Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim “Lean”, 1455-1459 [E7-330]
Download as PDF
Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Rules and Regulations
State
County
VERMONT .................
VIRGINIA ...................
WASHINGTON ..........
ALL COUNTIES ......................................................................................................................................
ALL COUNTIES ......................................................................................................................................
ADAMS, ASOTIN, BENTON, CHELAN, COLUMBIA, DOUGLAS, FRANKLIN, GARFIELD, GRANT,
KITTITAS, KLICKITAT, LINCOLN, OKANOGAN, SPOKANE, WALLA WALLA, WHITMAN,
YAKIMA,.
FERRY, PEND OREILLE, STEVENS .....................................................................................................
CLALLAM, CLARK, COWLITZ, GRAYS HARBOR ISLAND, JEFFERSON, KING, KITSAP, LEWIS,
MASON, PACIFIC, PIERCE, SAN JUAN, SKAGIT, SKAMANIA, SNOHOMISH, THURSTON,
WAHKIAKUM, WHATCOM.
ALL COUNTIES ......................................................................................................................................
ALL COUNTIES ......................................................................................................................................
ALBANY, CAMPBELL, CARBON, CONVERSE, GOSHEN, HOT SPRINGS, JOHNSON, LARAMIE,
LINCOLN, NATRONA, NIOBRARA, PLATTE, SHERIDAN, SWEETWATER, FREMONT,
SUBLETTE, UINTA, WASHAKIE.
BIG HORN, CROOK, PARK, TETON, WESTON ...................................................................................
..................................................................................................................................................................
WEST VIRGINIA ........
WISCONSIN ..............
WYOMING .................
ALL OTHER ZONES
(Fee/acre/yr)
[FR Doc. E6–22365 Filed 1–11–07; 8:45 am]
I. Background
BILLING CODE 6717–01–P
In the Federal Register of November
25, 2005 (70 FR 71041), FDA published
a proposed rule to amend the definition
of the nutrient content claim ‘‘lean’’ (21
CFR 101.62) to include foods
categorized as ‘‘mixed dishes not
measurable with a cup’’ that are
regulated by FDA and that meet the
criteria in the rule for total fat, saturated
fat, and cholesterol. FDA issued this
proposed rule in response to a petition
filed under section 403(r)(4) of the act
(21 U.S.C. 343(r)(4)) and in part 101 (21
CFR part 101) in § 101.69. Section
403(r)(2)(A)(i) of the act (21 U.S.C.
343(r)(2)(A)(i)) states that a nutrient
content claim may be made only if the
characterization of the level made in the
claim uses terms which are defined in
regulations of the Secretary of Health
and Human Services (the Secretary)
(and, by delegation, FDA). Section
403(r)(4) of the act sets out the
procedures that FDA is to follow upon
receiving a nutrient content claim
petition.
´
On January 9, 2004, Nestle (the
petitioner) submitted a petition
requesting that the agency amend the
nutrient content claim regulation for
‘‘lean’’ (21 CFR 101.62(e)) to include
‘‘mixed dishes not measurable with a
cup’’ as defined in the ‘‘Reference
amounts customarily consumed per
eating occasion’’ regulation (21 CFR
101.12), based on certain qualifying
criteria for total fat, saturated fat, and
cholesterol. FDA filed the petition for
comprehensive review in accordance
with section 403(r)(4) of the act on April
22, 2004.
FDA’s definition of the nutrient
content claim ‘‘lean’’ includes flesh
foods, such as seafood and game meat
products, which are foods that are
similar to the U.S. Department of
Agriculture (USDA)-regulated meat and
poultry products, and also includes
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 2004P–0183]
RIN 0910–ZA27
Food Labeling: Nutrient Content
Claims, Expansion of the Nutrient
Content Claim ‘‘Lean’’
AGENCY:
Food and Drug Administration,
HHS.
rmajette on PROD1PC67 with RULES
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending its
food labeling regulations for the
expanded use of the nutrient content
claim ‘‘lean’’ on the labels of foods
categorized as ‘‘mixed dishes not
measurable with a cup’’ that meet
certain criteria for total fat, saturated fat,
and cholesterol content. This final rule
responds to a nutrient content claim
´
petition submitted by Nestle Prepared
´
Foods Co. (Nestle) under the Federal
Food, Drug, and Cosmetic Act (the act).
This action is also being taken to
provide reliable information that would
assist consumers in maintaining healthy
dietary practices.
DATES: This final rule is effective
January 12, 2007.
FOR FURTHER INFORMATION CONTACT:
Vincent de Jesus, Center for Food Safety
and Applied Nutrition (HFS–830), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–1774.
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
15:29 Jan 11, 2007
Jkt 211001
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
1455
29.20
29.20
$14.60
21.90
29.20
29.20
21.90
7.28
21.90
5.74
meal-type products (i.e., main dishes
and meal products), which are included
in the USDA definition. Prior to the
publication of this final rule, FDA’s
definition of ‘‘lean,’’ did not extend to
foods categorized as ‘‘mixed dishes not
measurable with a cup.’’ Such foods,
e.g., burritos, egg rolls, enchiladas,
pizza, quiches, and sandwiches, are
generally similar to the foods subject to
the definition of ‘‘main dish’’ (21 CFR
101.13(m)) but do not meet the weight
criterion for ‘‘main dish’’ foods (6
ounces (oz) per labeled serving). The
Reference Amount Customarily
Consumed (RACC) for ‘‘mixed dishes
not measurable with a cup’’ is 140
grams (g) (5 oz) (21 CFR 101.12(b), Table
2), which is 1 oz less than the 6 oz per
labeled serving required to qualify as a
‘‘main dish.’’ Thus, food products
categorized as ‘‘mixed dishes not
measurable with a cup’’ and that weigh
less than 6 oz were not eligible to bear
a ‘‘lean’’ nutrient content claim under
§ 101.62(e).
FDA considered the evidence
presented in the petition as part of its
review, as well as information
previously considered by the agency in
the January 6, 1993, nutrient content
claim final rule (58 FR 2302). Based on
the available evidence, FDA
acknowledged the following in the
proposed rule (70 FR 71041 at 71044):
• ‘‘mixed dishes not measurable with
a cup’’ have found their way into the
American diet and serve as a convenient
‘‘meals-on-the-go’’ eating option that is
consistent with America’s changing
lifestyle;
• This category has become a well
established product category that
consumers have come to rely on; and
• There is a growing interest in
healthful alternatives to traditional food
options, including vegetarian
alternatives.
FDA believes that portable food
products, particularly those that are
E:\FR\FM\12JAR1.SGM
12JAR1
1456
Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Rules and Regulations
nutrient (i.e., total fat, saturated fat, and
cholesterol) and portion controlled,
serve a useful purpose in assisting
consumers in selecting a diet that is
consistent with current dietary
recommendations (e.g., Dietary
Guidelines for Americans 2005). In this
final rule, the agency concludes that
providing a ‘‘lean’’ definition for
‘‘mixed dishes not measurable with a
cup’’ will provide more consistency
with similar USDA products and help
consumers construct a diet that is
consistent with current dietary
recommendations (i.e., limiting dietary
intake of saturated fat and cholesterol).
