[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Rules and Regulations]
[Pages 65172-65204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22549]



[[Page 65171]]

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Part III





Department of Agriculture





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Animal and Plant Health Inspection Service



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7 CFR Parts 301 and 305



 Citrus Canker; Movement of Fruit From Quarantined Areas; Final Rule

Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / 
Rules and Regulations

[[Page 65172]]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Parts 301 and 305

[Docket No. APHIS-2007-0022]
RIN 0579-AC34


Citrus Canker; Movement of Fruit From Quarantined Areas

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the citrus canker regulations to modify the 
conditions under which fruit may be moved interstate from a quarantined 
area. We are eliminating the requirement that the groves in which the 
fruit is produced be inspected and found free of citrus canker, and 
instead are requiring that every lot of fruit produced in the 
quarantined area be inspected by the Animal and Plant Health Inspection 
Service at a packinghouse operating under a compliance agreement and 
found to be free of visible symptoms of citrus canker. We are retaining 
the requirement that the fruit be treated with a surface disinfectant 
and the prohibition on the movement of fruit from a quarantined area 
into commercial citrus-producing States. These changes will relieve 
some restrictions on the interstate movement of fresh citrus fruit from 
Florida while maintaining conditions that will help prevent the 
artificial spread of citrus canker.

DATES: Effective Date: November 19, 2007.

FOR FURTHER INFORMATION CONTACT: Mr. Stephen Poe, Senior Operations 
Officer, Emergency and Domestic Programs, Plant Protection and 
Quarantine, APHIS, 4700 River Road Unit 137, Riverdale, MD 20737-1231; 
(301) 734-4387.

SUPPLEMENTARY INFORMATION:

Background

    Citrus canker is a plant disease caused by the bacterium 
Xanthomonas axonopodis pv. citri (referred to below as Xac) that 
affects plants and plant parts, including fresh fruit, of citrus and 
citrus relatives (Family Rutaceae). Citrus canker can cause defoliation 
and other serious damage to the leaves and twigs of susceptible plants. 
It can also cause lesions on the fruit of infected plants, which render 
the fruit unmarketable, and cause infected fruit to drop from the trees 
before reaching maturity. The aggressive A (Asiatic) strain of citrus 
canker can infect susceptible plants rapidly and lead to extensive 
economic losses in commercial citrus-producing areas. Citrus canker is 
only known to be present in the United States in the State of Florida.
    The regulations to prevent the interstate spread of citrus canker 
are contained in Sec. Sec.  301.75-1 through 301.75-14 of ``Subpart--
Citrus Canker'' (7 CFR 301.75-1 through 301.75-17, referred to below as 
the regulations). The regulations restrict the interstate movement of 
regulated articles from and through areas quarantined because of citrus 
canker and provide, among other things, conditions under which 
regulated fruit may be moved into, through, and from quarantined areas 
for packing. These regulations are promulgated pursuant to the Plant 
Protection Act (7 U.S.C. 7701 et seq.).
    On June 21, 2007, we published in the Federal Register (72 FR 
34180-34191, Docket No. APHIS-2007-0022) a proposal \1\ to amend the 
citrus canker regulations by modifying the conditions under which fruit 
may be moved interstate from quarantined areas. We proposed to 
eliminate the requirement that the groves in which the fruit is 
produced be inspected and found free of citrus canker, and instead 
proposed to require that every lot of fruit produced in the quarantined 
area be inspected by the Animal and Plant Health Inspection Service 
(APHIS) at a packinghouse operating under a compliance agreement and 
found to be free of visible symptoms of citrus canker. We proposed to 
retain the requirement that the fruit be treated with a surface 
disinfectant and the prohibition on the movement of fruit from a 
quarantined area into commercial citrus-producing States.
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    \1\ To view the proposed rule, the supporting analyses, and the 
comments we received, go to http://www.regulations.gov/fdmspublic/
component/main?main=DocketDetail&d=APHIS-2007-0022.
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    We solicited comments concerning our proposal for 30 days ending 
July 23, 2007. We subsequently reopened and extended the deadline for 
comments until August 7, 2007, in a document published in the Federal 
Register on July 27, 2007 (Docket No. APHIS-2007-0022, 72 FR 41239). We 
received 72 comments by the close of the comment period. They were from 
producers, exporters, researchers, and representatives of State 
governments. They are discussed below by topic.

Pest Risk Assessment and Risk Management Analysis

    To inform the deliberations that led to the proposed rule, we 
prepared two documents that addressed the risk associated with the 
interstate movement of citrus fruit from a quarantined area: A pest 
risk assessment (PRA) and a risk management analysis (RMA). The PRA, 
which was titled ``Evaluation of asymptomatic citrus fruit (Citrus 
spp.) as a pathway for the introduction of citrus canker disease 
(Xanthomonas axonopodis pv. citri),'' considered all available evidence 
associated with asymptomatic citrus fruit as a pathway for the 
introduction of citrus canker. The PRA concluded that asymptomatic, 
commercially produced citrus fruit treated with a surface disinfectant 
and subject to other mitigations is not epidemiologically significant 
\2\ as a pathway for the introduction and spread of citrus canker. We 
first made this document available for comment on April 6, 2006, when 
we published a notice in the Federal Register (71 FR 17434-17435, 
Docket No. APHIS-2006-0045), announcing its availability for comment 
for 60 days; the comment period was subsequently extended to 90 days. 
We also submitted it for peer review in accordance with the U.S. 
Department of Agriculture (USDA) guidelines for peer review developed 
in response to the Office of Management and Budget's peer review 
bulletin. We received 19 comments by the end of the comment period, 
which we also submitted to the peer review panel members for their 
consideration.\3\ We carefully considered the comments of the public 
and peer reviewers, and made revisions to the analysis based on 
concerns they raised. The revisions did not change the conclusions of 
the PRA; the revised version of the PRA was provided with the proposed 
rule.
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    \2\ We use the term ``epidemiologically significant'' to refer 
to minimum conditions required for disease transmission.
    \3\ The original PRA and the comments we received on it can be 
viewed at http://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2006-0045.
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    In light of the comments by the public and peer reviewers, it 
became clear that additional analysis was necessary to apply the 
conclusions of the PRA to the situation in Florida. In order to apply 
the conclusions of the PRA, we needed to extend its application to 
evaluate methods by which fruit \4\ could be produced, treated, 
inspected, packaged, and shipped without resulting in the

[[Page 65173]]

spread of citrus canker to commercial citrus-producing areas. 
(Commercial citrus-producing areas are listed in Sec.  301.75-5 of the 
regulations and are referred to in this document as commercial citrus-
producing States. Those States, listed in Sec.  301.75-5(a), are: 
American Samoa, Arizona, California, Florida, Guam, Hawaii, Louisiana, 
Northern Mariana Islands, Puerto Rico, Texas, and the U.S. Virgin 
Islands.)
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    \4\ Given the practical difficulties in ensuring that only 
asymptomatic fruit enters interstate commerce under any regulatory 
strategy, we refer here to host fruit in general.
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    To address the considerations described above, APHIS prepared the 
RMA, which was titled ``Movement of commercially packed fresh citrus 
fruit (Citrus spp.) from citrus canker (Xanthomonas axonopodis pv. 
citri) disease quarantine areas, March 2007.'' We made the RMA 
available for comment along with the proposed rule.\5\ The RMA was also 
submitted for peer review, which occurred concurrently with the public 
comment period for the proposed rule.\6\ The RMA analyzed the potential 
of fresh commercially packed citrus fruit and associated packing 
material to serve as a pathway for the introduction and spread of 
citrus canker into new areas. It also identified and evaluated options 
for regulating the interstate movement of citrus fruit from quarantined 
areas with the goal of reducing the potential for citrus canker 
introduction and spread. The recommendations in the RMA served as the 
basis for the proposed rule.
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    \5\ The RMA is available on the Regulations.gov Web site and in 
our reading room (see ADDRESSES above) and may be obtained from the 
person listed under FOR FURTHER INFORMATION CONTACT.
    \6\ The peer review materials for the RMA may be viewed at 
http://www.aphis.usda.gov/peer_review/peer_review_agenda.shtml.
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    To develop the RMA, we reviewed available evidence regarding the 
biology and epidemiology of Xac and the management of citrus canker 
disease. The RMA concluded that the introduction and spread of Xac into 
other commercial citrus-producing States through the movement of 
commercially packed fresh citrus fruit from quarantined areas is 
unlikely because:
     Fresh citrus fruit is produced and harvested using 
techniques that reduce the prevalence of Xac-infected fruit;
     Citrus fruit is commercially packed using techniques that 
reduce the prevalence of infected or contaminated fruit, including 
disinfectant treatment for epiphytic contamination;
     For a successful Xac infection that results in disease 
outbreaks to occur, an unlikely sequence of events would have to occur;
     Reports of citrus canker disease outbreaks linked to fresh 
fruit are absent; and
     Large quantities of fresh citrus fruit shipped from 
regions with Xac have not resulted in any known outbreaks of citrus 
canker disease.
    Nevertheless, the RMA concluded that the evidence is not currently 
sufficient to support a determination that fresh citrus fruit produced 
in a Xac-infested grove cannot serve as a pathway for the introduction 
of Xac into new areas. Therefore, the RMA evaluated several 
packinghouse-centered risk management options for the interstate 
movement of fresh commercially packed citrus fruit from regions 
infested with citrus canker to regions without the disease. These 
packinghouse-centered risk management options were evaluated to 
determine whether they provide an appropriate level of phytosanitary 
protection without the resource constraints and other practical 
considerations that make it difficult to maintain the grove-centered 
regulatory approach in Florida. The risk management options evaluated 
were:
     Option 1: Allow unrestricted distribution of all types and 
varieties of commercially packed citrus fruit to all U.S. States.
     Option 2: Allow distribution of all types and varieties of 
commercially packed citrus fruit to all U.S. States, subject to 
packinghouse treatment with APHIS-approved disinfectant and APHIS 
inspection of finished fruit that has completed the packinghouse 
culling, washing, disinfection, and grading processes.
     Option 3: Allow distribution of all types and varieties of 
commercially packed citrus fruit (except tangerines) in U.S. States 
except commercial citrus-producing States. Allow distribution of 
commercially packed tangerines to all U.S. States, including commercial 
citrus-producing States. Require packinghouse treatment of all such 
citrus fruit with APHIS-approved disinfectant and APHIS inspection of 
finished fruit (all types and varieties) for citrus canker disease 
symptoms.
     Option 4: Allow distribution of all types and varieties of 
commercially packed citrus fruit in U.S. States except commercial 
citrus-producing States and require packinghouse treatment of citrus 
fruit with APHIS-approved disinfectant and APHIS inspection of finished 
fruit (all types and varieties) for citrus canker disease symptoms.
     Option 5: Leave the current regulations for the interstate 
movement of citrus fruit from citrus canker quarantined areas in place 
and unchanged.
    We proposed to implement Option 4. This option would have limited 
distribution of all types and varieties of citrus fruit to States other 
than commercial citrus-producing States, with mitigations conducted at 
packinghouses operating under compliance agreements. Those mitigations 
are the use of an approved disinfectant for all fruit and APHIS 
phytosanitary inspection.
    We received several comments on the overall level of risk 
associated with the movement of commercially packed citrus from a 
citrus canker quarantined area, as well as our selection of Option 4. 
These comments have not led us to change our determination that Option 
4 is the most appropriate option to implement. The RMA that we are 
making available with this final rule contains revisions based on the 
comments we received on the proposed rule and the comments we received 
through the peer review process, but its overall conclusion is the 
same. Accordingly, this final rule implements Option 4. (We are making 
some changes to the regulatory requirements associated with the 
implementation of Option 4. These changes are discussed later in this 
document.)
    Some commenters believed that the evidence presented in the RMA 
warranted the selection of Option 2, which would have allowed the 
distribution of citrus fruit to all States, subject to packinghouse 
treatment with APHIS-approved disinfectant and APHIS inspection of 
finished fruit. These commenters stated that it was extremely unlikely 
that the circumstances necessary for the movement of commercially 
packed fresh citrus fruit to result in the introduction and spread of 
Xac into other commercial citrus-producing States would ever occur.
    One commenter stated that the decision to allow the movement of 
regulated fruit from a citrus canker quarantined area only into States 
other than commercial citrus-producing States, rather than into all 
States, was based on politics rather than on science.
    One commenter stated that no Florida citrus fruit infected with 
citrus canker has ever been found in a commercial citrus-producing 
State under the current regulations and that, at the commenter's 
packinghouse, not a single piece of fruit with citrus canker had been 
found by any inspectors or employees during the last growing season.
    One commenter noted more generally that citrus canker has not been 
found outside Florida since the disease was first detected there, and 
stated that more certainty than uncertainty exists regarding the risk 
of commercially

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packed citrus fruit as a viable pathway for citrus canker.
    Another commenter noted that the PRA stated the following in its 
executive summary: ``The combination of conditions necessary for 
introduction are so difficult to achieve that the likelihood of such 
occurrence is greater than the baseline exposure represented by 
unregulated pathways. The conclusions of the evaluation are reinforced 
by a strong record of empirical data from experience and 
interceptions.''
    We acknowledge the efforts of the Florida citrus industry to put 
safeguards in place against citrus canker infestation. The proposed 
rule recognized the effectiveness of those safeguards by providing for 
the interstate movement to States other than commercial citrus-
producing States of any lot of citrus fruit that is commercially 
packed, treated with APHIS-approved disinfectant, and inspected by 
APHIS and found to be free of visible canker lesions.
    The RMA concludes that commercially packed fresh citrus fruit is an 
unlikely pathway for the introduction and spread of Xac and that a 
phytosanitary inspection ensures, with high confidence, that few 
shipped fruit would have symptoms of citrus canker disease. However, 
the model in Appendix 1 to the RMA indicates the potential for some 
commercially packed fruit with visible canker lesions to be shipped to 
commercial citrus-producing States. That potential for such fruit to 
reach commercial citrus-producing States, coupled with the 
aforementioned uncertainty regarding fruit as a pathway, led to the 
determination that the additional mitigation of prohibiting 
distribution to commercial citrus-producing States was required. If, in 
the future, evidence is developed to support a determination that 
commercially packed citrus fruit (both symptomatic and asymptomatic) is 
not an epidemiologically significant pathway for the introduction and 
spread of citrus canker, we would undertake rulemaking to amend our 
regulations accordingly.
    Under section 412(a) of the Plant Protection Act (7 U.S.C. 
7712(a)), the Secretary of Agriculture may prohibit or restrict the 
movement in interstate commerce of any plant or plant product if the 
Secretary determines that the prohibition or restriction is necessary 
to prevent the dissemination of a plant pest or noxious weed within the 
United States. Based on information provided in the PRA and RMA, we 
have determined that it is not necessary to prohibit the interstate 
movement of citrus fruit from a quarantined area into States other than 
commercial citrus-producing States under the conditions described in 
the proposed rule. While APHIS has concluded that commercially packed 
citrus fruit is an unlikely pathway for the introduction and spread of 
citrus canker, the remaining uncertainty about the level of risk 
associated with the movement of citrus fruit from a quarantined area 
has led us to maintain the prohibition on the movement of citrus fruit 
into commercial citrus-producing States.
    One commenter supplied a report that provided initial data 
demonstrating that transmission of Xac from infected fruit placed 
directly under highly susceptible grapefruit seedlings does not occur.
    The research (which can be viewed at http://www.regulations.gov/
fdmspublic/component/main?main=DocumentDetail&d=APHIS-2007-0022-0053) 
is suggestive; when it is completed, it will help better determine 
whether citrus fruit can serve as a pathway for the introduction of 
citrus canker to commercial citrus-producing States outside the 
quarantined area. We encourage interested parties to make research on 
this issue available to us.
    Two commenters stated that APHIS' treatment of the risk associated 
with citrus canker was inconsistent with its treatment of the risk 
associated with other plant pests. For example, one of the commenters 
stated, the evidence is clear that the interstate movement of nursery 
stock is a pathway for the long-distance spread of P. ramorum, but 
APHIS' regulations continue to allow high-risk nursery stock to move to 
all States, under specified conditions. The commenter cited APHIS' 
actions with respect to the light brown apple moth as another example.
    The provisions governing the movement of regulated articles for 
each pest for which APHIS maintains quarantine requirements are the 
result of separate considerations of the available science and the risk 
posed by the plant pest in question. We make our determinations of risk 
based on, among other things, the likelihood that a pest will follow a 
specific pathway, the economic and environmental value of resources 
that could be damaged by the pest, and the likelihood of introduction 
of the pest into an unaffected area. Our choice of regulatory approach 
is based on, among other things, the likelihood that the mitigations 
available to us will be sufficient to prevent the introduction or 
spread of a plant pest. We have determined that the level of protection 
against the interstate spread of citrus canker that will be provided by 
the regulations as amended by this final rule is appropriate.
    One commenter asked why APHIS allows fruit to be exported from the 
quarantined area into the citrus-producing areas of Europe, given that 
we proposed to prohibit the distribution of fruit from quarantined 
areas into commercial citrus-producing States. Other commenters asked 
that we allow the interstate movement of fruit from quarantined areas 
into commercial citrus-producing States under conditions similar to 
those required by the European Union (EU) for the importation of citrus 
fruit into the EU.
    APHIS certifies U.S. plant products for export according to the 
conditions set by the importing country for the exportation of those 
products from the United States. The EU's requirements for the 
importation of citrus fruit apply to all areas where citrus canker is 
present, not just in the United States but in other countries whose 
citrus production areas are affected by citrus canker.
    The EU import requirements involve certification of grove freedom 
from citrus canker and are similar to, but less restrictive than, the 
requirements that were in the regulations before the publication of 
this final rule. For reasons discussed in the RMA, we do not consider 
these requirements to be sufficient to allow the movement of fruit from 
citrus canker quarantined areas into commercial citrus-producing States 
at this time. We will continue to review the available science and will 
update the regulations if necessary.
    Two commenters stated that Option 3, which would have allowed the 
unlimited distribution of tangerines subject to treatment and APHIS 
inspection, should be implemented. One commenter stated that canker 
finds have been few and far between, if the disease has been found at 
all, on some varieties of tangerine. Another stated that mandarin 
varieties are the least susceptible to citrus canker, and that the 
commercial citrus-producing States of California and Texas are 
important markets for producers of this fruit.
    Tangerines are generally grouped in the species Citrus reticulata 
and are widely regarded as less susceptible to citrus canker disease 
than other commercially grown Citrus species. But many of the 
``tangerine'' varieties grown in Florida are hybrids of C. reticulata 
with other more susceptible Citrus species. Clearly, tangerines in 
Florida are not immune to citrus canker, as APHIS records indicate 
that, during the 2005-2006 growing season grove surveys, Xac was 
detected on 274 samples from tangerine, tangor, and tangelo groves. 
APHIS pest interception data indicate that between 1985 and

