[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Rules and Regulations]
[Pages 46627-46639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19984]



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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

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Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / 
Rules and Regulations

[[Page 46627]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 318 and 319

[Docket No. APHIS-2010-0082]
RIN 0579-AD71


Establishing a Performance Standard for Authorizing the 
Importation and Interstate Movement of Fruits and Vegetables

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending our regulations governing the importation of 
fruits and vegetables by broadening our existing performance standard 
to provide for approval of all new fruits and vegetables for 
importation into the United States using a notice-based process. We are 
also removing the region- or commodity-specific phytosanitary 
requirements currently found in these regulations. Likewise, we are 
making an equivalent revision of the performance standard in our 
regulations governing the interstate movement of fruits and vegetables 
from Hawaii and the U.S. territories (Guam, Northern Mariana Islands, 
Puerto Rico, and the U.S. Virgin Islands) and removing the commodity-
specific phytosanitary requirements from those regulations. This action 
will allow for the approval of requests to authorize the importation or 
interstate movement of new fruits and vegetables in a manner that 
enables a more flexible and responsive regulatory approach to evolving 
pest situations in both the United States and exporting countries. It 
will not, however, alter the science-based process in which the risk 
associated with importation or interstate movement of a given fruit or 
vegetable is evaluated or the manner in which risks associated with the 
importation or interstate movement of a fruit or vegetable are 
mitigated.

DATES: Effective October 15, 2018.

FOR FURTHER INFORMATION CONTACT: Regarding the commodity import request 
evaluation process, contact Mr. Benjamin J. Kaczmarski, Assistant 
Director, Regulatory Coordination and Compliance, PPQ, APHIS, 4700 
River Road Unit 133, Riverdale, MD 20737-1231; (301) 851-2127.
    Regarding import conditions for particular commodities, contact Mr. 
Tony Rom[aacute]n, Senior Regulatory Policy Specialist, Regulatory 
Coordination and Compliance, PPQ, APHIS, 4700 River Road Unit 133, 
Riverdale, MD 20737-1231; (301) 851-2242.

SUPPLEMENTARY INFORMATION: 

Background

    Under the regulations in ``Subpart--Fruits and Vegetables'' (7 CFR 
319.56-1 through 319.56-83, referred to below as the regulations or the 
fruits and vegetables regulations), the Animal and Plant Health 
Inspection Service (APHIS) of the United States Department of 
Agriculture (USDA) prohibits or restricts the importation of fruits and 
vegetables into the United States from certain parts of the world to 
prevent plant pests from being introduced into and spread within the 
United States.
    The regulations in 7 CFR part 318, ``State of Hawaii and 
Territories Quarantine Notices'' (referred to below as the Hawaii and 
territories regulations), prohibit or restrict the interstate movement 
of fruits, vegetables, and other products from Hawaii, Puerto Rico, the 
U.S. Virgin Islands, and Guam to the continental United States to 
prevent the spread of plant pests and noxious weeds that occur in 
Hawaii and the territories.
    Under our current process for authorizing importation of fruits or 
vegetables under the fruits and vegetables regulations or interstate 
movement under the Hawaii and territories regulations, when APHIS 
receives a request from a country's national plant protection 
organization (NPPO) or a State department of agriculture to allow 
importation or interstate movement of a fruit or vegetable whose 
importation or interstate movement is currently not authorized, that 
NPPO or State department of agriculture must first gather and submit 
information to APHIS concerning that fruit or vegetable. In the case of 
imports, a description of the required information is contained in 7 
CFR 319.5(d). This information, in addition to our own research, allows 
APHIS to conduct a pest risk analysis.
    The pest risk analysis usually contains two main components: (1) A 
pest risk assessment (PRA), pest list, or other pest risk document to 
determine what pests of quarantine significance are associated with the 
proposed fruit or vegetable and which of those are likely to follow the 
import or interstate movement pathway, and (2) a risk management 
document (RMD), to identify phytosanitary measures that could be 
applied to the fruit or vegetable and evaluate the potential 
effectiveness of those measures. When the PRA, pest list, or other pest 
risk document is complete, if quarantine pests are associated with the 
fruit or vegetable in the country, State, or other region of origin,\1\ 
APHIS then evaluates whether the risk posed by each quarantine pest can 
be mitigated by one or more of the designated phytosanitary measures of 
the fruits and vegetables regulations or the designated phytosanitary 
measures of the Hawaii and territories regulations. If the designated 
phytosanitary measures alone are not sufficient to mitigate the risk 
posed by the importation or interstate movement of the commodity, any 
further action on approving the fruit or vegetable for importation or 
interstate movement is undertaken using the rulemaking process, which 
entails publishing a proposed and final rule. The pest risk analysis is 
made available to the public for review and comment at the time of the 
publication of the proposed rule.
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    \1\ Pest risk assessments can consider a country, part of a 
country, all or parts of several countries, a State or territory, 
part of a State or territory, or all or parts of several States or 
territories.
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    However, if APHIS determines in an RMD that the risk posed by each 
identified quarantine pest associated with the fruit or vegetable in 
the country, State, or other region of origin can be mitigated by one 
or more of the designated phytosanitary measures listed in Sec.  
319.56-4(b) of the fruits and vegetables regulations or Sec.  318.13-
4(b) of the Hawaii and territories regulations (these measures are 
referred to elsewhere in this document as designated phytosanitary 
measures or designated phytosanitary measures of

[[Page 46628]]

the fruits and vegetables regulations), the findings are communicated 
using the notice-based process.
    Under the notice-based process, APHIS publishes in the Federal 
Register, a notice announcing the availability of the pest risk 
analysis for a minimum of 60 days public comment. Each pest risk 
analysis made available for public comment through a notice specifies 
which of the designated phytosanitary measures APHIS would require to 
be applied. APHIS evaluates comments received in response to the notice 
of availability of the pest risk analysis. In the event that APHIS 
receives no comments, or in the event that commenters do not provide 
APHIS with analysis or data that indicate that the conclusions of the 
pest risk analysis are incorrect and that changes to the pest risk 
analysis are necessary, APHIS then publishes another notice in the 
Federal Register announcing that the Administrator has determined that, 
based on the information available, the application of one or more of 
the designated phytosanitary measures (as specified in a given pest 
risk analysis) is sufficient to mitigate the risk that quarantine pests 
could be introduced or disseminated within the United States via the 
importation or interstate movement of the fruit or vegetable. APHIS 
then authorizes the importation or interstate movement of the 
particular fruit or vegetable, subject to the conditions described in 
the pest risk analysis, on the date specified in the Federal Register 
notice.
    In the event that commenters provide APHIS with information that 
shows that changes to the pest risk analysis are necessary, and if the 
changes made affect the conclusions of the analysis (e.g., that the 
application of the identified phytosanitary measures will not be 
sufficient to mitigate the risk posed by the identified pests), APHIS 
proceeds as follows:
    <bullet> If additional phytosanitary measures beyond the designated 
phytosanitary measures are determined to be necessary to mitigate the 
risk posed by the particular fruit or vegetable, any further action on 
the fruit or vegetable follows the rulemaking process.
    <bullet> If additional risk mitigation measures beyond those 
evaluated in the pest risk analysis are determined to be necessary, but 
the added measures only include one or more of the designated 
phytosanitary measures of the fruits and vegetables regulations or the 
designated phytosanitary measures of the Hawaii and territories 
regulations, APHIS may publish another notice announcing that the 
Administrator has determined that the application of one or more of the 
designated phytosanitary requirements will be sufficient to mitigate 
the risk that quarantine pests could be disseminated within the United 
States via the importation or interstate movement of the fruit or 
vegetable. The notice also explains the additional mitigation measures 
required for the importation or interstate movement of the fruit or 
vegetable to be authorized and how APHIS made its determination. APHIS 
then begins allowing the importation or interstate movement of the 
particular fruit or vegetable, subject to the conditions described in 
the revised pest risk analysis, beginning on the date specified in the 
Federal Register notice. Alternatively, if APHIS believes that the 
revisions to the pest risk analysis are substantial, and there may be 
continued uncertainty as to whether the designated measures are 
sufficient to mitigate the risk posed by importation of the fruit or 
vegetable, APHIS may elect to make the revised pest risk analysis 
available for public comment via a notice in the Federal Register, or 
may make any further action on approving the commodity for importation 
subject to rulemaking.
    When commodities are approved for importation or interstate 
movement, either through rulemaking or the notice-based process, all 
permits issued list the commodity-specific importation requirements as 
determined by the pest risk analyses. Those requirements are also 
listed in Fruits and Vegetables Import Requirements (FAVIR) 
database,\2\ in the case of imported fruits and vegetables, as well as 
the appropriate manual, in the case of fruits and vegetables that are 
moved interstate from Hawaii and the U.S. territories. In order to 
ensure producer compliance with the listed procedures, an APHIS 
inspector or an official authorized by APHIS monitors any treatments 
(e.g., cold treatment, fumigation, irradiation) that are required. Upon 
arrival, consignments are inspected to ensure compliance with any 
particular shipping requirements, such as arrangement of fruits or 
vegetables on pallets or pest-exclusionary packaging, as well as for 
the presence of any pests of concern. In the event that a pest is 
discovered upon inspection at the port of first arrival, APHIS works 
with the inspectors and, in the case of imports, the NPPO of the 
exporting country, in order to investigate and, if necessary, re-
evaluate shipments of the fruit or vegetable in question from that 
country or State.
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    \2\ You may search FAVIR at http://www.aphis.usda.gov/favir/.
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    On September 9, 2014, we published in the Federal Register (79 FR 
53346-53352, Docket No. APHIS-2010-0082) a proposal\3\ to amend the 
regulations by expanding the use of the notice-based process to all 
decisions related to the importation and interstate movement of new 
fruits and vegetables. We also proposed to remove the remaining region- 
or commodity-specific phytosanitary requirements currently found in 
Sec. Sec.  319.56-13, 319.56-20 through 319.56-70, 318.13-16, and 
318.13-20 through 318.13-26. Since that time, Sec.  319.56-71 through 
Sec.  319.56-83 have been added to the regulations. This rule will 
remove those commodity-specific sections as well.
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    \3\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2010-0082.
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    We solicited comments concerning our proposal for 60 days ending 
November 10, 2014. We reopened and extended the deadline for comments 
until January 29, 2015, in a document published in the Federal Register 
on December 4, 2014 (79 FR 71973, Docket No. APHIS-2014-0082) and 
reopened and extended the deadline for comments a second time ending 
March 10, 2015, in a document published in the Federal Register on 
February 6, 2015 (80 FR 6665, Docket No. APHIS-2010-0082). We received 
22 comments on the proposed rule by that date. They were from 
representatives of State and foreign governments, industry 
organizations, importers and exporters, distributors, and private 
citizens. Two comments were supportive. The remainder of the comments 
are discussed below by topic.