The agency determined that the nutrient
requirements for ‘‘mixed dishes not
measurable with a cup’’ required in this
final rule would allow it to achieve
criteria which would enable consumers
to maintain intakes of fat within current
dietary recommendations without being
unnecessarily restrictive. The agency is
basing the nutrient criteria for total fat,
saturated fat, and cholesterol on the
current criteria for main dishes (21 CFR
101.13(m)), but applying the criteria to
the RACC (140 grams (g)) for ‘‘mixed
dishes not measurable with a cup’’
rather than the minimum weight for
main dishes (170.1 g). The agency chose
the main dish minimum weight
requirement of 170.1 g (6 oz) for use in
its calculations, rather than the 283.4 g
(10 oz) minimum weight requirement
for meal products because main dishes
are closer to ‘‘mixed dishes not
measurable with a cup’’ in portion, size,
and contribution to the overall diet.
rmajette on PROD1PC67 with RULES
II. Summary of Comments and the
Agency’s Response
The agency received comments to the
proposed rule from an individual
consumer, a food manufacturer, an
industry trade organization, a public
interest foundation, and the petitioner.
Three comments supported the
proposed rule. One comment noted the
need for consumer education for
developing understanding of the
nutrient content claim ‘‘lean’’ and the
role of calories and nutrients in the diet.
The remaining comments requested
changes to the proposed rule. The latter
comments and FDA’s responses are set
forth in this section (section II of this
document), except the comment
addressing the agency’s regulatory
impact analysis is discussed in the
‘‘Analysis of Impact’’ section of this
document.
(Comment 1) One comment opposed
the proposed rule because the proposed
fat levels are too high. The comment did
not provide any specific information or
data in support of their position.
VerDate Aug<31>2005
15:29 Jan 11, 2007
Jkt 211001
(Response) FDA disagrees with the
comment. As we discussed in the
proposed rule, the agency believes that
the method we chose to establish total
fat, saturated fat, and cholesterol levels
(i.e., calculating the percent of the
proportion of the weight of the RACC
for ‘‘mixed dishes not measurable with
a cup’’ (140 g) to the minimum weight
of main dishes (170.1 g) and multiplying
the percent by the nutrient criteria for
total fat, saturated fat, and cholesterol
for main dishes) is less restrictive than
the other options considered and would
potentially allow more foods for
increased consumer choice. Moreover,
we stated that consumers could achieve
a diet using ‘‘lean’’ ‘‘mixed dishes not
measurable with a cup’’ that is
consistent with current dietary
recommendations (70 FR 71041 at
71047). We retain this view in the final
rule and this comment has not provided
us with any information to support
revising the proposed method for
determining total fat, saturated fat, and
cholesterol levels.
(Comment 2) Another comment
opposing the proposed rule
recommended that, if ‘‘lean’’ is
considered to be a claim that represents
‘‘healthier’’ food options, nutrient
eligibility criteria be modified for both
FDA- and USDA- regulated foods to
include limitations in ‘‘negative’’
nutrients’’ (such as sodium) and include
‘‘good’’ nutrient requirements.
(Response) FDA disagrees with the
comment. The term ‘‘lean’’ is a
description of fat content. As a nutrient
content claim, ‘‘lean’’ was first
established by the USDA as a descriptor
to allow consumers to distinguish
between products of varying fat content
(56 FR 60302, November 27, 1991). FDA
subsequently established the claim
‘‘lean’’ for products that it regulated that
had a contribution to the diet that was
similar to the USDA-regulated products
(i.e., seafood, game meat, meal products,
and main dish products) (58 FR 632,
January 6, 1993). FDA has already
established other nutrient content
claims to address a wider range of
nutrients other than the nutrients
describing fat content (e.g. healthy (21
CFR 101.65(d))). FDA believes that all
nutrient requirements for the claim
‘‘lean’’ should remain descriptors of fat
content in order for ‘‘lean’’ to continue
to allow consumers to distinguish
between products of varying fat content.
Therefore, FDA is making no changes in
response to this comment.
(Comment 3) One comment stated
that FDA and USDA nutrient content
claim requirements for foods in the
‘‘mixed dishes not measurable with a
cup’’ category should be consistent and
PO 00000
Frm 00042
Fmt 4700
Sfmt 4700
that different criteria will be confusing
and provide no benefit for consumers or
manufacturers.
(Response) FDA is aware of the
difference between the FDA and USDA
nutrient requirements as it
acknowledged this difference in the
proposed rule, and the agency
considered these differences in
developing FDA’s proposed definition
for ‘‘lean.’’ FDA has concluded, as
described in the proposed rule, that
FDA-regulated ‘‘mixed dishes not
measurable with a cup’’ may not play a
comparable role in the diet to that of
meat and poultry products, may not
contribute to the total dietary intake of
total fat, saturated fat, and cholesterol
like meat and poultry products, and
may not be consumed in the same
manner as USDA-regulated meal-type
products. Because of the similarity in
portion size and contribution to the
overall diet to FDA-regulated main
dishes, FDA has concluded that it is
more appropriate to base the nutrient
criteria for total fat, saturated fat, and
cholesterol on the current criteria for
main dishes, but apply the criteria to the
RACC for ‘‘mixed dishes not measurable
with a cup.’’ Calculating the nutrient
criteria for ‘‘mixed dishes not
measurable with a cup’’ per RACC from
the current nutrient content criteria on
the minimum weight for main dishes
provides criteria for ‘‘mixed dishes not
measurable with a cup’’ that are
comparable in their contribution of total
fat, saturated fat, and cholesterol on a
per 100-g basis to that contributed by
main dishes on a per 100-g basis.
Moreover, the comment provided no
basis for its assertion that the definition
provides no benefit and would be
confusing to consumers or
manufacturers. Therefore, FDA is
making no changes in response to this
comment.
FDA is adopting as a final rule,
without change, the proposed
amendment to the ‘‘lean’’ definition in
§ 101.62(e) by allowing eligible foods
categorized as ‘‘mixed dishes not
measurable with cup’’ use of the
nutrient content claim ‘‘lean.’’
III. Analysis of Economic Impacts
A. Regulatory Impact Analysis
FDA has examined the impacts of the
final rule under Executive Order 12866.
Executive Order 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, and other advantages;
E:\FR\FM\12JAR1.SGM
12JAR1
rmajette on PROD1PC67 with RULES
Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Rules and Regulations
distributive impacts; and equity). The
agency believes that this final rule is not
a significant regulatory action as defined
by the Executive order.
Regulatory options
We considered regulatory options as
follows: (1) Take no new regulatory
action; and (2) adopt as final the
proposed regulatory action allowing
‘‘mixed dishes not measurable with a
cup’’ to contain a ‘‘lean’’ claim based on
the proposed criteria of 8 grams of total
fat, 3.5 grams or less of saturated fat,
and 80 milligrams of cholesterol per
reference amount customarily
consumed.
Option (1): Take No New Regulatory
Action
The first regulatory option, take no
action, would require denying the
´
Nestle petition requesting that FDA
authorize a nutrient content claim
‘‘lean’’ for ‘‘mixed dishes not
measurable with a cup.’’ Taking no
regulatory action to amend the
definition of ‘‘lean’’ is the state of the
world and our baseline. By convention,
we treat the option of taking no new
regulatory action as the baseline for
determining the costs and benefits of the
other options. Therefore, we associate
neither costs nor benefits with this
option. The consequences of taking no
action are reflected in the costs and
benefits of the other options.
