[Federal Register Volume 83, Number 29 (Monday, February 12, 2018)]
[Rules and Regulations]
[Pages 5871-5878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02694]



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 Rules and Regulations
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 This section of the FEDERAL REGISTER contains regulatory documents 
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  Federal Register / Vol. 83, No. 29 / Monday, February 12, 2018 / 
Rules and Regulations  

[[Page 5871]]



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: Final rule.

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SUMMARY: We are amending 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, will 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 amending 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 will provide for a 
greater degree of phytosanitary protection. We are also adding 
requirements concerning the establishment of compliance agreements for 
U.S. entities that operate fumigation facilities. Finally, we are 
harmonizing 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 language in the 
cold treatment regulations. These actions will serve to codify and make 
enforceable existing procedures concerning compliance agreements for 
these facilities.

DATES: Effective March 14, 2018.

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.  
[thinsp]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 facilities used to provide upon arrival 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 upon arrival 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.
---------------------------------------------------------------------------

    \1\ The PPQ Treatment Manual is available at http://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 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).
    On June 30, 2016, we published in the Federal Register (81 FR 
42569-42576, Docket No. APHIS-2013-0081) a proposal \3\ to amend the 
regulations by

[[Page 5872]]

establishing 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 the approval and 
operation of new cold treatment facilities in the Southern and Western 
States of the United States.
---------------------------------------------------------------------------

    \3\ To view the proposed rule, supporting documents, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2013-0081.
---------------------------------------------------------------------------

    We also proposed to expand our requirements for initial cold 
treatment facility certification and recertification; 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; combine requirements both domestic and foreign 
cold treatment facilities and importers would have to meet in order to 
enter into a compliance agreement with APHIS; add language regarding 
compliance agreements required in association with articles moved 
interstate from Hawaii and the U.S. territories; add a section to the 
regulations concerning fumigation treatment to provide that both 
domestic and foreign fumigation treatment facilities and importers 
enter into a compliance agreement with APHIS; add a definition for 
``treatment facility'' to the regulations in Sec.  [thinsp]305.1; and 
remove a cold treatment schedule from the PPQ Treatment Manual.
    We solicited comments concerning our proposal for 60 days ending 
August 29, 2016. We received 42 comments by that date. They were from 
producers, exporters, industry groups, private citizens, and a State 
department of agriculture. Of those, 26 were wholly supportive of the 
proposed action. The remainder are discussed below by topic.

General Comments

    Several commenters argued that granting the exemptions described 
previously that have allowed for the establishment of cold treatment 
facilities in a number of Southern and Western States mistakenly served 
to further liberalize the regulations and lessen the phytosanitary 
safety of the United States.
    As stated previously, prior to the establishment of those cold 
treatment facilities, we conducted site-specific evaluations for each 
location and determined that regulated articles could be safely 
transported to, handled in, and treated subject to special conditions 
designed to mitigate the possible escape of pests of concern. These 
evaluations and proposals were made available both to the States in 
which the facilities would be established and the general public for 
review and comment. We have successfully established cold treatment 
facilities in seven locations outside of the areas established by the 
regulations and they have operated without incident. If a facility were 
to be found out of compliance with the requirements of the regulations, 
we would take appropriate remedial action to ensure ongoing 
phytosanitary security.
    A number of commenters hypothesized that the proposed rule was 
intended to satisfy nonagricultural entities (e.g., importers, facility 
owners) with little concern for the phytosanitary risk involved to the 
agricultural sector.
    We have determined that the measures specified in the treatment 
evaluation document (TED) that accompanied the proposed rule (e.g., 
requirements concerning facility planning and location, transport of 
regulated articles to the facility for treatment, and handling of 
regulated articles after treatment) will effectively lessen the risk 
associated with locating cold treatment facilities in the Southern and 
Western States of the United States. In addition, as noted in the 
proposed rule, the criteria we are establishing are similar to those 
successfully used for the approval of new irradiation facilities in the 
Southern United States found in Sec.  [thinsp]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. APHIS' evaluation process is solely based on this 
evaluated level of phytosanitary risk and not on the identity of any of 
the individuals or entities supportive of the change. The commenters 
did not provide any evidence suggesting that the measures are not 
effective.
    One commenter asked about the impetus for the proposed rule. The 
commenter suggested that greater flexibility for importers and a higher 
volume of imports serving as a revenue generating device for ports were 
the two obvious motivations for the change.
    We developed the proposed rule in response to a number of pending 
requests for the approval of cold treatment facilities. After 
considering the issue and the associated phytosanitary risks, we 
determined that generic criteria could be established for the approval 
of new facilities that would streamline the approval process while at 
the same time minimizing the risk of pests escaping from regulated 
articles prior to cold treatment.
    Another commenter stated that U.S. Customs and Border Protection 
(CBP) has reported pest interceptions and that the volume of those 
interceptions is greater today than it was in the past.
    The commenter provided no evidence to support the claim of 
increased pest interceptions related to commercial commodities imported 
or moved interstate in the United States for cold treatment. In 
addition, the commenter did not specify the identities of the pests of 
concern, the commodities with which the pests are associated, whether 
those commodities were imported or moved commercially or non-
commercially, or what State or States are the focus of particular 
concern when it comes to the supposed increase in interceptions. In the 
absence of specific information we cannot provide targeted CBP data to 
address the commenter's claim, however we have not noted a general 
increase in pest interceptions.

