Document ID: FDA-1997-P-0007-0002
Agency: fda
Document Type: Proposed Rule
Title: Revocation of Standards of Identity: Artificially Sweetened Fruit Jelly and Artificially Sweetened Fruit Preserves and Jams
Posted Date: 2012-12-04T05:00Z

[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]

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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.

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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: http://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 
http://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 http://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 http://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 http://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 http://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