[Federal Register Volume 63, Number 78 (Thursday, April 23, 1998)]
[Proposed Rules]
[Pages 20148-20156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10743]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 102

[Docket No. 94P-0043]


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 regulation for crabmeat by adding the species Callinectes sapidus 
(C. sapidus) to those listed in the regulation and to provide that the 
common or usual name of crabmeat derived from this species is ``Blue 
crabmeat.'' FDA is further proposing, on its own initiative, to adopt 
common or usual names for 18 additional crab species. FDA is proposing 
these names based on ``The Seafood List'' and the information provided 
in the National Blue Crab Industry Association (NBCIA) petition. This 
proposal, which is in response to a citizen petition submitted by the 
NBCIA, is intended to allow crabmeat packers to properly identify their 
product so that consumers can make informed decisions.

DATES: Written comments by July 7, 1998. See section IV of this 
document for the proposed effective date of a final rule based on this 
document.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Anthony P. Brunetti, Center for Food 
Safety and Applied Nutrition (HFS-416), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3160.

SUPPLEMENTARY INFORMATION:

I. Background

A. Crabmeat Labeling

    The NBCIA, 1525 Wilson Blvd., suite 500, Arlington, VA 22209, filed 
a petition on February 15, 1994, 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 C. 
sapidus is ``Blue crabmeat.''
    Section 102.50 lists the following genera and species of crabs and 
the associated common or usual name of the meat from these crabs: 
Chionoecetes opilio, Chionoecetes tanneri, Chionoecetes bairdii, and 
Chionoecetes angulatus as Snow crabmeat; Erimacrus isenbeckii as Korean 
variety crabmeat or Kegani crabmeat; Lithodes aequispina as Brown King 
crabmeat; Paralithodes brevipes as King crabmeat or Hanasaki crabmeat; 
and Paralithodes camtschaticus and Paralithodes platypus as King 
crabmeat. (Note: The latter listing is currently incorrect in the Code 
of Federal Regulations (CFR). The CFR lists the common or usual names 
of Paralithodes camtschaticus as King crabmeat and Paralithodes 
Platypus. This error is being corrected in this document.)
    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 later codified this policy and the other 
common or usual names for crabmeat in Sec. 102.50 when it issued part 
102--Common or Usual Names For Nonstandardized Foods (21 CFR part 102) 
in 1973 (38 FR 6966, March 14, 1973).
    Guidance on the appropriate labeling of the crabmeats derived from 
species that are not listed in Sec. 102.50 is set forth in the agency's 
Compliance Policy Guides (CPG 7108.04). Under this guidance, products 
derived from domestic sources that are labeled as ``crabmeat,'' without 
additional qualification, are generally accepted as being derived from 
C. sapidus (blue crab), historically one of the most common and widely 
recognized sources of crabmeat in the United States. In labeling other 
species of crab, the CPG encourages the use of a prefix that

[[Page 20149]]

identifies the country where the crab was caught (e.g., ``Taiwan 
Crabmeat'').
    The NBCIA petition asserted that this policy no longer ensures that 
the meat of C. sapidus is unambiguously identified. The petition argued 
that consumers in the United States are being misled because, while 
they have come to expect that products that are labeled only as 
``crabmeat'' are derived from C. sapidus, in many instances, other, 
less desirable crabmeats are being substituted, in whole or in part, 
for the expected C. sapidus meat. Therefore, the petitioner requested 
that FDA establish by regulation that the common or usual name ``Blue 
crabmeat'' applies only to the meat of C. sapidus, thereby ensuring 
that consumers will not be misled about the source and nature of the 
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 the 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 
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 21 CFR 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 (see also section 403(b) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(b)).
    Before proposing a common or usual name regulation, FDA tries to 
ensure that the name that it is considering is not false or misleading 
within the meaning of section 403(a) of the act, and that the name 
conforms to the provisions of Sec. 102.5. Moreover, to prevent 
confusion and deceptive economic practices, the agency must ensure that 
the name is not inappropriately similar to one that has already been 
established by regulation.
    In the case of crabmeats, to conform to these principles, the 
common or usual name needs to clearly identify the characterizing 
properties that consumers in the United States associate with the meat 
of a particular species or group of crab species (e.g., see 59 FR 
36103, July 15, 1994). In some cases a geographical prefix serves this 
purpose by alerting the consumer that the meat is not that of domestic 
species.

C. Need to Establish a Common or Usual Name by Regulation

    Section 403(a)(1) of the act states that a food shall be deemed to 
be misbranded if its labeling is false or misleading in any particular. 
Under section 403(b), a food is misbranded if it is offered for sale 
under the name of another food. If a less valuable crabmeat is 
substituted for the species represented on the label or labeling, the 
product is adulterated under section 402(b)(2) of the act (21 U.S.C. 
342(b)(2)), which states that a food shall be deemed to be adulterated 
if any substance has been substituted wholly or in part thereof (i.e., 
economic adulteration). Consequently, it is a clear violation of the 
act when a food such as crabmeat is not correctly identified on its 
label or in its labeling.
     The agency may provide guidelines about how to label a class of 
foods, as in the case of fish and crabmeat, so that they are identified 
in a manner that promotes honesty and fair dealing in the interest of 
consumers. Nonetheless, false or misleading labeling practices 
sometimes arise that persuade FDA of the need to require the use of a 
common or usual name that will ensure that consumers are able to make 
fair value judgments about a food they buy. For example, a regulation 
prescribing a common or usual name may become necessary when there is 
not consistent adherence to a guideline on labeling practice (e.g., to 
the recommendation in CPG 7108.04 to provide the name of the country of 
origin as a prefix to ``crabmeat'' for crabmeat other than that of C. 
sapidus), when guidelines are not available, or when the guidance 
provided would not adequately resolve differences that distinguish 
similar foods, (e.g., the King crabmeats listed in Sec. 102.50 that are 
harvested from the same waters).
    Such a situation has arisen with respect to C. sapidus. As 
explained in section II of this document, FDA has become convinced that 
its admonition to marketers to follow the guidance in CPG 7108.04 is 
not being followed. As a result, many consumers are not being 
appropriately informed of the identity of the crabmeat that they are 
buying. Therefore, under Sec. 102.19, FDA is proposing to adopt ``Blue 
crabmeat'' as the common or usual name of meat from the species C. 
sapidus and to adopt common or usual names for crabmeat derived from 18 
other species of crab of which the agency is aware.

