Irradiation Facilities for 

Phytosanitary 

Treatments in the 

Southern United States

Environmental Assessment

January 2012
Irradiation Facilities for 

Phytosanitary treatments in the 

Southern United States

Environmental Assessment,

January 2012

Agency Contact:

Dr. Inder P.S. Gadh

Senior Risk Manager—Treatments

PPQ PHP Regulations, Permits and Manuals

Animal Plant Health Inspection Service

U.S. Department of Agriculture

4700 River Rd.

Riverdale, MD 20737

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Table of Contents

I. Background ............................................................................... 1

II. Purpose and Need..................................................................... 1

 

III. Alternatives ............................................................................... 2

A. No Action Alternative .......................................................... 2

B. Rule Amendment (Preferred Alternative)........................... 2

IV. Environmental Impacts ............................................................. 4

A. No Action Alternative .......................................................... 4

B. Rule Amendment (Preferred Alternative)........................... 4

V. Cumulative Impacts................................................................... 8

VI. Other Environmental Concerns................................................ 8

A. Threatened and Endangered Species................................ 8

B. Other Considerations .......................................................... 9

VII. Agencies Consulted................................................................ 10

VIII. References............................................................................... 11 
1

I. Background

In 1997, the U.S. Department of Agriculture’s (USDA) Animal and Plant 

Health Inspection Service (APHIS) proposed irradiation as a regulatory 

treatment method for phytosanitary certification of some agricultural 

commodities. This method would be used as an alternative treatment to 

mitigate pest risk to allow the import/export and interstate movement of 

commodities. Prior to 1997, APHIS considered irradiation treatments 

only on a case-by-case basis for each facility or commodity use pattern. 

Irradiation for Phytosanitary Regulatory Treatment Environmental 

Assessment (USDA–APHIS, 1997) was prepared in October 1997 to 

examine the potential environmental effects from the use of the treatment 

method for phytosanitary certification of fruits and vegetables. The 

environmental assessment (EA) examined the potential impacts to human

health, nontarget species, and environmental quality from the use of 

gamma rays or electron beams on fruits and vegetables.

The current regulations allow irradiation facilities for the application of 

phytosanitary treatments to be located in any State of the United States 

except the South (Alabama, Arizona, California, Florida, Georgia, 

Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North Carolina, 

South Carolina, Tennessee, Texas, and Virginia). This was based on a 

study (Stewart, 1994) which identified areas in the United States where 

conditions favored the establishment of exotic fruit flies. The study 

recommended restricting or prohibiting the movement of fruit fly host 

materials through these areas unless strict measures were applied to 

manage the associated risks.

APHIS has authorized several locations in the Southern United States to 

have cold treatment facilities and three locations to have irradiation 

facilities: the maritime ports in Gulfport, Mississippi, and Wilmington, 

North Carolina, and the airport in Atlanta, Georgia. The approvals were 

based on the implementation of specific conditions that were determined 

by APHIS to result in the safe transport of regulated articles to the 

treatment facilities, and the safeguarding of the articles prior to treatment

to prevent the escape and establishment of exotic fruit flies in these areas.

II. Purpose and Need

In recent years, the number of applicants that want to conduct irradiation 

for imports in the Southern United States has increased. This rulemaking 

will set forth specific criteria that new facilities would have to meet in 

order to be approved for use as a phytosanitary irradiation facility and to 

meet the phytosanitary import requirements. The criteria aim to establish 

guidelines that are clear to stakeholders and interested parties for future 
2

planning. These criteria were developed based on the conditions used for 

the three southern locations currently approved for phytosanitary 

treatment, and take into account extreme scenarios.

This EA will analyze the potential effects of using the specific criteria as 

conditions for approving the establishment of irradiation facilities in the 

Southern United States. This EA will also focus on the potential 

environmental effects from irradiation facilities, allowing untreated 

commodities to be transported into the Southern United States, and safety 

of food that has been irradiated. This EA does not cover the 

environmental effects of the approval of a specific site for phytosanitary 

import requirements. Prior to approval of irradiation facilities, 

environmental concerns will be addressed. 

