[Federal Register Volume 74, Number 90 (Tuesday, May 12, 2009)]
[Proposed Rules]
[Pages 22318-22345]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-10188]



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Part III





Department of Agriculture





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Animal and Plant Health Inspection Service



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7 CFR Parts 301, 305, 318, et al.



Phytosanitary Treatments; Location of and Process for Updating 
Treatment Schedules; Proposed Rule

  Federal Register / Vol. 74, No. 90 / Tuesday, May 12, 2009 / Proposed 
Rules  

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 301, 305, 318, 319, 330, and 352

[Docket No. APHIS-2008-0022]
RIN 0579-AC94


Phytosanitary Treatments; Location of and Process for Updating 
Treatment Schedules

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to revise the phytosanitary treatment 
regulations in 7 CFR part 305 by removing the lists of approved 
treatments and treatment schedules from the regulations, while 
retaining the general requirements for performing treatments and 
certifying or approving treatment facilities. We would remove treatment 
schedules from other places where they are currently found in 7 CFR 
chapter III as well. Approved treatment schedules would instead be 
found in the Plant Protection and Quarantine Treatment Manual, which is 
available on the Internet. We are also proposing to establish a new 
process to provide the public with notice and the opportunity to 
comment on changes to treatment schedules. Finally, we would harmonize 
and combine the requirements for performing irradiation treatment for 
imported articles, articles moved interstate from Hawaii and U.S. 
territories, and articles moved interstate from an area quarantined for 
fruit flies. These changes would simplify and expedite our processes 
for adding, changing, and removing treatment schedules while continuing 
to provide for public participation in the process. These changes would 
also simplify our presentation of treatments to the public by 
consolidating all treatments into one document and eliminating 
redundant text from the regulations.

DATES: We will consider all comments that we receive on or before July 
13, 2009.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0022 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2008-0022, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2008-0022.
    Reading Room: 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.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Inder P. S. Gadh, Senior Risk 
Manager-Treatments, Regulations, Permits, and Manuals, PPQ, APHIS, 4700 
River Road Unit 133, Riverdale, MD 20737-1236; (301) 734-8758.

SUPPLEMENTARY INFORMATION: 

Background

    The regulations in 7 CFR chapter III are intended, among other 
things, to prevent the introduction or dissemination of plant pests and 
noxious weeds into or within the United States. Under the regulations, 
certain plants, fruits, vegetables, and other articles must be treated 
before they may be moved into the United States or interstate. The 
phytosanitary treatments regulations contained in part 305 of 7 CFR 
chapter III (referred to below as the regulations) set out standards 
and schedules for treatments required in parts 301, 318, and 319 of 7 
CFR chapter III for fruits, vegetables, and other articles.
    Broadly speaking, the regulations in part 305 contain four types of 
provisions:
     General requirements to follow approved treatment 
schedules and provisions for monitoring and certifying treatments.
     Lists of approved treatments for fruits, vegetables, and 
other articles. These are currently contained in Sec.  305.2. Entries 
in the lists of approved treatments include the article in question, 
the pests of concern, and the treatment approved to neutralize those 
pests for that article. For fruits and vegetables, whose approved 
treatments are listed in paragraph (h) of Sec.  305.2, entries in the 
lists also include the country or area of origin of the fruit or 
vegetable for which treatment is approved.
     General requirements for each type of treatment (chemical 
treatment, heat treatment, cold treatment, etc.). These include 
requirements for treatment facility construction, certifying or 
approving treatment facilities, and performing and monitoring 
treatments. These requirements are contained at the beginning of 
treatment-specific subparts. For example, ``Subpart--Chemical 
Treatments'' begins with a section (Sec.  305.5) that sets out 
requirements for facilities performing chemical treatments, general 
chemical treatment procedures, and requirements for monitoring chemical 
treatments.
     Treatment schedules. For example, in ``Subpart--Chemical 
Treatments,'' Sec.  305.6 contains various methyl bromide fumigation 
treatment schedules, which set out the required pressure, temperature, 
dosage rate, and exposure period for each schedule. Some treatment 
schedules are also found elsewhere in 7 CFR chapter III. For example, 
some treatment schedules for logs, lumber, and other unmanufactured 
wood articles are contained in Sec.  319.40-7.
    Most of the phytosanitary treatments authorized by the Animal and 
Plant Health Inspection Service (APHIS) and listed in part 305 are also 
contained in the Plant Protection and Quarantine (PPQ) Treatment 
Manual. Among other things, the PPQ Treatment Manual contains 
approximately 400 treatment schedules, detailed instructions for 
administering the treatments, and requirements for certification of 
facilities that administer the treatments. The PPQ Treatment Manual may 
be found on the Internet at http://www.aphis.usda.gov/import_export/plants/manuals/ports/treatment.shtml.
    We are proposing to remove the lists of authorized treatments and 
treatment schedules from the regulations, while retaining the general 
requirements for performing treatments and certifying or approving 
treatment facilities. We would remove treatment schedules from other 
places where they are currently found in parts 301 and 319 as well. 
Treatment schedules in those parts that are not currently found in the 
PPQ Treatment Manual would be added to it, and the PPQ Treatment Manual 
would serve as the official reference for all approved treatment 
schedules. The inclusion of a treatment schedule in the PPQ Treatment 
Manual would indicate that the treatment was approved, making the 
inclusion of separate lists of approved treatments in the regulations 
unnecessary.

[[Page 22319]]

    The general requirements to follow approved treatment schedules and 
the specific provisions for monitoring and certification would be 
retained in the regulations. The regulations would refer the reader to 
the PPQ Treatment Manual as the source for approved treatment 
schedules. We would also retain the general requirements for each type 
of treatment in part 305.
    We are also proposing to establish a new process to make changes to 
the lists of approved treatments and the treatment schedules that would 
be contained in the Treatment Manual. Rather than making changes 
through the rulemaking process, as is necessary for treatments listed 
in the regulations, we would publish notices in the Federal Register to 
inform the public of the change we are proposing and to solicit 
comments. Following the close of the comment period, we would also 
publish notices to inform the public of our decision.
    The regulations in Sec.  319.56-4(c)(2) set out a process by which 
APHIS can authorize the importation of fruits and vegetables through 
the publication of notices in the Federal Register. This process can be 
used if a pest risk analysis is completed and APHIS makes the 
determination that the application of one or more of the designated 
phytosanitary measures listed in paragraph (b) of Sec.  319.56-4 is 
sufficient to mitigate the risk that plant pests or noxious weeds could 
be introduced into or disseminated within the United States via the 
imported fruits or vegetables. One of the measures listed in paragraph 
(b) is treatment in accordance with part 305. Imports are authorized 
through this process by announcing, through the publication of a notice 
in the Federal Register, the availability of the pest risk analysis and 
the Administrator's determination that the application of one or more 
of the designated measures is sufficient to address the risk. A 
subsequent notice may then be issued to announce our intent to issue a 
permit to authorize importation of the commodity.
    However, the current structure of part 305 often makes it 
impossible to use the notice-based process for authorizing the 
importation of fruits and vegetables in Sec.  319.56-4 if one of the 
designated measures to address pest risk is a phytosanitary treatment. 
As noted earlier, in the lists of authorized treatments for imported 
fruits and vegetables in Sec.  305.2(h)(2)(i), fruits and vegetables 
are listed by their country of origin. This is inappropriate because 
the country of origin of a fruit or vegetable does not necessarily 
affect the efficacy of a treatment at neutralizing the pest associated 
with that fruit or vegetable. For example, we would expect the cold 
treatment schedule CT T107-a to be effective at neutralizing the 
Mediterranean fruit fly (Ceratitis capitata) in grapes from any 
country, and it is currently listed as an approved treatment for that 
pest for grapes from several countries. The PPQ Treatment Manual 
recognizes this principle; it does not typically include countries in 
its lists of commodities, pests, and approved treatments.\1\ As part of 
this proposed action, we would also remove any specific country 
designations on treatments in the PPQ Treatment Manual, except when 
country-specific circumstances or lack of data on a treatment's 
efficacy have led us to approve a treatment only for a specific 
country-commodity-pest combination.
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    \1\ PPQ maintains a separate database, the Fruits and Vegetables 
Import Requirements database, that provides information about 
countries from which the importation of fruits and vegetables is 
approved and, among other things, any treatments that may be 
required. This database is available at http://www.aphis.usda.gov/import_export/plants/plant_imports/quarantine_56/favir.shtml.
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    Currently, to approve the use of a treatment for a fruit or 
vegetable from a new country that is affected by a pest for which there 
is an approved treatment, we must amend the regulations in part 305. To 
authorize the importation of grapes from a new country subject to 
treatment with CT T107-a for Mediterranean fruit fly, we would need to 
undertake rulemaking to add the new country to the list in Sec.  
305.2(h)(2)(i) as a country from which grapes may be treated with CT 
T107-a, even though we could otherwise authorize the importation of 
those grapes through the notice-based process in Sec.  319.56-4.
    Similarly, countries requesting that we allow the importation of a 
commodity sometimes provide efficacy data on treatments for pests 
prevalent in that country. Reviewing this information often allows us 
to develop a treatment schedule to neutralize those pests. For example, 
Australia could submit data on the efficacy of cold treatment for fruit 
flies in strawberries, a commodity for which we currently have no 
approved treatment schedules, as part of a request that we approve the 
importation of strawberries from Australia. If treatment was one of the 
phytosanitary measures we determined to be necessary to mitigate the 
risk associated with strawberries from Australia, strawberries from 
Australia would not be eligible for the notice-based process in Sec.  
319.56-4 until the new treatment schedule was added through rulemaking. 
We currently have no means to add a new approved treatment schedule 
except through the rulemaking process.
    In both of the cases described above, establishing a notice-based 
process to amend the lists of approved treatments and treatment 
schedules would enable additional use of the streamlined process in 
Sec.  319.56-4 to authorize the importation of fruits and vegetables. 
As APHIS pursues the use of streamlined processes for approving the 
movement of other commodities in the future, we expect that we would 
need to approve new treatments.
    In this proposal, we would also establish a process by which we 
could make immediate changes to the lists of approved treatments and to 
the treatment schedules, also through publishing notices in the Federal 
Register. We would only use the process for making immediate changes in 
certain circumstances, which would be listed in the regulations.
    When we discover pests that have not been neutralized after an 
article has been treated for those pests, we may make immediate changes 
to the relevant treatment schedule to ensure its continued 
effectiveness (unless we determine that the treatment has not been 
correctly applied, in which case we take other actions). We may also 
need to remove a treatment schedule if it cannot be adjusted to make it 
effective, and in some cases we may need to add a new one in its place 
to allow trade in a commodity to continue. In addition, treatment 
schedules developed for certain conditions may become difficult to 
administer if those circumstances change; there may be a simple 
adjustment that can be made to the treatment schedule that will ensure 
that it can still be administered, without affecting its efficacy. 
Finally, the use of certain treatments, particularly chemical 
treatments, is dependent on the authorization of other Federal 
agencies, and we may need to withdraw certain treatment schedules 
immediately if those treatments are no longer authorized.
    The Plant Protection Act (7 U.S.C. 7701 et seq.) provides APHIS 
with the necessary statutory authority to take some of these actions 
immediately, and we will do so whenever necessary to ensure that 
treatments are effective at neutralizing plant pests. In addition, we 
would not allow treatments to be performed if another Federal agency 
does not permit them to be performed; the chemical treatment 
regulations in current Sec.  305.5(c)(1) make this clear by stating 
that if the U.S. Environmental Protection Agency (EPA) cancels approval 
for the use of a pesticide on a commodity, then the treatment schedule

[[Page 22320]]

prescribed in the PPQ Treatment Manual is no longer authorized for that 
commodity. Having a notice-based process in place for making immediate 
changes to the lists of approved treatments or to the treatment 
schedules would ensure that the PPQ Treatment Manual contains only 
approved treatment schedules, ensure that our decisionmaking processes 
are transparent, and give the public an opportunity to provide input on 
changes to the PPQ Treatment Manual.
    In addition to approved treatment schedules, the PPQ Treatment 
Manual contains other information, such as the procedures for 
performing certain types of treatments (e.g., fumigation under a 
tarpaulin). Under this proposal, only the approved treatment schedules 
in the PPQ Treatment Manual, including information such as the 
temperature, duration, dose, or end point of the treatment, would need 
to be amended using the notice-based process described in this 
proposal. Other information in the PPQ Treatment Manual, such as the 
detailed information on treatment preparation, administering 
treatments, facility construction, and compliance with other applicable 
Federal regulations, would be amended without requesting comment from 
the public, as is the case now.

Changes to 7 CFR Part 305

    Much of part 305 would be removed under this proposal. We are 
providing a distribution table and a derivation table below to give the 
reader an overview of the changes we are proposing. Those changes are 
discussed in detail directly after the tables.

                                 Table 1--Distribution of Current 7 CFR Part 305
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       Current section          Section title (subject)          New location                  Comments
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305.1.......................  Definitions...............  305.1.....................  Changes made to section to
                                                                                       reflect removal of
                                                                                       schedules, references to
                                                                                       PPQ Treatment Manual.
305.2.......................  Approved treatments.......  Paragraph (a) remains in    Some changes.
                                                           305.2; rest added to PPQ
                                                           Treatment Manual.
305.3.......................  Monitoring and              305.4.....................  Some changes.
                               certification of
                               treatments.
305.5.......................  Treatment requirements      305.5.....................  Updates to refer to PPQ
                               (chemical treatments).                                  Treatment Manual.
305.6.......................  Methyl bromide fumigation   PPQ Treatment Manual......
                               treatment schedules.
305.7.......................  Phosphine treatment         PPQ Treatment Manual......
                               schedules.
305.8.......................  Sulfuryl fluoride           PPQ Treatment Manual......
                               treatment schedules.
305.9.......................  Aerosol spray for aircraft  PPQ Treatment Manual......
                               treatment schedules.
305.10......................  Treatment schedules for     PPQ Treatment Manual......
                               combination treatments.
305.11......................  Miscellaneous chemical      PPQ Treatment Manual......
                               treatments.
305.15......................  Treatment requirements      305.6.....................  Updates to refer to PPQ
                               (cold treatment).                                       Treatment Manual.
305.16......................  Cold treatment schedules..  PPQ Treatment Manual......
305.17......................  Authorized treatments;      305.7.....................  No longer lists approved
                               exceptions (quick freeze).                              treatments.
305.18......................  Quick freeze treatment      PPQ Treatment Manual......
                               schedule.
305.20......................  Treatment requirements      305.8.....................  Updates to refer to PPQ
                               (heat treatment).                                       Treatment Manual.
305.21......................  Hot water dip treatment     PPQ Treatment Manual......
                               schedule for mangoes.
305.22......................  Hot water immersion         PPQ Treatment Manual......
                               treatment schedules.
305.23......................  Steam sterilization         PPQ Treatment Manual......
                               treatment schedules.
305.24......................  Vapor heat treatment        PPQ Treatment Manual......
                               schedules.
305.25......................  Dry heat treatment          PPQ Treatment Manual......
                               schedules.
305.26......................  Khapra beetle treatment     PPQ Treatment Manual......
                               schedule for feeds and
                               milled products.
305.27......................  Forced hot air treatment    PPQ Treatment Manual......
                               schedules.
305.28......................  Kiln sterilization          PPQ Treatment Manual......
                               treatment schedule.
305.29......................  Vacuum heat treatment       PPQ Treatment Manual......
                               schedule.
305.31......................  Irradiation treatment of    305.9.                      Sec.  Sec.   305.31,
                               imported regulated                                      305.32, and 305.34 would
                               articles for certain                                    be combined and
                               plant pests.                                            harmonized.
305.32......................  Irradiation treatment of    305.9.....................
                               regulated articles to be
                               moved interstate from
                               areas quarantined for
                               fruit fly.
305.34......................  Irradiation treatment of    305.9.....................
                               certain regulated
                               articles from Hawaii,
                               Puerto Rico, and the U.S.
                               Virgin Islands.
305.40......................  Garbage treatment           PPQ Treatment Manual......
                               schedules for insect
                               pests and pathogens.
305.42......................  Miscellaneous treatment     PPQ Treatment Manual......
                               schedules.
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                                 Table 2--Derivation of Proposed 7 CFR Part 305
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        Section                             Title                                     Derivation
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305.1..................  Definitions................................  Current Sec.   305.1.
305.2..................  Approved treatments........................  Current Sec.   305.2(a).
305.3..................  Process for adding, revising, or removing    New language.
                          treatment schedules.
305.4..................  Monitoring and certification of treatments.  Current Sec.   305.3.
305.5..................  Chemical treatment requirements............  Current Sec.   305.5.
305.6..................  Cold treatment requirements................  Current Sec.   305.15.
305.7..................  Quick freeze treatment requirements........  Current Sec.   305.17.
305.8..................  Heat treatment requirements................  Current Sec.   305.20.
305.9..................  Irradiation treatment requirements.........  Current Sec.  Sec.   305.31, 305.32, and
                                                                       305.34.
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Definitions (Sec.  305.1)

    We would remove the definitions of the following terms, as these 
terms are only referred to in the treatment schedules in 7 CFR part 
305: autoclaving, forced hot air, hitchhiker pest, hot water immersion 
dip, phosphine, steam heat, vacuum heat treatment, and vapor heat. 
Because we are removing the treatment schedules that include these 
terms from the regulations, these definitions would not need to be 
included in Sec.  305.1.
    We are proposing to add three new definitions.
    The term neutralize would be defined as, in the case of treatments 
other than irradiation, to kill a plant pest; in the case of 
irradiation, to prevent the establishment of the pest by killing it, 
sterilizing it, or preventing its development from an immature stage 
into an adult capable of emerging from its host, reproducing, or 
becoming established.
    As stated in the proposed definition of neutralize, an effective 
irradiation treatment does not necessarily kill a plant pest; rather, 
it may render the plant pest incapable of causing an infestation, by 
sterilizing it or preventing its maturation. This definition would help 
to clarify that point.
    The current definition of irradiation reads: ``The use of 
irradiated energy to kill or devitalize organisms.'' To refer to the 
new definition, we would replace the word ``devitalize'' with the word 
``neutralize.'' In addition, we would correct an error in the 
definition by referring to ionized energy rather than irradiated 
energy.
    Plant Protection and Quarantine (PPQ) would be defined as the Plant 
Protection and Quarantine program of APHIS.
    PPQ Treatment Manual would be defined as the document that contains 
the treatment schedules that are approved for use under 7 CFR part 305. 
The definition would also state that the Treatment Manual is available 
on the Internet at http://www.aphis.usda.gov/import_export/plants/manuals/index.shtml or by contacting the Animal and Plant Health 
Inspection Service, Plant Protection and Quarantine, Manuals Unit, 92 
Thomas Johnson Drive, Suite 200, Frederick, MD 21702.

Approved Treatments (Sec.  305.2)

    Most of proposed Sec.  305.2 would be drawn from current paragraph 
(a) of Sec.  305.2, with modifications to reflect the relocation of the 
lists of approved treatments and the treatment schedules to the 
Treatment Manual. Paragraphs (b) through (v) of current Sec.  305.2 
contain lists of approved treatments for various articles and would 
thus be removed.
    Proposed paragraph (a) of Sec.  305.2 would state that certain 
commodities or articles require treatment, or are subject to treatment, 
prior to the interstate movement within the United States or 
importation or entry into the United States. It would also state that 
treatment is required as indicated in parts 301, 318, and 319 of this 
chapter, on a permit, or by an inspector.
    Proposed paragraph (b) would indicate that lists of approved 
treatments and approved treatment schedules are set out in the PPQ 
Treatment Manual. It would also require treatments to be administered 
in accordance with the treatment requirements that we would retain in 
part 305 and in accordance with treatment schedules found in the PPQ 
Treatment Manual.
    Proposed paragraph (c), which would be retained unchanged from 
current paragraph (a)(4), would indicate that APHIS is not responsible 
for losses or damages incurred during treatment and would recommend 
that a sample be treated first before deciding whether to treat the 
entire shipment.

