[Federal Register Volume 72, Number 169 (Friday, August 31, 2007)]
[Rules and Regulations]
[Pages 50201-50204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-17295]
========================================================================
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.
========================================================================
Federal Register / Vol. 72, No. 169 / Friday, August 31, 2007 / Rules
and Regulations
[[Page 50201]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 305
[Docket No. APHIS-2006-0050]
Cold Treatment Regulations; Technical Amendment
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Interim rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: In an interim rule published in the Federal Register on July
2, 2007, with an effective date of August 31, 2007, we amended the
phytosanitary treatment regulations by making several changes to the
requirements for cold treatment enclosures and the requirements for
conducting cold treatment. A final rule that was published in the
Federal Register on July 18, 2007, and effective August 17, 2007,
reorganized the cold treatment regulations by moving requirements
regarding cold treatment that had previously been contained in the
regulations governing the importation of fruits and vegetables to the
section of the regulations containing the requirements for cold
treatment enclosures and conducting cold treatment. This technical
amendment indicates how the changes in the July 2 interim rule will
appear in the regulations as they have been reorganized by the July 18
final rule.
DATES: This technical amendment is effective on August 31, 2007.
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 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 requirements 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).
In an interim rule \1\ titled ``Cold Treatment Regulations'' and
published in the Federal Register on July 2, 2007, with an effective
date of August 31, 2007 (72 FR 35909-35915, Docket No. APHIS-2006-
0050), we amended Sec. 305.15 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.
---------------------------------------------------------------------------
\1\ To view the interim rule, go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2006-0050.
---------------------------------------------------------------------------
In a separate final rule \2\ titled ``Revision of Fruits and
Vegetables Import Regulations'' and published in the Federal Register
on July 18, 2007 and effective August 17, 2007, we revised and
reorganized the regulations pertaining to the importation of fruits and
vegetables to consolidate requirements of general applicability and
eliminate redundant requirements, update terms and remove outdated
requirements and references, update the regulations that apply to
importations into territories under U.S. administration, and make
various editorial and nonsubstantive changes to regulations to make
them easier to use. As part of this final rule, we reorganized the cold
treatment regulations in Sec. 305.15 by moving requirements to Sec.
305.15 that had previously been found in the regulations governing the
importation of fruits and vegetables, specifically in Sec. 319.56-2d.
The final rule moved into Sec. 305.15 all the provisions contained in
Sec. 319.56-2d that were not already present in Sec. 305.15. The
regulations were otherwise not amended. However, these changes
necessitated a reorganization of the regulations in Sec. 305.15.
---------------------------------------------------------------------------
\2\ To view the final rule, go to http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&d=APHIS-2005-0106-0060.
---------------------------------------------------------------------------
Due to this reorganization, the amendatory language in the July 2
interim rule no longer refers to the provisions in the regulations that
we intended to amend through that interim rule. This technical
amendment sets out the regulations in Sec. 305.15 as they will appear
when the July 2 interim rule and this technical amendment become
effective on August 31, 2007. This technical amendment does not change
the provisions of the July 2 interim rule; it only establishes how the
provisions of the July 2 interim rule will appear in Sec. 305.15 as
amended by the July 18 final rule.
We have provided a table showing where the provisions of the July 2
interim rule will appear in Sec. 305.15 as that section was
reorganized by the July 18 final rule for the convenience of the
reader.
Table 1.--Location of Provisions From July 2, 2007, Interim Rule in the
Reorganized Sec. 305.15
------------------------------------------------------------------------
Now appears in Sec. 305.15
Subparagraph from July 2 interim rule: as:
------------------------------------------------------------------------
(b)(1).................................... (c)(1).
(b)(2).................................... (c)(2).
(f)(1).................................... (d)(1).
(f)(2).................................... (d)(3).
[[Page 50202]]
(f)(3).................................... (d)(4).
(f)(4).................................... (d)(5).
(f)(5).................................... (d)(6).
(f)(6).................................... (d)(7) (see below).