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2006, Xac was intercepted 632 times on C. reticulata fruit. The level 
of susceptibility was expressed as a continuum across ``tangerine'' 
varieties rather than as a discrete immunity for all varieties. This 
creates a regulatory problem when an overlap occurs in the level of 
susceptibility expressed by, for example, a more susceptible tangerine 
variety and a more resistant nontangerine citrus variety. Sufficient 
evidence does not exist to exclude tangerines from regulations 
applicable to other Florida citrus varieties. We are making no changes 
to the proposed rule in response to these comments.
    Several commenters supported Option 4 but asked APHIS to continue 
to examine the scientific evidence with a view toward allowing 
unlimited distribution of fruit moved interstate from areas quarantined 
for citrus canker at some future time.
    We will continue to examine scientific evidence regarding whether 
commercially packed citrus fruit (both with and without visible canker 
lesions) is an epidemiologically significant pathway for the 
introduction and spread of citrus canker. If, in the future, evidence 
is developed to support a determination that commercially packed citrus 
fruit is not an epidemiologically significant pathway for the 
introduction and spread of citrus canker, we would undertake rulemaking 
to amend our regulations accordingly.
    Some commenters proposed other options to allow the movement of 
fruit from quarantined areas. One commenter stated that fruit from 
groves that are free of citrus canker and that are 1,500 feet or 
farther from an affected grove should be allowed to move fruit to 
commercial citrus-producing States.
    It has been our experience in the State of Florida that citrus 
canker can spread more than 1,500 feet in stormy conditions. We 
recognize that citrus canker-free areas may exist adjacent to infected 
areas, but implementing the commenter's suggestion would require grove 
certification programs similar to those in place prior to the 
publication of this final rule. We have determined that certification 
of fruit for interstate movement at the packinghouse level rather than 
at the grove level will ensure an appropriate level of phytosanitary 
security; would be more reliable and less easily circumvented than the 
preharvest grove survey required by Option 5; would be consistent with 
the risk associated with citrus canker and commercially packed fruit 
from Florida; and would be easier and potentially less costly to 
implement and enforce than a grove-centered system of mitigations.
    Some commenters disagreed with our determination that prohibiting 
the distribution of citrus fruit from a quarantined area into 
commercial citrus-producing States would be an effective mitigation. 
Commenters holding this view stated that the illegal movement of citrus 
fruit harboring citrus canker from a quarantined area to a commercial 
citrus-producing State may be expected through current commercial 
channels; they cited the movement of Spanish clementines from Georgia 
to Florida through retailer distribution when such movement was 
prohibited as one example of the potential for incorrect distribution. 
Another commenter cited the discovery of Florida fruit in commercial 
citrus-producing States as a result of distribution mistakes.
    These commenters also stated that the potential for the movement of 
Florida citrus by tourists and visitors from nearby States into 
commercial citrus-producing States should also be taken into account, 
and that excluding shipments to buffer States would reduce the risk 
that this movement poses to commercial citrus-producing States. One 
commenter stated that the history of citrus disease movement such as 
citrus canker and citrus greening into Florida shows the high risk of 
movement by plant or by fruit from other citrus-growing countries. In 
these cases the initial infections were in urban areas, but movement to 
production areas was undetected until an epidemic was finally observed.
    One commenter also stated that we had not addressed mail-order 
shipment or gift-pack movement of citrus from Florida.
    These commenters proposed that we limit the distribution of fruit 
from citrus canker quarantined areas to other States in addition to the 
commercial citrus-producing States, thus creating a ``buffer zone'' 
around the commercial citrus-producing States. The buffer zones 
proposed by the commenters varied:
     One commenter suggested that only States east of the 
Mississippi River should be eligible to receive fruit moved interstate 
from quarantined areas.
     Two commenters suggested that only States in the northern 
tier of the United States and east of the Mississippi River should be 
eligible to receive such fruit.
     Two others suggested a buffer zone of all the States 
surrounding the commercial citrus-producing States.
    We do not agree that a buffer zone, such as these commenters 
suggest, is appropriate or necessary. Due to the geographic separation 
between Florida and other commercial citrus-producing States, citrus 
canker is not likely to spread through natural means (such as through 
storms) from Florida to a State that is not a commercial citrus-
producing State and then to a commercial citrus-producing State. While 
it is correct that the movement of plants for planting presents a high 
risk of spreading citrus canker from a quarantined area, the 
regulations already contain a prohibition on the movement of plants for 
planting; currently, only calamondin and kumquat plants are allowed to 
move interstate from the quarantined area, and those plants must be 
produced under conditions designed to prevent their infection with 
citrus canker. As mentioned earlier, we have determined that it is 
unlikely that the movement of commercially packed citrus fruit is an 
epidemiologically significant pathway for the spread of citrus canker.
    The proposed rule included requirements that boxes or other 
containers of fruit moving interstate from a quarantined area include a 
limited permit mark as well as the statement indicating that the fruit 
is not to be distributed into a commercial citrus-producing State. This 
requirement (which applies to mail-order and gift-pack shipments as 
well as truck shipments) will help to prevent inadvertent movement of 
citrus from quarantined areas into a commercial citrus-producing State. 
To strengthen the protection provided by the limited permit 
requirement, we are also adding a requirement in this final rule that 
the limited permit mark and the distribution statement appear on any 
shipping documents accompanying boxes or other containers in which 
fruit is moved interstate.
    To ensure that regulated parties comply with distribution 
restrictions, APHIS routinely monitors wholesalers and fresh fruit 
markets in commercial citrus-producing States and monitors distribution 
routes that are bound for commercial citrus-producing States to ensure 
that Florida citrus fruit does not unlawfully enter those States. This 
monitoring is conducted primarily by APHIS' Smuggling, Interdiction, 
and Trade Compliance program.
    If we find Florida citrus in a commercial citrus-producing State, 
we will trace the product back to its distributor and its origin in 
Florida. We will investigate violations (through APHIS' Investigative 
and Enforcement Services) and may seek penalties against any 
distributor that moves Florida citrus to commercial citrus-producing 
States. We may seize the prohibited products and destroy them or ensure 
they are moved from the area of concern. We

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will conduct surveillance on other methods of sale such as Internet 
sales and gift-pack shipments to ensure that the fruit is not 
advertised as being available for delivery to commercial citrus-
producing States. We will also provide outreach to retailers and 
wholesalers who are moving products to help prevent any inadvertent 
movement of citrus from a quarantined area into a commercial citrus-
producing State.
    The packinghouse measures of disinfection and APHIS inspection 
ensure that even if a given shipment were illegally moved to a 
commercial citrus-producing State, the shipment would have a low 
likelihood of containing fruit with the potential to cause an outbreak 
of citrus canker disease.
    As mentioned earlier, the RMA examined four options for allowing 
the interstate movement of citrus fruit from a citrus canker 
quarantined area under a packinghouse-centered approach. Of those four 
options, we determined that Option 4 was most appropriate, based on the 
available scientific evidence, which indicates that fruit subject to 
commercial packing, treatment, and APHIS inspection will be unlikely to 
serve as a pathway for the introduction or spread of citrus canker.
    We recognize that individual consumers may move fruit from Florida 
into States other than commercial citrus-producing States and then 
subsequently move that fruit into commercial citrus-producing States. 
However, such movement could have occurred under the regulations in 
place before the publication of this final rule as well; APHIS does not 
have the regulatory infrastructure to monitor interstate movement of 
fruit by individual consumers. Additionally, even with a buffer zone in 
place, tourists and visitors would often travel across multiple States 
to reach their destinations, meaning that a buffer zone would not be 
highly effective at eliminating this consumer movement. For tourists 
and visitors, as well as for local residents who routinely move between 
commercial citrus-producing States and other States, the distance 
between the borders of commercial citrus-producing States and the 
citrus-producing areas within those States acts as a buffer as well, 
further decreasing the risk associated with such movement. Finally, the 
volume of such movement is extremely low when compared with the volume 
of commercial movement of fruit, making the risk of citrus canker 
establishment in commercial citrus-producing States through this 
scenario highly unlikely. These factors, combined with our 
determination that the introduction and spread of Xac into other 
commercial citrus-producing States through the movement of commercially 
packed fresh citrus fruit is unlikely and that the mitigations of 
treatment and APHIS inspection are highly effective, have led us to 
determine that a buffer zone to address such movement is unnecessary.

Scientific Evidence Used in the PRA and RMA

    We received several general comments on the scientific evidence we 
used to make our determinations in the PRA and RMA. One commenter 
stated that the conclusion reached by the RMA is in part based on the 
lack of evidence that citrus fruit could play a role in the 
introduction of citrus canker in new areas, but that this lack of 
evidence is a consequence of the lack of scientific studies and is not 
based on scientific data; this commenter suggested that we evaluate the 
risks further using fruit produced subject to the regulations that were 
in place before the publication of this final rule. Another commenter 
suggested an extensive list of experimental data that the commenter 
believed were necessary to prove that the introduction and spread of 
Xac into other commercial citrus-producing States through the 
interstate movement of commercially packed fresh citrus fruit from a 
quarantined area is unlikely. One commenter stated that this program, 
which the commenter characterized as precedent-setting, requires a much 
more solid foundation of science and process affirmation than has been 
developed to date. Other commenters stated that not enough of the 
evidence we used in developing the RMA had been published in peer-
reviewed scientific journals and that we had relied too much on 
preliminary research in making our determinations.
    We used the best scientific evidence available to develop the PRA 
and the RMA, and we have detailed extensively how this evidence 
supports the conclusions we present in those documents. It is important 
to note that, based on the available evidence, we did not conclude that 
commercially packed citrus fruit could not serve as a pathway for the 
introduction and spread of Xac, but rather that it was unlikely that 
commercially packed citrus fruit serves as an epidemiologically 
significant pathway. That is why this final rule prohibits the 
distribution of such fruit to commercial citrus-producing States.
    The Plant Protection Act charges us with ensuring that our 
decisions affecting imports, exports, and interstate movement of plants 
and plant products that we regulate under the Act are based on sound 
science. To fulfill this mission, we use all the scientific evidence 
that may be brought to bear on an issue, not just studies published in 
peer-reviewed journals. Observations based on APHIS' experience, survey 
and pest detection data, and preliminary experimental results can all 
provide valuable information to inform a regulatory decision, and we 
have used them in the PRA and RMA when appropriate. Having said that, 
the vast majority of the sources cited in the PRA and RMA have been 
peer-reviewed, as have both the PRA and RMA themselves.
    Comments on specific studies we cited in the RMA and PRA are 
discussed later in this document.
    The peer review for the RMA was conducted concurrently with the 
comment period for the proposed rule. One commenter stated that 
stakeholders should have the opportunity to review the peer reviewers' 
comments when submitting their own comments on this document.
    We appreciate the commenter's concerns. APHIS had already provided 
for peer review of and public comment on the PRA, which informed the 
development of the RMA. In accordance with the Office of Management and 
Budget's bulletin on peer review, we are also making all the materials 
associated with the peer review, including the peer reviewers' 
comments, available at http://www.aphis.usda.gov/peer_review/peer_
review_agenda.shtml. The conclusion of the RMA did not change as a 
result of the peer review, which was generally favorable.
    One commenter included a late comment on the PRA as a reference, 
stating that APHIS had not made appropriate changes to the PRA based on 
the comment.
    We reviewed the comment that the commenter included when we 
developed the revised version of the PRA. We addressed all the 
substantive points raised by that comment in the revised version of the 
PRA published with the proposed rule. Many of the points raised by that 
comment had been previously raised in other comments submitted on the 
PRA during the comment period.
    As discussed earlier, the PRA concluded that asymptomatic, 
commercially produced citrus fruit treated with a surface disinfectant 
and subject to other mitigations is not epidemiologically significant 
as a pathway for the introduction and spread of citrus canker. However, 
in order to apply the conclusions of the PRA, we determined that we 
needed to extend its application to evaluate methods by

[[Page 65177]]

which fruit could be produced, treated, inspected, packaged, and 
shipped without resulting in the spread of citrus canker to commercial 
citrus-producing areas. Accordingly, the RMA addresses the risk 
associated with all commercially packed fruit; the RMA's 
recommendations have served as the basis for the Secretary's 
determination that it is not necessary to prohibit the interstate 
movement of citrus fruit from a quarantined area into States other than 
commercial citrus-producing States under the conditions described in 
the proposed rule. Therefore, specifically addressing comments on the 
PRA is unnecessary for the purposes of this rulemaking.

The Packinghouse-Centered Approach and the Current Regulations

    In evaluating the risk associated with asymptomatic fruit, the PRA 
assumed that the citrus fruit in question was commercially produced 
under a specific set of pest management measures. The RMA, while 
recognizing that effective pest management measures for Xac are 
available to private and commercial growers and are normal production 
practices for many of these growers, does not assume that measures in 
the grove are mandatory. Instead, the RMA focuses on treatment with an 
APHIS-approved disinfectant at the packinghouse and APHIS inspection of 
fruit to be moved interstate. The recommendations in the RMA served as 
the basis for the proposed rule.
    The regulations in place at the time the proposed rule was 
published required that fruit moved interstate originate in a grove 
that was found by an inspector to be free of citrus canker no more than 
30 days before harvest (with additional requirements for limes), in 
addition to treatment of vehicles, equipment, and other articles that 
are used on the grove and treatment of the fruit itself.
    Several commenters objected to APHIS moving away from the grove 
inspection approach and to the fact that we did not propose to require 
the use of the commercial production practices described in both the 
PRA and the RMA. These commenters stated that, under the proposed rule, 
measures such as copper sprays, designation and exclusion of infected 
trees, field culling of fruit, and packinghouse culling of fruit were 
all voluntary, and their effectiveness was unknown. The commenters 
expressed concern that not requiring these measures would increase the 
risk associated with citrus fruit moved interstate from a quarantined 
area.
    One commenter stated that in other countries such as Argentina that 
ship fruit to citrus-producing countries in Europe, strict guidelines 
are followed that include field inspections and the planting of wind 
breaks between orchards that minimize wind velocity and subsequent 
dispersal of inoculum. The commenter stated that these countries 
realize that inspection of ``finished'' fruit in the packinghouse alone 
is not enough to guarantee the shipment of disease-free fruit.
    One commenter stated that the objective of a rule addressing 
Florida's situation should be to prevent citrus canker from being 
introduced into disease-free areas in the United States; such a rule 
should not be designed with the primary objective of allowing shipments 
of fresh fruit from canker-affected areas. This commenter stated that 
the building blocks of premises and assumptions set forth in the 
proposed rule and the RMA create risk rather than develop protective 
barriers.
    The regulations promulgated in this final rule include protective 
barriers against the introduction of citrus canker into other citrus-
producing areas: Treatment with a surface disinfectant, APHIS 
inspection, and a prohibition of the movement of citrus fruit from a 
quarantined area into commercial citrus-producing States. We have 
determined that these barriers provide an appropriate level of 
protection with regard to the movement of citrus fruit from areas 
quarantined for citrus canker.
    The grove certification requirement in place prior to the 
publication of this final rule and the APHIS packinghouse inspection 
required under this final rule are not dissimilar in their approach to 
preventing the interstate movement of fruit with visible canker 
lesions. Under the regulations in place before the publication of this 
final rule, none of the grove-centered measures cited by the commenters 
(copper sprays, designation and exclusion of infected trees, and field 
culling of fruit) were required. Rather, growers were required to 
demonstrate that their groves were free from citrus canker, on the 
basis of an inspection. In order to be found free from citrus canker, 
and thus have fruit from their groves be eligible for the interstate 
market, growers had incentives to employ the grove-centered measures 
described in the PRA and RMA and mentioned by the commenters.
    Instead of a grove inspection, this final rule requires an 
inspection of the finished fruit at the packinghouse, which must 
operate under a compliance agreement and treat fruit with an approved 
surface disinfectant. Every lot of fruit must be inspected by an APHIS 
inspector for visible canker lesions. While growers are not required to 
practice measures that would reduce the prevalence of citrus canker in 
their fruit, and packinghouses are not required to perform their own 
culling process to remove fruit with visible canker lesions, the 
regulations promulgated in this final rule still provide them with a 
strong incentive to do so, since lots of fruit that fail APHIS 
inspection will not be eligible for interstate movement. Additionally, 
packinghouse culling for blemished fruit of any kind is already a 
standard business practice, and field management programs that include 
the use of copper sprays and field sanitation are already available to 
producers.
    The purpose of the APHIS inspection at the packinghouses is to 
ensure that fruit moved interstate is free of visible canker lesions, 
and to prohibit the interstate movement of fruit that is not free of 
those lesions. From each lot of fruit intended for interstate movement, 
APHIS will inspect a quantity that is sufficient to detect, with a 95 
percent level of confidence, any lot of fruit containing 0.38 percent 
or more fruit with visible canker lesions. Lots of fruit that fail 
inspection will not be allowed to enter interstate commerce.
    A packinghouse-based inspection can ensure an appropriate level of 
phytosanitary security and will be easier to implement and enforce than 
the grove certification system in place before the publication of this 
final rule. Because it focuses on the end product, a packinghouse-based 
inspection will be more reliable and less easily circumvented than the 
preharvest grove survey that has been required in the regulations. A 
packinghouse-based inspection is also consistent with the risk 
associated with citrus canker and commercially packed fruit from 
Florida. In addition, a phytosanitary packinghouse inspection creates a 
performance standard for packed fruit that allows citrus producers 
greater flexibility to determine the most efficient and effective means 
of producing a compliant product.
    Our choice of a packinghouse-based APHIS inspection as a means to 
prevent fruit with visible canker lesions from being moved interstate, 
rather than requiring specific grove and packinghouse practices to 
ensure the production of fruit free of visible canker lesions, is 
consistent with the recommendations of the 1997 Presidential/
Congressional Commission on Risk Assessment and Risk Management. The 
commission recommended that agencies use alternatives to command-and-
control

[[Page 65178]]

measures that dictate the use of specific technologies, where 
applicable (CRARM 1997), in order to encourage flexibility in the 
choice of risk management alternatives.
    One commenter characterized the approach of the proposed rule as a 
control point approach, and stated that in the past APHIS has applied 
control point approaches only to quarantine treatments that are able to 
demonstrate a probit 9 level of effectiveness.
    The probit 9 standard (99.997 percent mortality) applies to 
treatments for insect pests such as fruit flies, not to treatment of 
pathogens. In any case, the probit 9 standard is not applicable for the 
surface disinfectant treatment and packinghouse-based APHIS inspection 
that we are requiring. Scientific evidence indicates that both of these 
measures are highly effective.
    One commenter stated that the PRA and RMA appeared to imply that 
packinghouse studies conducted to date were based upon fruit with known 
levels of contamination with Xac. The commenter asked how the 
packinghouse inspection process would achieve the results described in 
the RMA without grove inspections and without the ability to determine 
the infection pressure. The commenter also asked how the proposed 
measures can be effective without knowing the magnitude of the hazard, 
as expressed by the proportion of infected fruit.
    Both of the packinghouse measures that we are requiring in this 
final rule are effective regardless of infection pressure. The surface 
disinfectant treatments approved by APHIS reduce numbers of Xac cells 
to low or undetectable levels. The APHIS packinghouse-based inspection 
is sufficient to detect, with a 95 percent level of confidence, any lot 
of fruit containing 0.38 percent or more fruit with visible canker 
lesions. In other words, if the infection pressure is higher than 0.38 
percent of the fruit, it is 95 percent likely that the lot will be 
rejected from interstate commerce.
    Two commenters cited findings of canker symptoms on fruit exported 
from Argentina and Uruguay to Spain in stating that symptomatic fruit 
will often pass through the packinghouse process. These commenters 
stated that the price growers and packers are receiving for citrus is 
what drives the quality of the citrus shipped, and that with low 
prices, low-quality fruit, such as those with canker, are more likely 
to be introduced into distribution channels.
    We agree that, in general, price helps to determine the quality of 
fruit supplied. However, under the regulations established by this 
final rule, the fruit will be subject to an additional APHIS inspection 
separate from any field inspection and culling or packinghouse culling 
that may occur. Any lot that fails APHIS inspection will not be 
approved to move for interstate commerce. Given that, if there is a 
financial advantage to being able to supply fresh citrus to the 
interstate market, producers and packinghouses in quarantined areas are 
likely to employ measures and processes that will allow them to supply 
fruit free of visible canker lesions for APHIS inspection.

