[Federal Register Volume 70, Number 97 (Friday, May 20, 2005)]
[Proposed Rules]
[Pages 29214-29235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9958]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 410
[Docket No. 95-051P]
RIN 0583-AC72
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 130
[Docket No. 1995N-0294]
RIN 0910-AC54
Food Standards; General Principles and Food Standards
Modernization
AGENCIES: Food Safety and Inspection Service, USDA; Food and Drug
Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) and the Food and
Drug Administration (FDA) (we, our, the agencies) are proposing to
establish a set of general principles for food standards. The adherence
to these principles will result in standards that will better promote
honesty and fair dealing in the interest of consumers and protect the
public, allow for technological advances in food production, be
consistent with international food standards to the extent feasible,
and be clear, simple, and easy to use for both manufacturers and the
agencies that enforce compliance with the standards. The proposed
general principles will establish the criteria that the agencies will
use in considering whether a petition to establish, revise, or
eliminate a food standard will be the basis for a proposed rule. In
addition, each agency may propose to establish, revise, or eliminate a
food standard on its own initiative or may propose revisions to a food
standard in addition to those a petitioner has requested. These
proposed general principles are the agencies' first step in instituting
a process to modernize their standards of identity (and any
accompanying standards of quality and fill of container) and standards
of composition.
DATES: Submit written or electronic comments by August 18, 2005.
ADDRESSES: You may submit comments to FSIS, identified by Docket No.
95-051P, by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions):
Send an original and two copies of comments to: FSIS Docket Clerk,
Docket No. 95-051P, rm. 102, Cotton Annex Bldg., 300 12th St. SW.,
Washington, DC 20250-3700.
Instructions: All submissions received must include the agency name
and Docket No. 95-051P or regulatory information number (RIN) 0583-
AC72.
Other Information: All comments submitted in response to this
proposal, as well as research and background information used by FSIS
in developing this document, will be available for public inspection in
the FSIS Docket Room at the address listed above between 8:30 a.m. and
4:30 p.m., Monday through Friday. The comments also will be posted on
the Agency's Web site at http://www.fsis.usda.gov/OPPDE/rdad/FRDockets.htm.
You may submit comments to FDA, identified by Docket No. 1995N-0294
and/or RIN 0910-AC54, by any of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
E-mail: [email protected]. Include Docket No. 1995N-
0294 and/or RIN 0910-AC54 in the subject line of your e-mail message.
FAX: 301-827-6870.
Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions):
[[Page 29215]]
Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket No. 1995N-0294 or RIN 0910-AC54. All comments received will
be posted without change to http://www.fda.gov/ohrms/dockets/default.htm, including any personal information provided. For detailed
instructions on submitting comments and additional information on the
rulemaking process, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FSIS: Robert C. Post, Labeling and
Consumer Protection Staff, rm. 602, Cotton Annex Bldg., 1400
Independence Ave. SW., Washington, DC 20250-3700, 202-205-0279.
FDA: Ritu Nalubola, Center for Food Safety and Applied Nutrition
(HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy.,
College Park, MD 20740, 301-436-2371.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
A. FSIS Food Standards
B. FDA Food Standards
C. Advance Notices of Proposed Rulemaking
D. Comments to the ANPRMs
E. Options in the Food Standards Modernization Process
F. Consumer Research
II. The Proposed General Principles
III. FSIS and FDA Requests for Information
IV. Executive Order 12866: Cost Benefit Analysis
A. Need for the Rule
B. Regulatory Options
V. Regulatory Flexibility Analysis
VI. Executive Order 12988: Civil Justice Reform
VII. Executive Order 13132: Federalism
VIII. Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Additional Public Notification
XI. Comments
XII. References
I. Background
FSIS and FDA share responsibility for ensuring that food labels are
truthful and not misleading. FSIS has the authority to regulate the
labeling of meat and poultry products, and FDA has the authority to
regulate the labeling of all other foods. Some foods, such as eggs, are
regulated by both agencies. Food standards are used to ensure that
products sold under particular names have the characteristics expected
by consumers.
A. FSIS Food Standards
Meat and poultry product standards of identity or composition are
codified in title 9 of the Code of Federal Regulations (CFR). FSIS has
established by regulation approximately 80 meat and poultry product
standards of identity or composition (9 CFR parts 319 and 381, subpart
P, for meat and poultry products, respectively) under its authorities
in the Federal Meat Inspection Act (FMIA) and the Poultry Products
Inspection Act (PPIA) (21 U.S.C. 607(c) and 457(b)). These sections
provide:
The Secretary [of Agriculture], whenever he determines such
action is necessary for the protection of the public, may prescribe
* * * definitions and standards of identity or composition for
articles subject to [the FMIA and PPIA] and standards of fill of
container for such articles not inconsistent with any such standards
established under the Federal Food, Drug, and Cosmetic Act [act] (21
U.S.C. 301 et seq. ) and there shall be consultation between the
Secretary [of Agriculture] and the Secretary of Health and Human
Services prior to the issuance of such standards under [the FMIA,
PPIA, or act] relating to articles subject to this chapter to avoid
inconsistency in such standards and possible impairment of the
coordinated effective administration of [the FMIA, PPIA and the
act]. There shall also be consultation between the Secretary [of
Agriculture] and an appropriate advisory committee provided for in
[21 U.S.C. 454 and 661] prior to the issuance of such standards * *
* to avoid, insofar as feasible, inconsistency between Federal and
State standards.
Consistent with the statutes, FSIS has consulted with FDA regarding
the proposed general principles. In addition, FSIS consulted with the
National Advisory Committee on Meat and Poultry Inspection about this
proposed rule in November 2001, and incorporated their comments in this
document. FSIS's food standards regulations cover many different foods.
The contents of individual food standards or groups of food standards
are extremely varied, depending on the complexity of the food and the
level of detail necessary to define the characterizing features of the
food. Some food standards are relatively simple, consisting of only a
sentence or two (e.g., beef stew, 9 CFR 319.304), or a paragraph or two
(e.g., deviled ham, 9 CFR 319.760). Other food standards are extremely
detailed and prescriptive. For example, the standard for frankfurter,
frank, furter, hotdog, weiner, vienna, bologna, garlic bologna,
knockwurst and similar products describes the form of the product, the
expected ingredients, and the allowable meat and nonmeat ingredients
and poultry products that can be used in these products (9 CFR
319.180). There are more standards for meat products than for poultry
products because processed meat products have been in existence longer
and have been consumed more widely than processed poultry products.
Although the FMIA and PPIA authorized standards of fill, FSIS has not
established any standards of fill in regulations.
FSIS standards of identity generally require the presence of
certain expected ingredients in a food product or mandate how a product
is to be formulated or prepared. For example, a poultry product labeled
``(kind) a la Kiev'' is required to be stuffed with butter, which may
be seasoned (9 CFR 381.161). In the poultry products inspection
regulations, the term ``kind'' refers to the type of poultry used. In
this standard of identity, butter is an expected ingredient, and the
standard also requires that the product be prepared by stuffing the
butter in the poultry. The standard of identity for barbecued meats
requires that barbecued meats be cooked by the direct action of dry
heat resulting from the burning of hard wood or the hot coals therefrom
for a sufficient period to assume the usual characteristics of a
barbecued article, which include the formation of a brown crust on the
surface and the rendering of surface fat (9 CFR 319.80). This standard
of identity specifies exactly how the product must be prepared and also
includes a description of the defining characteristics of products that
meet the standard.
Standards of composition specify the minimum or maximum amount of
ingredients in a product. Many of these standards for meat products
establish a minimum amount of meat or a maximum amount of fat in the
product. For example, the standards of composition for ground beef,
chopped beef, hamburger, and fabricated steaks require that the product
contain no more than 30 percent fat (9 CFR 319.15). Several of the
poultry standards of composition specify minimum poultry levels and
maximum added liquid levels. For example, canned boned poultry,
labeled, ``boned (kind)'' must
[[Page 29216]]
contain at least 90 percent cooked, deboned poultry meat of the kind
indicated on the label, with skin, fat and seasoning, and may contain
no more than 10 percent added liquid (9 CFR 381.157). The standards of
composition for mechanically separated (species) (9 CFR 319.5) and
mechanically separated (kind) (9 CFR 381.173) limit the amount and size
of bone particles that the product may contain.
Some FSIS standards require that product be labeled with a specific
name, such as ``hamburger'' (9 CFR 319.15(b)) or ``(kind) patties'' (9
CFR 381.160), while other standards provide examples of terms that can
be used to label the products but do not prescribe the exact terms or
phrases that must be used to label the product. For example, numerous
phrases may be used in labeling fabricated steaks, including ``beef
steak, chopped, shaped, frozen,'' ``minute steak, formed, wafer sliced,
frozen,'' or ``veal steaks, beef added, choppedmolded- cubed-frozen,
hydrolyzed plant protein, and flavoring'' (9 CFR 319.15(d)). Fabricated
steaks also may be labeled with other terms not specified in the
regulations.
In addition, some FSIS standards require specific label
information. For example, Italian sausage products that are cooked must
be labeled with the word ``cooked'' in the product name (9 CFR
319.145(c)), and cooked sausages, such as frankfurters, franks,
furters, or hotdogs, that are prepared with meat from a single species
of cattle, sheep, swine, or goats must be labeled with the term
designating the particular species in conjunction with the generic name
of the sausage (9 CFR 319.180(c)). The standard for poultry rolls
requires that when binding agents are added in excess of 3 percent for
cooked rolls and 2 percent for raw rolls, the common name of the agent
or the term ``binders added'' must be included in the name of the
product (9 CFR 381.159(a)).
Under FSIS's food standards regulations, products that do not
conform to a standard may not represent themselves as the standardized
food. However, such products still may be sold under another name. For
example, a beef stew that contains less than 25 percent beef can be
marketed as ``gravy, vegetables, and beef'' or ``chunky beef soup,''
but can not be identified as ``beef stew'' because the food standard
for meat stew requires that the product contain not less than 25
percent of meat of the species named on the label (9 CFR 319.304). A
product that does not meet the sausage standard (9 CFR 319.140) because
it contains more than 10 percent of added water in the finished product
may be marketed under another name, such as ``pork, water, and soy
protein concentrate link.''
Finally, in addition to its food standards regulations, FSIS has
established numerous informal or ``policy'' food standards for meat and
poultry products in the FSIS ``Food Standards and Labeling Policy
Book'' (Policy Book).
B. FDA Food Standards
FDA has established over 280 food standards of identity, some of
which include standards of quality and fill of container, under the
authority set forth in section 401 of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 341). This section provides in part:
Whenever in the judgment of the Secretary [of Health and Human
Services] such action will promote honesty and fair dealing in the
interest of consumers, he shall promulgate regulations fixing and
establishing for any food, under its common or usual name so far as
practicable, a reasonable definition and standard of identity, a
reasonable standard of quality, or reasonable standards of fill of
container.
The standards of identity, quality, and fill of container for foods
regulated by FDA are codified in title 21, parts 130 to 169 (21 CFR 130
to 169). FDA food standards establish the common or usual name for a
food and define the nature of the food, generally in terms of the types
of ingredients that it must contain (i.e., mandatory ingredients), and
that it may contain (i.e., optional ingredients). FDA food standards
may specify minimum levels of the valuable constituents and maximum
levels for fillers and water. They also may describe the manufacturing
process when that process has a bearing on the identity of the finished
food. Finally, FDA food standards provide for label declaration of
ingredients used in the food and may require other specific labeling,
such as the declaration of the form of the food, packing medium, and
flavorings or other characterizing ingredients, as part of the name of
the food or elsewhere on the principal display panel of the label.
Individual FDA food standards vary widely in their content. These
variations have developed because of the different aspects of food
technology that are responsible for providing the defining
characteristics of a food. Some foods are defined and distinguished by
their ingredients. The standards for these foods set specific limits on
the levels of ingredients that must be used. For example, the standard
of identity for fruit preserves and jams (Sec. 150.160 (21 CFR
150.160)) lists the minimum amount of fruit and sugar that these foods
must contain. Other food standards focus on compositional
characteristics of the food, rather than on the specific ingredients.
For example, the standards of identity for milk products (part 131)
list the minimum levels of milkfat and milk solids (excluding fat) that
must be contained in these foods. Still other foods owe their
distinctive characteristics to the manner in which they are produced,
and the standards for these foods reflect this fact. For example, the
standards of identity for cheese products (part 133) specify the
manufacturing process, in addition to compositional characteristics, to
distinguish one cheese from another. Some other foods are defined by
their physical characteristics. For example, particle size is an
important factor in distinguishing cracked wheat from crushed wheat,
and the standards of identity for these foods (Sec. 137.190 and
137.195, respectively) include methods of analysis for the
determination of the particle size of these foods. Depending on the
level of detail necessary to define the characteristics of the food,
some food standards of identity consist of only a few paragraphs (e.g.,
sap sago cheese in Sec. 133.186), while others are longer. For
example, the canned tuna standard (Sec. 161.190) covers approximately
eight pages in the CFR and prescribes the vegetables that must be used
if the tuna is seasoned with vegetable broth.
FDA's food standards of quality set minimum specifications for such
factors as tenderness, color, and freedom from defects for canned
fruits and vegetables. Such characteristics would not be readily
apparent to the purchaser of these foods because of the nature of the
foods and the manner in which they are presented to the consumer
(inside a can). FDA food standards of fill of container set out
requirements as to how much food must be in a container. These
requirements are particularly important when foods are packed in
liquids and sealed in opaque containers.
In a manner similar to the FSIS food standard regulations, FDA's
food standard regulations do not permit products that do not conform to
a standard to be represented as the standardized food; such products,
however, may be sold under other nonstandardized names. For example, a
fruit product that does not meet the standard of identity for fruit
preserves and jams (Sec. 150.160), because its fruit content is lower
than the standard requires, may be marketed under another name, such as
``fruit topping.''
