[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Rules and Regulations]
[Pages 9323-9325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5493]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 164
[Docket No. 93N-0473]
Peanut Butter; Amendment of Standard of Identity
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
standard of identity for peanut butter to remove the specific reference
to the addition of vitamins, so that modified peanut butter products
with added vitamins can be made 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'')
in conjunction with the standardized term, peanut butter. This action
will assist consumers in maintaining healthy dietary practices by
providing for modified forms of peanut butter. This action will also
promote honesty and fair dealing in the interest of consumers.
DATES: Effective March 8, 1996.
FOR FURTHER INFORMATION CONTACT: Felicia Satchell, 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 February 3, 1994 (59 FR 5153), FDA
published a proposal to amend the standard of identity for peanut
butter in Sec. 164.150 (21 CFR 164.150) to remove the specific
prohibition against added vitamins. The proposal was based on comments
the agency received in response to a final rule that was published in
the Federal Register of January 6, 1993 (58 FR 2066). The comments
noted that the requirements of the general definition and standard of
identity in Sec. 130.10 (21 CFR 130.10) create a problem for firms
interested in producing modified (e.g., ``reduced fat'') peanut butter
products. They pointed out that Sec. 130.10(b) requires that the
modified food may not be nutritionally inferior to the traditional
standardized food, and that Sec. 130.10(d)(3) prohibits the addition of
ingredients that are specifically prohibited by the standard for the
traditional food. Because there is a specific prohibition against the
addition of vitamins to peanut butter in Sec. 164.150(c), modified
peanut butter products that are not nutritionally inferior to peanut
butter could not be made under Sec. 130.10.
To eliminate this problem, FDA proposed to remove the specific
prohibition against the addition of vitamins in the peanut butter
standard. The agency stated in that proposal that removal of the term
``added vitamins'' from Sec. 164.150(c) would allow the addition of
vitamins to modified peanut butter products made to comply with
Sec. 130.10, but that the agency still felt that added vitamins are not
suitable ingredients for peanut butter when the food is used in a
balanced diet. Interested persons were given until April 4, 1994, to
submit comments.
II. Comments
The agency received 12 letters, each containing one or more
comments, from a manufacturer, several trade associations, and food
processors. Seven letters supported the proposal, and five opposed it.
One comment that expressed support for the proposed change suggested an
additional change in the standard of identity for peanut butter, and
others requested clarification of the nutrient requirements for
modified peanut butter. Most of the comments that opposed amendment of
the peanut butter standard cited, as grounds for their opposition,
issues that are outside the scope of this rulemaking (e.g., whether a
modified peanut butter product under the general definition and
standard of identity could or should be made with 90 percent of
peanuts, as required by the standard of identity for peanut butter, and
whether FDA is enforcing its regulations with respect to modified
peanut butter products in the marketplace) and they need not be
addressed here. A summary of the relevant comments and the agency's
responses follow.
1. A comment from a trade association that opposed the proposal
stated that its membership believes it would be misleading if the
standard of identity for peanut butter were changed. It expressed the
opinion that peanut butter is nutritionally sound without vitamin
additives.
The agency agrees that peanut butter is nutritionally sound without
added vitamins. The removal of the specific prohibition against added
vitamins in the peanut butter standard is only to permit their
addition, as necessary, to modified peanut butter products made under
the general definition and standard of identity in Sec. 130.10. FDA
clearly stated in the proposed rule that the removal of this
prohibition would not change the agency's position that added vitamins
are not suitable ingredients in peanut butter when it is not being
modified to reduce, for example, its fat content. Thus, in this final
rule, the agency is merely removing the prohibition on the addition of
vitamins to peanut butter in the standard of identity in Sec. 164.150.
It is not making any provision for the addition of these ingredients to
this food under Sec. 164.150. If vitamins are added to peanut butter,
it would have to be labeled in compliance with Sec. 130.10, i.e.,
``peanut butter with added vitamins.'' Any such addition of vitamins to
the food would have to be consistent with the provisions of the
fortification policy in 21 CFR 104.20, or be otherwise rational.
