Papaya, Carambola, and Litchi From Hawaii

Federal RegisterJul 23, 1996

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 318

[Docket No. 95-069-1]

Papaya, Carambola, and Litchi From Hawaii

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to increase the irradiation treatment dose

required for papayas intended for interstate movement from Hawaii and

to allow carambolas and litchis to be moved interstate from Hawaii with

irradiation treatment. We are also proposing to allow papayas,

carambolas, and litchis from Hawaii to undergo irradiation treatment

either in Hawaii or in non-fruit fly supporting areas of the mainland

United States. We are also proposing to allow litchis to be moved

interstate from Hawaii if they are inspected and found free of the

litchi fruit moth and undergo hot water treatment for fruit flies. In

addition, we are proposing several amendments to the requirements for

irradiation procedures and facilities and the handling of treated and

untreated fruits and vegetables. Finally, we are proposing to amend the

definition for inspector to include State plant regulatory officials

designated by the Administrator of the Animal and Plant Health

Inspection Service, U.S. Department of Agriculture. These proposed

actions would facilitate the interstate movement of papayas,

carambolas, and litchis from Hawaii while continuing to provide

protection against the spread of injurious plant pests from Hawaii to

other parts of the United States.

DATES: For comments on all portions of this proposed rule except the

rule's information collection and recordkeeping requirements that are

subject to the Paperwork Reduction Act, consideration will be given

only to comments received on or before August 22, 1996. For comments on

the Paperwork Reduction Act requirements of this proposed rule,

consideration will be given only to comments received on or before

September 23, 1996.

ADDRESSES: Please send an original and three copies of your comments to

Docket No. 95-069-1, Regulatory Analysis and Development, PPD, APHIS,

suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please

state that your comments refer to Docket No. 95-069-1. Comments

received may be inspected at USDA, room 1141, South Building, 14th

Street and Independence Avenue SW., Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday, except holidays. Persons wishing to

inspect comments are requested to call ahead on (202) 690-2817 to

facilitate entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Mr. Peter M. Grosser, Senior Staff

Officer, Port Operations, PPQ, APHIS, 4700 River Road Unit 139,

Riverdale, MD 20737-1236, (301) 734-8295.

SUPPLEMENTARY INFORMATION:

Background

The Hawaiian Fruits and Vegetables regulations, contained in 7 CFR

318.13 through 318.13-17 (referred to below as the regulations),

govern, among other things, the interstate movement of fruits and

vegetables, including papayas, from Hawaii. Regulation is necessary to

prevent the spread of the Mediterranean fruit fly (Ceratitis capitata),

the melon fly (Bactrocera cucurbitae), and the Oriental fruit fly

(Bactrocera dorsalis), which occur in Hawaii. These types of fruit

flies are collectively referred to in this document as Trifly.

The regulations allow papayas to be moved interstate from Hawaii to

any destination in the United States if,

[[Page 38109]]

among other things, they have been treated for Trifly. One approved

treatment for Trifly in papayas is irradiation. Section 318.13-4f

provides for irradiation of papayas at an approved facility in Hawaii

at an irradiation dose of 150 Gray (15 krad).

Irradiation Dosage Levels

The Agricultural Research Service (ARS), United States Department

of Agriculture, recently reevaluated the irradiation treatment for

fruits and vegetables, including papayas, and has formally recommended

a change from 150 Gray to 250 Gray for the dose necessary to control

Trifly. At the current dosage levels, normal-appearing, sterile adult

pests may emerge after treatment. Although these insects cannot

reproduce, the emergence of normal-appearing adults presents problems

for surveillance programs designed to intercept exotic insects, because

there is no practical way to distinguish an irradiated (sterile) insect

from an untreated one. ARS has determined that the 250 Gray (25 krad)

dosage would prevent adult emergence altogether, including the

emergence of normal-appearing, sterile adult insects capable of flight.

The Food and Drug Administration (FDA) regulations permit the use

of irradiation at doses not to exceed 1,000 Gray (100 krad) to inhibit

the growth and maturation of fresh foods and to disinfest food of

arthropod pests. The 250 Gray (25 krad) dosage recommended by ARS is

well within FDA limits. We are therefore proposing to amend

Sec. 318.13-4f by increasing the irradiation treatment dose required

for papayas intended for interstate movement from Hawaii from 150 Gray

(15 krad) to 250 Gray (25 krad).

