Cold Treatment Regulations, 35909-35915 [E7-12768]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 72, Number 126 (Monday, July 2, 2007)]
[Rules and Regulations]
[Pages 35909-35915]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12768]


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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: Interim rule and request for comments.

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SUMMARY: We are amending the phytosanitary treatment regulations by 
making several changes to the requirements for cold treatment 
enclosures and the requirements for conducting cold treatment. The 
changes include: Adding more specific and stringent requirements for 
precooling fruit prior to cold treatment, requiring the use of 
temperature recording devices that are password-protected and 
tamperproof, adding requirements to increase the effectiveness of cold 
treatment conducted in vessel holds, and providing for officials 
authorized by the Animal and Plant Health Inspection Service to conduct 
audits of the cold treatment process. We are making these changes in 
response to the results of external and internal reviews of the cold 
treatment requirements that have been in place. The changes we are 
making will improve the effectiveness of cold treatment and thus will 
help to prevent the introduction of quarantine plant pests into the 
United States.

DATES: This interim rule is effective on August 31, 2007. We will 
consider all comments that we receive on or before August 31, 2007.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://
www.regulations.gov, select ``Animal and Plant Health Inspection 
Service'' from the agency drop-down menu, then click ``Submit.'' In the 
Docket ID column, select APHIS-2006-0050 to submit or view public 
comments and to view supporting and related materials available 
electronically. Information on using Regulations.gov, including 
instructions for accessing documents, submitting comments, and viewing 
the docket after the close of the comment period, is

[[Page 35910]]

available through the site's ``User Tips'' link.
     Postal Mail/Commercial Delivery: Please send four copies 
of your comment (an original and three copies) to Docket No. APHIS-
2006-0050, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. APHIS-2006-0050.
    Reading Room: You may read any comments that we receive on this 
docket in our reading room. The reading room is located in room 1141 of 
the USDA South Building, 14th Street and Independence Avenue, SW., 
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., 
Monday through Friday, except holidays. To be sure someone is there to 
help you, please call (202) 690-2817 before coming.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at https://www.aphis.usda.gov.

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

SUPPLEMENTARY INFORMATION: 

Background

    The phytosanitary treatments regulations contained in 7 CFR part 
305 set out standards and schedules for treatments required in 7 CFR 
parts 301, 318, and 319 for fruits, vegetables, and articles to prevent 
the introduction or dissemination of plant pests or noxious weeds into 
or through the United States. Within 7 CFR part 305, the cold 
treatments subpart (Sec. Sec.  305.15 and 305.16, referred to below as 
the regulations) sets out requirements for performing cold treatment 
and cold treatment schedules for imported fruits and vegetables and for 
regulated articles moved interstate from quarantined areas within the 
United States.
    Section 305.15 sets out the requirements for performing cold 
treatment. These include standards that must be met by the facility 
performing cold treatment and the enclosure in which cold treatment is 
performed; monitoring requirements; procedural requirements for 
performing cold treatment; and a required compliance agreement or 
workplan to ensure that these requirements are followed, under 
appropriate oversight from the Animal and Plant Health Inspection 
Service (APHIS).
    Industry representatives and other interested parties have 
expressed concern that the procedural requirements that were in place 
prior to the publication of this interim rule were not adequate to 
prevent the development of ``hot spots,'' which are areas in the 
treatment enclosure in which the temperature of fruit being treated 
rises above the temperature required by a cold treatment schedule for 
extended periods. Fruit in these hot spots would thus not be treated at 
the proper temperature to neutralize pests of concern. To assess this 
risk, APHIS commissioned an evaluation of the process and design of 
cold treatment from the firm Cannon Design. Their report, dated June 
30, 2004, and titled ``Supplementary Guidelines for Cold Treatment 
Application,'' included specific recommended changes to the cold 
treatment requirements to prevent the development of hot spots and 
other failures of the treatment process.\1\ In addition, an internal 
review of the cold treatment procedures by the Center for Plant Health 
Science and Technology (CPHST) of APHIS' Plant Protection and 
Quarantine program indicated that additional changes were necessary to 
ensure that cold treatment is effective and to better allow officials 
authorized by APHIS to verify that treatment has been conducted 
properly.
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    \1\ Copies of this report are available from the person listed 
under FOR FURTHER INFORMATION CONTACT or on Regulations.gov; see the 
ADDRESSES block for instructions on accessing Regulations.gov. 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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    In this interim rule, we are amending the regulations to 
incorporate the changes recommended by the Supplementary Guidelines for 
Cold Treatment Application and by CPHST. The key change we are making 
is to require that fruit intended for in-transit cold treatment be 
precooled to the temperature at which it will be treated, as verified 
by an official authorized by APHIS. If treatment is conducted at a cold 
treatment facility in the United States, the fruit must be precooled to 
the temperature at which it will be treated, as verified by an official 
authorized by APHIS, prior to beginning treatment.
    Other changes we are making include requiring that fruit pulp 
temperature be maintained following the treatment schedule and within a 
specific temperature range; requiring the use of temperature recording 
devices that are password-protected and tamperproof; requiring the use 
of a minimum of four temperature probes or sensors when cold treatment 
is conducted in a vessel hold; prohibiting the use of hanging decks or 
hatch coamings as treatment enclosures without prior written approval 
from APHIS; and providing for officials authorized by APHIS to conduct 
audits of the cold treatment process.\2\
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    \2\ Officials authorized by APHIS may include inspectors as 
defined in Sec.  305.1 (any individual authorized by the 
Administrator of APHIS or the Commissioner of Customs and Border 
Protection, Department of Homeland Security, to enforce the 
regulations in part 305) or officials employed by or authorized by 
foreign national plant protection organizations and authorized by 
APHIS to supervise treatment.
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    Within Sec.  305.15, this interim rule revises paragraph (b), which 
sets out performance requirements for cold treatment enclosures, and 
paragraph (f), which sets out procedural requirements for cold 
treatment. We are retaining most provisions that have been in paragraph 
(f), while adding many provisions to it; we are also reorganizing 
paragraph (f) so that the procedural requirements for performing cold 
treatment are set out in roughly the order in which they should be 
followed while performing cold treatment. As an aid to the reader, the 
derivation of each subparagraph of the new paragraph (f) is listed in 
table 1. We have set out the entire text of the new paragraph (f) in 
the regulatory text at the end of this document.