2. One comment stated that it supported the proposal to remove the
phrase ``added vitamins'' in Sec. 164.150(c), but that the proposal did
not go far enough. It stated that the agency should remove the entire
statement contained in paragraph Sec. 164.150(c), i.e., ``except that
artificial flavorings, artificial sweeteners, chemical preservatives,
added vitamins, and color additives are not suitable ingredients of
peanut butter.'' The comment stated that none of these ingredients
would be permitted in peanut butter notwithstanding the above language
because the only optional ingredients permitted in peanut butter under
the standard are ``safe and suitable seasoning and stabilizing
ingredients.'' The comment contended that few would argue that these
``prohibited'' ingredients (artificial flavorings, artificial
sweeteners, chemical preservatives, vitamins, and color additives)
qualify as seasoning or stabilizing ingredients. The comment further
contended that if the agency has a concern in this regard, it could
state for the record that stabilizing and seasoning ingredients, as
used in the
[[Page 9324]]
peanut butter standard, do not include these categories of ingredients.
The comment also noted that many peanut butters include a sweetener
seasoning, and that there might be an opportunity to use an approved
high intensity artificial sweetener to replace sugar or corn syrup in
the formulation of a modified peanut butter. Likewise, the comment
stated, if someone wanted to use a safe and suitable artificial flavor
in a modified peanut butter product (the inclusion of which would be
required to be adequately communicated via the labeling requirements
contained in 21 CFR 101.22), there is no reason to prohibit its use.
Thus, the comment urged the agency to fix the entire problem presented
in the language of the peanut butter standard coupled with the
requirement in Sec. 130.10(d)(3) that specifically prohibits the use in
the modified food of any ingredient whose use is specifically
prohibited by the standard of identity for that food.
FDA is not making the requested change. The suggested removal of
the prohibition against the addition of artificial flavorings,
artificial sweeteners, chemical preservatives, and color additives from
Sec. 164.150(c) was not foreshadowed in the proposed rule. Further,
there is no compelling reason, such as a conflict with the provisions
of the general definition and standard of identity, to make the change
at this time. When FDA developed the general definition and standard of
identity, it specifically included a provision in Sec. 130.10(d)(3) to
prohibit the use of ingredients that were explicitly prohibited by the
standard of identity for the traditional food. The purpose of the
provision was to ensure that the modified food would resemble the
traditional food in as many ways as possible. One way to ensure such
resemblance was to require the use of similar ingredients in the new
food and to exclude those ingredients that were prohibited in the
traditional food.
The agency notes that if the manufacturers of modified peanut
butter products find that these remaining prohibitions in
Sec. 164.150(c) represent significant barriers to the development of
peanut butter products modified to meet a nutrition goal, such as
``reduced calorie'' or ``reduced fat'' products, they may submit a
petition to further amend the peanut butter standard of identity.
3. One comment noted that the agency's proposal only deals with
added vitamins in modified peanut butter products and questioned
whether added minerals were also of concern to the agency.
Depending on the degree of modification of the peanut butter,
manufacturers may need to add minerals to the modified peanut butter
product to ensure that the food will not be nutritionally inferior to
peanut butter. There is, however, no specific prohibition in the
standard of identity for peanut butter that would preclude the addition
of minerals to a modified peanut butter. FDA notes that the general
definition and standard of identity in Sec. 130.10(b) states that
nutrients shall be added to the modified food to restore nutrient
levels, so that the product will not be nutritionally inferior, as
defined in Sec. 101.3(e)(4) (21 CFR 101.3(e)(4)), to the traditional
standardized food. Nutritional equivalence of modified peanut butter
products to peanut butter is defined in the common or usual name
regulation for peanut spreads in Sec. 102.23 (21 CFR 102.23). Section
102.23(b) includes a nutrient profile based on the levels of nutrients
found in peanut butter that may be used as guidance by manufacturers in
determining whether nutrients need to be added to a modified peanut
butter product. This nutrient profile includes requirements for protein
content and quality, as well as minimum levels of niacin, vitamin
B6, folic acid, iron, zinc, magnesium, and copper that must be
present in the food.