Proposed New Process for Adding, Revising, or Removing Treatment 
Schedules (Sec.  305.3)

    Proposed Sec.  305.3 would set out the notice-based processes we 
are proposing to use to amend the Treatment Manual. There would be two 
processes: A normal process and a process for taking immediate action.
    Paragraph (a) of proposed Sec.  305.3 would describe the normal 
process. Under this process, APHIS would publish in the Federal 
Register a notice describing the reasons we have determined that it is 
necessary to add, revise, or remove a treatment schedule and, if 
necessary, making available the new or revised treatment schedule as it 
would be added to the PPQ Treatment Manual. In our notice, we would 
provide for a public comment period on the new or revised treatment 
schedule or on the removal of the treatment schedule from the PPQ 
Treatment Manual.
    If we have prepared documentation to support the proposed change, 
we would also announce its availability via this notice. We anticipate 
preparing supporting documentation for most changes to the Treatment 
Manual, to indicate what data led us to propose the change in question. 
However, some changes would not require such data, such as a change to 
clarify a requirement or a change to remove a schedule whose use is not 
authorized by another Federal agency.
    After the close of the public comment period, we would issue a 
notice indicating that the treatment schedule specified in the initial 
notice would be added to the PPQ Treatment Manual, revised as described 
in the notice, or removed from the PPQ Treatment Manual if:
     No comments were received on the notice;
     The comments on the notice supported our action; or
     The comments on the notice were evaluated but did not 
change our determination that it was necessary to add, revise, or 
remove the treatment schedule, as described in the notice.
    If the final notice indicated that we were making the change 
described in the initial notice, we would also make available, at the 
Web address referred to earlier, an updated version of the

[[Page 22322]]

Treatment Manual that would reflect the addition, revision, or removal 
of the particular treatment schedule.
    If comments presented information that caused us to determine that 
the change described in the notice was not appropriate, APHIS would 
issue a notice informing the public of this determination after the 
close of the comment period.
    While we anticipate the process in proposed paragraph (a) to be 
suitable for many changes to the PPQ Treatment Manual, certain 
circumstances require that treatment schedules be added, revised, or 
removed immediately. Paragraph (b) of proposed Sec.  305.3 would set 
out those circumstances and describe a process for making immediate 
changes to the Treatment Manual.
    Paragraph (b)(1) of proposed Sec.  305.3 would describe the 
circumstances in which the immediate process could be used. Under this 
paragraph, treatment schedules could be immediately added to the PPQ 
Treatment Manual, revised, or removed from the PPQ Treatment Manual if 
any of the following circumstances applied:
     PPQ has determined that an approved treatment schedule is 
ineffective at neutralizing the targeted plant pest(s). For example, 
when we find live pests when inspecting treated articles, we may adjust 
treatment schedules to ensure that treatment is effective.
     PPQ has determined that, in order to neutralize the 
targeted plant pest(s), the treatment schedule must be administered 
using a different process than was previously used. Some treatment 
schedules contain specific instructions for their use. Upon finding 
live pests when inspecting treated articles, we may determine that the 
treatment must be administered differently, or that we must set out 
more specific conditions for the administration of the treatment. For 
example, we may determine that methyl bromide fumigation without a 
tarpaulin covering the treated commodity is not effective but that the 
same schedule employed with a tarpaulin will be effective.
     PPQ has determined that a new treatment schedule is 
effective, based on efficacy data, and that ongoing trade in a 
commodity or commodities may be adversely impacted unless the new 
treatment schedule is approved for use. For example, if a facility used 
to perform chemical treatment on a commodity suddenly becomes 
unavailable to producers in a foreign country, but a facility is 
available to perform cold treatment on the commodity using a schedule 
not currently approved by APHIS, we may approve the use of that 
schedule to treat that commodity if efficacy data supports it.
     The use of a treatment schedule is no longer authorized by 
EPA or by any other Federal entity. The use of certain chemicals in 
phytosanitary treatments is authorized by EPA; if EPA withdraws 
approval for the use of a chemical, we must also withdraw any treatment 
schedules that require the use of that chemical. Similarly, if the 
Department of Health and Human Services' Food and Drug Administration 
changed the maximum absorbed dose of irradiation for food, we might 
need to revise our irradiation treatment requirements to reflect the 
new limit.
    If we determined that a change to the Treatment Manual needed to be 
made immediately, we would publish in the Federal Register a notice 
describing the reasons we determined that it is necessary to 
immediately add, revise, or remove a treatment schedule and, if 
necessary, making available the new or revised treatment schedule as it 
has been added to the PPQ Treatment Manual. Treatment schedules that 
were added to the PPQ Treatment Manual or revised under this process 
would be listed in a separate section of the PPQ Treatment Manual as 
having been added or revised through the immediate process described in 
proposed paragraph (b). The PPQ Treatment Manual would indicate that 
these treatment schedules are subject to change or removal based on 
public comment. In our notice, we would provide for a public comment 
period on the new or revised treatment schedule or on the removal of 
the treatment schedule from the PPQ Treatment Manual.
    After the close of the public comment period, we would issue a 
notice affirming the action described in the initial notice if:
     No comments were received on the notice;
     The comments on the notice supported our action; or
     The comments on the notice were evaluated but did not 
change our determination that it was necessary to add, revise, or 
remove the treatment schedule, as described in the notice.
    If the notice issued after the close of the public comment period 
indicates that the initial change to the PPQ Treatment Manual is 
affirmed, APHIS would make available a new version of the PPQ Treatment 
Manual that would reflect the addition, revision, or removal of the 
particular treatment schedule in the main body of the PPQ Treatment 
Manual.
    If comments on the initial notice present information that causes 
us to determine that it is necessary to change a treatment schedule 
added to the PPQ Treatment Manual under the immediate process or to 
further revise a treatment schedule that was revised under this 
process, APHIS would publish a notice in the Federal Register informing 
the public of this determination after the close of the comment period 
and would revise the treatment schedule accordingly.
    If comments present information that causes us to determine that 
the change described in the initial notice was not appropriate, APHIS 
would publish a notice in the Federal Register informing the public of 
this determination after the close of the comment period and will, if 
necessary, remove the new or revised treatment schedule from the 
separate section of the PPQ Treatment Manual.
    These notice-based processes would enable us to make changes more 
quickly to the treatment schedules in the PPQ Treatment Manual while 
continuing to provide for public participation in the process. Changes 
to the general treatment requirements that we propose to retain in part 
305 would still be made through rulemaking. We invite public comment on 
this approach.

Monitoring and Certification of Treatments

    Proposed Sec.  305.4 would set out requirements for monitoring and 
certification of treatments. Paragraph (a) of proposed Sec.  305.4 is 
taken from current Sec.  305.3(a) and states that all treatments 
approved under part 305 are subject to monitoring and verification by 
APHIS.
    Paragraph (b) of proposed Sec.  305.4 is based on current Sec.  
305.3(b). The regulations in Sec.  305.3(b) require any treatment 
performed outside the United States to be monitored and certified by an 
inspector or an official from the national plant protection 
organization (NPPO) of the exporting country. If monitored and 
certified by an official of the NPPO of the exporting country, the 
regulations require treated commodities to be accompanied by a 
phytosanitary certificate issued by the NPPO of the exporting country 
certifying that treatment was applied in accordance with APHIS 
regulations. The phytosanitary certificate must be provided to an 
inspector when the commodity is offered for entry into the United 
States. During the entire interval between treatment and export, the 
consignment must be stored and

[[Page 22323]]

handled in a manner that prevents any infestation by pests and noxious 
weeds.
    This proposal would amend these requirements to indicate that any 
treatment performed outside the United States must be monitored and 
certified by an inspector or an official authorized by APHIS, to be 
consistent with the other requirements in part 305, which refer to 
officials authorized by APHIS rather than NPPO officials specifically. 
Proposed Sec.  305.4(b) would state that the phytosanitary 
certification requirement applies when monitoring or certification 
involves an official authorized by APHIS. Proposed Sec.  305.4(b) would 
also refer to treatment having been conducted in accordance with APHIS 
regulations, rather than to treatment having been applied, as the term 
``conducted'' is more inclusive.

Chemical Treatment, Cold Treatment, Quick Freeze Treatment, and Heat 
Treatment Requirements Sections (Sec. Sec.  305.5 Through 305.8)

    These proposed sections are retained from the sections in part 305 
that currently contain these requirements, as listed in table 2 earlier 
in this document. As part of this proposal, we would make some minor 
changes to these sections, as described below.
    In all of these sections, we would indicate where appropriate that 
treatment schedules would be found in the PPQ Treatment Manual.
    In the chemical treatment requirements section (Sec.  305.5), 
paragraph (c)(3) currently provides that the volume of the commodity 
stacked inside a chemical treatment enclosure must not exceed \2/3\ of 
the volume of the enclosure. However, there may be some circumstances 
in which stacking that exceeds \2/3\ of the volume of the enclosure is 
appropriate; these circumstances would be specified in the treatment 
schedule. Therefore, we would amend paragraph (c)(3) to indicate that 
the volume of the commodity stacked inside a chemical treatment 
enclosure must not exceed \2/3\ of the volume of the enclosure unless 
otherwise specified in the PPQ Treatment Manual.
    In the cold treatments requirements section (proposed Sec.  305.6), 
paragraph (a) currently requires, among other things, that APHIS 
reapprove facilities or carriers that perform cold treatment annually, 
or as often as APHIS directs. We are proposing to change this to refer 
to reapproval every 3 years, or as often as APHIS directs. Three years 
is an adequate interval at which to conduct reapproval if there is no 
indication that the facility or carrier has problems performing cold 
treatment. If reapproval at shorter intervals is necessary, we would 
still have the option to require reapproval as often as APHIS directs.
    Also in the cold treatment requirements section, paragraph (h) 
contains additional requirements for treatments performed after arrival 
in the United States. Several of these requirements call for the use of 
fruit fly traps to be used near the facility, and specifically list 
Jackson/methyl eugenol and McPhail traps. We are proposing to instead 
refer to ``APHIS-approved fruit fly traps,'' so that it would not be 
necessary to update the regulations if other effective fruit fly traps 
are developed in the future.
    The quick freeze treatment section (Sec.  305.17) currently lists 
commodities for which quick freeze is not an authorized treatment. We 
are proposing to move these requirements to Sec.  305.7 and to remove 
the list of commodities for which quick freeze treatment is not 
authorized. Instead, we would state that the PPQ Treatment Manual 
indicates the fruits and vegetables for which quick freeze is an 
authorized treatment. We would make changes to that list of fruits and 
vegetables through the notice-based process described earlier in this 
document.

Irradiation Treatment Requirements (Proposed Sec.  305.9)

    Part 305 currently contains three sections that set out 
requirements for performing irradiation treatment: Sec.  305.31, for 
irradiation treatment of imported regulated articles; Sec.  305.32, for 
regulated articles moved interstate from areas quarantined for fruit 
fly; and Sec.  305.34, for regulated articles moved interstate from 
Hawaii, Puerto Rico, and the U.S. Virgin Islands. The requirements in 
these sections are mostly similar, and some of them are identical. As 
part of revising part 305, we are proposing to consolidate and 
harmonize the existing irradiation requirements into one section that 
would set out irradiation requirements for all articles for which 
irradiation is an authorized treatment.
    Current Sec. Sec.  305.31, 305.32, and 305.34 refer to approval of 
certain processes and equipment both by APHIS and by the Administrator. 
In proposed Sec.  305.9, we would only refer to approval by APHIS. We 
would replace references to ``plant protection service'' with 
references to ``national plant protection organization,'' as that is 
the term used in the International Plant Protection Convention's (IPPC) 
Glossary of Phytosanitary Terms (International Standard for 
Phytosanitary Measures No. 5).\2\ We would also replace references to 
``fruits and vegetables'' with references to ``articles,'' as 
irradiation is also approved to treat commodities other than fruits and 
vegetables, such as nuts, foliage, and cut flowers.
---------------------------------------------------------------------------

    \2\ To view this and other standards on the Internet, go to 
http://www.ippc.int/IPP/En/default.jsp and click on the ``Adopted 
ISPMs'' link under the ``Standards (ISPMs)'' heading.
---------------------------------------------------------------------------

    As noted previously, current Sec.  305.34 states that it applies to 
irradiation treatment of certain regulated articles from Hawaii, Puerto 
Rico, and the U.S. Virgin Islands. In a final rule published in the 
Federal Register on January 16, 2009 (74 FR 2770-2786, Docket No. 
APHIS-2007-0052) and effective on February 17, 2009, we revised the 
regulations for the interstate movement of most regulated articles in 
part 318. The final rule amended certain general provisions in part 318 
that had applied only to Hawaii, Puerto Rico, and the U.S. Virgin 
Islands and extended their applicability to Guam and the Commonwealth 
of the Northern Mariana Islands. We would extend the applicability of 
the irradiation regulations similarly. (For ease of reading, we will 
refer to these jurisdictions collectively as ``Hawaii and U.S. 
territories'' in the Background section of this document and would do 
so as well in proposed Sec.  305.9.)
    Currently, paragraph (a) of Sec.  305.31 sets out approved 
irradiation doses for specific plant pests. Paragraph (a)(1) of Sec.  
305.34 sets out approved irradiation doses for some specific fruits and 
vegetables moved interstate from Hawaii, Puerto Rico, and the U.S. 
Virgin Islands. In addition, paragraph (a)(1) of Sec.  305.32 refers to 
treatment for fruit fly at the approved dose listed in Sec.  305.31(a), 
and paragraph (a)(2) of Sec.  305.34 refers to treatment of other 
regulated articles from Hawaii, Puerto Rico, and the U.S. Virgin 
Islands at the doses listed in Sec.  305.31(a). We would remove this 
information from the regulations and add it to the PPQ Treatment 
Manual.
    Proposed Sec.  305.9 would begin with a statement that irradiation, 
carried out in accordance with the provisions of proposed Sec.  305.9, 
is approved as a treatment for any imported regulated article (i.e., 
fruits, vegetables, cut flowers, and foliage), for any regulated 
article moved interstate from Hawaii and U.S. territories, and for any 
berry, fruit, nut, or vegetable listed as a regulated article in Sec.  
301.32-2(a) (i.e., the fruit fly quarantine regulations).
    Proposed paragraph (a) of Sec.  305.9 would set out requirements 
for the

[[Page 22324]]

location of facilities. Paragraph (a)(1) would address the location of 
facilities used to treat imported regulated articles and regulated 
articles moved interstate from Hawaii or U.S. territories. Requirements 
for the location of facilities used to treat such articles are 
currently found in Sec.  305.31(b) and Sec.  305.34(b)(1). These 
requirements are identical except that Sec.  305.31(b) contains a 
footnote that also allows irradiation facilities to be located at the 
maritime ports of Gulfport, MS, or Wilmington, NC, or the airport of 
Atlanta, GA, if certain special conditions are met, including 
requirements for movement and handling of articles, fruit fly trapping, 
and disposal of articles. Section 305.34(b)(1) does not contain this 
footnote. We are proposing to move these conditions into the regulatory 
text of proposed paragraph (a)(1). As these special conditions would be 
adequate to address the pest risk associated with the movement of 
regulated articles moved interstate from Hawaii or U.S. territories for 
irradiation treatment at those ports, we would provide for the use of 
these special conditions for both imported regulated articles and 
regulated articles moved interstate from Hawaii and U.S. territories.
    The footnote in current Sec.  305.31(b) requires the use of 
Jackson/methyl eugenol and McPhail traps; similar to the changes 
proposed for the cold treatment requirements, we would instead refer in 
proposed paragraph (a)(1) to ``APHIS-approved fruit fly traps,'' so 
that it will not be necessary to update the regulations if other 
effective fruit fly traps are developed in the future.
    Proposed paragraph (a)(2) of Sec.  305.9 would address the location 
of facilities used to treat regulated articles to be moved interstate 
from areas quarantined for fruit flies. The regulations in Sec.  305.32 
currently do not contain a specific requirement related to the location 
of facilities. Under proposed Sec.  305.9(a)(2), facilities for 
irradiation of articles that are moved interstate from areas 
quarantined for fruit flies could be located either within or outside 
of the quarantined area. If the articles are treated outside the 
quarantined area, they would have to be accompanied to the facility by 
a limited permit issued in accordance with Sec.  301.32-5(b), the 
paragraph in the domestic fruit fly quarantine regulations that 
contains provisions for limited permits, and would have to be moved in 
accordance with any safeguards determined to be appropriate by APHIS. 
This provision would ensure that APHIS could impose any safeguards that 
may be necessary for the safe movement of untreated articles from a 
fruit fly quarantined area to a facility located outside the 
quarantined area, just as APHIS has the option to impose safeguards on 
the movement of untreated articles from foreign countries or from 
Hawaii and U.S. territories to an irradiation facility for treatment.
    Paragraph (b) of proposed Sec.  305.9 would state that the 
irradiation treatment facility would have to be approved by APHIS. In 
order to be approved, a facility would have to fulfill the requirements 
in paragraphs (c) and (d) of proposed Sec.  305.9.
    Paragraph (c) of proposed Sec.  305.9 would set out requirements 
for compliance agreements. Proposed paragraph (c)(1) would set out the 
compliance agreement requirements for facilities treating imported 
articles; paragraphs (c)(1)(i) and (c)(1)(ii) would apply to facilities 
located in the United States and to facilities outside the United 
States, respectively. These paragraphs would contain the requirements 
currently in paragraphs (c) and (d) of Sec.  305.31.
    Proposed paragraph (c)(2) would address the compliance agreement 
requirements for facilities treating regulated articles moved 
interstate from Hawaii and U.S. territories. It would require a 
compliance agreement with APHIS to be completed as provided in Sec.  
318.13-3(d), the paragraph in part 318 that governs compliance 
agreements for the movement of regulated articles from Hawaii and U.S. 
territories. This requirement is currently found in Sec.  
305.34(b)(2)(iii).
    Proposed paragraph (c)(3) addresses the compliance agreement 
requirements for facilities treating regulated articles to be moved 
interstate from areas quarantined for fruit flies. It would require a 
compliance agreement with APHIS to be completed as provided in Sec.  
301.32-6. This requirement is currently found in Sec.  305.32(a)(3).
    Proposed paragraph (d) would set out requirements for certification 
of an irradiation treatment facility. The introductory text of 
paragraph (d) would contain the certification and recertification 
requirements currently found in the introductory text of Sec.  
305.31(e), paragraph (a)(4) of Sec.  305.32, and paragraph (b)(2)(iv) 
of Sec.  305.34.
    Under proposed paragraph (d), the irradiation treatment facility 
would have to be certified by APHIS. This language is drawn from 
current Sec.  305.31(e). Unlike Sec.  305.31(e), Sec. Sec.  
305.32(a)(4) and 305.34(b)(2)(iv) refer to certification by PPQ and 
require annual recertification. We have determined that it is not 
necessary to require annual recertification for facilities used to 
treat regulated articles moved interstate from Hawaii and U.S. 
territories or regulated articles moved interstate from areas 
quarantined for fruit flies, in the absence of one of the events 
currently listed in the regulations as a reason for recertification.
    Recertification would be required in the event of an increase or 
significant decrease in the amount of radioisotope, a major 
modification to equipment that affects the delivered dose, or a change 
in the owner or managing entity of the facility. Only the regulations 
in Sec.  305.31(e) currently include a change in the owner or managing 
entity of the facility as a reason for recertification; we have 
determined that this requirement would be appropriate for irradiation 
facilities used to treat regulated articles moved interstate from 
Hawaii and U.S. territories and regulated articles to be moved 
interstate from areas quarantined for fruit flies as well, to ensure 
that currently certified facilities continue to comply with the 
regulations under new ownership or management. (The regulations 
currently refer only to a decrease in the amount of radioisotope; 
because the amount of radioisotope decreases in very small amounts 
during treatment, we are proposing to add the word ``significant'' to 
better characterize the type of decrease that would require 
recertification.)
    Recertification also could be required in cases where a significant 
variance in dose delivery has been measured by the dosimetry system. 
The requirements in Sec. Sec.  305.32(a)(4) and 305.34(b)(2)(iv) refer 
to recertification in cases where a significant variance in dose 
delivery is indicated; the language in Sec.  305.31(e), which we use in 
this proposal, provides helpful additional specificity.
    Proposed paragraphs (d)(1) through (d)(3) set out requirements for 
certification. In order to be certified, a facility would have to:
     Be capable of administering the minimum absorbed ionizing 
radiation doses specified in the PPQ Treatment Manual to the regulated 
articles. This requirement is drawn from Sec. Sec.  305.31(e)(1), 
305.32(a)(1), and 305.34(b)(2)(i). We would add the reference to the 
PPQ Treatment Manual to be consistent with the other changes in this 
proposal.
     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 would have to be separated by a permanent 
physical barrier such as a wall or chain link fence

