[Federal Register: February 26, 2003 (Volume 68, Number 38)]
[Rules and Regulations]
[Page 8817-8820]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26fe03-1]
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Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
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[[Page 8817]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 301
[Docket No. 02-129-2]
Mexican Fruit Fly; Treatments
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Interim rule and request for comments.
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SUMMARY: We are amending the Mexican fruit fly regulations to allow the
use of irradiation as a treatment for fruits listed as regulated
articles. This action will provide an additional option for qualifying
those regulated articles for movement from regulated areas.
DATES: This interim rule was effective February 20, 2003. We will
consider all comments that we receive on or before April 28, 2003.
ADDRESSES: You may submit comments by postal mail/commercial delivery
or by e-mail. If you use postal mail/commercial delivery, please send
four copies of your comment (an original and three copies) to: Docket
No. 02-129-2, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. 02-129-2. If you use e-mail,
address your comment to regulations@aphis.usda.gov. Your comment must
be contained in the body of your message; do not send attached files.
Please include your name and address in your message and ``Docket No.
02-129-2'' on the subject line.
You may read any comments that we receive on this docket in our
reading room. The reading room is located in room 1141 of the USDA
South Building, 14th Street and Independence Avenue SW., Washington,
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through
Friday, except holidays. To be sure someone is there to help you,
please call (202) 690-2817 before coming.
APHIS documents published in the Federal Register, and related
information, including the names of organizations and individuals who
have commented on APHIS dockets, are available on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Mr. Stephen A. Knight, Senior Staff
Officer, PPQ, APHIS, 4700 River Road Unit 134, Riverdale, MD 20737-
1236; (301) 734-8247.
SUPPLEMENTARY INFORMATION: The Mexican fruit fly (Anastrepha ludens) is
a destructive pest of citrus and many other types of fruit. The short
life cycle of the Mexican fruit fly allows rapid development of serious
outbreaks that can cause severe economic losses in commercial citrus-
producing areas.
The Mexican fruit fly regulations, contained in 7 CFR 301.64
through 301.64-10 (referred to below as the regulations), were
established to prevent the spread of the Mexican fruit fly to
noninfested areas of the United States. The regulations impose
restrictions on the interstate movement of regulated articles from the
regulated areas.
We are amending the Mexican fruit fly regulations to include
irradiation as a treatment for those fruits that are listed as
regulated articles in Sec. 301.64-2(a) of the regulations. Without
irradiation, the only treatments for fruit made available by the
regulations have been cold treatment, fumigation, or high-temperature
forced air, and those treatments have been made available for only some
of the fruits listed as regulated articles. The addition of irradiation
provides a treatment option for use on those regulated articles for
which treatments have been available, as well as for those regulated
articles for which no treatments have been listed in the regulations.
To accommodate the inclusion of irradiation as an authorized
treatment under the Mexican fruit fly regulations, we are amending
Sec. 301.64-10, ``Treatments,'' by adding the irradiation provisions
as a new paragraph (g).
The provisions we are adding to the Mexican fruit fly regulations
for the use of irradiation as a treatment are, for all practical
purposes, the same as those provided in Sec. 301.78-10(c) of
``Subpart-Mediterranean Fruit Fly'' (7 CFR 301.78 through 318.78-10),
which provides for the use of irradiation as a treatment for nuts,
berries, fruits, and vegetables grown in areas quarantined because of
the Mediterranean fruit fly (Ceratitis capitata). The irradiation
provisions we have added to the Mexican fruit fly regulations differ
from those of Sec. 301.78-10(c) in only two substantive respects: (1)
The pest (A. ludens rather than C. capitata) and commodities for which
irradiation is an approved treatment and (2) the prescribed irradiation
dose rate. These two differences are discussed below.
With respect to the first difference cited above-the commodities
for which irradiation is an authorized treatment-the irradiation
provisions we are adding to the Mexican fruit fly regulations will
provide for the use of irradiation to treat several commodities that
are listed as regulated articles in the Mexican fruit fly regulations
that are not also listed as regulated articles under the Mediterranean
fruit fly regulations. Those additional commodities are as follows:
Cherimoya (Annona cherimola)
Custard apple (Annona reticulata)
Mamey (Mammea americana)
Sapota, Sapodilla (Sapotaceae)
Sargentia, yellow chapote (Sargentia greggii)
Spanish plum, purple mombin or Ciruela (Spondias spp.)
As noted in APHIS' policy statement regarding the application of
irradiation to phytosanitary problems (published in the Federal
Register on May 15, 1996, 61 FR 24433-24439, Docket No. 95-088-1), the
U.S. Department of Agriculture's (USDA's) Agricultural Research Service
(ARS) conducted exhaustive research to determine commodity-generic
irradiation dose rates that will provide an acceptable level of
quarantine security with regard to certain pests. Given that a
commodity-generic dose rate has been established for Mexican fruit fly,
we believe that it is appropriate to provide the prescribed irradiation
treatment as an option for growers of any of the fruits listed as
regulated articles in Sec. 301.64-2(a) who wish to obtain
certification for the interstate movement of their commodities on the
basis of treatment.