Comments on Phytosanitary Security

    One commenter expressed concern over the phytosanitary risk 
inherent in allowing untreated fruits and vegetables to travel through 
areas where host material may exist to a facility in proximity to 
domestic host material. Another commenter said that APHIS should not 
allow cold treatment facilities to be located near areas producing 
domestic host material, nor should we allow access to such facilities 
via highways or railways that run through areas producing host 
material. One commenter stated that invasive species are not introduced 
directly to farming communities, but instead become established first 
in urban areas adjacent to ports or terminal markets before spreading 
elsewhere. The commenter urged us to examine this phenomenon.
    A number of commenters expressed specific concerns regarding 
potential pest incursion into the State of Florida. One commenter 
stated the recent establishment of citrus canker, citrus black spot, 
and citrus greening should serve to eliminate Florida as a potential 
location for cold treatment facilities. Four commenters said that, due 
to the overall risk of fruit fly and other pest introduction to the 
State of Florida, APHIS should exclude commodities originating from 
areas where certain fruit flies are known to exist from the 
consolidated regulations. Two commenters said that cold treatment 
should be completed prior to any shipment's arrival in the State of 
Florida in order to ensure the phytosanitary security of domestic 
crops. Another commenter argued that because foreign production areas 
are not well monitored, cold treatment should occur prior to departure 
from the shipment's country of origin.

[[Page 5873]]

