Standardizing Phytosanitary Treatment Regulations: Approval of Cold Treatment and Irradiation Facilities; Cold Treatment Schedules; Establishment of Fumigation and Cold Treatment Compliance Agreements, 42569-42576 [2016-15568]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 81, Number 126 (Thursday, June 30, 2016)]
[Proposed Rules]
[Pages 42569-42576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15568]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 81, No. 126 / Thursday, June 30, 2016 / 
Proposed Rules

[[Page 42569]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 305

[Docket No. APHIS-2013-0081]
RIN 0579-AD90


Standardizing Phytosanitary Treatment Regulations: Approval of 
Cold Treatment and Irradiation Facilities; Cold Treatment Schedules; 
Establishment of Fumigation and Cold Treatment Compliance Agreements

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the phytosanitary treatment 
regulations to establish generic criteria that would allow for the 
approval of new cold treatment facilities in the Southern and Western 
States of the United States. These criteria, if met, would allow us to 
approve new cold treatment facilities without rulemaking and facilitate 
the importation of fruit requiring cold treatment while continuing to 
provide protection against the introduction of pests of concern into 
the United States. We are also proposing to amend the fruit cutting and 
inspection requirements in the cold treatment regulations in order to 
expand cutting and inspection to commodities that have been treated for 
a wider variety of pests of concern. This action would provide for a 
greater degree of phytosanitary protection. We are also proposing to 
add requirements concerning the establishment of compliance agreements 
for all entities that operate fumigation facilities. Finally, we are 
proposing to harmonize language concerning State compliance with 
facility establishment and parameters for the movement of consignments 
from the port of entry or points of origin in the United States to the 
treatment facility in the irradiation treatment regulations with 
proposed language in the cold treatment regulations. These actions 
would serve to codify and make enforceable existing procedures 
concerning compliance agreements for these facilities.

DATES: We will consider all comments that we receive on or before 
August 29, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov/#!docketDetail;D=APHIS-2013-0081.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2013-0081, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at https://www.regulations.gov/#!docketDetail;D=APHIS-2013-
0081 or in our reading room, which 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) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Mr. David B. Lamb, Senior Regulatory 
Policy Specialist, IRM, PPQ, APHIS, 4700 River Road Unit 133, 
Riverdale, MD 20737-1231; (301) 851-2103.

SUPPLEMENTARY INFORMATION: 

Background

    The phytosanitary treatments regulations in 7 CFR part 305 set out 
general requirements for certifying or approving treatment facilities 
and for performing treatments listed in the Plant Protection and 
Quarantine (PPQ) Treatment Manual \1\ for fruits, vegetables, and other 
articles to prevent the introduction or dissemination of plant pests or 
noxious weeds into or through the United States. Within part 305, Sec.  
305.6 (referred to below as the regulations) sets out requirements for 
treatment procedures, monitoring, facilities, and enclosures needed for 
performing sustained refrigeration (cold treatment) sufficient to kill 
certain insect pests associated with imported fruits and vegetables and 
with regulated articles moved interstate from quarantined areas within 
the United States. Under the regulations, all domestic facilities used 
to provide cold treatment for these articles must operate under a 
compliance agreement with the Animal and Plant Health Inspection 
Service (APHIS) and be certified as capable of delivering required cold 
treatment and handling articles to prevent reinfestation of treated 
articles. An inspector \2\ monitors all domestic treatments. The 
regulations require safeguards to prevent the escape of pests during 
transportation to and while at the facility. These include, but are not 
limited to, inspections, precooling, and physical separation of 
untreated and treated articles. The facility must maintain records of 
all treatments and must periodically be recertified. These conditions 
have allowed for the safe, effective treatment of many different kinds 
of articles, as is demonstrated by the track record of cold treatment 
facilities currently operating in the United States and other 
countries.
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    \1\ The PPQ Treatment Manual is available at (https://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf).
    \2\ Section 305.1 defines an inspector as ``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 this part.''
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Cold Treatment in Southern and Western States

    In Sec.  305.6, paragraph (b) allows cold treatment facilities to 
be located in the area north of 39[deg] latitude and east of 104[deg] 
longitude. When the cold treatment regulations were established, areas 
outside of these coordinates were identified as having conditions 
favorable for the establishment of exotic fruit flies. The location 
restrictions served as an additional safeguard against the possibility 
that fruit flies could escape from imported articles prior to treatment 
and become established in the United States.
    Although the regulations initially did not allow cold treatment 
facilities to be located in Southern and Western States, APHIS 
periodically received requests for exemptions. In response to these 
requests, APHIS conducted site-specific evaluations for these locations 
and determined that regulated articles can be safely transported to, 
handled in, and treated by specific cold treatment facilities outside 
of the areas established

[[Page 42570]]

by the regulations under special conditions to mitigate the possible 
escape of pests of concern. Over the years, APHIS has amended its 
regulations to allow cold treatment facilities to be located at the 
maritime ports of Wilmington, NC; Seattle, WA; Corpus Christi, TX; and 
Gulfport, MS; Seattle-Tacoma International Airport, Seattle, WA; 
Hartsfield-Atlanta International Airport, Atlanta, GA; and, most 
recently, MidAmerica St. Louis Airport, Mascoutah, IL.
    In addition to those requests, certain importers of fruits and 
vegetables have shown considerable interest in locating cold treatment 
facilities in places that are not currently allowed under the 
regulations (e.g., Miami and Port Everglades, FL, and Savannah, GA).

