[Federal Register Volume 67, Number 203 (Monday, October 21, 2002)]
[Rules and Regulations]
[Pages 64702-64739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26668]



[[Page 64701]]

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Part II





Department of Agriculture





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Animal and Plant Health Inspection Service



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7 CFR Part 319



Importation of Clementines From Spain; Final Rule

  Federal Register / Vol. 67, No. 203 / Monday, October 21, 2002 / 
Rules and Regulations  

[[Page 64702]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. 02-023-4]
RIN 0579-AB40


Importation of Clementines From Spain

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the fruits and vegetables regulations to allow 
the importation of clementines from Spain to resume if the clementines 
are cold treated en route to the United States, and provided that other 
pre-treatment and post-treatment requirements are met. These 
requirements include provisions that the clementines be grown in 
accordance with a Mediterranean fruit fly management program 
established by the Government of Spain, that the clementines be subject 
to an inspection regimen that includes fruit cutting prior to, and 
after, cold treatment, and that the clementines meet other conditions 
designed to protect against the introduction of the Mediterranean fruit 
fly into the United States. This final rule also includes restrictions 
on the distribution of imported Spanish clementines for the 2002-2003 
shipping season. We are taking this action based on our finding that 
the restrictions described in this final rule will reduce the risk of 
introduction of Mediterranean fruit fly associated with the importation 
of clementines from Spain.

EFFECTIVE DATE: October 15, 2002.

FOR FURTHER INFORMATION CONTACT: Dr. I. Paul Gadh, Import Specialist, 
Phytosanitary Issues Management Team, PPQ, APHIS, 4700 River Road Unit 
140, Riverdale, MD 20737-1236; (301) 734-6799.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in ``Subpart--Fruits and Vegetables'' (7 CFR 319.56 
through 319.56-8) prohibit or restrict the importation of fruits and 
vegetables into the United States from certain parts of the world to 
prevent the introduction or dissemination of plant pests, including 
fruit flies, that are new to or not widely distributed within the 
United States.
    Until recently, the Animal and Plant Health Inspection Service 
(APHIS) authorized the importation of clementines from Spain under the 
regulations in Sec.  319.56-2(e)(2). As such, clementines from Spain 
were imported under permit, provided that they were cold treated for 
the Mediterranean fruit fly (Ceratitis capitata) (Medfly). Clementines 
imported from Spain were not required to meet any additional regulatory 
requirements in order to be imported into the United States, but were 
subject to inspection at the port of entry.
    Between November 20 and December 11, 2001, several live Medfly 
larvae were intercepted in clementines from Spain. On December 5, 2001, 
APHIS notified the Government of Spain that it was suspending the 
importation of clementines. Beginning December 5, 2001, all shipments 
of clementines from Spain were refused entry into the United States. 
APHIS also announced restrictions on the marketing of Spanish 
clementines that had already been released into domestic commerce.
    APHIS believes, based on the available evidence, that there are 
several possible explanations for the survival of Medfly larvae in 
imported Spanish clementines during the 2001-2002 shipping season.
    In order to address this problem, since December 5, 2001, APHIS has 
prohibited the importation of clementines from Spain while it 
considered alternate approaches to mitigating the Medfly risk posed by 
clementines from Spain.

Revised Risk Mitigation for Spanish Clementines

    On April 16, 2002, we published in the Federal Register (67 FR 
18578-18579, Docket No. 02-023-1) a notice of availability and request 
for comments on a risk management analysis, ``Risk mitigation for 
Mediterranean fruit flies with special emphasis on risk reduction for 
commercial imports of clementines (several varieties of Citrus 
reticulata) from Spain'' (referred to elsewhere in this document as 
``risk management analysis'' or ``RMA''). The RMA describes and 
evaluates the use of certain risk-mitigating measures associated with 
the importation of clementines from Spain. We solicited comments on the 
RMA for 30 days ending May 16, 2002.
    On May 24, 2002, we published in the Federal Register (67 FR 36560-
36561, Docket No. 02-023-2) a notice in which we reopened and extended 
the comment period for our risk management analysis until June 14, 
2002. We received a total of 17 comments on the RMA by that date. We 
considered the comments and described changes made to the RMA in a 
revision dated July 5, 2002.
    On July 11, 2002, we published in the Federal Register (67 FR 
45922-45933, Docket No. 02-023-3) a proposal to amend fruits and 
vegetables regulations to allow the importation of clementines from 
Spain to resume if the clementines are cold treated en route to the 
United States, and provided that other pre-treatment and post-treatment 
requirements are met. These requirements included provisions that the 
clementines be grown in accordance with a Medfly management program 
established by the Government of Spain, that the clementines be subject 
to an inspection regimen that includes fruit cutting prior to, and 
after, cold treatment, and that the clementines meet other conditions 
designed to protect against the introduction of the Medfly into the 
United States. We proposed this action based on our finding that the 
requirements described in the proposed rule would reduce the risk of 
introduction of Medfly and other plant pests associated with the 
importation of clementines from Spain. The proposed rule also provided 
notice of two public hearings related to our proposal and detailed the 
dates, times, and locations of those hearings.
    We solicited comments concerning our proposal for 60 days ending 
September 9, 2002. We received 33 comments by that date, in addition to 
testimony provided by 30 persons at the two public hearings. The 
comments were from officials of State departments of agriculture, 
officials of foreign Governments, Members of Congress, scientists, 
representatives of associations such as farm bureaus, marketing 
associations, consumer groups, and trade associations, and growers, 
packers, and shippers of fruits and vegetables. Twelve of the 
commenters supported the rule, and 40 opposed some aspect of it. 
Fifteen commenters noted that APHIS should ensure that its decision to 
proceed with a final rule is based on science, and at least 10 
commenters stated that APHIS should delay action until additional 
information is available to eliminate uncertainty in its approach. The 
issues raised in the comments are discussed below, by topic.

Determination by the Secretary

    In this document, APHIS is adopting its proposal to allow the 
importation of clementines from Spain to resume as a final rule, with 
the changes discussed in this document.
    Under Sec.  412(a) of the Plant Protection Act, the Secretary of 
Agriculture may prohibit or restrict the importation and entry of any 
plant product if the Secretary determines that the

[[Page 64703]]

prohibition or restriction is necessary to prevent the introduction 
into the United States or the dissemination within the United States of 
a plant pest or noxious weed.
    The Secretary has determined that it is not necessary to prohibit 
the importation of clementines from Spain in order to prevent the 
introduction into the United States or the dissemination within the 
United States of a plant pest or noxious weed. This determination is 
based on the finding that the application of the remedial measures 
contained in this final rule will prevent the introduction or 
dissemination of plant pests into the United States. The factors 
considered in arriving at this determination include: (1) A risk 
management analysis (revised October 4, 2002), (2) a review of the 
existing cold treatment for clementines from Spain, ``Evaluation of 
cold storage treatment against Mediterranean Fruit Fly, Ceratitis 
capitata (Wiedemann) (Diptera: Tephritidae)'' (May 2, 2002) (referred 
to elsewhere in this document as ``cold treatment evaluation''), (3) a 
quantitative analysis of available data related to cold treatment for 
Medfly that was produced by USDA's Office of Risk Assessment and Cost 
Benefit Analysis (ORACBA), ``Revised Quantitative Analysis of Available 
Data on the Efficacy of Cold Treatment Against Mediterranean Fruit Fly 
Larvae'' (September 20, 2002), referred to elsewhere in this document 
as ``ORACBA analysis,'' and (4) the determinations of USDA technical 
experts.

Discussion of Public Comments

Clarification of Terms

    Several commenters expressed confusion over our use of the terms 
``shipment'' and ``lot.'' We discuss this issue in more detail later in 
this document. In response to those commenters' requests for 
clarification, we have defined those terms.
    In our final rule, a lot of clementines is considered to include a 
number of units of clementines that are from a common origin (i.e., a 
single producer or a homogenous production unit).\1\ The definition of 
the term shipment depends on the context in which it is used. 
Specifically, the definition depends on whether or not fruit has been 
treated. The term can refer to one or more lots of clementines that are 
presented to an APHIS inspector for pre-treatment inspection. Such a 
shipment may not include more than 200,000 boxes of clementines (555 
pallets). The term can also refer to one or more lots of clementines 
that are imported into the United States on the same conveyance. Our 
use of these terms in the remainder of this document is consistent with 
these definitions.
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    \1\ A homogeneous production unit is a group of adjacent 
orchards in Spain that are owned by one or more growers who follow a 
homogenous production system under the same technical guidance. The 
fruit produced by these units is pooled and packed together, and all 
the orchards in the group are regulated as one unit in the event 
that traceback of infested fruit is necessary.
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General Comments

    Several commenters questioned whether Spain, in just 9 months, has 
taken the proper steps to ensure their product is free from Medfly, and 
asked what changes have taken place in Spain's production areas since 
the shutdown of their exports in December 2001.
    The system we have designed for the resumption of imports of 
Spanish clementines is designed to ensure that APHIS will be able to 
detect infestation levels of 1.5 percent or greater with a high (95 
percent) level of confidence through the pre-treatment cutting of 
randomly selected fruit.\2\ If a single live Medfly in any stage of 
development is detected during pre-treatment fruit cutting, the 
shipment of clementines in which the Medfly is found will not be 
approved for export to the United States.
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    \2\ We will also be able to detect lower levels of infestation 
in clementines with varying levels of confidence as described in 
detail under the heading, ``Infestation Levels, Inspection, and 
Fruit Cutting.''
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    Conversely, if no infested fruit are detected via fruit cutting, 
APHIS's analysis shows that the revised cold treatment will eliminate 
any undetected low-level Medfly infestations. Furthermore, fruit 
cutting at the port of entry is designed to provide additional 
assurance that the revised cold treatment was successful.
    For these reasons, APHIS believes the new Spanish clementine import 
program will prevent the introduction or dissemination of Medflies into 
the United States. Nonetheless, to further ensure that the program does 
not result in the introduction of Medflies into the United States, we 
have required Spanish growers, in order to be approved to export to the 
United States, to enter into the Government of Spain's Medfly 
management program, which APHIS must approve, and which must ensure low 
levels of infestation in clementine production areas. We believe the 
activities required under Spain's program, which include phytosanitary 
measures that must be followed in the field and at packinghouses, 
represent a significant improvement over Spain's efforts in 2001.
    Several commenters noted that APHIS still does not know ``what went 
wrong'' in 2001, when there were multiple live larvae finds on Spanish 
clementines in several different regions of the United States. The 
commenters suggested that designing a solution when the problem is not 
fully understood is risky. Specifically, one of those commenters 
proposed that despite APHIS's determination that there are two possible 
scenarios that could explain the discovery of live larvae in 
clementines imported from Spain, a third scenario, that both those 
things occurred, is also possible.
    APHIS acknowledges that the cause of last year's infestations of 
imported Spanish clementines has not been definitively established; 
however, we have responded as if the problem resulted from one or both 
of the following: (1) Despite the assumed mortality rate of the cold 
treatment (99.9968 percent), any small or partial failure in the 
application of the cold treatment could have allowed Medflies to 
survive in clementines imported from Spain due to the above-average 
levels of Medflies in the growing areas in Spain, or (2) the level of 
Medfly infestation in imported clementines simply overwhelmed the 
capabilities of the cold treatment process, even though the treatment 
was properly applied. These two scenarios have received support from 
State agricultural officials and domestic stakeholders. We believe the 
system we have designed addresses all possible explanations for the 
problem.
    In order to address the first explanation for last year's problem, 
APHIS has extended cold treatment as described in this document, and is 
confident that the prescribed cold treatment will provide a high level 
of mortality of target pests (equivalent to probit 9 mortality). The 
extension of cold treatment also addresses concerns that the cold 
treatment under the previous schedule may not have provided probit 9 
mortality.\3\ We have conducted a thorough review of the documentation 
of cold treatment application and have found no evidence that cold 
treatment was improperly applied during the 2001 shipping season, 
although a long-term thermal-mapping study on the application of cold 
treatment is underway. That study, which was initiated before the 
Medfly infestations of Spanish clementines occurred in 2001, is 
described in more

[[Page 64704]]

detail later in this document under the heading ``Cold Treatment.''
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    \3\ A level or percentage of mortality of target pests (i.e., 
99.9968 percent mortality or 32 survivors out of a million) caused 
by a control measure.
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    Regarding the second explanation for the problem, we have required 
that levels of infestation of Spanish clementines presented for export 
be kept at low levels (levels that cannot be detected via fruit 
cutting) in order to ensure that high levels of infestation do not 
cause the treatment to be overwhelmed. Inspection and cutting of 
clementines prior to cold treatment will ensure that this requirement 
is met.
    One commenter noted that shortly after the interceptions of Medfly 
larvae in Spanish clementines, APHIS advised that the situation would 
be handled with transparency, stakeholder involvement, and most 
critically, that science would be the only determinant relative to 
developing a protocol and plan for the potential resumption of Spanish 
clementine shipments into the United States. The commenter stated that 
APHIS has failed to honor its commitment as a result of a predetermined 
decision to allow clementines back into the U.S. market for this 
upcoming season.
    APHIS has upheld its commitment to handle the issue of the 
importation of Spanish clementines with transparency and stakeholder 
involvement, and the Secretary has based her determination to allow the 
importation of clementines from Spain to resume on science, and in 
accordance with the requirements of the Administrative Procedure Act. 
We have made the documents that support this rule available for public 
comment, some for as long as 120 days. We have listened to stakeholder 
concerns in meetings and at public hearings. We have made changes to 
our supporting documents based on stakeholder review and comments. We 
have considered all comments received on our proposed rule and its 
supporting documents and have documented our responses in this final 
rule. For the reasons outlined in this document, our decision to allow 
the resumption of clementines from Spain is based on science.
    Two commenters claimed that APHIS's characterization of the events 
leading to the December 5, 2001, suspension of clementine imports from 
Spain is questionable. They stated that at no time has APHIS produced 
credible and verifiable evidence of live and viable Medfly larvae in 
shipments of Spanish clementines.
    APHIS takes quarantine action on imported commodities if a given 
commodity is found to be infested with a live quarantine pest, and 
APHIS's actions in December 2001 were based on repeated findings of 
live Medfly larvae in imported Spanish clementines. APHIS believes that 
it is often impossible and always impractical to determine the true 
viability of a live pest intercepted in an imported commodity, 
especially one that has undergone cold treatment. Therefore, APHIS has 
no other alternative but to take action to protect American agriculture 
based on the finding of a live pest in any stage of development. This 
course of action is consistent with our authority under the Plant 
Protection Act.
    Determining the true viability of Medflies would require APHIS to 
rear them to adults, allow them to mate, lay eggs, etc., all under high 
security conditions to protect against the escape of the pest to the 
natural environment. APHIS has no doubt, based on visual inspections by 
field and headquarters personnel, including expert identifiers, that 
the larvae were indeed alive upon interception in the United States.
    One commenter claimed that there has never been such a catastrophic 
failure of an APHIS program as there was with Spanish clementines in 
2001, and APHIS has no idea what the results of that failure will be. 
The commenter questioned whether Medfly could be established somewhere 
in the United States as a result of 2001 imports of Medfly-infested 
Spanish clementines.
    APHIS believes that if clementines imported from Spain caused the 
establishment of Medfly in the mainland United States, that would 
indeed represent a catastrophic failure of the APHIS import program. 
However, APHIS has no evidence to indicate that infested Spanish 
clementines have resulted in a Medfly establishment in the United 
States. Despite the events of 2001, APHIS's actions to address the 
situation appear to have been successful. Since October 2001, the only 
wild Medfly detected in the mainland United States has been a single 
female trapped in San Bernardino County, CA, in August 2002. The 
results of DNA tests to determine the origin of the Medfly were 
inconclusive, though they did show a banding pattern that may be 
consistent with Medfly from Central America, South America (except 
Venezuela and most of Brazil), Mediterranean countries, or Sub-Saharan 
Africa.\4\
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    \4\ DNA tests are actually better at clarifying where Medflies 
did not originate, as opposed to where they did originate. In this 
case, DNA tests revealed that banding patterns are not consistent 
with Medflies in Hawaii, Venezuela, and most of Brazil.
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    One commenter questioned whether APHIS has the resources available 
to effectively carry out and enforce the new import program, especially 
given congressional proposals to transfer the 3,200 APHIS employees at 
ports of entry to a proposed Department of Homeland Security. The 
commenter stated that, given the uncertainty surrounding the move of 
port personnel to the Department of Homeland Security, the reentry of 
Spanish clementines should be delayed.
    APHIS has reviewed its resources and believes it has adequate 
coverage in Spain and across the United States to ensure compliance 
with this final rule. We have no reason to believe that inspectors and 
preclearance personnel will be unable to continue to carry out their 
current responsibilities in the event that they are moved to the 
proposed Department of Homeland Security.
    One commenter noted that APHIS states that it is imposing a 
combination of measures aimed at achieving probit 9 protection from 
entry on Medfly into the United States. These measures comprise (1) 
pre-export controls in orchards and inspection at point of export, (2) 
cold treatment, extended by 2 days compared with previous conditions, 
and (3) post-import inspection. This commenter asked that we explain 
what contribution each step makes to achieving probit 9 protection.
    Probit 9 was established by A.C. Baker in 1939 as a useful concept 
when trying to assess mortality of commodity treatments against fruit 
flies.\5\
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    \5\ Baker, A.C.. 1939. ``The Basis for Treatment of Products 
Where Fruitflies are Involved as a Condition for Entry into the 
United States.'' Circular No. 551. US Department of Agriculture, 
Washington, DC.
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    APHIS considers ``probit 9 protection'' to be relevant only to cold 
treatment in this case. As stated earlier in this document and in the 
proposed rule, the term ``probit 9'' refers to a level or percentage of 
mortality of target pests (i.e., 99.9968 percent mortality or 32 
survivors out of a million) caused by a control measure. APHIS has 
historically used the term ``probit 9'' in association with the 
mortality rate caused by commodity treatments (including vapor heat, 
high temperature forced air, methyl bromide, and cold treatments) for 
fruit flies. We do not believe the term can be assigned generally as a 
measure of success of a pest-excluding regulatory approach if the term 
is used as a representation of the risk reduction potential of (1) a 
systems approach to pest management or (2) any combination of treatment 
and other types of safeguards other than treatment. This is to say that 
APHIS uses the term only as a representation of the level of mortality 
of pests caused by a specific treatment, in this case cold treatment.

[[Page 64705]]

    The level of mortality called ``probit 9'' is a historical, well-
recognized benchmark in the area of phytosanitary security. It has been 
useful as a benchmark, but recent findings \6\ suggest that requiring a 
probit 9 treatment may or may not be sufficient in a given case (i.e., 
in situations where there are significant pest populations). 
Conversely, the use of probit 9 under other circumstances (i.e., in 
situations with very low or nonexistent pest populations) may be more 
restrictive than is necessary to protect against pest infestation of 
imported fruits or vegetables. In such cases, risk analysis is 
necessary to determine the effect and role of treatment in a given 
pest-management approach.
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    \6\ A detailed consideration of the shortcomings associated with 
any measure that uses a fixed expression of proportion of mortality 
(such as probit 9) may be found in: Landolt, P., D. Chambers, and V. 
Chew. 1984. ``Alternative to the use of probit 9 mortality as a 
criterion for quarantine treatments of fruit fly infested fruit.'' 
J. Econ. Entomol. 77(2): 285-287.
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    In our RMA, APHIS considered that cold treatment approximated the 
``probit 9'' level. We also stated that the risk management analysis 
for our proposal ``considers other risk-mitigating measures as 
necessary to ensure that cold treatment has the potential to provide 
approximately a probit 9 level of quarantine security.'' Upon further 
consideration, this statement, and other similar statements made in our 
proposed rule and supporting documents require clarification. The RMA 
assesses the extent to which other risk-mitigating measures, in 
combination with cold treatment, reduce the risk that a mated pair of 
Medflies could enter the United States via imported Spanish 
clementines. Population levels have significance in the context of the 
RMA's calculations regarding the probability that a mated pair of 
Medflies could enter into the United States via Spanish clementines 
imported under the provisions of the proposed rule. However, the probit 
9 efficacy of cold treatment is not dependent on population levels of 
Medflies in Spanish production areas in the sense that the same 
proportion of mortality is expected regardless of the Medfly population 
density. We have revised our RMA to clarify that fact.
    To elaborate, if 32 Medflies survive out of each 1 million that are 
subject to a probit 9 treatment, one should expect that reducing the 
number of Medflies present to 500,000 would reduce the number of 
survivors to 16; if 100,000 are treated, then 3 will survive; and so 
on. We believe this clearly illustrates the relevance and effect of low 
pest population density, not to cold treatment itself, but to the 
overall success of a pest-exclusion program.
    As a general rule, APHIS has required treatments for fruit flies to 
provide probit 9 mortality in cases where treatment is the only 
mitigation measure applied against the pest of concern. This is because 
the level of mortality represented by this benchmark is considered 
extremely high and stringent, especially when the field infestation 
rates are low.\7\ In this rule, we are requiring a treatment that we 
are confident will provide a level of quarantine security that is 
equivalent to probit 9, but we are also requiring that fruit be 
consistently at low rates of infestation by Medflies in order to ensure 
that there is a very low probability that Medflies could survive cold 
treatment and become established in the United States.
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    \7\ See footnote 6.
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Appropriate Level of Protection and Level of Risk

    Several commenters claimed that, according to the court decision on 
APHIS's rule authorizing the importation of citrus from Argentina 
(Harlan Land Company, et al. vs. United States Department of 
Agriculture, et al., Case CV-F-00-6106-REC/LJO (D. Ariz. Sept. 
27, 2001)) (referred to elsewhere in this document as Harlan Land Co.), 
as a matter of law, APHIS must define what it considers to be a 
``negligible level of risk'' in the context of a rule authorizing the 
importation of fruit from a disease and pest infested area. The 
commenters elaborated that APHIS must define what it considers to be a 
negligible or acceptable level of risk (referred to by one commenter as 
a ``quarantine security standard''), and it must also adequately 
explain that determination, and claimed that the proposed rule does not 
do so, nor has APHIS made any attempt to articulate why the issue is 
not addressed. The commenters stated that without a discussion of the 
issue, there is no way to judge whether APHIS is meeting the 
congressional expectation that its regulations will prevent the 
movement into and through the United States of commodities that ``could 
present an unacceptable risk of introducing or spreading plant pests.''
    The RMA does not conclude that there is negligible risk associated 
with such importations. Rather, it concludes that there is a very low 
likelihood that mated pairs of Medflies could enter the United States 
via clementines imported from Spain. Furthermore, APHIS does not agree 
that the Harlan Land Co. court decision requires APHIS to define what 
it considers to be a ``negligible level of risk'' in the context of 
this rule, or any other rule apart from the rule at issue in Harlan 
Land Co.
    The term ``negligible'' is one that was used by APHIS in prior 
rulemaking and risk analysis documents unrelated to this action to 
describe risk in a qualitative, descriptive sense. APHIS has never 
intended that ``negligible level of risk'' should be interpreted as a 
term of art, but instead has used the term in its plain meaning. APHIS 
believes that its decisionmaking is tied directly to the authority 
given to the Secretary of Agriculture by the Plant Protection Act.
    Under the Plant Protection Act, the Secretary may prohibit or 
restrict the importation and entry of any plant product if the 
Secretary determines that the prohibition or restriction is necessary 
to prevent the introduction into the United States or the dissemination 
within the United States of a plant pest or noxious weed. In the case 
of clementines from Spain, the Secretary has determined that it is not 
necessary to prohibit the importation of clementines from Spain in 
order to prevent the introduction into the United States or the 
dissemination within the United States of a plant pest. This 
determination is based on the finding that the application of the 
remedial measures contained in this rule will provide the protection 
necessary to prevent the introduction or dissemination of plant pests 
into the United States.
    One commenter stated that, under the provisions of the World Trade 
Organization's (WTO) sanitary and phytosanitary (SPS) Agreement, as 
well as the standards that have been developed to implement the SPS 
Agreement by the International Plant Protection Convention (IPPC), a 
definition of the ``appropriate level of protection'' is the first step 
that must be taken when a country is considering allowing the 
importation of a commodity from another country. The commenter claimed 
that only after the ``appropriate level of protection'' or the 
``acceptable level of risk'' is established, will the destination 
country be in a position to consider what phytosanitary measures, if 
any, need to be implemented in order to assure that its phytosanitary 
requirements will be met.
    APHIS believes the commenter has misinterpreted provisions of the 
SPS Agreement and IPPC standards. The commenter appears to suggest 
that, under the SPS agreement and IPPC standards, the identification of 
an appropriate level of protection is a kind of procedural requirement 
that must be

[[Page 64706]]

fulfilled prior to each individual instance when the United States 
considers allowing the importation of a commodity from another country. 
Under the SPS Agreement and IPPC standards, there is no obligation to 
complete such a task. Furthermore, guidelines on how to implement SPS 
Agreement Article 5.5 reveal that an indication of a country's 
appropriate level of protection:

``* * * may be contained in a published statement or other text 
generally available to interested parties. The statement of the 
appropriate level of protection may be qualitative or quantitative, 
and should serve to guide its consistent implementation over time, 
and also to increase the transparency of the sanitary or 
phytosanitary regime. Examples might include government policy 
statements with regard to appropriate levels of protection in 
response to certain risks, or documents on animal health protection 
objectives or with respect to plant protection.'' \8\

    \8\ See http://docsonline.wto.org/DDFDocuments/t/G/SPS/15.DOC.
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    For plant health in the United States, Congress has expressed the 
United States' ``appropriate level of protection'' in the Plant 
Protection Act (a text generally available to interested parties) in 
the specific discretion provided to the Secretary of Agriculture. The 
Plant Protection Act authorizes the Secretary to ``prohibit or restrict 
the importation, entry, exportation, or movement in interstate commerce 
of any plant, plant product, biological control organism, noxious weed, 
article, or means of conveyance, if the Secretary determines that the 
prohibition or restriction is necessary to prevent the introduction 
into the United States or the dissemination of a plant pest or noxious 
weed within the United States.'' The Plant Protection Act further 
elaborates on the Secretary's discretion in carrying out that 
determination by stating that the Secretary may promulgate regulations 
requiring permits, or certificates for importation, and may require 
remedial measures that ``the Secretary determines to be necessary to 
prevent the spread of plant pest or noxious weeds.''
    The Plant Protection Act ensures that our phytosanitary measures 
are transparent and implemented consistently over time, and thus is 
consistent with the guidelines cited above.
    There is no obligation to express the ``appropriate level of 
protection'' quantitatively under either the SPS Agreement or IPPC 
standards, and Congress, in the Plant Protection Act, did not establish 
a quantitative expression of the ``appropriate level of protection'' or 
require APHIS to set such a quantitative expression. The SPS Agreement 
obligates members to be consistent in the level of protection they 
consider appropriate in similar cases. Allowing imports of clementines 
from Spain reflects consistency with our determinations to allow citrus 
imports from other countries and regions where Medfly is found. 
Therefore, this final rule is consistent with our obligations under 
Article 5.5 of the SPS Agreement.
    One commenter noted that, in its Regulatory Impact Analysis (RIA) 
for the proposed rule, APHIS says that it ``attempts to maintain the 
risk of Medfly introduction at an acceptable level in order to protect 
U.S. agricultural resources and maintain the marketability of 
agricultural products,'' but the Agency does not say what an 
``acceptable level'' of risk is in that document or in the RMA. The 
commenter also noted that the Appendix 1 to the RMA defines the term 
``acceptable level,'' but it does so tautologically, stating: 
``Acceptable level means the presence of a hazard that does not pose 
the likelihood of causing an unacceptable phytosanitary risk.'' In 
other words, ``acceptable'' means ``not unacceptable.''
    For the reasons stated above, we do not identify an ``acceptable 
level of risk'' in either the RIA or the RMA because those documents 
are, respectively, analyses of (1) the economic effects that could 
occur under this final rule, and (2) the probability that a mated pair 
of Medflies could enter the United States via a shipment of clementines 
from Spain. Neither document is intended to provide a decision or 
judgment as to whether this final rule provides a defined acceptable or 
appropriate level of protection, i.e., in a qualitative or quantitative 
sense. The documents are intended simply to inform the decisionmaker in 
her consideration of whether to allow the importation of Spanish 
clementines.
    Furthermore, Congress stated in Sec.  402(3) of the Plant 
Protection Act that,

``* * * it is the responsibility of the Secretary to facilitate 
exports, imports, and interstate commerce in agricultural products 
and other commodities that pose a risk of harboring plant pests or 
noxious weeds in ways that will reduce, to the extent practicable, 
as determined by the Secretary, the risk of dissemination of plant 
pests or noxious weeds.''

