65FR34113 Irradiation Phytosanitary Treatment of Imported Fruits and Vegetables, Part 2/2
robop...@us.govnews.org
Posting-number: Volume 65, Issue 103, Page 34113, Part 1
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\6\ To adjust irradiation unit costs estimated in the 1994 study
from 1987 dollars to 1998 dollars, values are multiplied by a factor
of 1.23 (producer price index for capital equipment, series ID:
WPSSOP3200, Bureau of Labor Statistics, U.S. Dept. of Labor).
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Preshipment and quarantine uses of MB, along with critical
agricultural and emergency uses, are exempted from the MB phaseout
required by the Clean Air Act.\7\ These exemptions essentially segment
the MB market into restricted and unrestricted parts. Demand for MB
used for exempted purposes is expected to remain unaffected as its use
as a soil fumigant is restricted. However, reduced production due to
the phaseout may cause the price of MB used for phytosanitary purposes
to rise, due to an increase in the unit cost of production. Most MB in
the world is manufactured by only three companies, two in the United
States and one in Israel. Whether their economies of production can be
maintained will depend on the demand for MB for exempted purposes in
the United States and other developed countries, and overall demand in
developing countries (where final phaseout is scheduled under the
Montreal Protocol for 2015).
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\7\ Ten percent of methyl bromide used annually in agriculture
in the United States is for commodity and quarantine treatment,
compared to 85 percent for soil fumigation and 5 percent for
structural fumigation. The 1999 Omnibus Consolidated and Emergency
Supplemental Appropriations Act (Public Law 105-277) made specific
changes to the Clean Air Act, to harmonize the U.S. phaseout of
methyl bromide with the Montreal Protocol phaseout schedule for
developed countries. This schedule requires U.S. methyl bromide
production and importation reductions (from 1991 levels) of 25
percent in 1999, 50 percent in 2001, 70 percent in 2003, and 100
percent in 2005; exempted from this phaseout schedule are critical
agricultural, emergency, and preshipment and quarantine uses. With
respect to traded commodities, the amendment states that ``the [EPA]
Administrator shall exempt the production, importation, and
consumption of methyl bromide to fumigate commodities entering or
leaving the United States or any State (or political subdivision
thereof) for purposes of compliance with Animal and Plant Health
Inspection Service requirements * * * '' (www.epa.gov/ozone/mbr/
mbrqa.html).
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The demand for irradiation as a treatment alternative will be
influenced by product quality and phytotoxicity issues. Product shelf
life can be extended by irradiation. Moreover, some fruits and
vegetables that are damaged by fumigation or temperature-modifying
treatments are tolerant of irradiation. On the other hand, as indicated
above for grapes, some fruits and vegetables are considered not very
tolerant of irradiation. Assuming consumers accept irradiation as a
phytosanitary treatment, its use will be determined not only by the
availability of alternative treatments and relative costs but also by
its enhancing or diminishing effects on product quality.
When the latter range of unit costs (3.4 to 3.9 cents per pound)
are applied to fumigated quantities of 11 varieties of fruits imported
in fiscal year 1996 that have a high or medium tolerance of
irradiation, costs of irradiation treatment range, in 1998 dollars,
between $2.7 million and $3.1 million.\8\ Applying MB fumigation costs
assumed in the 1994 study, 0.6 to 1.2 cents per pound in 1998 dollars,
yields a total treatment cost of $0.5 million to $0.9 million for this
same set of imports. It is apparent that the use of irradiation for
phytosanitary purposes is probably not a cost-competitive alternative
to MB fumigation at present. However, the phaseout of MB as a soil
fumigant may result in an increase in its unit cost of production,
thereby making the cost of irradiation and other treatment alternatives
more competitive.
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\8\ The 11 fruits are apricot, banana/plantain, grapefruit,
orange, papaya, peach/nectarine, pineapple, plum, strawberry,
tangerine, and tomato. The combined weight of import shipments of
these fruits that were fumigated with MB in fiscal year 1996 was
approximately 78.3 million pounds. This represented only 2.43
percent, by weight, of total imports of these 11 fruits (see, op.
cit., ``Quarantine Uses of Methyl Bromide by the United States,
Fiscal Year 1996'' [Draft], Table 1). The range of costs is probably
underestimated, since it assumes economies of size would be captured
in all cases.
