Phytosanitary Treatments; Location of and Process for Updating Treatment Schedules, 4228-4253 [2010-1375]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 75, Number 16 (Tuesday, January 26, 2010)]
[Rules and Regulations]
[Pages 4228-4253]
From the Federal Register Online via the Government Printing 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

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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 (https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0022).
    \2\ At (https://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 (https://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

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``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

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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