Artificially Sweetened Fruit Jelly and Artificially Sweetened Fruit Preserves and Jams; Proposed Revocation of Standards of Identity, 71746-71750 [2012-29181]
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By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012–29149 Filed 12–3–12; 8:45 am]
BILLING CODE 8011–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 150
[Docket No. FDA–1997–P–0007] (formerly
Docket No. 1997P–0142)
Artificially Sweetened Fruit Jelly and
Artificially Sweetened Fruit Preserves
and Jams; Proposed Revocation of
Standards of Identity
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA or we) is
proposing to revoke the standards of
identity for artificially sweetened jelly,
preserves, and jams. We are taking this
action primarily in response to a citizen
petition submitted by the International
SUMMARY:
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Jelly and Preserve Association (IJPA).
We are taking this action because we
tentatively conclude that these
standards are both obsolete and
unnecessary in light of our regulations
for foods named by use of a nutrient
content claim and a standardized term.
We also tentatively conclude that this
action will promote honesty and fair
dealing in the interest of consumers.
DATES: Submit electronic or written
comments on the proposed rule by
March 4, 2013.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–1997–P–
0007 (formerly Docket No. 1997P–0142),
by any of the following methods.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper or CD–ROM submissions):
Division of Dockets Management,
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
Instructions: All submissions received
must include the Agency name and
Docket No. FDA–1997–P–0007
(formerly Docket No. 1997P–0142) for
this rulemaking. All comments received
may be posted without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket numbers found in brackets in the
heading of this document into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.P≤FOR
FURTHER INFORMATION CONTACT:
FOR FURTHER INFORMATION CONTACT:
Daniel Reese, Center for Food Safety
and Applied Nutrition (HFS–820), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–2371.
SUPPLEMENTARY INFORMATION:
I. Background
For more than 50 years, FDA has
maintained standards of identity for
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fruit jelly (jelly) (21 CFR 150.140) and
fruit preserves and jams (preserves and
jams) (21 CFR 150.160). The standards
establish the common or usual name for
these products and provide that these
products may contain nutritive
sweeteners (e.g., sugar). In 1959, FDA
added new standards of identity for
artificially sweetened fruit jelly
(artificially sweetened jelly) (21 CFR
150.141) and artificially sweetened fruit
preserves and jams (artificially
sweetened preserves and jams) (21 CFR
150.161) (24 FR 8896; October 31, 1959)
that permit the use of non-nutritive
sweeteners (e.g., saccharin). Notably,
§§ 150.141 and 150.161 limit the types
of non-nutritive sweeteners that can be
used in products that are governed by
those standards of identity. Such
products may only use saccharin,
sodium saccharin, calcium saccharin, or
any combination thereof, and may not
use newer forms of non-nutritive
sweeteners that have been established
since the standard of identity
regulations were issued.
The Nutrition Labeling and Education
Act (NLEA) of 1990 amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to provide for a number
of fundamental changes in food
labeling, leading to a new regulatory
framework for the naming of foods that
do not fully comply with the relevant
standards of identity. In response to
NLEA, FDA established in part 101 (21
CFR part 101), among other things,
definitions for specific nutrient content
claims using terms such as ‘‘free,’’
‘‘low,’’ ‘‘light’’ or ‘‘lite,’’ and ‘‘less,’’ and
provided for their use in food labeling
(58 FR 2302; January 6, 1993). FDA also
prescribed at the same time in § 130.10
(21 CFR 130.10) a general definition and
standard of identity for foods named by
a nutrient content claim defined in part
101, such as ‘‘low calorie’’ or ‘‘sugar
free,’’ in conjunction with a traditional
standardized food term (58 FR 2431;
January 6, 1993). A nutrient content
claim applied to the standardized food
‘‘grape jelly,’’ for example, could be
‘‘low calorie grape jelly.’’ Section
130.10(d)(1) allows the addition of safe
and suitable ingredients to a food
named by use of a nutrient content
claim and a standardized term when
these ingredients are used to, among
other things, add sweetness to ensure
that the modified food is not inferior in
performance characteristic to the
standardized food even if such
ingredients are not specifically provided
for by the relevant food standard. Thus,
under certain circumstances, § 130.10
permits manufacturers to use safe and
suitable artificial sweeteners (e.g.,
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aspartame) that are not expressly listed
in §§ 150.141 and 150.161 in the
manufacture of jelly, fruit preserves, and
jams (collectively, ‘‘fruit spreads’’).
Therefore, fruit spread products named
with a nutrient content claim (for
example, ‘‘low calorie grape jelly’’) may
contain newer artificial sweeteners to
add sweetness to fruit spread products
so that they are not inferior in their
sweetness compared to their
standardized counterparts (for example,
‘‘grape jelly’’). The provisions of
§ 130.10 do not require these products
to declare the presence of such nonnutritive sweeteners within the name of
these foods. FDA took this action to
assist consumers in maintaining healthy
dietary practices by providing for a
modified version of a traditional
standardized food to achieve a nutrition
goal (e.g., reduction in sugar
consumption or calories) and that has a
descriptive name that is meaningful to
consumers. The provisions of § 130.10
do not, however, permit the use of
nutrient content claims as part of the
name of a food for foods governed by
standards of identity that established
the phrase ‘‘artificially sweetened’’ as
part of the standard of identity.
Accordingly, jelly, preserves, and jams,
that use saccharin, sodium saccharin,
calcium saccharin, or any combination
thereof as non-nutritive sweeteners
must still include the term ‘‘artificially
sweetened’’ in their names and are not
permitted to bear a nutrient content
claim as part of the name; however,
similar products that use newer nonnutritive sweeteners are governed by
§ 130.10 and must not include the term
‘‘artificially sweetened’’ in their names.