Proposed Changes to the Regulations Governing Cold Treatment Facilities 
in Southern and Western States

    In anticipation of future requests to locate additional cold 
treatment facilities in the Southern and Western States of the United 
States, we are proposing to establish generic phytosanitary criteria 
that would replace the current location-specific criteria for cold 
treatment facilities at the ports mentioned previously and would also 
apply to new cold treatment facilities in the Southern and Western 
States of the United States. The proposed criteria are similar to those 
successfully used for the approval of new irradiation facilities in the 
Southern United States found in Sec.  305.9 of the regulations, as 
untreated fruit moving to irradiation facilities in those States 
presents the same pest risks as untreated fruit moving to cold 
treatment facilities. We would not require currently approved cold 
treatment facilities in Southern and Western States to immediately meet 
the proposed generic criteria since the specific requirements presently 
in place for each facility would continue to provide adequate 
phytosanitary protection. Nevertheless, we would require currently 
approved facilities to meet the new generic requirements as each comes 
up to renew its required recertification, which takes place at 3 year 
intervals or at other times as determined by APHIS based on treatments 
performed, commodities handled, and operations conducted at the 
facility.
    All cold treatment facilities in the Southern and Western States 
would be required to meet the current criteria for cold treatment 
facilities north of 39[deg] latitude and east of 104[deg] longitude, in 
addition to the proposed generic criteria. These generic criteria would 
be supplemented as necessary by additional measures, which would be 
described in a compliance agreement (discussed below), based on pests 
of concern associated with specific regulated articles to be treated at 
the facility and the location of the specific facility. Facilities that 
meet these requirements could then be approved for the treatment of 
regulated articles that are imported, moved interstate from Hawaii or 
U.S. territories, or moved interstate from areas quarantined for 
certain pests of concern.
    Using APHIS-approved cold treatment facilities located in the 
United States, rather than those located outside of the United States, 
to treat imported articles offers the advantage of greater ease of 
monitoring treatment. Using generic criteria, rather than site by site 
approval, for future cold treatment facilities located in Southern and 
Western States would make explicit our criteria for approving these 
facilities while eliminating the need to undertake rulemaking in order 
to approve new facilities.
    To support this action, we have prepared a treatment evaluation 
document (TED) entitled ``Phytosanitary Criteria for Establishing 
Locations for Cold Treatment Facilities in Areas of the United States 
Currently Not Allowed.'' Copies of the TED may be obtained from the 
person listed under FOR FURTHER INFORMATION CONTACT and may be viewed 
on the Internet on the Regulations.gov Web site or in our reading room 
(see ADDRESSES above for instructions for accessing Regulations.gov and 
the location and hours of the reading room). In the TED, we concluded 
that the pest risks presented by cold treatment facilities in the 
Southern and Western States can be adequately managed through the use 
of special conditions to mitigate the possible escape of pests of 
concern.
    We are therefore proposing to amend the regulations by replacing 
the current specific criteria for cold treatment facilities at the 
maritime ports of Wilmington, NC; Seattle, WA; Corpus Christi, TX; and 
Gulfport, MS; Seattle-Tacoma International Airport, Seattle, WA; 
MidAmerica St. Louis Airport, Mascoutah, IL; and Hartsfield-Atlanta 
International Airport, Atlanta, GA, in Sec.  305.6 with generic 
phytosanitary criteria for any cold treatment facility in a Southern or 
Western State. The proposed generic criteria would have to be followed 
in addition to the current requirements that apply to all cold 
treatment facilities. The proposed generic criteria for new facilities 
in the Southern and Western States are based on the current conditions 
for allowing cold treatment facilities at the maritime ports of 
Wilmington, NC; Seattle, WA; Corpus Christi, TX; and Gulfport, MS; 
Seattle-Tacoma International Airport, Seattle, WA; MidAmerica St. Louis 
Airport, Mascoutah, IL; and Hartsfield-Atlanta International Airport, 
Atlanta, GA.
    In proposed paragraph (b)(1)(i) of Sec.  305.6, we would require 
that prospective facility operators submit a detailed layout of the 
facility site and its location to APHIS. APHIS would evaluate plant 
health risks based on the proposed location and layout of the facility 
site before a facility is approved. APHIS would only approve a proposed 
facility if the Administrator determines that regulated articles can be 
safely transported to the facility from the port of entry or points of 
origin in the United States. Proposed paragraph (b)(1)(ii) of Sec.  
305.6 provides that the State government of the Southern or Western 
State in which the facility would be located would also have to concur 
in writing with the location of the cold treatment facility; if it does 
not concur, the State government must provide a written explanation of 
concern based on pest risks. In instances where the State government 
does not concur with the proposed facility location, and provides a 
written explanation of concern based on pest risks, then APHIS and the 
State would need to agree on a strategy to resolve such risks before 
APHIS approved the facility. If the State does not provide a written 
explanation of concern based on pest risks, then State concurrence will 
not be required before APHIS approves the facility location.
    Under this proposal, paragraphs (b)(1)(iii) and (b)(1)(iv) of Sec.  
305.6 would provide, respectively, that untreated articles may not be 
removed from their packaging prior to treatment under any 
circumstances, and that facilities must have contingency plans, 
approved by APHIS, for safely destroying or disposing of regulated 
articles if the facility were unable to properly treat a shipment. 
Alternatively, facilities could be approved to apply alternative 
treatments, if available, such as fumigation with methyl bromide or 
irradiation.
    Proposed paragraph (b)(1)(v) of Sec.  305.6 would allow a cold 
treatment facility to treat only those articles that are approved by 
APHIS for treatment at that facility. If, during the approval process 
for regulated articles, APHIS determines that additional safeguards 
(such as trapping for specific pests using specific lures, inspection 
for any pests of concern not mitigated by cold treatment or to monitor 
pest population in the consignment, or applying