Comments on the Comment Period

    Several commenters requested that we extend the comment period for 
the proposed rule. As stated previously, we extended the comment period 
twice. Along with the initial comment period on the proposed rule, 
these extensions gave the public 180 days in which to review the 
proposal and submit comments.
    In addition to the comment period extension, several commenters 
said that APHIS should issue an additional notice to clarify the scope 
and application of the proposed rule.
    One commenter observed that, in 2006 when we proposed a notice-
based process for a limited number of fruit and vegetable import 
requests, APHIS provided four public field hearings to ensure adequate 
interested-party input. The commenter said that similar efforts

[[Page 46629]]

were warranted in this case as well. Two commenters suggested that 
APHIS convene a stakeholder working group in association with the 
extension of the comment period in order to review the proposed rule. 
The commenters requested that special attention be paid to addressing 
significant barriers that impact trade within certain countries. The 
commenters argued that this working group would allow stakeholders to 
provide greater input for the proposed action.
    While we did not issue an informational notice as suggested by the 
first commenters or convene a working group, we did host a webinar open 
to the public. This briefing provided an overview of the proposed 
changes and gave stakeholders an opportunity to learn more about the 
rule and to ask questions. Additionally, APHIS published an explanatory 
questions and answers (Q&A) document on the APHIS website.\4\ Unlike 
our 2006 action, which represented a new rulemaking procedure, we did 
not hold public meetings in association with the proposed rule because 
the noticed-based process has been successfully employed since that 
time and the proposed action was merely an expansion of the existing 
program.
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    \4\ You may view the Q&A document as well as slides from the 
webinar on the internet at http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/planthealth/sa_import/sa_permits/sa_plant_plant_products/sa_fruits_vegetables/ct_q56-streamlining-questions-answers/!ut/p/a0/04_Sj9CPykssy0xPLMnMz0vMAfGjzOK9_D2MDJ0MjDzd3V2dDDz93HwCzL29jAx8TfULsh0VAY_1WkE!/.
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General Comments

    Several commenters stated that the proposed rule did not make clear 
which administrative review steps would be eliminated if APHIS adopted 
a notice-based process.
    Since notices are not considered rulemaking documents, we 
anticipate that the primary administrative time-savings will be a 
result of procedural steps that apply to rulemaking in the Federal 
Government, such as the development and publication of a proposed rule 
or final rule. The notice-based process is an informal adjudication 
process in that the Code of Federal Regulations (7 CFR parts 318 and 
319) sets out general mitigation measures and criteria that will be 
applied for the interstate movement or importation of fruits and 
vegetables into the United States. For each interstate movement or 
import request, the agency will conduct a risk assessment applicable to 
the specific commodity/place of origin and adjudicate the matter 
through the publication of a notice announcing the availability of the 
risk analysis and the solicitation of comments. The final notice 
published in the Federal Register constitutes a final agency action 
which may be subject to challenge in court under the Administrative 
Procedure Act.
    Another commenter stated that since the proposed changes would 
include a broad list of most or all available risk mitigation measures, 
which is far beyond currently established treatments, inspections, and 
certifications, APHIS should explain how efficacy and performance will 
be measured within each commodity import request in order to evaluate 
whether the notice-based process will enhance trade.
    The commenter's characterization of the proposed designated 
measures as being beyond established treatments is incorrect. Any 
phytosanitary treatment required must be among those that appear in the 
Plant Protection and Quarantine (PPQ) treatment manual. Any additions 
to the listed treatments in the treatment manual are done so only after 
we provide notice via a Federal Register notice and evaluate any 
comments received on that notice. Mitigations apart from phytosanitary 
treatments will continue to be recognized as parts of systems 
approaches via FAVIR, which will include information on all other 
required mitigations.
    One commenter cited the 2010-2015 APHIS Strategic Plan's 
characterization of the Agency's mission to ``Protect the health and 
value of U.S. agricultural, natural and other resources.'' The 
commenter claimed that the proposal was in contradiction with that 
statement and requested clarification on how the action aligns with the 
APHIS mission, particularly as it relates to benefits to U.S. 
agricultural resources.
    This rule does not alter the way in which APHIS carries out its 
mission to protect the health and value of U.S. agricultural, natural, 
and other resources. Our risk-based decisionmaking will not change as a 
result of this rule, nor will the level of phytosanitary security 
provided by the mitigation measures we will assign to address 
identified risks. U.S. consumers and businesses will benefit from more 
timely access to fruits and vegetables, and the more timely approval of 
the interstate movement of fruits and vegetables from Hawaii and the 
U.S. territories will be beneficial to U.S. producers.

Comments on Alternatives and Additions to the Proposed Action

    One commenter suggested that, as an alternative approach, APHIS 
should consider import requests for each commodity in a way that 
encompasses at least three different perspectives: Pests and diseases, 
economic impact, and possible environmental impact.
    The process for developing PRAs and determining mitigation measures 
would remain the same, giving the public opportunity to review, 
evaluate, and comment. Additionally, the requirements of the National 
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et 
seq.) will still apply. As such, for each additional fruit or vegetable 
approved for importation, APHIS will make available to the public 
documentation related to our analysis of the potential environmental 
effects of such new imports. This documentation will likely be made 
available at the same time and via the same Federal Register notice as 
the risk analysis for the proposed new import. Finally, while the 
notices published using the notice-based approach will not contain 
economic analyses, we will certainly continue to consider the potential 
economic consequences of pest introduction in the pest risk analysis. 
Similarly, we will document our consideration of trade volume and other 
economic factors. We commit to inclusion of an evaluation of the 
economic impacts of those actions that would have been deemed 
``economically significant'' under Executive Order 12866 prior to the 
effective date of this final rule.
    Several commenters said that APHIS should consider maintaining a 
dual track approach to considering import requests. The commenters 
suggested that requests that depend on a systems approach for risk 
mitigation be reviewed by APHIS so that APHIS could then make a 
determination as to whether a notice-based or rulemaking-based decision 
was appropriate based on a set of criteria that evaluate relative level 
of risk, the probability of success of the mitigation measures, and the 
economic impact of the associated pests in the event that an 
introduction took place. The commenters concluded that APHIS should 
then make the rationale for that determination available for public 
comment.
    Under the expanded notice-based process, the development of pest 
risk analyses and determination of mitigation measures would remain the 
same, giving the public opportunity to review, evaluate, and comment. 
This action will not alter our science-based

