[Federal Register Volume 75, Number 16 (Tuesday, January 26, 2010)]
[Rules and Regulations]
[Pages 4228-4253]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-1375]



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Part IV





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; Final Rule

  Federal Register / Vol. 75, No. 16 / Tuesday, January 26, 2010 / 
Rules and Regulations  

[[Page 4228]]


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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: Final rule.

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SUMMARY: We are amending 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 are removing treatment schedules from other 
places where they are currently found in 7 CFR chapter III as well. 
Approved treatment schedules will instead be found in the Plant 
Protection and Quarantine Treatment Manual, which is available on the 
Internet. We are also establishing a new process to provide the public 
with notice and the opportunity to comment on changes to treatment 
schedules. Finally, we are harmonizing and combining 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 will 
simplify and expedite our processes for adding, changing, and removing 
treatment schedules while continuing to provide for public 
participation in the process. These changes will also simplify our 
presentation of treatments to the public by consolidating all 
treatments into one document and eliminating redundant text from the 
regulations.

EFFECTIVE DATE: February 25, 2010.

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) 734-0627.

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.
    On May 12, 2009, we published in the Federal Register (74 FR 22318-
22345, Docket No. APHIS-2008-0022) a proposal\1\ to amend the 
regulations 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 proposed to remove treatment schedules from 
other places where they are currently found in 7 CFR chapter III as 
well, instead listing approved treatment schedules in the Plant 
Protection and Quarantine (PPQ) Treatment Manual, which is available on 
the Internet.\2\ We also proposed to establish a new process to provide 
the public with notice and the opportunity to comment on changes to 
treatment schedules. Finally, we proposed to 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.
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    \1\ To view the proposed rule and the comments we received, go 
to (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0022).
    \2\ At (http://www.aphis.usda.gov/import_export/plants/manuals/ports/treatment.shtml).
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    We solicited comments concerning our proposal for 60 days ending 
July 13, 2009. We received 14 comments by that date. They were from 
nursery owners, academics, treatment facility operators, and 
representatives of State and foreign governments. They are discussed 
below by topic.

General Comments About the Treatment Requirements

    As part of proposing to remove treatment schedules from 7 CFR 
chapter III, we proposed to move the general requirements for each type 
of treatment (chemical treatment, cold treatment, etc.) in 7 CFR part 
305 to new locations within that part. We also proposed to make some 
minor changes to the existing treatment requirements.
    One commenter suggested that we identify the common requirements 
for all treatments in the remaining provisions of 7 CFR part 305 and 
present them in an introductory section, setting out specific 
requirements for the individual types of treatments in later sections. 
The commenter also suggested that there is a common set of mitigations 
for fruit flies (packaging, product movement, and location of treatment 
facilities) that could be contained in a separate section and 
referenced in the appropriate treatment requirements. The commenter 
stated that such changes would provide more clarity in the specific 
treatment requirements while creating more certainty that all 
regulations governing treatment in part 305 are included without 
unnecessary repetition.
    As we proposed to move the treatment requirements but not to make 
any significant changes to them, making large-scale revisions to those 
requirements would be outside the scope of this final rule. However, we 
appreciate the commenter's suggestion and will consider whether to make 
such changes in a future rulemaking.
    One commenter stated that there are inconsistencies in how the 
terms ``approve,'' ``authorize,'' and ``certify'' are used in the 
existing treatment requirements. The commenter pointed out that 
proposed Sec.  305.5(a), which contains requirements for chemical 
treatment facilities, is headed ``Certified facility,'' while proposed 
Sec.  305.6(a), which contains requirements for cold treatment 
facilities, is headed ``Approval of treatment facilities.'' (Paragraph 
(a) of proposed Sec.  305.8(a), which contains requirements for heat 
treatment facilities, is also headed ``Certified facility.'') The 
commenter stated that authorization of a quarantine treatment facility 
may be a complex process that could include licenses from local, State, 
or Federal regulatory agencies other than the Animal and Plant Health 
Inspection Service (APHIS), or a foreign national plant protection 
organization (NPPO), in the case of foreign facilities. The commenter 
stated that ``certification'' would be a more appropriate term for the 
process undertaken by APHIS or a foreign NPPO to ensure that a facility 
can consistently perform efficacious phytosanitary treatments, 
including post-treatment safeguarding and documentation.
    Another commenter stated that proposed Sec.  305.9(b), which 
referred to approval of an irradiation facility by APHIS, should 
instead refer to certification of the irradiation facility by APHIS.
    We agree with the first commenter's general point that a 
distinction should be drawn between certification of a facility as 
capable of performing treatment and approval of that facility to

[[Page 4229]]

perform treatments. In proposed Sec.  305.9, which contained our 
proposed revision of the irradiation treatment requirements, we 
referred to certification of a facility as part of the process for 
approval of a facility; the other part of that process was completing 
the necessary compliance agreements or workplans. Our use of the term 
``certification'' in proposed Sec. Sec.  305.5 and 305.8 was consistent 
with the use in proposed Sec.  305.9. To be consistent, this final rule 
refers to certification, rather than approval, of cold treatment 
facilities in Sec.  305.6(a). For reasons mentioned earlier, we are not 
making the change suggested by the second commenter.

Definitions

    We proposed to add or change the definitions of some terms in Sec.  
305.1.
    The definition of irradiation has read: ``The use of irradiated 
energy to kill or devitalize organisms.'' We proposed to replace the 
reference to ``irradiated energy'' with a reference to ``ionized 
energy.'' We also proposed to replace the reference to ``devitalize'' 
in the definition of irradiation with a reference to ``neutralize.''
    Two commenters suggested that we refer instead to ``ionizing 
energy,'' as it is not the energy itself that is ionized; rather, the 
energy has the effect of ionizing atoms that are hit by the 
irradiation.
    We agree with these commenters.
    One commenter suggested that we add the word ``pest'' before the 
word ``organisms'' in the definition of irradiation.
    The commenter did not provide any specific reason for making this 
change. We believe the suggested change is unnecessary, as any organism 
for which treatment is required will be a plant pest.
    The International Plant Protection Convention's (IPPC) Glossary of 
Phytosanitary Terms\3\ defines irradiation as ``treatment with any type 
of ionizing radiation.'' As this definition is substantially similar to 
the proposed definition, and adopting the IPPC definition would make 
the regulations consistent with international standards, we are 
adopting the IPPC definition of irradiation in this final rule.
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    \3\ The Glossary of Phytosanitary Terms is International 
Standard for Phytosanitary Measures (ISPM) Number 5. To view this 
and other ISPMs on the Internet, go to (http://www.ippc.int/) and 
click on the ``Adopted Standards'' link under the ``Core 
activities'' heading.
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    We proposed to add a definition of neutralize to reflect the fact 
that an effective irradiation treatment does not necessarily kill a 
plant pest. The proposed definition of neutralize read: ``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.''
    Two commenters recommended that the definition of neutralize make 
no distinction between irradiation and other treatments. One commenter 
noted that stating that treatments other than irradiation must result 
in the death of a plant pest does not provide options for other 
treatments that may be demonstrated to achieve a quarantine objective 
without causing mortality. For example, the commenter stated, the use 
of juvenile hormones as a treatment would prevent the development of 
larva into adults, while not killing the insect directly. In this case, 
the quarantine objective would be met, as the pest would not be able to 
reproduce and establish. While such treatments are not currently 
approved under the regulations or within the PPQ Treatment Manual, the 
commenter stated that, should such treatments be approved, it would be 
beneficial to allow for their subsequent inclusion within the PPQ 
Treatment Manual without having to amend the definition of neutralize.
    We agree with these commenters and have removed the distinction 
between methods of treatment in the definition of neutralize in this 
final rule.
    One commenter recommended that we remove the phrase ``reproducing 
or becoming established'' from the proposed definition of neutralize 
and instead refer to preventing a pest's development from an immature 
stage into an adult capable of emerging from its host or pupal case. As 
both non-emergence of adults and sterility of any life stage would 
effectively prevent a pest from reproducing and thereby becoming 
established, the commenter stated that highlighting that both of these 
are potentially acceptable outcomes would allow for the different 
biology of the range of pests for which a quarantine treatment might be 
applied.
    We agree with the commenter's general point. However, with regard 
to the specific suggested language, ``pupal case'' would be 
inappropriately limiting, as a treatment that prevented development of 
pests in the larval stage would also be considered to be effective. 
Referring generally to preventing the development of a pest from an 
immature stage will encompass all of the potential successful outcomes. 
We have changed the proposed definition of neutralize accordingly.
    With these changes, the definition of neutralize in this final rule 
reads: ``To prevent the establishment of a plant pest by killing it, 
sterilizing it, preventing its development from an immature stage, or 
preventing its emergence from its host.''
    One commenter suggested that we add a definition of the term 
monitor, a term used in the general treatment requirements. The 
commenter stated that readers could be confused regarding whether 
monitor implies constant oversight of the treatment process or 
validation of the process at critical points in time.
    The tenth edition of Merriam-Webster's Collegiate Dictionary 
defines ``monitor'' as ``to keep watch of, track, or check.'' Other 
dictionaries provide similar definitions. This definition indicates 
that monitoring occurs while the treatment is occurring, but does not 
necessarily indicate constant oversight, which is consistent with the 
monitoring that officials authorized by APHIS perform for treatments. 
The IPPC Glossary of Phytosanitary Terms is consistent with the general 
definition, defining monitoring as ``an official ongoing process to 
verify phytosanitary situations.'' We do not see a need to add a 
definition of monitor to the regulations, since our use of monitor is 
consistent with common understanding of the term and with international 
standards.