Irradiation Treatment on the Mainland

Hawaii has not been able to ship irradiated fresh papayas to the

mainland under the existing regulations due to the lack of an

irradiation facility in the State. We believe that routine commercial

shipments of papayas can be authorized for treatment in any State of

the continental United States except Alabama, Arizona, California,

Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada, New Mexico,

North Carolina, South Carolina, Tennessee, Texas, or Virginia. Prior to

treatment, movement into and through the United States would be limited

to the area authorized under Sec. 318.13-17(e) for fruits and

vegetables from Hawaii that transit the United States en route to a

foreign destination. It is unlikely that Trifly would be able to

establish reproducing populations in the States on the mainland where

treatment would be allowed because of either the relatively cool

climate or the lack of suitable host material in those areas.

Therefore, we are proposing to amend the regulations at Sec. 318.13-3

and 318.13-4f to allow untreated papayas from Hawaii to undergo

irradiation treatment in the areas of the mainland United States

described above.

We are also proposing to require that untreated papayas moved

interstate from Hawaii for treatment at an irradiation facility in an

approved area on the mainland United States be accompanied by a limited

permit. The purpose of a limited permit is to allow movement, under

certain restrictions, of a commodity that may not otherwise be

authorized for movement. This document provides a way to track the

commodity and ensure that it moves only as authorized.

In addition, we are proposing to prohibit the commingling of

untreated papayas shipped from Hawaii to the mainland United States

with other fruits and vegetables. This appears necessary to prevent

other commodities from becoming infested with Trifly.

Irradiation Procedures and Facilities

We are proposing to amend Sec. 318.13-4f to eliminate the

requirement that dose indicators be attached to the cartons or the

pallet loads of treated papayas. Instead, we would require that

absorbed dose be measured at the treatment facility using a dose

indicator that can accurately measure an absorbed dose of 250 Gray (25

krad). We would require that the number and placement of dosimeters

used to measure the absorbed dose be in accordance with standards of

the American Society for Testing and Materials (ASTM). (See Designation

E 1261-94, ``Standard Guide for Selection and Calibration of Dosimetry

Systems for Radiation Processing,'' American Society for Testing and

Materials, Annual Book of ASTM Standards.) We would add that the

dosimetry system (the system used for determining absorbed dose,

consisting of dosimeters, measurement instruments, reference standards,

and procedures) in place at the treatment facility must demonstrate

that the absorbed dose, including areas of minimum and maximum dose, is

mapped, controlled, and recorded, and we would rely on the treatment

facility records to verify the treatment. Under the current

regulations, the treatment facility is required to maintain records of

treatment for a period of time that exceeds the shelf life of the

irradiated product by 1 year. The regulations require the records to

include the lot identification, scheduled process, evidence of

compliance with the scheduled process, ionizing energy source, source

calibration, dosimetry, dose distribution in the product, and the date

of irradiation. All records must be available for inspection.

In addition, we are proposing to amend Sec. 318.13-4f to require

that approved irradiation treatment facilities be certified annually by

Plant Protection and Quarantine (PPQ), APHIS, and that they be

recertified in the event that an increase or decrease in radioisotope

or a major equipment modification affects the delivered dose. This

action would ensure that irradiation facilities are capable of properly

administering effective treatments.

Packaging Requirements

We are proposing to amend specific provisions regarding packaging

and wrapping of papayas under Sec. 318.13-4f to require that all

treated papayas be packaged in pest-proof cartons to protect them from

re-infestation by Trifly. Then, to ensure that no cartons are added to

or removed from a pallet load of cartons, pallet loads would have to be

wrapped in one of the following ways, as is currently required under

Sec. 318.13-4f(b)(6): With polyethylene sheet wrap, with net wrapping,

or with strapping so that each carton on an outside row of the pallet

load is constrained by a metal or plastic strap. We further propose to

require that pallet loads of treated papayas be marked with treatment

lot numbers, packing and treatment facility identification and

locations, and dates of packing and treatment. This information would

allow an inspector to identify the treatment lots and trace them back

to the packing and treatment facilities. This method of labeling would

replace the current requirement that individual cartons and pallet-

loads of cartons be marked with a ``Treated'' stamp.