II. Grounds for the Petition

    The NBCIA petition requested that FDA amend Sec. 102.50 to include 
the species C. sapidus and to provide for the use of ``Blue crabmeat'' 
as the common or usual name of the meat of this species.
    The petition contended that it is necessary for FDA to establish a 
common or usual name regulation for the following reasons:
    (1) Even though C. sapidus is commonly known as ``blue crab,'' 
there has also been wide acceptance of the generic term ``crabmeat'' to 
refer to its meat because it is by far the most commonly available type 
of crabmeat in many areas of the United States. It has become 
commonplace, however, to import and repack, in the United States, 
crabmeats that are generally of lower value, primarily derived from 
non-C. sapidus species, and to label them also as ``crabmeat.''
    (2) In some cases the imported crabmeat is blended with higher 
value domestic blue crabmeat and misrepresented as being entirely C. 
sapidus.
    (3) Industry observations and Federal and State enforcement 
activities provide evidence that the country of origin of imported 
crabmeat often does not appear on the label after the meat has been 
repacked in the United States, even though U.S. Customs Service 
regulations require that the labels of imported products identify the 
country of origin unless it has been substantially transformed.
    (4) In the absence of a regulation, there are no binding rules to 
determine which crabmeat products may be appropriately identified by 
the name ``blue crabmeat.''
    In support of its contention that the imported meats of other crab 
species are being substituted for and represented as domestic C. 
sapidus, the petition included a copy of a newspaper account of a 
processor convicted in the State of Virginia of misbranding imported 
crabmeat by representing it as locally harvested domestic crabmeat 
(i.e., C. sapidus). The petition also included a copy of an Import 
Alert issued by FDA for the detention of misbranded seafoods, including 
products identified as blue crabmeat (No. 16-04--Revised, December 6, 
1988). The Import Alert advised FDA inspectors to conduct surveillance 
sampling and to review the import documents of incoming seafoods to 
prevent the unlawful entry of ``various species of fish or other 
seafood offered for entry into the United States under the name of a 
fictitious, incorrect, or substituted species.'' The alert further

[[Page 20150]]

advised that inspectors should sample entries of seafood labeled as a 
species not common to the exporting country. The alert included as 
guidance an appendix listing seafoods associated with previous 
misbranding events, and the market names of species that might be 
substituted, their scientific or likely fictitious name, and the region 
or country from which specific species are normally available.
    The petition asserted that ``blue crab'' is the appropriate common 
or usual name to codify for C. sapidus because it is the widely 
accepted common or usual name for this species. FDA acknowledges that 
it has been the agency's longstanding policy to accept ``blue crab'' as 
the common or usual name for C. sapidus. The Import Alert, as well as 
the CPG for the appropriate labeling of crabmeats, demonstrate not only 
FDA's acceptance of the common or usual name ``blue crabmeat,'' but 
also attest to the measures the agency has taken to deal with the 
ongoing problem associated with the proper identification and labeling 
of crabmeats. For example, CPG 7188.04 states that ``Product labeled as 
`crabmeat,' from domestic sources, without qualification are generally 
accepted to have been derived from the blue crab, Callinectes 
sapidus.'' Similarly, the petition noted that in the appendix of Import 
Alert No. 16-04--Revised, FDA identified ``blue crabmeat'' as the 
market name for C. sapidus and identified its source as the Atlantic 
Ocean. Whenever possible, FDA recommends the use of the established 
common or usual name of a food as the market name.
    More recently, FDA identified C. sapidus with the common name 
``blue crab'' in ``The Seafood List,'' which is the agency's guide to 
acceptable market names and common names for the species of food fish 
and invertebrates sold in U.S. interstate commerce that do not have 
common or usual names established by regulation (57 FR 47144, September 
14, 1994). In compiling this guide, FDA started with its own 
information and experience, but the agency relied primarily on 
consultation with seafood experts and authoritative works on seafood 
nomenclature.
    FDA has confirmed that authoritative nomenclature and trade 
publications continue to accept ``blue crab'' as the common or usual 
name for C. sapidus. For example, 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 and recognizes only C. sapidus by the common name 
``blue crab'' (Ref. 1).
    A nomenclature reference with an international perspective, ``Fish: 
Five-Language Dictionary of Fish, Crustaceans and Molluscs,'' also 
lists C. sapidus as ``blue crab'' (Ref. 2). Similarly, the 
``Multilingual Dictionary of Fish and Fish Products,'' identifies 
``blue crab (Atlantic-U.S.A.)'' as C. sapidus (Ref. 3).
    Consequently, FDA agrees with the petitioner that ``blue crab'' is 
the common or usual name for C. sapidus. That name is not only 
descriptive of the remarkably distinctive blue coloration of the 
animal's claws, but it is the meaningful and informative name that has 
been established by common use.