              Table 1.--Derivation of New Sec.   305.15(f)
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           New subparagraph                       Derived from
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(f)(1)................................  (f)(1).
(f)(2)................................  First sentence of (f)(2).
(f)(3)................................  New language.
(f)(4)................................  (f)(3) and new language.
(f)(5)................................  (f)(6) and new language.
(f)(6)................................  New language.
(f)(7)................................  (f)(4) and new language.
(f)(8)................................  New language.
(f)(9)................................  (f)(5).
(f)(10)...............................  Last two sentences of (f)(7) and
                                         new language.
(f)(11)...............................  (f)(8) and new language.
(f)(12)...............................  (f)(10).
(f)(13)...............................  New language.
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    We are removing the second sentence of former paragraph (f)(2), 
which had addressed precooling of fruit to be cold treated, and 
replacing it with new paragraph (f)(3), which sets out substantially 
more rigorous precooling requirements. We are also removing the first 
sentence of former paragraph (f)(7) and all of former paragraph (f)(9).
    The new requirements and our reasons for adopting them are 
discussed in detail directly below.

[[Page 35911]]

Precooling

    In the Supplementary Guidelines for Cold Treatment Application, 
Cannon Design found that hot spots developed in cold treatment loads 
due to heat generated by respiration of the fruit and respiration of 
any insects that may have infested the fruit. (Fruit that is being 
shipped continues to convert oxygen to carbon dioxide during shipping. 
This process generates heat.) Given common fruit stacking 
configurations, respiration could produce areas within the fruit stacks 
in which some fruit reach a temperature significantly warmer than the 
temperature required by the cold treatment schedule. The goal of the 
Supplementary Guidelines for Cold Treatment Application was to 
determine methods by which the risk of development of such hot spots 
could be minimized. Cannon Design used both temperature observations 
from a simulation of real-world cold treatment conditions and 
observations from computational fluid dynamics modeling to draw its 
conclusions.
    The key measure to mitigate the risk of hot spots that was 
identified by the Supplementary Guidelines for Cold Treatment 
Application is cooling fruit that is intended for cold treatment to the 
temperature required by the intended cold treatment schedule prior to 
beginning treatment, a process known as precooling. While the 
regulations have contained a precooling requirement, the requirement 
was not sufficiently stringent; prior to loading in cold treatment 
containers, fruit had been allowed to be either precooled to a uniform 
temperature up to 4.5 [deg]C (40 [deg]F), or precooled at the terminal 
to 2.2 [deg]C (36 [deg]F). However, the cold treatment schedules in 
Sec.  305.16 require temperatures as low as 0 [deg]C (32 [deg]F), and 
most schedules require temperatures at or below 2.2 [deg]C (36 [deg]F). 
The cold treatment requirements that had been in the regulations also 
did not include any measures allowing officials authorized by APHIS to 
ensure that the precooling had been properly performed.
    This interim rule adds a new paragraph (f)(3) to Sec.  305.15 that 
sets out detailed requirements for precooling prior to cold treatment. 
These requirements are as follows:
     Fruit intended for in-transit cold treatment must be 
precooled to the temperature at which the fruit will be treated prior 
to beginning treatment. The in-transit treatment enclosure may not be 
used for precooling unless an official authorized by APHIS approves the 
loading of the fruit in the treatment enclosure as adequate to allow 
for fruit pulp temperatures to be taken prior to beginning treatment.
    Previously, the regulations required precooling to be performed 
either at an APHIS-approved dockside refrigeration warehouse or in an 
APHIS-approved enclosure aboard a vessel. However, when precooling is 
performed outside the treatment enclosure, we do not believe that it is 
necessary to specify the facility in which precooling is performed, as 
long as the other precooling requirements are fulfilled.
    We are only allowing the use of in-transit enclosures for 
precooling subject to APHIS approval because the typical loading of 
