[Federal Register: June 10, 2005 (Volume 70, Number 111)]
[Rules and Regulations]
[Page 33803-33819]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jn05-4]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 319 and 381
[Docket No. 92-024F]
Rin 0583-AC82
Food Standards: Requirements for Substitute Standardized Meat and
Poultry Products Named by Use of an Expressed Nutrient Content Claim
and a Standardized Term
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
[[Page 33804]]
SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal meat and poultry products inspection regulations to establish a
general definition and standard of identity for standardized meat and
poultry products that have been modified to qualify for use of an
expressed nutrient content claim in their product names. These products
will be identified by an expressed nutrient content claim, such as
``fat free,'' ``low fat,'' and ``light,'' in conjunction with an
appropriate standardized term, e.g., ``low fat bologna.'' FSIS is
taking this action to: Assist consumers in maintaining healthy dietary
practices by providing for modified versions of standardized meat and
poultry products that have reductions of certain constituents that are
of health concern to some consumers, such as fat, cholesterol, and
sodium; increase regulatory flexibility and support product innovation,
and provide consumers with an informative nutrition labeling system.
DATES: This final rule will be effective January 1, 2008, the uniform
compliance date for all meat and poultry products subject to labeling
regulations issued by FSIS between January 1, 2005 and December 31,
2006. However, establishments may begin to produce meat and poultry
products in compliance with this final rule anytime before the
effective date.
FOR FURTHER INFORMATION CONTACT: Dr. Robert Post, Director, Labeling
and Consumer Protection Staff, Office of Policy, Program, and Employee
Development, Food Safety and Inspection Service, U.S. Department of
Agriculture, Washington, DC 20250-3700; (202) 205-0279.
SUPPLEMENTARY INFORMATION:
Background
On December 29, 1995, FSIS published a proposed rule in the Federal
Register to amend the Federal meat and poultry products inspection
regulations to establish a general definition and standard of identity
(the ``general standard'') for standardized meat and poultry products
that have been modified to qualify for use of an expressed nutrient
content claim in their product names (60 FR 67474). Under the proposed
general standard, meat and poultry products with a regulatory standard
of identity or composition in 9 CFR Parts 319 and 381, subpart P, would
be permitted to be formulated and processed with ingredients otherwise
not provided for, or in amounts greater than, that allowed by the
standard in order to qualify for certain expressed nutrient content
claims permitted in 9 CFR 317 subpart B and 381, subpart Y, such as
``fat free,'' ``low fat,'' and ``light.'' Instead of being identified
as ``substitute'' standardized meat and poultry products, as required
by the current regulations (9 CFR 317.313(d) and 381.413(d)),
standardized meat and poultry products formulated or processed in
accordance with the proposed general standard could be identified by an
expressed nutrient content claim in conjunction with the standardized
term.
To allow modified versions of standardized meat and poultry
products that have been formulated to reduce their fat content to be
marketed without having to be labeled as ``substitutes,'' FSIS issued
Policy Memo 123, ``Modified Breakfast Sausage, Cooked Sausage, and
Fermented Sausage Products Identified by a Nutrient Content Claim and a
Standardized or Traditional Name,'' and Policy Memo 121B ``Labeling of
Low Fat Ground Beef and Low Fat Hamburger Containing Added
Ingredients,'' in January of 1995. These policy memoranda stated, among
other things, that these products are permitted to be identified by a
nutrient content claim that reflects the reduction in fat content in
the product in conjunction with the appropriate standardized product
name, e.g., ``Fat Free Bologna,'' ``Low Fat Pepperoni,'' or ``Low Fat
Hamburger, Water, and Carrageenan Product.'' Both Policy Memo 121B and
Policy Memo 123 were issued as interim measures until such time that
rulemaking could be completed. Both of these policy memoranda will be
rescinded by this final rule.
In this final rule, FSIS is establishing a general definition and
standard of identity for modified versions of meat and poultry products
that substitute for meat and poultry products defined by a regulatory
standard of identity or composition in 9 CFR Part 319 and 381, subpart
P, i.e., ``substitute standardized products.'' This rule is needed to
facilitate the development and availability of substitute standardized
meat and poultry products that have reductions in constituents that are
of health concern to some people, e.g., fat, cholesterol, and sodium.
The rule allows FSIS to rely more on labeling requirements and less on
restrictive recipe-type standards to carry out its mandate to ensure
that the labels of meat and poultry products are truthful and not
misleading to consumers.
Comments and Agency Response
FSIS received 56 comments in response to the proposed rule from
members of the meat and poultry processing industry, industry trade
associations, members of the flavoring and ingredients industry,
members of the soybean industry, academia, health professionals,
governmental entities, consumer advocacy groups, and individual
consultants. In general, the comments submitted in response to the
proposed rule were favorable. Most commenters agreed that FSIS should
establish a regulatory general standard for substitute standardized
products that are lower in fat, cholesterol, or sodium.
One commenter opposed the rule because the commenter believed it
did not go far enough in providing flexibility to industry. This
commenter stated that, rather than converting FSIS Policy Memo 123 into
regulation, FSIS should create a new standard for substitute
standardized meat and poultry products to allow the use of non-
traditional ingredients in all products, not just versions of products
that are identified by a nutrient content claim and a standardized
product name.
Response: FSIS recognizes the need to explore this and other issues
concerning reform of the meat and poultry product standards. However,
expanding the use of non-traditional ingredients for all standardized
products is an issue that is outside the scope of this rulemaking. The
Agency is, however, exploring this and other related issues in a
separate rulemaking to modernize meat and poultry product standards.
This rulemaking is discussed in greater detail later in this document.
Policy Memo 123 and Policy Memo 121B
Comment: A few commenters felt that FSIS Policy Memo 121B and
Policy Memo 123 should remain in effect once this final rule becomes
effective so that products produced under these policies can continue
to be manufactured. Other commenters stated that the general standard
defined in the proposed rule should apply to food products whose
standards are documented in the FSIS Food Standards and Labeling Policy
Book (the Policy Book), as well as those products whose standards of
identity and composition are codified in Parts 319 and 381, subpart P.
The commenters noted that the wording in proposed 9 CFR 319.10(a) and
381.172(a) does not specifically include the standards described in the
Policy Book, while FSIS Policy Memo 123 does. They were concerned that
once the rule is in place, and Policy Memo 123 is rescinded, certain
products, such as ``Low Fat Pepperoni,'' would no longer be permitted
because pepperoni
[[Page 33805]]
does not have a standard of identity codified in the regulations.
Response: The policy embodied in the proposed general standard will
also apply to the informal standards for products, such as pepperoni,
that are described in the Policy Book. Thus, Policy Memo 121B and
Policy Memo 123 will not remain in effect once the proposed rule
becomes final. FSIS issued both Policy Memo 121B and Policy 123 as
interim measures to accommodate certain lower fat substitute meat and
poultry products until such time that rulemaking was completed. This
final rule incorporates, expands, and codifies the intent of these
policy memoranda. Thus, rescinding Policy Memo 121B and Policy Memo 123
will not preclude the production of products that have been made under
those policies. The Agency intends to clarify this point in a policy
bulletin, which is a more appropriate document for addressing the
informal standards described in the Policy Book.
Nutrient Content Claims That Emphasize the Presence of an Ingredient
Comment: Some commenters disagreed with the Agency's proposal to
permit only expressed nutrient content claims that relate to reductions
in constituents such as fat, cholesterol, or sodium, in conjunction
with the standardized name of the substitute product. These commenters
felt that nutrient content claims, such as ``high in'' and ``good
source of,'' that emphasize the presence of an ingredient, should also
be permitted to be used as part of the substitute standardized
product's name, provided that the product qualifies for these claims
under 9 CFR part 317 subpart B or 9 CFR 381 subpart Y.
Response: Under the current regulations, meat and poultry products
that satisfy the criteria for use of nutrient content claims defined in
9 CFR part 317 subpart B and 9 CFR 381 subpart Y are permitted to make
claims, such as ``high in'' or ``good source of,'' that emphasize the
presence of a nutrient. The ability to make these kinds of nutrient
content claims is not affected by this rulemaking.
In the preamble to the proposed rule, FSIS noted that the meat and
poultry product standards did not appear to preclude the making and
marketing of standardized products that qualify for the use of claims
such as ``high in'' and ``good source of.'' Therefore, in the proposed
regulation, the Agency did not expressly provide for these types of
nutrient content claims in the general standard. However, in the
proposal, FSIS did solicit comments on whether current regulatory
standards prevent the distribution of products with nutrient content
claims other than those that reflect a reduction in the level of a
nutrient.
None of the comments received suggested that the existing meat and
poultry product standards preclude the making and marketing of
standardized products that qualify for the use of claims such as ``high
in'' or ``good source of.'' Furthermore, because of the FSIS policy
that precludes direct nutrient fortification of meat and poultry
products, standardized meat and poultry products are not permitted to
be modified to qualify to use a nutrient content claim by adding
nutrients to the product. Therefore, FSIS has decided not to modify the
scope of coverage in this final rule to permit nutrient content claims
other than those that reflect a reduction of constituents that are of
health concern to some people, e.g., fat, cholesterol, and sodium, to
be used as part of the product name. Products that qualify for ``high
in'' and ``good source of'' nutrient content claims may continue to
highlight these claims as provided in 9 CFR 317.354 and 9 CFR 381.454.
Nutrient Fortification
Comment: Four commenters suggested that FSIS reexamine its policy
precluding direct nutrient fortification of meat and poultry products.
Two of these commenters suggested that FSIS allow selective nutrient
fortification in meat and poultry products to permit standardized
products to be modified so that they qualify to use nutrient content
claims, such as ``high in Vitamin A,'' as part of the product name. One
of these commenters requested that FSIS modify the language in proposed
9 CFR 319.10(a) to delete the following italicized words `` * * *
because of a compositional deviation that results from reduction of a
constituent that is described by an expressed nutrient content claim *
* *''
Another commenter suggested that FSIS permit selective protein
fortification in substitute standardize products so that they may use
claims such as ``High in Protein'' and ``Good Source of Protein'' as
part of the product name. This commenter recommended that FSIS continue
to require substitute standardized products to meet the same basic
minimum meat and poultry content requirements contained in the existing
meat and poultry product standards, but that the overall protein level
in these products should be allowed to be fortified using ingredients
such as soy protein. Another commenter that expressed support for
permitting direct nutrient fortification of meat and poultry products
felt that, because the over-consumption of protein in the American
diet, that protein fortification should not be permitted.
Two other commenters requested that FSIS allow fortification to
replace vitamins and minerals that may be lost due to formulation
adjustments to produce nutrient-modified foods. These commenters also
requested that FSIS exempt substitute standardized products subject to
the general standard from the minimum meat and poultry content
requirements imposed by the existing meat and poultry product
standards. Both commenters suggested that for these substitute
products, FSIS should focus on nutritional equivalency to the
traditional standardized product rather than meat content equivalency,
and permit reductions in the meat and poultry content for purposes of
reducing the product's fat content. The commenters stated that if FSIS
were to permit such reductions in the meat and poultry content,
fortification might be necessary to replace lost nutrients.
