[Federal Register Volume 64, Number 68 (Friday, April 9, 1999)]
[Proposed Rules]
[Pages 17295-17298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8795]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 98P-0968]
Food Labeling: Declaration of Ingredients
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its ingredient labeling regulations to permit the use of ``and/or''
labeling for the various fish species used in the production of
processed seafood products, i.e., surimi and surimi-containing foods.
This action responds to a petition submitted by the National Fisheries
Institute (NFI) requesting more flexible ingredient labeling for the
fish ingredients used in the production of surimi products. This
proposed rule would permit manufacturers of surimi and surimi-
containing products to maintain a single label inventory identifying
all of the fish species that may be used in the manufacture of the
surimi product.
DATES: Comments by June 23, 1999. See section VIII of this document for
the proposed effective date of a final rule based on this document.
ADDRESSES: Written comments to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT: Felicia B. Satchell, Center for Food
Safety and Applied Nutrition (HFS-158), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5099.
SUPPLEMENTARY INFORMATION:
I. Background
``Surimi'' is a fish protein product made from minced fish meat
that has been washed to remove fat, blood, pigments, odorous and other
undesirable substances and that has been mixed with cryoprotectants
such as sugar or sorbitol to prevent freezer burn (Ref. 1). The fish
species used in surimi and surimi-containing products are primarily
Alaskan pollock, Pacific whiting/hake, cod, and arrowtooth flounder. As
an intermediate processed seafood product, surimi is then used in the
formulation of a variety of finished seafood products, such as
imitation crab and lobster meat.
Section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 343(i)(2)) provides that the label of a food like
surimi that is fabricated from two or more ingredients must bear the
common or usual name of each ingredient. Section 403(i)(2) of the act
further provides that when compliance with this requirement is
impracticable, or results in deception or unfair competition, FDA can
establish exemptions by regulation. FDA's regulations implementing
section 403(i)(2) of the act generally require that ingredients used to
fabricate a food must be declared on the label by their common or usual
name in descending order of predominance by weight (Sec. 101.4(a)(1)
and (b)(2) (21 CFR 101.4(a)(1) and (b)(2))). However, under section
403(i)(2) of the act, FDA has, through rulemaking, issued exceptions to
the requirement in Sec. 101.4(a)(1) and (b)(2) when the agency has
concluded that compliance with these provisions is impracticable or may
result in deception or unfair competition. For example, FDA allows
``and/or'' ingredient labeling when the agency believes it is
impracticable for manufacturers to adhere to a fixed ingredient
profile. The most recent rulemaking where FDA has provided for the use
of ``and/or'' labeling is in the declaration of wax and resin coatings
on fresh fruits and vegetables (58 FR 2850 at 2875, January 6, 1993).
With respect to the general requirements for compliance with
section 403(i)(2) of the act, the agency has specifically outlined in
guidance documents how ingredients in certain foods should be declared.
For processed and/or blended seafood products that
[[Page 17296]]
are composed, all or in part, of surimi, FDA's Compliance Policy Guide
(CPG) 540.700 advises that manufacturers of these products should
declare the specific names of all seafoods used in the product in the
ingredient statement in descending order of predominance. To comply
with section 403(i)(2) of the act and Sec. 101.4(a) and (b), ingredient
statements on the labels of surimi and surimi-containing products that
are made from more than one fish species must declare each of the fish
species used to fabricate that food in descending order of predominance
by weight (Sec. 101.4(a)).
II. The Petition
A. Requested Provisions
FDA received a citizen petition from the NFI (filed October 13,
1998, Docket No. 96P-0968) (hereinafter referred to as the petition)
requesting that the agency revise CPG 540.700 to permit the use of
``and/or'' labeling in the ingredient declaration of the fish species
used in surimi and surimi-containing foods (Ref. 2). Specifically, the
petition requested that the CPG be revised as follows:
The specific names of all seafoods used in the product shall
appear in the ingredient statement in descending order of
predominance (``pollock'' must be used as opposed to ``white fish'';
``snow crab'' rather than ``crab''), except that, if the
manufacturer is unable to adhere to a constant pattern of fish
species in the product, the listing of species need not be in
descending order of predominance. Fish species not present in the
product may be listed if they are sometimes used in the product.
Such ingredients shall be identified by words indicating that they
may or may not be present, such as ``or,'' ``and/or,'' or ``contains
one or more of the following:''.
The petition contends that the requested action would alleviate
significant quality, manufacturing, logistical, and financial burdens
that the surimi industry currently faces, yet still ensure that
consumers receive truthful, nonmisleading information about the
composition of surimi and surimi-containing products.
