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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

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Rules and Regulations Federal Register

22463 

Vol. 77, No. 73 

Monday, April 16, 2012 

1To view the proposed rule, the economic 

analysis, and the comments we received, go to 

http://www.regulations.gov/ 

#!docketDetail;D=APHIS-;2010-0036. 

2 International Standards for Phytosanitary 

Measures, ISPM No. 31: Methodologies for 

Sampling of Consignments (2008): https:// 

www.ippc.int/file_uploaded/ 

1229532867492_ISPM31_2008_E.pdf. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 319 

[Docket No. APHIS–2010–0036] 

RIN 0579–AD27 

Importation of Clementines From 

Spain; Amendment to Inspection 

Provisions 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are amending the 

regulations governing the importation of 

clementines from Spain by removing 

from the regulations the number of 

clementines per consignment intended 

for export to the United States that are 

required to be sampled by inspectors of 

the Animal and Plant Health Inspection 

Service (APHIS). In place of this 

number, we will state in the regulations 

that inspectors will cut and inspect a 

sample of clementines determined by 

APHIS. By removing from the 

regulations the number of clementines 

per consignment from Spain to be 

sampled, we will have the flexibility to 

respond to changing risk levels while 

continuing to provide protection against 

the introduction of quarantine pests. 

DATES: Effective Date: May 16, 2012. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Paul McGowan, Operational Director, 

Preclearance and Offshore Programs, 

PPQ, APHIS, 4700 River Road Unit 133, 

Riverdale, MD 20737–1231; (301) 851– 

2312. 

SUPPLEMENTARY INFORMATION: 

Background 

The regulations in ‘‘Subpart–Fruits 

and Vegetables’’ (7 CFR 319.56–1 

through 319.56–54, referred to below as 

the regulations) prohibit or restrict the 

importation of fruits and vegetables into 

the United States from certain parts of 

the world to prevent the introduction 

and spread of plant pests that are new 

to or not widely distributed within the 

United States. 

The regulations in § 319.56–34 list 

specific requirements for the 

importation into the United States of 

clementines from Spain, one of which is 

that 200 clementines from each 

consignment be cut and inspected (i.e., 

sampled) before undergoing cold 

treatment. The purpose of this 

inspection is to detect live 

Mediterranean fruit flies (Ceratitis 

capitata, or Medfly) in any stage of 

development that may be present. If a 

single live Medfly is found in any stage 

of development, the entire consignment 

is rejected. 

On December 29, 2010, we published 

in the Federal Register (75 FR 81942– 

81943, Docket No. APHIS–2010–0036) a 

proposal 1 to amend the regulations by 

removing the requirement in § 319.56– 

34(f) that 200 fruit from each 

consignment be sampled by cutting 

before treatment and replacing it with 

the statement that the number of fruit to 

be sampled before treatment will be 

determined by the Animal and Plant 

Health Inspection Service (APHIS). We 

explained in the proposal that this 

change would give us the flexibility to 

raise or lower the fruit sampling rate 

when conditions indicate a higher or 

lower risk of Medfly. With this change, 

we stated that we would be able to 

adjust the sampling rate and thereby 

detect pests that might otherwise go 

undetected prior to treatment. We also 

stated that the actual sampling rate 

would continue to be included in the 

workplan agreed to by APHIS and the 

Government of Spain, which describes 

in detail how the regulations are 

implemented operationally. 

We solicited comments concerning 

our proposal for 60 days ending 

February 28, 2011. We received three 

comments by that date. They were from 

the national plant protection 

organization (NPPO) of Spain, a 

domestic citrus trade association, and a 

group of students. All opposed our 

proposal to remove the set number of 

200 fruit and replace it with a statement 

that the number of fruit to be sampled 

will be determined by APHIS. 

Two commenters stated that our 

proposal contained no objective criteria 

on which to base increases in the 

sampling rate or to evaluate the risk 

level of Medfly. One of these 

commenters, the NPPO of Spain, noted 

that they and APHIS had signed a 

bilateral workplan in October 2010, in 

which both parties agreed that sampling 

200 fruit per consignment would 

provide a 95 percent confidence level of 

detecting a 1.5 percent infestation level. 

The Spanish NPPO expressed concern 

that the lack of specific criteria in our 

proposed change to the regulations 

could be difficult to interpret and lead 

to disruptions in Spanish exports. 