Notice-Based Process for Amending Treatments

    Proposed Sec.  305.3 set out a notice-based process for amending 
approved treatments. We received several comments supporting the use of 
such a process. One commenter noted that the addition, revision, and 
deletion of treatment schedules will directly affect the interests of 
trading partners and asked that APHIS provide notification of such 
changes to the World Trade Organization (WTO), with a sufficient period 
for comment, so that trading partners will be informed of these changes 
in a timely manner.
    We plan to provide WTO notifications for notices published under 
this process, as we do for other trade-related notices. The notice will 
provide for a public comment period during which trading partners, as 
well as any other interested parties, may submit comments.
    We are making two minor changes to the proposed provisions for the 
notice-based process. We are changing paragraph (b)(1)(iii) to refer to 
``articles'' rather than ``commodities,'' because

[[Page 4230]]

``articles'' is the more commonly used general term.
    In addition, proposed paragraph (b)(2) stated that treatments added 
or revised through the process we proposed to use for immediate changes 
to treatment schedules 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). However, in the current 
PPQ Treatment Manual, all of the treatments are listed by type 
(chemical treatment, cold treatment, etc.), which makes it easy for 
facility operators and others to see all the treatments that could 
potentially be employed at a specific treatment facility. Listing 
treatments approved through the immediate process in a separate section 
would make the PPQ Treatment Manual less user-friendly. Therefore, we 
have changed this provision in this final rule to indicate that 
treatment schedules that have been added to the PPQ Treatment Manual or 
revised under this process will be identified in the PPQ Treatment 
Manual as having been added or revised through the immediate process. 
The identification will make it clear that such treatments may be 
subject to change pending the comments we receive on the added or 
revised treatments.

Monitoring and Certification of Treatments

    Section 305.3 has contained requirements for monitoring and 
certification of treatments. We proposed to move these requirements to 
Sec.  305.4 and amend them.
    Paragraph (b) of Sec.  305.3 has required any treatment performed 
outside the United States to be monitored and certified by an inspector 
or an official from the NPPO of the exporting country. In proposed 
Sec.  305.4(b), we proposed to require instead that any treatment 
performed outside the United States must be monitored and certified by 
an inspector or an official authorized by APHIS. We proposed this 
change to make this requirement consistent with the other requirements 
in part 305, which refer to officials authorized by APHIS rather than 
NPPO officials specifically.
    Three commenters recommended that we not change the language 
currently in the regulations. Two commenters stated that the current 
regulations allow for APHIS to require preclearance, in which an APHIS 
inspector is present during the treatment and certifies that the 
treated commodity is free of quarantine pests, or certification by the 
NPPO; these commenters objected to what they perceived as the removal 
of the latter option.
    One of these commenters further noted that international agreements 
recognize the NPPO as the official service that certifies consignments 
to have been disinfected or disinfested when being moved in 
international trade and provides the necessary endorsements on 
phytosanitary certificates. This commenter also stated that, unless a 
risk assessment demonstrates that preclearance is necessary, requiring 
preclearance imposes significant additional costs to exporters without 
increasing the quarantine security of consignments. This commenter 
recommended that we change the references to ``an official authorized 
by APHIS'' in other sections of the regulations to refer to officials 
from the NPPO of the exporting country, to be consistent with the 
original text of Sec.  305.3.
    The provisions we proposed allow everything that is allowed under 
the current regulations; we did not propose to remove any options. 
Officials authorized by APHIS would include any officials of a foreign 
NPPO who currently certify treatments for articles exported to the 
United States. They would also include third parties that conduct 
treatments. Currently, third-party officials authorized by APHIS who 
monitor treatments include operators of niger seed treatment 
facilities, operators of wood packing material treatment facilities, 
officials who monitor precooling treatment temperatures for cold 
treatment, and others. As such, the provisions we proposed are more 
inclusive than those currently in the regulations and reflect current 
treatment activities; reverting to the original text would remove some 
options for exporters. In addition, the provisions we proposed continue 
to allow for preclearance or certification of treatment by the NPPO, as 
appropriate. We have made no changes in response to these comments.
    We also proposed to require treated commodities to be accompanied 
by a phytosanitary certificate issued by the NPPO of the exporting 
country certifying that treatment was conducted in accordance with 
APHIS regulations when monitoring or certification of a treatment 
involves an official authorized by APHIS. The current regulations 
require phytosanitary certificates when treatment is monitored and 
certified by an official of the exporting country. We proposed to 
retain the requirement that the phytosanitary certificate be presented 
to an inspector when the commodity is offered for entry into the United 
States.
    One commenter stated that it is inappropriate for the NPPO of the 
exporting country to certify that a treatment has been conducted in 
accordance with APHIS regulations if the treatment is not monitored by 
an NPPO official. This commenter also noted that some treated 
commodities are not required to be accompanied by phytosanitary 
certificates.
    When treatments are conducted in a foreign country, an NPPO 
official is always involved in monitoring the treatment. However, the 
commenter is correct that many articles whose importation is authorized 
only if they are treated are not required to be accompanied by a 
phytosanitary certificate; for example, regulated wood packaging 
material is required under Sec.  319.40-3(b) to be treated before 
importation, but a stamp on the wood packaging indicates that the 
treatment has been conducted. Requirements that phytosanitary 
certificates accompany imported articles are typically contained in 
APHIS permits or in the regulations in 7 CFR part 319, which contains 
requirements for importing various articles; it is not necessary to 
include a separate phytosanitary certificate requirement for treated 
articles in part 305, especially when there would be many exceptions to 
that requirement. Therefore, we will not be finalizing the 
phytosanitary certificate-related provisions discussed earlier that we 
had proposed to include in Sec.  305.4(b).

