limited use of stabilizers and
emulsifiers in these foods. FDA received a number of objections and
requests for a hearing based on its failure to provide for unrestricted
use of stabilizers. These objections maintained that stabilizers could
improve the palatability of lower-fat milks and would be more
economical than nonfat milk-derived solids.
On December 5, 1974, FDA published a notice staying the provision
that would have limited the use of stabilizers and emulsifiers in
lower-fat milks (39 FR 42351). In an attempt to avoid a hearing, FDA
proposed to amend the standards for lowfat milk and skim milk to expand
the uses of stabilizers and emulsifiers (41 FR 46873, October 26,
[[Page 8165]]
1976) (the 1976 proposal). Subsequently, based on comments to the 1976
proposal, FDA published a final rule in the Federal Register of
December 12, 1980 (45 FR 81734), terminating the 1976 rulemaking and
continuing the stay on the provisions in the 1973 standard that would
have restricted the use of stabilizers and emulsifiers in lowfat and
skim milks. In 1983, FDA published a notice announcing a public hearing
on stayed provisions of the 1973 final rule. Based on a motion by FDA
for summary judgment, and a lack of opposition by the original
objectors, an administrative law judge issued an order, dated December
12, 1983, finding that the provisions in the original standards that
limited the use of stabilizers and emulsifiers would promote honesty
and fair dealing in the interest of consumers (51 FR 40313, November 6,
1986).
After carefully reviewing the record on this issue, FDA concludes
that nothing in the record of the 1973 final rule raises an issue of
fact about the agency's decision with respect to the use of stabilizers
and emulsifiers that is embodied in the November 1996 final rule. The
controversy in 1973 concerned a comparison between lower-fat milks
containing stabilizers and emulsifiers and lower-fat milks to which
milk solids not fat (msnf) are added so that the finished product
contains 10 percent msnf. In that context, FDA concluded (45 FR 81734
at 81736) that lower-fat milks thickened with stabilizers and
emulsifiers would be nutritionally inferior to the same products
containing not less than 10 percent msnf, and that, therefore, use of
stabilizers and emulsifiers to thicken lower-fat milk products would
not promote honesty and fair dealing in the interest of consumers. No
conclusions were reached in that rulemaking on the broader issue of
adding ingredients, including stabilizers and emulsifiers, to a
nutritionally modified food (that is, foods to which vitamins have been
added to avoid nutritional inferiority) to restore functional
properties that are reduced or lost when fat is removed compared to the
same food without added ingredients, which is the issue that FDA
decided in replacing the standards in 21 CFR 131.135 and 131.143 with
the general standard in the November 1996 final rule.
Furthermore, and more importantly, the finding of an administrative
law judge in 1983 that a standard of identity will promote honesty and
fair dealing in the interest of consumers does not mean that that
standard cannot be changed. FDA's administrative regulations in 21 CFR
10.30 provide that interested persons may petition the agency to amend
standards to reflect changes in consumer needs and perceptions, along
with advances in technology, whenever such changes will promote honesty
and fair dealing in the interest of consumers. Further, FDA can propose
on its own initiative to amend a standard when the agency considers the
amendment to be appropriate. To raise an issue of fact that would
justify a hearing, an objector must do more than point out that a
standard has changed, yet that is all the objector has done here.
In addition, Mid-America appears to misunderstand the impact of the
November 1996 final rule in at least one important regard. Removing the
standards of identity for lowfat milk and skim milk in 21 CFR 131.135
and 131.143 does not mean that these foods are not covered by a
standard of identity. Rather, these foods will continue to be regulated
as standardized foods under the requirements in the general standard
(21 CFR 130.10).
Mid-America failed to identify any specific evidence in support of
its objection. FDA has carefully reviewed the record associated with
issuing the original standards of identity for lowfat and skim milk.
The agency has been unable to find anything in that record that
conflicts with the agency's determination that creating new standards
for lower-fat milk products under the general standard will promote
honesty and fair dealing in the interest of consumers, in a way that
raises a material issue of fact.
FDA concludes that the objection did not raise a genuine and
substantial issue of fact that might be readily resolved by the
evidence identified in the objection. Therefore, Mid-America's first
objection fails, under 21 CFR 12.24(b)(1), to justify a hearing, and
thus its request for a hearing on this objection is denied.
2. Mid-America objected to the removal of the standards for lowfat
milk and skim milk on the basis that relying on other sections of the
regulations to protect consumers is factually unsound. In support of
its second objection, Mid-America maintained that a number of factual
issues remain unresolved. This assertion was followed by a series of
questions, including, for example: ``(1) What ingredients may be added
to lowfat milk and skim milk [under 21 CFR 130.10]?'' and ``(2) In what
amount may those ingredients be added?'' These questions were not
accompanied by any additional information that could have clarified the
position of Mid-America or that indicated why resolution of the
question in any particular way might be in conflict with the agency's
action in the November 1996 final rule.