[[Page 29217]]
C. Advance Notices of Proposed Rulemaking
In 1995, FSIS and FDA began reviewing our regulatory procedures and
requirements for food standards to determine whether food standards
were still needed, and if so, whether they should be modified or
streamlined. To initiate this review, we published advance notices of
proposed rulemaking (ANPRMs) on food standards (60 FR 67492, December
29, 1995 (FDA), and 61 FR 47453, September 9, 1996 (FSIS)). These
ANPRMs discussed regulations and policy governing food standards, the
history of food standards, and the possible need to revise the food
standards.
In the ANPRMs, we identified problems with existing food standards.
Specifically, we stated that some food standards might impede
technological innovation in the food industry. FSIS stated that the
existing food standards also may prevent the food industry from
producing products that have lower amounts of constituents associated
with negative health implications, such as fat, saturated fat,
cholesterol, and sodium (61 FR 47453). FDA stated that manufacturers of
nonstandardized foods are developing new ingredients and plant
varieties to enhance a food's organoleptic or functional properties,
alter its nutritional profile, or extend shelf life. Incorporation of
these advances into standardized foods may be difficult without the
laborious amendment of the relevant standard (60 FR 67492).
In the ANPRMs, FDA and FSIS presented alternatives to the existing
food standards. The alternatives presented by FSIS included permitting
the use of a lesser amount of meat or poultry in standardized products
provided the product's label contained a declaration of the percentage
of the meat or poultry content in the product; establishing a general
standard of identity for standardized products that would provide for
deviations from current ingredient allowances and restrictions
(deviations would be highlighted in the ingredient statement on the
product label); establishing categories of meat or poultry products and
corresponding recommendations for expected meat and poultry contents;
amending the statutes to allow private organizations to certify that
food products meet consumer expectations; and revoking existing food
standards and regulating all foods as nonstandardized foods (61 FR
47453).
The alternatives presented by FDA included revoking existing food
standards and regulating all foods as nonstandardized foods; requiring
that products declare the percentage of all major ingredients on the
label; requiring that products declare the percentage of characterizing
ingredients in the food name; identifying ``parent'' products with
minimum compositional requirements (for example, creating a standard
for jam or jelly that specifies minimum fruit content requirements) to
avoid misleading use of percentage declaration on the food label;
establishing generic food standards (such as the standards of identity
for hard cheeses (Sec. 133.150) and spiced, flavored standardized
cheeses (Sec. 133.193)); amending the statute to allow private
organizations to certify that food products meet consumer expectations;
and requiring appropriate labeling of foods that deviate from
government quality standards (60 FR 67492).
In the ANPRMs, the agencies asked for comments on the benefits or
lack of benefits of the food standards regulations in facilitating
domestic and international commerce and on the benefits of the food
standards regulations to consumers. We asked how the food standards
could be revised to grant the flexibility necessary for timely
development and marketing of products that meet consumer needs, while
at the same time providing consumer protection. We also asked for
comments on the alternatives to the food standards presented in the
ANPRMs and whether to coordinate efforts to revise the food standards
regulations.
D. Comments to the ANPRMs
FSIS received 28 letters, each containing one or more comments,
from industry, consumers, a consumer group, and the U.S. Department of
Agriculture (USDA) Food and Consumer Service (FCS) (now known as Food,
Nutrition, and Consumer Services) in response to its ANPRM. FDA
received 95 letters, each containing 1 or more comments, from industry,
consumers, consumer groups, and the USDA FCS in response to its ANPRM.
Most comments to both ANPRMs strongly supported the concept of food
standards, while a few requested that standards be eliminated. However,
very few comments to both ANPRMs supported the existing food standards
as currently written. The types of concerns expressed in the comments
to the ANPRMs follow.
Many of the comments that supported retaining food standards stated
that they protect consumers from fraudulent and substandard products by
establishing the basis upon which similar products are formulated.
Others argued that food standards ensure that products meet consumers'
nutritional expectations and needs. Several comments from industry, a
consumer, and two consumer groups stated that nutrition labeling and
ingredient declarations cannot substitute for food standards, as
reliance on nutrition labeling and ingredient declarations would be a
burden to consumers.
Several industry comments that supported food standards also stated
that the Federal food standards ensure a level playing field for
industry because they provide direction to industry members producing
standardized products. Several industry comments and one comment from
the USDA FCS also stated that, in the absence of Federal food
standards, the States would be able to establish their own food
standards and manufacturers would be confronted with the challenge of
meeting different States' requirements. In addition, many industry
comments stated that the food standards provide a basis for
negotiations related to the international harmonization of standards
and facilitate international trade. One comment stated that, without a
U.S. food standards system, food standards development could shift to
international bodies, which may not be sensitive to the American
consumer or industry. Another comment stated that the absence of food
standards could pose a barrier to exports and international markets.
Although most comments supported retaining food standards in some
form, they requested that food standards be simplified, be made more
flexible, or be clarified. For example, one industry comment stated
that food standards should not include manufacturing methods,
prohibitions regarding classes of ingredients, or product-specific
labeling (other than the acceptable product name). This comment also
stated that standardized and nonstandardized food product labeling
should be the same. Similarly, other industry comments requested that
the food standards be made more flexible to allow for alternative safe
and suitable ingredients and alternative technologies that do not
change the basic nature or basic characteristics of the food. Several
industry comments recommended limiting food standards to the name of
the product and the essential characterizing properties of the product.
Several industry comments to FSIS's ANPRM recommended that food
standards be limited to meat and poultry content requirements.
Conversely, other industry comments to FSIS's ANPRM recommended that
[[Page 29218]]
industry be given the flexibility to reduce the percentage of meat in
standardized products.
Several industry comments and a consumer comment to FDA's ANPRM
recommended that FDA revise certain specific food standards (e.g.,
jams, jellies, preserves, milk chocolate, and sweetened condensed milk)
to provide more flexibility in food technology and ingredient options.
In response to FSIS's and FDA's requests for suggestions as to how
they should revise food standards, several comments from industry and
from a consumer group recommended rescinding or modifying them on a
case-by-case basis. Some comments from industry recommended instituting
advisory committees, contracting with independent groups, or forming
nongovernment groups to revise the food standards. Further, several
industry comments recommended establishing general or ``guiding''
principles or a fundamental philosophy for reviewing food standards and
revising them. Other industry comments and a consumer group suggested
that revisions to standards should be initiated by petitions and
supported by adequate data. Finally, several comments to both ANPRMs
stated that FSIS and FDA food standards should be consistent, and that
we should attempt to harmonize our efforts to revise the food
standards.
Comments to FSIS's alternatives: Few comments supported the
alternatives to food standards that FSIS presented in its ANPRM. A
consumer organization was opposed to all of the alternatives presented
in the ANPRM. Several trade groups specifically stated their opposition
to percentage labeling. One of these groups stated that products would
be cheapened if this alternative were allowed. The USDA FCS comment
stated that percentage labeling had merit, but that this alternative
does not address all the factors that might make a product inferior in
quality. The USDA FCS comment-and several industry comments that
generally opposed the other alternatives presented in the ANPRM-
expressed support for the general standard alternative that would
provide for deviations from current ingredient allowances and
restrictions. These comments stated that this approach would allow
consumers to discern differences between the standardized product and
the modified version. One of these comments stated that this approach
may not allow enough ingredient deviations in standardized products.
Another of these comments stated that a general standard's approach
should expressly permit reduction of meat and poultry content in
standardized products. Many of the industry comments opposed private
certification that food products meet consumer expectations.
Comments to FDA's alternatives: Several comments opposed the
alternatives presented in FDA's ANPRM. One trade association stated
that percentage labeling was not an adequate substitute for standards.
One industry comment stated that percentage labeling might be
acceptable if it provided for the marketing of ``heavily breaded
shrimp'' without requiring ``imitation'' labeling but that any other
use of percentage labeling would be too cumbersome and could give away
proprietary information. The USDA FCS comment stated that percentage
labeling has merit but does not address all of the factors that could
make a product inferior in quality. Another alternative that was
presented in conjunction with percentage characterizing ingredient
labeling was to identify a ``parent'' product, for example, a
standardized jam or jelly that complies with minimum compositional
requirements, to avoid misleading use of the percentage declaration on
a food label. In response, one industry comment stated that this
approach might be useful, but would not be adequate to replace all
standards. Another industry comment stated that minimal compositional
standards are necessary to provide a benchmark to ensure product
integrity and to satisfy consumer expectations. Comments also opposed
the alternative of extending the generic food standard concept (such as
the existing standard of identity for hard cheeses (Sec. 133.150) or
the generic standard for nutritionally modified versions of traditional
standardized foods in Sec. 130.10 (21 CFR 130.10)) to other classes of
food standards. Two industry comments stated that generic food
standards should not be used to create standards for nonstandardized
foods, while another industry comment stated that the current generic
standards in Sec. 130.10 were adequate. On the other hand, an industry
comment stated that generic standards in addition to those covered in
Sec. 130.10 could be beneficial to maintain product characteristics.
Similarly, the USDA FCS stated that the generic standards approach has
merit. With regard to the alternative of requiring that foods that
deviate from government quality standards be labeled appropriately, one
comment stated that foods that deviate from standards should be named
so that they are readily distinguishable from the standardized food.
Another comment stated that current labeling requirements provide
sufficient information concerning deviation from standards. While two
industry comments supported private certification of foods that meet
consumer expectations, most comments opposed this alternative.
E. Options in the Food Standards Modernization Process
As noted previously, several comments recommended that FDA and FSIS
establish general principles or a fundamental philosophy for reviewing
food standards and revising them. The agencies agree with these
comments supporting the development of general principles for reviewing
and revising food standards regulations and also agree with the
comments that stated that the agencies should work in concert to
develop consistent food standards regulations.
On September 12, 1996, FDA convened an internal agency task force
to discuss the current and future role of food standards and to draft a
set of principles for reviewing and revising FDA's food standards
regulations. The task force agreed that the food standards should
protect consumers without unduly inhibiting technological advances in
food production and marketing.
To ensure that FSIS and FDA were consistent as the food standards
reform process continued, in January 1997, a joint FDA and FSIS Food
Standards Work Group (the Work Group) was convened, chaired by the
Director of the FDA's former Office of Food Labeling (now incorporated
into the Office of Nutritional Products, Labeling, and Dietary
Supplements) and the Director of the FSIS Labeling and Compounds Review
Division (now the Labeling and Consumer Protection Staff). The Work
Group revised the principles that the FDA task force had developed to
reflect the goals and needs of both agencies.
In addition to developing these general principles, the Work Group
considered five options, as the next step in the process of food
standards reform, and analyzed the advantages and disadvantages of each
option. The first option the Work Group considered was not proceeding
any further with the review of the food standards regulations. The
advantage of this option is that, in the short run, it would require
little or no increase in the agencies' use of resources.
A major disadvantage of this option is that there is very little
industry or consumer support for it. As noted previously, the majority
of comments supported revising the existing system of food standards to
simplify them and
[[Page 29219]]
to make them more flexible. In addition, even if this first option were
adopted, we would need to continue to expend resources interpreting and
enforcing food standards that may be outdated. Additionally, a system
of food standards that does not allow technological advancement in food
production may not be in the long-term interest of consumers. If we do
not revise the food standards, FDA would need to continue to devote
resources to temporary marketing permit (TMP) applications, which allow
companies to sell products that deviate from established food standards
while testing the marketplace for consumer acceptance of the new
product (Sec. 130.17), and both agencies would need to devote
resources to keeping their respective standards systems functioning. In
the long run, demands on each agency's resources would likely increase
as technological and marketing advances conflict with the requirements
in the existing food standards regulations. However, if food standards
were revised to provide flexibility in manufacturing, the number of TMP
applications would be reduced and agencies' resources conserved.
Finally, not reviewing or revising food standards to ensure that they
are current with international food standards, as appropriate, could
create difficulties in international negotiations and trade.
The second option the Work Group considered was removing all food
standards from the regulations and treating all foods as
nonstandardized foods. One advantage of this option is that, in most
cases, fewer agency resources would be required to eliminate food
standards than to review and revise them. Also, under this option, we
no longer would devote resources to responding to petitions requesting
an amendment to an existing standard or the establishment of a new food
standard.
As with the first option, however, very few comments on the ANPRMs
supported eliminating food standards completely. We agree with the
comments that stated that States might establish their own food
standards in the absence of Federal food standards. For meat and
poultry products, if there were no Federal standards, States with their
own meat and poultry inspection programs could have State standards for
meat and poultry products and these would only apply to products
produced at establishments within the State that are distributed within
the State. Such food standards for meat and poultry products could
differ from State to State. For FDA-regulated food products, if there
were no Federal food standards, States would be free to create their
own standards which might differ from each other, making compliance by
manufacturers more difficult. Without Federal food standards, there
would be no reference point for ensuring consistency of products for
national commodity programs or feeding programs, such as the National
School Lunch Program. In addition, as comments stated, without Federal
food standards, the United States would have no reference point for
negotiating international food standards, or facilitating international
trade.
Another disadvantage of this option is the loss of enforcement
efficiency. Without food standards, we would have to rely solely on the
general adulteration and misbranding provisions of our statutes rather
than upon the specified requirements of a food standard to determine if
a product were economically adulterated (i.e., adulterated under Sec.
402(b)(1)) or misbranded. This would likely require more enforcement
resources than a food standards system would require.
The third option the Work Group considered was using our resources
to review and revise food standards to make them internally consistent,
more flexible for manufacturers and consumers, and easier to
administer. The majority of comments supported this option and several
provided specific suggestions concerning regulatory revisions. If we
were to revise the food standards, we would ensure that the revisions
reduced the burden on industry and ensured adequate protection of
consumers. The disadvantage of this option is competing priorities
would make it unlikely we could do this in a timely manner.
