United States 

Department of 

Agriculture

Marketing and 

Regulatory

Programs

Animal and 

Plant Health 

Inspection 

Service

Final Rulemaking for the 

Importation of Swine 

Commodities from 

Hungary

Environmental Assessment,

May 2011
Final Rulemaking for the 

Importation of Swine 

Commodities from Hungary

Environmental Assessment,

May 2011

Agency Contact for the Rulemaking:

Donald Link 

Import Risk Analyst, Regionalization Evaluation Services 

National Center for Import and Export, Veterinary Services 

Animal and Plant Health Inspection Service 

U.S. Department of Agriculture

920 Main Campus Drive, Suite 200

Raleigh, NC 27606

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USDA is an equal opportunity provider and employer. 
Table of Contents

 I. Need for the Proposed Action .................................................. 1

 II. Alternatives............................................................................... 3

III. Potential Environmental Impacts.............................................. 4

IV. Agencies or Persons Contacted............................................. 11

 V. References............................................................................. 11
1

I. Need for the Proposed Action

The United States Department of Agriculture (USDA), Animal and Plant 

Health Inspection Service (APHIS) regulates the importation of animals 

and animal products into the United States to guard against the 

introduction of animal diseases. APHIS’ regulations allow for the 

importation of animal products from regions that are free of or low risk for 

classical swine fever (CSF). The country of Hungary submitted a request 

to APHIS seeking recognition as a region free of CSF in order to export 

live swine and swine-derived products including semen, pork, and pork 

products (hereafter referred to as “swine commodities”) to the United 

States according to requirements in APHIS import regulations. CSF is a

highly contagious viral disease of swine. CSF is exotic to the United 

States and is one of the diseases of concern to APHIS in its regulation of 

animal and animal product importation into the United States.

In response to Hungary’s request, APHIS conducted a risk analysis to 

assess the risk of introduction of CSF into the United States from Hungary

(in “APHIS Risk Analysis of the Status of Hungary Regarding Classical 

Swine Fever”) (USDA, APHIS, 2008)). APHIS’ evaluation found that 

Hungary meets the requirements for being recognized as low risk for CSF. 

Based on this finding, APHIS proposes to amend its regulations to add 

Hungary to the list of European Union (EU) Member States that comprise 

the APHIS-defined EU CSF region (9 CFR §§ 93.500, 94.0, and 98.30)—

which APHIS considers low risk for CSF (9 CFR §§ 94.9, 94.10)—and 

thereby allow importation of swine commodities from this country (9 CFR 

§§ 94.10, 94.24, and 98.38). 

Allowing the trade of swine commodities from Hungary would be 

consistent with the World Organization for Animal Health (commonly 

referred to as the Office International des Epizooties (OIE)) Terrestrial 

Animal Health Code for CSF. CSF is among the OIE-listed diseases of 

concern for international trade. The rulemaking action is needed to allow 

the importation of swine commodities from Hungary because there is no 

scientific basis for prohibiting trade based on the CSF disease status of

Hungary. 

This environmental assessment (EA) has been prepared to comply with the 

provisions of the National Environmental Policy Act of 1969 (NEPA) 

(42 United States Code (U.S.C.) 4321 et seq.) as prescribed in 

implementing regulations adopted by the Council on Environmental 

Quality (40 Code of Federal Regulations (CFR) §§ 1500–1508), USDA’s 

NEPA regulations (7 CFR part 1b), and APHIS’ NEPA implementing 

procedures (7 CFR part 372). This EA evaluates the potential effects on 
2

the quality of the human environment1from a rulemaking that seeks to 

allow the importation of swine commodities according to APHIS import 

requirements. The import requirements are designed to manage animal 

health risks associated with the presence of diseases in swine. APHIS’ 

NEPA implementing procedures classify rulemakings that seek to remedy 

specific animal health risks as actions normally requiring preparation of 

EAs.2 

In accordance with requirements under the APHIS NEPA regulations, this 

EA was made available for public review and comment along with 

APHIS’ risk evaluation and proposed rulemaking for this matter. APHIS 

received no comments on this EA. APHIS also welcomed public 

comments on the approach for future proposed actions of the same nature 

as in this EA, discussed in the following two paragraphs; no comments 

were received on the approach. 