We have subsequently held 

discussions with the Government of 

Spain regarding specific confidence and 

infestation levels. Changes in the 

sampling rate to achieve agreed-upon 

target levels will be based on 

internationally recognized sampling 

methodologies 2 and included in an 

annex to the bilateral workplan. 

The same commenter recommended 

that target detection levels and sampling 

rates should be negotiated within the 

sphere of annual bilateral meetings with 

APHIS rather than set through 

rulemaking. 

It was necessary for us to propose 

changing the regulations themselves 

because they require the use of a single, 

invariable sampling rate. With the 

change we are making to the regulations 

in this final rule, we will have the 

flexibility to make future adjustments to 

sampling rates in the context of bilateral 

discussions with the Government of 

Spain. 

Another commenter noted that the 

current sampling rate of 200 fruit was 

established based on a scientific risk 

assessment, and that if a smaller sample 

is taken without conducting a similar 

assessment APHIS may not be able to 

determine the efficacy of the inspection 

process until Medfly are found in the 

channels of distribution. The 

commenter recommended that, for those 

reasons, 200 fruit per consignment be 

the minimum required sampling rate. 

We are making no changes in 

response to this comment. In most of 


emcdonald on DSK29S0YB1PROD with RULES
22464 Federal Register / Vol. 77, No. 73 / Monday, April 16, 2012 / Rules and Regulations 

our systems approaches for importing 

fruits and vegetables that involve 

sampling of fruit prior to export, we do 

not specify the sampling rate in the 

regulations; instead, fruit is sampled at 

a rate agreed upon by the NPPO of the 

exporting country and APHIS and 

contained in the bilateral workplan. 

This final rule will make our approach 

with respect to sampling clementines 

from Spain consistent with other 

systems approaches for fruits and 

vegetables set out in the regulations. 

The scientific risk assessment that 

established the 200 fruit sample 

indicated that such a sample would give 

us a 95 percent confidence rate of 

detecting a 1.5 percent level of 

infestation. The risk assessment 

determined that such a detection rate 

would be sufficient to ensure that 

Medfly populations in the clementines 

were low enough to be mitigated by the 

subsequent required cold treatment. The 

sampling rate change we proposed was 

prompted by the desire to increase the 

number of fruit sampled and thus 

increase the confidence that we were 

detecting any shipments with an 

infestation rate of 1.5 percent or more. 

We anticipate using the greater 

flexibility provided by this final rule to 

allow for such increases, when 

conditions warrant. 

In the other systems approaches in the 

regulations that include sampling of 

fruits and vegetables, we only lower the 

initial sampling rate after years of few 

or no pest detections have established a 

definitive record of low pest prevalence 

in the commodity. At some point, 

conditions may warrant sampling a 

lower number of clementines from 

Spain, thus providing a lower level of 

confidence that the sampling method is 

detecting all consignments of fruit with 

a 1.5 percent or more infestation level. 

For that reason, it is appropriate that the 

regulations provide the flexibility to 

reduce the sampling rate. 

If we were to determine that lowering 

the sampling rate for Spanish 

clementines was warranted, we would 

share the data that led to our 

determination with our domestic 

stakeholders and State partners prior to 

finalizing any adjustments with the 

NPPO of Spain. After the sampling rate 

was lowered, we would continue to 

monitor inspection results closely; if 

detections were to increase, we would 

promptly return the number of fruit 

sampled to 200 per consignment or 

more, depending on conditions. 

The NPPO of Spain expressed 

concern that an increase in the sampling 

rate would require more time for APHIS 

inspectors to sample the additional 

fruit, potentially resulting in costly 

treatment and shipping delays. 

If the sampling rate is increased in 

order to detect infestations of Medfly 

that might otherwise go undetected, we 

estimate that the number of additional 

fruit to be sampled would not be so high 

as to cause significant delays in treating 

or shipping consignments of fruit. A 

consignment of clementines consists of 

one or more lots containing no more 

than a combined total of 200,000 boxes 

of clementines that are presented to an 

inspector for pre-treatment inspection. 

Under the current regulations, the 

percentage of sampled clementines 

ranges from 0.02 percent to 0.1 percent 

per consignment inspected. Even if 

inspection amounts were to be 

increased two or three times, the 

sampling rate would still be well under 

1 percent of the consignment. 

Another commenter asked whether 

we intended to establish timeframes for 

increasing the sampling rate and, if so, 

how those timeframes would be 

determined. 

We have no plans to establish 

timeframes in conjunction with any 

changes to the clementine sampling 

rate. They will be changed on the basis 

of changing risk, as discussed earlier. 