The fourth option the Work Group considered was to request external
industry groups to review, revise, and administer the food standards
(private certification). This option would require little or no use of
the agencies' resources. In addition, the revised food standards would
provide the level of flexibility that industry desires. However, for
private organizations to review, revise, and administer the food
standards, the act, FMIA, and PPIA would have to be amended, so that
these standards would have the force of law.
Although a few industry comments supported private certification of
food standards, most comments to the ANPRMs opposed private
certification. In addition, the Work Group determined that this option
might not provide a mechanism for consumer input, unless required by
legislation. Therefore, consumers' interests would not necessarily be
reflected in the revised food standards, which might result in the
standards failing to promote honesty and fair dealing in the interest
of consumers or to protect the public. Also, food standards for which
industry was unwilling to commit resources would not be revised. Under
this option, there might be no mechanism for resolving conflict, should
it arise, among industry segments, unless legislative changes provided
such a mechanism. Furthermore, we determined that food standards
established and maintained by industry would be voluntary, not
mandatory, unless legislative changes authorized industry to establish
and maintain the standards.
The fifth option the Work Group considered was to rely on external
groups-consumer, industry, commodity, or other groups-to draft
recommended revisions to existing Federal food standards but retain the
agencies' authority to establish the final food standards. Under this
option, we would continue to codify the food standards in our
respective regulations. The external groups would use the general
principles put forward by us to draft new food standards and would
submit these in petitions. Similarly, external groups would use the
general principles to draft revised food standards or to propose
eliminating existing food standards. We would review any petitions
submitted to ensure that they were consistent with the general
principles. Under this option, if we determined that a petition to
establish, revise, or eliminate a standard was consistent with the
general principles, and provided adequate data and support for the
suggested change, we would more quickly propose and, when appropriate,
finalize a new or revised and simplified standard or the elimination of
a standard.
One major advantage of this option is that it would require the use
of fewer of our agencies' resources than would be required if we were
to review and propose amendments to the food standards without the
benefit of petitions. In addition, this option allows for the
participation of consumer groups and an opportunity for them to express
interest through the petition process and through the submission of
comments in response to proposed rules on new or revised food
standards. Because we would have ultimate authority and jurisdiction
over the final food standard established or eliminated, we would ensure
that consumer interests were protected. Another advantage of this
option is that it would rely largely on information from those groups
that have the most interest in, and knowledge of, the particular food
standards being
[[Page 29220]]
considered for revision. These groups could draw on technical experts
with knowledge of current production practices and marketing trends who
could suggest which aspects of a specific standard are necessary to
define the essential characteristics of a particular food. This
approach would also likely result in consistent food standards because
the general principles would govern all changes that are made to the
standards.
The disadvantage to this fifth option is that, if a consumer,
industry, or commodity group does not feel strongly about revising a
particular group of food standards, we might not receive a petition and
would then need to commit resources to reviewing the food standards
without the benefit of a petition. However, comments to the ANPRMs and
informal communications with external groups following publication of
the ANPRMs indicate the willingness of consumer, industry, and
commodity groups to submit for our consideration complete and thorough
revisions for many food standards. In the event we do not receive a
petition requesting that we revise, revoke, or establish a food
standard, we, on our own initiative, may, when appropriate, propose to
revise, revoke, or establish a standard.
For the reasons discussed previously, we have tentatively
determined that the fifth option is the most appropriate course of
action. The Work Group preliminarily determined that we could rely on
external groups to suggest new food standards, revisions to existing
food standards, or elimination of certain food standards that are
consistent with the proposed general principles. The general principles
approach would allow us to chart the basic course of food standards
review and modernization. Moreover, it would allow consumer and
industry groups to participate in the development of new and revised
food standards and to identify food standards that should be
eliminated. In addition, it would provide an opportunity for consumer
and industry groups to submit data to support any claims made in
petitions relating to consumer expectations or beliefs, and hence,
protect consumer interests.
F. Consumer Research
To gain a preliminary understanding of current consumer attitudes
toward Federal food standards of identity and the usefulness of food
standards to consumers, we funded a series of focus group discussions
(FGDs) that were conducted by the Research Triangle Institute, North
Carolina. A total of 64 household grocery shoppers were recruited to
participate in 8 FGDs held, 2 each in 4 cities: Raleigh, NC; San Diego,
CA; Philadelphia, PA; and St. Louis, MO. Male and female participants
were selected to represent diversity in age, level of education, and
race. The purpose of this research was to collect the following
information on consumers: (1) Attitudes toward arguments for and
against standards of identity regulations; (2) preferences for
standards of identity regulations for different types of food products;
(3) preferences for various types of requirements in standards of
identity regulations; (4) preferences for possible alternatives to
standards of identity regulations; and (5) attitudes towards the
standards setting process and suggestions for improving it.
The FGDs revealed that the opinion of participants on standards of
identity varied widely ranging from those who felt that such standards
are always necessary to those who felt that such standards are never
necessary. However, the FGDs did not generate sufficient data to
explain the basis for these differences. The majority of participants
at these FGDs supported the need for food standards to ensure product
quality and protect consumers, and opined that food standards should
not be eliminated. Some participants stated that standards were
necessary to ensure that products are named and labeled appropriately,
and that food standards would allow consumers to base purchase
decisions simply on the name of the product. Some participants also
stated that standards should be based on consumers' beliefs about
minimum acceptable levels of product characteristics and were concerned
that a lack of standards would lead to increased shopping time and
costs associated with trying different brands of a particular food to
find one that meets their expectations. A majority of participants also
indicated that food standards help ensure a certain degree of product
uniformity.
However, some participants did not support the use of food
standards. A few participants in the FGDs questioned the need for
standards. With respect to quality provisions in standards, some
participants stated that they prefer variety over a set standard
quality of a food product; they also felt that some consumers might
value the ability to choose a product of lower quality at a reduced
price. These participants believed that standards were not necessary
because consumer expectations of essential product characteristics and
product quality can vary, and normal market forces, including the
ability of a product to meet consumers' expectations, will determine
whether it stays on the market. Therefore, they maintained that
government oversight over product quality and uniformity was not
needed. Some of these participants asserted that food standards do not
serve consumers because they do not reflect the diversity of consumer
expectations and beliefs, and restrict product choice and innovation.
In addition to being asked whether they support or oppose the need
for food standards, participants were asked which food products or
characteristics of food products it was most important to standardize
and monitor. In response, participants stated that they considered food
standards to be most necessary for foods with multiple, unrecognizable
ingredients (e.g., cheeses or hot dogs) and least necessary for foods
with a single, recognizable ingredient (e.g., milk or canned corn).
Many participants identified requirements for the types and amounts of
ingredients and the quality of a product as the most important ones of
a food standard, while the physical characteristics of a food were
stated as least important.
Additionally, several participants suggested that we review food
standards periodically and revise them as needed on a case-by-case
basis to accommodate changes in consumer preferences and reflect
advances in processing and ingredient technologies. Finally,
participants expressed the need for FSIS and FDA to obtain input from
consumers during the process of establishing and revising food
standards so consumers' preferences and beliefs are accurately
reflected in food standards (Refs. 1 and 2).
Overall, although the opinion of participants on standards of
identity varied widely, some tentative conclusions can be drawn. Many
participants found standards of identity to be valuable. Participants
stated that having uniform product names for products with certain
defined characteristics makes shopping easier. Many participants also
felt that standards of identity help ensure a product has its expected
characteristics. Most participants did not agree that standards hinder
the variety of products available on the market. In general,
participants felt that it was more important for standards to address
characteristics that participants could not readily observe (such as
ingredients in products with multiple, unrecognizable ingredients)
rather than characteristics they could observe (such as appearance,
size, or number). Participants also stated that standards of
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identity should be based on consumer beliefs and expectations about the
product that are implied by a product's name and its minimum acceptable
characteristics. In addition, participants believed that standards
should be periodically revised to accommodate changes in consumer
beliefs and technological advances. Most participants also expressed
the desire for consumers to play a role in the development or revision
of standards and did not feel that the government should rely solely on
input from industry. Although tentative, and drawn from the limited
focus group research data that is available, these conclusions provide
support for the general principles discussed in section II of this
document.
II. The Proposed General Principles
We are proposing general principles for establishing new food
standards and for revising or eliminating existing food standards. In
the list of proposed general principles for both of our agencies, the
first four state the purpose or function of a food standard, and the
remaining principles state how the requirements of a food standard
should be written and what should be incorporated, in general, in the
standard. Although the general principles have been developed to be
consistent between our two agencies, they are not identical. Because
FSIS and FDA regulate different products, principles that are specific
to a particular agency were developed to reflect that agency's
regulatory needs and perspectives.
FSIS is proposing to establish 9 CFR 410.1(a) and FDA is proposing
to amend 21 CFR 130.5(b) to include these new general principles. Under
this proposed rule, the agencies will deny a petition to establish a
food standard if the proposed food standard is not consistent with all
of the general principles that apply to the proposed standard. The
agencies recognize that not all of the general principles will be
applicable to every food standard. The agencies will deny a petition to
revise an existing standard if the proposed revision is inconsistent
with any of the general principles that apply to the proposed revision.
Under this proposed rule, when proposing a revision to a standard,
petitioners will not be required to propose all the revisions that
might be needed to modernize the entire existing standard. Rather, the
petitioner may propose only limited changes to existing standards,
provided the proposed revisions are consistent with the general
principles that apply to them.
The first four general principles state the purpose or function of
a food standard. These principles are the most fundamental principles
addressing consumer protection from an economic standpoint. Therefore,
the agencies are proposing to deny a petition to eliminate a food
standard if the petition does not demonstrate how the standard proposed
to be eliminated is inconsistent with any one of the first four general
principles. As stated in section I.B of this document, the act
explicitly states that regulations establishing food standards of
identity shall be issued when such action will ``promote honesty and
fair dealing in the interest of consumers'' (21 U.S.C. 341). In
addition, as stated in section I.A of this document, the FMIA and PPIA
require that standards of identity or composition established under
these acts be consistent with standards of identity, quality, or fill
of container established under the act. Also, as stated previously, the
FMIA and PPIA authorize the Secretary of Agriculture, after
consultation with the Secretary of Health and Human Services, to
prescribe definitions and standards of identity or composition for meat
and poultry products whenever he or she determines that such action is
necessary for the protection of the public. Therefore, all of the
general principles set forth in this proposal have been designed to
achieve the goals of promoting honesty and fair dealing in the interest
of consumers and protecting the public. This is further explained as
each individual or group of general principles is discussed below.
Consistent with section 401 of the act, section 457(b) of the PPIA, and
section 607(c) of the FMIA, the first four proposed general principles
primarily address consumer protection from an economic standpoint.
These first four principles are consistent with the findings of the
focus group studies where a majority of participants maintained that
food standards are needed to ensure product quality and uniformity and
to protect consumers from economic deception. The first general
principle listed under proposed 9 CFR 410.1(a)(1) and 21 CFR
130.5(b)(1) makes it explicit that FSIS' purpose for a food standard is
to protect the public and FDA's is to promote honesty and fair dealing
in the interest of consumers. Food standards would provide a system by
which consumer interests are protected and consumer expectations of a
food are met. Historically, food standards have been beneficial because
they provide assurance to consumers of product uniformity with respect
to certain significant characteristics of standardized foods, resulting
in the expectation and belief of consumers that all products bearing a
particular name will possess the same essential characteristics,
irrespective of where they are purchased, or by whom they are
manufactured or distributed. Thus, to ensure that consumers are not
misled by the name of the food, to meet consumers' expectations of
product characteristics and uniformity, and, in turn, to promote
honesty and fair dealing in the interest of consumers and to protect
the public, a food standard should, as stated in proposed 9 CFR
410.1(a)(2) and 21 CFR 130.5(b)(2), describe the basic nature of the
food. The basic nature of the food is directly related to consumer
expectations and beliefs about the food.
Also, to promote honesty and fair dealing in the interest of
consumers and to protect the public, proposed 9 CFR 410.1(a)(3) and 21
CFR 130.5(b)(3) would state that the food standard should reflect the
essential characteristics of the food. While the basic nature of a food
is directly related to consumer expectations and beliefs about the
food, the essential characteristics are the attributes of a food that
make the food what it is even though they may not be readily apparent
to the consumer. The essential characteristics of a food are those that
define or distinguish a food or describe the distinctive properties of
a food. Further, the essential characteristics of a food may contribute
to achieving the basic nature of the food or may reflect relevant
consumer expectations of a food product. Foods may be defined or
distinguished by their ingredients, compositional characteristics,
physical characteristics, levels of certain nutrients, or the manner in
which they are produced--all of which are the essential characteristics
of a food. For example, the essential characteristics of a hotdog
include a certain fat and moisture content, and the use of water or ice
to form an emulsion, whereas the basic nature of a hotdog is that it is
a comminuted, semisolid sausage prepared from one or more kinds of raw
skeletal muscle meat and/or cooked poultry meat. Similarly, the
essential characteristics of a particular type of cheese may include
the bacterial culture used, the processing method, and the fat and
moisture content that contribute to the unique characteristics of that
cheese and the basic nature of that cheese is that it is a milk-derived
food of a certain form and consistency. Likewise, the essential
characteristics of wheat flour
[[Page 29222]]
include granulation requirements (the percentage of flour that has to
pass through a certain sieve size), its moisture content, and its ash
content, whereas the basic nature of wheat flour is that it is a ground
product of cleaned wheat grain. Therefore, although the essential
characteristics of a food may contribute to achieving the basic nature
of that food or may be relevant to meeting certain consumer
expectations about the food, they differ from the basic nature of the
food in that consumers may not be aware of the essential
characteristics that make the food what it is.
Preserving the basic nature and essential characteristics of a food
would promote honesty and fair dealing in the interest of consumers and
protect the public by ensuring that consumer expectations of the
economic and nutritional value of a food are met. Historically, food
standards have been adopted to protect consumers of traditional foods
from deceptive, inferior quality products of lesser economic value.