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Adopting this rule would broaden the choices among phytosanitary
treatment alternatives for U.S. fruit and vegetable importers. No net
societal gains and losses other than small price-related changes are
expected from this proposed rule if irradiation is used only to treat
fruits and vegetables that would have been imported otherwise using an
alternative treatment. Income earned by firms providing the irradiation
services would be income forgone by the displaced fumigators or other
treatment providers. But if irradiation enables importations that would
not otherwise occur, then societal gains (increased imports) could be
attributed to its phytosanitary use. Irradiation treatment most likely
will both serve as an alternative treatment for a fraction of current
imports and stimulate additional imports for certain fruits and
vegetables, such as papaya, that need to be treated for fruit flies and
have a high tolerance for irradiation.
Allowing irradiation to be used as a phytosanitary treatment for 11
fruit fly species and one seed weevil species would most immediately
benefit four firms, three of which are small entities, that currently
provide irradiation services on contract for sterilization and
decontamination purposes. Participation of these firms, and entry of
other firms, in the treatment of imported fruits and vegetables will
depend upon the demand that develops for irradiation in relation to
alternative treatments.
The major alternative to this proposed rule would be to not allow
these irradiation treatments. In that case, importers and irradiation
businesses would not accrue the benefits described above, and firms
providing existing treatment alternatives would continue operating as
at present (with MB fumigation becoming less competitive as its supply
is constrained).
This proposed rule contains various recordkeeping and reporting
requirements. These requirements are described in this document under
the heading ``Paperwork Reduction Act.''
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
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.
National Environmental Policy Act
An environmental assessment and finding of no significant impact
have
[[Page 34122]]
been prepared for this proposed rule. The assessment provides a basis
for the conclusion that the irradiation methods proposed in this rule
would not present a risk of introducing or disseminating plant pests
and would not have a significant impact on the quality of the human
environment. Based on the finding of no significant impact, the
Administrator of the Animal and Plant Health Inspection Service has
determined that an environmental impact statement need not be prepared.
The environmental assessment and finding of no significant impact
were prepared in accordance with: (1) The National Environmental Policy
Act of 1969, as amended (NEPA) (42 U.S.C. 4321 et seq.), (2)
regulations of the Council on Environmental Quality for implementing
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA
Implementing Procedures (7 CFR part 372).
Copies of the environmental assessment and finding of no
significant impact are available for public inspection 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 copies are requested to
call ahead on (202) 690-2817 to facilitate entry into the reading room.
In addition, copies may be obtained by writing to the individual listed
under FOR FURTHER INFORMATION CONTACT.
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. 98-030-1.
Please send a copy of your comments to: (1) Docket No. 98-030-1,
Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River
Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer,
OCIO, 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 authorize irradiation as a treatment for 11
species of fruit flies and one species of seed weevil in imported
fruits and vegetables. This proposal would facilitate the importation
of fruits and vegetables by giving importers another alternative to
currently approved treatments required for articles attacked by these
species of fruit flies and mango seed weevils.
Implementing this rule would necessitate the use of seven new
paperwork collection activities (in the form of a compliance agreement,
24-hour notification, labeling requirements, dosimetry recordings,
requests for dosimetry device approval, recordkeeping requirements, and
requests for facility approval).
Labeling requirements represent a substantial part of the paperwork
burden. The proposed rule would require that pallet loads of irradiated
fruits and vegetables be marked by irradiation facility personnel or by
the shipper 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. The burden of
this marking requirement would increase for importers who arrange to
have pallet loads broken apart into individual cartons before entry
into the United States, because, in such cases, individual cartons
would have to bear the required information to allow successful
traceback.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond, such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
Estimate of burden: Public reporting burden for this collection of
information is estimated to average .0825 hours per response.
Respondents: Irradiation facilities and shippers.
Estimated annual number of respondents: 125.
Estimated annual number of responses per respondent: 999.
Estimated annual number of responses: 124,885.
Estimated total annual burden on respondents: 10,305.
Copies of this information collection can be obtained from:
Clearance Officer, OCIO, USDA, Room 404-W, 14th Street and Independence
Avenue SW., Washington, DC 20250.
List of Subjects
7 CFR Part 305
Irradiation, Phytosanitary treatment, Plant diseases and pests,
Quarantine, Reporting and recordkeeping requirements.
7 CFR Part 319
Bees, Coffee, Cotton, Fruits, Honey, Imports, Logs, Nursery Stock,
Plant diseases and pests, Quarantine, Reporting and recordkeeping
requirements, Rice, Vegetables.
Accordingly, we propose to amend title 7, chapter III, of the Code
of Federal Regulations as follows:
1. A new part 305 would be added to read as follows:
PART 305--PHYTOSANITARY TREATMENTS
Sec.