We are not proposing similar packaging requirements for untreated

papayas moving interstate to the mainland United States. Any Trifly

that might be present in the shipment of untreated papayas would most

likely be eggs and larvae, and it is unlikely that eggs and larvae

could escape. If Trifly eggs and larvae were present in the shipment,

and if they reached maturity and escaped, it is unlikely that they

could establish a reproducing population in the areas in which movement

of untreated papayas would be authorized under this section because of

either the relatively cool climate or the lack of suitable host

material in those areas. Further, untreated papayas would be treated on

[[Page 38110]]

the mainland before being distributed, minimizing the possibility that

any eggs and larvae could reach maturity and escape.

Carambolas from Hawaii

Carambola (Averrhoa carambola) fruit is a recorded host of Trifly.

Based on ARS research and recommendations, 1 we are also proposing

to amend Sec. 318.13-4f to allow the interstate movement of carambolas

from Hawaii with irradiation treatment. The same provisions proposed

for papaya, including irradiation treatment dosage, would apply.

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\1\ Information on this and other ARS research may be obtained

by writing to Dr. Ken Vick, USDA, ARS, NPS, BARC-West, Building 005,

Beltsville, MD 20705.

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Litchis from Hawaii

Litchi (Litchi chinensis) fruit is a recorded host of the

Mediterranean fruit fly and Oriental fruit fly, among other pests, but

litchi is not a recorded host for melon fly. Based on ARS research and

recommendations, we are proposing to further amend Sec. 318.13-4f to

allow the interstate movement of litchis from Hawaii with irradiation

treatment. The same provisions proposed for papaya, including

irradiation treatment dosage, would apply.

We have determined, however, that irradiation treatment may not

affect other pests that may be carried by litchi. One pest, the litchi

rust mite (Eriphyes litchi), would not be easily detected by an

inspector. Therefore, the entry of litchi from Hawaii into Florida,

where most mainland litchi is grown, would be prohibited as a

precaution against the possible introduction of litchi rust mite.

Accordingly, the cartons in which the litchi are packed would have to

be stamped ``Not for importation into or distribution in FL.''

Other pests that may be carried by the litchi, including the litchi

fruit moth (Cryptophlebia spp.), could be easily detected by

inspection. We propose to require that the litchis be inspected by an

inspector and found free of plant pests prior to interstate movement

under a limited permit.

Allowing the interstate movement of litchis from Hawaii under the

conditions described above would facilitate trade while continuing to

provide protection against the spread of plant pests into other parts

of the United States.

As an alternative to the irradiation treatment for litchi from

Hawaii, we are proposing to allow the interstate movement of litchis

from Hawaii if the litchis are inspected and found free of the litchi

fruit moth (Cryptophlebia spp.) and other plant pests by an inspector

and then treated with hot water for the Mediterranean fruit fly and

Oriental fruit fly under the supervision of an inspector before the

litchis' interstate movement.

However, because the litchi rust mite cannot be effectively

detected by inspection and would not be eliminated by hot water

treatment, we are proposing that the litchi be prohibited movement into

Florida. Accordingly, the cartons in which the litchi are packed would

have to be stamped ``Not for importation into or distribution in FL.''

The provisions described above for litchi from Hawaii would be

added to the regulations as a new Sec. 318.13-4e.

Research conducted by ARS indicates that the following hot water

treatment of litchis would provide probit 9 quarantine security (no

more than 3 individuals surviving from an estimated treatment

population of 100,000 target) against any potential infestations of

Mediterranean fruit fly or Oriental fruit fly:

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Water temperature Time

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49 deg.C (120.2 deg.F) or above...... 20 minutes.

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Treatment would begin when the water temperature is 49 deg.C

(120.2 deg.F) or above in all locations throughout the tank; the tank

must be designed to allow sufficient water circulation and heating to

maintain treatment temperatures during the 20 minute treatment cycle.