fruit in an in-transit treatment enclosure does not allow for sampling 
fruit pulp temperatures prior to beginning treatment. If precooling is 
performed in the treatment enclosure, the loading of the fruit must be 
adequate to accommodate this essential step in the cold treatment 
process.
     If the fruit is precooled outside the treatment enclosure, 
an official authorized by APHIS will take pulp temperatures manually 
from a sample of the fruit as the fruit is loaded for in-transit cold 
treatment to verify that precooling was completed. If the pulp 
temperatures for the sample are 0.28[deg]C (0.5[deg]F) or more above 
the temperature at which the fruit will be treated, the pallet from 
which the sample was taken will be rejected and returned for additional 
precooling until the fruit reaches the treatment temperature.
    These requirements allow officials authorized by APHIS to verify 
that precooling has been properly conducted and that the temperature of 
the fruit pulp has been reduced to the treatment temperature prior to 
beginning treatment.
     If fruit is precooled in the treatment enclosure, or if 
treatment is conducted at a cold treatment facility in the United 
States, the fruit must be precooled to the temperature at which it will 
be treated, as verified by an official authorized by APHIS, prior to 
beginning treatment.
    In treatment enclosures that are approved for precooling and in 
cold treatment facilities, the loading of fruit allows fruit 
temperatures to be sampled, meaning that an official authorized by 
APHIS can verify that the fruit has been precooled to the treatment 
temperature. Since fruit in an approved enclosure or a cold treatment 
facility can simply be cooled for additional time if it has not yet 
reached the treatment temperature, we do not believe it is necessary to 
specify conditions under which precooling would be rejected if it takes 
place in an approved enclosure or a cold treatment facility in the 
United States.
    We believe that precooling is essential to ensuring that cold 
treatment is effective, and these requirements will ensure that 
precooling is conducted properly.
    In a related change, this interim rule also revises paragraph 
(b)(1) in Sec.  305.15. This paragraph has required that cold treatment 
enclosures be capable of precooling, cooling, and holding fruit at 
temperatures less than or equal to 2.2 [deg]C (36 [deg]F). However, 
under this interim rule, some enclosures, such as vessel holds and 
containers, may only be used to precool fruit prior to in-transit cold 
treatment subject to APHIS approval. Additionally, we believe that the 
requirements for cold treatment enclosures should refer to holding 
fruit at or below the temperature that is required by the relevant cold 
treatment schedule, to avoid any possible confusion. Therefore, we are 
revising paragraph (b)(1) to require that cold treatment enclosures be 
capable of maintaining the treatment temperature before the treatment 
begins and holding fruit at or below the treatment temperature during 
the treatment.

Loading of Fruit in Treatment Enclosures

    Paragraph (f)(3) of Sec.  305.15 has required that breaks, damage, 
or other problems in the treatment enclosure that preclude maintaining 
correct temperatures be repaired before use and that an official 
authorized by APHIS approve loading of compartment, number and 
placement of sensors, and initial fruit temperature readings before 
beginning the treatment. In this interim rule, we are moving these 
requirements to paragraph (f)(4).
    We are also adding two more specific requirements regarding the 
loading of fruit within the treatment enclosure. Specifically, we are 
prohibiting the use of hanging decks and hatch coamings within vessels 
as enclosures for in-transit cold treatment without prior written 
approval from APHIS. If additional cargo is loaded into these 
enclosures above the fruit that is stacked for cold treatment, it can 
be difficult to ensure that airflow around the fruit is sufficient to 
maintain temperature properly during the cold treatment. Additionally, 
some of these spaces have structures that make it difficult to generate 
sufficient airflow. While some hanging decks and hatch coamings are 
suitable for use as cold treatment enclosures, we believe it is 
necessary to verify that prior to authorizing their use.
    In addition, we are prohibiting the double-stacking of pallets. As 
stated earlier, hot spots are more likely to develop when large 
quantities of fruit

[[Page 35912]]

are stacked together; prohibiting double-stacking of pallets is one way 
to help ensure that this does not occur.