[[Page 22325]]

6 or more feet high to prevent transfer of cartons, or some other means 
approved during certification to prevent reinfestation of articles and 
spread of pests. This requirement is drawn from Sec.  305.31(e)(2). The 
same requirements are included in Sec. Sec.  305.32(a)(2) and 
305.34(b)(2)(ii), except that these paragraphs do not provide for the 
use of some means other than a physical barrier that would be approved 
during certification to prevent reinfestation of articles and spread of 
pests. Providing such an option for irradiation facilities treating 
regulated articles moved interstate from Hawaii and U.S. territories 
and regulated articles to be moved interstate from areas quarantined 
for fruit flies would increase flexibility for such facilities without 
increasing risk, since any other means used to prevent reinfestation 
would be subject to APHIS approval during certification.
     If the facility is to be used to treat imported articles 
and is located in the United States, the facility would only be 
certified if APHIS determines that regulated articles would 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. This requirement is drawn from 
Sec.  305.31(e)(3). It is not necessary to include a similar 
requirement for facilities treating articles moved interstate from 
Hawaii and U.S. territories or articles moved interstate from an area 
quarantined for fruit flies, as their movement is governed by a limited 
permit; before granting a limited permit, APHIS would have to determine 
that the movement of the articles could be accomplished safely.
    Paragraph (e) of proposed Sec.  305.9 would set out requirements 
for monitoring and interagency agreements. The introductory text of 
proposed paragraph (e) would state that treatment must be monitored by 
an inspector and that this monitoring will include inspection of 
treatment records and unannounced inspections of the facility by an 
inspector, and may include inspection of articles prior to or after 
irradiation. This requirement is drawn from current Sec. Sec.  
305.31(f), 305.32(b), and 305.34(b)(3).
    Proposed paragraph (e)(1) would set out requirements for monitoring 
and interagency agreements for irradiation facilities located in 
foreign countries. These requirements would be moved from Sec.  
305.31(f). These requirements currently apply to any facility treating 
imported articles, and they are somewhat more detailed and rigorous 
than the monitoring requirements for irradiation facilities treating 
articles moved interstate from Hawaii and U.S. territories and from 
areas quarantined for fruit flies. The additional requirements are 
necessary because ensuring that the irradiation treatment requirements 
are met when monitoring irradiation treatment in a foreign country 
involves an additional layer of complexity; such monitoring requires us 
to work with foreign governments to ensure that all requirements are 
met, while monitoring the irradiation treatment of articles treated 
within the United States does not.
    Irradiation treatment of imported articles can be conducted either 
in the country of origin or within the United States, but the detailed 
requirements for monitoring and interagency agreements in Sec.  
305.31(f) only apply to facilities located in foreign countries, for 
the reasons described above. Therefore, we are proposing to clearly 
indicate in the regulatory text that these requirements only apply to 
irradiation facilities located in foreign countries, not necessarily 
all facilities that treat imported articles.
    We would make one change to the requirements for monitoring and 
interagency agreements for facilities located in foreign countries. The 
trust fund agreement requirements refer to the NPPO of the country in 
which the irradiation facility is located entering into a trust fund 
with APHIS. Often, we enter into the trust fund with a private export 
group that operates the facility. Therefore, we would amend the 
existing text describing trust fund agreements to refer to entering 
into the agreement either with the NPPO or with a private export group. 
This change would be consistent with the general language governing 
trust fund agreements related to the importation of fruits and 
vegetables in Sec.  319.56-6.
    Proposed paragraph (e)(2) would set out requirements for monitoring 
and interagency agreements for irradiation facilities located within 
the United States. This paragraph would contain the current 
requirements for irradiation facilities treating articles moved 
interstate from areas quarantined for fruit flies and from Hawaii and 
U.S. territories in Sec. Sec.  305.32(b) and 305.34(b)(3), 
respectively; those paragraphs are identical. For the reasons described 
above, we have determined that these requirements would also be 
appropriate for irradiation facilities located within the United States 
that are used to treat imported articles.
    Proposed paragraph (f) of Sec.  305.9 would set out packaging 
requirements. Under proposed paragraph (f)(1), irradiated articles 
would not be allowed to be packaged for shipment in a carton with 
nonirradiated articles. This requirement is drawn from current 
Sec. Sec.  305.31(g)(1) and 305.34(b)(2), which apply to articles 
imported into the United States and articles moved interstate from 
Hawaii, Puerto Rico, and the U.S. Virgin Islands, respectively; we have 
determined that it is appropriate for articles moved interstate from 
areas quarantined for fruit flies as well, as it helps to reduce the 
risk of reinfestation of treated articles.
    Current paragraph (g)(1) of Sec.  305.31 also requires irradiated 
articles to be shipped in the same cartons in which they are treated; 
the irradiation treatment regulations for articles moved interstate 
from Hawaii, Puerto Rico, and the U.S. Virgin Islands and for articles 
moved interstate from areas quarantined for fruit flies do not contain 
such a requirement. We have determined that requiring irradiated 
articles to be shipped in the same cartons in which they are treated is 
unnecessary. The requirement is intended to prevent untreated articles 
from being shipped and to prevent treated articles from being infested 
with fruit flies after treatment, but other requirements in the 
irradiation treatment regulations (such as those discussed directly 
above and below) adequately address this issue. Additionally, treatment 
is always monitored by an inspector, who will be able to ensure that 
adequate safeguarding measures are practiced. Accordingly, the 
irradiation treatment regulations proposed here do not include the 
same-carton requirement.
    The current packaging requirements in the irradiation treatment 
regulations specifically address fruit flies. However, irradiation 
treatment is approved for pests other than fruit flies, and some 
commodities that are irradiated are not fruit fly hosts. Therefore, we 
are proposing to amend the current requirements to refer to packaging 
sufficient to prevent the infestation or reinfestation of the treated 
articles by the pests of concern, rather than fruit flies specifically.
    Proposed paragraph (f)(2) sets out packaging requirements for 
imported articles treated prior to arrival in the United States; for 
regulated articles moved interstate from Hawaii or U.S. territories and 
irradiated prior to arrival in the mainland United States; and for 
regulated articles to be moved interstate from areas quarantined for 
fruit flies that are treated within the quarantined area. The 
requirements in proposed paragraph (f)(2) are drawn from Sec. Sec.  
305.31(g)(3), 305.32(c), and 305.34(b)(4)(i).

[[Page 22326]]

    Under this paragraph, the articles to be irradiated would have to 
be packaged either:
     In insect-proof cartons that have no openings that will 
allow the entry of the pests of concern. The cartons would have to be 
sealed with seals that will visually indicate if the cartons have been 
opened. The cartons could be constructed of any material that prevents 
entry or oviposition (if applicable) by the pests of concern into the 
articles in the carton; or
     In noninsect-proof cartons that are stored immediately 
after irradiation in a room completely enclosed by walls or screening 
that completely precludes access by the pests of concern. If stored in 
noninsect-proof cartons in a room that precludes access by the pests of 
concern, prior to leaving the room, each pallet of cartons would have 
to be completely enclosed in polyethylene shrink wrap, or another solid 
or netting covering that completely precludes access to the cartons by 
the pests of concern.
    These two options are drawn from current Sec.  305.31(g)(3), which 
applies to imported commodities treated prior to arrival in the United 
States. Current Sec. Sec.  305.32(c) and 305.34(b)(4)(i), which apply, 
respectively, to articles treated in Hawaii, Puerto Rico, or the U.S. 
Virgin Islands and to articles treated in an area quarantined for fruit 
fly, do not provide the option to use noninsect-proof cartons; 
providing this option for treatment of those articles increases 
flexibility without increasing risk, since APHIS would have to approve 
any room used to store treated articles in noninsect-proof cartons.
    Each pallet-load of cartons containing the fruits and vegetables 
would have to be wrapped before leaving the irradiation facility in one 
of the following ways:
     With polyethylene shrink 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.
    These requirements are drawn from current Sec. Sec.  
305.31(g)(3)(ii), 305.32(c)(2), and 305.34(b)(4)(i)(B). Current Sec.  
305.31(g)(3)(ii) states that the wrapping requirements are intended to 
preserve the identity of treated lots. Instead of referring to the 
identity of the treated lots, we are proposing to refer to the 
integrity of the treated lots, as the requirements are intended to 
allow treated lots to be easily identifiable and separated from 
untreated lots.
    Packaging would have to be labeled with treatment lot numbers, 
packing and treatment facility identification and location, and dates 
of packing and treatment. This requirement is drawn from current 
Sec. Sec.  305.31(g)(3)(iii), 305.32(c)(3), and 305.34(b)(4)(i)(C).
    Under current Sec.  305.31(g)(3)(iii), pallets of imported articles 
that are treated prior to arrival in the United States must remain 
intact as one unit until entry into the United States and may have one 
such label per pallet, and 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. We would retain 
these requirements in proposed Sec.  305.9(f)(2)(iii)(A) and would 
extend their applicability in proposed Sec.  305.9(f)(2)(iii)(B) to 
articles moved interstate from Hawaii and U.S. territories that are 
treated prior to arrival in the mainland United States. We are also 
proposing to require label information on individual cartons if the 
pallets will be broken apart after entry into the mainland United 
States as well. These requirements would ensure that we can conduct 
traceback to the treatment facility if necessary and would also 
indicate to inspectors that the articles have been subject to an 
approved treatment and have moved under certificate or limited permit, 
whichever is applicable.
    Similar requirements for labeling of cartons within pallets are not 
necessary for articles moved interstate from areas quarantined for 
fruit flies and treated prior to interstate movement, because the 
articles enter commerce directly after treatment, meaning that there is 
no gap in distance or time between treatment and distribution that 
would necessitate additional information for traceback. In addition, 
because such articles are moved directly into commerce, they are not 
typically palleted.
    Proposed paragraph (f)(3) of Sec.  305.9 would set out the 
requirements for packaging for articles imported to be irradiated upon 
arrival in the United States, moved interstate to be irradiated upon 
arrival in the mainland United States, or moved interstate from areas 
quarantined for fruit flies to be irradiated. Under this paragraph, 
such articles would have to be packed in cartons that have no openings 
that will allow the exit of the pests of concern and that are sealed 
with seals that will visually indicate if the cartons have been opened. 
They could be constructed of any material that prevents the pests of 
concern from exiting the carton. These requirements are drawn from 
current Sec.  305.31(g)(2), which applies to articles irradiated after 
importation into the United States; we have determined that they are 
appropriate for regulated articles irradiated after interstate movement 
from Hawaii and U.S. territories and regulated articles irradiated 
after interstate movement from areas quarantined for fruit flies as 
well, in order to provide additional protection against the 
introduction of quarantine pests. Current Sec.  305.31(g)(2) refers to 
preventing the entry of the pests of concern into the cartons; we are 
proposing to refer to the exit of those pests, because this measure is 
designed to prevent pests that have infested the articles from being 
introduced into the United States before the articles are treated.
    Proposed paragraph (f)(3) would also require that cartons of such 
articles be shipped in shipping containers sealed prior to their 
shipment with seals that will visually indicate if the shipping 
containers have been opened. This requirement is drawn from Sec.  
305.34(b)(4)(ii), which applies to articles treated before they are 
moved interstate from Hawaii, Puerto Rico, or the U.S. Virgin Islands 
into the United States. We have determined that this requirement is 
appropriate for imported articles treated after importation and 
articles moved interstate from areas quarantined for fruit flies that 
are treated after movement as well, because it provides additional 
protection against the introduction of quarantine pests.
    The labeling requirements in Sec.  305.34 also include provisions 
prohibiting the interstate movement of litchi and longan from Hawaii 
into Florida and requiring all cartons in which litchi or longan are 
packed to be stamped ``Not for importation into or distribution in 
FL.'' These provisions would be better placed in the regulations 
governing the interstate movement of fruits and vegetables in part 318, 
since the labeling requirements here are not related to irradiation 
treatment but rather to the risk posed by the litchi rust mite, which 
is not addressed by irradiation. Accordingly, we are proposing to amend 
the table of regulated articles allowed interstate movement under 
specified conditions in Sec.  318.13-16 by adding entries for litchi 
and longan from Hawaii; these entries would indicate that the 
interstate movement of litchi and longan from Hawaii is subject to the 
distribution restriction and labeling requirements that are currently 
found in Sec.  305.34. We would also change the required stamp to refer 
correctly to movement into Florida, rather than importation.
    Proposed paragraph (g) of Sec.  305.9 would require that containers 
or vans that will transport treated articles be free of pests prior to 
loading the treated articles. This requirement is drawn from

[[Page 22327]]

current Sec.  305.31(h), which applies to imported articles that have 
been treated with irradiation. We are also proposing to apply this 
requirement to the transportation of treated articles moved interstate 
from Hawaii and U.S. territories and treated articles to be moved 
interstate from areas quarantined for fruit flies, as it provides 
additional phytosanitary security.
    Proposed paragraph (h) of Sec.  305.9 would contain the 
phytosanitary certification requirement for imported articles that is 
currently found in Sec.  305.31(i). However, we would amend this 
requirement to refer to consignments rather than shipments, as 
``consignments'' is the term used in the IPPC Glossary of Phytosanitary 
Terms.
    Paragraph Sec.  305.34(b)(7) of the regulations governing 
irradiation treatment of articles moved interstate from Hawaii, Puerto 
Rico, and the U.S. Virgin Islands contains specific requirements for 
certification or limited permits for the interstate movement of several 
commodities that apply in addition to irradiation treatment. For 
example, breadfruit and jackfruit, which have specific requirements for 
certification and limited permits in Sec. Sec.  305.34(b)(7)(i)(C) and 
305.34(b)(7)(ii)(C), respectively, must be inspected and found to be 
free of various pests, treated with irradiation for fruit flies, 
subjected to a treatment for external feeders or originate from an 
orchard or growing area that has been treated with a broad-spectrum 
insecticide, free of stems and leaves, and originate from an orchard 
that was treated with a fungicide appropriate for the fungus 
Phytophthora tropicalis or subjected to a post-harvest fungicidal dip 
appropriate for that fungus. These requirements are not related to 
irradiation treatment, but rather address other pest risks that 
irradiation treatment does not mitigate. Accordingly, we are proposing 
to move the specific certification and limited permit requirements 
currently found in Sec.  305.34(b)(7)(i)(A) through (H) and Sec.  
305.34(b)(7)(ii)(A) through (D) to part 318. Specifically:
     The certification and limited permit requirements for 
litchi from Hawaii, which are found in paragraphs (b)(7)(i)(A) and 
(b)(7)(ii)(A) of Sec.  305.34, respectively, refer only to inspection 
for freedom from pests. As movement of any fruit or vegetable from 
Hawaii is subject to inspection for freedom from pests under Sec.  
318.13-3, it would not be necessary to retain this specific requirement 
in the regulations.
     The certification and limited permit requirements for 
sweetpotatoes, which are found in paragraphs (b)(7)(i)(B) and 
(b)(7)(ii)(B) of Sec.  305.34, respectively, would be added to Sec.  
318.13-25, which contains requirements for the interstate movement of 
sweetpotatoes from Hawaii with vapor heat treatment.
     The certification and limited permit requirements for 
breadfruit and jackfruit, which are found in paragraphs (b)(7)(i)(C) 
and (b)(7)(ii)(C) of Sec.  305.34, respectively; the certification and 
limited permit requirements for fresh pods of cowpea and its relatives, 
which are found in paragraphs (b)(7)(i)(D) and (b)(7)(ii)(D) of Sec.  
305.34, respectively; and the certification requirements for dragon 
fruit, mangosteen, melon, and moringa pods, which are found in 
paragraphs Sec.  305.34(b)(7)(i)(E) through (b)(7)(i)(H), respectively, 
would be included in a new Sec.  318.13-26. This new section would 
indicate explicitly that irradiation treatment is required for these 
commodities, in addition to the other requirements.
    In addition, because we are proposing to remove specific 
irradiation doses from the regulations, as discussed earlier, we would 
amend the specific certification and limited permit provisions by 
removing references to specific irradiation doses and replacing them 
with references to irradiation treatment for certain pests. For 
example, in order to be certified for interstate movement under current 
Sec.  305.34(b)(7)(i)(C), breadfruit and jackfruit must be inspected in 
Hawaii and found to be free of certain pests and treated at the 150 
gray dose to neutralize fruit flies. Inspection for plant pests of the 
class Insecta (except pupae and adults of the order Lepidoptera) is 
unnecessary if the fruits are treated at the 400 gray dose, which is 
approved to neutralize those plant pests. Rather than include the doses 
in the revised irradiation treatment requirements, we would simply 
refer in the new Sec.  318.13-26 to treatment at a dose approved to 
neutralize fruit flies or at a dose approved to neutralize all plant 
pests of the class Insecta, except pupae and adults of the order 
Lepidoptera. We would also remove references to treatment schedule 
T102-c, which is a soapy water dip treatment for external pests, and 
instead refer to treatment in accordance with part 305 for external 
pests. This would allow the regulations to conform with any changes we 
might make to the approved irradiation doses or other treatments 
through the notice-based process outlined earlier in this proposal.
    General certification and limited permit provisions for articles 
moved interstate from Hawaii and U.S. territories are found in Sec.  
318.13-3; similarly, general certification and limited permit 
provisions for articles moved interstate from areas quarantined for 
fruit flies are found in Sec.  301.32-5 of the domestic fruit fly 
quarantine regulations. It is not necessary to duplicate those general 
provisions in the irradiation treatment requirements.
    Proposed paragraph (i) of Sec.  305.9 would require that the 
regulated articles receive the minimum absorbed ionizing radiation dose 
specified in the PPQ Treatment Manual. The similar requirements 
currently found in Sec. Sec.  305.32(d), for articles moved interstate 
from areas quarantine for fruit flies, and 305.34(b)(5), for articles 
moved interstate from Hawaii, Puerto Rico, and the U.S. Virgin Islands, 
refer to receiving the dose specified in the regulations; we would 
change this reference as part of moving the lists of approved 
treatments and schedules to the PPQ Treatment Manual. The regulations 
for the irradiation treatment of imported articles do not contain a 
similar requirement, although it is implied; we believe it would be 
helpful to make the requirement explicit for all types of articles.
    Proposed paragraph (j) of Sec.  305.9 sets out requirements for 
dosimetry systems at the irradiation facility. Such requirements are 
currently contained in Sec. Sec.  305.31(j), 305.32(e), and 
305.34(b)(6). Although there are wording differences among the current 
requirements for dosimetry systems, they are substantively identical, 
and we have incorporated them into the proposed text with minor changes 
to ensure consistency.
    Proposed paragraph (j)(1) would require dosimetry to indicate the 
doses needed to ensure that all the articles will receive the minimum 
dose prescribed.
    Proposed paragraph (j)(2) would require the absorbed dose, as 
measured using an accurate dosimetry system, to meet or exceed the 
absorbed dose for the pest(s) of concern required by the PPQ Treatment 
Manual. The current dosimetry requirements refer to receiving the dose 
specified in the regulations; we would change this reference as part of 
moving the lists of approved treatments and scheduled to the PPQ 
Treatment Manual.
    Proposed paragraph (j)(3) would require the facility operator, when 
designing the facility's dosimetry system and procedures for its 
operation, to address guidance and principles from the International 
Standards Organization/American Society for Testing and Materials 
standard or an equivalent standard recognized by APHIS.