    APHIS believes the process it follows in evaluating risks prior to 
rulemaking on a given subject is consistent with the clearly stated 
intent of Congress.
    Regarding the commenter's statement that RMA defines the term 
``acceptable level'' tautologically, the SPS Agreement employs a 
similar approach. The SPS Agreement defines ``appropriate level of * * 
* phytosanitary protection'' as ``The level of protection deemed 
appropriate by the Member [country] establishing a * * * phytosanitary 
measure to protect human, animal or plant life or health within its 
territory.'' We believe this is further testament to the fact that 
APHIS has no obligation under any of its authorities or international 
agreements to set a quantitative level of protection that it believes 
is acceptable. Again, we believe the United States expresses its 
appropriate level of protection in the Plant Protection Act, which 
authorizes the Secretary to prohibit or restrict the importation and 
entry of any plant product if the Secretary determines that the 
prohibition or restriction is necessary to prevent the introduction 
into the United States or the dissemination within the United States of 
a plant pest or noxious weed.
    One commenter stated that the RMA does not purport to assess the 
likelihood of Medfly introduction at all; it simply estimates the 
probability that a mated pair of Medflies will arrive at a suitable 
location in the United States, and while this is said to be ``directly 
related'' to the likelihood of introduction, it is not, according to 
APHIS, the same thing. The commenters further noted that the RMA does 
not reach any judgment as to whether the risk of Medfly introduction 
under the proposed rule is ``acceptable.'' Instead, it merely asserts 
that the mitigation activities associated with a 1.5 percent maximum 
infestation rate decrease the risks of introduction as compared to the 
baseline of cold treatment alone. The proposed rule addresses the issue 
by saying the Secretary has determined ``that the application of the 
remedial measures contained in the proposed rule will provide the 
protection necessary to prevent the introduction or dissemination of 
plant pests into the United States,'' but APHIS does not say what this 
necessary level of protection is, or how much risk is compatible with 
``preventing the introduction'' of Medflies. The commenter stated that 
none of the supporting documents conclude that the mitigation measures 
will ``prevent the introduction'' of Medflies.
    While the RMA does not directly assess the likelihood of Medfly 
introduction quantitatively, it does (1) provide a discussion of the 
relationship between the likelihood of Medfly introduction and the 
probability that a mated pair of Medflies could enter the United States 
in a shipment of Spanish clementines, and (2) provide a baseline

[[Page 64707]]

figure to which the likelihood of introduction can be compared. In 
order to quantitatively assess the likelihood of introduction, 
additional analysis would be required to evaluate the possibility that 
a mated pair of Medflies that has entered the United States in Spanish 
clementines and arrived in a suitable area can then (1) find a host, 
(2) find fruit that is sufficiently mature in which to oviposit, (3) 
oviposit viable eggs, and (4) avoid death by dessication, heat or cold, 
or other factors. The effect of these other variables on the ability of 
a mated pair to survive, reproduce, and spread would, in all cases, 
further reduce the likelihood that Medfly could be introduced into the 
United States below the already very low probability that a mated pair 
of Medflies could enter the United States via Spanish clementines.
    One commenter stated that the Harlan Land Co. court decision made 
it clear that ``unless an agency describes the standard under which it 
has arrived at its conclusion, the court has no basis for exercising 
its responsibility to determine whether the agency's decision is 
arbitrary, capricious, an abuse of discretion, or otherwise in 
avoidance with the law.'' The commenter stated that according to the 
court's statement, an agency must cite information to support its 
position; without data the court owes no deference to an agency's line-
drawing.
    APHIS believes that the standard under which it has arrived at its 
conclusion is tied directly to the authority given to the Secretary of 
Agriculture by the Plant Protection Act. Under the Plant Protection 
Act, the Secretary may prohibit or restrict the importation and entry 
of any article if the Secretary determines that the prohibition or 
restriction is necessary to prevent the introduction into the United 
States or the dissemination within the United States of a plant pest or 
noxious weed. In the case of clementines from Spain, the Secretary has 
determined that it is not necessary to prohibit the importation of 
clementines from Spain in order to prevent the introduction into the 
United States or the dissemination within the United States of a plant 
pest. Several analyses (the RMA the cold treatment evaluation, the 
ORACBA analysis, and the judgment of USDA technical experts), provide 
the basis for the Secretary's finding that the application of the 
remedial measures contained in this rule will provide the protection 
necessary to prevent the introduction or dissemination of plant pests 
into the United States. Furthermore, the Secretary's determination is 
consistent with the congressional charge that she ``facilitate exports, 
imports, and interstate commerce in agricultural products and other 
commodities that pose a risk of harboring plant pests or noxious weeds 
in ways that will reduce, to the extent practicable, as determined by 
the Secretary, the risk of dissemination of plant pests or noxious 
weeds.''

Trade Issues, International Agreements, and Equivalence

    One commenter claimed that any delay that prevents the re-entry of 
clementines into the United States beyond the beginning of the next 
shipping season would constitute unreasonable delay in violation of the 
Administrative Procedure Act and in contravention of the U.S. 
Government's WTO obligations.
    Under the Administrative Procedure Act, USDA's rulemaking review 
policy, and the requirements of several Executive Orders, APHIS must 
follow certain procedures in the drafting and review of rulemaking 
documents. This process takes time. APHIS must consider issues raised 
in comments submitted before the close of the comment period, and then 
determine what action to take on its proposal given the issues raised 
by commenters. It must then draft a rule that documents its response to 
comments, and must circulate the rule through a significant review and 
approval process. APHIS is committed to rulemaking based on science and 
according to the requirements of the Administrative Procedure Act, and 
will not produce a final rule until we have carefully considered the 
issues raised by commenters and have followed our formal review 
process. This is consistent with member obligations under the WTO SPS 
Agreement.
    Three commenters stated that the proposed rule violates WTO 
prohibitions against discriminatory trade practices by requiring an 
extra 2 days of cold treatment for Spanish exports that are not 
required of clementine exports from other countries susceptible to 
Medfly infestation.
    In the October 15, 2002 issue of the Federal Register, APHIS 
published an interim rule (APHIS Docket No. 02-071-1) under which all 
commodities, including clementines from other countries, that are 
subject to cold treatment for Medfly must be treated under the same 
treatment schedule that we are requiring for Spanish clementines.
    Two commenters stated that the proposed rule violates WTO 
prohibitions against discriminatory trade practices by imposing a field 
treatment regimen for control of Medfly in Spanish clementine orchards, 
as well as pre- and post-treatment fruit cutting, but does not require 
an equivalent field treatment regimen for other countries exporting 
clementines to the United States from areas susceptible to Medfly 
infestation.
    It is true that APHIS has not placed additional pre-treatment, 
population-limiting requirements on clementines and other Medfly-host 
fruits and vegetables from other areas where Medflies are present. In 
the event that emergency measures are required to address a pest risk, 
APHIS applies them to the extent they are necessary, and APHIS has no 
evidence to support the conclusion that clementines or other fruits and 
vegetables from other Medfly-infested areas pose the same risk as 
clementines from Spain. We have conducted extensive fruit cutting and 
inspection activities associated with imports of clementines and other 
fruits and vegetables from other areas, and have not found a single 
live Medfly larvae. As stated previously in this document and in the 
proposed rule, given that high Medfly populations in production areas 
in Spain in 2001 could have caused the infestations discovered that 
year, APHIS believes it has sufficient reason to adopt specific 
measures that it believes will ensure against a similar occurence in 
future years. If we had evidence that suggested an equivalent problem 
in other regions, we would require equivalent safeguards. The available 
evidence does not, however, support that course of action.
    The interim rule for other cold treated commodities, nonetheless, 
provides that those commodities, like Spanish clementines, will be 
subject to post-treatment fruit cutting, though fewer of certain 
commodities will have to be inspected and cut due to their non-
preferred Medfly host status.
    Several commenters stated that the technical trapping protocol, 
type of trap, baits, frequency of inspection, etc., used by the Spanish 
growers should mirror the same protocol that is used by APHIS within 
the United States. The commenters claim that should a temporary Medfly 
infestation occur in a U.S. production area, the citrus within the 
established quarantine area cannot, under any circumstances, move to 
market, and they note that, in contrast, APHIS has proposed to allow 
foreign origin fruit from permanently infested production areas to be 
brought into the United States with only the provisos that the pest 
detections in the export groves are relatively low and the fruit is 
cold treated. Some commenters also questioned whether cold treatment is 
actually available to domestic producers

[[Page 64708]]

in the event of a Medfly outbreak in the United States.
    We do not agree that the technical trapping protocol, type of trap, 
baits, and frequency of inspection and other requirements regarding the 
Spanish clementine import program should mirror the same protocol that 
is used by APHIS within the United States for a reason the commenter 
has pointed out: Different requirements are warranted for fruit moving 
from Medfly-free areas in which there is an outbreak than for fruit 
moving from generally infested areas. The Spanish are not attempting to 
eradicate Medfly, nor does APHIS believe they have to do so in order to 
export fruit to the United States, provided they can mitigate the pest 
risk posed to the United States by their exports.
    U.S. producers and agricultural officials have a longstanding 
policy to eradicate Medfly infestations if they are detected in the 
mainland United States.\9\ Spanish producers use trapping as an 
indicator of the presence of Medflies in production areas, and use that 
indicator to trigger bait spray applications that are intended to lower 
Medfly population densities. U.S. producers and agricultural officials 
employ trapping programs to monitor for the presence of Medflies in 
free areas. For these reasons, APHIS does not believe there is a 
demonstrated need for trapping and bait treatment measures to be the 
same in Spain as they are in the United States. APHIS would, however, 
require equivalent measures if the intent of the Spanish program was 
maintaining Medfly freedom.
---------------------------------------------------------------------------

    \9\ Hawaii is generally infested with Medfly and uses treatments 
to certify movements.
---------------------------------------------------------------------------

    Furthermore, APHIS disagrees with the commenters' statements that 
citrus may not move from a U.S. area that is under quarantine for 
Medfly. In fact, under Sec.  301.78-10(b)(3), APHIS allows the movement 
of regulated articles, which include citrus fruit, from quarantined 
areas provided they are treated with the same cold treatment schedule 
that we use for the importation of Spanish clementines. There are also 
other treatments available, as specified in Sec.  301.78-10.
    Several commenters noted that other countries will not accept U.S. 
fruit if it is 1.5 percent infested with Medfly.
    Some countries will not accept fruit known to be infested with 
Medfly, and the United States is one of those countries. To clarify, we 
are not allowing imported Spanish clementines to be 1.5 percent 
infested or less upon arrival in the United States. Rather, we are 
requiring inspection and fruit cutting of 200 randomly selected fruit 
per shipment of clementines prior to cold treatment. If a single live 
Medfly is found during inspection in Spain, the entire shipment of 
clementines will not be eligible for export. If no infested fruit is 
found upon inspection, that provides a very high level of confidence 
(95 percent) that the shipment sampled has a low level of infestation 
(a level that cannot be detected via fruit cutting). Furthermore, 
according to our RMA, fruit that is 1.5 percent infested or less and 
that is cold treated has a low probability of carrying a mated pair of 
Medflies into a suitable location in the United States. If we find one 
live Medfly larva in a shipment of clementines at the port of entry in 
the United States, we will reject that shipment.
    We suspect that the commenters doubt whether other countries would 
adopt a similar protocol in general for U.S. exports. Such a program 
would not seem to be necessary, since there currently is no Medfly 
infestation in the mainland United States. However, we do believe that 
the Spanish clementine import program could serve as an effective model 
for exports from Medfly infested areas in the United States to other 
countries. In the event that such a program is necessary, we would 
negotiate with foreign Governments to secure export opportunities for 
citrus and other Medfly hosts from Medfly-infested areas under this 
same protocol, and we would continue to allow interstate movements of 
such articles under the requirements of 7 CFR 301.78 through 301.78-10.

Cold Treatment

    Several commenters noted that the time-temperature response surface 
model contained in the ORACBA analysis can be read to suggest that for 
treatment periods less than 16 days, a probit 9 level of phytosanitary 
security may not be achieved even at temperatures of 32 [deg]F, 33 
[deg]F, or 34 [deg]F, yet APHIS's revised protocol would allow 
treatment for only 12, 13, and 14 days, respectively, at those 
temperatures. One commenter recommended that, until the uncertainty is 
resolved regarding the lower temperatures and durations of cold 
treatment, the cold treatment protocol be kept at a minimum duration of 
14 days. Other commenters urged APHIS to review data relevant to this 
subject that were recently developed in Australia and South Africa.
    APHIS has obtained and evaluated data collected in Australia by its 
Department of Agriculture and Horticulture Australia regarding time/
temperature combinations that provide apparent complete mortality of 
Medfly.\10\ Copies of that data are available from the person listed 
under FOR FURTHER INFORMATION CONTACT. These data have also been 
factored into an updated version of the ORACBA analysis. In short, the 
data provide evidence that the longer durations of cold treatment (16 
days/35 [deg]F, and 18 days/36 [deg]F) are likely to provide a very 
high level of quarantine security (probit 9 or above).
---------------------------------------------------------------------------

    \10\ De Lima, C.P.F, A. Jessup, and R. McLauchlan. 2002. ``Cold 
disinfestations of citrus using different temperatures X time 
combinations.'' Horticulture Australia Ltd. Project Number: CT96020.
---------------------------------------------------------------------------

    The specific South African data cited by commenters were not 
submitted to APHIS by commenters. We were able to communicate with the 
persons conducting the study, and the information they provided 
supports the cold treatment we are requiring under this final rule.
    Regarding the question of whether cold treatment provides probit 9 
mortality at all the proposed time/temperature combinations, APHIS 
agrees with the commenters that additional statistical or experimental 
evidence is necessary to continue to support the conclusion that the 12 
days/32 [deg]F and 13 days/33 [deg]F combinations provide probit 9 
mortality. However, as evidenced clearly by Figure 3 of the ORACBA 
analysis, there are sufficient data available to conclude that 14 days/
34 [deg]F, 16 days/35 [deg]F, and 18 days/36 [deg]F treatments do 
provide probit 9 level quarantine security.
    Given that the calculations of risk in our RMA depend on the 
assumption that cold treatment provides probit 9 mortality, we have 
removed the 12 days/32 [deg]F and 13 days/33 [deg]F cold treatment 
combinations from this final rule, due to the unavailability of 
sufficient data to continue to support those time/temperature 
combinations as providing probit 9 mortality. Thus, the revised T107-a 
cold treatment schedule for clementines from Spain will require fruits 
to be treated according to the following schedule:

------------------------------------------------------------------------
                                                               Exposure
                        Temperature                          period  (in
                                                                days)
------------------------------------------------------------------------
34 [deg]F or below.........................................           14
35 [deg]F or below.........................................           16
36 [deg]F or below.........................................           18
------------------------------------------------------------------------

    The revised ORACBA analysis provides statistical justification for 
our selection of the above schedule, and is based on all available 
data.
    Some commenters noted that Spanish exporters claimed that their 
fruit was

[[Page 64709]]

cooled to 32 [deg]F for 12 to 14 days in 2001, which is as long or 
longer than the revised protocol would require, and yet a substantial 
number of Medfly larvae survived that treatment. If the previous 
statement is true, asked the commenters, how is APHIS's proposed 
approach different from 2001?
    We have conducted a review of available cold treatment records for 
shipments of Spanish clementines into the ports of Philadelphia, PA, 
and Elizabeth, NJ. The results of our review are as follows: (1) There 
was no clear pattern for the use of specific time/temperature 
combinations of cold treatment; and (2) though some shipments of 
clementines were treated for more days than were required at various 
approved temperatures, there is no evidence to suggest that the 
treatment time/temperature combinations cited by the commenter were 
used on more than a few occasions. In fact, the records show that in 
2001, the 10 day/32 [deg]F treatment schedule was the least used of the 
five options available, perhaps because shippers were hesitant to 
subject the fruit to the damage that can be caused by freezing 
temperatures.
    While our review did reveal that, in some cases, treatments were 
applied for longer durations (several hours to several days) than was 
required under the previous treatment schedule, we have no direct 
evidence that fruit found to be infested with Medfly were treated for 
more time than was required under the previous treatment schedule.
    Upon the detection of Medfly in Spanish clementines in 2001, APHIS 
was able to trace the initial interceptions to particular sea vessels, 
including the M/V Japan Senator and the M/V Green Maloy. The records 
for the M/V Japan Senator, which arrived in Elizabeth, NJ, on November 
7, 2001, show that each of the eight sea containers imported on that 
vessel met only the minimum time/temperature combinations provided 
under the previous treatment schedule. The records for the M/V Green 
Maloy, which arrived in Philadelphia on November 11, 2001, show that 
some time/temperature combinations in the 12 compartments on the vessel 
met only the minimum standards of the previous treatment schedule, 
while other compartments were cold treated for as many as 3 extra days. 
Since APHIS cannot trace back the fruit that was found to be infested 
to a specific hold on either vessel, we cannot know whether the fruit 
was exposed to more cold treatment than was required. We do know, 
however, that the infested fruit was held for at least as long as the 
previous treatment schedule required, which suggests a failure of the 
previous schedule to provide near 100 percent mortality, but not 
necessarily a failure of the revised schedule.
    Furthermore, the approach we use in this final rule also addresses 
the risk posed by high levels of infestation of imported clementines. 
There were no such restrictions on infestation levels in 2001.
    One commenter claimed that APHIS's proposal to extend cold 
treatment is based exclusively on the recommendation made by a panel 
put together by APHIS, using studies and scientific literature that are 
not recent and not credible enough. The commenter stated that cold 
treatment should not be extended, as any extension should be based upon 
more detailed scientific studies with internationally accepted 
credibility.
    Upon further analysis of all the available data, as stated above, 
APHIS is amending the cold treatment schedule to allow cold treatment 
for Medfly only at the longer time/temperature combinations (14, 16, or 
18 days, at the temperatures listed above). This change is based on the 
results of the ORACBA analysis, which essentially combines the results 
of available cold treatment research and uses a model to assess and 
show the ability of certain time/temperature combinations to provide 
probit 9 mortality of Medfly. The ORACBA analysis does not contradict 
the recommendations of the cold treatment review panel that drew up the 
cold treatment recommendation document that was cited in our proposed 
rule. Rather, the ORACBA analysis shows that data are only available to 
support cold treatment at the longer time/temperature combinations 
suggested by the panel. Given the clarity of the available data, 
including data recently made available by the Australian Government, we 
are confident that our revised cold treatment is science-based.
    Two commenters questioned whether APHIS allows the use of a single 
fruit temperature probe in a cold treatment container or ship hold, and 
stated that a single data point does not allow an estimate of the 
variation in temperature that normally occurs, and the protocol does 
not incorporate the necessary treatment time adjustment associated with 
this temperature variation. The commenters stated that there are very 
little published data on temperature variation in marine shipments, so 
the actual level of temperature variation in some shipments may be 
high.
    APHIS's cold treatment protocols do not authorize the use of only a 
single data point in the load. Multiple temperature sensors are 
required (in the fruit pulp, as well as in the air), and readings from 
these sensors must print out once an hour during the entire voyage. The 
larger the cargo space, the more sensors that are required, and sensors 
must be checked and calibrated before each treatment begins. 
Furthermore, all cold treatment containers and compartments must be 
checked and certified by APHIS, and APHIS verifies the treatment 
records upon arrival of the imported commodity. Given that APHIS 
requires the use of multiple sensors, given that we require all 
temperature sensor readings to meet the appropriate treatment schedule, 
and given the certification requirements for treatment equipment, we 
are confident that our existing procedure accounts for any temperature 
variation that may occur during cold treatment.
    One commenter expressed concern that fruit subject to break bulk 
shipment and that is not pre-cooled will take 100 hours to reach 
desired temperatures. Other commenters asked exactly when cold 
treatment is considered to begin. Others questioned whether the cold 
chain is broken when fruit is brought to the port for loading onto the 
ship. Another commenter noted that, under break bulk shipping, cooling 
fans are not normally operated until 75 percent of the cargo hold is 
loaded, and stated that this condition further exacerbates the problem 
of breaking the cold chain.
    Cold treatment is not considered to have begun until all 
temperature sensors within a particular compartment in a sea vessel or 
a container reach treatment temperature or below. If the cold chain is 
broken at any time during treatment, the treatment must start over, and 
must be completed in its entirety. As stated above, multiple 
temperature sensors are used (in the fruit pulp, as well as in the 
air), and readings from each sensor must be printed out once an hour 
during the entire voyage.
    APHIS recommends that the fruit be pre-chilled before loading. 
However, many foreign seaports have not built cold-storage facilities, 
and precooling is not essential given that treatment according to the 
schedules described in this document provide probit 9 mortality. 
Loading warm fruit mandates a later starting time for the treatment, 
often several days after the ship has left the port. In some cases, the 
required number of days may not have elapsed by the time the ship 
reaches its destination in the United States. This delay may be 
minimized at the port of embarkation by loading only one compartment at 
a time, and running the

[[Page 64710]]

cooling fans during loading. In cases where the treatment is not 
complete upon arrival, the ship must either remain in port until the 
cold treatment is completed in the last compartment, or the fruit is 
consigned to a cold-treatment warehouse on shore, where treatment can 
be completed or re-initiated.
    Several commenters stated that APHIS should delay the final rule 
until additional research on the application of cold treatment is 
completed, as it has not established why the previous program failed. 
The commenters cited an ongoing APHIS study to investigate temperature 
distribution in cold treatment holds in ships to see whether it is 
necessary to increase the number of temperature sensors in the holds.
    APHIS's review of the application of cold treatment to shipments of 
clementines that produced live Medfly larvae yielded no evidence that 
treatment was improperly applied. Given our analysis of available data 
on cold treatment, which is documented in the ORACBA analysis, we are 
confident that the revised cold treatment schedule for Spanish 
clementines will provide probit 9 mortality. Though there is a 
temperature mapping study underway regarding the application of cold 
treatment (which was underway before the 2001 Spanish clementine 
shipping season), we do not expect the results of the study to suggest 
dramatic changes to existing guidance on the deployment and placement 
of sensors in cold treatment compartments and containers. Given the 
clarity of the available cold treatment data, as discussed in the 
ORACBA analysis, the probit 9 mortality of cold treatment, and the 
other mitigating measures contained in this rule, we see no need to 
delay this final rule.
    Two commenters stated that APHIS's cold treatment protocol should 
require that more temperature data be collected in each container to 
determine the variation in temperature of a load, as this is the only 
way to ensure that fruit is subject to disinfestation temperatures for 
the required time period. They claimed that the current protocol 
potentially allows significant portions of a load to be delivered 
without adequate treatment, and that a minimum of three temperature 
probes per unit of fruit are needed. One of the commenters stated that 
USDA research reports published in the 1980's indicate that the fruit 
temperature range in a refrigerated container is typically about 3 
[deg]F, and based on that figure, single temperature monitors measuring 
average temperatures could fail to reveal temperatures above the level 
permitted by the treatment schedule.
    APHIS requires the use of multiple sensors, given that we require 
all temperature sensor readings to meet the appropriate treatment 
schedule, and given the certification requirements for treatment 
equipment, we are confident that our existing procedure accounts for 
temperature variation that may occur during cold treatment.
    For shipping containers, we require a minimum of three temperature 
sensors to be placed in fruit pulp. For sea vessel compartments, we 
require a minimum of four temperature sensors, but the number required 
may be larger, depending on the size of the treatment compartment. See 
Chapter 6 of the Plant Protection and Quarantine (PPQ) Treatment Manual 
\11\ for additional information.
---------------------------------------------------------------------------

    \1\ See http://www.aphis.usda.gov/ppq/manuals/pdf_files/TM.pdf.
---------------------------------------------------------------------------

    Several commenters noted that in December 2001, when the Government 
of Spain proposed that APHIS extend the cold treatment on two of the 
vessels then docked in U.S. ports with a view to permitting the fruit 
to enter the United States if the treatment were successful, APHIS 
rejected the approach, saying it had ``no data to support the efficacy 
of extending the time or temperature of the approved cold treatment.'' 
These commenters claimed that APHIS still has no such data.
    At the time of the Government of Spain's proposal, APHIS had not 
conducted its review of the available data on cold treatment, and would 
not suggest a remedial measure without a basis in science. Furthermore, 
for the reasons stated previously in this document, we must disagree 
with the commenters' conclusion. We believe there are adequate data 
available to support our revised cold treatment protocol.
    One commenter stated that the effects of precooling on the ability 
of Medflies to survive cold treatment are not known and pointed out 
that the draft workplan for the clementine import program states that 
``Additional long-term research will be needed to determine if the rate 
of precooling has an effect on insect tolerance of the cold 
treatment.''
    Studies on other fruit fly species have shown that pre-cooling does 
not have a significant effect on fruit fly mortality. Whether pre-
cooling would have a beneficial effect with respect to Medfly mortality 
remains to be determined. If so, it is possible that adjustment (i.e., 
shortening) of the treatment schedule would be possible, as available 
evidence shows that the extended cold treatment required under this 
final rule already provides quarantine security equivalent to the 
probit 9 level.
    Two commenters stated that it is possible that Medflies in Spain 
may be able to withstand colder temperatures than can more tropical 
populations of Medflies since most, if not all, cold treatment work has 
been done on strains of Medfly other than that found in Spain.
    While it is possible that Medflies in Spain may be able to 
withstand colder temperatures than some other Medflies, there is no 
evidence available to support or verify that supposition. There is, 
however, evidence, which is cited in our risk mitigation analysis, that 
Medflies have not established in the colder inland areas of Spain where 
they would be expected to occur if they had become adapted to colder 
conditions. Indeed, the distribution of Medflies in Spain is consistent 
with a Mediterranean climate, not a temperate or cold environment.
    One commenter stated that Medfly larvae have the capability to 
overwinter in freezing conditions.
    Larvae may survive brief periods (e.g. 2 to 3 days) of exposure to 
freezing conditions, especially if protected from actual freezing by 
host fruit. Available evidence (cited in the RMA) indicates that larvae 
cannot survive long-term exposure (i.e., 3 to 4 days) to freezing 
temperatures.
    One commenter stated that the statement in the proposed rule that 
APHIS inspectors will examine the cold treatment data prior to clearing 
an incoming shipment is very troubling, as it infers that this might 
not have been occurring previously even though the PPQ Treatment Manual 
cold treatment protocol requires a review of the treatment logs or 
charts for any irregularities that might have occurred during treatment 
(and, time permitting, examination of the load and compartments) prior 
to clearance of any cold treated shipment.
    APHIS always reviews the cold treatment records of each compartment 
or container that contains imported cold treated fruits and vegetables. 
For each imported shipment, an inspector reviews the treatment charts 
to ensure that the treatment cold chain was uninterrupted and that the 
time/temperature combinations meet the required treatment schedule. Our 
statement in the proposed rule was intended to reinforce this 
requirement, not to imply it had not been applied.
    One commenter stated that methyl bromide fumigation is a proven 
treatment meeting a probit 9 standard of quarantine security with 
regard to Medfly infestation, and that based on

[[Page 64711]]

applications of methyl bromide to mandarin crops (a citrus fruit 
similar to clementines), methyl bromide treatment would have minimal 
aging effects on the fruit and little to no cosmetic effects provided 
that the fumigation was properly applied. The commenter pointed out 
that the established PPQ treatment schedules for citrus for methyl 
bromide use is listed as T101-w-1-2 in the PPQ Treatment Manual.
    The treatment referred to by the commenter is listed in the PPQ 
Treatment Manual as an approved Medfly treatment for citrus moving 
interstate within the United States. However, APHIS only employs that 
treatment for use as a precautionary treatment for fruit moving from 
areas near areas where Medfly has been trapped. Treatment T101-1-2 does 
not provide probit 9 mortality, and there is no approved methyl bromide 
treatment for citrus that provides probit 9 mortality of Medfly.