305.1 Definitions.
305.2 Irradiation treatment of imported fruits and vegetables for
certain fruit flies and mango seed weevils.
Authority: 7 U.S.C. 150dd, 150ee, 150ff, 151-167, 450, 2803, and
2809; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.2(c).
Sec. 305.1 Definitions.
The following definitions apply for the purposes of this part:
Administrator. The Administrator, Animal and Plant Health
Inspection Service, United States Department of Agriculture, or any
person delegated to act for the Administrator in matters affecting this
part.
APHIS. The Animal and Plant Health Inspection Service, United
States Department of Agriculture.
Dose mapping. Measurement of absorbed-dose within a process load
using dosimeters placed at specified locations to produce a one-, two-,
or three-dimensional distribution of absorbed dose, thus rendering a
map of absorbed-dose values.
Dosimeter. A device that, when irradiated, exhibits a quantifiable
[[Page 34123]]
change in some property of the device that can be related to absorbed
dose in a given material using appropriate analytical instrumentation
and techniques.
Dosimetry system. A system used for determining absorbed dose,
consisting of dosimeters, measurement instruments and their associated
reference standards, and procedures for the system's use.
Sec. 305.2 Irradiation treatment of imported fruits and vegetables for
certain fruit flies and mango seed weevils.
(a) Approved doses. Irradiation at the following doses for the
specified fruit flies and seed weevils, carried out in accordance with
the provisions of this section, is approved as a treatment for all
fruits and vegetables:
Irradiation for Fruit Flies and Seed Weevils in Imported Fruits and
Vegetables
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Scientific name Common name Dose (gray)
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Bactrocera dorsalis............ Oriental fruit fly..... 250
Ceratitis capital.............. Mediterranean fruit fly 225
Bactrocera cucurbitae.......... Melon fly.............. 210
Anastrepha fraterculus......... South American fruit 150
fly.
Anastrepha suspensa............ Caribbean fruit fly.... 150
Anastrepha ludens.............. Mexican fruit fly...... 150
Anastrepha obliqua............. West Indian fruit fly.. 150
Anastrepha serpentina.......... Sapote fruit fly....... 150
Bactrocera tryoni.............. Queensland fruit fly... 150
Bactrocera jarvisi............. (No common name)....... 150
Bactrocera latifrons........... Malaysian fruit fly.... 150
Cryptorhynchus mangiferae...... Mango seed weevil...... 100
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(b) Location of facilities. Where certified irradiation facilities
are available, an approved irradiation treatment may be conducted for
any fruit or vegetable either prior to shipment to the United States or
in the United States. Irradiation facilities certified under this
section may be located in any State on the mainland United States
except Alabama, Arizona, California, Florida, Georgia, Kentucky,
Louisiana, Mississippi, Nevada, New Mexico, North Carolina, South
Carolina, Tennessee, Texas, and Virginia. Prior to treatment, the
fruits and vegetables to be irradiated may not move into or through any
of the States listed in this paragraph, except that movement is allowed
through Dallas/Fort Worth, Texas, as an authorized stop for air cargo,
or as a transloading location for shipments that arrive by air but that
are subsequently transloaded into trucks for overland movement from
Dallas/Fort Worth into an authorized State by the shortest route.
(c) Compliance agreement with importers and facility operators for
irradiation in the United States. If irradiation is conducted in the
United States, both the importer and the operator of the irradiation
facility must sign compliance agreements with the Administrator. In the
facility compliance agreement, the facility operator must agree to
comply with any additional requirements found necessary by the
Administrator to prevent the escape, prior to irradiation, of any fruit
flies that may be associated with the articles to be irradiated. In the
importer compliance agreement, the importer must agree to comply with
any additional requirements found necessary by the Administrator to
ensure the shipment is not diverted to a destination other than
treatment and to prevent escape of plant pests from the articles to be
irradiated during their transit from the port of first arrival to the
irradiation facility in the United States.
(d) Compliance agreement with irradiation facilities outside the
United States. If irradiation is conducted outside the United States,
the operator of the irradiation facility must sign a compliance
agreement with the Administrator and the plant protection service of
the country in which the facility is located. In this agreement, the
facility operator must agree to comply with the requirements of this
section, and the plant protection service of the country in which the
facility is located must agree to monitor that compliance and to inform
the Administrator of any noncompliance.
