[Federal Register Volume 59, Number 103 (Tuesday, May 31, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-13056]
[[Page Unknown]]
[Federal Register: May 31, 1994]
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DEPARTMENT OF AGRICULTURE
9 CFR Part 96
[Docket No. 92-133-2]
Animal Casings From Countries Where African Swine Fever or Bovine
Spongiform Encephalopathy Exists
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are adopting as a final rule, with two changes, an interim
rule that amended the regulations by prohibiting the importation of
ruminant casings from countries where bovine spongiform encephalopathy
exists, and by prohibiting the importation of swine casings from
countries where African swine fever exists. As amended by this
document, the rule prohibits the importation of bovine casings, except
bovine casings made from stomachs, from countries where bovine
spongiform encephalopathy exists, and prohibits the importation of
swine casings from countries where African swine fever exists. This
action is necessary to prevent imported casings from introducing these
diseases into the United States.
EFFECTIVE DATE: May 31, 1994.
FOR FURTHER INFORMATION CONTACT: Dr. John H. Gray, Senior Staff
Veterinarian, Import-Export Products Staff, National Center for Import-
Export, Veterinary Services, APHIS, USDA, room 756, Federal Building,
6505 Belcrest Road, Hyattsville, MD 20782, (301) 436-7885.
SUPPLEMENTARY INFORMATION:
Background
Animal casings are intestines, stomachs, esophagi, and urinary
bladders from cattle, sheep, swine, or goats that are used to encase
processed meats, such as sausage. The regulations in 9 CFR part 96
(referred to below as ``the regulations'') govern the importation of
animal casings into the United States to prevent the introduction of
contagious livestock diseases.
Among the most destructive communicable diseases of ruminants and
swine, respectively, are bovine spongiform encephalopathy (BSE) and
African swine fever (ASF). BSE, a neurological disease first identified
in 1986, appears to be caused by the same agent as scrapie, a
destructive disease of sheep and goats. ASF, a hemorrhagic disease, is
caused by a virus.
ASF virus may be present in, and spread by, swine, pork, and pork
products; BSE may be present in, and spread by, ruminant products used
for animal feed and by veterinary biological products containing BSE-
infected ruminant byproducts. ASF or BSE could become established in
the United States if materials carrying the ASF virus or BSE agent,
such as certain meat, animal products, and animal byproducts from swine
or ruminants in countries where the respective diseases exist, were
imported and fed to or injected into swine or ruminants in the United
States. Because the importation of those materials would pose a risk of
introducing ASF and BSE into the United States, the regulations in 9
CFR parts 94 and 95 prohibit or restrict the importation of animal
products and byproducts into the United States from countries where
these diseases exist.
In an interim rule effective and published in the Federal Register
on September 7, 1993 (58 FR 47029-47031, Docket No. 93-133-1), we
amended the animal casings regulations in 9 CFR part 96 to prohibit the
importation of ruminant casings from countries where BSE exists, and to
prohibit the importation of swine casings from countries where ASF
exists. This action was necessary to prevent imported casings from
introducing these diseases into the United States.
We solicited comments concerning the interim rule for a 60-day
comment period ending November 8, 1993. We received 7 comments by that
date. They were from foreign governments and commissions, trade
associations, and a U.S. veterinary medical association. We have
carefully considered all of the comments we received. They are
discussed below by topic.
African Swine Fever
Only two of the comments directly addressed the interim rule
prohibition on swine casings from countries where ASF exists. One
commenter supported the entire interim rule, including the ASF-related
portion; the other commenter supported only the ASF-related portion of
the rule. Neither commenter suggested any changes in the ASF-related
portion of the rule.
One other commenter perceived discrepancies between the ASF rules
and the BSE rules. However, the commenter did not object to the ASF-
related portion of the rule or suggest any changes in that portion of
the rule.
Therefore, we are not making any changes in the portion of the
interim rule concerning ASF.
Covering Additional Diseases
One commenter suggested that a rule similar to the interim rule be
adopted for casings from countries where foot-and-mouth disease,
rinderpest, Rift Valley fever, and other exotic diseases exist. Another
commenter suggested that casings from countries where scrapie exists
should be restricted ``if new findings would lead the scientific
community to raise the level of BSE transmission risk due to sheep
proteins * * * .'' A third commenter stated that the rule was
``inappropriate'' because it prohibited all ruminant casings
``irrespective of the scrapie status of the country of origin * * *.''