Sealing of Cold Treatment Containers

    Paragraph (f)(6) of Sec.  305.15 has required that only the same 
type of fruit in the same type of package be treated together in a 
container, with no treatment of any mixture of fruits in a container. 
In this interim rule, we are moving this requirement to paragraph 
(f)(5) and adding a new requirement that a numbered seal be placed on 
the doors of the loaded container. The seal may be removed only at the 
port of destination by an official authorized by APHIS. This is a 
standard requirement for shipment of containers that prevents tampering 
with the fruit loaded in the container during transit. Adding this 
requirement to the cold treatment procedures will help to ensure the 
integrity of the cold treatment process.

Requirements for Temperature Recording Devices

    Paragraph (c) in Sec.  305.15 requires that APHIS approve the 
recording devices and sensors used to monitor temperatures during cold 
treatment. However, the regulations in Sec.  305.15 have not contained 
any more specific requirements for temperature recording devices. In 
this interim rule, we are adding a new paragraph (f)(6) that contains 
requirements intended to ensure the integrity of temperature recording 
devices used during cold treatment. (A temperature recording device 
records the temperatures from each of the temperature probes or sensors 
that are used in the cold treatment enclosure.) Specifically, paragraph 
(f)(6) requires that:
     Temperature recording devices used during treatment must 
be password-protected and tamperproof.
     The devices must be able to record the date, time, sensor 
number, and temperature during all calibrations and during treatment.
    Additionally, paragraph (f)(6) provides that, if records of 
calibrations or treatments are found to have been manipulated, the 
vessel or container in which the treatment is performed may be 
suspended from conducting cold treatments until proper equipment is 
installed and an official authorized by APHIS has recertified it. 
APHIS' decision to recertify a vessel or container will take into 
account the severity of the infraction that led to suspension. This 
provision ensures that APHIS is able to take action in the event that 
the integrity of the temperature recording devices is compromised.

Use of Additional Temperature Probe or Sensor in Vessel Holds

    Paragraph (f)(4) has required that a minimum of three temperature 
sensors be used in the treatment compartment during treatment. In this 
interim rule, we are moving this requirement to paragraph (f)(7) and 
additionally requiring that a minimum of four temperature probes or 
sensors be used when cold treatment is conducted in vessel holds, while 
retaining the requirement that a minimum of three temperature probes or 
sensors be used in other enclosures. (We are adding ``probe'' as a 
synonym for ``sensor'' in the regulations because both terms are 
commonly used.) Vessel holds are larger than containers, and thus more 
temperature probes or sensors must be used in vessel holds to ensure 
that treatment is being conducted at the proper temperatures. Paragraph 
(f)(7) also provides that an official authorized by APHIS will have the 
option to require that additional temperature probes or sensors be 
used, depending on the size of the treatment enclosure.

Maintaining Fruit Pulp Temperatures

    In this interim rule, we are revising paragraph (b)(2), which has 
required cold treatment enclosures to maintain fruit pulp temperatures 
according to treatment schedules with no more than a 0.3 [deg]C (0.54 
[deg]F) variation in temperature, to refer instead to maintaining no 
more than a 0.39 [deg]C (0.7 [deg]F) variation in temperature. In 
addition, we are adding a new paragraph (f)(8) that requires that fruit 
pulp temperatures be maintained at the temperature specified in the 
treatment schedule with no more than a 0.39 [deg]C (0.7 [deg]F) 
variation in temperature between two consecutive hourly readings.
    Maintaining fruit pulp temperatures at the treatment temperature is 
essential to ensuring that cold treatment is effective. We have 
determined that allowing fruit pulp temperatures to vary by up to 0.39 
[deg]C (0.7 [deg]F) will not threaten the effectiveness of the 
treatment while accounting for normal variation in fruit pulp 
temperatures. We are amending the temperature variation for cold 
treatment enclosures allowed by paragraph (b)(1) to make it consistent 
with the temperature variation allowed by the new paragraph (f)(8).
    Paragraph (f)(8) also explicitly provides that failure to comply 
with this requirement will result in invalidation of the treatment 
unless an official authorized by APHIS can verify that the pulp 
temperature was maintained at or below the treatment temperature for 
the duration of the treatment. An official authorized by APHIS has the 
option to accept a treatment in which fruit pulp temperature varies by 
amounts greater than those required in the regulations if the official 
authorized by APHIS can determine from other evidence that the fruit 
was adequately treated. If there is no evidence confirming that the 
fruit was adequately treated, an official authorized by APHIS will 
invalidate the treatment.