[[Page 46630]]

process for approval. If a risk analysis is conducted, the first step 
of which is typically a PRA or pest list, stakeholders will continue to 
have 30 days to consult on draft PRAs or pest lists before APHIS 
initiates the notice-based process. Once APHIS and the foreign NPPO 
have reached agreement on the PRA, the exporting country will notify 
APHIS about the mitigation measures they will be implementing. APHIS 
will then develop an RMD which includes specific requirements for 
addressing the pests of concern highlighted in the PRA or pest list. 
Market access requests developed via the notice-based process involving 
a systems approach will not be any less effective than rulemaking and 
will not compromise phytosanitary security.
    Another commenter recommended that APHIS apply the expanded notice-
based approach only to the importation of fruits and vegetables 
authorized after the regulations are finalized. The commenter added 
that market access requests currently under review should remain 
subject to the existing rulemaking process as transferring those 
requests from the existing rulemaking process into the new notice-based 
process could result in possible lost opportunities for the industry to 
review and provide comment. A second commenter wanted to know if the 
notice-based process would apply to pending decisions where draft PRAs 
have already been issued for public comment or only to new requests.
    We disagree with the first commenter's suggestion. As stated in the 
proposed rule, initial notices in the Federal Register will be 
available for review and comment for a minimum of 60 days, which is 
identical to the comment period we typically set out for proposed 
rules. We also have the option of extending that comment period if 
necessary. This provides ample time for stakeholder review and 
engagement. As to the second commenter's question: This rule will be 
applied to all pending requests. If an importation or interstate 
movement request has already been submitted and the results of our pest 
risk analysis lead us to conclude that the commodity can be safely 
imported or moved interstate under one or more designated measures, 
then we will follow the notice-based approach. The final notice 
published in the Federal Register constitutes a final agency action 
which may be subject to challenge in court under the Administrative 
Procedure Act.
    One commenter stated that APHIS should provide annual reports to 
the House and Senate Committees on Agriculture detailing import 
requests petitions addressed and granted each calendar year under the 
notice-based process. The commenter stated that these reports should be 
provided either annually or bi-annually.
    While APHIS does not supply such reports currently, if either 
committee were to request documentation along these lines, we would 
supply it.

Comments on Notice-Based Process

    One commenter asked if rulemaking would still be an option after 
this final rule became effective, and, if so, what the threshold would 
be for initiating rulemaking.
    As stated in the proposed rule, we are removing the region- or 
commodity-specific phytosanitary requirements currently found in the 
regulations concerning importation or interstate movement from Hawaii 
and the Territories. The rulemaking process regarding importation or 
interstate movement of commodities will be replaced by the notice-based 
process.
    Two commenters asked if the notice-based process would apply only 
to amendments of existing importation and interstate movement 
requirements or to all decisions related to the importation and 
interstate movement of fruits and vegetables.
    The notice-based process will apply to all decisions related to the 
importation and interstate movement of fruits and vegetables, both to 
changes in requirements for those already allowed under the regulations 
and new requests for importation or interstate movement.
    One commenter stated that it is unclear how the process will work 
if the new approval of a commodity or a change in requirement involves 
a phytosanitary measure that is listed in the proposed list of 
designated phytosanitary measures, but is not aligned to some other 
subpart elsewhere in the APHIS regulations.
    Under the revised regulations, all phytosanitary measures 
pertaining to the importation of fruits and vegetables would be removed 
from the regulations. As stated previously, importation and interstate 
movement requirements would be found in FAVIR, in the case of imported 
fruits and vegetables, as well as the appropriate manual, in the case 
of fruits and vegetables that are moved interstate from Hawaii and the 
U.S. territories. Treatments would continue to be listed in the PPQ 
Treatment Manual and new treatments would continue to be approved in 
accordance with 7 CFR part 305.
    The same commenter asked for clarification regarding reference to 
treatments within the CFR. As an example of this scenario, the 
commenter wondered whether the acceptance of a new phytosanitary 
treatment depends on the availability of this treatment option under 
the treatments listed in 7 CFR part 305.
    Section 305.3 of the regulations sets forth a notice-based process 
for adding, revising, and removing treatments contained in the PPQ 
Treatment Manual. Under those regulations, APHIS will publish in the 
Federal Register a notice describing our reasons for adding, revising, 
or removing a treatment schedule and provide for public comment on the 
action. After the close of the comment period APHIS will publish a 
notice announcing our final determination and, if appropriate, make 
available the final treatment schedule if any changes were made as a 
result of public comments.
    One commenter suggested that communication regarding import 
requests in the form of notices might not receive the same careful 
attention from industry representatives as is currently given to 
proposals issued under the traditional rulemaking process.
    We disagree. Stakeholders and other interested parties have reason 
to attend to any potential changes in their industries or other areas 
of interest. We will continue to provide our draft PRAs on the APHIS 
website for review and comment before publication of an initial notice. 
We will also continue to provide alerts via the PPQ Stakeholder 
Registry and issue press releases. Finally, the initial notice will 
include a comment period of at least 60 days. These actions provide the 
public ample opportunity to submit opinions and information on any 
given action.
    Another commenter said that statements by APHIS personnel made in 
the webinar described previously appeared to indicate that the notice-
based process will be of use for revisions to existing regulations that 
are minor in nature. The commenter also cited the questions and answers 
document as supporting this impression. The commenter was therefore 
puzzled by the broad scope of the process as described in the proposal.
    We proposed to use the notice-based approach for all commodity 
import requests. Any reference to the time it takes APHIS to address 
minor changes to the regulations under traditional rulemaking was 
intended to serve as an example of how even a straightforward 
alteration to the regulations may end up taking a very long time under 
the current system. More complicated rulemakings are typically even 
more time-consuming. It is the success of our more limited notice-based 
process that

[[Page 46631]]

indicates that this broad process may be successfully implemented.
    One commenter stated that we should expand upon our explanation of 
which measure out of the previous list of designated measures APHIS no 
longer finds sufficient to mitigate the phytosanitary risk posed by 
importation or interstate movement and how this will affect existing 
approved measures.
    We believe the commenter misunderstood our characterization of the 
action as it was set out in the proposed rule. None of the five 
designated phytosanitary measures that had been previously approved for 
use with the notice-based process were determined to be inadequate to 
mitigate the pest risks for which they have been used, we instead 
proposed to expand and reorganize the categories of designated measures 
in conjunction with an expanded notice-based process.
    Another commenter asked how APHIS intends to handle importation 
situations that include a disease or pest not previously dealt with in 
connection with the commodity under consideration for importation or 
interstate movement.
    The same commenter wanted to know how APHIS will address a 
situation where a substantial importation volume of a given commodity 
is expected when the commodity originates in an area where one or more 
pests and diseases of quarantine significance exist. The commenter 
observed that high volumes of an export put pressure on both the 
exporter to adhere to the required systems approach, and on inspections 
in the exporting country and the United States.
    Systems approaches allow for flexibility in modifying mitigation 
requirements when evolving pest situations both in the United States 
and in exporting countries occur. As stated previously, the scientific 
basis for the application of mitigations will not change. A novel or 
high import volume situation such as the one described by the commenter 
would be thoroughly analyzed in the PRA and RMD prior to the approval 
of any importation or interstate movement. APHIS considers that market 
access requests through notice-based process involving a systems 
approach will not be any less effective than rulemaking and will not 
compromise phytosanitary security.
    One commenter wanted to know when the proposed systems approach 
would be described under the notice-based process in order to allow for 
stakeholder input. As described in the proposed rule, the process for 
developing PRAs and determining mitigation measures will remain the 
same, giving the public opportunity to review, evaluate, and comment. 
PPQ will continue to make the draft PRAs, pest lists, or other pest 
risk documents available for review and comment by stakeholders upon 
completion. After incorporating any changes to the draft PRA, APHIS 
will then publish in the Federal Register, a notice announcing the 
availability of the pest risk analysis for a minimum of 60 days public 
comment. Each pest risk analysis made available for public comment 
through a notice specifies which of the designated phytosanitary 
measures APHIS would require to be applied, giving interested parties a 
chance to specifically comment on those measures. As previously 
mentioned, the final notice published in the Federal Register 
constitutes a final agency action which may be subject to challenge in 
court under the Administrative Procedure Act.
    The same commenter stated that the operational workplans developed 
for use by APHIS and the NPPO of the exporting country are documents 
that can be changed quickly if the need arises. The commenter said that 
operational workplans are therefore not legally binding documents, 
particularly as compared to the weight and authority of traditional 
rulemaking. The commenter asked what the consequences would be if an 
exporting country were to violate the terms of the operational 
workplan.
    Contrary to the commenter's assertion, operational workplans are 
binding documents. Every operational workplan includes a detailed 
description of the objectives, proposed activities, and expected 
results and benefits of the importation of a specific commodity and the 
related roles responsibilities, and resources contributed by each 
signatory. Penalties for violations of the terms of an operational 
workplan vary depending upon the violation in question, but can include 
such things as temporary or permanent ban on the importation of the 
commodity from the violating country.
    The same commenter observed that the proposed rule did not address 
the way in which APHIS intends to handle or incorporate treatment of 
pest free areas under the expanded notice-based process.
    The requirements regarding pest free area recognition are found in 
Sec.  319.56-5 of the regulations and remain unchanged by this rule.
    The same commenter asked what the principle source of information 
regarding a given commodity would be under the expanded notice-based 
system. The commenter hypothesized that this information would be kept 
in FAVIR and asked if that database would be updated and kept current 
with the issuance of final notices regarding imports.
    As stated in the proposed rule, fruits or vegetables approved for 
import under this approach will be listed in FAVIR, which is available 
on the APHIS website. Similarly, approved fruits and vegetables from 
Hawaii and the territories and their corresponding movement 
requirements will be listed in APHIS' Hawaii and Puerto Rico/U.S. 
Virgin Islands manuals, which are available for viewing and download on 
APHIS' website. All information in these sources will be updated as new 
commodities are approved for import or interstate movement.
    The same commenter said that we did not specify when a preclearance 
program in the exporting country would be required. The commenter 
observed that preclearance is an important aspect of import requests, 
made more so as systems approaches become more complex.
    Under some circumstances, we find that inspection prior to 
exportation is a necessary part of mitigating pest risk and the 
exporting country would need to inspect the commodity. Such an 
inspection requirement would be one of the mitigations included in the 
pest risk analysis and determination of need would be made on a case-
by-case basis.

