# Irradiation Facilities for Phytosanitary Treatments in the S outhern United States

Environmental Assessment January 201 2

# Irradiation Facilities for Phytosanitary treatments in the S outhern United States

Environmental Assessment, January 2 01 2

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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.

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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

V I

. Other Environmental Concerns

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

................................ 8 B. Other Considerations

................................ .......................... 9

VII. Agencies Consulted

................................ ................................ 10

VIII. References

................................ ................................ ............... 111 

## 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 meth od 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 pa ttern. 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 fruit s and vegetables. The environmental assessment ( EA ) examined the potential impacts to human health, non target species , and environmental quality from the use of

gamma rays or electron beams on fruits and vegetables.

The current regulations allow irradiat ion 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 Car olina, 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 Unite d States to
have cold treatment facilities and three locations to have irradiat ion facilities: the maritime ports in Gulfport, M ississippi , and Wilmington,
N orth C arolina

, and the airport in Atlanta, G eorgia

. The approvals were
b ased on the implementation of specific conditions that were determined by APHIS to result in the safe tra nsport of regulated ar ticles to the
treatment facilities

, and the safeguarding of the articles prior to treatment to prevent the escape and establishme nt of exotic fruit flies in these area s

.


## II

. Purpose and Need

In recent years, the number of applicant s that want to conduct irradiation for imports in the S outhern 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 future2 planning. These criteria were developed based on the conditions used for
the three s outhern location s currently approved for phytosanitary

treatment

, and take into account extreme scenarios.

T his EA will analyze the potential effects of using the specific criteria as conditions for approving the establishment of irradiation facilities in the
S outhern Un ited States. This EA will also focus on the potential
environmental effects from irradiation facilities, allowing untreated commodities to be transported into the S outhern Un ited 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

.


## I I I

. Alternatives

This EA analyzes potential environmental con sequences f rom the implement ation of this rule, which will amend the irradiation regulations,
7 Code of Federal Regulations ( CFR ) § 305. 9 , to allow irradiation
facilities in the S outhern United States. Two possible alternatives
considered in this EA are ( 1) the current irradiation regulations that do not
allow for irradiation facilities in the S outhern United States (no action alternative)

, and (2) amendment (the preferred alternative)

.



### A. No Action Alternative

Under the no action alternative, the irra diation 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 ( S outhern United States ).
APHIS has permitted irradiation facilities in Gulfport, M ississippi

, Wilmington, N orth C arolina , and Atlanta, G eorgia based on special conditions that were determined by APHIS to result in the safe transport of regulated articles to the treatment facility. Other f uture 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 facilit ies in
the S outhern 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 States3 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 A PHIS 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 Homela nd 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 S outhern United States. The facility must maintain and provide an updated map identifying places where horticultural or other crops are grown within 4 square mile s of the f acility. 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 generi c criteria will be used to establish an irradiation facility at a specific location in the S outhern United States

—

1. The facility will only be certified if the Administrator determines that any regulated articles can be safely transported to the facilit y 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 appro ved articles described in the facility compliance agreement ( FCA )

, in approved insect proof containers/pallets/bins, from approved places of production, State s , or countries of export are to be accepted by the facility for treatment. The facility must ens ure 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 m ust 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 p hysical 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
be for e movement to other States )

.

5. The facility must have an APHIS

- approved contingency plan for safely destroying or disposing of untreated or improperly treated article s

.

6. The facility must comply with any additional requirements that APHIS may require for a particular facility based on local conditions, which
wi ll be described in the FCA.



## I V

. 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 S outhern
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 guideline s and transparency to
stakeholders

, and save time from the

, otherwise

, repetitive rulemaking process in approving new facilit ies 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 S outhern United States to5 accept untreated commodities under a specific set of conditions. The potential environmental effects from irradiation facilities, the plant pest
risk during transportation , and the i rradiated food are discussed in detail
below

.

The United States has approximately 50 irradiation f acilities 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 nontarge ts, 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, 2010 a ).

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 i rradiation typically
involves cobalt

- 60 sources. Cobalt is e ncapsulated in stainless steel “pencils” and then placed in the irradiator. The c obalt “pencils” are shipped in ha rdened steel shipping canisters which have undergone extensive testing to ensure their integrity in case of an accident (ICGFI, 1999; EPA, 20 10 a ).

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, 2010 a ; 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, 2010 a ). If workers need to enter an i rradiation 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, 2010 a ; 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
Facilities6 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 h uman environment are expected (EPA, 2010 a ; ICGFI, 1999 )

.

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

, and pose a significant risk to agricul ture in the
United States. The fruit flies live and feed inside fr uit causi ng economic losses from spoilage and destruction of the commodity. A study conducted in 1994 (Stewart, 1994) identif ied 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 S outhern United States because of the possibility of fruit flies establishing if they escaped from the untreated
containers.

Subsequently, APHIS has authorized facilities for irradi ation treatment of fruits and vegetables at Gulfport, M ississippi , Wilmington, N orth
C arolina , and Atlanta, G eorgia under special conditions which were determined by APHIS to result in the safe transport of regulated articles to the treatment facility. T h e rule amendment would include t he generic criteria based on the restrictions of the previous ly authorized facilities with
added measures. APHIS ha s determined that the criteria under the proposed rule are ad equate to manage the pest risk s , especially the fruit fly risks ( USDA

– APHIS , 20 10 a ).