III. Alternatives

This EA analyzes potential environmental consequences from the

implementation of this rule, which will amend the irradiation regulations, 

7 Code of Federal Regulations (CFR) § 305.9, to allow irradiation 

facilities in the Southern United States. Two possible alternatives 

considered in this EA are (1) the current irradiation regulations that do not 

allow for irradiation facilities in the Southern United States (no action 

alternative), and (2) amendment (the preferred alternative).

A. No Action Alternative

Under the no action alternative, the irradiation regulations at 

7 CFR § 305.9 would remain unchanged. The current regulations do not 

provide for specific criteria to allow for irradiation facilities to be built in 

areas where exotic fruit flies may establish (Southern United States). 

APHIS has permitted irradiation facilities in Gulfport, Mississippi, 

Wilmington, North Carolina, and Atlanta, Georgia based on special 

conditions that were determined by APHIS to result in the safe transport of 

regulated articles to the treatment facility. Other future sites could 

continue to be reviewed on a case-by-case basis.

B. Rule Amendment (Preferred Alternative)

This final rule will amend the irradiation regulations at 7 CFR § 305.9 to 

allow for the approval of phytosanitary treatment irradiation facilities in 

the Southern United States to receive untreated commodities subject to the 

following criteria.

Required Generic Phytosanitary Criteria to Allow Irradiation Facilities 

to be Located in the Southern United States
3

The following generic criteria will be used to allow for the establishment 

of irradiation facilities in the Southern United States—

1. For articles being moved interstate or intrastate that require irradiation, 

the location for the facility needs to be within the local commuting area 

for APHIS employees to perform oversight and monitoring activities as 

provided in the regulations 7 CFR part 305. For imported articles that 

require irradiation, the location for the facility must also be within an 

area over which the U.S. Department of Homeland Security is assigned 

the authority to accept entries of merchandise, to collect duties, and to 

enforce the various provisions of the customs and navigation laws in 

force. 

2. APHIS will require that the owner/operator of the proposed facility 

obtain in writing from the State where the facility is to be located either 

the State’s concurrence for the establishment of a facility or the State’s 

explanation of valid phytosanitary concerns, based on pest risks, which 

formed the basis for the State’s denial. 

3. APHIS will require that the owner/operator of the proposed facility 

submit to APHIS a detailed layout of the facility location for APHIS to 

evaluate safeguards in light of the plant health risks involved. 

4. The location of the facility must be a site that minimizes the presence 

of host material for the pests of concern in the Southern United States. 

The facility must maintain and provide an updated map identifying 

places where horticultural or other crops are grown within 4 square 

miles of the facility. Trapping or other pest monitoring activities may 

be required based on the crops present and the pest risks involved. 

Required Generic Phytosanitary Criteria for Irradiation Facilities 

Located in the Southern United States

The following generic criteria will be used to establish an irradiation 

facility at a specific location in the Southern United States—

1. The facility will only be certified if the Administrator determines that 

any regulated articles can be safely transported to the facility from the 

point of entry or origin without significant risk that plant pests will 

escape in transit to the facility or while the regulated articles are at the 

facility.

2. The facility and APHIS must agree in advance about all parameters, 

such as time, routing, and conveyance, by which the consignment will 

move from the point of entry or origin to the treatment facility. Also, 
4

arrangements for treatment must be made before the departure of a 

consignment from its point of entry or origin.

3. Only approved articles described in the facility compliance agreement 

(FCA), in approved insect proof containers/pallets/bins, from approved 

places of production, States, or countries of export are to be accepted 

by the facility for treatment. The facility must ensure that the 

conveyance transporting the article to the facility is either refrigerated

(via motorized refrigeration equipment or other methods, including ice 

or insulation), or set at a temperature based on the article that would 

minimize the mobility of the pests of concern. The facility must ensure 

that cartons are off-loaded from conveyances in a safeguarded 

environment, and at no time are the articles to be removed from the 

insect-proof cartons prior to the treatment.