Comments on Pest Risk Analyses

    One commenter observed that the PRA is simply a list of the pests 
and diseases present in the country requesting access to the U.S. 
market, while the more important issue for U.S. growers concerns the 
mitigation measures that will be required to address those pests and 
diseases. The commenter stated that this information should be made 
available in detail at the same time as the draft PRA is released for 
comment. The commenter also stated that, even if the RMD were to be 
released simultaneous to the draft PRA, it is fairly general in nature 
and does not provide details about the proposed systems approach.
    As the commenter noted, mitigation measures for the pests of 
concern identified in the PRA are addressed in the RMD that is made 
available with the initial notice. This document is then subject to 
public comment for at least 60 days. As stated previously, we will 
continue to provide our draft PRAs on the APHIS website for review and 
comment before publication of an initial notice. Comments submitted 
during the 30 day review period for the draft PRA will be considered 
and may result in changes to the final PRA. The PRA also

[[Page 46632]]

informs the process of country consultation, which occurs after 
development of the PRA. The RMD is drafted after this consultation has 
concluded. Generally, the measures included in the RMD are those that 
have been certified as effective, standardized, and proven via use on 
similar or identical pest complexes. Information on the specific steps 
necessary to meet the requirements of the systems approaches are 
located in the operational workplan established between APHIS and the 
exporting country. Copies of the operational workplan may be requested 
from APHIS.
    The same commenter said that the removal of the PRA from the APHIS 
website after the close of the comment period makes no sense to 
stakeholders and industry observers. The commenter suggested that all 
PRAs remain available on the APHIS website for all interested parties 
to access.
    The PRA to which the commenter refers is a draft document. We post 
all draft PRAs on the APHIS website for comment for 30 days prior to 
finalizing the PRA and RMD and subsequently publishing any rule or 
notice concerning those PRAs. After the close of the comment period we 
remove the PRA from the APHIS website in order to make any necessary 
changes. Subsequent versions of the PRA are made available for review 
and comment in association with the Federal Register notice on 
Regulations.gov. The draft PRA and a summary of any comments we 
received are preserved and are available upon request.
    The same commenter noted that it is impossible to determine the 
priority assigned by APHIS to any specific import request, and thus the 
PRA that addresses that request, from the information available on the 
APHIS website. The commenter asked that APHIS provide some indication 
of the order in which the PRAs are being considered.
    APHIS handles market access requests in the order that they are 
received. However, issues such as the need for additional information 
from the requesting country may delay a given request, at which point 
we often move on to the next request while awaiting necessary 
information.
    Another commenter said that we should make the data underlying PRAs 
and RMDs more readily available to stakeholders. The commenter 
suggested that, where proprietary data issues occur, data summaries or 
other forms of explanation should be provided to stakeholders.
    We disagree. PRAs and RMDs represent a synthesis of research, 
knowledge, and experience. As such, they offer the most complete 
picture of the pest and disease situation in any potential production 
area as well as the best representation of the measures APHIS believes 
will mitigate any phytosanitary risks. We do note that we include 
references in the completed documents, which interested parties may 
examine if they so choose.
    Two commenters asked if details such as the credibility of the 
foreign NPPO, infrastructure of programs, and facilities being employed 
would be made available. The commenters particularly cited the State of 
Florida as having requested on many occasions to have the opportunity 
to work more closely with APHIS to lend expertise and increase their 
level of knowledge regarding import programs. The commenters concluded 
that it is not acceptable for the State of Florida to concur with a 
list of phytosanitary measures without knowing firsthand what is being 
done to assure compliance.
    PPQ and the National Plant Board work together to utilize our 
respective Federal and State authorities, assets, and expertise to 
safeguard plant health and enable safe trade. While it is not 
appropriate from a policy standpoint nor practicable from a scheduling 
standpoint for individual States to directly participate in such 
activities on a regular basis, we do note that representatives from the 
State of Florida accompanied APHIS on a site visit to Peru in November 
2014 in order to examine the cold treatment program for citrus from 
that country. In past years, representatives of other States such as 
California have been included in similar visits.
    One commenter said that we should develop procedures for 
facilitating stakeholder consultation into the process prior to 
publication of the draft PRA, including a defined period for review and 
public comment on pest and disease lists.
    With respect to allowing the public to comment on pest and disease 
lists during the drafting phase of the pest risk analyses, such a 
process would have a serious adverse impact on the timely preparation 
of these documents. We believe a process in which an analysis is 
prepared, reviewed, and brought to a point where wider circulation and 
publication for comment is appropriate yields constructive comments 
that can be considered before any analysis is finalized. Therefore, we 
do not plan to take comments on pest and disease lists while they are 
under development.
    The same commenter suggested we include regulated non-quarantine 
pests and other pests of concern in the PRA in addition to pests of 
quarantine significance.
    The pests described by the commenter are currently included in 
every PRA prepared by APHIS.
    Another commenter observed that the expanded notice-based process 
will not provide time efficiencies in the pest risk analysis 
development process, which is responsible for long delays in the 
processing of pending import applications for fruit and vegetables. The 
commenter suggested that APHIS consider this part of the approval 
process with the goal of identifying options to create further 
efficiencies.
    In 2011, APHIS began a business process improvement initiative to 
identify and ameliorate inefficiencies in the manner in which we 
evaluate and respond to import applications for fruits and vegetables. 
While this initiative does not pertain solely to pest risk analyses, we 
have been working on an ongoing basis to improve the pest risk analysis 
development process since the initiative began.
    One commenter expressed concern that the time reduction associated 
with the notice-based process may negatively impact the scientific 
scrutiny needed for the assurance of safety against potential exotic 
pests and diseases. The commenter urged APHIS to ensure that any time 
reduction does not also include a less thorough review of the 
scientific and technical review process.
    We agree with the commenter's point that APHIS should ensure that 
any time reduction does not result in a less thorough review. As stated 
in the proposed rule, we will continue our specific reviews following 
market access requests as we have always done and provide the public 
opportunity to review and comment on the documents produced as a result 
of those reviews. The amount of time we devote to developing these pest 
risk analyses will not change. The shortened time period discussed in 
the proposed rule was in reference to that portion of the rulemaking 
process that begins after the pest risk analysis is finalized.
    Another commenter stated that the proposed expansion of the notice-
based process increases the types of measures that may be used as part 
of approved systems approaches. The commenter questioned whether the 
additional measures, either alone or in concert, would maintain the 
efficacy of the more limited notice-based system currently in use. The 
commenter asked that APHIS clarify how a given performance standard 
would be set and where

[[Page 46633]]

stakeholders would look in order to understand how the efficacy of 
these standards was measured. The commenter concluded that, while the 
RMD is supposedly where some of this information will be located, such 
documents do not necessarily include all of the data required for 
stakeholders to evaluate efficacy.
    The documentation provided in support of an acceptable level of 
phytosanitary risk reduction will not change under the new process. The 
RMDs used for noticed-based process are identical to those used in 
traditional rulemaking. For new treatments we will also utilize a 
Treatment Evaluation Document, which specifically addresses the 
efficacy of those treatments with which we have less experience. We 
would note, however, that most treatments and mitigations required by 
APHIS are not novel. Various types of treatments (e.g., fumigation, 
heat treatment, and irradiation) and mitigations (e.g., pest-
exclusionary structures, use of clean boxes for transit, and waxing) 
are effective against a wide variety of pests and diseases.
    One commenter stated that we should consider limiting consignments 
of fruits and vegetables into States that have crops that are highly 
susceptible to infestation by pests and diseases from countries which 
do not have equivalent plant pest agencies. The commenter also stated 
that pest and risk information should be supplied to regulatory 
officials in those vulnerable States and regions.
    We will continue to consider limiting distribution of imports on a 
case-by-case basis when the findings of pest risk analysis indicate 
that such an action might be necessary and if it is operationally 
feasible. Limited distribution is specifically cited as an example of a 
safeguarding and movement mitigation that may be applied. We provide 
our expertise via analysis in the form of pest risk assessments and 
other risk documentation, which is available to all interested parties 
via publication of material in the Federal Register as well as through 
PPQ's stakeholder registry.