[[Page 42571]]

required treatments in addition to cold treatment) are deemed necessary 
during transport or while at a specific cold treatment facility, the 
compliance agreement for the facility would be amended accordingly.
    Under proposed paragraph (b)(1)(vi) of Sec.  305.6, APHIS, the 
importer, and the cold treatment facility would need to agree on 
arrangements for treatment before the departure of a consignment from 
its country of origin or point of origin in the United States. This 
would ensure that untreated shipments of regulated articles arriving at 
the facility would not have to wait for an extended period of time for 
cold treatment. The expeditious treatment of the articles would 
minimize the risk of pests of concern maturing in fruits, vegetables, 
or other articles. In addition, we are proposing that APHIS and the 
cold treatment facility would have to agree in advance about all 
parameters, such as time, routing, and conveyance, by which every 
consignment would move from the port of entry or points of origin in 
the United States to the cold treatment facility. In most instances, 
this would be determined by establishing the shortest route between the 
port of entry or points of origin in the United States and the cold 
treatment facility that does not include an area that contains host 
material for pests of concern during the time of year that the host 
material is most abundant in the region. This route would then be used 
at all times of the year, since an area that is free of host material 
during the time of year that it is most abundantly grown, would be 
unlikely to grow host material at any other time of year. This 
predetermined route would reduce the amount of time that a shipment 
would have to wait before undergoing cold treatment and would reduce 
the risk that any pests of concern in the shipments would come into 
contact with host material en route to the cold treatment facility. If 
APHIS and the cold treatment facility cannot reach agreement in advance 
on all parameters by which consignments would move from the port of 
entry or points of origin in the United States then no consignments may 
be moved to that facility until an agreement has been reached.
    We are also proposing to require in paragraph (b)(1)(vii) of Sec.  
305.6 that the conveyance transporting the regulated article to the 
cold treatment facility would need to be refrigerated using motorized 
refrigeration equipment to a temperature that would minimize the 
mobility of the pests of concern for the article. Fruits and vegetables 
requiring cold treatment are typically transported in refrigerated 
conveyances in order to preserve freshness of the commodity and prevent 
development of toxins that may affect their flavor.
    Proposed paragraph (b)(1)(viii) of Sec.  305.6 would stipulate that 
the cold treatment facility would be required to apply all required 
post-treatment safeguards as required by the compliance agreement to 
provide phytosanitary protection (e.g., larger consignments broken up 
into smaller boxes following treatment and those treated articles 
subsequently packaged in pest-proof containers per an agreement between 
the treatment facility and the importer) before releasing the articles 
to the importer or the importer's designated representative or before 
moving the articles interstate. Paragraph (b)(1)(ix) would require the 
facility to remain locked when not in operation. These requirements are 
intended to minimize the risk of cross-contamination between treated 
and untreated articles and to prevent unauthorized persons access to 
the facility, which may result in the unintended entry of pests of 
concern.
    The current regulations for cold treatment facilities at the 
maritime ports of Seattle, WA; Corpus Christi, TX; and Gulfport, MS; 
Seattle-Tacoma International Airport, Seattle, WA; and Hartsfield-
Atlanta International Airport, Atlanta, GA, require blacklight or 
sticky paper to be used within the cold treatment facility and other 
trapping methods to be used within the 4 square miles surrounding the 
facility. Proposed paragraph (b)(1)(x) of Sec.  305.6 requires, in 
addition, that the facility maintain and provide APHIS an updated map 
identifying places where horticultural or other crops are grown within 
4 square miles of the facility. APHIS will use this information to 
determine if any host material of concern is present. To help prevent 
establishment of pests in the unlikely event that they escape despite 
the required precautions, the presence of any host material within 4 
square miles of the facility would then necessitate specific trapping 
or other pest monitoring activities to help prevent establishment of 
any escaped pests of concern, which would be funded by the facility and 
described in the compliance agreement. All trapping and pest monitoring 
activities would need to be approved by APHIS.
    The cold treatment facility would also need to have a pest 
management plan within the facility, which would cover such topics as 
monitoring for pests in storage and treatment areas and the actions to 
be taken in the event of the detection of pests within the facility. 
Cold treatment facilities would also be required to comply with any 
additional requirements that APHIS might require for a particular 
facility based on local conditions and any other risk factors of 
concern. This could include inspection for certain pests for which cold 
treatment is not an approved treatment, such as mites and scales. 
Proposed paragraph (b)(1)(xi) of Sec.  305.6 would require that 
facilities comply with any additional APHIS requirements including, but 
not limited to, the use of pest-proof packaging and container seals. 
Such additional requirements would be contained in a compliance 
agreement. Compliance agreements are required for all facilities in 
paragraph (f) of Sec.  305.6, which we are proposing to amend as 
detailed below under the heading ``Cold Treatment Facilities in All the 
United States.''
    We also propose to add language specifying the way in which 
domestically produced fruit would be safeguarded when moving interstate 
from areas within the United States that are quarantined for fruit 
flies. In proposed paragraph (b)(2) of Sec.  305.6, we would stipulate 
that, for articles that are moved interstate from areas quarantined for 
fruit flies, cold treatment facilities would be permitted to be located 
within or outside of the quarantined area. If the articles are treated 
outside the quarantined area, they would have to be accompanied to the 
facility by a limited permit issued in accordance with 7 CFR 301.32-
5(b) of our fruit fly regulations and must be moved in accordance with 
any safeguards determined appropriate by APHIS. These additions are 
necessary because the current cold treatment regulations do not address 
interstate movement and this addition would serve to clarify our 
requirements.