Chemical Treatment

    We proposed to retain the requirements for chemical treatment in 
Sec.  305.5, with minor changes. Paragraph (a) of Sec.  305.5 requires 
fumigation treatment facilities to be certified by APHIS and to be 
inspected and recertified annually, or as often as APHIS directs, 
depending upon treatments performed, commodities handled, and 
operations conducted at the facility.
    One commenter stated that, consistent with international 
agreements, the NPPO of the exporting country is capable of testing 
treatment facilities and certifying them as being capable of delivering 
the treatments required by the importing country. The commenter stated 
that this level of certification is not justified and presents a 
significant logistical and cost burden on treatment facilities, while 
not necessarily improving the quarantine security of consignments being 
exported to the United States. The commenter suggested that, at most, 
the certification be based on information submitted by the NPPO of the 
exporting country that is sufficient to demonstrate that the

[[Page 4231]]

facilities treating consignments are capable of meeting the 
requirements of Sec.  305.5(a).
    We did not propose to change the certification requirements for 
fumigation treatment facilities, and we would want to allow the public 
to comment on such a change before it was implemented. Therefore, we 
have made no changes to these provisions in response to this comment. 
However, we will consider the change the commenter suggested; if we 
determine that it is warranted, we will publish a proposed rule 
soliciting public comment on the change.

Cold Treatment

    We proposed to move the requirements for cold treatment from Sec.  
305.15 to Sec.  305.6, with minor changes. Paragraph (d)(6) of Sec.  
305.15, which is identical to proposed Sec.  305.6(d)(6), has stated 
that 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.
    One commenter suggested that we define ``type.'' The commenter 
stated that a ``type'' of fruit, for the purpose of cold treatment, 
should be those fruits that are to be treated under the same schedule 
and that belong to the same genus. The commenter stated that different 
types of packaging might affect the delivery of cold treatment due to 
issues associated with the circulation of cold air, but different 
varieties of a particular species (such as Lisbon and Meyer lemons, or 
Washington Navel and Valencia oranges) do not affect treatment 
efficacy.
    We agree with the commenter that varietal differences within a 
species do not affect the efficacy of cold treatment. However, we have 
determined that variations among species are significant enough that 
only fruit of the same species should be treated together using 
currently approved cold treatments; thus, we currently allow only fruit 
of the same species to be treated together. That said, we may determine 
in the future that a cold treatment schedule can be applied to fruit of 
the same genus. For that reason, we are not adding a definition of 
``type'' to the regulations, but we are adding guidance on the meaning 
of ``type'' to the PPQ Treatment Manual. If we determine that a 
schedule could be used for fruit of the same genus, we would then be 
able to update the PPQ Treatment Manual to reflect that determination 
through the notice-based process we are adding to the regulations in 
this final rule.
    This commenter also stated that, where the same treatment is 
applied and the same packaging type is used, the inclusion of both 
lemons and oranges in a single treatment container should not 
necessarily be considered to invalidate the treatment, provided the 
more stringent of the two available treatments is applied. The 
commenter stated that these fruit are closely related, have a similar 
structure, and would be predicted to have a similar rate of respiration 
that would influence the cold treatment and the development of any 
``hot spots'' in the treatment enclosure.
    We believe that the commenter's suggestion has some potential 
merit, but operational issues could make such a treatment process 
difficult to implement. However, we will consider the change the 
commenter suggested; if we determine that it is warranted, and that the 
operational issues associated with such a change could be adequately 
resolved, we will publish a proposed rule soliciting public comment on 
the change.

Heat Treatment

    We proposed to move the requirements for heat treatment from Sec.  
305.20 to Sec.  305.8, with minor changes. Paragraph (a)(1) of Sec.  
305.20, which is identical to proposed Sec.  305.8(a)(1), has stated 
that a certified facility must have equipment that is capable of 
adequately circulating air or water (as relevant to the treatment).
    One commenter asked whether the interpretation of ``air'' in the 
regulations would include steam or vapor. The commenter noted that 
three main forms of heat treatment are generally accepted, hot water 
immersion, high temperature forced air, and vapor heat treatment, and 
suggested that the text of this section include the term ``air/vapor.''
    Steam and vapor are simply phases of water and, as used in 
treatments, are thus a mixture of air and water. As the regulations 
include requirements for circulation of air and water, we have 
determined that it is not necessary to further specify that facilities 
must be able to adequately circulate vapor.

Irradiation

    The regulations have contained 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 
flies; and Sec.  305.34, for regulated articles moved interstate from 
Hawaii, Puerto Rico, and the U.S. Virgin Islands. The requirements in 
these sections were mostly similar, and some of them were identical. We 
proposed 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. We also proposed to make minor changes to the irradiation 
treatment requirements.
    One commenter stated that the irradiation treatment regulations 
provide a much greater level of detail than the equivalent sections for 
other treatments. The commenter asked whether it is necessary to 
include this level of detail in the regulations, or whether it would be 
beneficial to include much of this detail in either the PPQ Treatment 
Manual or the other documentation specific to the irradiation 
treatment, such as the irradiation treatment framework equivalency 
workplan (FEWP). The commenter stated that reducing the level of detail 
in the regulations to be consistent with the other treatments would 
provide APHIS with more flexibility to amend the treatment requirements 
in the future, rather than having to complete rulemaking to do so.
    The level of detail we proposed to include in the regulations 
reflects the level of detail that has been in the regulations. We did 
not propose to change the provisions of the irradiation regulations 
except as necessary to harmonize among the three sets of regulations 
and to correct errors and inconsistencies. Based on the comments we 
received, we will examine the irradiation regulations; if warranted, we 
will publish a separate proposal to amend them by removing detail and 
invite public comment on the proposal.
    Two commenters stated that several requirements in the irradiation 
treatment regulations are related specifically to fruit flies. One of 
these commenters stated that the regulations contain requirements 
related to packaging, labeling, movement, and facility location that 
are specific to fruit flies and recommended that the regulations make 
it clear that irradiation is approved for many pests other than fruit 
flies.
    The other commenter suggested that we review the proposed 
regulations and replace references to fruit flies with references to 
``pests of concern'' where appropriate. This commenter specifically 
suggested that we change proposed Sec.  305.9(c)(1)(i), which relates 
to compliance agreements for facilities treating imported articles in 
the United States. As proposed, this paragraph indicated that, 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

[[Page 4232]]