4. The facility must maintain physical separation of treated articles from 

untreated articles, and apply all required safeguards (e.g., the treated 

articles are packaged in insect-proof containers before releasing or 

before movement to other States).

5. The facility must have an APHIS-approved contingency plan for safely 

destroying or disposing of untreated or improperly treated articles.

 

6. The facility must comply with any additional requirements that APHIS 

may require for a particular facility based on local conditions, which 

will be described in the FCA.

IV. Environmental Impacts

A. No Action Alternative

Under the no action alternative, there would be limited impacts to the 

human environment. The environmental impacts under the no action and 

preferred alternative are the same; the only difference between the current 

regulations and the amended regulations is establishing a list of standard 

conditions for the approval of irradiation facilities in the Southern

United States. These conditions would still require a review by APHIS to 

ensure that the facilities meet these standards. However, the criteria under 

the rule amendment would provide proper guidelines and transparency to 

stakeholders, and save time from the, otherwise, repetitive rulemaking 

process in approving new facilities on a case-by-case basis.

B. Rule Amendment (Preferred Alternative)

Under the rule amendment, the irradiation regulations would allow for 

APHIS’ approval of irradiation facilities in the Southern United States to 
5

accept untreated commodities under a specific set of conditions. The 

potential environmental effects from irradiation facilities, the plant pest 

risk during transportation, and the irradiated food are discussed in detail 

below.

The United States has approximately 50 irradiation facilities throughout 

the States, primarily used for medical supplies and other non-food items. 

There is only one facility in Iowa that is APHIS-approved for food 

irradiation phytosanitary treatments. The potential radiation exposure to the 

environment and nontargets, including humans in the surrounding 

communities, is minimal. Irradiation facilities are strictly regulated for 

human and environmental safety. Each facility is licensed, regulated, and 

inspected by national radiological safety and health authorities. The 

specific regulation depends on the source of radiation used. The U.S. 

Nuclear Regulatory Commission regulates facilities that use radioactive 

sources. The U.S. Food and Drug Administration regulates x ray and 

electron beam facilities (EPA, 2010a). 

The food irradiation process can use one of three types of ionizing 

radiation sources cobalt-60 gamma sources, electron beam generators, and 

x-ray generators (EPA, 2010b; ICGFI, 1999). Food irradiation typically 

involves cobalt-60 sources. Cobalt is encapsulated in stainless steel 

“pencils” and then placed in the irradiator. The cobalt “pencils” are 

shipped in hardened steel shipping canisters which have undergone 

extensive testing to ensure their integrity in case of an accident (ICGFI, 

1999; EPA, 2010a).

According to the U.S. Environmental Protection Agency (EPA), the basic 

elements of radiation protection at all food irradiation facilities consist of 

facility design; worker training, procedures, and supervision; and 

regulatory oversight. Shielding the radiation source is an important 

component of facility design. While the amount of shielding necessary 

depends on the strength of the radiation source, facility treatment 

chambers may be surrounded with as much as 9 feet of concrete, or a 

combination of concrete and earth or sand (EPA, 2010a; ICGFI, 1999). 

Facility designs must also anticipate and protect workers and the 

surrounding communities from natural disasters, such as an earthquake, 

fire, or tornado (EPA, 2010a). If workers need to enter an irradiation 

room, the energy source is turned off in an electron beam facility, or the 

energy source is lowered into a pool of water that absorbs the radiation 

and protects the workers from exposure (FDA, 2000). 

While EPA has indicated that accidents have occurred at irradiation 

facilities which resulted in contamination, all occurred when safety 

systems and control procedures were bypassed (EPA, 2010a; ICGFI, 

1999). Under the proposed control program, a written certification by a 

licensed engineering and safety inspector would be issued showing that an 

1. Irradiation 

Facilities 
6

irradiation facility meets all safety and health requirements for safe 

operation in compliance with 7 CFR part 305. Provided that safety 

standards and control procedures are adhered to, no impacts to the human 

environment are expected (EPA, 2010a; ICGFI, 1999).