Option (2): Adopt as Final the
Proposed Regulatory Action
• Benefits
In the analysis of the proposed rule,
we used sales data from the 1997
Economic Census, the prevalence of
reduced-fat claims from FDA’s Food
Label and Packaging Survey, and the fat
contents of representative ‘‘mixed
dishes not measurable with a cup’’ from
USDA’s National Nutrient Database for
Standard Reference to estimate the
reduction in fat consumption to be
between 0 and 0.02 percent, with a
mean of 0.01 percent that would result
from this rule. Moreover, we suggested
that the magnitude of the reduction in
total fat intake from consuming ‘‘lean’’
‘‘mixed dishes not measurable with a
cup’’ may be tempered if consumers
supplement their ‘‘lean’’ selections with
other higher-fat selections from other
food categories. Finally, we suggested
that there would be a price premium for
‘‘mixed dishes not measurable with a
cup,’’ and to the extent that income and
overweight status are negatively
correlated, consumers at risk of
overweight related diseases may be
comparatively less likely to purchase
‘‘lean’’ ‘‘mixed dishes not measurable
with a cup’’ than their higher-income
counterparts with less-acute, weightrelated health risks. This could mitigate
VerDate Aug<31>2005
15:29 Jan 11, 2007
Jkt 211001
overall health benefits from what they
otherwise would be.
(Comment 4) One comment stated
that our estimate of 0.67 percent of total
food consumption represented by
‘‘mixed dishes not measurable with a
cup’’ that could qualify for the ‘‘lean’’
claim, understates the full impact of this
rule because it neglects to account for
dynamic aspects of the market including
growing consumer interest in healthier
diets, and new product development. In
addition, the comment suggested that
the discussion of possible consumption
behavior that would mitigate any
reduction in fat intake, such as
increased consumption of higher fatcontaining foods to compensate for the
consumption of reduced fat ‘‘lean’’
‘‘mixed dishes not measurable with a
cup,’’ is inappropriate for policies
designed to promote the consumption of
lean foods. The comment also stated
that the discussion on possible
diminishing effect on health benefits if
there is a price premium for ‘‘lean’’
‘‘mixed dishes not measurable with a
cup,’’ and if incomes and health risks
from overweight status are negatively
correlated, is also inappropriate for the
same reason. Finally, the comment
suggested that any policy measure
tending to increase consumption of lean
foods, including a successful publicity
campaign to increase consumption of
green vegetables, could have both the
‘‘compensating’’ and price premium
distributional effects.
(Response) FDA disagrees that our
estimate of 0.67 percent of total food
purchases that could potentially make a
‘‘lean’’ claim is inappropriate for this
analysis because it does not consider
dynamic aspects of consumption and
production that would favor such
products. While we do not disagree with
the possibility of a general trend toward
healthier diets and lifestyles, we believe
the trend would just as likely affect the
markets for food products from all
categories as it would ‘‘mixed dishes not
measurable with a cup.’’ Moreover, to
characterize uncertainty in our methods
used in the analysis, we estimated the
upper end of the range for the reduction
in fat intake that would result from this
rule, to be 100 percent more than the
mid-point which was estimated using
the 0.67 percent share of total purchases
that could potentially make a ‘‘lean’’
claim. Consequently, we believe that
our estimated range incorporates a wide
range of uncertainty, and is reasonable
and based on sound data and
assumptions.
In regulatory analyses, it is frequently
easier to obtain quantitative estimates of
the costs compared to the benefits of a
rule because credible cost data is
PO 00000
Frm 00043
Fmt 4700
Sfmt 4700
1457
usually easier to obtain. The relative
scarcity of quantitative estimates of
benefits elevates the importance of
qualitative descriptions in the benefits
analysis. In the analysis of the proposed
rule, FDA framed the qualitative
discussion of the benefits from allowing
the ‘‘lean’’ claim on ‘‘mixed dishes not
measurable with a cup’’ on the
theoretical framework used by Teisl and
Levy in a study to address a related
question (Ref. 1).
Consistent with Teisl and Levy, FDA
assumed that consumer demand for a
food product depends on its price, taste
characteristics, and nutritional
characteristics. The results obtained by
Teisl and Levy indicate that all three
characteristics are important
determinants of consumer purchase
behavior, and also that there is evidence
of ‘‘switching’’ consumption behavior
among many food products so that
overall nutrient consumption (e.g., fat in
that study) tends to remain constant or
change less than predicted by a simple
comparison of the nutrient contents of
the products. In the analysis of the
proposed rule we did not quantitatively
estimate the size of the ‘‘switching’’
effect, but rather suggested its existence
in order to fully describe the range of
benefits of the final rule.
Consistent with our theoretical model,
we also addressed the implications of a
premium on the price for ‘‘lean’’ labeled
‘‘mixed dishes not measurable with a
cup,’’ which may affect the size of the
health benefits from the rule. The
qualitative discussion is of heightened
importance since evidence exists of a
negative correlation between obesity
and health risks from overweight status
and income (Ref. 2). We agree that any
regulation that promotes the
consumption of lean foods, including a
successful publicity campaign to
increase consumption of green
vegetables, could have both the
‘‘compensating’’ and price premium
effects, and in the analysis of the
proposed rule we applied that concept
to ‘‘mixed dishes not measurable with a
cup.’’
• Costs
There were no comments on the
analysis of the costs, including
estimates made of the voluntarily
incurred change-over costs from the
proposed rule. All costs incurred by
manufacturers of ‘‘mixed dishes not
measurable with a cup’’ who choose to
label their products as ‘‘lean’’ would be
voluntarily incurred because no
manufacturer would incur them if it
were not profitable to do so. We
reproduce the estimated annualized
voluntarily incurred re-labeling and
reformulation costs estimated in the
E:\FR\FM\12JAR1.SGM
12JAR1
1458
Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Rules and Regulations
analysis of the proposed rule using both
a 3-percent and 7-percent discount rate.
TABLE 1.—ANNUALIZED VOLUNTARILY INCURRED CHANGE-OVER COSTS FOR PROPOSED RULE
12-Month Time Period
24-Month Time Period
3-percent discount rate
5 percent
(low)
$32,000
$21,000
mean
$250,000
$151,000
95 percent
(high)
$515,000
$308,000
$72,000
$46,000
$561,000
$326,000
$1,158,000
$666,000
7-percent discount rate
5 percent
(low)
mean
95 percent
(high)
In table 1 of this document, we report
the annualized change-over costs for the
proposed rule computed assuming
discount rates of 3 percent and 7
percent over an infinite time horizon for
assumed 12- and 24-month periods for
relabeling and reformulation. For a 12month period, all costs are assumed to
be incurred in the beginning of the
second year. For a 24-month period, all
costs are assumed to be incurred in the
beginning of the third year. Because
producers choose the time period for the
reformulation and relabeling of
products, the actual time periods for the
changes can be of any length, with the
costs differing from those in the table.