One commenter suggested that, while existing FDA regulations state
that the FDA does not consider it appropriate to fortify meat and
poultry products (21 CFR 104.20(a)), the FDA regulations appear to make
an exception for fortification of foods that replace traditional foods
when fortification is necessary to avoid nutritional inferiority.
Response: The comments requesting that FSIS reexamine its policy on
nutrient fortification raise some interesting points, particularly with
respect to the issues concerning nutritional equivalency versus meat
content equivalency. However, the decision to allow fortification of
meat and poultry products involves several complex issues, many of
which are outside the scope of this rulemaking.
FSIS'' fortification policy is derived from FDA's policy statement
on nutrient fortification codified at 21 CFR part 104, subpart B, which
states, in part, that the FDA ``* * * does not consider it appropriate
to fortify fresh produce; meat, poultry, or fish products * * * (21 CFR
104.20(a)). The fundamental objective of FDA's fortification policy is
``* * * to establish a uniform set of principles that will serve as a
model for the rational addition of nutrients to food'(21 CFR
104.20(a)). As stated in its policy, FDA determined that, ``* * *
random fortification of foods could result in over-or under-
fortification in consumer diets and create nutrient imbalances in the
food supply'' (21 CFR 104.20(a)).
[[Page 33806]]
FSIS has a long history of prohibiting direct fortification of meat
and poultry products, which is supported by the codified FDA
fortification policy. Thus, when determining whether to revise its
nutrient fortification policy for meat and poultry products, FSIS must
consider the issues in relationship to the codified FDA policy
statement on fortification. Furthermore, in order to maintain
consistent policies regarding nutrient fortification between the two
agencies, any effort by FSIS to revise its prohibition on direct
nutrient fortification of meat and poultry products should include FDA
participation and involve the scientific community (e.g., the National
Academy of Sciences, Institute of Medicine). FSIS, FDA, and the
scientific community need to first consider the guiding scientific
principles that form the basis for establishing a public health need
for fortifying meat and poultry with nutrients. Only after these
principles are applied could there be consideration of revising the
current fortification policy.\1\ Obviously, this type of effort is
outside the intended purpose and scope of this rulemaking. It would be
more appropriate to consider this matter in a separate rulemaking where
the Agency can receive the benefit of an open and thorough review of
all issues related to the fortification of meat and poultry products.
---------------------------------------------------------------------------
\1\ See report: Institute of Medicine, National Academy of
Science, 2003. Dietary Reference Intakes, Guiding Principles for
Nutrition Labeling and Fortification. The National Academies Press,
Washington, DC.
---------------------------------------------------------------------------
Furthermore, FSIS believes that the formulation adjustments needed
to produce substitute standardized products with reductions in
constituents such as fat, cholesterol, and sodium, will not result in a
product that is nutritionally inferior to the product for which it is a
substitute. Important nutrients, such as iron, zinc, B vitamins, and
protein, are associated with the lean muscle portion of meat and
poultry tissue, not the fat. Because the minimum meat and poultry
requirement for substitute standardized products is not changed by this
rule, reductions in the fat content should not affect the levels of
nutrients associated with the lean muscle portion of these products.
Therefore, nutrient fortification is not necessary to prevent the
products subject to the general standard defined by this rule from
being nutritionally inferior to the standardized products for which
they are a substitute.
Differences in Performance Characteristics
Comment: The proposed regulation stated that a substitute
standardized product with performance characteristics, e.g., cooking
quality, freezing quality, spreadability of product, and shelf-life,
that materially limit the use of the product must include a disclaimer
on the product's label adjacent to the product name informing the
consumer of such differences.
Most commenters agreed that limitations in a product's performance
characteristics should be disclosed on the product label, and be
conspicuous and readable. A number of commenters stated that the
disclaimer should be adjacent to the most prominent claim on the label.
One commenter, although in agreement with the disclaimer requirement,
felt that disclosure on the label, not necessarily adjacent to the
product name as provided in the proposed rule, was sufficient to inform
the consumer of performance differences. This same commenter
recommended that FSIS harmonize the requirement for labeling of
performance differences with a similar FDA rule, which requires a
disclaimer adjacent to the most prominent claim on the label (21 CFR,
101.13(d)). Another commenter stated that the disclaimer should be
adjacent to the most prominent claim and should most likely appear on
the principal display panel.
Response: In the preamble to the proposed rule, FSIS stated that
``if there is a difference in performance characteristics that
materially limits the use of the product, the product may still be
considered a substitute if the label includes a disclaimer adjacent to
the most prominent claim in accordance with 9 CFR 317.313(d)(1) and (2)
and 9 CFR 381.413(d)(1) and (2), informing the consumer of such
difference'' (60 FR 67480). However, in the text of the proposed rule,
FSIS stated that the label must include, ``adjacent to the product
name,'' a statement in accordance with 9 CFR 317.313(d)(1) and (2) and
9 CFR 381.413(d)(1) and (2) informing the consumer of differences in
performance characteristics (60 FR 67486, 67487). Thus, the preamble
and the text of the proposed rule differed in that the preamble did not
mention that the disclaimer must be ``adjacent to the product name.''
The regulations referenced by both the preamble and the text of the
proposed rule, 9 CFR 317.313(d)(1) and 9 CFR 381.413(d)(1), require
that differences in performance characteristics that materially limit
the performance of a substitute product be disclosed adjacent to the
most prominent claim on the product label.
FSIS is resolving the discrepancy regarding placement of the
disclaimer. FSIS agrees with the comment that disclosure on the label,
not necessarily adjacent to the product name, is sufficient to inform
the consumer of performance differences. Therefore, in this final rule,
FSIS is not requiring that the disclaimer be placed adjacent to the
product name. As in FDA regulations 21 CFR 130.10 and 101.13(d), a
disclaimer for differences in performance characteristics shall be
placed adjacent to the most prominent claim on the label. To reflect
this decision, FSIS is removing the phrase ``adjacent to the product
name'' from proposed Sec. Sec. 319.10(b)and 381.172(b).
Comment: Two commenters disagreed with the need for the proposed
disclaimer requirement and suggested that disclosure of any limitations
in the performance characteristics of a substitute standardized product
be voluntary. One of these commenters stated that disclaimers on a
product's labeling informing consumers of performance characteristics
that materially limit the use of the product need not be required by
regulations because a substitute standardized product produced under
the general standard will succeed or fail in the market place based on
consumer expectations associated with the product's performance. This
commenter stated that businesses would voluntarily place disclaimers on
a product's label in the absence of a regulation requiring that they do
so because it would be good business to inform consumers that a product
they are purchasing can not be used in a traditional application.
The other commenter agreed that, in practice, poorly formulated
products would fail in the marketplace long before any regulatory
system could determine that they did not meet the specific performance
characteristics they would be expected to have. However, this commenter
acknowledged that requiring a disclaimer informing consumers of
limitations in a product's performance characteristics, when they
exist, will require manufacturers of substitute standardized products
to monitor performance characteristics during product development and
may help ensure that new low- and reduced-fat standardized products are
formulated well from the beginning. The commenter went on to state that
consumers are also more likely to accept this category of substitute
products if they are well formulated from the beginning.
[[Page 33807]]
Response: FSIS disagrees with the commenters' suggestion that
disclosure of performance characteristics that materially limit the use
of a substitute standardized product compared to the use of the
traditional standardized product should be voluntary. The FMIA and the
PPIA require that the labeling of a meat or poultry product must be
truthful and not misleading, and that such labeling accurately disclose
to consumers what they are buying when they purchase any meat or
poultry product. Information disclosing differences in performance
characteristics that affect the use of a substitute standardized
product (e.g., cooking quality, freezing quality, spreadability of
product, and shelf life) is a material fact that must be disclosed on
the labeling of these products. Without such labeling, consumers would
be misled about significant characteristics and uses the product has
compared to the standardized product for which it substitutes.
Accordingly, this information must be communicated to consumers on the
product's label, or the label will be misleading and the product will
be misbranded under the FMIA or PPIA.
Moreover, FSIS agrees with the commenter who suggested that
processors are more likely to monitor the performance characteristics
of substitute standardized products during product development when
limitations in the product's performance characteristics are required
to be disclosed on the product's labeling. FSIS also agrees that if
substitute standardized products are well formulated from the
beginning, it will promote consumer acceptance of this category of meat
and poultry products.
Comment: One commenter pointed out that it may be possible for
performance characteristics to be introduced into a substitute
standardized product that improve upon the performance characteristics
of the traditional standardized product. The commenter suggested that
the Agency consider substituting the term ``not inferior'' for ``
similar'' in proposed 9 CFR 319.10(b).
Response: FSIS did not intend to prohibit improvements in the
performance characteristics of substitute products when it proposed
that substitute standardized products subject to the general standard
perform similarly to the traditional standardized products for which
they substitute. However, FSIS disagrees that it should require that
substitute standardized products have performance characteristics that
are ``not inferior to'' rather than ``similar to'' the traditional
standardized products as suggested by the commenter. As proposed,
Sec. Sec. 319.10(b) and 381.172(b) permit products subject to the
general standard to have limitations in performance characteristics
provided that such limitations are properly disclosed on the product's
labeling. The Agency believes that requiring disclosure of any
performance limitations on the labeling of products subject to the
general standard provides sufficient incentive for manufacturers of
these products to market products that are not inferior to the
traditional standardized products. Furthermore, proposed 9 CFR
319.10(b) and 9 CFR 381.172(b) require a disclaimer for performance
characteristics that ``materially limit'' the use of a substitute
standardized product, not for characteristics that improve the
performance of the product. Thus, the disclaimer requirement contained
in proposed 9 CFR 319.10(b) and 9 CFR 381.172(b) will not discourage
manufacturers from making improvements to the performance
characteristics of substitute products when it is possible to do so.
Enforcement
Comment: Two commenters questioned FSIS's ability to enforce and
ensure uniform compliance with the performance characteristics
requirements proposed in 9 CFR 319.10(b) and 381.172(b). One commenter
asked how FSIS intends to determine differences in performance
characteristics. The commenter went on to state that the proposed
performance characteristics requirements seem to be ``command and
control'' regulations that are not related to product safety. The other
commenter stated that, in practice, poorly formulated products would
fail in the marketplace long before any regulatory system could
determine that they did not meet the specific performance
characteristics discussed in the proposal.
Response: FSIS expects that substitute standardized products that
are produced under the general standard will conform to the performance
characteristics requirements set forth in proposed 9 CFR 319.10(b) and
381.172(b). To ensure that there is compliance, FSIS will examine the
performance characteristics and product quality of substitute products
as it would other types of products, through scientific review and
experimental investigations. In addition, FSIS will use traditional
methods available to the Agency, such as sample analysis, inspections,
surveys, and follow-up investigations of consumer and trade complaints
to identify products that do not comply with the new regulations in
order to enforce this regulation as the need arises.