First, FDA notes that most of the questions asked by Mid-America
have already been addressed by the agency, either in the preamble of
the November 1996 final rule or in the preambles to the proposal (56 FR
60512, November 27, 1991) and final rule (58 FR 2431, January 6, 1993)
establishing the general standard, and Mid-America has not provided any
basis for finding that a factual issue persists with respect to these
questions. For example, both the November 20, 1996, and the January 6,
1993, final rules contain extensive discussions about the extent to
which a nutritionally modified food named using a nutrient content
claim and a standardized term may deviate from the food for which it
substitutes and the types of labeling necessary to inform consumers
about such deviations (61 FR 58991 at 58994 and 58 FR 2431 at 2433). In
addition, requirements limiting such deviations are codified in 21 CFR
130.10. The objector's questions raised no new issues that have not
previously been considered by the agency. Secondly, to the extent that
any of the questions posed by Mid-America are not fully answered, Mid-
America did not provide any basis to find that there is a factual issue
with respect to any of those questions. Thus, the questions represent
nothing more than mere allegations. Under 21 CFR 12.24(b)(2), a hearing
will not be granted on the basis of mere allegations. Thus, the
questions posed in support of the objection do not justify the granting
of a hearing.
Furthermore, as noted in the agency's response to the first
objection, it is not clear whether the objection takes into
consideration that, although FDA removed the standards of identity in
21 CFR 131.135 and 131.143, there are new standards for lower-fat milk
products under 21 CFR 131.10. Mid-America did not provide any evidence
that would provide a basis for questioning the agency's finding that
the new standards for lower-fat milk products under 21 CFR 130.10 are
in the interest of consumers and promote fair dealing.
FDA concludes that Mid-America's second objection did not raise any
genuine and substantial issue of fact that would justify a hearing.
Rather, the questions posed in support of the second objection amount
to little more than ``mere allegations or denials or general
description and contentions'' that the agency has said in 21 CFR
12.24(b)(2) will not justify a hearing. Consistent with this
regulation, the relevant case law provides that where a party
requesting a hearing only offers allegations without an adequate
proffer to support them, the agency may properly disregard those
allegations
[[Page 8166]]
(General Motors Corp. v. FERC, 656 F.2d 791, 798 n.20 (D.C. Cir.
1981)). Mid-America failed to submit any evidence that creating new
standards for lowfat milk and skim milk under the general standard will
not promote honesty and fair dealing in the interest of consumers.
Because it did not proffer support for its allegations, Mid-America did
not justify a hearing on this issue. Therefore, FDA denies the request
for a hearing on the second objection.
3. Mid-America cited the agency's desire to reduce the burden of
regulation and a need for increased flexibility in at least some
standards of identity. At the same time, Mid-America said that none of
these facts justify removing the standards for lowfat milk and skim
milk that promote honesty and fair dealing in the interest of
consumers. As with its second objection, Mid-America maintained that
this objection raised several ``factual issues'' and proceeded to list
a series of questions. The questions included: ``What do consumers
expect when they purchase `lowfat milk' or `skim milk'?'' ``Would
honesty and fair dealing in the interest of consumers be promoted if
products labeled as `lowfat milk' and `skim milk' are permitted to
contain any `safe and suitable ingredients'?''
Mid-America's third objection did not raise any genuine and
substantial issue of fact that might be readily resolved by any
evidence identified in the objection. Again, the questions posed in
support of the objection amount to little more than mere allegations or
denials or general description and contentions that, under 21 CFR
12.24(b)(2), will not justify a hearing. Therefore, FDA denies the
request for a hearing on this objection.
FDA notes that the letter containing objections and a request for a
hearing was filed within the time specified in 21 CFR 12.22(e).
However, as noted in section III.1. and III.2. of this document, the
objections to the final rule removing the standards for lowfat and skim
milk and placing these foods under new standards in 21 CFR 130.10 do
not raise genuine and substantial issues of fact for resolution through
a public hearing or other procedure as provided for under 21 CFR 12.24,
nor did the objections provide any evidence that the November 1996
final rule would not promote honesty and fair dealing in the interest
of consumers. Therefore, in accordance with 21 CFR 12.28, FDA is
denying Mid-America's requests for a hearing. There were no objections
to the November 1996 final rule other than those addressed above.
List of Subjects
21 CFR Part 131
Cream, Food grades and standards, Milk, Yogurt.
21 CFR Part 133
Cheese, Food grades and standards, Food labeling.
Therefore, under the Federal Food, Drug, and Cosmetic Act (secs.
201, 401, 403, 409, 701, 721 (21 U.S.C. 321, 341, 343, 348, 371, 379e))
and under authority delegated to the Commissioner of Food and Drugs (21
CFR 5.10), notice is hereby given that the objections received did not
justify a hearing, and that the final regulation to amend parts 131 and
133 by removing the standards of identity for various lower-fat milk,
sour half-and-half, and cottage cheese products and amending the
standard of identity for dry cream, as issued in the Federal Register
of November 20, 1996 (61 FR 58991), will become effective on January 1,
1998. Any labels or labeling that require revision as a result of the
final regulation must comply no later than January 1, 1998.
Dated: February 14, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-4365 Filed 2-18-97; 4:10 pm]
BILLING CODE 4160-01-F
