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[Federal Register: August 25, 2010 (Volume 75, Number 164)]
[Rules and Regulations]               
[Page 52213-52218]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au10-1]                         

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 
Prices of new books are listed in the first FEDERAL REGISTER issue of each 
week.

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[[Page 52213]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 305

[Docket No. APHIS-2006-0050]

 
Cold Treatment Regulations

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are adopting as a final rule, with changes, an interim rule 
that amended the phytosanitary treatment regulations for cold treatment 
enclosures and procedures, including regulations for precooling 
temperatures and temperature recording devices. The interim rule as 
amended by this document requires articles destined for cold treatment 
to be precooled at or below the highest temperature listed in the 
prescribed treatment schedule rather than at the intended treatment 
temperature. The amended interim rule also requires entities performing 
cold treatment to use measures approved by the Animal and Plant Health 
Inspection Service as adequate to ensure the security and integrity of 
cold treatment temperature data rather than requiring password-
protected and tamperproof temperature recording devices specifically. 
These actions relieve certain requirements that we have determined are 
not necessary while continuing to ensure the effectiveness of cold 
treatment and prevent the introduction of plant pests into the United 
States.

EFFECTIVE DATE: August 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 20737-1231; (301) 734-0627.

SUPPLEMENTARY INFORMATION:

Background

    The phytosanitary treatments regulations in 7 CFR part 305 set out 
general requirements for certifying or approving treatment facilities 
and for performing treatments listed in the Plant Protection and 
Quarantine (PPQ) Manual\1\ for fruits, vegetables, and other articles 
to prevent the introduction or dissemination of plant pests or noxious 
weeds into or through the United States. Within part 305, Sec.  305.6 
(referred to below as the regulations) sets out requirements for 
treatment procedures, monitoring, facilities, and enclosures needed for 
performing cold treatment for imported fruits and vegetables and for 
regulated articles moved interstate from quarantined areas within the 
United States.
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    \1\ The PPQ Treatment Manual is available at (http://www.aphis.usda.gov/import_export/plants/manuals/ports/treatment.shtml).
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    In an interim rule\2\ published in the Federal Register on July 2, 
2007 (72 FR 35909-35915, Docket No. APHIS-2006-0050), and effective on 
August 31, 2007, we amended cold treatment regulations by:
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    \2\ To view the interim rule, the comments we received, and a 
distribution table listing changes to paragraph numbering in the 
regulations after publication of the interim rule, go to (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0050).
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     Imposing more stringent requirements for precooling fruit 
prior to cold treatment;
     Requiring the use of password-protected and tamperproof 
temperature recording devices;
     Adding requirements to increase the effectiveness of cold 
treatment conducted in vessel holds and treatment enclosures; and
     Providing for officials authorized by APHIS to conduct 
audits of the cold treatment process.
    We based these changes on recommendations made in an internal 
review of treatment procedures by the Center for Plant Health Science 
and Technology (CPHST) of APHIS' Plant Protection and Quarantine (PPQ) 
program and on the findings of an APHIS-commissioned study conducted by 
the Cannon Design firm. Their report, dated June 30, 2004, and titled 
``Supplementary Guidelines for Cold Treatment Application,'' analyzed 
cold treatment practices described in the regulations and the PPQ 
Treatment Manual and offered treatment recommendations.\3\ Both the 
CPHST review and the Cannon Design study were initiated in response to 
concerns by industry representatives and other interested parties that 
existing procedural requirements were inadequate to prevent the 
development of ``hot spots,'' in which parts of fruit consignments 
undergoing cold treatment remain several degrees warmer than the 
temperature prescribed in the cold treatment schedule.
---------------------------------------------------------------------------