From our labeling cost and
reformulation models, however, we
expect that costs would be substantially
higher for time periods under 12
months, and substantially lower for time
periods over 24 months (Refs. 3 and 4).
We also expect that the time periods
chosen would be shorter and the costs
higher, the greater the perceived
consumer response to these product
claims.
rmajette on PROD1PC67 with RULES
B. Regulatory Flexibility Analysis
We have examined the economic
implications of this final rule as
required by the Regulatory Flexibility
Act (5 U.S.C. 601–612). If a rule has a
significant economic impact on a
substantial number of small entities, the
Regulatory Flexibility Act requires the
agency to analyze regulatory options
that would minimize the economic
impact of the rule on small entities.
VerDate Aug<31>2005
15:29 Jan 11, 2007
Jkt 211001
As previously explained, the final
rule will not generate any compliance
costs for any small entities because it
does not require small entities to
undertake any new activity. No small
business will choose to use the ‘‘lean’’
nutrient content claim authorized by
this rule unless it believes that doing so
will increase private benefits by more
than it increases private costs.
Accordingly, the agency certifies that
the final rule will not have a significant
economic impact on a substantial
number of small entities. Under the
Regulatory Flexibility Act, no further
analysis is required.
C. Unfunded Mandates
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 (2 U.S.C.
1532(a)) requires that agencies prepare a
written statement, which includes an
assessment of anticipated costs and
benefits, before issuing any final rule
‘‘that may result in the expenditure by
State, local, and tribal governments, in
the aggregate, or by the private sector, of
$100,000,000 or more (adjusted
annually for inflation) in any one year.’’
The current threshold after adjustment
for inflation is $122 million, using the
most current (2005) Implicit Price
Deflator for the Gross Domestic Product.
FDA does not expect this final rule to
result in any 1-year expenditure that
would meet or exceed this amount.
IV. Environmental Impact
FDA has determined under 21 CFR
25.32(p) that this action is of the type
that does not individually or
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
V. Paperwork Reduction Act of 1995
FDA concludes that the labeling
provisions of this final rule are not
subject to review by the Office of
Management and Budget because they
do not constitute a ‘‘collection of
information’’ under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). Rather, the food labeling nutrient
content claim ‘‘lean’’ is a ‘‘public
disclosure of information originally
supplied by the Federal Government to
the recipient for the purpose of
disclosure to the public’’ (5 U.S.C.
1320.3(c)(2)).
VI. Federalism
FDA has analyzed this final rule in
accordance with the principles set forth
in Executive Order 13132. FDA has
determined that the rule will have a
preemptive effect on State law. Section
4(a) of the Executive Order requires
agencies to ‘‘construe * * * a Federal
statute to preempt State law only where
the statute contains an express
preemption provision or there is some
other clear evidence that the Congress
intended preemption of State law, or
where the exercise of State authority
conflicts with the exercise of Federal
authority under the Federal statute.’’
Section 403A of the act (21 U.S.C. 343–
1) is an express preemption provision.
Section 403A(a)(5) of the act (21 U.S.C.
E:\FR\FM\12JAR1.SGM
12JAR1
rmajette on PROD1PC67 with RULES
Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Rules and Regulations
343–1(a)(5)) provides that: * * * no State
or political subdivision of a State may
directly or indirectly establish under
any authority or continue in effect as to
any food in interstate commerce—
* * * ‘‘(5) any requirement respecting
any claim of the type described in
section 403(r)(1) made in the label or
labeling of food that is not identical to
the requirement of section 403(r) * * *.’’
Currently, this provision operates to
preempt States from imposing nutrient
content claim labeling requirements
concerning the claim ‘‘lean’’ because
FDA has imposed such requirements
under section 403(r) of the act. This
final rule amends existing food labeling
regulations to add a definition for the
claim ‘‘lean’’ for eligible foods
categorized as ‘‘mixed dishes not
measurable with a cup.’’ Although this
rule has a preemptive effect, in that it
would preclude States from
promulgating any nutrient content claim
labeling requirements for the claim
‘‘lean’’ that are not identical to those
required by this final rule, this
preemptive effect is consistent with
what Congress set forth in section 403A
of the act. Section 403A(a)(5) of the act
displaces both State legislative
requirements and State common law
duties. Medtronic v. Lohr, 518 U.S. 470,
503 (1996) (Breyer, J., concurring in part
and concurring in judgment); id. at 510
(O’Connor, J., joined by Rehnquist, C.J.,
Scalia, J., and Thomas, J., concurring in
part and dissenting in part); Cipollone v.
Liggett Group, Inc., 505 U.S. 504, 521
(1992) (plurality opinion); id. at 548–49
(Scalia, J., joined by Thomas, J.,
concurring in judgment in part and
dissenting in part).
FDA believes that the preemptive
effect of the final rule is consistent with
Executive Order 13132. Section 4(e) of
the Executive order provides that ‘‘when
an agency proposes to act through
adjudication or rulemaking to preempt
State law, the agency shall provide all
affected State and local officials notice
and an opportunity for appropriate
participation in the proceedings.’’ FDA
provided the States with an opportunity
for appropriate participation in this
rulemaking when it sought input from
all stakeholders through publication of
the proposed rule in the Federal
Register on November 25, 2005 (70 FR
71041). FDA received no comments
from any states on the proposed
rulemaking.
In addition, on February 16, 2006,
FDA’s Division of Federal and State
Relations provided notice by fax and
email transmission to State health
commissioners, State agriculture
commissioners, food program directors,
and drug program directors as well as
VerDate Aug<31>2005
15:29 Jan 11, 2007
Jkt 211001
FDA field personnel, of FDA’s intended
amendment to add a definition for the
claim ‘‘lean’’ for eligible foods
categorized as ‘‘mixed dishes not
measurable with a cup’’ (21 CFR
101.62(e)). The notice provided the
States with further opportunity for input
on the rule. It advised the States of the
publication of the proposed rule and
encouraged State and local governments
to review the notice and to provide any
comments to the docket (docket number
2004P–0183), opened in the November
25, 2005 Federal Register, by a date 75
days from the date of the notice (i.e., by
March 2, 2006), or to contact certain
named individuals. FDA received no
comments in response to this notice.
The notice has been filed in the above
numbered docket.
In conclusion, the agency believes
that it has complied with all of the
applicable requirements under the
Executive order and has determined that
the preemptive effects of this rule are
consistent with Executive Order 13132.
VIII. References
The following references have been
placed on display in the Division of
Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Teisl, M. and A. Levy, ‘‘Does Nutrition
Labeling Lead to Healthier Eating?’’ Journal
of Food Distribution Research, October 1997.
2. Drewnowski, A., and S. Specter,
‘‘Poverty and Obesity: The Role of Energy
Density and Energy Costs,’’ The American
Journal of Clinical Nutrition, Vol. 79, No. 1:
6–16, January 2004.
3. RTI International, ‘‘Cost of
Reformulating Foods and Cosmetics, Final
Report,’’ prepared for Ed Puro, FDA, Center
for Food Safety and Applied Nutrition
(CFSAN), prepared by White, W.J., E.
Gledhill, S. Karns, and M. Muth, RTI Project
Number 08184.003, July 2002.
