This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

53346 

Vol. 79, No. 174 

Tuesday, September 9, 2014 

1 You may search FAVIR at http://

www.aphis.usda.gov/favir/. 

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: Proposed rule. 

SUMMARY: We are proposing to amend 

our regulations governing the 

importations 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 

proposing to remove the region- or 

commodity-specific phytosanitary 

requirements currently found in these 

regulations. Likewise, we are proposing 

an equivalent revision of the 

performance standard in our regulations 

governing the interstate movements of 

fruits and vegetables from Hawaii and 

the U.S. territories (Guam, Northern 

Mariana Islands, Puerto Rico, and the 

U.S. Virgin Islands) and the removal of 

commodity-specific phytosanitary 

requirements from those regulations. 

This proposal would 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 

would not however, alter the sciencebased 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: We will consider all comments 

that we receive on or before November 

10, 2014. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/

#!docketDetail;D=APHIS–2010–0082. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2010–0082, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road Unit 118, 

Riverdale, MD 20737–1238. 

Supporting documents and any 

comments we receive on this docket 

may be viewed at http://

www.regulations.gov/

#!docketDetail;D=APHIS–2010–0082 or 

in our reading room, which is located in 

room 1141 of the USDA South Building, 

14th Street and Independence Avenue 

SW., Washington, DC. Normal reading 

room hours are 8 a.m. to 4:30 p.m., 

Monday through Friday, except 

holidays. To be sure someone is there to 

help you, please call (202) 799–7039 

before coming. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Nicole L. Russo, Assistant Director, 

Regulatory Coordination and 

Compliance, PPQ, APHIS, 4700 River 

Road Unit 133, Riverdale, MD 20737– 

1231; (301) 851–2159. 

SUPPLEMENTARY INFORMATION: 

Background 

Foreign Quarantine Notices 

Under the regulations in ‘‘Subpart— 

Fruits and Vegetables’’ (7 CFR 319.56– 

1 through 319.56–70, 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. 

In a final rule published in the 

Federal Register on July 18, 2007 (72 FR 

39482–39528, Docket No. APHIS–2005– 

0106), and effective on August 17, 2007, 

we established a process by which we 

allow certain fruits and vegetables to be 

approved for importation. That rule 

established a notice-based process for 

approving the importation of fruits or 

vegetables that, based on the findings of 

a pest risk analysis, can be safely 

imported subject to one or more of the 

designated phytosanitary measures 

listed in § 319.56–4(b) of the 

regulations. These measures, which are 

referred to elsewhere in this document 

as designated phytosanitary measures or 

designated phytosanitary measures of 

the fruits and vegetables regulations, 

are: 

• The fruits or vegetables are subject 

to inspection upon arrival in the United 

States and comply with all applicable 

provisions of § 319.56–3; 

• The fruits or vegetables are 

imported from a pest-free area in the 

country of origin that meets the 

requirements of § 319.56–5 for freedom 

from that pest and are accompanied by 

a phytosanitary certificate stating that 

the fruits or vegetables originated in a 

pest-free area in the country of origin; 

• The fruits or vegetables are treated 

in accordance with 7 CFR part 305; 

• The fruits or vegetables are 

inspected in the country of origin by an 

inspector or an official of the national 

plant protection organization (NPPO) of 

the exporting country, and have been 

found free of one or more specific 

quarantine pests identified by the risk 

analysis as likely to follow the import 

pathway; and/or 

• The fruits or vegetables are 

imported as commercial consignments 

only. 

Under the notice-based process, 

amendments to the regulations are not 

needed, as approval of fruits and 

vegetables for importation from various 

countries or regions is accomplished via 

the publication of notices in the Federal 

Register (this practice is described in 

detail below under the heading ‘‘Current 

Processes’’). To list approved 

commodities and the requirements for 

their importation, APHIS’s Plant 

Protection and Quarantine (PPQ) 

program developed the Fruits and 

Vegetables Import Requirements 

(FAVIR) database, which is accessible 

via the APHIS Web site.1 FAVIR 

includes not only those commodities 

approved using the notice-based 

process, but also commodities approved 

through rulemaking. FAVIR allows 

individuals to search for authorized 

fruits and vegetables by commodity or 


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Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Proposed Rules 53347 

country, and quickly and easily 

determine the requirements for their 

importation into the United States. In 

addition, FAVIR allows APHIS officials 

and the Department of Homeland 

Security’s Customs and Border 

Protection agricultural inspectors to 

quickly determine whether or not a fruit 

or vegetable is authorized entry into the 

United States. Approved commodities 

are also listed in PPQ’s Fresh Fruits and 

Vegetables Import Manual and will 

continue to be so listed. 