    \3\ Copies of this report are available on Regulations.gov at 
the address in footnote 2. If you access the report through 
Regulations.gov, please be aware that the PDF file of the report is 
approximately 17 megabytes in size and may take a long time to 
download.
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    [NOTE: On August 31, 2007, we published a technical amendment to 
the interim rule in the Federal Register (72 FR 50201-50204, Docket No. 
APHIS-2006-0050). The technical amendment, which was effective upon 
publication, was necessary because another rule (72 FR 39482-39528, 
Docket No. APHIS-2005-0106, published on July 18, 2007, and effective 
on August 17, 2007) reorganized the regulations by moving some of the 
treatment-related provisions of the fruits and vegetables regulations 
in 7 CFR part 319 to the cold treatments regulations. This 
reorganization meant that the amendatory instructions in the interim 
rule no longer matched up with the paragraph numbers that we intended 
to amend in the cold treatment regulations. The technical amendment 
corrected this problem by changing the paragraph numbers in the interim 
rule's amendatory instructions to reflect those that were changed in 
the cold treatments subpart. The technical amendment did not alter the 
provisions of the interim rule, but only presented how the changes to 
the interim rule appear in the cold treatments subpart of the 
regulations after the subpart was amended by the final rule that became 
effective on August 17, 2007.
    Also, on December 11, 2007, we published a correction to the 
interim rule (72 FR 70219-70220, Docket No. APHIS-2006-0050) that 
reinstated provisions that were inadvertently dropped from the rule 
during the reorganization of the regulations described in the August 
2007 technical amendment.
    Finally, a final rule published in the Federal Register on January 
26, 2010,

[[Page 52214]]

and effective on February 25, 2010 (75 FR 4228-4253, Docket No. APHIS-
2008-0022), removed treatments and treatment schedules from part 305 
(and elsewhere in 7 CFR chapter III) and relocated them to the PPQ 
Treatment Manual. As part of this change, the section containing 
requirements for performing cold treatment was redesignated from Sec.  
305.15 to Sec.  305.6, and minor changes were made to the section. The 
amendatory instructions in this document reflect that change.
    To help guide the reader through this reorganization of the 
regulations, a distribution table laying out the changes in paragraph 
numbers from the interim through the final rule can be found on the 
Regulations.gov Web site (see footnote 2).
    We solicited comments on the interim rule for 60 days ending August 
31, 2007, and received three comments by that date. They were from 
foreign national plant protection organizations (NPPOs) and a private 
citizen. We have carefully considered the comments we received. One 
commenter raised no issues related to cold treatment or the changes we 
made in the interim rule. The issues raised by the other two commenters 
are discussed below.

General Comments

    One commenter expressed concern that, because the rule was 
published as an interim rule, the commenter and other interested 
parties were not given an opportunity to contribute to the wording of 
the rule before it became effective.
    Immediate action was necessary to amend the cold treatment 
regulations to ensure that such treatment continued to be effective 
against quarantine plant pests and thus prevent their introduction into 
the United States. During the 60 days between publication of the rule 
and its effective date, commenters were given the opportunity to review 
the rule and submit comments.
    The same commenter also noted that the changed regulations would 
become effective during the produce export season of the commenter's 
country, giving exporters insufficient time for implementing the 
changes required for conducting cold treatment.
    We made the interim rule effective 60 days after publication so 
that affected parties would have time to prepare for the changes in 
operations that would become necessary on the effective date of the 
rule.