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 certifi ed by
APHIS to ensure that the regulated articles will be safely transported to the facility without significant risk that the plant pests w i ll escape in transit or while the regulated articles are at the facility (USDA

– APHIS, 2010 a).

The facility must provide a map identifying places where horticultural or other crops are grown within 4 square mile s of the facility ; t rapping and other monitoring activities may be required based on the crops presen t and the pest risks involved . In addition, the facility must ha ve 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, 2010 a )

.

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

, and conveya nce by which the commodity will be move d 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 destro ying or disposing of fruit in case the facility cannot treat the articles properly or in 2. Plant Pest Risk During Transportation7 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, 2010 a )

.

In addition to the above, the facility must maintain physical separation of
treated articles ( which are packaged in insect

- proof containers ) from

untrea ted 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, 2010 a )

.

APHIS has determined that the set of criteria are adequate to manage pest
risk s associated with t he preferred alternative (USDA

– APHIS, 2010 a ). The criteria include multiple layers of protection to minimize risk from pest escape during tran sport or at the facility (USDA

– APHIS, 2010 a ). Upon evaluation of specific requests, if add itional criteria are necessary, the criteria for that facility wil l be amended accordingly (USDA

– APHIS,
2010 a ).

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

, ” and must display the irradiation logo (s ee f igure 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 an d food additives since the 1960 s for
sterilization (EPA, 2010 a ). However, food irradiation for phytosanitary purposes has only been use d since the late 1990s. Irradiation at 1 50 Grays ( Gy ) is effective agai nst 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
sanit ize meats and other commodities from bacteria. 3. Irridated Food8 Irradiation does not harm the nutritional value of food, nor does it make the food unsafe to eat (CDC, 2005; EPA, 2010 b ; ICGFI, 1999; 21 CFR part 179). The U.S. Department of Health and Human Services, Foo d and Drug Administration (FDA) issued a final rule regarding food irradiation in 1986 (21 CFR part 179) which states th at absorption rates below 1,000 Gy will not make food radioactive, affect the safety of the food,
alter the nutritional value of the foo d, 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 t hat F ederal agencies analyze the potential
cumulative effects of an action meaning “the impact on the environment
which results from the incremental i mpact 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 phyto sanitary protection ( USDA

– APHIS, 2010 a ). The se mitigations are designed to prevent adverse cumulative impacts on the environment by decreasing the risk of introduction and establis hment 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 E xecutive orders with the analysis of environmental impacts (7 CFR § 372.7). The following laws and E xecutive orders have been considered in this EA

.



### A

. Threatened and E ndangered 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 dest ruction or adverse modification of critical habitat.

USDA

– APHIS has considered the potenti al environmental effects of the proposed rule making to approve irradiation facilities in the S outhern
United States. Because the rule’s criteria for irradiation f acilities are
des igned to be effective in preventing the establishment of fruit flies and9 other quarantine pests of concern

, no adverse impact on identified potential host species in the continental United States is anticipated ( US DA

– APHIS

, 2010 a ). The im pacts associated with the building of the
facilit ies in the S outhern 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 E xecutive 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
Minor ity Populations an d Low

- I ncome 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, t here will be no disproportionate adverse effects to children or minority or low

- income population s of the U nited States.10 

## V II

. Agencies Consulted

U.S. Department of Agriculture Animal and Plant Health Inspection Service Policy and Program Development
Environmental and Risk Analysis Service s 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 I nspection Service Plant Protection Quarantine
P lanning, Analysis, and Regulatory Coordination 4700 River Road, Unit 141 Riverdale, MD 2073711 

## VIII

. References

CDC

— See Center for Disease Control and Prevention

Center for Disease Contr ol and Preventio n, 2005. Food i rradiation. [Online]. Available : http://www.cdc.gov/ncidod/DBMD/diseaseinfo/
foodirradiation.htm ( October, 2005). [2010, Mar. 23].

EPA

— See U.S. Environ mental Protection Agency

ICGFI

— See International Consultative Group on Food Irradiation

International Consultative Group on Food I rradiation, 1999. Facts about
f

ood i rradiation: a series of f act s heets from the International Consultative Group on Food I rradiation. 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. Irradia tion for phytosanitary r egulatory t reatment

,
e nvironmental a ssessment. Riverdale, MD. October 1997.

U

. S

. Department of Agriculture, Animal and Plant Health Inspection Service, 2010 a . Generic phytosanitary criteria for establishing locations
for irradia t ion facilities in the S outhern U nited S tates, 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, Pl ant Protection and Quarantine. Riverdale, MD. Nov

. 2010.

U.S. Environmental Protection Agency, 2010 a . Radia tion protection:
Food i rradiation: Facility s afety and environmental i mpact. [Online].
Available : http://www.epa.gov/rpdweb00/sources/facility_ env.html

. [2010, Nov. 29].

U.S. Enviro nmental 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