Treatments and Surface Contamination With Xac

    The regulations require all fruit moved interstate from an area 
quarantined for citrus canker to be treated in accordance with Sec.  
301.75-11(a). This paragraph has included two treatments: Thorough 
wetting for at least 2 minutes with a solution containing 200 parts per 
million (ppm) sodium hypochlorite, with the solution maintained at a pH 
of 6.0 to 7.5; or thorough wetting with a solution containing sodium-o-
phenyl phenate (SOPP) at a concentration of 1.86 to 2.0 percent of the 
total solution, for 45 seconds if the solution has sufficient soap or 
detergent to cause a visible foaming action or for 1 minute if the 
solution does not contain sufficient soap to cause a visible foaming 
action.
    One commenter noted that disinfectants are only effective if the 
active ingredient is not degraded. The commenter gave the example that 
sodium hypochlorite is degraded by sunlight and organic matter.
    We agree with the commenter's point that it is important to ensure 
that the treatment is conducted properly. APHIS regularly monitors the 
treatment of fruit to ensure that the disinfectant agent is at the 
proper concentration and, in the case of sodium hypochlorite, pH, thus 
ensuring the effectiveness of the treatment. Under this final rule, we 
will conduct monitoring under conditions specified in the compliance 
agreements with packinghouses.
    In this final rule, we are amending the treatment regulations to 
require fruit to be treated at a commercial packinghouse whose owner 
operates under a compliance agreement. Previously, the regulations had 
required that treatment be performed either in the presence of an 
inspector or at a facility whose owner operates under a compliance 
agreement under Sec.  301.75-7(a)(2); this change will reflect the fact 
that all fruit intended for interstate movement must be treated at a 
commercial packinghouse under this final rule.
    Several commenters stated that these surface disinfectant 
treatments may not be 100 percent effective, citing various reports 
that indicated that bacteria could be recovered from citrus fruit that 
had been treated with sodium hypochlorite or SOPP, including reports by 
Verdier (2006) and Golmohammadi (2007) and a newspaper article 
reporting on a lecture by Gottwald in which he presented unpublished 
preliminary results. With regard to the last of these, two commenters 
requested that we provide information about the followup studies 
mentioned in the article.
    As stated in the RMA, the surface disinfectant treatments approved 
by APHIS reduce numbers of Xac cells to low or undetectable levels, but 
do not necessarily provide complete eradication. The evidence cited by 
the RMA does demonstrate that the treatments allowed under the rule 
substantially reduce bacterial populations, including Xac, found on the 
surface of citrus fruit to the extent practicable using surface 
disinfectant treatments currently registered for use in the United 
States on raw fruits and vegetables.
    Recovery of Xac from fruit after surface disinfectant treatment 
does not demonstrate that the treatment is ineffective. Microbial 
detection or recovery tests simply measure the presence or absence of 
the organism in a sample and do not enumerate or measure the difference 
between the pre- and post-treatment bacteria population levels or 
infectivity. The treatments in the regulations are consistently 
reported as dramatically reducing Xac populations on the surface of 
fruit, if not eliminating them entirely. For example, Verdier (2006), 
cited by the commenters, measured the pre- and post-treatment levels in 
the wash solution and found that the bacteria population level was 
reduced 99.8 percent from an average of 39.4 colony-forming units 
(cfu)/mL on untreated controls to an average of 0.06 cfu/mL on treated 
fruit.
    The information from Gottwald (2006) the commenters cite has not 
been published, and the followup studies referred to in news reports 
are currently being completed. We are not able to obtain the 
unpublished data that have been collected to this point. We will review 
the Gottwald information when it becomes available in final form. It is 
important to note again that the recovery of some bacteria after 
treatment is not inconsistent with treatment being highly effective at 
reducing Xac population levels, as described earlier.
    Another commenter, referring to a study by Brown and Schubert 
(1987)

[[Page 65179]]

that the RMA cited, stated that the study's use of Xanthomonas 
campestris pv. vesicatoria as a proxy for X. axonopodis pv. citri in 
assessing the efficacy of SOPP was not appropriate, because the 
behavior of closely related bacteria may be very different.
    The use of a proxy in efficacy testing is not unusual; for example, 
the Environmental Protection Agency (EPA) requirements for testing the 
efficacy of disinfectants allow the use of a proxy. A proxy organism 
was used in this study because the study was conducted in a model 
packinghouse. It is difficult to experiment with quarantine plant 
pathogens in the field because of the need to provide safeguards 
against their spread. While the bacteria in question are not identical, 
SOPP has a broad range of efficacy; there is no reason to believe that 
some feature of Xac would defeat the mechanism of SOPP. In addition, 
the RMA cited other studies establishing the efficacy of SOPP as a 
treatment against Xac itself.
    The PRA contained the following statement regarding treatment 
effectiveness: ``Studies performed in Argentina on the effectiveness of 
sodium hypochlorite on mature symptomless fruit artificially 
contaminated with Xac showed that sodium hypochlorite levels as low as 
8 ppm were effective in eliminating epiphytic or surface bacteria from 
the fruit (Canteros, undated).'' One commenter stated that there were 
no references about the viability of the bacteria, which is an 
important factor for risk assessment.
    This particular study was one of many studies cited in the PRA and 
RMA establishing the effectiveness of sodium hypochlorite as a 
treatment. Other studies we cited included references about the 
viability of the bacteria.
    Related to the presence of bacteria on the surface of treated fruit 
(also referred to as epiphytic bacteria or contamination), several 
commenters stated that fruit with such populations pose a risk of 
spreading citrus canker that was not addressed by the measures 
recommended in the RMA.
    While surface populations of Xac undoubtedly exist on some citrus 
fruit that is packed in a quarantined area, and commenters cited 
scientific evidence establishing this point, substantial evidence 
indicates that surface bacterial populations do not infect mature fruit 
or survive on mature fruit long enough to infect other hosts. The 
evidence cited in the RMA regarding epiphytic survival indicates that 
epiphytic populations on harvested, mature fruit decline rapidly. For 
example, researchers in Brazil sprayed asymptomatic fruit, picked from 
trees, with a bacterial suspension of 106 cfu/mL; no 
bacteria were recovered after 5 days at room temperature under 
laboratory conditions (Belasque and Rodriguez Neto 2000). Epiphytic 
bacteria do not multiply in water on leaf surfaces or on dry leaves 
(Timmer et al. 1996). Graham et al. (2000) found that Xac survived for 
48 to 72 hours on a variety of inanimate surfaces in sun or shade, 
respectively. Additionally, there is no authenticated record of 
movement of diseased fruit as the origin for a citrus canker disease 
outbreak, which is especially suggestive given the brisk global trade 
in such fruit and the likely presence of some level of epiphytic 
bacteria on many fruit that is exported from citrus canker-affected 
areas.
    Commenting on the PRA, one commenter noted that a low concentration 
of 8 cfu/mL (cited as a result of treatment by one study) may mean very 
high numbers of bacteria in tons of fruit.
    The commenter's assertion is correct. However, shipments of fruit 
are commercially packed in boxes or other approved containers and are 
dispersed through market channels all over the United States, greatly 
diluting the concentration of bacteria which are at the same time 
experiencing rapid mortality. Therefore, such bacterial concentrations 
would not occur in the real world. In any case, for the reasons stated 
above, we have determined that fruit with epiphytic bacterial 
populations is not an epidemiologically significant pathway for the 
spread of citrus canker.
    Some commenters were also concerned about the possible presence of 
Xac on other materials, citing reports of Xac survival for various 
periods on media like clean microscopic slides; leaf surfaces, plastic, 
wood, and other materials; cloth, sawdust and shavings, dried herbarium 
tissue, and sterile soil; and non-host weeds.
    While Xac undoubtedly persists on a number of surfaces, it does not 
multiply outside of hosts. Under the regulations, the interstate 
movement of any regulated article other than fruit, calamondin and 
kumquat plants, and seed is prohibited. Regulated articles include 
leaves and grass clippings. In addition, under paragraph (c) of Sec.  
301.75-3, an inspector may designate any other product, article, or 
means of conveyance, of any character whatsoever as a regulated article 
when it is determined by an inspector that it presents a risk of spread 
of citrus canker and the person in possession thereof has actual notice 
that the product, article, or means of conveyance is subject to the 
provisions of this subpart. We do not typically regulate the movement 
of the other articles cited by the commenters under the current 
regulations because populations of Xac on such articles are very 
unlikely to infect mature citrus fruit.
    Two commenters were concerned about the possibility that canker-
infected fruit could contaminate packinghouse equipment with Xac. One 
commenter stated that packinghouse equipment needs to be disinfected if 
citrus canker is found in a lot run on that equipment. The other 
expressed a specific concern about contamination of existing wounds in 
fruit and stated that surface disinfestation cannot be continuously 
done during the commercial packing of fruit where both diseased and 
healthy fruit are being packed. This commenter suggested that we amend 
the regulations to exclude fruit from being packed from orchards or 
harvested fruit lots with an incidence of citrus canker above some 
established threshold, in order to minimize contamination of packing 
lines.
    We acknowledge that infected fruit in a lot could contaminate the 
packing line with Xac, but, as stated above, substantial evidence 
indicates that the epiphytic bacterial populations that could be 
transferred from the packing line to the fruit do not infect mature 
fruit or survive on mature fruit long enough to infect other hosts. For 
that reason, we have determined that grove inspections are not 
necessary to mitigate the risk associated with such contamination, nor 
is disinfection of the packing line equipment necessary if canker is 
found during the inspection of a lot of fruit.
    The RMA stated that ``Bacteria within lesions may be more protected 
from the detrimental effects of washing, disinfection and drying. 
Viable Xac has been recovered by APHIS pathologists from citrus canker 
lesions on fruit culled from packinghouse lines after postharvest 
treatments (Riley 2007).'' A few commenters expressed concern relating 
to this statement. One stated that chlorine is well known as a surface 
sanitizer but has no ability to penetrate beyond the surface--for 
example, into lesions. Another commenter noted that none of the 
experiments mentioned in the PRA or RMA evaluate the effect of 
disinfectants on Xac within the fruit, either in visible lesions (of 
any size) or in circumstances where the effects of Xac are not visible 
to the naked eye. The third, reacting to the statement about recovery 
of viable Xac by APHIS pathologists after postharvest treatments, asked 
what treatment had been performed, what level of recovery

[[Page 65180]]

had occurred, what preharvest management the fruits were subject to, 
why the fruits were not culled on the packing line before treatment, 
and whether the postharvest treatment included wax.
    As stated earlier, the surface disinfectant treatments required in 
this final rule reduce numbers of Xac cells to low or undetectable 
levels. The RMA acknowledges that treatment with surface disinfectants 
is not effective on canker lesions, which is why this final rule also 
requires an APHIS inspection of each lot of fruit for canker lesions.
    The canker lesions referred to in Riley (2007) occurred in fruit 
produced under the regulations that were in place before the 
publication of this final rule, i.e., with certification of grove 
freedom and with surface disinfectant treatment. As the regulations in 
place before the publication of this final rule did not require 
specific canker management measures, we do not have records of what 
canker management measures the fruit may have been subject to beyond 
the measures required by the regulations.

Addition of Peroxyacetic Acid Treatment

    We proposed to add a new surface disinfectant treatment using 
peroxyacetic acid (PAA). The proposed rule would have required the 
regulated fruit to be thoroughly wetted for at least 1 minute with a 
solution containing 85 ppm peroxyacetic acid. At the request of growers 
in Florida, we evaluated the efficacy of this treatment and determined 
that the disinfectant is at least as efficacious as a surface 
disinfectant treatment as the currently approved disinfectants listed 
in the regulations. In the RMA, we described the tests that had been 
performed to confirm the efficacy of PAA. These tests were conducted on 
X. axonopodis pv. citrumelo (Xa citrumelo), which was used as a 
surrogate for X. axonopodis pv. citri (i.e., Xac).
    Two commenters stated that PAA should be tested on Xac itself 
rather than on a surrogate. One stated that Xa citrumelo does not 
infect fruit and does not survive in orchards, making it a poor 
surrogate, and asked that we make the data referred to in the RMA 
publicly available. Another stated that, while it seems highly likely 
that PAA may be effective against Xac, to allow its use without any 
testing against the particular organism of concern appears to be 
unnecessarily optimistic. The commenter recommended testing in field 
conditions for this application or at least to demand post-introduction 
testing to demonstrate efficacy in the field.
    We are making the data on PAA testing available on the 
Regulations.gov Web site with this final rule (see footnote 1 at the 
beginning of this final rule) or from the person listed under FOR 
FURTHER INFORMATION CONTACT.
    As noted earlier in this document, the use of a proxy or surrogate 
is not unusual when testing a treatment's efficacy on a quarantine 
pathogen. The EPA label for PAA, which states the approved instructions 
for use and applicability of the disinfectant, acknowledges that it was 
tested on Xa citrumelo as a surrogate for Xac.
    X. axonopodis pv. citrumelo and X. axonopodis pv. citri differ 
primarily in the hosts they infect. (``pv.'' stands for ``pathovar,'' 
which distinguishes strains or subspecies of the same bacteria based on 
their ability to only infect specific hosts.) X. axonopodis pv. 
citrumelo is generally considered to be more resistant to disinfection 
than X. axonopodis pv. citri, making the former a suitable surrogate 
for the latter.
    In addition, PAA is an oxidizing agent whose mode of action has 
been shown to be effective on many bacteria, including Bacillus cereus, 
B. subtilis, B. stearothermophilus, Clostridium botulinum, C. 
butyricum, C. sporogenes, Ditylenchus dipsaci, Enterococcus faecium, 
Escherichia coli (including E. coli O157:H7), Fusarium oxysporum, 
Gluconobacter oxydans, Lactobacillus plantarum, L. thermophilus, 
Leuconostoc mesenteroides, Listeria monocytogenes, Pseudomonas 
aeruginosa, P. fluorescens, Saccharomyces cerevisiae, Salmonella 
typhimurium, Staphylococcus aureus, Streptococcus delbreuckii subsp. 
bulgaricus, and Yersinia enterocolitica. Based on PAA's characteristics 
as a general disinfectant and the results of the testing on Xa 
citrumelo, we have determined that PAA will be effective on Xac as 
well, and we are adding PAA as a surface disinfectant treatment for 
fruit in this final rule.
    We are making three other changes related to PAA. While paragraph 
(a) of Sec.  301.75-11 sets out treatments for fruit, paragraph (d) of 
that section sets out requirements for treatment of vehicles, 
equipment, and other articles. A solution of 85 ppm of PAA is also 
effective when used on vehicles, equipment, and other articles, and the 
availability of PAA as a treatment for packing line equipment would be 
useful for packinghouses in the quarantined area to fulfill the 
requirements in Sec.  301.75-7(c)(2)(iv) for disinfection of packing 
equipment between packing lots of regulated fruit produced in a 
quarantined area and packing lots of fruit not produced in a 
quarantined area. Therefore, this final rule also adds PAA, when used 
indoors, as an approved treatment for vehicles, equipment, and other 
articles in paragraph (d) of Sec.  301.75-11. We may decide to add PAA 
as a treatment for outdoor use in a separate rulemaking if we receive 
requests to do so.
    The proposed rule would have added PAA as a fruit treatment in a 
new paragraph (a)(4) in Sec.  301.75-11. Paragraphs (a)(1) and (a)(2) 
authorize the use of sodium hypochlorite and SOPP, respectively, as 
treatments for fruit; paragraph (a)(3) requires that these two surface 
disinfectants be applied in accordance with label directions. Instead 
of adding PAA in a new paragraph (a)(4), we have redesignated paragraph 
(a)(3) as (a)(4), added PAA in paragraph (a)(3), and amended paragraph 
(a)(4) to indicate that PAA must be applied in accordance with label 
directions as well.
    The regulations in 7 CFR part 305 set out the requirements for 
phytosanitary treatments. Section 305.11 contains the two treatments 
that have been authorized for citrus fruit moved from a citrus canker 
quarantined area. Accordingly, in this final rule, we are amending that 
section to add PAA as a treatment for fruit.

Inspection and Potential for Mature Fruit Without Visible Lesions To 
Serve as Pathway for Infection

    As mentioned earlier in this document, the PRA examined the risks 
associated with asymptomatic fruit. The PRA used the term 
``asymptomatic'' to refer to the lack of visible signs or symptoms of 
citrus canker. The RMA examined the risks associated with all fruit 
that has been commercially packed, regardless of its disease status. We 
also prepared a quantitative model (Appendix 1 to the RMA) based on 
Florida production and shipping data to evaluate the efficacy of three 
levels of phytosanitary inspection in ensuring that symptomatic fruit 
does not enter commercial citrus-producing States. In the qualitative 
model, we defined ``symptomatic'' as meaning that the fruit have 
visible Xac lesions 1 millimeter (mm) in diameter and greater. One 
commenter pointed out that these terms were used inconsistently in the 
PRA and the RMA.
    We appreciate the comment. In the version of the RMA that 
accompanies this final rule, Appendix 1 refers to fruit that have 
visible canker lesions and fruit that do not, rather than to 
symptomatic and asymptomatic fruit.