II. IJPA Petition and Grounds
IJPA is a national trade association
representing the manufacturers of jelly,
preserves, jams, and nonstandardized
fruit spreads, and suppliers of goods
and services to the industry, including
ingredient suppliers of fruit, sweeteners,
and pectin. IJPA submitted a citizen
petition dated March 31, 1997 (now
Docket No. FDA–1997–P–0007),
requesting the revocation of the
standards of identity for artificially
sweetened jelly, preserves, and jams.
IJPA submitted its petition in response
to FDA’s advance notice of proposed
rulemaking announcing that FDA was
planning to review its food standards
regulations (60 FR 67492; December 29,
1995). In that document, we sought
comments on, inter alia, the benefits or
lack of benefits of such regulations in
facilitating domestic and international
commerce, the value of these
regulations to consumers, and
alternative means of accomplishing the
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statutory objective of food standards
(i.e., to promote honesty and fair dealing
in the interest of consumers in the
manufacture and sale of food products
covered by the standard of identity
regulations).
IJPA asserts in its citizen petition that
the standards of identity for artificially
sweetened jelly, jams, and preserves are
outdated. According to IJPA, the
standards have not been updated to take
into account new non-nutritive
sweeteners that have been approved by
FDA since 1959. The petition maintains
that the general standard in § 130.10
provides fruit spread manufacturers
with sufficient flexibility to use newer,
intense non-nutritive sweeteners in lieu
of traditional nutritive sweeteners, and
it would be appropriate to rely on that
general standard rather than seek
piecemeal amendments to the standards
of identity to reflect the development of
any new sweeteners. IJPA stated that by
using the general standard in § 130.10,
manufacturers can create products with
nutrient content claims for reductions in
calories or sugar content that are
established in FDA regulations.
According to IJPA, nutrient content
terms (e.g., ‘‘low calorie’’) also better
communicate to the consumer the
nutritional benefit of the use of nonnutritive sweeteners than does the term
‘‘artificially sweetened,’’ which is
required to appear in the labels of
products manufactured in conformity
with §§ 150.141 and 150.161. Therefore,
IJPA concluded in its petition that the
standards of identity for artificially
sweetened jelly, preserves, and jams are
both obsolete and unnecessary, and
requested that we revoke these
standards. Finally, IJPA stated that as of
the date of submission of its citizen
petition, there were few products being
manufactured under these two
standards of identity and that some
manufacturers are already using the
general standard in § 130.10 to
formulate products that have reduced
sugar and caloric content. IJPA stated
that if these standards are revoked, any
products that are currently
manufactured in conformity with the
standards could remain on the market
by operation of § 130.10.
III. The Proposal
We have reviewed IJPA’s petition. We
find merit in IJPA’s argument that
revoking the artificially sweetened
standards of identity would allow
manufacturers to more accurately and
consistently describe the attributes of
the fruit spreads that currently conform
to those standards. We therefore
tentatively conclude that revoking the
standards would promote honesty and
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fair dealing in the interest of consumers
and is, thus, appropriate under section
401 of the FD&C Act (21 U.S.C. 341). We
tentatively reach this conclusion
because we find that nutrient content
claims, such as ‘‘low calorie’’ or
‘‘reduced sugar’’ better characterize the
nutritional profile of the affected fruit
spreads than does the term ‘‘artificially
sweetened.’’ Further, revoking
§§ 150.141 and 150.161 provides
manufacturers with the flexibility to use
the three non-nutritive sweeteners listed
in those standards while also naming
their products using FDA-defined
nutrient content claims, in accordance
with § 130.10. Moreover, other safe and
suitable artificial sweeteners that might
be developed in the future could be
used in these products under § 130.10
without the need to further revise
relevant standards of identity.
Enactment of NLEA and the
development of newer artificial
sweeteners, thus, renders the standards
of identity for artificially sweetened
jelly, preserves, and jams in §§ 150.141
and 150.161 obsolete. They no longer
serve their intended purpose of ensuring
honesty and fair dealing while allowing
for the use of artificial sweeteners in
standardized fruit jelly and
standardized fruit preserves and jams as
firms may now use certain artificial
sweeteners under § 130.10. The
standards for artificially sweetened jelly
and artificially sweetened preserves and
jams predate the nutrient content claim
provisions of § 130.10. Removal of the
artificially sweetened standards of
identity would mean that products that
are currently subject to the requirements
of §§ 150.141 and 150.161 would
instead be subject to the requirements of
§ 130.10, the general definition and
standard of identity for foods named by
a nutrient content claim defined in part
101. Thus, these products would be
named by use of a nutrient content
claim (e.g., ‘‘reduced calorie’’ or ‘‘no
sugar added’’) along with a standardized
term (‘‘jelly’’ or ‘‘jam’’), in accordance
with § 130.10. Revoking §§ 150.141 and
150.161 also would promote honesty
and fair dealing in the interest of
consumers by requiring manufacturers
to more accurately and consistently
describe the attributes of the food (e.g.,
less sugar or reduced calories); would
allow any safe and suitable nonnutritive sweetener to be used in
standardized jams, jellies, and
preserves; and would allow better
comparison to other jams, jellies, and
preserves currently modified under the
provisions of § 130.10. For example,
under current requirements, a jelly that
is sweetened with saccharin must be
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called ‘‘artificially sweetened jelly’’ (in
accordance with § 150.141) whereas a
similar jelly sweetened with aspartame
may be named as ‘‘reduced sugar jelly’’
(in accordance with § 130.10 and
provided it meets the requirements for
the nutrient content claim ‘‘reduced
sugar’’ in § 101.60.(c)(5)) to distinguish
it from the standardized food (jelly in
§ 150.140). Revoking the standards
would provide consistency and
uniformity among such products
because all fruit spreads sweetened with
non-nutritive sweeteners would be
subject to the same requirements. This
proposed rule also is consistent with
FDA’s proposed general principles for
modernizing food standards (70 FR
29214; May 20, 2005). In addition, this
proposal is consistent with Executive
Order 12866 of September 30, 1993 (58
FR 51735), and Executive Order 13653
of January 21, 2011 (76 FR 3821),
regarding improving Agency
regulations, regulatory planning, and
regulatory review.