III. The Proposed Regulation

    The U.S. Government, including FDA, is concerned about recurring 
incidents of misrepresentations about the content of domestic products 
that are derived in whole or in part from imported crabmeat. The U.S. 
Customs Service expressed this concern in a detailed examination and 
ruling that addressed the relationship between the extent of domestic 
processing performed on imported crabmeat (i.e., whether a 
``substantial transformation'' has occurred) and the requirement for 
country of origin labeling on the finished consumer product (Ref. 4). 
The U.S. Customs Service ruling held that:
    * * * the domestic processing of imported crab meat by thawing, 
sorting, blending with domestic crabmeat, canning and pasteurization 
does not constitute a substantial transformation. Accordingly, the 
repacked crab meat is subject to the country of origin marking 
requirements of 19 U.S.C. 1304 and 19 CFR 134 * * *.
The ruling also concluded that none of the above processing operations 
``taken individually or together is sufficient to substantially 
transform the crab meat into a product with a different name, character 
or use.'' (Ref. 4)
    The U.S. Customs Service ruling underscores the petitioner's 
contention that the labeling of imported crabmeats is misleading, 
particularly with regard to providing consumers with information that 
will enable them to distinguish these crabmeats from domestic C. 
sapidus similarly labeled as ``crabmeat.'' In light of the record of 
misbranding of imported crabmeat products, including the agency's own 
efforts to detect and prevent such abuses, FDA tentatively concludes 
that the petitioner's claims that consumers are being misled are valid.
    The agency agrees with the petitioner that, in the absence of a 
regulation that requires C. sapidus to be labeled as ``Blue crabmeat,'' 
there is nothing that would require a conclusion that another crabmeat 
is misbranded when it is identified as ``Blue crabmeat.'' FDA also 
agrees with the petitioner that the generic ``crabmeat'' labeling of 
imports misleads because it implies that the crabmeat is domestic Blue 
crabmeat. Moreover, the term ``crabmeat'' does not adequately identify 
the food or allow consumers to distinguish between similar crabmeats 
that differ in value.
    This proposal will remedy this situation because, if the agency 
adopts the proposed regulation, the meat of C. sapidus is misbranded 
unless it is labeled ``Blue crabmeat,'' and, conversely, if crabmeats 
of other species are labeled as ``Blue crabmeat,'' they also will be 
misbranded. Thus, the proposed action will protect consumers from the 
confusing and misleading labeling of C. sapidus meat and from non-C. 
sapidus meat being labeled as ``Blue Crabmeat.''
    Consequently, FDA tentatively finds that the adoption of the common 
or usual name ``Blue crabmeat'' for C. sapidus meat will promote 
honesty and fair dealing in the interest of the consumer, and that this 
name accurately identifies, in simple and direct terms, the basic 
nature of the food and its characterizing properties. Accordingly, the 
agency tentatively concludes that Sec. 102.50 should be amended to 
include the name ``Blue crabmeat'' as the common or usual name for the 
meat of C. sapidus.
    However, FDA is not persuaded that this amendment will fully 
respond to the labeling concerns raised and reflected in the petition. 
Even if this proposed action becomes final, the meat of other crab 
species not listed in Sec. 102.50 would continue to be labeled simply 
as ``crabmeat,'' which many consumers will interpret as meaning that 
the meat is from C. sapidus. For this reason and because of the 
persistent misrepresentation of crabmeats, FDA has tentatively 
concluded that the amendment requested by the petitioner is necessary 
but not sufficient to prevent the continuing abusive crabmeat labeling 
practices reviewed here. Therefore, the agency is proposing, on its own 
initiative, to amend Sec. 102.50 more broadly than requested and to 
provide that all crabmeats must be identified on their label or 
labeling by the common or usual name of the species from which they are 
derived, as identified by FDA in ``The Seafood List.''
    The extension of Sec. 102.50 to include the common or usual name of 
all crabmeats is consistent with Sec. 102.5(a): ``Each class or 
subclass of food shall be given its own common or usual name

[[Page 20151]]