flies that may be associated with the articles to be irradiated.
    We agree with these commenters that the regulations should indicate 
that irradiation can be used to treat pests other than fruit flies, as 
irradiation is approved as a treatment for all pests of the class 
Insecta, other than pupae and adults of the order Lepidoptera. The 
proposed rule included several changes to the existing irradiation 
requirements to refer to pests of concern rather than to fruit flies 
specifically. In addition, we are taking the second commenter's 
suggestion to replace the reference to fruit flies in proposed Sec.  
305.9(c)(1)(i) with a reference to ``pests of concern.''
    Some of the references to fruit flies in the regulations relate to 
the fact that, for articles moved within the continental United States, 
irradiation has only been approved as a treatment for articles moved 
interstate from areas quarantined for fruit flies. However, under this 
final rule, such facilities can treat any pest for which there is an 
approved dose in the PPQ Treatment Manual. We did not propose to expand 
the use of irradiation to facilities located in any areas quarantined 
for other pests in the proposal, although we may do so in the future.
    Of the requirements cited by the first commenter, only the facility 
location requirements are specifically related to fruit flies. These 
are discussed in further detail in response to the next comment. 
However, the packaging, labeling, and movement requirements in the 
regulations all act as general safeguards against pests of concern, and 
the regulations as amended by this final rule reflect that.
    Paragraph (a) of proposed Sec.  305.9 contained the facility 
location requirements referred to earlier, which were taken from Sec.  
305.31(b). Under the proposed requirements, 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 certain special conditions are met. Those conditions are 
designed to mitigate the risk of escape of fruit flies from the 
facility.
    One commenter stated that no reason for excluding those listed 
States was included in the proposal and suggested that information on 
why these States are excluded be added to the rule. The commenter 
suggested that, if it is only Federal or State legislation that 
prevents the use of irradiation facilities in those States for imported 
commodities, the additional legislation could be referenced and the 
specific list of States included only in the PPQ Treatment Manual, 
rather than the regulations. This change, the commenter stated, would 
prevent the need for a formal rule change should States be added to or 
removed from the list.
    The States listed in the regulations are States where fruit flies 
could become established if introduced into the United States. We 
exclude these States to safeguard against the possibility that, despite 
the container and movement restrictions in the irradiation treatment 
regulations, fruit flies could escape from regulated articles in the 
United States prior to treatment. This rationale was given in the final 
rule establishing the irradiation treatment regulations for imported 
articles, which was published in the Federal Register and effective on 
October 23, 2002 (67 FR 65016-65029, Docket No. 98-030-4). As the 
relevant climatic conditions in these States are not expected to 
change, removing this list from the regulations to facilitate future 
changes in the list is not necessary.
    One commenter noted that the regulations provide conditions for the 
placement of a facility in the listed States at three specific ports of 
entry. The commenter suggested that these provisions should not be in 
the regulations but in the PPQ Treatment Manual. The commenter stated 
that this type of detail, which might change based on specific 
approvals, would be better handled within the PPQ Treatment Manual. 
Amendments to the list could follow the same notice-and-comment process 
we proposed for changes to the PPQ Treatment Manual.
    We are considering rulemaking to establish conditions under which 
facilities could be located in the States listed in paragraph (a) of 
proposed Sec.  305.9. Should we decide to promulgate rulemaking to 
establish such conditions, we would include the list of approved 
facilities in the Treatment Manual, as the commenter suggests. However, 
making such a change in this final rule would be beyond the scope of 
the proposed rule.
    The irradiation treatment regulations require that an irradiation 
treatment facility be certified by APHIS. The proposal included this 
requirement in paragraph (d) of proposed Sec.  305.9. For the initial 
certification of a facility, the irradiation treatment regulations 
require that an inspector make a personal inspection of the facility to 
determine whether it complies with the irradiation treatment facility 
requirements; the proposal included this requirement in paragraph (l) 
of proposed Sec.  305.9.
    One commenter stated that this level of certification is not 
justified and presents a significant logistical and cost burden on 
treatment facilities, while not necessarily improving the quarantine 
security of consignments being exported to the United States. The 
commenter stated that the key parts of the irradiation system are the 
dose mapping system and the routine dosimetry system. Because the 
regulations require these dosimetry systems to be compliant with the 
International Standards Organization/American Society for Testing and 
Materials (ISO/ASTM) standard or an equivalent standard recognized by 
APHIS, the commenter stated that there should be no need for specific 
certification visits by APHIS officials, provided that these standards 
are met. In this case, the commenter suggested, APHIS could use audit 
trails and certificates provided by accredited testing and 
certification laboratories to determine whether the treatment facility 
meets all the necessary requirements.
    We have determined that, for the initial certification of a 
facility, it is necessary to conduct a personal inspection to ensure 
that the facility is in compliance with the ISO/ASTM standard. Audit 
trails and certificates provided by accredited testing and 
certification laboratories would not provide adequate assurance that 
the facility is in compliance with the standard. In addition, while we 
agree that the dose mapping and routine dosimetry systems are key 
components of irradiation treatment, the regulations include many other 
requirements that are necessary to ensure the phytosanitary security of 
treated articles, such as provisions to separate treated and untreated 
articles and to prevent the infestation of treated articles by 
quarantine pests after treatment. The facility's systems and processes 
to ensure compliance with these requirements also need to be verified 
by a personal inspection. We are making no changes in response to this 
comment.
    The irradiation treatment regulations have referred to an increase 
or decrease in the amount of radioisotope as an event because of which 
recertification would be required. These events are found in the 
introductory text of paragraph (d) of proposed Sec.  305.9. We proposed 
to add the word ``significant'' to better characterize the type of 
decrease that would require recertification, since radioisotope 
decreases in very small amounts during

[[Page 4233]]

treatment; otherwise, we did not propose to change this requirement.
    Two commenters stated that increases in the amount of isotope 
should not necessitate recertification, and one stated that decreases 
in the amount of isotope should not either. Both commenters stated that 
if processes for maintaining the isotope have been established by the 
facility and approved by APHIS, changes in isotope should not require 
additional review by APHIS, except as necessary to confirm that the 
processes are being properly implemented.
    As noted, the requirement for recertification in the event of a 
change in the amount of radioisotope has been found in all three sets 
of irradiation treatment facility provisions; we did not propose to 
change that requirement, other than making it more specific and thus 
more clear regarding what events require recertification. We have 
required recertification in the event of a change in the amount of 
radioisotope in order to verify that the radioisotope is at a proper 
level and treatment is being conducted in accordance with the ISO/ASTM 
standard and the facility's standard operating procedures. As discussed 
in more detail later in this document, it is especially important to 
verify that irradiation treatment is being properly conducted. We are 
making no changes in response to these comments.
    However, we have determined that the proposed text could be more 
specific in describing what decreases warrant recertification. This 
final rule refers to a decrease in the amount of radioisotope for a 
reason other than natural decay, rather than to a significant decrease 
in the amount of radioisotope, as a reason for recertification. This 
reflects the intent of the proposed change more specifically and 
provides helpful additional information to the reader.
    The irradiation treatment regulations require irradiation treatment 
to be monitored by an inspector. 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. The proposal included these requirements in paragraph (e) 
of proposed Sec.  305.9.
    One commenter stated that such monitoring should not be required. 
The commenter stated that monitoring and inspection of treatment 
records can be performed by the NPPO of the exporting country. The 
commenter also stated that specific provisions for inspection prior to 
or after irradiation should not be included, as these should be 
performed during or after the issuance of a phytosanitary certificate 
by the NPPO of the exporting country.
    We have determined that the current level of monitoring is 
appropriate. Verifying that irradiation treatment is being applied 
properly is particularly important because an inspector looking at 
treated articles themselves after treatment would have no practical way 
to determine, based on physical evidence from the commodity itself, 
that the articles have been irradiated. Irradiation leaves no residue 
and usually causes no discernable change to an article's color or 
texture. In addition, as discussed earlier in this document, an 
effective irradiation treatment may not kill all larvae, but instead 
might prevent adult emergence. In cases where an inspector at the port 
of entry encounters live larvae of the target pest in a shipment that 
is documented as irradiated, it is extremely important that the 
inspector be able to determine with full confidence that the article 
was properly treated according to APHIS requirements. We are making no 
changes in response to this comment.
    One commenter stated that provisions in proposed paragraph (e) 
imply that an inspector need not necessarily be present at all times 
during treatment. However, the commenter stated, the requirement that 
treatment ``must be monitored by an inspector'' will lead to some 
confusion. The commenter suggested clarifying that an inspector may not 
be required on site during treatment.
    The commenter's interpretation that monitoring may or may not be on 
site is correct. Immediately after the requirement the commenter cites, 
the regulations go on to explain that 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. If an unannounced visit is not being 
conducted, monitoring would only necessarily include a review of 
treatment records, which could be done off site. We believe the current 
language is sufficiently clear on this point.
    To ensure the appropriate level of monitoring for facilities 
treating imported articles, the regulations in Sec.  305.31(f) have 
required three agreements to be signed before articles can be imported 
in accordance with the irradiation treatment requirements: An FEWP, a 
facility preclearance workplan, and a trust fund agreement. We proposed 
to move these requirements to proposed Sec.  305.9(e)(1). The only 
change we proposed was to limit the applicability of these requirements 
to facilities located in foreign countries, 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 within the United States of imported articles 
does not.
    One commenter stated that, as specific details regarding the 
inspection of irradiated articles are included in the FEWP and the 
associated operational workplans, some of the specific details included 
in proposed paragraph (e) are not necessary. Similarly, the commenter 
suggested, as the extent of treatment oversight and monitoring would be 
defined in the FEWP, the text of proposed paragraph (e)(1)(iii), which 
contains the trust fund agreement requirements, could be simplified to 
remove specific references to the duties undertaken by APHIS in the 
exporting country.
    The specific details the commenter cites are presented in the 
regulations as examples and not as exhaustive lists. For example, the 
requirements for the facility preclearance workplan that have been 
found in Sec.  305.31(f)(2) and were proposed in Sec.  305.9(e)(1)(ii) 
cite typical activities to be described in the workplan. These details 
provide helpful additional detail to the reader. We are making no 
changes in response to this comment.
    Two commenters specifically addressed the FEWP. The regulations in 
Sec.  305.31(f)(1), which we included in Sec.  305.9(e)(1)(i) of the 
proposal, have required the NPPO of a country from which articles are 
to be imported into the United States in accordance with the 
irradiation treatment regulations to sign an FEWP with APHIS. In the 
FEWP, both the NPPO and APHIS will specify the following items for 
their respective countries:
     Citations for any requirements that apply to the 
importation of irradiated fruits and vegetables;
     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
     Any other conditions that must be met to allow the 
importation of irradiated fruits and vegetables into that country.
    One commenter suggested that we revise these requirements to simply 
state that APHIS maintains the right to either deny the application 
for, or retract the approval of, an operational workplan for an 
irradiation facility if the