We are not making any changes based on these comments. The
regulations in 9 CFR part 96 currently apply to casings from all
countries, and thereby apply to casings from countries where foot-and-
mouth disease, rinderpest, scrapie, Rift Valley fever, and other
diseases exist. Based on our experience over the years casings have
been imported into the United States, we believe the regulations in
part 96 are adequate to prevent importation of the diseases named by
the commenters. Of course, if new findings about any disease indicate
that the regulations are not adequate to prevent importation of a
disease, we will consider amending the regulations.
Scrapie in the United States
Several commenters implied that casings from countries where BSE
exists should not be regulated, or should be regulated differently,
because scrapie exists in the United States. The commenters are correct
that scrapie exists in the United States. It is also true that scrapie
appears to be caused by the same agent that causes BSE. However,
scrapie infects only sheep and goats, and there is, as discussed
elsewhere in this document, no evidence for cross-species transmission
of scrapie. Therefore, the presence of scrapie in the United States is
not, we believe, relevant to our regulating casings which could
transmit BSE. For this reason we are making no changes based on these
comments.
Scientific Basis or Justification for Rule
Several commenters stated that the interim rule, as it relates to
BSE, is without scientific basis. One commenter stated that the
scientific evidence does not justify a rule of ``its broad scope.''
Another commenter contrasted our interim rule with our regulations in 9
CFR 94.18. The regulations in Sec. 94.18 allow meat and other edible
animal products to be imported for human consumption from countries
where BSE exists if the bone and visible lymphatic and nerve tissue
have been removed. The commenter asked why we do not allow casings to
be imported for human consumption if the major lymphoid tissues
(Peyer's patches) have been removed.
We acknowledge that the scientific knowledge about BSE is, as one
commenter put it, modest. However, there is enough information to
establish that BSE is an insidious and devastating disease.
Unfortunately, there is not enough information to demonstrate that
completely removing Peyer's patches from bovine casings would be
adequate to prevent the spread of BSE. And there is doubt that Peyer's
patches could be completely removed. According to the minutes of a
World Health Organization meeting held in November, 1991, ``Peyer's
patches may be partially retained after processing.''1 Therefore
we are not making any changes in the rule based on these comments.
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\1\See p. 8 of November 19, 1991, minutes, draft 4, of World
Health Organization ``Consultation on Public Health Issues Related
to Animal and Human Spongiform Encephalopathies,'' held in Geneva,
Switzerland, November 12 through 14, 1991.
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Interspecies Transfer of BSE
The issue of interspecies transfer of BSE was also raised by
commenters. One commenter stated that interspecies transfer is ``highly
rare and mostly undocumented.'' Several other commenters stated that
there is no scientific evidence that BSE-infected bovine material can
contaminate ovine material or that ovine material can be infected with
BSE.
We have carefully considered these comments. We agree with the
comments that there is no evidence at this time that bovine material
can contaminate ovine material. Among ruminants, BSE appears to affect
mainly bovines. We are therefore amending the interim rule to change
the word ``ruminant'' to ``bovine'' in Sec. 96.2(b). The effect of this
terminology change is to remove restrictions on importation of ovine
casings, while retaining restrictions on importation of bovine casings.
Bovine Stomachs
One commenter specifically objected to banning importation of
bovine stomachs used as casings.2 According to the commenter,
there is no scientific support for such a ban.
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\2\Animal casings are intestines, stomachs, esophagi, and
urinary bladders from cattle, sheep, swine, or goats that are used
to encase processed meats, such as sausage.
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We have reviewed available data on this subject. According to the
minutes of a World Health Organization meeting in November, 1991,
stomachs do not need to be regulated ``because these organs, when
prepared for food, do not contain significant quantities of lymphoid
tissue.''3 For this reason we are removing bovine stomachs from
our rule.
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\3\Ibid.
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Rendered Products
One commenter stated that there is no longer any risk from rendered
products because of changes in rendering procedures, and implied that
we should amend our rules because of this. We are not making any
changes based on this comment. Casings are not rendered products. It is
therefore not relevant to our interim rule whether there is a risk from
rendered products.
Banning Ruminant Protein in Ruminant Feed
One commenter stated that banning feeds which contain ruminant
proteins is adequate to keep BSE out of the United States. It is
believed that the spread of BSE in the United Kingdom was due to the
practice of using ruminant protein in ruminant feedstuffs. In 1988 this
practice was prohibited in the United Kingdom. However, BSE cases
continued to increase in the United Kingdom until 1992. There has been
an insignificant reduction since that time, and 700 to 800 cases
continue to be diagnosed weekly.