Confidence Building and Limited Distribution

    Many commenters had concerns about the potential limited 
distribution of Spanish clementines. The proposed rule explained that 
APHIS was considering restricting the distribution of imported Spanish 
clementines to non-citrus producing States for the first year of the 
program as a confidence-building measure. With limited distribution, 
clementines would not be eligible for distribution in California, 
Arizona, Texas, Florida, Louisiana, Puerto Rico, the U.S. Virgin 
Islands, the Northern Mariana Islands, Guam or American Samoa. Four 
commenters stated that such a requirement is unwarranted and 
unjustified given the findings of the RMA, and especially given the new 
stringent controls included in the proposed rule. One commenter stated 
that the requirement would be contrary to the provisions of the SPS 
Agreement, which requires measures to be based on scientific 
principles. Twelve other commenters stated that limited distribution 
was warranted, and each had different ideas as to what APHIS's limited 
distribution protocol should actually entail. Some commenters claimed 
that distribution should be allowed only in States without Medfly host 
material and conditions for Medfly survival. Others stated that 
distribution should not be allowed in citrus-producing States or States 
that border citrus-producing States. Other commenters agreed with 
APHIS's original suggestion. One commenter suggested that APHIS limit 
distribution for 2 years rather than 1 year to build added stakeholder 
confidence in the new program.
    APHIS has determined that, in order to ensure the success of our 
new approach, it is necessary to limit the distribution of Spanish 
clementines to non-citrus producing States during the upcoming (2002-
2003) Spanish clementine shipping season. This means that, under Sec.  
319.56-2jj(i) of this final rule, the importation and distribution of 
Spanish clementines will not be allowed in Arizona, California, 
Florida, Louisiana, Texas, Puerto Rico, the U.S. Virgin Islands, the 
Northern Mariana Islands, Guam and American Samoa \12\ during the 2002-
2003 shipping season, and all boxes of Spanish clementines will be 
required to bear the following statement: ``Not for distribution in AZ, 
CA, FL, LA, TX, Puerto Rico, and any other U.S. Territories.'' All 
labeling must be large enough to clearly display the required 
information and must be located on the side of the cartons to 
facilitate inspection. APHIS has determined that this measure is 
necessary to provide added protection to areas in the United States 
that are most vulnerable to Medfly establishment.
---------------------------------------------------------------------------

    \12\ Hawaii produces citrus, but is generally infested with 
Medfly, and therefore is not included in the list of citrus-
producing States where distribution of Spanish clementines will be 
prohibited for the 2002-2003 shipping season.
---------------------------------------------------------------------------

    Our strategy is limited to fewer States than some commenters would 
have preferred because we do not believe it is necessary, especially 
given the RMA's characterization of the likelihood that a mated pair 
could enter the United States via imported Spanish clementines, for us 
to temporarily prohibit the distribution of Spanish clementines in any 
States except those where Medfly could become established for the long 
term. We acknowledge that Medfly attacks many crops other than citrus, 
and that those crops are produced in some non-citrus producing States, 
but those States do not have favorable climatic conditions and 
sufficient host material present throughout the year to support Medfly 
establishment. APHIS is adopting this requirement on a temporary basis 
to protect the most sensitive agricultural production areas of the 
United States from infestation with Medfly. Therefore, we are confident 
that we are well within our rights as a WTO member country.
    Several commenters stated that limited distribution is not good 
regulatory policy and does not work, as shipments of commodities 
entering California from other States have been found to contain live 
Medfly larvae. The commenters noted that the California Department of 
Food and Agriculture routinely finds exotic pests in parcels handled by 
the U.S. Postal Service and commercial delivery firms at various 
locations in California and stated that USDA cannot implement a 100-
percent effective program to stop transshipment of clementine fruit 
from other States into California.
    APHIS has had success with compliance systems for limited 
distribution of fruits and vegetables. The keys to this success have 
been communication, labeling, trade verification, and enforcement. 
Communication of regulations for limited distribution has been made via 
public notice, APHIS Industry Reports, internet websites, direct 
mailings to members of the Produce Marketing Association and American 
Trucking Association, and issuance of compliance agreements and 
permits.
    Distribution statements are required on the shipping boxes for all 
limited distribution commodities, as will be the case for Spanish 
clementines. These statements inform the importer, shipper, or market 
owner of the areas in which the products are prohibited from being 
distributed. Verification of commodity and required labeling takes 
place at the initial port of entry and at internal markets within the 
United States. Commodities found to have been moved in violation of 
limited distribution requirements are recalled and/or destroyed. 
Reports of illegal movement are investigated and civil penalties are 
issued to violators as appropriate.
    For example, APHIS has monitored importation and compliance with 
the limited distribution of Mexican avocados since 1997. Compliance has 
been 98 to 99 percent by volume during the past 5 shipping seasons. In 
spite of an increased volume of imports, the 2001-2002 season saw a 
notable decline in violations over past years. In the 2001-2002 
shipping season, APHIS had three violations under investigation for 
illegal transshipment to Tennessee and Georgia. Approximately 85 boxes 
were found in several unapproved markets, of which 80 (1 shipment) were 
reported to agricultural officials by the receiver in Georgia and 
returned.
    We are confident that limited distribution of Spanish clementines 
can be enforced and can work, as shown by past experience.
    Two commenters stated that APHIS should consider a trial period 
during which limited volumes of clementines would be allowed to be 
imported to northern-tier States for a minimum of one shipping season, 
so as to ensure that the system works.

[[Page 64712]]

    As stated in previous responses, APHIS is confident that limiting 
distribution to non-citrus producing States should be adequate to 
provide confidence that the new approach works, especially given the 
very low probability of a Medfly infestation identified in the RMA, 
which does not even consider limited distribution as a mitigation 
measure.

Operational Workplan

    Several commenters stated that, in order to truly understand 
whether or not the risk mitigation measures chosen will provide an 
appropriate level of protection, APHIS's analysis must contain the 
workplan that will be used to implement the mitigation strategy chosen. 
The commenters said that, without the workplan, there is no way for any 
cooperator or other stakeholder to ascertain if the measures chosen 
will be effective.
    The workplan referred to by commenters is, in essence, an 
operational agreement between APHIS and other parties (the Spanish 
Government and a group representing clementine exporters) as to the 
responsibilities of each for the operation of the preclearance program. 
The provisions of the workplan intertwine with the regulations and are 
more detail-oriented.
    When APHIS designs a regulatory approach for a particular issue, it 
places or proposes to place all measures deemed to be necessary 
according to risk analysis in the Code of Federal Regulations. If a 
specific measure is not relevant to our calculations of risk, that 
measure may be included in the regulations, and it may not. There is no 
bright line between what is included in a workplan and what is included 
in the regulations, save that the regulations must include all 
provisions necessary to properly enforce the approach evaluated by risk 
analysis.
    As a longstanding matter of policy, APHIS does not make 
preclearance workplans available for public comment, nor does it have 
the intention of doing so in this case, though APHIS has, on some 
occasions, consulted stakeholders (who are not signatories of the 
workplan) on the contents of such workplans. In fact, at the request of 
stakeholders, APHIS has met with several State plant health officials 
as to the content of the preclearance workplan for this rulemaking. 
Nonetheless, APHIS does not believe that the contents of the workplan 
should be included in the rulemaking at hand.
    To elaborate, APHIS has received a number of comments urging 
specific handling of trapping and monitoring activities in Spain--i.e., 
commenters have suggested the use of a certain fruit fly traps, and 
certain spacing of trap locations. APHIS believes that such points do 
not have to be included in the rulemaking at hand, given that the rule 
is designed to provide for a measure of performance that will be 
demonstrated primarily via inspection and fruit cutting. Moreover, 
regardless of what trap is used and how the traps are spaced, under 
this rule, growers of Spanish clementines must ensure that products 
submitted for export to the United States have a low Medfly infestation 
level (a level that cannot be detected via fruit cutting). If they do 
not meet this standard, clementines intended for treatment will be 
rejected. APHIS will reject a shipment of fruit presented for export if 
it is found to contain live larvae upon fruit cutting. In short, if the 
fruit is found to be infested, it will be rejected. If fruit is not 
found to be infested, the extended cold treatment will provide that the 
fruit can be safely imported.
    One commenter stated that without the workplan, there is no way for 
any cooperator or other stakeholder to ascertain if there is sufficient 
APHIS oversight planned in Spain. The commenter stated that the 
workplan should allow APHIS unfettered access to production areas and 
packing and shipping facilities, regular auditing of Spanish records, 
and other procedures to ensure that APHIS personnel verify compliance 
with the terms and conditions of the operational workplan.
    The requirements described in the proposed rule and this rule 
clearly state that the Spanish Medfly management program must provide 
that clementine producers allow APHIS inspectors access to clementine 
production areas in order to monitor compliance with the Medfly 
management program, and that all trapping and control records kept by 
the Government of Spain or its designated representative must be made 
available to APHIS upon request. APHIS will have inspectors working 
full time in Spain on the verification of the Spanish clementine import 
protocol-including inspections at the port of export and production 
area monitoring. The inspectors will be present to conduct and monitor 
fruit cutting at the exporting port, and will be able to review records 
kept by the Government of Spain regarding its management program. Only 
APHIS personnel and personnel of Spain's Plant Protection Service will 
be allowed to conduct fruit cutting, and any fruit cutting performed by 
the Government of Spain will be supervised by APHIS.

Infestation Levels, Inspection, and Fruit Cutting

    Several commenters expressed concern or confusion over our 
reference to a 1.5 percent level of infestation. One commenter stated 
that allowing 1.5 percent of imported Spanish clementines to be 
infested is unacceptable, and that 1.5 percent is a high level of 
infestation of any pest, even in the field, while several other 
commenters claimed that our selection of that level of infestation is 
not supported by science.
    We recognize that our reference to a 1.5 percent level of 
infestation of Spanish clementines may have caused confusion among 
commenters. To clarify, under this rule, the detection of a single live 
Medfly during any sampling of clementines will result in the rejection 
of the shipment sampled. Hence our actual target infestation level of 
fruit is zero, not 1.5 percent. However, as a practical matter, it is 
impossible to sample a sufficient number of fruit to arrive at a 
statistically valid conclusion that the fruit sampled is Medfly-free. 
Therefore, we have selected a sampling rate (200 fruit per shipment) 
that provides a high level of confidence that we will be able to detect 
low levels of Medfly infestation in clementines from Spain. This 
particular level of inspection was selected because inspection and 
fruit cutting at lower rates would provide decreased confidence in our 
ability to detect low-level infestations of fruit, and because 
inspection and fruit cutting at higher rates would either not be 
practical from an operational standpoint or would not measurably 
improve confidence in our ability to detect such infestations. While 
this sampling rate was represented in the proposed rule as a measure 
that provided 95 percent confidence that we could detect Medfly in 
fruit that were no less than 1.5 percent infested, the same sampling 
rate will also provide a relatively high degree of confidence that even 
lower levels of Medfly infestation could be detected. For example, 
based on established hypergeometric sampling rates shown in the table 
below, we would still have a relatively high level of confidence (75 
percent) that we could find an infested fruit if the unit sampled is 
only 0.70 percent infested with Medflies.

------------------------------------------------------------------------
                                                           Confidence in
                                                            detection,
                                                           assuming 200
       Percentage of fruit infested with Medflies          fruit sample
                                                             \1\  (in
                                                             percent)
------------------------------------------------------------------------
0.05....................................................            9.52
0.10....................................................           18.13

[[Page 64713]]

 
0.11....................................................           19.76
0.12....................................................           21.36
0.20....................................................           32.99
0.30....................................................           45.17
0.40....................................................           55.15
0.50....................................................           63.32
0.60....................................................           70.00
0.70....................................................           75.47
0.80....................................................           79.95
0.90....................................................           83.61
1.00....................................................           86.61
1.10....................................................           89.06
1.20....................................................           91.06
1.30....................................................           92.70
1.40....................................................           94.04
1.50....................................................           95.14
1.60....................................................           96.03
1.70....................................................           96.76
1.80....................................................           97.36
1.90....................................................           97.85
2.00....................................................          98.24
------------------------------------------------------------------------
\1\ Assuming shipments of clementines are within the maximum and minimum
  sizes described in this final rule (166,000 to 4.5 million fruit).

    While this sampling rate (200 fruit per shipment) provides a high 
level of confidence that we can detect low levels of infestation, we 
acknowledge that some small percentage of infested fruit may be missed 
during sampling. However, as discussed elsewhere in this document, the 
calculations of our RMA suggest that the application of cold treatment 
to such fruit would result in a very low probability that such fruit 
could serve as a pathway for Medfly to enter the United States into a 
suitable area.
    If exporters of Spanish clementines are to avoid having shipments 
of clementines routinely rejected by inspectors, they must ensure that 
the infestation level of fruit is below detectable levels. Furthermore, 
given that APHIS may shut down the export program if shipment rejection 
rates rose above 20 percent in a given month, we believe that an 
appropriate target maximum infestation level for fruit presented for 
export would have to be well below 1.5 percent.
    Again, we did not intend to identify a 1.5 percent level of 
infestation as a target infestation level for the fruits in the field. 
Given this fact, and the confusion expressed by commenters, we believe 
it is necessary to clarify and revise part of our proposal. 
Specifically, Sec.  319.56-2jj(c)(1) of our proposed rule required that 
``* * * bait treatments * * * be applied in the production areas at a 
rate appropriate to maintain the level of infestation of clementines by 
Mediterranean fruit flies at 1.5 percent or less.'' This proposed 
language was inappropriate, because maintaining levels of infestation 
at 1.5 percent would result in the majority of shipments of clementines 
being rejected. In addition, the responsibility for operating the 
Medfly management program in Spain resides with the Spanish Government, 
and this rule contains no provisions for APHIS or any other party to 
verify levels of infestation of clementines in the field. Rather, this 
rule provides for such verification through examination of clementines 
at the port of export. Therefore, we are amending Sec.  319.56-
2jj(c)(1) in this final rule to require that ``* * * bait treatments * 
* * be applied in the production areas at the rate specified in Spain's 
Medfly management program.'' We are making this revision because, while 
we do believe bait treatments need to be applied in order to ensure low 
levels of infestation of fruit that are presented for export to the 
United States, we do not believe it is necessary or appropriate for 
APHIS to specify the level of infestation that must be maintained in 
production areas via those bait treatments. We are confident, however, 
that we can appropriately monitor the infestation level of fruit 
presented for export via inspection and fruit cutting of 200 randomly 
selected fruit.
    One commenter stated that APHIS last surveyed the Spanish 
clementine growing regions in December 2001 and has no more recent 
data. The commenter stated that, given the age and unreliability of 
Spanish Government data on trapping and pest populations, APHIS cannot 
determine with any confidence the type of spraying required and the 
duration and frequency of the treatments necessary to reach the 1.5 
percent desired level.
    APHIS believes that a well-maintained trapping program can be used 
as an accurate indicator of the localized prevalence of Medflies. We do 
not believe that trapping is precise enough to accurately determine 
infestation levels of fruit, though it is useful as an indicator for 
when bait treatment applications are necessary. APHIS believes that 
inspection and fruit cutting provide a more effective means to 
determine the level of infestation in fruit submitted for cold 
treatment than can trapping. For this rule, we use inspection and fruit 
cutting as a means of determining the level of infestation of Spanish 
clementines.
    Two commenters claimed that APHIS has presented no data showing 
that an infestation rate of 1.5 percent or less, combined with cold 
treatment, will successfully prevent mated pairs of live Medfly larvae 
from entering the United States. The commenters noted that direct 
sampling data compiled by APHIS inspectors from vessels unloaded at 
ports of entry in 2001 showed an overall average infestation rate (0.16 
to 0.18 percent) that is an order of magnitude lower than the maximum 
infestation rate (1.5 percent) contemplated under the proposed rule, 
yet there were multiple finds of live Medfly larvae in Spanish 
clementines last year. The commenters questioned the particular 
significance of a 1.5 percent infestation level, asked why it is a 
critical control point, and stated its selection appears to be 
arbitrary.
    As stated in this document, we believe it is highly likely that 
infestations of imported Spanish clementines were due to the inability 
of the cold treatment schedule to provide probit 9 mortality. We are 
confident that the revised treatment schedule, in combination with the 
reduction in Medfly infestation levels ensured via fruit cutting, 
provide that needed quarantine security.
    Regarding the infestation levels in 2001, APHIS acknowledges that 
all samples taken after the initial infestations of 2001 were detected 
revealed low level infestations. It was not possible to randomly (that 
is, in an unbiased manner) sample fruit from shipments that had already 
been distributed and/or sold through retail outlets; given that those 
early-season shipments are the origin of first interceptions of live 
Medfly larvae in 2001, APHIS is unconvinced that the level of 
infestation observed in samples taken later in the shipping season are 
representative of the level of infestations of early season shipments. 
The unprecedented, numerous reports of live larvae from retail outlets 
and ports suggest that high densities of live larvae were indeed 
associated with early season shipments.
    As stated earlier in this document, the sampling rate used for 
inspecting clementines presented for export was selected primarily 
because it provides a high level of confidence of detecting low level 
infestations of clementines. For this reason, we do not agree that its 
selection was arbitrary. We believe that the RMA provides ample 
evidence that the level of Medfly mortality caused by cold treatment 
(probit 9 or above), in conjunction with the low levels of pest 
infestation ensured via fruit cutting reveal that there is an extremely 
low likelihood that a viable mated pair of Medflies would enter the 
United States with imported Spanish clementines.
    Furthermore, as discussed earlier in this document, APHIS is 
unconvinced

[[Page 64714]]

that the level of infestation observed in samples taken later in the 
shipping season (presumably, the samples referred to by the commenter) 
are representative of the level of infestation of early season 
shipments. APHIS has assumed that the infestations associated with 
early season shipments were higher than average. This is a reasonable 
assumption based on the available evidence, which includes the 
unprecedented and numerous reports of live larvae, the higher than 
average trap captures in Spain during the growing season, and the 
higher than average temperatures in Spain during the growing season.
    One commenter stated that the 1.5 percent value was chosen not 
because it was shown to provide any particular level of phytosanitary 
security, but because 200 fruit per shipment was the maximum amount 
APHIS felt it was capable of inspecting in a reasonable amount of time 
and at reasonable expense.
    As stated in response to the previous comment and others, the 200 
fruit per shipment sample size was selected primarily because it 
provides a practical means to verify with a high level of confidence 
that fruit is infested at low levels. We stated in our proposed rule 
that we consider fruit cutting (200 randomly selected fruit per 
shipment) to provide a statistical basis on which we can infer whether 
the shipment inspected is 1.5 percent infested or greater. The use of 
this measure in combination with cold treatment will result in a very 
low probability that a viable mated pair of Medflies would enter the 
United States with imported Spanish clementines.
    Several commenters noted that after the first shipping season, the 
pre-treatment sampling rate would not ensure with 95 percent confidence 
that sampled fruit is 1.5 percent infested or less, but rather that is 
3.0 percent infested or less. The commenters also noted that in future 
years, the sampling rate could be reduced to 76 fruit per shipment, and 
the sampling would provide only a 90 percent confidence level that the 
infestation rate is no greater than 3 percent. The commenters 
questioned how the findings of the risk management analysis are 
affected by changing the sample size from 200 to 100 to 76 fruit. Some 
of the commenters noted that the lower sampling amounts are 
inconsistent with USDA's Pre-Clearance Program Guidelines, which define 
``quarantine security'' as ``a level of control which assures a 95 
percent confidence level that a pest population will not become 
established based on the inspection/treatment certification 
procedure(s) used when considering the biology and ecology of the pest 
species.'' Commenters stated that there is no biological justification 
for reducing the sampling rate in one year based on rejection rates of 
shipments in the previous year since infestation rates in one year may 
differ substantially from rates a year earlier, and stated that APHIS 
has provided no evidence that there is any correlation between 
infestation rates in different years.
    APHIS does not necessarily agree with the commenters' assertion 
that there is no biological justification for reducing the sampling 
rate in one year based on rejection rates of shipments in the previous 
year, though we do acknowledge that we did not provide a clear 
justification for such a measure in the proposed rule. To elaborate, if 
orchards in Spanish clementine productions areas are well managed for 
Medfly on an ongoing basis according to specific measures contained in 
a pest management program, then there would be a clear connection 
between the Medfly populations in those areas from one year and the 
next. Nonetheless, given that the RMA does not consider the effect of 
decreasing the pre-treatment fruit cutting sample size from one year to 
the next, in the final rule we are simply requiring that fruit be cut 
at a rate of 200 fruit per shipment, as that level of inspection is the 
only one evaluated in the RMA.
    Two commenters stated that the maximum size of a shipment or lot 
should be set according to the number of boxes, not the number of 
pallets, and noted that the maximum lot size specified in the rule 
appears to be smaller than that specified in discussions regarding the 
program workplan. Several commenters expressed concerns over our 
explanation for what constitutes a ``shipment'' of clementines under 
the proposed rule. Those commenters suggested that the rule needs a 
clear definition of the term ``shipment'' as it relates to cutting 
requirements, and argued that the proposed rule does not specify how it 
will be made clear, in advance of an inspection, what constitutes the 
particular ``shipment'' when fruit is presented for inspection.
    As pointed out by one commenter, the maximum size of shipment 
described in the proposed rule was 120 pallets (approximately 43,243 
boxes). This figure was incorrect, as we allow a maximum size shipment 
of 200,000 boxes (555 pallets) under the operational workplan. We have 
corrected this error in this final rule.\13\ Further, due to the 
confusion caused by our use of the terms ``shipment'' and ``lot,'' we 
are making changes in the final rule based on these comments. In our 
final rule, a lot of clementines is considered to include a number of 
units of clementines that are from a common origin (i.e., a single 
producer or a homogenous production unit \14\). The definition of the 
term shipment depends on the context in which it is used. Specifically, 
the definition depends on whether or not fruit has been treated. The 
term can refer to one or more lots of clementines that are presented to 
an APHIS inspector for pre-treatment inspection. Such a shipment may 
not include more than 200,000 boxes of clementines (555 pallets). The 
term can also refer to one or more lots of clementines that are 
imported into the United States on the same conveyance. These 
definitions are included in a revised Sec.  319.56-2jj(k). Furthermore, 
inspectors must be able to easily distinguish one shipment from the 
next, and exporters are required to present their shipments for 
inspection in an orderly manner to facilitate inspection.
---------------------------------------------------------------------------

    \13\ This change has no effect on calculations of risk, as the 
same level of confidence (95 percent) is provided by inspection and 
cutting 200 fruit out of either 120 pallets or 555 pallets, 
according to hypergeometric sampling rates.
    \14\ A homogeneous production unit is a group of adjacent 
orchards in Spain that are owned by one or more growers who follow a 
homogeneous production system under the same technical guidance. The 
fruit produced by these units is pooled and packed together, and all 
orchards in the group are regulated as one unit in the event that 
traceback of infested fruit is necessary.
---------------------------------------------------------------------------

    One commenter stated that the proposed rule does not say what is 
meant by the term ``orchard,'' and requested that APHIS clarify the 
term's meaning. The commenter noted that it is unclear how APHIS will 
determine whether two shipments with infested fruit are from the same 
``orchard'' or how APHIS will determine the bounds of the ``orchard'' 
that is to be removed from the export program.
    We have added a definition for the term ``orchard'' to Sec.  
319.56-2jj(k). For the purposes of this rule, the term ``orchard'' 
refers to each plot on which clementines are grown that is separately 
registered in the Spanish Medfly management program. Some orchards 
could be owned by one person, and some could be owned by several 
persons (in Spain, such cooperatives are called ``homogenous production 
units''). Some orchards could be less than an acre in size, while 
others could include hundreds of acres. APHIS will be able to determine 
the origin of infested fruit via box markings that are required

[[Page 64715]]

under this final rule. The box markings will provide a means to 
identify the particular orchard owner or homogeneous production unit 
from which infested fruit originated. In order to confirm that fruit 
are eligible under the export program, APHIS checks the box markings on 
cartons submitted for cold treatment to verify the orchard's status in 
the export program.
    One commenter noted that the pretreatment fruit cutting sample size 
represents too small a percentage of the actual sample itself. The 
commenter noted that the samples represent .0012 percent of the 
smallest shipment of fruit, and .0002 percent of the largest shipment 
respectively. The commenter stated that inspecting and cutting a small 
random sample of fruit does not ensure the shipment is clean prior to 
cold treatment.
    These sampling techniques are not designed to ensure that fruit is 
pest-free. Rather, sampling is intended to provide confidence that the 
infestations levels in fruit are low enough to ensure a low probability 
that a viable mated pair of Medflies would enter the United States via 
imported Spanish clementines. As stated in response to the previous 
comment, the maximum size of a shipment would be 200,000 boxes, 
containing approximately 4.5 million fruit. Even so, according to 
established hypergeometric sampling rates, whether cutting 200 fruit 
out of (1) a 166,050 fruit sample or (2) a 4.5 million fruit sample, if 
samples are randomly selected, the negative results would provide 95 
percent confidence that the unit sampled is less than 1.5 percent 
infested.
    One commenter stated that if Medflies at any stage of development 
are discovered in two or more shipments in one season from the same 
orchard, the orchard should be removed from the export program until it 
can certify compliance with Medfly management and commodity export 
programs, rather than only being removed for the remainder of the 
shipping season.
    APHIS believes that fruit cutting is the most effective means to 
determine the infestation level of fruit presented for cold treatment, 
and thus does not agree that such a review is needed to qualify an 
orchard for re-entry into the export program. If the orchard is not 
managing Medfly populations effectively, that fact will be evident in 
fruit cutting required under this rule.
    One commenter stated that APHIS should specify the cutting rates 
and procedures that will be used once the fruit reaches the United 
States or the basis on which the rates will be determined.
    Post-treatment fruit cutting is not considered as a mitigation 
measure in the calculations of risk of the RMA. Since the RMA estimates 
a very low probability that a viable mated pair of Medflies would enter 
the United States with imported Spanish clementines under the other 
provisions of this rule, we see no need to specify the level of post-
treatment fruit cutting in the rule itself. We will continue to require 
post-treatment fruit cutting of clementines, and will cut 1,500 fruit 
per bulk shipment and 150 fruit per shipping container for the first 
shipping season. Sample sizes may decrease in future years based on the 
success of the program.
    Two commenters claimed that the reliability of fruit cutting as a 
sampling technique is questionable, at best. One of those commenters 
cited studies indicating that, on average, inspectors will identify 
only 35 percent of infested fruit, noted that the infestation rate of 
Spanish clementines could actually be as high as 4.3 percent during the 
first shipping year when the 1.5 percent limit applies (1.5 percent / 
0.35 = 4.3 percent), and argued that cutting a statistically determined 
sample will not ensure that the infestation rate on fruit accepted for 
shipment does not exceed 1.5 percent. The other commenter stated that 
the effectiveness of inspection is dependent on both the skill and 
qualifications of the personnel carrying out the exercise and the 
standardization of the activity. The commenter stated that without 
assurances that the fruit cutting will be undertaken in a uniform, 
standardized manner and by fully qualified inspectors, there can be no 
confidence that these procedures, whether applied pre-or post-cold 
treatment, can accurately measure whether the infestation level in the 
groves is 1.5 percent or less, or that the Medfly control program, 
including cold treatment, has been effectively applied.
    Inspection is a measure used worldwide to mitigate the risk posed 
by pests that may be present in imported agricultural commodities. 
APHIS inspectors are trained to find pests in agricultural commodities, 
and our pest interception records for the past 17 years support this. 
Since 1985, we have intercepted 485 fruit flies in Citrus reticulata, 
with 38 of those being Medflies.
    The RMA discusses the reliability of fruit cutting, and discusses 
the effect of that variability on its calculations. Given the 
characteristics of clementines-they are small, easy to peel and cut, 
and their pulp is translucent-we believe our inspectors will be able to 
detect Medfly infestations in imported clementines with a high level of 
confidence. Further, we wish to clarify again that we are not 
attempting to determine the level of infestation of fruit in the groves 
where they grow. We are simply attempting to ensure that fruit 
presented for treatment is infested with Medflies at low levels (i.e., 
levels that cannot be detected via fruit cutting), as discussed earlier 
in this document.