(e) Certified facility. The irradiation treatment facility must be
certified by the Administrator. Recertification is required in the
event of an increase or decrease in radioisotope, a major modification
to equipment that affects the delivered dose, or a change in the owner
or managing entity of the facility. Recertification also may be
required in cases where a significant variance in dose delivery has
been measured by the dosimetry system. In order to be certified, a
facility must:
(1) Be capable of administering the minimum absorbed ionizing
radiation doses specified in paragraph (a) of this section to the
fruits and vegetables; \1\
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\1\ The maximum absorbed ionizing radiation dose and the
irradiation of food is regulated by the Food and Drug Administration
under 21 CFR part 179.
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(2) Be constructed so as to provide physically separate locations
for treated and untreated fruits and vegetables, except that fruits and
vegetables traveling by conveyor directly into the irradiation chamber
may pass through an area that would otherwise be separated. The
locations must be separated by a permanent physical barrier such as a
wall or chain link fence 6 or more feet high to prevent transfer of
cartons.
(3) If the facility is located in the United States, the facility
will only be certified if the Administrator determines that regulated
articles will be safely transported to the facility from the port of
arrival without significant risk that plant pests will escape in
transit or while the regulated articles are at the facility.
(f) Treatment monitoring. Treatment must be monitored by an
inspector. This monitoring must include inspection of treatment records
and unannounced inspections of the facility by an inspector. Facilities
that carry out continual irradiation operations must notify an
inspector at least 24 hours before the date operations commence.\2\
Facilities that carry out periodic irradiation operations must notify
an inspector of scheduled operations at least 24 hours before scheduled
operations.
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\2\ Inspector means any employee of the Animal and Plant Health
Inspection Service, or other person, authorized by the Administrator
in accordance with law to enforce the provisions of the regulations
of this part. Inspectors are assigned to local offices of the Animal
and Plant Health Inspection Service, which are listed in telephone
directories.
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(g) Packaging. Fruits and vegetables that are irradiated in
accordance with
[[Page 34124]]
this section must be packaged in cartons in the following manner:
(1) All irradiated fruits and vegetables must be shipped in the
same cartons in which they are irradiated. Irradiated fruits and
vegetables may not be packaged for shipment in a carton with
nonirradiated fruits and vegetables.
(2) For all fruits and vegetables irradiated prior to arrival in
the United States:
(i) The fruits and vegetables to be irradiated must be packaged
either:
(A) In insect-proof cartons that have no openings that will allow
the entry of fruit flies. The cartons must be sealed with seals that
will visually indicate if the cartons have been opened. The cartons may
be constructed of any material that prevents the entry of fruit flies
and prevents oviposition by fruit flies into the articles in the
carton; \3\ or
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\3\ If there is a question as to the adequacy of a carton, send
a request for approval of the carton, together with a sample carton,
to the Animal and Plant Health Inspection Service, Plant Protection
and Quarantine, Oxford Plant Protection Center, 901 Hillsboro
Street, Oxford, NC 27565.
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(B) In noninsect-proof cartons that are stored immediately after
irradiation in a room completely enclosed by walls or screening that
completely precludes access by fruit flies. If stored in noninsect-
proof cartons in a room that precludes access by fruit flies, prior to
leaving the room each pallet of cartons must be completely enclosed in
polyethylene, shrink-wrap, or another solid or netting covering that
completely precludes access to the cartons by fruit flies.
(ii) To preserve the identity of treated lots, each pallet-load of
cartons containing the fruits and vegetables must be wrapped before
leaving the irradiation facility in one of the following ways:
(A) With polyethylene shrink wrap;
(B) With net wrapping; or
(C) With strapping so that each carton on an outside row of the
pallet load is constrained by a metal or plastic strap.
(iii) Packaging must be labeled with treatment lot numbers, packing
and treatment facility identification and location, and dates of
packing and treatment. Pallets that remain intact as one unit until
entry into the United States may have one such label per pallet.
Pallets that are broken apart into smaller units prior to or during
entry into the United States must have the required label information
on each individual carton.
(h) Dosimetry systems at the irradiation facility. (1) Dosimetry
mapping must indicate the doses needed to ensure that all the commodity
will receive the minimum dose prescribed.
(2) Absorbed dose must be measured using an accurate dosimetry
system that ensures that the absorbed dose meets or exceeds the
absorbed dose required by paragraph (a) of this section (150, 210, 225,
or 250 Gray, depending on the target species of fruit fly).
(3) The utilization of the dosimetry system, including the number
and placement of dosimeters used, must be in accordance with American
Society for Testing and Materials (ASTM) standards.\4\
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\4\ 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.