[[Page 65181]]

    This commenter further stated that the proposed APHIS inspections 
of fruit target only relatively large symptoms readily visible to the 
naked eye, not whether any bacteria are present on the fruit. While the 
APHIS inspection is probably fairly effective at limiting the 
occurrence of larger Xac lesions in marketed fruit, the commenter 
stated, inspection is totally ineffective at detecting and limiting 
lesions smaller than 1 mm or at detecting Xac-infected fruit that have 
no visible lesions at the time of inspection. This commenter and other 
commenters also addressed surface populations of bacteria, stating that 
focusing inspection efforts on visible lesions ignores risk associated 
with bacteria.
    We addressed the risk associated with epiphytic bacterial 
populations earlier in this document. We have determined that the other 
situations described by these commenters are unlikely to occur outside 
of an experimental setting. The reasoning behind this determination is 
discussed below.
    Small lesions (less than 1 mm). Commenters cited Koizumi (1972), in 
which Satsuma mandarin were either prick inoculated with Xac or 
naturally infected. The experimenter found that, in addition to lesions 
greater than 1 mm, lesions referred to as ``late detection (small)'' of 
a size of 0.1 to 0.15 mm also occurred. This would be below what we 
have determined to be the size threshold for a detectable lesion, as 
defined in Appendix 1 to the RMA. Besides stating that the existence of 
such lesions indicates that fresh fruit could be a pathway for the 
introduction or spread of citrus canker, the commenter also stated that 
it is possible that disinfecting the surface of the fruit might 
exacerbate the subsequent infectivity of Xac exuding from small 
lesions, by removing other (e.g., rot-provoking) organisms that might 
directly or indirectly accelerate the decline of Xac after harvesting.
    As discussed in the RMA, in the field, immature citrus is most 
susceptible to infection with Xac and lesion development. Mature citrus 
fruit have natural wax layers on their surface, decreasing 
susceptibility by reducing access to natural openings, such as stomata. 
In addition, mature (not expanding) asymptomatic fruit without injuries 
or blemishes are not known to develop symptoms in the field. In the 
Koizumi (1972) study, mature fruit were experimentally inoculated while 
the fruit was still attached to the tree; equivalent conditions are 
extremely unlikely to occur naturally.
    The lesions Koizumi observed resulted from a combination of 
artificial (prick) inoculations and natural infections and therefore 
provide little information about how the ratio of typical to atypical 
lesions on fruit varies under natural conditions. Koizumi's results 
varied greatly over the several years he conducted these experiments; 
the commenters cite results from the year with the highest incidence of 
infection, which coincided with unusually high temperatures and two 
typhoons (hurricanes). Koizumi speculated that the atypical lesions 
were the result of restricted expansion brought on by physiological 
changes in the maturing fruit and lower ambient temperatures. As noted 
by Graham et al. (1992b), the small late season lesions were 
characterized by a ``lack of bacterial proliferation.'' Lesions without 
proliferation would not provide an epidemiologically significant source 
of inoculum for Xac infections.
    While other studies have conducted similar inoculation tests on 
fruit before (Fulton and Bowman 1929) and after (Graham et al. 1992b; 
Verniere et al. 2003), Koizumi (1972) remains the only paper to 
describe this type of lesion. Fulton and Bowman noted that if one was 
not careful to avoid oil glands when making puncture inoculations, the 
released oils cause injuries to the adjacent tissue. One could 
speculate that at least some of Koizumi's atypical lesions might, in 
fact, be injuries. We have no evidence that the lesions described by 
Koizumi (1972) occur in nature and therefore cannot agree that they 
would occur at the rates cited by the commenters.
    Nevertheless, conditions could exist in which small Xac lesions 
occur. However, as noted above, immature fruit are most susceptible to 
Xac infection, and Xac lesions grow as the fruit matures; the growth of 
the lesions slows as the fruit reaches maturity. Picking mature fruit 
from the tree causes senescence of the fruit and further inhibits 
lesion development. Therefore, while small lesions might occur on 
immature fruit, they would typically grow into larger lesions as the 
fruit matures; if there were small lesions present on such fruit, it 
would be likely that lesions larger than 1 mm would be present as well. 
In general, APHIS inspectors do not see fruit with only lesions smaller 
than 1 mm; small lesions occur in association with larger lesions 
(Riley 2007).
    The packinghouse culling and grading procedures are designed to 
remove fruit with visible lesions and would result in removal of the 
fruits likely to harbor the highest pathogen loads, and therefore 
present the greatest risk of disease transmission. The APHIS inspection 
after the packing process is completed will result in the rejection of 
any lot of fruit that has visible canker lesions and will prevent that 
lot from moving in interstate commerce.
    Wounded fruit. One commenter cited Fulton and Bowman (1929), who 
inoculated a mature grapefruit from the market and 75 days later tested 
the grapefruit. The test indicated that there were ``something like 
32,000 bacteria per puncture,'' although the fruit had not developed 
external lesions. Another commenter stated that a general principle of 
postharvest pathology is that surface disinfestation of fruit with 
standard oxidizing chlorine washes will inactivate most microorganisms 
from the surface of non-wounded fruit, but not from fruit wounds.
    The grapefruit described in Fulton and Bowman (1929) was one of a 
number of market fruit that were inoculated in this way, the rest of 
which either rotted after inoculation or supported bacterial 
populations that did not multiply. All these fruits were kept in moist 
laboratory conditions designed to facilitate the development of Xac 
bacteria.
    Regarding the grapefruit, Fulton and Bowman stated the following in 
their 1929 study: ``There is apparently a very marked difference in the 
behavior of the canker organism following inoculations in the peel of 
mature fruit after removal from the tree as compared with its behavior 
in the peel of mature fruit still on the tree. Possibly changes in the 
physiological condition of the fruit resulting from its removal from 
the tree are responsible for the difference * * * senescent changes in 
the peel favor the development of fungi having saprophytic tendencies; 
it is not inconsistent to presume these changes would in equal degree 
hinder the development of an organism having definitely parasitic 
habits like Pseudomonas citri [Xac].'' This is consistent with a 
determination that infected wounds would occur extremely rarely in 
real-world conditions.
    Fulton and Bowman also reported that infection only occurred if the 
wound stayed moist until the time of inoculation. Wounds that were 
allowed to dry and were inoculated after 26 hours did not result in 
infection. That is, infections occurred only when oil glands were 
avoided and inoculum was applied within 26 hours of wounding (Fulton 
and Bowman 1929). Verniere et al. (2003) reported a disease incidence 
of zero when inoculating mature fruit either by pin prick or spray 
inoculation.
    As noted above, the conditions that would allow citrus canker to 
develop in wounds in the field are unlikely to

[[Page 65182]]

occur. In addition, any fruit with wounds would likely be culled in the 
field or by the packinghouse before it could be submitted for APHIS 
inspection.
    Based on this evidence, we have determined that fruit with small 
lesions or infected wounds would occur extremely rarely and are not 
likely to be epidemiologically significant when they do appear. 
Therefore, it is appropriate to focus our inspection efforts on 
detecting lesions 1 mm or greater.
    The RMA stated that APHIS plant pathologists have intercepted fruit 
in final packed cartons with lesions in the 2-3 mm range and have 
observed that the majority of the symptomatic fruit that APHIS 
inspectors intercepted after passing through the packing line 
undetected by graders have only one lesion (Riley 2007). Two commenters 
addressed this statement. Both asked for data on interceptions in 
Florida fruit, with one asking for information on how many fruit were 
detected and what varieties were found to be infected.
    These data are available from the person listed under FOR FURTHER 
INFORMATION CONTACT.
    One commenter stated that the fact that APHIS inspectors 
intercepted fruit with lesions did not substantiate the statement made 
later in the RMA that grading and inspection procedures are effective 
in removing fruit with visible lesions. Another commenter stated that 
all canker infections cannot be detected in packinghouses without 
knowing whether the fruit originates from a canker-free grove, or at 
least a grove with a very low level of canker infection. The commenter 
stated that it is very difficult, if not impossible, to distinguish 
canker blemishes from numerous other blemishes, especially in the 
growing conditions that prevail in Florida, where many blemishes appear 
on fruit.
    One commenter cited the example of citrus affected by septoria, a 
fungus, that are exported to Korea. This commenter stated that the 
California citrus industry conducts vigorous training programs for line 
employees to identify and eliminate fruit with distinguishable symptoms 
and that this culling is then augmented by laboratory analysis. The 
commenter stated that lab analysis has always detected symptoms on a 
small percentage of fruit missed by highly trained employees.
    We appreciate the opportunity to clarify this point. Various 
evidence, as cited in the RMA, indicates that packinghouse grading and 
inspection procedures are effective in removing fruit with visible 
lesions. Packinghouse graders and inspectors in Florida also receive 
training provided by the State in identifying canker lesions. The 
phytosanitary inspection that will be performed by APHIS in this final 
rule will provide another layer of inspection protection. We provided 
evidence supporting these points in the RMA, including detailed 
evidence about the efficacy of APHIS' inspection process. Scientific 
evidence indicates that these measures are highly effective, but since 
uncertainty remains about the epidemiological significance of 
symptomatic fruit, we are prohibiting the distribution of fruit moved 
interstate to commercial citrus-producing States.
    As discussed earlier in this document, the APHIS packinghouse-based 
inspection is sufficient to detect, with a 95 percent level of 
confidence, any lot of fruit containing 0.38 percent or more fruit with 
visible canker lesions. In other words, if the infection pressure is 
higher than 0.38 percent of the fruit, it is extremely likely that the 
lot will be rejected from interstate commerce. APHIS inspection is thus 
effective regardless of infection pressure.
    One commenter, responding to both the evidence presented for APHIS 
inspectors' detection efficacy in the qualitative portion of the RMA 
and in the model in Appendix 1, stated that none of the evidence 
provided for APHIS inspectors' detection efficacy corresponds to field 
conditions for detection of lesions. The commenter noted that the cited 
figures for refresher training correspond to identification within 40 
seconds of a lesion presented to the inspector, which the commenter 
stated was inconsistent with location of a rare lesion on a fruit in a 
continuous search of 1,000 fruit samples within an average of 5 
seconds, an estimate we presented in the Regulatory Impact Analysis for 
the proposed rule in the context of describing the proposal's potential 
impact on packinghouse operations. The commenter stated that evaluation 
of enzyme-linked immunosorbent assay (ELISA) Dip Stick tools and the 
evaluation of a diagnostic tool (if that is a separate exercise from 
the ELISA Dip Stick tool) also corresponded to classification of 
already-detected lesions.
    We appreciate the opportunity to clarify the evidence presented in 
the RMA on the APHIS phytosanitary inspection. The evidence provided in 
the RMA is consistent with the proposed rule's approach of using 
inspection to detect lesions in the packinghouse. The training for 
phytosanitary inspectors was done in packinghouse conditions, using 
culled fruit for the test sample. Both in training and testing and in 
the packinghouse, inspection is performed on fruit that has been 
removed from the packing line.
    Under packinghouse conditions, there is no time limit for fruit 
inspection once the fruit is randomly sampled. This can be accomplished 
because the fruit is inspected individually, away from the packing 
line. The 40-second time limit during training is a performance 
requirement for training, not a packinghouse inspection requirement. 
The estimate that the packinghouse inspection would require 5 seconds 
per fruit is also not an APHIS packinghouse inspection requirement; 
rather, this figure was cited in the context of the potential economic 
impact of the lot inspection on the packinghouse, and specifically in 
discussing possible delays associated with inspection. Inspectors who 
see questionable lesions will be able to take whatever time is 
necessary to determine whether those lesions are canker lesions.
    The ELISA Dip Stick test did correspond to already detected 
lesions. The results of the ELISA Dip Stick test were cited in the RMA 
to provide empirical data on the size of lesions that can be detected 
by inspectors. The ELISA Dip Stick test is not part of the detection 
system that will be used in commercial packinghouses under this final 
rule; it will be used only for confirmation of lesions found by 
inspectors.
    One commenter disagreed with the idea that only ``finished'' fruit 
would be inspected for citrus canker in the packinghouse. The commenter 
stated that citrus canker is more easily detected on fruit that has not 
been through the packing process. Brushing of fruit on the packing line 
may remove diseased tissue, the commenter stated, and waxing of the 
fruit will make the disease harder to diagnose.
    Inspection of fruit before they go through the packing process 
would not allow the packinghouses themselves to cull canker-infected 
fruit prior to packing. In the RMA, we described in detail the efficacy 
of inspection of finished fruit for citrus canker, as discussed 
earlier.
    Our experience indicates that washing fruit will make it easier to 
detect citrus canker lesions. Citrus fruit that comes directly from the 
field is often covered in dirt, sooty mold, and other debris and 
material that could obscure citrus canker lesions. Washing the fruit 
removes some of this material. Because citrus canker lesions occur 
within the peel of the fruit, they would not be brushed off during 
finishing. Additionally, the wax used on fruit is transparent, which 
means it would not impede disease detection.

[[Page 65183]]

Potential Pathways for Spread of Citrus Canker Through Movement of 
Fruit

    As mentioned earlier, the RMA that was made available with the 
proposed rule concluded that the introduction and spread of Xac into 
other commercial citrus-producing States through the movement of 
commercially packed fresh citrus fruit is unlikely because:
     Fresh citrus fruit is produced and harvested using 
techniques that reduce the prevalence of Xac-infected fruit;
     Citrus fruit is commercially packed using techniques that 
reduce the prevalence of infected or contaminated fruit, including 
disinfectant treatment for epiphytic contamination;
     For a successful Xac infection that results in disease 
outbreaks to occur an unlikely sequence of events would have to occur;
     Reports of citrus canker disease outbreaks linked to fresh 
fruit are absent; and
     Large quantities of fresh citrus fruit shipped from 
regions with Xac have not resulted in any known outbreaks of citrus 
canker disease.
    One commenter stated that we did not enumerate any complete 
pathways for transmission and so did not evaluate the scientific 
evidence in such a way as to evaluate the possibility or likelihood for 
transmission along such pathways. The commenter also stated that there 
are pathways (including illegal diversion of fruit and perfectly legal 
amateur grower activities) from every part of the country that may lead 
to infection of commercial citrus areas and that have not been 
evaluated. This commenter and another commenter suggested several 
potential pathways that we had not addressed in the RMA.
    In general, it is difficult to examine quantitatively the pathways 
by which infected fruit could theoretically spread citrus canker. Those 
pathways are dependent on consumer behaviors and biological events for 
which we lack data that we could use to quantify them, and no such data 
were provided by the commenters. This lack of data is one reason we 
have determined that it is appropriate to prohibit distribution of 
fruit moved interstate from a quarantined area to commercial citrus-
producing States. As discussed earlier, such a prohibition, combined 
with the monitoring and enforcement efforts APHIS will use to ensure 
that the prohibition is adhered to, is effective at preventing the 
illegal movement of fruit.
    We discuss the specific pathways brought up by the commenters 
below.
    One commenter suggested that citrus canker could be spread through 
long-distance movement due to storm or cyclone activity.
    The available evidence indicates that the maximum range for spread 
of citrus canker through storm activity would not be sufficient to 
spread citrus canker from Florida to another commercial citrus-
producing State.
    One commenter suggested that citrus canker could be spread through 
movement on workers' clothes and picking bags.
    As discussed earlier, while Xac can persist on a number of 
surfaces, its infectivity outside lesions is unknown. We do not agree 
that it is likely that workers will move between Florida and other 
commercial citrus-producing States without laundering their clothes and 
while carrying their own picking bags. The commenter provides no 
evidence that could be used to empirically estimate the frequency of 
such behavior, and APHIS is unaware of any such evidence.
    Two commenters suggested that citrus canker could be spread if 
fruit or peel from citrus fruit infected with Xac is placed in or 
around susceptible host plants, after which a water event moves the 
bacterium from the fruit or peel to the host plant. One commenter cited 
Koizumi (1972) as evidence that Xac could be recovered from fruit peel 
for months if the peel was placed in physiological solution for 2 
hours. This commenter stated that only one bacterium is required to 
cause infection. Another commenter cited fruit with live Xac cells that 
are thrown into a compost pile or bin under a backyard citrus tree, 
after which a splash or water movement occurs. Once a backyard citrus 
plant was infected, these commenters stated, rain or storm events could 
spread the bacterium to commercial citrus groves.
    The Koizumi (1972) study recovered bacteria using physiological 
solution, a buffered saline solution that ensures optimal conditions 
for bacterial recovery. Analogous conditions do not occur in nature. 
Additionally, for this scenario to occur, citrus fruit that is infected 
would have to have been moved from a quarantined area into a commercial 
citrus-producing State--movement that is prohibited by the regulations. 
As discussed earlier, we are increasing monitoring and disease 
surveillance activities and making changes to the regulations in order 
to help prevent the illegal or inadvertent movement of fruit from 
quarantined areas into commercial citrus-producing States. If an 
infected fruit was illegally moved into a commercial citrus-producing 
State, it would have to be exposed to susceptible plants under very 
specific physical and environmental conditions for infection to occur.
    While it is true that one bacterium is sufficient to cause 
infection, that one bacterium would have to encounter conditions that 
were appropriate for infection. There is a very low likelihood that any 
one bacterium will encounter conditions sufficient to cause infection; 
it is difficult to create these conditions even in a laboratory 
setting. Under natural conditions, it would require thousands if not 
millions of tries for one bacterium to cause infection. Gottwald and 
Graham (1992) estimated that as few as 2.4 Xac bacteria forced into a 
water congested stomatal cavity of a susceptible plant were sufficient 
to cause a lesion. However, they also determined that the minimum 
concentration of bacteria in the inoculum needed to produce an 
infection, and presumably to place the estimated 2.4 bacteria in a 
stomatal cavity, was 10\5\ cfu/mL. Thus, although it may take only 2.4 
infective bacteria in the right place to cause infection, it takes 
exponentially greater numbers of bacteria in the inoculum for those 2.4 
bacteria to occur in the right place at the right time.
    The data submitted by one commenter (see http://
www.regulations.gov/fdmspublic/component/
main?main=DocumentDetail&d=APHIS-2007-0022-0053), in which infected 
fruit were placed next to grapefruit seedlings in natural conditions 
for 2 months without infection of the seedlings, suggests that the 
likelihood of such an occurrence may be low.
    Finally, for this pathway to occur, rain or storm conditions would 
have to prevail that could spread the bacterium over long distances, 
but Borchert et al. (2007) concluded that such conditions are unlikely 
to prevail outside Florida, the State that is currently quarantined for 
citrus canker.
    We acknowledge that it is possible that all of these circumstances 
could prevail, but such a ``perfect risk'' scenario would be an 
extremely rare event. The commenter provides no evidence that could be 
used to empirically estimate the frequency of this behavior, and APHIS 
is unaware of any such evidence.
    One commenter suggested a fruit-to-human-to-plant pathway for the 
introduction of citrus canker into a commercial citrus-producing State. 
A hobbyist who cultivates citrus in a State other than a commercial 
citrus-producing State could handle infective citrus from the 
quarantined area, then infect the plants the hobbyist is cultivating. 
The hobbyist might not notice the canker infection and could

[[Page 65184]]

subsequently move the infected plants into a commercial citrus-
producing State.
    We acknowledge that such an occurrence is possible, but such a 
``perfect risk'' scenario would be an extremely rare event. The 
commenter provides no evidence that could be used to empirically 
estimate the frequency of such amateur citrus grower behavior, and 
APHIS is unaware of any such evidence.
    None of the pathway scenarios suggested by the commenters have 
changed the RMA's conclusion that an unlikely sequence of 
epidemiological events would have to occur for a successful Xac 
infection that results in disease outbreaks to occur as a result of the 
movement of commercially packed, treated, and APHIS-inspected fruit to 
States other than commercial citrus-producing States.