Furthermore, FSIS disagrees with the comment that the proposed
performance characteristics requirements are ``command and control''
regulations. Under Sec. Sec. 319.10(b) and 381.172(b), FSIS is not
establishing specific criteria for determining similarities in
performance characteristics. FSIS believes that judgments about
similarity are best left to product developers, who have the incentive
to market a product that resembles the traditional standardized product
as closely as possible and to disclose product performance limitations
to ensure that there is consumer satisfaction with the substitute
standardized product.
Safe and Suitable Ingredients
Comment: There was general agreement among the commenters that the
ingredients used in a substitute standardized product produced under
the general standard should be those ingredients provided by the
traditional standard, with the exception of ``safe and suitable
ingredients,'' as defined in (former) 9 CFR 318.7 and 381.147, at the
minimum level necessary to improve texture and prevent syneresis.
However, several commenters requested clarification and expansion of
the ingredients permitted under this provision.
Three commenters stated that allowances for ingredients should be
broadened to include any safe and suitable ingredients to replace
functional characteristics. These commenters all noted that the FSIS
proposal limits ingredient usage to achieve textural improvement and to
prevent syneresis. They felt that FSIS should build additional
flexibility into the final rule to allow for a wider use of safe and
suitable ingredients to replace functional characteristics that may be
lost when a formulation is adjusted to meet a claim requirement. These
commenters mentioned that the comparable FDA regulation allows the use
of safe and suitable ingredients ``* * * to add flavor, extend shelf
life, improve appearance, or add sweetness'' (21 CFR 130.10(d)). One
commenter suggested that any ingredient that is generally recognized as
safe (GRAS) or that is an approved additive should be permitted to be
used as desired by the manufacturer. Another commenter stated that
limiting the use of safe and suitable ingredients to the minimum level
necessary to improve texture and to prevent syneresis severely limits
the ability to produce a consumer-acceptable meat or poultry product.
One
[[Page 33808]]
commenter specifically requested that FSIS clarify the acceptability of
flavorings, especially meat flavorings, as safe and suitable
ingredients in substitute standardized products.
Response: For purposes of clarification, since it published the
general standard proposal, FSIS issued the final rule ``Food
Ingredients and Sources of Radiation Listed or Approved for Use in Meat
and Poultry Products'' (64 FR 72168, December 23, 1999). The rule is
intended to improve the efficiency of the procedures used by FSIS and
FDA to review and approve the use of food ingredients and sources of
radiation in the production of meat and poultry products. Under the new
regulations, rather than listing substances approved for use in the
production of meat and poultry products in the chart of substances
contained in former 9 CFR 318.7(c)(4) and former 9 CFR 381.147(f)(4),
FDA now lists food ingredients and sources of radiation that are safe
for specific use in the production of meat and poultry products in its
regulations in title 21 of the CFR. In the final rule, FSIS also
created a list of food ingredients approved for use in the production
of meat and poultry products by combining the listing contained in
former section 318.7(c)(4) with the listing contained in former section
381.147(f)(4) and moving the combined listing to section 424.21(c). The
final rule became effective on January 24, 2000.
FSIS did not include ingredients that would affect flavor, shelf
life, or sweetness because these kinds of ingredients do not affect the
ability of a manufacturer to modify a meat or poultry product to reduce
fat, cholesterol, or sodium, which was the focus of this rulemaking.
Thus, Sec. Sec. 319.10 and 381.172 provide only for increased amounts
of safe and suitable ingredients that are needed to achieve the effect
of replacing fat, i.e., binders, texturizers, and emulsifiers.
As for the acceptability of flavorings in substitute standardized
products, manufacturers will not be limited by Sec. Sec. 319.10 or
381.172 in their ability to use ingredients that impart flavor. This
final rule does not limit a manufacturer's ability to use safe and
suitable meat and poultry flavorings.
``Fat Replacing'' Binders
Comment: In the preamble to the proposed rule, FSIS provided a list
of ``fat replacing'' binders to assist meat and poultry processors to
understand the types of ingredients that are permitted to be used to
achieve the effects of fat in making substitute standardized products
under the general standard. However, the list was not intended to be
all-inclusive. One commenter supported the use of ingredients not
identified in the preamble as part of a fat replacement system and
requested that FSIS clarify whether other fat replacers, such as milk
protein concentrates, would be permitted in substitute standardized
products, given this substance's similarities to the listed substances.
The commenter also requested that the preamble to the final rule
specifically note that milk protein concentrates and egg whites are
acceptable substances in fat replacement systems.
Three commenters agreed that the ingredients listed in the preamble
are appropriate for use in a substitute version of a standardized
product but felt that the list should be broadened to include other
safe and suitable ingredients that have a demonstrated ability to
function as a fat replacement system. One of these commenters requested
that if the list provided within the context of the preamble is not
meant to be all-inclusive, FSIS should state that fact. The commenters
also encouraged FSIS to include a list of criteria for evaluating fat
replacing binders not on the list to determine whether they qualify as
acceptable binders.
Response: The list of ``fat-replacing binders'' presented in the
preamble to the proposed rule represents examples of ingredients or
additives historically classified as binders by food scientists and
ingredient technologists. This list is not intended to be all
encompassing, and other safe and suitable ingredients historically
recognized as binders are permitted to be used in ``fat replacement''
systems for substitute standardized products produced under the general
standard.
In general, a safe and suitable ingredient qualifies for use as a
fat replacing binder under this final rule if it is only used for its
functional properties and does not impart other characterizing
qualities, such as taste and nutritional value, to the standardized
product when used in the product formulation. FSIS will evaluate
whether safe and suitable ingredients that were not listed in the
preamble to the proposal qualify as fat replacing ingredients on a
case-by-case basis.
As a point of clarification, milk protein concentrates have
historically been used by meat and poultry product manufacturers as
binding ingredients in meat and poultry products and therefore, under
the general standard, FSIS will permit milk protein concentrates to be
used as binders in fat replacement systems for substitute standardized
products.
Regarding the use of egg whites as a fat replacing binder, egg
whites are considered an egg product and as such function as an
individual food product that is consumed for its own taste and
nutritional value. Thus, FSIS considers the use of egg whites in the
formulation of a meat or poultry product to be sufficiently
characterizing so as to result in a product that is not a substitute
standardized product, but one that is a non-standardized product, e.g.,
identified with a true product name, such as ``Low Fat Pork Sausage
made with Egg Whites.''
Although FSIS is not providing an all inclusive list of suitable
fat replacing binders in this final rule, the Agency did provide an
extensive listing of binders in the preamble to the proposed rule to
convey the intent of the rule (see 60 FR 67481). Persons interested in
determining whether an ingredient is an appropriate fat replacing
binder may refer to this original listing.Furthermore, safe and
suitable ingredients that meet the general criteria outlined above,
i.e., have historically been classified as binders, are only used for
their functional properties, and do not impart other characterizing
qualities when used in the formulation of substitute products, will
also qualify as acceptable fat replacing binders under this final rule.
Textured Vegetable Protein (TVP) as a ``Fat Replacer''
Comment: In the preamble to the proposed rule, FSIS stated that the
Agency views TVP as a ``meat or poultry replacer,'' and that the use of
TVP as a fat replacing ingredient in a substitute standardized product
subject to the general standard would be inappropriate. At the time
that the proposal was published, FSIS had determined that the use of
TVP in a substitute standardized product would change the nature of the
product to such an extent that it would no longer be a substitute
product within the parameters of the proposed rule. This view, in part,
was based on the belief that TVP was used as a ``meat replacing''
ingredient in foods considered ``meat replacing products,'' such as
``veggie-burgers,'' which are primarily TVP with water, flavorings, and
seasonings.
FSIS received numerous comments expressing strong disagreement with
FSIS's historic views. Forty-three commenters submitted statements in
support of allowing TVP as a fat replacer in substitute standardized
meat and poultry products subject to the
[[Page 33809]]
general standard so that these products may be identified by a nutrient
content claim. Many of these commenters provided supporting studies on
the health and nutritional benefits of soy protein, along with data on
consumer awareness and acceptance of products containing TVP. Many
commenters felt that not permitting TVP as a fat replacing ingredient
would greatly limit the ability of the industry to develop substitute
standardized meat and poultry products that are lower in fat. These
commenters stated that the use of TVP as a fat replacer is important in
expanding the flexibility of the meat and poultry industry to create
and market an increased variety of healthful substitute meat and
poultry products. Some commenters specifically mentioned that
prohibiting TVP would limit product development in areas of coarse
ground cooked and fermented sausage.
Several commenters stated that TVP should be permitted as a fat
replacer so long as its use conforms to the requirements of the general
standard. These commenters stated that TVP should be permitted as part
of a ``fat replacement system'' in substitute standardized meat and
poultry products so long as: (1) Its use does not substantially change
the nature of the finished product; (2) it is not used to replace the
meat or poultry content required by the traditional standard; and (3)
it is used only at the minimum level necessary in a fat replacement
system to qualify for use of the nutrient content claim.
A number of commenters stated that TVP should be regulated on the
basis of its functional properties rather than on its physical form.
Many of these commenters pointed out that, while in the past TVP was
used as a ``filler'' or ``substitute'' for meat components in food,
advancements in TVP technology have made TVP a highly functional
ingredient that could now be used as part of a fat replacement system
to improve the textural character and quality of a substitute
standardized meat or poultry product. Many commenters noted that TVP,
when used in combination with other water binders, provides improved
product texture, visual appearance, performance, and storage
characteristics. Data supporting this view were presented to the
Agency.
Some commenters felt that TVP should be allowed as a fat replacer
in all meat items where non-textured vegetable proteins are allowed.
One commenter stated that texture is a matter of degree, and that forms
of vegetable proteins range from fine powders, to small granules, to
small flakes, to larger granules and flakes. This commenter stated that
it is arbitrary to require that TVP be excluded as a ``fat replacer''
but not the powdered forms. One commenter questioned the logic of
permitting soy flour, soy protein concentrate, and isolated soy protein
in products because they replace fat, but prohibiting the use of TVP
because it is inappropriately thought to replace meat. The commenter
pointed out that the proposed rule does not permit a reduction in the
meat or poultry content, and therefore, TVP could not be used as a meat
replacer. Another commenter mentioned that other binders, such as
carrageenan, can be texturized, and therefore, TVP is being singled out
unfairly.
A number of commenters stated that, because the presence of TVP can
be disclosed in product labeling, consumers should be allowed to decide
for themselves whether to purchase a lower fat standardized product
that contains TVP. Some commenters pointed out that the presence of TVP
in a meat food product could be communicated to consumers in the same
manner as any other ingredient, in the ingredient statement. The
commenters asserted that appropriate product labeling required by the
general standard would ensure that consumers would not be misled about
the presence of TVP in substitute standardized products produced.