[[Page 22328]]

    Proposed paragraph (k) of Sec.  305.9 set outs requirements for 
recordkeeping. These requirements are copied from Sec. Sec.  305.31(k), 
305.32(f), and 305.34(b)(8), which are identical.
    Proposed paragraph (l) of Sec.  305.9 sets out requirements for 
requesting certification and inspection of a facility. Under this 
paragraph, persons requesting certification of an irradiation treatment 
facility would have to submit the request for approval in writing to 
the Animal and Plant Health Inspection Service, Plant Protection and 
Quarantine, Center for Plant Health Inspection and Technology, 1730 
Varsity Drive, Suite 400, Raleigh, NC 27606-5202. The initial request 
would have to 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 would make a 
personal inspection of the facility to determine whether it complies 
with the standards of proposed Sec.  305.9.
    These requirements are taken from current Sec.  305.31(l), which 
applies to facilities used to treat imported articles. Similar 
requirements are contained in Sec. Sec.  305.32(g), which applies to 
facilities used to treat articles moved interstate from areas 
quarantined for fruit flies, and 305.34(c), which applies to facilities 
used to treat articles moved interstate from Hawaii, Puerto Rico, and 
the U.S. Virgin Islands. Proposed paragraph (l) differs in that it 
refers to the certification of a facility, rather than to approval of a 
facility. Current Sec. Sec.  305.32(g) and 305.34(c) also do not 
include the requirement that the initial request for certification 
include the information described earlier. The submission of such 
information in requests for certification of irradiation facilities 
used to treat regulated articles moved interstate from Hawaii and U.S. 
territories or regulated articles to be moved interstate from areas 
quarantined for fruit flies would allow us to more efficiently evaluate 
requests for certification.
    In this proposal, we would also update the address of the Center 
for Plant Health Science and Technology, which is now located at the 
address given above.
    Proposed paragraph (m) of Sec.  305.9 sets out provisions for 
denial and withdrawal of certification. These requirements are taken 
from current Sec.  305.31(m). Except for referring to approval of a 
facility rather than certification, the requirements for denial and 
withdrawal in Sec. Sec.  305.32(h) and 305.34(d) are identical to the 
requirements in proposed Sec.  305.31(m).
    Proposed paragraph (n) of Sec.  305.9 informs the reader that the 
Department is not responsible for damage to treated articles. This 
proposed paragraph is copied from current Sec. Sec.  305.31(n), 
305.32(i), and 305.34(e), which are identical.
    The proposed changes to the irradiation treatment regulations would 
make the requirements more consistent across different types of 
facilities and would eliminate redundant text. We invite public comment 
on these changes.

Removal of Treatment Schedules From 7 CFR Parts 301 and 319

    Although part 305 serves as the main source for treatment schedules 
authorized under 7 CFR chapter III, there are also some other treatment 
schedules contained in parts 301 and 319. As part of this proposal, we 
would remove those schedules from the regulations and (if necessary) 
add them to the PPQ Treatment Manual. The schedules we are proposing to 
remove from the regulations are:
     Fumigation and cold treatment schedules for pine shoot 
beetle in paragraphs (a) through (c) of Sec.  301.50-10;
     Various treatments for citrus canker in Sec.  301.75-11;
     Chemical treatments in the appendix to the subpart for 
imported fire ant (Sec. Sec.  301.81 through 301.81-10);
     Heat and disinfection treatments for sugarcane diseases in 
Sec.  301.87-10;
     Cleaning and disinfection treatments for Karnal bunt in 
Sec.  301.89-13;
     Heat treatments for Phytophthora ramorum in Sec.  301.92-
10;
     A methyl bromide fumigation treatment for Unshu oranges 
from Japan and Korea in Sec.  319.28(b)(5);
     Heat treatment and fumigation schedules for regulated wood 
packing material in Sec.  319.40-3(b)(1);
     Heat treatment, fumigation, and surface pesticide 
treatments for regulated wood in Sec.  319.40-7(c) through (f);
     Treatments for disinfection of broomcorn and broomcorn 
products in Sec.  319.41-5a;
     A specific temperature requirement for quick freeze 
treatment in Sec.  319.56-12;
     Disinfection treatments for Karnal bunt in paragraphs 
(d)(3)(i) through (d)(3)(iii) of Sec.  319.59-4; and
     Fumigation treatment schedules for cut flowers in 
paragraph (c)(2) of Sec.  319.74-2.
    Under the heading ``4. Imported-Fire-Ant-Free Nursery--
Containerized Plants Only,'' the appendix to the imported fire ant 
subpart describes a systems approach for ensuring nursery freedom from 
imported fire ant and provides conditions under which containerized 
nursery stock may be certified for interstate movement under Sec.  
301.81-5. We would move this systems approach to a new section Sec.  
301.81-11, moving the chemical treatment schedules included in the 
systems approach to the PPQ Treatment Manual and making minor editorial 
changes to accommodate the movement of the systems approach 
requirements into the new section. This change would thus remove the 
appendix from the imported fire ant subpart.
    Because we would remove the schedules listed above from the 
regulations, we would also need to update references to those schedules 
elsewhere in the regulations. The specific changes we are consequently 
proposing can be found in the regulatory text at the end of this 
document.
    We would retain in the regulations treatments that are not intended 
for use on regulated articles but rather for use on premises, such as 
the malathion or spinosad bait spray treatments in Sec.  301.32-10(b) 
for premises in fruit fly quarantined areas.

Miscellaneous Changes

    In addition to removing treatment schedules, the changes proposed 
here would also make it necessary to update several references to 
treatments throughout 7 CFR chapter III. For example, several 
requirements within ``Subpart--Fruits and Vegetables'' (Sec. Sec.  
319.56-1 through 319.56-48) refer to authorized treatments listed in 7 
CFR part 305. As we are proposing to revise it, part 305 would not list 
specific authorized treatments; it would instead refer the reader to 
the PPQ Treatment Manual for specific approved treatments. Accordingly, 
we would amend references to authorized treatments listed in 7 CFR part 
305 to refer instead to treatment in accordance with 7 CFR part 305.
    Other changes are required when the regulatory text refers to 
specific sections or treatments in the current 7 CFR part 305; for 
example, the ``Subpart--Hawaiian Fruits, Vegetables, and Flowers'' 
regulations sometimes refer specifically to irradiation treatment in 
accordance with Sec.  305.34. These references would be amended to 
refer

[[Page 22329]]

generally to part 305, rather than to a specific section or treatment. 
All of the changes we are making to ensure consistency with the 
proposed changes can be found in the regulatory text at the end of this 
document.
    Some requirements in 7 CFR chapter III refer to treatment of 
articles, but do not refer specifically to treatment in accordance with 
part 305. We are proposing to include references to treatment in 
accordance with part 305 in existing treatment requirements in 
Sec. Sec.  318.47-3(a), 319.8-23(a)(1), and 319.55-6(b)(1).
    Some other provisions in 7 CFR chapter III refer generally to 
treatment as well. Within part 330, which addresses the risks posed by 
movement of plant pests; soil, stone, and quarry products; and garbage, 
Sec. Sec.  330.106(a) and 330.300 refer to treatment as a mitigation an 
inspector can direct to be employed in certain circumstances. In part 
352, which contains provisions for safeguarding plants and plant 
products that transit the United States, Sec.  352.10(b)(2)(viii) 
refers to the availability of treatment facilities as a factor in 
granting a transit permit, and Sec.  352.30 refers to treatment as may 
be required by an inspector for shipping containers used to transport 
untreated citrus in order to prevent plant pest dissemination. We are 
proposing to amend these references to ``treatment'' to refer 
specifically to treatment in accordance with part 305.
    The regulations for the interstate movement of sweetpotatoes from 
Hawaii with vapor heat treatment in Sec.  318.13-25 contain packaging 
requirements similar to those for irradiated articles moved interstate 
from Hawaii. These packaging requirements refer to preventing 
infestation by fruit flies, but sweetpotato is not a host of fruit 
flies. For the same reasons discussed earlier with respect to the 
irradiation packaging requirements, we would amend these requirements 
to refer instead to ``the pests of concern.''

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. 
The rule has been determined to be not significant for the purposes of 
Executive Order 12866 and, therefore, has not been reviewed by the 
Office of Management and Budget.
    APHIS is proposing amendments to 7 CFR parts 301, 305, 318, and 319 
to streamline the process for adding, revising, and removing treatment 
schedules and for authorizing the use of existing treatments for 
additional commodities. As required by the Regulatory Flexibility Act, 
we have evaluated the potential economic effects of this action on 
small businesses, small organizations, and small governmental 
jurisdictions
    The regulations in 7 CFR chapter III are intended, among other 
things, to prevent the introduction or dissemination of plant pests and 
noxious weeds into or within the United States. Under the regulations, 
certain plants, fruits, vegetables, and other articles must be treated 
before they may be moved into the United States or interstate. The 
phytosanitary treatments regulations contained in part 305 set out 
standards and schedules for treatments required in parts 301, 318, and 
319 for fruits, vegetables, and other articles.
    APHIS is proposing to remove the lists of authorized treatments and 
treatment schedules from part 305, while retaining the general 
requirements for performing treatments and treatment facilities. We 
would remove treatment schedules from other places where they are 
currently found in parts 301 and 319 as well. Treatment schedules would 
instead be found in the PPQ Treatment Manual. We are also proposing to 
establish a new process to make changes to the lists of approved 
treatments and the treatment schedules and to inform the public and 
solicit comments on the changes. We would also establish a process by 
which we could make immediate changes to the lists of approved 
treatments and to the treatment schedules, and establish criteria for 
when we could use this process. The current regulations do not address 
situations where there is an immediate need to withdraw treatments, 
modify treatments, or apply treatments differently. Finally, we would 
harmonize the separate requirements for performing irradiation 
treatment for imported articles, articles moved interstate from Hawaii, 
Puerto Rico, and the U.S. Virgin Islands, and articles moved interstate 
from an area quarantined for fruit flies. These changes would simplify 
and expedite our processes for adding, changing, and removing treatment 
schedules while continuing to provide for public participation in the 
process. These changes would also simplify our presentation of 
treatments to the public by consolidating all treatments into one 
document and eliminating redundant text from the regulations.
    Eliminating the need for specific prior rulemaking for approving 
new treatments or treatment schedules or for revising existing ones 
under the proposed notice-based process, could result in considerable 
time savings. The rulemaking process is an inherently longer process 
than a notice-based process. Additionally, establishing a notice-based 
process for approving new treatments or treatment schedules would 
facilitate use of the already-established notice-based process for 
authorizing the importation of fruits and vegetables set out in Sec.  
319.56-4. Under Sec.  319.56-4, APHIS can authorize the importation of 
fruits and vegetables via a notice-based process if APHIS makes the 
determination that the application of one or more designated 
phytosanitary measures is sufficient to mitigate the risk that plant 
pests or noxious weeds could be introduced into or disseminated within 
the United States via the imported fruits or vegetables. Currently, 
however, if one of the prescribed designated measures is a treatment 
that requires an amendment to part 305, rulemaking is still required to 
amend the lists of approved treatments or treatment schedules. 
Establishing a notice-based process to amend the lists of approved 
treatments or treatment schedules would streamline this process.
    Consumers benefit from the opportunity to consume commodities from 
a variety of sources, foreign as well as domestic. Consumer 
expenditures for fruit and vegetables are growing faster than for any 
food group other than meats. In many cases, fruit and vegetable imports 
can occur only after those commodities have been treated to prevent the 
introduction or movement of plant pests and/or diseases. This proposed 
rule would allow treatments to be put in use more quickly when 
treatment changes are necessary and when existing treatments are 
applied to new commodities; treated products would become available to 
meet consumer demand sooner than at present. Treated imports supplement 
domestic supplies, especially of fresh products during the winter. 
Treatments also allow for movement of domestically produced products to 
markets around the country that otherwise would not occur. This 
movement results in increased choices for consumers. Even where new 
imports compete directly with domestic production, consumers benefit 
when increased competition results in lower prices.
    Those entities most likely to be affected by the rule are domestic 
importers and producers of plants and plant products. The Small 
Business Administration (SBA) has established guidelines for 
determining which establishments are to be considered small. Import/
export merchants, agents, and brokers are identified within the broader 
wholesaling trade sector. A firm primarily engaged in wholesaling is

[[Page 22330]]

considered small if it employs not more than 100 persons. In 2002, more 
than 96 percent of fresh fruit and vegetable merchant wholesalers, more 
than 99 percent of grain and field bean merchant wholesalers, and more 
than 98 percent of flower and nursery stock wholesalers were considered 
small by SBA standards.\3\ All types of farms are considered small if 
they have annual receipts of $0.75 million or less. In 2002, more than 
99 percent of oilseed and grain farms, more than 99 percent of 
vegetable and melon farms, more than 99 percent of fruit and tree nut 
farms, more than 99 percent of greenhouse, nursery, and floriculture 
producers, and more than 99 percent of other crop farms were considered 
small by SBA standards.\4\
---------------------------------------------------------------------------

    \3\ 2002 Economic Census. Department of Commerce. U.S. Bureau of 
the Census. North American Industry Classification System (NAICS) 
Categories. 424480--Fresh fruit & Vegetable merchant wholesalers; 
424510--Grain & field bean merchant wholesalers; 424930--Flower, 
nursery stock, and florists' supplies merchant wholesalers.
    \4\ 2002 Census of Agriculture. US Department of Agriculture. 
National Agricultural Statistics Service. NAICS Categories--1111: 
Oilseed & Grain farming; 1112: Vegetable and melon farming; 1113: 
Fruit and tree nut farming; 1114: Greenhouse, nursery & Floriculture 
production; and 1119: Other Crop farming.
---------------------------------------------------------------------------

    Treatments are applicable to a wide variety of products including 
fruits, vegetables, live plants, bulbs, seeds, grains, logs, lumber, 
and other plants and plant products in a wide variety of circumstances. 
Vast quantities of treated products move into and through the United 
States annually. The United States is among the top producers and 
consumers of plants and plant products. U.S. per capita use of fruit 
and tree nuts totals nearly 300 pounds each year, ranking third in per 
capita consumption of major food groups, next to dairy and vegetables. 
Oranges, apples, grapes, and bananas are the most popular fruit while 
almonds, pecans, and walnuts are the most preferred tree nuts. Annual 
per capita use of all vegetables and melons averaged 445 pounds during 
the first 5 years of the 2000s.

       Table 3--U.S. Production Value of Selected Crops, 2004-2006
                               [$ million]
------------------------------------------------------------------------
                   Item                       2004      2005      2006
------------------------------------------------------------------------
Field and miscellaneous crops:
    Cotton, tobacco, sugar................     8,674     8,702     8,648
    Dry beans, peas, lentils..............       596       650       637
    Grains, hay...........................    47,367    45,225    57,209
    Oilseeds..............................    20,115    19,681    22,412
    Potatoes, misc........................     4,054     4,472     4,731
Fruit and nuts:
    Apples, pears.........................     1,696     1,969     2,567
    Berries...............................     2,082     2,300     2,668
    Citrus................................     2,485     2,303     2,738
    Grapes................................     3,010     3,494     3,304
    Nuts, other noncitrus.................     4,047     4,784     4,132
    Stone fruit...........................     1,243     1,462     1,563
Fresh vegetables:
    Brassica..............................     1,111     1,118     1,225
    Lettuce, spinach......................     2,062     2,108     2,635
    Melons................................       728       873       877
    Onions, peppers.......................     1,300     1,501     1,674
    Tomatoes..............................     2,445     2,609     2,670
    Other vegetables......................     1,430     1,599     1,619
------------------------------------------------------------------------

    In 2006, U.S. production of field and miscellaneous crops was 
valued at more than $93 billion, with grains, hay, and oilseeds 
accounting for the majority of this value. Fruit and tree nuts 
production was valued at about $17 billion. More than 63 percent of 
this production was in grapes, apples, almonds, oranges, and 
strawberries. Commercial vegetable production for the fresh market was 
valued at almost $11 billion, with tomatoes, lettuce, onions, broccoli, 
and sweet corn accounting for about 60 percent of this value.
    Imports have become increasingly important for domestic 
consumption. Imports of plants and plant products have expanded rapidly 
over the past two decades, and include many new and newly traded 
commodities. In 2006, the United States imported approximately $5.8 
billion in fresh fruits and tree nuts, about $2.5 billion in fresh 
vegetables, and about $1.5 billion in live plants and other plant 
products. Logs, lumber, and other timber product imports were valued at 
nearly $12 billion in 2006.

      Table 4--U.S. Imports of Plants and Plant Products, 2004-2006
                               [$ million]
------------------------------------------------------------------------
                   Item                       2004      2005      2006
------------------------------------------------------------------------
Live plants, bulbs, etc.:
    Bulbs, tubers.........................       208       208       208
    Cut flowers, dried....................       706       709       768
    Foliage...............................       102       114       123
    Other live plants.....................       362       352       358
Fruit and nuts:
    Bananas...............................     1,102     1,134     1,201
    Citrus, fresh.........................       307       356       407

[[Page 22331]]

 
    Coconuts, Brazil nuts.................       640       660       602
    Dates, figs, pineapples...............       570       812       936
    Grapes................................       743       980       953
    Other fruits and nuts.................     1,127     1,174     1,297
Fresh vegetables:
    Cucumbers, gherkins...................       349       319       421
    Melons................................       369       393       431
    Onions, shallots......................       254       308       282
    Tomatoes..............................     1,054     1,075     1,234
    Other vegetables......................       417       508       543
Logs, lumber, and other timber products:
    Wood in the rough.....................       246       348       347
    Wood, sawn or chipped.................     8,799     8,989     8,333
    Other wood............................     2,894     3,074     3,235
------------------------------------------------------------------------

    While treatments are applicable to a wide variety of plants and 
plant products in a wide variety of circumstances, the changes proposed 
in this rule would not alter current treatment requirements, the manner 
in which new treatments are evaluated, or when and how treatments are 
ultimately used other than in emergency situations. The proposed rule 
would allow treatment changes to be implemented more rapidly and 
therefore facilitate the movement of treated products to meet consumer 
demand. These changes are not expected to significantly impact the 
total supply of plants and plant products in the United States. 
Therefore, we expect at most small effects on U.S. marketers and 
consumers.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

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 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.

Paperwork Reduction Act

    This proposed rule contains no new information collection or 
recordkeeping requirements under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501 et seq.).

Lists of Subjects

7 CFR Part 301

    Agricultural commodities, Plant diseases and pests, Quarantine, 
Reporting and recordkeeping requirements, Transportation.

7 CFR Part 305

    Agricultural commodities, Chemical treatment, Cold treatment, Heat 
treatment, Imports, Irradiation, Phytosanitary treatment, Plant 
diseases and pests, Quarantine, Quick freeze, Reporting and 
recordkeeping requirements, Transportation.

7 CFR Part 318

    Cotton, Cottonseeds, Fruits, Guam, Hawaii, Plant diseases and 
pests, Puerto Rico, Quarantine, Transportation, Vegetables, Virgin 
Islands.

7 CFR Part 319

    Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant 
diseases and pests, Quarantine, Reporting and recordkeeping 
requirements, Rice, Vegetables.