Hot water treatment tanks with upper temperature limits of 49.5 deg.C

(121.1 deg.F) would be recommended, because temperatures exceeding

49.5 deg.C (121.1 deg.F) could cause phytotoxicity damage due to

overheating. Hydrocooling for 20 minutes at temperatures of 24 deg.C

(75.2 deg.F) # 4 deg.C (7.2 deg.F) would also be recommended to

prevent injury to the fruit from the hot water treatment. This

treatment schedule for litchis from Hawaii would be added to the Plant

Protection and Quarantine (PPQ) Treatment Manual, which is incorporated

into the regulations by reference at 7 CFR 300.1.

Definition of Inspector

We are proposing to amend the definition of inspector in

Sec. 318.13-1 to enable a greater number of qualified people to perform

inspections on, issue limited permits for, and certify fruits and

vegetables moving interstate from Hawaii. We propose that the new

definition define an inspector as ``An employee of Plant Protection and

Quarantine, or a State plant regulatory official designated by the

Administrator to inspect and certify to shippers and other interested

parties, as to the condition of the products inspected. To be eligible

for designation, a State plant regulatory official must have a

bachelor's degree in the biological sciences, a minimum of 2 years'

experience in State plant regulatory activities, and a minimum of 2

years' experience in recognizing and identifying plant pests known to

occur within Hawaii. Six years' experience in State plant regulatory

activities may be substituted for the degree requirement.'' We believe

that this proposed definition, which is based in part on the definition

for inspector found in 7 CFR 353, ``Phytosanitary Export

Certification,'' would allow greater State participation in the

inspection process while continuing to provide protection against the

spread of injurious plant pests from Hawaii to other parts of the

United States.

Miscellaneous

We are proposing to amend Sec. 318.13-4f so that it permits

irradiation treatment for certain fruits or vegetables, not exclusively

for papayas. Although papayas, carambolas, and litchis would be the

only commodities listed in Sec. 318.13-4f as being approved for this

treatment, we expect that additional fruits and vegetables from Hawaii

may be approved for irradiation treatment and added to this section

through rulemaking in the future.

We are also proposing to amend Sec. 318.13-4f(c) to update the

address for requests for approval and inspection of irradiation

facilies.

This proposed rule would facilitate the interstate movement of

papayas, carambolas, and litchis from Hawaii while continuing to

provide protection against the spread of injurious plant pests from

Hawaii to other parts of the United States.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866.

For this action, the Office of Management and Budget has waived its

review process required by Executive Order 12866.

In accordance with 5 U.S.C. 603, we have performed an Initial

Regulatory Flexibility Analysis, which is set out below, regarding the

impact of this proposed rule on small entities. However, we do not

currently have all the data necessary for a comprehensive analysis of

the effects of this rule on small entities. Therefore, we are inviting

comments concerning potential effects. In particular, we are interested

in determining the number and kind of

[[Page 38111]]

small entities that may incur benefits or costs from implementation of

this proposed rule.

In accordance with 7 U.S.C. 162, the Secretary of Agriculture is

authorized to promulgate regulations governing the interstate movement

of plants and plant products from a State or territory of the United

States to prevent the spread of a dangerous plant disease or insect

infestation new to or not widely prevalent or distributed within or

throughout the United States.

This proposed rule would increase the irradiation treatment dose

required for papayas from Hawaii and allow irradiation treatment of

carambolas and litchis from Hawaii. The proposed rule would also allow

papayas, carambolas, and litchis from Hawaii to undergo irradiation

treatment in non-fruit fly supporting areas of the mainland United

States. In addition, the proposed rule would allow litchis to be moved

interstate from Hawaii if they are inspected and found free of the

litchi fruit moth and other plant pests and then undergo hot water

treatment for Medfly and Oriental fruit fly. Finally, the proposed rule

would amend the requirements for irradiation procedures and facilities

and the handling of treated and untreated fruits and vegetables.

Economic impacts associated with this rulemaking would largely be the

result of untreated papayas, carambolas, or litchis being allowed to

move to the mainland United States for irradiation treatment.