Precooling Requirements

    The interim rule amended the requirements for precooling, a 
procedure that involves cooling fruits or other regulated articles to a 
specified temperature before initiating cold treatment. To gain a 
better understanding of the precooling process, we commissioned Cannon 
Design to conduct a study and report their conclusions and 
recommendations. Cannon Design focused their investigation on the 
problem of ``hot spots'' in pallets of fruit undergoing cold treatment 
while in transit. Hot spots can occur when fruit continues to convert 
oxygen to carbon dioxide, a process that generates heat. After 7 days 
of treatment, fruit respiration can raise temperatures and create hot 
spots at the center of large fruit consignments several degrees warmer 
than fruit stacked at the perimeter. In their study, Cannon Design 
established that, in pallets of fruit loaded at 20 [deg]C (68 [deg]F) 
without significant air gaps between them, the fruit could maintain 
temperatures at or above the loading temperature during cold treatment. 
They concluded in their report that precooling before beginning 
treatment was essential to reducing the likelihood of hot spots.
    The cold treatment schedules in the PPQ Treatment Manual allow for 
treatment temperatures ranging from -17.8 [deg]C to 2.2 [deg]C (0 
[deg]F to 36 [deg]F), depending on the treatment schedule and the 
article to be treated. The highest treatment temperature listed in the 
treatment schedules, 36 [deg]F (2.2 [deg]C), was used by Cannon Design 
as the threshold for defining a hot spot. Through their modeling, they 
determined that precooling the fruit to 5 [deg]C (41 [deg]F) or lower 
eliminated hot spots (spots where the temperature was greater than 2.2 
[deg]C). Based on their findings, Cannon Design recommended that all 
fruit in a consignment be precooled to at least 5 [deg]C before 
initiating cold treatment.
    Prior to the interim rule, the regulations allowed precooling 
temperatures up to 4.5 [deg]C (40 [deg]F) for articles before 
undergoing cold treatment. However, based on our ongoing experience 
with administering cold treatments, we determined that this requirement 
was not sufficient to ensure that plant pests would be treated 
successfully. Accordingly, in the interim rule we amended the 
regulations to require that fruit intended for in-transit cold 
treatment be precooled to the treatment temperature. With that change, 
the required precooling temperature will always be 2.2 [deg]C or lower, 
because none of the treatment options in the cold treatment schedules 
uses a treatment temperature above 2.2 [deg]C. As a result of the 
August 2007 technical amendment and the January 2010 final rule, this 
requirement now appears in Sec.  305.6(d)(4).
    One commenter stated that APHIS has not established that precooling 
to the treatment temperature is necessary to achieve an effective 
treatment and that the requirements as amended in the interim rule are 
more restrictive than necessary.
    The commenter stated that Cannon Design's modeling approach treats 
groups of pallet stacks as a single undifferentiated mass, with no gaps 
between stacks for airflow factored into the model. Should different 
pallet configurations be modeled, the commenter stated, the resulting 
changes in airflow could affect the size, location, and duration of any 
hot spots, which in turn could change the minimum precooling 
temperature needed to eliminate them.
    The commenter suggested that APHIS revisit the modeling and include 
options in the final rule for equivalent methods of precooling that 
consider different pallet configurations and different precooling 
temperatures for each cold treatment, or range of treatments, within a 
treatment schedule and for each type of treatment enclosure. The 
commenter added that our requirements do not follow the less stringent 
precooling temperature of 5 [deg]C or below recommended in the Cannon 
Design report we commissioned, and suggested that, in the case of cold 
treatment performed at temperatures up to 3 [deg]C (37.4 [deg]F), 
precooling to 5 [deg]C is likely to be more than adequate.
    We used the Cannon Design report as guidance in formulating the 
precooling requirements, but it should not be considered the definitive 
source for our decisions. The CPHST internal review and our experience 
in administering cold treatment also provided us with information for 
this purpose.
    We acknowledge the commenter's point that further modeling of 
pallet configurations and airflow may yield additional information 
about the development of hot spots and optimal precooling temperatures. 
However, every consignment of shipped fruit is subject to numerous 
variables, including treatment enclosure conditions, pallet 
configurations, and airflow patterns, all of which can influence fruit 
temperatures within the consignment. Given these variables, we consider 
it infeasible to model scenarios and develop separate requirements for 
each different treatment environment.
    As for the commenter's suggestion to raise the required precooling 
temperature to 5 [deg]C, our review indicates that doing so would not 
provide adequate protection against

[[Page 52215]]