Based upon (1) the Findings of No Significant Impact for EAs prepared 

for a rulemaking to allow the importation of swine and swine commodities 

from EU Member States in the past,

3

(2) the determination from an APHIS 

evaluation that Hungary is low risk for CSF, and (3) APHIS 

determinations that measures are in place to mitigate the risk of CSF 

introduction into the United States through importation of swine and swine 

commodities from countries or regions that APHIS recognizes as low risk 

for CSF, such as Hungary, APHIS will consider that future proposed 

actions of this nature4 would pose negligible environmental impact. 

This consideration applies to each EU Member State or country that has 

entered into an agricultural equivalency agreement with the European 

Union, provided that a disease status assessment finds them to be free of 

or a low risk for the relevant diseases. Accordingly, APHIS plans to 

consider future actions of this nature as posing negligible environmental 

impact and included under this environmental assessment. We would do 

so provided that, based on our evaluation of the disease status of the 

country, no extraordinary circumstances exist that require the preparation 

of an environmental assessment or environmental impact statement, the 

proposed action does not trigger the need for other environmental review 

under NEPA, and the proposed action would not individually or 

cumulatively have a significant environmental impact.

 

1

The “human environment” is interpreted comprehensively to include the natural and physical 

environment and the relationship of people with that environment (40 CFR § 1508.14).

2

7 CFR § 372.5(b)(1).

3

 The Czech Republic, Latvia, Lithuania, and Poland (72 Federal Register (FR) 67227–67233; 

November 28, 2007).

4

 By “of this nature,” we mean that the same disease concern is being considered, the same or 

comparable commodities are being considered for importation, the same or equivalent risk mitigation 

measures are in place in the exporting country and in APHIS import regulations, and our risk 

evaluation determines that the importation of the commodities into the United States would pose no 

greater risk than those authorized importation from previously assessed countries.
3

II. Alternatives

The two alternatives considered in this EA include (1) the no action 

alternative in which the current regulations would remain unchanged, 

continuing to omit Hungary from the list of EU Member States comprising 

the APHIS-defined EU CSF region (a region considered low risk for CSF)

and, therefore, continuing to not allow the importation of swine 

commodities from that region to the United States, and (2) the rule 

amendment, which would designate Hungary as low risk for CSF and 

would, therefore, allow the importation of swine commodities from 

Hungary according to certain conditions. 

A. No Action

The no action alternative would leave the current importation regulations 

unchanged. Under this alternative, Hungary would continue to not be 

listed as part of the APHIS-defined EU CSF region considered low risk for 

CSF; consequently, Hungary would not be allowed to export swine 

commodities to the United States. The low-risk CSF status of Hungary is 

not reflected in the current import regulations. The continuance of such 

unsupported trade restrictions would be contrary to U.S. obligations under 

international trade agreements.

B. Rule Amendment 

The rule amendment alternative would amend the current regulations to 

add Hungary to the list of EU Member States comprising the APHISdefined EU CSF region in 9 CFR §§ 93.500, 94.0, and 98.30,5

and include 

it as one of the Member States in a region that APHIS considers as low 

risk for CSF under 9 CFR §§ 94.9 and 94.10 and therefore subject to the 

import conditions specified under 9 CFR §§ 94.24 and 98.38. This 

alternative would allow the importation of swine and swine commodities 

from Hungary if certain conditions are met and would be consistent with 

U.S. obligations under international trade agreements. 

C. Alternatives Eliminated from Further 

Consideration

Alternatives differing from those mentioned above were eliminated from 

consideration because changes in the requirements either would not 

 

5

 The APHIS-defined EU CSF region currently consists of Austria, Belgium, the Czech Republic, 

Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, 

Poland, Portugal, Republic of Ireland, Spain, Sweden, and the United Kingdom (England, Scotland, 

Wales, the Isle of Man, and Northern Ireland). 
4

mitigate the potential risk from the region or would place excessive 

restrictions on the imports that would serve as a de facto trade barrier. 

The certification requirements in the rule provide sufficient mitigation 

measures without being overly restrictive.