Comments on Other Supporting Analyses

    Several commenters asked if economic impact studies and 
determinations of significance or economic significance would remain 
part of the streamlined process.
    Our determination as to whether a new agricultural commodity can be 
safely imported is based on the findings of the pest risk analysis, not 
on economic factors. However, we will continue to consider the 
potential economic consequences of pest introduction in the PRA. 
Similarly, we will document our consideration of trade volume and other 
economic factors.
    One commenter said that the proposal appeared to create disparity 
in the consideration of the importation of fruits and vegetables versus 
other commodities, such as meat, citing a lack of interagency review 
and economic analysis as two such examples. The commenter stated that 
the import review process for all commodities should currently be of 
equivalent depth and rigor. Finally, the commenter concluded that the 
rulemaking process across all of APHIS' activities, not only those 
concerning the importation of fruits and vegetables, must be similarly 
time-consuming and therefore all in need of streamlining so that 
importations of all commodities may be treated equivalently.
    We disagree with the commenter that market access requests for 
fruits and vegetables would be subject to less rigor and interagency 
review under the proposed rule than market access requests for other 
agricultural commodities, live animals, or animal products. As we 
stated previously in this document, we will continue to conduct PRAs, 
and these PRAs will continue to evaluate the potential economic 
consequences of pest introduction associated with the importation of 
the fruit or vegetable.
    We agree with the commenter, however, regarding the need to 
evaluate and, if possible, streamline our processes regarding the 
importation of other agricultural commodities, live animals and animal 
products. Indeed, there is an ongoing APHIS initiative to do precisely 
that. The initiative has yielded a final rule \5\ (83 FR 11845-11867, 
Docket No. APHIS-2008-0011) to restructure our plants for planting 
regulations to make them less cumbersome to change, and we are 
currently evaluating our regulations regarding the importation of live 
animals and animal products to identify how they could potentially be 
streamlined.
---------------------------------------------------------------------------

    \5\ To view the final rule, its supporting documents, or the 
comments that we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2008-0011.
---------------------------------------------------------------------------

    Another commenter said that it is crucial to maintain a review of 
specific varieties of fruits and vegetables in connection with the 
origin of the commodity in order to properly analyze the risks 
associated with exporting the commodity to the United States. The 
commenter stated that each region and crop variety poses different 
risks and should be reviewed separately in order to identify proper 
phytosanitary mitigation measures and receive relevant public comment.
    We agree with the commenter. Our proposal was not to eliminate 
review of specific varieties of fruits and vegetables in connection 
with those varieties' country or region of origin, it was merely to 
remove those specific references from the regulations. We will continue 
our specific reviews following market access requests as we have always 
done and provide the public opportunity to review and comment on the 
documents produced as a result of those reviews. However, the 
requirements for the importation of specific commodities will no longer 
be found in the regulations themselves. The requirements will continue 
to be located in the FAVIR database or APHIS' Hawaii and Puerto Rico/
U.S. Virgin Islands manuals.
    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 elimination of the economic impact analysis is in conflict 
with the WTO mandate, as it will impact APHIS' ability to consider such 
consequences. The commenter concluded that, given the rapid changes to 
global fruit and vegetable production patterns, it is not reasonable 
for APHIS to make a blanket determination that the future economic 
impact of unspecified foreign imports entering the United States will 
always be of little significance.
    We disagree that our actions are in conflict with WTO Article 5. As 
stated previously, we will continue to consider the potential economic 
consequences of pest introduction in the PRAs. This shift to a fully 
notice-based system will not alter that approach.

[[Page 46634]]

Comments on Phytosanitary Security

    One commenter expressed concern regarding the varying capabilities 
of countries seeking to export fruit and vegetables to the United 
States to meet the proposed expanded mitigation measures APHIS may 
recommend. The commenter recommended that APHIS proceed cautiously on 
approving new market access from countries with regulatory agencies 
that have questionable capacity in meeting the scientifically based 
import requirements needed to ensure the phytosanitary security of U.S. 
produce.
    Several commenters noted that the more steps that are included in a 
systems approach, the more chance that exists for error in its 
application. One of the commenters suggested that, therefore, 
particular attention should be paid to the way in which systems 
approaches are designed, executed, and enforced.
    We disagree with the commenters that the number of steps in a 
systems approach is necessarily correlated to the likelihood of error 
in its application. Most mitigation measures that are included in 
systems approaches, such as packinghouse inspections, follow generally 
applicable standard operating procedures that typically do not vary 
significantly from systems approach to systems approach or country to 
country. In our experience, a systems approach that consists solely of 
such routine measures is unlikely to encounter errors in its 
application.
    Rather, in our experience, the likelihood of error in the 
application of mitigation measures most often occurs in those 
relatively rare instances where the application of a mitigation measure 
in the systems approach does vary from country to country or site to 
site, with the chance for error increasing relative to the degree to 
which those measures differ from more routine measures. In such 
instances, to address this possibility for error, we exercise a higher 
degree of APHIS oversight to implement those particular mitigation 
measures. We also are more likely to conduct a follow-up site visit in 
the exporting country to monitor the implementation of the operational 
workplan.
    The same commenter stated that it is impossible to test systems 
approaches designed to address complex pest and disease situations, 
some of which are being used for the first time, until a considerable 
volume of fruits or vegetables are imported under the requirements.
    Many of these systems are already utilized by U.S. domestic 
producers to meet requirements required by our trading partners when 
exporting commodities from the United States. Further, as stated above, 
very few if any of the elements of the systems approaches will be 
novel; their effects are well known to APHIS and backed by years of 
research, knowledge, and experience.
    Another commenter said that part of the reduction in the overall 
timeframe for consideration of import requests comes from the 
elimination of the Office of Management and Budget's (OMB's) ability to 
review APHIS rules. The commenter asked how APHIS will ensure that 
adequate resources are being devoted to mitigation measures in 
exporting countries or that the appropriate standards for approval of 
import requests are being achieved if OMB is precluded from undertaking 
a review of APHIS' actions.
    As stated previously, the standards set by APHIS are phytosanitary 
in nature and, as such, are solely based on sound science. APHIS 
generally reviews its operational workplans and importation agreements 
on a yearly basis to ensure that exporting countries are able to 
continue to meet those requirements. In addition, APHIS will continue 
to apprise OMB of all notice-based import or interstate movement 
actions.

Comments on Stakeholder Engagement

    One commenter stated that the domestic industry must be provided 
sufficient time for review and evaluation of any importation request 
and questioned whether the reduced timeframe afforded by the proposed 
streamlining process would provide adequate time for APHIS to properly 
conduct a pest risk analysis. The commenter also noted the absence of 
OMB review from the streamlined process.
    Another commenter proposed that the expanded notice-based process 
would create a need for increased communication with U.S. stakeholders, 
specifically when those stakeholders are potentially impacted by 
specific commodities imported subject to phytosanitary mitigations. The 
commenter supposed that there would be an increased need for extended 
public comment periods as well as greater opportunity for stakeholders 
to evaluate the risk assessment process, including the data supporting 
inclusion of a given action within the required systems approach.
    Another commenter questioned whether 60 days is sufficient time for 
the industry and other stakeholders to adequately review the science 
behind the PRA and risk mitigation document. The commenter argued that, 
depending upon the time of year that the notice is provided, the 
ability to gather adequate stakeholders with the technical expertise to 
provide useful input on APHIS' documents may be limited. The commenter 
asked whether APHIS intends to formally notify the industry upon 
receipt of a market access request and the beginning of the pest risk 
analysis development process. If not, the commenter wanted to know if 
an extension beyond the 60-day review period will be possible. A second 
commenter stated that stakeholders should be provided opportunities for 
comment and consultation prior to publication of the draft PRA.
    In addition to the draft PRA review period of 30 days, the notices 
would provide for a comment period of at least 60 days, which would 
give interested parties a total of 90 days to review and comment on 
various aspects of the proposed action. While we will not be issuing 
notification when we first receive a market access request, as the pest 
risk analysis development process can be quite lengthy depending on the 
country, the pest situation, and the commodity, the notice-based 
process does not preclude us from extending the comment period when 
necessary. During the comment period for the initial notice, 
stakeholders will have further opportunity to comment on any aspect of 
the PRA they deem necessary. We have no plans to incorporate 
stakeholder review and consultation into the process prior to posting 
the draft PRA. The time savings and regulatory flexibility we 
anticipate as a result of this change will be realized only through 
shortening of the rule development process. We will continue to prepare 
scientific documentation with the same rigor as we have always 
utilized. In addition to the economic considerations required to be 
included in the PRA, APHIS will continue to apprise OMB of all notice-
based import or interstate movement actions. Further, if the 
information that will be disseminated in a pest risk analysis is 
determined to be ``influential'' or ``highly influential'' as those 
terms are used in the Office of Management and Budget's ``Final 
Information Quality Bulletin for Peer Review,'' (see 70 FR 2664-2667, 
published January 14, 2005), then a peer review will be conducted in 
accordance with USDA's peer review guidance (see http://www.ocio.usda.gov/document/usdas-peer-review-guidelines).
    The same commenter requested clarification of the current criteria 
for stakeholder notification in the event that a phytosanitary 
mitigation measure