Remedial Measures

    Two commenters stated that if live larvae are detected in imported 
Spanish clementines, the investigation should be performed jointly by 
APHIS and Spain. The commenters requested that APHIS ensure that access 
to all relevant data and samples is provided to the importer and the 
Spanish authorities to permit independent verification of the findings 
of the U.S. inspectors.
    APHIS is not opposed to Spain participating as appropriate in an 
investigation that may be necessary if Medflies are found in imported 
Spanish clementines, and we will share data relevant to such findings 
with the Spanish. However, APHIS will not delay any part of such an 
investigation based on the availability, or lack thereof, of Spanish 
Government personnel.
    Several commenters stated that fruit should not be destroyed if it 
arrives at a U.S. port and (1) treatment has not been properly applied 
or (2) fruit are found to be infested. The commenters expressed concern 
that the proposed rule allows for the destruction of improperly treated 
or infested fruit, and suggested that APHIS apply the least drastic 
measures necessary at the port of entry in the event that Medfly is 
detected in Spanish clementines.
    APHIS gives fruit importers the choice of what to do with shipments 
of fruit that are found to be infested with pests, unless the 
exporter's choice poses a risk that pests could be introduced into the 
United States. For instance, APHIS would not require the destruction of 
fruit that is found, upon inspection, to be infested with Medflies if 
the fruit can safely be reexported.
    One commenter asked if APHIS has ever considered requiring 
exporting countries to put up a performance bond to ensure against the 
devastation of American agriculture in the event that legally imported 
fruit introduce serious agricultural pests into this country.
    The idea of a protective bond to be paid by a foreign region to 
U.S. producers in the event that imported fruit causes a catastrophic 
pest emergency in the United States is not a new idea, nor is it a 
practical one. Such ``insurance'' against pest infestation and loss of 
agricultural production has been

[[Page 64716]]

determined to be contrary not only to the will of foreign exporters, 
but to the will of domestic exporters, who would be expected by other 
countries to put up similar bonds for their exports. The matter is 
further complicated by the fact that it is very difficult to tie an 
outbreak to a specific source, as per past experience. For these 
reasons, the use of such bonds is considered impractical.
    One commenter stated that the handling of potentially infested 
cargo at ports of entry is subjective and criteria for suspension of 
the program is ambiguous.
    The regulations do not cite specific courses of action to be 
followed in the event that infested fruit are intercepted at the port 
of entry, as each such situation could require a unique reaction. APHIS 
believes that decisionmaking related to such events is best handled on 
a case by case basis, and we believe our position is well within the 
authority given to the Secretary by Congress.
    One commenter questioned whether APHIS, upon finding live Medflies 
in imported Spanish clementines, would allow consignments which are en 
route to be inspected, possibly at a higher rate, with appropriate 
action taken on a case by case basis.
    As stated in the proposed rule and in this final rule, if a single 
live Medfly in any stage of development is found in a shipment of 
clementines being imported into the United States, the shipment will be 
held until an investigation is completed and appropriate remedial 
actions have been implemented. If APHIS determines at any time that the 
safeguards contained in the regulations are not protecting against the 
introduction of Medflies into the United States, APHIS may suspend the 
importation of clementines and conduct an investigation into the cause 
of the deficiency.

Risk Analysis

    One commenter stated that the RMA is not (and does not purport to 
be) a risk assessment, and noted that, according to the IPPC standard, 
a pest risk assessment--which evaluates the probability of the 
introduction and spread of a pest--should be performed as a predicate 
to conducting a risk mitigation analysis to select the most appropriate 
pest risk management options. The commenter claimed that APHIS has not 
performed a pest risk assessment as a predicate to conducting the RMA, 
and thus commenters do not know what APHIS believes to be the 
probability of the introduction of Medfly under the baseline or 
mitigated scenario, and it is not possible to determine whether APHIS 
has selected the most appropriate management options to mitigate the 
identified pest risk.
    The events of the 2001 Spanish clementine shipping season suggested 
that a review of risk mitigation for Medflies was justified, and the 
risk mitigation document is such a review. Based on the updated 
decision sheet \15\ contained in Appendix 4 of the RMA, and based on 
more than 20 years of previous imports of Spanish clementines, we have 
no reason to believe that there are other pests of quarantine 
significance that require additional risk mitigation, and therefore 
disagree with the commenter's claim that we have not conducted a pest 
risk assessment. Indeed, we evaluated the risk posed by all known pests 
of clementines, and our analysis is documented in the decision sheet, 
which was made available to the public when the original draft of the 
RMA was released for public comment on April 16, 2002.
---------------------------------------------------------------------------

    \15\ Before we began routinely preparing pest risk assessments 
to inform our decisionmaking relative to commodity import requests, 
APHIS based its decisionmaking on documents called ``decision 
sheets.'' Such documents contained relatively the same information 
that is contained in modern pest risk assessments, but without the 
standardized format. We have updated the decision sheet for Spanish 
clementines to reflect all available pest information and modern 
pest risk assessment structure, and are confident it considers the 
risks posed by all pests of Spanish clementines.
---------------------------------------------------------------------------

    The decision sheet notes that the following insect pests are known 
to occur in Spain and are also associated with clementine fruit, and 
may be imported with the commodity:

Ceratitis capitata (Medfly) (Wiedemann) (Diptera: Tephritidae)
Ceroplastes rusci (L.) (Homoptera: Coccidae)
Ceroplastes sinensis Del Guercio (Homoptera: Coccidae)
Cryptoblabes gnidiella (Milliere) (Lepidoptera: Pyralidae)
Parlatoria cinerea Hadden (Homoptera: Diaspididae)
Parlatoria ziziphi (Lucas) (Homoptera: Diaspididae)
Prays citri Milliere (Lepidoptera: Plutellidae)
    The decision sheet concludes that, even though the seven quarantine 
pests listed above have the potential of being imported with 
clementines, all pests listed except Medfly would be easily detected by 
visual inspection during preclearance procedures.
    The scale insects, Ceroplastes rusci, Ceroplastes sinensis, 
Parlatoria cinerea and Parlatoria ziziphi, are relatively large and are 
located on the surface of the fruit. The larval stages of both 
Lepidopteran pests, Cryptoblabes gnidiella and Prays citiri, reside in 
or adjacent to the rind of the fruit. However, these two pests create 
large entrance holes in the fruit that are easily detected during even 
a cursory inspection. This is not the case with the larvae of Medfly, 
which require a careful analysis of the fruit pulp because they feed 
inside the fruit and the oviposition entrance holes are usually not 
readily visible. The decision sheet also noted that, of the 20 plant 
pathogens or the 4 parasitic nematode pests identified, none are of 
quarantine significance.
    Furthermore, we also disagree with the commenter's claim that it is 
not possible to determine whether APHIS has selected the most 
appropriate management options to mitigate the identified pest risk, 
since our RMA is intended to evaluate the risk reduction potential of 
our approach.
    One commenter noted that the ORACBA analysis is not referenced in 
the RMA, and its conclusions and the conclusions used in the RMA are 
not the same.
    We agree that we did not cite the ORACBA document in the RMA, 
though we have done so in the October 4, 2002 revision. For the reasons 
discussed earlier in this document, we are confident that the ORACBA 
document supports the extension of cold treatment described in this 
rule, and that its findings provide support the conclusion that the 
revised treatment will provide the requisite probit 9 mortality assumed 
in the RMA.
    One commenter stated that the RMA should include a qualitative 
analysis that describes and characterizes the risk elements that are 
analyzed quantitatively. The commenter noted that, whereas the 
quantitative analysis allows for any variability, it does not capture 
the analyst's view of what the variability he/she believes might exist.
    We believe that the quantitative analysis captures the variability 
associated with the clementine pathway. Several of the steps that make 
up the pathway were evaluated using maximum, and therefore, most 
conservative, estimates. These conservative estimates isolate the 
conclusions of the RMA from the effects of variability.
    For example, the RMA assumed that the distribution of imported 
clementines in the United States would, over time, follow population 
demographic trends that suggest human population levels will increase 
in southern States where the risk of Medfly establishment is greater. 
This to say that the RMA assumes exaggerated current and near-

[[Page 64717]]

term distribution of clementines to southern States, as it evaluates 
risk based on projected population levels in southern States that will 
not be realized until approximately 25 years from now. The RMA assumes 
that an additional 30 percent of clementines are shipped to those areas 
than is currently the case, to account for population trends assumed to 
occur in the future.
    The RMA also assumed that every shipment of clementines that 
arrives in a suitable location is equally likely to arrive in an area 
where suitable hosts for Medfly are present; however, during the fall 
and winter (when most clementines are shipped) this is a conservative 
assumption. By assuming conservative values, we were able to account 
for additional variability beyond that expressed explicitly in the 
RMA's simulation model (quantitative analysis).
    We would, however, like to note that a qualitative analysis of the 
risk of Medfly introduction into the United States is provided in the 
RMA under the heading ``Likelihood of Introduction.''
    One commenter stated that using the likelihood of the movement of a 
single container of fruit to a susceptible grove as a means to assess 
the likelihood of successful invasion is uncharacteristic of Medfly 
invasion patterns. The commenter noted that clementines are imported 
for consumption, and historically, infestations have been detected in 
urban settings where a variety of residential plantings provide fruit 
year round. Thus, the commenter concluded that infestation of 
commercial production areas is most likely to occur via natural spread 
or artificial movement of infested fruit from a residential area to a 
commercial production area.
    We agree with the commenter and have revised our analysis such that 
it no longer assumes that an entire container is likely to be released 
into suitable conditions. Rather, we used evidence provided by Wearing 
et al. 2001 and Roberts et al. 1998\16\ which suggests that a maximum 
of 5 percent of fruit that ends up in a given region is discarded. 
Since fruit that is not discarded is assumed to be consumed, we used 
the value suggested by Wearing et al. 2001 and Roberts et al. 1998 (the 
range provided was 0.5 percent to 5 percent) to estimate the actual 
amount of fruit that is not consumed and therefore, presents risks. 
Although we used the most conservative estimates (the maximum value for 
discards), our estimate of the overall probability of a mated pair in 
shipments was reduced. This is because, prior to consideration of this 
comment, the RMA's estimates treated all fruit as if it was not going 
to be consumed, and that all fruit, therefore, was likely to constitute 
hazards. This was clearly an overestimate, and the available evidence, 
as suggested by public comments, provided good reason for us to refine 
our estimates.
---------------------------------------------------------------------------

    \16\ Wearing, C.H., J. Hansen, C. Whyte, C.E. Miller, J. Brown. 
2001. ``The potential for spread of codling moth (Lepidoptera: 
Tortricidae) via commercial sweet cherry fruit: a critical review 
and risk assessment.'' Crop Protection 20: 465-488 and Roberts, R.C. 
Hale, T. van der Zwet, C. Miller, S. Redlin. 1998. ``The potential 
for spread of Erwinia amylovora and fire blight via commercial apple 
fruit; a critical review and risk assessment.'' Crop. Prot. 19-28.
---------------------------------------------------------------------------

    One commenter stated that the RMA's statistical calculations are 
incomplete, and fail to take into account more than one container of 
clementines. Consideration has not been given to additional shipments.
    The RMA estimated the risk associated with (1) a single shipment 
moving to suitable areas and (2) multiple shipments moving to suitable 
areas. The probability of a mated pair in a shipment of Spanish 
clementines arriving in a suitable area was estimated to be low. 
According to published evidence,\17\ a shipment that includes a single 
container is already a conservative estimate of risk. Landolt et al. 
states:
---------------------------------------------------------------------------

    \17\ Landolt, P., D. Chambers, and V. Chew. 1984. ``Alternative 
to the use of probit 9 mortality as a criterion for quarantine 
treatments of fruit fly (Diptera: Tephritidae)-infested fruit.'' J. 
Econ. Entomol 77: 285-287.

    ``The most practical point to assess the risk of an introduction 
occurring is the probability of a potential mating pair or gravid 
female * * * getting through quarantine. A potential mated pair 
might be defined as a nonsterile male and a nonsterile female 
occurring in the same area during the same period such that mating 
is possible. For our purposes, a pair of fruit flies emerging from 
the same shipment would be considered a potential mated pair. The 
additional problems of survival, feeding, dispersal, mate finding 
and host finding are unknown but add a large degree of safety beyond 
the probability of a mated pair occurring. The risk of an 
introduction should then be calculated as the probability of one or 
---------------------------------------------------------------------------
more mated pairs per shipment surviving quarantine measures.''

    These statements clearly support our approach to using single 
shipments as the unit of risk. Nonetheless, the effects of multiple 
shipments (cited above) were still estimated using methods obtained 
from peer reviewed methodologies cited in the RMA.\18\
---------------------------------------------------------------------------

    \18\ Wearing, C.H., J. Hansen, C. Whyte, C.E. Miller, J. Brown. 
2001. ``The potential for spread of codling moth (Lepidoptera: 
Tortricidae) via commercial sweet cherry fruit: a critical review 
and risk assessment.'' Crop Protecton 20: 465-488 and Whyte, C.F., 
R. Baker, J. Cowley, and D. Harte. 1996. ``Pest establishment, a 
quantitative method for calculating the probability of pest 
establishment from imported plants and plant products, as a part of 
pest risk assessment.'' NZ Plant Protection Centre Publications, No. 
4, ISSN 1173-6704. Lynfield, NZ.
---------------------------------------------------------------------------

    One commenter stated that the calculation of the overall 
probability for a ``mated pair'' relies on a formula that combines the 
effects of many U.S. domestic shipments, but that formula uses as an 
input the probability for a mated pair in just a single shipment, 
whereas APHIS has already indicated that the probabilities differ for 
different shipments. The commenter claimed that the calculation cannot 
be correct if it just uses a single value, because that value does not 
represent all shipments, and therefore does not account for 
variability.
    Our calculations regarding the risk posed by a single shipment use 
the maximum risk posed by a single shipment, thus causing the figure to 
represent a worst-case scenario. For instance, we made assumptions 
regarding the Medfly populations in shipments that would be consistent 
with relatively high levels of infested fruit. Available evidence 
(e.g., Agusti, M. 2000. Citricultura. Ediciones Mundi-Prensa. Madrid, 
Spain. 416 pp. and Ministerio de Agricultura, Pesca y Alimentacion de 
Spain Trapping records) indicates that as fall arrives, the population 
levels of Medfly drop precipitously in Spain, thus making late season 
shipments much less likely to harbor Medfly than assumed by our 
baseline (maximum) value. Our approach has addressed some of the 
elements of variability as such via the use of maximum values, as 
discussed previously in this document.
    One commenter stated that, according to the RMA, the chances of 
live mated pairs of Medfly being introduced into the United States via 
every imported shipment going at the same time to the same suitable 
location is an unrealistic scenario. However, the commenter noted, it 
appears that the RMA calculates the probability for mated pairs of 
Medfly from any shipment going to any suitable location at any point in 
time, which is actually a fairly realistic scenario. Why did APHIS 
choose the scenarios it evaluated, and why did it not use real world 
scenarios?
    As stated earlier in this document, based on scientific research 
and published evidence, a single shipment is already a conservative 
unit for which to estimate risk. We estimated the likelihood that a 
mated pair of fruit flies would be present in a shipment (of 166,050 
fruit) in the RMA. However,

[[Page 64718]]

comments received from stakeholders on the draft RMA requested that we 
estimate alternative scenarios (for example, millions of fruit being 
deposited in close proximity such that flies from different shipments 
and shipped during different times would be assumed to find each 
other). These scenarios are clearly unrealistic, as the chance that the 
entirety of one shipping season's Spanish clementines going unconsumed, 
and ending up in close proximity to each other in a location that has 
available host material and the right environmental conditions is not 
likely. The figure calculated, does, however, provide an upper 
theoretical threshold. Analysts estimated these upper thresholds and 
noted that if there is a low probability of Medfly entry into a 
suitable area associated with extreme scenarios (such as those just 
described), then the probability of Medfly entry under more realistic, 
constrained scenarios is clearly lower.
    Nonetheless, again in response to comments, in our final RMA, we 
have estimated risk associated with a single container arriving in a 
suitable location and multiple containers moving to suitable locations.
    One commenter stated that it is very difficult to follow where some 
of the input values used in the RMA originated and why they were 
chosen, particularly since, in a number of cases, the values selected 
seem to be inconsistent with the referenced data. The commenter noted 
that:
    [sbull] The most likely values for the number of fruit shipped are 
not shown in Tables 4a and 4b of the RMA, and the volumes that are 
shown are inconsistent with the volumes assumed in the Regulatory 
Impact Analysis.
    [sbull] The evidentiary basis and rationale for selecting the shape 
of the probability distributions are not transparent.
    [sbull] In many cases, ``personal communications'' are referenced 
as the source of information without the precise contents of those 
communications being disclosed.
    To summarize some of the key values of concern to the commenter, we 
briefly review them here. The values chosen for the different 
components assume that:
    [sbull] Approximately 166,050 clementines may be associated with a 
single shipment,
    [sbull] A maximum 1.5 percent of fruit will be infested with flies 
prior to cold treatment,
    [sbull] No more than 8 flies emerge as viable adults from infested 
fruit,
    [sbull] Cold treatment approximates the probit 9 level,
    [sbull] 44 percent of fruit imported go to States where suitable 
hosts and conditions are found,
    [sbull] 5 percent of all fruit imported is discarded and not 
consumed, and
    [sbull] More than 6,400 total shipments will arrive in the United 
States each year.
    Our rationale for selecting the above values is detailed in the RMA 
is also summarized as follows:
    The maximum number of clementines was based on the number of fruit 
that fit in a box (from 20 to 25), the number of boxes contained in a 
pallet (360), and the number of pallets (20-21) that can fit into a 
forty-foot ground transport container. This information was obtained 
through a review of shipping and packing documents and was confirmed 
via personal communications with experienced port inspectors.
    In addition to the total number of fruit in a container, we also 
estimated the total number of containers that could be exported to the 
United States. We used historical data and shipping records through 
2001 to determine the maximum number of containers shipped to the 
United States (6,408 shipments). The RIA for this rule, however, 
considers a maximum number of shipments based on the historical 
evidence cited above, but also considers future trends. For 
consistency, we have updated the final RMA to reflect the same maximum 
number identified in the RIA.
    As stated earlier in this document, the 1.5 percent level of 
infestation was derived from our ability to determine maximum 
infestation levels of fruit via sampling. Based on a sampling rate of 
200 randomly selected fruit per shipment of clementines, APHIS can 
verify with a high level of confidence (95 percent) that the fruit 
sampled is 1.5 percent infested or less, based on negative results of 
sampling. Support for this approach can be found in standard 
statistical texts.\19\
---------------------------------------------------------------------------

    \19\ See Steel, R. and J. Torrie. 1980 ``Principles and 
Procedures of Statistics.'' McGraw Hill, Inc. New York, NY. 633 pp.
---------------------------------------------------------------------------

    The maximum level is further supported by evidence from shipping 
during a presumably ``high density'' year such as 2001. As stated 
elsewhere in this document, sampling data for 2001 did not provide 
evidence that infestation levels were above 1.5 percent; however, 
sampling was not unbiased, and therefore was not representative of the 
level of infestation of fruit imported during the early part of the 
shipping season.
    In addition to purely statistical evidence, we also consulted with 
port inspectors and Spanish scientists. There was agreement that, as a 
practical matter, it was possible to limit the the proportion of 
infested fruit using the measures required by this rule.
    We also used evidence to support our minimum estimated values. The 
minimum expected pest infestation proportion is 0 percent infested 
fruit. Prior to 2001, port inspections had never found multiple live 
Medfly larvae in commercial shipments of citrus from Spain. This level 
was the minimum value for infestation most commonly cited by 
inspectors, and was used a minimum value for the purposes of the RMA.
    The maximum number of larvae per fruit that are viable (i.e., that 
grow to fully functional, potentially reproductive adults) was 
estimated as eight and the minimum was estimated as zero. The values 
noted were supported by evidence from direct laboratory experiments 
\20\ on clementine fruit. We also used additional evidence from other 
studies on other related fruit flies \21\ because tephritid flies share 
many common traits, because some family generalizations are 
appropriate, and because USDA scientists agreed that the commonalities 
between other tephritid fruit flies and the Medfly would allow us to 
make some comparisons. We concluded from a review of the evidence that 
a maximum eight larvae and a most likely three larvae would 
successfully develop and lead to viable adults from each clementine 
fruit under typical field conditions such as those studied.
---------------------------------------------------------------------------

    \20\ Santaballa, E., R. Laborda, M. Cerda. 1999. ``Informe sobre 
tratamiento frigorifico de cuarentena contra Ceratitis capitata 
(Wied.) para exportar mandarinas clementines a Japon.'' Univ. 
Polytecnica de Velencia. 25 pp.
    \21\ Leyva, J.L., H. Browning, and F. Gilstrap. 1991. 
``Development of A. ludens in several hosts.'' Environ.Entomol 
20(4): 1160-1165.
---------------------------------------------------------------------------

    We based our cold treatment parameters on the assumption that the 
revised treatment schedules, as proposed, would provide a ``probit 9'' 
level of quarantine security or better. This assumption is supported 
qualitatively by the cold treatment recommendation and quantitatively 
by the ORACBA analysis. However, as discussed in detail elsewhere in 
this document, and as evidenced by the quantitative analysis of 
available data in the ORACBA analysis, not all of the cold treatment 
time/temperature combinations suggested in the cold treatment 
recommendation document will provide probit 9 mortality. As a result, 
in this final rule, based on the findings of the ORACBA analysis, we 
are only allowing cold treatment of

[[Page 64719]]

clementines at the 14 day/34 [deg]F, 16 day/35 [deg]F, and 18 day/36 
[deg]F combinations, as these are the only time/temperature 
combinations for which there is sufficient evidence available to 
support a finding that they provide probit 9 mortality.
    We only estimated the risk posed by fruit that would arrive at a 
suitable location where Medflies could become established. We assumed 
that there are two factors that affect the amount of fruit imported 
that will arrive at suitable locations; One is tied to the distribution 
of people who consume clementines, and the other is tied to the rate at 
which they discard fruit.
    For the purposes of our analysis, we assumed that there is small 
number of States where Medfly could become established. This includes 
South Carolina, Georgia, Florida, Alabama, Mississippi, Louisiana, 
Texas, New Mexico, Arizona, and California. According to U.S. Census 
data, some 34 percent of the population currently lives in those 
States. Furthermore, according to the U.S. Census Bureau, in 25 years, 
some 44 percent of the population will live in those same States. We 
used this higher value (44 percent) to estimate how much of the 
population lives in suitable areas, and assumed that clementines would 
follow market patterns that are driven by population (i.e., that 
clementines are distributed evenly with population). For reasons 
explained in detail elsewhere in this document, we believe the value we 
used (44 percent) is a conservative estimate.
    Further, fruit is intended for consumption, and a large portion can 
be assumed to be eaten. We therefore assume that fruit that is consumed 
does not pose risks of Medfly introduction. We investigated the number 
of fruit that goes unconsumed and provide evidence in the RMA for the 
fact that, at most, 5 percent of fruit is discarded by consumers in a 
way such that it might lead to pest introduction.\22\ It is this 
discarded fruit in a suitable area that was the focus of our analysis.
---------------------------------------------------------------------------

    \22\ Wearing et al., 2001; Roberts et al. 1998.
---------------------------------------------------------------------------

    One commenter stated that the understandability and transparency of 
the RMA's outputs leave much to be desired, and that despite extensive 
comments provided during the comment period on the draft RMA, there 
have been no changes to the methodology of risk mitigation, and no 
justification given for why comments were used or not used. The 
commenter claimed that despite recommendations made during the comment 
period for the draft RMA, Table 4D, which intended to reflect the risks 
of introduction of Medfly under three different scenarios, is still 
completely incomprehensible.
    APHIS believes that, given the detailed technical comments we have 
received on the proposed rule and its supporting documents, persons who 
are knowledgeable in the field of risk analysis were certainly able to 
understand what the RMA's inputs were derived from, and how we 
calculated its outputs. All calculations contained in the RMA were 
presented to the public in the actual spreadsheet used by APHIS, and 
the spreadsheet includes all the input values we used. We have, however 
attempted to make the outputs in Table 4D easier to understand in 
response to commenters' concerns, and have made some changes to our 
methodology where appropriate as described elsewhere in this document 
and in the RMA. We have also provided evidence and documentation for 
the scientific basis of our findings and for the use of specific 
methods that we used throughout the analysis. The changes made in 
response to comments do not change our conclusion that the combination 
of cold treatment and the limitation of Medfly infestation in Spanish 
clementines will result in a minimal likelihood that mated pairs of 
Medflies will arrive in shipments of Spanish clementines.
    One commenter stated that a key holding of the court in Harlan Land 
Co. was that the risk assessment should be transparent, with ``complete 
and transparent documentation of data used in the assessment,'' and 
claimed that the risk mitigation analysis that has been prepared for 
the Spanish clementine import proposal does not meet that test. The 
commenter claimed that even informed experts are not able to comprehend 
the analysis contained in that document.
    Based on the lengthy and substantive comments we received on the 
proposed rule and supporting documentation, we believe the documents 
were sufficiently comprehensible. These comments were considered and 
helped to strengthen the RMA as described in detail in this document 
and in the RMA itself.
    Several commenters stated that limiting the RMA to citrus is a 
gross underestimation of the potential economic and social impact that 
could occur if Medfly is introduced into both agricultural communities 
and residential communities. The commenter noted that Medfly is not 
just a citrus pest, but a pest of many agricultural commodities.
    The RMA does not assume that the Medfly poses a threat to only 
citrus. To the contrary, throughout the RMA, APHIS fully acknowledges 
the multiple hosts and seriousness of this pest. The RMA does, however, 
focus on the likelihood that this serious and multiple-host pest would 
occur in association with clementines after they were treated in the 
field and after harvest, and it does evaluate risk based on the 
likelihood that the mated pairs of fruit flies enter the United States 
and arrive in a suitable area. For the purposes of our analysis, we 
consider citrus-producing States to be the most suitable areas for 
Medfly establishment because those are the only States that have the 
climatic conditions and year-round host availability to support an 
established Medfly population.
    One commenter stated that, despite the fact that phytosanitary 
security in Spanish clementine production areas has been nonexistent, 
USDA has not required that Spain follow a systems approach to risk 
mitigation.
    We did not refer to our approach regarding the importation of 
clementines from Spain as a formal ``systems approach,'' though our 
approach, by definition, could constitute a systems approach by virtue 
of its two critical control points (Medfly population control and cold 
treatment). Given that clementines were imported for upwards of 20 
years with no significant problems despite only being subject to cold 
treatment, in this rulemaking, we attempted to simply resolve some of 
the uncertainty associated with the events of 2001 by tightening 
existing restrictions, and did not see the value in referring to the 
revised protocol as a systems approach.
    One commenter stated that the Hazard Analysis and Critical Control 
Point (HACCP) approach to calculating the potential for a Medfly to be 
exported to the United States from Spain is a risk mitigation tool that 
is invaluable perhaps in a food safety program, but must be fully 
considered for its appropriateness when dealing with invasive pests. 
The commenter claimed that until our trading partners concede or 
provide reciprocity to such a HACCP-like approach, it seems 
inappropriate to use this as a tool, and certainly in this instance.
    We did not incorporate new risk management paradigms as part of 
this rulemaking. Rather, in the RMA, we noted that our procedures are 
consistent with other procedures such as HACCP. HACCP was cited to 
establish parallels, not as an effort to integrate new procedures into 
our approach. The mitigations considered by APHIS are supported by 
scientific evidence, decades of successful experiences, and expert 
panel recommendations, and, in this case, the mitigations and system