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(i) Records. An irradiation processor must maintain records of each
treated lot for 1 year following the treatment date and must make these
records available for inspection by an inspector during normal business
hours (8 a.m. to 4:30 p.m., Monday through Friday, except holidays).
These records must 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.
(j) Request for certification and inspection of facility. Persons
requesting certification of an irradiation treatment facility must
submit the request for approval in writing to the Animal and Plant
Health Inspection Service, Plant Protection and Quarantine, Oxford
Plant Protection Center, 901 Hillsboro Street, Oxford, NC 27565. The
initial request must identify the owner, location, and radiation source
of the facility, and the applicant must supply additional information
about the facility construction, treatment protocols, and operations
upon request by APHIS if APHIS requires additional information to
evaluate the request. Before the Administrator determines whether an
irradiation facility is eligible for certification, an inspector will
make a personal inspection of the facility to determine whether it
complies with the standards of this section.
(k) Denial and withdrawal of certification. (1) The Administrator
will withdraw the certification of any irradiation treatment facility
upon written request from the irradiation processor.
(2) The Administrator will deny or withdraw certification of an
irradiation treatment facility when any provision of this section is
not met. Before withdrawing or denying certification, the Administrator
will inform the irradiation processor in writing of the reasons for the
proposed action and provide the irradiation processor with an
opportunity to respond. The Administrator will give the irradiation
processor an opportunity for a hearing regarding any dispute of a
material fact, in accordance with rules of practice that will be
adopted for the proceeding. However, the Administrator will suspend
certification pending final determination in the proceeding if he or
she determines that suspension is necessary to prevent the spread of
any dangerous insect. The suspension will be effective upon oral or
written notification, whichever is earlier, to the irradiation
processor. In the event of oral notification, written confirmation will
be given to the irradiation processor within 10 days of the oral
notification. The suspension will continue in effect pending completion
of the proceeding and any judicial review of the proceeding.
(l) Department not responsible for damage. This treatment is
approved to assure quarantine security against the listed fruit flies.
From the literature available, the fruits and vegetables authorized for
treatment under this section are believed tolerant to the treatment;
however, the facility operator and shipper are responsible for
determination of tolerance. The Department of Agriculture and its
inspectors assume no responsibility for any loss or damage resulting
from any treatment prescribed or monitored. Additionally, the Nuclear
Regulatory Commission is responsible for ensuring that irradiation
facilities are constructed and operated in a safe manner. Further, the
Food and Drug Administration is responsible for ensuring that
irradiated foods are safe and wholesome for human consumption.
PART 319--FOREIGN QUARANTINE NOTICES
2. The authority citation for part 319 would continue to read as
follows:
Authority: 7 U.S.C. 150dd, 150ee, 150ff, 151-167, 450, 2803, and
2809; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.2(c).
3. In Sec. 319.56-2, a new paragraph (k) would be added to read as
follows:
Sec. 319.56-2 Restrictions on entry of fruits and vegetables.
* * * * *
(k) Any fruit or vegetable that is required by this subpart or the
Plant Protection and Quarantine Treatment Manual to be treated or
subjected to other growing or inspection requirements to control one or
more of the 11 species of fruit flies and one
[[Page 34125]]
species of seed weevil listed in Sec. 305.2(a) of this chapter as a
condition of entry into the United States may instead be treated by
irradiation in accordance with part 305 of this chapter.
4. In Sec. 319.56-2x, paragraph (a), the introductory text
preceding the table would be revised to read as follows:
Sec. 319.56-2x Administrative instructions; conditions governing the
entry of certain fruits and vegetables for which treatment is required.
(a) The following fruits and vegetables may be imported into the
United States only if they have been treated in accordance with the
Plant Protection and Quarantine (PPQ) Treatment Manual, which is
incorporated by reference at Sec. 300.1 of this chapter. Treatment by
irradiation in accordance with part 305 of this chapter may be
substituted for treatments in the PPQ Treatment Manual for the mango
seed weevil Cryptorhynchus mangiferae or for one or more of the
following 11 species of fruit flies: Anastrepha ludens, Anastrepha
obliqua, Anastrepha serpentina, Anastrepha suspensa, Bactrocera
cucurbitae, Bactrocera dorsalis, Bactrocera tryoni, Bactrocera jarvisi,
Bactrocera latifrons, and Ceratitis capitata.
* * * * *
Done in Washington, DC, this 23rd day of May 2000.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-13291 Filed 5-25-00; 8:45 am]
BILLING CODE 3410-34-U