Some commenters stated that if TVP is permitted as a fat replacer
in substitute standardized products, the substitute product should
provide the same amount of animal protein as the traditional
standardized product. One commenter stated that this approach would
provide manufacturers with optimum flexibility, yet guarantees that the
consumer receives a product that is at least as valuable as the
unmodified product. Another commenter mentioned that consumers are
interested in over-all nutrition, not in specific ingredients.
Some commenters expressed the view that TVP should not be
considered as a ``food,'' because it is not consumed by itself as a
food. These commenters stated that TVP is a functional food ingredient
that can be used as part of a fat replacement system.
Response: FSIS has been persuaded by the comments, information, and
other data submitted by commenters to permit the use of TVP as a part
of a fat replacing system in substitute standardize products produced
under the general standard. Accordingly, in this final rule, proposed
Sec. Sec. 319.10(c) and 381.172(c) have been modified to provide for
the use of TVP, alone or in combination with other binders and water,
as part of a fat replacement system.
The Agency will permit the use of TVP as a functional food
ingredient that is used to replace fat. Like the other fat replacing
ingredients permitted to be used under this final rule, the use of TVP
as an ingredient in a substitute standardized product will be permitted
only at the lowest level necessary to achieve the intended effect of
replacing fat. When TVP is used to replace fat, the ingredients
statement on the product label must alert the consumer to the fact that
TVP is not permitted in the traditional standardized product or is used
in excess of amounts permitted in the traditional standardized product.
The labeling requirements will ensure that consumers will not be misled
when TVP is used to replace fat in substitute standardized meat and
poultry products subject to the general standard.
Under this final rule, TVP may not be used to replace the meat or
poultry content of a product when a product standard specifies a
minimum meat or poultry content requirement. However, if the
formulation of a substitute product produced under the general standard
contains the same amount of meat or poultry prescribed by the
traditional standard, the fat component of the meat or poultry in the
substitute product may be removed during processing and replaced with
TVP, or any other safe and suitable binder, alone or in combination
with water as part of a fat replacement system.
For example, the product standard for ``chili con carne'' provides
that the product shall contain not less than 40% meat computed on the
weight of the fresh meat (9 CFR 319.300). The product formulation for a
substitute version of chili con carne produced under the general
standard must contain 40% meat, but the fat content of the meat
component may be replaced with TVP during processing.
According to information presented to the Agency, TVP is
particularly useful in developing lower fat versions of cooked sausages
and other comminuted meat and poultry products. Although the standards
for these kinds of products generally do not prescribe a minimum meat
or poultry content, most of these standards limit the amount of fat
that is permitted in the product. For example, the standard for cooked
sausages defined in 9 CFR 319.180 limits the fat content of these
products to no more than 30% of the finished product, and the standard
for ground beef defined in 9 CFR 319.15 limits the fat content in this
product to no more than 30%. Thus, under this final rule, the amount of
TVP permitted in such
[[Page 33810]]
products will be limited by both the requirement that fat replacing
ingredients may be used only at the lowest level necessary to replace
fat and by the minimum fat content requirement established by the
product standard.
For example, a substitute cooked sausage produced under the general
standard is permitted to contain up to 30% TVP, provided that the sole
function of the TVP is to replace the fat. For purposes of this rule,
FSIS does not consider replacing the fat component of a single
ingredient standardized product, such as ground beef, as reducing the
product's meat content, provided that the product complies with the
manufacturing and labeling requirements prescribed in this final rule.
To eliminate the possibility of confusion, the phrases ``textured
vegetable protein shall not replace meat'' and ``textured vegetable
protein shall not replace poultry,'' which were used as examples in the
regulatory text of proposed 9 CFR 319.10(c)(2) and 381.172(c)(2), will
be removed in the final rule. These phrases are unnecessary because the
regulation already prohibits reductions in the meat or poultry content
required by a regulatory standard regardless of whether TVP is used in
the product.
Other Foods as ``Fat Replacers''
Nine commenters indicated that in the final rule, FSIS should
permit foods, such as bread, rice, potatoes, fruits, and vegetables to
be used in substitute standardized meat and poultry products to reduce
their fat content. Some of these commenters stated that these
ingredients could serve the same role as the water and binder systems
permitted as fat replacers in the proposed rule, but that food
ingredients are more beneficial because they may contain some
nutritional constituents, such as vitamins and minerals, that many
binders do not. One commenter stated that food ingredients, when used
at proper levels, help to provide consumers with substitute
standardized products that perform similarly to traditional
standardized products. Another commenter stated that the nutrition
label would enable consumers to make informed purchase decisions based
on the entire nutritional profile of the product. This commenter
pointed out that many consumers would prefer the nutritional profile of
substitute standardized products that use starchy vegetables and
complex carbohydrates, such as rice and potatoes, rather than a
combination of water and ingredients such as highly refined vegetable
gums to lower the percentage of calories from fat. One commenter stated
that it makes sense to allow other foods as fat replacers if the goal
is to make more healthful products available to consumers. Another
commenter suggested that consumers might be more interested in overall
nutritional quality, taste, convenience, and performance of the product
than in the specific ingredients present in the product.
Response: FSIS concedes that because foods such as bread, rice,
potatoes, fruits, and vegetables, have little or no fat, their use as
ingredients in standardized meat and poultry product could have the
effect of reducing the fat content of such products. However, when
foods are used as ingredients in a standardized product, the
composition of the product may be altered to such an extent that the
resulting product is not a substitute version of the traditional
standardized product but a new and different product with a separate
identity that reflects the combination of the individual foods. For
example, because diced apples and rice are not specified as ingredients
in the standardized product ``Pork Sausage,'' when they are added to
``Pork Sausage,'' the result is a new product, which, provided that it
does not have a standard of identity or composition prescribed by 9 CFR
part 319 or other established common or usual name, is required to bear
a descriptive name, such as ``Pork Sausage with Diced Apples and
Rice,'' that clearly identifies the product (see 9 CFR 317.2(c)(1) and
(e) and 9 CFR 381.117(a)). Because the product ``Pork Sausage with
Diced Apples and Rice'' is a new product and not a substitute version
of the standardized product ``Pork Sausage,'' it is not the type of
product that the general standard established by this final rule is
intended to address.
As a point of clarification, this final rule does not prevent non-
standardized meat and poultry products that use food ingredients to
reduce their fat content from using a traditional nutrient content
claim permitted under 9 CFR 317 subpart B and 381 subpart Y, provided
they meet the requirements of the claim. For example, the product
``Pork Sausage with Diced Apples and Rice'' is permitted to bear the
claim ``low fat'' on its label if it complies with Sec. 317.362, and
therefore, may be referred to as ``Low Fat Pork Sausage with Diced
Apples and Rice.'' Consumers who prefer the nutritional profile of meat
and poultry products that use other foods, rather than binders and
water, or other functional food additives, to reduce their fat content
will be able to identify these products by their descriptive product
name and the traditional nutrient content claim on the product
labeling. Furthermore, any benefits in the nutritional profile of
products that use foods as ingredients to reduce their fat content will
be reflected in the nutrition facts panel, as well, if appropriate, in
other nutrient content claims.
Prohibited Ingredients
Comment: One commenter expressed agreement with the provision in
proposed 9 CFR 319.10(c)(3) and 381.172(c)(3) that states that
ingredients specifically prohibited for use in standardized meat and
poultry products should also be prohibited for use in substitute
standardized products subject to the general standard. However, the
commenter felt that ingredients prohibited from use in all meat and
poultry products should be based on safety considerations rather than
quality considerations.
Response: The general standard allows for the use of any safe and
suitable fat replacement ingredient, e.g., binders and water. Under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), FDA is
responsible for determining the safety of food ingredients for use in
food in general. Under the authority of the FMIA and PPIA, FSIS
acquiesces to FDA's safety judgments, but FSIS determines the
suitability of ingredients determined to be safe by FDA for use in meat
and poultry products. These responsibilities are fully described in the
final rule ``Food Ingredient and Sources of Radiation Listed or
Approved for Use in the Production of Meat and Poultry Products,''
which was published in the December 23, 1999, Federal Register (64 FR
72168).
Thus, although it is the responsibility of the FDA to evaluate the
safety of a substance for use in meat or poultry products, under the
authority of the FMIA and PPIA, FSIS may preclude the use of a
substance in meat or poultry products for reasons other than safety.
There are instances in which the use of a substance, even if safe, may
promote deception when used in a meat and poultry product, and,
accordingly, such use would be prohibited by FSIS. For example, paprika
is considered GRAS by FDA and is also listed for use as a color
additive, but the FSIS regulations prohibit its use on fresh, uncooked
meat products because such use adds color that may make the meat appear
fresher than it actually is (9 CFR 424.23(a)(1)). Therefore, it is
incumbent upon FSIS to consider suitability, as well as the safety, of
ingredients for use in the production of meat and poultry
[[Page 33811]]
products in order to prevent these products from being adulterated or
misbranded.
Processing Methods/Anatomical Location for Meat and Poultry Ingredients
Comment: One commenter stated that the provision in proposed
Sec. Sec. 319.10 and 381.172 that requires that the meat portion of a
substitute standardized product undergo the same basic processing
procedures as the traditional standardized product for which it is a
substitute has the potential to limit the use of new technologies
without producing any stated goal that would justify the limitation.
The commenter stated, that as long as the substitute standardized
product has performance characteristics that are similar to the
traditional standardized product, and is produced only from authorized
ingredients, additional restrictions on processing procedures are
unnecessary and undesirable.
Another commenter stated that the general standard should permit
substitute standardized products to contain different meat species and
different kinds of poultry than those prescribed by the traditional
standard, and that it should permit meat or poultry from different
anatomical locations than the locations prescribed by the traditional
standard, provided that the difference in species or anatomical
location is stated in the product name. This commenter felt that a
literal reading of the proposed regulation could be interpreted to mean
that products such as ``Beef Bacon'' or ``Pork Shoulder Bacon'' would
no longer be permitted to include the term ``Bacon'' in their product
names if coupled with a nutrient content claim. The commenter went on
to say that these kinds of products should continue to be permitted to
be marketed under the same familiar names that have been used in the
past, and that use of a nutrient content claim next to the product name
should not change this.
Response: The intent of the general standard for substitute
standardized products is to enable the meat and poultry industries to
produce modified versions of standardized products that have reductions
of certain constituents that are of health concern to some consumers,
such as fat, cholesterol, and sodium, and to increase flexibility and
support product innovation. Under this rule, deviations from the
existing standards are not expected to result in a product that no
longer resembles the original standardized product. Thus, the use of a
different meat species or kind of poultry, or the use of meat or
poultry from different anatomic locations from those specified in the
standard, that results in a product that is so physically dissimilar
from the traditional standardized product that it does not meet the
definition of ``substitute'' set forth in 9 CFR 317.313(d) and
381.413(d) would be inconsistent with the intent of this rule. For
these kinds of products to represent themselves as substitute
standardized products would be false and misleading under the FMIA and
PPIA.