Cold Treatment Facilities in All the United States

    In paragraph (a) of Sec.  305.6, we are proposing to expand our 
requirements for initial facility certification and recertification. A 
prospective facility would only be certified if the Administrator 
determines that the location of that facility is operationally feasible 
insofar as the Federal agencies involved in its operation and oversight 
have adequate resources to conduct the necessary operations at the 
facility, that the pest risks can be managed at that location, and that 
the facility meets all criteria for approval. Facility recertification 
would continue to be required at 3 year intervals or at other times as 
determined by APHIS based on treatments performed, commodities handled, 
and operations conducted at the facility.

[[Page 42572]]

    Currently, as part of the approval process for cold treatment 
facilities, APHIS considers whether a proposed cold treatment facility 
is located within the local commuting area for APHIS employees so that 
they will be able to perform the oversight and monitoring activities 
required by Sec.  305.6. When imported articles are to be treated at a 
facility, APHIS also considers whether the facility is located within 
an area over which the U.S. Department of Homeland Security (DHS) \3\ 
has customs authority for enforcement purposes. We are proposing to 
amend paragraph (e) of Sec.  305.6, which contains requirements for 
monitoring and interagency agreements for cold treatment facilities, to 
require all cold treatment facilities to be located within the local 
commuting area for APHIS employees \4\ for oversight and monitoring 
purposes. For facilities treating imported articles, we are also 
proposing that the location of the facility would have to be within an 
area over which DHS has customs authority for enforcement purposes.
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    \3\ The U.S. Department of Homeland Security is assigned 
authority to accept entries of merchandise, to collect duties, and 
to enforce the provisions of the customs and navigation laws in 
force.
    \4\ Commuting area would be determined by contacting the local 
APHIS Plant Protection and Quarantine office, State Plant Health 
Director, located in each State, Eastern Regional Office, or Western 
Regional Office.
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    The regulations in Sec.  305.6(d)(15) currently stipulate that an 
inspector will sample and cut fruit from consignments that have been 
cold treated for Mediterranean fruit fly (Medfly) in order to monitor 
treatment effectiveness. We are proposing to expand the fruit cutting 
and inspection requirements in order to state that consignments treated 
for other fruit flies and pests of concern may be subject to sampling 
and cutting. This would create an extra level of phytosanitary security 
for cold treated shipments.
    If the national plant protection organization cuts and inspects the 
commodity in the exporting country as part of a biometric sampling 
protocol that we have approved, however, we are proposing that we may 
waive this requirement. In such instances, inspection and cutting would 
be duplicative.
    Paragraph (f) of Sec.  305.6 currently requires that cold treatment 
facilities located in the United States must enter into a compliance 
agreement with APHIS. These compliance agreements set out requirements 
for equipment, temperature, circulation, and other operational 
requirements for performing cold treatment to ensure that treatments 
are administered properly. They also allow for inspection by APHIS in 
order to monitor compliance with those requirements. Paragraph (g) 
contains requirements for facilities located outside the United States, 
which may only operate under a bilateral workplan. A bilateral workplan 
may contain some of the same requirements as a domestic compliance 
agreement, with the potential addition of trust fund agreement 
information regarding payment of the salaries and expenses of APHIS 
employees on site. We are proposing to combine these requirements into 
a single paragraph that would set out the requirements that both 
domestic and foreign cold treatment facilities and importers would have 
to meet in order to enter into a compliance agreement with APHIS. We 
are also proposing to add language regarding compliance agreements 
required in association with articles moved interstate from Hawaii and 
the U.S. territories. These requirements are consistent with those 
required for importers shipping articles to irradiation facilities 
located in the southern United States and are necessary to ensure that 
consignments of fruits or vegetables are not diverted to any 
destination other than an approved treatment facility, to prevent 
escape of plant pests from the articles to be treated during their 
transit from the port of first arrival into the United States to the 
approved cold treatment facility, and to ensure that APHIS is aware of 
the time, route, and conveyance by which consignments will move to the 
treatment facility.