7 CFR Part 330

    Customs duties and inspection, Imports, Plant diseases and pests, 
Quarantine, Reporting and recordkeeping requirements, Transportation.

7 CFR Part 352

    Customs duties and inspection, Imports, Plant diseases and pests, 
Quarantine, Reporting and recordkeeping requirements, Transportation.

    Accordingly, we propose to amend 7 CFR chapter III as follows:

PART 301--DOMESTIC QUARANTINE NOTICES

    1. The authority citation for part 301 continues to read as 
follows:

    Authority:  7 U.S.C. 7701-7772 and 7781-7786; 7 CFR 2.22, 2.80, 
and 371.3.
    Section 301.75-15 issued under Sec. 204, Title II, Public Law 
106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 
issued under Sec. 203, Title II, Public Law 106-224, 114 Stat. 400 
(7 U.S.C. 1421 note).

    2. In Sec.  301.32-10, in the introductory text, the first sentence 
is revised to read as follows:


Sec.  301.32-10  Treatments.

    Regulated articles may be treated in accordance with part 305 of 
this chapter to neutralize fruit flies. * * *
* * * * *


Sec.  301.50-5  [Amended]

    3. In Sec.  301.50-5, paragraph (a)(1)(i) is amended by removing 
the citation ``Sec.  301.50-10(d)'' and adding the citation ``Sec.  
301.50-10(b)'' in its place.
    4. Section 301.50-10 is amended as follows:
    a. By revising paragraph (a) to read as set forth below.
    b. By removing paragraphs (b) and (c).
    c. By redesignating paragraph (d) as paragraph (b).


Sec.  301.50-10  Treatments and management method.

    (a) Regulated articles may be treated in accordance with part 305 
of this chapter to neutralize the pine shoot beetle.
* * * * *

[[Page 22332]]

Sec.  301.75-4  [Amended]

    5. In Sec.  301.75-4, paragraphs (d)(2)(i)(C), (d)(2)(ii)(C), 
(d)(2)(ii)(D), (d)(2)(ii)(E), and (d)(4) are amended by removing the 
words ``Sec.  301.75-11(d) of this subpart'' and adding the words 
``part 305 of this chapter'' in their place; and paragraph (d)(4) is 
amended by removing the words ``Sec.  301.75-11(c) of this subpart'' 
and adding the words ``part 305 of this chapter'' in their place.


Sec.  301.75-6  [Amended]

    6. In Sec.  301.75-6, paragraphs (b)(5) and (b)(6) are amended by 
removing the words ``Sec.  301.75-11(d)'' and adding the words ``part 
305 of this chapter'' in their place; and paragraph (b)(5) is amended 
by removing the words ``Sec.  301.75-11(c)'' and adding the words 
``part 305 of this chapter'' in their place.


Sec.  301.75-7  [Amended]

    7. In Sec.  301.75-7, paragraphs (a)(3), (c)(1)(ii), and (c)(2)(v) 
are amended by removing the words ``Sec.  301.75-11(a) of this 
subpart'' and adding the words ``part 305 of this chapter'' in their 
place; and paragraph (c)(2)(iv) is amended by removing the words 
``Sec.  310.75-11(d) of this subpart'' and adding the words ``part 305 
of this chapter'' in their place.


Sec.  301.75-8  [Amended]

    8. In Sec.  301.75-8, paragraph (b) is amended by removing the 
words ``Sec.  301.75-11(b) of this subpart'' and adding the words 
``part 305 of this chapter'' in their place.


Sec.  301.75-11  [Removed and Reserved]

    9. Section 301.75-11 is removed and reserved.


Sec.  301.81-4  [Amended]

    10. Section 301.81-4 is amended as follows:
    a. In paragraph (a)(2)(iii), by removing the words ``the methods 
and procedures prescribed in the Appendix to this subpart (``III. 
Regulatory Procedures'')'' and adding the words ``part 305 of this 
chapter'' in their place.
    b. In paragraph (b), by removing the words ``the methods and 
procedures prescribed in the Appendix to this subpart (``III. 
Regulatory Procedures''), or in accordance with the methods and 
procedures prescribed in''.
    11. Section 301.81-5 is amended as follows:
    a. In paragraph (a)(3)(ii), at the end of the paragraph, by 
removing the word ``or''.
    b. In paragraph (a)(3)(iii), by removing the words ``methods and 
procedures prescribed in the Appendix to this subpart (``III. 
Regulatory Procedures'')'' and adding the words ``part 305 of this 
chapter'' in their place; and by adding the word ``or'' at the end of 
the paragraph.
    c. By adding a new paragraph (a)(3)(iv) to read as set forth below.


Sec.  301.81-5  Issuance of a certificate or limited permit.

    (a) * * *
    (3) * * *
    (iv) If the article is containerized nursery stock, it has been 
produced in accordance with Sec.  301.81-11 of this subpart.
* * * * *


Sec.  301.81-6  [Amended]

    12. Section 301.81-6 is amended by removing the words ``the 
``Imported Fire Ant Program Manual,'' as set forth in the appendix to 
this subpart'' and adding the words ``part 305 of this chapter'' in 
their place.
    13. A new Sec.  301.81-11 is added to read as follows:


Sec.  301.81-11  Imported fire ant detection, control, exclusion, and 
enforcement program for nurseries producing containerized plants.

    This detection, control, exclusion, and enforcement program is 
designed to keep nurseries free of the imported fire ant and provides a 
basis to certify containerized nursery stock for interstate movement. 
Participating regulated establishments must be operating under a 
compliance agreement in accordance with Sec.  301.81-6. Such compliance 
agreements shall state the specific requirements that a shipper agrees 
to follow to move plants in accordance with the requirements of the 
program. Certificates and a nursery identification number may be issued 
to the nursery for use on shipments of regulated articles.
    (a) Detection. (1) Nursery owners are required to survey visually 
their entire premises twice monthly for the presence of imported fire 
ants.
    (2) Nurseries participating in this program will be inspected by 
Federal or State inspectors at least twice per year. More frequent 
inspections may be necessary depending upon imported fire ant 
infestation levels immediately surrounding the nursery, the 
thoroughness of nursery management in maintaining imported-fire-ant-
free premises, and the number of previous detections of imported fire 
ants in or near containerized plants. Inspections by Federal and State 
inspectors should be more frequent just before and during the peak 
shipping season. Any nurseries determined during nursery inspections to 
have imported fire ant colonies must be immediately treated to the 
extent necessary to eliminate the colonies.
    (b) Control. Nursery plants that are shipped under this program 
must originate in a nursery that meets the requirements of this 
section. Nursery owners must implement a treatment program with 
registered bait and contact insecticides. The premises, including 
growing and holding areas, must be maintained free of the imported fire 
ant. As part of this treatment program, all exposed soil surfaces 
(including sod and mulched areas) on property where plants are grown, 
potted, stored, handled, loaded, unloaded, or sold must be treated in 
accordance with part 305 of this chapter at least once every 6 months. 
The first application must be performed early in the spring. Followup 
treatments with a contact insecticide in accordance with part 305 must 
be applied to eliminate all remaining colonies.
    (c) Exclusion. (1) For plants grown on the premises, treatment of 
soil or potting media in accordance with part 305 of this chapter prior 
to planting is required.
    (2) For plants received from outside sources, to prevent the spread 
into a nursery free of the imported fire ant by newly introduced, 
infested nursery plants, all plants must be:
    (i) Obtained from nurseries that comply with the requirements of 
this section and that operate under a compliance agreement in 
accordance with Sec.  301.81-6; or
    (ii) Treated upon delivery in accordance with part 305 of this 
chapter, and within 180 days be either:
    (A) Repotted in treated potting soil media;
    (B) Retreated in accordance with part 305 of this chapter at 180-
day intervals; or
    (C) Shipped.
    (d) Enforcement. (1) The nursery owner must maintain records of the 
nursery's surveys and treatments for the imported fire ant. These 
records must be made available to State and Federal inspectors upon 
request.
    (2) If imported fire ants are detected in nursery stock during an 
inspection by a Federal or State inspector, issuance of certificates 
for movement will be suspended until necessary treatments are applied 
and the plants and nursery premises are determined to be free of the 
imported fire ant. A Federal or State inspector may declare a nursery 
to be free of the imported fire ant upon reinspection of the premises. 
This inspection must be conducted no sooner than 30 days after 
treatment. During this period, certification may be based upon 
treatments for plants in accordance with part 305 of this chapter.

[[Page 22333]]

    (3) Upon notification by the department of agriculture in any State 
of destination that a confirmed imported fire ant infestation was found 
on a shipment from a nursery considered free of the imported fire ant, 
the department of agriculture in the State of origin must cease its 
certification of shipments from that nursery. An investigation by 
Federal or State inspectors will commence immediately to determine the 
probable source of the problem and to ensure that the problem is 
resolved. If the problem is an infestation, issuance of certification 
for movement on the basis of imported-fire-ant-free premises will be 
suspended until treatment and elimination of the infestation is 
completed. Reinstatement into the program will be granted upon 
determination that the nursery premises are free of the imported fire 
ant, and that all other provisions of this subpart are being followed.
    (4) In cases where the issuance of certificates is suspended 
through oral notification, the suspension and the reasons for the 
suspension will be confirmed in writing within 20 days of the oral 
notification of the suspension. Any person whose issuance of 
certificates has been suspended may appeal the decision, in writing, 
within 10 days after receiving the written suspension notice. The 
appeal must state all of the facts and reasons that the person wants 
the Administrator to consider in deciding the appeal. A hearing may be 
held to resolve any conflict as to any material fact. Rules of practice 
for the hearing will be adopted by the Administrator. As soon as 
practicable, the Administrator will grant or deny the appeal, in 
writing, stating the reasons for the decision.


Sec.  301.87-5  [Amended]

    14. In Sec.  301.87-5, paragraph (a)(1)(i) is amended by removing 
the words ``Sec.  301.87-10 of this subpart'' and adding the words 
``part 305 of this chapter'' in their place.


Sec.  301.87-10  [Removed and Reserved]

    15. Section 301.87-10 is removed and reserved.


Sec.  301.89-5  [Amended]

    16. In Sec.  301.89-5, paragraph (b) is amended by removing the 
words ``the methods and procedures prescribed in Sec.  301.89-13'' and 
adding the words ``part 305 of this chapter'' in their place.


Sec.  301.89-6  [Amended]

    17. In Sec.  301.89-6, paragraph (a)(3)(iii) is amended by removing 
the words ``methods and procedures prescribed in Sec.  301.89-13'' and 
adding the words ``part 305 of this chapter'' in their place.


Sec.  301.89-7  [Amended]

    18. Section 301.89-7 is amended by removing the citation ``Sec.  
301.89-13'' and adding the words ``part 305 of this chapter'' in its 
place.


Sec.  301.89-12  [Amended]

    19. In Sec.  301.89-12, paragraphs (a), (b), and (c) are amended by 
removing the citation ``Sec.  301.89-13'' and adding the words ``part 
305 of this chapter'' in its place.


Sec.  301.89-13  [Removed and Reserved]

    20. Section 301.89-13 is removed and reserved.


Sec.  301.92-5  [Amended]

    21. In Sec.  301.92-5, paragraph (a)(1)(i) is amended by removing 
the words ``Sec.  301.92-10 or''.


Sec.  301.92-10  [Removed and Reserved]

    22. Section 301.92-10 is removed and reserved.
    23. Part 305 is revised to read as follows:

PART 305--PHYTOSANITARY TREATMENTS

Sec.
305.1 Definitions.
305.2 Approved treatments.
305.3 Processes for adding, revising, or removing treatment 
schedules.
305.4 Monitoring and certification of treatments.
305.5 Chemical treatment requirements.
305.6 Cold treatment requirements.
305.7 Quick freeze treatment requirements.
305.8 Heat treatment requirements.
305.9 Irradiation treatment requirements.

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 21 U.S.C. 136 and 
136a; 7 CFR 2.22, 2.80, and 371.3.


Sec.  305.1  Definitions.

    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.
    Cold treatment. Exposure of a commodity to a specified cold 
temperature that is sustained for a specific time period to kill 
targeted pests, especially fruit flies.
    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 
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.
    Fumigant. A gaseous chemical that easily diffuses and disperses in 
air and is toxic to the target organism.
    Fumigation. Releasing and dispersing a toxic chemical in the air so 
that it reaches the target organism in a gaseous state.
    Inspector. Any individual authorized by the Administrator of APHIS 
or the Commissioner of Customs and Border Protection, Department of 
Homeland Security, to enforce the regulations in this part.
    Irradiation. The use of ionized energy to kill or neutralize 
organisms.
    Methyl bromide. A colorless, odorless biocide used to fumigate a 
wide range of commodities.
    Neutralize. In the case of treatments other than irradiation, to 
kill a plant pest; in the case of irradiation, to prevent the 
establishment of the pest by killing it, sterilizing it, or preventing 
its development from an immature stage into an adult capable of 
emerging from its host, reproducing, or becoming established.
    Plant Protection and Quarantine (PPQ). The Plant Protection and 
Quarantine program of APHIS.
    PPQ Treatment Manual. The document that contains the treatment 
schedules that are approved for use under this part. The Treatment 
Manual is available on the Internet at http://www.aphis.usda.gov/import_export/plants/manuals/index.shtml or by contacting the Animal 
and Plant Health Inspection Service, Plant Protection and Quarantine, 
Manuals Unit, 92 Thomas Johnson Drive, Suite 200, Frederick, MD 21702.
    Quick freeze. A commercially acceptable method of quick freezing at 
subzero temperatures with subsequent storage and transportation at not 
higher than 20 [deg]F. Methods that accomplish this are known as quick 
freezing, sharp freezing, cold pack, or frozen pack, but may be any 
equivalent commercially acceptable freezing method.
    Section 18 of Federal Insecticide, Fungicide, and Rodenticide Act 
(FIFRA). An emergency exemption granted by the U.S. Environmental 
Protection Agency to Federal or State agencies authorizing an 
unregistered use of a pesticide for a limited time.

[[Page 22334]]

    Vacuum fumigation. Fumigation performed in a gas-tight enclosure. 
Most air in the enclosure is removed and replaced with a small amount 
of fumigant. The reduction in pressure reduces the required duration of 
the treatment.


Sec.  305.2  Approved treatments.

    (a) Certain commodities or articles require treatment, or are 
subject to treatment, prior to interstate movement within the United 
States or importation or entry into the United States. Treatment is 
required as indicated in parts 301, 318, and 319 of this chapter, on a 
permit, or by an inspector.
    (b) Approved treatment schedules are set out in the PPQ Treatment 
Manual. Treatments may only be administered in accordance with the 
treatment requirements of this part and in accordance with treatment 
schedules found in the PPQ Treatment Manual.
    (c) APHIS is not responsible for losses or damages incurred during 
treatment and recommends that a sample be treated first before deciding 
whether to treat the entire shipment.


Sec.  305.3  Processes for adding, revising, or removing treatment 
schedules.

    (a) Normal process for adding, revising, or removing treatment 
schedules. Unless there is a need to immediately add, revise, or remove 
a treatment schedule, as provided in paragraph (b)(1) of this section, 
a treatment schedule may be added to the PPQ Treatment Manual, revised, 
or removed from the PPQ Treatment Manual as follows:
    (1) Notice of change to treatment schedule. APHIS will publish in 
the Federal Register a notice describing the reasons we have determined 
that it is necessary to add, revise, or remove a treatment schedule 
and, if necessary, making available the new or revised treatment 
schedule as it would be added to the PPQ Treatment Manual. In our 
notice, we will provide for a public comment period on the new or 
revised treatment schedule or on the removal of the treatment schedule 
from the PPQ Treatment Manual.
    (2) Response to comments. (i) APHIS will issue a notice after the 
close of the public comment period indicating that the treatment 
schedule specified in the initial notice will be added to the PPQ 
Treatment Manual, revised as described in the notice, or removed from 
the PPQ Treatment Manual if:
    (A) No comments were received on the notice;
    (B) The comments on the notice supported our action; or
    (C) The comments on the notice were evaluated but did not change 
our determination that it is necessary to add, revise, or remove the 
treatment schedule, as described in the notice.
    (ii) If the notice issued after the close of the public comment 
period indicates that a change will be made to the PPQ Treatment 
Manual, APHIS will make available a new version of the PPQ Treatment 
Manual that reflects the addition, revision, or removal of the 
particular treatment schedule.
    (iii) If comments present information that causes us to determine 
that the change described in the notice is not appropriate, APHIS will 
issue a notice informing the public of this determination after the 
close of the comment period.
    (b) Process for immediately adding, revising, or removing treatment 
schedules. Treatment schedules may be immediately added to the PPQ 
Treatment Manual, revised, or removed from the PPQ Treatment Manual 
under the circumstances described in paragraph (b)(1) of this section 
and in accordance with the process described in paragraphs (b)(2) and 
(b)(3) of this section.
    (1) Circumstances in which the immediate process may be used. 
Treatment schedules may be immediately added to the PPQ Treatment 
Manual, revised, or removed from the PPQ Treatment Manual if any of the 
following circumstances apply:
    (i) PPQ has determined that an approved treatment schedule is 
ineffective at neutralizing the targeted plant pest(s);
    (ii) PPQ has determined that, in order to neutralize the targeted 
plant pest(s), the treatment schedule must be administered using a 
different process than was previously used;
    (iii) PPQ has determined that a new treatment schedule is 
effective, based on efficacy data, and that ongoing trade in a 
commodity or commodities may be adversely impacted unless the new 
treatment schedule is approved for use; or
    (iv) The use of a treatment schedule is no longer authorized by the 
U.S. Environmental Protection Agency or by any other Federal entity.
    (2) Process for immediate change to treatment schedules. If PPQ 
determines that one or more of the circumstances in paragraph (b)(1) of 
this section applies and that it is necessary to take immediate action, 
APHIS will publish in the Federal Register a notice describing the 
reasons we have determined that it is necessary to immediately add, 
revise, or remove a treatment schedule and, if necessary, making 
available the new or revised treatment schedule as it has been added to 
the PPQ Treatment Manual. Treatment schedules that have been added to 
the PPQ Treatment Manual or revised under this process will be listed 
in a separate section of the PPQ Treatment Manual as having been added 
or revised through the immediate process described in this paragraph 
(b). The PPQ Treatment Manual will indicate that these treatment 
schedules are subject to change or removal based on public comment. In 
our notice, we will provide for a public comment period on the new or 
revised treatment schedule or on the removal of the treatment schedule 
from the PPQ Treatment Manual.
    (3) Response to comments. (i) APHIS will issue a notice after the 
close of the public comment period affirming the action described in 
the initial notice if:
    (A) No comments were received on the notice;
    (B) The comments on the notice supported our action; or
    (C) The comments on the notice were evaluated but did not change 
our determination that it was necessary to add, revise, or remove the 
treatment schedule, as described in the notice.
    (ii) If the notice issued after the close of the public comment 
period indicates that the initial change to the PPQ Treatment Manual is 
affirmed, APHIS will make available a new version of the PPQ Treatment 
Manual that will reflect the addition, revision, or removal of the 
particular treatment schedule in the main body of the PPQ Treatment 
Manual.
    (iii) If comments present information that causes us to determine 
that it is necessary to change a treatment schedule added to the PPQ 
Treatment Manual under this process or to further revise a treatment 
schedule that was revised under this process, APHIS will publish a 
notice in the Federal Register informing the public of this 
determination after the close of the comment period and will revise the 
treatment schedule accordingly.
    (iv) If comments present information that causes us to determine 
that the change described in the initial notice was not appropriate, 
APHIS will publish a notice in the Federal Register informing the 
public of this determination after the close of the comment period and 
will, if necessary, remove the new or revised treatment schedule from 
the separate section of the PPQ Treatment Manual.


Sec.  305.4  Monitoring and certification of treatments.

    (a) All treatments approved under part 305 are subject to 
monitoring and verification by APHIS.

