[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Rules and Regulations]
[Pages 60359-60361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-25097]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 305

[Docket No. APHIS-2008-0022]
RIN 0579-AC94


Phytosanitary Treatments; Location of and Process for Updating 
Treatment Schedules; Technical Amendment

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule; technical amendment.

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SUMMARY: In a final rule that was published in the Federal Register on 
January 26, 2010, and effective on February 25, 2010, we amended the 
phytosanitary treatment regulations by removing the lists of approved 
treatments and treatment schedules from the regulations, while 
retaining the general requirements for performing treatments and 
certifying or approving treatment facilities. The final rule also 
removed treatment schedules from other places where they had been found 
in APHIS regulations and provided that approved treatment schedules 
will instead be found in the Plant Protection and Quarantine Treatment 
Manual, which is available on the Internet. In the final rule, we 
neglected to provide for the Administrator of the Animal and Plant 
Health Inspection Service to approve treatments that are not found in 
the Treatment Manual, and we did not retain text explaining that 
irradiation can be used as a substitute for other treatments. In this 
amendment, we are amending the regulation to provide for such approval 
of treatments and to restore the text we removed.

DATES: Effective Date: September 29, 2011.

FOR FURTHER INFORMATION CONTACT: Dr. Inder P. S. Gadh, Senior Risk 
Manager--Treatments, Regulations, Permits, and Manuals, PPQ, APHIS, 
4700 River Road Unit 133, Riverdale, MD 20737-1236; (301) 734-0627.

SUPPLEMENTARY INFORMATION:

Background

    In a final rule that was published in the Federal Register on 
January 26, 2010 (75 FR 4228-4253, Docket No. APHIS-2008-0022), and 
effective on February 25, 2010, we amended the phytosanitary treatment 
regulations in 7 CFR part 305 by removing the lists of approved 
treatments and treatment schedules from the regulations, while 
retaining the general requirements for performing treatments and 
certifying or approving treatment facilities. The final rule also 
removed treatment schedules from other places where they had been found 
in 7 CFR chapter III.
    We replaced the lists of approved treatments that had been in Sec.  
305.2 with a general statement in paragraph (b) of that section that 
approved treatment schedules are set out in the Plant Protection and 
Quarantine (PPQ) Treatment Manual. Paragraph (b) went on to state that 
treatments may only be administered in accordance with the treatment 
requirements of part 305 and in accordance with treatment schedules 
found in the PPQ Treatment Manual. We also amended the general 
requirements for performing treatments and certifying or approving 
treatment facilities to indicate that such facilities need to be able 
to conduct the treatments in the PPQ Treatment Manual.
    However, while the PPQ Treatment Manual contains only approved 
treatment schedules, it is inappropriate to refer to the PPQ Treatment 
Manual as the sole place where approved treatment schedules may be 
found and to set requirements for treatment facilities based only on 
the treatments in the PPQ Treatment Manual. A treatment schedule is 
ultimately approved for use not by dint of its inclusion in the PPQ 
Treatment Manual but because the Administrator of the Animal and Plant 
Health Inspection Service has decided that the treatment schedule is 
effective at neutralizing the targeted plant pest. Ultimately, the 
regulations should refer to approval by the Administrator as the 
standard for use of a treatment schedule.
    Therefore, we are amending paragraph (b) of Sec.  305.2 to indicate 
that treatments may only be administered in accordance with the 
requirements of part 305 and in accordance with treatment schedules 
approved by the Administrator as effective at neutralizing quarantine 
pests. We are also amending paragraph (b) to explicitly indicate that 
the treatment schedules found in the PPQ Treatment Manual have been 
approved by the Administrator.

[[Page 60360]]