Hawaii and Territories Quarantine 

Notices 

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. 

In a final rule published in the 

Federal Register on January 16, 2009 

(74 FR 2770–2786, Docket No. APHIS– 

2007–0052), we revised those 

regulations in order to establish a 

regulatory approach that is similar but 

not identical to that in the fruits and 

vegetables regulations discussed above. 

That final rule established a noticebased process for approving the 

interstate movement of fruits or 

vegetables from Hawaii and the 

territories that, based on the findings of 

a pest risk analysis, can be safely moved 

interstate subject to one or more of the 

designated phytosanitary measures 

listed in § 318.13–4(b) of the 

regulations. These measures, which are 

referred to elsewhere in this document 

as designated phytosanitary measures or 

designated phytosanitary measures of 

the Hawaii and territories regulations, 

are: 

• The fruits and vegetables are 

inspected in the State of origin or in the 

first State of arrival; 

• The fruits and vegetables originated 

from a pest-free area in the State of 

origin and the grower from which the 

fruit or vegetable originated has entered 

into a compliance agreement with the 

Administrator; 

• The fruits and vegetables are treated 

in accordance with 7 CFR part 305 and 

the treatment is certified by an 

inspector; 

• The fruits and vegetables are 

inspected and certified in the State of 

origin by an inspector and have been 

found free of one or more specific 

quarantine pests identified by risk 

analysis as likely to follow the pathway; 

• The fruits and vegetables are moved 

as commercial consignments only; and/ 

or 

• The fruits and vegetables may be 

distributed only within a defined area 

and the boxes or containers in which 

the fruits or vegetables are distributed 

must be marked to indicate the 

applicable distribution restrictions. 

Commodity-Specific Requirements 

The notice-based approach described 

above for imports and for interstate 

movement from Hawaii and the 

territories allows us to maintain our 

science- and risk-based evaluation 

process and shorten the administrative 

process involved in approval of new 

fruits and vegetables, while continuing 

to provide opportunity for public 

comment and engagement on the 

science- and risk-based analysis 

associated with such imports and 

interstate movements. It also enables us 

to adapt our import requirements more 

quickly in the event of any changes to 

a country’s pest or disease status or as 

a result of new scientific information or 

treatment options. One example of this 

adaptability may be found in a notice 

entitled ‘‘Importation of Garlic From the 

European Union and Other Countries 

Into the Continental United States,’’ 

which was published in the Federal 

Register on March 21, 2011 (76 FR 

15279–15280, Docket No. APHIS–2011– 

0015). Prior to the publication of that 

notice, the importation of garlic from 

these countries was approved only if 

consignments were first treated using 

vacuum fumigation with methyl 

bromide. Based on the conclusions of a 

commodity import evaluation 

document, we were able to determine 

that application of one or more of the 

designated phytosanitary measures 

would sufficiently mitigate the pest risk 

and that the use of methyl bromide was 

no longer necessary. Under the noticebased approach, APHIS was able to 

address this issue within 5 months, 

while, on average, it takes us 18 months 

using the traditional rulemaking 

process. 

Both the fruits and vegetables 

regulations and the Hawaii and 

territories regulations continue to list 

certain fruits and vegetables for which 

additional phytosanitary measures are 

needed beyond one or more of those 

designated phytosanitary measures cited 

in the regulations. Additional 

phytosanitary measures may include 

requirements such as limitations on the 

distribution of the fruits and vegetables 

and box marking of fruit or vegetable 

consignments. Certain other fruits and 

vegetables must meet combinations of 

requirements (in some cases, called 

‘‘systems approaches’’) to be eligible for 

importation into or interstate movement 

within the United States. Such measures 

include sampling regimens, pest 

surveys, packing requirements, and 

other measures determined to be 

necessary to mitigate the pest risk posed 

by the particular fruit or vegetable. 