Current food standards ensure the economic value of a food. For
example, the standards of identity for cheeses (part 133) specify milk
solids or milkfat content requirements to prevent the substitution of
less valuable ingredients for more valuable ingredients.
In addition to ensuring the economic value of a food, FDA food
standards, on occasion, also may serve to ensure the nutritional
quality of a food by imposing requirements in addition to the labeling
requirements in part 101 (21 CFR part 101). For example, the
requirements for mandatory addition of vitamin D to evaporated milk and
of vitamin A to margarine are specified within the standards of
identity for these foods (Sec. Sec. 131.130 and 166.110,
respectively). These nutritional requirements are an integral part of
the standards of identity of these two foods and are not regulated
under FDA's other nutritional quality provisions, such as its nutrient
content claims regulations (part 101). The use of food standards as
vehicles to improve the nutritional quality of the food supply has
always been based on documented public health need and substantiated
with sound science to ensure that, within the context of the total
diet, the food is suitable for its intended use with reasonable
assurance of effectiveness and safety in achieving the nutritional
goals. FDA will continue to apply this standard for any future use of
standardized foods or any other food as a vehicle to improve the
nutritional quality of the food supply.
Numerous FSIS standards specify the minimum amounts of meat and
poultry and maximum amounts of fat or other ingredients a product may
contain. These provisions ensure both the economic value and
nutritional quality of standard meat and poultry products.
Therefore, proposed 9 CFR 410.1(a)(4) and 21 CFR 130.5(b)(4) state
that the food standard should ensure that the food does not appear to
be better or of a greater value than it is. Additionally, the food
standard may be used as a vehicle to improve the overall nutritional
quality of the food supply.
In addition to protecting the consumer, the next three proposed
general principles would promote clear and straightforward requirements
for food manufacturers. They would also promote, to the extent
feasible, flexibility in food technology.
Regulatory requirements written in plain and simple language
facilitate the manufacture of foods that comply with the regulations
and, thereby, help reduce manufacturers' costs of compliance and
government costs of enforcement. Lowered costs of producing foods that
meet the standards may potentially benefit consumers in the form of
lowered prices of products in the marketplace. Therefore, proposed 9
CFR 410.1(a)(5) and 21 CFR 130.5(b)(5) state that the food standard
should contain clear and easily understood requirements to facilitate
compliance by food manufacturers.
Establishing regulations that do not stifle innovations in food
technology and allow for technological alternatives and advancements in
food processing would improve manufacturing efficiency and lessen costs
which may be passed on to the consumer. Improved technologies may
additionally benefit product quality and diversity. Increased diversity
in, and potentially lower costs of, food products in the marketplace
that continue to meet consumer expectations would promote honesty and
fair dealing in the interest of consumers and protect the public.
Therefore, proposed 9 CFR 410.1(a)(6) and 21 CFR 130.5(b)(6) provide
that the food standard should permit maximum flexibility in the food
technology used to prepare the standardized food, so long as that
technology does not alter the basic nature or essential
characteristics, or adversely affect the nutritional quality, or safety
of the food. In addition, these provisions would state that the food
standard should provide for any suitable, alternative manufacturing
process that accomplishes the desired effect and should describe
ingredients as broadly and generically as feasible.
We are proposing the provision concerning flexibility in food
technology to ensure that any requirement of a standard accomplishes
its purpose without impeding technological advances that are not in
conflict with the intent of the requirement. For example, in FSIS's
current regulations, the standard for barbecued meats requires that
products such as ``beef barbecue'' or ``barbecued pork'' be cooked by
the direct action of dry heat (9 CFR 319.80). However, there may be
other cooking methods that result in the same product characteristics
that the direct action of dry heat achieves, such as infrared heating.
During FGDs, consumers expressed the need to revise food standards to
reflect current advances in food manufacturing technology, and we
believe that this general principle provides an avenue to keep food
standards current with technological advances.
In addition to addressing flexibility in food technology, proposed
9 CFR 410.1(a)(6) and 21 CFR 130.5(b)(6) would also state that the food
standard should provide for any suitable, alternative manufacturing
process that accomplishes the desired effect and should describe
ingredients as broadly and generically as possible. Examples of
standards that would permit flexibility in manufacturing processes
would be those that provided for any suitable procedure for removing
glucose from dried eggs, for instantizing flours, or for low-
temperature rendering of meat. We proposed that any food standard that
includes a specific manufacturing process should allow for alternative
procedures. If the manufacturing process specified in a food standard
is essential to the character of the food, the food standard should
allow for the use of any alternative procedure that yields a product
with the same physical, nutritional, and sensory characteristics as the
food made according to the traditional procedure specified in existing
food standards.
To allow for flexibility in ingredients used to formulate
standardized products, the ingredients for frozen raw breaded shrimp,
for example, might be described to be ``batter and breading
ingredients'' (Sec. 161.175) and those in frankfurters, frank, furter,
hotdog, weiner, vienna, bologna, garlic bologna, knockwurst, and
similar products might be described to be ``byproducts and variety
meats'' (9 CFR 319.180). If it is necessary to specify ingredients, the
standard should specify these ingredients by functional use category,
e.g., ``stabilizers and thickeners'' or ``texturizers,'' rather than by
listing specific ingredients. Also, where appropriate, in accordance
with current
[[Page 29223]]
regulations, the specific levels of ingredients that can be used may be
modified if they reflect safe and suitable levels or those levels that
reflect good manufacturing practices.
The general principles would also promote uniformity between
Federal food standards and any international standards for the same
food. With the rising trend in globalization and increased
accessibility of U.S. goods to other nations' markets, efforts to
harmonize U.S. food standards with international food standards will
facilitate international trade and foster competition. These efforts
may also result in lowered costs and the increased diversity of the
food supply, which in turn would benefit consumers. Therefore, we are
proposing harmonization of U.S. standards with international food
standards to the extent feasible, while preserving the integrity,
quality, and economic value that U.S. consumers expect of the food.
Proposed 9 CFR 410.1(a)(7) and 21 CFR 130.5(b)(7) state that the food
standard should be harmonized with international food standards to the
extent feasible. If a food standard presented in a petition is
different from the requirements in a Codex standard for the same food,
we are proposing that the petition should specify the reasons for these
differences. This principle is consistent with FDA's existing
regulation, 21 CFR 130.6, which states that food standards adopted by
the Codex Alimentarius Commission will be reviewed by FDA, and either
will be accepted (with or without change) or will not be accepted. This
regulation also states that petitioners who petition FDA for a new or
amended food standard based on the relevant Codex food standard shall
specify any deviations in the requested standard from those in the
Codex standard and the reasons for any such deviations.
The next six proposed general principles promote simplicity,
brevity, and consistency in food standards. Providing regulatory
requirements that are simply and concisely stated and are consistent
among different foods would help improve efficiency and reduce the
costs of compliance by industry, as well as reduce enforcement costs by
regulatory agencies. Increased industry efficiency may also result in
lowered costs of food products. Unnecessary details and requirements in
a food standard not only burden enforcement and compliance efforts but
also limit manufacturing options and create inefficiencies. Therefore,
proposed 9 CFR 410.1(a)(8) and 21 CFR 130.5(b)(8) state that the food
standard provisions should be simple, easy to use, and consistent among
all food standards. This proposed principle also states that food
standards should include only those elements that are necessary to
define the basic nature and essential characteristics of a particular
food, and that any unnecessary details should be eliminated. As noted
in section I.B of this document, the existing FDA food standards vary
widely in their content and level of detail. In this principle, we are
proposing to make it clear that simplicity in, and consistency among,
food standards is essential. This proposed principle makes it clear
that any unnecessary details, such as details related to manufacturing
processes, ingredients, or variations of different forms of the same
food that are not necessary to define the basic nature and essential
characteristics of a food, should be eliminated from the standards
regulations. For example, in the FSIS food standards, the list of
curing ingredients in the corned beef hash standard (9 CFR
319.303(a)(3)) is an unnecessary detail because curing agents permitted
in meat products are listed in 9 CFR chapter III, subchapter E or in 21
CFR chapter I, subchapter A or B. Also, in addition to the standard for
corned beef hash, the FSIS regulations contain a standard for hash (9
CFR 319.302). It may not be necessary to have separate standards for
different forms of hash. An example of unnecessary detail in FDA food
standards may be the provision for nutritive carbohydrate sweeteners in
the standard for ``yogurt'' (Sec. 131.200), ``lowfat yogurt'' (Sec.
131.203), and ``nonfat yogurt'' (Sec. 131.206), which lists several
sweeteners, because nutritive sweeteners have been defined in Sec.
170.3(o)(21) (21 CFR 170.3(o)(21)). This provision could be
incorporated by simply using the functional category ``nutritive
carbohydrate sweeteners'' without listing the different sweeteners.
This general principle is consistent with the findings of FGDs
where participants expressed the belief that certain characteristics of
a food, such as its type and amount of ingredients, are the more
important elements of a food standard than certain other
characteristics of a food.
Proposed sections 9 CFR 410.1(a)(9) and 21 CFR 130.5(b)(9) state
that the food standard should allow for variations in the physical
attributes of the food. Also, this proposed principle states that where
it is necessary to provide for specific variations in the physical
attributes of a food within the food standard, the variations should be
consolidated into a single food standard. Thus, this provision would
promote simplification of food standards. For example, it is necessary
to provide for specific variations of cereal flours (e.g., flour,
bromated flour, instantized flour, and phosphated flour (21 CFR part
137)). According to this proposed principle, the variations for these
standards should be consolidated into a single food standard.
Similarly, existing provisions in FSIS's food standards for different
forms of ham (e.g., chopped, ground, flaked, chipped, and pressed for
cured ham products (``ham patties,'' ``chopped ham,'' ``pressed ham,''
``spiced ham,'' and similar products (9 CFR 319.105) and ``deviled
ham'' (9 CFR 319.760))) could be simplified or consolidated. In order
to promote food standards that are simple and consistent, proposed 9
CFR 410.1(a)(10) and 21 CFR 130.5(b)(10) state that, whenever possible,
general requirements that pertain to multiple food standards of a
commodity group should be incorporated into general regulatory
provisions that address the commodity group. For example, enrichment
requirements for cereal flours and related products might be codified
in a new subpart A of part 137 entitled ``General Provisions.''
Further, the methods of analysis relevant to different foods within the
same commodity group might be codified under the general provisions for
that commodity group. Additionally, the curing requirements common to
cured beef products could be codified in a new section at the beginning
of 9 CFR part 319, subpart D. When provisions are of a general nature
and affect more than one commodity group, we would consider codifying
these requirements all together in an appropriate CFR section. For
example, some fill of container requirements are codified in 21 CFR
part 100, subpart F (``Misbranding for Reasons Other Than Labeling'')
and apply to a wide array of products. Likewise, Sec. 130.10
Requirements for foods named by use of a nutrient content claim and a
standardized term permits the modification of a standardized food to
achieve a nutrition goal, such as a reduction in fat or calories. Such
modified foods may be named by the use of a nutrient content claim,
such as ``reduced fat'' and a standardized term, such as ``cheddar
cheese'' (i.e., reduced fat cheddar cheese). To further promote
consistency among food standards, proposed 9 CFR 410.1(a)(11) states
that any proposed new or revised food standard should take into account
whether there are FSIS labeling regulations or ingredient regulations
that are affected by, or that cover, the new or revised food standard.
FSIS is
[[Page 29224]]
proposing this principle so that any requirements of the standards are
consistent with other regulatory requirements. Similarly, proposed
Sec. 130.5(b)(11) states that any proposed new or revised FDA food
standard should take into account any other relevant regulations. For
example, a proposed new or revised food standard should be consistent
with common or usual name regulations for related commodities or
products. FDA is proposing this general principle to encourage the
grouping of similar food products when changes to food standards are
addressed, so that there is a consistent approach to establishing,
revising, and eliminating food standards in the regulations.
Separately from FSIS, FDA is further proposing within this general
principle (Sec. 130.5(b)(11)) that any specific requirements for foods
intended for further manufacturing should be incorporated within the
reference food standard rather than being established as a separate
food standard. FDA believes that any specific and important
requirements for foods that are to be manufactured further could be
incorporated within the standard for its particular reference food,
and, therefore, existing FDA standards for foods-for-further
manufacturing should be considered for elimination and incorporation
within the appropriate reference food standard. For example, important
elements of the requirements stated in the FDA food standard for cocoa
with dioctyl sodium sulfosuccinate for manufacturing (21 CFR 163.117)
could be incorporated as a separate paragraph within the standard for
its reference food (i.e., cocoa). Similarly, the requirements stated in
the FDA food standard, cheddar cheese for manufacturing (Sec.
133.114), could be incorporated into the food standard for cheddar
cheese. This proposed principle also applies to FDA food standards
where the differences between a standardized food and the same food-
for-further-manufacturing are minimized by processes used to make a
finished food from the food-for-further-manufacturing. Because FSIS
does not have standards for foods-for-further-manufacturing, there is
no parallel provision in FSIS's proposed general principle, 9 CFR
410.1(a)(11). Proposed 9 CFR 410.1(a)(12) and 21 CFR 130.5(b)(12) state
that food standards should provide the terms that can be used to name a
food and should allow such terms to be used in any order that is not
misleading to consumers.
Thus, under this proposed principle, the food standard should
provide the terms that can be used to name a food and should provide
that such terms can be used in any order that is not misleading, rather
than list every possible combination of terms that may be used to name
a standardized food (e.g., the nomenclature in the current FDA standard
of identity for wheat and soy macaroni product (21 CFR 139.140) and the
FSIS standard for braunschweiger and liver sausage or liverwurst (9 CFR
319.182)).