that states, in clear terms, what it is in a way that distinguishes it 
from different foods.'' Under this proposal, consumers will have a 
means of differentiating among these similar foods. Products labeled 
simply as ``crabmeat'' will be misbranded.
    Moreover, FDA tentatively concludes that it is appropriate and 
consistent with the efficient use of agency resources, to include these 
additional common or usual names in one amendment to Sec. 102.50, 
rather than to continue to propose separate rulemakings to codify these 
names on a piecemeal basis, as it has since 1954.
    As discussed under section II of this document, FDA has already 
expended considerable public resources to make ``The Seafood List'' 
available. It is an authoritative compendium of seafood nomenclature 
issued by FDA to promote the consistent and informative labeling of 
seafood species. To aid in their proper identification, this 
publication provides the scientific, ``common,'' and recommended market 
names (and in some cases regional vernacular names as well) for all of 
the domestic and imported species of finfish and invertebrates (shrimp, 
shellfish, and crustaceans) that are sold interstate in significant 
amounts as food in the United States.
    The names entered under the ``Market'' heading in ``The Seafood 
List'' are the common or usual names of the species that have been 
established by common usage or by regulation. It is not uncommon to 
find that closely related species have the same common or usual 
(market) name. This also is the case with the species listed in 
Sec. 102.50, where the meat from three different species of the 
Paralithodes genera share the common or usual name ``King crabmeat.'' 
The names under the heading ``Common'' in ``The Seafood List'' are the 
English language equivalent of the scientific name, and not the common 
or usual name, although these two types of common name frequently are 
very similar. When a common or usual name has not been established for 
a species, FDA recommends the use of the listed ``common'' name as an 
appropriate market name.
    In addition to the common or usual names of the 6 crabmeats (from 9 
species) that are currently listed in Sec. 102.50, ``The Seafood List'' 
identifies the following 19 crab species by their scientific and common 
or usual (market) names: Callinectes sapidus (Blue crab), Lithodes 
antarcticus (Centolla crab), Lithodes murrayi (Centolla crab), 
Paralomis granulosa (Deepsea crab), Cancer magister (Dungeness crab), 
Geryon fenneri (Golden crab), Cancer borealis (Jonah crab), Neolithodes 
brodiei (Lithodes crab), Geryon quinquedens (Red crab), Cancer 
irroratus (Rock crab), Cancer pagurus (Rock crab), Jacquinotia 
edwardsii (Spider crab), Maja squinado (Spider crab), Menippi adina 
(Stone crab), Menippi mercenaria (Stone crab), Callinectes arcuatus 
(Swimming crab), Callinectes toxotes (Swimming crab), Portunus 
pelagicus (Swimming crab), and Portunus puber (Swimming crab).
    FDA tentatively finds that, given the process that has gone into 
identifying and verifying the scientific and common or usual names of 
the crab species included in ``The Seafood List,'' it is appropriate to 
codify them in Sec. 102.50 Crabmeat. Accordingly, FDA proposes to add 
the scientific and corresponding common or usual names of the 19 crab 
species listed in ``The Seafood List'' to Sec. 102.50.
    FDA solicits public comment on whether the agency should require, 
as it has proposed, that all crabmeat labeling include the use of an 
appropriate common or usual name to provide consumers with a more 
complete identification of the crabmeats available in the marketplace. 
FDA also solicits comment on whether there are other crab species that 
should be included in Sec. 102.50, and, if there are, what the common 
or usual names is of each of these species.
    If this proposal is finalized, anyone engaged in the interstate 
commerce of a crabmeat that is not listed in Sec. 102.50 will have to 
petition FDA to include that species in the common or usual name 
regulation. The petition should demonstrate either the existence of an 
accepted common or usual name or propose to establish an appropriate 
one.
    In recent years, FDA has developed a computer data base known as 
the ``Regulatory Fish Encyclopedia'' (RFE) to help ensure that the 
economic adulteration of seafoods can be detected and confirmed by 
scientific methods. As an aid to the identification of species by FDA 
field investigators, industry, and the public, the RFE is readily 
accessible on the Internet (vm.cfsan.fda.gov/ centsfrf/
rfe0.html) and from FDA's World Wide Web site. The RFE makes available 
high resolution, annotated color images of more than 60 authenticated 
fish species, as well as the unique electrophoretic patterns of the 
flesh proteins of about two-thirds of these species (i.e., their 
``biochemical fingerprints'') (Ref. 5). Thus, in addition to a visual 
comparison of their anatomical features, an authentic protein pattern 
of a species that is displayed in the RFE can be compared with one 
obtained by isoelectric focusing methods from a suspected substitute 
species to determine whether misbranding and economic adulteration have 
occurred.
    FDA is in the early stages of collecting and photographing 
authenticated species of various crabs, including C. sapidus; and the 
agency has plans to determine the unique biochemical pattern of their 
flesh proteins or, if necessary because crabmeat is often cooked, to 
determine the patterns of their cellular DNA (deoxyribonucleic acid) 
components for inclusion in the RFE. Thus, the RFE resources, when 
combined with requirements for the unambiguous labeling of these foods 
as proposed herein, will provide FDA with an effective means of 
establishing the identity of different crabmeats and combating economic 
fraud.
    Under the proposed action, crabmeats that are labeled as ``Blue 
crabmeat'' and found to consist in whole or in part of crabmeat from 
other than C. sapidus will be misbranded and may be adulterated and 
will be subject to compliance action by the agency. Similarly, all 
other crabmeat will be misbranded unless labeled in accordance with the 
common or usual (market) name given in Sec. 102.50.
    Therefore, after a careful review of the petition and consideration 
of all of the available information, FDA is proposing to amend 
Sec. 102.50 Crabmeat, by adding the crabmeat of the species C. sapidus, 
identified by the common or usual name ``Blue crabmeat.'' FDA is also 
proposing to amend Sec. 102.50 by adding the scientific names of 18 
additional crab species and the associated 11 common or usual names of 
their crabmeats as identified in ``The Seafood List.'' For the ease of 
the reader, FDA is proposing to further revise the table in Sec. 102.50 
by placing the ``Common or usual name of crabmeat'' in the first column 
followed by the ``Scientific name of crab'' in the second column. FDA 
also is correcting an inadvertent error that occurred in the Federal 
Register of July 3, 1995 (60 FR 34459 at 34460), in the scientific name 
column whereby the scientific name Paralithodes Platypus was 
incorrectly placed in the ``Common or usual name of crabmeat'' column 
and the word Platypus was incorrectly capitalized.
    The impacts of this proposed rule on U.S. consumers and businesses 
are discussed in section V of this document. However, this proposed 
rule may also raise international trade issues that are not discussed 
in section V of this document. International trade issues may arise 
because the labeling changes necessitated by common or usual names may 
increase the demand for certain species of crab and decrease the demand

[[Page 20152]]

for other species of crab and because different countries and regions 
may harvest different species of crab. In some cases, these changes in 
demand will simply reflect preexisting differences in the value 
consumers place on the different species of crab. However, in other 
cases, these changes in demand might result from adverse consumer 
attitudes towards certain of the proposed common or usual names. For 
example, some consumers might find the name ``Spider crabmeat'' 
unappealing, creating an aversion to Spider crabmeat that did not 
previously exist. International trade effects caused by adverse 
consumer attitudes toward certain of the proposed common or usual names 
would ordinarily be considered a greater cause of concern than 
international trade effects caused by preexisting consumer preferences 
for different species of crab. FDA requests information on the 
international trade effects of this rule.

