Cold Treatment Regulations; Technical Amendment, 50201-50204 [E7-17295]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 72, Number 169 (Friday, August 31, 2007)]
[Rules and Regulations]
[Pages 50201-50204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17295]



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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 https://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 https://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