III. Potential Environmental Impacts

A. Background 

The disease of concern with regard to allowing the importation of swine 

commodities from Hungary is CSF. CSF is a highly contagious viral 

disease affecting swine and wild boar. The incubation period for CSF is 

2 to 14 days. CSF is transmitted by direct contact from pig to pig; through 

ingestion of products, including fresh, frozen, or cured pork, that contain 

the virus; and by aerosols. CSF also can be introduced or spread by

infected swine semen. Indirect contact with body secretions and 

excretions from infected animals (including dead animals) and viral 

contamination of objects may lead to mechanical transfer of the virus. 

Thus, movement of people, wild animals, and inanimate objects, such as 

trucks used to transport animals, may indirectly transmit the CSF virus. 

The CSF virus is hardy, being stable between pH 4 and 10 and also stable 

at low temperatures (thus, it is unlikely to be destroyed by the postmortem decrease in muscle pH that accompanies carcass maturation), and 

is unlikely to be destroyed by transport or cold storage (USDA, APHIS, 

2006). More information about the characteristics of CSF is provided in 

the APHIS risk analysis (USDA, APHIS, 2008) for this matter. 

The risk analysis, “APHIS Risk Analysis of the Status of Hungary

Regarding Classical Swine Fever,” evaluates the risk of CSF introduction 

to U.S. animals from allowing these commodities from Hungary (USDA, 

APHIS, 2008). In preparing the risk analysis, APHIS evaluated the status 

of Hungary with regard to its infrastructure and control measures in place 

for these diseases, including an assessment of disease surveillance 

measures, import practices, laboratory capacity, emergency response 

procedures, and other factors that could influence the risk of disease 

introduction into the United States. 

Hungary, a Member State of the EU since 2004, adopted the legislation of 

the European Commission (EC) regarding animal health, welfare, and 

identification including legislation pertaining to CSF. Hungary also 

adopted the harmonized EC legislation regarding import, export, and trade 

of live animals, meat, and animal products. The APHIS-defined EU CSF 

region is considered low risk with respect to CSF. 
5

As discussed in APHIS’ evaluation of Hungary’s CSF status, Hungary

shares borders with seven countries, four of which are EU Member States: 

Austria, Slovakia, Slovenia, and Romania. Of the bordering EU Member 

States, APHIS currently recognizes Austria in 9 CFR §§ 94.9 and 94.10 as 

part of the EU region that is low risk for CSF, and APHIS evaluations 

have been completed to determine the CSF risk status of Slovenia and 

Slovakia. Romania, which joined the EU in January 2007, continues to 

experience CSF outbreaks in wild boar and domestic swine; Hungary

provides for enhanced checks for forbidden pork products from Romania 

in passenger baggage at and near the Hungary/Romania border. The other 

three border countries, Croatia, Serbia and Montenegro, and the Ukraine, 

are EC-designated third countries—countries that are approved by the 

EU’s Food and Veterinary Office to export live animals or animal 

products to EU Member States because they meet certain requirements, 

including animal health standards that are at least equivalent to those 

required of EU Member States. However, these three countries are not 

necessarily approved to export live swine or pork to EU Member States. 

Animals and animal products from the third countries must meet certain 

requirements and can only enter through certain border inspection points. 

While CSF outbreaks have occurred in domestic and/or wild boar 

populations in five of the adjacent countries (details of which are provided 

in APHIS’ evaluation of Hungary’s CSF status (USDA, APHIS, 2008), 

Hungary enforces EC legislation regarding import prohibitions on animals 

and products from non-EU countries as well as CSF-affected regions 

within EU countries, implemented surveillance practices for CSF in wild 

boar that have demonstrated the ability to detect evidence of circulation of 

the virus within this population, implemented effective biosecurity 

practices in domestic swine facilities, and has not had a CSF case in its 

domestic swine population since 1993. 

The potential for impacts on the human environment from the importation 

of swine commodities from Hungary is dependent upon the ability of 

mitigative factors and mitigation measures to prevent the introduction of 

CSF via the biological pathways of transmission of the disease. 

