[Federal Register Volume 59, Number 135 (Friday, July 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17289]
[[Page Unknown]]
[Federal Register: July 15, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 102
[Docket No. 92P-0476]
Crabmeat; Amendment of Common or Usual Name Regulation
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the common or usual name regulation for crabmeat by adding the species
Lithodes aequispina to those listed in this regulation and by providing
that the common or usual name of crabmeat derived from this species is
``Brown King crabmeat.'' This proposal is in response to a citizen
petition submitted by the Alaska Seafood Marketing Institute (ASMI).
DATES: Written comments by September 13, 1994. The agency proposes that
any final rule that may issue based on this proposal become effective
30 days after its publication in the Federal Register.
ADDRESSES: Written comments may be sent to the Dockets Management
Branch (HFA-05), Food and Drug Administration, rm. 1-3, 12420 Parklawn
Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Mary I. Snyder, Center for Food Safety
and Applied Nutrition (HFS-16), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, 202-254-3888.
SUPPLEMENTARY INFORMATION:
I. Background
A. Crabmeat Labeling
The Shellfish Promotion Committee of ASMI, 1011 Western Ave., suite
603, Seattle, WA 98104, filed a petition on December 17, 1992, to amend
the common or usual name regulation for crabmeat (Sec. 102.50 (21 CFR
102.50)) to provide that the common or usual name of crabmeat derived
from the species L. aequispina is ``Brown King crabmeat.''
Section 102.50 lists the following genera and species and the
associated common or usual name of their crabmeat: Paralithodes
camtschatica and P. platypus as King crabmeat; P. brevipes as King
crabmeat or Hanasaki crabmeat; Erimacrus isenbeckii as Korean variety
crabmeat or Kegani crabmeat; and Chionoecetes opilio, Chionoecetes
tanneri, Chionoecetes bairdii, and Chionoecetes angulatus as Snow
crabmeat. Thus, Sec. 102.50 provides that only the crabmeat from three
species of the genus Paralithodes may be called ``King crabmeat.''
FDA has been dealing with common or usual name issues involving
crabmeat since 1954. In the Federal Register of April 8, 1954 (19 FR
2013), FDA announced its policy for the appropriate labeling of
imported canned crabmeat. FDA stated that the term ``King crabmeat'' is
an acceptable common name for the product prepared from any one of the
above three Paralithodes species, and that ``Hanasaki crabmeat'' was an
acceptable alternative common name for a product prepared from P.
brevipes. FDA later codified these and the other common or usual names
for crabmeat in Sec. 102.7 when it promulgated 21 CFR part 102 in 1973
(38 FR 6964 at 6966, March 14, 1973). (Section 102.7 was later
redesignated as Sec. 102.50 (42 FR 14322, March 15, 1977)).
FDA's policy on the labeling of the crabmeat of species not listed
in Sec. 102.50 is set forth in the agency's Compliance Policy Guide
(CPG 7108.04). Under this policy, products derived from domestic
sources that are labeled as ``crabmeat,'' without qualification, are
generally accepted to have been derived from Callinectes sapidus (blue
crab). In other cases, the agency encourages the use of a prefix that
identifies the country where the crab was caught (e.g., ``Taiwan
Crabmeat'').
B. Common or Usual Name Provisions
The common or usual name of a food is the prevalent and meaningful
name by which consumers ordinarily identify a specific food. This
vernacular name may lack the specificity of the scientific or technical
name of a food, but an appropriate common or usual name permits the
public to unambiguously distinguish between similar foods that are
available in the marketplace. The common or usual name of a food may be
established by a history of common usage or by regulation. Section
102.5 requires that the common or usual name of a food accurately
identify, in simple and direct terms, the basic nature of the food and
its characterizing properties. The name must be uniform among all
identical or similar products. In fact, under Sec. 101.3(b)(1), a food
with a common or usual name that has been established by regulation is
misbranded if it is not identified by that name.
Before establishing a common or usual name by regulation, FDA must
conclude that the proposed name is not false or misleading within the
meaning of section 403(a) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 343(a)) and that the name for the food conforms
with the provisions of Sec. 102.5. Moreover, to prevent confusion and
deceptive economic practices, the agency must ensure that a proposed
common or usual name is not inappropriately similar to one that has
already been established by regulation. Therefore, suitable identifying
terms in the proposed name are necessary to ensure that consumers can
distinguish one product from another similar product (28 FR 10900,
October 11, 1963).