Auditing Cold Treatment

    We are adding a new paragraph (f)(13) that provides for officials 
authorized by APHIS to perform audits to ensure that the treatment 
procedures comply with the regulations. The official authorized by 
APHIS must be given the appropriate materials and access to the 
facility, container, or vessel necessary to perform the audits. This 
provision will ensure that, if officials authorized by APHIS become 
concerned about whether cold treatment is being conducted according to 
the regulations, they will be able to gather any necessary information 
in order to investigate the matter.

Other Changes

    The first sentence of paragraph (f)(7) has read as follows: ``Fruit 
must be stacked to allow cold air to be distributed throughout the 
enclosure, with no pockets of warmer air, and to allow random sampling 
of pulp temperature in any location in the load.'' The random sampling 
requirement did not reflect the conditions under which in-transit cold 
treatment is typically performed. To maximize the volume of fruit that 
can be treated during shipment, fruit is typically packed tightly into 
the treatment enclosure, leaving a crawl space above the fruit for 
circulation of air. Random sampling of the fruit during treatment thus 
could not take place. Instead, we have relied on data gathered from 
temperature probes or sensors to determine whether cold treatment is 
being effectively administered, as described earlier. In addition, the 
requirement that fruit be stacked to allow cold air to be distributed 
throughout the enclosure is unnecessary given the specific requirement 
for maintaining a constant fruit pulp temperature added by this interim 
rule. Therefore, the revised paragraph (f) set out by this interim rule 
does not include the first sentence of former paragraph (f)(7).
    Paragraph (f)(9) has read as follows: ``Pretreatment conditioning 
(heat shock or 100.4 [deg]F for 10 to 12 hours) of fruits is optional 
and is the responsibility of

[[Page 35913]]

the shipper.'' Because this step is optional, we would prefer to convey 
information about pretreatment conditioning through the guidance 
provided in the Plant Protection and Quarantine Treatment Manual rather 
than through the regulations. We have therefore not included any 
information about pretreatment conditioning in the revised paragraph 
(f) set out by this interim rule.
    This interim rule moves the temperature recording requirements that 
had previously been in the last two sentences of paragraph (f)(7) to a 
new (f)(10). In addition, we are amending the sentence ``Gaps of longer 
than 1 hour may invalidate the treatment or indicate treatment 
failure'' to indicate that the treatment will be invalidated unless an 
official authorized by APHIS can verify that the pulp temperature was 
maintained at or below the treatment temperature for the duration of 
the treatment, for reasons discussed earlier under the heading 
``Maintaining Fruit Pulp Temperatures.''
    This interim rule moves the requirements that had previously been 
in paragraph (f)(8) to a new paragraph (f)(12). We are also amending 
the sentence ``Cold treatment is not completed until so designated by 
an official authorized by APHIS or the certifying official of the 
foreign country'' by replacing the word ``designated'' with the word 
``declared.'' We believe this word more clearly indicates that an 
official authorized by APHIS must serve as the final authority in 
determining whether cold treatment has been completed.
    The changes we are making in this interim rule are designed to 
ensure that cold treatment neutralizes the target pests in shipments of 
fruit and to ensure that officials authorized by APHIS are able to 
review accurate records of treatment and take action if the cold 
treatment is not being conducted in accordance with the regulations. We 
welcome public comment on any aspect of these changes.