[[Page 8818]]
The second difference cited above pertains to the prescribed
irradiation dose rate. The commodity-generic dose rate established by
ARS for Mexican fruit fly is 150 Gray (15 krad), so we have established
150 Gray as the prescribed dose rate in the Mexican fruit fly
regulations, rather than the 225 Gray (22.5 krad) prescribed in Sec.
301.78-10(c) of the Mediterranean fruit fly regulations.
The remaining provisions of Sec. 301.78-10(c) of the Mediterranean
fruit fly regulations--i.e., those provisions regarding approved
facilities, treatment monitoring, packaging, dosimetry systems,
certification based on treatment, recordkeeping, requests for approval
and inspection of facilities, denial and withdrawal of approval, and
the USDA's non-responsibility for loss or damage resulting from
treatment--have been carried over to Sec. 301.64-10(g) of the Mexican
fruit fly regulations and serve the same purpose as in Sec. 301.78-
10(c).
Emergency Action
This rulemaking is necessary on an emergency basis to provide an
additional option for qualifying regulated articles for movement from
regulated areas. Under these circumstances, the Administrator has
determined that prior notice and opportunity for public comment are
contrary to the public interest and that there is good cause under 5
U.S.C. 553 for making this rule effective less than 30 days after
publication in the Federal Register.
We will consider comments we receive during the comment period for
this interim rule (see DATES above). After the comment period closes,
we will publish another document in the Federal Register. The document
will include a discussion of any comments we receive and any amendments
we are making to the rule.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. For this
action, the Office of Management and Budget has waived its review under
Executive Order 12866.
This rule amends the Mexican fruit fly regulations by allowing the
use of irradiation as a treatment for fruits listed as regulated
articles. This action will provide an additional option for qualifying
those regulated articles for movement from regulated areas.
This emergency situation makes timely compliance with section 604
of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) impracticable.
We are currently assessing the potential economic effects of this
action on small entities. Based on that assessment, we will either
certify that the rule will not have a significant economic impact on a
substantial number of small entities or publish a final regulatory
flexibility analysis.
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 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts all State and local laws and
regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(j) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection and
recordkeeping requirements included in this interim rule have been
submitted for emergency approval to the Office of Management and Budget
(OMB). OMB has assigned control number 0579-0215 to the information
collection and recordkeeping requirements.
We plan to request continuation of that approval for 3 years.
Please send written comments on the 3-year approval request to the
following addresses: (1) Office of Information and Regulatory Affairs,
OMB, Attention: Desk Officer for APHIS, Washington, DC 20503; and (2)
Docket No. 02-129-2, Regulatory Analysis and Development, PPD, APHIS,
Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238.
Please state that your comments refer to Docket No. 02-129-2 and send
your comments within 60 days of publication of this rule.
This interim rule allows for the use of irradiation as a treatment
for those fruits that are listed as regulated articles in Sec. 301.64-
2(a) of the regulations. This action provides an additional option for
qualifying regulated articles for movement from regulated areas. Any
person engaged in the business of growing, handling, or moving
regulated articles may enter into a compliance agreement to facilitate
the movement of regulated articles under Sec. 301.64-6. The compliance
agreement is a written agreement between a person engaged in those
previously mentioned activities and Plant Protection and Quarantine,
wherein the person agrees to comply with the provisions set forth in
Sec. 301.64-6. We are soliciting comments from the public (as well as
affected agencies) concerning our information collection and
recordkeeping requirements. These comments will help us:
(1) Evaluate whether the 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
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 .6399 hours per response.
Respondents: Growers and State plant regulatory officials.
Estimated annual number of respondents: 722.
Estimated annual number of responses per respondent: 1.
Estimated annual number of responses: 722.
Estimated total annual burden on respondents: 462 hours. (Due to
averaging, the total annual burden hours may not equal the product of
the annual number of responses multiplied by the reporting burden per
response.)
Copies of this information collection can be obtained from Mrs.
Celeste Sickles, APHIS' Information Collection Coordinator, at (301)
734-7477.
Government Paperwork Elimination Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the Government Paperwork Elimination Act (GPEA), which
requires Government agencies in general to provide the public the
option of submitting information or transacting business electronically
to the maximum extent possible. For information pertinent to GPEA
compliance related to this interim rule, please contact Mrs. Celeste
Sickles, APHIS' Information
[[Page 8819]]
Collection Coordinator, at (301) 734-7477.
List of Subjects in 7 CFR Part 301
Agricultural commodities, Plant diseases and pests, Quarantine,
Reporting and recordkeeping requirements, Transportation.
Accordingly, we are amending 7 CFR part 301 as follows:
PART 301--DOMESTIC QUARANTINE NOTICES
1. The authority citation for part 301 continues to read as
follows:
Authority: 7 U.S.C. 7711, 7712, 7714, 7731, 7735, 7751, 7752,
7753, 7754, and 7760; 7 CFR 2.22, 2.80, and 371.3.