In the case of crabmeat, the common or usual name ``King crabmeat''
identifies a food with the common characterizing properties that
consumers in the United States associate with the meat of the large
spider crabs found in the waters of the North Pacific. These King
crabs, also known as ``Alaskan King Crabs,'' are characterized by a
spiny shell, six long spidery legs, a large and a small claw, and a
typical weight of about 4\1/2\ Kilograms (kg) (10 pounds (lb)) (Refs. 1
and 2). Thus, the common name ``King crabmeat'' applies to the meat
derived from any of three scientifically different crab species whose
meats are sufficiently similar that consumers accept them as being
interchangeable.
This proposal, if finalized, will establish a new common or usual
name that is similar to ``King crabmeat.'' FDA tentatively finds,
however, that the similarity in names will not be deceptive because the
ASMI petition includes data that show that the meat of L. aequispina
and P. camtschatica (King crabmeat) are similar. Moreover, inclusion of
the qualifying prefix ``brown'' in the proposed common or usual name
for the meat of L. aequispina will help consumers to distinguish that
crabmeat from that of the Paralithodes spp. Finally, data in the ASMI
petition also show that ``Brown King crabmeat'' is the commonly
accepted name for L. aequispina.
C. Previous King Crabmeat Petitions
FDA has previously denied petitions to amend Sec. 102.50 to permit
the use either of the term ``King crabmeat'' or a qualified version of
that name as the common or usual name of crabmeat from either L.
aequispina or L. antarctica (Docket Nos. 76P-182, 81P 0327/CP, and 84P-
046). In each instance, the agency concluded that the petitioner had
not presented sufficient evidence of the comparability of the meats of
the Lithodes spp. with the King crabmeat of the Paralithodes spp. to
support the requested amendment (Refs. 3, 4, 5, and 6). In these
denials the agency held that a petitioner must demonstrate that each of
the significant characteristics of King crabmeat that are valued by
consumers is present in the new species before the agency will permit
meat from that species to be identified in Sec. 102.50 as ``King
crabmeat.''
The petition that FDA denied in 1978 (Docket No. 76P-182) requested
that the common or usual name ``King crabmeat'' be established for L.
aequispina. The agency denied the petition primarily because it found
that, based on the limited numbers of L. aequispina marketed at that
time, there was not a sufficient basis to find that there was a common
or usual name for the species (Ref. 6). The available information on
the name by which this species was commonly known within the industry
showed that it was referred to by various names, including ``brown
crab'' and ``golden crab,'' as well as ``King crab'' and ``golden King
crab.''
II. Grounds for the Petition
A. Introduction
The ASMI petition requests that FDA amend Sec. 102.50 to include
the species L. aequispina and provide for the use of ``Brown King
crabmeat'' as the common or usual name of its crabmeat. In support of
the amendment, the petition provides: (1) Data and results of tests
that compare L. aequispina with P. camtschatica. The tests scored the
preferences of a consumer panel for the taste, texture, appearance, and
appropriateness of labeling each species as King crabmeat; (2)
photographs that compare the size and color of the cooked legs and
claws of these species; (3) literature bearing on crab fishery
practices, marketing, and the nomenclature and comparative morphology
of L. aequispina and other crab species; (4) a compilation of the
average measurements of the shoulder, merus, carpus, and propodus for
the crab legs used in the consumer panel visual display to determine
preference for ``King crab'' labeling; and (5) ten letters from major
processors of Alaska King crab and a letter from the National Fisheries
Institute endorsing the petition and attesting that consumers and the
industry accept L. aequispina (``Alaska golden or brown crab'') as King
crab.
B. Brown or Golden King Crab
1. Market Acceptance as King Crabmeat
The ASMI states that L. aequispina has been commonly identified,
marketed, and accepted as ``Gold,'' ``Golden,'' or ``Brown King crab''
since the early 1980's, when its fishery began to develop. The ASMI
also states that no resistance or confusion has arisen from the general
buying public concerning the use of the term ``King crab'' to describe
the product. The petitioner further states that increased demand and
recent developments in deep water harvesting technology have resulted
in a significant commercial fishery for L. aequispina, and that, over
the last decade, as the availability of P. camtschatica and P. platypus
has decreased, the demand for and supply of L. aequispina has grown.