    As the regulations in part 305 now indicate that treatment must be 
administered in accordance with treatment schedules approved by the 
Administrator, it is appropriate to provide a means by which persons 
can request that the Administrator approve other treatment schedules. 
Therefore, we are adding a new paragraph (c) to Sec.  305.2. This 
paragraph indicates that persons who wish to have a treatment schedule 
approved by the Administrator as effective at neutralizing a quarantine 
pest or pests may apply for approval by submitting the treatment 
schedule, along with any supporting information and data, to the Animal 
and Plant Health Inspection Service, Plant Protection and Quarantine, 
Center for Plant Health Science and Technology, 1730 Varsity Drive, 
Suite 400, Raleigh, NC 27606-5202. Upon receipt of such an application, 
the Administrator will review the schedule and the supporting 
information and data and respond with approval or denial of the 
treatment schedule. If the Administrator determines the treatment 
schedule to be of potential general use, the Administrator may add the 
new treatment schedule to the PPQ Treatment Manual or revise an 
existing schedule, as appropriate, in accordance with the process 
described in Sec.  305.3.
    To accommodate this change, we are redesignating current paragraph 
(c) of Sec.  305.2 as paragraph (d). We are also amending the 
definition of PPQ Treatment Manual in Sec.  305.1 to make it clear that 
all treatment schedules in the manual are approved by the 
Administrator, and we are amending the heading of Sec.  305.3, which 
describes the process for adding, revising, or removing treatment 
schedules, to indicate that it specifically applies to the PPQ 
Treatment Manual.
    These changes also necessitate changes in Sec. Sec.  305.5 through 
305.9, which set out the requirements for administering chemical 
treatment, cold treatment, quick freeze treatment, heat treatment, and 
irradiation treatment, respectively. Where these sections have referred 
to facilities capable of performing treatments in accordance with 
treatment schedules in the PPQ Treatment Manual, they now also refer to 
performing treatments in accordance with treatment schedules approved 
in accordance with Sec.  305.2. For other references to the PPQ 
Treatment Manual in those sections, we have added references to 
treatment schedules approved in accordance with Sec.  305.2 as well. A 
complete list of these changes can be found in the regulatory text at 
the end of this document.
    As noted earlier, before the publication of the January 2010 final 
rule, Sec.  305.2 listed approved treatments for various articles. 
Paragraph (h) of Sec.  305.2 listed approved treatments for fruits and 
vegetables. At the beginning of the list, paragraph (h)(1) stated that 
irradiation treatment in accordance with part 305 could be substituted 
for other approved treatments for any pests for which irradiation was 
an approved treatment. For example, several fruits and vegetables may 
be treated with cold treatment to neutralize certain fruit flies; as 
irradiation is an approved treatment for fruit flies, irradiation for 
fruit flies in accordance with part 305 may be substituted for cold 
treatment for those fruits and vegetables.
    We did not include this text in the revised part 305; it is 
contained in the PPQ Treatment Manual, thus confirming that 
substitution of irradiation for other approved treatments has been 
approved by the Administrator. However, since the publication of the 
January 2010 final rule, there has been some confusion among the 
regulated community regarding our policy on substituting irradiation 
for other approved treatments.
    To address this confusion, we are adding a new paragraph (o) to 
Sec.  305.9, which contains requirements for performing irradiation 
treatment, that describes our policy on substituting irradiation for 
other approved treatments. The new paragraph reads: ``Treatment of 
fruits and vegetables that are from foreign localities, from Hawaii, 
Puerto Rico, and the U.S. Virgin Islands, or from domestic areas under 
quarantine with irradiation in accordance with this section may be 
substituted for other approved treatments if the target pests of the 
other approved treatments are approved for treatment with irradiation 
in the PPQ Treatment Manual or approved for treatment with irradiation 
in accordance with Sec.  305.2.''

List of Subjects in 7 CFR Part 305

    Agricultural commodities, Chemical treatment, Cold treatment, Heat 
treatment, Imports, Irradiation, Phytosanitary treatment, Plant 
diseases and pests, Quarantine, Quick freeze, Reporting and 
recordkeeping requirements, Transportation.
    Accordingly, we are amending 7 CFR part 305 as follows:

PART 305--PHYTOSANITARY TREATMENTS

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

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 21 U.S.C. 136 and 
136a; 7 CFR 2.22, 2.80, and 371.3.


0
2. In Sec.  305.1, in the definition of PPQ Treatment Manual, the first 
sentence is revised to read as follows:


Sec.  305.1  Definitions.

* * * * *
    PPQ Treatment Manual. A document that contains treatment schedules 
that are approved by the Administrator for use under this part. * * *
* * * * *

0
3. Section 305.2 is amended as follows:
0
a. By revising paragraph (b) to read as set forth below.
0
b. By redesignating paragraph (c) as paragraph (d).
0
c. By adding a new paragraph (c) to read as set forth below.


Sec.  305.2  Approved treatments.