Proposed 9 CFR 410.1(a)(13) and 21 CFR 130.5(b)(13) state that the
names of ingredients and functional use categories in a food standard
should be consistent with other food standards and relevant regulations
and, when appropriate, incorporate current scientific nomenclature.
Functional use categories include, but are not limited to, emulsifiers,
sweeteners, antioxidants, stabilizers and thickeners, and texturizers.
We are proposing these provisions because some discrepancies exist in
the designated name of ingredients and the designated name of
functional use categories in different food standards written at
different times. For example, the standards for artificially sweetened
canned fruits in 21 CFR part 145, for frozen concentrate for
artificially sweetened lemonade in Sec. 146.121 (21 CFR 146.121), and
for artificially sweetened fruit jams, preserves, and jellies in part
150 are not consistent in the designated names of artificial sweeteners
permitted. Another example is the use of the terms ``thickening
ingredient'' in the standard for frozen concentrate for artificially
sweetened lemonade in Sec. 146.121 and ``bulking agents'' in the
standards for cocoa or sweet and milk chocolates and vegetable fat
coatings in 21 CFR part 163. Although these ingredients are designated
using different terms, both of them fall into the functional category
``stabilizers and thickeners'' as described in Sec. 170.3(o)(28). The
food ingredients regulations in 21 CFR chapter I, subchapters A and B
and in 9 CFR part 424 have specific names for different ingredients and
functional use categories, which should be incorporated into the
revised food standards.
To ensure that it is as easy as possible to monitor compliance with
food standards, FSIS is proposing 9 CFR 410.1(a)(14), which states that
the food standard should be based on the finished product. FSIS can
most easily assess the compliance with a food standard when it is based
on the finished product. For example, FSIS could verify that chicken
tetrazzini is comprised of 15 percent chicken by weighing the poultry
in the finished product (9 CFR 381.167). Some of the existing FSIS food
standards are based on products as they are formulated for processing,
such as when the ingredients are assembled for cooking. For example,
the standard for meat stews requires that stews such as ``beef stew''
or ``lamb stew'' shall contain not less than 25 percent of meat of the
species named on the label, computed on the weight of the fresh (that
is, uncooked) meat (9 CFR 319.304). Therefore, to assess compliance
with the standard, FSIS needs to observe the product's formulation or
it needs to review relevant establishment records. In these cases, FSIS
has traditionally monitored compliance at the point of formulation,
while it is being assembled for cooking. FSIS is considering doing more
of its consumer protection monitoring on a finished product basis,
which would include in-distribution monitoring for compliance with
standards.
FSIS believes that monitoring compliance with standards based on an
analysis of the finished product would protect the public because
consumers purchase products once they are finished, not at the point of
formulation. By enforcing standards for finished products, FSIS could
better ensure that products meet consumer expectations. In addition,
enforcing standards for finished products would reduce compliance costs
for FSIS, because monitoring for compliance when a product is in-
distribution requires less staff time and is, therefore, less expensive
for FSIS than monitoring compliance at the point of product
formulation.
FSIS requests comment on how it should determine the compliance of
a food with a standard based on the finished product. FSIS is
interested in verification methods that can be used when the product is
no longer in the plant. Any such verification methods will have to be
able to measure the important characteristics of the finished product.
Although FDA food standards establish certain requirements about
the product formulation, such as the ingredients or types of
ingredients permitted in the manufacturing of a food, the essential
characteristics of the food are based on the finished product, rather
than at the point of formulation or at intermediate stages during
manufacturing. Therefore, FDA does not believe there is a need for a
parallel provision for this principle in the proposed FDA food
standards principles.
FSIS is also proposing 9 CFR 410.1(a)(15), which states that the
food
[[Page 29225]]
standard should identify whether the product is ready-to-eat or not
ready-to-eat. FSIS is proposing this principle to ensure that
manufacturer, consumer, and agency expectations for the product are the
same. The existing FSIS food standards do not specifically require the
food conforming to the standard to be ready-to-eat or not ready-to-eat.
As part of its consumer focus group research, FSIS is asking whether
this information should be required to appear on the label of the
standardized food. FSIS believes that whether a product is ready-to-eat
or not ready-to-eat is part of the basic nature of the food.
Therefore, this proposed principle would protect the public by
ensuring that standardized products meet consumer expectations. Due to
the basic nature of standardized foods regulated by FDA, FDA does not
believe that there is a need for FDA food standards to address whether
the food is ready to eat or not. Therefore, there is no parallel
provision for this principle in the proposed FDA food standards
principles.
In proposed 9 CFR 410.1(b), FSIS is proposing that a petition to
establish a new food standard should include a comprehensive statement
that explains how the proposed new standard conforms to the general
principles that apply to the new standard. In addition, FSIS is
proposing that a petition to revise an existing food standard should
include a comprehensive statement that explains how the proposed
revision to the existing standard conforms to the general principles
that apply to the proposed revision. Also in proposed 9 CFR 410.1(b),
FSIS is proposing that a petition to eliminate an existing standard
should include a comprehensive statement that explains how the standard
proposed to be eliminated does not conform to any one of the first four
general principles. Similarly, in proposed Sec. 130.5(c), FDA is
proposing that, for petitions to FDA, this comprehensive statement
should be provided as part of the ``Statement of Grounds'' currently
required in a FDA citizen petition under 21 CFR 10.30.
The agencies are proposing that any revision to a food standard
proposed in a petition to revise an existing food standard must be
consistent with all of the general principles that apply to it.
Therefore, according to this proposed rule, petitioners could consider
proposing limited changes to existing standards. However, we recommend
that petitioners consider all of the general principles and suggest
appropriate changes to an existing standard that make that entire
standard consistent with all of the general principles that apply to
that standard.
If a petitioner proposes a revision that is consistent with the
general principles that apply to the proposed revision but the revision
does not include all of the changes that are needed to modernize the
entire standard, the relevant agency will review the entire existing
standard in light of all of the general principles to determine whether
revisions in addition to those that the petitioner has requested are
necessary to modernize the food standard. This process will ensure that
there is a complete and thorough review of the food standard to address
all relevant issues and incorporate all necessary revisions to the
standard at one time, rather than through multiple rulemakings.
Although we would not deny a petition solely because it proposed only
limited changes to a standard, provided the proposed changes are
consistent with the general principles that apply to them, it is likely
that we would more quickly publish a proposed and final rule revising
the standard, in response to a petition, if a petitioner has considered
an entire existing standard in light of all the applicable general
principles.
Finally, under proposed 9 CFR 410.1(c) and 21 CFR 130.5(d), we are
proposing that petitions seeking to establish or revise a food standard
that is not consistent with the applicable general principles will be
denied. In addition, we are proposing that petitions seeking to
eliminate a food standard that do not demonstrate that the food
standard is inconsistent with any one of the first four general
principles will be denied. The petitioner would be notified of the
reason for the denial.
We would encourage organizations or individuals submitting
petitions to establish, revise, or eliminate a food standard, under
these proposed regulations, to confer with different interest groups
(consumers, industry, the academic community, professional
organizations, and others) in formulating them. We would recommend that
petitioners seek out and document the support of consumers and industry
for any recommended changes to the standards regulations to encourage
communication with interested groups and to ensure broad support for
any proposed standards. Petitioners could document consumer and
industry support by including the written concurrence of
representatives of various consumer and industry groups in the
petitions submitted. Additionally, petitioners could include a
statement of any meetings and discussions that have been held with
interest groups. Appropriate weight would be given to petitions that
reflect a consensus of different interest groups.
However, under the present regulations, documentation of the
support of interest groups would not be an acceptable substitute for
the information or data that is needed to substantiate statements and
claims made in the petition. Thus, petitions that make claims about
consumer expectations or beliefs for the purposes of defining the basic
nature and essential characteristics of a food should also provide
information or data that substantiate those claims. Marketing data,
food formulary compilations, studies of restaurant menus, and consumer
survey and focus group research data are potentially acceptable data
sources to substantiate statements and claims made in the petition.
Finally, this proposed rule is not intended to and, when finalized,
will not by itself change the existing food standards nor result in the
complete modernization of all of the food standards; rather, it will
address the submission of petitions to establish, revise, or eliminate
individual food standards and the evaluation of such petitions by us.
The proposed general principles are the agencies' first step in
instituting a process to modernize their food standards. In the long
term, the agencies expect that all food standards, including those for
which the agencies receive no petitions to revise or eliminate, will be
modernized or eliminated. However, as noted in section I.E of this
document (see the third option that the Work Group considered), limited
resources and competing priorities make it unlikely that the agencies
could complete a comprehensive review of all food standards on their
own initiative in a timely manner. A more efficient means of
modernizing a food standard or a category of food standards is through
petitions that demonstrate that a food standard(s) has been reviewed
for consistency with the proposed principles. Thus, in the event we do
not receive a petition requesting that we establish, revise, or
eliminate a particular standard, we may, when appropriate, propose to
establish, revise, or remove a standard on our own initiative. We will
follow the proposed general principles as we review existing standards
to determine whether a standard should be established, removed, or
revised to ensure that all standards are consistent with the relevant
statutes and the general principles.
[[Page 29226]]
The agencies welcome petitions to consolidate variations in the
physical attributes in standardized foods within a single food
standard. We also welcome petitions to incorporate general requirements
that pertain to multiple food standards of a commodity group into
general regulatory provisions that address the commodity group (see
proposed general principles 9 CFR 410.1 (a)(9) and (10) and 21 CFR
130.5(b)(9) and (10)). However, the agencies recognize that developing
these types of petitions may require more time than developing
petitions that pertain to a single food standard. We request comment on
the best way to efficiently and effectively make standards consistent
with these two general principles. In particular, we are interested in
recommendations concerning the role we should take and the role the
public should take in revising the standards to make them consistent
with these two general principles.
FSIS intends to eliminate all informal or ``policy'' standards in
the Policy Book, which address the meat and poultry content of certain
products or define methods of processing, for which it does not receive
a petition requesting that it adopt the entry as a regulation. FSIS
intends to follow this course of action because few of the standards in
the Policy Book are consistent with the proposed general principles.
III. FSIS and FDA Requests for Information
After their submission of comments, a number of commenters on the
FSIS and the FDA ANPRMs have informally indicated that they would like
another opportunity to provide comments to us. This proposal provides
that opportunity.
We request comments both on the general principles and on how to
best implement them. In particular, we request comments on the
usefulness of the general principles for evaluating petitions for new
food standards and for revising or eliminating existing food standards.
We are also seeking comments on how to enhance the usefulness of the
principles as a guide to external groups or individuals in evaluating
and preparing petitions to establish, revise, or eliminate food
standards.
IV. Executive Order 12866: Cost Benefit Analysis
We have examined the economic implications of this proposed rule as
required by Executive Order 12866. Executive Order 12866 directs
agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). Executive Order 12866 classifies a
rule as significant if it meets any one of a number of specified
conditions, including having an annual effect on the economy of $100
million or more, adversely affecting in a material way a sector of the
economy, adversely affecting competition, or adversely affecting jobs.
A regulation is also considered a significant regulatory action if it
raises novel legal or policy issues. We have determined that this
proposed rule is a significant regulatory action as defined by
Executive Order 12866 because it raises novel legal or policy issues.
The Unfunded Mandates Reform Act of 1995 (Public Law 104-4), requires
cost-benefit and other analyses for significant regulatory actions.
Section 1532(a) of the Unfunded Mandates Reform Act of 1995 defines a
significant rule as ``any Federal mandate that may result in the
expenditure by State, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 (adjusted annually for
inflation) in any 1 year * * *'' We have determined that this rule is
not a significant rule under the Unfunded Mandates Reform Act.
A. Need for the Rule
Under some conditions, standards of identity may be economically
desirable because they reduce product search costs for consumers.
Standards can reduce search costs by requiring products that bear
certain standardized names to have the set of characteristics that most
consumers expect products bearing that name to have. In this document,
we call this set of characteristics the ``basic nature'' of a food.
Standards are most effective at reducing search costs when most
consumers' beliefs about the basic nature of a food are similar, and
less effective when many consumers have different beliefs about the
basic nature of a food.
However, as currently written, some standards may contain
requirements that do not contribute to this useful economic function
because they do not correspond to most consumers' beliefs or
expectations about the basic nature of those foods. Such standards may
increase, rather than decrease, overall search costs because they may
cause consumers to impute differences to products that do not actually
exist. Increasing search costs reduces product variety and inhibits the
introduction of new products because, if search costs increase, then
some consumers may be more willing to settle for familiar products
rather than spending additional time comparing products and examining
ingredient statements to find a product they prefer. Many new products
are developed specifically to enhance the healthfulness of traditional
products. Therefore, increasing search costs and inhibiting the
introduction of new products may also generate health costs for
consumers because, if search costs increase, then some consumers may be
more willing to settle for familiar products rather than spending
additional time comparing products and examining ingredient statements
to find similar but healthier products. In addition, standards that
contain unnecessary elements or that fail to provide flexibility in
terms of allowable food technology, may generate unnecessary production
costs, and impede technological innovation in the food industry. Such
standards may also serve as effective barriers to competition, thereby
raising product prices and transferring resources from consumers to
producers. Finally, some standards may be inconsistent with
international standards, which may impede international trade. Impeding
international trade may also restrict competition and lead to higher
product prices.
The benefits of appropriate standards and the costs of
inappropriate standards suggest that we need to develop: (1) A list of
principles that will govern our assessment of the standards; and (2) a
system to facilitate the timely revision, implementation, and
elimination of standards regulations, as appropriate.
B. Regulatory Options
We considered the following regulatory options:
1. Take no action;
2. Take the proposed action;
3. Eliminate all food standards;
4. Establish principles for assessing standards (only); and
5. Establish principles for assessing standards, but allow external
parties to administer those principles.