Fruit flies are among the most destructive pests of fruits and vegetables 

around the world, and pose a significant risk to agriculture in the 

United States. The fruit flies live and feed inside fruit causing economic 

losses from spoilage and destruction of the commodity. A study 

conducted in 1994 (Stewart, 1994) identified certain areas in the 

United States where conditions favored establishment of exotic fruit flies. 

This study formed the basis for not allowing the movement of untreated 

fruit fly host material in the Southern United States because of the 

possibility of fruit flies establishing if they escaped from the untreated 

containers.

Subsequently, APHIS has authorized facilities for irradiation treatment of 

fruits and vegetables at Gulfport, Mississippi, Wilmington, North 

Carolina, and Atlanta, Georgia under special conditions which were 

determined by APHIS to result in the safe transport of regulated articles to 

the treatment facility. The rule amendment would include the generic 

criteria based on the restrictions of the previously authorized facilities with 

added measures. APHIS has determined that the criteria under the 

proposed rule are adequate to manage the pest risks, especially the fruit fly

risks (USDA–APHIS, 2010a).

To ensure that pests, especially fruit flies, do not escape from the 

commodity, only approved articles in approved insect-proof containers are 

to be accepted by the facility. In addition, the facility must be certified by 

APHIS to ensure that the regulated articles will be safely transported to the 

facility without significant risk that the plant pests will escape in transit or 

while the regulated articles are at the facility (USDA–APHIS, 2010a). 

The facility must provide a map identifying places where horticultural or 

other crops are grown within 4 square miles of the facility; trapping and 

other monitoring activities may be required based on the crops present and 

the pest risks involved. In addition, the facility must have a pest 

management plan. These measures will help to ensure that even if a pest

should escape the commodity, APHIS can respond quickly (USDA–

APHIS, 2010a).

The facility must also provide APHIS all parameters such as time, 

direction, and conveyance by which the commodity will be moved from 

the point of entry into the treatment facility prior to departure from the 

point of entry. This transit plan must be approved by APHIS. In addition,

the facility must have a contingency plan for safely destroying or 

disposing of fruit in case the facility cannot treat the articles properly or in 

2. Plant Pest 

Risk During 

Transportation
7

a timely manner. This will help to ensure that once the commodity enters 

the United States, it is treated quickly and appropriately and, in cases 

where the commodity cannot be treated, the risk of pest escape is limited 

by destroying the commodity (USDA–APHIS, 2010a).

In addition to the above, the facility must maintain physical separation of 

treated articles (which are packaged in insect-proof containers) from 

untreated articles to ensure that all commodities which leave the treatment 

facility have been treated and have not been contaminated once they have 

been treated (USDA–APHIS, 2010a).

APHIS has determined that the set of criteria are adequate to manage pest 

risks associated with the preferred alternative (USDA–APHIS, 2010a). 

The criteria include multiple layers of protection to minimize risk from 

pest escape during transport or at the facility (USDA–APHIS, 2010a).

Upon evaluation of specific requests, if additional criteria are necessary, 

the criteria for that facility will be amended accordingly (USDA–APHIS, 

2010a).

Any food treated by irradiation must be labeled with the words “Treated 

by Irradiation,” and must display the irradiation logo (see figure 1). Food 

that has been irradiated has been exposed to gamma rays, electron beams, 

or x rays which are a part of the electromagnetic spectrum. This 

technology has been used routinely for more than 50 years to sterilize 

medical, dental, and household products, as well as some food products. 