IV. Effective Date

    The agency periodically has established by final rule in the 
Federal Register uniform effective dates for compliance with food 
labeling requirements (see, e.g., the Federal Register of December 27, 
1996 (61 FR 68145)). FDA proposes that any final rule that may issue 
based upon this proposal become effective in accordance with a uniform 
effective date for compliance with food labeling requirements, which is 
established by final rule in the Federal Register and which is not 
sooner than 1 year following publication of any final rule based upon 
this proposal. The final rule would apply to affected products 
initially introduced or initially delivered for introduction into 
interstate commerce on or after its effective date. However, FDA notes 
that it generally encourages industry to comply with new labeling 
regulations as quickly as feasible. Thus, when industry members 
voluntarily change their labels, it is appropriate that they respond to 
any new requirements that have been published as final regulations up 
to that time. On the other hand, if any industry members can foresee 
that the proposed effective date will create particular problems, they 
should bring these problems to the agency's attention in comments on 
this proposal.

V. Analysis of Impacts

A. Executive Order 12866

    FDA has examined the impacts of this proposed rule under Executive 
Order 12866. Executive Order 12866 directs Federal agencies to assess 
the 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 effects; distributive impacts; and equity). According 
to Executive Order 12866, a regulatory action is ``economically 
significant'' if it meets any one of a number of specified conditions, 
including having an annual effect on the economy of $100 million or 
adversely affecting in a material way a sector of the economy, 
competition, or jobs. A regulation is considered ``significant'' under 
Executive Order 12866 if it raises novel legal or policy issues. FDA 
finds that this proposed rule is neither an economically significant 
nor 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.
1. Options
    FDA has assessed the costs and benefits of the following regulatory 
alternatives: Take no action, take the proposed action, or establish a 
common or usual name only for crabmeat derived from blue crab.
2. Benefits and Costs
    a. Option one: Take no action. By convention, the option of taking 
no action is the baseline in comparison with which the costs and 
benefits of the other options are determined. Therefore, neither costs 
nor benefits are associated with taking no action.
    b. Option two: Take the proposed action.
    i. Benefits. The benefit of the proposed action is that consumers 
will be able to more easily identify the species source of crabmeat for 
which this proposed rule establishes common or usual names. The value 
consumers place on being able to more easily identify crabmeat derived 
from these species of crab is not known. However, in general terms, if 
consumer valuation of crabmeat differs widely by species, and consumers 
cannot differentiate those species in the absence of the proposed 
common or usual name regulations, then consumers will derive greater 
benefit from the establishment of the proposed common or usual names. 
If, in addition, consumers assume that products labeled simply as 
containing crabmeat contain a particular and relatively valuable 
species of crab, then the proposed common or usual names will protect 
consumers from the economic fraud associated with the substitution of 
crabmeat derived from a less valuable species of crab for that crabmeat 
derived from the more valuable species of crab. On the other hand, if 
consumer valuation of crabmeat does not differ widely by species, or if 
consumers can already differentiate species, e.g., because they are 
already labeled in a manner consistent with the proposed common or 
usual name regulations, then consumers will place relatively little 
value on the establishment of the proposed common or usual names.
    FDA requests information about the following: Whether consumers can 
differentiate crabmeats derived from different species of crabs and, if 
so, how; whether consumers assume that products labeled simply as 
containing crabmeat contain a particular species of crab; and whether 
consumers place different values on crabmeats derived from different 
species of crabs. The agency also is interested in pricing data for 
crabmeat from different species. In particular, the agency is 
interested in data that takes into account seasonal availability and 
other factors that complicate price comparisons. The agency also 
requests information from consumers, crabmeat packers, and crabmeat 
product distributors about their experiences with species substitution 
practices, that is, where a less valuable crabmeat is substituted for a 
more valuable crabmeat.
    ii. Costs. The primary social cost of the proposed action is the 
cost of changing the labels of crabmeat products that are not already 
labeled in a manner consistent with the proposed common or usual names. 
Depending on market conditions, these costs may be borne by crabmeat 
processors, packers, or repackers or may be passed on to consumers in 
the form of higher prices. This rule may also produce distributive 
effects, that is, this rule may make some firms and regions better off 
and some firms and regions worse off.
    Labeling costs were estimated using a model developed for that 
purpose by Research Triangle Institute (RTI) under contract to FDA. The 
model allows one to estimate labeling costs based on the length of the 
compliance period, the complexity of the labeling change, and the 
Standard Industrial Code (SIC) classifications of the affected firms. 
The resulting labeling costs were comprised of administrative, 
redesign, and inventory costs. Total labeling costs are calculated by 
multiplying administrative costs by the number of affected firms and by 
multiplying redesign and inventory costs by the number of affected 
product lines, or Stock Keeping Units (SKU's). SKU's

