[Federal Register Volume 59, Number 23 (Thursday, February 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-2359]
[[Page Unknown]]
[Federal Register: February 3, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 164
[Docket No. 93N-0473]
Peanut Butter: Proposed Amendment of Standard of Identity
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the standard of identity for peanut butter to remove the statement that
added vitamins are not suitable ingredients of this food. If this
change is adopted, manufacturers will be able to add vitamins to make
modified peanut butter in accordance with the agency's general
definition and standard of identity for food named by the use of a
nutrient content claim (such as ``reduced fat'' or ``reduced calorie'')
and a standardized term (peanut butter). FDA is proposing to take this
action because it tentatively finds that providing for modified forms
of peanut butter will assist consumers in maintaining healthy dietary
practices. Thus, the agency tentatively concludes that this action will
promote honesty and fair dealing in the interest of consumers.
DATES: Comments by April 4, 1994. FDA proposes that any final rule that
may issue based on this proposal become effective 60 days after date of
publication in the Federal Register.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Nannie H. Rainey, Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5099.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 6, 1993 (58 FR 2431), FDA
adopted Sec. 130.10 (21 CFR 130.10). This regulation provides for the
use of nutrient content claims defined in part 101 (21 CFR part 101),
such as ``fat free,'' ``low calorie,'' or ``light,'' in conjunction
with a traditional standardized food name (e.g., ``sour cream'') to
define a new food such as ``reduced fat sour cream.'' The purpose of
the new general standard of identity is to provide for modified
versions of certain standardized foods and thereby to assist consumers
in maintaining healthy dietary practices.
The general standard of identity in Sec. 130.10 requires, among
other things, that the modified versions of the standardized foods: (1)
Not be nutritionally inferior to the traditional standardized food, (2)
possess performance characteristics, such as physical properties,
flavor characteristics, functional properties, and shelf life, that are
similar to those of the traditional standardized food, (3) contain a
significant amount of any mandatory ingredient required to be in the
traditional food, and (4) be made from the same types of ingredients as
permitted in the standard for the traditional food, except that
ingredients may be used to improve texture, prevent syneresis, add
flavor, extend shelf life, improve appearance, or add sweetness.
Section 130.10(d)(5) also provides for the use of water and fat analogs
to replace fat and calories but specifically prohibits the replacement
of required ingredients of standardized foods with ingredients from a
different source. For example, vegetable oil may not replace milkfat in
the manufacture of a modified version of sour cream. Furthermore,
Sec. 130.10(d)(3) of the general standard of identity prohibits the use
in the modified food of any ingredient or component of an ingredient
whose use in the traditional food is specifically prohibited by the
standard of identity for that food (21 CFR parts 131 through 169).
In the Federal Register of January 6, 1993, in a document entitled
``Food Labeling Regulations Implementing the Nutrition Labeling and
Education Act of 1990; Opportunity for Comments'' (58 FR 2066)
(hereinafter referred to as the ``implementation final rule''), FDA
provided an opportunity for comment on technical issues raised by the
final regulations on food labeling that it published on that date,
including Sec. 130.10. The implementation final rule, among other
things, provided 30 days for the submission of comments on technical
issues.
In response to the implementation final rule, the agency received
several inquiries regarding ingredients whose use in modified foods is
prohibited under Sec. 130.10(d)(3) of the general standard. Comments
claimed that this provision is inconsistent with Sec. 130.10(b), which
requires that nutrients be added to the new food to restore nutrient
levels so that the new food is not nutritionally inferior to the
traditional food. One comment suggested that FDA amend
Sec. 130.10(d)(3) by adding an exception to allow for compliance with
Sec. 130.10(b). This comment contended that without such an exception,
no nutritionally improved versions of important products such as peanut
butter would be permitted, except when labeled as imitations.
In the Federal Register of August 18, 1993, FDA published a final
rule entitled ``Food Labeling: Nutrient Content Claims, General
Principles, Petitions, Definition of Terms; Definitions of Nutrient
Content Claims for Fat, Fatty Acids, and Cholesterol content of Foods;
Food Standards: Requirements for Foods Named by Use of a Nutrient
Content Claim and a Standardized Term; Technical Amendment'' (58 FR
44020) (hereinafter referred to as ``the technical amendment''). In
this document, the agency acknowledged that it was arguable that there
was a conflict between Sec. 130.10(b) and (d)(3) (58 FR 44020 at page
44028) but stated that no conflict between these provisions was
intended. It recognized, however, that while the need to ensure that
the modified food is consistent in characteristics with the traditional
standardized food in as many ways as possible, and the need to ensure
that the modified food is not made with ingredients not permitted in
the traditional food, normally support each other, in the case of
peanut butter, and only peanut butter, they work to prevent the
creation of modified peanut butter products.
The standard of identity for peanut butter in Sec. 164.150(c) (21
CFR 164.150(c)) states that artificial flavorings, artificial
sweeteners, chemical preservatives, added vitamins, and color additives
are not suitable ingredients for use in the food. Based on testimony at
the hearings held when the standard of identity for peanut butter was
adopted and the resulting findings of fact (33 FR 10506 at 10509, July
24, 1968), the agency adopted this prohibition on the addition of
vitamins to peanut butter because such addition is unnecessary when the
peanut butter is consumed as part of a balanced diet. As a result of
the prohibition on vitamin addition in the peanut butter standard
(Sec. 164.150(c)), it may not be possible to formulate a modified
peanut butter product that is not nutritionally inferior to peanut
butter under the general standard of identity. For example, if the
level of vitamins is reduced in making the modified peanut butter
product, e.g., a ``reduced calorie'' or ``reduced fat'' peanut butter,
vitamins would have to be added to ensure compliance with
Sec. 130.10(b).