Potential for Citrus Canker Establishment in Commercial Citrus-
Producing Areas

    The RMA included a discussion of the susceptibility of commercial 
citrus-producing areas that are not currently quarantined for citrus 
canker to the spread of the disease. This discussion included a 
reference to a study by Borchert et al. (2007) that developed a citrus 
canker spread model using the North Carolina State University APHIS 
Plant Pest Forecast System to identify areas where citrus canker could 
become established in the major citrus-producing regions of the United 
States.
    Two commenters stated that modeling of pathogen establishment, 
infection, and disease severity should be an essential component of the 
risk assessment for each citrus-producing State and region within the 
State, adding that the Borchert project results should be made publicly 
available.
    We disagree that modeling of pathogen establishment, infection, and 
disease severity in commercial citrus-producing States is a necessary 
component of the risk assessment. The RMA concluded that the 
introduction and spread of Xac into other commercial citrus-producing 
States through the movement of commercially packed fresh citrus fruit 
from quarantined areas is unlikely. Nevertheless, because the RMA 
concluded that the evidence is not currently sufficient to support a 
determination that fresh citrus fruit produced in a Xac-infested grove 
cannot serve as a pathway for the introduction of Xac into new areas, 
we are prohibiting the interstate movement of fruit from a quarantined 
area into commercial citrus-producing States. This measure makes 
modeling of pathogen establishment, infection, and disease severity in 
commercial citrus-producing States unnecessary.
    The Borchert et al. (2007) study is an internal APHIS document. We 
made the study available to commenters who requested it during the 
comment period, and it is available from the person listed under FOR 
FURTHER INFORMATION CONTACT. The Borchert et al. (2007) study provides 
the modeling requested by the commenters.
    Some commenters addressed the risk citrus canker posed to specific 
States. One commenter stated that California is a fresh citrus State 
with more than 200,000 acres dedicated to the fresh market production 
of oranges, lemons, grapefruit, mandarins, and other citrus varieties. 
Although the majority of the oranges are grown in arid areas, many of 
the lemons and some of the grapefruit are produced in climates with 
higher humidity and rainfall. The commenter stated that the survival of 
canker in these areas would be expected; the survival of canker in the 
more arid areas is less certain, but canker's potential impact cannot 
be ignored based on survival reports from other arid lands. Another 
commenter, addressing the suitability of California's climate for 
development of citrus canker, stated that Dalla Pria et al. (2006) 
stated that the greatest severity of canker occurred at 24 hours of 
leaf wetness, with 4 hours of wetness being the minimum duration 
sufficient to cause 100 percent incidence at optimal temperatures of 25 
[deg]C to 35 [deg]C.
    Another commenter stated that when Texas had citrus canker, it was 
in southeast Texas, which has higher rainfall than the Rio Grande 
Valley. The Rio Grande Valley generally has high relative humidity, 
although the commenter stated that there is tremendous variability in 
Texas' weather patterns; for example, July 2007 has been very wet. The 
commenter stated that canker would be able to thrive in the conditions 
present in the commercial growing area of South Texas. Surveys for 
citrus greening, the commenter stated, have revealed that Texas has 
substantial amounts of citrus in an area approximately 100 miles north 
of the Gulf of Mexico from Brownsville to Houston. The commenter noted 
that the challenges of eradicating canker in the urban areas of Florida 
contributed to the failure of the eradication program and anticipated 
that many of those same difficulties would be experienced in Texas if 
citrus canker appeared in urban areas.
    We agree with these commenters that citrus canker could be 
introduced to California and Texas. The RMA cited Peltier and Frederich 
(1926) as indicating that the disease ``could develop in all of the 
citrus regions of the world sometime over the growing season.'' These 
facts do not change our conclusions that (1) only a small portion of 
each commercial citrus-producing State actually produces citrus, and an 
even smaller portion has a climate suitable for canker disease 
development; and (2) the climate in Florida is the most favorable of 
any State for the development of citrus canker, and it would be more 
difficult for citrus canker to be introduced into and subsequently 
become established in any other State. Regardless, the remaining 
uncertainty about the level of risk associated with the movement of 
citrus fruit from a quarantined area has led us to maintain the current 
prohibition on the movement of citrus fruit into commercial citrus-
producing States.
    Two commenters urged APHIS to address the risk of spreading citrus 
canker to other potential host areas, which may not be areas where 
citrus is commercially produced. One commenter stated that citrus (not 
just fruit-bearing trees) can be and is grown in other areas of the 
United States, and those areas are also at risk of citrus canker. The 
commenter noted that during the initial outbreak of citrus canker in 
the mainland United States, disease outbreaks were also recorded in 
Alabama, Mississippi, South Carolina, and Georgia. The commenter also 
noted that Borchert et al. (2007) were tasked ``to identify areas where 
citrus canker could become established in the major citrus producing 
regions of the United States,'' rather than all the areas in the United 
States in which citrus canker could become established.
    These commenters recommended that the RMA and the proposed rule 
take account not only of current commercial citrus-producing areas, but 
also areas where citrus currently grows (even if it is not commercially 
grown) and areas where citrus could grow, but does not currently. These 
commenters stated that establishment of citrus canker in any such area 
might subsequently lead to establishment in commercial areas, since 
many of these areas are contiguous with commercial areas, and long-
distance transport now appears to be more likely than historically, 
presumably due to the presence of the Asian leafminer (Phyllocnistis 
citrella Stainton) in Florida. These commenters also stated that citrus 
canker establishment in areas where citrus is not commercially produced 
would lead to other pathways for establishment in areas where it is.

[[Page 65185]]

    The focus of the citrus canker program has been on commercial 
citrus-producing States because these States present the highest 
likelihood for introduction of the disease, due to the density of 
citrus plantings in those States. Prohibiting the movement of fruit 
from areas quarantined for citrus canker to States other than 
commercial citrus-producing States would be overly restrictive.
    We acknowledge that dooryard plantings of citrus exist outside of 
commercial citrus-producing States. However, while canker infection in 
a State other than a commercial citrus-producing State could serve as a 
pathway for introduction into a commercial citrus-producing State, as 
discussed earlier under the heading ``Potential Pathways for Spread of 
Citrus Canker Through Movement of Fruit,'' an unlikely sequence of 
epidemiological events would have to occur in order for citrus canker 
to be introduced and established through the movement of citrus fruit 
from a quarantined area.
    If, in the future, commercial quantities of citrus are planted in a 
State that is not currently designated as a commercial citrus-producing 
State, we will designate that State as a commercial citrus-producing 
State in Sec.  301.75-5.
    As discussed in the RMA, injuries caused by the Asian leafminer can 
produce wounds that serve as infection courts in leaves and, to a 
lesser extent, fruit, but the leafminer itself is not a vector for the 
spread of citrus canker.

Potential Application of the Packinghouse-Based APHIS Inspection System 
to Imported Citrus

    The regulations in 7 CFR 319.28 prohibit the importation of citrus 
fruit from areas where citrus canker is present, except for Unshu 
oranges from Japan and Cheju Island, Republic of Korea, that are 
produced in accordance with the systems approach described in paragraph 
(b) of that section. The systems approach for Unshu oranges from Japan 
and Korea requires measures to ensure that the oranges are produced in 
an area free from citrus canker; for Unshu oranges from Japan, the 
systems approach requirements also address the citrus fruit fly.
    Several commenters expressed concern that the proposed regulations, 
if implemented, could lead to requests from other citrus-producing 
countries to export citrus fruit under conditions similar to those we 
proposed for the interstate movement of fruit from citrus canker 
quarantined areas. The commenters noted that, under international trade 
agreements, APHIS has agreed not to impose conditions on the 
importation of commodities that are more restrictive than those we 
impose on the domestic movement of similar commodities. These 
commenters stated that the RMA should consider the risk associated not 
only with the interstate movement of citrus fruit from domestic 
quarantined areas but also the risk associated with potential imports 
from foreign citrus-producing areas affected with citrus canker.
    One commenter who had expressed concern about illegal movement of 
Florida citrus into commercial citrus-producing States stated that this 
potential problem would only increase if citrus fruit was allowed to be 
imported from foreign areas affected with citrus canker.
    Our analysis of the risk associated with the importation of citrus 
fruit from other countries where citrus canker exists under conditions 
similar to those in this final rule would be conducted separately from 
the analysis we conducted for this rulemaking. Before we would consider 
using an approach similar to that promulgated in this final rule to 
allow the importation of citrus fruit from canker-affected areas in 
another country, the national plant protection organization of such a 
country would need to submit a request that we do so. A country 
requesting to be able to use this framework to export citrus to us 
would have to demonstrate the ability to perform the required 
treatments and phytosanitary inspections; it would also be required to 
have a bilateral workplan in place with APHIS. Depending on the 
circumstances, we may allow imports only through a preclearance program 
staffed by APHIS inspectors whose salaries are funded by the exporting 
country. In addition, there may be other citrus pests in foreign citrus 
production areas whose risk would need to be mitigated separately from 
the risk posed by citrus canker. For these reasons, we have not amended 
the RMA that accompanies this final rule to discuss potential imports 
from other countries.
    One commenter specifically noted that the requirements for Unshu 
oranges from Japan are not in harmony with the proposed rule.
    The proposed rule and the risk management analysis are based on the 
most recent science and our determination of the appropriate level of 
protection for the citrus canker pathogen. We may reassess the risk 
associated with the importation of Unshu oranges from Japan in the 
future if Japan requests that we do so. If we reassess the risk 
associated with Unshu oranges from Japan, as discussed earlier, the 
assessment will take into account all relevant local conditions and all 
pests that are present in Japanese citrus production areas.
    It is important to note that Unshu oranges from Japan, if they are 
fumigated for arthropod pests, are allowed to be imported into 
commercial citrus-producing States, because they are produced under a 
systems approach. Fruit moved interstate from citrus canker quarantined 
areas is not allowed to be moved into those States under this final 
rule.
    One commenter noted that the term ``commercially packed'' can be 
interpreted in different ways. In South Korea, the commenter stated, 
one group of growers used a ``commercial'' packing shed that was no 
more than 75 meters by 50 meters and in which the post-harvest 
treatment with sodium hypochlorite was performed in a small bath. The 
commenter stated that it is important to recognize that different 
circumstances prevail in different countries when harmonizing domestic 
regulations with import regulations.
    We fully agree with the commenter that the circumstances in a 
country would need to be assessed before we could allow the importation 
of citrus from a citrus canker-affected area under conditions similar 
to those under which we are allowing the movement of citrus from a 
citrus canker quarantined area.
    With regard to the specific circumstance cited by the commenter, we 
have determined that it is necessary to define the term ``commercial 
packinghouse'' in this final rule, given that the PRA and RMA analyzed 
the risk associated with the interstate movement of commercially packed 
fruit. In this final rule, we are adding a definition of commercial 
packinghouse to the regulations. This definition reads: ``An 
establishment in which space and equipment are maintained for the 
primary purpose of packing citrus fruit for commercial sale. A 
commercial packinghouse must be registered as a packinghouse with the 
State in which it operates or hold a business license for treating and 
packing fruit.'' This definition will help to ensure that the 
packinghouses that pack fruit for interstate movement under this final 
rule have equipment and operating procedures that are consistent with 
those described in the PRA and RMA.
    Because the PRA and RMA referred specifically to the risks 
associated with commercially packed fruit, we are amending the proposed 
regulations in Sec.  301.75-7 to refer specifically to commercial 
packinghouses.
    One commenter stated that implementation of the proposed rule

[[Page 65186]]

may also result in foreign countries requesting APHIS to consider a 
similar approach for fresh commodities other than citrus. The commenter 
stated that the approach described in the proposed rule could be 
applied in any number of other situations in which a systems approach 
is not operationally or financially feasible.
    It is important to note in response to this comment that we 
determine what phytosanitary mitigations are appropriate for the 
importation or interstate movement of commodities based on our 
assessment of the risk their importation or interstate movement poses 
and the appropriate level of phytosanitary protection against that 
risk. If we determined that a set of mitigations was necessary to 
provide the appropriate level of protection for a commodity proposed 
for importation, but that set of mitigations was determined not to be 
operationally or financially feasible by the national plant protection 
organization of the exporting country, we would not allow the 
importation of that commodity.
    We would only allow the importation of a commodity under an 
approach similar to the approach used in this final rule if we 
determined that this approach could provide the appropriate level of 
phytosanitary protection. In past cases where we have determined that 
inspection, treatment, and limited distribution mitigations similar to 
those implemented in this final rule can provide an appropriate level 
of protection against the introduction of plant pests by imported 
commodities, we have employed such mitigations. For example, litchi 
imported from Thailand are inspected for a fungal pathogen, irradiated 
for arthropod pests, and prohibited from being imported or moved into 
Florida due to the litchi rust mite.
    In order for us to determine that a packinghouse-centered approach 
provided an appropriate level of phytosanitary protection, we would 
have to determine that the biology of the pest supported such an 
approach and that the pest in question could be effectively detected by 
inspection of the commodity. In addition, other considerations may 
apply based on the level of risk we determine importation of the 
commodity to pose.

Miscellaneous Comments on the RMA

    One commenter noted that, since viable Xac have been found in 
fruits with canker lesions that are imported into Europe, it is clear 
that the importation of symptomless fruits from canker-infected areas 
has a risk of introducing the disease if all the control steps, carried 
out by many people at different times, are not always perfectly 
implemented.
    The RMA concluded that the introduction and spread of Xac into 
other commercial citrus-producing States through the movement of 
commercially packed fresh citrus fruit from quarantined areas is 
unlikely. While fruit with visible canker lesions has likely been 
imported into the EU, the importation of citrus fruit from areas where 
citrus canker is present has not resulted in the introduction of the 
disease in the EU, despite the fact that all fruit imported into the EU 
is allowed to move to citrus-producing areas within the EU. (This is 
discussed in more detail in the RMA in Section 5.6.2, ``International 
and Interstate Movement of Citrus Fruit.'') In addition, treatment and 
inspection will both serve as effective mitigations against the 
potential of fruit moved interstate to introduce citrus canker to other 
States. Nevertheless, the RMA concluded that the evidence is not 
currently sufficient to support a determination that fresh citrus fruit 
produced in a Xac-infested grove cannot serve as a pathway for the 
introduction of Xac into new areas. That is why this final rule 
prohibits the distribution of fruit moved interstate from quarantined 
areas to commercial citrus-producing States.
    In the RMA, we stated that there is no authenticated record of the 
movement of fresh fruit infected with Xac being related to the 
epidemiology of citrus canker disease. One commenter stated that pest-
free areas are now established on the basis of a pest being ``known (as 
demonstrated by scientific evidence) not to occur'' rather than ``not 
known to occur,'' and the same standard of evidence should apply to 
this statement; research should be conducted to establish this 
statement as fact.
    We agree with the commenter's characterization of the process by 
which pest-free areas are established. Our statement was not meant to 
imply that we had positively established that fresh fruit infected with 
Xac has never served as a pathway for the transmission of citrus 
canker. Rather, it reflects the fact that no outbreaks of citrus canker 
have ever been attributed to the movement of infected fruit, despite 
the brisk global trade in such fruit. (The majority of outbreaks of 
citrus canker whose cause is known were caused by the movement of 
infected citrus nursery stock, rather than fruit.)
    The RMA noted the Asian leafminer interacts with Xac by providing 
wounds that serve as infection courts in leaves and, to a lesser 
extent, fruit. Leafminer wounds create suitable microclimates for Xac 
development, and leafminer-damaged leaves have more and larger lesions. 
One commenter asked whether injuries from the peel miner, an insect 
present in California, could result in higher infection of fruits.
    Injuries from the peel miner would be likely to increase the 
susceptibility of fruit to infection, and increase the severity of the 
infection if they became infected. In terms of overall spread of citrus 
canker, the peel miner would not likely be as epidemiologically 
significant as the Asian leafminer, since leaves of citrus trees and 
plants are more susceptible to citrus canker infection than the peels 
of citrus fruit.
    One section of the RMA discussed the effect of shipping and storage 
temperatures on Xac populations, concluding that typical shipping and 
storage temperatures reduce such populations. One commenter noted that 
pathologists are able to keep Xac-infected samples in refrigerators at 
2 [deg]C to 4 [deg]C and still isolate the bacterium. The commenter 
stated that the emphasis of this section should be on the survival of 
the bacterium.
    We agree with the commenter that cool temperatures do not 
necessarily cause mortality for Xac, and the RMA noted accordingly that 
such temperatures influence survival rather than stating that they 
inactivate the bacteria. However, in the context of an analysis of the 
likelihood of citrus fruit serving as a pathway for the introduction or 
spread of citrus canker, it is important to note that shipping and 
storage temperatures reduce Xac populations. In addition, commercial 
refrigeration is also quite dry, and Xac is highly influenced by 
humidity, so the dryness of refrigeration is more likely to have 
mortality effects than the cold.
    The RMA stated that fruit are susceptible to citrus canker 
infection from petal fall until they are around 6 cm in diameter, and 
are most susceptible at a fruit diameter of about 2-4 cm. One commenter 
stated that fruit size cannot be related to susceptibility unless the 
variety is indicated, as some varieties (such as grapefruit) are bigger 
than others (such as mandarins).
    We agree with the commenter, and we have amended the discussion in 
the RMA to state that fruit are susceptible to natural (stomatal) 
infection from petal fall until they are fully expanded (around 6 cm in 
diameter for some varieties), and are most susceptible after stomata 
form and fruit is in a stage of rapid expansion, a period of about 90 
to 120 days (at a fruit diameter of about 2-6 cm for some varieties).
    In discussing the international and interstate movement of citrus 
fruit, the

[[Page 65187]]

RMA noted that in 2004, India (where Xac is reported) shipped 8 metric 
tons of citrus to Ghana and 2 metric tons to South Africa, and that no 
outbreaks of Xac have been reported in any of the recipient countries. 
One commenter stated that the shipment of citrus from India to South 
Africa seems a dubious record.
    These data were drawn from the Food and Agriculture Organization's 
``World trade and crop production statistics'' database at http://
faostat.fao.org. The commenter provided no further information 
establishing these records as dubious.
    We also discussed the movement of fresh citrus from Florida during 
Xac outbreaks. One commenter asked whether the earlier shipments of 
Florida fruit were from canker-free areas, or at least canker-free 
areas of production under official control.
    We noted in the RMA that these shipments of Florida citrus may have 
originated in areas of low prevalence or free of Xac. These shipments 
were required to originate in groves that had been certified to be free 
of Xac based on an inspection.