(f)(7).................................... (d)(8).
(f)(8).................................... (d)(9).
(f)(9).................................... (d)(10) (see below).
(f)(10)................................... (d)(11).
(f)(11)................................... (d)(12) (see below).
(f)(12)................................... (d)(13).
(f)(13)................................... (d)(14).
------------------------------------------------------------------------
Paragraph (d) of Sec. 305.15 as amended by the July 18 final rule
sets out requirements related to precooling fruit. The precooling
requirements in the July 2 interim rule (which that rule would have
added in paragraph (f)(3)) were intended to replace all previous
precooling requirements. Accordingly, this technical amendment will
remove paragraph (d) of Sec. 305.15 from the regulations. Paragraphs
(e), (f), (g), and (h) in Sec. 305.15 will be redesignated as (d),
(e), (f), and (g), respectively.
Paragraph (c)(4) of Sec. 305.15 as amended by the July 18 final
rule sets out requirements for temperature sensors. Paragraph (f)(6) in
the July 2 interim rule contained requirements that complement those in
(c)(4). To collect all the requirements relating to temperature sensors
in one place, this technical amendment will add paragraph (f)(6) from
the July 2 interim rule to Sec. 305.15 as paragraph (d)(7), will
incorporate into that paragraph (d)(7) the requirements from former
(c)(4), and will remove paragraph (c)(4) of Sec. 305.15.
In the July 2 interim rule, paragraph (f)(6) read:
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.
Paragraph (c)(4) indicates that the cold treatment enclosure must
be equipped with recording devices, such that automatic, continuous
temperature records are maintained and secured, and that recording
devices must be capable of generating temperature charts for
verification of treatment by an inspector. The new paragraph (d)(7) in
Sec. 305.15 will thus read:
Temperature recording devices used during treatment must be
password-protected and tamperproof. The devices must be able to
record the date, time, and sensor number and automatic and
continuous records of the temperature during all calibrations and
during treatment. Recording devices must be capable of generating
temperature charts for verification by an inspector. If records of
calibrations or treatments are found to have been manipulated, the
vessel or container in which the treatment is performed may be
suspended from conducting cold treatments until proper equipment is
installed and an official authorized by APHIS has recertified it.
APHIS' decision to recertify a vessel or container will take into
account the severity of the infraction that led to suspension.
Paragraph (f)(9) in the July 2 interim rule stated: ``The time
required to complete the treatment begins when all temperature probes
reach the prescribed cold treatment schedule temperature.'' This
paragraph was intended to replace a more general provision requiring
that the time to complete the treatment begins when the temperature
inside the fruit reaches the required temperature. The July 18 final
rule added to that provision a requirement that refrigeration continue
until the vessel arrives at the port of destination and the fruit is
released for unloading by an inspector even though this may prolong the
period required for the cold treatment. This technical amendment will
amend Sec. 305.15 to retain both the requirement from the July 2
interim rule relating to the temperature probes and the refrigeration
requirement established in the regulations by the July 18 final rule.
Paragraph (f)(11) of the July 2 interim rule referred to conditions
under which shipments of treated commodities may be discharged.
Paragraph (e)(10) contains a similar statement that refers to
consignments, rather than shipments. The term ``consignments'' is the
preferred term, as it is used in international standards. Accordingly,
we will add (f)(11) to Sec. 305.15 as (d)(12), but we will replace the
word ``shipments'' with the word ``consignments.''
For the reasons given in the July 2 interim rule, this technical
amendment will remove the requirements in the first sentence of
paragraph (e)(9) and in paragraph (e)(11), as these paragraphs appear
in the July 18 final rule.
Paragraphs (e)(13) and (e)(14) in the current form of Sec. 305.15
will appear as paragraphs (d)(15) and (d)(16), respectively. However,
the requirements in paragraph (e)(17) of Sec. 305.15 will appear in a
new paragraph (h) at the end of the section. Paragraph (e)(17) sets out
additional requirements for treatments performed after arrival in the
United States at specific ports; we believe it will assist the reader
to set out all the general conditions applying to cold treatment before
listing port-specific conditions.