* * * * *
    (b) Treatments may only be administered in accordance with the 
requirements of this part and in accordance with treatment schedules 
approved by the Administrator as effective at neutralizing quarantine 
pests. The treatment schedules found in the PPQ Treatment Manual have 
been approved by the Administrator. Treatment schedules may be added to 
the PPQ Treatment Manual in accordance with Sec.  305.3. Treatment 
schedules may also be approved by the Administrator in accordance with 
paragraph (c) of this section.
    (c) Persons who wish to have a treatment schedule approved by the 
Administrator as effective at neutralizing a quarantine pest or pests 
may apply for approval by submitting the treatment schedule, along with 
any supporting information and data, to the Animal and Plant Health 
Inspection Service, Plant Protection and Quarantine, Center for Plant 
Health Science and Technology, 1730 Varsity Drive, Suite 400, Raleigh, 
NC 27606-5202. Upon receipt of such an application, the Administrator 
will review the schedule and the supporting information and data and 
respond with approval or denial of the treatment schedule. If the 
Administrator determines the treatment schedule to be of potential 
general use, the Administrator may add the new treatment schedule to 
the PPQ Treatment Manual or revise an existing schedule, as 
appropriate, in accordance with Sec.  305.3.
* * * * *

0
4. In Sec.  305.3, the section heading is revised to read as follows:

[[Page 60361]]

Sec.  305.3  Processes for adding, revising, or removing treatment 
schedules in the PPQ Treatment Manual.

* * * * *


Sec.  305.5  [Amended]

0
5. Section 305.5 is amended as follows:
0
a. In paragraph (a)(1), by adding the words ``or in another treatment 
schedule approved in accordance with Sec.  305.2'' after the word 
``Manual''.
0
b. In paragraph (c)(1), in the first sentence, by adding the words ``or 
in another treatment schedule approved in accordance with Sec.  305.2'' 
after the word ``Manual''; and, in the second sentence, by adding the 
words ``or approved in accordance with Sec.  305.2'' after the word 
``Manual''.
0
c. In paragraph (c)(3), in the first sentence, by adding the words ``or 
in another approved treatment schedule'' after the word ``Manual''.


Sec.  305.6  [Amended]

0
6. Section 305.6 is amended as follows:
0
a. In paragraph (a) introductory text, by adding the words ``or in 
another treatment schedule approved in accordance with Sec.  305.2'' 
after the word ``Manual''.
0
b. In paragraph (c)(1), by adding the words ``or in another approved 
treatment schedule'' after the word ``Manual''.
0
c. In paragraph (d)(14), by adding the words ``or in accordance with 
another approved treatment schedule'' after the word ``Manual''.

0
7. Section 305.7 is amended as follows:
0
a. In the second sentence, by removing the word ``the'' before the word 
``fruits''.
0
b. By adding a new sentence at the end of the section to read as set 
forth below.


Sec.  305.7  Quick freeze treatment requirements.

    * * * Requests to authorize quick freeze as a treatment for other 
fruits and vegetables may be made in accordance with Sec.  305.2(c).


Sec.  305.8  [Amended]

0
8. In Sec.  305.8, paragraph (a)(1) is amended by adding the words ``or 
in another treatment schedule approved in accordance with Sec.  305.2'' 
after the word ``Manual''.

0
9. Section 305.9 is amended as follows:
0
a. In paragraph (d)(1), by adding the words ``or in another treatment 
schedule approved in accordance with Sec.  305.2'' after the word 
``Manual''.
0
b. In paragraph (i), by adding the words ``or in another approved 
treatment schedule'' after the word ``Manual''.
0
c. In paragraph (j)(2), by adding the words ``or by another approved 
treatment schedule'' after the word ``Manual''.
0
d. In paragraph (n), by adding the words ``or the plant pests for which 
another treatment schedule is approved in accordance with Sec.  305.2'' 
after the word ``Manual''.
0
e. By adding a new paragraph (o) to read as set forth below.


Sec.  305.9  Irradiation treatment requirements.

* * * * *
    (o) Substitution of irradiation for other treatments. Treatment of 
fruits and vegetables that are from foreign localities, from Hawaii, 
Puerto Rico, and the U.S. Virgin Islands, or from domestic areas under 
quarantine with irradiation in accordance with this section may be 
substituted for other approved treatments if the target pests of the 
other approved treatments are approved for treatment with irradiation 
in the PPQ Treatment Manual or approved for treatment with irradiation 
in accordance with Sec.  305.2.
* * * * *

    Done in Washington, DC, this 23rd day of September 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-25097 Filed 9-28-11; 8:45 am]
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