[[Page 22335]]

    (b) Any treatment performed outside the United States must be 
monitored and certified by an inspector or an official authorized by 
APHIS. If monitoring and certification involves an official authorized 
by APHIS, the treated commodities must be accompanied by a 
phytosanitary certificate issued by the national plant protection 
organization of the exporting country certifying that treatment was 
conducted in accordance with APHIS regulations. The phytosanitary 
certificate must be provided to an inspector when the commodity is 
offered for entry into the United States. During the entire interval 
between treatment and export, the consignment must be stored and 
handled in a manner that prevents any infestation by pests and noxious 
weeds.


Sec.  305.5  Chemical treatment requirements.

    (a) Certified facility. The fumigation treatment facility must be 
certified by APHIS. Facilities are required to be inspected and 
recertified annually, or as often as APHIS directs, depending upon 
treatments performed, commodities handled, and operations conducted at 
the facility. In order to be certified, a fumigation facility must:
    (1) Be capable of administering the required dosage range for the 
required duration and at the appropriate temperature, as specified in 
the treatment schedules in the PPQ Treatment Manual.
    (2) Be adequate to contain the fumigant and be constructed from 
material that is not reactive to the fumigant.
    (3) For vacuum fumigation facilities, be constructed to withstand 
required negative pressure.
    (b) Monitoring. Treatment must be monitored by an official 
authorized by APHIS to ensure proper administration of the treatment, 
including that the correct amount of gas reaches the target organism 
and that an adequate number and placement of blowers, fans, sampling 
tubes, or monitoring lines are used in the treatment enclosure. An 
official authorized by APHIS approves, adjusts, or rejects the 
treatment.
    (c) Treatment procedures. (1) To kill the pest, all chemical 
applications must be administered in accordance with an Environmental 
Protection Agency (EPA) approved pesticide label and the APHIS-approved 
treatment schedule prescribed in the PPQ Treatment Manual. If EPA 
cancels approval for the use of a pesticide on a commodity, then the 
treatment schedule prescribed in the PPQ Treatment Manual is no longer 
authorized for that commodity. If the commodity is not listed on the 
pesticide label and/or included in a Federal quarantine or crisis 
exemption in accordance with FIFRA section 18, then no chemical 
treatment is available.
    (2) Temperature/concentration readings must be taken for items 
known to be sorptive or whose sorptive properties are unknown when 
treatment is administered in chambers at normal atmospheric pressure.
    (3) Unless otherwise specified in the PPQ Treatment Manual, the 
volume of the commodity stacked inside the treatment enclosure must not 
exceed \2/3\ of the volume of the enclosure. Stacking must be approved 
by an official authorized by APHIS before treatment begins. All 
commodities undergoing treatment must be listed on the label or 
authorized under Section 18 of FIFRA.
    (4) Recording and measuring equipment must be adequate to 
accurately monitor the gas concentration, to ensure the correct amount 
of gas reaches the pests, and to detect any leaks in the enclosure. At 
least three sampling tubes or monitoring lines must be used in the 
treatment enclosure.
    (5) An adequate number of blowers or fans must be used inside of 
the treatment enclosure to uniformly distribute gas throughout the 
enclosure. The circulation system must be able to recirculate the 
entire volume of gas in the enclosure in 3 minutes or less.
    (6) The exposure period begins after all gas has been introduced.
    (7) For vacuum fumigation: The vacuum pump must be able to reduce 
pressure in the treatment enclosure to 1-2 inches of mercury in 15 
minutes or less.


Sec.  305.6  Cold treatment requirements.

    (a) Approval of treatment facilities. All facilities or locations 
used for refrigerating fruits or vegetables in accordance with the cold 
treatment schedules in the PPQ Treatment Manual must be approved by 
APHIS. Reapproval of the facility or carrier is required every 3 years, 
or as often as APHIS directs, depending on treatments performed, 
commodities handled, and operations conducted at the facility. In order 
to be approved, facilities and carriers must:
    (1) Be capable of keeping treated and untreated fruits, vegetables, 
or other articles separate so as to prevent reinfestation of articles 
and spread of pests;
    (2) Have equipment that is adequate to effectively perform cold 
treatment.
    (b) Places of treatment; ports of entry. Precooling and 
refrigeration may be performed prior to, or upon arrival of fruits and 
vegetables in the United States, provided treatments are performed in 
accordance with applicable requirements of this section. Fruits and 
vegetables that are not treated prior to arrival in the United States 
must be treated after arrival only in cold storage warehouses approved 
by the Administrator and located in the area north of 39[deg] longitude 
and east of 104[deg] latitude or at one of the following ports: The 
maritime ports of Wilmington, NC; Seattle, WA; Corpus Christi, TX; and 
Gulfport, MS; Seattle-Tacoma International Airport, Seattle, WA; and 
Hartsfield-Atlanta International Airport, Atlanta, GA.
    (c) Cold treatment enclosures. All enclosures, in which cold 
treatment is performed, including refrigerated containers, must:
    (1) Be capable of maintaining the treatment temperature specified 
in the PPQ Treatment Manual before the treatment begins and holding 
fruit at or below the treatment temperature during the treatment.
    (2) Maintain fruit pulp temperatures according to treatment 
schedules with no more than a 0.39 [deg]C (0.7 [deg]F) variation in 
temperature.
    (3) Be structurally sound and adequate to maintain required 
temperatures.
    (d) Treatment procedures. (1) All material, labor, and equipment 
for cold treatment performed on a vessel must be provided by the vessel 
or vessel agent. An official authorized by APHIS monitors, manages, and 
advises in order to ensure that the treatment procedures are followed.
    (2) Refrigeration must be completed in the container, compartment, 
or room in which it is begun.
    (3) Fruit that may be cold treated must be safeguarded to prevent 
cross-contamination or mixing with other infested fruit.
    (4) Fruit intended for in-transit cold treatment must be precooled 
to the temperature at which the fruit will be treated prior to 
beginning treatment. The in-transit treatment enclosure may not be used 
for precooling unless an official authorized by APHIS approves the 
loading of the fruit in the treatment enclosure as adequate to allow 
for fruit pulp temperatures to be taken prior to beginning treatment. 
If the fruit is precooled outside the treatment enclosure, an official 
authorized by APHIS will take pulp temperatures manually from a sample 
of the fruit as the fruit is loaded for in-transit cold treatment to 
verify that precooling was completed. If the pulp temperatures for the 
sample are 0.28 [deg]C (0.5 [deg]F) or more above the temperature at 
which the fruit will be treated, the pallet from which the sample was 
taken will be rejected

[[Page 22336]]

and returned for additional precooling until the fruit reaches the 
treatment temperature. If fruit is precooled in the treatment 
enclosure, or if treatment is conducted at a cold treatment facility in 
the United States, the fruit must be precooled to the temperature at 
which it will be treated, as verified by an official authorized by 
APHIS, prior to beginning treatment.
    (5) Breaks, damage, etc., in the treatment enclosure that preclude 
maintaining correct temperatures must be repaired before the enclosure 
is used. An official authorized by APHIS must approve loading of 
compartment, number and placement of temperature probes or sensors, and 
initial fruit temperature readings before beginning the treatment. 
Hanging decks and hatch coamings within vessels may not be used as 
enclosures for in-transit cold treatment without prior written approval 
from APHIS. Double-stacking of pallets is not allowed.
    (6) Only the same type of fruit in the same type of package may be 
treated together in a container; no mixture of fruits in containers may 
be treated. A numbered seal must be placed on the doors of the loaded 
container and may be removed only at the port of destination by an 
official authorized by APHIS.
    (7) Temperature recording devices used during treatment must be 
password-protected and tamperproof. The devices must be able to record 
the date, time, and sensor number and automatic and continuous records 
of the temperature during all calibrations and during treatment. 
Recording devices must be capable of generating temperature charts for 
verification by an inspector. If records of calibrations or treatments 
are found to have been manipulated, the vessel or container in which 
the treatment is performed may be suspended from conducting cold 
treatments until proper equipment is installed and an official 
authorized by APHIS has recertified it. APHIS' decision to recertify a 
vessel or container will take into account the severity of the 
infraction that led to suspension.
    (8) A minimum of four temperature probes or sensors is required for 
vessel holds used as treatment enclosures. A minimum of three 
temperature probes or sensors is required for other treatment 
enclosures. An official authorized by APHIS will have the option to 
require that additional temperature probes or sensors be used, 
depending on the size of the treatment enclosure.
    (9) Fruit pulp temperatures must be maintained at the temperature 
specified in the treatment schedule with no more than a 0.39 [deg]C 
(0.7 [deg]F) variation in temperature between two consecutive hourly 
readings. Failure to comply with this requirement will result in 
invalidation of the treatment unless an official authorized by APHIS 
can verify that the pulp temperature was maintained at or below the 
treatment temperature for the duration of the treatment.
    (10) The time required to complete the treatment begins when all 
temperature probes reach the prescribed cold treatment schedule 
temperature. Refrigeration continues until the vessel arrives at the 
port of destination and the fruit is released for unloading by an 
inspector even though this may prolong the period required for the cold 
treatment.
    (11) Temperatures must be recorded at intervals no longer than 1 
hour apart. Gaps of longer than 1 hour will invalidate the treatment or 
indicate treatment failure unless an official authorized by APHIS can 
verify that the pulp temperature was maintained at or below the 
treatment temperature for the duration of the treatment.
    (12) Cold treatment is not completed until so declared by an 
official authorized by APHIS or the certifying official of the foreign 
country; consignments of treated commodities may not be discharged 
until APHIS clearance has been fully completed, including review and 
approval of treatment record charts.
    (13) Cold treatment of fruits in break bulk vessels or containers 
must be initiated by an official authorized by APHIS if there is not a 
treatment technician who has been trained to initiate cold treatments 
for either break bulk vessels or containers.
    (14) An official authorized by APHIS may perform audits to ensure 
that the treatment procedures comply with the regulations in this 
section and that the treatment is administered in accordance with the 
treatment schedules in the PPQ Treatment Manual. The official 
authorized by APHIS must be given the appropriate materials and access 
to the facility, container, or vessel necessary to perform the audits.
    (15) An inspector will sample and cut fruit from each consignment 
cold treated for Mediterranean fruit fly (Medfly) to monitor treatment 
effectiveness. If a single live Medfly in any stage of development is 
found, the consignment will be held until an investigation is completed 
and appropriate remedial actions have been implemented. If APHIS 
determines at any time that the safeguards contained in this section do 
not appear to be effective against the Medfly, APHIS may suspend the 
importation of fruits from the originating country and conduct an 
investigation into the cause of the deficiency.
    (16) The cold treatments required for the entry of fruit are 
considered necessary for the elimination of plant pests, and no 
liability shall attach to the U.S. Department of Agriculture or to any 
officer or representative of that Department in the event injury 
results to fruit offered for entry in accordance with these 
instructions. In prescribing cold treatments of certain fruits, it 
should be emphasized that inexactness and carelessness in applying the 
treatments may result in injury to the fruit or its rejection for 
entry.
    (e) Monitoring. Treatment must be monitored by an inspector to 
ensure proper administration of the treatment. An inspector must also 
approve the recording devices and sensors used to monitor temperatures 
and conduct an operational check of the equipment before each use and 
ensure sensors are calibrated. An inspector may approve, adjust, or 
reject the treatment.
    (f) Compliance agreements. Facilities located in the United States 
must operate under a compliance agreement with APHIS. The compliance 
agreement must be signed by a representative of the cold treatment 
facility and APHIS. The compliance agreement must contain requirements 
for equipment, temperature, circulation, and other operational 
requirements for performing cold treatment to ensure that treatments 
are administered properly. Compliance agreements must allow officials 
of APHIS to inspect the facility to monitor compliance with the 
regulations.
    (g) Workplans. Facilities located outside the United States may 
operate in accordance with a bilateral workplan. The workplan, if and 
when required, must be signed by a representative of the cold treatment 
facility, the national plant protection organization (NPPO) of the 
country of origin, and APHIS. The workplans must contain requirements 
for equipment, temperature, circulation, and other operational 
requirements for performing cold treatment to ensure that cold 
treatments are administered properly. Workplans for facilities outside 
the United States may also include trust fund agreement information 
regarding payment of the salaries and expenses of APHIS employees on 
site. Workplans must allow officials of the NPPO and APHIS to inspect 
the facility to monitor compliance with APHIS regulations.
    (h) Additional requirements for treatments performed after arrival 
in the United States.

[[Page 22337]]

    (1) Maritime port of Wilmington, NC. Consignments of fruit arriving 
at the maritime port of Wilmington, NC, for cold treatment, in addition 
to meeting all other applicable requirements of this section, must meet 
the following special conditions:
    (i) Bulk consignments (those consignments which are stowed and 
unloaded by the case or bin) of fruit must arrive in fruit fly-proof 
packaging that prevents the escape of adult, larval, or pupal fruit 
flies.
    (ii) Bulk and containerized consignments of fruit must be cold-
treated within the area over which the U.S. Department of Homeland 
Security is assigned the authority to accept entries of merchandise, to 
collect duties, and to enforce the various provisions of the customs 
and navigation laws in force.
    (iii) Advance reservations for cold treatment space must be made 
prior to the departure of a consignment from its port of origin.
    (iv) The cold treatment facility must remain locked during non-
working hours.
    (2) Maritime port of Seattle, WA. Consignments of fruit arriving at 
the maritime port of Seattle, WA, for cold treatment, in addition to 
meeting all other applicable requirements of this section, must meet 
the following special conditions:
    (i) Bulk consignments (those consignments which are stowed and 
unloaded by the case or bin) of fruit must arrive in fruit fly-proof 
packaging that prevents the escape of adult, larval, or pupal fruit 
flies.
    (ii) Bulk and containerized consignments of fruit must be cold 
treated within the area over which the U.S. Department of Homeland 
Security is assigned the authority to accept entries of merchandise, to 
collect duties, and to enforce the various provisions of the customs 
and navigation laws in force.
    (iii) Advance reservations for cold treatment space must be made 
prior to the departure of a consignment from its port of origin.
    (iv) The cold treatment facility must remain locked during non-
working hours.
    (v) Black light or sticky paper must be used within the cold 
treatment facility, and other trapping methods, including APHIS-
approved fruit fly traps, must be used within the 4 square miles 
surrounding the cold treatment facility.
    (vi) The cold treatment facility must have contingency plans, 
approved by the Administrator, for safely destroying or disposing of 
fruit.
    (3) Airports of Atlanta, GA, and Seattle, WA. Consignments of fruit 
arriving at the airports of Atlanta, GA, and Seattle, WA, for cold 
treatment, in addition to meeting all other applicable requirements of 
this section, must meet the following special conditions:
    (i) Bulk and containerized consignments of fruit must arrive in 
fruit fly-proof packaging that prevents the escape of adult, larval, or 
pupal fruit flies.
    (ii) Bulk and containerized consignments of fruit arriving for cold 
treatment must be cold treated within the area over which the U.S. 
Department of Homeland Security is assigned the authority to accept 
entries of merchandise, to collect duties, and to enforce the various 
provisions of the customs and navigation laws in force.
    (iii) The cold treatment facility and APHIS must agree in advance 
on the route by which consignments are allowed to move between the 
aircraft on which they arrived at the airport and the cold treatment 
facility. The movement of consignments from aircraft to a cold 
treatment facility will not be allowed until an acceptable route has 
been agreed upon.
    (iv) Advance reservations for cold treatment space must be made 
prior to the departure of a consignment from its port of origin.
    (v) The cold treatment facility must remain locked during non-
working hours.
    (vi) Black light or sticky paper must be used within the cold 
treatment facility, and other trapping methods, including APHIS-
approved fruit fly traps, must be used within the 4 square miles 
surrounding the cold treatment facility.
    (vii) The cold treatment facility must have contingency plans, 
approved by the Administrator, for safely destroying or disposing of 
fruit.
    (4) Maritime ports of Gulfport, MS, and Corpus Christi, TX. 
Consignments of fruit arriving at the ports of Gulfport, MS, and Corpus 
Christi, TX, for cold treatment, in addition to meeting all other 
applicable requirements of this section, must meet the following 
special conditions:
    (i) All fruit entering the port for cold treatment must move in 
maritime containers. No bulk consignments (those consignments which are 
stowed and unloaded by the case or bin) are permitted.
    (ii) Within the container, the fruit intended for cold treatment 
must be enclosed in fruit fly-proof packaging that prevents the escape 
of adult, larval, or pupal fruit flies.
    (iii) All consignments of fruit arriving at the port for cold 
treatment must be cold treated within the area over which the U.S. 
Department of Homeland Security is assigned the authority to accept 
entries of merchandise, to collect duties, and to enforce the various 
provisions of the customs and navigation laws in force.
    (iv) The cold treatment facility and APHIS must agree in advance on 
the route by which consignments are allowed to move between the vessel 
on which they arrived at the port and the cold treatment facility. The 
movement of consignments from vessel to cold treatment facility will 
not be allowed until an acceptable route has been agreed upon.
    (v) Advance reservations for cold treatment space at the port must 
be made prior to the departure of a consignment from its port of 
origin.
    (vi) Devanning, the unloading of fruit from containers into the 
cold treatment facility, must adhere to the following requirements:
    (A) All containers must be unloaded within the cold treatment 
facility; and
    (B) Untreated fruit may not be exposed to the outdoors under any 
circumstances.
    (vii) The cold treatment facility must remain locked during non-
working hours.
    (viii) Black lights or sticky paper must be used within the cold 
treatment facility, and other trapping methods, including APHIS-
approved fruit fly traps, must be used within the 4 square miles 
surrounding the cold treatment facility at the maritime port of 
Gulfport, MS, and within the 5 square miles surrounding the cold 
treatment facility at the maritime port of Corpus Christi, TX.
    (ix) During cold treatment, a backup system must be available to 
cold treat the consignments of fruit should the primary system 
malfunction. The facility must also have one or more reefers (cold 
holding rooms) and methods of identifying lots of treated and untreated 
fruits.
    (x) The cold treatment facility must have the ability to conduct 
methyl bromide fumigations on site.
    (xi) The cold treatment facility must have contingency plans, 
approved by the Administrator, for safely destroying or disposing of 
fruit.


Sec.  307.8  Quick freeze treatment requirements.

    Quick freeze treatment for fruits and vegetables imported into the 
United States or moved interstate from Hawaii or Puerto Rico must be 
conducted in accordance with Sec. Sec.  319.56-12, 318.13-

[[Page 22338]]

4a, or 318.58-4a, respectively. The PPQ Treatment Manual indicates the 
fruits and vegetables for which quick freeze is an authorized 
treatment.


Sec.  305.8   Heat treatment requirements.