The petition states that as a result of these factors, L. aequispina
has become a major source of King crabmeat in the United States,
whereas the supply of crabmeat from P. camtschatica and P. platypus has
been greatly reduced and is often limited to a few market areas.
As discussed above, FDA concluded in 1978 that the use of the term
``golden'' or ``brown crab'' for L. aequispina was not sufficiently
common in U.S. markets to be established as the common or usual name
for this food. However, the available evidence shows that, beginning in
the 1980's, the size of the commercial catch of L. aequispina has
increased to a large fraction of what the industry has called the
``total King crab harvest.'' For example, from 1981 to 1982, L.
aequispina represented 1.4 percent of the total Alaskan King crab catch
(Paralithodes spp. plus L. aequispina) in the western region. From 1983
to 1984, it represented 21.7 percent of the total catch (see Docket No.
84P-0046).
In addition to the information in the petition, FDA has sought to
corroborate the general acceptance of L. aequispina as a King crab, and
that it is commonly known as ``brown'' King crab, by consulting
authoritative references on nomenclature for aquatic species, as well
as the scientific and trade literature. All of these sources commonly
refer to L. aequispina as either ``golden King crab'' or ``brown King
crab'' (Refs. 2 and 7 through 12).
FDA relied in part on publications of the American Fisheries
Society (``List of Common and Scientific Names of Fishes from the
United States and Canada'') in preparing a guide to acceptable common
and market names for the species of food fish sold in U.S. interstate
commerce that do not have common or usual names established by
regulation (54 FR 12284, March 24, 1989). The American Fisheries
Society Special Publication 17, ``Common and Scientific Names of
Aquatic Invertebrates from the United States and Canada: Decapod
Crustaceans,'' addresses adherence to uniform scientific and common
nomenclature of aquatic invertebrates (Ref. 9). L. aequispina is among
the species recognized in this compilation under the family heading
``Lithodidae-stone and King crabs.'' This compilation also identifies
this species with the common name ``golden King crab.''
Similarly, a compilation that focuses on the fishery region of
interest, ``Alaska's Saltwater Fishes and Other Sea Life, A Field
Guide'', prepared by the National Marine Fisheries Service of the
National Oceanic and Atmospheric Administration, U.S. Department of
Commerce, identifies L. aequispina as ``Golden King Crab, Brown King
Crab, or Deep Water Crab'' (Ref. 7). This source also presents
illustrations and the dimensions of the species listed.
A nomenclature reference with an international perspective, ``Fish:
Five-Language Dictionary of Fish, Crustaceans and Molluscs,'' lists L.
aequispina as ``golden King crab'' (Ref. 10).
Literature unrelated to species identification or nomenclature also
distinguishes L. aequispina as a King crab. For example, a treatise
dealing with the diseases of aquatic species, ``Principal Diseases of
Marine Fish and Shellfish,'' refers to this species as ``golden king
crabs'' (Ref. 11). Similarly, an article reporting a joint government/
industry ocean survey to gather information on the size of L.
aequispina at maturity is entitled ``Brown King Crab'' (Ref. 8), and
regulations of the Alaska Board of Fisheries for Commercial Fishing in
Alaska identify the species as ``brown king crab'' (Ref. 15).
Correspondingly, trade periodicals dealing with the market price
and availability of King crab consistently classify or refer to L.
aequispina as a King crab (prefaced by either ``golden'' or ``brown'')
and commonly regard it as an Alaskan King crab (Refs. 2, 12, and 13).
Thus, the agency tentatively finds that these names for L. aequispina
have been commonly used in the United States for about a decade, and
that this usage, in contrast with the situation in 1978, supports the
requested amendment of Sec. 102.50.
In addressing the similarities between L. aequispina and P.
camtschatica, the petition does not address the value that the
marketplace ascribes to each species, as reflected by the market prices
they command. Nor does the petition address whether establishing the
proposed common or usual name for L. aequispina will affect the price
of its meat. FDA believes that in the case of unprocessed raw products
such as crabs, consumers and crabmeat processors will normally pay a
comparable price for similar products that are equally desirable. For
example, from January 1990 to January 1992, prices for ``King'' crab
legs and claws (12/14 count) were reported to have varied from $2.10 to
$3.85 more per pound than those of ``Brown King'' (21/24 count) (Ref.