Comments on the Model in Appendix 1 to the RMA

    As mentioned earlier, to assist in evaluating the options we 
identified for packinghouse-centered risk management, we prepared a 
quantitative model (Appendix 1 to the RMA) based on Florida production 
and shipping data to evaluate the efficacy of three levels of 
phytosanitary inspection in ensuring that fruit with visible canker 
lesions does not enter commercial citrus-producing States. The three 
inspection levels were determined by preliminary estimates of the Plant 
Protection and Quarantine program's Citrus Health Response Program 
staff of inspection levels that might be operationally feasible. The 
three inspection levels evaluated were 500 fruit per lot, 1,000 fruit 
per lot, and 2,000 fruit per lot. Statistically, randomized inspection 
of 500, 1,000 fruit, or 2,000 fruit per lot will ensure, with 95 
percent confidence, that the proportion of undetected fruit with 
visible canker lesions in a cleared lot is no more than 0.75, 0.38, and 
0.19 percent, respectively.
    The outputs of the quantitative model were probability 
distributions. The model determined, with 95 percent confidence, that 
the total number of citrus fruit shipped from Florida to 5 citrus-
producing States (Arizona, California, Hawaii, Louisiana and Texas) 
over a single shipping season would be 181,283,744 or less if unlimited 
distribution is permitted. The model determined, with 95 percent 
confidence, that the number of Xac-symptomatic fruit reaching those 5 
States in a single shipping season would be 633,152 or less at the 
1,000 randomly sampled fruit inspection level. We anticipate that about 
double that number (approximately 1,266,304 or less) of Xac-symptomatic 
fruit would reach those States at the 500 fruit inspectional level. 
About half that number (approximately 316,576 or less) would reach 
those States at the 2,000 fruit inspectional level. The model further 
determined with 95 percent confidence that the number of symptomatic 
fruit reaching citrus-producing areas within those States in a single 
shipping season would be 2,135 or less at the 1,000 fruit inspectional 
level, about double that number (approximately 4,270 or less) at the 
500 fruit inspectional level, and about half that number (approximately 
1,067 or less) at the 2,000 fruit inspectional level. (As discussed in 
Section 9.3.3.4 of Appendix 1 to the RMA, the actual acreage on which 
citrus is produced within a citrus-producing State is a small fraction 
of the total acreage of that State.) The base level inspection of 1,000 
randomly sampled fruit per lot was adopted because it is operationally 
feasible with small adjustments to the current phytosanitary inspection 
process in Florida.
    The potential for fruit with visible canker lesions to reach 
commercial citrus-producing States, coupled with the aforementioned 
uncertainty regarding fruit as a pathway, led to the determination that 
additional mitigations were required.
    We received several comments from one commenter addressing the 
model in Appendix 1 to the RMA.
    The commenter stated that the model failed to take into account the 
increased numbers of fruit that would be moved interstate from Florida 
and imported from citrus canker-affected areas in other countries, and 
thus underestimated the number of potentially infected fruit that could 
reach commercial citrus-producing States. The commenter cited another 
comment that estimated that the spread of canker has resulted in an 
additional 20 percent of Florida's total fresh citrus groves becoming 
ineligible for interstate movement under the regulations that were in 
place before the publication of this final rule. That 20 percent, that 
commenter stated, represents approximately 8 million 4/5-bushel cartons 
or an approximately $80 million potential business opportunity under 
the proposal.
    The comment estimating the potential increase in fruit moved 
interstate under this final rule is dealt with in more detail under the 
heading ``Comments on the Preliminary Regulatory Impact Analysis and 
Initial Regulatory Flexibility Analysis'' later in this document. We 
have concluded that the increase in the number of fruit that will be 
moved interstate under this final rule is likely much less than the 
commenter estimates, although we have been unable to quantify the 
probable increase.
    This final rule does not change our requirements for the 
importation of citrus fruit from areas in other countries where citrus 
canker is present. Therefore, this final rule will not increase the 
amount of fruit imported from such areas. As stated earlier in this 
document under the heading ``Potential Application of the Packinghouse-
Based APHIS Inspection System to Imported Citrus,'' our analysis of the 
risk associated with the importation of citrus fruit from other 
countries where citrus canker exists under conditions similar to those 
in this final rule would be conducted separately from the analysis we 
conducted for the proposal and this final rule.
    In Section 9.3.3.1 of Appendix 1, we determined probability 
distributions for the number of \4/5\-bushel cartons shipped per 
growing season for each commercial citrus-producing State destination 
and variety of fruit. To determine the probability distributions, we 
used the minimum, average, and maximum values of the last 4 years (2003 
through 2006) of historical data on citrus fruit shipping from Florida 
to other commercial citrus-producing States.
    One commenter stated that the last 4 seasons of data have been 
strongly affected by both natural events (damage caused by hurricanes, 
tree destruction in an attempt to eradicate the canker outbreak) and 
imposed movement restrictions (due to the canker outbreak). The 
commenter noted that over the 10 years preceding the 2003 through 2006 
data, the average domestic shipping quantity was 1.6 times higher than 
it was during those years. The commenter stated that the uncertainty in 
the expected average number of fruit that will be shipped from Florida 
is therefore considerably higher than would be expected from 
examination of just the last four seasons, unless APHIS considers that 
the decline in numbers is a permanent feature of the Florida industry 
and the last four seasons are typical.
    The amount of citrus moved interstate has declined steadily since 
the 1996-97

[[Page 65188]]

season, with a larger decline in 2004-05, when fruit production was 
affected by hurricanes. (See figure 1.)
[GRAPHIC] [TIFF OMITTED] TR19NO07.000

    The trends and changes occurring in the Florida citrus industry 
suggest that the last four seasons are typical. The 2006 Commercial 
Citrus Inventory for Florida (USDA-NASS 2007) states the following 
about the 2-year trend for Florida citrus fruit production: ``Florida's 
citrus acreage peaked again at 857,687 in 1996 but has been declining 
ever since. The 2006 total is 621,373, down 17.0 percent in a 2-year 
period noted for hurricanes, diseases, and urban development. The net 
change, a loss of 127,182 acres, is the greatest in any non-freeze 
period and 2nd overall. The Indian River District bore one-third of 
this loss. Removals out-numbered new plantings by a ratio of more than 
5:1. The 23,623 acres of new plantings are the least recorded in any 
two-year period since 1970-71.'' The last two sentences are especially 
germane to this discussion, as any rebound in Florida fresh citrus 
production would depend on new plantings. The Commercial Citrus 
Inventory also states that acreage decreases were reported for all 30 
counties included in the survey, and that ``only 197,027 acres (28.2 
percent) remain from the 697,929 reported in the 1988 census.'' This 
evidence indicates a continued trend toward a decline in Florida citrus 
production. Therefore, we are making no changes in response to this 
comment. However, as shipping data for the 2006-07 season are now 
available, we use those data in Appendix 1 of the RMA that accompanies 
this final rule.
    In Section 9.3.3.2 of Appendix 1 of the RMA, we presented a 
determination of the number of fruit shipped per \4/5\-bushel carton. 
We used USDA-National Agricultural Statistics Service (NASS) forecasts 
of fruit sizes to determine percentage distributions for the number of 
fruit that would be contained in each \4/5\-bushel carton, and then 
used the minimum, mean, and maximum from each of these distributions as 
parameters in a Pert distribution to define the number of fruit of each 
variety per \4/5\-bushel carton.
    The commenter made several comments about this technique, stating 
that:
     The USDA-NASS forecasts of fruit sizes are properly 
represented by a discrete, rather than a continuous, distribution;
     No basis was given for the use of Pert distributions to 
account for the uncertainties in annual shipments;
     The Pert distributions generated have mean values that 
differ from the mean values of the data, because the mean values of the 
data were improperly used as the modes for the Pert distributions;
     The actual use of Pert distributions, which is 
accomplished by fitting the discrete data to a Pert distribution and 
then finding the mean and standard deviation of the Pert distribution, 
is inefficient, not well defined, and has an unknown error rate; and
     The Florida Department of Citrus has data on the actual 
average numbers of fruit per \4/5\-bushel carton, which we should have 
used.
    The commenter stated that these flaws had an impact on a later 
section of the analysis as well, Section 9.3.4, in which our evaluation 
of the uncertainty associated with the number of fruit that will move 
interstate from Florida relies on the uncertainty in the Pert 
distributions that the commenter stated were incorrectly employed.
    We agree that the analysis would have been improved by the use of 
the actual average numbers of fruit per \4/5\-bushel carton. To improve 
the model in Appendix 1 for this final rule, we have obtained from the 
Florida Department of

[[Page 65189]]

Citrus the total number of \4/5\-bushel cartons of fruit for each type 
and size of fruit that was shipped to commercial citrus-producing 
States and the average number of fruit per bushel for each fruit size. 
Our use of these data makes using the USDA-NASS fruit size forecasts 
and the resulting Pert distributions unnecessary, thus addressing the 
commenter's concerns.
    For some varieties, using real data increases the number of fruit 
moved interstate; for other varieties, using real data decreases that 
number. A summary is provided in Table 1.

     Table 1.--Q1: Annual Amount of Florida Citrus by Variety Shipped to Commercial Citrus-Producing States
----------------------------------------------------------------------------------------------------------------
                                                                     June 2007        Current       Percentage
                             Variety                                 approach        approach         change
----------------------------------------------------------------------------------------------------------------
Grapefruit:                                                       ..............  ..............  ..............
    5th percentile..............................................       4.523,165       3,137,949             -31
    Mean........................................................       6,169,582       5,386,794             -13
    95th percentile.............................................       7,893,953       7,637,299              -3
Oranges:                                                          ..............  ..............  ..............
    5th percentile..............................................      20,948,908      13,525,400             -35
    Mean........................................................      25,081,498      19,351,870             -23
    95th percentile.............................................      29,425,176      25,158,470             -15
Temples:                                                          ..............  ..............  ..............
    5th percentile..............................................          91,786         103,295              13
    Mean........................................................         242,332         438,078              81
    95th percentile.............................................         392,884         773,018              97
Tangelos:                                                         ..............  ..............  ..............
    5th percentile..............................................         241,718         395,323              64
    Mean........................................................         406,334         804,408              98
    95th percentile.............................................         575,434       1,210,151             110
Honey tangerines:                                                 ..............  ..............  ..............
    5th percentile..............................................      78,052,912      58,535,060             -25
    Mean........................................................      88,549,976      68,711,030             -22
    95th percentile.............................................      99,601,208      78,917,320             -21
Other tangerines:                                                 ..............  ..............  ..............
    5th percentile..............................................      43,050,856      34,651,600             -20
    Mean........................................................      47,975,284      42,753,630             -11
    95th percentile.............................................      52,948,348      50,701,440              -4
----------------------------------------------------------------------------------------------------------------

    Taken together, these changes do not result in significant changes 
in the outputs of the model.
    In Section 9.3.3.3 of Appendix 1 to the RMA, we estimated the true 
prevalence of symptomatic fruit in lots that are inspected, found to be 
free of visible canker lesions, and approved to enter interstate 
commerce. The true prevalence was based on the apparent prevalence 
(papparent), which was adjusted to account for inspection sensitivity. 
We used the beta distribution to estimate the apparent prevalence 
assuming a sample size of n fruit that are examined by inspectors. 
Since we are estimating the true prevalence in the lots of fruit that 
have been inspected and found to be free of visible canker lesions, x = 
0, which means that the equation for the beta distribution we used was:

papparent = Beta(x+1, n-x+1) = Beta(1, n+1)

    One commenter stated that such an estimate applies only to an 
isolated single lot, with no further information available, and does 
not apply to the system we proposed, in which many lots would be 
evaluated. The commenter stated that what is required is the average 
over many lots, where lots are either accepted or rejected, and takes 
no account of the known fact of infected fruit being present.
    The commenter suggested considering the issue in the following way: 
Suppose that the fruit entering the inspection process is infected at 
an incidence rate r, and this rate is the same for all fruit lots 
inspected. The inspection of n fruit will then fail to detect any 
infected fruit with probability (1-r)\n\, and detect at least one 
infected fruit with probability 1-(1-r)\n\. The lot rejection rate for 
such fruit will thus be 1-(1-r)\n\, independent of the size of the lot. 
Accepted lots will be passed to market (still with infection rate r), 
and rejected lots will be dealt with in some other way. The commenter 
stated that this meant that any infection rate whatever can occur in 
the accepted lots; the controlling factor is likely to be the 
economically acceptable rejection rate. The commenter also raised 
issues related to the disposition of lots that are not approved to 
enter interstate commerce.
    The approach suggested by the commenter provides results that are 
equivalent to the procedure that we used. Under the assumption used by 
the commenter, the Beta distribution method we used indicates that 
while any prevalence can theoretically occur in accepted lots, 97 
percent of lots approved for shipment would have a true prevalence of 
fruit with visible canker lesions of less than 0.004 (0.4 percent). The 
method presented by the commenter indicates that a lot with a true 
prevalence of fruit with visible canker lesions of 0.004 has a 97 
percent probability of being rejected.
    We do not consider the prevalence of fruit with visible canker 
lesions in rejected lots because those fruit are not approved for 
shipment outside the quarantined area; this final rule explicitly 
prohibits reconditioning and resubmitting fruit for inspection (see the 
discussion under the heading ``Reconditioning'' later in this 
document). Furthermore, it is not necessary to know the prevalence of 
symptomatic fruit produced in the quarantined area in order for APHIS 
inspection to ensure that fruit shipped outside the quarantined area 
has a high probability of containing a low prevalence of symptomatic 
fruit. If the prevalence were to increase (or decrease), APHIS 
inspection would result in a higher (or lower) rate of lot rejection.
    The commenter stated that the analysis was flawed because it did 
not address fruit contaminated with surface bacteria, fruit with wounds 
that could be infected with citrus canker, and fruit with lesions 
smaller than 1 mm.

[[Page 65190]]

    For the reasons we discussed earlier in this document under the 
headings ``Treatments and Surface Contamination With Xac'' and 
``Inspection and Potential for Mature Fruit Without Visible Lesions to 
Serve as Pathway for Infection,'' we have determined that these fruit 
are not likely to be an epidemiologically significant pathway for the 
introduction or spread of citrus canker; in the case of wounded fruit 
or fruit with lesions smaller than 1 mm, we have also determined that 
such fruit are unlikely to occur in real-world conditions. Therefore, 
we do not consider them in the model in Appendix 1 to the RMA that 
accompanies this final rule.
    In Section 9.3.3.4 of Appendix 1 to the RMA, we used a model to 
determine the proportion of fruit with visible canker lesions shipped 
to citrus-growing areas within commercial citrus-growing States, based 
on the amount of citrus-bearing acreage (including acreage for backyard 
trees) in each citrus-producing county, the human population in each 
citrus-producing county and commercial citrus-producing State, and the 
area of each citrus-producing county.
    The commenter stated that we had only considered in our analysis 
those counties for which the production acreage is reported in the NASS 
statistics, and that those counties or parishes with commercial 
production that are listed in the NASS statistics, but for which 
production acreage is not reported to prevent inferences about 
individual farms, should have been included in the model.
    We agree with the commenter. While acreage is not available for 
these counties, NASS does report the number of farms in the counties. 
We have multiplied the number of farms by the mean farm size in the 
State in each of the counties in which farms were reported to estimate 
the citrus-producing acreage within each of those counties. We then 
added that acreage to the model. This results in an approximately 10 
percent increase in the total citrus-producing acreage included in the 
model.
    We attempted to model backyard citrus acreage in order to determine 
what proportion of fruit is consumed in reasonably close proximity to 
Xac host trees outside of commercial citrus production areas. Having 
estimated the backyard citrus acreage, we added it to commercial citrus 
production acreage data in order to determine the total citrus-bearing 
acreage in the county. We then used the proportion of citrus-bearing 
acreage in a county to the total acreage in a county to estimate how 
much of the citrus that is moved to a county is consumed in the citrus-
bearing acreage.
    The commenter stated that, rather than using acreage to determine 
how much citrus is consumed in reasonably close proximity to Xac host 
trees, we should use population. The commenter stated that consumption 
of citrus is definitely not uniform over the area of the county, but 
rather is concentrated where the population is. The commenter stated 
that the approach of prorating consumption by area fails entirely to 
account for the proximity of a large fraction of the population to 
citrus plant material (including backyard trees). The commenter 
suggested using data from the RMA and data on average household size 
for owner-occupied houses to estimate the fraction of the population 
living in owner-occupied houses with backyard citrus trees within 
counties containing commercial citrus groves.
    The model used in the RMA makes a simplifying assumption that fruit 
consumption occurs randomly throughout the area of each county in which 
citrus is produced. Admittedly, this is an imperfect estimate. However, 
the alternate simplifying assumptions presented by the commenter--that 
all fruit consumed by residents of households where citrus trees are 
present is consumed in residential dooryards--would result in a great 
overestimate of the proportion of citrus consumed in reasonably close 
proximity to Xac host trees. Such an assumption would imply that 
residents of households in citrus-producing counties do not consume 
fruit indoors (at work, at school, in restaurants, or inside their 
homes), and that they do not discard the peel of the consumed fruit in 
a trash can. For example, the commenter's assumption results in an 
estimate that 13.6 percent of fruit consumed in Arizona would be 
consumed and disposed in reasonably close proximity to Xac host trees.
    The commenter's suggested methodology thus assumes the maximum 
possible exposure. The Presidential/Congressional Commission on Risk 
Assessment and Risk Management observed that the use of unrealistic 
maximum exposure scenarios impairs the scientific credibility of risk 
assessment (CRARM 1997b).
    We are making no changes to the model in Appendix 1 of the RMA in 
response to this comment. We believe the assumptions we used are 
reasonable, if imperfect. However, it is important to note that the 
model was used to evaluate Option 2, which would have provided for 
unlimited distribution of fruit from the quarantined are, subject to 
treatment and APHIS inspection. If we were able to determine that the 
assumption we used to determine how much fruit is consumed in 
reasonably close proximity to Xac host trees resulted in an 
underestimate, the conclusions drawn from the model would not change: 
Some fruit with visible canker lesions would be consumed in reasonably 
close proximity to Xac host trees.
    With the modifications described here, the model in Appendix 1 of 
the RMA that accompanies this final rule has determined, with 95 
percent confidence, that the total number of citrus fruit shipped from 
Florida to 5 citrus-producing States (Arizona, California, Hawaii, 
Louisiana and Texas) over a single shipping season would be 152,358,900 
or less if unlimited distribution is permitted. The model determined, 
with 95 percent confidence, that the number of fruit with visible Xac 
lesions reaching those 5 States in a single shipping season would be 
514,229 or less at the 1,000 fruit inspectional level. The model 
further determined with 95 percent confidence that the number of fruit 
with visible Xac lesions reaching citrus-producing areas within those 
States in a single shipping season would be 1,747 or less at the 1,000 
fruit inspectional level.
    As the original model did, the revised model indicates that, under 
unlimited distribution, fruit with visible canker lesions would be 
moved interstate from Florida into citrus-producing areas within 
commercial citrus-producing States. Given that the evidence is not 
currently sufficient to support a determination that fresh citrus fruit 
produced in a Xac-infested grove cannot serve as a pathway for the 
introduction of Xac into new areas, the model in Appendix 1 to the RMA 
continues to support our selection of Option 4.

Comments on the Proposed Regulatory Provisions and Other Comments

Program Monitoring and Review

    Four commenters requested that APHIS put in place some type of 
program review if the provisions of the proposed rule were implemented. 
Three requested that the program allowing the interstate movement of 
fruit from a quarantined area under the conditions described in the 
proposal be a pilot program that would last for 2 years, after which a 
comprehensive performance review could be conducted to determine 
whether to extend the program. One commenter requested that a program

[[Page 65191]]

review be conducted after each of the first two shipping seasons under 
the program.
    APHIS recognizes the value of periodic program reviews to assess 
performance and effectiveness. As discussed earlier, although the 
safeguards we proposed will be highly effective at preventing the 
interstate spread of citrus canker, we are planning monitoring and 
disease surveillance activities to ensure that the program is indeed 
effective. If we determine that part or all of the program is not 
meeting our expectations, we have the option to amend the regulations 
accordingly. Given this, we do not agree that it is necessary to limit 
the amount of time the program will be in place through the 
regulations.
    One commenter recommended that APHIS provide funding for additional 
surveys for citrus canker in commercial citrus-producing States to 
provide those States with evidence allowing them to declare freedom 
from citrus canker and to quickly detect the disease if it spreads. The 
commenter stated that, in the event that citrus canker spreads to other 
States, there will be a need for similar regulations to protect those 
States where the disease is not present.
    We are providing funding for citrus canker surveys in susceptible 
States. We have also worked with commercial citrus-producing States to 
develop emergency response guidelines should citrus canker be found in 
those States, and we will continue to review and refine those 
guidelines to ensure that they will be effective in the event of a 
detection.
    The regulations presently in place provide standards and 
requirements sufficient to prevent the spread of citrus canker from any 
area in the United States that might be quarantined for citrus canker, 
not just for the State of Florida.
    One commenter stated that, before implementing the packinghouse-
centered approach for regulating fruit described in the proposed rule, 
APHIS should propose and seek review for the approach through the North 
American Plant Protection Organization (NAPPO) and the International 
Plant Protection Convention (IPPC).
    NAPPO facilitates cooperation and the development of standards 
among the national plant protection organizations of Canada, the United 
States, and Mexico, and the IPPC performs a similar function for the 
wider international community. Neither body has the authority to set 
regulatory policy for the United States. We conducted our risk analyses 
and developed the proposed rule on the basis of the available science 
and the conditions prevailing in areas quarantined for citrus canker 
within the United States.