4. RTI International, ‘‘FDA Labeling Cost
Model, Final Report,’’ prepared for Amber
Jessup, FDA, CFSAN, prepared by Muth, M.,
E. Gledhill, and S. Karns, RTI Project Number
06673.010, January 2003.
List of Subjects in 21 CFR Part 101
Food labeling, 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, 21 CFR part 101 is
amended as follows:
I
PART 101—FOOD LABELING
1. The authority citation for 21 CFR
part 101 continues to read as follows:
I
PO 00000
Frm 00045
Fmt 4700
Sfmt 4700
1459
Authority: 15 U.S.C. 1453, 1454, 1455; 21
U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C.
243, 264, 271.
2. Section 101.62 is amended by
revising paragraph (e) to read as follows:
I
§ 101.62 Nutrient content claims for fat,
fatty acid, and cholesterol content of foods.
*
*
*
*
*
(e) ‘‘Lean’’ and ‘‘extra lean’’ claims.
(1) The term ‘‘lean’’ may be used on the
label or in labeling of foods except meal
products as defined in § 101.13(l) and
main dish products as defined in
§ 101.13(m) provided that the food is a
seafood or game meat product and as
packaged contains less than 10 g total
fat, 4.5 g or less saturated fat, and less
than 95 mg cholesterol per reference
amount customarily consumed and per
100 g;
(2) The term defined in paragraph
(e)(1) of this section may be used on the
label or in labeling of a mixed dish not
measurable with a cup as defined in
§ 101.12(b) in table 2, provided that the
food contains less than 8 g total fat, 3.5
g or less saturated fat and less than 80
mg cholesterol per reference amount
customarily consumed;
(3) The term defined in paragraph
(e)(1) of this section may be used on the
label or in the labeling of meal products
as defined in § 101.13(l) or main dish
products as defined in § 101.13(m)
provided that the food contains less
than 10 g total fat, 4.5 g or less saturated
fat, and less than 95 mg cholesterol per
100 g and per labeled serving;
(4) The term ‘‘extra lean’’ may be used
on the label or in the labeling of foods
except meal products as defined in
§ 101.13(l) and main dish products as
defined in § 101.13(m) provided that the
food is a discrete seafood or game meat
product and as packaged contains less
than 5 g total fat, less than 2 g saturated
fat, and less than 95 mg cholesterol per
reference amount customarily
consumed and per 100 g; and
(5) The term defined in paragraph
(e)(4) of this section may be used on the
label or in labeling of meal products as
defined in § 101.13(l) and main dish
products as defined in § 101.13(m)
provided that the food contains less
than 5 g of fat, less than 2 g of saturated
fat, and less than 95 mg of cholesterol
per 100 g and per labeled serving.
*
*
*
*
*
Dated: January 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–330 Filed 1–11–07; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\12JAR1.SGM
12JAR1
Agencies
[Federal Register Volume 72, Number 8 (Friday, January 12, 2007)]
[Rules and Regulations]
[Pages 1455-1459]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-330]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 2004P-0183]
RIN 0910-ZA27
Food Labeling: Nutrient Content Claims, Expansion of the Nutrient
Content Claim ``Lean''
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its food
labeling regulations for the expanded use of the nutrient content claim
``lean'' on the labels of foods categorized as ``mixed dishes not
measurable with a cup'' that meet certain criteria for total fat,
saturated fat, and cholesterol content. This final rule responds to a
nutrient content claim petition submitted by Nestl[eacute] Prepared
Foods Co. (Nestl[eacute]) under the Federal Food, Drug, and Cosmetic
Act (the act). This action is also being taken to provide reliable
information that would assist consumers in maintaining healthy dietary
practices.
DATES: This final rule is effective January 12, 2007.
FOR FURTHER INFORMATION CONTACT: Vincent de Jesus, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1774.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of November 25, 2005 (70 FR 71041), FDA
published a proposed rule to amend the definition of the nutrient
content claim ``lean'' (21 CFR 101.62) to include foods categorized as
``mixed dishes not measurable with a cup'' that are regulated by FDA
and that meet the criteria in the rule for total fat, saturated fat,
and cholesterol. FDA issued this proposed rule in response to a
petition filed under section 403(r)(4) of the act (21 U.S.C. 343(r)(4))
and in part 101 (21 CFR part 101) in Sec. 101.69. Section
403(r)(2)(A)(i) of the act (21 U.S.C. 343(r)(2)(A)(i)) states that a
nutrient content claim may be made only if the characterization of the
level made in the claim uses terms which are defined in regulations of
the Secretary of Health and Human Services (the Secretary) (and, by
delegation, FDA). Section 403(r)(4) of the act sets out the procedures
that FDA is to follow upon receiving a nutrient content claim petition.
On January 9, 2004, Nestl[eacute] (the petitioner) submitted a
petition requesting that the agency amend the nutrient content claim
regulation for ``lean'' (21 CFR 101.62(e)) to include ``mixed dishes
not measurable with a cup'' as defined in the ``Reference amounts
customarily consumed per eating occasion'' regulation (21 CFR 101.12),
based on certain qualifying criteria for total fat, saturated fat, and
cholesterol. FDA filed the petition for comprehensive review in
accordance with section 403(r)(4) of the act on April 22, 2004.
FDA's definition of the nutrient content claim ``lean'' includes
flesh foods, such as seafood and game meat products, which are foods
that are similar to the U.S. Department of Agriculture (USDA)-regulated
meat and poultry products, and also includes meal-type products (i.e.,
main dishes and meal products), which are included in the USDA
definition. Prior to the publication of this final rule, FDA's
definition of ``lean,'' did not extend to foods categorized as ``mixed
dishes not measurable with a cup.'' Such foods, e.g., burritos, egg
rolls, enchiladas, pizza, quiches, and sandwiches, are generally
similar to the foods subject to the definition of ``main dish'' (21 CFR
101.13(m)) but do not meet the weight criterion for ``main dish'' foods
(6 ounces (oz) per labeled serving). The Reference Amount Customarily
Consumed (RACC) for ``mixed dishes not measurable with a cup'' is 140
grams (g) (5 oz) (21 CFR 101.12(b), Table 2), which is 1 oz less than
the 6 oz per labeled serving required to qualify as a ``main dish.''
Thus, food products categorized as ``mixed dishes not measurable with a
cup'' and that weigh less than 6 oz were not eligible to bear a
``lean'' nutrient content claim under Sec. 101.62(e).
FDA considered the evidence presented in the petition as part of
its review, as well as information previously considered by the agency
in the January 6, 1993, nutrient content claim final rule (58 FR 2302).
Based on the available evidence, FDA acknowledged the following in the
proposed rule (70 FR 71041 at 71044):
``mixed dishes not measurable with a cup'' have found
their way into the American diet and serve as a convenient ``meals-on-
the-go'' eating option that is consistent with America's changing
lifestyle;
This category has become a well established product
category that consumers have come to rely on; and
There is a growing interest in healthful alternatives to
traditional food options, including vegetarian alternatives.
