[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.
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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
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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