plant pests. In fact, we initiated the interim rule because we 
determined that the previous required precooling temperature of 4.5 
[deg]C, a lower precooling temperature than that recommended by the 
commenter, was not sufficient to eliminate hot spots for all treatment 
schedules at all temperatures.
    However, we acknowledge that the amended precooling temperature 
requirements in the interim rule, which required precooling the entire 
consignment to the prescribed treatment temperature, can be made less 
restrictive and yet maintain an effective level of phytosanitary 
security.
    A cold treatment ``passes'' when an official authorized by APHIS 
verifies that the fruit was held at the correct temperature for the 
correct time period in accordance with the regulations, and no hot 
spots are observed to have developed. Our past experience has 
established that cold treatments initiated after the fruit had been 
precooled to the highest temperature within the applicable treatment 
schedule can pass at treatment temperatures lower than the temperature 
at which the fruit was precooled. To cite an example, cold treatment 
schedule T107-a contains three treatment options: 36 [deg]F or lower 
for 18 days, 35 [deg]F or lower for 16 days, or 34 [deg]F or lower for 
14 days. Under T107-a, a consignment of fruit might first be precooled 
to the highest temperature in the schedule, 36 [deg]F, and then begin 
treatment at 36 [deg]F for 18 days. Soon after treatment begins, if the 
shipper estimates that the shipping time will be shorter than initially 
expected and subsequently decides to treat at 34 [deg]F for 14 days, 
the fruit could be cooled to 34 [deg]F for at least 14 days, and the 
treatment would pass, with no hot spots observed. Based on this 
experience, we have determined that the treatment temperature does not 
necessarily have to be equal to the precooling temperature to result in 
an effective treatment, although we also established that the previous 
precooling temperature of 4.5 [deg]C is too high.
    Given these considerations, we are changing the precooling 
temperature requirement to allow fruit intended for in-transit cold 
treatment to be precooled to a temperature no higher than the highest 
temperature of the treatment schedule under which the fruit will be 
treated. With the change we are making to the precooling temperature 
requirements, the maximum allowable precooling temperature will never 
be above 36 [deg]F (2.2 [deg]C), which is 2.3 [deg]C lower than the 
precooling temperature required prior to publication of the interim 
rule.
    It should be noted that this change does not affect any of the 
required cold treatments themselves; it only slightly adjusts the 
precooling requirements. Depending on what treatment option is selected 
from a schedule, some fruit will still require precooling at the actual 
treatment temperature. However, our experience indicates that as long 
as a consignment of fruit is precooled to the highest treatment 
temperature listed in the applicable schedule and treatment is 
performed in accordance with all other treatment requirements, any of 
the treatment options within that schedule can be administered to 
provide effective phytosanitary security against the plant pests of 
concern.
    The interim rule required that fruit precooled outside the 
treatment enclosure be no more than 0.28 [deg]C (0.5 [deg]F) above the 
temperature at which the fruit will be treated prior to loading for 
treatment. We are amending that requirement in this final rule because 
in some cases the difference between the treatment temperature and the 
highest temperature in the overall treatment schedule is greater than 
0.28 [deg]C. As amended, Sec.  305.6(d)(4) requires that fruit 
precooled outside the treatment enclosure be no more than 0.28 [deg]C 
above the highest treatment temperature in the schedule under which the 
fruit will be treated, as listed in the applicable treatment schedule.

Temperature Monitoring Requirements

    In the interim rule, we added a requirement that allowed precooling 
in in-transit treatment enclosures only if 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. In order to manually monitor fruit temperatures 
prior to treatment, an official must ensure that there is sufficient 
space within the enclosure to gain access to the entire consignment. If 
fruit is precooled outside the treatment enclosure, an official 
authorized by APHIS must 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.
    One commenter stated that the requirement for manual sampling was 
unnecessary, adding that it fails to recognize alternative and 
equivalent options for using remote monitoring to measure fruit 
temperature. As support, the commenter cited a test conducted by Cannon 
Design in which a pallet of citrus was cooled, followed by pulp 
temperature readings being taken in fruit throughout the pallet. While 
readings taken at the bottom of the pallet were lower due to direct 
airflow, fruit temperatures throughout the rest of the pallet were 
nearly uniform due to thermal conduction. The commenter reasoned from 
this finding that the specific fruit sampled, and the carton from which 
it is chosen, are essentially unimportant to determining whether 
precooling requirements for a given pallet have been met, so there 
should be no requirement for an inspector to have the ability to 
manually monitor fruit temperatures prior to beginning treatment. The 
commenter suggested that we amend the regulations to provide for 
methods other than the manual sampling of pulp temperatures.
    We acknowledge that the Cannon Design report found that pallets of 
fruit are cooled primarily by thermal conduction, although the report 
also cites airflow through box openings as a contributing factor to the 
cooling process. Cooler temperature readings at the bottom of the 
pallet indicate that airflow can influence temperature variations among 
individual pallets of fruit. Depending on the type of enclosure and the 
configuration of pallets, differences in airflow patterns can 
accelerate or impede cooling in different parts of a consignment. For 
this reason, an official must be able to sample a pallet on all sides 
to verify that precooling has uniformly and sufficiently cooled the 
entire consignment. Remote probes will not achieve the same result; 
they remain in a fixed position and cannot account for container and 
airflow variables, meaning they cannot provide as thorough or reliable 
a level of verification.