Fumigation Treatment and Compliance Agreements

    We are proposing to add a section to the regulations concerning 
fumigation treatment found in Sec.  305.5 to provide that both domestic 
and foreign fumigation treatment facilities and importers enter into a 
compliance agreement with APHIS, and agree to comply with any 
requirements deemed necessary by the Administrator. Although we 
currently enter into compliance agreements with domestic chemical 
treatment facilities and have done so for more than 20 years, the 
addition of a requirement for compliance agreements to the fumigation 
treatment regulations will add a degree of enforceability to the terms 
of those agreements in addition to codifying our existing practices.
    We are also proposing to add a requirement concerning establishment 
of a compliance agreement, or an equivalent agreement such as a 
workplan agreement, for those fumigation treatment facilities located 
outside the United States. Such facilities had not been previously 
required to sign such an agreement to treat articles imported into the 
United States under the fumigation treatment regulations. The proposed 
requirements would be identical to those found in the sections of the 
treatment regulations concerning cold treatment and heat treatment, and 
would be added in a new paragraph (c) in Sec.  305.5.

Irradiation Treatment and State and Facility Compliance

    We are proposing to harmonize the language concerning State 
compliance with irradiation treatment facility establishment and 
facility agreements found in Sec.  305.9 with the proposed language 
concerning this compliance in the cold treatment regulations.
    Section 305.9(a)(1)(ii) states that the government of the State in 
which the facility is to be located must concur in writing with the 
establishment of the facility or, if it does not concur, must provide a 
written explanation of concern based on pest risks. In instances where 
the State government does not concur with the proposed facility 
location, APHIS and the State will agree on a strategy to resolve the 
pest risk concerns prior to APHIS approval. We would add that, if the 
State does not provide a written explanation of concern based on pest 
risks, then State concurrence will not be required before APHIS 
approves the facility location.
    Section 305.9(a)(1)(vi) states that APHIS and the irradiation 
treatment facility must agree on all parameters, such as time, routing, 
and conveyance, by which the consignment will move from the port of 
entry or points of origin in the United States to the treatment 
facility. We are proposing to clarify that if APHIS and the facility 
cannot reach agreement in advance on these parameters then no 
consignments may be moved to that facility until an agreement has been 
reached.

Definitions

    We are also proposing to add a definition for ``treatment 
facility'' as follows to the regulations in Sec.  305.1: ``Any APHIS-
certified place, warehouse, or approved enclosure where a treatment is 
conducted to mitigate a plant pest.'' This is intended to provide 
clarity and guidance in the regulations as the term is included in the 
proposed additions to the regulations.

Treatment Schedules

    Finally, the current regulations in Sec.  305.2, paragraph (b), 
state that approved treatment schedules are set out in the PPQ 
Treatment Manual.

[[Page 42573]]