    The regulations in Sec.  [thinsp]305.6 allow for cold treatment of 
articles either prior to or after arrival in the United States, 
provided that an APHIS-approved facility is available. Articles may be 
treated in the United States instead of the exporting country for 
several reasons, including when the exporting country lacks the 
resources, technical expertise, or infrastructure to treat articles 
prior to export. The regulations require safeguards that have 
successfully prevented the introduction or dissemination of plant pests 
into or within the United States via the importation or interstate 
movement of cold treated articles in the past. Based on our experience, 
we are confident that exporting countries have the ability to comply 
with all APHIS requirements and commodities from exporting countries 
can be safely treated in the United States.
    APHIS recognizes that the Southern and Western States of the United 
States have conditions favorable for the establishment of certain 
pests, and that is why we proposed additional safeguards for cold 
treatment facilities in these States that go beyond the current 
requirements that apply to all cold treatment facilities. These 
safeguards include the requirements that untreated articles may not be 
removed from their packaging prior to treatment under any 
circumstances, that refrigerated or air-conditioned conveyances must be 
used to transport regulated articles to the treatment facility, and 
that facilities have contingency plans for safely destroying or 
disposing of regulated articles if the facility was unable to properly 
treat a shipment. To help prevent establishment of pests in the 
unlikely event that they escape despite the required precautions, we 
will require trapping and other pest monitoring activities within 4 
square miles of the facility to help prevent establishment of any 
escaped pests of concern. Those activities will be paid for by the 
facility.
    APHIS will only approve a proposed facility if the Administrator 
determines that regulated articles can be safely transported to the 
facility from a port of entry or points of origin in the United States. 
We believe that the mitigations included in this final rule have proven 
effective in mitigating the risk associated with the importation of 
commodities into the United States, and thus will provide protection 
against the introduction or dissemination of pests of concern into the 
United States.
    A number of commenters asked what had changed in APHIS' assessment 
of phytosanitary risk since the cold treatment regulations were 
originally established. The commenters specifically pointed to Sec.  
305.6(b), which states that ``cold treatment facilities are to be 
located in the area North of the 39th latitude and east of the 104th 
longitude as areas outside of these coordinates are identified as 
having conditions favorable for the establishment of exotic fruit 
flies.'' The commenters argued that the original justification for the 
prohibition on facility location is still valid.
    The TED that accompanied the proposed rule referenced a study 
conducted in 1994, which was the basis for our initial decision to 
prohibit the movement of host materials to cold treatment facilities in 
the Southern and Western States of the United States. The study 
recommended restricting or prohibiting the movement of host materials 
through these States unless strict measures were applied to manage the 
associated risks. Since that time, in response to petitions and after 
site-specific evaluations, APHIS has approved several Southern and 
Western locations where facilities could be established to receive and 
cold treat foreign fruits or vegetables provided certain conditions 
determined by APHIS to result in the safe transport of regulated 
articles to the treatment facility, were followed. It is our experience 
with these stringent, additional measures that has led us to conclude 
that generic criteria can be safely established.
    Many commenters stated that the potential escape of fruit flies 
represented too great a phytosanitary risk and added that the proposed 
regulations could expose domestic citrus crops to citrus leprosis 
virus, spread by Brevipalpus mites. Several other commenters cited the 
dangers to the domestic avocado industry posed by laurel wilt, spread 
by the ambrosia beetle (Xyleborus glabratus). Another commenter argued 
that even with restrictions in place, devastating insects such as the 
emerald ash borer (Agrilus planipennis, EAB), Asian longhorned beetle 
(Anoplophora glabripennis, ALB), and brown marmorated stink bug 
(Halyomorpha halys) eluded detection, established, and spread. One 
commenter used the State of Florida's Mediterranean fruit fly 
(Ceratitis capitata, Medfly) trapping program as a cautionary example. 
The commenter stated that, despite the State's use of trapping and the 
release of sterile insects, accidental incursions of Medfly occurred in 
2010 and 2011, resulting in a cost of approximately $4 million in each 
case to achieve eradication.
    As this rule does not certify any additional cold treatment 
facilities, such specific pest concerns are outside the scope of the 
current regulation, although we note that the introductions of EAB, 
ALB, and brown marmorated stink bug were all associated with wood 
packing material, which, at the time of the pests' first entrance into 
the United States, was not safeguarded at the level of imported fruits 
and vegetables. Any new treatment facilities would have to be 
authorized using the criteria described in the regulation, which would 
include analysis of any potential host materials in the area. The 
commenter did not specify whether the Medfly incursions in 2010 and 
2011 were determined by the State of Florida to originate from 
commercial or noncommercial sources, but we would note that accidental 
incursions of fruit flies from commercially produced fruit represent 
less phytosanitary risk, as produce grown commercially is less likely 
to be infested with plant pests than noncommercial consignments due to 
the standardized way in which it is grown, harvested, and packaged.
    A commenter said that the cumulative results of authorizing cold 
treatment facilities in the Southern and Western States of the United 
States should not be ignored. The commenter argued that, while 
individual approvals may create negligible risk, taken as a whole they 
lead to an overall decline in phytosanitary safety. The commenter 
further stated that the subsequent establishment of quarantine pests 
domestically then hampers the ability of domestic producers to export 
their products due to increased stringency in import markets abroad.
    We disagree with the commenter's point. While it is true that cold 
treatment facilities were and will continue to be evaluated on an 
individual basis, as stated previously, the fact that pests of concern 
are more likely to become established in the Southern and Western 
States of the United States is why we proposed additional safeguards 
for cold treatment facilities in these States that go beyond the 
current requirements that apply to all cold treatment facilities. We 
disagree that any increase in the number of authorized cold treatment 
facilities will necessarily create an unacceptable level of risk. 
Prospective facility operators must submit a detailed layout of the 
facility site and its location to APHIS. Location information would 
include any nearby facilities and those facilities would be a part of 
APHIS' overall consideration of plant health risks for the requested 
location. We also note that the requirements regarding safeguarding 
during transit to, treatment, and shipment from the facilities will 
also

[[Page 5874]]

serve to preclude escape of quarantine pests into the environment, 
regardless of the number of other treatment facilities in a given area. 
The commenter provided no evidence that the establishment of quarantine 
pests in domestic host material is a given, therefore the commenter's 
final point about potential impacts to domestic producers does not 
apply.