[[Page 4234]]

NPPO of the exporting country refuses to allow the importation of 
articles treated with irradiation. The commenter stated that such 
language would grant APHIS the legal right to determine equitable 
reciprocity and take appropriate action. The commenter stated that, in 
the case of domestic irradiation facilities that do not involve 
operational workplans with foreign NPPOs, reciprocity should not be 
required.
    Another commenter requested that the requirement for the FEWP be 
removed. This commenter stated that the requirement for the FEWP was 
not based on science and thus constituted an unjustified barrier to 
trade. Because the requirement for the FEWP is not based on science, 
the commenter stated, APHIS is not authorized to impose such a 
requirement under the Plant Protection Act (7 U.S.C. 7701 et seq.), 
which states that decisions affecting imports, exports, and interstate 
movement of regulated products shall be based on sound science. The 
commenter stated that the requirement for the FEWP was causing costly 
delays in attempts by the commenter's business to establish a facility 
for irradiating products for export to the United States, as the 
government of the country in which the facility is intended to be 
located is reluctant to take the steps that government has determined 
to be necessary to agree to an FEWP.
    The FEWP was originally established in the irradiation regulations 
to support the equivalence principle of the WTO Agreement on the 
Application of Sanitary and Phytosanitary Measures by clearly stating 
what legislative, regulatory, and other requirements must be met, and 
what monitoring and other activities must occur, for irradiated 
articles to be imported into the United States, or into the foreign 
country. We did not propose to change the provisions required to be 
included in the FEWP requirements.
    The FEWP does not obligate the government of a country in which an 
irradiation facility is located to agree to any specific conditions for 
the use of irradiation as a phytosanitary measure, but merely to 
document the conditions under which irradiated articles can be imported 
into that country. We will provide clarification regarding this point 
to any country that is encountering difficulty in preparing an FEWP.
    As noted above, we proposed to change the FEWP requirement so that 
it only applied to facilities located outside the United States. 
However, upon further considering the purpose of the FEWP, we have 
determined that the FEWP should continue to be required for all 
facilities treating imported articles, whether located outside or 
inside the United States, as the equivalence principle applies 
regardless of where imported articles are treated. Therefore, this 
final rule contains the FEWP requirement in a separate paragraph (e)(1) 
that applies to all facilities treating imported articles. Paragraph 
(e)(2) contains the remaining requirements for facilities located in 
foreign countries, and paragraph (e)(3) contains the requirements for 
facilities located in the United States; the latter paragraph refers to 
the FEWP requirement in paragraph (e)(1) for facilities located in the 
United States that are treating imported articles.
    With regard to the first commenter's suggestion, the current FEWP 
provisions provide helpful additional specificity regarding what 
information about the exporting country's irradiation requirements 
needs to be conveyed in order for equivalence to be established. We are 
making no changes in response to this comment.
    Two commenters specifically addressed the 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 irradiation 
treatment 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 irradiation treatment requirements. This 
facility preclearance workplan will be reviewed and renewed by APHIS 
and the foreign NPPO on an annual basis.
    Both commenters stated that preclearance should not be mandatory in 
all cases and that this specific workplan should be renamed. One 
commenter suggested calling it the ``treatment facility workplan,'' and 
the other suggested the ``irradiation facility workplan.'' The latter 
commenter stated that making this change would allow the flexibility to 
move from a preclearance program to one in which treatments are 
monitored by officials authorized by APHIS and the commodity is shipped 
with a phytosanitary certificate issued by the NPPO of the exporting 
country, given sufficient evidence regarding the success of the 
program.
    We assume that the commenters are referring to ``preclearance'' as 
the activity in which APHIS inspectors are present in a foreign country 
and conduct inspections there prior to export of the inspected 
articles. That is how APHIS has commonly used the term in developing 
export programs for particular articles. However, the regulations for 
irradiation treatment facilities use ``preclearance'' in a different 
sense, to refer to preclearing treatments conducted at the facility. 
Because inspectors monitor treatment, there is no additional 
verification of the treatment that needs to be done at the port of 
entry, which is important given that there is no practical way to 
verify treatment, as discussed earlier.
    However, articles treated in a precleared facility are not 
necessarily themselves precleared. Irradiated articles may be subject 
to mitigations besides irradiation treatment for certain pests. For 
example, litchi from Thailand are required by Sec.  319.56-47 to be 
treated with irradiation for several insect pests and also to be 
inspected by the Thai NPPO and found to be free of the fungus 
Peronophythora litchi, which is not neutralized by irradiation 
treatment. Thus, litchi from Thailand are not precleared for entry into 
the United States, even though the irradiation treatment facility in 
which they are treated is precleared.
    As discussed earlier, we need to retain the facility preclearance 
workplan in support of our monitoring requirements, given the 
difficulty associated with verifying that irradiation has been 
conducted properly. As the regulations refer specifically to a 
``facility preclearance workplan'' and not a general preclearance 
workplan, we do not believe any further change is necessary to indicate 
that the preclearance discussed applies to treatments conducted in the 
facility and not necessarily to any articles treated by the facility.
    The regulations have required in Sec. Sec.  305.32(b) and 
305.34(b)(3) that facilities located within the United States that 
carry out continual irradiation operations notify an inspector at least 
24 hours before the date of operations, while facilities that carry out 
periodic irradiation operations must notify an inspector of scheduled 
operations at least 24 hours before scheduled operations. This 
requirement