12). In 1988, graded sections of P. camtschatica were $1.75 to $2.00
more per pound than those of Brown King crab (Ref. 13). Thus, although
L. aequispina is classified and sold as a King crab, the substantial
price difference between these species means that they are not
typically regarded as interchangeable foods by the marketplace.
A certain amount of the price differential between these species
may be attributable to the current scarcity of the Paralithodes spp.
However, FDA believes that most of the difference in price is a result
of the disparity in size. The agency recognizes that one of the primary
distinguishing and valued features of Paralithodes spp. is their large
size relative to other crabs. Therefore, fair dealing and the interest
of the consumer require that, among other considerations, any crabmeat
that is labeled either as ``King crabmeat'' or as a variety of King
crabmeat (e.g., Brown King crabmeat) should be derived from a species
of crab that has dimensions that are similar to those which consumers
associate with King crab (Paralithodes spp.).
Literature in the petition (Ref. 7) shows that the length of L.
aequispina (listed as ``Golden King Crab,'' ``Brown King Crab,'' or
``Deep Water Crab''), measured across the body shell (carapace), is 23
centimeters (cm) (9 inches (in)), and that its width is up to 23 cm (9
in). The respective carapace dimensions for P. camtschatica and P.
platypus are given as: 23 cm (9 in) and up to 28 cm (11 in) across the
carapace; 20 cm (8 in) and up to 25 cm (10 in) in width.
These dimensions show that while L. aequispina is not as large as
the two Paralithodes spp., selected examples of the three species can
be comparable in overall body size. The actual sizes of the crabs
generally available to the consumer or crabmeat processor, however, are
governed by the size of the crabs customarily found in the commercial
catch. This size, in turn, may be determined more by the minimum
harvestable size imposed for a specific harvesting area or fishery,
than by the larger sizes that are known to exist but are not caught in
significant numbers.
The larger sizes of L. aequispina apparently are not caught in
significant numbers (Ref. 8). As a consequence, the minimum legal size
limit for harvest in some fishery areas might be reduced to crabs as
small as 13.75 cm (5\1/2\ in) in carapace width, to make the fishery
commercially viable for L. aequispina (Ref. 8). The agency believes
that these factors may result in crab parts and crabmeat chunks that
typically are somewhat smaller than those of the Paralithodes spp.
The petition states that because each of the species is harvested
from widespread areas in Alaskan waters, the size of the crabs has
always varied. To compensate for this variation, the legs and claws are
repacked to provide uniform counts per 4\1/2\-kg (10-lb) unit. Thus,
the petitioner contends that the retailer and the consumer will get a
uniform range of sizing regardless of which species of Lithodes or
Paralithodes is purchased as ``King crab.'' However, as described
above, the generally lower market price of L. aequispina indicates that
providing uniform counts per unit weight does not cause processors and
consumers to accept its meat as interchangeable with that of the
Paralithodes spp.
2. Comparative Sensory Testing
The petitioner states that in establishing an appropriate common or
usual name, consumers must be protected from deceptive practices, but
that the proposed name is justified because there are more similarities
than differences between L. aequispina crabmeat and that of the three
species of Paralithodes listed in Sec. 102.50. The petition states that
the crabmeat from all four species is nearly identical in flavor,
texture, and color. The petition describes a slight variation in the
reddish hue of the carotenoid layer surrounding the white meat of each
leg segment of L. aequispina but states that there is a range of the
reddish hue in the meat between samples of any one species. Photographs
comparing the cooked legs and claws of L. aequispina and P.
camtschatica demonstrate that these pieces share a similar color and
morphology.
Consumer acceptance studies were conducted with a total of 158
individuals tested in three geographic areas (Chicago, Los Angeles, and
New York City). The tests compared L. aequispina with P. camtschatica
by rating consumer preference, in terms of degree of ``liking,'' based
on the appearance of previously frozen crab legs and the taste and
texture of their crabmeat, presented as precooked split merus (the
section of the leg of a king crab which is closest to the shoulder
(Ref. 16)) portions in the shell. The test panel also rated the
appropriateness of labeling each species' crabmeat as ``King crab,''
based on a display of cooked, whole crab legs. All products were from
crab legs sized 16/20 pieces per 4\1/2\ kg (10 lb).
