[Federal Register Volume 68, Number 38 (Wednesday, February 26, 2003)]
[Rules and Regulations]
[Pages 8817-8820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-4526]



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 Rules and Regulations
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  Federal Register / Vol. 68, No. 38 / Wednesday, February 26, 2003 / 
Rules and Regulations  

[[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 [email protected]. 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]
BILLING CODE 3410-34-P