Continuation of Current Procedures

    A commenter representing a foreign NPPO asked whether that 
organization could continue using its own requirements for precooling 
prior to cold treatment instead of following the new requirements for 
precooling in the interim rule (which now appear in Sec.  305.6(d)(4)). 
The commenter's NPPO observes the following requirements: 1) Fruit must 
be precooled to the target temperature for 72 hours and must be at the 
target temperature for the last 24 hours of this period (APHIS imposes 
no time requirement for cooling in the regulations); and 2) a variance 
of 0.3 [deg]C is allowed when the temperature is checked with a 
handheld thermometer (we allowed a variance of 0.28 [deg]C in the 
interim rule, though it did not specify the type of thermometer).

[[Page 52216]]

    We have determined that the precooling requirements observed by the 
commenting NPPO are consistent with the new requirements established in 
the interim rule, as the NPPO already requires precooling to the 
treatment temperature. However, for fruit precooled outside the 
treatment enclosure, we require that fruit pulp temperature samples be 
taken prior to loading the fruit, and that these sample temperatures 
not vary more than 0.28 [deg]C above the highest temperature of the 
prescribed treatment schedule.

Sampling Location

    The interim rule provided that an official authorized by APHIS must 
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. One commenter asked whether sampling can be conducted after 
removing the fruit from the precooling space and before loading it into 
the treatment enclosure.
    Temperature sampling should be conducted immediately before the 
fruit is loaded into the treatment enclosure. If the fruit sits outside 
the precooling space for any length of time before loading into the 
treatment enclosure, this location should be where the temperature 
sampling is conducted.

Officials Authorized by APHIS

    The interim rule also included requirements that only officials 
authorized by APHIS may oversee proper administration of cold 
treatment, which includes approving the loading of fruit in the 
treatment enclosure and sampling fruit pulp temperatures. One 
commenter, a foreign NPPO, sought confirmation that an official 
authorized by APHIS can be an NPPO official from the commenter's 
country. Likewise, a commenter from another foreign NPPO requested that 
inspectors from that country be allowed to act as an official 
authorized by APHIS as defined in the interim rule.
    The NPPOs of both these countries are signatories to the 
International Plant Protection Convention (IPPC) and therefore observe 
phytosanitary treatment standards that are recognized by other 
signatories, including the United States. Officials from any IPPC 
member country who are trained and authorized by APHIS can verify 
compliance with precooling requirements, approve the loading of fruit 
into treatment enclosures, initiate in-transit cold treatment, and 
exercise other responsibilities specified in the regulations.

Pallet Stacking

    In the interim rule, we added requirements regarding vessel 
enclosures used for in-transit cold treatment of fruit. One specific 
change we made was to prohibit double-stacking of pallets, because 
doing so can constrict airflow to the fruit and allow hot spots to 
form.
    A commenter requested that we define the term double-stacking with 
regard to pallets of fruit.
    We define the term to mean one loaded pallet physically resting 
atop another loaded pallet.
    Another commenter disagreed with our prohibition on double-stacking 
of pallets. They noted that the Cannon Design report recommended 
placing spacers between pallets to maintain adequate cooling airflow.
    The Cannon Design study examined the effects of airflow on 
temperature in pallets of fruit. Through computer modeling and real-
world simulations, Cannon Design determined that airflow patterns 
around pallet stacks influence the rate of cooling. To speed the rate 
of cooling in fruit, they recommended that air gaps be maintained by 
placing spacers between pallet stacks.
    We concur with Cannon Design's conclusion that air gaps between and 
around pallets can affect the rate of cooling, but the report does not 
discuss using spacers as part of the physical testing that was 
conducted. We therefore lack sufficient data to determine the actual 
implications of using spacers between double-stacked pallets of fruit. 
For this reason, we are not changing the regulations established by the 
interim rule regarding double-stacking of pallets.