Considering the information in this
document, we are proposing to revoke
the standards of identity for artificially
sweetened jelly, preserves, and jams in
§§ 150.141 and 150.161, respectively.
We request comments on our tentative
conclusion that these two standards of
identity are obsolete and unnecessary,
and that revoking them would promote
honesty and fair dealing in the interest
of consumers.
IV. Analysis of Impacts
We have examined the impacts of the
proposed rule under Executive Order
12866, Executive Order 13563, the
Regulatory Flexibility Act (5 U.S.C.
601–612), and the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4).
Executive Orders 12866 and 13563
direct 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; distributive
impacts; and equity). Executive Order
13563 emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. We
tentatively conclude that this proposed
rule is not a significant regulatory action
as defined by the Executive Orders.
The Regulatory Flexibility Act
requires Agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because we have tentatively
concluded, as set forth in this
document, that this rule would not
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generate significant compliance costs,
we expect that this proposed rule, if
finalized, would not have a significant
economic impact on a substantial
number of small entities. We request
comment on the impact of this rule on
small entities.
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that Agencies prepare a written
statement, which includes an
assessment of anticipated costs and
benefits, before proposing ‘‘any rule that
includes any Federal mandate 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 $139
million, using the most current (2011)
Implicit Price Deflator for the Gross
Domestic Product. We do not expect
this proposed rule to result in any 1year expenditure that would meet or
exceed this amount.
A. Need for This Regulation
We are proposing to revoke the
standards of identity for artificially
sweetened jelly, preserves, and jams
because we have tentatively concluded
that these standards are obsolete and
unnecessary. The current standards of
identity for artificially sweetened jelly
(§ 150.141) and artificially sweetened
preserves and jams (§ 150.161) provide
that they may be manufactured only
with specific, non-nutritive artificial
sweeteners: saccharin, sodium
saccharin, calcium saccharin, or any
combination thereof. These standards of
identity, therefore, do not permit the use
of newer, safe and suitable artificial
sweeteners, such as aspartame.
The development of newer artificial
sweeteners and the enactment of the
NLEA have made the current standards
of identity for artificially sweetened
jelly, preserves, and jams obsolete. The
NLEA and § 130.10 permit the
modification of a traditional
standardized food to achieve a nutrition
goal, such as a reduction in calories.
Section 130.10(d)(1) allows the addition
of safe and suitable ingredients to a food
named by use of a nutrient content
claim and a standardized term when
these ingredients are used to, among
other things, add sweetness to ensure
that the modified food is not inferior in
performance characteristic to the
standardized food, even if such
ingredients are not specifically provided
for by the relevant food standard.
Standardized jelly and standardized
preserves and jams products modified
under § 130.10 must use nutrient
content claims to communicate the
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modified standardized product’s
nutritional profile to consumers. Under
§ 130.10, nonspecific, safe and suitable
artificial sweeteners other than the three
named in §§ 150.141 and 150.161 can be
used to make reduced calorie or reduced
sugar products labeled with a nutrient
content claim that is established in FDA
regulations. Revoking the standards of
identity, as proposed, would mean that
any product subject to §§ 150.141 and
150.161 would instead be subject to
§ 130.10. This would allow consumers
to better compare any fruit spreads
currently covered by §§ 150.141 and
150.161 with other spreads that are
named and modified under the
provisions of § 130.10. Revoking the
standards would also provide
manufacturers with the flexibility to use
the three non-nutritive sweeteners listed
in §§ 150.141 and 150.161, while
naming their products under the
provisions of § 130.10 using a defined
nutrient content claim.
B. Regulatory Options
In assessing our regulatory options,
we considered the option of taking no
action and the option of taking the
action proposed by this rule. We have
tentatively concluded that the proposed
rule, if finalized as proposed, would not
be an economically significant
regulatory action. We are not
quantitatively estimating the benefits
and costs of the regulatory alternatives
to the proposed rule. In the following
paragraphs, we qualitatively compare
the costs and benefits of the regulatory
options to the costs and benefits of the
proposed rule.
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1. The Option of Taking No Action
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 associated with taking
the action set forth in this proposed
rule.
2. The Option of Taking the Proposed
Action
If the proposed rule is finalized as
proposed, and we revoke §§ 150.141 and
150.161, products that are currently
subject to the requirements of these
standards of identity would no longer be
required to use the phrase ‘‘artificially
sweetened’’ as part of their product
name. Furthermore, revoking §§ 150.141
and 150.161 would mean that these
same products would be permitted to
bear nutrient content claims along with
a standardized term (e.g., ‘‘reduced
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calorie jelly’’ or ‘‘no sugar added jam’’),
in accordance with § 130.10.