Reconditioning

    In the proposed rule, we asked for comments on reconditioning 
(i.e., treating and culling fruit again after its initial treatment and 
culling). The proposed regulations left open the issue of allowing a 
lot of fruit that was initially found to be ineligible for interstate 
movement to be reconditioned and resubmitted for inspection. Because we 
had not thoroughly examined all operational aspects of the 
reconditioning of fruit, we invited comments on this topic.
    We received five comments on the issue, all of which supported 
allowing the reconditioning of fruit. None of the commenters provided 
guidance on any specific circumstances in which reconditioning should 
be allowed.
    After careful consideration of the issues involved in 
reconditioning, we have decided not to provide for reconditioning of 
rejected fruit in this final rule. One of the purposes of the APHIS 
inspection requirement is to give growers and commercial packinghouses 
an incentive to supply fruit free of visible canker lesions for 
interstate movement. If we allow a lot of fruit that has been rejected 
to be reconditioned and resubmitted for inspection, the incentive to 
provide fruit free of visible canker lesions substantially diminishes. 
Reconditioning could also provide the packinghouse with a greater 
incentive to ``take its chances'' in submitting a lot of fruit that may 
contain visible canker lesions for inspection. Therefore, allowing 
reconditioning could weaken the protection provided by the APHIS 
inspection. Additionally, if fruit undergo surface disinfectant 
treatment multiple times, residues of the disinfectant may exceed EPA 
tolerances; it would be difficult to control how many times fruit came 
into contact with surface disinfectants if we allowed reconditioning. 
For these reasons, we are not allowing reconditioning in this final 
rule.

Definition of Lot

    We proposed to define the term lot as ``The inspectional unit for 
fruit composed of a single variety of fruit that has passed through the 
entire packing process in a single continuous run not to exceed a 
single workday (i.e., a run started one day and completed the next is 
considered two lots).''
    One commenter asked that the rule allow commercial packinghouses 
flexibility and discretion in working with APHIS to define specific lot 
and sample sizes and define the inspection process, as different 
operational issues exist in each packinghouse.
    We appreciate this commenter's concern. The compliance agreement 
under which a commercial packinghouse must operate in order to be 
eligible to pack fruit for interstate movement under this final rule 
will provide a great deal of flexibility in defining lot size and 
meeting the inspection requirements.
    One commenter asked whether the definition would mean that fruit 
from several growers will be considered one lot by APHIS if the fruit 
is of the same variety and packed on the same day. The commenter also 
asked whether the definition would mean that, if symptomatic fruit is 
found packed in a lot, then fruit from all the growers for that variety 
packed on that day will be ineligible for interstate commerce, even if 
the fruit from the groves of some growers did not have detectable 
lesions.
    Packinghouses are free to define their lots as less than the amount 
of each variety of fruit that is packed in 1 day if they wish. Under 
the compliance agreement that packinghouses will be required to have in 
place, packinghouses must provide notice to APHIS about the estimated 
sizes of the lots they are running; APHIS will not set lot sizes 
itself. Regardless of the size of a lot, APHIS will inspect the lot at 
a rate sufficient to detect, with a 95 percent level of confidence, any 
lot of fruit containing 0.38 percent or more fruit with visible canker 
lesions.
    If any symptomatic fruit are found in a lot, as the lot has been 
defined by the packinghouse in accordance with the definition of lot in 
Sec.  301.75-1 and the provisions of the compliance agreement, then all 
fruit in that lot will be ineligible for interstate commerce, 
regardless of whether the lot is composed of fruit from one or from 
several sources. This provides an incentive for growers and 
packinghouses to ensure that each lot contains no fruit with detectable 
lesions.
    One commenter stated that the proposed definition of lot is vague 
and not consistent with the definition of lot in the IPPC's Glossary of 
Phytosanitary Terms.\7\ The commenter recommended that the definition 
be clarified, by variety, in the final rule.
---------------------------------------------------------------------------

    \7\ See the International Glossary of Phytosanitary Terms 
(2007), which is International Standard for Phytosanitary Measures 
(ISPM) Number 5. To view this ISPM on the Internet, go to http://
www.ippc.int/IPP/En/default.jsp and click on the ``Approved 
standards'' link under the ``Standards (ISPMs)'' heading.
---------------------------------------------------------------------------

    While APHIS always considers the IPPC Glossary when determining how 
to

[[Page 65192]]

define a term, our use of the term ``lot'' in the proposal is 
consistent with U.S. citrus industry practices; using another term 
would likely provoke unnecessary confusion. There is no phytosanitary 
or statistical reason to set lot sizes by variety.
    We stated in the proposal that we intend to inspect fruit at a rate 
of inspection sufficient to detect, with a 95 percent level of 
confidence, any lot of fruit containing 0.38 percent or more fruit with 
visible canker lesions. This is equivalent to randomly sampling 1,000 
fruit per lot.
    One commenter stated that it is essential that APHIS establish the 
maximum lot size that could be run with only 1,000 fruit inspected. The 
commenter stated that leaving the establishment of a lot size to 
packinghouse discretion creates the potential for a wide variation in 
the number of fruit actually cleared by APHIS inspectors. The 
commenters stated that it is obvious that a lot size of 200,000 pieces 
of fruit is considerably different than one of 50,000, because the 
potential for infected pieces of fruit to slip through the treatment 
and inspection steps is four times as great in the latter case.
    It may seem counterintuitive that randomly sampling the same number 
of fruit for a lot composed of 50,000 fruit and a lot composed of 
200,000 pieces of fruit provides the same confidence of detecting fruit 
with visible canker lesions at the 0.38 percent prevalence level. 
However, as discussed in Section 9.3.3.3 of Appendix 1 to the RMA, the 
hypergeometric sampling algorithm (which assumes that the fruit is 
sampled without being returned to the lot, thus ensuring that the same 
piece of fruit is not inspected twice) indicates that randomly sampling 
1,000 fruit is adequate to detect, with a 95 percent level of 
confidence, any lot of fruit containing 0.38 percent or more fruit with 
visible canker lesions for any lot of 100,000 fruit or more. For lot 
sizes less than 100,000 fruit, randomly sampling 1,000 fruit actually 
gives better than 95 percent confidence of detecting the prevalence of 
0.38 percent.
    The reason this is true can be seen by imagining a large barrel and 
a small keg, both of which are filled with marbles. The barrel holds a 
million marbles, while the keg only holds 10,000 marbles. In both the 
barrel and the keg, though, 99.9 percent of the marbles are white and 
0.1 percent are black. If one randomly samples the same number of 
marbles from both the barrel and the keg, one has the same chance of 
drawing a black marble from either the barrel or the keg. Even though 
there are 100 times more total marbles in the barrel, the proportion of 
white marbles to black marbles is the same in both the barrel and the 
keg. Similarly, we have designed the sampling procedure to detect fruit 
with visible canker lesions at a targeted prevalence of 0.38 percent; 
while we do not know the prevalence of fruit with visible canker 
lesions in any lot, the prevalence at which our sampling protocol will 
detect fruit with visible canker lesions is fixed. Thus, randomly 
sampling 1,000 fruit from a lot is appropriate for both lots composed 
of 50,000 fruit and lots composed of 200,000 fruit, because the 
targeted prevalence of 0.38 percent or more fruit with visible canker 
lesions is the same for each lot.
    It should be noted that, in cases where fruit cannot be randomly 
sampled (for example, when fruit has already been packed in boxes for 
shipping), inspection of more than 1,000 pieces of fruit may be 
necessary in order to inspect the lot at a rate sufficient to detect, 
with a 95 percent level of confidence, any lot of fruit containing 0.38 
percent or more fruit with visible canker lesions. We will communicate 
inspection requirements to packinghouses as part of the implementation 
of the compliance agreements.
    One commenter stated that the statistical sampling procedure 
described in the proposed rule was not appropriate for lots packed by 
gift fruit packers, as such lots are very different from large-scale 
commercial lots.
    We intend to inspect fruit at a rate of inspection sufficient to 
detect, with a 95 percent level of confidence, any lot of fruit 
containing 0.38 percent or more fruit with visible canker lesions. This 
is equivalent to randomly sampling 1,000 fruit per lot for most lots. 
However, for smaller lots, the number of fruit that must be randomly 
sampled to detect, with a 95 percent level of confidence, a lot of 
fruit containing 0.38 percent or more fruit with visible canker lesions 
could be less than 1,000, as discussed in Section 9.3.3.3 of Appendix 1 
to the RMA. This principle may be applicable to gift fruit lots, which 
are sometimes smaller than 1,000 fruit. For lots larger than 1,000 
fruit, the statistical principles behind determination of how many 
fruit must be inspected to achieve this detection level apply 
regardless of whether the fruit is from a gift packer or a larger 
packinghouse.
    We are making one change to clarify the requirement for the 
inspection level. The proposed rule stated that we would require the 
number of fruit to be inspected to be the quantity that is sufficient 
to detect, with a 95 percent level of confidence, any lot of fruit 
containing 0.38 percent or more fruit with visible canker lesions. This 
is the level of inspection that we will be conducting as of the 
publication of this final rule. However, we also included provisions 
allowing the inspection of another quantity that gives a statistically 
significant confidence of detecting the disease at a level of infection 
to be determined by the Administrator. In the preamble to the proposed 
rule, we stated that ``If at some time in the future conditions warrant 
changing this rate of inspection, APHIS would provide for public 
participation in that process through the publication of a notice in 
the Federal Register.'' To make our process for changing the inspection 
level clear in the regulations, this final rule adds a footnote to the 
regulations that includes the information regarding the other sampling 
level and the information that appeared in the preamble to the proposed 
rule.

Dooryard Fruit

    We stated in the proposal that our proposed provisions would allow 
any Florida citrus growers, including commercial, gift fruit, and 
dooryard growers, to move their fruit interstate to States other than 
commercial citrus-producing States provided they comply with the 
conditions discussed in the proposed rule. Dooryard growers are 
typically homeowners who have citrus trees in their yards and wish to 
ship the fruit from those trees interstate to friends or family. The 
regulations in place before the publication of this final rule required 
fruit moved interstate to originate from a grove that had been 
inspected and found to be free of citrus canker and required vehicles, 
equipment, and other articles used in the grove to be treated upon 
leaving the grove. Since dooryard growers could not comply with these 
requirements, the interstate movement of dooryard fruit was effectively 
halted.
    One commenter submitted comments on the regulations in place before 
the publication of this final rule, stating that dooryard growers 
should be allowed to ship fruit interstate under these conditions:
     Inspectors could certify dooryard trees as free of citrus 
canker upon request.
     Surface disinfectant treatment would not be required if 
the tree was certified as free of citrus canker.
     Dooryard fruit would be permitted to be moved only to 
States other than commercial citrus-producing States.
     The number of boxes a dooryard grower could ship in a 
season would be restricted to 20.

[[Page 65193]]

    The regulations promulgated in this final rule do not distinguish 
between dooryard growers and commercial growers for the purposes of 
moving fruit interstate. Anyone can move fruit interstate if he or she 
has the fruit packed at a commercial packinghouse and treated and 
inspected as described in the amended regulations.
    The approved disinfectants listed in the regulations in Sec.  
301.75-11(a) reduce numbers of Xac cells to low or undetectable levels 
on citrus fruit moving interstate from citrus canker quarantined areas. 
The APHIS inspection can detect, with a 95 percent level of confidence, 
any lot of fruit containing 0.38 percent or more fruit with visible 
canker lesions. These restrictions are necessary to address the risk 
associated with the interstate movement of fresh citrus fruit from a 
quarantined area. We expect that some commercial packinghouses will 
establish processes under which dooryard fruit can be treated and 
inspected to allow it to move interstate.
    Two commenters objected to allowing dooryard fruit to be moved 
interstate from a quarantined area. One noted that the RMA considered 
the risk associated with commercially packed fruit, but we proposed to 
allow the movement of dooryard fruit under the same conditions. The 
other commenter stated that there is nothing in the proposed rule that 
provides any degree of confidence that dooryard fruit will not be 
shipped from Florida and that in all likelihood dooryard fruit will not 
be treated with an approved surface disinfectant in a packinghouse.
    The RMA addressed the risks associated with commercially packed 
fruit; accordingly, we are only allowing the movement of dooryard fruit 
if it is commercially packed, treated, and inspected by APHIS. Like 
commercial fruit growers, dooryard fruit growers have an incentive to 
supply fruit that is free of visible canker lesions, as any lot of 
fruit that is found through inspection to contain fruit with visible 
canker lesions will be ineligible for interstate movement. We will 
conduct outreach efforts to ensure that dooryard growers are aware of 
the new requirements.

Gift Fruit Packers and Compliance Agreements

    One commenter, a gift fruit packer, stated that the proposed 
regulations were written primarily for the 50 large citrus packing 
operations registered with the State of Florida rather than the 92 
small citrus packinghouses that are also registered with the State. The 
commenter specifically stated that several of the provisions of the 
compliance agreement described in the proposal would pose difficulties 
for smaller packinghouses, including the requirements for:
     Notice of estimated lot size and run times;
     Need for notice when APHIS inspectors are not present on a 
regular basis;
     Need for notice when there are significant changes in the 
amount of fruit being packed;
     Provisions for holding fruit when packing is done at a 
time when an APHIS inspector is not present; and
     Hours of coverage for APHIS packinghouse inspections.
    The commenter noted that packages of gift fruit often incorporate 
citrus of multiple varieties, and that random sampling of packed boxes 
is not an option at gift fruit packinghouses, since once the fruit is 
boxed, the boxes are glued and labeled for shipping.
    The commenter expressed specific concerns about the sporadic nature 
of operations for many smaller packinghouses, which run fruit when 
there are orders to be filled for most of the year and then run 
constantly during the busy season in December. Since we proposed to 
require that an APHIS inspector would have to be present whenever a 
packinghouse was operating, the commenter was concerned that the gift 
fruit packinghouses might not be able to provide notice of the need for 
an inspector during the slow times and then might be left without the 
services of an inspector during busy times. Another commenter also 
expressed general concerns about the availability of inspectors.
    We appreciate the commenter bringing these issues to our attention. 
It has always been our intention to design a system suitable for both 
large and small commercial packinghouses. We are aware of the packing 
patterns of the smaller packinghouses and are planning our inspection 
staffing accordingly. We can address all the issues raised by the 
commenter in the context of the compliance agreement, which will 
provide a great deal of flexibility in how an individual operation can 
fulfill this final rule's treatment and inspection requirements.
    As discussed in the proposed rule, in the compliance agreement, the 
owner or operator of the packinghouse will agree to treat fruit to be 
moved interstate with one of the approved treatments according to the 
procedures specified in Sec.  301.75-11, and to see that this fruit is 
packed only in boxes marked in accordance with the requirements in 
Sec.  301.75-7(a)(6). The compliance agreement will also contain (but 
not to be limited to) specific provisions pertaining to:
     Access to the facility, and to necessary records and 
documents by APHIS inspectors;
     Means by which lots are designated and notice of estimated 
lot sizes and run times;
     Need for notice when APHIS inspectors are not present on a 
regular basis;
     Need for notice when there are significant changes in the 
amount of fruit being packed;
     Conditions (access to fruit, lighting, safety, etc.) that 
must be met in order for APHIS inspectors to carry out the required 
inspections;
     Provisions for handling and storage of fruit, including 
provisions not allowing the movement of any part of a lot from the 
packinghouse until APHIS inspection is complete;
     Hazard-free access to treatment areas so that APHIS 
inspectors can monitor the concentrations of chemicals used for fruit 
treatment;
     Provisions for holding fruit when packing is done at a 
time when an APHIS inspector is not present; and
     Hours of coverage for APHIS packinghouse inspections.
    Using the compliance agreement to provide conditions for 
implementing the regulations will give APHIS some flexibility to 
accommodate packinghouse procedures. For example, in the compliance 
agreement, we will allow commercial packinghouses to work with APHIS to 
determine methods for sampling the fruit. For gift fruit packers, we 
would sample each lot of fruit before it is packed into boxes. Once a 
lot is inspected by APHIS and approved to enter interstate commerce, 
fruit from the lot can be combined with fruit from other lots that have 
been inspected and approved, in any way that is convenient for the 
packer; all that is required is that all the fruit so combined be from 
lots that have been inspected by APHIS and approved to enter interstate 
commerce.

Boxes or Other Containers

    We proposed that, in order to be moved interstate, regulated fruit 
would have to be packaged in boxes or other containers that are 
approved by APHIS and that are used exclusively for regulated fruit to 
be moved interstate.
    One commenter, a gift fruit packer, was concerned that the boxes 
used by such packers are not similar to the boxes used by large 
packinghouses. The commenter recommended that the issue be worked out 
somehow, perhaps by

[[Page 65194]]

exempting gift fruit from the requirement.
    APHIS has the option to approve any boxes or containers. We are not 
aware of any boxes used by gift fruit packers that would not be 
approved. The use of the limited permit statement on boxes or other 
containers will indicate that the container has been approved by APHIS.

Limited Permits and Marking of Boxes or Other Containers

    We proposed to require that the boxes or other containers in which 
regulated fruit is packaged for interstate movement would have to be 
clearly marked with the statement ``Limited Permit: USDA-APHIS-PPQ. Not 
for distribution in AZ, CA, HI, LA, TX, American Samoa, Guam, Northern 
Mariana Islands, Puerto Rico, and Virgin Islands of the United 
States.'' (The regulations in place before the publication of this 
final rule did not include the ``Limited Permit: USDA-APHIS-PPQ'' 
portion of that statement.) The proposed provisions also stated that 
only fruit that meets all of the requirements of the section may be 
packed in boxes or other containers that are marked with the above 
statement. We proposed these additional provisions in order to help 
ensure that only fruit that has been handled in accordance with all of 
the requirements described in Sec.  301.75-7 would be packaged in boxes 
or other containers bearing the limited permit statement.
    One commenter stated that the use of the term ``Limited Permit'' on 
shipments of gift fruit would be unnecessarily legalistic in the 
context of gift fruit shipments, which are addressed to specific people 
in States other than commercial citrus-producing States. The commenter 
suggested that we either retain the language that had been in place at 
the time the proposed rule was published or allow gift fruit shipments 
to use language like ``Please don't take any of your fruit to citrus-
producing areas in the United States, which are AZ, CA, HI, LA, TX, 
American Samoa, Guam, Northern Mariana Islands, Puerto Rico, and the 
U.S. Virgin Islands.''
    We appreciate the commenter's concerns and agree that the risk of 
gift fruit shipments being sent to a commercial citrus-producing State 
is likely to be extremely low. However, adding the ``Limited Permit: 
USDA-APHIS-PPQ'' statement to the boxes or other containers in which 
regulated fruit is moved interstate allows us to ensure that the 
statement appears only on boxes or other containers filled with fruit 
that is eligible for interstate movement. Therefore, we consider this 
statement to be an essential part of our efforts to ensure that fruit 
that is moved interstate meets all the requirements in the regulations.
    Nine commenters did not object to the labeling change, but stated 
that the fact that their current inventory of boxes and other 
containers does not include the ``Limited Permit: USDA-APHIS-PPQ'' 
statement would pose a problem for them in complying with the new 
regulations. One of the commenters, a representative of Florida 
commercial packinghouses, stated that the current inventory of boxes 
and other containers with the old markings is worth $2 to $2.5 million. 
These commenters requested that we allow them to use up their current 
inventory of containers while box and container manufacturers retool 
their equipment to produce containers with the new statement.
    We appreciate the concerns of these commenters as well. We note 
that this final rule requires only that the boxes or other containers 
approved by APHIS be marked with the statement, not that the statement 
be printed directly on the boxes or other containers; if commercial 
packinghouses have inventories of boxes or other containers without the 
``Limited Permit: USDA-APHIS-PPQ'' statement, they can add that 
statement through means such as a sticker or stamp, as long as the 
statement is clearly marked.
    However, it is not practical to modify bags of fruit in this 
manner, as the distribution statement printed on bags is often small or 
attached to the bag, and the limited permit statement often cannot be 
added to it. For this reason, we are temporarily allowing fruit to be 
packed for interstate movement in bags if those bags are clearly marked 
with the distribution statement and if those bags are then packed in a 
box that is marked with both the limited permit statement and the 
distribution statement. Fruit will only be allowed to be packed in bags 
that are marked with the distribution statement if that fruit is 
eligible for interstate movement. Because the bags must be packed in 
boxes that are marked with both the limited permit and the distribution 
statements, and because bagged fruit is not unloaded from the boxes in 
which it is shipped until it reaches the point of sale, we believe that 
this requirement will provide the same level of protection against 
illegal movement of fruit from the quarantined area as the requirement 
in the proposed rule, while allowing some flexibility for regulated 
parties.
    As the commenters requested, this exemption is temporary; it will 
expire on August 1, 2008. After that date, all fruit intended for 
interstate movement will be required to be packed in boxes or other 
containers that are clearly marked with both the limited permit and 
distribution statements.
    In this final rule, we are also providing that fruit that is not 
eligible for a limited permit may not be packed in boxes that are 
marked with only the distribution statement. This means that either 
fruit are eligible for a limited permit, in which case they must be 
packed in boxes that are marked with the limited permit and 
distribution statements, or ineligible, in which case neither of these 
statements may appear on the boxes. Fruit that is not eligible for a 
limited permit and is moved for intrastate sale or for export can be 
packed in the same boxes or other containers, including bags, as fruit 
that is eligible for interstate movement, as long as the limited permit 
and distribution statements are removed or obscured (through means such 
as opaque ink or a sticker) before the fruit is shipped.
    As mentioned earlier in this document under the heading ``Pest Risk 
Assessment and Risk Management Analysis,'' this final rule also 
requires the limited permit and distribution statements to be printed 
on any shipping documents accompanying the fruit.