B. No Action Alternative 

The “no action” alternative would not allow swine commodities to be 

imported from Hungary; the current rules governing the importation of 

these commodities would remain unchanged with regard to Hungary. This 

alternative would have no potential effect on U.S. animal health, public 

health, or the physical environment. This alternative, however, is 

inconsistent with the requirements of international trade agreements. 
6

C. Rule Amendment (Proposed Action)

The rule amendment alternative would allow the importation of swine 

commodities from Hungary according to certain requirements that are 

designed to prevent the introduction of CSF. Any potential for impacts to 

the human environment would be the result of exposure to the CSF virus 

via a breakdown in the requirements that are designed to mitigate the risk 

of exposure of U.S. livestock to these viruses. Animal health, the physical 

environment, and public health are addressed in this document as 

components of the U.S. human environment that have the potential to be 

impacted in the event that the CSF virus were to be introduced as a result 

of the rule amendment. Also, other environmental review considerations 

for the protection of the human environment are addressed in this section 

of the EA.

When allowing importation of swine commodities from a foreign region, 

the health of animals in the region of origin and the region’s ability to 

prevent introduction of animal diseases is important in determining the 

risk to the health of U.S. animals. CSF was last reported in domestic 

swine in Hungary in 1993. CSF virus was detected in wild boar that were 

hunted and killed in January 2007 in Nógrád County of Hungary, adjacent 

to the border with Slovakia, with additional finds in 2007 and through July

2008 in both Nógrád and Pest counties. APHIS evaluated the CSF status 

of the potential exporting region and found that Hungary appears to have 

addressed this disease incursion in a timely and effective manner and has 

implemented necessary measures to prevent CSF transmission to domestic 

swine in Hungary. The results of the evaluation are reported in a risk 

analysis (USDA, APHIS, 2008).

The risk analysis assessed potential pathways

6

by which the CSF virus 

could be introduced into Hungary from other EU Member States or 

affected third countries, thereby potentially resulting in risk to U.S. 

animals by allowing the importation of swine commodities from Hungary. 

The risk analysis noted that for each of the pathways identified, Hungary

has in place numerous mitigating factors and safeguards, including 

requirements under EC legislation, that are designed to reduce the risk of 

disease introduction. These factors or safeguards include, but are not 

limited to, the following:

- Hunting restrictions for wild boar in the infected area, including 

the requirement that all shot boar must be serologically and 

virologically evaluated.

 

6

 (1) through contact with infected wild boar, either in Hungary or from adjacent countries, (2) through 

exposure to infected swine or swine products from other EU Member States or third countries, and 

(3) through exposure to contaminated objects (e.g., vehicles or passengers) from other EU Member 

States or third countries that are experiencing outbreaks of CSF, again either due to direct contact, or 

secondary contact via wild boar..

1. Animal 

 Health
7

- Combination of control activities aimed at affected wild boar 

populations, including enhanced biosecurity measures on farms in 

the infected area, such as disinfection of personnel entering and 

exiting pig holding buildings, mandatory indoor housing of swine, 

enhanced reporting requirements for signs of disease in domestic 

swine, and a prohibition on the movement of swine and pork 

products, including semen and embryos or ova from the infected 

area for intra-community trade. 

- Public outreach programs, e.g., awareness campaigns for the public

and informational flyers for hunters.

- Training in emergency response aimed at disease experts and

training for customs officers, veterinarians, technicians, and 

administrative staff at border inspection points.

- Prohibition against garbage feeding to domestic swine.

The risk estimation component of the APHIS risk analysis concludes that 

the likelihood of live swine, pork, pork products, or swine semen entering 

the United States from Hungary and exposing U.S. livestock to the CSF 

virus, considering the mitigation measures that have to be met for all EU 

Member States in APHIS’ regulations (under 9 CFR §§ 94.24 for pork and 

pork products, 94.24 for breeding swine, and 98.38 for swine semen) to be 

very low (USDA, APHIS, 2008). 

If CSF transmission were to occur in domestic swine in Hungary after 

receiving recognition as a region considered low risk for CSF, importation 

of infected swine commodities would be mitigated by requirements that 

must be met in 9 CFR §§ 94.24 and 98.38. The requirements specified in 

APHIS regulations are designed to prevent the introduction of CSF into 

the United States from low-risk regions and include, but are not limited to, 

the following:

- Official certification of the CSF-free origin of swine commodities;

- Approval of exporting slaughtering establishments by USDA’s Food 

Safety and Inspection Service and certification by an official 

veterinarian of the exporting country that this condition has been 

met;

- No commingling or contact of swine, pork, or pork products with 

swine, pork, or pork products from CSF-affected regions; 

- Origin of swine semen must be from animals at an approved 

collection center; and 

- Restrictions on the use of transportation equipment for live swine 

and movement of the commodities to prevent CSF infection. 