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. Section 305.15 is amended as follows:
0
a. By revising paragraph (c) to read as set forth below.
0
b. By removing paragraph (d).
0
c. By redesignating paragraphs (e), (f), (g), and (h) as paragraphs
(d), (e), (f), and (g), respectively.
0
d. By revising newly redesignated paragraph (d) to read as set forth
below.
0
e. By adding a new paragraph (h) to read as set forth below.
Sec. 305.15 Treatment requirements.
* * * * *
(c) 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.
(3) Be structurally sound and adequate to maintain required
temperatures.
(d) 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) Refrigeration must be completed in the container, compartment,
or room in which it is begun.
(3) Fruit that may be cold treated must be safeguarded to prevent
cross-
[[Page 50203]]
contamination or mixing with other infested fruit.
(4) Fruit intended for in-transit cold treatment must be precooled
to the temperature at which the fruit will be treated prior to
beginning treatment. The in-transit treatment enclosure may not be used
for precooling unless an official authorized by APHIS approves the
loading of the fruit in the treatment enclosure as adequate to allow
for fruit pulp temperatures to be taken prior to beginning treatment.
If the fruit is precooled outside the treatment enclosure, an official
authorized by APHIS will take pulp temperatures manually from a sample
of the fruit as the fruit is loaded for in-transit cold treatment to
verify that precooling was completed. If the pulp temperatures for the
sample are 0.28 C (0.5 F) or more above the temperature at which the
fruit will be treated, the pallet from which the sample was taken will
be rejected and returned for additional precooling until the fruit
reaches the treatment temperature. If fruit is precooled in the
treatment enclosure, or if treatment is conducted at a cold treatment
facility in the United States, the fruit must be precooled to the
temperature at which it will be treated, as verified by an official
authorized by APHIS, prior to beginning treatment.
(5) Breaks, damage, etc., in the treatment enclosure that preclude
maintaining correct temperatures must be repaired before the enclosure
is used. An official authorized by APHIS must approve loading of
compartment, number and placement of temperature probes or sensors, and
initial fruit temperature readings before beginning the treatment.
Hanging decks and hatch coamings within vessels may not be used as
enclosures for in-transit cold treatment without prior written approval
from APHIS. Double-stacking of pallets is not allowed.
(6) Only the same type of fruit in the same type of package may be
treated together in a container; no mixture of fruits in containers may
be treated. A numbered seal must be placed on the doors of the loaded
container and may be removed only at the port of destination by an
official authorized by APHIS.
(7) Temperature recording devices used during treatment must be
password-protected and tamperproof. The devices must be able to record
the date, time, and sensor number and automatic and continuous records
of the temperature during all calibrations and during treatment.
Recording devises must be capable of generating temperature charts for
verification by an inspector. If records of calibrations or treatments
are found to have been manipulated, the vessel or container in which
the treatment is performed may be suspended from conducting cold
treatments until proper equipment is installed and an official
authorized by APHIS has recertified it. APHIS' decision to recertify a
vessel or container will take into account the severity of the
infraction that led to suspension.
(8) A minimum of four temperature probes or sensors is required for
vessel holds used as treatment enclosures. A minimum of three
temperature probes or sensors is required for other treatment
enclosures. An official authorized by APHIS will have the option to
require that additional temperature probes or sensors be used,
depending on the size of the treatment enclosure.
(9) Fruit pulp temperatures must be maintained at the temperature
specified in the treatment schedule with no more than a 0.39 C (0.7
[deg]F) variation in temperature between two consecutive hourly
readings. Failure to comply with this requirement will result in
invalidation of the treatment unless an official authorized by APHIS
can verify that the pulp temperature was maintained at or below the
treatment temperature for the duration of the treatment.