Papayas

Papayas are produced commercially on about 340 farms in Hawaii.

Nearly 65 percent of those farms are owned by individuals whose major

occupation is not farming, while the balance are operated by

individuals whose major occupation is farming.

Papaya farms with average annual revenues of less than $500,000 are

considered small. All papaya farms in Hawaii are therefore considered

small.

In 1994, Hawaii produced 62 million pounds of papaya (valued at $15

million). Fresh papaya comprised 56.2 million pounds of this total.

During that year, Hawaii shipped about 37.8 million pounds of papaya.

Shipment of fresh papaya to the mainland totaled about 19.4 million

pounds, and the remainder was exported to other countries. Of the

approximately 19.4 million pounds of fresh papayas shipped from Hawaii

to the mainland in 1994, most went to the West Coast. Seventy five

percent of them were sold directly to retailers, and the rest were sold

to wholesalers.

The United States imported about 41.2 million pounds of fresh

papaya (valued at $10.9 million) in 1994. Most of the imported papayas

came from Mexico (80 percent), Belize (9.6 percent), Jamaica (6.3

percent), and the Dominican Republic (1.9 percent). The United States

exported 18.4 million pounds of fresh papayas (valued at $15.4 million)

in 1994. The major importers were Japan (66.8 percent) and Canada (27.1

percent). Almost all United States exports of papayas go out of Hawaii,

while all imports come into the mainland United States.

There are five firms currently operating nine papaya treatment

facilities in the State of Hawaii. Four firms use the vapor-heat

treatment method and one uses the dry heat (or high-temperature forced

air) method. The total capacity of these treatment chambers is 85,000

pounds per run.

Both heat treatment methods have the potential to damage the

papayas. They require the center of each papaya fruit to reach about 47

deg.C (about 117 deg.F), a temperature sufficient to kill fruit fly

eggs and larvae. Because of variation in fruit size and ripeness, the

papayas may not be uniformly heated. This may result in the fruit

becoming lumpy and losing flavor. For both methods, careful control of

the uniformity of fruit size and ripeness is necessary for effective

treatment. In addition, both methods require between 4 and 6 hours of

treatment. Efforts to speed up the process result in fruit which is

either scalded externally or hardened on the inside. The cost of

treatment for both methods ranges from 9 to 23 cents per pound.

Although the regulations currently allow papayas to be treated by

irradiation in Hawaii, there are no irradiation facilities in that

State. Allowing irradiation to be performed on the mainland appears to

be an attractive option. The subsequent diversion of untreated papayas

from Hawaii to the mainland would likely result in loss of business to

the existing vapor heat and dry heat facilities. This could result in

lay-offs and possibly the shut-down of some of these facilities.

However, if papaya producers respond by producing more papayas,

continuing traditional treatment for some and shipping others for

irradiation, this would not necessarily occur.

Carambolas

The United States produced about 6 million pounds of carambola in

1994, with a total value of approximately $4 million to $4.5 million.

In the United States, carambola is grown on about 100 farms. All of

these farms have a market value of less than $500,000 and are thus

considered to be small businesses according to the Small Business

Administration's size standards.

In 1994, Hawaii produced only about 50,700 pounds of carambola,

valued at approximately $38,000, on 35 farms. The provisions proposed

in this rule concerning irradiation treatment of carambola fruits by

the mainland facilities are expected to stimulate growth of the

carambola industry in Hawaii and provide greater access to the larger

mainland market.

No economic impact on mainland carambola growers is anticipated,

since the total Hawaii production of carambola is less than one percent

of the mainland production. Therefore, even in the unlikely event that

Hawaii could ship 100 percent of its production to the mainland, supply

would only increase by less than one percent. However, mainland

consumers would likely benefit from increased seasonal and regional

availability, as well as from the increased variety of fresh carambola.

Additionally, carambola growers in Hawaii would benefit from the

opportunity to sell their product in a larger and more diverse market.

This proposed rule would enable carambola from Hawaii to be

irradiated at an existing irradiation facility on the mainland and is

not expected to impose additional costs on carambola producers in

Hawaii. We expect that carambola producers in Hawaii would benefit from

the proposed irradiation treatment because this treatment could deliver

better product quality, extended shelf life of the fruit, and cost

effective treatment of the fruit. However, the overall impact of the

carambola provisions of the proposed rule is expected to be

insignificant.