1. Option One: Take No Action
By convention, we treat the option of taking no new regulatory
action as the base line for determining the costs and benefits of the
other options. Therefore, we associate neither costs nor benefits with
this option. The consequences of taking no action are reflected in the
costs and benefits of the other options.
[[Page 29227]]
2. Option Two: Take the Proposed Action
The proposed action has two primary components: (1) The
establishment of a set of principles that we will use when assessing
food standards, and (2) a statement of the system by which we intend to
revise, eliminate, or establish standards in response to petitions
submitted by external parties or on our own initiative.
a. Benefits. One benefit of establishing a set of principles for
assessing food standards is that it simplifies our assessment of
standards. First, it eliminates the need for us to develop and explain
the basis for accepting or rejecting proposed changes to standards in a
piecemeal fashion. Establishing principles ensures that we use a
consistent and systematic approach when assessing standards.
A second benefit is that the principles apprise external parties of
the framework we intend to use when assessing standards, thereby
reducing the costs for external parties to petition us to change
standards. In the absence of principles, external parties would need to
spend time reviewing past rulemakings to piece together the factors we
consider relevant in assessing standards. Also, in the absence of
established principles, external parties may expend resources
developing petitions that we would be unable to accept, and we would
expend resources evaluating such petitions. If the principles allow
external parties to present more acceptable petitions, then we will be
able to act on the petitions more quickly and make necessary changes to
the standards regulations more quickly. This means that benefits for
consumers and industry will take place more quickly than would
otherwise have been the case. A third benefit is that establishing the
set of principles specified in this proposed rule ensures that we
assess standards with respect to their ability to reduce consumers'
search costs, while also reducing the likelihood that standards will
impose unnecessary costs, or reduce competition and thereby increase
prices.
The proposed rule would establish a system by which we intend to
revise, eliminate, or establish standards in response to petitions
submitted by external parties or on our own initiative and would
generate benefits by encouraging external parties to submit such
petitions. External parties may already submit such petitions, and we
already consider them. However, by stating that such petitions will
henceforth be the primary means for initiating changes to the
standards' regulations, we are making it clear to interested parties
that they should submit petitions if they desire changes in the
standards, rather than wait for us to act on our own initiative. The
total social costs of revising, eliminating, or establishing standards
are probably lower if external parties participate in the process than
if they do not because external parties are often in the best position
to identify problem areas. Such a system also transfers some of the
costs that we currently bear in assessing standards to private
individuals and groups, thereby allowing us to reallocate our resources
to issues that may have greater public health significance, while still
allowing us to address standards reform in a timely fashion. However,
this public health benefit is probably small because we have been
unable to devote significant resources to standards reform to date. We
do not know the net effect of this transfer on social costs because
private expenditures on standards also displace activity associated
with social benefits. We have insufficient information to quantify
these benefits. However, we will also conduct cost-benefit, regulatory
flexibility, and other relevant analyses for all proposed and final
regulations changing the standards regulations.
b. Costs. One of the potential costs of establishing the proposed
principles results from the possibility that we might finalize a set of
principles that do not maximize the net social benefits from standards
regulations. This could generate costs because we will be assessing the
standards with respect to those principles. If the principles in the
final rule do not maximize net social benefits within the statutory
framework of food standards, then we might deny some changes to the
standards that would have net social benefits, or might accept some
changes that would have net social costs. However, we believe that this
potential cost is small because we believe the principles as stated
maximize net social benefits, and because we can revise the principles
in response to comments or in subsequent rulemakings, if necessary.
A second potential cost of establishing the proposed principles
results from the inherent limitations of the approach to standards that
we have adopted in the proposed principles. Under the proposed
principles, a standard must reflect the basic nature of a food and its
essential characteristics.
Standards may accommodate certain variations of a food, provided
those variations preserve the basic nature of the food and its
essential characteristics. For example, shredded, grated, or diced
forms of cheese would be permitted because they do not alter the basic
nature of the food. However, this restriction may also generate certain
costs. For example, if we did not require that standards preserve the
basic nature of the food and its essential characteristics, the
information the standards provide for consumers might be reduced.
Without such restrictions, a particular standard might be able to cover
more diverse compositions of a particular food under a single name and
thus address a greater variety of consumer health and dietary needs and
preferences. Under this alternate approach, a ``cheese'' could be made
with non-milk ingredients to be free of lactose or milk protein, and
``bread'' could be made using soy flour to improve the protein
composition of the food. Under the proposed principles, such variations
of these foods would not be permitted because they do not preserve the
basic nature of these foods consistent with consumer expectations and
beliefs. Such foods, however, can be marketed using nonstandardized
names (although we recognize that, in some cases, having to market
under a nonstandardized name may be costly and, therefore, may create a
disincentive to create such foods). To the extent the proposed general
principles lead to an increase in the number of foods covered by
standards, the costs described here and other costs associated with
standards will increase.
Another potential cost of establishing a system to revise,
eliminate, or establish standards in response to petitions submitted by
external parties is that the goals and interests of such parties may
differ from our goals. For example, external parties that work for for-
profit entities will presumably submit petitions only if they believe
that the changes requested in their petitions will increase their
profits by more than the cost of preparing the petitions. Such parties
might request changes that raise profits in a manner consistent with
the proposed principles, such as by eliminating unnecessary or
inappropriate requirements, or in a manner that is inconsistent with
the proposed principles, such as by restricting competition or
preventing the introduction of new products or technology. Similarly,
external nonprofit (or not-for-profit) groups also may have incentives,
such as increasing their political visibility or funding, that cause
their goals to diverge from our goals. In both cases, we think this
cost will probably be small for three reasons. First, we will be able
to identify inappropriate recommendations during
[[Page 29228]]
the petition review process because they will be inconsistent with the
proposed principles. Second, we do not intend to accept statements
about consumer beliefs or expectations for the purposes of defining the
basic nature of a food without data or evidence supporting such
statements. Third, we will publish proposed rules for any prospective
changes to the standards regulations. Other interested parties will be
able to comment on those changes and help us identify any inappropriate
recommendations that we may have overlooked during our initial review
of the petition.
Another potential cost of establishing a system that relies
primarily on petitions submitted by external parties is that some
standards that ought to be revised, eliminated, or established may be
difficult for interested external parties to identify as such. This is
most likely to be a problem for standards that contain requirements
that do not reflect what most consumers believe is the basic nature of
those foods, but that also do not generate significant costs for
industry. Such standards may increase consumer search costs, inhibit
the introduction of new products, and indirectly adversely affect
consumer health. However, the typical consumer may have insufficient
knowledge of the existing standard or the effects of that standard and
thus not know to submit a petition requesting changes to the standard.
A similar situation exists with products that do not currently have a
standard, but for which a standard would generate potential benefits
for consumers. Again, the typical consumer may have insufficient
information or resources to submit a petition that establishes the case
for such a standard. We expect these costs to be small for the
following two reasons: (1) Consumer groups may have sufficient
resources and interest to investigate and submit petitions that include
information on consumer expectations and beliefs in cases in which
individual consumers would not, and (2) although we envision that
petitions will be the driving force behind most changes in the
standards regulations, we may, in some cases, continue to propose
changes to the standards regulations on our own initiative. Finally,
involving external parties in the standards review process would
generate social costs if: (1) Those parties would not have prepared
petitions in the absence of the proposed action, (2) we would have
assessed the need for those changes on our own initiative in the
absence of the proposed action, and (3) the costs of the external
parties are above and beyond the costs we would have faced. Under these
conditions, this rule would cause additional social resources to be
expended on making changes to the standards regulations. These costs
are probably small because we have no information suggesting that
external parties' costs of submitting petitions is significantly
different from our costs of investigating the need for comparable
changes in the regulations.
Based on the preceding discussion of why we expect the social costs
associated with this rule to be small and the benefits to be relatively
substantial, we believe that the benefits of establishing the proposed
principles outweigh the costs.
c. Description of the affected industry. FSIS regulations contain
approximately 80 standards for meat and poultry products. Most of these
standards are for heat-treated products; however, some are for raw
products (such as ground beef, hamburger, and cuts of raw poultry).
Therefore, all processing plants may produce at least one type of
standardized product. According to the 1999 Report of the Secretary of
Agriculture to the U.S. Congress, there are 1,067 meat processing
plants, 168 poultry processing plants, and 3,130 meat and poultry
processing plants (4,347 total processing plants). Most standards are
for heat-treated products. Based on the 1997 Census of Manufacturers
information, there are 1,630 establishments producing readyto- eat and
partially heat-treated meat and poultry products; FSIS used this
estimate in the proposed rule entitled ``Production of Processed Meat
and Poultry Products'' (66 FR 12611). These plants would produce heat-
treated, standardized meat and poultry products.
FDA regulations contain over 280 food standards covering a variety
of different foods. Determining the exact number of affected firms
would be time consuming and would not be justified by the significance
of that information for this analysis. A significant proportion of the
26,361 establishments identified under the North American Industry
Classification System (NAICS) classification ``food manufacturing'' in
the 1997 Economic Census probably produce at least some products that
are governed by FDA food standards.
3. Option Three: Eliminate All Food Standards
Another option would be to eliminate or significantly reduce the
number of food standards. The benefit of eliminating all food standards
is that it would also eliminate all of the social costs potentially
generated by those standards. One such cost is our expenditures, and
the expenditures of external parties, that are currently devoted to
analyzing, developing, promulgating, modifying, and enforcing
standards. Other social costs that would be eliminated include
compliance costs, indirect inhibition of new technologies, and
limitations on competition. Finally, this option would eliminate the
ability of standards to perpetuate consumer beliefs or expectations
that may lead some consumers to make product choices that are less
healthful than they might otherwise make (a potential effect that is
significantly reduced by nutrient content claim regulations).
The cost of eliminating all standards is that many consumers would
face increased search costs because they would lose the assurances
provided by standards that standardized products exhibit the basic
nature that those consumers expect those products to have. Although we
could continue to pursue the objective of maintaining the accuracy of
the information conveyed by product names through regulations against
adulteration and misbranding, enforcing those regulations would require
more agency resources, and would generally be a less effective method
of pursuing that objective. Another cost of eliminating Federal
standards is that the Federal Government would no longer have a
reference point for negotiating international food standards for the
purpose of facilitating international trade with countries and
organizations of countries that maintain such standards.
We have insufficient information to quantify the costs and benefits
of this option or to compare them to those of the proposed option.
However, the benefits of this option would be quite similar to those of
the proposed option because the proposed principles will eliminate or
significantly reduce the social costs associated with standards
regulation. However, as explained previously, the expenditure, social,
search, and loss of reference point costs of this option would probably
be greater than the same costs of the proposed option. Therefore, this
option would probably lead to lower net benefits than the proposed
option.
4. Option Four: Establish Principles for Assessing Standards (Only)
We could also establish the proposed principles for assessing
standards but rely solely on our own resources to develop proposals for
changing the standards regulations. The costs and benefits of this
option would be generated solely by the establishment of
[[Page 29229]]
the proposed principles, and would correspond in type to the costs and
benefits we discussed for Option Two. However, we believe this option
would have lower net benefits than Option Two because it would result
in fewer petitions to establish, revise, or eliminate food standards.
If we do not specify that we are relying on petitions to initiate
changes to food standards regulations, some external parties may wait
for us to act on our own initiative. Acting on our own initiative would
eliminate the benefit of transferring cost to external parties because
we would have to allocate our limited resources toward revising,
eliminating, and establishing new standards without the aid of
information from petitions.
5. Option Five: Establish Principles for Assessing Standards, but Allow
External Parties to Administer Those Principles
A final option would be for us to allow external parties to revise,
eliminate, and establish food standards using the proposed principles.
The benefits and costs of the first component of this option,
establishing the proposed principles, would be essentially the same as
the corresponding benefits and costs discussed under Option Two.
The benefit of the second component of this option, allowing
external parties to administer mandatory standards, is that it would
allow us to reallocate resources to areas that may have greater public
health significance than standards. This reallocation, and its
potential public health consequences, would be greater than that
discussed under Option Two because under this option we would not
devote resources to reviewing petitions, writing proposed rules,
reviewing public comments, writing final rules, or enforcing final
rules.
One of the primary costs of allowing external parties to administer
standards is that their objectives may diverge from ours. This cost
would be greater than the similar cost discussed under Option Two
because under Option Five we would transfer additional responsibilities
to external parties. For example, although the proposed principles
provide general directions for decisionmaking, they do not set forth in
detail all potentially relevant considerations that might need to be
dealt with. Although we could produce additional and more detailed
principles, we would probably not be able to provide principles that
are sufficiently detailed to cover all potentially relevant
considerations and situations. Among the issues on which we might need
to provide additional information to external parties would be the
following: (1) Evaluating data on consumer perceptions and beliefs, or
on scientific or technical issues, (2) soliciting and analyzing
comments from consumers and other interested parties, (3) adjudicating
conflicts between interest groups, (4) analyzing the costs and benefits
of proposed changes, (5) addressing the impact of changes on small
entities, and (6) assessing the impact of changes on international
trade. Providing this type of additional and more detailed information
would also generate costs, which would reduce the benefits of this
option. In addition, if we administer the standards, then there may be
situations in which it would be apparent to us that we need to revise
the principles. External parties may not have a sufficient appreciation
of the overall objectives of standards to recognize such situations.
It should also be noted that this option is not legally feasible at
this time: legislative action would be needed to amend the act, FMIA,
and PPIA in order for external parties to develop standards having the
force of law. Without such changes, standards established by external
parties would be voluntary.