Section 301.75-15 also issued under Sec. 204, Title II, Pub. L.
106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 also
issued under Sec. 203, Title II, Pub. L. 106-224, 114 Stat. 400 (7
U.S.C. 1421 note).
2. In Sec. 301.64-10, a new paragraph (g) is added to read as
follows:
Sec. 301.64-10 Treatments.
* * * * *
(g) Approved irradiation treatment. Irradiation, carried out in
accordance with the provisions of this paragraph, is approved as a
treatment for any fruit listed as a regulated article in Sec. 301.64-
2(a).
(1) Approved facility. The irradiation treatment facility and
treatment protocol must be approved by the Animal and Plant Health
Inspection Service. In order to be approved, a facility must:
(i) Be capable of administering a minimum absorbed ionizing
radiation dose of 150 Gray (15 krad) to the fruit; \8\
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\8\ The maximum absorbed ionizing radiation dose and the
irradiation of food are regulated by the Food and Drug
Administration under 21 CFR part 179.
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(ii) Be constructed so as to provide physically separate locations
for treated and untreated fruit, except that fruit 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;
(iii) Complete a compliance agreement with the Animal and Plant
Health Inspection Service as provided in Sec. 301.64-6; and
(iv) Be certified by Plant Protection and Quarantine for initial
use and annually for subsequent use. Recertification is required in the
event that an increase or decrease in radioisotope or a major
modification to equipment that affects the delivered dose.
Recertification may be required in cases where a significant variance
in dose delivery is indicated.
(2) Treatment monitoring. Treatment must be carried out under the
monitoring of an inspector. This monitoring must include inspection of
treatment records and unannounced inspection visits to the facility by
an inspector. Facilities that carry out continual irradiation
operations must notify an inspector at least 24 hours before the date
of operations. Facilities that carry out periodic irradiation
operations must notify an inspector of scheduled operations at least 24
hours before scheduled operations.\9\
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\9\ Inspectors are assigned to local offices of the Animal and
Plant Health Inspection Service, which are listed in telephone
directories.
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(3) Packaging. Fruits and vegetables that are treated within a
quarantined area must be packaged in the following manner:
(i) The cartons must have no openings that will allow the entry of
fruit flies and must be sealed with seals that will visually indicate
if the cartons have been opened. They may be constructed of any
material that prevents the entry of fruit flies and prevents
oviposition by fruit flies into the fruit in the carton.\10\
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\10\ 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 St.,
Oxford, NC 27565.
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(ii) The pallet-load of cartons must be wrapped before it leaves
the irradiation facility in one of the following ways:
(A) With polyethylene sheet 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.
(4) Dosage. The fruits and vegetables must receive a minimum
absorbed ionizing radiation dose of 150 Gray (15 krad).\11\
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\11\ See footnote 8.
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(5) Dosimetry systems. (i) Dosimetry mapping must indicate the dose
needed to ensure the fruit will receive the minimum dose prescribed.
(ii) Absorbed dose must be measured using an accurate dosimetry
system that ensures that the absorbed dose meets or exceeds 150 Gray
(15 krad).
(iii) When designing the facility's dosimetry system and procedures
for its operation, the facility operator must address guidance and
principles from American Society for Testing and Materials (ASTM)
standards.\12\
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\12\ Designation ISO/ASTM 51261-2002(E), ``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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(6) Records. Records or invoices for each treated lot must be made
available for inspection by an inspector during normal business hours
(8 a.m. to 4:30 p.m., Monday through Friday, except holidays). An
irradiation processor must maintain records as specified in this
section for a period of time that exceeds the shelf life of the
irradiated food product by 1 year, and must make these records
available for inspection by an inspector. 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.
(7) Request for approval and inspection of facility. Persons
requesting approval of an irradiation treatment facility and treatment
protocol 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 St., Oxford, NC 27565.
Before the Administrator determines whether an irradiation facility is
eligible for approval, an inspector will make a personal inspection of
the facility to determine whether it complies with the standards of
paragraph (g)(1) of this section.
(8) Denial and withdrawal of approval. (i) The Administrator will
withdraw the approval of any irradiation treatment facility when the
irradiation processor requests in writing the withdrawal of approval.
(ii) The Administrator will deny or withdraw approval of an
irradiation treatment facility when any provision of this section is
not met. Before withdrawing or denying approval, 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
approval pending final determination in the proceeding, if he or she
determines that suspension is necessary to prevent the spread of any
dangerous insect infestation. The suspension will be effective upon
oral
[[Page 8820]]
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.
(9) Department not responsible for damage. This treatment is
approved to assure quarantine security against Mediterranean fruit fly.
From the literature available, the fruits 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 supervised. 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.
(Approved by the Office of Management and Budget under control
number 0579-0215.)
Done in Washington, DC, this 20th day of February 2003.
Bobby R. Acord,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-4526 Filed 2-25-03; 8:45 am]
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