These fruits or vegetables and their 

importation or interstate movement 

requirements are listed in §§ 319.56–20 

through 319.56–70 of the fruits and 

vegetables regulations and §§ 318.13–20 

through 318.13–26 of the Hawaii and 

territories regulations, respectively. 

These commodity-specific 

requirements are similar to the 

designated phytosanitary measures of 

the fruits and vegetables regulations and 

the Hawaii and territories regulations in 

that both the requirements listed in the 

regulations and those imposed through 

the notice-based process are established 

by APHIS using the same rigorous 

science- and risk-based approach, which 

begins with the development of the pest 

risk analysis. 

Current Processes 

Using 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 

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, 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, to identify 

phytosanitary measures that could be 

applied to the fruit or vegetable and 

evaluate the potential effectiveness of 

those measures. When the pest risk 

assessment is complete, if quarantine 

pests are associated with the fruit or 

vegetable in the country, State, or other 


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2Pest 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. 

region of origin,2 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 a 

risk management document 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 

requirements, the findings are 

communicated using 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. 

Under the notice-based process, 

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 

measures described earlier in this 

document 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 

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 FAVIR, in the case of 

imported fruits and vegetables, as well 

as the appropriate fruits and vegetables 

manual, in the case of both fruits and 

vegetables that are imported and those 

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, reevaluate shipments of the fruit or 

vegetable in question from that country 

or State. 

Proposed Revisions 

The 2007 final rule concerning 

imports and the 2009 final rule 

concerning interstate movement from 

Hawaii and the territories streamlined 

the authorization process for those fruits 

or vegetables whose phytosanitary 

requirements consisted of measures that 

were used most frequently. The noticebased processes established by those 

rules are as transparent and accessible 

to our stakeholders and other interested 

parties as the rulemaking process, while 

providing APHIS with the ability to 

make more responsive decisions on 

import issues and by reducing the time 

involved in approving the commodity 

for importation or interstate movement. 

For a number of reasons, which are 

explained below, we are proposing to 

expand the use of the notice-based 

process to all decisions related to the 

importation and interstate movement of 

new fruits and vegetables. We are also 

proposing to remove the remaining 

region- or commodity-specific 

phytosanitary requirements currently 

found in §§ 319.56–20 through 319.56– 

70, 318.13–16, and 318.13–20 through 

318.13–26. As stated previously, those 

requirements would continue to be 

listed in FAVIR. 

Under this proposal, the unique 

requirements currently found in 

§§ 319.56–20 through 319.56–70 would 

be replaced by the designated 

phytosanitary measures listed in 

§ 319.56–4(b) of the regulations. 


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Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Proposed Rules 53349 

3To view the rule go to http://

www.regulations.gov/#!docketDetail;D=APHIS2010-0127. 

4 You may sign up for PPQ’s Stakeholder Registry 

at https://public.govdelivery.com/accounts/

USDAAPHIS/subscriber/new. 

Similarly, we would remove the specific 

requirements in §§ 318.13–20 through 

318.13–26 and replace them with the 

designated phytosanitary measures 

listed in § 318.13–4(b) of the 

regulations. We are also proposing to 

expand the categories of designated 

phytosanitary measures from those 

measures listed previously, which 

would be found in new § 319.56–4(b)(1) 

through 319.56–4(b)(5) and 318.13– 

4(b)(1) through 318.13–4(b)(5) of the 

regulations. These measures would 

stipulate that fruits and vegetables may 

be imported or moved from Hawaii and 

the territories subject to one or more of 

the following: 

• Phytosanitary treatments, which 

could include, but are not limited to, 

pest control treatments in the field or 

growing site, and post-harvest 

treatments; 

• Growing area pest mitigations, 

which could include, but are not limited 

to detection surveys, trapping 

requirements, pest exclusionary 

structures, and field inspections; 

• 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; 

• 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; and 

• Any other measures that the 

Administrator determines are 

appropriate. 

We are also proposing that, in the 

event that the Administrator determines 

that the phytosanitary measures 

required for a fruit or vegetable that has 

been previously authorized for 

importation are no longer sufficient to 

mitigate the pest risk posed by the fruit 

or vegetable, and the Administrator 

must take emergency action to protect 

U.S. agriculture, we will prohibit or 

further restrict importation of the fruit 

or vegetable in accordance with our 

existing standard emergency procedures 

and importation restriction at the port of 

entry. We would also publish a notice 

in the Federal Register advising the 

public of our findings, specifying any 

amended import requirements, 

providing an effective date for the 

change, and inviting public comment on 

the subject. In the event that the 

Administrator determines that any of 

the phytosanitary measures required for 

a fruit or vegetable that has been 

previously authorized for importation 

are no longer necessary to mitigate pest 

risk, we would make pest risk 

documentation available for comment 

prior to issuing any revised permits. 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. 