[[Page 4235]]

was included in Sec.  305.9(e)(2) of the proposal.
    One commenter stated that what is meant by ``continual'' and 
``periodic'' operations is not clear. The commenter suggested that we 
either clarify or simply change the proposed text from ``...before the 
date of operations...'' to ``...before the date of initial 
operations....''.
    Re-examining the current requirements, we note that an inspector 
must be notified 24 hours before scheduled operations regardless of 
whether operations are continual or periodic. Therefore, as the 
commenter suggests, we have simplified this requirement in the final 
rule by eliminating distinctions between the two types of facilities.
    In order to ensure that inspectors have adequate notice, we are 
also clarifying this provision to indicate that the notification must 
come at least 24 hours, excluding Saturday, Sunday, and Federal 
holidays, before scheduled operations, so that notification for 
irradiation that is scheduled for the next Monday does not arrive on a 
Saturday, a Sunday, or a Federal holiday, which are not standard 
business days for APHIS inspectors. The provision thus reads as follows 
in this final rule: ``Facilities located within the United States must 
notify an inspector at least 24 hours (excluding Saturday, Sunday, and 
Federal holidays) before scheduled operations.''
    Paragraph (f) of proposed Sec.  305.9 contained the packaging 
requirements of the irradiation treatment regulations. Paragraph (f)(2) 
contained requirements for packaging articles that are irradiated prior 
to arrival in the United States, prior to interstate movement from 
Hawaii or U.S. territories, and prior to movement from an area 
quarantined for fruit flies. The regulations for irradiation treatment 
of articles moved interstate from Hawaii and U.S. territories and from 
quarantined areas only allow irradiated articles to be packaged in 
insect-proof cartons. The regulations for irradiation treatment of 
imported articles allow either insect-proof cartons or noninsect-proof 
cartons to be used; if noninsect-proof cartons are used, the cartons 
must be 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. We proposed in 
Sec.  305.9(f)(2)(i)(B) to allow the use of noninsect-proof cartons, 
subject to these conditions, for articles moved interstate from areas 
quarantined for fruit flies and from Hawaii and U.S. territories as 
well.
    One commenter expressed uncertainty regarding whether the complete 
enclosure of the pallet in polyethylene shrink wrap or other covering 
should include the underside of the product and, if so, how one can 
shrink wrap all six sides of a pallet of product.
    If the bottom of a pallet was insect-proof, we would not require 
the bottom of the pallet to be wrapped in polyethylene shrink wrap. The 
requirements for the use of noninsect-proof cartons are satisfied if 
access to the pallet is precluded by polyethylene shrink wrap or solid 
or netting covering.
    One commenter stated that the requirement to wrap pallets of 
noninsect-proof cartons to prevent access by the pests of concern may 
be an appropriate safeguarding measure for articles transported by air, 
since the pallets are almost always exposed during the loading of the 
aircraft, but is not appropriate for maritime shipments, when the 
pallets of treated articles are loaded directly into the maritime 
container at the packing shed under adequate safeguards and 
subsequently sealed by the inspector or by another official authorized 
by APHIS. The commenter suggested that proposed Sec.  305.9(f)(2)(i)(B) 
be reworded to make a distinction between requirements for air and 
maritime shipment, as is the case in other programs such as the program 
for hot water treatment of mango, and incorporated into the PPQ 
Treatment Manual rather than remain in the regulations.
    The intent of this requirement is to prevent the treated articles 
from being reinfested by the pests of concern after treatment. As 
articles are exposed to potential pest infestation while they are being 
loaded into maritime containers, it is necessary to include a 
requirement to address this risk for maritime shipments as well. 
Although the mango hot water treatment program allows for such loading 
to be conducted without wrapping the mangoes, as noted earlier, it is 
much more difficult for an inspector at a port of entry to verify that 
an article has been treated with irradiation; in contrast, an inspector 
could easily determine that live fruit flies in mangoes that have been 
treated with hot water represented a failure of either the treatment or 
the post-treatment safeguarding and take appropriate action. We will 
consider whether providing for supervision of the maritime transloading 
process might adequately mitigate this risk; if we determine that it 
would, we would propose rulemaking to provide for such supervision, and 
take public comment on the change.
    The regulations in Sec. Sec.  305.31(g)(3)(ii), 305.32(c)(2), and 
305.34(b)(4)(i)(B) have required each pallet-load of cartons containing 
irradiated articles 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.
    We included this requirement in Sec.  305.9(f)(2)(ii) of the 
proposal.
    One commenter stated an assumption that the concern of proposed 
paragraph (f)(2)(ii) is to ensure that pallets do not topple and that 
nontreated cartons cannot be inserted into pallets of treated articles. 
The commenter suggested that we substitute the word ``secured'' for the 
word ``wrapped,'' as it more accurately describes the process when 
cornices and strapping are used to stabilize the pallet. The commenter 
also stated that requiring the strapping to pass and constrain each 
carton on the outside row of the pallet load exceeds current industry 
practices and would increase operational costs. The commenter suggested 
that the requirement be reworded to indicate that pallet loads should 
be secured by shrink wrap, netting, or strapping, without specifying 
how the strapping is to be applied.
    We agree with the commenter's suggestions. Accordingly, Sec.  
305.9(f)(2)(ii) in this final rule uses the word ``secured'' rather 
than the word ``wrapped,'' and does not include specific instructions 
on how to use strapping to secure the pallet.
    In addition, the packaging requirements for sweetpotatoes moved 
interstate from Hawaii in Sec.  318.13-25 are similar to the packaging 
requirements for irradiated articles, and contain identical 
requirements for wrapping pallets; we are also changing those 
requirements in this final rule, to be consistent with the changes we 
are making in the irradiation regulations.
    The regulations in Sec. Sec.  305.31(g)(3)(iii), 305.32(c)(3), and 
305.34(b)(4)(i)(C) have required packaging to be labeled with treatment 
lot numbers, packing and treatment facility identification and 
location, and dates of packing and treatment. We included this 
requirement in Sec.  305.9(f)(2)(ii) of the proposal.
    One commenter stated that this level of detail does not need to be 
included in the regulations and that it would be

[[Page 4236]]

preferable for the regulations to only state that the packaging be 
labeled in such a way as to enable the necessary level of traceback. 
The inclusion of any identifying mark on the packaging that would 
permit APHIS to correlate the specific shipment to a treatment 
certificate, import permit, or other system would provide an equivalent 
level of traceback. As this detail already exists in the draft 
operational workplans, the commenter suggested that the principle of 
traceback be mentioned in paragraph (f)(2)(iii) without specifically 
requiring treatment facility codes, dates, or other information. As the 
operational workplans will be more easily amended than the regulations, 
the commenter stated that this option would allow APHIS to more easily 
take into consideration the specific systems in the exporting country.
    We agree with the commenter's suggestion. In this final rule, 
paragraph (f)(2)(iii) specifies that packaging must be labeled in a 
manner that allows an inspector to determine treatment lot numbers, 
packing and treatment facility identification and location, and dates 
of packing and treatment. This ensures that the information necessary 
to conduct traceback is available while allowing flexibility in 
providing that information. We will approve packaging to be used at a 
specific facility or for a specific commodity as part of the 
development of the operational workplan for the facility.
    In addition, the labeling requirements for sweetpotatoes moved 
interstate from Hawaii in Sec.  318.13-25 contain similar requirements 
for labeling cartons; we are also changing those requirements in this 
final rule, to be consistent with the changes we are making in the 
irradiation regulations.
    One commenter suggested that APHIS change the wording (``Treated by 
irradiation'' or ``Treated with radiation'') that must be stamped or 
pre-printed on each carton to indicate that the articles were 
irradiated to mitigate pest risks.
    The wording is required by the Food and Drug Administration in its 
regulations at 21 CFR 179.26(c). We have no authority to make changes 
to those regulations.
    Paragraph Sec.  305.31(h) has required containers or vans that will 
transport treated commodities to be free of pests prior to loading the 
treated commodities. We proposed to include this requirement in Sec.  
305.9(g) and to make it applicable not only to facilities treating 
imported articles but to facilities treating articles moved interstate 
from Hawaii and U.S. territories and from areas quarantined for fruit 
flies as well.
    One commenter requested clarification on this requirement. The 
commenter asked:
     Whether the intent was to prevent infestation by pests of 
concern or hitchhikers;
     Whether the requirement applies to product treated in an 
area where the pest(s) of concern are present, other areas, or both;
     If articles are treated in a domestic facility, why it is 
important that the container or van be pest-free after the product has 
been processed; and
     If the pests are not pests of concern, whether freedom 
would need to be established inside the container or outside the 
container.
    The intent of the requirement is to prevent infestation by pests of 
concern. The requirement applies regardless of whether pests of concern 
are present in the area in which the articles are treated. Ensuring 
that containers are free of pests of concern is a basic safeguarding 
principle; for example, even if an irradiation facility was located in 
an area free of pests of concern, a container could have been used to 
carry infested articles, improperly cleaned, and brought to the 
irradiation facility to contain treated articles.
    To clarify this requirement, we are changing proposed Sec.  
305.9(g) to refer specifically to pests of concern. We are also 
changing proposed Sec.  305.9(g) to refer to ``articles,'' rather than 
``commodities,'' as the term ``articles'' is used throughout Sec.  
305.9.
    Proposed paragraph (l) of Sec.  305.9 set out requirements for 
requesting certification and inspection of a facility. These 
requirements were taken from Sec.  305.31(l); similar requirements are 
contained in Sec. Sec.  305.32(g) and 305.34(c). Each of these 
paragraphs provides that, 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 regulations.
    One commenter asked whether this paragraph also applied to 
recertification and, if so, suggested that we change this requirement 
to indicate that an inspector may make a personal inspection, rather 
than that an inspector will make a personal inspection. The commenter 
stated that a minor technical reason for recertification should not 
obligate APHIS to perform a personal inspection of the facility.
    The requirements in proposed paragraph (l) apply only to the 
initial certification of a facility, not to recertification. We have 
added references to initial certification to paragraph (l) to make this 
more clear.
    We are also changing paragraph (n) of proposed Sec.  305.9, which 
informs the reader that the Department is not responsible for damage to 
treated articles and is taken from current Sec. Sec.  305.31(n), 
305.32(i), and 305.34(e). This paragraph refers to ``listed plant 
pests,'' which we are updating to refer to ``plant pests listed in the 
PPQ Treatment Manual.'' It also refers to fruits and vegetables being 
authorized for treatment; however, since articles other than fruits and 
vegetables are authorized for treatment, ``articles'' is a more 
appropriate term, and we are changing paragraph (n) accordingly.