As an illustration, the regulatory standard for ``Bacon'' under 9
CFR 319.107 requires that this product be prepared from cured, sliced
pork bellies. Curing and slicing a cut of meat from a different
livestock species or from a different anatomical location, or preparing
sliced pork bellies using a method other than curing, would result in a
product with physical characteristics so different from the
standardized product ``Bacon'' that the resulting product could not be
considered a ``substitute'' for bacon under 9 CFR 317.313(d) and
381.413(d). Thus, instead of being identified as a substitute product,
the product would be identified by a descriptive term such as ``Beef
Bacon'' or ``Pork Shoulder Bacon.''
However, FSIS will consider the types of changes requested by the
commenters, such as amending a standard to permit the use of
alternative processing methods, on a case-by-case basis. FSIS agrees
that certain technologies used to prepare standardized foods may yield
a product with the same physical, nutritional, and sensory
characteristics as the food made in accordance with the traditional
standards. To reflect this fact, instead of specifying that substitute
standardized products must contain all ingredients specifically
required by a standard of identity or composition, and that the meat or
poultry portion of substitute products come from the same anatomical
location, be of the same kind and amount, and undergo the same basic
processing procedures as the standardized product as was proposed, FSIS
is revising Sec. Sec. 319.10(c)(4) and 381.172(c)(4) to require only
that substitute standardized products comply with all other applicable
standards of identity or composition.
Regarding the comment expressing concern that under the general
standard, products such as ``Beef Bacon'' or ``Pork Shoulder Bacon''
would no longer be permitted to include ``Bacon'' in their product
names if coupled with a nutrient content claim, as previously
mentioned, FSIS intends to apply the principles embodied in the general
standard established by this final rule to other products as
appropriate. The Agency will clarify this fact in a policy bulletin
after this final rule is published.
Thus, this final regulation will not prohibit the ``bacon-like''
products described in the Policy Book, such as ``Turkey Bacon-Cured
Turkey Breast Meat-Chopped and Formed,'' from being modified to qualify
to use a nutrient content claim as part of the product name. The
modified version of this ``bacon-like'' product would be permitted to
be identified as ``Low Fat Turkey Bacon-Cured Turkey Breast Meat-
Chopped and Formed.'' FSIS reiterates that the intent of this rule is
to provide a wider array of nutritionally improved substitute products
that would provide consumers with more meat and poultry products from
which to choose. The intent is not to diminish or interfere with
markets providing innovative as well as traditional kinds of products
to consumers.
Minimum Meat and Poultry Requirement
Comment: Several commenters submitted statements both for and
against the proposed requirement that a substitute standardized product
subject to the general standard rule maintain the same minimum meat or
poultry requirement as the standardized product for which it is a
substitute. Seven commenters agreed that substitute standardized
products should be required to maintain the minimum meat and poultry
requirement established by the traditional standard, while ten
commenters expressed disagreement with this requirement.
Several commenters stated that the meat or poultry content of a
standardized product often contains the highest concentration of fat,
and, while it may be theoretically possible for manufacturers to use
leaner meat to reduce fat, it is not economical. One of these
commenters stated that fat-reduced products that meet the existing
minimum meat or poultry content requirement would be prohibitively
expensive. Another commenter stated that relying exclusively on leaner
meat to reduce fat might also make products tougher in texture and less
palatable. Another commenter stated that, without reducing the ``meat
block'' (meat or poultry content), the proposed general standard can
not deliver on its promise to encourage innovation and the production
of nutritionally improved meat and poultry products.
Some commenters stated that minimum meat and poultry content
requirements for substitute products are not necessary so long as the
labeling of
[[Page 33812]]
the substitute standardized products provides sufficient information to
distinguish these products from the traditional standardized products
for which they substitute. One commenter submitted data showing that
consumers do not mind if part of the meat block in a substitute product
is replaced with another ingredient, so long as the labeling of the
substitute standardized product discloses the presence of the replacing
ingredient. Another commenter stated that trends in consumer behavior,
which include reducing the amount of meat consumed in order to reduce
fat intake, strongly support the argument that consumers will not be
misled by nutrient-modified food products that contain less meat and
poultry than is required by the traditional standardized form of the
food. One commenter suggested that a substitute standardized product
with reductions in its meat or poultry content should state on its
label that, ``in order to reduce fat, this product contains less meat
than the traditional standardized product.'' Some commenters stated
that nutritional equivalency, rather than meat-content equivalency,
should serve as the basis for defining requirements for the use of
nutrient content claims. These commenters felt that FSIS should allow
for necessary reductions in meat or poultry content to meet the
requirements of the claim, with the reduction accomplished in such a
manner that nutritional equivalency to the traditional standardized
product is maintained. One commenter stated that meat replacers may be
more desirable than some of the fat replacers, which hold water but
contribute little in taste or nutritional value.
One commenter stated that it is widely recognized that the
requirements for minimum meat content are based on the notion that meat
and poultry represented the most valuable constituent of a meat or
poultry product. This commenter claimed that meat and poultry are
simply no longer the indisputable ``highest value'' components of food
products. Another commenter mentioned that FDA regulations provide for
marketing of products, such as reduced-fat peanut butter, which allows
for reduction of the peanut content of the product below that required
for the standardized product.
Those commenters that agreed with the requirement that substitute
standardized products subject to the general standard maintain the same
minimum meat and poultry requirement as the standardized product for
which they are a substitute maintained that consumers have come to
expect a certain amount of meat or poultry in products that bear a
standardized term, and that the meat and poultry content of the product
is still the most valued constituent.
Response: Because many consumers have come to expect a certain
amount of meat or poultry in products that bear a standardized term,
deviations in the prescribed meat or poultry content will not be
permitted in this final rule. Moreover, while FSIS appreciates these
comments, the Agency does not view this rulemaking as the appropriate
vehicle for changing the specific meat and poultry content requirements
of meat and poultry product standards. These issues will be considered
in a separate rulemaking that will examine FSIS's overall regulatory
approach to standardized meat and poultry products that was described
in the ANPR ``Meat and Poultry Standards of Identity and Composition''
published in the September 9, 1996, edition of the Federal Register (61
FR 47453).
In response to that ANPR, FSIS and FDA are jointly working on a
more comprehensive approach to modernizing food standards whose goal is
to establish ``general principles'' that interested parties could
follow in requesting changes to food standards. One change that
interested parties may be able to pursue, if these principles are
adopted, would be reductions in the meat or poultry content
requirements of standardized products. FSIS and FDA expect to soon
publish the joint proposed rule in the Federal Register.
Nomenclature-Labeling of Nutrient Content Claims
Comment: Of those who commented, all agreed that the name of a
substitute standardized product subject to the general standard should
be an expressed nutrient content claim in conjunction with (i.e., next
to) the appropriate standardized term, as provided in the proposal.
However, several commenters did not agree with the provision in
proposed 9 CFR 319.10(d) and 9 CFR 381.172(d) that states that the
nutrient content claim and standardized term should be presented ``in
the same style, color, and size of type on the product label.''
One commenter stated that it was unaware of any evidence that
consumers are confused or misled by the labels currently in the
marketplace on similar FDA-regulated products, which are not subject to
a style, color, and size of type requirement. The commenter stated that
the 3:1 type size requirement that generally applies to names on FSIS-
regulated products should apply to foods that are marketed under the
general standard rule.
Another commenter stated that some flexibility should be allowed
for the type size of the nutrient content claim. The commenter stated
that some product names are fairly lengthy, and therefore, FSIS's
Policy Memo 87A , Word Size in Labeling of Product Names and Fanciful
Names, states that the Agency will not object to a \1/3\ type size
flexibility between the largest letter and the smallest letter in a
product name. The commenter also noted that the existing FSIS
regulations for nutrient content claims allow a \1/2\ type size
flexibility to assure that nutrient claims are not disproportionately
larger than the product's statement of identity.
Two commenters stated that the FDA regulation establishing a
general standard for FDA-regulated substitute standardized products (21
CFR 130.10(e)) does not contain the same restrictions on the style,
color, and size of type of the nutrient content claim that FSIS's
proposed rule does. One of these commenters requested that FSIS
consider modifying the proposed nomenclature for products subject to
its general standard to make it similar in format to that prescribed by
the FDA regulation. A similar comment suggested that FSIS delete the
last clause from the nomenclature section, i.e., `` * * * which shall
be in the same style, color, and size of type,'' because it is
unwarranted and unnecessary to inform consumers of the nature of the
substitute product.
Response: FSIS agrees with the commenters' arguments and in this
final rule has deleted the last clause from the nomenclature section
(`` * * * which shall be in the same style, color, and size of type'').
FSIS has been persuaded by the arguments against requiring the nutrient
content claim portion of the substitute standardized product's name to
be presented in the same style, color, and size of type, as the
standardized product term and agrees that this requirement is
unnecessary for consumers to distinguish the substitute product from
other products that bear nutrient content claims but that are not
substitute products that meet the requirements of this final rule.
Therefore, to harmonize, to the extent possible, its labeling
requirements with the labeling requirements of FDA's corresponding
regulations found in 21 CFR 130.10, FSIS will not require that the
expressed nutrient content claim that is part of the product identity
appear in ``the same style, color, and size of type'' as the
standardized term. The product name on the principal display panel of
the substitute product,
[[Page 33813]]
as well as its ingredients statement, are the pertinent labeling
features that identify the differences between the traditional
standardized product and the modified version bearing the standardized
name.
Ingredient Labeling
Comment: Twenty commenters expressed agreement with the provision
in proposed 9 CFR 319.10(e) and 381.172(e) that all safe and suitable
ingredients not provided for by the traditional standard, as well as
permitted ingredients added at a level in excess of those allowed by
the traditional standard, must be appropriately identified as such with
an asterisk in the ingredients statement. Three commenters disagreed.
Two commenters stated that because a nutrient content claim calls
the consumer's attention to the fact that the product has been modified
from the traditional standardized product, there is no need for
asterisks to be included in the labeling information. These commenters
believed that the product name with the appropriate nutrient content
claim, along with the ingredients statement, is all that is necessary
to adequately inform the consumer that the product has been modified
from the traditional standard. One commenter stated that, in addition
to adding to label clutter, the requirement to highlight ingredients
present in amounts greater than in the standardized product could
result in the ``ludicrous'' situation where a label indicates that the
substitute product contains more meat than the traditional standardized
product. The commenter felt that requiring an asterisks for particular
ingredients will provide a disincentive for meat and poultry processors
to make products using the new technologies in fat replacement products
because they must market products with labels that are cluttered with
additional statements.
One commenter expressed support for using an asterisk to identify
ingredients not provided for, or used in excess of those levels
provided for, by the traditional standard in so far as it provides
parity with FDA's regulation but questioned the real value of this
labeling feature to the consumer. The commenter suggested that this
labeling requirement be applicable on a short-term basis, with
provisions for its phase-out in no more than three years as consumer
become more familiarly with nutritionally-modified foods.