The costs of this proposed rule, if
finalized as proposed, would result from
the need to relabel any existing jelly,
preserves, and jams that conform with
the standards in §§ 150.141 and
150.161. Any products currently
manufactured in accordance with the
standards in §§ 150.141 and 150.161
would have to be relabeled in order to
comply with § 130.10 if this proposed
rule is finalized as proposed. Our
review of supermarket scanner data for
the years 2001 through 2010, however,
revealed that no such products are
currently being sold. Sales for products
manufactured in accordance with
§§ 150.141 and 150.161 were last
reported in 2002. A memorandum
summarizing the results of this scanner
data can be found in Reference 1. The
data support our tentative conclusion
that most manufacturers most likely
have discontinued production of
artificially sweetened jelly, preserves,
and jams, presumably because of a
perception that the phrase ‘‘artificially
sweetened’’ is unattractive to
consumers. The data also support our
tentative conclusion that it is unlikely
that this proposed rule would generate
significant compliance costs due to the
need to relabel products. In fact,
removal of the artificially sweetened
standards of identity would allow
manufacturers to re-introduce products
covered under §§ 150.141 and 150.161
to be sold as products covered by
§ 130.10. That is, they would be named
by use of a nutrient content claim in
conjunction with a standardized term
(e.g., ‘‘reduced calorie jelly’’ or ‘‘no
sugar added jam’’), in accordance with
§ 130.10. Therefore, we tentatively
conclude that any relabeling compliance
costs would be negligible.
We do not classify as anticipated costs
of this proposed rule, if finalized as
proposed, any expenses that firms might
voluntarily incur if they choose to
change their product formulas or
manufacturing practices in response to
the proposed revocation of the
‘‘artificially sweetened’’ standards of
identity. Any such costs are not costs
that would be required by this proposed
regulatory change. Instead, these costs
would result from voluntary business
decisions made by manufacturers.
We tentatively conclude that the
principal benefits that would result
from the proposed rule, if finalized as
proposed, derive from increased
information and flexibility. Revoking
the artificially sweetened standards of
identity would provide producers of
jelly, preserves, and jams with the
flexibility to use saccharin, sodium
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saccharin, calcium saccharin, or any
combination thereof, in their
formulations without having to include
the term ‘‘artificially sweetened’’ in
their product names. Manufacturers
could instead name their products in
accordance with approved nutrient
content claims, as provided for under
§ 130.10, thus providing consumers
with additional information about the
nutritional profile of affected products.
Additionally, revoking §§ 150.141 and
150.161 would assist consumers in
comparing products covered by the
standards with other similar jelly,
preserves, and jams manufactured in
accordance with § 130.10.
Accordingly, while we do not
quantify the costs and benefits of this
proposed rule, we tentatively conclude
that potential benefits will outweigh any
potential costs associated with the rule.
C. Initial Regulatory Flexibility Analysis
The Regulatory Flexibility Act
requires Agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because compliance costs, if
any, generated by this proposed rule are
expected to be negligible, we tentatively
conclude that this proposed rule, if
finalized, would not have a significant
economic impact on a substantial
number of small entities. We request
comment on this tentative conclusion.
The following analysis, in conjunction
with the discussion in this document,
constitutes our initial regulatory
flexibility analysis as required by the
Regulatory Flexibility Act.
This proposed rule, if finalized,
would revoke the standards of identity
for artificially sweetened jelly,
preserves, and jams. The revocation of
these artificially sweetened standards of
identity would provide small fruit
spread firms with the flexibility to use
the three non-nutritive sweeteners listed
in §§ 150.141 and 150.161 and to name
their products with FDA-defined
nutrient content claims in accordance
with § 130.10, as is currently done for
fruit spread products manufactured
with other non-nutritive sweeteners.
We do not classify as costs of this
proposed rule any expenses that some
small firms might voluntarily incur
because they choose to change their
product formulas or manufacturing
practices in ways that would be
permitted by the proposed rule, if
finalized. As discussed in this
document, any such costs would not be
costs required by this proposal, if
finalized. We request comments on the
provisions of this proposed rule that
might require small firms to change
their current practices.
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71750
Federal Register / Vol. 77, No. 233 / Tuesday, December 4, 2012 / Proposed Rules
V. Federalism
We have analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. 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 FD&C Act (21
U.S.C. 343–1) is an express preemption
provision. Section 403A(a) of the FD&C
Act 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—(1) any
requirement for a food which is the
subject of a standard of identity
established under section 401 that is not
identical to such standard of identity or
that is not identical to the requirement
of section 403(g).’’
The express preemption provision of
section 403A(a) of the FD&C Act does
not preempt any State or local
requirement respecting a statement in
the labeling of food that provides for a
warning concerning the safety of the
food or component of the food (section
6(c)(2) of the NLEA, Public Law 101–
535, 104 Stat. 2353, 2364 (1990)).
This proposed rule, if finalized,
would impose requirements that fall
within the scope of section 403A(a) of
the FD&C Act.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IX. Reference
The following source has been placed
on display in the Division of Dockets
Management (see ADDRESSES) and may
be seen by interested persons between 9
a.m. and 4 p.m., Monday through
Friday, and is available electronically at
https://www.regulations.gov.
1. Memorandum to the file, from
Cristina McLaughlin, FDA, November
26, 2012.
List of Subjects in 21 CFR Part 150
Food grades and standards, Fruits.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, and redelegated to
the Associate Commissioner for Policy
and Planning, it is proposed that 21 CFR
part 150 be amended as follows:
PART 150—FRUIT BUTTERS, JELLIES,
PRESERVES, AND RELATED
PRODUCTS
1. The authority citation for 21 CFR
part 150 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 343, 348,
371, 379e.
§§ 150.141 and 150.161
[Removed]
2. Remove §§ 150.141 and 150.161.
Dated: November 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
VII. Paperwork Reduction Act
We conclude that the provisions of
this proposed 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).
srobinson on DSK4SPTVN1PROD with
VI. Environmental Impact
We have determined under 21 CFR
25.32(a) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
Food and Drug Administration
VIII. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
VerDate Mar<15>2010
16:10 Dec 03, 2012
Jkt 229001
[FR Doc. 2012–29181 Filed 12–3–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
21 CFR Part 573
[Docket No. FDA–2012–F–1100]
DSM Nutritional Products; Filing of
Food Additive Petition (Animal Use)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
provide for the safe use of benzoic acid
as a feed acidifier in swine feed.