Another commenter stated that any 

reduction in the sampling rate may 

result in higher pest control costs and 

cause inspectors to bow to budgetary 

pressures by reducing inspections in an 

arbitrary or capricious way. 

We have no indications that 

inspectors would approach inspections 

in this way due to any budgetary 

pressures. Inspectors authorized by 

APHIS are required to follow a welldefined, scientifically based inspection 

protocol. 

Therefore, for the reasons given in the 

proposed rule and in this document, we 

are adopting the proposed rule as a final 

rule, without change. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This final rule has been determined to 

be not significant for the purposes of 

Executive Order 12866 and, therefore, 

has not been reviewed by the Office of 

Management and Budget. 

In accordance with the Regulatory 

Flexibility Act, we have analyzed the 

potential economic effects of this action 

on small entities. The analysis is 

summarized below. Copies of the full 

analysis are available on the 

Regulations.gov Web site (see footnote 1 

in this document for a link to 

Regulations.gov) or by contacting the 

person listed under FOR FURTHER

INFORMATION CONTACT. 

A consignment of clementines 

consists of one or more lots containing 

no more than a combined total of 

200,000 boxes of clementines that are 

presented to an inspector for 

pretreatment inspection. Under the 

regulations that require sampling of 200 

clementines, the percentage of sampled 

clementines ranges from 0.02 percent to 

0.1 percent per consignment inspected. 

Even if inspection amounts are 

increased 2 or 3 times when there is a 

higher pest risk, the sampling rate will 

still be under 1 percent of the 

consignment. 

While this rule will help reduce the 

risk of pest introduction, we are unable 

to quantify the economic impact of 

decreasing the probability of 

introducing Medfly into the United 

States. Medfly introductions can be very 

costly to producers and to the Federal 

and State Governments. The mean cost 

of eradicating six Medfly outbreaks in 

2007 was $13.54 million. 

This rule will not have a significant 

economic effect on producers of 

clementines or other U.S. entities, 

regardless of their size or resources. As 

described, an adjustment in the number 

of fruit sampled will have a negligible 

effect on the number of clementines 

imported from Spain. 

Under these circumstances, the 

Administrator of the Animal and Plant 

Health Inspection Service has 

determined that this action will not 

have a significant economic impact on 

a substantial number of small entities. 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. This rule: (1) Preempts 

all State and local laws and regulations 

that are inconsistent with this rule; (2) 

has no retroactive effect; and (3) does 

not require administrative proceedings 

before parties may file suit in court 

challenging this rule. 

Paperwork Reduction Act 

This final rule contains no 

information collection or recordkeeping 

requirements under the Paperwork 

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

et seq.). 

List of Subjects in 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 

part 319 as follows: 


emcdonald on DSK29S0YB1PROD with RULES
Federal Register / Vol. 77, No. 73 / Monday, April 16, 2012 / Rules and Regulations 22465 

1To view the proposed rule and supporting 

documents, go to http://www.regulations.gov/ 

#!docketDetail;D=APHIS-2010-0113. 

PART 319—FOREIGN QUARANTINE 

NOTICES 

■ 1. 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. 

§ 319.56–34 [Amended] 

■ 2. In § 319.56–34, paragraph (f) is 

amended as follows: 

■ a. In the paragraph heading, by 

removing the words ‘‘; rates of 

inspection’’. 

■ b. By removing the words ‘‘200 fruit’’ 

and adding in their place the words ‘‘a 

sample of clementines determined by 

APHIS’’. 

Done in Washington, DC, this 9th day of 

April 2012. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2012–9067 Filed 4–13–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 319 

[Docket No. APHIS–2010–0113] 

RIN 0579–AD40 

Importation of Fresh Pitaya Fruit From 

Central America Into the Continental 

United States 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are amending the fruits 

and vegetables regulations to allow the 

importation of fresh pitaya fruit from 

Central America into the continental 

United States. As a condition of entry, 

the pitaya fruit must be produced in 

accordance with a systems approach 

that includes requirements for 

monitoring and oversight, establishment 

of pest-free places of production, and 

procedures for packing the pitaya fruit. 

This action will allow for the 

importation of pitaya fruit from Central 

America into the continental United 

States while continuing to provide 

protection against the introduction of 

plant pests. 

DATES: Effective Date: May 16, 2012. 

FOR FURTHER INFORMATION CONTACT: Mr. 