Two commenters felt that FSIS should require more than just the
identification of the substitute ingredients in the ingredients
listing, as proposed by the Agency. These commenters suggested that
FSIS also require that whenever ingredients are present in the
substitute product that are not permitted by the traditional product
standard, an appropriate disclosure (e.g. ``made with non-standard
ingredients--see back panel for ingredient lists'') appear on the
principal display panel. One of these commenters stated that such a
disclosure would alert consumers to the fact that a substitute product
is different from the standardized product and would direct them to
specific information about the differences.
Several commenters requested that FSIS clarify whether the
ingredient ``water'' or the added moisture not normally in or in excess
of that permitted in a standardized product should be indicated with an
asterisk.
Response: FSIS disagrees with the comment that ingredients not
provided for by the traditional standard, as well as permitted
ingredients added at a level in excess of those allowed by the
traditional standard, need not be identified as such with an asterisk
in the ingredients statement. Differences between the ingredients in a
standardized product and a substitute standardized product identified
in part by a nutrient content claim must be highlighted so that
consumers will be able to differentiate between the traditional
standardized product and the substitute version. Highlighting these
ingredient differences also ensures that the labeling of the substitute
product will not be misleading. Furthermore, as a point of
clarification, when water or added moisture not found in or used in
excess of that permitted in a traditional standardized product is added
to a substitute standardized product, this fact must be highlighted
with an asterisk as is required for all other safe and suitable
ingredients not found in, or used in excess of, the amount permitted by
the traditional standard.
FSIS disagrees with the comment that requiring an asterisks to
highlight specific ingredients present in a substitute standardized
product will provide a disincentive for meat and poultry processors to
make and manufacture standardized products with reductions in their fat
content. Similar labeling has been required on FDA-regulated products
for several years and does not appear to have been a disincentive for
industry to develop these kinds of products. FSIS also disagrees that
labeling features in addition to those provided in the proposed rule
are necessary to inform consumers of ingredient differences between a
traditional standardized product and its nutritionally modified
substitute. Highlighting ingredient differences with an asterisk in the
ingredients statement, along with the product name on the principal
display panel, are the pertinent labeling features that identify the
differences between the traditional standardized product and the
substitute version. Furthermore, to some consumers, statements such as
``made with non-standard ingredients'' may imply that the ingredients
used in a substitute product are inferior or harmful to the ingredients
used in the traditional standardized product. Such statements could be
misleading because only ingredients that have been found to be safe and
suitable for use in meat and poultry products are permitted to be used
in formulating substitute standardized products.
Consumers who have purchased substitute standardized products
manufactured pursuant to FDA's general standard codified at 21 CFR
130.10 are familiar with the labeling of such products through the use
of asterisks and the statement referenced by the asterisks, which
appear adjacent to the ingredient list. Thus, many consumers already
look to the ingredient statement to determine differences in
formulation between traditional standardized products and nutritionally
modified versions of these products. Harmonizing labeling to the extent
possible with that of the FDA benefits consumers by providing a more
consistent food labeling system across all foods.
FSIS finds no merit in the comment that asterisks are unnecessary
because they could lead to the ``ludicrous'' situation where an
ingredients statement asterisk would indicate that more meat or poultry
than required by the food standard has been used in the product.
Because food standards for meat and poultry products generally require
minimum amounts of meat and poultry and maximum amounts of fat and
water, it has always been possible for manufacturers to include more
meat or poultry than the minimum established by the food standard in
the product formulation. This rule does not change that fact and there
is no need to require an asterisk to highlight the fact that a
manufacture chose to include more meat or poultry in a substitute
product than the minimum required by the traditional standard.
Regarding the comment that the asterisk provision should be phased
out at some point in the future, FSIS does not agree with this view
because the ingredient statement is the primary feature where the
differences between the standardized product and the substitute version
can be made known to the consumer in labeling. As
[[Page 33814]]
described earlier, during the joint FSIS and FDA standards
modernization activities, if appropriate, the agencies may revisit the
issue of phasing out the asterisk requirement and consider it within
the context of a more comprehensive approach to food standards
modernization.
The Final Rule
In this final rule, FSIS is establishing a general definition and
standard of identity for standardized meat and poultry products that
have been modified to qualify for use of an expressed nutrient content
claim in their product names in conjunction with a standardized term.
FSIS is adding new Sec. Sec. 319.10 and 381.172 to the meat and
poultry products regulations in title 9 of the CFR. As was proposed,
Sec. Sec. 319.10(a) and 381.172(a) describe the type of meat and
poultry products that are defined by the general standard. These are
products that substitute, in accordance with 9 CFR 317.313(d) or
381.413(d), for a standardized product, but that do not comply with the
established standard because of a compositional deviation that results
from reductions of a constituent that is described by an express
nutrient content claim, such as ``low fat'' or ``fat free.''
As was proposed, Sec. Sec. 319.10(b) and 381.172(b) require that a
substitute standardized product subject to the general standard have
similar performance characteristics to the traditional standardized
product for which it is a substitute. However, if a substitute product
has performance characteristics that materially limit the uses of the
product compared to the uses of the traditional standardized product,
Sec. Sec. 319.10(b) and 381.172(b) require that a product's label
include a disclaimer informing consumers of such differences, such as
``not suitable for grilling.'' In response to some of the comments and
to be consistent with the existing definition of substitute products
found in 9 CFR 317.313 and 381.413, FSIS is removing the provision in
proposed Sec. Sec. 319.10(b) and 381.172(b) that would have required
the performance characteristics disclaimer to appear ``adjacent to the
product name.'' Deleting this provision is also intended to provide
consistency with 21 CFR 130.10 of the FDA regulations, which is the
codified general standard of identity for substitute standardized
products under FDA jurisdiction. As was proposed, Sec. Sec. 319.10(b)
and 381.172(b) will require that deviations in the ingredients in a
substitute standardized product be the minimum necessary to qualify for
the nutrient content claim.
Sections 319.10(c) and 381.172(c) prescribe the ingredients that
must be used in, and the ingredients that are permitted to be used in,
substitute standardized products under the general standard. As was
proposed, Sec. Sec. 319.10(c)(1) and 381.172(c)(1) require that the
ingredients used in a substitute standardized product be those
ingredients provided for by the traditional standard, except that in
addition, safe and suitable ingredients may be used in the substitute
product at the minimum level necessary to improve texture or prevent
synereses. The final rule replaces references to former Sec. Sec.
318.7 and 381.147 with the phrase ``as provided in a regulation
permitting that use in this subchapter or in 9 CFR Chapter III,
Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B,''
to reflect the issuance of the final rule ``Food Ingredients and
Sources of Radiation Listed or Approved for Use in Meat and Poultry
Products'' (64 FR 72168).
As was proposed, Sec. Sec. 319.10(c)(2) and 381.172(c)(2) forbid
substitute standardized products to replace or exchange ingredients
required by the traditional standard with functionally similar
ingredients from other sources not provided for in the traditional
standard. In the final rule, FSIS is removing the phrases ``textured
vegetable protein shall not replace meat'' and ``textured vegetable
protein shall not replace poultry'' from proposed Sec. Sec. 319.10
(c)(2) and 381.172(c)(2). These phrases are unnecessary and could
potentially cause confusion since the final rule permits TVP to be used
in limited amounts as a fat replacer, although it may not be used to
replace meat. Reductions in the meat or poultry content required by the
traditional standard are already prohibited by the final rule
regardless of whether TVP is used in the product.
As was proposed, Sec. Sec. 319.10(c)(3) and 381.172(c)(3) prohibit
substitute standardized products from containing ingredients that are
prohibited for use in traditional standardized products. Proposed
Sec. Sec. 319.10(c)(2) and(3), and 381.172(c)(2) and (3) use the
phrase ``[a]n ingredient or component of an ingredient'' when
describing the ingredients permitted and prohibited in substitute
standardized products. In this final rule, FSIS is deleting the words
``or component of an ingredient'' because they are unnecessary and may
cause confusion.
Proposed, Sec. Sec. 319.10(c)(4) and 381.172(c)(4) required
substitute standardized products to conform to certain aspects of the
traditional standard, such as the meat or poultry content specified in
the standard, the anatomic location and kind of meat or poultry
specified in the standard, and the processing procedures specified in
the standard. As previously mentioned, deviations from these types of
requirements may result in a product that is so physically dissimilar
from the traditional standardized product that it does not come within
the established definition of a substitute product.
However, because certain technologies used to prepare standardized
foods may yield a product with the same physical, nutritional, and
sensory characteristics as the food made in accordance with the
traditional standards, FSIS intends to consider certain deviations from
product standards, such as alternative processing methods, on a case-
by-case basis. As stated above, FSIS and FDA are jointly working on a
more comprehensive approach to modernizing food standards to establish
``general principles'' that interested parties would follow in
requesting changes to or creating new food standards. Therefore, FSIS
is revising proposed Sec. Sec. 319.10(c)(4) and 381.172(c)(4) to
require that substitute standardized products comply with all other
applicable standards of identity or composition unless otherwise
specified in part 319 or part 381. The Agency is making this revision
to accommodate changes to food standards that may result from the joint
FSIS/FDA food standards modernization approach.
As was proposed, Sec. Sec. 319.10(c)(5) and 381.172(c)(5) permit
water and fat-replacing binders to be used to reduce the fat content in
a substitute standardized product subject to the general standard.
Based on the comments and data submitted in response to the proposal in
support of using TVP as a ``fat replacer,'' FSIS will permit the use of
TVP as a functional fat replacing ingredient in substitute standardized
products defined by the general standard. FSIS is adding new language
to the final rule that permits the use of TVP as part of a fat
replacement system at the lowest level necessary to achieve the
technical effect of replacing the characteristics of fat in the
substitute product. This language is found in new Sec. Sec.
319.10(c)(6) and 381.172(c)(6). Because Sec. Sec. 319.10(c)(2) and
381.172(c)(2) of the final rule forbid reductions in the meat or
poultry content of a substitute product where one is established by a
standard, under the final rule, TVP may only be used to replace fat
component and not to replace the lean meat or poultry content of the
substitute standardized product.
[[Page 33815]]
Sections 319.10(d) and 381.172(d) prescribe the nomenclature for
the substitute meat and poultry products that comply with the general
standard. As was proposed, these products may be identified by the
appropriate expressed nutrient content claim and the applicable
standardized term (e.g., ``Fat Free Bologna''). If a product meets the
requirements of the general standard, it is itself a standardized
product, and therefore, its name will not be required to contain the
term ``substitute'' despite the fact that it does not meet all of the
requirements of the traditional product standard.
This final rule removes the provisions in proposed Sec. Sec.
319.10(d) and 381.172(d) that would have required that the expressed
nutrient content claim part of the substitute standardized product's
name appear in the ``same style, color and size type'' as the
standardized term. This change is in response to public comments and to
harmonize, to the extent possible, with similar FDA regulations.