B. Basis for Requested Provisions
The request in the petition for permission to use ``and/or''
labeling for surimi-containing products was based on several arguments.
While the agency finds merit in all of the arguments discussed in the
petition, it will only discuss in this document those arguments that
pertain to the standards set out in section 403(i)(2) of the act and
form the primary basis on which the agency has been persuaded to
propose an exception to the existing ingredient labeling regulations.
1. Due to Seasonality and Quota Limitations, Manufacturers are Unable
To Adhere to a Constant Pattern of Fish Species in Producing Surimi and
Surimi-Containing Foods
According to the petition, the commercial availability of a
specific fish species used in the manufacture of surimi and surimi-
containing foods is variable and depends upon several factors out of
the manufacturer's control, including: The length of the harvesting
season, the quota limitations for each species, and the cost. Each fish
species is available for harvesting only during certain periods of the
year. For example, the harvest season for pollock ``A'' normally opens
in mid-January and runs through mid-February. The harvest season for
Pollock ``B'' typically runs from mid-September through mid-October.
Similarly, the harvest season for Pacific whiting begins in May and
continues into the summer.
Harvest quotas will also impact on the availability of a particular
fish species. According to the petition, only limited quantities of
specific fish species may be harvested during a given season. Due to
provisions established under the Magnuson-Stevens Fishery Conservation
and Management Act (16 U.S.C. 1801 et seq.), harvest quotas are
established through the National Fishery Management Program and are
managed by regional fishery management councils. Once a quota has been
filled, no more of that species may be harvested until the next season.
(Thus, the actual length of a harvest season can be unpredictable,
depending upon the type and number of companies or vessels entering a
fishery, and the pace with which applicable quotas are filled.) Quotas
fluctuate according to estimated species biomass, and, therefore, vary
from season to season, and from year to year. In sum, the petition
contends that, because surimi can be and is made from a variety of fish
species, the variability in harvest seasons and quotas confounds
prediction of the specific composition of surimi that will be available
at any given time for processing into a finished seafood product.
2. FDA's Current Ingredient Labeling Requirements Place Unwarranted
Burdens on Manufacturers of Surimi and Surimi-containing Foods by
Forcing Them to Maintain and Coordinate Several Inventories of Species-
specific Surimi and Contingent Labels That Declare the Specific Fish
Species Used to Make the Surimi
The petition states that the associated label storage burdens
(i.e., maintaining different label inventories for surimi-containing
foods that account for all possible fish species or predominance
combinations) are compounded because frozen surimi quickly loses its
functionality during storage, and manufacturers are constantly forced
to adjust overall product formulations to maintain consistent
quality.\1\ Therefore, the petition argues that modification of the
existing ingredient labeling requirements would not only significantly
reduce the economic burden on surimi manufacturers, but also promote
the goal of effective management of harvestable resources.
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\1\ The petition further mentioned that the limitations created
by the existing ingredient labeling requirements also hinder the
ability of the seafood industry to use conventional and innovative
surimi processing technologies to optimize the yield of both target
fish species (e.g., pollock, cod, Pacific whiting) and nontarget, by
catch species (e.g., arrowtooth flounder) and that the North
American Pacific Fishery Management Council has imposed increased
utilization and recovery mandates on seafood harvesters and
processors.
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The petition contends that because of the inventory constraints on
holding multiple labels for the same product, administrative
difficulties of ensuring that correct labels are used, and logistical
problems of having multiple product codes for the same item, companies
are effectively forced to produce finished surimi food products from
single fish species. This becomes a problem, however, due to the
limitations of availability of various fish species used to make
surimi. Consequently, the petition contends that it is impracticable
for manufacturers of surimi and surimi-containing foods to comply with
the existing ingredient labeling regulations and that an exception in
the form of ``and/or'' labeling is warranted. According to the
petition, permitting the use of a single label that declares each of
the fish species that may be present in the product would ease the
impracticability and unwarranted burdens of the existing ingredient
labeling requirements.
The petition also explains that, because the fish ingredients used
in surimi are decharacterized through processing, the specific fish
species used in surimi is unimportant and neither characterizes the
food nor influences consumers' purchase decisions. According to the
petition, finished surimi products have similar economic value and
nutritional attributes regardless of the species originally used in its
manufacture.