Submit either electronic or
written comments on the petitioner’s
request for categorical exclusion from
preparing an environmental assessment
or environmental impact statement by
January 3, 2013.
DATES:
Submit electronic
comments to: https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Isabel W. Pocurull, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6853,
email: isabel.pocurull@fda.hhs.gov.
Under the
Federal Food, Drug, and Cosmetic Act
(section 409(b)(5) (21 U.S.C. 348(b)(5))),
notice is given that a food additive
petition (FAP 2273) has been filed by
DSM Nutritional Products, 45
Waterview Blvd., Parsippany, NJ 07054.
The petition proposes to amend Title 21
of the Code of Federal Regulations (CFR)
in part 573 Food Additives Permitted in
Feed and Drinking Water of Animals (21
CFR part 573) to provide for the safe use
of benzoic acid as a feed acidifier in
swine feed.
The petitioner has requested a
categorical exclusion from preparing an
environmental assessment or
environmental impact statement under
21 CFR 25.32(r). Interested persons may
submit a single copy of either electronic
or written comments regarding this
request for categorical exclusion to the
Division of Dockets Management (see
DATES and ADDRESSES). Identify
comments with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday, and will be
posted to the docket at https://
www.regulations.gov.
SUPPLEMENTARY INFORMATION:
Dated: November 29, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012–29202 Filed 12–3–12; 8:45 am]
Notice of petition.
BILLING CODE 4160–01–P
The Food and Drug
Administration (FDA) is announcing
that DSM Nutritional Products has filed
a petition proposing that the food
additive regulations be amended to
SUMMARY:
PO 00000
Frm 00028
Fmt 4702
Sfmt 9990
E:\FR\FM\04DEP1.SGM
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]]>Agencies
[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Proposed Rules]
[Pages 71746-71750]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29181]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 150
[Docket No. FDA-1997-P-0007] (formerly Docket No. 1997P-0142)
Artificially Sweetened Fruit Jelly and Artificially Sweetened
Fruit Preserves and Jams; Proposed Revocation of Standards of Identity
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
revoke the standards of identity for artificially sweetened jelly,
preserves, and jams. We are taking this action primarily in response to
a citizen petition submitted by the International Jelly and Preserve
Association (IJPA). We are taking this action because we tentatively
conclude that these standards are both obsolete and unnecessary in
light of our regulations for foods named by use of a nutrient content
claim and a standardized term. We also tentatively conclude that this
action will promote honesty and fair dealing in the interest of
consumers.
DATES: Submit electronic or written comments on the proposed rule by
March 4, 2013.
ADDRESSES: You may submit comments, identified by Docket No. FDA-1997-
P-0007 (formerly Docket No. 1997P-0142), by any of the following
methods.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management, (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-1997-P-0007 (formerly Docket No. 1997P-0142) for
this rulemaking. All comments received may be posted without change to
https://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket numbers found in brackets in the heading of this document into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852.P>FOR FURTHER INFORMATION CONTACT:
FOR FURTHER INFORMATION CONTACT: Daniel Reese, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.
SUPPLEMENTARY INFORMATION:
I. Background
For more than 50 years, FDA has maintained standards of identity
for
[[Page 71747]]
fruit jelly (jelly) (21 CFR 150.140) and fruit preserves and jams
(preserves and jams) (21 CFR 150.160). The standards establish the
common or usual name for these products and provide that these products
may contain nutritive sweeteners (e.g., sugar). In 1959, FDA added new
standards of identity for artificially sweetened fruit jelly
(artificially sweetened jelly) (21 CFR 150.141) and artificially
sweetened fruit preserves and jams (artificially sweetened preserves
and jams) (21 CFR 150.161) (24 FR 8896; October 31, 1959) that permit
the use of non-nutritive sweeteners (e.g., saccharin). Notably,
Sec. Sec. 150.141 and 150.161 limit the types of non-nutritive
sweeteners that can be used in products that are governed by those
standards of identity. Such products may only use saccharin, sodium
saccharin, calcium saccharin, or any combination thereof, and may not
use newer forms of non-nutritive sweeteners that have been established
since the standard of identity regulations were issued.
The Nutrition Labeling and Education Act (NLEA) of 1990 amended the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) to provide for a
number of fundamental changes in food labeling, leading to a new
regulatory framework for the naming of foods that do not fully comply
with the relevant standards of identity. In response to NLEA, FDA
established in part 101 (21 CFR part 101), among other things,
definitions for specific nutrient content claims using terms such as
``free,'' ``low,'' ``light'' or ``lite,'' and ``less,'' and provided
for their use in food labeling (58 FR 2302; January 6, 1993). FDA also
prescribed at the same time in Sec. 130.10 (21 CFR 130.10) a general
definition and standard of identity for foods named by a nutrient
content claim defined in part 101, such as ``low calorie'' or ``sugar
free,'' in conjunction with a traditional standardized food term (58 FR
2431; January 6, 1993). A nutrient content claim applied to the
standardized food ``grape jelly,'' for example, could be ``low calorie
grape jelly.'' Section 130.10(d)(1) allows the addition of safe and
suitable ingredients to a food named by use of a nutrient content claim
and a standardized term when these ingredients are used to, among other
things, add sweetness to ensure that the modified food is not inferior
in performance characteristic to the standardized food even if such
ingredients are not specifically provided for by the relevant food
standard. Thus, under certain circumstances, Sec. 130.10 permits
manufacturers to use safe and suitable artificial sweeteners (e.g.,
aspartame) that are not expressly listed in Sec. Sec. 150.141 and
150.161 in the manufacture of jelly, fruit preserves, and jams
(collectively, ``fruit spreads''). Therefore, fruit spread products
named with a nutrient content claim (for example, ``low calorie grape
jelly'') may contain newer artificial sweeteners to add sweetness to
fruit spread products so that they are not inferior in their sweetness
compared to their standardized counterparts (for example, ``grape
jelly''). The provisions of Sec. 130.10 do not require these products
to declare the presence of such non-nutritive sweeteners within the
name of these foods. FDA took this action to assist consumers in
maintaining healthy dietary practices by providing for a modified
version of a traditional standardized food to achieve a nutrition goal
(e.g., reduction in sugar consumption or calories) and that has a
descriptive name that is meaningful to consumers. The provisions of
Sec. 130.10 do not, however, permit the use of nutrient content claims
as part of the name of a food for foods governed by standards of
identity that established the phrase ``artificially sweetened'' as part
of the standard of identity. Accordingly, jelly, preserves, and jams,
that use saccharin, sodium saccharin, calcium saccharin, or any
combination thereof as non-nutritive sweeteners must still include the
term ``artificially sweetened'' in their names and are not permitted to
bear a nutrient content claim as part of the name; however, similar
products that use newer non-nutritive sweeteners are governed by Sec.