Litchis

Litchis are produced commercially on 257 farms in Hawaii. In 1993,

the United States produced about 770,000 pounds of litchi. Of that

total, approximately 85,000 pounds was produced in Hawaii.

Litchi farms with average annual revenues of less than $500,000 are

considered small. All litchi farms in Hawaii are considered small.

The litchi industry in Hawaii has been constrained by the lack of

an approved treatment for fruit flies since the cancellation of

ethylene dibromide in 1994. Approving irradiation treatment of litchis

on the mainland would be expected to stimulate growth of the industry

and provide access to the larger mainland market. No information is

available on the effect of approving inspection and hot water treatment

as an alternative method for moving litchis interstate.

[[Page 38112]]

The United States is a net importer of fresh litchi, with a total

import of about 165,000 pounds in 1994. In 1994, nearly 70 percent of

imported litchi came from Mexico; the remainder came from Israel. The

total supply of litchi on the mainland is about 850,000 pounds.

Wholesale prices of litchi range between $1.00 per pound and $4.50 per

pound.

The economic impact on mainland litchi growers and prices on the

mainland will not be significant. Even in the unlikely event that

Hawaii shipped 25 percent of its production to the mainland, supply

would increase by only about 2.3 percent. However, mainland consumers

would benefit from increased seasonal and regional availability, an

increased variety of fresh litchi, and stable prices. Additionally,

litchi growers in Hawaii would benefit from the increased opportunity

to sell their product in a larger and more diverse market.

According to recent research conducted by the ARS, irradiation

appears to be an effective treatment option that does not require

control of either fruit size or ripeness. Irradiation typically

requires only 40 minutes for treatment. The irradiation method may be

more cost effective depending on volume treated, because it costs only

about 5 to 12 cents per pound.

The proposed rule is expected to benefit producers, since

irradiation appears to offer a number of advantages over current

treatment options, including greater flexibility of fruit size and

ripeness, reduction in treatment time, improved effectiveness against

pest infestation, better product quality, extended shelf life, and

improved cost effectiveness. Consumers also could benefit from a better

quality product. The overall impact upon supply, price, and

competitiveness is expected to be insignificant.

This proposed rule contains paperwork requirements. Under this

proposed rule, a limited permit would be required for untreated

papayas, carambolas, and litchis moved interstate from Hawaii for

irradiation.

The alternative to this proposed rule would be to take no action.

We do not consider taking no action a reasonable alternative. Papayas,

carambolas, and litchis are not currently moved interstate from Hawaii

because of a lack of suitable treatment options. This proposed rule

would facilitate the interstate movement of papayas, carambolas, and

litchis from Hawaii while continuing to provide protection against the

spread of injurious plant pests from Hawaii to other parts of the

United States.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic

Assistance under No. 10.025 and is subject to Executive Order 12372,

which requires intergovernmental consultation with State and local

officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12778

This proposed rule has been reviewed under Executive Order 12778,

Civil Justice Reform. If this proposed rule is adopted: (1) All State

and local laws and regulations that are inconsistent with this rule

will be preempted; (2) no retroactive effect will be given to this

rule; and (3) administrative proceedings will not be required before

parties may file suit in court challenging this rule.

Paperwork Reduction Act

In accordance with section 3507(d) of the Paperwork Reduction Act

of 1995 (44 U.S.C. 3501 et seq.), the information collection or

recordkeeping requirements included in this proposed rule have been

submitted for approval to the Office of Management and Budget (OMB).

Please send written comments to the Office of Information and

Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,

DC 20503. Please state that your comments refer to Docket No. 95-069-1.

Please send a copy of your comments to: (1) Docket No. 95-069-1,

Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River

Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer,

OIRM, USDA, room 404-W, 14th Street and Independence Avenue SW.,

Washington, DC 20250. A comment to OMB is best assured of having its

full effect if OMB receives it within 30 days of publication of this

proposed rule.

We are proposing to increase the irradiation treatment dose