FDA believes that portable food products, particularly those that
are
[[Page 1456]]
nutrient (i.e., total fat, saturated fat, and cholesterol) and portion
controlled, serve a useful purpose in assisting consumers in selecting
a diet that is consistent with current dietary recommendations (e.g.,
Dietary Guidelines for Americans 2005). In this final rule, the agency
concludes that providing a ``lean'' definition for ``mixed dishes not
measurable with a cup'' will provide more consistency with similar USDA
products and help consumers construct a diet that is consistent with
current dietary recommendations (i.e., limiting dietary intake of
saturated fat and cholesterol). The agency determined that the nutrient
requirements for ``mixed dishes not measurable with a cup'' required in
this final rule would allow it to achieve criteria which would enable
consumers to maintain intakes of fat within current dietary
recommendations without being unnecessarily restrictive. The agency is
basing the nutrient criteria for total fat, saturated fat, and
cholesterol on the current criteria for main dishes (21 CFR 101.13(m)),
but applying the criteria to the RACC (140 grams (g)) for ``mixed
dishes not measurable with a cup'' rather than the minimum weight for
main dishes (170.1 g). The agency chose the main dish minimum weight
requirement of 170.1 g (6 oz) for use in its calculations, rather than
the 283.4 g (10 oz) minimum weight requirement for meal products
because main dishes are closer to ``mixed dishes not measurable with a
cup'' in portion, size, and contribution to the overall diet.
II. Summary of Comments and the Agency's Response
The agency received comments to the proposed rule from an
individual consumer, a food manufacturer, an industry trade
organization, a public interest foundation, and the petitioner. Three
comments supported the proposed rule. One comment noted the need for
consumer education for developing understanding of the nutrient content
claim ``lean'' and the role of calories and nutrients in the diet. The
remaining comments requested changes to the proposed rule. The latter
comments and FDA's responses are set forth in this section (section II
of this document), except the comment addressing the agency's
regulatory impact analysis is discussed in the ``Analysis of Impact''
section of this document.
(Comment 1) One comment opposed the proposed rule because the
proposed fat levels are too high. The comment did not provide any
specific information or data in support of their position.
(Response) FDA disagrees with the comment. As we discussed in the
proposed rule, the agency believes that the method we chose to
establish total fat, saturated fat, and cholesterol levels (i.e.,
calculating the percent of the proportion of the weight of the RACC for
``mixed dishes not measurable with a cup'' (140 g) to the minimum
weight of main dishes (170.1 g) and multiplying the percent by the
nutrient criteria for total fat, saturated fat, and cholesterol for
main dishes) is less restrictive than the other options considered and
would potentially allow more foods for increased consumer choice.
Moreover, we stated that consumers could achieve a diet using ``lean''
``mixed dishes not measurable with a cup'' that is consistent with
current dietary recommendations (70 FR 71041 at 71047). We retain this
view in the final rule and this comment has not provided us with any
information to support revising the proposed method for determining
total fat, saturated fat, and cholesterol levels.
(Comment 2) Another comment opposing the proposed rule recommended
that, if ``lean'' is considered to be a claim that represents
``healthier'' food options, nutrient eligibility criteria be modified
for both FDA- and USDA- regulated foods to include limitations in
``negative'' nutrients'' (such as sodium) and include ``good'' nutrient
requirements.
(Response) FDA disagrees with the comment. The term ``lean'' is a
description of fat content. As a nutrient content claim, ``lean'' was
first established by the USDA as a descriptor to allow consumers to
distinguish between products of varying fat content (56 FR 60302,
November 27, 1991). FDA subsequently established the claim ``lean'' for
products that it regulated that had a contribution to the diet that was
similar to the USDA-regulated products (i.e., seafood, game meat, meal
products, and main dish products) (58 FR 632, January 6, 1993). FDA has
already established other nutrient content claims to address a wider
range of nutrients other than the nutrients describing fat content
(e.g. healthy (21 CFR 101.65(d))). FDA believes that all nutrient
requirements for the claim ``lean'' should remain descriptors of fat
content in order for ``lean'' to continue to allow consumers to
distinguish between products of varying fat content. Therefore, FDA is
making no changes in response to this comment.
(Comment 3) One comment stated that FDA and USDA nutrient content
claim requirements for foods in the ``mixed dishes not measurable with
a cup'' category should be consistent and that different criteria will
be confusing and provide no benefit for consumers or manufacturers.
(Response) FDA is aware of the difference between the FDA and USDA
nutrient requirements as it acknowledged this difference in the
proposed rule, and the agency considered these differences in
developing FDA's proposed definition for ``lean.'' FDA has concluded,
as described in the proposed rule, that FDA-regulated ``mixed dishes
not measurable with a cup'' may not play a comparable role in the diet
to that of meat and poultry products, may not contribute to the total
dietary intake of total fat, saturated fat, and cholesterol like meat
and poultry products, and may not be consumed in the same manner as
USDA-regulated meal-type products. Because of the similarity in portion
size and contribution to the overall diet to FDA-regulated main dishes,
FDA has concluded that it is more appropriate to base the nutrient
criteria for total fat, saturated fat, and cholesterol on the current
criteria for main dishes, but apply the criteria to the RACC for
``mixed dishes not measurable with a cup.'' Calculating the nutrient
criteria for ``mixed dishes not measurable with a cup'' per RACC from
the current nutrient content criteria on the minimum weight for main
dishes provides criteria for ``mixed dishes not measurable with a cup''
that are comparable in their contribution of total fat, saturated fat,
and cholesterol on a per 100-g basis to that contributed by main dishes
on a per 100-g basis. Moreover, the comment provided no basis for its
assertion that the definition provides no benefit and would be
confusing to consumers or manufacturers. Therefore, FDA is making no
changes in response to this comment.
FDA is adopting as a final rule, without change, the proposed
amendment to the ``lean'' definition in Sec. 101.62(e) by allowing
eligible foods categorized as ``mixed dishes not measurable with cup''
use of the nutrient content claim ``lean.''
III. Analysis of Economic Impacts
A. Regulatory Impact Analysis
FDA has examined the impacts of the final rule under Executive
Order 12866. Executive Order 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, and other advantages;
[[Page 1457]]
distributive impacts; and equity). The agency believes that this final
rule is not a significant regulatory action as defined by the Executive
order.
Regulatory options
We considered regulatory options as follows: (1) Take no new
regulatory action; and (2) adopt as final the proposed regulatory
action allowing ``mixed dishes not measurable with a cup'' to contain a
``lean'' claim based on the proposed criteria of 8 grams of total fat,
3.5 grams or less of saturated fat, and 80 milligrams of cholesterol
per reference amount customarily consumed.
Option (1): Take No New Regulatory Action
The first regulatory option, take no action, would require denying
the Nestl[eacute] petition requesting that FDA authorize a nutrient
content claim ``lean'' for ``mixed dishes not measurable with a cup.''
Taking no regulatory action to amend the definition of ``lean'' is the
state of the world and our baseline. By convention, we treat the option
of taking no new regulatory action as the baseline for determining the
costs and benefits of the other options. Therefore, we associate
neither costs nor benefits with this option. The consequences of taking
no action are reflected in the costs and benefits of the other options.