The sensory characteristics of the samples were evaluated on a
hedonic scale, ranging from 9 for ``like extremely'' to 1 for ``dislike
extremely.'' The reported average scores in each of the four rated
categories of ``liking'' (overall degree of liking, appearance, flavor,
and texture) for each species were not statistically different at the
90 percent confidence level, and these average scores were
approximately 7 on the hedonic scale (like moderately) for each
category. The averaged results thus indicate that the panel members
found no significant differences between the crabmeats of the two
species. However, a slightly greater number of responses in the top
degrees of liking (extremely and very much) indicated a consistent
margin of preference for P. camtschatica across these four categories.
Analysis of the data by FDA confirmed the reported results but
found that the results for all of the categories evaluated were
dependent on the order in which the species were presented (Ref. 14).
The ratings for ``appearance'' showed that the respondents that were
given the P. camtschatica crabmeat first rated it significantly higher
(p <0.01) than="" they="" rated="" l.="" aequispina.="" when="" the="" species="" were="" presented="" to="" other="" respondents="" in="" the="" reverse="" order,="" l.="" aequispina="" was="" rated="" significantly="" higher="" (p="">< 0.01).="" similarly,="" when="" rated="" for="" ``flavor,''="" p.="" camtschatica="" meat="" scored="" significantly="" higher="" (p="">< 0.01)="" if="" presented="" first,="" while="" the="" reverse="" order="" of="" presentation="" resulted="" in="" flavor="" ratings="" that="" were="" about="" the="" same="" on="" average="" (p=""><0.15). in="" the="" case="" of="" the="" rating="" for="" ``overall''="" acceptance,="" respondents="" that="" were="" given="" p.="" camtschatica="" crabmeat="" first="" rated="" it="" significantly="" higher="" (p=""><0.001) than="" l.="" aequispina,="" while="" those="" presented="" with="" the="" products="" in="" the="" reverse="" order="" rated="" the="" two="" products="" about="" the="" same="" on="" average="" (p=""><0.15). a="" similar="" pattern="" was="" found="" for="" the="" ``texture''="" ratings.="" the="" ratings="" for="" the="" appropriateness="" of="" labeling="" either="" crab="" as="" ``king="" crab,''="" based="" on="" the="" appearance="" of="" the="" whole="" crab="" legs,="" resulted="" in="" a="" statistically="" significant="" higher="" mean="" score="" for="" l.="" aequispina.="" however,="" the="" petition="" does="" not="" state="" to="" what="" degree="" the="" display="" represented="" the="" most="" commonly="" available="" leg="" sizes="" of="" each="" species.="" again,="" however,="" fda="" analysis="" of="" the="" data="" indicated="" that="" the="" order="" of="" presentation="" appeared="" to="" affect="" the="" results.="" respondents="" observing="" p.="" camtschatica="" legs="" first="" rated="" l.="" aequispina="" significantly="" higher="" (p=""><0.001) than="" p.="" camtschatica.="" when="" given="" in="" the="" reverse="" order,="" the="" two="" products="" were="" rated="" about="" the="" same="" on="" average="" (p="">0.25).
The apparent dependence of the preferences expressed by the panel
on the order of species presentation raises questions about the
adequacy of the statistical design of the study. However, FDA does not
believe that the effects observed from the order of species
presentation are of a type or an extent that invalidates the overall
test panel results, which show that the crabmeats are similar. For
example, in four of the five categories evaluated, reversing the order
in which the crabmeat was presented (e.g., L. aequispina before P.
camtschatica) did not result in L. aequispina being favored over P.
camtschatica, as might be expected if there was a meaningful
correlation between preference and order of presentation. Instead,
those served L. aequispina first rated the two crabmeats about the same
on average, suggesting that any bias introduced by the order of
crabmeat presentation was not a determining factor in the overall panel
ratings. Therefore, FDA tentatively concludes that the approximately
equivalent average scores for each species in each of the four sensory
categories compared are valid findings, and that they are sufficient to
demonstrate that the test panels found that the two crabmeats are
similar foods when compared for flavor, texture, appearance, and
overall degree of liking.