[[Page 20153]]

differ from one another on the basis of either product formulation or 
packaging.
    The proposed effective date is the next uniform effective date for 
labeling regulations following the publication of a final rule based on 
this proposal. This effective date will provide a compliance period of 
at least 1 year. The relevant SIC codes appear to be 2091, Canned and 
Cured Fish and Seafoods, and 2092, Fresh or Frozen Packaged Fish. The 
complexity of the required labeling changes depends on the current 
labeling of the affected products. If these products are currently 
labeled in such a way that only the ingredient list needs to be 
changed, then the required labeling changes will be relatively simple. 
If these products are currently labeled in such a way that both the 
ingredient list and the principal display panel must be changed, then 
the required labeling changes will be relatively complex. FDA has 
insufficient information on the current labeling of these products to 
estimate the proportion of products requiring label changes of 
different levels of complexity. Therefore, labeling costs will be 
estimated both for the case in which all affected products require only 
changes to the ingredient list and for the case in which all affected 
products require changes to both the ingredient list and the principal 
display panel. Actual labeling costs should fall somewhere between 
these two estimates.
    The number of firms potentially affected by the proposed rule was 
determined using two data sources. These data sources differ with 
respect to data collection techniques, the frequency with which the 
data are updated, and so forth. Evaluation of the strengths and 
weaknesses of these data sources would be quite complex. Therefore, 
both data sources have been used.
    One data source used to estimate the number of potentially affected 
firms was the Duns Market Identifiers data base. A search of this data 
base identified 108 establishments associated with 92 firms that appear 
to produce crab products of the type that would be affected by this 
proposed rule. In this case, the search procedure involved identifying 
establishments with either SIC 2091 or 2092 as their primary or 
secondary activity and having the word ``crab,'' but not the word 
``imitation,'' in the description of their activity. The number of 
firms associated with these establishments was determined by further 
limiting the search to single establishment firms or headquarters of 
multiestablishment firms.
    The other data source used to estimate the number of potentially 
affected firms was FDA Official Establishment Inventory (OEI). The OEI 
is a list of all establishments known to FDA.
    A search of the OEI identified 594 establishments that are listed 
as either manufactures of crab products or crab repackers and that, 
therefore, could be affected by the proposed rule. Based on FDA 
experience, most of these plants probably represent independent firms. 
Based on these two data sources, the number of firms that might be 
affected by the proposed rule is estimated to be in the range of 92 to 
594 firms.
    The potential number of SKU's involved was estimated using the 
average number of distinct items per brand for crab products listed in 
the A. C. Nielsen Co. SCANTRACK Market Planner data base. This data 
base listed 210 brands and 346 items, for an average of 1.6 items per 
brand. Items are defined with respect to both product formulation and 
package size and, therefore, should correspond to SKU's. This average 
number of items or SKU's per brand was then multiplied by the estimated 
range of potentially affected firms to get a range of potentially 
affected SKU's. This procedure assumes that each firm is associated 
with only one brand name. Although some large firms may produce 
products under multiple brand names, the assumption of one brand name 
per firm is probably reasonable for most firms. Under these 
assumptions, the number of potentially affected SKU's is estimated to 
be between 147 and 950.
    Some of the firms and SKU's that are potentially affected by the 
proposed rule might not actually be affected. In particular, some firms 
producing crab products might produce products containing only those 
nine species of crab for which common or usual names are already 
required by Sec. 102.50. The products produced by these firms would not 
require label changes. In addition, some of the firms producing 
products containing species of crab for which common or usual names are 
being proposed might already be using the proposed common or usual 
name, which would be consistent with existing FDA labeling guidance 
provided in ``The Seafood List.'' Label changes would also not be 
required for these products. However, information is not available on 
the number of products that meet either of these conditions. To address 
the uncertainty generated by the absence of information on this issue, 
labeling costs will be estimated as a range with the low end of the 
range set to $0. Although it is unlikely that no products would require 
label changes, and that the cost of relabeling would actually be $0, it 
is possible that only a few products may need to be relabeled, and that 
relabeling costs might be quite low.
    For a compliance period of 1 year, the RTI labeling cost model 
estimates the administrative costs for changing only the ingredient 
list and for changing both the ingredient list and the principal 
display panel to be $850 per firm for firms having fewer than 10 
employees and to be $6,300 per firm for firms having 10 or more 
employees. Administrative costs are the same for firms in both SIC 2091 
and 2092. With respect to firms listed in the Dun's Market Identifiers 
data base, 23 of the 92 firms are identified as having fewer than 10 
employees. Data on the number of employees is not available for firms 
listed in the OEI. In the absence of other information, it is 
reasonable to suppose that the proportion of firms listed in the OEI 
that have fewer than 10 employees is the same as the proportion of 
firms listed in Dun's Market Identifiers. Under this assumption, 149 of 
the 594 firms listed in the OEI would have fewer than 10 employees. 
Based on these data and assumptions, total potential administrative 
costs are estimated to between $0.5 million and $3 million. Taking into 
account the fact that some potentially affected products may not 
contain the relevant species of crab or may already be labeled 
appropriately, administrative costs are estimated to be between $0 and 
$3 million.
    For a compliance period of 1 year, the RTI labeling cost model 
estimates combined redesign and inventory costs for changing the 
ingredient statement only to be $290 per SKU for firms in SIC 2091 and 
$714 per SKU for firms in SIC 2092. That model estimates combined 
redesign and inventory costs for changing the ingredient statement and 
the principal display panel to be $1,740 per SKU for firms in SIC 2091 
and $4,284 per SKU for firms in SIC 2092. Based on data from Dun's 
Market Identifiers, 17 potentially affected number are listed in SIC 
2091, 62 firms are listed in SIC 2092, and 13 firms are listed in both. 
For the purposes of estimating costs, it seems reasonable to distribute 
the 13 firms that are in both SIC classes to one of the two relevant 
SIC classes in the same proportion as the firms found in only one of 
the relevant SIC classes. Under this assumption, 20 potentially 
affected firms would be found in SIC 2091 and 72 affected firms would 
be found in SIC 2092. Based on 1.6 SKU's per firm, this implies that 
the number of potentially affected SKU's in SIC 2091 is 32 and the