Immediate Action

    Immediate action is necessary to ensure that cold treatment is 
effective at neutralizing quarantine plant pests and thus preventing 
their introduction into the United States.
    This rule is being made effective 60 days after publication because 
affected parties will need time to prepare for the changes in 
operations that will become necessary on the effective date of this 
rule. Because prior notice and other public procedures with respect to 
this action are impracticable and contrary to the public interest under 
these circumstances, we find good cause under 5 U.S.C. 553 to make this 
rule effective 60 days after publication in the Federal Register.
    We will consider comments we receive during the comment period for 
this interim rule (see DATES above). After the comment period closes, 
we will publish another document in the Federal Register. The document 
will include a discussion of any comments we receive and any amendments 
we are making to the rule.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. For this 
action, the Office of Management and Budget has waived its review under 
Executive Order 12866.
    In accordance with 5 U.S.C. 603, we have performed an initial 
regulatory flexibility analysis, which is set out below, regarding the 
economic effects of this interim rule on small entities. Based on the 
information we have, there is no reason to conclude that adoption of 
this interim rule will result in any significant economic effect on a 
substantial number of small entities. However, we do not currently have 
all of the data necessary for a comprehensive analysis of the effects 
of this interim rule on small entities that may incur benefits or costs 
from the implementation of this interim rule.
    Under the Plant Protection Act (7 U.S.C. 7701 et seq.), the 
Secretary of Agriculture is authorized to regulate the importation of 
plants, plant products, and other articles to prevent the introduction 
of plant pests into the United States or the dissemination of plant 
pests within the United States.
    This interim rule amends the cold treatment regulations by making 
several changes to the requirements for cold treatment enclosures and 
the requirements for conducting cold treatment. The changes include: 
Adding more specific and stringent requirements for precooling fruit 
prior to cold treatment, requiring the use of temperature recording 
devices that are password-protected and tamperproof, adding 
requirements to increase the effectiveness of cold treatment conducted 
in vessel holds, and providing for officials authorized by APHIS to 
conduct audits of the cold treatment process. We are making these 
changes in response to the results of external and internal reviews of 
the cold treatment requirements that have been in place. These changes 
will improve the effectiveness of cold treatment and thus will help to 
prevent the introduction of quarantine plant pests into the United 
States.
    Operational costs of precooling under this interim rule are 
expected to be largely the same as they were prior to the publication 
of this interim rule, when precooling was allowed to be conducted on 
vessels without APHIS approval of the treatment enclosure. There may be 
a cost increase per quantity of fruit shipped due to the pulp 
temperature sampling requirements, but we do not have information that 
would enable us to quantify the increase. Similarly, precooling costs 
for fruit that undergoes cold treatment at a facility in the United 
States are expected to be largely the same as they are under the 
regulations that have been in place.
    Fruit intended for cold treatment may still be precooled in the 
treatment enclosure subject to APHIS approval of the loading of the 
fruit. However, because loading of fruit in the treatment enclosure is, 
in most cases, not adequate to allow an official authorized by APHIS to 
sample the pulp temperatures of the precooled fruit, we expect that 
most fruit intended for cold treatment will be precooled outside the 
treatment enclosures. If countries decide to construct dockside 
refrigeration warehouses to meet these requirements, the warehouses 
themselves could be a potential additional cost. (To find the 
additional cost, one would subtract any ship utilization costs forgone 
by not conducting the precooling in ship holds from the total cost of 
constructing and using a dockside refrigeration warehouse.) Based on 
costs for the construction of such facilities in the United States, a 
medium-sized refrigerated facility (between 60,000 square feet and 
100,000 square feet) may cost between $7 million and $10 million.\3\
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    \3\ The Port of Corpus Christi, TX, completed, in July 2000, a 
new 99,520-square-foot refrigerated warehouse at a total cost of 
$9.2 million (about $92.5 per square foot) for importing and 
exporting fruits, vegetables, meats, and other commodities. See 
https://www.mgn.com/pressreleasedetails.cfm?id=1200 and https://
www.expansionmanagement.com/cmd/articledetail/articleid/15068/
default.asp. As another example, a new 60,000-square-foot 
refrigerated warehouse at the Port of Wilmington, DE, was completed 
at a total cost of $7.5 million (about $125 per square foot). The 
facility will be used primarily for fresh fruit. (See https://
www.drba.net/press/releases/files/20040615drbarowanuniversity.pdf.)
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    In theory, if exporters do experience a cost increase because of 
this interim rule, the quantity of fruit supplied may decrease. This 
decrease could result in an increase in the price of fruit, benefiting 
U.S. producers and suppliers. However, these impacts are expected to be 
negligible; any additional precooling

[[Page 35914]]

costs will represent a small fraction of the price of the fruit.
    Nine countries (Chile, Mexico, Spain, New Zealand, Argentina, South 
Africa, Canada, Australia, and Italy) supplied over 95 percent of total 
U.S. fruit imports in 2005. These nine countries have large worldwide 
markets, accounting for 54 percent of world exports of fresh fruits. 
About 10.3 percent of their fruit exports in 2005 were shipped to the 
United States.\4\ We expect that many if not all of these major fruit-
exporting countries already have facilities available for precooling, 
and that any cost increases attributable to the interim rule will be 
minimal.
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    \4\ Fruit imports from other countries were much smaller, with 
22 countries shipping less than a single bulk shipment (8,000 metric 
tons).
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Impact on Small Entities