Comments on Implementation

    Two commenters expressed concern at the elimination of the need for 
rulemaking for future individual cold treatment facility approvals in 
Southern and Western States. The commenters were particularly worried 
about the elimination of a public comment period and other stakeholder 
outreach methods.
    Prior to approving a new cold treatment facility, APHIS will enter 
into consultation with the State in which the prospective facility will 
be located. Facility approval will be coordinated through APHIS' Field 
Operations unit, which routinely keeps potentially affected 
stakeholders apprised of any pending APHIS approvals. These actions 
will serve to complement the State's own outreach. As circumstances 
warrant APHIS may use additional outreach tools.
    One commenter was partially supportive of our proposal but 
suggested that we require that approved cold treatment facilities also 
be approved to apply alternative treatments, such as fumigation with 
methyl bromide or irradiation.
    While it is certainly possible for a treatment facility to be 
certified to perform more than one variety of treatment, we see no 
reason to require that cold treatment facilities be so certified 
because we are confident that our regulations require that any 
regulated articles be separated prior to, during, and after treatment. 
If a facility were to engage in different varieties of treatment those 
treatments would be required to be completed separate from one another.
    Another commenter recommended that we require, whenever possible, 
that phytosanitary treatments be performed prior to shipment arrival in 
the United States in order to prevent accidental introduction of pests 
of concern.
    As stated previously, the regulations in Sec.  [thinsp]305.6 allow 
for cold treatment of articles either prior to or after arrival in the 
United States, provided that an APHIS-approved facility is available.
    The State government of the Southern or Western State in which the 
facility will be located will also have to concur in writing with the 
location of the cold treatment facility. If the State government does 
not concur, it 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 will need to 
agree on a strategy to resolve such risks before APHIS approves the 
facility.
    A commenter suggested that we stipulate that written explanations 
be provided within 60 days of the submission of the required documents 
by the prospective facility owner. The commenter also suggested that, 
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 
within a reasonable period not to exceed 120 days from the submission 
of the required documents by the prospective facility owner.
    A reasonable length of time to be determined by APHIS will be given 
for the State to respond after the proposal for the location and layout 
of the facility site are submitted to APHIS by the prospective facility 
owner. Time frames for response will be determined on a case-by-case 
basis, based on APHIS' own evaluation of the submitted materials.
    One commenter asked that a State's ability to maintain an objection 
to the placement of a cold treatment facility beyond the stipulated 
consultation and negotiation with APHIS be specifically addressed in 
the regulations.
    As stated previously, we will first come to concurrence with the 
State in which the prospective cold treatment facility will be located 
before approving the facility. Because concurrence is reached on a 
case-by-case basis, this allows us to ensure that the State's 
phytosanitary risk-based concerns have been thoroughly addressed.
    Another commenter said that a State should not be able to veto a 
given proposal simply because it opposes the establishment of cold 
treatment facilities within its borders or insists upon an unrealistic 
level of phytosanitary protection. The commenter requested language be 
included that assures prospective facility owners that reasonable 
efforts will be made to come to agreement on the establishment of 
facilities deemed acceptable by APHIS and objectionable by individual 
States.
    The standards are similar to the procedure we successfully use for 
the approval of irradiation facilities in Southern and Western States 
as currently described in Sec.  305.9. In instances where the State 
government does not concur with the proposed facility location, APHIS 
and the State will collaborate to resolve these concerns. These 
requirements are intended to give States an opportunity to provide 
information to APHIS to help ensure that all facilities will have 
appropriate safeguards in place prior to APHIS approval.
    Several commenters argued that cold treatment facilities should not 
be located in the State of Florida due to its wide range of diverse 
habitats and climate ranges and the resulting likelihood of accidental 
exotic plant pest introduction and establishment.
    While APHIS acknowledges that Florida's environment is uniquely 
hospitable to the establishment of certain plant pests, the generic 
criteria for establishing cold treatment facilities in Southern and 
Western States include safeguarding measures above and beyond those 
already in place for facilities located elsewhere in the country. 
Additionally, when the location of the proposed facility raises 
phytosanitary concerns that are not addressed by the generic criteria, 
additional safeguards will be required for any facility established in 
that area, such as increased inspections and trapping based on 
quarantine pests associated with specific regulated articles. Any 
additional measures mandated for a particular facility will be 
stipulated in the facility compliance agreement. Finally, States will 
have the opportunity to review the layout of the facility and its 
proposed location prior to any APHIS approval, and to present pest risk 
concerns that may be associated with the facility or its location that 
necessitate further safeguarding. It is possible that, collectively, 
these safeguards would mitigate phytosanitary risk to a level allowing 
for the establishment of a facility in the State of Florida. We 
therefore cannot grant the commenter's request for a blanket 
prohibition on constructing facilities in that State.