[[Page 64720]]

used by APHIS happen to be consistent with other well-known monitoring 
programs such as HACCP. As stated in our proposed rule, our analysis 
does not represent a departure from existing guidelines for the 
phytosanitary risk analysis, but rather, is a refinement that reflects 
more emphasis on certain risk mitigating elements of a set of 
phytosanitary measures (e.g., the critical control points).
    One commenter suggested the RMA include a third critical control 
point. The commenter stated that the additional critical control point 
could be (1) the review of cold treatment records prior to release of 
any shipment on arrival, or (2) a program review every 3 to 5 years.
    We agree with the commenter that there is a need for stringent 
oversight of the program, and we intend to conduct program reviews on 
similar timeline to the one suggested by the commenter. Review of cold 
treatment records prior to release of any shipment is considered as 
part of our analysis, and making it a critical control point would have 
no meaningful effect on our calculations of risk or the actual 
enforcement of the requirement.
    One commenter stated that the RMA fails to define what it means by 
``variability.'' The commenter stated that, while certain variabilities 
are described, such as variations among different populations and 
carton-to-carton variability in the number of clementines, the key 
variability--the variation expected in the number of surviving Medflies 
in each shipment to the United States--is missing. The commenter stated 
that the modeling has to correctly account for the different pest 
populations for which the variabilities are defined, and claimed that 
the RMA currently does not do that.
    We have generally discussed the topics of variability and 
uncertainty in detail in Appendix 3 of the RMA, and elsewhere in this 
document. Regarding variation expected in the number of surviving 
Medflies in each shipment to the United States, we believe that is 
addressed by the parameters of the cold treatment. This is to say that 
we assumed that cold treatment assures levels of mortality that are 
equivalent to, or greater than, the probit 9 level. This assumption is 
supported by recent large scale tests, as evaluated in the ORACBA 
analysis, and as discussed elsewhere in this document. The recent tests 
of cold treatment show that, at certain time/temperature combinations, 
the observed mortality of cold treatment was 100 percent, and 
additional data support the other approved time/temperature 
combinations. Again, the ORACBA analysis considers available data, and 
provides an assessment of where the proposed cold treatment schedule 
provides probit 9 level quarantine security, and where it does not. We 
do consider variation in survivors of cold treatment, and this 
variation is documented in Appendix 3 of the RMA, which cites the 
minimum, maximum, mean, and 95th percentile values of the distribution 
used for variation in a shipment. As for the proportion of infested 
fruit and number of larvae in a shipment, this is explored by 
multiplying single fruit estimations (i.e., number of Medfly larvae per 
fruit, which varies from zero to eight) by the proportion of fruit that 
is infested (varies from zero to 1.5 percent).
    One commenter stated that the RMA does not take into account how 
certain we can be that the calculated results correspond to reality, 
particularly the calculation concerning the probability that mated 
pairs of Medflies reach susceptible areas of the United States.
    We address the question of how our results correspond to reality by 
questioning the validity of our assumptions. APHIS believes that the 
maximum number of shipments of clementines is well described by the 
values used (6,408 per year), that the number of infested fruit can be 
realistically kept below 1.5 percent, that the number of viable larvae 
associated with clementines is low (zero to eight per fruit), that the 
cold treatment is effective (approximating probit 9), that not all 
fruit is discarded (most fruit will be consumed), and that the majority 
of fruit will not be shipped to areas suitable for Medfly development. 
APHIS strongly believes that these fundamental assumptions are correct.
    We also further believe that, by using a system that assures low 
population densities in fruit prior to cold treatment, and then 
applying a cold treatment schedule that kills more than 99.9 percent of 
the Medflies that are present, there is a very low likelihood that a 
mated pair will be associated with any given shipment of fruit.
    We address uncertainty by considering the effects of maximum values 
of inputs for the system. In essence, the investigation of maximum 
values helps us establish if our assumptions are realistic and whether 
the model used is realistic. As such, multiplication of maximum values 
results in conservative estimates of risk. Though such estimates may 
not always be realistic, they provide a point of comparison for mean 
values, and allow us to identify areas of uncertainty in the system.
    One commenter stated that the RMA incorrectly compares the effects 
of two systems--one with field controls in place, and the ``baseline'' 
without such field controls. The commenter stated that the difference 
evaluated in the RMA should not be between two inventions of the 
analysts. Instead, the RMA should start with the baseline scenario, and 
then add the effect of the controls. The commenter stated that this 
would modify the baseline distribution for infestation rates by the 
likelihood of non-detection due to the controls added, and that with 
such an approach, the effect of the controls can actually be evaluated, 
not just the inventiveness of the analysts.
    The key difference between the two scenarios (the baseline-cold 
treatment only--and the mitigated scenario employed by this rule) 
considered in the RMA was the addition of field population limits in 
the mitigated scenario. These scenarios do not reflect a contrived 
system but represent USDA's understanding of the key elements that are 
being refined and that will increase its ability to safeguard against 
Medfly risks. The parameters used were, therefore, not contrived but 
linked to the evidence presented. Whereas the values of specific 
parameters may be subject to refinement, the final conclusions are 
robust. They are robust because changes in the assumptions and 
exploration of the effect of changing values (e.g., decreasing the 
effectiveness of cold treatment, increasing the proportion of infested 
fruit) did not change our findings that the probability that a mated 
pair of Medflies could enter into the United States via Spanish 
clementines is very low. Whereas a comparison to a baseline is useful, 
the estimation of the likelihood of introduction even without reference 
to a baseline is valid. That is, if we were to consider a single 
scenario (cold treatment plus limitation of field populations) we would 
not find otherwise. Indeed, we would conclude that, the probability 
that a mated pair of Medflies arrives in a suitable location in the 
United States as part of multiple shipments is low.
    One commenter stated that the RMA fails to track the effect of new 
controls when everything else is equal. The commenter noted that the 
RMA compares the difference between averages with and without controls; 
when what is really required is calculation of a distribution of the 
differences with and without controls. This requires a single Monte 
Carlo analysis that evaluates the baseline and new scenario 
simultaneously, and with

[[Page 64721]]

such analysis, it is clearer when the new controls have an effect and 
the extent of the effect.
    We tested two scenarios independently; one scenario included a 
simulation that used what we termed ``baseline'' input values. Those 
values were associated with no field controls, which are the only 
difference between the baseline and the second ``mitigated'' scenario. 
Both scenarios included cold treatments. The baseline scenario assumed 
that there could be higher populations (up to a maximum 15 percent 
infested fruit) than what is allowable in the mitigated scenario. A 
comparison of the output from these two simulations allowed us to 
obtain a relative estimate of the impact of the proposed mitigation 
measures (namely, the addition of field controls as the single key 
additional mitigation measure).
    One commenter noted that the RMA does not consider the possibility 
of mated Medfly pairs coming from a source other than Spanish 
clementines. The commenter stated that, if the probability for a Medfly 
from another source is higher than the probability from a given 
clementine shipment, it is the single Medfly per shipment, not the 
probability of a male/female pair within a shipment that will matter 
most.
    Given that Medfly is not established in the mainland United States, 
we see no need to assess the scenario posed by the commenter.\23\ 
Indeed, the RMA is based on the assumption that Medfly is not 
established in the mainland United States. The probability that a 
Medfly from another source would mate with a Medfly from Spanish 
clementines is even lower than the probability that a mated pair could 
enter the United States via a shipment of clementines from Spain.
---------------------------------------------------------------------------

    \23\ Hawaii is generally infested with Medfly, but all Medfly 
host commodities moving interstate from Hawaii to the mainland must 
be treated for Medfly prior to movement into a State on the 
mainland.
---------------------------------------------------------------------------

    One commenter stated that the RMA evaluates the probability for a 
mated pair at all locations, and for all suitable locations, using a 
formula that corresponds to Medflies from different shipments being 
unable to get together and mate. The commenter claimed that the 
calculations actually performed do not correspond to the ``worst case'' 
as APHIS implies; they are not upper bounds on the probabilities, but 
instead assume the best possible case. Therefore, they are lower 
bounds.
    The possibility that 9 tons of produce (a single container) are 
distributed within a small area such that output from many containers 
could in effect coalesce and allow for Medflies from many different 
containers to emerge, fly to suitable hosts, find their mates, mate, 
oviposit, etc. is not realistic given the evidence considered in the 
RMA. The RMA uses a formula that evaluates the probability of a mated 
pair in any of multiple, independent containers. That probability does 
not represent a lower bound, but rather a conservative estimate of the 
likelihood of Medfly entry to a suitable location. Assumptions such as 
(1) All containers to all suitable locations will find suitable 
conditions, (2) emerging flies will find suitable hosts at any given 
time, and (3) that the maximum amount (5 percent) of fruit is discarded 
by consumers are all conservative assumptions. Our estimates and the 
formula we used are based on peer reviewed evidence (i.e., Wearing et 
al.).

Trapping, Bait Treatments, Monitoring

    A number of commenters raised concerns about the content of the 
Spanish Medfly management program. One commenter noted that the first 
of the ``minimum criteria'' for a measure that is a required component 
of a systems approach is that the measure be ``clearly defined.'' The 
mitigation requirements of the proposed rule do not meet this standard. 
The proposed rule does not say what kinds of traps are to be used, or 
how many, or by whom, or how the traps should be baited and rotated, or 
what kind of records must be kept. Another commenter claimed that 
without assurance that trapping activities are adequate to determine 
the current pest population in Spain, the effectiveness of a spraying 
program cannot be evaluated.
    The Plant Protection Act defines a systems approach as defined set 
of phytosanitary procedures, at least two of which have an independent 
effect in mitigating pest risk associated with the movement of 
commodities. While the regulatory approach employed by this rule could 
constitute a systems approach by virtue of its two critical control 
points (Medfly population control and cold treatment), in a simple 
sense, the measures referred to by the commenter have no real bearing 
on the calculations of risk contained in the RMA. For this simple 
reason, we do not agree that these measures should be more clearly 
defined than they already have been in the proposed rule. To elaborate, 
we do not believe that a continuing debate about an issue such as what 
fruit fly trap the Spanish use would result in any significant 
improvement to the approach we have chosen. As stated previously in 
this document, details of the Spanish Medfly program, such as the type 
of trap and bait used, the type of bait sprays required, the spacing of 
Medfly traps, and the triggers for bait sprays have no connection to 
our calculations of risk. We also believe that fruit cutting is the 
best available indicator of the level of Medfly infestation of Spanish 
clementines, and the success of this measure is not dependent on any of 
the other measures cited by commenters.
    Three commenters stated that APHIS should delay resumption of 
shipments of Spanish clementines until an aggressive, comprehensive, 
and consistent trapping program fully operated, monitored, and 
documented by Spanish Government officials has been in place through a 
full shipping season.
    The operation of such a program for a full year would have little 
or no bearing on the ability of the safeguards we have chosen to 
provide the risk reduction identified by our analysis. This is to say 
that, regardless of pest populations, trap types, and bait spray 
applications, if Medfly infestations of Spanish clementines are not 
kept at low levels, APHIS will confirm as much via inspection and fruit 
cutting and will refuse to allow those clementines to be exported to 
the United States. If Medfly populations are maintained at low levels 
(levels that cannot be detected via fruit cutting), we are confident 
that cold treatment will ensure a low probability that a viable mated 
pair of Medflies could enter the United States via imported Spanish 
clementines.
    Several commenters expressed concern over servicing and monitoring 
of Medfly traps, application of bait treatments, and recordkeeping 
activities associated with these activities. Some of those commenters 
stated that APHIS should not allow the Spanish citrus industry to 
service and monitor the traps in the production areas or apply bait 
treatments, and argued that the Government of Spain should be given 
those tasks to better ensure compliance with the regulations. Others 
noted that according to the report of the APHIS Technical Review from 
the trip made in December of 2001, Spain has not kept the type of 
records on trapping and bait spraying programs that the work plan 
required them to keep. The commenters questioned why U.S. stakeholders 
should now have confidence that there will be a new commitment by the 
Spanish industry to actually follow an updated protocol when there was 
a failure to follow the previous protocol, and urged APHIS to insist on 
scrupulous adherence to the work plan and regulations, and issue steep 
penalties for not doing so.

[[Page 64722]]

    Under this rule, the Government of Spain or its designated 
representative must keep records that document fruit fly trapping and 
control activities conducted under the Government of Spain's Medfly 
management program. These records must be kept for all areas that 
produce clementines for export to the United States. All trapping and 
control records kept by the Government of Spain or its designated 
representative must be made available to APHIS upon request. APHIS 
inspectors may review those records at any time, and therefore, will be 
able to determine whether the conditions of the regulations and Spain's 
Medfly management program are being complied within areas that produce 
clementines for export to the United States. We agree with the 
commenter that APHIS should be able to insist on compliance with these 
requirements, and we are clarifying in this final rule that APHIS may 
suspend the importation of clementines in any case if we determine 
there is a failure to follow the program requirements. This requirement 
is reflected in the revised Sec.  319.56-2jj(j).
    APHIS has received full cooperation from its Spanish counterparts 
in this matter, and is confident that they will ensure compliance with 
all aspects of this new regulatory approach. To clarify, during its 
site visit in December 2001, APHIS was not able to obtain documentation 
on trapping and bait sprays in clementine production areas not because 
the documentation did not exist, but because there was no central 
repository for the documentation, and because it took some time for the 
Spanish to assemble the appropriate records and forward them to APHIS. 
In January/February 2002, during a second site visit, APHIS received 
all documents requested and these were incorporated into the risk 
management analysis.
    Furthermore, given that we believe trapping is not precise enough 
to accurately determine infestation levels of fruit, while fruit 
cutting is, we do not agree that there is a need for the Government of 
Spain to service and monitor all traps and apply bait treatments. The 
Government of Spain is, however, responsible for maintaining trapping 
records for the program.
    One commenter stated that the rule does not say how that bait 
treatment application rate gets determined, or by whom, or when the 
treatments will be applied. The commenter noted that, according to the 
RMA, the practice in Spain has been to spray when trapping results 
reach a rate of 0.5 flies/trap/day, yet APHIS has provided no 
justification for the 0.5 flies/trap/day trigger for spraying and the 
rule itself does not require it.
    This final rule does not include a trigger for bait sprays in Spain 
because APHIS believes it is the responsibility of Spanish producers to 
provide a product that is minimally infested with Medflies. They may 
accomplish this through whatever bait spraying regimen that they deem 
appropriate, as we have designed a regulatory approach that simply 
requires fruit to be infested at low levels upon inspection prior to 
treatment. The RMA identified the 0.5 fly per trap per day trigger as a 
``key phytosanitary measure,'' however, this designation is not 
appropriate, as the measure has no bearing on the calculations of risk 
contained in the RMA. We have revised the RMA to clarify this fact.
    One commenter noted that the proposed rule specifies that traps 
must be placed in preferred Medfly hosts at least 6 weeks prior to the 
harvest of clementines. The commenter suggested that APHIS remove the 
word ``preferred.''
    We agree with the commenter, as preferred hosts may not be 
available in all areas where trapping may occur, and we have removed 
the word ``preferred'' from Sec.  319.56-2jj(c)(1) in this final rule.
    Several commenters urged APHIS to maintain strict oversight of the 
Spanish clementine import program at all points in the system, and 
requested that industry representatives, university researchers, and 
State Government officials be included in the on-site review process.
    As stated earlier in this document, the Spanish Medfly management 
program must provide that clementine producers allow APHIS inspectors 
access to clementine production areas in order to monitor compliance 
with the Medfly management program, and that all trapping and control 
records kept by the Government of Spain or its designated 
representative must be made available to APHIS upon request. APHIS will 
have inspectors working full time on the verification of the Spanish 
clementine import protocol--including inspections and production area 
monitoring. The inspectors will be present to conduct and monitor fruit 
cutting at the exporting port, and will be able to review records kept 
by the Government of Spain regarding its management program. Only APHIS 
personnel and personnel of Spain's plant protection service will be 
allowed to conduct fruit cutting. The salaries of APHIS inspectors are 
paid by APHIS, but the Government of Spain reimburses APHIS for those 
costs under the requirements of Sec.  319.56-2jj(a).
    APHIS does not see the necessity of including representatives of 
industry, university researchers, and State Government officials in 
site visits. We will, however, make it known to stakeholders when we 
are conducting a site visit, and will invite questions and suggestions 
that we will follow up on in Spain. Upon our return, we will make a 
report of our visit available to interested persons.
    One commenter stated that APHIS should review documentation of the 
execution of Medfly trapping and population reduction sprays before 
fruit is moved into export channels.
    APHIS is confident that review of documentation prior to the 
movement of fruit into export channels is not necessary because our 
risk management measures are designed to protect against the arrival of 
a mated pair of Medflies in the United States regardless of the actual 
infestation level in Spanish production areas. For this reason, we will 
monitor for compliance with Spain's Medfly management generally, but 
will not review the control activities of a given production area as a 
condition of export. As stated previously, we believe that fruit 
cutting is more accurate indicator of the population of Medflies in 
production areas than trapping.
    Two commenters stated that the rule should require the 
establishment of buffer zones in Spain.
    There is no scientific justification for requiring the 
establishment of buffer zones in Spain under this rule, as the 
clementine production areas in Spain are not Medfly-free areas. The 
approach that APHIS has designed accounts for the presence of Medflies 
in the production areas in Spain, and is intended to ensure that the 
prevalence levels remain low, so that fruit presented for export is 
minimally infested. Buffer zones would only be useful if Spain were 
trying to establish and maintain pest-free areas.
    One commenter noted that the APHIS review team found that no fines 
or penalties were issued for noncompliance with the ``mandatory'' fruit 
fly detection and control program in place in 2001, yet the proposed 
rule does not specify any penalties for non-compliance with the 
proposed Medfly management program and does not require that the 
Spanish authorities impose them. The commenter questioned that, given 
their past record, why should the Spanish regulatory officials be 
relied on to enforce compliance with the Medfly management program?
    APHIS agrees that it should have the authority to suspend growers 
from

[[Page 64723]]

participating in the Spanish export program if the grower is not in 
compliance with our regulations, which, by extension, also require 
compliance with Spain's Medfly management program. To provide for this, 
we have added the following statement to paragraph (c) of the 
regulations: ``If APHIS determines that an orchard is not operating in 
compliance with the regulations in this section, it may suspend exports 
of clementines from that orchard.''
    One commenter stated that the proposed rule does not require all 
orchards in a defined area to participate in the Medfly management 
program, yet individual clementine orchards in Spain are very small 
(0.5-2.0 hectares in size), and ``physical barriers to segregate [them] 
are limited to a ledge about 4 inches wide and 6 inches tall.'' The 
commenters noted that adult Medflies may be carried by the wind for 2.4 
km or more, are reported to have migratory movements up to 72 km, and 
are known to fly up to 40 miles, and thus, can easily move from one 
grove to the next; these commenters stated that APHIS has not 
considered what happens when one grower plans to sell fruit to the 
United States and participates in the Medfly management program, while 
a neighboring grower does not.
    As stated previously in this document, our regulatory approach is 
designed to ensure that clementines subjected to cold treatment are 
minimally infested with Medflies. Since all fruit submitted for export 
is sampled, and since fruit cutting will provide a means to reject 
fruit that is found to be infested, we do not believe that the 
proximity of approved orchards to nonapproved orchards is relevant to 
our calculations of risk.
    One commenter stated that there should be an incentive to encourage 
Spanish growers to keep Medfly populations in check, such as requiring 
a previous season average of 1.5 percent infestation, or less, to ship 
to the United States.
    The incentive for the Spanish to keep populations in check is 
simple: If they do not do so, APHIS will determine as much via fruit 
cutting, and will reject shipments intended for export to the United 
States.
    One commenter requested that APHIS approve a pesticide for use in 
the Spanish export program.
    We are considering the commenter's request, and will advise the 
commenter of our findings when our review is complete.
    One commenter stated that APHIS should not specify the pesticides 
to be utilized in Spain's Medfly management program without consulting 
Spain's Ministry of Agriculture, especially considering that the use of 
this type of pesticide changes over time. The commenter stated that the 
regulations should simply state that acceptable pesticides are those 
approved by both APHIS and Spain's Ministry of Agriculture.
    We agree with the commenter that any pesticide used in the Spanish 
Medfly management program should be approved by both APHIS and the 
Government of Spain, and have amended Sec.  319.56.2jj(c)(1) in this 
final rule to reflect this change.

Traceback

    Several commenters stated that APHIS's proposal to traceback to the 
orchard in the event of Medfly detection during fruit cutting is likely 
to be ineffective because (1) Spanish clementine production is 
comprised of thousands of small growers who often commingle their fruit 
with fruit of other small growers at the packinghouse which prevents 
any reliable traceback to the individual grower; and (2) the season for 
Spanish clementines is only a few months, so remedial action that would 
remove a grower from the export program for the remainder of that year 
would have few consequences for the grower, since the grower would have 
already shipped all or most of his fruit for the season by the time 
remedial action was taken. The commenters suggested that remedial 
action should be taken against the packinghouse, not the grower, and 
should affect the packinghouse's ability to export for the present and 
next shipping season, unless the packinghouse provides evidence that 
controls are in place to prevent further failure of the quarantine 
measures.
    We disagree with the commenter. Under the new Spanish export 
program, packinghouses are required to ensure that fruit from one 
orchard is not commingled with fruit from others. In the odd event that 
traceback of an infested fruit does not lead to a single orchard (a 
single producer or a homogenous production unit), APHIS will continue 
traceback to next largest traceable unit. If this means that traceback 
can only go so far as a group of producers who have shipped fruit to 
the same packinghouse, then that entire group of producers will be 
subject to suspension from the program for the shipping season in the 
event that another infested fruit is traced to their orchard or their 
group of producers. It is therefore in the interest of Spanish 
producers to facilitate the accurate traceback of infested fruit to the 
orchard where it was produced. We believe it is appropriate to suspend 
only orchards from the program, and not packinghouses, as suggested by 
the commenter, because packinghouses have no significant role in 
mitigating any Medfly risk posed by exports. Orchard managers, however, 
are responsible for maintaining low levels of Medfly infestation in 
their orchards.
    One commenter stated that if fruit is sampled before it is packed 
in cartons, carton labeling will not help in tracing back infested 
fruit.
    Sampling typically occurs at the port of export, and in some cases, 
at the packinghouse after fruit have been boxed.
    One commenter questioned whether, upon detecting live Medflies in 
clementines submitted for treatment, it is sufficient to remove just 
the single orchard (perhaps just a few acres in size) from the export 
program for the balance of the shipping season since adjacent orchards 
likely have the same Medfly problems.
    As stated in response to previous comments, given our ability to 
determine infestation levels of fruit via fruit cutting, there is no 
need to penalize orchards that happen to be adjacent to orchards with 
higher pest populations. Adjacent orchards may employ very different 
Medfly treatment regimens, and we believe that inspection and fruit 
cutting provides sufficient evidence to determine that fruit is 
minimally infested, even if it is from an orchard adjacent to a highly 
infested orchard.

Eradication

    One commenter stated that the Spanish clementine industry should be 
required to eradicate Medfly, not simply control it.
    As stated earlier in this document, APHIS does not believe the 
Spanish have to be required to eradicate Medfly from their clementine 
production areas in order to export fruit to the United States, 
provided they can adequately mitigate the pest risk posed to the United 
States by their exports. The RMA supports the Secretary's determination 
that it is not necessary to prohibit the importation of clementines 
from Spain, provided that the clementines are subject to the 
requirements contained in this final rule.
    Two commenters stated that, in the event of a Medfly outbreak, 
eradication strategies used in previous years will not be possible. The 
commenters suggested that APHIS has to take that into consideration in 
its analysis, as ``the next Medfly infestation in the

[[Page 64724]]

United States may end agriculture as we know it in the infested 
location.''
    APHIS believes that it has sufficient tools to eradicate any new 
Medfly outbreaks. New technologies, including the use of sterile 
insects, make it possible to eradicate Medfly infestations in areas 
where chemical treatments are not acceptable.