Security of Temperature Recorders

    In the interim rule, we added requirements to the treatment 
procedures to help ensure the integrity of temperature recording. We 
required the temperature recording devices used during treatment to be 
password-protected and tamperproof. In addition, we required the 
devices to be capable of recording the date, time, and sensor number 
and automatic and continuous records of the temperature during all 
calibrations and during treatment.
    One commenter stated that the requirement for password-protected 
and tamperproof temperature recording devices does not allow for 
equivalent measures for recording fruit temperatures. The commenter 
added that the security and integrity of cold treatment data could be 
achieved by other methods, such as proprietary software for interfacing 
with temperature recorders, encrypted data, limited distribution of 
necessary software, or locking doors to rooms containing recording 
equipment. The commenter requested that APHIS recognize equivalent 
temperature recording methods that can provide an effective level of 
security.
    We agree that the security and integrity of cold treatment data is 
achievable through equivalent measures, as long as the recording 
devices and methods used conform to all applicable requirements. For 
this reason, we are revising the sentence ``Temperature recording 
devices used during treatment must be password-protected and 
tamperproof'' in Sec.  305.6(d)(7) to read ``Temperature recording 
devices used during treatment must be secured using measures approved 
by APHIS as adequate to ensure the security and integrity of cold 
treatment data.'' Regardless of which measures are employed to ensure 
the security and integrity of temperature recording devices, officials 
authorized by APHIS are required to identify instances of recording 
device manipulation or malfunction and make decisions about certifying 
consignments as necessary.
    One commenter asked APHIS which organization was responsible for 
ensuring that shippers comply with the requirements for password-
protected and tamperproof temperature recording devices. The commenter, 
a foreign NPPO, also asked whether officials of its organization with 
access to temperature recording devices and passwords would be liable 
for any problems involving the equipment, and expressed concerns about 
the availability and cost to exporters of such devices.
    As noted above, we are amending the regulations established by the 
interim rule so that they no longer specifically require that 
temperature recording devices be password-protected and tamperproof. As 
a result, exporters will have the flexibility to use other measures to 
ensure adequate data security and integrity. APHIS and other NPPOs work 
in cooperation to ensure compliance with treatment requirements, 
including data security and integrity.

Placement of Temperature Probes or Sensors

    In the interim rule, we added provisions specifying that a minimum 
of four temperature probes or sensors is required for vessel holds used 
as treatment enclosures, and a minimum of three temperature probes or 
sensors is required for other treatment enclosures.

[[Page 52217]]

    One commenter stated that it is standard practice for APHIS to 
require a minimum of four pulp temperature sensors and two air sensors 
in an independent deck; six pulp sensors (three per deck) and three air 
sensors (one in the bottom deck and two in the upper deck) for a common 
deck; and two pulp sensors in a small lower bow deck. The commenter 
noted the interim rule requires a minimum of four temperature probes or 
sensors for vessel holds used as treatment enclosures and three sensors 
for other types of treatment enclosures and asked where the additional 
temperature sensors are to be placed in the vessel hold.
    The requirements established in the interim rule set the minimum 
number of probes or sensors required for an approved vessel hold 
regardless of deck size or type, and provide that an official 
authorized by APHIS will have the option to require that additional 
temperature probes or sensors be used depending on variables such as 
treatment enclosure conditions, pallet configurations, and airflow 
patterns.\4\
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    \4\ See Chapter 6 of the PPQ Treatment Manual for practices 
regarding sensor placement on vessels: (http://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf).
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    Therefore, for the reasons given in the interim rule and this 
document, we are adopting the interim rule as a final rule with the 
changes discussed in this document.
    This final rule also affirms the information contained in the 
interim rule concerning Executive Orders 12372 and 12988 and the 
Paperwork Reduction Act.
    Further, for this action, the Office of Management and Budget has 
waived its review under Executive Order 12866.