(10) The time required to complete the treatment begins when all
temperature probes reach the prescribed cold treatment schedule
temperature. Refrigeration continues until the vessel arrives at the
port of destination and the fruit is released for unloading by an
inspector even though this may prolong the period required for the cold
treatment.
(11) Temperatures must be recorded at intervals no longer than 1
hour apart. Gaps of longer than 1 hour will invalidate the treatment or
indicate treatment failure unless an official authorized by APHIS can
verify that the pulp temperature was maintained at or below the
treatment temperature for the duration of the treatment.
(12) Cold treatment is not completed until so declared by an
official authorized by APHIS or the certifying official of the foreign
country; consignments of treated commodities may not be discharged
until APHIS clearance has been fully completed, including review and
approval of treatment record charts.
(13) Cold treatment of fruits in break bulk vessels or containers
must be initiated by an official authorized by APHIS if there is not a
treatment technician who has been trained to initiate cold treatments
for either break bulk vessels or containers.
(14) An official authorized by APHIS may perform audits to ensure
that the treatment procedures comply with the regulations in this
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.
(15) Inspection of fruits after cold treatment for Mediterranean
fruit fly. An inspector will sample and cut fruit from each consignment
cold treated for Mediterranean fruit fly (Medfly) to monitor treatment
effectiveness. If a single live Medfly in any stage of development is
found, the consignment will be held until an investigation is completed
and appropriate remedial actions have been implemented. If APHIS
determines at any time that the safeguards contained in this section do
not appear to be effective against the Medfly, APHIS may suspend the
importation of fruits from the originating country and conduct an
investigation into the cause of the deficiency.
(16) Caution and disclaimer. The cold treatments required for the
entry of fruit are considered necessary for the elimination of plant
pests, and no liability shall attach to the U.S. Department of
Agriculture or to any officer or representative of that Department in
the event injury results to fruit offered for entry in accordance with
these instructions. In prescribing cold treatments of certain fruits,
it should be emphasized that inexactness and carelessness in applying
the treatments may result in injury to the fruit or its rejection for
entry.
* * * * *
(h) Additional requirements for treatments performed after arrival
in the United States.
(1) Maritime port of Wilmington, NC. Consignments of fruit arriving
at the maritime port of Wilmington, NC, for cold treatment, in addition
to meeting all other applicable requirements of this section, must meet
the following special conditions:
(i) Bulk consignments (those consignments which are stowed and
unloaded by the case or bin) of fruit must arrive in fruit fly-proof
packaging that prevents the escape of adult, larval, or pupal fruit
flies.
(ii) Bulk and containerized consignments of fruit must be cold-
treated within the area over which the U.S. Department of Homeland
Security is assigned the authority to accept entries of merchandise, to
collect duties, and to enforce the various provisions of
[[Page 50204]]
the customs and navigation laws in force.
(iii) Advance reservations for cold treatment space must be made
prior to the departure of a consignment from its port of origin.
(iv) The cold treatment facility must remain locked during non-
working hours.
(2) Maritime port of Seattle, WA. Consignments of fruit arriving at
the maritime port of Seattle, WA, for cold treatment, in addition to
meeting all other applicable requirements of this section, must meet
the following special conditions:
(i) Bulk consignments (those consignments which are stowed and
unloaded by the case or bin) of fruit must arrive in fruit fly-proof
packaging that prevents the escape of adult, larval, or pupal fruit
flies.
(ii) Bulk and containerized consignments of fruit must be cold
treated within the area over which the U.S. Department of Homeland
Security is assigned the authority to accept entries of merchandise, to
collect duties, and to enforce the various provisions of the customs
and navigation laws in force.
(iii) Advance reservations for cold treatment space must be made
prior to the departure of a consignment from its port of origin.
(iv) The cold treatment facility must remain locked during non-
working hours.
(v) Blacklight or sticky paper must be used within the cold
treatment facility, and other trapping methods, including Jackson/
methyl eugenol and McPhail traps, must be used within the 4 square
miles surrounding the cold treatment facility.
(vi) The cold treatment facility must have contingency plans,
approved by the Administrator, for safely destroying or disposing of
fruit.