4. One comment requested that FDA clarify how the equivalent
micronutrient levels for modified peanut butter products are to be
determined. It noted that the nutrient levels vary from product to
product. The comment suggested the use of U.S. Department of
Agriculture Handbook data or an industry generated data base for
nutrient data on peanut butter and requested that the agency state in
the final rule what source is appropriate. The comment included a copy
of data on the vitamin E content of peanut butter from its submission
that it made to the agency in the rulemaking to establish a common or
usual name regulation for peanut spreads in Sec. 102.23 (see 40 FR
51052, November 3, 1975, and 42 FR 36452, July 15, 1977).
As noted above in the response to comment 3, FDA has established
requirements for nutrient levels in spreadable peanut products in the
common or usual name regulation on peanut spreads in Sec. 102.23. These
levels may be used by manufacturers as guidance in determining
nutritional equivalency to peanut butter. However, manufacturers may
make comparisons to their own traditional peanut butter formulation.
The types and levels of nutrient additions will depend on the types of
modifications that need to be made in formulating the modified peanut
butter product and the effects of such modifications on the composition
of the finished food.
With respect to the comment's resubmission of data on vitamin E,
FDA addressed that data in the final rule establishing Sec. 102.23 (see
42 FR 36452 at 36454). At that time, the agency stated that the values
submitted by the comment were consistent with published literature
values and suggested that 10 international units per 100 grams of
peanut butter would approximate the average content of vitamin E in
peanut butter. However, because the vitamin E content of peanut butter
is subject to variation, additional data would be necessary before the
agency could establish a value for nutritional equivalence in peanut
spreads. Therefore, the agency stated that no peanut spread would be
considered to be an imitation of peanut butter solely because it
contains less vitamin E than peanut butter. The agency has not received
any information to change that position. Thus, modified peanut products
that comply with the minimum requirements for nutrient levels specified
for peanut spreads (Sec. 102.23) will not be considered to be
nutritionally inferior to peanut butter under the provisions in
Sec. 101.3(e)(4).
After considering the comments received and the other relevant
factors that the agency discussed in the proposal, FDA concludes that
it will promote honesty and fair dealing in the interest of consumers
to amend the standard of identity for peanut butter in the manner
proposed. Accordingly, FDA is revising Sec. 164.150(c) by removing the
specific reference to ``added vitamins.'' This change will allow the
replacement of nutrients normally present in peanut butter that may be
lost in formulating and manufacturing modified peanut butter products,
thereby ensuring that the modified version of the food will not be
nutritionally inferior to peanut butter.
III. Economic Impacts
FDA has examined the impact of this final rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs Federal agencies to assess the 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). According to Executive
Order 12866, a regulatory action is ``economically significant'' if it
meets any one of a number of specified conditions, including having an
annual
[[Page 9325]]
effect on the economy of $100 million or adversely affecting in a
material way a sector of the economy, competition, or jobs. A
regulation is considered ``significant'' under Executive Order 12866 if
it raises novel legal or policy issues. The Regulatory Flexibility Act
requires Federal agencies to minimize the economic impact of their
regulations on small business.
There are no compliance costs associated with this final rule
because this final rule will not prohibit any current activity. The
benefit of this final rule is that it allows modified peanut butter
products to be labeled with a nutrient content claim and the
standardized term ``peanut butter.'' This labeling may reduce the cost
of identifying these products for some consumers. Therefore, FDA finds
that this final rule is neither an economically significant nor
significant regulatory action as defined by Executive Order 12866. In
compliance with the Regulatory Flexibility Act, FDA certifies that this
final rule, if promulgated, will not have a significant impact on a
substantial number of small businesses.
IV. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(11) 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.
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, 21 CFR part
164 is amended as follows:
PART 164--TREE NUT AND PEANUT PRODUCTS
1. The authority citation for 21 CFR part 164 continues 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: February 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-5493 Filed 3-7-96; 8:45 am]
BILLING CODE 4160-01-F