Effective Date

    Pursuant to the administrative procedure provisions in 5 U.S.C. 
553, we find good cause for making this rule effective less than 30 
days after publication in the Federal Register. This rule revises the 
precooling temperature and temperature recording device requirements 
included in the interim rule to make them less restrictive. Therefore, 
the Administrator of the Animal and Plant Health Inspection Service has 
determined that this rule should be effective upon publication in the 
Federal Register.

Regulatory Flexibility Act

    This final rule follows an interim rule that amended the 
regulations for cold treatment enclosures and procedures, including 
regulations for precooling temperatures and temperature recording 
devices.
    We have prepared an economic analysis for this final rule. The 
analysis, which considers the number and types of entities that are 
likely to be affected by this action and the potential economic effects 
on those entities, provides the basis for the Administrator's 
determination that the rule will not have a significant economic impact 
on a substantial number of small entities. The full economic analysis 
may be viewed on the Regulations.gov Web site (see footnote 2 for 
instructions for accessing Regulations.gov). Copies of the economic 
analysis are also available from the person listed under FOR FURTHER 
INFORMATION CONTACT.
    This final rule follows an interim rule that amended the 
phytosanitary treatment regulations for cold treatment enclosures and 
procedures, including regulations for precooling. As described in the 
economic analysis, it is unlikely that U.S. entities will be directly 
affected by the new cold treatment requirements; compliance will be the 
responsibility of the exporting entity. Any reporting or recordkeeping 
requirements for U.S. entities will be those normally associated with 
importing fruit from abroad. In theory, if foreign exporters do 
experience a cost increase because of this amendment, the quantity of 
fruit supplied may decrease. This decrease could result in an increase 
in the price of fruit, costing U.S. consumers and benefiting U.S. 
producers and suppliers. However, these impacts, if they occur, are 
expected to be negligible. Any additional costs because of this 
amendment will represent only a small fraction of the price of the 
fruit.
    The number of U.S. industries that could be potentially affected by 
this amendment are small, and any impacts on these industries due to 
these changes in the cold treatment regulations will be insignificant.
    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.

List of Subjects in 7 CFR Part 305

    Irradiation, Phytosanitary treatment, Plant diseases and pests, 
Quarantine, Reporting and recordkeeping requirements.

0
Accordingly, the interim rule amending 7 CFR part 305 that was 
published at 72 FR 35909-35915 on July 2, 2007, and amended in 
documents published at 72 FR 50201-50204 on August 31, 2007, and 72 FR 
70219-70220 on December 11, 2007, is adopted as a final rule with the 
following changes:

PART 305--PHYTOSANITARY TREATMENTS

0
1. The authority citation for part 305 continues to read as follows:

    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.

0
2. Section 305.6 is amended as follows:
0
a. In paragraph (c)(1), by removing the words ``treatment temperature'' 
the first time they occur and adding the words ``highest temperature of 
the treatment schedule under which the fruit will be treated'' in their 
place.
0
b. By revising paragraph (d)(4) to read as set forth below.
0
c. In paragraph (d)(7), by removing the words ``password-protected and 
tamperproof'' and adding the words ``secured using measures approved by 
APHIS as adequate to ensure the security and integrity of cold 
treatment data'' in their place.

Sec.  305.6  Cold treatment requirements.

* * * * *
    (d) * * *
    (4) Fruit intended for in-transit cold treatment must be precooled 
to no more than the highest temperature of the treatment schedule under 
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 highest temperature of the treatment schedule 
under 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 highest temperature of the treatment schedule 
under which the fruit will be treated. 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 
highest temperature of the treatment schedule under which the fruit 
will be treated, as verified by an

[[Page 52218]]

official authorized by APHIS, prior to beginning treatment.
* * * * *
    Done in Washington, DC, this 18\th\ day of August 2010.

Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-21134 Filed 8-24-10; 8:45 am]
BILLING CODE 3410-34-S
```