As noted previously, the fish species used in surimi and surimi-
containing products are primarily Alaskan pollock, Pacific whiting/
hake, cod, and
[[Page 17297]]
arrowtooth flounder. When making surimi, the fish are processed shortly
after they are caught. They are headed, gutted, gilleted, skinned,
deboned, and minced. Once minced, the meat is processed through a
series of washes. After each wash, the minced fish is pressed through a
rotary screen to dewater the product. The wash and screening steps are
critical in removing blood, fat, pigments, and enzymes characteristic
of the particular fish species used. Each wash step, beginning with the
first, removes features associated with taste, smell, and color. The
resultant fish ingredient is further refined, mixed with
cryoprotectants, extruded into blocks, and frozen.
The petition argues that this processing produces a completely
decharacterized myofibrillar (i.e., muscle fiber) protein such that
even the most sophisticated laboratory techniques cannot determine with
certainty the source fish of the protein. Likewise, the petition
argues, this processing allows the interchangeability of different fish
species because regardless of the fish species used, the resultant
myofibrillar proteins are functionally interchangeable.
III. Agency Response
The agency has considered the arguments raised in the petition and
finds that there is considerable merit in the need for more flexible
ingredient labeling with regard to the particular fish species used in
the production of surimi and surimi-containing foods. Information
available to the agency (Ref. 1) supports the position stated in the
petition that the processing of surimi sufficiently decharacterizes the
fish protein such that the species from which the fish protein is
derived is no longer distinguishable. In addition, the agency
recognizes the limitations imposed by harvesting seasons and quotas on
the availability of specific fish species, and the impracticability of
maintaining different label inventories to reflect any and all possible
formulation combinations. Consequently, the agency tentatively
concludes that the existing ingredient labeling requirements are
impracticable for the declaration of the fish ingredient in surimi and
surimi-containing foods. Moreover, the agency is persuaded by the
arguments presented in the petition that the use of a more flexible
ingredient labeling requirement will not disadvantage consumers because
the specific source of the fish protein has little bearing on the
economic value, taste, or quality of the finished food. Under the
provision the agency is proposing in this document, consumers who use
the ingredient label to avoid certain foods for health-related reasons
will still receive adequate information about the basic nature of the
food and will be able to make informed purchase decisions. Thus, the
agency tentatively finds that, like other permitted uses of ``and/or''
ingredient labeling, the use of such labeling for the declaration of
the fish species in processed seafood products is consistent with other
exceptions to the ingredient labeling requirements and would not
compromise the type or amount of information received by the consumer
regarding surimi and surimi-containing foods.
The agency notes, however, that the action requested in the
petition, i.e., revision of CPG 540.700, is not an appropriate
mechanism for the type of relief requested. As set out in section
403(i)(2) of the act, FDA can affirmatively sanction the use of ``and/
or'' labeling only through notice and comment rulemaking. Thus, the
agency is proposing to amend its ingredient labeling regulations in
Sec. 101.4(b) to provide for the use of ``and/or'' labeling of the
specific fish species used in the fabrication of surimi and surimi-
containing foods. (The agency notes that at the time a final rule is
issued in this matter, a revised CPG also will be issued to reflect the
final rule.)
IV. The Proposal
As noted in section III of this document, revising the CPG is not
an appropriate mechanism to provide for the use of ``and/or'' labeling
in the ingredient declaration of the fish protein species in surimi and
surimi-containing foods. Consequently, the agency is not proposing the
language that was suggested in the petition. However, the agency
believes that the language that it is proposing in this document will
effectively permit manufacturers of surimi and surimi-containing foods
to maintain a single label inventory for use on such products
formulated from protein derived from a variety of fish species.
Furthermore, the agency believes that the action it is proposing in
this document is consistent with its other provisions providing
flexibility in ingredient declaration of certain ingredients.
Specifically, the agency is proposing that the specific fish species
may be declared using ``and/or'' labeling to list the fish species that
are sometimes used in the food. Considering the information presented
in the petition regarding the processing of the fish ingredient coupled
with other information available to the agency describing the
production of surimi (Ref. 1), the agency believes that a term such as
``fish protein'' could be used to describe the fish ingredient used in
the production of surimi. For example, a manufacturer of a processed
seafood product that contains surimi could list the various fish
species that might be used to produce the surimi in the product's list
of ingredients by stating ``fish protein (contains one or more of the
following: Pollock, cod and/or pacific whiting).''
V. Analysis of Economic Impacts
A. Benefit-Cost Analysis
FDA has examined the impacts of this proposed rule under 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).