Miscellaneous Changes

    One commenter pointed out two typographical errors in the proposed 
rule:
     In proposed Sec.  305.6(b), the text ``and located in the 
area north of 39[deg] longitude and east of 104[deg] latitude'' should 
read ``and located in the area north of 39[deg] latitude and east of 
104[deg] longitude''.
     The section for quick freeze treatments was listed in the 
regulatory text of the proposed rule as being Sec.  305.8. The 
commenter pointed out that the section number should be Sec.  305.7.
    We have corrected both of these errors in the final rule.
    We are making two other miscellaneous changes to the proposed rule. 
We proposed to remove the chemical treatment schedules in the appendix 
to the subpart for imported fire ant (Sec. Sec.  301.81 through 301.81-
10), retaining only the systems approach for ensuring nursery freedom 
from imported fire ant in a new Sec.  301.81-11. This systems approach 
refers to treatment at 180-day intervals. However, as treatments for 
the imported fire ant are added or changed, different intervals may be 
required for treatment. To add flexibility to the systems approach, we 
are changing the references to 180-day intervals in proposed Sec.  
301.81-11 to refer instead to ``the specified number of days'' and 
``the specified interval.''
    Proposed Sec.  305.6(c) set out the requirements for cold treatment 
enclosures that have been found in Sec.  305.15(c). Proposed paragraph 
(c)(2) indicated that such enclosures must maintain fruit pulp 
temperatures according to treatment schedules with no more than a 0.39 
[deg]C (0.7 [deg]F) variation in temperature. This is related to a 
requirement for performing cold treatment that we proposed to include 
in Sec.  305.6(d)(9), which requires fruit pulp temperatures to be 
maintained at

[[Page 4237]]

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. To make these requirements consistent and 
strengthen the connection between them, we are changing paragraph 
(c)(2) in this final rule to indicate that the cold treatment enclosure 
must maintain fruit pulp temperatures with no more than the specified 
variation between two consecutive hourly readings as well.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This final 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.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities.
    APHIS is amending 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 amending 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 are removing treatment schedules from other 
places where they are currently found in 7 CFR chapter III as well. 
Approved treatment schedules will instead be found in the PPQ Treatment 
Manual, which is available on the Internet. We are also establishing a 
new process to provide the public with notice and the opportunity to 
comment on changes to treatment schedules. Finally, we are harmonizing 
and combining 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 will simplify and expedite our processes for 
adding, changing, and removing treatment schedules while continuing to 
provide for public participation in the process. These changes will 
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 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 will 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 will 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. This final rule will 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 
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.\4\ 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.\5\
---------------------------------------------------------------------------

    \4\ 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.
    \5\ 2002 Census of Agriculture. U.S. 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

[[Page 4238]]

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 1.--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 2.--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
----------------------------------------------------------------------------------------------------------------

[[Page 4239]]

 
Fruit and nuts:                        ........................  ......................  .......................
----------------------------------------------------------------------------------------------------------------
Bananas                                1,102                     1,134                   1,201
----------------------------------------------------------------------------------------------------------------
Citrus, fresh                          307                       356                     407
----------------------------------------------------------------------------------------------------------------
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 in this 
final rule will 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 final rule will 
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 will 
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 final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Has no retroactive effect and (2) 
does not require administrative proceedings before parties may file 
suit in court challenging this rule.

Paperwork Reduction Act

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

List 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.

0
Accordingly, we are amending 7 CFR chapter III as follows:

[[Page 4240]]

PART 301--DOMESTIC QUARANTINE NOTICES

0
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).


0
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]

0
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.

0
4. Section 301.50-10 is amended as follows:
0
a. By revising paragraph (a) to read as set forth below.
0
b. By removing paragraphs (b) and (c).
0
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.
* * * * *


Sec.  301.75-4  [Amended]

0
5. In Sec.  301.75-4, paragraph (d)(2)(i)(C) is amended by removing the 
words ``Sec.  301-11(d) of this subpart'' and adding the words ``part 
305 of this chapter'' in their place; paragraphs (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]

0
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]

0
7. In Sec.  301.75-7, paragraph (a)(2) is amended by removing the 
citation ``Sec.  301.75-11(a)'' and adding the words ``part 305 of this 
chapter'' in its place.


Sec.  301.75-8  [Amended]

0
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]

0
9. Section 301.75-11 is removed and reserved.


Sec.  301.81-4  [Amended]

0
10. Section 301.81-4 is amended as follows:
0
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.
0
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''.

0
11. Section 301.81-5 is amended as follows:
0
a. In paragraph (a)(3)(ii), at the end of the paragraph, by removing 
the word ``or''.
0
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; or'' in their place.
0
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.
* * * * *


Sec.  301.81-6  [Amended]

0
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.

0
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 visually survey 
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 of 
this chapter 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

[[Page 4241]]

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 the specified number of days be either:
    (A) Repotted in treated potting soil media;
    (B) Retreated in accordance with part 305 of this chapter at the 
specified interval; 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.
    (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.
Appendix to Subpart--Imported Fire Ant [Removed]

0
14. The Appendix to Subpart--Imported Fire Ant is removed.


Sec.  301.87-5  [Amended]

0
15. 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]

0
16. Section 301.87-10 is removed and reserved.


Sec.  301.89-5  [Amended]

0
17. In Sec.  301.89-5, paragraphs (a)(2)(iii) and (b) are 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]

0
18. 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]

0
19. 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]

0
20. 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]

0
21. Section 301.89-13 is removed and reserved.


Sec.  301.92-5  [Amended]

0
22. 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]

0
23. Section 301.92-10 is removed and reserved.

0
24. 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.