Using a notice-based process provides 

several advantages over codifying 

import requirements in the regulations. 

The plant health import regulatory 

system is based on a highly complex 

and evolving body of scientific 

information. For example, a single 

approved commodity may require 

several mitigations to address the risk 

posed by one pest or may require one 

mitigation to address several pests. 

Some imported fruits and vegetables are 

subject to a dozen or more distinct 

conditions of entry, and even a minor 

change to one of those conditions 

requires rulemaking if those conditions 

are listed in our regulations. New 

information about pests that affect 

imports is constantly becoming 

available, and changes must therefore be 

made frequently to existing import 

protocols. Listing requirements in the 

regulations can impede timely and 

effective decisionmaking, and in some 

cases, has costs to the regulated public. 

For example, new information recently 

became available which led APHIS to 

conclude that Hass avocados, under 

certain conditions, are not a host for 

Mediterranean fruit fly (Medfly), as was 

previously believed. The regulations for 

importing Hass avocados from countries 

where Medfly is present had previously 

required a treatment, which APHIS 

concluded was no longer necessary. 

Similarly, the interstate movement of 

avocados from areas quarantined for 

Medfly was also prohibited unless the 

avocados were treated.3 To relieve these 

restrictions, which were codified in our 

regulations, rulemaking was required. 

Having import requirements codified in 

the regulations prevents us from quickly 

and transparently updating import 

requirements if a pest expands its 

distribution to a country, territory, or 

area approved to export hosts of that 

pest that was not previously regulated 

for that pest, or when APHIS needs to 

eliminate import restrictions pertaining 

to a given pest because, for example, the 

pest now exists in the United States and 

is not under official control. We believe 

that such revisions can and should be 

made more efficiently and effectively, 

with equivalent transparency and public 

engagement and with the same scientific 

rigor. 

Many of our domestic program 

regulations are designed and effectively 

administered to provide the flexibility 

to adjust promptly to changing 

phytosanitary information. For example, 

under the regulations concerning 

emerald ash borer (EAB), which may be 

found in 7 CFR 301.53–1 through 

301.53–9, regulated articles may move 

interstate from quarantined areas if 

certain performance-based criteria are 

met. Specifically, the EAB regulations in 

§ 301.53–5 allow articles regulated for 

EAB to move interstate if they are 

certified by an inspector or person 

operating under a compliance 

agreement to have been grown, 

produced, manufactured, stored, or 

handled in a manner that, in the 

judgment of the inspector, prevents the 

regulated article from presenting a risk 

of spreading EAB. The precise 

requirements for interstate movement of 

various types of articles are not listed in 

the regulations, but rather are spelled 

out in the associated compliance 

agreements. We believe the EAB 

regulations provide an effective 

regulatory process. 

Using a notice-based approach allows 

for prompt communication with the 

public as well as reduced administrative 

burden, while carrying out the same 

rigorous risk analysis process we use to 

support decisions made via rulemaking. 

The notice-based process also allows us 

to enforce phytosanitary requirements 

in permits in the same manner as is 

used to enforce requirements codified in 

the regulations. 

The process for developing pest risk 

assessments and determining mitigation 

measures (as detailed above under the 

heading ‘‘Current Processes’’) would 

remain the same, giving the public 

opportunity to review, evaluate, and 

comment. In addition, in order to 

further engage the public in the 

decisionmaking process, as well as to 

increase the transparency of our 

regulatory approach, PPQ has 

established a process that makes the 

draft risk assessments or pest lists 

available for review by stakeholders 

upon their completion and prior to 

being made available formally through a 

Federal Register notice. PPQ also 

maintains a Stakeholder Registry on the 

Internet 4 that allows anyone to register 


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53350 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Proposed Rules 

5The PPQ Fresh Fruits and Vegetables Import 

Manual may be found on the Internet at http://

www.aphis.usda.gov/import_export/plants/

manuals/ports/downloads/fv.pdf. 