Figure 1. The Irradiation Logo

Irradiation has been used on food and food additives since the 1960s for 

sterilization (EPA, 2010a). However, food irradiation for phytosanitary 

purposes has only been used since the late 1990s. Irradiation at 150 Grays 

(Gy) is effective against all fruit flies (USDA–APHIS, 2010b). Other 

plant pests have phytosanitary treatment schedules of up to 400 Gy

(USDA–APHIS, 2010b). These values are lower than those used to 

sanitize meats and other commodities from bacteria. 

3. Irridated Food
8

Irradiation does not harm the nutritional value of food, nor does it make 

the food unsafe to eat (CDC, 2005; EPA, 2010b; ICGFI, 1999; 21 CFR 

part 179). The U.S. Department of Health and Human Services, Food and 

Drug Administration (FDA) issued a final rule regarding food irradiation 

in 1986 (21 CFR part 179) which states that absorption rates below 

1,000 Gy will not make food radioactive, affect the safety of the food, 

alter the nutritional value of the food, or adversely affect the balance 

between microbial spoilage organisms and pathogenic organisms. The 

safety of irradiated foods has been endorsed by the World Health 

Organization (WHO), the Centers for Disease Control and Prevention 

(CDC), Department of Health and Human Services, as well as by USDA 

and FDA.

V. Cumulative Impacts

NEPA regulations require that Federal agencies analyze the potential 

cumulative effects of an action meaning “the impact on the environment 

which results from the incremental impact of the action when added to 

other past, present, and reasonably foreseeable future actions” 

(40 CFR § 1508.7).

The mitigations of the preferred alternative are expected to provide an 

effective level of phytosanitary protection (USDA–APHIS, 2010a). These

mitigations are designed to prevent adverse cumulative impacts on the 

environment by decreasing the risk of introduction and establishment of 

quarantine plant pests. 

VI. Other Environmental Concerns

The APHIS NEPA implementing procedures require, to the fullest extent 

possible, the integration of Federal environmental laws and Executive 

orders with the analysis of environmental impacts (7 CFR § 372.7). The 

following laws and Executive orders have been considered in this EA.

A. Threatened and Endangered Species

Section 7 of the Endangered Species Act 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. 

USDA–APHIS has considered the potential environmental effects of the

proposed rulemaking to approve irradiation facilities in the Southern 

United States. Because the rule’s criteria for irradiation facilities are 

designed to be effective in preventing the establishment of fruit flies and 
9

other quarantine pests of concern, no adverse impact on identified 

potential host species in the continental United States is anticipated 

(USDA–APHIS, 2010a). The impacts associated with the building of the 

facilities in the Southern United States will be identified, and consultations 

with Fish and Wildlife Services and/or the National Marine Fisheries 

Service would occur, as needed, once future sites are identified.

B. Other Considerations

Certain Executive orders, such as Executive Order 13045 (Protection of 

Children from Environmental Health Risks and Safety Risks), Executive 

Order 12898 (Federal Actions to address Environmental Justice in 

Minority Populations and Low-Income Populations), Executive Order 

12114 (Environmental Effects Abroad of Major Federal Actions), and 

departmental or agency directives call for special environmental reviews 

in certain circumstances. Under the preferred alternative, there will be no

disproportionate adverse effects to children or minority or low-income 

populations of the United States.
10

VII. Agencies Consulted

U.S. Department of Agriculture

Animal and Plant Health Inspection Service

Policy and Program Development

Environmental and Risk Analysis Services

4700 River Road, Unit 149

Riverdale, MD 20737

U.S. Department of Agriculture

Animal and Plant Health Inspection Service

Policy and Program Development

Regulatory Analysis and Documentation

4700 River Road, Unit 118

Riverdale, MD 20737

U.S. Department of Agriculture

Animal and Plant Health Inspection Service

Plant Protection and Quarantine

Emergency and Domestic Programs

4700 River Road, Unit 137

Riverdale, MD 20737

U.S. Department of Agriculture

Animal and Plant Health Inspection Service

Plant Protection Quarantine

Planning, Analysis, and Regulatory Coordination

4700 River Road, Unit 141

Riverdale, MD 20737
11

VIII. References

CDC—See Center for Disease Control and Prevention

Center for Disease Control and Prevention, 2005. Food irradiation. 