[[Page 46635]]

is no longer sufficient. The commenter also wanted to know how APHIS 
reaches such a conclusion via evaluation or review of technical data.
    Interception of even one target quarantine pest for a commodity 
(usually those pests rated high or medium risk in the PRA) at a port of 
entry triggers an immediate review of the risk mitigations for that 
commodity. Other factors that may trigger review are an increase in the 
pest population in the exporting country and reports of a new pest in 
the exporting country. The procedures for adding or removing measures 
would be the same regardless of whether or not the fruit or vegetable 
in question was approved prior to the implementation of the proposed 
process.
    Regarding our current process for notifying stakeholders in the 
event that we change the risk mitigations for a certain commodity, we 
issue a Federal Order alerting the general public to the changes in the 
mitigation measures; this Federal Order is issued through the APHIS 
Stakeholder Registry, among other means. Federal Orders constitute 
final agency action under the Administrative Procedure Act and may be 
subject to challenge in court. A Federal Order is usually accompanied 
by a letter to State plant regulatory officials regarding its issuance. 
As soon as possible, we update FAVIR and contact existing permit 
holders regarding the change. If the change in the mitigation structure 
will be permanent in nature, we initiate rulemaking to codify that 
change. The new process will be an initial and final notice regarding 
any permanent change to established mitigations.
    Another commenter wanted to know what the process would be in the 
event that one or more of the designated phytosanitary measures is 
found insufficient to mitigate the phytosanitary risk associated with a 
given commodity or the pest risk analysis requires amendments as a 
result of stakeholder consultation.
    Any necessary changes to the PRA based on stakeholder input would 
be made either at the end of the 30 day comment period specific to the 
PRA (prior to the publication of the initial notice) or following the 
close of the comment period on the initial Federal Register notice. 
Changes to the risk mitigation document would be made following the 
close of the comment period on the initial Federal Register notice. If 
information is provided during that time that leads us to conclude that 
the proposed mitigation measures are insufficient to mitigate the 
phytosanitary risk posed by the pests of concern, we would have the 
option of adding additional requirements to mitigate that risk or not 
finalizing the proposed action. We would notify stakeholders of our 
decision via Federal Register notice as well as other methods such as 
the PPQ Stakeholder Registry. Likewise, if the mitigation measures 
assigned to an already approved fruit or vegetable are found to be no 
longer sufficient, we will take measures appropriate to addressing the 
risk and communicate them through the same channels. In an emergency 
situation a Federal Order may be issued to alter the conditions of 
movement or halt it completely.
    One commenter requested that APHIS provide more opportunity for 
stakeholders to provide input regarding import requests. The commenter 
argued that, in cases where exporting countries are less sophisticated 
in their agricultural practices than the United States, U.S. industry 
expertise would prove vital in designing an effective systems approach.
    We disagree with the commenter's suggestion. If, based on the 
findings of our pest risk analysis, we determine that the fruit or 
vegetable cannot be imported safely, then we would not propose to allow 
for its importation. Our analyses have always included not only the 
efficacy of any required treatments or handling methods, but the 
ability of the exporting country to meet those standards. As stated 
previously, after initial approval for importation, we examine each 
program periodically to ensure that the NPPO and foreign exporters are 
operating according to established standards. The opportunity for 
public input, which is at least 60 days, is ample time in which 
stakeholders may address any concerns, questions, or additional 
necessary information to APHIS.

Comments on Trade Issues

    One commenter expressed concern about a potential trade imbalance 
due to the requirement for cost recovery associated with preclearance 
and verification inspections through trust fund arrangements. The 
commenter stated that this obligation creates high administrative cost 
for U.S. importers and creates an imbalance in relation with trading 
partners, such as the European Union, that do not engage in cost 
recovery for phytosanitary inspections undertaken in the United States.
    APHIS employs trust fund agreements only for countries that operate 
under preclearance programs that require APHIS personnel to be 
stationed in the country. Only a few countries have such programs, and 
the programs themselves pertain only to a few commodities exported to 
the United States from those countries. For these reasons, we believe 
that the commenter overstated the trade imbalances associated with the 
use of trust fund agreements and cost recovery.
    It is worth noting, moreover, that the United States generally does 
not require such programs, but enters into them typically at the 
request of the exporting country or an export group from that country. 
Countries or export groups that request such programs do so based on a 
belief that the time and cost savings associated with preclearance 
inspections, rather than inspection at the port of first arrival into 
the United States, will justify the costs associated with the 
preclearance inspections. In instances where concern has been raised 
about the costs of the preclearance program, APHIS has worked with the 
NPPO to explore ways to minimize those costs.
    Another commenter asked what assurances domestic producers have 
that facilitating our import approval process will prompt a similar 
response from foreign countries. The commenter also noted that a review 
of imports and exports of fruits and vegetables in recent years reveals 
that while imports into the United States continue to grow, exports of 
U.S. fruits and vegetables lag at a considerable pace. The commenter 
stated that this result is in direct opposition to assurances made 
regarding the United States concurrence with the WTO Sanitary and 
Phytosanitary (SPS) Agreement.
    USDA actively and vigorously pursues foreign market access for U.S. 
products. These efforts have yielded a significant increase in U.S. 
exports of agricultural products in recent years; indeed, between 2006 
and 2014, U.S. agricultural exports more than doubled. Under the SPS 
Agreement, signatory countries may set the level of phytosanitary 
protection that they consider appropriate, as long as there is a 
scientific justification. The level of phytosanitary protection often 
has direct bearing on how long it takes to approve a market access 
request. In some instances, USDA has successfully worked with foreign 
governments to set new terms for market access, thereby facilitating 
the import approval process for U.S. products.
    The same commenter asked that APHIS provide the number of staff 
hours currently dedicated to fruit and vegetable importation issues and 
compare that to the number of staff hours that have been dedicated to 
working on new export opportunities for the U.S. fruit and vegetable 
industry.

[[Page 46636]]

    We cannot provide such an accounting given that a number of APHIS 
staff members work on multiple import and export requests 
simultaneously. Without clear benefit to associated with keeping such a 
record, to do so would be time-consuming and overly burdensome. 
Streamlining our administrative processes will allow the agency to 
concentrate its expertise on more complex tasks. As stated previously, 
we also view this rule as a measure for improving the timeliness of our 
action on import requests, and of our emphasis on science as a basis 
for decisionmaking while maintaining the fullest practicable 
opportunity for all interested parties to participate in the process.
    The same commenter stated that APHIS indicated during the December 
webinar that approximately 34 requests for imports into the United 
States have been handled under the notice-based process since its 
inception in 2007. The commenter said that APHIS should provide 
information on how much progress has been made with respect to exports 
from the United States in that time.
    As noted above, U.S. agricultural exports more than doubled between 
2006 and 2014.
    Another commenter observed that during the webinar, APHIS indicated 
that U.S. agricultural export interests would benefit due to future 
reciprocity from trading partners. The commenter said that domestic 
fruit and vegetable exporters currently face plant quarantine barriers 
in foreign markets that appear to have little scientific basis, but 
there is no basis for the assumption that foreign markets will follow 
the U.S. lead in facilitating the importation process for U.S. 
commodities. The commenter inquired if APHIS has undertaken any studies 
to determine whether this claim involving foreign market reciprocity is 
correct or if APHIS has received assurances from trading partners that 
they will provide reciprocal access.
    APHIS has not performed any studies analyzing the trade reciprocity 
factor. As stated previously, we are obligated to follow the principles 
and procedures of the SPS Agreement, including the obligation to base 
our regulations on science. Other signatories of the SPS Agreement are 
obligated to do so as well.