If the proposed action (to add Hungary to the list of EU Member States 

comprising the APHIS-defined EU CSF region) were implemented and an 

incursion of CSF were to occur in domestic swine in an area of Hungary, 

APHIS regulations would prohibit for a specified period of time the
8

importation of swine commodities from the affected area that could be 

effectively regionalized for disease status.7 For a CSF outbreak in 

domestic swine, restrictions would be lifted without rulemaking once the 

designation as a restricted zone is lifted by the competent veterinary

authority of Hungary or 6 months following depopulation of the swine on 

the affected premises in the restricted zone and the cleaning and 

disinfection of the last affected premises in the zone, whichever is later. 

For a CSF outbreak in wild boar, restrictions would remain in place from 

the time of detection until the designation of the zone as a restricted zone 

is removed by the Member State’s competent veterinary authority. 

Additional requirements under APHIS’ import regulations further mitigate 

the risk of exposure of U.S. swine to any potentially infected swine from 

Hungary or decrease the likelihood of infected swine being chosen for 

import as follows:

 a minimum quarantine of 15 days for all imported swine (9 CFR § 

93.510). 

 swine imports are limited to breeding swine only and prohibit 

imported swine originating or commingling with swine from any 

region in which CSF is known to exist or any restricted areas 

within the EU due to the detection of CSF in domestic swine or 

wild boar (9 CFR § 94.24). 

If CSF were introduced into the United States, APHIS would implement

disease eradication measures, which could include quarantine and 

depopulation in areas where an effective barrier to the introduction of the 

disease can be established, surveillance of the area around an outbreak, 

and measures aimed at preventing any virus spread by swine commodities, 

contaminated material, and vehicles. 

If the introduction of CSF to U.S. swine were to occur, potential for 

impacts to the physical environment could occur in relation to disposal of 

carcasses due to death from disease and depopulation of infected animals 

or disposal of contaminated bedding and manure. Disposal methods could 

include rendering, burial, and incineration. If not handled properly, 

disposal of infected animals and materials could impact air, water, and soil 

quality and potentially could release the live CSF virus into the 

environment. Factors influencing proper disposal methods include the 

volume of infected animals and contaminated materials, geographic 

features of the area (e.g., water resources and soil type), other physical 

environment considerations (such as weather and temperature), and 

available funds, equipment, and personnel. 

 

7

In the event of an animal disease outbreak, APHIS considers the counties in Hungary to be the 

smallest administrative units for animal disease status recognition purposes.

2. Physical 

Environment
9

Potential for impacts to the physical environment from the introduction of 

CSF could occur in relation to the use of disinfectants to prevent the 

transfer of the CSF virus from surfaces. As part of an eradication 

program, measures aimed at preventing spread of the CSF virus, including 

disinfection of equipment, transport vehicles, and/or premises where 

infected swine were maintained, would be required in order to prevent 

mechanical transfer of the virus. Disinfectants used for such purposes 

would have to be approved for the specific use with the U.S. 

Environmental Protection Agency and used according to registration 

requirements. Label instructions for disinfectants would be provided for 

their proper application to prevent potential environmental impacts 

associated with the use of the registered product.

Conditions or mitigation measures that would be required to be met in 

order to comply with APHIS import regulations for swine and swine 

products from Hungary are designed to prevent the introduction of CSF 

into the United States. Under the proposed action and according to the 

finding in APHIS’ evaluation that CSF does not exist in domestic swine 

populations in Hungary, no significant impact on the physical environment 

as a result of allowing the importation of swine or swine products from 

Hungary is reasonably foreseeable. 

The CSF virus is not known to affect humans (USDA, APHIS, 2008; The 

Center for Food Security & Public Health, 2005). Indirect transmission of 

the CSF virus to swine may occur via movement of people and inanimate 

objects such as live-haul trucks (as cited in USDA, APHIS, 2008). 