    (a) Certified facility. The treatment facility must be certified by 
APHIS. Recertification is required annually, or as often as APHIS 
directs, depending upon treatments performed, commodities handled, and 
operations conducted at the facility. In order to be certified, a heat 
treatment facility must:
    (1) Have equipment that is capable of adequately circulating air or 
water (as relevant to the treatment), changing the temperature, and 
maintaining the changed temperature sufficient to meet the treatment 
schedule parameters in the PPQ Treatment Manual.
    (2) Have equipment used to record, monitor, or sense temperature, 
maintained in proper working order.
    (3) Keep treated and untreated fruits, vegetables, or articles 
separate so as to prevent reinfestation and spread of pests.
    (b) Monitoring. Treatment must be monitored by an official 
authorized by APHIS to ensure proper administration of the treatment. 
An official authorized by APHIS approves, adjusts, or rejects the 
treatment.
    (c) Compliance agreements. Facilities located in the United States 
must operate under a compliance agreement with APHIS. The compliance 
agreement must be signed by a representative of the heat treatment 
facilities located in the United States and APHIS. The compliance 
agreement must contain requirements for equipment, temperature, water 
quality, circulation, and other measures for performing heat treatments 
to ensure that treatments are administered properly. Compliance 
agreements must allow officials of APHIS to inspect the facility to 
monitor compliance with the regulations.
    (d) Workplans. Facilities located outside the United States must 
operate in accordance with a workplan. The workplan must be signed by a 
representative of the heat treatment facilities located outside the 
United States, the national plant protection organization of the 
country of origin (NPPO), and APHIS. The workplan must contain 
requirements for equipment, temperature, water quality, circulation, 
and other measures to ensure that heat treatments are administered 
properly. Workplans for facilities outside the United States must 
include trust fund agreement information regarding payment of the 
salaries and expenses of APHIS employees on site. Workplans must allow 
officials of the NPPO and APHIS to inspect the facility to monitor 
compliance with APHIS regulations.
    (e) Treatment procedures. (1) Before each treatment can begin, an 
official authorized by APHIS must approve the loading of the commodity 
in the treatment container.
    (2) Sensor equipment must be adequate to monitor the treatment, its 
type and placement must be approved by an official authorized by APHIS, 
and the equipment must be tested by an official authorized by APHIS 
prior to beginning the treatment. Sensor equipment must be locked 
before each treatment to prevent tampering.
    (3) Fruits, vegetables, or articles of substantially different 
sizes must be treated separately; oversized fruit may be rejected by an 
official authorized by APHIS.
    (4) The treatment period begins when the temperature specified by 
the treatment schedule has been reached. An official authorized by 
APHIS may abort the treatment if the facility requires an unreasonably 
long time to achieve the required temperature.


Sec.  305.9  Irradiation treatment requirements.

    Irradiation, carried out in accordance with the provisions of this 
section, is approved as a treatment for any imported regulated article 
(i.e., fruits, vegetables, cut flowers, and foliage); for any regulated 
article moved interstate from Hawaii, Puerto Rico, the U.S. Virgin 
Islands, Guam, and the Commonwealth of the Northern Marianas Islands 
(referred to collectively, in this section, as Hawaii and U.S. 
territories); and for any berry, fruit, nut, or vegetable listed as a 
regulated article in Sec.  301.32-2(a) of this chapter.
    (a) Location of facilities. (1) Where certified irradiation 
facilities are available, an approved irradiation treatment may be 
conducted for any imported regulated article either prior to shipment 
to the United States or in the United States. For any regulated article 
moved interstate from Hawaii or U.S. territories, irradiation treatment 
may be conducted either prior to movement to the mainland United States 
or in the mainland United States. For articles that are imported or 
moved interstate from Hawaii or U.S. territories, irradiation 
facilities may be located in any State on the mainland United States 
except Alabama, Arizona, California, Florida, Kentucky, Louisiana, 
Nevada, New Mexico, South Carolina, Tennessee, Texas, and Virginia. In 
the States of Georgia, Mississippi, and North Carolina, irradiation 
facilities may only be located at the maritime ports of Gulfport, MS, 
or Wilmington, NC, or the airport of Atlanta, GA, and only if the 
following special conditions are met: The articles to be irradiated 
must be imported or moved interstate packaged in accordance with 
paragraph (f)(3) of this section; the irradiation facility and APHIS 
must agree in advance on the route by which shipments are allowed to 
move between the vessel on which they arrive and the irradiation 
facility; untreated articles may not be removed from their packaging 
prior to treatment under any circumstances; blacklight or sticky paper 
must be used within the irradiation facility, and other trapping 
methods, including APHIS-approved fruit fly traps, must be used within 
the 4 square miles surrounding the facility; and the facility must have 
contingency plans, approved by APHIS, for safely destroying or 
disposing of regulated articles. 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, TX, 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.
    (2) For articles that are moved interstate from areas quarantined 
for fruit flies, irradiation facilities may be located either within or 
outside of the quarantined area. If the articles are treated outside 
the quarantined area, they must be accompanied to the facility by a 
limited permit issued in accordance with Sec.  301.32-5(b) and must be 
moved in accordance with any safeguards determined to be appropriate by 
APHIS.
    (b) Approved facilities. The irradiation treatment facility must be 
approved by APHIS. In order to be approved, a facility must fulfill the 
requirements in paragraphs (c) and (d) of this section.
    (c) Compliance agreements--(1) Irradiation facilities treating 
imported articles--(i) Compliance agreements with importers and 
facility operators for irradiation in the United States. If irradiation 
of imported articles is conducted in the United States, both the 
importer and the operator of the irradiation facility must sign 
compliance agreements with APHIS. In the facility compliance agreement, 
the facility operator must agree to comply with any additional 
requirements found necessary by APHIS 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

[[Page 22339]]

must agree to comply with any additional requirements found necessary 
by APHIS to ensure the shipment is not diverted to a destination other 
than an approved treatment facility 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.
    (ii) Compliance agreement with irradiation facilities outside the 
United States. If irradiation of imported articles is conducted outside 
the United States, the operator of the irradiation facility must sign a 
compliance agreement with APHIS and the national plant protection 
organization (NPPO) 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 NPPO of the country in which the 
facility is located must agree to monitor that compliance and to inform 
the Administrator of any noncompliance.
    (2) Irradiation facilities treating articles moved interstate from 
Hawaii and U.S. territories. Irradiation facilities treating articles 
moved interstate from Hawaii and U.S. territories must complete a 
compliance agreement with APHIS as provided in Sec.  318.13-3(d) of 
this chapter.
    (3) Irradiation facilities treating articles moved interstate from 
areas quarantined for fruit flies. Irradiation facilities treating 
articles moved interstate from areas quarantined for fruit flies must 
complete a compliance agreement with APHIS as provided in Sec.  301.32-
6 of this chapter.
    (d) Certified facility. The irradiation treatment facility must be 
certified by APHIS. Recertification is required in the event of an 
increase or a significant decrease in the amount of 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 the PPQ Treatment Manual to the regulated 
articles; \1\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    (2) Be constructed so as to provide physically separate locations 
for treated and untreated articles, except that articles 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, or some other means approved 
during certification to prevent reinfestation of articles and spread of 
pests.
    (3) If the facility is to be used to treat imported articles and is 
located in the United States, the facility will only be certified if 
APHIS 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.
    (e) Monitoring and interagency agreements. Treatment must be 
monitored by an inspector. This monitoring will include inspection of 
treatment records and unannounced inspections of the facility by an 
inspector, and may include inspection of articles prior to or after 
irradiation.
    (1) Irradiation facilities located in foreign countries. Facilities 
in foreign countries that carry out irradiation operations must notify 
the Director of Preclearance, PPQ, APHIS, 4700 River Road Unit 140, 
Riverdale, MD 20737-1236, of scheduled operations at least 30 days 
before operations commence, except where otherwise provided in the 
facility preclearance workplan. To ensure the appropriate level of 
monitoring, before articles may be imported in accordance with this 
section, the following agreements must be signed:
    (i) Irradiation treatment framework equivalency workplan. The NPPO 
of a country from which articles are to be imported into the United 
States in accordance with this section must sign a framework 
equivalency workplan with APHIS. In this plan, both the NPPO and APHIS 
will specify the following items for their respective countries:
    (A) Citations for any requirements that apply to the importation of 
irradiated fruits and vegetables;
    (B) The type and amount of inspection, monitoring, or other 
activities that will be required in connection with allowing the 
importation of irradiated fruits and vegetables into that country; and
    (C) Any other conditions that must be met to allow the importation 
of irradiated fruits and vegetables into that country.
    (ii) Facility preclearance workplan. Prior to commencing 
importation into the United States of articles treated at a foreign 
irradiation facility, APHIS and the NPPO of the country from which 
articles are to be imported must jointly develop a preclearance 
workplan that details the activities that APHIS and the foreign NPPO 
will carry out in connection with each irradiation facility to verify 
the facility's compliance with the requirements of this section. 
Typical activities to be described in this workplan may include 
frequency of visits to the facility by APHIS and foreign plant 
protection inspectors, methods for reviewing facility records, and 
methods for verifying that facilities are in compliance with the 
requirements for separation of articles, packaging, labeling, and other 
requirements of this section. This facility preclearance workplan will 
be reviewed and renewed by APHIS and the foreign NPPO on an annual 
basis.
    (iii) Trust fund agreement. Irradiated articles may be imported 
into the United States in accordance with this section only if the NPPO 
of the country in which the irradiation facility is located or a 
private export group has entered into a trust fund agreement with 
APHIS. That agreement requires the NPPO or the private export group to 
pay, in advance of each shipping season, all costs that APHIS estimates 
it will incur in providing inspection and treatment monitoring services 
at the irradiation facility during that shipping season. Those costs 
include administrative expenses and all salaries (including overtime 
and the Federal share of employee benefits), travel expenses (including 
per diem expenses), and other incidental expenses incurred by APHIS in 
performing these services. The agreement will describe the general 
nature and scope of APHIS services provided at irradiation facilities 
covered by the agreement, such as whether APHIS inspectors will monitor 
operations continuously or intermittently, and will generally describe 
the extent of inspections APHIS will perform on articles prior to and 
after irradiation. The agreement requires the NPPO or private export 
group to deposit a certified or cashier's check with APHIS for the 
amount of those costs, as estimated by APHIS. If the deposit is not 
sufficient to meet all costs incurred by APHIS, the agreement further 
requires the NPPO or the private export group to deposit with APHIS a 
certified or cashier's check for the amount of the remaining costs, as 
determined by APHIS, before any more articles irradiated in that 
country may be imported into the United States. After a final audit at 
the conclusion of each shipping season, any overpayment of funds would 
be returned to the NPPO or the private export group or held on

[[Page 22340]]

account until needed, at the option of the NPPO or the private export 
group .
    (2) Irradiation facilities located within the United States. 
Facilities located within the United States 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.\2\
---------------------------------------------------------------------------

    \2\ Inspectors are assigned to local offices of the Animal and 
Plant Health Inspection Service, which are listed in telephone 
directories.
---------------------------------------------------------------------------

    (f) Packaging. Articles that are irradiated in accordance with this 
section must be packaged in cartons in the following manner:
    (1) Irradiated articles may not be packaged for shipment in a 
carton with nonirradiated articles.
    (2) For all imported articles irradiated prior to arrival in the 
United States, all articles moved interstate from Hawaii or U.S. 
territories and irradiated prior to arrival in the mainland United 
States, and all regulated articles to be moved interstate from an area 
quarantined for fruit flies that are treated within the quarantined 
area:
    (i) The fruits and vegetables must be packaged either:
    (A) In insect-proof cartons that have no openings that will allow 
the entry of the pests of concern. 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 entry or 
oviposition (if applicable) by the pests of concern into the articles 
in the carton;\3\ or
---------------------------------------------------------------------------

    \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, Center for Plant Health Inspection and Technology, 
1730 Varsity Drive, Suite 400, Raleigh, NC 27606-5202.
---------------------------------------------------------------------------

    (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 the pests of concern. If stored in 
noninsect-proof cartons in a room that precludes access by the pests of 
concern, 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 the 
pests of concern.
    (ii) To preserve the integrity 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.
    (A) For imported articles that are treated prior to arrival in the 
United States, 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, or that will be broken apart into smaller units after 
entry into the United States, must have the required label information 
on each individual carton.
    (B) For articles moved interstate from Hawaii or U.S. territories 
that are treated prior to arrival in the mainland United States, 
pallets that remain intact as one unit until entry into the mainland 
United States may have one such label per pallet. Pallets that are 
broken apart into smaller units prior to or during entry into the 
mainland United States, or that will be broken apart into smaller units 
after entry into the mainland United States, must have the required 
label information on each individual carton.
    (3) For all articles imported to be irradiated upon arrival in the 
United States, moved interstate from Hawaii or U.S. territories to be 
irradiated upon arrival in the mainland United States, or moved 
interstate from areas quarantined for fruit flies to be irradiated 
outside the quarantined area, the articles must be packed in cartons 
that have no openings that will allow the exit of the pests of concern 
and that are sealed with seals that will visually indicate if the 
cartons have been opened. They may be constructed of any material that 
prevents the pests of concern from exiting the carton. Cartons of 
untreated articles must be shipped in shipping containers sealed prior 
to their shipment with seals that will visually indicate if the 
shipping containers have been opened.
    (g) Containers or vans. Containers or vans that will transport 
treated commodities must be free of pests prior to loading the treated 
commodities.
    (h) Certification of treatment for articles treated outside the 
United States. For each consignment treated in an irradiation facility 
outside the United States, a phytosanitary certificate, with the 
treatment section completed and issued by the NPPO, must accompany the 
consignment.
    (i) Dosage. The regulated articles must receive the minimum 
absorbed ionizing radiation dose specified in the PPQ Treatment Manual.
    (j) Dosimetry systems at the irradiation facility. (1) Dosimetry 
must indicate the doses needed to ensure that all the articles will 
receive the minimum dose prescribed.
    (2) The absorbed dose, as measured using an accurate dosimetry 
system, must meet or exceed the absorbed dose for the pest(s) of 
concern required by the PPQ Treatment Manual.
    (3) When designing the facility's dosimetry system and procedures 
for its operation, the facility operator must address guidance and 
principles from the International Standards Organization/American 
Society for Testing and Materials standard \4\ or an equivalent 
standard recognized by APHIS.
---------------------------------------------------------------------------

    \4\ 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.
---------------------------------------------------------------------------

    (k) 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.
    (l) 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, Center for 
Plant Health Inspection and Technology, 1730 Varsity Drive, Suite 400, 
Raleigh, NC 27606-5202. 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.
    (m) Denial and withdrawal of certification. (1) The Administrator 
will withdraw the certification of any

[[Page 22341]]

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.
    (n) Department not responsible for damage. This treatment is 
approved to assure quarantine security against the listed plant pests. 
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.


(Approved by the Office of Management and Budget under control numbers 
0579-0155, 0579-0215, and 0579-0198)

PART 318--STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES

    24. The authority citation for part 318 continues to read as 
follows:

    Authority:  7 U.S.C. 7701-7772 and 7781-7786; 7 CFR 2.22, 2.80, 
and 371.3.


Sec.  318.13-3  [Amended]

    25. In Sec.  318.13-3, paragraph (b)(2) is amended by removing the 
words ``approved in'' and adding the words ``approved under'' in their 
place.
    26. Section 318.13-16 is amended as follows:
    a. In the table in paragraph (a), by adding, under Hawaii, new 
entries for litchi and longan to read as set forth below.
    b. By adding a new paragraph (b)(1)(ii) to read as set forth below.


Sec.  318.13-16  Regulated articles allowed interstate movement subject 
to specified conditions.

    (a) * * *

----------------------------------------------------------------------------------------------------------------
State, territory, or district of                                                                  Additional
             origin                    Common name         Botanical name     Plant part(s)      requirements
----------------------------------------------------------------------------------------------------------------
Hawaii
                                  Litchi..............  Litchi chinensis...  Fruit.........  (b)(1)(ii),
                                                                                              (b)(3)(ii).
                                  Longan..............  Dimocarpus longan..  Fruit.........  (b)(1)(ii),
                                                                                              (b)(3)(ii).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

     (b) * * *
    (1) * * *
    (ii) May not be moved interstate into Florida. Cartons must be 
stamped ``Not for movement into or distribution in FL.''
* * * * *


Sec.  318.13-22  [Amended]

    27. Section 318.13-22 is amended by revising paragraphs (b)(1) and 
(b)(2) to read as follows:


Sec.  318.13-22  Bananas from Hawaii.

* * * * *
    (b) * * *
    (1) The bananas are irradiated in accordance with part 305 of this 
chapter for the Mediterranean fruit fly (Ceratitis capitata), the melon 
fruit fly (Bactrocera curcurbitae), the Oriental fruit fly (Bactrocera 
dorsalis), and the green scale (Coccus viridis) and are inspected, 
after removal from the stalk, in Hawaii and found to be free of the 
banana moth (Opogona sacchari (Bojen)) by an inspector before or after 
undergoing irradiation treatment; or
    (2) The bananas are irradiated in accordance with part 305 of this 
chapter for the Mediterranean fruit fly (Ceratitis capitata), the melon 
fruit fly (Bactrocera curcurbitae), and the Oriental fruit fly 
(Bactrocera dorsalis) and are inspected, after removal from the stalk, 
in Hawaii and found to be free of the green scale (Coccus viridis) and 
the banana moth (Opogona sacchari (Bojen)) before or after undergoing 
irradiation treatment.
* * * * *
    28. Section 318.13-25 is revised to read as follows:


Sec.  318.13-25  Sweetpotatoes from Hawaii.

    Sweetpotatoes may be moved interstate from Hawaii in accordance 
with this section only if the sweetpotatoes meet the conditions in 
paragraph (a) or paragraph (b) of this section or if the sweetpotatoes 
are fumigated with methyl bromide in accordance with part 305 of this 
chapter.
    (a) Vapor heat treatment and inspection. (1) The sweetpotatoes must 
be treated with vapor heat in accordance with part 305 of this chapter.
    (2) The sweetpotatoes must be sampled, cut, and inspected and found 
to be free of the ginger weevil (Elytrotreinus subtruncatus). Sampling, 
cutting, and inspection must be performed under conditions that will 
prevent any pests that may emerge from the sampled sweetpotatoes from 
infesting any other sweetpotatoes intended for interstate movement in 
accordance with this section.
    (3) The sweetpotatoes must be inspected and found to be free of the 
gray pineapple mealybug (Dysmicoccus neobrevipes) and the Kona coffee-
root knot nematode (Meloidogyne konaensis).
    (4)(i) Sweetpotatoes that are treated in Hawaii must be packaged in 
the following manner:
    (A) The cartons must have no openings that will allow the entry of 
the pests of concern and must be sealed with seals that will visually 
indicate if the cartons have been opened. They may be constructed of 
any material that

[[Page 22342]]

prevents the entry of the pests of concern.\5\
---------------------------------------------------------------------------

    \5\ 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, Center for Plant Health Science and Technology, 1730 
Varsity Drive, Suite 400, Raleigh, NC 27606.
---------------------------------------------------------------------------

    (B) The pallet-load of cartons must be wrapped before it leaves the 
treatment facility in one of the following ways:
    (1) With polyethylene sheet wrap;
    (2) With net wrapping; or
    (3) With strapping so that each carton on an outside row of the 
pallet load is constrained by a metal or plastic strap.
    (C) Packaging must be labeled with treatment lot numbers, packing 
and treatment facility identification and location, and dates of 
packing and treatment.
    (ii) Cartons of untreated sweetpotatoes that are moving to the 
mainland United States for treatment must be shipped in shipping 
containers sealed prior to interstate movement with seals that will 
visually indicate if the shipping containers have been opened.
    (5)(i) Certification on basis of treatment. Certification shall be 
issued by an inspector for the movement of sweetpotatoes from Hawaii 
that have been treated in accordance with part 305 of this chapter and 
handled in Hawaii in accordance with this section.
    (ii) Limited permit. A limited permit shall be issued by an 
inspector for the interstate movement of untreated sweetpotato from 
Hawaii for treatment on the mainland United States in accordance with 
this section.
    (b) Irradiation treatment and inspection. (1) The sweetpotatoes 
must be treated with irradiation in accordance with part 305 of this 
chapter.
    (2) Sweetpotatoes that are not treated with an irradiation dose 
approved to neutralize the ginger weevil (Elytrotreinus subtruncatus) 
must be sampled, cut, and inspected and found to be free of the ginger 
weevil by an inspector in Hawaii. Sampling, cutting, and inspection 
must be performed under conditions that will prevent any pests that may 
emerge from the sampled sweetpotatoes from infesting any other 
sweetpotatoes intended for interstate movement in accordance with this 
section.
    (3)(i) To be certified for interstate movement under this 
paragraph, sweetpotato from Hawaii must be inspected in Hawaii and 
found free of the gray pineapple mealybug (Dysmicoccus neobrevipes) and 
the Kona coffee-root knot nematode (Meloidogyne konaensis) by an 
inspector before undergoing irradiation treatment in Hawaii.
    (ii) To be eligible for a limited permit under this section, 
untreated sweetpotato from Hawaii must be inspected in Hawaii and found 
free of the gray pineapple mealybug (Dysmicoccus neobrevipes) and the 
Kona coffee-root knot nematode (Meloidogyne konaensis) by an inspector.