Option (2): Adopt as Final the Proposed Regulatory Action
Benefits
In the analysis of the proposed rule, we used sales data from the
1997 Economic Census, the prevalence of reduced-fat claims from FDA's
Food Label and Packaging Survey, and the fat contents of representative
``mixed dishes not measurable with a cup'' from USDA's National
Nutrient Database for Standard Reference to estimate the reduction in
fat consumption to be between 0 and 0.02 percent, with a mean of 0.01
percent that would result from this rule. Moreover, we suggested that
the magnitude of the reduction in total fat intake from consuming
``lean'' ``mixed dishes not measurable with a cup'' may be tempered if
consumers supplement their ``lean'' selections with other higher-fat
selections from other food categories. Finally, we suggested that there
would be a price premium for ``mixed dishes not measurable with a
cup,'' and to the extent that income and overweight status are
negatively correlated, consumers at risk of overweight related diseases
may be comparatively less likely to purchase ``lean'' ``mixed dishes
not measurable with a cup'' than their higher-income counterparts with
less-acute, weight-related health risks. This could mitigate overall
health benefits from what they otherwise would be.
(Comment 4) One comment stated that our estimate of 0.67 percent of
total food consumption represented by ``mixed dishes not measurable
with a cup'' that could qualify for the ``lean'' claim, understates the
full impact of this rule because it neglects to account for dynamic
aspects of the market including growing consumer interest in healthier
diets, and new product development. In addition, the comment suggested
that the discussion of possible consumption behavior that would
mitigate any reduction in fat intake, such as increased consumption of
higher fat-containing foods to compensate for the consumption of
reduced fat ``lean'' ``mixed dishes not measurable with a cup,'' is
inappropriate for policies designed to promote the consumption of lean
foods. The comment also stated that the discussion on possible
diminishing effect on health benefits if there is a price premium for
``lean'' ``mixed dishes not measurable with a cup,'' and if incomes and
health risks from overweight status are negatively correlated, is also
inappropriate for the same reason. Finally, the comment suggested that
any policy measure tending to increase consumption of lean foods,
including a successful publicity campaign to increase consumption of
green vegetables, could have both the ``compensating'' and price
premium distributional effects.
(Response) FDA disagrees that our estimate of 0.67 percent of total
food purchases that could potentially make a ``lean'' claim is
inappropriate for this analysis because it does not consider dynamic
aspects of consumption and production that would favor such products.
While we do not disagree with the possibility of a general trend toward
healthier diets and lifestyles, we believe the trend would just as
likely affect the markets for food products from all categories as it
would ``mixed dishes not measurable with a cup.'' Moreover, to
characterize uncertainty in our methods used in the analysis, we
estimated the upper end of the range for the reduction in fat intake
that would result from this rule, to be 100 percent more than the mid-
point which was estimated using the 0.67 percent share of total
purchases that could potentially make a ``lean'' claim. Consequently,
we believe that our estimated range incorporates a wide range of
uncertainty, and is reasonable and based on sound data and assumptions.
In regulatory analyses, it is frequently easier to obtain
quantitative estimates of the costs compared to the benefits of a rule
because credible cost data is usually easier to obtain. The relative
scarcity of quantitative estimates of benefits elevates the importance
of qualitative descriptions in the benefits analysis. In the analysis
of the proposed rule, FDA framed the qualitative discussion of the
benefits from allowing the ``lean'' claim on ``mixed dishes not
measurable with a cup'' on the theoretical framework used by Teisl and
Levy in a study to address a related question (Ref. 1).
Consistent with Teisl and Levy, FDA assumed that consumer demand
for a food product depends on its price, taste characteristics, and
nutritional characteristics. The results obtained by Teisl and Levy
indicate that all three characteristics are important determinants of
consumer purchase behavior, and also that there is evidence of
``switching'' consumption behavior among many food products so that
overall nutrient consumption (e.g., fat in that study) tends to remain
constant or change less than predicted by a simple comparison of the
nutrient contents of the products. In the analysis of the proposed rule
we did not quantitatively estimate the size of the ``switching''
effect, but rather suggested its existence in order to fully describe
the range of benefits of the final rule.
Consistent with our theoretical model, we also addressed the
implications of a premium on the price for ``lean'' labeled ``mixed
dishes not measurable with a cup,'' which may affect the size of the
health benefits from the rule. The qualitative discussion is of
heightened importance since evidence exists of a negative correlation
between obesity and health risks from overweight status and income
(Ref. 2). We agree that any regulation that promotes the consumption of
lean foods, including a successful publicity campaign to increase
consumption of green vegetables, could have both the ``compensating''
and price premium effects, and in the analysis of the proposed rule we
applied that concept to ``mixed dishes not measurable with a cup.''
Costs
There were no comments on the analysis of the costs, including
estimates made of the voluntarily incurred change-over costs from the
proposed rule. All costs incurred by manufacturers of ``mixed dishes
not measurable with a cup'' who choose to label their products as
``lean'' would be voluntarily incurred because no manufacturer would
incur them if it were not profitable to do so. We reproduce the
estimated annualized voluntarily incurred re-labeling and reformulation
costs estimated in the
[[Page 1458]]
analysis of the proposed rule using both a 3-percent and 7-percent
discount rate.
Table 1.--Annualized Voluntarily Incurred Change-Over Costs for Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
12-Month Time Period 24-Month Time Period
--------------------------------------------------------------------------------------------------------------------------------------------------------
3-percent discount rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
5 percent (low) $32,000 $21,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
mean $250,000 $151,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
95 percent (high) $515,000 $308,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
7-percent discount rate
--------------------------------------------------------------------------------------------------------------------------------------------------------
5 percent (low) $72,000 $46,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
mean $561,000 $326,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
95 percent (high) $1,158,000 $666,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
In table 1 of this document, we report the annualized change-over
costs for the proposed rule computed assuming discount rates of 3
percent and 7 percent over an infinite time horizon for assumed 12- and
24-month periods for relabeling and reformulation. For a 12-month
period, all costs are assumed to be incurred in the beginning of the
second year. For a 24-month period, all costs are assumed to be
incurred in the beginning of the third year. Because producers choose
the time period for the reformulation and relabeling of products, the
actual time periods for the changes can be of any length, with the
costs differing from those in the table. From our labeling cost and
reformulation models, however, we expect that costs would be
substantially higher for time periods under 12 months, and
substantially lower for time periods over 24 months (Refs. 3 and 4). We
also expect that the time periods chosen would be shorter and the costs
higher, the greater the perceived consumer response to these product
claims.
B. Regulatory Flexibility Analysis
We have examined the economic implications of this final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires the agency to analyze
regulatory options that would minimize the economic impact of the rule
on small entities.
As previously explained, the final rule will not generate any
compliance costs for any small entities because it does not require
small entities to undertake any new activity. No small business will
choose to use the ``lean'' nutrient content claim authorized by this
rule unless it believes that doing so will increase private benefits by
more than it increases private costs. Accordingly, the agency certifies
that the final rule will not have a significant economic impact on a
substantial number of small entities. Under the Regulatory Flexibility
Act, no further analysis is required.
C. Unfunded Mandates
Section 202(a) of the Unfunded Mandates Reform Act of 1995 (2
U.S.C. 1532(a)) requires that agencies prepare a written statement,
which includes an assessment of anticipated costs and benefits, before
issuing any final rule ``that may result in the expenditure by State,
local, and tribal governments, in the aggregate, or by the private
sector, of $100,000,000 or more (adjusted annually for inflation) in
any one year.'' The current threshold after adjustment for inflation is
$122 million, using the most current (2005) Implicit Price Deflator for
the Gross Domestic Product. FDA does not expect this final rule to
result in any 1-year expenditure that would meet or exceed this amount.