Because of the long incubation period for BSE, enough time has not
yet elapsed since the feed ban was instituted to ensure that such a ban
is adequate to stop, not just slow, the spread of the disease. If the
ban is adequate, there are still numerous sources of infection in all
countries where BSE exists. We anticipate that new cases of BSE will
continue to be identified. For this reason, we do not believe that
banning ruminant feeds containing ruminant protein, by itself, is
adequate to prevent BSE from being introduced into the United States.
Casings Collected in BSE-Free Countries but Processed in Countries
Where BSE Exists
Several commenters objected to our prohibiting the importation of
ruminant casings collected in BSE-free countries but processed in
countries where BSE exists.
We have carefully considered these comments. However, we are not
making any changes based on them. We are not aware of any demand for
processing bovine casings from BSE-free countries in a country where
BSE exists. Moreover, criteria for establishments processing bovine
products from BSE-free countries in countries where BSE exists, to
prevent their possible exposure to BSE, have not been developed. There
is demand for processing ovine casings from BSE-free countries in a
country where BSE exists. However, as explained elsewhere in this
document, we are amending our interim rule to remove restrictions on
ovine casings from countries where BSE exists. This will allow ovine
casings from BSE-free countries to be processed in countries where BSE
exists for importation into the United States.
Area-Wide vs. Country-Wide Restrictions
One commenter urged us to impose restrictions only on casings from
specific areas where BSE exists, not on casings from entire countries.
We are not making any changes in the rule based on this comment. We do
not believe that approach is appropriate with regard to BSE. BSE has an
extremely long incubation period. There is little evidence as to how
the disease is spread. Within any given country, livestock move freely
and constantly. On the other hand, livestock movements across
international borders are usually controlled. In addition, restrictions
on the movement of animals, designed to prevent the spread of disease,
are generally more effectively enforced at the borders of a country,
than between areas within a country. For these reasons, at this time we
believe country-by-country restrictions are most effective in
preventing the spread of BSE.
Distinguishing Between Countries Where BSE Exists
Two commenters addressed whether we should distinguish in our
regulations between importations from countries with a high incidence
of BSE and countries with lower incidences of the disease. One
commenter stated that:
* * * no difference is made between countries of a high BSE
incidence * * *, a low incidence * * *, and cases found only in
imported cattle * * *. This would seem to be contradictory to the
EC/US Agreement on veterinary issues, in particular, * * * in issue
59 of this Agreement USDA recognizes the different BSE
epidemiological situations in EC Member States and the consequently
variable risks of importation in relation to these situations.
The other commenter states that the interim rules do not refer to
any study to assess the risk of introducing BSE into the United States,
and suggested that we have violated Annex I of the European Economic
Community Council Directive 72/462/EEC, issue 59. Issue 59, as it
applies to the United States, states:
The USDA recognizes that BSE is of low incidence in Ireland and
France and presents a different epidemiological situation to that in
the United Kingdom. The USDA accepts that a different incidence of a
specific disease may exist between different countries and that the
risk of importation from countries with a low incidence is less than
from those with a high incidence, and will evaluate BSE and Scrapie
research available, study OIE recommendations, and implement risk
assessment studies with view to modify import procedure.
In response to both these commenters, we would like to point out
that our regulations already distinguish between imports from different
countries, if the disease situation or risk posed by imports justifies
different treatment. For example, ruminant meat imported from different
countries is prohibited or must meet different requirements, depending
on the diseases present in the country of origin. In the interim rule
we distinguished only between countries where BSE exists and countries
where BSE is not known to exist. Based on current knowledge, we do not
believe the risks posed by casings imported from various countries
where BSE exists are different enough to justify distinct regulations
for casings from each country.
In addition, under Annex I of the European Economic Community
Council Directive 72/462/EEC, issue 59, we acknowledge that there may
be a different risk of BSE between different countries where BSE
exists. However, USDA does not agree under appendix I to necessarily
change APHIS regulations. USDA will study the situation in each country
and review OIE recommendations. If it appears justified, based on the
results of that study and review, we may modify our import procedures.