6Currently, APHIS does not maintain fruits and 

vegetables manuals for Commonwealth of the 

Northern Mariana Islands (CNMI) and Guam 

because there are no regulated articles being moved 

from those areas. If it becomes necessary to 

maintain a list of fruits and vegetables from CNMI 

or Guam, APHIS would list such information on its 

Web site at http://www.aphis.usda.gov/import_

export/plants/manuals/online_manuals.shtml. 

7The Puerto Rico and the U.S. Virgin Islands 

fruits and vegetables manual may be found on the 

Internet at http://www.aphis.usda.gov/import_

export/plants/manuals/ports/downloads/puerto_

rico.pdf. The Hawaii fruits and vegetables manual 

may be found on the Internet at http://

www.aphis.usda.gov/import_export/plants/

manuals/ports/downloads/hawaii.pdf. 

to receive information on a specified 

area of interest. 

As indicated earlier, if this proposed 

process is adopted for use by APHIS, we 

would remove all commodity-specific 

requirements from both the fruits and 

vegetables regulations and the Hawaii 

and territories regulations. Fruits or 

vegetables approved for import under 

this approach would be listed in FAVIR, 

which is available on the APHIS Web 

site, as well as in PPQ’s Fresh Fruits and 

Vegetables Import Manual, which is 

available for viewing and download on 

APHIS’s Web site.5 Similarly, approved 

fruits and vegetables from Hawaii and 

the territories and their corresponding 

movement requirements would be listed 

in APHIS’s Hawaii and Puerto Rico/U.S. 

Virgin Islands fruits and vegetables 

manuals,6 which are available for 

download on APHIS’s Web site.7 Fruits 

or vegetables approved prior to the 

institution of the proposed process 

would continue to be allowed to be 

imported under the same requirements 

under which they were approved. 

Definitions 

As a result of the changes we are 

proposing to the Hawaii and territories 

regulations and the fruits and vegetables 

regulations, a number of the definitions 

currently found in §§ 318.13–2 and 

319.56–2 would no longer be necessary 

because the terms would no longer be 

used in the regulations in those 

subparts. We are therefore proposing to 

remove the definitions for approved 

growing media from the regulations in 

§ 318.13–2 and the definitions for above 

ground parts, cucurbits, field, place of 

production, production site, and West 

Indies from the regulations in § 319.56– 

2. 

Frozen Fruits and Vegetables 

The regulations in § 318.13–13 

concern requirements for the movement 

of frozen fruits and vegetables from 

Hawaii and the territories into or 

through any other territory, State, or 

District of the United States. We are 

proposing to remove the last sentence of 

that section because it contains a 

reference to the regulations in 7 CFR 

305.17, which no longer exist due to a 

prior change to that section. 

Citrus Fruit 

We are also proposing to remove 

Subpart—Citrus Fruit from the 

regulations. This subpart, consisting of 

§ 319.28, imposes specific requirements 

on a certain type of fruit. Given that we 

are proposing to remove other specific 

requirements from the regulations, 

removal of the citrus fruit subpart 

would be consistent with those actions. 

The specific requirements would 

continue to apply and would be listed 

in the FAVIR database and PPQ’s Fresh 

Fruits and Vegetables Import Manual. 

Executive Orders 12866 and 13563 and 

Regulatory Flexibility Act 

This proposed 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. 

We have prepared an economic 

analysis 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 an 

initial 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 by contacting the person listed 

under FOR FURTHER INFORMATION

CONTACT or on the Regulations.gov Web 

site (see ADDRESSES above for 

instructions for accessing 

Regulations.gov). 

Based on the information we have, 

there is no reason to conclude that 

adoption of this proposed rule would 

result in any significant economic effect 

on a substantial number of small 

entities. However, we do not currently 

have all of the data necessary for a 

comprehensive analysis of the effects of 

this proposed rule on small entities. 

Therefore, we are inviting comments on 

potential effects. In particular, we are 

interested in determining the number 

and kind of small entities that may 

incur benefits or costs from the 

implementation of this proposed rule. 

The proposed rule would benefit both 

APHIS in its operations and U.S. 

businesses and consumers. APHIS 

would be able to use its resources more 

efficiently and the public would have 

more timely access to many of the fruits 

and vegetables for which importation or 

movement from Hawaii and the U.S. 

territories has yet to be approved. 