130.10 and must not include the term ``artificially sweetened'' in
their names.
II. IJPA Petition and Grounds
IJPA is a national trade association representing the manufacturers
of jelly, preserves, jams, and nonstandardized fruit spreads, and
suppliers of goods and services to the industry, including ingredient
suppliers of fruit, sweeteners, and pectin. IJPA submitted a citizen
petition dated March 31, 1997 (now Docket No. FDA-1997-P-0007),
requesting the revocation of the standards of identity for artificially
sweetened jelly, preserves, and jams. IJPA submitted its petition in
response to FDA's advance notice of proposed rulemaking announcing that
FDA was planning to review its food standards regulations (60 FR 67492;
December 29, 1995). In that document, we sought comments on, inter
alia, the benefits or lack of benefits of such regulations in
facilitating domestic and international commerce, the value of these
regulations to consumers, and alternative means of accomplishing the
statutory objective of food standards (i.e., to promote honesty and
fair dealing in the interest of consumers in the manufacture and sale
of food products covered by the standard of identity regulations).
IJPA asserts in its citizen petition that the standards of identity
for artificially sweetened jelly, jams, and preserves are outdated.
According to IJPA, the standards have not been updated to take into
account new non-nutritive sweeteners that have been approved by FDA
since 1959. The petition maintains that the general standard in Sec.
130.10 provides fruit spread manufacturers with sufficient flexibility
to use newer, intense non-nutritive sweeteners in lieu of traditional
nutritive sweeteners, and it would be appropriate to rely on that
general standard rather than seek piecemeal amendments to the standards
of identity to reflect the development of any new sweeteners. IJPA
stated that by using the general standard in Sec. 130.10,
manufacturers can create products with nutrient content claims for
reductions in calories or sugar content that are established in FDA
regulations. According to IJPA, nutrient content terms (e.g., ``low
calorie'') also better communicate to the consumer the nutritional
benefit of the use of non-nutritive sweeteners than does the term
``artificially sweetened,'' which is required to appear in the labels
of products manufactured in conformity with Sec. Sec. 150.141 and
150.161. Therefore, IJPA concluded in its petition that the standards
of identity for artificially sweetened jelly, preserves, and jams are
both obsolete and unnecessary, and requested that we revoke these
standards. Finally, IJPA stated that as of the date of submission of
its citizen petition, there were few products being manufactured under
these two standards of identity and that some manufacturers are already
using the general standard in Sec. 130.10 to formulate products that
have reduced sugar and caloric content. IJPA stated that if these
standards are revoked, any products that are currently manufactured in
conformity with the standards could remain on the market by operation
of Sec. 130.10.
III. The Proposal
We have reviewed IJPA's petition. We find merit in IJPA's argument
that revoking the artificially sweetened standards of identity would
allow manufacturers to more accurately and consistently describe the
attributes of the fruit spreads that currently conform to those
standards. We therefore tentatively conclude that revoking the
standards would promote honesty and
[[Page 71748]]
fair dealing in the interest of consumers and is, thus, appropriate
under section 401 of the FD&C Act (21 U.S.C. 341). We tentatively reach
this conclusion because we find that nutrient content claims, such as
``low calorie'' or ``reduced sugar'' better characterize the
nutritional profile of the affected fruit spreads than does the term
``artificially sweetened.'' Further, revoking Sec. Sec. 150.141 and
150.161 provides manufacturers with the flexibility to use the three
non-nutritive sweeteners listed in those standards while also naming
their products using FDA-defined nutrient content claims, in accordance
with Sec. 130.10. Moreover, other safe and suitable artificial
sweeteners that might be developed in the future could be used in these
products under Sec. 130.10 without the need to further revise relevant
standards of identity.
Enactment of NLEA and the development of newer artificial
sweeteners, thus, renders the standards of identity for artificially
sweetened jelly, preserves, and jams in Sec. Sec. 150.141 and 150.161
obsolete. They no longer serve their intended purpose of ensuring
honesty and fair dealing while allowing for the use of artificial
sweeteners in standardized fruit jelly and standardized fruit preserves
and jams as firms may now use certain artificial sweeteners under Sec.