Miscellaneous Changes

    We note that the proposed rule made reference to the fruit and 
vegetables manual PPQ maintained related to the importation of fruits 
and vegetables into the United States. Since the publication of the 
proposed rule, we have expanded the scope and detail of FAVIR, which 
rendered the fruit and vegetables manual unnecessarily duplicative. We 
have therefore discontinued that manual and removed references to it 
from this rule.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with that 
one change.

Executive Orders 12866, 13563, 13771 and Regulatory Flexibility Act

    This final rule has been determined to be significant for the 
purposes of Executive Order 12866 and, therefore, has been reviewed by 
the Office of Management and Budget. APHIS considers this rule to be a 
deregulatory action under Executive Order 13771 as the action will 
allow the public faster access to fruits and vegetables not previously 
approved for importation or movement from Hawaii and U.S. territories. 
This will benefit importers by allowing more timely access to U.S. 
markets. Quicker approval of requests to import fruits and vegetables 
will also benefit consumers. Details are provided in the economic 
analysis prepared for this rule.
    The economic analysis provides a cost-benefit analysis, as required 
by Executive Orders 12866 and 13563, which direct agencies to assess 
all costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and equity). Executive Order 13563 
emphasizes the importance of quantifying both costs and benefits, of 
reducing costs, of harmonizing rules, and of promoting flexibility. The 
economic analysis also provides a final regulatory flexibility analysis 
that examines the potential economic effects of this rule on small 
entities, as required by the Regulatory Flexibility Act. The economic 
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 person listed under FOR 
FURTHER INFORMATION CONTACT.
    Requirements for the importation of fruits and vegetables include 
risk mitigation measures such as treatments, inspections, and 
certifications. A fruit or vegetable is not allowed to be imported 
until APHIS has completed the rulemaking process or the notice-based 
process to approve entry of the fruit or vegetable, based on specific 
phytosanitary measures. This rule will establish a single performance 
standard that, when met, will allow notice-based approval of fruits and 
vegetables for importation into the United States. The region- and 
commodity-specific phytosanitary requirements currently in the 
regulations will be removed and replaced with this single performance 
standard. The rule will also establish an equivalent single performance 
standard that will govern the interstate movement of fruits and 
vegetables from Hawaii and U.S. territories.
    The rule will benefit both APHIS in its operations and U.S. 
businesses and consumers. APHIS will be able to use its resources more 
efficiently and the public will have quicker access to fruits and 
vegetables newly approved for importation or movement from Hawaii and 
U.S. territories.
    APHIS has already established a notice-based process for allowing 
the importation or movement from Hawaii and U.S. territories of certain 
fruits and vegetables, subject to one or more specified phytosanitary 
measures. For fruits and vegetables for which the risks are not 
adequately mitigated by these specified measures and thereby do not 
qualify under the current notice-based process, the rulemaking process 
can range from 18 months to over 3 years. The time needed for approval 
under the notice-based process ranges from 6 to 12 months, that is, 6 
months to 2.5 years sooner.
    Consumers and businesses will benefit from more timely access to 
fruits and vegetables for which entry or movement approval currently 
requires rulemaking. While certain businesses will face increased 
competition at an earlier time for the subject fruits and vegetables, 
if they are produced domestically, overall economic impacts of the rule 
will be positive. The rule will not alter the manner in which the risks 
associated with a fruit or vegetable import or interstate movement 
request are evaluated and mitigated. Principal industries that could be 
affected by the rule, fruit and vegetable farms and fruit and vegetable 
importers, are largely composed of small entities.
    As a measure of the net benefit of the rule to U.S. businesses and 
consumers, we estimate net welfare gains that could have been realized 
for a set of past import actions (11 import rules allowing 8 
commodities from 7 countries or regions, in various combinations) if 
the quicker, notice-based process for acquiring market access had been 
possible. The rules were in preparation or promulgated over the 7 year 
period, 2012 through 2018. The 7 year sum of annual net welfare gains 
is estimated to range from about $13.7 million to $47.5

[[Page 46637]]

million, yielding annual average net welfare gains from these import 
actions of $2.0 million to $6.8 million.
    Net welfare gains that could have been realized under this rule for 
this set of import actions range from about $1 million to $17 million 
(calculated as the low-range annual net welfare gain multiplied by half 
year and the high-range annual net welfare gain multiplied by 2.5 
years). These estimates are derived based on the time period and 
commodities specified, and are considered representative of future 
welfare gains that will be attributable to the rule. Net welfare gains 
actually realized will depend on the particular commodities that 
acquire market access, their source countries, and market conditions at 
that time.
    Interpreting these gains as cost savings accrued by using the 
quicker notice-based process rather than having to wait for rule 
promulgation, and in accordance with guidance on complying with 
Executive Order 13771, the primary cost savings estimate for this rule 
is $562,500. This value is the mid-point estimate of cost savings 
annualized in perpetuity using a 7 percent discount rate.

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.

Executive Order 13175

    This rule has been reviewed in accordance with the requirements of 
Executive Order 13175, ``Consultation and Coordination with Indian 
Tribal Governments.'' Executive Order 13175 requires Federal agencies 
to consult and coordinate with Tribes on a government-to-government 
basis on policies that have tribal implications, including regulations, 
legislative comments or proposed legislation, and other policy 
statements or actions that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes.
    APHIS has assessed the impact of this rule on Indian Tribes and 
determined that this rule does not, to our knowledge, have Tribal 
implications that require tribal consultation under Executive Order 
13175. If a Tribe requests consultation, APHIS will work with the 
Office of Tribal Relations to ensure meaningful consultation is 
provided where changes, additions and modifications identified herein 
are not expressly mandated by Congress.

National Environmental Policy Act

    The majority of the regulatory changes in this document are 
nonsubstantive, and would therefore have no effects on the environment. 
However, this rule will allow APHIS to approve certain new fruits and 
vegetables for importation into the United States without undertaking 
rulemaking. Despite the fact that those fruits and vegetable imports 
will no longer be contingent on the completion of rulemaking, the 
requirements of the National Environmental Policy Act of 1969 (NEPA), 
as amended (42 U.S.C. 4321 et seq.) will still apply. As such, for each 
additional fruit or vegetable approved for importation, APHIS will make 
available to the public documentation related to our analysis of the 
potential environmental effects of such new imports. This documentation 
will likely be made available at the same time and via the same Federal 
Register notice as the risk analysis for the proposed new import.

Paperwork Reduction Act

    In accordance with section 3507 (d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), some of the information collection 
requirements included in this final rule are approved by OMB under 
control number 0579-0346. In addition, on January 29, 2018, APHIS 
published a 60-day notice in the Federal Register (83 FR 4023-4024, 
Docket No. APHIS-2017-0108), to reinstate OMB control number 0579-0049 
which includes burden activities implemented by this rule. In 
accordance with the procedure for reinstating an information 
collection, USDA will be publishing a 30-day notice in the Federal 
Register. Once OMB control number 0579-0049 is approved, as fruits and 
vegetables are approved for importation or interstate movement based on 
this rule, their associated burden activities and burden will be added 
to the information collection via the submission of a quarterly report 
to OMB.

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

7 CFR Part 318

    Cotton, Cottonseeds, Fruits, Guam, Hawaii, Plant diseases and 
pests, Puerto Rico, Quarantine, Transportation, Vegetables, Virgin 
Islands.

7 CFR Part 319

    Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant 
diseases and pests, Quarantine, Reporting and recordkeeping 
requirements, Rice, Vegetables.

    Accordingly, we are amending 7 CFR parts 318 and 319 as follows:

PART 318--STATE OF HAWAII AND TERRITORIES QUARANTINE NOTICES

0
1. The authority citation for part 318 continues to read as follows:

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


Sec.  318.13-2  [Amended]

0
2. Section 318.13-2 is amended by removing the definition for 
``Approved growing media''.

0
3. Section 318.13-4 is revised to read as follows:


Sec.  318.13-4  Authorization of certain fruits and vegetables for 
interstate movement.