Regulatory Impact Analysis

    Several commenters noted that, in the Regulatory Impact Analysis 
(RIA), APHIS states that the ``probability of a Medfly introduction per 
forty-foot container equivalent is * * * 1.3E-12,'' and it references 
the RMA as the basis for this estimate. The commenters stated that the 
RMA shows the mean probability per shipment (or forty-foot container 
equivalent) to be 2.5E-5, and thus, in the RIA, APHIS incorrectly used 
a probability value that appears to be off by almost seven orders of 
magnitude--i.e., the probability estimate used in the RIA is low by a 
factor of almost 10 million. The commenter claimed that as a result of 
this discrepancy, the RIA cannot support a finding that the rule would 
not have a significant economic impact on a substantial number of small 
entities. The commenters further stated that the RIA also incorrectly 
interprets the RMA as showing that the most likely infestation rate 
(based on the 5-percentile infestation rate from the Monte Carlo 
simulations) is 3.3E-3 percent (0.003 percent).
    APHIS believes these comments highlight the fact that the 
discussion in the economic analysis regarding the infestation rate 
needs clarification. The first number mentioned by the commenter is the 
expected number of introductions \24\ under the default model (see 
Table 4 of the RIA). It is not appropriate to compare the mean mated 
pair probability per shipment reported in the RMA, 2.50E-5, with the 
expected number of introductions. The RIA does not report a mean mated 
pair probability. However, the assumptions made in the RIA having to do 
with risks associated with potential Medfly introductions under the 
proposed rule are in scientific agreement with the information, data, 
and parameters reported in the RMA.
---------------------------------------------------------------------------

    \24\ Refer to the RIA (Sec. 2.1.4) for a discussion of the 
difference between mated pair probabilities per shipment and Medfly 
introductions.
---------------------------------------------------------------------------

    The objective of the RMA was to examine how the offshore risk 
mitigation measures in the proposed rule coupled with cold treatment 
might reduce mated pair probabilities per shipment in comparison to 
cold treatment alone. As such, the RMA employed wide ranges for several 
key parameters, including the infestation rate (the proportion of fruit 
infested with Medflies). The RMA estimated annual introductions under a 
worst case scenario, one in which fruit cutting and rejection of 
shipments did not occur and one in which parameters of the infestation 
rate distributions were specified conservatively. However, the 
regulations impose powerful economic incentives that will more than 
likely lead Spanish growers and exporters to manage Medfly populations 
and select fruit for export to the United States more effectively than 
was assumed in the risk analyses.
    The other major difference between the RMA and the RIA was that the 
RMA simulated levels for the biological model's parameters, including 
the infestation rate, number of larvae per infested fruit, cold 
treatment survival rate, proportion of larvae reaching a suitable area, 
and larval viability, by drawing random numbers from probability 
distributions parameterized using available data (See Tables 4a through 
4c in the RMA.) The RIA used expected values for all of the biological 
model's parameters and therefore employed a certainty-equivalence 
framework. The certainty-equivalence framework (values for biological 
and economic parameters were based on expected values) was used to 
estimate regulatory benefits and costs, based on the RMA and economic 
incentives facing Spanish parties from the proposed regulations.
    The main difference between the RIA and the RMA was that the former 
estimated regulatory costs and benefits for a typical year and the 
latter estimated mated pair probabilities under a worst case scenario. 
In addition, the RIA incorporated the fruit cutting and inspection 
program in the estimation of mated pair probabilities and relevant 
information for use in specifying the infestation rate. If Medflies are 
detected in clementine shipments under the proposed preclearance 
program, shipments will be diverted to other cheaper markets and 
growers may lose the ability to take advantage of the much more 
lucrative U.S. market, which typically offers prices 20 percent higher 
than prices offered in the rest of the world. In addition, if too many 
shipments are rejected, the entire clementine import program may be 
suspended. As a result, exporters will more than likely choose 
shipments designated for the United States from regions in which 
growers experience below average infestation rates and in which growers 
manage Medflies very well.
    Although the RIA uses a lower infestation rate, the two mated pair 
probabilities are not directly comparable, and the divergence is 
completely consistent with the assumptions of the RMA, the economic 
incentives facing clementine growers and exporters in Spain and the 
regulations.
    Two commenters stated that the economic and social impacts 
associated with the proposed rule are not to growers alone, and that 
APHIS must consider the social and economic impacts to farm workers and 
their families, packinghouses and their employees, canneries and their 
employees, the trucking industry and their employees, ports of entry 
and their workers, and local rural economies.
    The economic analysis for the proposed rule did not incorporate 
Medfly introduction costs on other industries that derive income from 
Medfly host crops because (1) there were no data to estimate these 
costs as most Medfly introductions occur in urban areas far removed 
from commercial agricultural production, and (2) the probability that a 
mated pair of Medflies could enter the United States via imported 
Spanish clementines is so low. The analysis for the final rule 
incorporates costs on these related industries.
    One commenter stated that it is critical that USDA evaluate the 
numerous economic impacts of a Medfly infestation in addition to those 
impacts on the citrus industry. The commenter claimed that the economic 
impact analysis should address the fact that other crops are negatively 
affected by the Medfly, and estimate State eradication costs, 
quarantine costs, loss of domestic and foreign markets, and producer 
cultural impacts if Medfly is discovered on U.S. crops.
    The economic analysis for the proposed rule incorporates these 
costs (See section 3.1 Costs Associated with the Proposed Rule, pp. 11-
12). Mean costs of eradicating six recent Medfly introductions in 1997 
and 1998, $10.93 million in 2000 dollars, which includes Federal and 
State expenditures, were used to estimate the impact of a potential 
Medfly introduction on U.S. Federal and State taxpayers. In addition, 
the analysis incorporates the expected impact of potential Medfly 
introductions on producers of Medfly hosts crops in the United States. 
In particular, the $3 million dollar economic impact on producers, 
during an introduction, includes individual monetary estimates 
associated with additional field sprays, post-harvest treatments, fruit 
losses due to yield loss

[[Page 64725]]

and post-harvest treatments, and loss of export markets. The economic 
analysis did not take into account cultural impacts on producers, 
because such costs are difficult to quantify.
    One commenter stated that the RIA does not specifically consider 
the effects of a Medfly outbreak on growers who employ IPM practices, 
and noted that the analysis focuses solely on the cost to the Federal 
Government should a mistake occur and the benefit to the consumer 
without any consideration to the impact on farmers, farms, farm 
workers, families, communities, and the industry.
    The analysis incorporated eradication expenditures of Federal and 
State Governments, which are borne by U.S. Federal and State taxpayers, 
as well as costs borne by producers of Medfly host crops associated 
with additional field sprays, post-harvest treatments, fruit losses, 
post-harvest fruit losses, and loss of export markets during an 
introduction (See section 3.1 Costs Associated with the Proposed Rule, 
pp. 11-12). The economic analysis did not take into account potential 
disruptions of integrated pest management (IPM) programs, because the 
likelihood of such disruptions is small on average, though it may be 
large to individual growers. Most Medfly outbreaks in the United States 
occur in urban areas with little if any commercial crops present. In 
addition, APHIS uses environmentally friendly eradication techniques, 
including use of beneficial-insect friendly cover sprays and mass 
release of sterile adult male Medflies, practices which are completely 
compatible with IPM practices, and in emergency situations, malathion 
bait sprays, which are much friendlier to the environment than 
malathion cover sprays. As a result, current eradication programs, 
which are extremely successful in eradicating the Medfly, would more 
than likely not greatly impact the IPM programs of producers of Medfly 
host crops. The economic analysis for the proposed rule did not 
incorporate Medfly introduction costs on other industries that derive 
income from Medfly host crops. The economic analysis for the final rule 
discusses these costs and points out that, even if every dollar of 
farmer sales of Medfly host crops generated an additional 10 dollars in 
associated industries, inclusion of these additional costs does not 
affect the conclusions of the economic analysis, because the 
probability that a mated pair of Medflies could enter the United States 
via imported Spanish clementines is so low.
    One commenter noted that the economic analysis for the rule states 
that the clementine export season runs from mid-September to late 
February, and stated that the season could actually extend beyond 
February.
    Economic impacts associated with the proposed rule were based on 
annual data, which are independent of the length of actual shipping 
seasons. As a result, the fact that the shipping season could extend 
beyond February will not affect the analysis as written.
    One commenter stated that the RIA cites sources and data indicating 
that imported clementines do substitute for domestic tangerines and 
that the price for tangerines is sensitive to clementine import 
volumes--i.e., the price for tangerines goes up when clementine imports 
are stopped. That being the case, the commenter noted, it seems 
reasonable to expect that the converse would hold true as well--i.e., 
the price for tangerines will go down when clementine imports resume, 
and this should be reflected in the RIA's analysis of competitive 
impact.
    The analysis of the rate of substitution between Spanish clementine 
(clementine) imports and domestically produced tangerines (tangerines) 
conducted in the RIA indicates that clementines do not substitute for 
tangerines in a statistically significant sense (See 3.3.1 Domestic 
Tangerine Market, p. 17-19). Data examined from the Citrus Advisory 
Committee indicated that tangerine prices were higher in 2001 relative 
to 2000, during a period in which clementines were imported in 2000 but 
were not imported in 2001 due to the ban, but that price differences 
were not statistically significant. In addition, the coefficient 
estimate on clementine imports in the inverse demand curve for 
tangerines was negative, indicating clementines and tangerines may be 
substitutes; however, the coefficient estimate again was not 
statistically different from zero. That is, substitutability between 
clementines and tangerines was only apparent and potentially due to 
chance variation in the data. As a result, the substitutability between 
clementines and tangerines could not be confirmed scientifically. 
Because the substitutability could not be confirmed, more tangerines 
are consumed than clementines in the United States, and clementines 
have been imported historically, the RIA did not estimate economic 
impacts on domestic tangerine producers associated with lifting the ban 
on clementines under the new import program.
    One commenter stated that the RIA's assumption that the total cost 
of a Medfly introduction to taxpayers and growers would be only $14 
million ($11 million for taxpayers and $3 million for growers) is 
questionable. The commenter noted that an independent analysis by a 
University of California, Berkeley, economist estimated that a Medfly 
introduction in California would impose increased production and post-
harvest treatment costs ranging from $316 million to $500 million, and 
that if Japan, Korea, Hong Kong, and Taiwan imposed an embargo on 
shipments of fresh produce from the affected areas, it would cost the 
California agricultural industry an additional $564.2 million in lost 
revenues.\25\ The commenter noted that, due to multiplier effects, the 
independent analysis estimates the impact on the California economy 
would ``amount to a $1.2 billion loss in income and a loss of 14,190 
jobs,'' and stated that this estimate is consistent with historical 
experience: Twenty years ago, the 1980-1982 Santa Clara Medfly 
infestation cost $100 million to eradicate and an additional $100 
million in lost sales due to embargoes on commodities grown within the 
quarantined zone.
---------------------------------------------------------------------------

    \25\ Siebert, J. 1999. Update on the economic impact of 
Mediterranean Fruit Fly on California agriculture. Subtropical Fruit 
News. 7(1):16-18.
---------------------------------------------------------------------------

    Mean costs of eradicating six recent Medfly introductions in 1997 
and 1998 ($10.93 million in 2000 dollars, which includes Federal and 
State expenditures) were used to estimate the impact of a potential 
Medfly introduction on U.S. Federal and State taxpayers. In addition, 
the RIA incorporates economic impact associated with a large Medfly 
introduction on producers of Medfly host crops in the United States. 
The $3 million economic impact on producers during a large introduction 
includes individual monetary estimates associated with additional field 
sprays, post-harvest treatments, fruit losses due to yield losses and 
post-harvest treatments, and loss of export markets (See 3.1 Costs 
Associated with the Proposed Rule, p. 11-12). The RIA did not 
incorporate potential impacts in other industries that derive income 
from Medfly host crops, including processors, canners, shippers, and 
export operations, because per introduction estimates of these costs 
were not available; however, the overall conclusions of the analysis 
are not affected when introduction costs are increased ten-fold from 
the $14 million specified in the RIA.
    The independent analysis referred to by commenters estimates costs 
associated with Medfly becoming established in California, including 
those associated with additional

[[Page 64726]]

pesticide use, post-harvest treatments, loss of export markets, and 
losses in industries that derive income from Medfly host crops. As 
such, the analysis points out the devastating impacts Medflies can have 
on producers of Medfly host crops and related industries in California, 
as well as other regions that can sustain Medfly populations, in the 
event Medflies become established. APHIS also recognizes the fact that 
the Medfly is an extremely damaging pest of fruit and vegetable crops 
and that, if left unchecked, could potentially wreak enormous damages 
on agricultural producers and related industries. This is why APHIS has 
developed and instituted the Fruit Fly Cooperative Eradication Program.
    However, we do not believe the costs identified in the independent 
analysis should be used to calculate expected losses to producers of 
Medfly host crops and associated industries resulting from a single 
introduction under the new clementine import program. This is because 
most Medfly introductions occur in urban areas and typically do not 
lead to long-run establishments that affect large agricultural 
production regions. Six recent Medfly introductions in Florida and 
California in 1997 and 1998, the same six introductions that were used 
to estimate Federal and State taxpayer eradication expenses in the RIA, 
were eradicated in an average 9.33 months, measured from the initial 
detection of Medflies to the release of affected areas from quarantine, 
and affected on average only 2.67 counties \26\ Long-run establishments 
adversely affecting large production regions did not result from these 
recent introductions.
---------------------------------------------------------------------------

    \26\ See APHIS. 1999. Exotic fruit fly infestations and 
eradications in the continental United States. Revised November 9, 
1999. Riverdale, MD. P. 15-21.
---------------------------------------------------------------------------

    In addition, the eradication program has been improved considerably 
since the 1980-1982 Santa Clara Medfly infestation. The primary reason 
why the Santa Clara infestation was so expensive to eradicate, and 
expensive for agricultural producers, was because sterile males and 
sterile females were released and a required 100:1 sterile-to-fertile 
Medflies ``overflooding'' ratio was not met. Using the current Sterile 
Insect Eradication Technique (SIT), which has been greatly improved 
since 1982, careful population monitoring and use of cover sprays are 
used to reduce populations in quarantined areas to the required 100:1 
sterile-to-fertile ratio before the release of sterile males only. 
APHIS is modifying its rearing facilities to only produce sterile males 
to allow for a more efficient and effective SIT system to reach the 
required 100:1 ``overflooding'' ratio. Sterile females are no longer 
released with sterile males in order to increase the likelihood that 
only sterile males mate with fertile females. Aerial cover sprays with 
spinosad, an environmentally- and beneficial-insect friendly compound, 
are used over affected agricultural production regions to reduce Medfly 
populations; ground applications of spinosad with backpack sprayers are 
used in urban areas. In emergency situations, APHIS may use malathion 
bait sprays, both aerially and using backpack sprayers and may release 
sterile males in amounts appropriate to achieve an expected 100:1 
sterile-to-fertile individual ``overflooding'' ratio. As a result, 
Medfly introductions, should they occur in the future, will more than 
likely not lead to the devastating economic losses experienced in 1980-
1982.
    One commenter stated that the RIA has taken no account of the 
impacts that pesticide application would have in a variety of areas, 
including destroying beneficial insects used as part of IPM programs, 
creating farm worker safety issues, and raising concerns about 
pesticide residues on the treated produce. For example, the commenter 
noted, because many export markets have not set residue tolerance 
limits for newer (less toxic) pesticides like spinosad, growers 
interested in exporting their product would have to use older, more 
toxic pesticides (such as organophosphates). The RIA also fails to 
consider the impacts that would result from an erosion of consumer 
confidence in the quality and security of the U.S. food supply.
    The RIA did not take into account potential disruptions of IPM 
programs because these costs will more than likely be small, on 
average. Most Medfly outbreaks in the United States occur in urban 
areas with little if any commercial crops present. In addition, APHIS 
coordinates the Medfly eradication program, uses environmentally 
friendly eradication techniques, including use of beneficial-insect 
friendly cover sprays (spinosad) and mass release of sterile adult male 
Medflies, practices which are completely compatible with IPM practices, 
and in emergency situations, malathion bait sprays, which are much 
friendlier to the environment than malathion cover sprays. As a result, 
current eradication programs, which are extremely successful in 
eradicating the Medfly, would more than likely not adversely affect the 
IPM programs of producers of Medfly host crops and create farm worker 
and environmental safety issues.
    However, only the parent compound spinosad has been registered for 
use by organic farmers. The compounds needed to dilute the parent 
compound into a foliar mixture have not been registered for use by 
organic farmers. As a result, organic farmers would not be able to 
market their crops as organic in the event of a Medfly outbreak that 
required the use of a spinosad cover spray, even though the IPM program 
would not be adversely affected. The pesticide industry is currently 
working to get the compounds needed to dilute spinosad into a foliar 
mixture registered for use by organic growers.
    The RIA incorporates costs associated with fruit losses due to 
yield loss, fruit losses due to post-harvest treatments, and losses of 
export markets in the calculation of losses potentially borne by 
agricultural producers in the event of a Medfly introduction. Because 
spinosad is registered for use by organic growers, spinosad residues 
will more than likely not affect market access for Medfly host crops in 
foreign markets, however, such crops might not be marketed as 
``organic.'' The RIA does not incorporate ``impacts that would result 
from an erosion of consumer confidence in the quality and security of 
the U.S. food supply.'' Instead, the RIA incorporates costs associated 
with the value of affected commodities lost due to yield and post-
harvest treatment losses. As for quality effects, we are aware of only 
two studies that estimate levels of pesticide residues on fruits and 
vegetables consumed in the United States, both of which report 
extremely low pesticide residues on produce (See ``The future role of 
pesticides in U.S. agriculture.'' (2000) National Research Council. 
National Academy Press. Washington, D.C., and a reference therein). 
Unfortunately, we are not aware of any studies that have examined 
quality impacts on food associated with Medfly introductions and, as a 
result, cannot incorporate quality impacts quantitatively. The economic 
analysis for the final rule discusses these costs.
    One commenter stated that because of concerns by the U.S. 
Environmental Protection Agency (EPA) and opposition from the public, 
it is far from clear that growers and State officials would be 
permitted to undertake the aerial spraying of pesticides necessary to 
wipe out a Medfly infestation. If that proved to be the case, Medflies 
could become established in growing areas on a long-term basis, with 
enormous cost implications that the RIA does not even begin to 
consider.

[[Page 64727]]

    Aerial spraying of spinosad is approved by EPA for use in 
production agriculture. In addition, ground application of spinosad 
using backpack sprayers is approved for urban areas. Further, the EPA 
has approved malathion bait sprays for emergency situations. Use of 
these technologies, in concert with the mass release of sterile adult 
males, has proven extremely effective in eradicating recent Medfly 
introductions, and APHIS is continuously striving to develop better 
more environmentally friendly eradication techniques. Because current 
technologies have proven so effective in eradicating recent Medfly 
introductions, it is likely that future introductions will not lead to 
long-run establishments of the Medfly. As such, the RIA incorporates 
costs potentially borne by Federal and State taxpayers and agricultural 
producers during an introduction under the assumption that the 
introduction is eradicated successfully.
    Moreover, the RIA assumes that, should an introduction occur, it 
would occur in an agricultural production area, even though most 
introductions occur in urban areas. As a result, the RIA estimates 
Medfly introduction costs conservatively.

Environmental Documentation

    One commenter noted that APHIS did not prepare an environmental 
impact statement (EIS) or an environmental assessment (EA) for the 
proposed rule, nor did it make a specific finding of no significant 
impact (FONSI). The commenter stated that since the RIA vastly 
underestimates the probability of a Medfly introduction, a finding of 
no significant impact based on the RIA would not be supportable. The 
commenter further stated that, because of the significant flaws in the 
RIA, there are serious questions as to the adequacy of APHIS's 
compliance with the requirements of the Regulatory Flexibility Act and 
the National Environmental Policy Act (NEPA).
    We disagree with the commenter that our RIA is flawed, for reasons 
stated earlier in this document. APHIS did not prepare and EIS, EA, or 
FONSI for this rule because we have determined that this action fits 
within the class of actions identified in 7 CFR 372.5(c) as 
categorically excluded from further environmental analysis.
    As noted in Sec.  372.5(c), categorically excluded actions share 
many of the same characteristics as the class of actions that normally 
require EA's but not necessarily EIS's. The major difference between 
categorically excluded actions and actions that require EA's is that 
the means through which adverse environmental impacts may be avoided or 
minimized have actually been built right into the actions themselves.
    We believe that this standard is applicable to the importation of 
Spanish clementines. In this case, we have designed a regulatory 
approach that results in a very low probability that a mated pair of 
Medflies could enter the United States via imported Spanish 
clementines. The only adverse environmental impacts that could be 
associated with the importation of Spanish clementines relate to the 
potential introduction of a pest via that commodity. As stated 
elsewhere in this document, we have determined that risks posed by all 
pests associated with Spanish clementines are mitigated via the 
measures employed in this rule. Hence, the means through which adverse 
environmental impacts are avoided has been built into the rule itself.
    Nonetheless, APHIS has considered the environmental impacts 
associated with eradicating Medflies and other fruit flies from the 
United States in the event that they are introduced. This analysis can 
be found in: ``Fruit Fly Cooperative Control Program, Final 
Environmental Impact Statement'' (2001). (Available on the Internet at: 
http://www.aphis.usda.gov/ppd/es/ppq/fffeis.pdf.)
    One commenter stated that APHIS has not discussed the expected 
economic and environmental impact of its proposal on Spain. The 
commenter claimed that there is no indication whether Spain would have 
the necessary resources to carry out an effective eradication and 
control program and no discussion of the environmental impacts that 
would occur in Spain in association with the requirements of the rule.
    APHIS is not requiring Spain to eradicate Medfly, and therefore, 
there is no need to assess Spain's ability to carry out an eradication 
program. The RIA discusses expected economic impacts on Spain in 
sections 2 (Background) and 3.1 (Costs Associated with the Proposed 
Rule). The Spanish already have an extensive Medfly management program 
in place, and according to the RIA, the additional costs associated 
with following the new risk mitigations called for under the proposed 
rule were small when compared to the value of clementine exports. This 
indicates that Spain will have the necessary resources to carry out an 
effective control program.
    We have also considered this rulemaking under the provisions of 
Executive Order 12114, ``Environmental Effects Abroad of Major Federal 
Actions,'' which ``represents the United States Government's exclusive 
and complete determination of the procedural and other actions to be 
taken by Federal agencies to further the purpose of the National 
Environmental Policy Act, with respect to the environment outside the 
United States, its territories and possessions.'' Inasmuch as virtually 
all impact-generating activities associated with this rulemaking will 
occur outside the United States, the provisions of this executive order 
may be said to apply. We believe, however, that this rulemaking is 
exempt from the procedural requirements of the executive order by 
virtue of the fact that Spain is participating with the United States 
and is otherwise involved in the action (see Sec.  2-3(b) of the 
executive order) and because the action will not have a significant 
effect on the environment outside the United States (Sec.  2-5(a)(i)).

Additional Specific Comments on the RMA and ORACBA Analysis

    One commenter provided a detailed critique of the RMA and the 
ORACBA analysis. The commenter's submission included analysis of some 
of the same data used in the ORACBA analysis to evaluate cold treatment 
and other elements of the model it uses. Several other commenters 
paraphrased or otherwise cited these comments in their own comments, so 
some of the points raised by the commenter have already been discussed 
in detail earlier in this document. We have made changes to the RMA in 
response to some of the commenter's points, as noted in detail below 
and elsewhere in this document. The net effect of these changes was an 
approximate 10-fold decrease in our original estimates of risk, 
suggesting that our original analysis overestimated the risk. The main 
reasons for the reduction in the revised risk estimates were due to 
initial overestimates of the effect of variability and due to 
overestimates in the proportion of a shipment that constitutes a 
hazard. Specific comments are addressed below.

Failure To Correctly Account for Variability

    The commenter stated that the RMA fails to properly account for 
variability and uncertainty.
    Conceptually, the difference between variability and uncertainty is 
clear. Variability refers to random variation that cannot be reduced 
through acquisition of additional information. Uncertainty refers to 
our state of

[[Page 64728]]

knowledge and may be reduced through additional information. A number 
of leaders in the field of risk analysis have drawn attention to cases 
where maintaining a rigorous distinction between uncertainty and 
variability, if possible, may be helpful in risk management 
decisonmaking. For example, if the statutory decisional criteria is 
``reasonable certainty of no harm,'' and this is administratively 
interpreted to mean protecting a hypothetical individual at the 99th 
percentile of the distribution of exposure to an environmental 
contaminant, then it may be useful to consider the uncertainty 
associated with estimating this percentile in the exposure variability 
distribution. In this context, performing so-called 2-dimensional 
uncertainty analysis in which variable and uncertain model inputs are 
separated can lead to statements such as, ``We are 95 percent confident 
that the individual at the 99th percentile in the exposure distribution 
does/not confront serious risk of illness.'' For evaluating the 
expected risk reduction potential of different risk management 
strategies, however, it is not clear that such a distinction between 
variability and uncertainty would be useful.
    Furthermore, while the conceptual distinction between uncertainty 
and variability is clear, the separation can be somewhat artificial or 
vague in practice. Morgan \27\ cautions that while variability and 
uncertainty are different and sometimes require different treatments, 
the distinction can be overdrawn. In many contexts, variability is 
simply one of several sources of uncertainty.\28\ The National Research 
Council Committee that produced Science and Judgment in Risk Assessment 
\29\ acknowledged complications that arise because uncertainty and 
variability work in tandem: Variability in one quantity can contribute 
to uncertainty in another, and the amount of variability is generally 
itself an uncertain parameter. Furthermore, this committee recognized 
that the lack of ``identifiability'' can frustrate efforts to partition 
variability and uncertainty. In the statistical sense, 
unidentifiability means that the parameters of a model cannot be 
estimated from the available information. For example, a single 
observation consists of a variability component (how this individual 
varies from the population mean) and an uncertainty component (e.g., 
measurement error). If there are no matching replicates, a common 
problem in spatial or time series data, then it is impossible to 
empirically estimate the separate variability and uncertainty 
components. This problem has long been recognized, for example, in the 
field of geostatistics where it is referred to as the ``nugget 
effect,'' where geological variation at a scale finer than the 
separation between measurement sites cannot be distinguished from 
uncertainty due to the survey protocol. Although various procedures 
have been developed in an effort to partition the ``nugget'' into 
variability and uncertainty, these procedures are themselves subject to 
uncertainty. Attempts to model ``uncertainty about uncertainty'' can 
lead to infinite regress. More recently, the National Research Council 
\30\ observed, ``[a]lthough the distinction between natural variability 
and knowledge uncertainty is both convenient and important, it is at 
the same time hypothetical. The division of uncertainty into a 
component related to natural variability and a component related to 
knowledge uncertainty is attributable to the model developed by the 
analyst * * * Modeling assumptions may cause ``natural randomness'' to 
become knowledge uncertainties, and vice versa.''
---------------------------------------------------------------------------

    \27\ Morgan, G. 1998. Uncertainty Analysis in Risk Assessment. 
Human and Ecological Risk Assessment 4:25-39.
    \28\ Morgan, M.G., M. Henrion, and M. Small. 1990. Uncertainty: 
A Guide to Dealing with Uncertainty in Quantitative Risk and Policy 
Analysis. Cambridge University Press, Cambridge.
    \29\ National Research Council. 1994. Science and Judgment in 
Risk Assessment. National Academy Press, Washington, DC.
    \30\ National Research Council. 2000. Risk Analysis and 
Uncertainty in Flood Damage Reduction Studies. National Academy 
Press, Wash., DC.
---------------------------------------------------------------------------

    Nevertheless, an effort was made to determine whether there was 
substantial informational value of a two-dimensional uncertainty 
analysis in the case of the risk management analysis for Spanish 
clementines. The two-dimensional uncertainty is represented by a figure 
that is contained in Appendix 3 to the RMA, which includes more 
detailed discussion of this matter.
    As indicated in the figure (and in the Summary Statistics table of 
Appendix 3 of the RMA report), the 95th percentile of the 1-dimensional 
analysis is approximately 2 x 10-5 (1.99E-05). Given 
modeling results of the same order of magnitude (10-5) and 
the presence of additional, unquantified uncertainties (e.g., the 
probability of establishment of a Medfly colony, given one or more 
mated pairs arriving in a suitable location), the difference between 
the results is probably insubstantial and suggests that, at least in 
this case, the 2-dimensional analysis provides little more than 
additional complexity.
Inadequacy of the Chosen Model and Appropriateness of Assumptions
    The commenter claimed that the model used to represent the movement 
of clementines to market appears to be oversimplified to the extent 
that it is likely to give misleading results. The commenter pointed out 
that many assumptions used in RMA may not be appropriate.
    We agree that some assumptions used in the RMA are a simplification 
of the real system; however, we did not try to replicate the real 
system but rather to model it. We aimed to capture key elements that 
represent the system such that our analysis can be informative for 
decisionmaking. For example, the commenter notes that we assume, among 
other things, that all clementines are exactly the same. We acknowledge 
that not all clementines are the same, that not all larvae are the 
same, and that biological systems in general rarely come in identical 
sets. However, our intent was to describe the system in terms of its 
key elements (listed as C1 to C5 in the RMA model), and characteristics 
of these elements, while a simplification, were sufficiently 
descriptive to allow for rational, science-based decisionmaking.
    Again, not all clementines are exactly the same, not all shipments 
are exactly the same, and there are no two boxes of fruit that are 
identical. However, we believe we have captured the key elements of 
variability in our simulation. That is, just because fruit are 
different, it does not follow that such will result in more or less 
fruit in a container, and thus, APHIS believes it has correctly 
described the variation associated with fruit in a container. Further, 
despite the fact that fruit are not the same and may be less or more 
suitable for a larva to complete development, APHIS believes that it 
correctly captures this interaction in its stated variation of survival 
of larvae in fruit to vary from zero to eight.
    We agree with the commenter that the system itself and the 
marketing of fruit has been simplified in our model. We do not agree, 
however, that the system we used is an oversimplification, because we 
believe we have captured those elements that are essential to 
understanding risks posed by imported Spanish clementines. We further 
believe that additional specification and description of the system 
will result in lowered estimates of risk.
    For example, the commenter stated that the division of the United 
States into areas that are strictly suitable and

[[Page 64729]]

unsuitable was an oversimplification. We disagree. It is indeed a 
simplification, but it allows us to correctly and conservatively 
capture the essence of the risk. For example, the State of Texas as a 
whole is considered suitable (as are the entire States of Arizona, 
Alabama, Georgia, South Carolina, Florida, California). However, the 
northern part of Texas (e.g., the ``Panhandle'') does not have 
conditions suitable for Medfly development. That area is arid, winters 
are cold, there are very few hosts available, and conditions are not 
suitable for Medfly to establish. Indeed, it is likely that only the 
areas of Texas that will support Medfly populations are areas where 
citrus \31\ occurs.
---------------------------------------------------------------------------

    \31\ Citrus is used here as an indicator species, and we 
acknowledge that it is not the only Medfly host.
---------------------------------------------------------------------------

    The RMA's inclusion of the entire state of Texas (and other States 
with similarly diverse climatic conditions) as a ``suitable area'' is 
indeed a simplification. It is not, however, a simplification that 
would result in USDA's underestimation of risk. This and other similar 
simplifications employed by the RMA result in conservative estimates, 
not otherwise. For these reasons, we disagree that we have 
oversimplified the system.
    The commenter stated that the RMA assumes that all areas can be 
exactly divided into exactly two classes: One hospitable to Medfly, the 
other completely inhospitable.
    We believe the commenter's assessment is correct, but it fails to 
note that our assumption results in conservative expressions of risk. 
For example, most of the State of Texas is considered suitable for 
Medfly development. Yet this is likely an overestimate because suitable 
hosts do not commonly occur in northern Texas where fruit production is 
secondary and because the conditions in northern Texas are not 
climatically suitable for the development of Medflies. Texas is 
illustrative because large populations of another fruit fly, the 
Mexican Fruit Fly (Anastrepha ludens)(Mexfly) are common and have been 
trapped in large numbers in southern Texas for the past decade. The 
Mexfly is also considered more tolerant of cold than the Medfly. 
Despite its occurrence in south Texas, there never have been 
establishments (or damages of any kind) recorded outside of the 
southernmost tip of Texas where citrus is produced. This is empirical 
evidence, but there is the additional evidence that Medflies have never 
become permanently established in areas where citrus does not occur. 
Thus, the partitioning of the United States into areas suitable and 
unsuitable is an approach that results in conservative estimates 
because we have identified entire States as suitable areas, when, in 
reality, only small portions of those States have all the conditions 
that would provide for the establishment of Medfly.
    The commenter also suggested that Medflies might emerge during 
shipment or transportation. We did not consider this a likely scenario 
because clementines are stored under refrigeration. Typical 
refrigeration dramatically slows or stops the development of these 
insects and thus the emergence during refrigerated storage and 
transport is not considered a significant system component.