130.10. The standards for artificially sweetened jelly and artificially
sweetened preserves and jams predate the nutrient content claim
provisions of Sec. 130.10. Removal of the artificially sweetened
standards of identity would mean that products that are currently
subject to the requirements of Sec. Sec. 150.141 and 150.161 would
instead be subject to the requirements of Sec. 130.10, the general
definition and standard of identity for foods named by a nutrient
content claim defined in part 101. Thus, these products would be named
by use of a nutrient content claim (e.g., ``reduced calorie'' or ``no
sugar added'') along with a standardized term (``jelly'' or ``jam''),
in accordance with Sec. 130.10. Revoking Sec. Sec. 150.141 and
150.161 also would promote honesty and fair dealing in the interest of
consumers by requiring manufacturers to more accurately and
consistently describe the attributes of the food (e.g., less sugar or
reduced calories); would allow any safe and suitable non-nutritive
sweetener to be used in standardized jams, jellies, and preserves; and
would allow better comparison to other jams, jellies, and preserves
currently modified under the provisions of Sec. 130.10. For example,
under current requirements, a jelly that is sweetened with saccharin
must be called ``artificially sweetened jelly'' (in accordance with
Sec. 150.141) whereas a similar jelly sweetened with aspartame may be
named as ``reduced sugar jelly'' (in accordance with Sec. 130.10 and
provided it meets the requirements for the nutrient content claim
``reduced sugar'' in Sec. 101.60.(c)(5)) to distinguish it from the
standardized food (jelly in Sec. 150.140). Revoking the standards
would provide consistency and uniformity among such products because
all fruit spreads sweetened with non-nutritive sweeteners would be
subject to the same requirements. This proposed rule also is consistent
with FDA's proposed general principles for modernizing food standards
(70 FR 29214; May 20, 2005). In addition, this proposal is consistent
with Executive Order 12866 of September 30, 1993 (58 FR 51735), and
Executive Order 13653 of January 21, 2011 (76 FR 3821), regarding
improving Agency regulations, regulatory planning, and regulatory
review.
Considering the information in this document, we are proposing to
revoke the standards of identity for artificially sweetened jelly,
preserves, and jams in Sec. Sec. 150.141 and 150.161, respectively. We
request comments on our tentative conclusion that these two standards
of identity are obsolete and unnecessary, and that revoking them would
promote honesty and fair dealing in the interest of consumers.
IV. Analysis of Impacts
We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4).
Executive Orders 12866 and 13563 direct 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; distributive impacts; and
equity). Executive Order 13563 emphasizes the importance of quantifying
both costs and benefits, of reducing costs, of harmonizing rules, and
of promoting flexibility. We tentatively conclude that this proposed
rule is not a significant regulatory action as defined by the Executive
Orders.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because we have tentatively concluded, as set forth
in this document, that this rule would not generate significant
compliance costs, we expect that this proposed rule, if finalized,
would not have a significant economic impact on a substantial number of
small entities. We request comment on the impact of this rule on small
entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate 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 $139 million, using the most current (2011) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
A. Need for This Regulation
We are proposing to revoke the standards of identity for
artificially sweetened jelly, preserves, and jams because we have
tentatively concluded that these standards are obsolete and
unnecessary. The current standards of identity for artificially
sweetened jelly (Sec. 150.141) and artificially sweetened preserves
and jams (Sec. 150.161) provide that they may be manufactured only
with specific, non-nutritive artificial sweeteners: saccharin, sodium
saccharin, calcium saccharin, or any combination thereof. These
standards of identity, therefore, do not permit the use of newer, safe
and suitable artificial sweeteners, such as aspartame.
The development of newer artificial sweeteners and the enactment of
the NLEA have made the current standards of identity for artificially
sweetened jelly, preserves, and jams obsolete. The NLEA and Sec.
130.10 permit the modification of a traditional standardized food to
achieve a nutrition goal, such as a reduction in calories. Section
130.10(d)(1) allows the addition of safe and suitable ingredients to a
food named by use of a nutrient content claim and a standardized term
when these ingredients are used to, among other things, add sweetness
to ensure that the modified food is not inferior in performance
characteristic to the standardized food, even if such ingredients are
not specifically provided for by the relevant food standard.
Standardized jelly and standardized preserves and jams products
modified under Sec. 130.10 must use nutrient content claims to
communicate the
[[Page 71749]]
modified standardized product's nutritional profile to consumers. Under
Sec. 130.10, nonspecific, safe and suitable artificial sweeteners
other than the three named in Sec. Sec. 150.141 and 150.161 can be
used to make reduced calorie or reduced sugar products labeled with a
nutrient content claim that is established in FDA regulations. Revoking
the standards of identity, as proposed, would mean that any product
subject to Sec. Sec. 150.141 and 150.161 would instead be subject to
Sec. 130.10. This would allow consumers to better compare any fruit
spreads currently covered by Sec. Sec. 150.141 and 150.161 with other
spreads that are named and modified under the provisions of Sec.
130.10. Revoking the standards would also provide manufacturers with
the flexibility to use the three non-nutritive sweeteners listed in
Sec. Sec. 150.141 and 150.161, while naming their products under the
provisions of Sec. 130.10 using a defined nutrient content claim.
B. Regulatory Options
In assessing our regulatory options, we considered the option of
taking no action and the option of taking the action proposed by this
rule. We have tentatively concluded that the proposed rule, if
finalized as proposed, would not be an economically significant
regulatory action. We are not quantitatively estimating the benefits
and costs of the regulatory alternatives to the proposed rule. In the
following paragraphs, we qualitatively compare the costs and benefits
of the regulatory options to the costs and benefits of the proposed
rule.
1. The Option of Taking No Action
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 associated with taking the action set forth in this
proposed rule.
2. The Option of Taking the Proposed Action
If the proposed rule is finalized as proposed, and we revoke
Sec. Sec. 150.141 and 150.161, products that are currently subject to
the requirements of these standards of identity would no longer be
required to use the phrase ``artificially sweetened'' as part of their
product name. Furthermore, revoking Sec. Sec. 150.141 and 150.161
would mean that these same products would be permitted to bear nutrient
content claims along with a standardized term (e.g., ``reduced calorie
jelly'' or ``no sugar added jam''), in accordance with Sec. 130.10.