Section 305.3 sets forth a process for adding, revising, or removing 
treatment schedules in the PPQ Treatment Manual. Paragraph (a)(1) 
provides that removal of a treatment schedule is subject to public 
comment.
    We are proposing to remove a cold treatment schedule from the PPQ 
Treatment Manual. Treatment schedule T107-f was authorized for use on 
shipments of Ya pears (Pyrus x bretscheideri) from APHIS-authorized 
areas within Shandong Province, China, in order to provide 
phytosanitary protection against the Oriental fruit fly (Bactrocera 
dorsalis). Based on Oriental fruit fly trapping results and 
climatological and biological considerations, we have determined that 
cold treatment of Ya pears is no longer necessary and are therefore 
proposing to remove the treatment schedule. All other requirements 
regarding the importation of Ya pears would remain in place.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been determined to be not significant for 
the purposes of Executive Order 12866 and, therefore, has not been 
reviewed by the Office of Management and Budget.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities. The 
analysis is summarized below. Copies of the full analysis are available 
on the Regulations.gov Web site (see ADDRESSES above for instructions 
for accessing Regulations.gov) or by contacting the person listed under 
FOR FURTHER INFORMATION CONTACT.
    We are proposing to establish general criteria for new cold 
treatment facilities in the Southern and Western United States. These 
general criteria would be supplemented as necessary by additional 
measures, which would be described in the facility's compliance 
agreement, based on pests of concern associated with specific regulated 
articles to be treated at the facility and the location of the specific 
facility.
    We do not anticipate that the proposed rule would have an economic 
impact, since it would simply set forth the general criteria, not 
approve any new facilities.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. APHIS-
2013-0081. Please send a copy of your comments to: (1) APHIS, using one 
of the methods described under ADDRESSES at the beginning of this 
document, and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th 
Street and Independence Avenue SW., Washington, DC 20250.
    APHIS is proposing to amend the phytosanitary treatment regulations 
to establish generic criteria that would allow for the approval of new 
cold treatment facilities in the Southern and Western States of the 
United States. These criteria, if met, would allow APHIS to approve new 
cold treatment facilities without rulemaking and facilitate the 
importation of fruit requiring cold treatment while continuing to 
provide protection against the introduction of pests of concern into 
the United States. APHIS is also proposing to amend the fruit cutting 
and inspection requirements in the cold treatment regulations in order 
to expand cutting and inspection to commodities that have been treated 
for a wider variety of pests of concern. This action would provide for 
a greater degree of phytosanitary protection. Finally, APHIS is 
proposing to add requirements concerning the establishment of 
compliance agreements for those entities that operate fumigation 
facilities. This action would serve to codify and make enforceable 
existing procedures concerning compliance agreements for these 
facilities.
    Implementing this rule will require the completion of compliance 
agreements, facility certification, detailed layouts of facilities and 
maps of the surrounding areas, State concurrence letters, limited 
permits, and contingency plans.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 0.5 hours per response.
    Respondents: NPPO, facility operators, importers, and State 
governments.
    Estimated annual number of respondents: 15.
    Estimated annual number of responses per respondent: 3.
    Estimated annual number of responses: 42.
    Estimated total annual burden on respondents: 21 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained from Ms. 
Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 
851-2727.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this proposed rule, please contact Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

[[Page 42574]]

List of Subjects in 7 CFR Part 305

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

    Accordingly, we propose to amend 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. Section 305.1 is amended by adding, in alphabetical order, a 
definition for treatment facility to read as follows:


Sec.  305.1  Definitions.

* * * * *
    Treatment facility. Any APHIS-certified place, warehouse, or 
approved enclosure where a treatment is conducted to mitigate a plant 
pest.
* * * * *
0
3. Section 305.5 is amended by redesignating paragraph (c) as paragraph 
(d) and adding a new paragraph (c).
    The addition reads as follows:


Sec.  305.5  Chemical treatment requirements.

* * * * *
    (c) Compliance agreements. Any person who conducts a fumigation or 
operates a facility where fumigation is conducted for phytosanitary 
purposes must sign a compliance agreement with APHIS.
    (1) Fumigation treatment facilities treating imported articles. (i) 
Compliance agreements with importers and facility operators for 
fumigation in the United States. If fumigation treatment of imported 
articles is conducted in the United States, both the importer and the 
fumigation treatment facility operator or the person who conducts 
fumigation must sign compliance agreements with APHIS. In the importer 
compliance agreement, the importer must agree to comply with any 
additional requirements found necessary by APHIS to ensure the shipment 
is not diverted to a destination other than an approved treatment 
facility and to prevent escape of plant pests from the articles to be 
treated during their transit from the port of first arrival to the 
fumigation treatment facility in the United States. In the facility 
compliance agreement, the fumigation facility operator or the person 
who conducts fumigation must agree to comply with the requirements of 
this section and any additional requirements found necessary by APHIS 
to prevent the escape of any pests of concern that may be associated 
with the articles to be treated.
    (ii) Compliance agreements with fumigation treatment facilities 
outside the United States. If fumigation treatment of imported articles 
is conducted outside the United States, the fumigation treatment 
facility operator or the person who conducts the fumigation must sign a 
compliance agreement or an equivalent agreement with APHIS and the 
national plant protection organization (NPPO) of the country in which 
the facility is located. In this agreement, the fumigation treatment 
facility operator or person conducting the fumigation must agree to 
comply with the requirements of this section, and the NPPO of the 
country in which the facility is located must agree to monitor that 
compliance and to inform the Administrator of any noncompliance.
    (2) Fumigation treatment facilities treating articles moved 
interstate from Hawaii and U.S. territories. Fumigation treatment 
facilities treating articles moved interstate from Hawaii and U.S. 
territories must complete a compliance agreement with APHIS as provided 
in Sec.  318.13-3(d) of this chapter.
    (3) Fumigation treatment facilities treating articles moved 
interstate from areas quarantined for fruit flies. Fumigation treatment 
facilities treating articles moved interstate from areas quarantined 
for fruit flies must complete a compliance agreement with APHIS as 
provided in Sec.  301.32-6 of this chapter.
    (4) Fumigation treatment facilities treating articles moved 
interstate from areas quarantined for Asian citrus psyllid. Fumigation 
treatment facilities treating articles moved interstate from areas 
quarantined only for Asian citrus psyllid, and not for citrus greening, 
must complete a compliance agreement with APHIS as provided in Sec.  
301.76-8 of this chapter.
* * * * *
0
4. Section 305.6 is amended as follows:
0
a. In the introductory text of paragraph (a), by adding two new 
sentences before the last sentence.
0
b. By redesignating paragraph (a)(2) as paragraph (a)(3).
0
c. By adding new paragraph (a)(2).
0
d. By revising paragraph (b).
0
e. By revising paragraph (d)(15).
0
f. In paragraph (e), by adding two new sentences after the last 
sentence.
0
g. By revising paragraph (f).
0
h. By removing paragraphs (g) and (h).
    The additions and revisions read as follows:


Sec.  305.6  Cold treatment requirements.

    (a) * * * A facility will only be certified or recertified if the 
Administrator determines that the location of the facility is such that 
those Federal agencies involved in its operation and oversight have 
adequate resources to conduct the necessary operations at the facility, 
that the pest risks can be managed at that location, and that the 
facility meets all criteria for approval. Other agencies that have 
regulatory oversight and requirements must concur in writing with the 
establishment of the facility prior to APHIS approval. * * *
* * * * *
    (2) Be capable of preventing the escape and spread of pests while 
regulated articles are at the facility; and
* * * * *
    (b)(1) Location of facilities. Where certified cold treatment 
facilities are available, an approved cold treatment may be conducted 
for any imported regulated article either prior to shipment to the 
United States or in the United States. For any regulated article moved 
interstate from Hawaii or U.S. territories, cold treatment may be 
conducted either prior to movement to the mainland United States or in 
the mainland United States. Cold treatment facilities may be located in 
any State on the mainland United States. For cold treatment facilities 
located in the area south of 39[deg] latitude and west of 104[deg] 
longitude, the following additional conditions must be met:
    (i) Prospective facility operators must submit a detailed layout of 
the facility site and its location to APHIS. APHIS will evaluate plant 
health risks based on the proposed location and layout of the facility 
site. APHIS will only approve a proposed facility if the Administrator 
determines that regulated articles can be safely transported to the 
facility from the port of entry or points of origin in the United 
States.
    (ii) The government of the State in which the facility is to be 
located must concur in writing with the location of the facility or, if 
it does not concur, must provide a written explanation of concern based 
on pest risks. In instances where the State government does not concur 
with the proposed facility location, and provides a written explanation 
of concern based on pest risks, APHIS and the State must agree on a 
strategy to resolve the pest risk concerns prior to APHIS approval. If 
the State does not provide a written explanation of concern based on 
pest risks, then State concurrence will not be required before APHIS 
approves the facility location.

[[Page 42575]]