[[Page 20154]]

number of potentially affected SKU's in SIC 2092 is 119.
    The OEI does not list firms by SIC. Therefore, it seems reasonable 
to suppose that the proportions of the relevant firms in SIC 2091 and 
SIC 2092 are the same as the proportions of the relevant firms in Dun's 
Market Identifiers. Under this assumption, 128 of the potentially 
affected 594 firms listed in the OEI would be in SIC 2091 and 466 of 
those firms would be in SIC 2092. Based on 1.6 SKU's per brand name, 
this implies that the number of potentially affected SKU's in SIC 2091 
is 211 and the number of potentially affected SKU's in SIC 2092 is 768.
    Based on the estimated number of potentially affected SKU's using 
Dun's Market Identifiers and the OEI, total potential redesign and 
inventory costs are estimated to be between $0 and $1 million for 
changing the ingredient statement only and between $1 million and $4 
million for changing both the ingredient statement and the principal 
display panel. Taking into account the fact that some potentially 
affected products may not contain the relevant species of crab or may 
already be labeled appropriately, redesign and inventory costs are 
estimated to be between $0 and $4 million. Total labeling costs, 
including administrative, redesign, and inventory costs, are estimated 
to be between $0 and $7 million.
    Labeling costs will be higher if some crabmeat products are 
currently made using any one of a number of species of crab. In that 
case, this proposed rule would require multiple product labels to be 
printed for products that currently use only one generic ``crabmeat'' 
label. Additional costs will be generated if compliance with the 
proposed labeling requirements involve other changes to the current 
method of manufacturing crabmeat products. However, FDA is not aware of 
any such costs. It should be noted that products may continue to be 
made with blends or mixtures of crabmeats, provided that each crabmeat 
in the blend or mixture is identified with its common or usual name. 
FDA requests information on the degree to which different crabmeats are 
used in the same products, and on any costs that may be generated by 
this proposed rule, including labeling, manufacturing, storage, and 
recordkeeping costs.
    In addition to social costs, there may be distributive effects 
associated with establishing the proposed common or usual names because 
the labeling changes necessitated by common or usual names may increase 
the demand for certain species of crab and decrease the demand for 
other species of crab. In some cases, these changes in demand will 
simply reflect preexisting differences in the value consumers place on 
the different species of crab. However, in other cases, these changes 
in demand might result from adverse consumer attitudes towards certain 
of the proposed common or usual names. For example, some consumers 
might find the name ``Spider crabmeat'' unappealing, creating an 
aversion to Spider crabmeat that did not previously exist. Distributive 
effects caused by adverse consumer attitudes toward certain of the 
proposed common or usual names would ordinarily be considered a greater 
cause of concern than distributive effects caused by preexisting 
consumer preferences for different species of crab. FDA has 
insufficient information to estimate changes in the demand for various 
species of crab or to determine the degree to which any changes in 
demand reflect either preexisting preferences or consumer attitudes 
toward the words used in the proposed common or usual names. FDA 
requests information on the distributive effects of this rule. In 
addition, FDA requests information on whether any of the proposed 
common or usual names might reduce the demand for a particular species 
of crab for reasons unrelated to preexisting preferences for that 
species of crab.
    c. Option three: Establish a common or usual name only for blue 
crabmeat.
    i. Benefits. FDA cannot estimate the difference in the benefits of 
this option relative to the benefits of taking the proposed action 
because FDA does not have information on the value consumers place on 
blue crabmeat relative to crabmeat from other species of crab, the 
degree to which consumers can already differentiate products that 
contain blue crabmeat from products that contain crabmeat from other 
species of crab, or the degree to which consumers assume that products 
labeled as ``crabmeat'' contain blue crabmeat. FDA requests public 
comment and information on these issues.
    ii. Costs. The costs associated with this option would be less than 
the costs associated with taking the proposed action because this 
option would affect only a subset of the products that would be 
affected by the proposed action. Therefore, estimated labeling costs 
would be less than $7 million and any other costs associated with the 
proposed action would also be less than they would be under the 
proposed action. FDA cannot estimate the difference in costs more 
precisely because FDA has information only on the number of products 
that contain crabmeat, not on the number of products than contain blue 
crabmeat. FDA requests information on the number of products containing 
exclusively blue crabmeat or on the proportion of all crabmeat-
containing products that contain blue crabmeat.

B. Analysis of Impacts on Small Businesses

    FDA has examined the impacts of this proposed rule under the 
Regulatory Flexibility Act. The Regulatory Flexibility Act (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. FDA finds that this proposed rule, if issued, 
might have a significant impact on a substantial number of small 
entities.
1. Options
    FDA has assessed the impacts on small entities of the following 
regulatory alternatives:
    Take no action, take the proposed action, or establish a common or 
usual name only for crabmeat derived from blue crab.
    a. Option one: Take no action. Taking no action would have no 
impact on small businesses.
    b. Option two: Take the proposed action. As discussed in the 
Executive Order 12866 analysis, the primary cost of taking the proposed 
action is the cost of changing the labels of products that contain the 
relevant species of crab and that are not already labeled in a manner 
consistent with the proposed common or usual names for those species. 
This cost was estimated to be between $0 and $7 million for all firms. 
The Small Business Administration's definition of a small business for 
the SIC codes identified as relevant in the Executive Order 12866 
analysis, SIC codes 2091 and 2092, is a firm having 500 or fewer 
employees. Under this definition, 88 of the 92 firms identified in the 
Dun's Market Identifiers data base as potentially affected by this 
proposed rule are small businesses. As indicated previously, the OEI 
does not contain information on the number of employees.
    Based on this information, it is likely that some portion of the 
costs estimated for all firms will be borne by small businesses. A more 
precise estimation of the proportion of estimated total costs borne by 
small firms would require information that is not currently available 
on the average difference in the number of SKU's (products and product 
sizes) produced by large and small firms. The estimated costs could be 
significant for some small firms.