[Online]. Available: http://www.cdc.gov/ncidod/DBMD/diseaseinfo/ 

foodirradiation.htm (October, 2005). [2010, Mar. 23]. 

EPA—See U.S. Environmental Protection Agency

ICGFI—See International Consultative Group on Food Irradiation

International Consultative Group on Food Irradiation, 1999. Facts about 

food irradiation: a series of fact sheets from the International Consultative 

Group on Food Irradiation. Vienna, Austria.

Stewart, R. D., 1994. Characterizing and mitigating relative risk 

associated with the movement of tropical fruit fly host material into the 

United States for cold treatment at certain ports. U.S. Department of 

Agriculture, Animal and Plant Health Inspection Service. Riverdale, MD. 

Feb. 1994.

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, 1997. Irradiation for phytosanitary regulatory treatment, 

environmental assessment. Riverdale, MD. October 1997.

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

Service, 2010a. Generic phytosanitary criteria for establishing locations 

for irradiation facilities in the Southern United States, treatment evaluation 

document. Riverdale, MD. July 2010.

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

Service, 2010b. Treatment manual. Animal and Plant Health Inspection 

Service, Plant Protection and Quarantine. Riverdale, MD. Nov. 2010.

U.S. Environmental Protection Agency, 2010a. Radiation protection: 

Food irradiation: Facility safety and environmental impact. [Online]. 

Available: http://www.epa.gov/rpdweb00/sources/facility_env.html.

[2010, Nov. 29].

U.S. Environmental Protection Agency, 2010b. Food irradiation. 

[Online]. Available: 

http://www.epa.gov/rpdweb00/sources/food_irrad.html. [2010, Nov. 29].
Finding of No Significant Impact 

For 

Irradiation Facilities for Phytosanitary Treatments in the Southern United States 

Environmental Assessment, 

January 2012 

The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), has prepared 

an environmental assessment (EA) that analyzes potential environmental consequences of allowing irradiation 

facilities in several locations in the Southern United States. The EA, incorporated by reference in this document, 

is available from: 

U.S. Department of Agriculture 

Animal and Plant Health Inspection Service 

Plant Protection and Quarantine 

Plant Health Programs 

Regulations, Permits, and Manuals 

4700 River Road, Riverdale, MD 20737 

The EA analyzed the following alternatives: (1) the current irradiation regulations that do not allow for irradiation 

facilities in the Southern United States (no action alternative), and (2) amendment (the preferred alternative). The 

amendment was preferred because it would not likely result in adverse environmental consequences. The 

mitigative measures serve to negate or reduce potential environmental consequences resulting from the rule 

amendment. 

APHIS has determined that there would be no significant impact to the human environment from the 

implementation of the proposed rule. APHIS' Finding of No Significant Impact for this regulatory action was 

based upon the expected limited environmental consequences, as analyzed in the EA. In addition, APHIS 

anticipates no impacts to threatened or endangered species or their habitats from this regulatory action. I find that 

the proposed action poses no disproportionate adverse effects to minority and low-income populations and the 

actions undertaken for this proposed action are entitely consistent with the principles of"environmental justice," 

as expressed in Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority 

Populations and Low· Income Populations." Likewise, I fmd that the proposed action poses no disproportionate 

adverse effects to children and the actions undertaken for this program comply with the policy of Executive Order 

13045, "Protection of Children from Environmental Health Risks and Safety Risks." 

Lastly, because I have not found evidence of any significant environmental impacts associated with the proposed 

rule, I further find that an environmental impact statement does not need to be prepared and that proposed rule 

may be implemented. 

pfJ':~ 

Dr~Gadh Senior Risk Manager- Treatments 

Regulations, Permits, and Manuals 

Plant Health Programs 

Plant Protection and Quarantine 

Animal and Plant Health Inspection Agency