IV. Environmental Impact
FDA has determined under 21 CFR 25.32(p) that this action is of the
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. Paperwork Reduction Act of 1995
FDA concludes that the labeling provisions of this final rule are
not subject to review by the Office of Management and Budget because
they do not constitute a ``collection of information'' under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the food
labeling nutrient content claim ``lean'' is a ``public disclosure of
information originally supplied by the Federal Government to the
recipient for the purpose of disclosure to the public'' (5 U.S.C.
1320.3(c)(2)).
VI. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
will have a preemptive effect on State law. Section 4(a) of the
Executive Order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an
express preemption provision. Section 403A(a)(5) of the act (21 U.S.C.
[[Page 1459]]
343-1(a)(5)) provides that: * * * no State or political subdivision of
a State may directly or indirectly establish under any authority or
continue in effect as to any food in interstate commerce-- * * * ``(5)
any requirement respecting any claim of the type described in section
403(r)(1) made in the label or labeling of food that is not identical
to the requirement of section 403(r) * * *.''
Currently, this provision operates to preempt States from imposing
nutrient content claim labeling requirements concerning the claim
``lean'' because FDA has imposed such requirements under section 403(r)
of the act. This final rule amends existing food labeling regulations
to add a definition for the claim ``lean'' for eligible foods
categorized as ``mixed dishes not measurable with a cup.'' Although
this rule has a preemptive effect, in that it would preclude States
from promulgating any nutrient content claim labeling requirements for
the claim ``lean'' that are not identical to those required by this
final rule, this preemptive effect is consistent with what Congress set
forth in section 403A of the act. Section 403A(a)(5) of the act
displaces both State legislative requirements and State common law
duties. Medtronic v. Lohr, 518 U.S. 470, 503 (1996) (Breyer, J.,
concurring in part and concurring in judgment); id. at 510 (O'Connor,
J., joined by Rehnquist, C.J., Scalia, J., and Thomas, J., concurring
in part and dissenting in part); Cipollone v. Liggett Group, Inc., 505
U.S. 504, 521 (1992) (plurality opinion); id. at 548-49 (Scalia, J.,
joined by Thomas, J., concurring in judgment in part and dissenting in
part).
FDA believes that the preemptive effect of the final rule is
consistent with Executive Order 13132. Section 4(e) of the Executive
order provides that ``when an agency proposes to act through
adjudication or rulemaking to preempt State law, the agency shall
provide all affected State and local officials notice and an
opportunity for appropriate participation in the proceedings.'' FDA
provided the States with an opportunity for appropriate participation
in this rulemaking when it sought input from all stakeholders through
publication of the proposed rule in the Federal Register on November
25, 2005 (70 FR 71041). FDA received no comments from any states on the
proposed rulemaking.
In addition, on February 16, 2006, FDA's Division of Federal and
State Relations provided notice by fax and email transmission to State
health commissioners, State agriculture commissioners, food program
directors, and drug program directors as well as FDA field personnel,
of FDA's intended amendment to add a definition for the claim ``lean''
for eligible foods categorized as ``mixed dishes not measurable with a
cup'' (21 CFR 101.62(e)). The notice provided the States with further
opportunity for input on the rule. It advised the States of the
publication of the proposed rule and encouraged State and local
governments to review the notice and to provide any comments to the
docket (docket number 2004P-0183), opened in the November 25, 2005
Federal Register, by a date 75 days from the date of the notice (i.e.,
by March 2, 2006), or to contact certain named individuals. FDA
received no comments in response to this notice. The notice has been
filed in the above numbered docket.
In conclusion, the agency believes that it has complied with all of
the applicable requirements under the Executive order and has
determined that the preemptive effects of this rule are consistent with
Executive Order 13132.
VIII. References
The following references have been placed on display in the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852 and may be seen by interested persons between 9 a.m. and 4
p.m., Monday through Friday.
1. Teisl, M. and A. Levy, ``Does Nutrition Labeling Lead to
Healthier Eating?'' Journal of Food Distribution Research, October
1997.
2. Drewnowski, A., and S. Specter, ``Poverty and Obesity: The
Role of Energy Density and Energy Costs,'' The American Journal of
Clinical Nutrition, Vol. 79, No. 1: 6-16, January 2004.
3. RTI International, ``Cost of Reformulating Foods and
Cosmetics, Final Report,'' prepared for Ed Puro, FDA, Center for
Food Safety and Applied Nutrition (CFSAN), prepared by White, W.J.,
E. Gledhill, S. Karns, and M. Muth, RTI Project Number 08184.003,
July 2002.
4. RTI International, ``FDA Labeling Cost Model, Final Report,''
prepared for Amber Jessup, FDA, CFSAN, prepared by Muth, M., E.
Gledhill, and S. Karns, RTI Project Number 06673.010, January 2003.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
101 is amended as follows:
PART 101--FOOD LABELING
0
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; 42 U.S.C. 243, 264, 271.
0
2. Section 101.62 is amended by revising paragraph (e) to read as
follows:
Sec. 101.62 Nutrient content claims for fat, fatty acid, and
cholesterol content of foods.
* * * * *
(e) ``Lean'' and ``extra lean'' claims. (1) The term ``lean'' may
be used on the label or in labeling of foods except meal products as
defined in Sec. 101.13(l) and main dish products as defined in Sec.
101.13(m) provided that the food is a seafood or game meat product and
as packaged contains less than 10 g total fat, 4.5 g or less saturated
fat, and less than 95 mg cholesterol per reference amount customarily
consumed and per 100 g;
(2) The term defined in paragraph (e)(1) of this section may be
used on the label or in labeling of a mixed dish not measurable with a
cup as defined in Sec. 101.12(b) in table 2, provided that the food
contains less than 8 g total fat, 3.5 g or less saturated fat and less
than 80 mg cholesterol per reference amount customarily consumed;
(3) The term defined in paragraph (e)(1) of this section may be
used on the label or in the labeling of meal products as defined in
Sec. 101.13(l) or main dish products as defined in Sec. 101.13(m)
provided that the food contains less than 10 g total fat, 4.5 g or less
saturated fat, and less than 95 mg cholesterol per 100 g and per
labeled serving;
(4) The term ``extra lean'' may be used on the label or in the
labeling of foods except meal products as defined in Sec. 101.13(l)
and main dish products as defined in Sec. 101.13(m) provided that the
food is a discrete seafood or game meat product and as packaged
contains less than 5 g total fat, less than 2 g saturated fat, and less
than 95 mg cholesterol per reference amount customarily consumed and
per 100 g; and
(5) The term defined in paragraph (e)(4) of this section may be
used on the label or in labeling of meal products as defined in Sec.
101.13(l) and main dish products as defined in Sec. 101.13(m) provided
that the food contains less than 5 g of fat, less than 2 g of saturated
fat, and less than 95 mg of cholesterol per 100 g and per labeled
serving.
* * * * *
Dated: January 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-330 Filed 1-11-07; 8:45 am]
BILLING CODE 4160-01-S