[[Page 4242]]

    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. Treatment with any type of ionizing radiation.
    Methyl bromide. A colorless, odorless biocide used to fumigate a 
wide range of commodities.
    Neutralize. To prevent the establishment of a plant pest by killing 
it, sterilizing it, preventing its development from an immature stage, 
or preventing its emergence from its host.
    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.
    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 an article 
or articles 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 
identified in 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;

[[Page 4243]]

    (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.
    (b) Any treatment performed outside the United States must be 
monitored and certified by an inspector or an official authorized by 
APHIS. 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) Certification 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 
certified by APHIS. Recertification 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 certified, 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] latitude 
and east of 104[deg] longitude 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 between two consecutive hourly readings.
    (3) Be structurally sound and adequate to maintain required 
temperatures.

[[Page 4244]]

    (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 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

[[Page 4245]]

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.
    (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.

[[Page 4246]]

    (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.  305.7  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 or 318.13-13, 
respectively, of this chapter. 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

[[Page 4247]]

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) of this 
chapter 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 pests of concern that may be associated with the 
articles to be irradiated. In the importer compliance agreement, the 
importer must agree to comply with any additional requirements found 
necessary by 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 in the amount of radioisotope, a decrease in the amount of 
radioisotope for a reason other than natural decay, 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 treating imported articles; 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.
    (2) 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, in addition to the 
irradiation treatment framework equivalency workplan required in 
paragraph (e)(1) of this section:
    (i) 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.
    (ii) 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

[[Page 4248]]

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 account 
until needed, at the option of the NPPO or the private export group.
    (3) Irradiation facilities located within the United States. 
Facilities located within the United States must notify an inspector at 
least 24 hours (excluding Saturday, Sunday, and Federal holidays) 
before scheduled operations.\2\ If the facility will be used to treat 
imported articles, the NPPO of the country from which the articles are 
to be imported into the United States in accordance with this section 
must also sign the irradiation treatment framework equivalency workplan 
required in paragraph (e)(1) of this section.
---------------------------------------------------------------------------

    \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 secured before 
leaving the irradiation facility in one of the following ways:
    (A) With polyethylene shrink wrap;
    (B) With net wrapping; or
    (C) With strapping.
    (iii) Packaging must be labeled in a manner that allows an 
inspector to determine 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 articles must be free of pests of concern prior to loading the 
treated articles.
    (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

[[Page 4249]]

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 initial certification and inspection of facility. 
Persons requesting initial 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 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 plant pests listed 
in the PPQ Treatment Manual. From the literature available, the 
articles 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

0
25. 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]

0
26. 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.

0
27. Section 318.13-16 is amended as follows:
0
a. In the table in paragraph (a), by adding, under Hawaii, new entries 
for litchi and longan in alphabetical order to read as set forth below.
0
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                                                                            Additional
  district of 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.''
* * * * *

0
28. 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,

[[Page 4250]]

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.
* * * * *

0
29. 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 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 secured 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.
    (C) Packaging must be labeled in a manner that allows an inspector 
to determine 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)

0
30. 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

[[Page 4251]]

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 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]

0
31. 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--FOREIGN QUARANTINE NOTICES

0
32. 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.

0
33. In Sec.  319.8-23, paragraph (a)(1) is revised to read as follows:


Sec.  319.8-23  Treatment.

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


Sec.  319.28  [Amended]

0
34. Section 319.28 is amended as follows:
0
a. In paragraph (b)(5), by adding the words ``treated in accordance 
with part 305 of this chapter'' after the words ``fumigated with methyl 
bromide''; and by removing the second sentence.
0
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]

0
35. 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.

0
36. 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.
* * * * *

0
37. Section 319.40-5 is amended as follows:
0
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.
0
b. In paragraph (b)(1)(i)(D), by removing the citation ``Sec.  319.40-
7(d)''

[[Page 4252]]

and adding the words ``part 305 of this chapter'' in its place.
0
c. 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.
0
d. 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.
0
e. 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.
0
f. 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.
0
g. 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.
0
h. In paragraph (d), by removing the citation ``Sec.  319.40-7(f)'' and 
adding the words ``part 305 of this chapter'' in its place.
0
i. In paragraph (f), by removing the citation ``Sec.  319.40-7(c)'' and 
adding the words ``part 305 of this chapter'' in its place.
0
j. By revising paragraph (l)(3) to read as set forth below.
0
k. In paragraph (m)(2)(iv)(A)(1), by removing the citation ``319.40-
7(f)'' and adding the words ``part 305'' in its place.
0
l. 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.
0
m. 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]

0
38. Section 319.40-6 is amended as follows:
0
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.
0
b. In paragraphs (b)(1) introductory text, (b)(1)(i), (b)(1)(ii), 
(b)(2)(ii), (c)(2)(i)(B), (c)(2)(iii), (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.
0
c. In paragraph (c)(1)(i)(A), by removing the citation ``Sec.  319.40-
7(e)'' each time it occurs and adding the words ``part 305 of this 
chapter'' in its place.
0
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.

0
39. Section 319.40-7 is amended as follows:
0
a. By removing paragraphs (c) through (f).
0
b. By adding a new paragraph (c) to read as set forth below.
0
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]

0
40. Section 319.41-5 is amended as follows:
0
a. In paragraph (a), second sentence, by removing the words ``other 
necessary''; and by adding the words ``in accordance with part 305 of 
this chapter,'' after the word ``treatment''.
0
b. In paragraph (a), third sentence, by adding the words ``in 
accordance with part 305 of this chapter'' after the word 
``treatment''.
0
c. 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]

0
41. Section 319.41-5a is removed.


Sec.  319.55-6  [Amended]

0
42. Section 319.55-6 is amended as follows:
0
a. In paragraph (a), in the first sentence, by adding the words ``in 
accordance with part 305 of this chapter'' after the word 
``disinfection''; and in the second sentence, by adding the words ``in 
accordance with part 305 of this chapter'' after the word 
``treatment''.
0
b. In paragraph (b)(1), in the first sentence, by adding the words ``in 
accordance with part 305 of this chapter'' after the word 
``treatment.''


Sec.  319.56-3  [Amended]

0
43. 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]

0
44. 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]

0
45. 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]

0
46. Section 319.56-12 is amended by removing in the second sentence 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]

0
47. Section 319.56-13 is amended as follows:
0
a. In paragraph (b)(1)(ii), by removing the words ``an approved 
treatment listed in''.
0
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]

0
48. In Sec.  319.56-21, paragraphs (b)(2) and (d)(2) are amended by 
removing the words ``an approved treatment listed in''.

0
49. 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.
* * * * *

0
50. Section 319.56-23 is amended as follows:
0
a. In footnote 3, by removing the words ``a treatment listed in''.
0
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) * * *

[[Page 4253]]

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


Sec.  319.56-38  [Amended]

0
51. 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]

0
52. 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]

0
53. Section 319.56-47 is amended as follows:
0
a. In paragraph (b), by removing the citation ``Sec.  305.31'' and 
adding the words ``part 305'' in its place.
0
b. In paragraph (d), by removing the citation ``Sec.  305.31'' and 
adding the words ``part 305 of this chapter'' in its place.

0
54. 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.
* * * * *

0
55. Section 319.74-2 is amended as follows:
0
a. By redesignating the introductory text to paragraph (c)(1) as the 
introductory text to paragraph (c); removing paragraph (c)(2); and 
redesignating paragraphs (c)(1)(i) and (c)(1)(ii) as paragraphs (c)(1) 
and (c)(2), respectively.
0
b. 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.
0
c. 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. * * *
* * * * *

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

0
56. 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]

0
57. In Sec.  330.106, paragraph (a) is amended by adding in the fourth 
sentence the words ``in accordance with part 305 of this chapter'' 
after the word ``treatment.''


Sec.  330.300  [Amended]

0
58. 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

0
59. 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]

0
60. 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]

0
61. 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, January 19, 2010.

Kevin Shea
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-1375 Filed 1-25-10: 8:45 am]
BILLING CODE 3410-34-S