As was proposed, Sec. Sec. 319.10(e) and 381.172(e) require each
of the ingredients used in the substitute product to be declared on the
product label as required by the applicable FSIS regulations. 9 CFR
parts 317 and 381, subpart N, require that all ingredients be listed by
common or usual name in descending order of predominance by weight. As
was proposed, Sec. Sec. 319.10(e) and 381.172(e) also require that all
safe and suitable ingredients not provided for by the traditional
standard, as well as those used in excess of those permitted by the
traditional standard, be identified as such with and asterisks in the
ingredients statement.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been determined to be significant and therefore has
been reviewed by OMB under EO 12866.
I. Need for the Rule
FSIS is issuing this rule to facilitate the development and
availability of substitute standardized products that have reductions
in certain constituents that are of health concern to some consumers,
such as fat, cholesterol, and sodium. This rule allows FSIS to rely
more on labeling requirements and less on restrictive recipe-like
standards in endeavoring to ensure that the labels of meat and poultry
products are truthful and not misleading as well as to improve the
public health. The names of products covered by the General Standard
will be composed of an express nutrient content claim that reflects the
modifications made in formulating and processing the product (so that
it qualifies to bear the claim) and an established standardized term.
FDA has already promulgated a corresponding General Standard for the
products that it regulates (21 CFR 130.10). By harmonizing an FSIS
labeling requirement with that of FDA, this final rule represents a
significant step towards providing consumers with an informative and
consistent food standard and labeling system. This final rule also
promotes product innovation by encouraging the production of meat and
poultry products that are low in constituents that are of health
concern to some people.
II. Description of Affected Industry
FSIS regulations contain approximately 80 standards of identity or
composition for meat and poultry products. Most of these standards are
for processed products, including sliced, injected, smoked, fermented,
heat-treated, and raw products. According to the Agency's Performance
Based Inspection System Database, in the second quarter of 2003, there
were approximately 6,600 Federal and State Establishments \2\ that
potentially will be affected by the final rule if they develop and make
available substitute products for standardized products. Some of these
establishments, however, are already producing sausage and other
comminuted meat and poultry products under FSIS Policy Memo 121B and
Policy Memo 123 which provide for the type of substitute products
defined under this final rule. Thus, this rule is likely to have little
or no impact on the processing establishments that are producing
products in accordance with the policy memos.
---------------------------------------------------------------------------
\2\ These establishments processed, froze, stored, or otherwise
held meat and poultry products.
---------------------------------------------------------------------------
Ingredient manufacturers who produce binders and textured (source)
protein products (e.g., textured soy or wheat protein) will be affected
by the final rule because the rule will permit the increased use of
these ingredients as fat replacing ingredients in some modified
standardized products.
III. Costs
The decision to produce products subject to the General Standard
established by this rule is voluntary. Therefore, only those
manufacturers that choose to produce and market these products will
incur the direct costs imposed by this rule. These costs include
research and development, production and marketing, and labeling
production. However, because the rule is voluntary, companies that
choose to produce products covered by the General Standard will do so
only if they determine that the benefits of producing and selling these
products outweigh the costs of complying with the final rule.
Furthermore, companies that are already producing and marketing
products under Policy Memo 121B and Policy Memo 123 (i.e., comminuted
meat and poultry products) are likely to incur minimal or no costs as a
result of this final rule.
Under most circumstances, companies are likely to charge a premium
for substitute standardized product produced in compliance with this
final rule because many consumers will be willing to pay a premium for
products with improved nutritional profiles. They view these products
as ``value added'' products.\3\ Therefore, based on the experience of
food companies that are operating under FDA's 21 CFR 130.10
regulations, e.g., the manufacturers of fat-free ice cream and reduced
fat cream cheese, any costs associated with producing and marketing
substitute products most likely will be passed on to the consumer in
the form of higher retail prices.
---------------------------------------------------------------------------
\3\ Consumer purchasing trends.
---------------------------------------------------------------------------
However, once this rule becomes effective, some companies that are
not producing substitute meat and poultry products under Policy Memo
121B or Policy Memo 123 may begin to manufacture and market substitute
standardized products in accordance with the General Standard because
of the market value of using traditional product names. Their decision
to do so could have the effect of increasing the supply of these types
of products in the short run, which could translate into lower prices
for consumers.
IV. Benefits
This rule will assist consumers in making dietary choices by
providing for modified versions of standardized meat and poultry
products that have reductions of certain constituents that are of
health concern to some consumers, such as fat, cholesterol, and sodium.
Therefore, there will be a greater opportunity for consumers to
maintain or to initiate healthy dietary practices. In the United
States, diets high in fat, cholesterol, and sodium are associated with
chronic diseases such as coronary heart disease, cancer, stroke, and
diabetes. In 2002, according to the Centers for Disease Control
National Center for Chronic Disease Prevention and Health Promotion, 7
out of every 10 U.S. deaths and more than 60% of medical care
expenditures are attributed to chronic diseases. In addition, the
[[Page 33816]]
prolonged illness and disability associated with many chronic diseases
decrease the quality of life for millions of consumers.
Estimated Direct and Indirect Costs of Cardiovascular Diseases, Stroke, Diabetes, and Cancer in the United
States--2002
[In Billion of Dollars]
----------------------------------------------------------------------------------------------------------------
Cardiovascular
Costs diseases Stroke Diabetes Cancer
----------------------------------------------------------------------------------------------------------------
Direct.......................................... $168.7 $30.8 $92.0 $61.0
Indirect........................................ 111.1 18.6 40.0 111.0
-----------------
Total....................................... 279.8 49.4 132.0 172.0
----------------------------------------------------------------------------------------------------------------
According to the 2002 Heart and Stroke Statistical Update published
by the American Heart Association and the American Stroke Association,
the total cost of cardiovascular diseases and strokes in the United
States was estimated at $279.8 billion and $49.4 billion, respectively,
as reflected in the above table and figure 1 below. Direct costs
($168.7 billion and $30.8 billion, respectively) consist of the cost of
physicians and other health professionals, hospital and nursing home
services, medication, home health care, and other medical durables.
Indirect costs ($111.1 billion and 18.6 billion, respectively) consist
of lost productivity resulting from morbidity and mortality.
[GRAPHIC] [TIFF OMITTED] TR10JN05.003
The total cost in 2002 associated with diabetes was $132 billion of
which $92 billion were direct costs and $40 billion were indirect
costs.\4\ The estimated total costs for all cancers in 2002 were $172
billion ($61 billion in direct costs and $110 billion in indirect
costs) \5\.
---------------------------------------------------------------------------
\4\ ``The Economic Costs of Diabetes in the U .S. 2002'',
American Diabetes Association.
\5\ Heart Disease and Stroke Statistics--2003 Update, American
Heart Association.
---------------------------------------------------------------------------
Most chronic diseases are preventable, or their onset can be
delayed, through increased physical activity and healthy eating. There
is research to support that practicing good nutrition lowers the risk
of chronic diseases for many consumers.\6\ The total estimated cost of
chronic diseases to the consumer is $633.2 billion. The extent to which
these costs might be reduced by an improved diet cannot be calculated
precisely, but some researchers estimate that a balanced and healthful
diet might forestall at least 20 percent of the annual deaths from
heart disease, stroke, cancer, and diabetes.\7\
---------------------------------------------------------------------------
\6\ CDC National Center for Chronic Disease Prevention and
Health Promotion, ``Physical Activity and Good Nutrition: Essential
Elements to Prevent Chronic Diseases and Obesity.''
\7\ ``The American Diet: A Costly Health Problem, Food Review.''
---------------------------------------------------------------------------
It is reasonably expected that the final rule could contribute to
the reduction of these costs, but this contribution, too, cannot be
calculated precisely. In the ``Economic Benefits of Nutrition Labeling:
A Case Study for Fresh Meat and Poultry Products,'' the Agency
estimated the potential benefits of reducing the incidence of coronary
heart disease and three types of cancers at $61.8 million, (7 percent
discount rate); and $125 million (3 percent discount rate).\8\
---------------------------------------------------------------------------
\8\ The Agency estimated the potential benefit of an FSIS rule
(2001). Nutrition Labeling of ground or chopped meat and poultry
products and single-ingredient products. Federal Register, 66, 4969-
4999.
---------------------------------------------------------------------------
The results of the 2002 ``Trends'' survey'' conducted by the Food
[[Page 33817]]
Marketing Institute (Trends in the United States, Consumer Attitudes
and the Supermarket) stated that 80 percent of consumers surveyed
indicated that they had sought out and purchased products based on
``low-fat'' claims; 60 percent had purchased products because of ``low
cholesterol'' claims; 59 percent purchased products because of
``natural'' claims; and 52 percent purchased products because of ``low
salt'' claims. If this trend continues, and the final rule is
promulgated, it is more than likely that the final rule will assist in
the reduced incidence of chronic diseases by expanding the availability
of meat and poultry products with lower levels of constituents such as
fat, cholesterol, and sodium.
In conclusion, this final rule will assist consumers who want to
reduce their dietary intake of fat, cholesterol, and sodium by
encouraging the production of modified versions of traditional meat and
poultry products that are formulated with fat, cholesterol, and sodium-
replacing ingredient systems that reduce these constituents. The final
rule will provide parity with FDA's regulations and will promote a
unified approach to food standards and labeling. Most importantly, the
final rule supports national efforts to reduce the expenditures for
health care and the cost of morbidity and lost productivity by
permitting the introduction of modified, substitute foods.
In terms of administrative benefits, the General Standard
established by this final rule will permit industry to introduce
modified, substitute versions of traditional standardized meat and
poultry products without having to petition FSIS to establish new
standards for products on a case-by-case basis. This will generate
efficiency within the food standards system by saving time and
resources that would have been expended by both the industry and FSIS
to establish new or modified product standards. It will also permit
companies to introduce standardized meat and poultry products with
improved nutritional profiles into the marketplace in a timely manner,
making such products more readily available to consumers.
V. Regulatory Flexibility Analysis
The FSIS Administrator has made a final determination that this
rule will not have a significant economic impact on a substantial
number of small entities, as defined by the Regulatory Flexibility Act
(5 U.S.C. 601).
This final rule will not impose any new requirements on small
entities. The decision to produce versions of standardized products
that have been modified to qualify for use of an expressed nutrient
content claim in conjunction with a traditional product name is
voluntary. Therefore, the requirements of this final rule will only
apply to those small manufacturers who choose to produce these types of
products. Those small entities that choose to produce these products
will be required to design new labels or to revise current labels to
comply with this new rule, and thereby incur some costs. However, small
entities who will be marketing these substitute products will most
likely have anticipated that the revenues generated from the sale of
these products will outweigh the costs of complying with the new
regulation.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This final rule: (1) Preempts State and local
laws and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule. However,
the administrative procedures specified in 9 CFR 306.5, 381.35, and
590.320 through 590.370 must be exhausted before any judicial challenge
of the application of the provisions of this rule, if the challenge
involves any decision of an FSIS employee relating to inspection
services provided under the FMIA or PPIA.