Shapes of Distributions/Construction of Distributions

    The commenter suggested that the shapes or constructions of certain 
distributions require refinement.
    We agree with the commenter that one distribution and several 
parameters could be refined. However, our refinements reduced our 
estimates of risk. As such, we reviewed the distribution for component 
1 (number of fruit in shipments). We had previously assumed that the 
fruit in a container would vary uniformly. The assumption of a normal 
distribution is better supported by the evidence. We thus changed the 
distribution used from a Uniform to a Normal, and that change is 
reflected in our final RMA.
    We also chose to simplify our treatment of component 5 of the RMA 
(amount of fruit that ends up in suitable areas) in response to 
suggestions by the commenter. We had previously used a Pert 
distribution. In the final version, we used constants. We selected 
maximum values based on evidence. Constant values were used instead of 
distributions for component 5 because demographic trends represented by 
a maximum will make our analysis valid (in terms of demographic 
expectations) for at least a quarter of a century. Other distributions 
chosen for other components were considered appropriately described by 
the Pert distribution, as specified previously and were not changed. 
Changes were made to some of the values used.
    For example, we previously had estimated that up to 15 larvae could 
occur in each fruit. We revised this value to eight maximum larvae 
based on the evidence provided by Santaballa 1999 and others. We also 
included the evidence from the proportion of fruit that is not consumed 
and is discarded from Wearing et al. and Roberts et al. This evidence 
was suggested by commenters and APHIS agreed that indeed most fruit is 
not discarded but is consumed and that it is important to analyze the 
fruit that constitutes a hazard. By virtue of being eaten, most fruit 
does not pose a risk of Medfly introduction. For that reason, we used 
the maximum value of discarded fruit (5 percent) reported in the 
evidence to determine what proportion of fruit that is shipped to 
suitable areas actually gets discarded.
    We also agreed that our text noted that in estimating the 
probability of a mated pair in multiple containers, these had to 
``coalesce'' in a given area. Whereas, we still believe that all 
containers of interest (because they may lead to fruit fly 
introductions) are limited to areas suitable to the Medfly, we 
clarified in our text that containers do not have to coalesce within a 
specific or relatively limited area. The estimated probability of a 
mated pair simply estimates the probability of a mated pair in 
multiple, independent containers. The commenter provided alternative 
ways to estimate the probability of a mated pair in multiple 
containers. In our final draft we continue to use the formula cited in 
the July 20, 2002, RMA because it is supported by several peer-reviewed 
scientific articles (e.g. Wearing et al.).
    Finally, several commenters were reportedly confused by our 
presentation of multiple results. In the final version of our analysis, 
we present two endpoints: probability of a pair of flies in a single 
shipment and probability of a mated pair in multiple shipments to 
suitable areas. A third estimate (probability of a mated pair in all 
shipments to all areas) presented in the previous draft was eliminated 
because it did not contribute to our explanation.

The Effects of Mitigation Efforts

    The commenter stated that separate Monte Carlo simulations are not 
representative of the modeled systems. He also noted that the separate 
simulations ``might be adequate, if the outputs computed are related to 
quarantine security.''
    This comment implies that our approach is only appropriate if we 
pre-specify a given level of quarantine security or appropriate level 
of protection and compare our results to that level. As stated 
elsewhere in this document, that was not the intent of the RMA. The 
simulations modeled two independent situations; one represents a 
baseline and employs cold treatment but not field controls, and the 
other employs cold treatment and field controls.

[[Page 64730]]

    We did not attempt to relate our output to pre-set levels of 
quarantine security in the risk mitigation document. That is, in 
examining the probability that a mated pair of flies could be 
associated with single or multiple shipments, we did not have in mind a 
pre-set level that would be considered appropriate. We simply conducted 
the analysis, used the simulation process to express our understanding 
of the variability, and reported our results in terms of the 
probability of a mated pair in containers of clementines (single and 
multiple).

Cold Treatment--Extrapolations From Available Evidence

    The commenter states that Baker (1939) and Phillips et al. (1997) 
show that under different conditions (e.g., in different fruit) 
different treatments are required to achieve the same mortality. This 
is speculative, however. Baker (1939, Fig. 3) indicates different 
probit slopes for the response of larvae in all fruits tested vs. the 
response of larvae in all fruits except kamani nut, but the statistical 
discussion is insufficient to determine whether the differences are 
statistically significant. The reported differences also may be due to 
the failure to control for the differential cooling rates among fruits. 
This factor is controlled for by the T107-a treatment schedule, which 
requires that treatment time begins once the internal temperature of 
the fruit has reached the designated temperature. Phillips et al. 
(1997) raises the possibility that ``host fruit may influence mortality 
of fruit flies exposed to cold treatments,'' but provides no test of 
this hypothesis. The hypothesized host effect ignores the possibility 
that variation in larval response to cold treatment within fruit 
species is comparable to the variation between fruit species. It is 
equally plausible that reported differences among studies are due to 
variation among Medfly populations used in different studies or due to 
different rearing or inoculation methods used prior to cold treatment. 
The situation is also clouded by the inability--at treatment efficacy 
levels in the neighborhood of probit 9--of empirically separating 
variability in response due to different experimental methods and 
materials (which are unique for each trial) from the uncertainty in the 
true but unknown proportion of survival. The RMA plausibly assumes that 
uncertainty dominates variability under the treatment conditions and 
commodities relevant to T107-a.
    The commenter also indicated that the ORACBA analysis has 
``probably included'' a 2-day cooldown time. The analysis assumes 
compliance with the T107-a treatment schedule, which specifies that the 
duration of treatment begins once the internal fruit temperature has 
reached the specified treatment temperature.

Outputs and Metrics Used for Comparison

    The commenter noted that our analysis evaluates the wrong outputs. 
Specifically, the commenter argues that a realistic estimate would 
evaluate the risk that all containers are shipped to all areas.
    We disagree that risk is posed by containers sent anywhere in the 
United States. Most fruit that is directed away from suitable areas 
will encounter conditions that will not support Medfly development and 
establishment. We have however, reassessed our presentation of outputs 
in the final version of the risk mitigation analysis. We have clearly 
indicated that our output is expressed in terms of the mean and 95th 
percentile of the distributions. We have also noted that our output 
emphasizes an endpoint describing the probability of a mated pair in a 
container or in multiple containers to suitable areas.

Unjustified Extrapolation

    The commenter noted that the RMA states that the risk posed by 
other Spanish citrus may be similar to that of clementines. The 
commenter claimed that the findings of the RMA might not be applicable 
to other commodities.
    APHIS believes that although the RMA addresses clementines 
specifically, the risk from other Medfly host citrus from Spain may be 
comparable, though there are some specific differences. Other citrus 
are similar, but larger, and thus fewer fruit would be contained in 
shipments, though the number of pests per shipment may be similar.
    Regardless, as a matter of policy, before allowing the importation 
of another type of citrus from Spain, APHIS would conduct additional 
risk analyses in support of such a proposal. A new commodity import 
request would be subject to the rulemaking process.

Analysis of Cold Treatment Data

    The commenter questioned the kind and nature of data used in the 
ORACBA analysis.
    The time-temperature response surface model presented in the ORACBA 
analysis was based on data reported by Back and Pemberton \32\ (Table 
1). The cold treatment temperatures directly relevant to the T107-a 
cold treatment schedule are in the 32-36 [deg]F range. The ORACBA 
analysis correctly listed the cold-storage temperature levels that were 
included in the analysis, with the temperature data coded as indicated 
in parentheses: 32 [deg]F (0 [deg]C), 32-33 [deg]F (0.28 [deg]C), 33-34 
[deg]F (0.83 [deg]C), 34-36 [deg]F (1.67 [deg]C), 36 [deg]F (2.22 
[deg]C), and 36-40 [deg]F (3.33 [deg]C). The ORACBA analysis also 
indicates that the final storage temperature level (36-40 [deg]F) was 
included to inform the high temperature and long duration regions of 
the response surface.
---------------------------------------------------------------------------

    \32\ Back, E.A. and C.E. Pemberton. 1916. Effect of cold-storage 
temperatures upon the Mediterranean fruit fly. Journal of 
Agricultural Research 5:657-666.
---------------------------------------------------------------------------

    The commenter points out, however, that the ORACBA analysis was 
unclear about the data that were used in this portion of the analysis. 
Six--not five, as indicated by the ORACBA analysis--cold storage 
temperature levels were included in the analysis.
    The ORACBA analysis indicated that data from the 40-45 [deg]F 
treatment level were excluded from the analysis but failed to indicate 
that data from the 38-40 [deg]F treatment level were also excluded. The 
ORACBA analysis indicates that the rationale for excluding these data 
from the analysis was to limit the effect of independent variable 
measurement error (i.e., treatment temperature) on the multiple 
regression analysis. Therefore the data used in the response surface 
analysis remain unchanged and are limited to the temperate range most 
relevant to the T107-a treatment schedule.

Analysis Methods

    The commenter stated that the ORACBA analysis did not describe the 
procedure used to empirically estimate the extra-binomial dispersion 
about the cold treatment response surface model.
    The extra-binomial dispersion was estimated to relax the default 
logit regression assumption that the errors about the model are 
binomially distributed. This estimate was obtained by dividing the 
deviance goodness of fit statistic by its degrees of freedom. 
Incorporating the extra-binomial dispersion does not affect the maximum 
likelihood estimates obtained for the regression model parameters; 
therefore, the model predictions are unaffected. Failing to correct for 
over-dispersion, however, causes underestimation of the standard error 
of the parameter estimates and would have resulted in overstating the 
statistical significance of

[[Page 64731]]

the model inputs. The ORACBA analysis (Table 2) indicates that the 
response surface model inputs of time and temperature remain 
statistically significant after allowing for extra-binomial dispersion.

Observed Trends in Data

    The commenter, after re-examining cold treatment data, stated that 
``binomial uncertainties are insufficient to explain the variations 
from the proposed model.''
    Using the same logit model used in the ORACBA analysis, the 
commenter indicates a slightly longer predicted time to achieve the 
probit 9 level of security than presented is presented in Figure 1 of 
the ORACBA analysis. This difference appears to be due to the inclusion 
by the commenter of the data reported by Back and Pemberton for 38-40 
[deg]F treatment level that was excluded by the ORACBA analysis for the 
reasons indicated above. (Note that the commenter's analysis represents 
the logit of probability of survival evaluated using base 10 logarithms 
so that the probit 9 level of security (a 3.2 x 10-5 
probability of survival) takes a value of -4.5 logits.)
    Based on Figure 3.1 of his comment, the commenter judges that the 
binomial confidence bounds are insufficient to explain the variations 
from the proposed logit model. As indicated above, however, the ORACBA 
analysis estimated the extra-binomial dispersion about the logit model. 
Figure A below presents the Back and Pemberton data with the model fit 
according to the ORACBA analysis and extra-binomial confidence bounds. 
Therefore, not only was the model statistically significant, but based 
on Figure A, the fit also appears reasonably good. Note that the 
confidence bounds in Figure A represent uncertainty about the true mean 
response only (i.e., logit model parameter uncertainty). The confidence 
interval for the mean response is a range of plausible values for the 
average of all responses at a given treatment level. The bounds in 
Figure A do not represent a prediction interval for an individual 
response, i.e. a range of plausible values for any single observation 
at a given treatment level. The latter is typically much broader than 
the former because it must account not only for uncertainty about the 
mean but also for individual random variation about the mean response 
for the population. Therefore a prediction interval for Figure A would 
envelope more of the raw data. Only approximate methods are available 
to estimate prediction intervals for non-linear models, however. The y-
axis in Figure A represents the logit of the probability of survival 
evaluated using the natural logarithm so that the probit 9 level of 
security takes a value of -10.3 logits. As indicated by 
Figure 3.1 provided by the commenter, one way of graphically presenting 
zero and 100 percent observed responses is to represent them by error 
bars that run off the bottom and top of the graph, respectively. Zero 
and 100 percent responses reported by Back and Pemberton have been 
omitted from Figure A below to ease visualization. The curves presented 
in Figure A have also been truncated to avoid extrapolation beyond the 
range of experimental observation.
BILLING CODE 3410-34-P

[[Page 64732]]

[GRAPHIC] [TIFF OMITTED] TR21OC02.000

BILLING CODE 3410-34-C

[[Page 64733]]

Models for Time and Temperature Response
    The commenter seems to suggest that only one model form was 
considered in the ORACBA analysis (in equation 1), and that other link 
functions and data transformations were not entertained. The ORACBA 
analysis states, however, that in developing the response surface 
model, it considered three generalized linear model link functions: The 
logit, normit, and complementary log-log. Each was fit with and without 
a logarithmic transformation of time and temperature. Among the models 
considered, the model based on the untransformed data and the logit 
link function in equation 1 was selected on the basis of statistical 
goodness-of-fit criteria.
    The commenter suggests that the response surface model developed 
for the ORACBA analysis is flawed because it fails to take account of 
both variability and uncertainty. The response surface model, however, 
represents only a portion of the quantitative analysis of the efficacy 
of cold treatment. As indicated, the response surface model based on 
the Back and Pemberton data is not intended to elaborate the definitive 
model of Medfly larval response to cold treatment. Instead, the primary 
aim of the analysis was to corroborate whether the existing cold 
treatment schedule fails to achieve the intended level of protection. 
To that end, the robustness of the model was assessed. To do this, 
response surface model predictions (point estimates omitting the 
unexplained variance consisting of variability and uncertainty) were 
compared with confidence intervals constructed about the independent 
results of more recent Medfly larvae cold treatment trials conducted 
under similar time-temperature combinations, as well as recent 
surveillance of shipping operations. In this manner, the complete 
quantitative analysis did take into account both variability and 
uncertainty regarding the response of Medfly larvae to cold treatment.
    As indicated above, the inclusion of the Back and Pemberton data 
for the 38-40 [deg]F treatment level explains the lack of 
correspondence between the parameter estimates obtained by the 
commenter and those reported in the ORACBA analysis.
    The commenter stated that it is unclear why a linear effect of 
temperature was chosen in the response surface model used in the ORACBA 
analysis. The logit regression analysis assumes a linear relationship 
between the independent variables and the logit of the observed 
response. A separate (unreported) analysis testing this assumption 
rejected the hypothesis of no linear relationship between the logit of 
survival and temperature. This is consistent with the finding of the 
commenter that a linear variation between temperature and the logit of 
response may not be ruled out.
    The commenter presents analysis of ``the published data of Baker'' 
on Medfly; however, Baker \33\ only presents figures summarizing data 
analysis, not raw data. Therefore, it is unclear how the commenter 
acquired and analyzed the data. Furthermore, Baker seems to have 
excluded data from treatments where no larvae survived on the basis 
that the lack of survival was regarded as ``not valid experimental 
information.'' Without full disclosure of all data, it difficult to 
judge the analysis.
---------------------------------------------------------------------------

    \33\ Baker, A.C. 1939. ``The Basis for Treatment of Products 
Where Fruit flies are Involved as a Condition for Entry into the 
United States.'' Circular No. 551 US Department of Agriculture, 
Washington, DC.
---------------------------------------------------------------------------

    Based on a regression analysis of data reported by Santaballa et 
al.,\34\ the commenter estimates that more than 18 days of cold 
treatment at 2 [deg]C (35.6 [deg]F) would be required to achieve the 
probit 9 level of security. This result, however, derives from the 
assumed statistical model form. Both Figure 3.5 provided by the 
commenter and Figure 3 of the ORACBA analysis indicate a high level of 
confidence that a 16-day cold treatment at 2 [deg]C (35.6 [deg]F) 
provides a high level of confidence of achieving the probit 9 level of 
security. This observation illustrates that for the purposes of 
revising the regulatory cold treatment schedule, elaborating a 
regression model relating time and temperature to survival needs to be 
interpreted cautiously. The ORACBA analysis notes that uncertainty 
remains regarding what statistical model form best describes the 
observed cold treatment data. The biological mechanism of larval 
mortality due to low temperature is not well understood, but if a 
critical physiological point exists (e.g., beyond which cell walls 
rapidly lose integrity), this might suggest using a discontinuous 
(e.g., splined) model form. Many discontinuous surface modeling 
approaches suffer, however, from a distinctly ad hoc flavor.
---------------------------------------------------------------------------

    \34\ Santabella, E., R. Laborda, and M. Cerda. 1999. ``Informe 
sobre tratamiento frigorifico de cuarentena contra Ceratitis 
capitata (Wied) para exportar mandarinas clementinas a Japon.'' 
Valencia, Spain, Universidad Politecnica de Valencia.
---------------------------------------------------------------------------

    The regression modeling approach employed by the commenter, 
however, is not the only valid approach to evaluating the efficacy of 
phytosanitary risk reduction measures. Instead of relying exclusively 
on a regression results that are contingent on the assumed model form 
being correct, the ORACBA analysis provides an approach whereby the 
efficacy of discrete time-temperature combinations (more recent 
experimental trial and surveillance results) are characterized by 
constructing confidence intervals obtained assuming only that the 
probability of larval survival is beta distributed (i.e., arises from a 
binomial process, as assumed by the commenter's analysis). This 
approach makes no assumption about the underlying form of the 
relationship between cold treatment response and time or temperature 
(e.g., it does not assume that a logit, normit, or complementary log-
log data transformation will be linearizing). Thus, limiting the 
analysis to discrete treatments within the range of time-temperature 
combinations relevant to regulatory decisionmaking has the advantage of 
relaxing or simply avoiding the far more numerous statistical 
assumptions inherent to regression analysis methods. This is of 
particular concern because predictions at the extremely low survival 
levels relevant to phytosanitary programs may be dominated not by the 
observed data but by the assumed statistical model form. For example, a 
heavy-tailed distribution may fit the data as well as a light-tailed 
distribution, but the predictions at very low survival levels will 
differ substantially due to differences in the assumed model form. In 
this case, therefore, simple data analysis making modest, justifiable 
assumptions may be preferable to elaborate regression modeling which 
inherently invokes numerous, often untestable, statistical assumptions.

Miscellaneous Points

    The data presented in the ORACBA analysis (Table 4) correctly 
identify the data for more mature or cold-tolerant larvae used in the 
analysis. Note the discussion in that analysis regarding the 
indeterminate evidence regarding the most cold-tolerant larval stage.
    Regarding the methods used in the ORACBA analysis for obtaining the 
beta distribution parameter estimates, both the method of matching 
moments and the parameterization suggested by the commenter are 
commonly used in the peer-reviewed literature. Some analysts prefer the 
method of moments because it obtains a beta distribution with an 
expected value equal to the sample mean and does not require specifying 
a subjective prior distribution, which is implicit in the 
parameterization

[[Page 64734]]

recommended by the commenter. The method of moments is limited, 
however, in that it cannot handle zero values for r, the number of 
survivors observed after treatment. Therefore, the ORACBA analysis 
employed the method of moments except in the case where r=0.
    The commenter criticized the treatment of zero proportion 
observations as ``bizarre'' and ``misleading,'' but they follow 
directly from the beta distribution parameterization that he 
recommends. Zero value observations in the ORACBA analysis (Figure 4), 
for example, are presented as the median of a beta distribution 
parameterized as [alpha]=r+1, [beta]=n-r+1. It is well recognized that 
estimated proportions of 0 and 1 pose special difficulties for variance 
estimation and calculation of confidence intervals. The commenter takes 
a bounding estimation approach to the problem that handles the 
``special case'' of r=0 or 1 by logical reasoning. This reasoning 
becomes more compelling, however, as the sample size (n) grows larger.
    For the reasons given in the proposed rule and in this document, we 
are adopting the proposed rule as a final rule, with the changes 
discussed in this document.

Incorporation by Reference

    This final rule requires clementines from Spain to be cold treated 
in accordance with treatment T107-a of the PPQ Treatment Manual, which 
is incorporated by reference at 7 CFR 300.1. On October 15, 2002, we 
published in the Federal Register an interim rule (APHIS Docket No. 02-
071-1) that revises treatment T107-a and other cold treatment schedules 
and updates the incorporation by reference for those treatments.

Effective Date

    This is a substantive rule that relieves restrictions and, pursuant 
to the provisions of 5 U.S.C. 553, may be made effective less than 30 
days after publication in the Federal Register.
    We are taking this action in response to a request from the 
Government of Spain and after determining that the restrictions 
described in this final rule will reduce the risk of introduction of 
Mediterranean fruit fly and other plant pests associated with the 
importation of clementines from Spain.
    Immediate implementation of this rule is necessary to provide 
relief to those persons who are adversely affected by restrictions we 
no longer find warranted. The shipping season for Spanish clementines 
begins approximately in mid-September. Making this rule effective 
immediately will allow interested persons to begin shipping Spanish 
clementines to the United States as soon as possible after that time. 
Therefore, the Administrator of the Animal and Plant Health Inspection 
Service has determined that this rule should be effective upon 
signature.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The 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.
    For this final rule, we have prepared an economic analysis. The 
economic analysis provides a cost-benefit analysis as required by 
Executive Order 12866, as well as an analysis of the potential economic 
effects of this rule on small entities, as required under 5 U.S.C. 603. 
The economic analysis is summarized below. See the full analysis for 
the complete list of references used in this document. Copies of the 
full analysis are available by contacting the person listed under FOR 
FURTHER INFORMATION CONTACT, or on the Internet at http://www.aphis.usda.gov/oa/clementine/index.html.
    Under the Plant Protection Act (7 U.S.C. 7701-7772), the Secretary 
of Agriculture is authorized to regulate the importation of plants, 
plant products, and other articles to prevent the introduction of 
injurious plant pests.

Summary of Economic Analysis

    In our analysis, we report estimates of regulatory benefits and 
costs for importers, wholesalers, retail consumers, federal and state 
taxpayers, and Medfly host crop producers in the United States. 
Regulatory benefits associated with U.S. imports of Spanish clementines 
and regulatory costs associated with potential Medfly introductions are 
estimated using an economic model, which incorporates salient features 
of Medfly biology, Medfly field control in Spanish groves, and fruit 
cutting and inspection procedures in the regulations. We estimate 
regulatory benefits and costs with and without limited distribution 
imposed, while focusing on the latter under the assumption that limited 
distribution will not be imposed after the first shipping season during 
a typical year. Regulatory benefits and costs for a typical year in the 
near future are estimated relative to the ban (baseline one), because 
the ban is currently in effect, and relative to the previous import 
program (baseline two), because this provides a useful benchmark for 
measuring relative benefits and costs.
    The economic analysis for the proposed rule (APHIS 2002a) used a 
certainty-equivalence framework (values for biological and economic 
parameters were based on expected values) to estimate regulatory 
benefits and costs, which was based on the risk analysis for the 
proposed rule (APHIS 2002b), the proposed regulations, and economic 
incentives facing Spanish parties. Because key biological and economic 
parameters will likely vary from expected values on an intra- and 
inter-seasonal basis and, more importantly, because the model is 
nonlinear in these parameters, we use Monte Carlo simulation to examine 
benefits and costs in the current analysis, following the approach 
taken in the risk analyses. Other than this change, as well as some 
changes in additional default biological parameters, the current 
analysis is very similar to the economic analysis for the proposed 
rule. As such, the model used in the current analysis draws heavily 
from the economic analysis for the proposed rule and the risk analysis 
for the final rule (APHIS 2002c). In addition, public comments received 
on the economic analysis for the proposed rule indicated that the 
methods used to estimate annual Medfly introductions were not 
adequately explained. Therefore, we provide a detailed discussion of 
the biological model in the analysis accompanying the regulations, 
where, in the interest of transparency, we also provide the computer 
program used to estimate regulatory benefits and costs under the 
default model.
    The results of our analysis indicate that regulatory benefits will 
outweigh regulatory costs relative to both baselines. Expected 
regulatory gains per year are roughly $207 million relative to the 
current ban (baseline one), including $118, $59, and $30 million in 
expected gains for importers, wholesalers, and consumers, respectively, 
with practically no increase in expected costs for federal and state 
taxpayers and agricultural producers in the United States associated 
with Medfly introductions. In addition, the regulations save an 
estimated $47,000 in annual Medfly introduction costs potentially 
incurred under the previous import program. Because import levels under 
the regulations will more than likely exceed import levels under the 
previous import program, net welfare associated with international 
trade in Spanish clementines under the regulations is expected to 
exceed net welfare under the previous import program by an average $23 
million per

[[Page 64735]]

year. That is, net regulatory welfare relative to the second baseline 
is $23 million per year.