Allowing external parties to administer voluntary standards could
lead to benefits similar to those of allowing them to administer
mandatory standards if the voluntary standards were combined with a
voluntary labeling system under which firms that produce products
meeting the voluntary standard could communicate that fact to
consumers. Setting aside the issue of the benefits of the proposed
principles, which we have already discussed, the benefit of
establishing a system in which external parties would administer
voluntary standards is that such a system would essentially eliminate
compliance costs for industry because firms would not participate in
the voluntary system unless doing so generated net profits. Although a
system in which external parties would administer voluntary standards
would ensure that any activity that firms take to comply with such
standards would not generate net social costs (assuming no market
failures), it would not eliminate the private costs associated with
that activity. In addition, voluntary standards might eliminate some of
the potential social costs of mandatory standards in that they would
accommodate at least some degree of consumer variability by allowing
standards to be used by those consumers who share the same beliefs
about the basic nature of the relevant products as expressed in the
standards, and ignored by those who do not.
The social cost generated by establishing a system by which
external parties would administer voluntary standards would be the loss
of some of the benefits currently generated by mandatory standards. The
benefits of voluntary standards are likely to be lower than the
benefits of mandatory standards for the following four reasons: (1)
Consumers who find the voluntary standards useful would need to spend
at least some time distinguishing standardized products from
nonstandardized products, so any reduction in search costs from
voluntary standards would be less than that generated by mandatory
standards; (2) external groups would probably not be able to enforce
voluntary standards to the same degree that we can enforce mandatory
standards, so standardized designations may become unreliable; (3)
voluntary standards would not provide a useful reference point for
negotiating international food standards for the purposes of
facilitating international trade with countries and organizations of
countries that maintain such standards; and (4) in order for consumers
to know whether the information conveyed via voluntary standards is
valuable for them, they would need to develop some understanding of the
standards. The costs associated with this activity might be quite high
for some consumers.
We do not have sufficient information to quantify the costs and
benefits of this option or to compare them to those of the proposed
option. However, based on the preceding discussion, this option is
unlikely to lead to higher net benefits than the proposed option.
6. Summary
For the reasons discussed previously, we believe that taking the
proposed action will generate net social benefits, and also that the
social costs of taking the proposed action are likely to be small. We
found that most of the other options were likely to have lower net
benefits because they had lower benefits, higher costs, or both.
V. Regulatory Flexibility Analysis
We have examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires us to analyze
regulatory options that would lessen the economic effect of the rule on
small entities. We have made an initial determination that this
proposed rule will not have a significant impact on a substantial
number of small entities.
[[Page 29230]]
Under the proposed rule, small entities would only incur direct
compliance costs when they decide to voluntarily submit a petition
using the general principles. These entities would only submit a
petition when it is clear that the benefits generated from submitting
the petition outweigh the costs of developing and submitting one.
However, this proposed rule could generate costs other than direct
compliance costs to the extent that it encouraged external parties to
submit petitions, and thereby increased the number of proposed changes
to standards that small entities may wish to analyze.
Although this decision would also be voluntary, the competitive
position of small entities could be impaired if they did not undertake
this activity and other external parties attempted to use standards
reform to gain a competitive advantage. However, this impact would
probably be minimal because: (1) It would be difficult or impossible
for external parties to misuse standards reform because requested
changes would need to conform to the principles set forth in this
proposed rule, (2) we intend to consider evidence of consensus within
affected industries, including small businesses when making our
decisions in regard to requested changes, (3) we do not intend to
accept statements about consumer beliefs or expectations about the
basic nature of a food without data or evidence supporting such
statements, and (4) we intend to analyze the impacts on small entities
of any proposed changes to the standards regulations.
With respect to the number of affected firms that are small
entities, the 1999 Report of the Secretary of Agriculture to the U.S.
Congress identifies 1,067 meat processing plants, 168 poultry
processing plants, and 3,130 meat and poultry processing plants (4,347
total). The majority of these establishments would qualify as small
businesses under the Small Business Administration definition of a
small business. All of these plants may produce at least one type of
standardized product because there are both raw and heattreated
standardized products. However, most of the standards are for
heattreated products. FSIS estimates that there are approximately 1,485
small establishments producing ready-to-eat or heat-treated products,
and many of these products are standardized products. This number is
based on data from the 1997 Census of Manufacturers. FSIS used this
data to estimate the number of small businesses that would be affected
by the proposed rule on performance standards for the production of
processed meat and poultry products, published in the Federal Register
of February 27, 2001 (66 FR 12590). In addition, there are
approximately 26,361 establishments identified in the 1997 Economic
Census as belonging to the NAICS classification ``food manufacturing.''
All of these establishments may produce at least some products that are
governed by FDA food standards. The vast majority of these
establishments would qualify as small businesses under the Small
Business Administration definition of a small business.
VI. Executive Order 12988: Civil Justice Reform
FSIS: This proposed rule has been reviewed under Executive Order
12988, Civil Justice Reform. States and local jurisdictions are pre-
empted by the FMIA and the PPIA from imposing any marking, labeling,
packaging, or ingredient requirements on federally inspected meat and
poultry products that are in addition to, or different than, those
imposed under the FMIA or the PPIA. However, States and local
jurisdictions may exercise concurrent jurisdiction over meat and
poultry products that are outside official establishments for the
purpose of preventing the distribution of meat and poultry products
that are misbranded or adulterated under the FMIA or PPIA, or, in the
case of imported articles, which are not at such an establishment,
after their entry into the United States.
The proposed rule is not intended to have retroactive effect. If
this proposed rule is adopted, administrative proceedings will not be
required before parties may file suit in court challenging this rule.
However, the administrative procedures specified in 9 CFR 306.5 and
381.35 must be exhausted before there is any judicial challenge of the
application of the proposed rule, if the challenge involves any
decision of an FSIS employee relating to inspection services provided
under the FMIA and PPIA. 65
VII. Executive Order 13132: Federalism
FSIS: Executive Order 13132, ``Federalism,'' requires that agencies
assess the federalism implications of their policy statements and
actions, i.e., the effects of those statements and actions on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. The FMIA and the PPIA pre-empt State and
local laws in regard to the manufacture and distribution of meat and
poultry products in interstate or foreign commerce. Therefore, FSIS
policy statements and actions affect federalism within the context of
these statutory pre-emptions.
States and local jurisdictions are pre-empted by the FMIA and PPIA
from imposing any marking, labeling, packaging, or ingredient
requirements on federally inspected meat and poultry products that are
in addition to, or different than, those imposed under the FMIA and the
PPIA. States and local jurisdictions may, however, exercise concurrent
jurisdiction over meat and poultry products that are within their
jurisdiction and outside official establishments for the purpose of
preventing the distribution of meat and poultry products that are
misbranded or adulterated under the FMIA and PPIA, or, in the case of
imported articles, that are not at such an establishment, after their
entry into the United States.
However, under section 301 of the FMIA and section 5 of the PPIA, a
State may administer a State meat and poultry inspection program
provided that it has developed and is effectively enforcing State meat
and poultry inspection requirements at least equal to those imposed
under titles I and IV of the FMIA and sections 1 to 4, 6 to 10, and 12
to 22 of the PPIA. These titles contemplate continuous ongoing
programs. When a State can no longer effectively enforce meat and
poultry inspection requirements at least equal to Federal requirements,
it must be ``designated'' by the Secretary of Agriculture and all
plants within that State must operate under Federal inspection. When
FSIS revises its meat and poultry inspection requirements, States that
administer their own inspection programs may be affected, since they
must continue to enforce requirements at least equal to those of FSIS.
To minimize any additional costs States must incur to modify their
inspection programs, FSIS grants the States significant flexibility
under the `equal to' provisions of the FMIA and PPIA. Further, States
are eligible to receive up to 50 percent Federal matching funds to
cover the costs of their inspection program.
FDA: FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has concluded that
this proposed rule does not contain policies that have federalism
implications as defined in the order and, consequently, a federalism
summary impact statement is not required. FDA is interested in comments
from elected State and local government officials and others on: (1)
The need for the proposed guiding
[[Page 29231]]
principles rule to modernize food standards; (2) the proposed guiding
principles' provisions; and (3) any other issues raised by this
proposed rule that possibly affect State laws and authorities.
VIII. Environmental Impact
FSIS: FSIS has been granted a categorical exclusion from the
National Environmental Policy Act (42 U.S.C. 4321 et seq. )
requirements by USDA regulations (7 CFR 1b. 4) unless the Administrator
of FSIS determines that such an action may have a significant
environmental effect. FSIS has determined that this rule would not have
a significant environmental effect.
FDA: FDA has determined under 21 CFR 25.30(h) that its part of this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IX. Paperwork Reduction Act of 1995
FSIS:
Title: General Principles and Food Standards Modernization.
Type of Collection: New.
Abstract: FSIS is proposing to establish a set of general
principles for food standards. The proposed general principles will
specify the criteria that the agencies will use in considering whether
a petition to establish, revise, or eliminate a food standard will be
the basis for a proposed rule. Under this rule, petitions to establish,
revise, or eliminate a standard should include a comprehensive
statement that explains how the proposed new or revised standard
conforms to the general principles or how the standard proposed to be
eliminated does not conform to the general principles.
Estimate of burden: FSIS estimates that developing a petition to
establish, revise, or eliminate a food standard that conforms to the
general principles and developing the comprehensive statement that
explains how the new or revised standard conforms to the general
principles or how the standard proposed to be eliminated does not
conform to the general principles will take an average of 40 hours.
Respondents: Manufacturers of meat and poultry products, trade
organizations, consumer organizations, or unaffiliated individuals.
Estimated number of respondents: 6.
Estimated number of responses per respondent: 1.
Estimated total annual burden on respondents: 240 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 St. SW., Washington,
DC 20250. Comments are invited on: (1) Whether the proposed collection
of information is necessary for the proper performance of the functions
of the agency, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) 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 John O'Connell, see address above, and the
Desk Officer for Agriculture, Office of Information and Regulatory
Affairs, Office of Management and Budget, Washington, DC 20253.
Comments are requested by July 19, 2005. To be most effective, comments
should be sent to the Office of Management and Budget (OMB) within 30
days of the publication date.
FSIS is committed to compliance with the Government Paperwork
Elimination Act (GPEA), which requires Government agencies, in general,
to provide the public the option of submitting information or
transacting business electronically to the maximum extent possible.
FDA:
This proposed rule contains information provisions that are subject
to review by OMB under the Paperwork Reduction act of 1995 (44 U.S.C.
3501-3520). A description of these provisions is given below with an
estimate of the annual reporting burden. Included in the estimate is
the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing
each collection of information.
FDA invites comments on the following topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Title: Food Standards; General Principles and Food Standards
Modernization
Description: This proposed rule would amend 21 CFR 130.5 to
establish a list of 13 general principles that we would use when
establishing, revising, or eliminating standards of identity. We wish
to establish these principles to ensure that we apply consistent
criteria when evaluating petitions relating to standards and to
communicate these criteria to potential petitioners. Under this
proposed rule, parties who petition us to establish a new standard or
to revise an existing standard would need to provide a comprehensive
statement explaining how the requested new standard or the requested
revision is consistent with each of the relevant general principles,
while parties who petition us to eliminate a standard would need to
provide a comprehensive statement explaining how the standard to be
eliminated is inconsistent with any one of the first four principles.
In addition, we encourage but do not require parties who petition us to
revise a standard in any way to analyze the entire existing standard
with respect to all of the general principles and to petition us to
make all of the revisions that such an analysis might suggest.
Description of Respondents: Individual businesses and industry
trade groups will probably generate most of the petitions. In addition,
consumer advocacy groups might submit petitions, and we might also
receive petitions from private individuals.
Burden:
Hour Burden Estimate
In table 1 of this document, we present an estimate of the total
annual hourly burden for the proposed information collection
requirements for petitions that seek to establish new standards or
revise existing standards. The time and cost will vary considerably
depending on the nature of the suggested changes in food standards, the
nature and complexity of the standards involved, and the existing
information that can be brought to bear on the relevant issues. The
burden hours in table 1 of this document include only that portion of
the compliance burden that goes beyond the burden associated with the
general requirements that apply to all citizen
[[Page 29232]]
petitions under 21 CFR 10.30, because only that portion represents a
new information collection. The burden would be lower for petitions
that seek to eliminate existing standards. However, the comments that
we received on the ANPRM suggest that most petitions would involve
revising existing standards or creating new standards. Therefore, we
have based our burden estimates on those types of petitions. We
received 10 petitions from 2000 through 2004, or approximately three
petitions per year. The proposed rule might either increase or decrease
the number of petitions. However, we do not have sufficient information
to estimate a change in the expected number of petitions. Therefore, we
assume that we will continue to receive three petitions per year. In
addition, we assume that each respondent will probably only submit one
petition per year. Therefore, we estimate three respondents per year
with an annual frequency of one response per year.
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency per Total Annual Hours per
21 CFR Section No. of Respondents Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
130.5(b) 3 1 3 136 408
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
In table 2 of this document, we list the various information
collection activities and burden hours that we used to estimate the
total hours per response that we present in table 1 of this document.
In some cases, we present our burden estimate in terms of a range and
average. The range reflects the fact that large firms probably do much
of the required activity as a normal part of product development. These
firms would simply need to compile existing information for the
comprehensive statement that shows consistency with the relevant
general principles. However, smaller firms, industry and consumer
groups, and private individuals may not otherwise undertake the
activity required for the comprehensive statement. Therefore, the
burden for these entities could be significantly higher. We expect
large firms will probably submit most petitions. Therefore, we have
assumed average burdens near the low end of the estimated ranges. We
estimate that the total annual hourly burden associated with this
information collection would be 264 to 1,512 hours. Within this range,
we estimate that the average total annual hourly burden would be 408
hours.
Table 2.--Average Hourly Burden of Information Collection Activities per
Petition
------------------------------------------------------------------------
Information Collection Activity Average Hours
------------------------------------------------------------------------
(1) Legal, technical, and scientific 8
interpretation of new information
collection requirements (all
principles): 8 hours.