According to Executive Order 12866, a regulatory action is
``significant'' if it meets any one of a number of specified
conditions, including having an annual effect on the economy of $100
million; adversely affecting in a material way a sector of the economy,
competition, or jobs; or if it raises novel legal or policy issues. FDA
finds that this proposed rule is not a significant regulatory action as
defined by Executive Order 12866. In addition, it has been determined
that this proposed rule is not a major rule for the purpose of
congressional review. For the purpose of congressional review, a major
rule is one which is likely to cause an annual effect on the economy of
$100 million; a major increase in costs or prices; significant effects
on competition, employment, productivity, or innovation; or significant
effects on the ability of U.S.-based enterprises to compete with
foreign-based enterprises in domestic or export markets.
FDA agrees with the petitioner that the current combination of
seasonal species harvests, harvesting limits, labeling regulations, and
limited product storage times places an unwarranted and costly
logistical burden on surimi manufacturers. This combination of
circumstances forces surimi manufacturers to maintain and coordinate
several inventories of species-specific surimi and contingent labels
that declare the specific fish species used to make the surimi. The
convergence of these conditions also hampers the seafood industry's
efforts to use conventional and innovative surimi processing
technologies to optimize fishery yield.
[[Page 17298]]
This proposed rule will mitigate the logistical burden faced by
surimi manufacturers. Because surimi manufacturers will be able to
maintain a single label inventory and use innovative technologies, they
will be able to operate more efficiently. Because of lower production
costs, consumers may see slightly lower prices for surimi. Because of
the greater flexibility for species usage, the goals of fisheries
management will be easier to achieve.
This proposed rule will not result in any increase in societal
costs. Because the proposed rule is permissive, there are no costs
imposed on producers. Because the new labels adequately inform
consumers, there will be no costs to them in terms of lost information
or increased search costs.
B. Small Entity Analysis
FDA has examined the impacts of this proposed rule under the
Regulatory Flexibility Act (RFA). The RFA (5 U.S.C. 601-612) requires
Federal agencies to consider alternatives that would minimize the
economic impact of their regulations on small businesses and other
small entities. In compliance with the RFA, FDA finds that this
proposed rule will not have a significant impact on a substantial
number of small entities.
Because this proposed rule imposes no costs, it will not have a
significant impact on a substantial number of small entities.
Accordingly, under the RFA (5 U.S.C. 601-612), the agency certifies
that this proposed rule will not have a significant economic impact on
a substantial number of small entities.
C. Unfunded Mandates Reform Act of 1995
FDA has examined the impacts of this proposed rule under the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). This rule
does not trigger the requirement for a written statement under section
202(a) of the UMRA because it does not impose a mandate that results in
an expenditure of $100 million (adjusted annually for inflation) or
more by State, local, and tribal governments in the aggregate, or by
the private sector, in any one year.
VI. Environmental Impact
The agency has determined under 21 CFR 25.30(k) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VII. Paperwork Reduction Act of 1995
This proposed rule contains ingredient declaration provisions that
fall within the scope of the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520). The agency tentatively concludes that the proposed
provisions set forth below for the declaration of fish ingredients
using ``and/or'' labeling would not impose any new information
collection requirements because they create an exception from existing
ingredient declaration requirements to make compliance easier. The
ingredient declaration burden under Sec. 101.4(b) has been approved by
the Office of Management and Budget (OMB control number 0910-0381). To
ensure that no additional burden has been overlooked, however, FDA
seeks public comment on this tentative conclusion.
VIII. Comments and Proposed Dates
Interested persons may, on or before June 23, 1999, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above, between 9
a.m. and 4 p.m., Monday through Friday.
FDA proposes that any final rule that may issue based on this
proposal become effective on the date that it is published in the
Federal Register.
IX. References
The following references have been placed on display at the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Lee, C. M., ``Surimi Process Technology,'' Food Technology,
pp. 69-80, 1984.
2. Letter from Roy E. Martin to the Food and Drug
Administration, dated October 13, 1998.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 is amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371.
2. Section 101.4 is amended by adding paragraph (b)(23) to read as
follows:
Sec. 101.4 Food; designation of ingredients.
* * * * *
(b) * * *
(23) When processed seafood products contain fish protein
ingredients consisting primarily of the myofibrillar protein fraction
from one or more fish species and the manufacturer is unable to adhere
to a constant pattern of fish species in the fish protein ingredient,
because of seasonal or other limitations of species availability, the
common or usual name of each individual fish species need not be listed
in descending order of predominance. Fish species not present in the
fish protein ingredient may be listed if they are sometimes used in the
product. Such ingredients must be identified by words indicating that
they may not be present, such as ``or'', ``and/or'', or ``contains one
or more of the following:'', e.g., ``fish protein (contains one or more
of the following: Pollock, cod, and/or pacific whiting)''.
Dated: March 27, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-8795 Filed 4-9-99; 8:45 am]
BILLING CODE 4160-01-F