One commenter also stated that our interim regulations violate a
November 14, 1992 ``Agreement in the Form of an Exchange of Letters
between the United States of America and the European Economic
Community Concerning the Application of the Community Third Country
Directive, Council Directive 72/462/EEC, and the Corresponding United
States of America Regulatory Requirements with Respect to Trade in
Fresh Bovine and Porcine Meat.'' The commenter appears to be suggesting
that the United States has failed to amend its legal and/or
administrative requirements as agreed to in the letters. However, the
letters, and any agreement contained in them, concern only bovine and
porcine meat, not casings. For this reason we are not making any
changes based on this comment.
Effect on International Business and Trade
One commenter expressed concern that the interim rule would
negatively impact companies in both the United States and abroad, that
``unscientific-based'' regulation would cause trade restrictions on
casings from numerous countries, including the United States, to
spread, possibly leading to reciprocal restrictions, and that world
trade would thereby be significantly lessened. Another commenter stated
that we should be careful not to enact regulations which place an
``undue strain on the trade of concerned products.''
We agree with these commenters that our interim rule has some
negative impacts. We also agree that regulations which place an ``undue
strain'' on trade should be avoided.
It is unfortunate that so little is known about the etiology and
spread of BSE. Regardless, it is clear that BSE is a devastating
disease with far-reaching and long-lasting economic consequences. At
this time there is no known treatment for BSE. There is some evidence,
mainly anecdotal, that feed bans and restrictions on the movement of
animals are helping to contain the disease. However, the long
incubation period of BSE makes it impossible, at this time, to
determine the degree to which these measures prevent spread of the
disease.
We believe it would be foolish, and possibly disastrous to U.S.
interests, to do nothing in the face of such a devastating disease.
However, we do not want our requirements to be unduly burdensome, and
we are concerned that restrictions we impose be fully supported, where
relevant information is available. For these reasons, as explained
fully elsewhere in this document, we are amending our interim rule to
relieve restrictions placed on the import of ovine casings and bovine
casings made from stomachs.
We acknowledge that the remaining restrictions impact trade by
limiting certain imports into the United States. However, if BSE were
to spread to the United States, restrictions would be placed on exports
from the United States. These restrictions would be devastating to U.S.
producers and exporters. Countries which depend on imports from the
United States would also be harmed.
For these reasons, we believe our interim rule, as amended by this
document, is appropriate to the situation and does not place an
``undue'' strain on trade. If new evidence is produced demonstrating
that less restrictive measures would be adequate to prevent spread of
the BSE, then we will review our regulations.
General Agreement on Tariffs and Trade
Two commenters raised issues concerning the General Agreement on
Tariffs and Trade (GATT). According to one commenter, we failed to
notify the GATT Committee on Technical Obstacles to Trade of our
interim regulations, as required by Article 10.4 of the Agreement.
We have carefully reviewed Article 10.4 of the GATT. It states that
GATT members will make copies of documents available and will do so at
an equitable price. Copies of our interim rule are available either
through the Federal Register or directly from APHIS. The Federal
Register charges every purchaser the same amount for copies; copies
obtained through APHIS also cost a uniform amount. For these reasons we
disagree with the commenter that we have violated the provisions of
Article 10.4 of the GATT.
Another commenter stated that the interim rule ``may * * * subject
the [United States] to claims that we violate GATT obligations to
substantiate and justify any trade restrictions imposed * * *.''
According to the commenter, this could open the United States to trade
retaliation by other countries.
We are not making any changes based on this comment. We believe our
regulations were substantiated and justified. As explained elsewhere in
this document, we are making two changes to the interim rule in
response to comments. We will continue to monitor the risk presented by
importing casings from countries where BSE exists, and will review our
regulations accordingly.
International Office of Epizootics
Several comments stated that the interim regulations, as they
pertain to casings from countries where BSE exists and casings
processed in countries where BSE exists, are contrary to, or ignore,
the provisions of International Office of Epizootics (OIE), Animal
Code.
We disagree. The United States is a member of the OIE. Chapter
3.2.13. of the International Animal Health Code, OIE 1992, concerns
BSE. Article 3.2.13.1. of the chapter reads, in part, as follows:
The following articles recommend [emphasis added] conditions
under which cattle and bovine products can with safety be traded for
human and animal consumption, and other uses.\4\
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\4\The recommended conditions are listed in Articles 3.2.13.2
through 3.2.13.12 of the chapter.
It is clear from this quotation that the OIE document recommends,
rather than requires, certain actions on the part of member countries.
In adopting our interim rule we carefully considered OIE
recommendations. We consider them an excellent starting point for
structuring a regulatory scheme to prevent the introduction of BSE.
