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.

Rules and Regulations Federal Register

46627 

Vol. 83, No. 179 

Friday, September 14, 2018 

1Pest 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. 

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. 

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 Roma ́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. 

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 § 319.56–4(b) of the fruits and 

vegetables regulations or § 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 


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46628 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Rules and Regulations 

2 You may search FAVIR at http://

www.aphis.usda.gov/favir/. 

3To view the proposed rule and the comments 

we received, go to http://www.regulations.gov/ 

#!docketDetail;D=APHIS-2010-0082. 

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: 

• 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. 

• 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 noticebased 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. 

On September 9, 2014, we published 

in the Federal Register (79 FR 53346– 

53352, Docket No. APHIS–2010–0082) a 

proposal3 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 §§ 319.56–13, 319.56–20 

through 319.56–70, 318.13–16, and 

318.13–20 through 318.13–26. Since 

that time, § 319.56–71 through § 319.56– 

83 have been added to the regulations. 

This rule will remove those commodityspecific sections as well. 

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 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Rules and Regulations 46629 

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-streamliningquestions-answers/!ut/p/a0/04_Sj9CPykssy0x

PLMnMz0vMAfGjzOK9_D2MDJ0MjDzd3V2dDDz93

HwCzL29jAx8TfULsh0VAY_1WkE!/. 

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. 

General Comments 

Several commenters stated that the 

proposed rule did not make clear which 

administrative review steps would be 

eliminated if APHIS adopted a noticebased process. 

Since notices are not considered 

rulemaking documents, we anticipate 

that the primary administrative timesavings 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 noticebased 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 


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46630 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Rules and Regulations 

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 noticebased 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 commodityspecific 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 noticebased 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 noticebased 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 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Rules and Regulations 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 noticebased 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 § 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 


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46632 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Rules and Regulations 

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 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Rules and Regulations 46633 

5To view the final rule, its supporting 

documents, or the comments that we received, go 

to http://www.regulations.gov/#!docketDetail;

D=APHIS-2008-0011. 

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. 

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. 


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46634 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Rules and Regulations 

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/usdaspeer-review-guidelines). 

The same commenter requested 

clarification of the current criteria for 

stakeholder notification in the event 

that a phytosanitary mitigation measure 


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


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46636 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Rules and Regulations 

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 


daltland on DSKBBV9HB2PROD with RULES
Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Rules and Regulations 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 highrange 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 midpoint 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 

■ 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. 

§ 318.13–2 [Amended] 

■ 2. Section 318.13–2 is amended by 

removing the definition for ‘‘Approved 

growing media’’. 

■ 3. Section 318.13–4 is revised to read 

as follows: 

§ 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 


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46638 Federal Register / Vol. 83, No. 179 / Friday, September 14, 2018 / Rules and Regulations 

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/completelist-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) 

§ 318.13–13 [Amended] 

■ 4. Section 318.13–13 is amended by 

removing the last sentence. 

§ 318.13–16 [Removed] 

■ 5. Section 318.13–16 is removed. 

§ 318.13–17 [Redesignated as § 318.13–16] 

■ 6. Section 318.13–17 is redesignated 

as § 318.13–16. 

§ 318.13–16 [Amended] 

■ 7. In newly redesignated § 318.13–16, 

paragraph (a)(1) is amended by 

removing the word ‘‘under’’ and adding 

the words ‘‘in accordance with’’ in its 

place. 

§§ 318.13–18 through 318.13–22 

[Removed] 

■ 8. Sections 318.13–18 through 

318.13–22 are removed. 

§ 318.13–23 [Redesignated as § 318.13–17] 

■ 9. Section 318.13–23 is redesignated 

as § 318.13–17. 

§§ 318.13–24 through 318.13–26 

[Removed] 

■ 10. Sections 318.13–24 through 

§ 318.13–26 are removed. 

PART 319—FOREIGN QUARANTINE 

NOTICES 

■ 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] 

■ 12. Subpart—Citrus Fruit, consisting 

of § 319.28, is removed. 

§ 319.56–2 [Amended] 

■ 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’’. 