    (iii) Untreated articles may not be removed from their packaging 
prior to treatment under any circumstances.
    (iv) The facility must have contingency plans, approved by APHIS, 
for safely destroying or disposing of regulated articles if the 
facility is unable to properly treat a shipment.
    (v) The facility may only treat articles approved by APHIS for 
treatment at the facility. Approved articles will be listed in the 
compliance agreement required in paragraph (f) of this section.
    (vi) Arrangements for treatment must be made before the departure 
of a consignment from its port of entry or points of origin in the 
United States. APHIS and the facility must agree on all parameters, 
such as time, routing, and conveyance, by which the consignment will 
move from the port of entry or points of origin in the United States to 
the treatment facility. If APHIS and the facility cannot reach 
agreement in advance on these parameters then no consignments may be 
moved to that facility until an agreement has been reached.
    (vii) Regulated articles must be conveyed to the facility in a 
refrigerated (via motorized refrigeration equipment) conveyance at a 
temperature that minimizes the mobility of the pests of concern for the 
article.
    (viii) The facility must apply all post-treatment safeguards 
required for certification under paragraph (a) of this section before 
releasing the articles.
    (ix) The facility must remain locked when not in operation.
    (x) The facility must maintain and provide APHIS with an updated 
map identifying places where horticultural or other crops are grown 
within 4 square miles of the facility. Proximity of host material to 
the facility will necessitate trapping or other pest monitoring 
activities, funded by the facility, to help prevent establishment of 
any escaped pests of concern, as approved by APHIS; these activities 
will be listed in the compliance agreement required in paragraph (f) of 
this section. The treatment facility must have a pest management plan 
within the facility.
    (xi) The facility must comply with any additional requirements 
including, but not limited to, the use of pest-proof packaging and 
container seals, that APHIS may require to prevent the escape of plant 
pests during transport to and from the cold treatment facility itself, 
for a particular facility based on local conditions, and for any other 
risk factors of concern. These activities will be listed in the 
compliance agreement required in paragraph (f) of this section.
    (2) For articles that are moved interstate from areas quarantined 
for fruit flies, cold treatment facilities may be located either within 
or outside of the quarantined area. If the articles are treated outside 
the quarantined area, they must be accompanied to the facility by a 
limited permit issued in accordance with Sec.  301.32-5(b) of this 
chapter and must be moved in accordance with any safeguards determined 
to be appropriate by APHIS.
* * * * *
    (d) * * *
    (15) An inspector will sample and cut fruit from each consignment 
after it has been cold treated to monitor treatment effectiveness. If a 
single live pest of concern 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 pests of concern, APHIS may suspend the 
importation of fruits from the originating country and conduct an 
investigation into the cause of the deficiency. APHIS may waive the 
sampling and cutting requirement of this paragraph, provided that the 
national plant protection organization of the exporting country has 
conducted such sampling and cutting in the exporting country as part of 
a biometric sampling protocol approved by APHIS.
* * * * *
    (e) * * * Facilities must be located within the local commuting 
area for APHIS employees for inspection purposes. Facilities treating 
imported articles must also be located within an area over which the 
U.S. Department of Homeland Security is assigned authority to accept 
entries of merchandise, to collect duties, and to enforce the 
provisions of the customs and navigation laws in force.
    (f) Compliance agreements. Any person who operates a facility where 
cold treatment is conducted for phytosanitary purposes must sign a 
compliance agreement with APHIS.
    (1) Compliance agreements with importers and facility operators for 
cold treatment in the United States. If cold treatment of imported 
articles is conducted in the United States, both the importer and the 
operator of the cold treatment facility or the person who conducts the 
cold treatment must sign compliance agreements with APHIS. In the 
importer compliance agreement, the importer must agree to comply with 
any additional requirements found necessary by APHIS to ensure the 
shipment is not diverted to a destination other than an approved 
treatment facility and to prevent escape of plant pests from the 
articles to be treated during their transit from the port of first 
arrival to the cold treatment facility in the United States. In the 
facility compliance agreement, the facility operator or person 
conducting the cold treatment, must agree to comply with the 
requirements of this section and any additional requirements found 
necessary by APHIS to prevent the escape of any pests of concern that 
may be associated with the articles to be treated.
    (2) Compliance agreements with cold treatment facilities outside 
the United States. If cold treatment of imported articles is conducted 
outside the United States, the operator of the cold treatment facility 
must sign a compliance agreement or an equivalent agreement with APHIS 
and the NPPO of the country in which the facility is located. In this 
agreement, the facility operator must agree to comply with the 
requirements of this section, and the NPPO of the country in which the 
facility is located must agree to monitor that compliance and inform 
the Administrator of any noncompliance.
    (3) Cold treatment facilities treating articles moved interstate 
from Hawaii and U.S. territories. Cold treatment facilities treating 
articles moved interstate from Hawaii and the U.S. territories must 
complete a compliance agreement with APHIS as provided in Sec.  318.13-
3(d) of this chapter.
0
5. Section 305.9 is amended:
0
a. By revising paragraph (a)(1)(ii).
0
b. By revising paragraph (a)(1)(vi).
    The revisions read as follows:


Sec.  305.9  Irradiation treatment requirements.

* * * * *
    (a) * * *
    (1) * * *
    (ii) The government of the State in which the facility is to be 
located must concur in writing with the location of the facility or, if 
it does not concur, must provide a written explanation of concern based 
on pest risks. In instances where the State government does not concur 
with the proposed facility location, and provides a written explanation 
of concern based on pest risks, APHIS and the State must agree on a 
strategy to resolve the pest risk concerns prior to APHIS approval. If 
the State does not provide a written explanation of concern based on 
pest risks, then State concurrence will not be required before APHIS 
approves the facility location.
* * * * *
    (vi) Arrangements for treatment must be made before the departure 
of a consignment from its port of entry or points of origin in the 
United States.

[[Page 42576]]

APHIS and the facility must agree on all parameters, such as time, 
routing, and conveyance, by which the consignment will move from the 
port of entry or points of origin in the United States to the treatment 
facility. If APHIS and the facility cannot reach agreement in advance 
on these parameters then no consignments may be moved to that facility 
until an agreement has been reached.
* * * * *

    Done in Washington, DC, this 24th day of June 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-15568 Filed 6-29-16; 8:45 am]
 BILLING CODE 3410-34-P