    If the price of imported fruit increases because of this rule, U.S. 
entities that may be affected include producers of crops that are hosts 
for fruit flies, many of which are categorized within the following 
North American Industry Classification System [NAICS] subsectors: NAICS 
111310 Orange Groves, NAICS 111320 Citrus (except Orange) Groves, NAICS 
111331 Apple Orchards, NAICS 111332 Grape Vineyards, NAICS 111333 
Strawberry Farming, NAICS 111334 Berry (except Strawberry) Farming, 
NAICS 111335 Tree Nut Farming, NAICS 111336 Fruit and Tree Nut 
Combination Farming, and NAICS 111339 Other Noncitrus Fruit Farming. 
These entities would benefit from the price effects, which would reduce 
the supply of imported crops that are hosts for fruit flies. Affected 
entities may also include fruit and vegetables wholesalers (NAICS 
422480), supermarkets and other grocery stores (NAICS 445110), 
warehouse clubs and superstores (NAICS 452910), and fruit and vegetable 
markets (NAICS 445230). If the theoretical price effects associated 
with this interim rule actually occur, these entities would experience 
negative effects from the higher prices and smaller supply of imported 
fruit.
    The vast majority of the businesses that comprise these industries 
are small entities. The Small Business Administration (SBA) classifies 
the farming operations identified above as small entities if their 
annual receipts are not more than $750,000.\5\ According to the 2002 
Census of Agriculture, there were over 119,000 operations that were 
engaged in the production of citrus and noncitrus fruits. Over 98 
percent of these entities were designated as small entities. The SBA 
classifies fresh fruit and vegetable merchant wholesalers (NAICS 
422480) as small entities if they employ 100 or fewer employees. 
According to the 2002 Economic Census, there were 4,644 of these 
entities, with 484 (or 10.4 percent) of them considered to be large. 
SBA classifies supermarkets and other grocery stores as small entities 
if their annual receipts are not more than $23 million. There were 
56,577 supermarkets and other grocery stores in 2002. Of these, only 
3,477, or 6.1 percent, are considered to be large. There were 2,761 
warehouse clubs and superstores (NAICS 452910), and these are 
considered small if their annual sales are less than $25 million. Of 
the above total, 2,593, or 93.9 percent, are considered to be large. 
Fruit and vegetable markets (NAICS 445230) are considered small if 
their annual sales are less than $6.5 million. In 2002, the most recent 
year for which data are available, there were 2,257 fruit and vegetable 
markets.\6\ Approximately 96 percent of these are considered to be 
small entities under the SBA's standards. However, for all of these 
categories of businesses, we do not know what proportion of them will 
be affected by this interim rule. We welcome comments on the economic 
effects of this interim rule on small entities and on how many small 
entities might be affected by the rule.
---------------------------------------------------------------------------

    \5\ SBA, Small Business Size Standards matched to North American 
Industry Classification System 2002, Effective January 2006 
(www.sba.gov/size/sizetable2002.html).
    \6\ U.S. Census Bureau, 2002 Economic Census Geographic Area 
Series: Manufacturing and Wholesale Trade, Revised January 2006 
(https://www.census.gov/econ/census02/guide/geosumm.htm).
---------------------------------------------------------------------------

    No significant alternatives were identified that would meet the 
objectives of the interim rule.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule: (1) Preempts all State and local laws and 
regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

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

List of Subjects in 7 CFR Part 305

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


0
Accordingly, we are amending 7 CFR part 305 as follows:

PART 305--PHYTOSANITARY TREATMENTS

0
1. The authority citation for 7 CFR 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. In Sec.  305.15, paragraphs (b) and (f) are revised to read as 
follows:


Sec.  305.15  Treatment requirements.