    (a) Determination by the Administrator. No fruit or vegetable is 
authorized for interstate movement from Hawaii or the territories 
unless the Administrator has determined that the risk posed by each 
quarantine pest associated with the fruit or vegetable can be 
reasonably mitigated by the application of one or more phytosanitary 
measures designated by the Administrator.
    (b) Designated phytosanitary measures. (1) The fruits and 
vegetables are subject to phytosanitary treatments, which could 
include, but are not limited to, pest control treatments in the field 
or growing site, and post-harvest treatments.
    (2) The fruits and vegetables are subject to growing area pest 
mitigations, which could include, but are not limited to, detection 
surveys, trapping requirements, pest exclusionary structures, and field 
inspections.
    (3) The fruits and vegetables are subject to safeguarding and 
movement mitigations, which could include, but are not limited to, 
safeguarded transport, box labeling, limited

[[Page 46638]]

distribution, insect-proof boxes, and importation as commercial 
consignments only.
    (4) The fruits and vegetables are subject to administrative 
mitigations, which could include, but are not limited to, registered 
fields or orchards, registered growing sites, registered packinghouses, 
inspection in the State of origin by an inspector, and operational 
workplan monitoring.
    (5) The fruits and vegetables are subject to any other measures 
deemed appropriate by the Administrator.
    (c) Authorized fruits and vegetables--(1) Comprehensive list. The 
name and origin of all fruits and vegetables authorized for interstate 
movement under this section, as well as the applicable requirements for 
their movement, may be found on the internet at https://www.aphis.usda.gov/aphis/ourfocus/planthealth/complete-list-of-electronic-manuals.
    (2) Fruits and vegetables authorized for interstate movement prior 
to October 15, 2018. Fruits and vegetables that were authorized for 
interstate movement under this subpart as of October 15, 2018 may 
continue to be moved interstate under the same requirements that 
applied before October 15, 2018, except as provided in paragraph (c)(4) 
of this section.
    (3) Other fruits and vegetables. Fruits and vegetables not already 
authorized for interstate movement as described in paragraph (c)(2) of 
this section may be authorized for interstate movement only after:
    (i) APHIS has analyzed the pest risk posed by the interstate 
movement of a fruit or vegetable and has determined that the risk posed 
by each quarantine pest associated with the fruit or vegetable can be 
reasonably mitigated by the application of one or more phytosanitary 
measures;
    (ii) APHIS has made its pest risk analysis and determination 
available for public comment for at least 60 days through a notice 
published in the Federal Register; and
    (iii) The Administrator has announced his or her decision in a 
subsequent Federal Register notice to begin allowing interstate 
movement of the fruit or vegetable subject to the phytosanitary 
measures specified in the notice.
    (4) Changes to phytosanitary measures. (i) If the Administrator 
determines that the phytosanitary measures required for a fruit or 
vegetable that has been authorized interstate movement under this 
subpart are no longer sufficient to reasonably mitigate the pest risk 
posed by the fruit or vegetable, APHIS will prohibit or further 
restrict interstate movement of the fruit or vegetable. APHIS will also 
publish a notice in the Federal Register advising the public of its 
finding. The notice will specify the amended interstate movement 
requirements, provide an effective date for the change, and invite 
public comment on the subject.
    (ii) If the Administrator determines that any of the phytosanitary 
measures required for a fruit or vegetable that has been authorized 
interstate movement under this subpart are no longer necessary to 
reasonably mitigate the pest risk posed by the fruit or vegetable, 
APHIS will make new pest risk documentation available for public 
comment, in accordance with paragraph (c)(3) of this section, prior to 
allowing interstate movement of the fruit or vegetable subject to the 
phytosanitary measures specified in the notice.

(Approved by the Office of Management and Budget under control 
number 0579-0346)


Sec.  318.13-13  [Amended]

0
4. Section 318.13-13 is amended by removing the last sentence.


Sec.  318.13-16  [Removed]

0
5. Section 318.13-16 is removed.


Sec.  318.13-17   [Redesignated as Sec.  318.13-16]

0
6. Section 318.13-17 is redesignated as Sec.  318.13-16.


Sec.  318.13-16  [Amended]

0
7. In newly redesignated Sec.  318.13-16, paragraph (a)(1) is amended 
by removing the word ``under'' and adding the words ``in accordance 
with'' in its place.


Sec. Sec.  318.13-18 through 318.13-22  [Removed]

0
8. Sections 318.13-18 through 318.13-22 are removed.


Sec.  318.13-23  [Redesignated as Sec.  318.13-17]

0
9. Section 318.13-23 is redesignated as Sec.  318.13-17.


Sec. Sec.  318.13-24 through 318.13-26  [Removed]

0
10. Sections 318.13-24 through Sec.  318.13-26 are removed.

PART 319--FOREIGN QUARANTINE NOTICES

0
11. The authority citation for part 319 continues to read as follows:

    Authority:  7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 
136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

Subpart--Citrus Fruit [Removed]

0
12. Subpart--Citrus Fruit, consisting of Sec.  319.28, is removed.


Sec.  319.56-2   [Amended]

0
13. Section 319.56-2 is amended by removing the definitions for ``Above 
ground parts,'' ``Cucurbits'', ``Field'', ``Place of production'', 
``Production site'', and ``West Indies''.

0
14. Section 319.56-4 is revised to read as follows:


Sec.  319.56-4   Authorization of certain fruits and vegetables for 
importation.

    (a) Determination by the Administrator. No fruit or vegetable is 
authorized importation into the United States unless the Administrator 
has determined that the risk posed by each quarantine pest associated 
with the fruit or vegetable can be reasonably mitigated by the 
application of one or more phytosanitary measures designated by the 
Administrator and the fruit or vegetable is imported into the United 
States in accordance with, and as stipulated in, the permit issued by 
the Administrator.
    (b) Designated phytosanitary measures. (1) The fruits and 
vegetables are subject to phytosanitary treatments, which could 
include, but are not limited to, pest control treatments in the field 
or growing site, and post-harvest treatments.
    (2) The fruits and vegetables are subject to growing area pest 
mitigations, which could include, but are not limited to detection 
surveys, trapping requirements, pest exclusionary structures, and field 
inspections.
    (3) The fruits and vegetables are subject to safeguarding and 
movement mitigations, which could include, but are not limited to, 
safeguarded transport, box labeling, limited distribution, insect-proof 
boxes, and importation as commercial consignments only.
    (4) The fruits and vegetables are subject to administrative 
mitigations, which could include, but are not limited to, registered 
fields or orchards, registered growing sites, registered packinghouses, 
inspection in the country of origin by an inspector or an official of 
the national plant protection organization of the exporting country, 
and operational workplan monitoring.
    (5) The fruits and vegetables are subject to any other measures 
deemed appropriate by the Administrator.
    (c) Authorized fruits and vegetables--(1) Comprehensive list. The 
name and origin of all fruits and vegetables authorized importation 
under this section, as well as the applicable

[[Page 46639]]

requirements for their importation, may be found on the internet at 
https://epermits.aphis.usda.gov/manual.
    (2) Fruits and vegetables authorized importation prior to October 
15, 2018. Fruits and vegetables that were authorized importation under 
this subpart either directly by permit or by specific regulation as of 
October 15, 2018 may continue to be imported into the United States 
under the same requirements that applied before October 15, 2018, 
except as provided in paragraph (c)(4) of this section.
    (3) Other fruits and vegetables. Fruits and vegetables not already 
authorized for importation as described in paragraph (c)(2) of this 
section may be authorized importation only after:
    (i) APHIS has analyzed the pest risk posed by the importation of a 
fruit or vegetable from a specified foreign region and has determined 
that the risk posed by each quarantine pest associated with the fruit 
or vegetable can be reasonably mitigated by the application of one or 
more phytosanitary measures;
    (ii) APHIS has made its pest risk analysis and determination 
available for public comment for at least 60 days through a notice 
published in the Federal Register; and
    (iii) The Administrator has announced his or her decision in a 
subsequent Federal Register notice to authorize the importation of the 
fruit or vegetable subject to the phytosanitary measures specified in 
the notice.
    (4) Changes to phytosanitary measures. (i) If the Administrator 
determines that the phytosanitary measures required for a fruit or 
vegetable that has been authorized importation under this subpart are 
no longer sufficient to reasonably mitigate the pest risk posed by the 
fruit or vegetable, APHIS will prohibit or further restrict importation 
of the fruit or vegetable. APHIS will also publish a notice in the 
Federal Register advising the public of its finding. The notice will 
specify the amended importation requirements, provide an effective date 
for the change, and will invite public comment on the subject.
    (ii) If the Administrator determines that any of the phytosanitary 
measures required for a fruit or vegetable that has been authorized 
importation under this subpart are no longer necessary to reasonably 
mitigate the pest risk posed by the fruit or vegetable, APHIS will make 
new pest risk documentation available for public comment, in accordance 
with paragraph (c)(3) of this section, prior to allowing importation of 
the fruit or vegetable subject to the phytosanitary measures specified 
in the notice.

(Approved by the Office of Management and Budget under control 
number 0579-0049)


Sec. Sec.  319.56-13 through 319.56-83   [Removed]

0
15. Sections 319.56-13 through 319.56-83 are removed.

    Done in Washington, DC, this 10th day of September 2018.
Greg Ibach,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 2018-19984 Filed 9-13-18; 8:45 am]
 BILLING CODE 3410-34-P