Comments on General Economic Effects

    While specific comments on the initial regulatory flexibility 
analysis are specifically addressed in this document and in the final 
regulatory flexibility analysis, we received a number of comments 
concerning the overall economic effect of the rule as it relates to the 
establishment of generic criteria that would allow for the approval of 
new cold treatment facilities in the Southern and Western States of the 
United States.

[[Page 5875]]

    One commenter cited the World Trade Organization's (WTO) Article 5, 
``Assessment of Risk and Determination of the Appropriate Level of 
Sanitary or Phytosanitary Protection,'' which states: ``In assessing 
the risk to animal or plant life or health and determining the measure 
to be applied for achieving the appropriate level of sanitary or 
phytosanitary protection from such risk, Members shall take into 
account as relevant economic factors: The potential damage in terms of 
loss of production or sales in the event of the entry, establishment or 
spread of a pest or disease; the costs of control or eradication in the 
territory of the importing Member; and the relative cost-effectiveness 
of alternative approaches to limiting risks.'' The commenter argued 
that the establishment of generic standards that eliminate the need for 
rulemaking to approve new facilities, and thus the elimination of the 
economic analyses that would be prepared as part of the rulemaking 
process, is in conflict with the WTO mandate, as it will impact APHIS' 
ability to consider such consequences. The commenter concluded that it 
is not reasonable for APHIS to make a blanket determination that the 
future economic impact of unspecified foreign imports entering the 
United States for cold treatment will always be of little significance.
    We disagree that our actions are in conflict with WTO Article 5. 
While specific economic analyses will not be conducted in connection 
with approvals of new cold treatment facilities, the potential economic 
consequences of pest introduction associated with a given commodity are 
considered at the same time we consider potential mitigation measures 
during the development of the risk mitigation document that accompanies 
proposed actions.
    Several commenters stated that the financial consequences of pest 
infestation would be too great to allow for any imported host material 
to be treated in the Southern or Western States.
    We believe that the cold treatment and the additional specific 
safeguarding measures that will be in place at a given facility under 
compliance agreement are adequate to mitigate the phytosanitary risks 
presented by such materials. If the risks cannot be adequately 
mitigated, a facility or specific commodities would not be approved.

Comments on the Economic Analysis

    One commenter observed that, while it is true that the rule does 
not approve individual facilities, it creates the mechanism for all 
future approvals. The commenter argued that we should therefore project 
the economic impact of utilization of the new process at various levels 
of intensity over time.
    The commenter is correct that the economic impact of any new 
facilities is not a direct result of this rulemaking. However, we do 
recognize that facilities that are currently awaiting approval will 
reasonably be expected to be evaluated under the new criteria of this 
rule. We have included a discussion of these facilities in the analysis 
for the final rule.
    The same commenter said that the economic analysis failed to 
consider the full scope of small entities potentially affected by the 
rule. The commenter stated that we should include possible impacts on 
farming activities in Southern and Western States that could be 
impacted by phytosanitary threats that are intended to be mitigated by 
cold treatment.
    We disagree. As stated previously, we believe that the additional 
specific safeguarding measures that will be required at a given 
facility under compliance agreement in a Southern or Western State will 
adequately mitigate the phytosanitary threats presented. If threats 
cannot be adequately mitigated, a facility or specific commodities will 
not be approved.

Fumigation Treatment and Compliance Agreements

    We proposed to add a section to the regulations concerning 
fumigation treatment found in Sec.  305.5 to provide that fumigation 
treatment facilities outside the United States enter into a compliance 
agreement, or an equivalent agreement such as a workplan agreement, 
with APHIS.
    Upon further consideration, we have decided not to finalize this 
requirement at this time. The vast majority of fumigations performed 
outside the United States are done in connection with importation of 
regulated wood articles, such as Chinese wooden handicrafts, for which 
there are already compliance agreements or workplan agreements in place 
with the production facilities, or international agreements on 
treatment with certification through the International Plant Protection 
Convention. We will continue to closely monitor the issue and address 
any problems that arise on a case-by-case basis. If circumstances 
dictate a need for greater APHIS oversight of these facilities, we will 
respond accordingly.
    We also proposed, when fumigation of imported plants and plant 
products is conducted domestically, to require that importers enter 
into a compliance agreement with APHIS, and agree to comply with any 
requirements deemed necessary by the Administrator.
    After further evaluation, we have determined that this proposed 
requirement is unnecessary. We proposed the requirement in order to 
establish consistency between requirements for the application of 
fumigation treatment of imported products, and the application of 
irradiation treatment for imported products.
    In so doing, however, we failed to adequately consider an important 
distinction between the two types of treatment: Approved irradiation 
facilities are often not located in port environs, and are sometimes 
located hundreds of miles from ports of entry, fumigation is almost 
always conducted within port of entry environs, and, in the few 
instances when it is not, there are many long-standing mechanisms in 
place to ensure chain of custody and safeguarded transit to the 
fumigation facility. Accordingly, while requiring importers to enter 
into compliance agreements plays a vital role in ensuring adequate 
safeguarding of imported commodities during their transit from ports of 
entry to irradiation facilities, there is no corresponding need for 
compliance agreements for articles destined for fumigation.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Orders 13771 and 12866 and Regulatory Flexibility Act