------------------------------------------------------------------------
(2) Social scientific analysis of 40
consumer surveys, focus groups, or
market data, or scientific and technical
analysis of restaurant menus or food
formulary compilations to demonstrate or
infer consumer expectations and beliefs
relating to product identity, the
relationship of observable and non-
observable product attributes to product
identity, the relationship of product
uniformity to product identity, the
significance of the order of terms in
the name of the food (if the new or
revised standard involves a newly
standardized product name containing
more than one term), and consumer
valuation of observable and non-
observable product attributes and
product uniformity (Principles 1 to 4,
6, 7, and 12): 8 to 320 hours, average
40 hours.
------------------------------------------------------------------------
(3) Plain English editorial review to 4
produce language that is clear, easily
understood, simple, and easy to use
(Principles 5 and 8): 4 hours.
------------------------------------------------------------------------
(4) Technical and scientific evaluation 32
of whether the new or revised standard
permits the maximum level of flexibility
in terms of food technology subject to
considerations of consumer expectations,
nutritional quality, and safety,
including an analysis of other suitable
alternative manufacturing processes. We
estimate the cost of generating or
compiling of some of the necessary
information on consumer expectations
under another activity. The new elements
for this activity include the safety and
nutritional quality review and the
investigation of the impact of
flexibility in terms of food technology
on product attributes that are related
to consumer expectations. Burden: 16 to
120 hours, average 32 hours.
------------------------------------------------------------------------
(5) Legal and scientific analysis of 8
whether petitioners have described any
ingredients featuring in the new
standard or revised standard as broadly
and generically as possible (Principle
6): 8 hours.
------------------------------------------------------------------------
(6) Legal, scientific, and technical 8
analysis of relevant Codex standards and
preparation of a rationale for any
differences between Codex standards and
the new or revised standards (Principle
7). In general, the rationale for any
differences will probably involve
referencing consumer expectations and
beliefs. We estimate the burden of
compiling or generating that information
under Activity 2. Burden: 8 hours.
------------------------------------------------------------------------
(7) Legal, scientific, and technical 8
review of other food standards to
establish that the new or revised
standard is consistent with existing FDA
food standards (Principles 8 and 11): 8
hours.
------------------------------------------------------------------------
(8) Legal, scientific, and technical 8
analysis of ingredient technology,
manufacturing processes, and food
composition to eliminate unnecessary
details (Principle 8): 8 hours.
------------------------------------------------------------------------
[[Page 29233]]
(9) Scientific and technical review to 8
demonstrate that the new or revised
standard allows for variation in the
physical attributes of the food
(Principle 9): 8 hours.
------------------------------------------------------------------------
(10) Legal and scientific review of 8
existing labeling and ingredient
regulations to establish that the new or
revised standard is consistent with
those regulations (Principle 11): 8
hours.
------------------------------------------------------------------------
(11) Scientific review of existing food 4
standards and current scientific
nomenclature reference works to
establish if the names of ingredients
and functional use categories in new and
revised standards are consistent with
those used in other food standards and
with current scientific nomenclature
(Principle 13). Petitioners could review
of ingredient names and functional use
categories in other food standards as
part of the general review of those
standards under Activity 8. However, the
review of nomenclature reference works
would be an additional activity. Burden:
4 hours
------------------------------------------------------------------------
Total Time Burden 136
------------------------------------------------------------------------
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3507(d)), we have submitted the information collection provisions of
this proposed rule to OMB for review. Interested persons are requested
to fax comments regarding information collection by June 20, 2005 to
the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer, FDA, Fax 202-395-6974.
X. 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 proposed rule, FSIS will announce it
online through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/2005_Proposed_Rules_Index/index.asp.
The Regulations.gov Web site is the central online rulemaking
portal of the U.S. 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 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 e-mail 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.
XI. Comments
FSIS: See information under DATES, and ADDRESSES, and section X of
this document.
FDA: Interested persons may submit to the Division of Dockets
Management (see ADDRESSES) written or electronic comments regarding
this document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. Received comments may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.
XII. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. CFSAN/FSIS, Memo on standards focus groups, May 30, 2001.
2. Cates, S.C., Consumer Attitudes Toward Potential Changes in
Food Standards of Identity, volume 1: Final Report to the FDA,
September 2000.
List of Subjects
9 CFR Part 410
Food grades and standards, Food labeling, Frozen foods, Meat
inspection, Oils and fats, Poultry and poultry products.
21 CFR Part 130
Food additives, Food grades and standards.
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Chapter III
Authority and Issuance
0
For the reasons discussed in the preamble, FSIS is proposing to amend
chapter III of title 9 of the Code of Federal Regulations by adding new
part 410 to subchapter E to read as follows:
PART 410--PRODUCT COMPOSITION
Authority: 21 U.S.C. 601-695; 21 U.S.C 451-472; 7 CFR 2.18,
2.53; 7 U.S.C. 2219(a).
Sec. 410.1 Procedure for establishing, revising, or eliminating a
food standard.
(a) A food standard proposed in a petition to establish a new food
standard in part 319 or part 381, subpart P, of this chapter must be
consistent with all of the following general principles that apply to
the new standard. Any revision to a food standard proposed in a
petition to revise an existing food standard in part 319 or part 381,
subpart P, of this chapter must be consistent with all of the following
general principles that apply to the proposed revision to the existing
[[Page 29234]]
standard. The agency will consider a petition that proposes eliminating
a food standard if it is demonstrated that the current food standard is
not consistent with any one of the general principles in paragraphs
(a)(1) through (a)(4) of this section.
(1) The food standard should protect the public.
(2) The food standard should describe the basic nature of the food
to ensure that consumers are not misled by the name of the food and to
meet consumers' expectations of product characteristics and uniformity.
(3) The food standard should reflect the essential characteristics
of the food. The essential characteristics of a food are those that
define or distinguish a food or describe the distinctive properties of
a food. The essential characteristics of a food may contribute to
achieving the food's basic nature or may reflect relevant consumer
expectations of a food product. For example, foods may be defined or
distinguished by their ingredients, compositional characteristics,
physical characteristics, nutrient levels, or the manner in which they
are produced.
(4) The food standard should ensure that the food does not appear
to be better or of a greater value than it is. The food standard may be
used as a vehicle to improve the overall nutritional quality of the
food supply.
(5) The food standard should contain clear and easily understood
requirements to facilitate compliance by food manufacturers.
(6) The food standard should permit maximum flexibility in the food
technology used to prepare the standardized food so long as that
technology does not alter the basic nature or essential
characteristics, or adversely affect the nutritional quality or safety,
of the food. The food standard should provide for any suitable,
alternative manufacturing process that accomplishes the desired effect,
and should describe ingredients as broadly and generically as feasible.
(7) The food standard should be harmonized with international food
standards to the extent feasible. If the food standard is different
from the requirements in a Codex standard for the same food, the
petition should specify the reasons for these differences.
(8) The food standard provisions should be simple, easy to use, and
consistent among all standards. Food standards should include only
those elements that are necessary to define the basic nature and
essential characteristics of a particular food, and any unnecessary
details should be eliminated.
(9) The food standard should allow for variations in the physical
attributes of the food. Where necessary to provide for specific
variations in the physical attributes of a food within the food
standard, the variations should be consolidated into a single food
standard.
(10) Whenever possible, general requirements that pertain to
multiple food standards of a commodity group should be incorporated
into general regulatory provisions that address the commodity group.
(11) Any proposed new or revised food standard should take into
account whether there are labeling or ingredient regulations in this
chapter that are affected by, or that cover, the new or revised food
standard, so that any requirements in the standard are consistent with
labeling or ingredient regulations.
(12) The food standard should provide the terms that can be used to
name a food and should allow such terms to be used in any order that is
not misleading to consumers.
(13) Names of ingredients and functional use categories in a food
standard should be consistent with other food standards in part 319 or
part 381, subpart P, of this chapter, and relevant regulations in Sec.
424.21 of this chapter, and, when appropriate, incorporate current
scientific nomenclature.
(14) The food standard should be based on the finished product.
(15) The food standard should identify whether the product is
ready-to-eat or not ready-to-eat.
(b) A petition to establish a new food standard should include a
comprehensive statement that explains how the proposed new standard
conforms to the general principles that apply to the new standard. A
petition to revise an existing food standard should include a
comprehensive statement that explains how the proposed revision to the
existing standard conforms to the general principles that apply to the
proposed revision. A petition to eliminate a food standard should
include a comprehensive statement that explains how the standard
proposed to be eliminated does not conform to any one of the general
principles in paragraphs (a)(1) through (a)(4) of this section.
(c) A petition that proposes the establishment or revision of a
food standard in part 319 or part 381, subpart P, of this chapter, that
is not consistent with the applicable general principles listed under
paragraph (a) of this section will be denied, and the petitioner will
be notified as to the reason for the denial. A petition that proposes
the elimination of a food standard in part 319 or part 381, subpart P,
of this chapter that does not demonstrate that the food standard is
inconsistent with any one of the general principles listed under
paragraphs (a)(1) through (a)(4) of this section will be denied, and
the petitioner will be notified as to the reason for the denial.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter I
Authority and Issuance
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that part 130 of chapter I of title 21 of the Code of Federal
Regulations be amended as follows:
PART 130--FOOD STANDARDS: GENERAL
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1. The authority citation for 21 CFR part 130 continues to read as
follows:
Authority: 21 U.S.C. 321, 336, 341, 343, 371.
0
2. Section 130.5 is amended by revising the section head and paragraph
(b), redesignating paragraphs (c) and (d) as paragraphs (e) and (f),
respectively, and adding new paragraphs (c) and (d) to read as follows:
Sec. 130.5 Procedure for establishing, revising, or eliminating a
food standard.
* * * * *
(b) A food standard proposed in a petition to establish a new food
standard in parts 130 to 169 of this chapter must be consistent with
all of the following general principles that apply to the new standard.
Any revision to a food standard proposed in a petition to revise an
existing food standard in parts 130 to 169 of this chapter must be
consistent with all of the following general principles that apply to
the proposed revision to the existing standard. The Food and Drug
Administration will consider a petition that proposes eliminating a
food standard if it is demonstrated that the current food standard is
not consistent with any one of the general principles in paragraphs
(b)(1) through (b)(4) of this section.
(1) The food standard should promote honesty and fair dealing in
the interest of consumers.
(2) The food standard should describe the basic nature of the food
to ensure that consumers are not misled by the name of the food and to
meet consumers' expectations of product characteristics and uniformity.
[[Page 29235]]
(3) The food standard should reflect the essential characteristics
of the food. The essential characteristics of a food are those that
define or distinguish a food or describe the distinctive properties of
a food. The essential characteristics of a food may contribute to
achieving the food's basic nature or may reflect relevant consumer
expectations of a food product. For example, foods may be defined or
distinguished by their ingredients, compositional characteristics,
physical characteristics, nutrient levels, or the manner in which they
are produced.
(4) The food standard should ensure that the food does not appear
to be better or of a greater value than it is. The food standard may be
used as a vehicle to improve the overall nutritional quality of the
food supply.
(5) The food standard should contain clear and easily understood
requirements to facilitate compliance by food manufacturers.
(6) The food standard should permit maximum flexibility in the
technology used to prepare the standardized food so long as that
technology does not alter the basic nature or essential
characteristics, or adversely affect the nutritional quality or safety,
of the food. The food standard should provide for any suitable,
alternative manufacturing process that accomplishes the desired effect,
and should describe ingredients as broadly and generically as feasible.
(7) Consistent with Sec. 130.6 of this chapter, the food standard
should be harmonized with international food standards to the extent
feasible. If the food standard is different from the requirements in a
Codex standard for the same food, the petition should specify the
reasons for these differences.
(8) The food standard provisions should be simple, easy to use, and
consistent among all food standards. Food standards should include only
those elements that are necessary to define the basic nature and
essential characteristics of a particular food, and any unnecessary
details should be eliminated.
(9) The food standard should allow for variations in the physical
attributes of the food. Where necessary to provide for specific
variations in the physical attributes of a food within the food
standard, the variations should be consolidated into a single food
standard.
(10) Whenever possible, general requirements that pertain to
multiple food standards of a commodity group should be incorporated
into general regulatory provisions that address the commodity group.
(11) The food standard should take into account any other relevant
regulations in this chapter. For example, a proposed new or revised
food standard should be consistent with common or usual name
regulations for related commodities or products. Further, any specific
requirements for foods intended for further manufacturing should be
incorporated within the reference food standard rather than being
provided as a separate food standard.
(12) The food standard should provide the terms that can be used to
name a food and should allow such terms to be used in any order that is
not misleading to consumers.
(13) Names of ingredients and functional use categories in a food
standard should be consistent with other food standards and relevant
regulations in this chapter, and, when appropriate, incorporate current
scientific nomenclature.
(c) As part of the Statement of Grounds required by section Sec.
10.30 of this chapter, a petition to establish a new food standard
should include a comprehensive statement that explains how the proposed
new standard conforms to the general principles that apply to the new
standard. A petition to revise an existing food standard should include
a comprehensive statement that explains how the proposed revision to
the existing standard conforms to the general principles that apply to
the proposed revision. A petition to eliminate a food standard should
include a comprehensive statement that explains how the standard
proposed to be eliminated does not conform to any one of the general
principles in paragraphs (b)(1) through (b)(4) of this section.
(d) A petition that proposes the establishment or revision of a
food standard that is not consistent with the applicable general
principles listed under paragraph (b) of this section will be denied,
and the petitioner will be notified as to the reason for the denial. A
petition that proposes the elimination of a food standard that does not
demonstrate that the food standard is inconsistent with any one of the
general principles listed under paragraphs (b)(1) through (b)(4) of
this section will be denied, and the petitioner will be notified as to
the reason for the denial.
* * * * *
Dated: April 14, 2005.
Barbara J. Masters,
Acting Administrator, FSIS.
Dated: April 8, 2005.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
[FR Doc. 05-9958 Filed 5-17-05; 11:25 am]
BILLING CODE 4160-01-S