[[Page 20155]]

 However, only relatively modest cost reductions would be produced by 
further lengthening the compliance period, and any level of cost could 
be significant for some small firms.
    With respect to the distributive effects discussed in the benefit-
cost analysis of this option, FDA has no information to suggest 
systematic differences in the species of crabs used by small and large 
firms. Therefore, FDA has no reason to suspect that any distributive 
effects will have a net negative effect on small firms as a class of 
firms. Of course, some of the firms that may be negatively affected by 
distributive effects may be small firms.
    c. Option three: Establish a common or usual name for blue crab 
only This option would reduce the impact of this proposed rule on small 
businesses because this option would affect only a subset of the 
products that would be affected by taking the proposed action. FDA 
cannot estimate the reduction of the impact on small businesses for two 
reasons. First, FDA has information only on the number of products that 
contain crabmeat, not on the number of products than contain blue 
crabmeat. Therefore, FDA cannot determine the degree to which total 
costs would be reduced by this option. Second, FDA has information only 
on the number of small businesses that manufacture products containing 
crabmeat, not on the number of small businesses that manufacture 
products containing blue crabmeat. Therefore, FDA cannot determine the 
proportion of the total cost reduction that would accrue specifically 
to those small businesses that manufacture crabmeat products without 
blue crabmeat. FDA requests information on the number of products that 
contain blue crabmeat and the number of small businesses that produce 
products containing blue crabmeat. FDA also requests information on the 
number of products that contain crabmeat from other species of crab, 
and the number of businesses and small businesses that produce products 
containing crabmeat from other species of crab. Finally, FDA also 
requests information on other alternatives that might reduce the burden 
of this proposed rule on small businesses.

VI. Environmental Impact

    The agency has determined under Sec. 25.30(k) (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. The purpose of the proposed rule is to 
ensure that consumers are informed about the identity of all crabmeats, 
and this will not change the intended use of this food product. The 
proposed action is not expected to increase the demand for blue 
crabmeat because the competition in the marketplace between blue 
crabmeat and lower priced crabmeat from other species of crabs can be 
expected to control the demand for blue crabmeat. However, because the 
impact of this proposed rulemaking on consumer demand for blue crabmeat 
is uncertain, FDA solicits public comment on any adverse effects the 
proposed labeling provisions may have on blue crab populations. The 
agency will evaluate its tentative conclusion that the proposed action 
warrants a categorical exclusion under Sec. 25.30(k) in light of any 
relevant comments responding to this proposal.

VII. 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. 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, pp. 41, 1989.
    2. Organization for Economic Cooperation and Development, 
``Multilingual Dictionary of Fish and Fish Products,'' 3d ed., 
Fishing News Books, pp. 63, 1990.
    3. Krane, W., ``Five-Language Dictionary of Fish, Crustaceans 
and Molluscs,'' Van Nostran Reinhold, pp. 32, 1986.
    4. Letter to the District Director, U.S. Customs Service, 
Department of the Treasury, from Harvy B. Fox, Director, Office of 
Regulations and Rulings, U.S. Customs Service, Department of the 
Treasury, Washington DC, regarding ``Country of Origin Marking of 
Canned Crabmeat,'' August 6, 1989.
    5. AOAC Official Methods of Analysis 980.16 Identification of 
Fish Species, Thin Layer Polyacrylamide Gel Isoelectric Focusing 
Method, p. 885, 1990.

VIII. Comments

    Interested persons may on or before July 7, 1998, 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: 21 U.S.C. 321, 343, 371.

    2. Section 102.50 is revised to read as follows:

Sec. 102.50  Crabmeat.

    The common or usual name of crabmeat derived from each of the 
following designated species of crabs shall be as follows:

                                                                        
------------------------------------------------------------------------
  Common or usual name of crabmeat         Scientific name of crab      
------------------------------------------------------------------------
Blue crabmeat                        Callinectes sapidus.               
Brown King crabmeat                  Lithodes aequispina.               
Centolla crabmeat                    Lithodes antarcticus and Lithodes  
                                      murrayi.                          
Deepsea crabmeat                     Paralomis granulosa.               
Dungeness crabmeat                   Cancer magister.                   
Golden crabmeat                      Geryon fenneri.                    
Jonah crabmeat                       Cancer borealis.                   
King crabmeat                        Paralithodes camtschaticus and     
                                      Paralithodes platypus.            
King crabmeat or Hanasaki crabmeat   Paralithodes brevipes.             
Korean variety crabmeat or Kegani    Erimacrus isenbeckii.              
 crabmeat                                                               

[[Page 20156]]

                                                                        
Lithodes crabmeat                    Neolithodes brodiei.               
Red crabmeat                         Geryon quinquedens.                
Rock crabmeat                        Cancer irroratus and Cancer        
                                      pagurus.                          
Snow crabmeat                        Chionoecetes angulatus,            
                                      Chionoecetes bairdi, Chionoecetes 
                                      opilio, and Chionoecetes tanneri. 
Spider crabmeat                      Jacquinotia edwardsii and Maja     
                                      squinado.                         
Stone crabmeat                       Menippi adina and Menippi          
                                      mercenaria.                       
Swimming crabmeat                    Callinectes arcuatus, Callinectes  
                                      toxotes, Portunus pelagicus, and  
                                      Portunus puber.                   
------------------------------------------------------------------------


    Dated: April 17, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-10743 Filed 4-22-98; 8:45 am]
BILLING CODE 4160-01-F