The costs of this proposed rule, if finalized as proposed, would
result from the need to relabel any existing jelly, preserves, and jams
that conform with the standards in Sec. Sec. 150.141 and 150.161. Any
products currently manufactured in accordance with the standards in
Sec. Sec. 150.141 and 150.161 would have to be relabeled in order to
comply with Sec. 130.10 if this proposed rule is finalized as
proposed. Our review of supermarket scanner data for the years 2001
through 2010, however, revealed that no such products are currently
being sold. Sales for products manufactured in accordance with
Sec. Sec. 150.141 and 150.161 were last reported in 2002. A memorandum
summarizing the results of this scanner data can be found in Reference
1. The data support our tentative conclusion that most manufacturers
most likely have discontinued production of artificially sweetened
jelly, preserves, and jams, presumably because of a perception that the
phrase ``artificially sweetened'' is unattractive to consumers. The
data also support our tentative conclusion that it is unlikely that
this proposed rule would generate significant compliance costs due to
the need to relabel products. In fact, removal of the artificially
sweetened standards of identity would allow manufacturers to re-
introduce products covered under Sec. Sec. 150.141 and 150.161 to be
sold as products covered by Sec. 130.10. That is, they would be named
by use of a nutrient content claim in conjunction with a standardized
term (e.g., ``reduced calorie jelly'' or ``no sugar added jam''), in
accordance with Sec. 130.10. Therefore, we tentatively conclude that
any relabeling compliance costs would be negligible.
We do not classify as anticipated costs of this proposed rule, if
finalized as proposed, any expenses that firms might voluntarily incur
if they choose to change their product formulas or manufacturing
practices in response to the proposed revocation of the ``artificially
sweetened'' standards of identity. Any such costs are not costs that
would be required by this proposed regulatory change. Instead, these
costs would result from voluntary business decisions made by
manufacturers.
We tentatively conclude that the principal benefits that would
result from the proposed rule, if finalized as proposed, derive from
increased information and flexibility. Revoking the artificially
sweetened standards of identity would provide producers of jelly,
preserves, and jams with the flexibility to use saccharin, sodium
saccharin, calcium saccharin, or any combination thereof, in their
formulations without having to include the term ``artificially
sweetened'' in their product names. Manufacturers could instead name
their products in accordance with approved nutrient content claims, as
provided for under Sec. 130.10, thus providing consumers with
additional information about the nutritional profile of affected
products. Additionally, revoking Sec. Sec. 150.141 and 150.161 would
assist consumers in comparing products covered by the standards with
other similar jelly, preserves, and jams manufactured in accordance
with Sec. 130.10.
Accordingly, while we do not quantify the costs and benefits of
this proposed rule, we tentatively conclude that potential benefits
will outweigh any potential costs associated with the rule.
C. Initial Regulatory Flexibility Analysis
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because compliance costs, if any, generated by this
proposed rule are expected to be negligible, we tentatively conclude
that this proposed rule, if finalized, would not have a significant
economic impact on a substantial number of small entities. We request
comment on this tentative conclusion. The following analysis, in
conjunction with the discussion in this document, constitutes our
initial regulatory flexibility analysis as required by the Regulatory
Flexibility Act.
This proposed rule, if finalized, would revoke the standards of
identity for artificially sweetened jelly, preserves, and jams. The
revocation of these artificially sweetened standards of identity would
provide small fruit spread firms with the flexibility to use the three
non-nutritive sweeteners listed in Sec. Sec. 150.141 and 150.161 and
to name their products with FDA-defined nutrient content claims in
accordance with Sec. 130.10, as is currently done for fruit spread
products manufactured with other non-nutritive sweeteners.
We do not classify as costs of this proposed rule any expenses that
some small firms might voluntarily incur because they choose to change
their product formulas or manufacturing practices in ways that would be
permitted by the proposed rule, if finalized. As discussed in this
document, any such costs would not be costs required by this proposal,
if finalized. We request comments on the provisions of this proposed
rule that might require small firms to change their current practices.
[[Page 71750]]
V. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. 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 FD&C Act (21 U.S.C. 343-1) is an express
preemption provision. Section 403A(a) of the FD&C Act 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--(1) any requirement for a food which
is the subject of a standard of identity established under section 401
that is not identical to such standard of identity or that is not
identical to the requirement of section 403(g).''
The express preemption provision of section 403A(a) of the FD&C Act
does not preempt any State or local requirement respecting a statement
in the labeling of food that provides for a warning concerning the
safety of the food or component of the food (section 6(c)(2) of the
NLEA, Public Law 101-535, 104 Stat. 2353, 2364 (1990)).
This proposed rule, if finalized, would impose requirements that
fall within the scope of section 403A(a) of the FD&C Act.
VI. Environmental Impact
We have determined under 21 CFR 25.32(a) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VII. Paperwork Reduction Act
We conclude that the provisions of this proposed 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).
VIII. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to https://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IX. Reference
The following source has been placed on display in the Division of
Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and is
available electronically at https://www.regulations.gov.
1. Memorandum to the file, from Cristina McLaughlin, FDA, November
26, 2012.
List of Subjects in 21 CFR Part 150
Food grades and standards, Fruits.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, and
redelegated to the Associate Commissioner for Policy and Planning, it
is proposed that 21 CFR part 150 be amended as follows:
PART 150--FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
1. The authority citation for 21 CFR part 150 continues to read as
follows:
Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379e.
Sec. Sec. 150.141 and 150.161 [Removed]
2. Remove Sec. Sec. 150.141 and 150.161.
Dated: November 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29181 Filed 12-3-12; 8:45 am]
BILLING CODE 4160-01-P