* * * * *
    (b) Cold treatment enclosures. All enclosures in which cold 
treatment is performed, including refrigerated containers, must:
    (1) Be capable of maintaining the treatment temperature before the 
treatment begins and holding fruit at or below the treatment 
temperature during the treatment.
    (2) Maintain fruit pulp temperatures according to treatment 
schedules with no more than a 0.39 [deg]C (0.7 [deg]F) variation in 
temperature.
* * * * *
    (f) Treatment procedures. (1) All material, labor, and equipment 
for cold treatment performed on vessels must be provided by the vessel 
or vessel agent. An official authorized by APHIS monitors, manages, and 
advises in order to ensure that the treatment procedures are followed.
    (2) Fruit that may be cold treated must be safeguarded to prevent 
cross-contamination or mixing with other infested fruit.
    (3) Fruit intended for in-transit cold treatment must be precooled 
to the temperature at which the fruit will be treated prior to 
beginning treatment. The in-transit treatment enclosure may not be used 
for precooling unless an official authorized by APHIS approves the 
loading of the fruit in the treatment enclosure as adequate to allow 
for fruit pulp temperatures to be taken prior to beginning treatment. 
If the fruit is precooled outside the treatment enclosure, an official 
authorized by APHIS will take pulp temperatures

[[Page 35915]]

manually from a sample of the fruit as the fruit is loaded for in-
transit cold treatment to verify that precooling was completed. If the 
pulp temperatures for the sample are 0.28 [deg]C (0.5 [deg]F) or more 
above the temperature at which the fruit will be treated, the pallet 
from which the sample was taken will be rejected and returned for 
additional precooling until the fruit reaches the treatment 
temperature. If fruit is precooled in the treatment enclosure, or if 
treatment is conducted at a cold treatment facility in the United 
States, the fruit must be precooled to the temperature at which it will 
be treated, as verified by an official authorized by APHIS, prior to 
beginning treatment.
    (4) Breaks, damage, etc., in the treatment enclosure that preclude 
maintaining correct temperatures must be repaired before the enclosure 
is used. An official authorized by APHIS must approve loading of 
compartment, number and placement of temperature probes or sensors, and 
initial fruit temperature readings before beginning the treatment. 
Hanging decks and hatch coamings within vessels may not be used as 
enclosures for in-transit cold treatment without prior written approval 
from APHIS. Double-stacking of pallets is not allowed.
    (5) Only the same type of fruit in the same type of package may be 
treated together in a container; no mixture of fruits in containers may 
be treated. A numbered seal must be placed on the doors of the loaded 
container and may be removed only at the port of destination by an 
official authorized by APHIS.
    (6) Temperature recording devices used during treatment must be 
password-protected and tamperproof. The devices must be able to record 
the date, time, sensor number, and temperature during all calibrations 
and during treatment. If records of calibrations or treatments are 
found to have been manipulated, the vessel or container in which the 
treatment is performed may be suspended from conducting cold treatments 
until proper equipment is installed and an official authorized by APHIS 
has recertified it. APHIS' decision to recertify a vessel or container 
will take into account the severity of the infraction that led to 
suspension.
    (7) A minimum of four temperature probes or sensors is required for 
vessel holds used as treatment enclosures. A minimum of three 
temperature probes or sensors is required for other treatment 
enclosures. An official authorized by APHIS will have the option to 
require that additional temperature probes or sensors be used, 
depending on the size of the treatment enclosure.
    (8) Fruit pulp temperatures must be maintained at the temperature 
specified in the treatment schedule with no more than a 0.39 [deg]C 
(0.7 [deg]F) variation in temperature between two consecutive hourly 
readings. Failure to comply with this requirement will result in 
invalidation of the treatment unless an official authorized by APHIS 
can verify that the pulp temperature was maintained at or below the 
treatment temperature for the duration of the treatment.
    (9) The time required to complete the treatment begins when all 
temperature probes reach the prescribed cold treatment schedule 
temperature.
    (10) Temperatures must be recorded at intervals no longer than 1 
hour apart. Gaps of longer than 1 hour will invalidate the treatment or 
indicate treatment failure unless an official authorized by APHIS can 
verify that the pulp temperature was maintained at or below the 
treatment temperature for the duration of the treatment.
    (11) Cold treatment is not completed until so declared by an 
official authorized by APHIS or the certifying official of the foreign 
country; shipments of treated commodities may not be discharged until 
APHIS clearance has been fully completed, including review and approval 
of treatment record charts.
    (12) Cold treatment of fruits in break bulk vessels or containers 
must be initiated by an official authorized by APHIS if there is not a 
treatment technician who has been trained to initiate cold treatments 
for either break bulk vessels or containers.
    (13) An official authorized by APHIS may perform audits to ensure 
that the treatment procedures comply with the regulations in this 
subpart. The official authorized by APHIS must be given the appropriate 
materials and access to the facility, container, or vessel necessary to 
perform the audits.

    Done in Washington, DC, this 26th day of June 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E7-12768 Filed 6-29-07; 8:45 am]
BILLING CODE 3410-34-P