Animal Casings From Countries Where African Swine Fever or Bovine Spongiform Encephalopathy Exists

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]

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