Impacts on public health according to conditions of APHIS’ import 

regulations to prevent the introduction and spread of CSF from swine or 

swine products from Hungary are not reasonably foreseeable. 

Other Federal agencies have direct authority over public health issues 

involving the importation of food products. The USDA’s Food Safety and 

Inspection Service (FSIS) enforces provisions under the Federal Meat 

Inspection Act (FMIA) (26 U.S.C. 601 et seq.) that are intended to protect 

public health through food safety requirements. These provisions extend 

to imported carcasses, parts of carcasses, and meat or meat food products, 

including from swine. Products that are allowed to be imported must be 

processed in a facility that has been inspected and approved by FSIS and 

meets requirements equivalent to those under the U.S.FMIA. Under 

section 304(h) of the Federal Food, Drug, and Cosmetic Act, the U.S. 

Department of Health and Human Services, Food and Drug 

Administration (FDA) has authority to detain an article of food for which 

there is credible evidence or information indicating such article presents a 

threat of serious adverse health consequences or death to humans or 

animals. This authority provides an added measure to ensure the safety of 

the nation's food supply (U.S. Food and Drug Administration, 2004).

3. Public Health
10

a. Environmental Executive Orders

Some executive orders such as Executive Order 13045, Protection of 

Children From Environmental Health Risks and Safety Risks, and 

Executive Order 12898, Federal Actions to Address Environmental Justice 

in Minority Populations and Low-Income Populations, and departmental 

or agency directives require special environmental reviews in certain 

circumstances. In considering these additional review requirements, no 

circumstance that would trigger the need for special environmental 

reviews is involved in implementing the proposed action considered in this 

document. Neither impacts on the health or safety of children nor

disproportionately high and adverse human health and/or environmental 

effects on any minority populations and/or low-income populations in the 

United States as a result of CSF exposure are reasonably foreseeable as a 

result of the rule amendment to allow the importation of swine or swine 

products from Hungary.

b. Endangered Species Act

Section 7 of the Endangered Species Act (ESA) and its implementing 

regulations require Federal agencies to ensure that their actions are not 

likely to jeopardize the continued existence of endangered or threatened 

species or result in the destruction or adverse modification of critical 

habitat. APHIS has considered the potential effects of the proposed action 

on endangered and threatened species and designated critical habitat. CSF 

is host-specific, and there are no known federally listed or proposed 

endangered or threatened species in the United States that would be 

affected by CSF; therefore, the rule amendment would have no effect on 

endangered or threatened species in the United States or critical habitat. 

4. Additional 

Environmental 

Review 

Considerations
11

IV. Agencies or Persons Contacted

Environmental and Risk Analysis Services

Policy and Program Development 

Animal and Plant Health Inspection Service

U.S. Department of Agriculture

4700 River Road, Unit 149

Riverdale, MD 20737–1238

V. References

The Center for Food Security and Public Health, 2005. Classical swine 

fever. College of Veterinary Medicine, Iowa State University. Ames, IA. 

Last updated May 5, 2008. Available at 

http://www.cfsph.iastate.edu/Factsheets/pdfs/classical_swine_fever.pdf. 

Accessed on 11/04/08.

USDA, APHIS—See U.S. Department of Agriculture, Animal and Plant 

Health Inspection Service.

U.S. Department of Agriculture, Animal and Plant Health Inspection 

Service, 2006. APHIS evaluation of the status of Lithuania regarding 

classical swine fever, swine vesicular disease, and foot and mouth disease. 

January 2006. Veterinary Services, National Center for Import and 

Export, Riverdale, MD.

U.S. Department of Agriculture, Animal and Plant Health Inspection 

Service, 2008. APHIS risk analysis of the status of Hungary regarding 

classical swine fever. September 2008. Veterinary Services, National 

Center for Import and Export, Riverdale, MD.

U.S. Food and Drug Administration, 2004. Protecting the food supply. 

Fact sheet on FDA'S new food bioterrorism regulation. Final Rule: 

Administrative Detention. Center for Food Safety and Applied Nutrition. 

Available at http://www.cfsan.fda.gov/~dms/fsbtac21.html. Accessed 

10/30/08.