(3) Airports of Atlanta, GA, and Seattle, WA. Consignments of fruit
arriving at the airports of Atlanta, GA, and Seattle, WA, for cold
treatment, in addition to meeting all other applicable requirements of
this section, must meet the following special conditions:
(i) Bulk and containerized consignments of fruit must arrive in
fruit fly-proof packaging that prevents the escape of adult, larval, or
pupal fruit flies.
(ii) Bulk and containerized consignments of fruit arriving for cold
treatment must be cold treated within the area over which the U.S.
Department of Homeland Security is assigned the authority to accept
entries of merchandise, to collect duties, and to enforce the various
provisions of the customs and navigation laws in force.
(iii) The cold treatment facility and APHIS must agree in advance
on the route by which consignments are allowed to move between the
aircraft on which they arrived at the airport and the cold treatment
facility. The movement of consignments from aircraft to a cold
treatment facility will not be allowed until an acceptable route has
been agreed upon.
(iv) Advance reservations for cold treatment space must be made
prior to the departure of a consignment from its port of origin.
(v) The cold treatment facility must remain locked during non-
working hours.
(vi) Blacklight or sticky paper must be used within the cold
treatment facility, and other trapping methods, including Jackson/
methyl eugenol and McPhail traps, must be used within the 4 square
miles surrounding the cold treatment facility.
(vii) The cold treatment facility must have contingency plans,
approved by the Administrator, for safely destroying or disposing of
fruit.
(4) Maritime ports of Gulfport, MS, and Corpus Christi, TX.
Consignments of fruit arriving at the ports of Gulfport, MS, and Corpus
Christi, TX, for cold treatment, in addition to meeting all other
applicable requirements of this section, must meet the following
special conditions:
(i) All fruit entering the port for cold treatment must move in
maritime containers. No bulk consignments (those consignments which are
stowed and unloaded by the case or bin) are permitted.
(ii) Within the container, the fruit intended for cold treatment
must be enclosed in fruit fly-proof packaging that prevents the escape
of adult, larval, or pupal fruit flies.
(iii) All consignments of fruit arriving at the port for cold
treatment must be cold treated within the area over which the U.S.
Department of Homeland Security is assigned the authority to accept
entries of merchandise, to collect duties, and to enforce the various
provisions of the customs and navigation laws in force.
(iv) The cold treatment facility and APHIS must agree in advance on
the route by which consignments are allowed to move between the vessel
on which they arrived at the port and the cold treatment facility. The
movement of consignments from vessel to cold treatment facility will
not be allowed until an acceptable route has been agreed upon.
(v) Advance reservations for cold treatment space at the port must
be made prior to the departure of a consignment from its port of
origin.
(vi) Devanning, the unloading of fruit from containers into the
cold treatment facility, must adhere to the following requirements:
(A) All containers must be unloaded within the cold treatment
facility; and
(B) Untreated fruit may not be exposed to the outdoors under any
circumstances.
(vii) The cold treatment facility must remain locked during non-
working hours.
(viii) Blacklights or sticky paper must be used within the cold
treatment facility, and other trapping methods, including Jackson/
methyl eugenol and McPhail traps, must be used within the 4 square
miles surrounding the cold treatment facility at the maritime port of
Gulfport, MS, and within the 5 square miles surrounding the cold
treatment facility at the maritime port of Corpus Christi, TX.
(ix) During cold treatment, a backup system must be available to
cold treat the consignments of fruit should the primary system
malfunction. The facility must also have one or more reefers (cold
holding rooms) and methods of identifying lots of treated and untreated
fruits.
(x) The cold treatment facility must have the ability to conduct
methyl bromide fumigations on site.
(xi) The cold treatment facility must have contingency plans,
approved by the Administrator, for safely destroying or disposing of
fruit.
Done in Washington, DC, this 27th day of August 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E7-17295 Filed 8-30-07; 8:45 am]
BILLING CODE 3410-34-P