    This final rule has been determined to be not significant for the 
purposes of Executive Order (E.O.) 12866 and, therefore, has not been 
reviewed by the Office of Management and Budget. This rule is not an 
E.O. 13771 regulatory action because this rule is not significant under 
E.O. 12866. Further, APHIS considers this rule to be a deregulatory 
action under E.O. 13771 as it will eliminate the need for specific 
rulemaking for the establishment of cold treatment facilities, thus 
reducing the time needed for approval of cold treatment facilities 
without affecting the analysis or mitigation of risk.
    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 website (see footnote 3 in this document for a 
link to Regulations.gov) or by contacting the

[[Page 5876]]

person listed under FOR FURTHER INFORMATION CONTACT.
    We are establishing general criteria for new cold treatment 
facilities in the Southern and Western United States. These general 
criteria will be supplemented as necessary by additional measures, as 
described in the facility's compliance agreement and based on its 
location and on the pests of concern associated with the regulated 
articles that will be treated at the facility. APHIS approval of new 
facilities will not require specific rulemaking. By eliminating the 
need for specific rulemaking for the establishment of cold treatment 
facilities, considerable time savings in bringing a new facility online 
may be achieved. A significant portion of the time needed to approve a 
new facility is due to the rulemaking process. This rule will reduce 
the time needed for approval of cold treatment facilities without 
affecting the analysis or mitigation of risk. The rule will 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 will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 2 CFR chapter IV.)

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection 
requirements included in this final rule, which were filed under 0579-
0450, have been submitted for approval to the Office of Management and 
Budget (OMB). When OMB notifies us of its decision, if approval is 
denied, we will publish a document in the Federal Register providing 
notice of what action we plan to take.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the EGovernment 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 rule, please contact Ms. Kimberly Hardy, 
APHIS' Information Collection Coordinator, at (301) 851-2483.

List of Subjects in 7 CFR Part 305

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

    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. 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 as follows:
0
a. By redesignating paragraph (c) as paragraph (d) and adding a new 
paragraph (c).
0
b. By adding an OMB citation at the end of the section.
    The additions read as follows:


Sec.  305.5   Chemical treatment requirements.

* * * * *
    (c) Compliance agreements. Any person who conducts a fumigation in 
the United States or operates a facility where fumigation is conducted 
in the United States for phytosanitary purposes must sign a compliance 
agreement with APHIS.
    (1) Fumigation treatment facilities treating imported articles; 
compliance agreements with facility operators for fumigation in the 
United States. If fumigation treatment of imported articles is 
conducted in the United States, the fumigation treatment facility 
operator or the person who conducts fumigation must sign a compliance 
agreement with APHIS. 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.
    (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.
* * * * *
(Approved by the Office of Management and Budget under control 
number 0579-0450)

0
4. Section 305.6 is amended as follows:
0
a. In paragraph (a) introductory text, by adding two 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 paragraphs (b) and (d)(15).
0
e. In paragraph (e), by adding two sentences at the end of the 
paragraph.
0
f. By revising paragraph (f).
0
g. By removing paragraphs (g) and (h).
0
h. By adding an OMB citation at the end of the section.
    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

[[Page 5877]]

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.
    (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 paragraph (d)(15) of this section, 
provided that the national plant protection organization (NPPO) 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

[[Page 5878]]

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.

(Approved by the Office of Management and Budget under control 
number 0579-0450)

0
5. Section 305.9 is amended by revising paragraphs (a)(1)(ii) and (vi) 
to 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. 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 6th day of February 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-02694 Filed 2-9-18; 8:45 am]
 BILLING CODE 3410-34-P