However, we believe, for reasons explained elsewhere in this document,
that strictly following the OIE recommendations would not, under
current circumstances, prevent the introduction of BSE into the United
States.
Should Rule Have Been an Interim Rule?
Several commenters objected to our publishing the regulation as an
interim rule, effective immediately. One commenter complained that no
time was given to accommodate products enroute to the United States.
This commenter also stated that we did not elaborate on the good cause
for immediate action, and did not cite any new scientific finding which
could justify an emergency action. The commenter suggested that, as BSE
was first described in the United Kingdom in 1986, no emergency could
exist at this time. Another commenter stated that immediate
implementation of a regulation was justified only for a new disease
situation where a serious threat exists, not stable situations such as
that involving BSE.
We did not base our interim rule on new scientific evidence, but
instead on the threat BSE poses to the health of livestock and possibly
of people in the United States. We stated in our document of September
7, 1993, that ``immediate action is necessary to prevent imported
casings from introducing * * * BSE into the United States.'' We stand
by this statement. Though BSE may be ``stable'' in the United Kingdom,
as the commenter says, it nonetheless poses a serious threat. The
disease has a very long incubation period; very little is known of how
it spreads; it is untreatable and incurable; it has a devastating
effect on livestock and livestock industries; and there are unanswered
questions concerning cross-species transmission (there are several
unexplained cases in the United Kingdom of house cats and humans with
BSE-like diseases). Consequently, we believe that immediate action was
necessary to prevent the introduction of BSE into the United States by
imported casings.
We regret the effect our action has had on casings already enroute
to the United States. However, allowing such casings to enter the
United States would defeat the intended effect of the interim rule.
Regulatory Flexibility Act Analysis
One commenter questioned the accuracy of our Regulatory Flexibility
Act Analysis (see 58 FR 47030) and suggested the rule should have been
a ``major rule.'' The commenter explained that effects on secondary
markets and businesses, such as domestic sausage producers, should have
been included in our analysis. According to the commenter, if we had
included these impacts, our total economic impact would have exceeded
$100 million.
The commenter is correct that we did not include figures concerning
secondary economic effects created by the rule. The reason is that it
is impossible to determine secondary economic effects with any
accuracy. Our decision not to include figures for secondary economic
effects is consistent with our standard methodology for economic
analyses.
The commenter also stated that Canadian and United States natural
sausage casings companies together do import ruminant casings, in the
form of ovine casings, from the United Kingdom and Portugal. (BSE
exists in the United Kingdom and, at the time the interim rule was
published, was considered to exist in Portugal.) The commenter stated
that this information appears to contradict the statement in our
September 7, 1993, rule that ``[no importers], in recent years, ha[ve]
imported * * * ruminant casings from a country where BSE exists.''
The commenter did not distinguish between casings imported into
Canada and those imported into the United States. However, the
commenter did state that the casings imported from countries where BSE
exists were ovine casings. As explained elsewhere in this document, we
are amending the interim rule to remove the restrictions on ovine
casings and bovine casings made of stomachs. This should lessen the
impact on domestic importers and users of natural casings.
The facts presented in the interim rule still provide a basis for
the rule.
This action also affirms the information contained in the interim
rule concerning Executive Order 12866 and the Regulatory Flexibility
Act, Executive Orders 12372 and 12778, and the Paperwork Reduction Act.
List of Subjects in 9 CFR Part 96
Imports, Livestock, Reporting and threshold requirements.
Accordingly, 9 CFR part 96 is amended to read as follows:
PART 96--RESTRICTION OF IMPORTATIONS OF FOREIGN ANIMAL CASINGS
OFFERED FOR ENTRY INTO THE UNITED STATES
1. The authority citation for part 96 continues to read as follows:
Authority: 21 U.S.C. 111, 136, 136a; 7 CFR 2.17, 2.51, and
371.2(d).
2. In Sec. 96.2, paragraph (b) is revised to read as follows:
Sec. 96.2 Casings from countries where African swine fever or bovine
spongiform encephalopathy exists.
* * * * *
(b) The importation of bovine casings, except stomachs, that
originated in or were processed in any country where bovine spongiform
encephalopathy exists, as listed in Sec. 94.18(a) of this subchapter,
is prohibited.
Done in Washington, DC, this 23rd day of May 1994.
Lonnie J. King,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 94-13056 Filed 5-27-94; 8:45 am]
BILLING CODE 3410-34-P
