[Federal Register Volume 72, Number 126 (Monday, July 2, 2007)]
[Rules and Regulations]
[Pages 35909-35915]
From the Federal Register Online via the Government Publishing 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 http://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 http://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
http://www.mgn.com/pressreleasedetails.cfm?id=1200 and http://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 http://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.
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\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
(http://www.census.gov/econ/census02/guide/geosumm.htm).
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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