(Approved by the Office of Management and Budget under control number 
0579-0281)
    29. A new Sec.  318.13-26 is added to read as follows:


Sec.  318.13-26  Breadfruit, jackfruit, fresh pods of cowpea, dragon 
fruit, mangosteen, and moringa pods from Hawaii.

    (a) Breadfruit and jackfruit. (1) To be eligible for interstate 
movement, breadfruit and jackfruit from Hawaii must be treated with 
irradiation in accordance with part 305 of this chapter.
    (2) To be certified for interstate movement, breadfruit and 
jackfruit from Hawaii must be inspected in Hawaii and found free of 
spiraling whitefly (Aleurodicus dispersus), inornate scale (Aonidiella 
inornata), red wax scale (Ceroplastes rubens), green scale (Coccus 
viridis), gray pineapple mealybug (Dysmicoccus neobrevipes), pink 
hibiscus mealybug (Maconellicoccus hirsutus), spherical mealybug 
(Nipaecoccus viridis), citrus mealybug (Pseudococcus cryptus), melon 
thrips (Thrips palmi) and signs of thrip damage before undergoing 
irradiation treatment in Hawaii at a dose approved to neutralize fruit 
flies. Fruit treated for fruit flies also must either receive a post-
harvest dip in accordance with part 305 of this chapter to treat 
external feeders or originate from an orchard or growing area that was 
previously treated with a broad-spectrum insecticide during the growing 
season and a pre-harvest inspection of the orchard or growing area 
found the fruit free of any surface pests as prescribed in a compliance 
agreement. Post-treatment inspection in Hawaii is not required if the 
fruit undergoes irradiation treatment at a dose approved to neutralize 
all plant pests of the class Insecta, except pupae and adults of the 
order Lepidoptera. Regardless of irradiation dose, the fruit must be 
free of stems and leaves and must originate from an orchard that was 
previously treated with a fungicide appropriate for the fungus 
Phytophthora tropicalis during the growing season and the fruit must be 
inspected prior to harvest and found free of the fungus or, after 
irradiation treatment, must receive a post-harvest fungicidal dip 
appropriate for Phytophthora tropicalis.
    (3) To be eligible for a limited permit, breadfruit and jackfruit 
from Hawaii must be free of stems and leaves and must originate from an 
orchard that was previously treated with a fungicide appropriate for 
the fungus Phytophthora tropicalis during the growing season and the 
fruit must be inspected prior to harvest and found free of the fungus 
or, after irradiation treatment, must receive a post-harvest fungicidal 
dip appropriate for Phytophthora tropicalis.
    (b) Fresh pods of cowpea. (1) To be eligible for interstate 
movement, fresh pods of cowpea and its relatives from Hawaii must be 
treated with irradiation in accordance with part 305 of this chapter.
    (2) To be certified for interstate movement, fresh pods of cowpea 
and its relatives from Hawaii must be inspected in Hawaii and found 
free of the cassava red mite (Oligonychus biharensis) and adults and 
pupae of the order Lepidoptera before undergoing irradiation treatment. 
The pods must be free of stems and leaves.
    (3) To be eligible for a limited permit, fresh pods of cowpea and 
its relatives from Hawaii must be free of stems and leaves and must be 
inspected in Hawaii and found free of the cassava red mite (Oligonychus 
biharensis) and adults and pupae of the order Lepidoptera.
    (c) Dragon fruit. To be certified for interstate movement, dragon 
fruit from Hawaii presented for inspection must have the sepals removed 
and must be inspected in Hawaii and found free of gray pineapple 
mealybug (Dysmicoccus neobrevipes), pink hibiscus mealybug 
(Maconellicoccus hirsutus), and citrus mealybug (Pseudococcus cryptus) 
before undergoing irradiation treatment in Hawaii at a dose approved to 
neutralize fruit flies. Fruit treated for fruit flies also must either 
receive a post-harvest dip in accordance with part 305 of this chapter 
to treat external feeders or originate from an orchard or growing area 
that was previously treated with a broad-spectrum insecticide during 
the growing season and a pre-harvest inspection of the orchard or 
growing area found the fruit free of any surface pests as prescribed in 
a compliance agreement. Post-treatment inspection in Hawaii is not 
required if the fruit undergoes irradiation treatment at a dose 
approved to neutralize all plant pests of the class Insecta, except 
pupae and adults of the order Lepidoptera. Regardless of irradiation 
dose, the fruit must be free of stems and leaves.
    (d) Mangosteen. To be certified for interstate movement, mangosteen 
from Hawaii must have the sepals removed

[[Page 22343]]

and must be inspected in Hawaii and found free of gray pineapple 
mealybug (Dysmicoccus neobrevipes), pink hibiscus mealybug 
(Maconellicoccus hirsutus), citrus mealybug (Pseudococcus cryptus), and 
Thrips florum before undergoing irradiation treatment in Hawaii at a 
dose approved to neutralize fruit flies. Fruit treated for fruit flies 
also must either receive a post-harvest dip in accordance with part 305 
of this chapter to treat external feeders or originate from an orchard 
or growing area that was previously treated with a broad-spectrum 
insecticide during the growing season and a pre-harvest inspection of 
the orchard or growing area found the fruit free of any surface pests 
as prescribed in a compliance agreement. Post-treatment inspection in 
Hawaii is not required if the fruit undergoes irradiation treatment at 
a dose approved to neutralize all plant pests of the class Insecta, 
except pupae and adults of the order Lepidoptera. Regardless of 
irradiation dose, the fruit must be free of stems and leaves.
    (e) Melon. To be certified for interstate movement, melon from 
Hawaii must be inspected in Hawaii and found free of spiraling whitefly 
(Aleurodicus dispersus) before undergoing irradiation treatment in 
Hawaii at a dose approved to neutralize fruit flies. Fruit treated for 
fruit flies also must either receive a post-harvest dip in accordance 
with part 305 of this chapter to treat external feeders or originate 
from an orchard or growing area that was previously treated with a 
broad-spectrum insecticide during the growing season and a pre-harvest 
inspection of the orchard or growing area found the fruit free of any 
surface pests as prescribed in a compliance agreement. Post-treatment 
inspection in Hawaii is not required if the fruit undergoes irradiation 
treatment at a dose approved to neutralize all plant pests of the class 
Insecta, except pupae and adults of the order Lepidoptera. Regardless 
of irradiation dose, melons must be washed to remove dirt and must be 
free of stems and leaves.
    (f) Moringa pods. To be certified for interstate movement, moringa 
pods from Hawaii must be inspected in Hawaii and found free of 
spiraling whitefly (Aleurodicus dispersus), inornate scale (Aonidiella 
inornata), green scale (Coccus viridis), and citrus mealybug 
(Pseudococcus cryptus) before undergoing irradiation treatment in 
Hawaii at a dose approved to neutralize fruit flies. Fruit treated for 
fruit flies also must either receive a post-harvest dip in accordance 
with part 305 of this chapter to treat external feeders or originate 
from an orchard or growing area that was previously treated with a 
broad-spectrum insecticide during the growing season and a pre-harvest 
inspection of the orchard or growing area found the fruit free of any 
surface pests as prescribed in a compliance agreement. Post-treatment 
inspection in Hawaii is not required if the fruit undergoes irradiation 
treatment at a dose approved to neutralize all plant pests of the class 
Insecta, except pupae and adults of the order Lepidoptera.


Sec.  318.47-3  [Amended]

    30. In Sec.  318.47-3, paragraph (a) is amended by adding the words 
``in accordance with part 305 of this chapter'' after the word 
``origin''.

PART 319--[AMENDED]

    31. The authority citation for part 319 continues to read as 
follows:

    Authority:  7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 
136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

    32. In Sec.  319.8-23, paragraph (a)(1) is revised to read as 
follows:


Sec.  319.8-23  Treatments.

    (a)(1) Vacuum fumigation as required in this subpart must be 
conducted in accordance with part 305 of this chapter.
* * * * *


Sec.  319.28  [Amended]

    33. Section 319.28 is amended as follows:
    a. In paragraph (b)(5), by adding the words ``in accordance with 
part 305 of this chapter'' after the words ``fumigated with methyl 
bromide''; and by removing the second sentence.
    b. In paragraphs (b)(7)(i) and (b)(7)(ii), by removing the words 
``paragraph (b)(5) of this section'' and adding the words ``part 305 of 
this chapter'' in their place.


Sec.  319.37-13  [Amended]

    34. In Sec.  319.37-13, paragraph (c) is amended by removing the 
words ``the Plant Protection and Quarantine Treatment Manual'' and 
adding the words ``7 CFR part 305'' in their place.
    35. In Sec.  319.40-3, paragraph (b)(1) is revised to read as 
follows:


Sec.  319.40-3  General permits; articles that may be imported without 
a specific permit; articles that may be imported without either a 
specific permit or an importer document.

* * * * *
    (b) * * *
    (1) The wood packaging material must have been treated in 
accordance with part 305 of this chapter.
* * * * *
    36. Section 319.40-5 is amended as follows:
    a. In paragraph (b)(1)(i)(C), by removing the citation ``Sec.  
319.40-7(f)(1)'' and adding the words ``part 305 of this chapter'' in 
its place.
    b. In paragraph (b)(1)(iii)(A), by removing the citations ``Sec.  
319.40-7(c)'' and ``Sec.  319.40-7(d)'' and adding the words ``part 305 
of this chapter'' in their place.
    c. In paragraph (b)(1)(iii)(C), by removing the citations ``Sec.  
319.40-7(c)'', ``Sec.  319.40-7(d)'', and ``Sec.  319.40-7(f)(3)'' each 
time they occur and adding the words ``part 305 of this chapter'' in 
their place.
    d. In paragraph (b)(2)(i), by removing the citation ``Sec.  319.40-
7(f)(2)'' and adding the words ``part 305 of this chapter'' in its 
place.
    e. In paragraph (b)(2)(ii), by removing the citations ``Sec.  
319.40-7(c)'' and ``Sec.  319.40-7(d)'' and adding the words ``part 305 
of this chapter'' in their place.
    f. In paragraph (c)(2), by removing the citation ``Sec.  319.40-
7(f)(1)'' and adding the words ``part 305 of this chapter'' in its 
place.
    g. In paragraph (d), by removing the citation ``Sec.  319.40-7(f)'' 
and adding the words ``part 305 of this chapter'' in its place.
    h. In paragraph (f), by removing the citation ``Sec.  319.40-7(c)'' 
and adding the words ``part 305 of this chapter'' in its place.
    i. By revising paragraph (l)(3) to read as set forth below.
    j. In paragraph (m)(2)(iv)(A)(1), by removing the citation 
``319.40-7(f)'' and adding the citation ``part 305'' in its place.
    k. In paragraph (m)(2)(iv)(A)(4), by removing the citation ``Sec.  
319.40-6'' and adding the words ``7 CFR part 305'' in its place.
    l. In paragraph (n)(1)(ii), by removing the citation ``Sec.  
319.40-7(c)'' and adding the words ``part 305 of this chapter'' in its 
place.


Sec.  319.40-5  Importation and entry requirements for specific 
articles.

* * * * *
    (l) * * *
    (3) Are fumigated in accordance with part 305 of this chapter prior 
to arrival in the United States.
* * * * *


Sec.  319.40-6  [Amended]

    37. Section 319.40-6 is amended as follows:
    a. In paragraph (a), by removing the citation ``Sec.  319.40-7(c)'' 
and adding the words ``part 305 of this chapter'' in their place.
    b. In paragraphs (b)(1), (b)(1)(i), (b)(1)(ii), (b)(2)(ii), 
(c)(2)(i)(B), (c)(2)(iii),

[[Page 22344]]

(c)(2)(iv), and (d), by removing the citation ``Sec.  319.40-7(c)'' 
each time it occurs and adding the words ``part 305 of this chapter'' 
in its place; and by removing the citation ``Sec.  319.40-7(d)'' each 
time it occurs and adding the words ``part 305 of this chapter'' in its 
place.
    c. In paragraph (c)(1)(i)(A), by removing the citation ``Sec.  
319.40-7(e)'' and adding the words ``part 305 of this chapter'' in its 
place.
    d. In paragraphs (c)(2)(i)(B), (c)(2)(iii), (c)(2)(iv), and (d), by 
removing the citation ``Sec.  319.40-7(f)(3)'' each time it occurs and 
adding the words ``part 305 of this chapter'' in its place.
    38. Section 319.40-7 is amended as follows:
    a. By removing paragraphs (c) through (f).
    b. By adding a new paragraph (c) to read as set forth below.
    c. By redesignating paragraph (g) as paragraph (d).


Sec.  319.40-7  Treatments and safeguards.

* * * * *
    (c) Treatments. Treatment of regulated articles under this subpart 
must be conducted in accordance with part 305 of this chapter.
* * * * *


Sec.  319.41-5  [Amended]

    39. Section 319.41-5 is amended as follows:
    a. In paragraph (a), by removing the words ``other necessary'' and 
by adding the words ``in accordance with part 305 of this chapter,'' 
after the word ``treatment''.
    b. In paragraphs (b), (c), (d)(1), and (d)(3), by adding the words 
``in accordance with part 305 of this chapter'' after the words ``other 
treatment'' each time they occur.


Sec.  319.41-5a  [Removed]

    40. Section 319.41-5a is removed.


Sec.  319.55-6  [Amended]

    41. In Sec.  319.55-6, in paragraph (b)(1), the first sentence is 
amended by adding the words ``in accordance with part 305 of this 
chapter'' after the word ``treatment'' the first time it appears.


Sec.  319.56-3  [Amended]

    42. In Sec.  319.56-3, paragraph (c)(2) is amended by removing the 
citation ``Sec.  305.15'' and adding the words ``part 305'' in its 
place.


Sec.  319.56-7  [Amended]

    43. In Sec.  319.56-7, paragraph (b)(1)(ii) is amended by removing 
the words ``with an approved treatment listed in'' and adding the words 
``in accordance with'' in their place.


Sec.  319.56-11  [Amended]

    44. In Sec.  319.56-11, paragraph (b)(1) is amended by removing the 
words ``with an approved treatment listed in'' and adding the words 
``in accordance with'' in their place.


Sec.  319.56-12  [Amended]

    45. Section 319.56-12 is amended by removing the words ``at a 
temperature not higher than 20 [deg]F during shipping and upon arrival 
in the United States, and''; and by removing the third sentence.


Sec.  319.56-13  [Amended]

    46. Section 319.56-13 is amended as follows:
    a. In paragraph (b)(1)(ii), by removing the words ``an approved 
treatment listed in''.
    b. In paragraphs (b)(5)(xiii) and (b)(5)(xv), by removing the words 
``with an approved treatment listed in 7 CFR'' and adding the words 
``in accordance with'' in their place; and by adding the words ``of 
this chapter'' after the words ``part 305''.


Sec.  319.56-21  [Amended]

    47. In Sec.  319.56-21, paragraphs (b)(2) and (d)(2) are amended by 
removing the words ``an approved treatment listed in''.
    48. In Sec.  319.56-22, paragraph (g)(2) is revised to read as 
follows:


Sec.  319.56-22  Apples and pears from certain countries in Europe.

* * * * *
    (g) * * *
    (2) Treatments must be conducted in accordance with part 305 of 
this chapter.
* * * * *
    49. Section 319.56-23 is amended as follows:
    a. In footnote 3, by removing the words ``a treatment listed in''.
    b. By revising paragraph (f)(2) to read as set forth below.


Sec.  319.56-23  Apricots, nectarines, peaches, plumcot, and plums from 
Chile.

* * * * *
    (f) * * *
    (2) Treatments must be conducted in accordance with part 305 of 
this chapter.
* * * * *


Sec.  319.56-38  [Amended]

    50. In Sec.  319.56-38, paragraph (d)(4)(ii)(B) is amended by 
removing the words ``an authorized treatment for the pest is available 
in'' and adding the words ``a treatment for the pest is authorized by'' 
in their place.


Sec.  319.56-46  [Amended]

    51. In Sec.  319.56-46, paragraph (a) is amended by removing the 
words ``by receiving a minimum absorbed dose of 400 Gy'' and adding the 
words ``for plant pests of the class Insecta, except pupae and adults 
of the order Lepidoptera'' in their place; and by removing the citation 
``Sec.  305.31'' and adding the words ``part 305'' in its place.


Sec.  319.56-47  [Amended]

    52. Section 319.56-47, is amended as follows:
    a. In paragraph (b) by removing the citation ``Sec.  305.31'' and 
adding the words ``part 305'' in its place.
    b. In paragraph (d) by removing the citation ``Sec.  305.31'' and 
adding the words ``part 305 of this chapter'' in its place.
    53. In Sec.  319.59-4, paragraph (d)(3) is revised to read as 
follows:
    Sec.  319.59-4 Karnal bunt.
* * * * *
    (d) * * *
    (3) Items that require disinfection prior to entry into the United 
States must be disinfected in accordance with part 305 of this chapter.
* * * * *
    54. Section 319.74-2 is amended as follows:
    a. In paragraph (c) by removing the paragraph designation (1) 
following the heading ``Fumigation for agromyziads'' and removing 
paragraph (c)(2).
    b. Redesignating paragraphs (c)(1)(i) and (c)(1)(ii) as paragraphs 
(c)(1) and (c)(2), respectively.
    c. In the newly redesignated introductory text of paragraph (c), by 
removing the words ``paragraph (c)(2) of this section'' and adding the 
words ``part 305 of this chapter'' in their place.
    d. By revising the first two sentences of paragraph (e) to read as 
set forth below.


Sec.  319.74-2  Conditions governing the entry of cut flowers.

* * * * *
    (e) Irradiation. Cut flowers and foliage that are required under 
this part to be treated or subjected to inspection to control one or 
more of the plant pests for which irradiation is an approved treatment 
under part 305 of this chapter may instead be treated with irradiation. 
Irradiation treatment must be conducted in accordance with the 
requirements of part 305 of this chapter. * * *
* * * * *

[[Page 22345]]

PART 330--FEDERAL PLANT PEST REGULATIONS; GENERAL; PLANT PESTS; 
SOIL, STONE, AND QUARRY PRODUCTS; GARBAGE

    55. The authority citation for part 330 continues to read as 
follows:

    Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21 
U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.


Sec.  330.106  [Amended]

    56. In Sec.  330.106, paragraph (a) the fourth sentence is amended 
by adding the words ``in accordance with part 305 of this chapter'' 
after the word ``treatment.''


Sec.  330.300  [Amended]

    57. In Sec.  330.300, paragraph (a) is amended by removing the 
words ``methods of'' and by adding the words ``in accordance with part 
305 of this chapter'' after the word ``treatment.''

PART 352--PLANT QUARANTINE SAFEGUARD REGULATIONS

    58. The authority citation for part 352 continues to read as 
follows:

    Authority:  7 U.S.C. 7701-7772 and 7781-7786; 21 U.S.C. 136 and 
136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.


Sec.  352.10  [Amended]

    59. In Sec.  352.10, paragraph (b)(2)(viii) is amended by adding 
the words ``in accordance with part 305 of this chapter'' after the 
word ``treatment.''


Sec.  352.30  [Amended]

    60. In Sec.  352.30, paragraph (a)(4)(iii) is amended by removing 
the word ``such'' and by adding the word ``any'' in its place; and by 
adding the words ``in accordance with part 305 of this chapter'' after 
the word ``treatment.''

    Done in Washington, DC, this 28th day of April 2009.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E9-10188 Filed 5-11-09; 8:45 am]
BILLING CODE 3410-34-P