Thus, with respect to these sensory attributes, the results are
consistent with the conclusion that the use of the terms ``King
crabmeat'' in the common or usual name of L. aequispina is not
misleading. Inasmuch as the proposed amendment will establish a common
name for a similar but separate type of ``King crabmeat,'' FDA
tentatively finds that tests showing that consumers accept the meat of
L. aequispina as identical to, or interchangeable with, that of the
three Paralithodes species are not necessary.
III. The Proposed Regulation
While the petition seeks to demonstrate the similarity between the
important characteristics of L. aequispina meat and that of the largest
of the Paralithodes crabs, the petitioner's proposed amendment requests
the use of a common or usual name other than ``King crabmeat.''
FDA believes that the data and information submitted in the
petition, as well as other information available to the agency, support
a tentative conclusion that L. aequispina is now widely accepted in the
United States as a bonafide King crab. This tentative conclusion is
based primarily on the use of the term ``King crab'' in the names
commonly used to identify it in the scientific and trade literature
(i.e., golden, gold, brown, and deep water King crab), as well as its
relative size and a decade of substantial sales and acceptance in the
United States as a type of King crab.
However, the agency also recognizes that L. aequispina is a
different genus than the species commonly known as ``King crab'' in the
United States, and that its somewhat smaller size and lower market
value clearly differentiate it from traditional King crab of the genus
Paralithodes. Consequently, FDA agrees with the petitioner, and one of
the processors that endorsed the petition by letter, that the crabmeat
of L. aequispina should be identified by a qualifying prefix that will
make consumers aware that it is not identical to the King crabmeat of
the three Paralithodes species listed in Sec. 102.50. Therefore,
because the requested name is a modified form of an established common
name for a similar food, FDA tentatively concludes that the proposed
name will not confuse or mislead consumers. FDA has tentatively
concluded the modified name ``Brown King crabmeat'' appropriately sets
this product apart from ``King crabmeat,'' and that ``Brown'' suitably
serves to identify and distinguish this similar but specific type of
crabmeat. Moreover, the name ``Brown King crabmeat'' has the benefit of
a history of common use that should augment the recognition among
consumers of the differences between these two foods.
The agency is aware that L. aequispina also has been commonly
referred to as ``Golden King crab.'' Nonetheless, FDA discourages the
use of the name ``Golden King crabmeat,'' because its use as a
statement of identity on food labels could mislead consumers. FDA
believes that the use of the prefix ``golden'' connotes a superior
quality or premium grade of crabmeat and thereby could unfairly affect
the price that consumers are willing to pay for the product.
Conversely, the agency tentatively concludes that the common or usual
name ``Brown King crabmeat'' does not convey similar ambiguous
implications about the nature or value of the crabmeat. FDA tentatively
finds that this name is consistent with fair dealing and the interest
of the consumer and should not unfairly affect the price of L.
aequispina crabmeat.
As provided by Sec. 101.3(b)(1), adoption by FDA of the proposed
amendment will require that the meat of L. aequispina be labeled as
``Brown King crabmeat.'' The agency tentatively finds that the
consistent use of this term will benefit consumers by providing a
consistent statement of identity, thereby precluding the use of various
potentially misleading names in or on labels and labeling pertaining to
this food.
The common or usual name ``Brown King crabmeat'' will provide
consumers with a common or usual name for L. aequispina crabmeat that
not only accurately identifies the basic nature of the food in simple
and direct terms as a meat derived from a King crab, but also provides
consumers with added characterizing information that will enable them
to distinguish it from traditional ``King crabmeat.''
Therefore, after a careful review of the petition and consideration
of all of the available information, FDA is proposing to amend
Sec. 102.50, by adding the crabmeat of the species L. aequispina,
identified by the common or usual name ``Brown King crabmeat.'' This
proposal is based in part on the acceptance of L. aequispina as a
``Brown King crab'' by the fishery industry and in the marketplace and
in part on the similarity of its meat in taste, texture, and appearance
with King crabmeat, as demonstrated by consumer acceptance studies.