David Lamb, Import Specialist, 

Regulatory Coordination and 

Compliance, PPQ, APHIS, 4700 River 

Road Unit 133, Riverdale, MD 20737– 

1236; (301) 851–2103. 

SUPPLEMENTARY INFORMATION: 

Background 

The regulations in ‘‘Subpart—Fruits 

and Vegetables’’ (7 CFR 319.56–1 

through 319.56–54, referred to below as 

the regulations) prohibit or restrict the 

importation of fruits and vegetables into 

the United States from certain parts of 

the world to prevent the introduction 

and dissemination of plant pests within 

the United States. 

On May 24, 2011, we published in the 

Federal Register (76 FR 30036–30040, 

Docket No. APHIS–2010–0113) a 

proposal 1 to amend the regulations by 

allowing fresh pitaya from Central 

America to be imported into the 

continental United States. We proposed 

that, as a condition of entry, the pitaya 

fruit must be produced in accordance 

with a systems approach that includes 

requirements for monitoring and 

oversight, establishment of pest-free 

places of production, and procedures for 

packing the pitaya fruit. 

We solicited comments concerning 

our proposal for 60 days ending July 25, 

2011. We did not receive any comments. 

Therefore, for the reasons given in the 

proposed rule, we are adopting the 

proposed rule as a final rule, without 

change. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This final rule has been determined to 

be not significant for the purposes of 

Executive Order 12866 and, therefore, 

has not been reviewed by the Office of 

Management and Budget. 

In accordance with the Regulatory 

Flexibility Act, we have analyzed the 

potential economic effects of this action 

on small entities. The analysis is 

summarized below. Copies of the full 

analysis are available by contacting the 

person listed under FOR FURTHER

INFORMATION CONTACT or on the 

Regulations.gov Web site (see footnote 1 

for a link to Regulations.gov). 

This rule will allow the importation 

of fresh pitaya fruit into the continental 

United States from the Central 

American countries of Belize, Costa 

Rica, El Salvador, Guatemala, Honduras, 

Nicaragua, and Panama in accordance 

with a systems approach that includes 

requirements for monitoring and 

oversight, establishment of pest-free 

places of production, and procedures for 

packing the pitaya fruit. Entities 

potentially affected by the rule are U.S. 

pitaya fruit growers, of which most, if 

not all, are small entities. 

Pitaya fruit is produced in Hawaii, 

California, and Florida, but the 

quantities produced, numbers of U.S. 

producers, quantities imported, and 

other factors needed to assess likely 

economic effects of this rule are not 

known. The quantity of pitaya fruit 

expected to be imported from Belize, 

Costa Rica, El Salvador, Guatemala, 

Honduras, and Panama is also 

unknown. Nicaragua estimates 

exporting 1,200 metric tons (60 fortyfoot containers) of pitaya fruit to the 

continental U.S. annually, and it is 

thought that the other countries may 

ship similar or lesser amounts. 

Executive Order 12988 

This final rule allows fresh pitaya to 

be imported into the United States from 

Central America. State and local laws 

and regulations regarding pitaya 

imported under this rule will be 

preempted while the fruit is in foreign 

commerce. Fresh fruits and vegetables 

are generally imported for immediate 

distribution and sale to the consuming 

public, and remain in foreign commerce 

until sold to the ultimate consumer. The 

question of when foreign commerce 

ceases in other cases must be addressed 

on a case-by-case basis. No retroactive 

effect will be given to this rule, and this 

rule will not require administrative 

proceedings before parties may file suit 

in court challenging this rule. 

Paperwork Reduction Act 

In accordance with the Paperwork 

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

et seq.), the information collection or 

recordkeeping requirements included in 

this rule have been approved by the 

Office of Management and Budget 

(OMB) under OMB control number 

0579–0378. 

E-Government Act Compliance 

The Animal and Plant Health 

Inspection Service is committed to 

compliance with the E-Government Act 

to promote the use of the Internet and 

other information technologies, to 

provide increased opportunities for 

citizen access to Government 

information and services, and for other 

purposes. For information pertinent to 

E-Government Act compliance related 

to this rule, please contact Mrs. Celeste 

Sickles, APHIS’ Information Collection 

Coordinator, at (301) 851–2908. 

List of Subjects in 7 CFR Part 319 

Coffee, Cotton, Fruits, Imports, Logs, 

Nursery stock, Plant diseases and pests, 

Quarantine, Reporting and 


emcdonald on DSK29S0YB1PROD with RULES