APHIS has already established a 

notice-based process for allowing the 

importation or movement from Hawaii 

and the U.S. territories of 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 for the notice-based process, the 

rulemaking process can range from 18 

months to over 3 years; using the noticebased process, the average time has been 

reduced to 6 to 12 months. 

Consumers and businesses would 

benefit from the more timely access to 

fruits and vegetables for which entry or 

movement would currently require 

rulemaking. This benefit would be 

reduced to the extent that certain 

businesses would face increased 

competition for the subject fruits and 

vegetables sooner due to their more 

timely approval. APHIS has not 

identified other costs that may be 

incurred because of the proposed rule. 

The rule would not alter the manner in 

which the risks associated with a fruit 

or vegetable import or interstate 

movement request are evaluated and 

mitigated. 

The proposed rule is expected to 

result in more efficient use of APHIS 

resources and more timely approval for 

importation or interstate movement of 

fruits and vegetables from Hawaii and 

the U.S. territories. Principal industries 

that could be affected by the proposed 

rule, which are fruit and vegetable farms 

and fruit and vegetable importers, are 

largely composed of small entities. 

Executive Order 12988 

This proposed rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. If this proposed rule is 

adopted: (1) All State and local laws and 

regulations that are inconsistent with 

this rule will be preempted; (2) no 

retroactive effect will be given to this 

rule; and (3) administrative proceedings 

will not be required before parties may 

file suit in court challenging this rule. 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Proposed Rules 53351 

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 

This proposed rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.). 

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 propose to amend 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 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 

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 http://www.aphis.usda.gov/ 

import_export/plants/manuals/ports/ 

index.shtml. 

(2) Fruits and vegetables authorized 

for interstate movement prior to 

[EFFECTIVE DATE OF FINAL RULE]. 

Fruits and vegetables that were 

authorized for interstate movement 

under this subpart as of [EFFECTIVE 

DATE OF FINAL RULE] may continue to 

be moved interstate under the same 

requirements that applied before 

[EFFECTIVE DATE OF FINAL RULE], 

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) Pest risk analysis and mitigations. 

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 mitigated by the application of 

one or more phytosanitary measures. 

(ii) Opportunity for public comment. 

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. 

(iii) Administrator’s decision. 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 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 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 


tkelley on DSK3SPTVN1PROD with PROPOSALS
53352 Federal Register / Vol. 79, No. 174 / Tuesday, September 9, 2014 / Proposed Rules 

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 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 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 

requirements for their importation, may 

be found on the Internet at http:// 

www.aphis.usda.gov/import_export/ 

plants/manuals/ports/downloads/fv.pdf 

or http://www.aphis.usda.gov/favir. 

(2) Fruits and vegetables authorized 

importation prior to [EFFECTIVE DATE 

OF FINAL RULE]. Fruits and vegetables 

that were authorized importation under 

this subpart either directly by permit or 

by specific regulation as of [EFFECTIVE 

DATE OF FINAL RULE] may continue 

to be imported into the United States 

under the same requirements that 

applied before [EFFECTIVE DATE OF 

FINAL RULE], 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) Pest risk analysis and mitigations. 

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 mitigated by the 

application of one or more 

phytosanitary measures. 

(ii) Opportunity for public comment. 

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. 

(iii) Import authorization. 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 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 

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 

0579–0293) 

§§ 319.56–13 through 319.56–69 

[Removed] 

■ 15. Sections 319.56–13 through 

319.56–69 are removed. 

§ 319.56–70 [Removed] 

■ 16. § 319.56–70, as added at 79 FR 

52543, September 4, 2014, and effective 

October 6, 2014, is removed. 

Done in Washington, DC, this 2nd day of 

September 2014. 

Gary Woodward, 

Deputy Under Secretary for Marketing and 

Regulatory Programs. 

[FR Doc. 2014–21406 Filed 9–8–14; 8:45 am] 

BILLING CODE 3410–34–P 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 72 

[NRC–2014–0120] 

RIN 3150–AJ42 

List of Approved Spent Fuel Storage 

Casks: Holtec International HI–STORM 

Underground Maximum Capacity 

Canister Storage System, Certificate of 

Compliance No. 1040 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Proposed rule. 


tkelley on DSK3SPTVN1PROD with PROPOSALS