■ 14. Section 319.56–4 is revised to read 

as follows: 

§ 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 


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

§§ 319.56–13 through 319.56–83 

[Removed] 

■ 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 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2018–0328; Airspace 

Docket No. 18–ASO–7] 

RIN 2120–AA66 

Amendment of Class D Airspace and 

Class E Airspace, and Revocation of 

Class E Airspace: New Smyrna Beach, 

FL 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Final rule, correction. 

SUMMARY: This action corrects a final 

rule published in the Federal Register 

on August 23, 2018, amending Class D 

airspace and Class E airspace extending 

upward from 700 feet or more above the 

surface at New Smyrna Beach 

Municipal Airport, New Smyrna Beach, 

FL. The longitude coordinate symbols 

for Massey Ranch Airpark listed in Class 

E airspace areas extending upward from 

700 feet were typed as degrees, minutes, 

minutes instead of degrees, minutes, 

and seconds. Also, a parenthesis was 

excluded from the airport’s geographic 

coordinates. 

DATES: Effective 0901 UTC, November 8, 

2018. The Director of the Federal 

Register approves this incorporation by 

reference action under title 1, Code of 

Federal Regulations, part 51, subject to 

the annual revision of FAA Order 

7400.11 and publication of conforming 

amendments. 

FOR FURTHER INFORMATION CONTACT: John 

Fornito, Operations Support Group, 

Eastern Service Center, Federal Aviation 

Administration, 1701 Columbia Av., 

College Park, GA 30337; telephone (404) 

305–6364. 

SUPPLEMENTARY INFORMATION:

History 

The FAA published a final rule in the 

Federal Register (83 FR 42585, August 

23, 2018) for Doc. No. FAA–2018–0328, 

amending Class D airspace, and Class E 

airspace extending upward from 700 

feet or more above the surface at New 

Smyrna Beach Municipal Airport, New 

Smyrna Beach, FL. Subsequent to 

publication, the FAA found that the 

symbols of the longitude coordinate for 

Massey Ranch Airpark, listed in the 

description under Class E airspace 

extending upward from 700 feet or more 

above the surface, was printed 

incorrectly. Also, a parenthesis was 

omitted from the geographic coordinates 

of New Smyrna Beach Municipal 

Airport. This action corrects these 

errors. 

Class D and E airspace designations 

are published in paragraphs 5000 and 

6005, respectively, of FAA Order 

7400.11B dated August 3, 2017, and 

effective September 15, 2017, which is 

incorporated by reference in 14 CFR 

part 71.1. The E airspace designations 

listed in this document will be 

published subsequently in the Order. 

Correction to Final Rule 

Accordingly, pursuant to the 

authority delegated to me, in the 

Federal Register of August 23, 2018 (83 

FR 42585) FR Doc. 2018–18035, 

Amendment of D Airspace and Class E 

Airspace, and Revocation of Class E 

Airspace; New Smyrna Beach, FL, is 

corrected as follows: 

§ 71.1 [Amended] 

ASO FL E5 New Smyrna Beach, FL 

[Corrected] 

■ On page 42586, column 3 line 53, 

remove Lat. 29°03′21′′ N, long. 80°56′56′′ 

W) and add in its place (Lat. 29°03′21′′ 

N, long. 80°56′56′′ W). 

■ On page 42586, column 3 line 55, 

remove (Lat. 28°58′44′′ N, long. 

80°55′29′ W) and add in its place (Lat. 

28°58′44′′ N, long. 80°55′29′′ W) 

Issued in College Park, Georgia, on 

September 6, 2018. 

Ken Brissenden, 

Acting Manager, Operations Support Group, 

Eastern Service Center, Air Traffic 

Organization. 

[FR Doc. 2018–19978 Filed 9–13–18; 8:45 am] 

BILLING CODE 4910–13–P 

FEDERAL TRADE COMMISSION 

RIN 3084–AA98 

16 CFR Part 310 

Telemarketing Sales Rule Fees 

AGENCY: Federal Trade Commission. 

ACTION: Final rule. 


daltland on DSKBBV9HB2PROD with RULES