[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