In the technical amendment, the agency discussed the
appropriateness of amending the standard of identity for peanut butter
to remove the specific prohibition regarding the addition of vitamins
in Sec. 164.150(c) as well as the appropriateness of the option
suggested in comments of modifying Sec. 130.10 to allow the addition of
nutrients to modified peanut butter products (58 FR 44020 at 44028 and
44029). FDA stated that it was the agency's preliminary view that it is
more appropriate to amend the standard of identity for peanut butter to
remove the specific prohibition regarding the addition of vitamins than
to modify Sec. 130.10. FDA said that amendment of the peanut butter
standard would accomplish the same result as the suggested modification
of Sec. 130.10 but would allow the general standard of identity to
remain a generic standard applicable to any standardized food. FDA is
now proposing to amend Sec. 164.150(c) to effect this change.
The agency points out that FDA's regulations make provision for
nonstandardized spreadable peanut products. Under Sec. 102.23 (21 CFR
102.23), these products may be labeled with the common or usual name
``peanut spreads,'' provided that the identity statement contains a
statement of the percent of peanut ingredient, and the product complies
with the nutrient content requirements in Sec. 102.23. This regulation
has not, however, fostered a large number of products.
FDA believes that amendment of the peanut butter standard to remove
the prohibition on added vitamins will lead to the creation of more
peanut products than has been the case under Sec. 102.23 because
manufacturers will be able to use the term ``peanut butter'' instead of
``peanut spread'' in the names of their products. Further, FDA believes
that the use of defined nutrient content claims will promote uniformity
in labeling and will enhance consumer recognition of modified peanut
butter products that have been designed to achieve a nutritional goal.
This enhanced recognition will assist consumers in maintaining healthy
dietary practices. Thus, FDA tentatively finds that a change in the
peanut butter standard that will permit the use of added vitamins in
the production of modified peanut butter products is in the best
interest of consumers. Accordingly, FDA is proposing to revise
Sec. 164.150(c) by removing the specific prohibition regarding ``added
vitamins.'' This change will allow the addition of nutrients normally
present in peanut butter that would otherwise be reduced in
manufacturing the modified peanut butter products, thereby ensuring
that the modified version of the food will not be nutritionally
inferior to peanut butter.
FDA notes that the removal of the specific prohibition against
added vitamins in the peanut butter standard does not change the
agency's position that added vitamins are not necessary for peanut
butter that has not been modified when it is consumed in a balanced
diet. Thus, if vitamins were added to a food that complies with the
standard of identity in Sec. 164.150, the resultant food would not be
peanut butter.
II. Economic Impact
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health, and safety effects;
distributive impacts; and equity). The Regulatory Flexibility Act
requires analyzing options for regulatory relief for small businesses.
The proposed removal of the specific prohibition regarding added
vitamins in the peanut butter standard of identity will not affect the
manufacture or labeling of peanut butter as defined in Sec. 164.150.
However, it will provide an additional option to manufacturers of
spreadable peanut products that do not comply with the standard of
identity for peanut butter. It will permit the manufacture and labeling
of some modified peanut butter products in accordance with the general
definition and standard of identity in Sec. 130.10. Products complying
with the general definition and standard of identity may be named by
use of a nutrient content claim and the standardized term ``peanut
butter,'' thereby minimizing confusion to consumers regarding the
nature of the food.
Because the manufacture of modified peanut butter products
complying with the new general definition and standard of identity is
optional, and manufacturers may continue to make nonstandardized
spreadable peanut products in accordance with the common or usual name
regulation in Sec. 102.23 and peanut butter in accordance with the
standard of identity in Sec. 164.150, FDA does not believe that the
proposed change to remove the specific prohibition regarding ``added
vitamins'' in the standard of identity will have any adverse economic
impact on manufacturers. Therefore, FDA finds that this proposed rule
is not a significant regulatory action as defined by Executive Order
12866. In addition, FDA certifies in accordance with section 605 of the
Regulatory Flexibility Act that no significant economic impact on a
substantial number of small entities will derive from this action.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(b)(1) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Comments
Interested persons may, on or before April 4, 1994, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 164
Food grades and standards, Nuts, Peanuts.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, it is proposed that 21 CFR part 164 be amended as follows:
PART 164--TREE NUT AND PEANUT PRODUCTS
1. The authority citation for 21 CFR part 164 is revised to read as
follows:
Authority: Secs. 201, 401, 403, 409, 701, 721 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371,
379e).
2. Section 164.150 is amended by revising paragraph (c) to read as
follows:
Sec. 164.150 Peanut butter.
* * * * *
(c) The seasoning and stabilizing ingredients referred to in
paragraph (a) of this section are suitable substances which are not
food additives as defined in section 201(s) of the Federal Food, Drug,
and Cosmetic Act (the act), or if they are food additives as so
defined, they are used in conformity with regulations established
pursuant to section 409 of the act. Seasoning and stabilizing
ingredients that perform a useful function are regarded as suitable,
except that artificial flavorings, artificial sweeteners, chemical
preservatives, and color additives are not suitable ingredients in
peanut butter. Oil products used as optional stabilizing ingredients
shall be hydrogenated vegetable oils. For the purposes of this section,
hydrogenated vegetable oil shall be considered to include partially
hydrogenated vegetable oil.
* * * * *
Dated: January 24, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-2359 Filed 2-2-94; 8:45 am]
BILLING CODE 4160-01-F