IV. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
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). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because L. aequispina has been marketed for 10 years
as golden or brown King crab, FDA estimates that there are no costs of
the proposed rule from labeling changes or for any other reason, the
agency certifies that the proposed rule will not have a significant
economic impact on a substantial number of small entities. Therefore,
under the Regulatory Flexibility Act, no further analysis is required.
V. Environmental Impact
The agency has determined under 21 CFR 25.24(b)(1) 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.
VI. References
The following references have been placed on display in 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. ``The Seafood Handbook, Seafood Standards, Establishing
Guidelines for Quality,'' published by Seafood Business Magazine,
Rockland, ME, Journal Publications, 1991.
2. Miller, R.J., ``North American Crab Fisheries: Regulations
and Their Rationales,'' Fisheries Bulletin, 74 (3):623, 1976.
3. Letter to Arne L. Abrams, Wendt International, Inc., from
Joseph P. Hile, FDA, April 12, 1982.
4. Letter to Patrick J. Ricci, Seven Seas, Inc., from Joseph P.
Hile, FDA, April 30, 1984.
5. Letter to Raquel B. Flisfisch, Embassy of Chile, ProChile
Chilean Government Trade Bureau, from Joseph P. Hile, FDA, September
28, 1984.
6. Letter to Charles O. Perkins, Technical Services, New England
Fish Company, from Joseph P. Hile, FDA, September 11, 1978.
7. Kessler, Doyne W., ``Alaska's Saltwater Fishes and Other Sea
Life, A Field Guide,'' The National Marine Fisheries Service, Alaska
Northwest Publishing Co., Anchorage, AK, p. 27, 1985.
8. Benveniste, K., ``Brown King Crab,'' Pacific Fishing, p. 44,
October 1983.
9. Williams, Austin B., Lawrence G. Abele, et al., ``Common and
Scientific Names of Aquatic Invertebrates from the United States and
Canada: Decapod Crustaceans,'' American Fisheries Society Special
Publication 17, p. 33, 1989.
10. Krane, W., ``Fish: Five-Language Dictionary of Fish,
Crustaceans and Molluscs,'' Van Nostrand Reinhold, p. 96, 1986.
11. Sindermann, C. J., ``Principal Diseases of Marine Fish and
Shellfish,'' vol. 2, 2d ed., Academic Press, Inc., San Diego, CA, p.
193, 1990.
12. ``North Pacific Crab,'' Seafood Leader, 12(2):213, 1992.
13. ``Buyer's Guide,'' Seafood Leader, 8:275, 1988.
14. Memorandum from Foster D. McClure, Statistical Analysis
Branch, Center for Food Safety and Applied Nutrition, FDA, to Spring
C. Randolph, Office of Seafood, FDA, November 1, 1993.
15. Alaska Department of Fish and Game, Regulations of the
Alaska Board of Fisheries and Commercial Fishing in Alaska, p. 128,
1990.
16. Dore, Ian, ``Fresh Seafood,'' The Commercial Buyers Guide,
Van Nostrand Reinhold, p. 210, 1984.
VII. Comments
Interested persons may, on or before September 13, 1994, 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.
List of Subjects in 21 CFR Part 102
Beverages, Food grades and standards, Food labeling, Frozen foods,
Oils and fats, Onions, Potatoes, Seafood.
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 102 be amended as follows:
PART 102--COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
1. The authority citation for 21 CFR part 102 continues to read as
follows:
Authority: Secs. 201, 403, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 343, 371).
2. Section 102.50 is amended by revising the table to read as
follows:
Sec. 102.50 Crabmeat.
* * * * *
------------------------------------------------------------------------
Scientific name of crab Common or usual name of crabmeat
------------------------------------------------------------------------
Chionoecetes opilio, Chionoecetes Snow crabmeat.
tanneri, Chionoecetes bairdii, and
Chionoecetes angulatus.
Erimacrus isenbeckii............... Korean variety crabmeat or Kegani
crabmeat.
Lithodes aequispina................ Brown King crabmeat.
Paralithodes brevipes.............. King crabmeat or Hanasaki crabmeat.
Paralithodes camtschatica and King crabmeat.
Paralithodes platypus.
------------------------------------------------------------------------
Dated: June 30, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-17289 Filed 7-14-94; 8:45 am]
BILLING CODE 4160-01-P