Regulatory Costs in Spain

    Regulatory costs in Spain include purchases of additional Medfly 
traps for producers, purchases of baits for the traps, monitoring and 
record keeping costs, additional bait spray costs, additional cold 
treatment costs, and trust fund expenses. Total annual trap and bait 
expenses for all Spanish growers under the regulations are only $660, 
or 8.39E-04% of average export market value during 1999 and 2000 
($78.69 million, FAS 2002). Total annual trust fund expenses for the 
Spanish government, or its agent, are estimated to be at least $90,000, 
including 16.15% administrative overhead (West 2002), or 1.14E-01% of 
average export market value during 1999 and 2000. Total annual cold 
treatment expenses for all exporters average $1.12 million (+/- $13 
thousand) per year, which is 1.42% of average export value during 1999 
and 2000, representing a significantly larger cost on exporters. 
Because the U.S. market is lucrative relative to markets in the rest of 
the world and because dramatic price declines in Europe associated with 
the Spanish clementine ban in the United States indicate that European 
markets are saturated at recent export levels, we assume that 
additional cold treatment expenses will not affect supply in the short 
run.
    We were unable to estimate additional costs associated with 
monitoring and record keeping in Spanish groves, which producers will 
be required to pay; however, these costs will likely be low. It is not 
clear if or by how much annual bait sprays and spray costs may 
increase; however, these costs may be borne entirely by federal and 
local governments in Spain and therefore not affect production 
decisions. Because the preceding regulatory costs are low relative to 
the gross value of the U.S. market and because alternative foreign 
markets for Spanish clementine growers appear to be saturated at recent 
export levels, we assume that export supply is perfectly inelastic with 
respect to U.S. import prices. As a result, marginal production and 
export costs borne by Spanish parties are not passed on to U.S. 
importers, wholesalers, and retail consumers. The assumption of 
perfectly inelastic supply is appropriate for a short-run analysis such 
as this and does not substantially affect the results of the analysis. 
Furthermore, assuming inelastic supply allows us to estimate clementine 
import levels and therefore Medfly introduction costs conservatively, 
the latter of which increase with import levels.

Fruit Cutting and Rejection Costs

    Fruit cutting and rejections of inspectional units in Spain and 
fruit cutting in the United States reduces U.S. clementine imports by 
an average 4.91% under the default model (0.99% of average export value 
for 1999 and 2000), leading to reductions in revenues for importers and 
wholesalers, consumer benefits, and expected Medfly introduction costs. 
Fruit will be cut and inspected in Spain at a rate of 200 clementines 
per inspectional unit, which can include as many as 555 pallets, with 
exporters choosing the size of the inspectional unit. Losses may also 
include rejections of inspectional units, where the rejection rate will 
depend on the proportion of fruit that is infested with Medflies in 
inspectional units (the infestation rate). A fruit cutting and 
rejection program occurs at the U.S. port. The economic model 
incorporates the effects of the fruit cutting and inspection programs 
in Spain and in the United States, including the rejection of 
inspectional units, on U.S. import levels and therefore on regulatory 
costs and benefits.

Medfly Introduction Costs

    Because current techniques and technologies used by APHIS have 
proven safe and effective in eradicating recent Medfly introductions 
and because most introductions occur in urban areas, we assume that 
introductions associated with Spanish clementine imports will not lead 
to long-run Medfly establishments in the United States. Annual Medfly 
introduction costs are given by the product of the expected number of 
introductions and an estimate of the cost of one introduction. We use 
the mean cost of eradicating six recent Medfly introductions in 
California and Florida during 1997 and 1998 in 2000 dollars, rounded up 
to $11 million, as our measure of federal and state taxpayer costs per 
introduction (APHIS 1999). Additional costs borne by producers of 
Medfly host crops during an introduction (additional field sprays, 
post-harvest treatments, fruit losses, post-harvest fruit losses, and 
loss of export markets) are based on producer cost estimates for a 
large introduction ($2.56 million) rounded up to $3 million (Vo and 
Miller 1993). Total taxpayer and industry costs associated with a 
potential Medfly introduction are therefore $14 million in the default 
model.
    Because eradication technologies are safe and effective and because 
most introductions occur in urban areas, Medfly introductions resulting 
from the importation of clementines from Spain will more than likely 
not lead to long-run establishments adversely affecting agricultural 
production regions in the United States. As a result, we do not 
incorporate all of the potential costs associated with a potential 
Medfly introduction for four reasons. First, we do not have data to 
estimate all of the potential costs. Second, in the aggregate these 
additional costs will likely not, on average, increase total regulatory 
costs significantly. At the same time, however, we recognize that some 
of these costs may be substantial for individual growers. Third, 
although most Medfly introductions occur in urban areas, we assume, for 
the purpose of estimating Medfly introduction costs, that any 
introduction occurs in a Medfly host production region in the United 
States. As a result, we may be overestimating Medfly introduction costs 
in the current analysis. Finally, even if we were to increase Medfly 
introduction costs by a factor of ten, regulatory costs would not 
increase significantly and the conclusions of the economic analysis 
would not be affected. (Please see subsection 2.1.3 Medfly Introduction 
Costs in the economic analysis accompanying the regulations for more 
detail on the specification of Medfly introduction costs.)

Medfly Introductions

    The number of Medfly introductions per year is given by the product 
of the number of forty-foot containers imported into areas in the 
United States suitable for the development of Medfly offspring and the 
probability that at least one adult male and one adult female (mated 
pair) survive the export process, in discarded fruit, per forty-foot 
container. We recognize the fact that, for a Medfly introduction to 
occur, it will be necessary for mated pairs to survive in their new 
environments long enough to find suitable hosts, for females to 
oviposit eggs in fruits that are sufficiently mature, for eggs to 
survive heat, cold, parasitism and disease, and for the eggs to develop 
into larvae that survive to adulthood and reproduce successfully. The 
effect of these other variables on the ability of a mated pair to 
survive, reproduce, and spread would, in all cases, further reduce the 
likelihood that Medflies could be introduced into the United States. 
Because data were not available to estimate the effects of these 
variables on Medfly introductions, our estimates may overstate the 
number of Medfly introductions that may actually occur,

[[Page 64736]]

leading to conservative estimates of Medfly introduction costs under 
the regulations and under the previous import program.
    We estimate the probability that at least one mated pair survives 
the export process, in discarded fruit, for each forty-foot container 
that passes fruit cutting and inspection in Spain and in the United 
States, using the biological model reported in the risk analyses (APHIS 
2002b, c). Importantly, the simulations incorporate likely variability 
in Spanish clementine export levels to the United States, which will 
contribute to variability in mated pair probabilities per shipment and 
therefore regulatory costs associated with Medfly introductions. 
Specifically, designated export quantities are drawn from a probability 
distribution with a minimum value of 83,631 metric tons, a most likely 
value of 90,032 metric tons, and a maximum value of 116,406 metric 
tons. The minimum value is based on the import quantity for marketing 
season 2000, the most likely value is based on the rate of growth in 
imports between marketing seasons 1999 and 2000, and the maximum value 
is based on the average annual rate of import growth during 1989-2000.
    The risk analyses (APHIS 2002b, c) examined how the difference in 
maximum infestation rates under the regulations and under the previous 
import program reduces the probability of a mated pair entering the 
United States, specifying a very wide range for the infestation rate 
under the regulations and a relatively wider range under the previous 
import program. The risk analyses estimated annual introductions under 
a worst case scenario, one in which fruit cutting and rejection of 
inspectional units did not occur and one in which parameters of the 
infestation rate distributions were specified conservatively. However, 
the regulations impose powerful economic incentives that will more than 
likely lead Spanish growers and exporters to manage Medfly populations 
and select fruit for export to the United States more effectively than 
was assumed in the risk analyses.
    If Medflies are detected in clementine shipments under the new 
preclearance program, shipments will be diverted to other cheaper 
markets and growers may lose the right to take advantage of the much 
more lucrative U.S. market, which typically offers prices 20% higher 
than prices offered in the rest of the world. In addition, if too many 
shipments are rejected, the import program will likely be suspended, 
leading to significant reductions in clementine prices received 
worldwide. As a result, exporters will more than likely choose 
shipments designated for the United States from regions in which 
growers experience below average infestation rates and in which growers 
manage Medflies very well. Further, although the risk analyses set the 
maximum infestation rate in Spanish groves at 1.50E-02 under the 
regulations in order to estimate mated pair probabilities 
conservatively, the infestation rate that suspends the import program 
is 1.60E-03 (0.16% fruit infested with Medflies) when the effectiveness 
of inspectors in identifying infested fruit is fixed at 75%. Because we 
estimate regulatory costs and benefits in the current analysis during a 
typical year, as opposed to regulatory costs and benefits under a worst 
case scenario, we set the maximum infestation rate at 1.60E-03, under 
the assumption that APHIS inspectors correctly identify an infested 
fruit 75% of the time. We believe that this specification of the 
maximum infestation rate is consistent with Spanish grower and exporter 
profit maximization under the regulations and therefore more 
appropriate for use in the current analysis. An implicit assumption 
made in the risk analyses is that APHIS inspectors never correctly 
identify an infested fruit in order to provide a conservative estimate 
of the number of potential Medfly introductions under the regulations. 
We base the 75% inspection efficacy on data reported in the risk 
analyses. (See subsection 2.1.2 Fruit Cutting and Rejection Costs in 
the economic analysis accompanying the regulations for information on 
the specification of inspection efficacy.)
    In addition, according to sources cited in the risk analyses, the 
infestation rate in fruit received by Spanish packinghouses ranged 
between zero and 1.50E-03, with the latter being associated with poorly 
managed fields. The most likely infestation rate in the risk analysis 
was set at 1.00E-03, which is only 33 and 38% lower than the 
infestation rate associated with poorly managed fields (1.50E-03) and 
the infestation rate that suspends the import program (1.60E-03), 
respectively. In addition, the risk analyses state that the most likely 
infestation rate could have been set at zero, because live Medflies 
were never observed in Spanish clementine shipments during 1985-2000. 
Because the regulations provide strong profit incentives for Spanish 
growers to manage Medfly populations effectively and for exporters to 
choose clementines from Spanish groves that are not poorly managed, the 
most likely infestation rate will more than likely be lower than the 
specification in the risk analyses, which was chosen conservatively. We 
therefore set the most likely infestation rate equal to the most likely 
infestation rate specified in the risk analyses, 1.00E-03, multiplied 
by (1.60E-03/1.50E-02), the proportional difference between the 
infestation rate that leads to suspension of the import program and the 
maximum infestation rate specified in the risk analyses. (See 
subsection 2.1.4 Medfly introductions in the economic analysis 
accompanying the regulations for a more detail.) Again, we believe that 
this specification of the most likely infestation rate is consistent 
with Spanish grower and exporter profit maximization under the 
regulations and therefore an appropriate specification for the current 
analysis. However, we also estimate regulatory benefits and costs using 
the infestation rate distribution specified in the risk analyses in 
order to ensure the reader that the same biological models are used in 
the current analysis and the risk analyses and in order to examine 
regulatory welfare under the more conservative distributional 
specification.
    Under the default model, that is, under typical Medfly pressure and 
effective field control in Spain, annual Medfly introduction costs in 
the United States average less than $10 per year, because the expected 
number of introductions is very low. Even when the infestation rate 
distribution is taken from the risk analyses (which do not consider 
economic incentives facing Spanish growers and exporters under the 
regulations and which set fruit cutting and inspection efficacy at 0%), 
introduction costs average less than $300 per year, with expected 
introductions per year remaining very low. Under the previous import 
program, Medfly introduction costs average roughly $47 thousand per 
year, which is 5.93E-02% of average export value during 1999 and 2000. 
These results indicate that expected Medfly introduction costs increase 
with the average infestation rate. However, the percent change in 
Medfly introduction costs for every percent change in the infestation 
rate (the infestation rate elasticity of introduction costs) declines 
as the infestation rate increases, because the rate inspectional units 
are rejected in Spain increases with the infestation rate. In addition, 
introduction costs stop increasing with infestation rates at or above 
the rate that leads to rejection of 100% of the inspectional units in 
Spain. Because the rate inspectional units are rejected increases 
rapidly with the

[[Page 64737]]

infestation rate and because the import program will likely be 
suspended if too many units are rejected, the regulations will likely 
be effective in terms of preventing Medfly introductions into the 
United States, regardless of how high the average annual infestation 
rate may be.

The Clementine Market

    Clementines are not grown domestically in significant quantities; 
therefore, U.S. consumption during the last 15 years (Snell 2002) has 
depended on imports from Spain, which contributed 90% of total U.S. 
imports during 1996-2000 (FAS 2002). Between 1991 and 2000, Spain's 
annual production of clementines averaged slightly over 1.1 million 
metric tons. During 1991-2000, Spain exported most of its clementines 
to Germany, France, the United Kingdom, and the Netherlands; however, 
exports to the United States grew 45% per year during this period, even 
though clementine production in Spain grew only 2% per year (FAS 1996-
2001, MAPA 1999). The phenomenal growth in exports to the United States 
has been due to increased demand, leading to higher import prices in 
the United States relative to import prices in the rest of the world. 
During 1989-2000, prices offered by U.S. importers averaged 20% higher 
than prices offered by all other importing countries, providing 
incentives sufficient for exporters to ship an average annual 6% of 
total exports to the United States in 1999 and 2000.
    Spain typically exports clementines to the United States during 
mid-September to mid-March. Morocco, Italy, and Israel also export 
clementines to the United States during this period; however, during 
1996-2000, only 2 and 0.1% of U.S. clementine imports were from Morocco 
and Italy, respectively, and during 1998-2000, only 0.4% of U.S. 
clementine imports were from Israel. This suggests that exporters in 
these countries have not established export market infrastructures 
sufficient to enable significant increases in shipments to the United 
States in the short run. In addition, clementines from these countries 
are typically of lower quality as reflected in lower average prices 
paid by U.S. importers. As a result, it is assumed that exports from 
Morocco, Italy, and Israel will not be able to fill the void left by 
the ban on Spanish clementines in the short run.
    It is not clear whether clementine imports and domestically 
produced tangerines (Citrus reticulata) may be substitutes for U.S. 
consumers. Pollack and Perez (2001) have suggested that the two types 
of citrus may be substitutes; however, they did not estimate a 
substitution rate. We estimate the rate of substitution using a linear 
relationship between tangerine prices received by U.S. producers, a 
constant, wholesale tangerine consumption, and U.S. clementine imports. 
Substitutability between clementines and tangerines could not be 
confirmed statistically; that is, the analysis showed little 
substitution between domestic tangerines and clementines. In addition, 
there are differences between Spanish clementines and tangerines, which 
may be important for U.S. consumers. In particular, clementines are 
seedless and packaged in decorative wooden boxes; whereas domestically 
produced tangerines are generally not seedless and are marketed in bulk 
quantities. Moreover, U.S. consumption of domestically produced 
tangerines (233,147 metric tons) was almost three times higher than 
consumption of clementines (83,631 metric tons) in 2000. Finally, until 
the ban in the fall of 2001, clementines had been imported into the 
United States for 15 years. As a result, we do not estimate regulatory 
impacts on U.S. tangerine producers.

Results of the Economic Analysis

    The results of the analysis indicate that regulatory benefits will 
likely outweigh regulatory costs relative to both baselines. Expected 
regulatory gains are roughly $207 million relative to the current ban 
(baseline one), including $118, $59, and $30 million in expected gains 
for importers, wholesalers, and consumers, respectively, with 
practically no increase in expected costs for federal and state 
taxpayers and agricultural producers in the United States. As a result, 
expected regulatory gains are much higher than expected regulatory 
costs relative to the current ban, because imports are positive and 
introduction costs are minimal under the regulations. In addition, due 
to the trend exhibited in the import data during 1989-2000, import 
levels under the regulations will more than likely exceed import levels 
under the previous import program. Furthermore, expected Medfly 
introduction costs under the previous import program are much higher 
than expected Medfly introduction costs under the regulations. As a 
result, net gains under the regulations are expected to exceed net 
gains under the previous import program by an average $23 million 
(baseline two), which is due almost entirely to higher imports under 
the former. (See chapter 3 in the economic analysis accompanying the 
regulations for a more complete discussion of regulatory welfare 
impacts.)

Regulatory Effects on Small Entities

    The U.S. Small Business Administration defines a small agricultural 
producer as one with annual sales receipts less than or equal to 
$750,000. We do not know whether the majority of producers of Medfly 
host crops (NAICS 111310 Orange Groves, NAICS 111320 Citrus (except 
Orange) Groves, NAICS 111331 Apple Orchards, NAICS 111332 Grape 
Vineyards, NAICS 111333 Strawberry Farming, NAICS 111334 Berry (except 
Strawberry) Farming, NAICS 111335 Tree Nut Farming, NAICS 111336 Fruit 
and Tree Nut Combination Farming, and NAICS Other Noncitrus Fruit 
Farming) in the United States are designated as small entities. 
However, regulatory costs on producers of Medfly host crops will more 
than likely not be significant, because Medfly introduction costs are 
low under the regulations, regardless of Medfly pest pressure and field 
control in Spain. As a result, the regulations will likely not have a 
significant economic impact on a substantial number of small Medfly 
host crop producers in the United States.
    There are approximately 15 Spanish clementine importers in the 
United States, three of which import the majority of clementines. In 
addition, individuals in foreign countries own at least two of the 
import companies in this list. It is not clear if the majority of U.S. 
clementine importers are designated as small entities by the SBA. These 
entities include fresh fruit and vegetable wholesalers (NAICS 422480) 
with 100 employees or less. In addition, the number of small 
wholesalers potentially affected by the regulations is not known. Small 
wholesalers include wholesalers and other grocery stores (NAICS 445110) 
with annual sales receipts of $23 million or less, warehouse clubs and 
superstores (NAICS 452910) with annual sales receipts of $23 million or 
less, and fruit and vegetable markets (NAICS 445230) with annual sales 
receipts of $6 million or less. Because the percentage of income 
derived from the sale of clementines by wholesalers is likely to be 
low, the regulations will likely not have a significant negative impact 
on any small wholesalers relative to either baseline. In addition, 
small importers and wholesalers will likely be better off under the 
regulations relative to the current ban and, during growing seasons 
characterized by typical Medfly pressure in Spanish groves and 
effective field control, better off under the

[[Page 64738]]

regulations relative to the previous import program.
    As a result, the regulations will likely not have a significant 
negative impact on small importers relative to either baseline. 
Further, because import levels will more than likely increase under the 
regulations, the effect of the average 2.5 days of additional cold 
treatment expenditures borne by Spanish exporters, which recall amount 
to 1.42% of average export value during 1999 and 2000, will likely not 
lead to a significant price increase, even under the unlikely situation 
in which all of the additional cost is borne by U.S. importers. Because 
historical markets for Spanish clementines in Europe appear to be 
saturated at recent import levels, export supply to the United States 
may not be extremely elastic, at least in the short run, because U.S. 
prices will remain higher than prices in European markets under the 
regulations, and Spanish exporters will not be able to divert supplies 
to other markets in response to the extra cold treatment costs without 
experiencing concomitant price declines in those markets. As a result, 
Spanish exporters will likely export similar and increasing quantities 
of clementines to the United States, until such time that Spanish 
clementine production has a chance to respond to changes in the world 
market associated with the regulations. Finally, during growing seasons 
in which Medfly pressure is atypically high and field control is 
ineffective, a higher percentage of shipments designated for export to 
the United States may be diverted to other markets, reducing import 
levels, raising import prices, and reducing regulatory gains for small 
importers relative to the previous import program. In addition, because 
clementine imports will more than likely be lower during the first 
shipping season, small importers and wholesalers will likely not 
realize regulatory gains equal to the previous import program, as 
imports will more than likely be lower than earlier levels.
    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 allows clementines to be imported into the United 
States from Spain. State and local laws and regulations regarding 
clementines imported under this rule will be preempted while the fruit 
is in foreign commerce. Fresh clementines 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 0579-0203.

List of Subjects in 7 CFR Part 319

    Bees, Coffee, Cotton, Fruits, Honey, 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:

PART 319--FOREIGN QUARANTINE NOTICES

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

    Authority: 7 U.S.C. 166, 450, 7711-7714, 7718, 7731, 7732, and 
7751-7754; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

    2. A new Sec.  319.56-2jj is added to read as follows:


Sec.  319.56-2jj  Administrative instructions; conditions governing the 
importation of clementines from Spain.

    Clementines (Citrus reticulata) from Spain may only be imported 
into the United States in accordance with the regulations in this 
section.
    (a) Trust fund agreement. Clementines from Spain may be imported 
only if the Government of Spain or its designated representative enters 
into a trust fund agreement with the Animal and Plant Health Inspection 
Service (APHIS) before each shipping season. The Government of Spain or 
its designated representative is required to pay in advance all 
estimated costs that APHIS expects to incur through its involvement in 
overseeing the execution of paragraphs (b) through (g) of this section. 
These costs will include administrative expenses incurred in conducting 
the services enumerated in paragraphs (b) through (g) of this section 
and all salaries (including overtime and the Federal share of employee 
benefits), travel expenses (including per diem expenses), and other 
incidental expenses incurred by the inspectors in performing these 
services. The Government of Spain or its designated representative is 
required to deposit a certified or cashier's check with APHIS for the 
amount of the costs estimated by APHIS. If the deposit is not 
sufficient to meet all costs incurred by APHIS, the agreement further 
requires the Government of Spain or its designated representative to 
deposit with APHIS a certified or cashier's check for the amount of the 
remaining costs, as determined by APHIS, before the services will be 
completed. After a final audit at the conclusion of each shipping 
season, any overpayment of funds would be returned to the Government of 
Spain or its designated representative or held on account until needed.
    (b) Grower registration and agreement. Persons who produce 
clementines in Spain for export to the United States must:
    (1) Be registered with the Government of Spain; and
    (2) Enter into an agreement with the Government of Spain whereby 
the producer agrees to participate in and follow the Mediterranean 
fruit fly management program established by the Government of Spain.
    (c) Management program for Mediterranean fruit fly; monitoring. The 
Government of Spain's Mediterranean fruit fly management program must 
be approved by APHIS, and must contain the fruit fly trapping and 
recordkeeping requirements specified in this paragraph. The program 
must also provide that clementine producers must allow APHIS inspectors 
access to clementine production areas in order to monitor compliance 
with the Mediterranean fruit fly management program.
    (1) Trapping and control. In areas where clementines are produced 
for export to the United States, traps must be placed in Mediterranean 
fruit fly host plants at least 6 weeks prior to harvest. Bait 
treatments using malathion, spinosad, or another pesticide that is 
approved by APHIS and the Government of Spain must be applied in the 
production areas at the rate specified by Spain's Medfly management 
program.
    (2) Records. The Government of Spain or its designated 
representative must keep records that document the fruit fly trapping 
and control activities in areas that produce clementines for export to 
the United States. All trapping and control records kept by the 
Government of Spain or its designated representative must be made 
available to APHIS upon request.

[[Page 64739]]

    (3) Compliance. If APHIS determines that an orchard is not 
operating in compliance with the regulations in this section, it may 
suspend exports of clementines from that orchard.
    (d) Phytosanitary certificate. Clementines from Spain must be 
accompanied by a phytosanitary certificate stating that the fruit meets 
the conditions of the Government of Spain's Mediterranean fruit fly 
management program and applicable APHIS regulations.
    (e) Labeling. Boxes in which clementines are packed must be labeled 
with a lot number that provides information to identify the orchard 
where the fruit was grown and the packinghouse where the fruit was 
packed. The lot number must end with the letters ``US.'' For the 2002-
2003 shipping season, boxes must also be labeled with the following 
statement ``Not for distribution in AZ, CA, FL, LA, TX, Puerto Rico, 
and any other U.S. Territories.'' All labeling must be large enough to 
clearly display the required information and must be located on the 
outside of the boxes to facilitate inspection.
    (f) Pre-treatment sampling; rates of inspection. For each shipment 
of clementines intended for export to the United States, prior to cold 
treatment, APHIS inspectors will cut and inspect 200 fruit that are 
randomly selected from throughout the shipment. If inspectors find a 
single live Mediterranean fruit fly in any stage of development during 
an inspection, the entire shipment of clementines will be rejected. If 
a live Mediterranean fruit fly in any stage of development is found in 
any two lots of fruit from the same orchard during the same shipping 
season, that orchard will be removed from the export program for the 
remainder of that shipping season.
    (g) Cold treatment. Clementines must be cold treated in accordance 
with the Plant Protection and Quarantine (PPQ) Treatment Manual, which 
is incorporated by reference at Sec.  300.1 of this chapter. Upon 
arrival of clementines at a port of entry into the United States, APHIS 
inspectors will examine the cold treatment data for each shipment to 
ensure that the cold treatment was successfully completed. If the cold 
treatment has not been successfully completed, the shipment will be 
held until appropriate remedial actions have been implemented.
    (h) Port of entry sampling. Clementines imported from Spain are 
subject to inspection by an inspector at the port of entry into the 
United States. At the port of first arrival, an inspector will sample 
and cut clementines from each shipment to detect pest infestation 
according to sampling rates determined by the Administrator. If a 
single live Mediterranean fruit fly in any stage of development is 
found, the shipment will be held until an investigation is completed 
and appropriate remedial actions have been implemented.
    (i) Limited distribution. For the 2002-2003 shipping season, 
clementines from Spain may not be imported into, or distributed within, 
the following U.S. States and Territories: Arizona, California, 
Florida, Louisiana, Texas, Puerto Rico, the U.S. Virgin Islands, the 
Northern Mariana Islands, Guam, or American Samoa.
    (j) Suspension of program. If APHIS determines at any time that the 
safeguards contained in this section are not protecting against the 
introduction of Medflies into the United States, APHIS may suspend the 
importation of clementines and conduct an investigation into the cause 
of the deficiency.
    (k) Definitions.
    Lot. A number of units of clementines that are from a common origin 
(i.e., a single producer or a homogenous production unit \1\).
---------------------------------------------------------------------------

    \1\ A homogeneous production unit is a group of adjacent 
orchards in Spain that are owned by one or more growers who follow a 
homogenous production system under the same technical guidance.
---------------------------------------------------------------------------

    Orchard. A plot on which clementines are grown that is separately 
registered in the Spanish Medfly management program.
    Shipment. (1) Untreated fruit. For untreated fruit, the term means 
one or more lots (containing no more than a combined total of 200,000 
boxes of clementines) that are presented to an APHIS inspector for pre-
treatment inspection.
    (2) Treated fruit. For treated fruit, the term means one or more 
lots of clementines that are imported into the United States on the 
same conveyance.
    Shipping season. For the purposes of this section, a shipping 
season is considered to include the period beginning approximately in 
mid-September and ending approximately in late February of the next 
calendar year.

(Approved by the Office of Management and Budget under control 
number 0579-0203.)

    Done in Washington, DC, this 15th day of October 2002 .
James G. Butler,
Acting Under Secretary for Marketing and Regulatory Programs, USDA.
[FR Doc. 02-26668 Filed 10-16-02; 11:03 am]
BILLING CODE 3410-34-P