Paperwork Reduction Act
In accordance with section 3507(j) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), FSIS will submit the information
collection and recordkeeping requirements in this final rule to the
Office of Management and Budget (OMB) for approval.
Title: Food Standards: Requirements for Substitute Standardized
Meat and Poultry Products Named by Use of an Expressed Nutrient Content
Claim and a Standardized Term.
Type of collection: New.
Abstract: Under this final rule, FSIS is requiring that
establishments that produce meat and poultry products in accordance
with the definition and general standard of identity for substitute
standardized products design new product labels and submit sketches of
the new labeling to FSIS for approval. To receive approval of the
labels, establishments must complete FSIS form 7234-1. FSIS employees
review FSIS form 7234-1 to ensure that information on the labels
complies with the regulations.
Estimate of burden: FSIS estimates that it will take 60 minutes to
design and develop modified product labels in accordance with the final
regulations and 15 minutes to prepare FSIS form 7234-1 and submit it,
along with the label, to FSIS.
Respondents: Establishments that produce substitute standardized
meat or poultry products in accordance with this final rule.
Estimated Number of Respondents: 100.
Estimated Number of Responses per Respondent: 5.
Estimated Total Annual Burden on Respondents: 625 hours.
Copies of this information collection assessment can be obtained
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety
and Inspection Service, USDA, 112 Annex, 300 12th Street, SW.,
Washington, DC 20250. Comments are invited on (a) Whether the
collection of information is necessary for the proper performance of
the functions of the Agency, including whether the information will
have practical utility; (b) the accuracy of the Agency's estimate of
the burden of the collection of information, including the validity of
the methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected, ways to
minimize the burden of the collection of information on those who are
to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques,
or other forms of information technology. Comments may be sent to both
John O'Connell, Paperwork Reduction Act Coordinator, at the address
provided above, and the Desk Officer for Agriculture, Office of
Information and Regulatory Affairs, Office of Management and Budget,
Washington, DC 20253. To be most effective, comments should be sent to
OMB within 30 days of publication.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that the
public and in particular minorities, women, and persons with
disabilities, are aware of this final rule, FSIS will announce it on-
line through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/2005_Interim_&_Final_Rules_Index/index.asp.
The Regulations.gov Web site is the central online
rulemaking portal of the United States government. It is being offered
as a public service to increase participation in the Federal
government's regulatory activities. FSIS participates in
Regulations.gov and will
[[Page 33818]]
accept comments on documents published on the site. The site allows
visitors to search by keyword or Department or Agency for rulemakings
that allow for public comment. Each entry provides a quick link to a
comment form so that visitors can type in their comments and submit
them to FSIS. The Web site is located at http://www.regulations.gov/.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health professionals,
scientific professionals, and other individuals who have requested to
be included. The update also is available on the FSIS Web page. Through
Listserv and the Web page, FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an email subscription service which
provides an automatic and customized notification when popular pages
are updated, including Federal Register publications and related
documents. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/
and allows FSIS customers to sign up
for subscription options across eight categories. Options range from
recalls to export information to regulations, directives and notices.
Customers can add or delete subscriptions themselves and have the
option to password protect their account.
List of Subjects
9 CFR Part 319
Food grades and standards, Meat inspection.
9 CFR Part 381
Food grades and standards, Meat inspection, Poultry and poultry
products.
0
For the reasons stated in the preamble, FSIS amends 9 CFR parts 319 and
381 as follows:
PART 319--DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION
0
1. The authority citation for part 319 continues to read as follows:
Authority: 7 U.S.C. 450, 1901-1906; 21 U.S.C. 601-695; 7 CFR
2.18, 2.53.
0
2. Part 319, subpart A is amended by adding a new Sec. 319.10 to read
as follows:
Sec. 319.10 Requirements for substitute standardized meat food
products named by use of an expressed nutrient content claim and a
standardized term.
(a) Description. The meat food products prescribed by this general
definition and standard of identity are those products that substitute,
in accordance with Sec. 317.313(d), for a standardized product defined
in this part and use the name of that standardized product in their
statements of identity, but that do not comply with the established
standard because of a compositional deviation that results from
reduction of a constituent that is described by an expressed nutrient
content claim that has been defined by regulation in part 317, subpart
B, of this subchapter. The expressed nutrient content claim shall
comply with the requirements of Sec. 317.313 of this subchapter and
with the requirements of part 317, subpart B, of this subchapter which
define the particular nutrient content claim that is used. The meat
food product shall comply with the relevant standard in this part in
all other respects, except as provided in paragraphs (b) and (c) of
this section.
(b) Performance characteristics. The performance characteristics,
such as physical properties, functional properties, and shelf-life, of
the meat food product shall be similar to those of the standardized
meat food product produced under this part. If there is a significant
difference in a performance characteristic that materially limits the
use of the product compared to the use of the standardized product
defined in this part, the label shall include a statement in accordance
with Sec. 317.313(d)(1) and (2) of this subchapter that informs the
consumer of such differences (e.g., if appropriate, ``not recommended
for frozen storage'' or ``not suitable for roller grilling'').
Deviations from the ingredient provisions of the standard must be the
minimum necessary to qualify for the nutrient content claim, while
maintaining similar performance characteristics.
(c) Ingredients used in substitute products. (1) Ingredients used
in the product shall be those ingredients provided for in the standard
as defined in this part, except that safe and suitable ingredients
permitted for use in meat food products as provided in a regulation
permitting that use in this subchapter or in 9 CFR Chapter III,
Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, may
be used at the minimum level necessary to improve texture and prevent
syneresis, so that the substitute product is not inferior in
performance characteristics from the standardized product defined in
this part for which it is a substitute.
(2) An ingredient that is specifically required by the standard
prescribed in this part shall not be replaced or exchanged with a
similar ingredient from another source, for example, turnip chunks
shall not replace potatoes in corned beef hash.
(3) An ingredient that is specifically prohibited from use in any
meat food product by this part shall not be added to the substitute
meat food product under this section.
(4) Unless otherwise specified in this part, a substitute meat food
product must meet all other requirements of the applicable standards of
identity or composition.
(5) Water and fat-replacers (e.g., binders), in combination, may be
added to replace fat in accordance with paragraph (c) of this section.
(6) Textured vegetable protein may be used by itself or in
combination with other binders and water as a fat replacer in
accordance with paragraph (c) of this section.
(d) Nomenclature. The name of a substitute meat food product that
complies with all parts of this section is the appropriate expressed
nutrient content claim and the applicable standardized term.
(e) Label declaration. (1) Each of the ingredients used in the
substitute meat food product shall be declared on the label as required
by this section and part 317 of this subchapter.
(2) Ingredients not provided for, and ingredients used in excess of
those levels provided for, by the standard as defined in this part,
shall be identified as such with an asterisk in the ingredients
statement. The statement ``*Ingredients not in regular --------'' (the
blank shall be filled in with the name of the traditional standardized
product) or ``**Ingredients in excess of amounts permitted in regular
--------'' (the blank shall be filled in with the name of the
traditional standardized product), or both, as appropriate, shall
immediately follow the ingredients statement in the same type and size.
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
0
3. The authority citation for part 381 would continue to read as
follows:
Authority: 7 U.S.C. 138f; 450, 21 U.S.C. 451-470, 7 CFR 2.18,
2.53.
0
4. Part 381, subpart P is amended by adding a new Sec. 381.172 to read
as follows:
[[Page 33819]]
Sec. 381.172 Requirements for substitute standardized poultry
products named by use of an expressed nutrient content claim and a
standardized term.
(a) Description. The poultry products prescribed by this general
definition and standard of identity are those products that substitute,
in accordance with Sec. 381.413(d), for a standardized product defined
in this subpart and use the name of that standardized product in their
statements of identity, but that do not comply with the established
standard because of a compositional deviation that results from
reduction of a constituent that is described by an expressed nutrient
content claim that has been defined by regulation in this subpart. The
expressed nutrient content claim shall comply with the requirements of
Sec. 381.413 and with the requirements in subpart Y of this part which
define the particular nutrient content claim that is used. The poultry
product shall comply with the relevant standard in this part in all
other respects, except as provided in paragraphs (b) and (c) of this
section.
(b) Performance characteristics. The performance characteristics,
such as physical properties, functional properties, and shelf-life, of
the poultry product shall be similar to those of the standardized
poultry product produced under subpart P of this part. If there is a
significant difference in a performance characteristic that materially
limits the use of the product compared to the use of the standardized
product defined in subpart P of this part, the label shall include a
statement in accordance with Sec. 381.413(d)(1) and (2) of this part,
that informs the consumer of such differences (e.g., if appropriate,
``not recommended for frozen storage'' or ``not suitable for roller
grilling''). Deviations from the ingredient provisions of the standard
must be the minimum necessary to qualify for the nutrient content
claim, while maintaining similar performance characteristics.
(c) Ingredients used in substitute products. (1) Ingredients used
in the product shall be those ingredients provided for in the standard
as defined in subpart P of this part, except that safe and suitable
ingredients permitted for use in poultry products as provided in a
regulation permitting that use in this subchapter or in 9 CFR Chapter
III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter
B, may be used at the minimum level necessary to improve texture and
prevent syneresis, so that the substitute product is not inferior in
performance characteristics from the standardized product defined in
subpart P of this part for which it is a substitute.
(2) An ingredient that is specifically required by the standard
prescribed in subpart P of this part shall not be replaced or exchanged
with a similar ingredient from another source, for example, extruded
turnips shall not replace noodles in poultry with noodles.
(3) An ingredient that is specifically prohibited from use in any
poultry product by subpart P of this part shall not be added to the
substitute poultry product under this section.
(4) Unless otherwise specified in this part, a substitute poultry
product must meet all other requirements of the applicable standards of
identity or composition.
(5) Water and fat-replacers (e.g., binders), in combination, may be
added to replace fat in accordance with paragraph (c) of this section.
(6) Textured vegetable protein may be used by itself or in
combination with other binders and water as a fat replacer in
accordance with paragraph (c) of this section.
(d) Nomenclature. The name of a substitute poultry product that
complies with this section is the appropriate expressed nutrient
content claim and the applicable standardized term.
(e) Label declaration. (1) Each of the ingredients used in the
substitute poultry product shall be declared on the label as required
by this section and subpart N of this part.
(2) Ingredients not provided for, and ingredients used in excess of
those levels provided for, by the standard as defined in subpart P of
this part, shall be identified as such with an asterisk in the
ingredients statement. The statement ``*Ingredients not in regular ----
----'' (the blank shall be filled in with the name of the traditional
standardized product) or ``**Ingredients in excess of amounts permitted
in regular --------'' (the blank shall be filled in with the name of
the traditional standardized product), or both, as appropriate, shall
immediately follow the ingredients statement in the same type and size.
Done in Washington, DC, on June 6, 2005.
Barbara J. Masters,
Acting Administrator.
[FR Doc. 05-11493 Filed 6-9-05; 8:45 am]