Movement of Regulated Fruit Through Commercial Citrus-Producing States

    The regulations do not currently provide for the movement of 
regulated fruit through commercial citrus-producing States for ultimate 
shipment to other States (i.e., transshipments). We did not propose to 
provide for such movement in the proposed rule.
    One commenter requested that the final rule provide for such 
movement. The commenter stated that, while the concerns of commercial 
citrus-producing States should be addressed through safeguards, the 
commenter believed allowing transshipments with suitable safeguards is 
consistent with the National Plant Board's Principles of Plant 
Quarantine. Another commenter stated that the proposal and RMA did not 
address transshipments via consumer modes.
    We did not consider the risk associated with transshipment in the 
proposed rule. We would need to determine the risk associated with 
transshipment and how it could be mitigated before adding provisions 
for transshipment to the regulations. Therefore, it is not appropriate 
to provide for transshipment in this final rule. We plan to examine the 
risks associated with transshipment and, if our examination indicates 
that transshipment can be accomplished

[[Page 65195]]

safely under certain conditions, propose to provide for it in a future 
rulemaking.

Kumquats With Foliage

    The regulations require regulated fruit moved interstate from a 
quarantined area to be free of leaves, twigs, and other plant parts, 
except for stems that are less than one inch long and attached to the 
fruit. We did not propose to change this requirement.
    One commenter requested that the final rule allow the interstate 
movement of kumquat fruit with decorative foliage to States other than 
commercial citrus-producing States under a limited permit and with 
product inspection. The commenter stated that such movement would pose 
no appreciable risk, as this foliage is resistant to citrus canker and 
not used for propagation.
    Foliage is subject to infection by citrus canker, and thus the risk 
posed by foliage would need to be evaluated before we could determine 
whether to allow its movement from the quarantined area. We did not 
address the risk posed by citrus foliage in any of the documentation 
accompanying this proposed rule. Therefore, it would be inappropriate 
to provide for the movement of citrus foliage in this final rule.
    In response to the comment, we plan to examine the risks associated 
with the interstate movement of citrus foliage from quarantined areas. 
If we decide that the movement of citrus foliage can be accomplished 
safely under certain conditions, we would propose to provide for it in 
a future rulemaking.

Citrus Greening

    One commenter stated that we should not put in place any rule 
allowing the interstate movement of fruit from Florida until we have a 
program in place to address the risk posed by citrus greening.
    Restrictions on the movement of certain articles due to the 
presence of citrus greening have been put in place under separate 
Federal orders; the initial order was issued on September 16, 2005, and 
was updated on May 3, 2006. We further updated our restrictions 
relating to citrus greening through a Federal order issued on November 
2, 2007, to expand the areas under quarantine due to the presence of 
citrus greening and the areas under quarantine due to the presence of 
the Asian citrus psyllid, a vector for the spread of citrus greening.
    We have received reports of preliminary scientific evidence 
indicating that, when seedlings are generated from seed that is taken 
from plants infected with citrus greening, a small percentage of those 
seedlings are themselves infected with citrus greening. In response to 
this evidence, we have also amended the Federal order to prohibit the 
movement of seed for planting from areas quarantined for citrus 
greening.
    We are currently evaluating the preliminary evidence to determine 
whether seed contained in fruit may serve as a pathway for the 
transmission of citrus greening disease, and, if so, what restrictions 
may be appropriate for the movement of fruit from areas quarantined for 
citrus greening. Any regulatory action we may take in response to this 
evidence would be taken separately from this rulemaking, which 
addresses the risk posed by the interstate movement of citrus fruit 
from areas quarantined for citrus canker.

Miscellaneous Change

    The regulations in Sec.  301.75-7(a)(5) have required that all 
vehicles, equipment, and other articles used in providing inspection, 
maintenance, harvesting, or related services in a grove in which 
regulated fruit are produced for interstate movement must be treated in 
accordance with Sec.  301.75-11(d) upon leaving the grove. This 
paragraph has also provided that all personnel who enter the grove or 
premises to provide these services must be treated in accordance with 
Sec.  301.75-11(c) upon leaving the grove. We did not propose to change 
these requirements in the proposal. However, these requirements are 
inappropriate for the packinghouse-centered approach that we are 
adopting in this final rule. Accordingly, this final rule removes 
paragraph (a)(5) from Sec.  301.75-7. It should be noted that growers 
will still have an incentive to perform such treatments, as they would 
help ensure that fruit produced in the grove remains free of visible 
canker lesions and thus eligible for interstate movement.

Comments on the Preliminary Regulatory Impact Analysis and Initial 
Regulatory Flexibility Analysis

    In accordance with the requirements of Executive Order 12866 and 
the Regulatory Flexibility Act, we prepared a preliminary regulatory 
impact analysis and initial regulatory flexibility act analysis for the 
proposed rule.
    Two commenters stated that this analysis was incomplete as it did 
not analyze the potential effects of the introduction of citrus canker 
into commercial citrus-producing States other than Florida. One 
commenter stated that costs involved with copper sprays, isolation 
fencing, and spraying for disinfection could take away the current 
narrow margins that citrus producers enjoy, and that monitoring and 
surveying utilizing very high-cost labor would be very expensive. One 
commenter stated that the current canker-free status of California 
gives that State an advantage in the fresh citrus marketplace for 
exports.
    We do not expect that the conditions in this final rule will result 
in the introduction of citrus canker into other commercial citrus-
producing States, as the final rule retains the prohibition of the 
shipment of regulated fruit from a quarantined area to other commercial 
citrus-producing States. For that reason, we have not analyzed the 
possible effects of a citrus canker introduction on California citrus, 
including on California citrus producers' ability to export their 
fruit.
    The use of copper sprays is already an industry practice to control 
other pests of citrus fruit. Further, copper sprays, isolation fences, 
and spraying for disinfection, while not required by APHIS, are 
considered to be best industry practices that help to prevent 
infestation by other pests. Incorporating best management practices 
into production practices benefits both the individual producer and the 
industry as a whole.
    Grove surveys should be conducted regardless of the citrus canker 
status of any grove because early detection of any disease (such as 
citrus canker, citrus greening, citrus variegated chlorosis, and other 
diseases) is key to successful eradication of the disease.
    One commenter, from Florida, estimated that the spread of canker 
has resulted in an additional 20 percent of Florida's total fresh 
citrus groves being declared ineligible to ship fruit interstate under 
the regulations that were in place before the publication of this final 
rule. That 20 percent, the commenter stated, represents approximately 8 
million \4/5\-bushel cartons or an approximately $80 million potential 
business opportunity under the proposal.
    Another commenter cited this figure and compared it to what the 
commenter stated was the billion-dollar California fresh citrus 
industry, indicating that the latter should not be risked for the 
benefit of the former. This commenter also noted that we characterized 
as small the changes to the supply of Florida fresh citrus in States 
other than commercial citrus-producing States resulting from additional 
shipments that would be newly eligible to move interstate under the 
proposed rule. The commenter asked why the rule was being rushed into 
place given the precedent the rule sets and the fact that

[[Page 65196]]

stakeholders would not be able to review the peer review comments 
before the publication of the final rule.
    While the change from grove inspections to APHIS packinghouse 
inspections of finished fruit will allow Florida growers to maintain 
the quantity of fresh citrus that is eligible for interstate movement, 
and may result in an increase in that quantity, we do not expect that 
interstate shipments of fresh citrus will increase by a proportion 
equivalent to the potential production for the fresh market from groves 
previously prohibited from shipping interstate due to citrus canker. 
Rather, APHIS expects the quantities of fresh citrus shipped interstate 
from Florida to reflect historic demand for Florida fresh citrus. Over 
the last decade, the proportions of Florida fresh citrus shipped within 
Florida, to other States, and internationally have remained fairly 
constant. Based on historical data from 1997-98 to 2006-07, an average 
of 10 percent of Florida's commercially packed fresh citrus was shipped 
intrastate (within Florida) each season, 52 percent was shipped to 
other States each season, and 39 percent was exported to other 
countries each season.
    Based on the commenter's estimation of an additional 20 percent of 
Florida's fresh citrus groves regaining interstate shipment eligibility 
under this final rule, and given historic distribution patterns, we 
project as an upper bound that the shipment of fresh citrus to States 
other than commercial citrus-producing States is likely to be closer to 
4.3 million \4/5\-bushel cartons per season.
    Additionally, groves that have been ineligible to produce fruit for 
interstate movement under the regulations in place before the 
publication of this final rule have been ineligible due to the presence 
of citrus canker. It is reasonable to assume that some proportion of 
the fruit produced in those groves will have visible canker lesions and 
thus be ineligible for interstate movement, further lowering the 
potential increase in interstate shipments. Florida fresh citrus 
shipments are also still subject to the market demand for fresh citrus 
in States other than commercial citrus-producing States.
    The commenter also suggests that the potential increase in revenues 
could be $80 million. However, the $80 million figure assumes that 
fruit produced from these same groves during past seasons were 
considered to be unmarketable. Some of that fruit would have been 
diverted to the processing sector or shipped both intrastate and 
internationally. The increase in revenue would have to take the revenue 
gained by these means into account.
    With regard to the second commenter's point, the comparison given 
is between the incremental benefit to the Florida fresh citrus industry 
and the total value of the California fresh citrus industry. The 
commenter did not quantify what costs the commenter expected the 
California fresh citrus industry to incur as a result of the proposed 
rule, which is the salient point. We do not expect the regulations 
promulgated in this final rule to allow the spread of citrus canker to 
California, and thus we expect the final rule's effect on the 
California fresh citrus industry to be small as well.
    In addition, while the benefits to Florida growers and packers are 
expected to be small in the short term, the RMA indicates that it will 
be very hard to certify citrus groves as canker-free in Florida in the 
future. In the long run, promulgating this rule may be expected to 
provide additional benefits over the existing regulations, while 
continuing to prevent the interstate spread of citrus canker.
    One commenter, noting that we stated that currently underutilized 
packing equipment may be utilized for dooryard fruit under the proposed 
rule, stated that no data are given regarding how much idle capacity 
exists.
    As the volume of fruit moved interstate has declined, approximately 
21 citrus packinghouses have shut down in Florida since the 2001-02 
season; we do not have data on how many of them could still be used for 
packing citrus fruit. Our reference to underutilized packing equipment 
refers mainly to smaller operations, such as gift packers, which are 
better suited to treating and packing small quantities of citrus. 
Growers of dooryard fruit who wish to ship their fruit interstate are 
required to have this citrus treated and inspected under the same 
provisions required by commercial citrus producers. As such, these 
growers will turn to facilities equipped to comply with the 
regulations, such as gift packers. While the cost of shipping citrus 
under these provisions could be substantial, evidence indicates that 
dooryard shipments are made purely for the intrinsic value of sharing 
the fruit with family and friends. As noted earlier in this document, 
the interstate movement of dooryard citrus from a quarantined area was 
effectively prohibited under the regulations in place before the 
publication of this final rule.

Environmental Assessment

    We prepared an environmental assessment (EA) documenting the 
proposed rule's potential effects on the human environment.
    One commenter stated that the EA should examine the potential 
environmental impacts of the introduction of citrus canker into another 
commercial citrus-producing State, should APHIS be incorrect in its 
assessment of the potential for canker to be established in citrus-
producing States outside of Florida under the proposed regulations.
    Because this final rule prohibits the interstate movement of 
regulated fruit to commercial citrus-producing States, we do not expect 
the final rule to result in the introduction or establishment of citrus 
canker in those States. Therefore, we did not assess the environmental 
impact that would be associated with such an introduction.

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. 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 Florida citrus fruit is in progress. 
Making this rule effective immediately will allow interested producers 
and others in the marketing chain to benefit during this year's 
shipping season. Therefore, the Administrator of the Animal and Plant 
Health Inspection Service has determined that this rule should be 
effective upon publication in the Federal Register.

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.
    We are amending the citrus canker regulations to modify the 
conditions under which fruit may be moved interstate from a quarantined 
area. We are eliminating the requirement that the groves in which the 
fruit is produced be inspected and found free of citrus canker, and 
instead requiring that every lot of fruit produced in the quarantined 
area be inspected by APHIS at a packinghouse operating under a 
compliance agreement and found to be free of visible symptoms of citrus 
canker. We are retaining the requirement that the fruit be treated with 
a surface disinfectant and the prohibition on the movement of fruit

[[Page 65197]]

from a quarantined area into commercial citrus-producing States. These 
changes will relieve some restrictions on the interstate movement of 
fresh citrus fruit from Florida while maintaining conditions that will 
help prevent the artificial spread of citrus canker.
    For this final rule, we have prepared an economic analysis. The 
analysis, which is summarized below, addresses economic impacts of the 
proposed new protocol for treatment and inspection of citrus fruit 
intended for the fresh market. Expected benefits and costs are examined 
in accordance with Executive Order 12866. Possible impacts on small 
entities are considered in accordance with the Regulatory Flexibility 
Act. Copies of the full analysis are available on the Regulations.gov 
Web site (see footnote 1 at the beginning of this final rule).
    Section 301.75-5 of the regulations lists the designated commercial 
citrus-producing States as American Samoa, Arizona, California, 
Florida, Guam, Hawaii, Louisiana, the Northern Mariana Islands, Puerto 
Rico, Texas, and the U.S. Virgin Islands. Of these 11 commercial 
citrus-producing States, only 6 States received fresh citrus interstate 
shipments from Florida during the 2004-05 and 2005-06 seasons: Arizona, 
California, Louisiana, Puerto Rico, the U.S. Virgin Islands, and Texas. 
As of August 1, 2006, these 6 States no longer receive fresh citrus 
shipments from Florida. In this analysis, U.S. commercial citrus-
producing States other than Florida are referred to as other commercial 
citrus-producing States.
    The overall objective of this final rule is to continue to prevent 
the spread of citrus canker to other commercial citrus-producing 
States, while relieving restrictions on Florida citrus producers, 
namely, the requirement for interstate movement of citrus fruit that 
every tree in the grove in which the fruit is grown be inspected, and 
that the grove be found to be free of citrus canker not more than 30 
days before the beginning of harvest. Under the final rule, the citrus 
fruit will be treated and inspected at the packinghouse prior to 
interstate movement. Based on the qualitative findings of this economic 
analysis, we expect the net economic impact of the final rule to be 
positive.
    While citrus produced in Florida is primarily intended for the 
processed market, citrus produced in California, Texas, Arizona, and 
Louisiana is largely intended for the fresh market. Approximately 89 
percent of Florida citrus production is produced for the juice market, 
which is not regulated by the final rule. In contrast, fresh 
utilization in California accounts for 73 percent of total citrus 
production. In Texas and Arizona, fresh utilization accounts for 
approximately 66 and 58 percent of total production, respectively. It 
is assumed that nearly all Louisiana citrus production is primarily 
utilized on the fresh market. This final rule continues to prohibit the 
movement of fresh citrus fruit from Florida to other commercial citrus-
producing States. The measures in this final rule are designed to 
ensure protection of the citrus industries in these States from the 
introduction of citrus canker and the increased production costs and 
loss of fresh fruit markets that would result if citrus canker were to 
be introduced in those States.

Overview of the U.S. Citrus Industry

    The total value of U.S. citrus production increased by 16 percent 
during the 2005-06 season over the previous season from $2.3 billion to 
nearly $2.7 billion. These gains in value reflect increased values for 
processed utilization for most varieties of citrus in the United States 
with the exception of grapefruit, which declined in overall value by 4 
percent.
    Florida is the largest citrus producer in the United States, 
accounting for approximately 68 percent of U.S. production during the 
2005-06 season. California produced approximately 28 percent of the 
citrus in the United States during the same period, and production in 
Texas and Arizona comprised the remaining 4 percent. The tumultuous 
hurricane season of 2004, which included four hurricanes that crossed 
Florida within a 2-month period, caused significant production losses 
to Florida's citrus industry and was largely to blame for the 42 
percent decline of total utilized production in the United States 
between the 2003-04 and 2004-05 seasons. Total value of production in 
Florida citrus fruits showed signs of improvement during the 2005-06 
season with a 30 percent increase over the previous season; the 
increase was largely attributable to higher on-tree prices for both 
processed and fresh utilization rather than an increase in production.
    Evidence suggests a continued trend toward a decline in Florida 
citrus production. The recent 2006 Commercial Citrus Inventory for 
Florida reported a 17 percent decline in 2006 over the previous year 
with the total commercial citrus acreage in Florida at 621,373; the 
decline is largely attributable to hurricanes, diseases, and urban 
development. With removals of citrus trees outnumbering new plantings 
by a ratio of more than 5:1, there is little indication that production 
will rebound within the next few years.
    The major citrus varieties produced in Florida are early-, mid-, 
and late-season orange varieties, red and white seedless grapefruit, 
early tangerines, honey tangerines, temples, and tangelos. Although 
approximately 89 percent of all Florida citrus is intended for the 
processed market, the share of production that is processed is highly 
dependent upon the variety. Approximately 95 percent of all Florida 
orange production is intended for the processing sector; whereas, 
nearly 68 percent of Florida tangerine production is utilized on the 
fresh market. During the 2005-06 season, nearly 36 percent of Florida 
grapefruit production was utilized on the fresh market. During the 
previous season, the proportion of Florida grapefruit utilized on the 
fresh market was approximately 58 percent, suggesting that the post-
hurricane higher prices for fresh grapefruit led to a diversion of 
Florida grapefruit from the processing sector to the fresh market. The 
reduced rate for fresh market share during the 2005-06 season may 
suggest a return to a more normal fresh market share of about 40 
percent.
    The major citrus varieties produced in California are navel and 
Valencia oranges, grapefruit, tangerines, and lemons. Approximately 73 
percent of California citrus was utilized on the fresh market during 
the 2005-06 season, including nearly 72 percent of California's oranges 
(making California the largest U.S. producer of fresh-market oranges), 
88 percent of the State's grapefruit, 75 percent of its tangerines, and 
72 percent of its lemons.
    The citrus varieties produced in Texas during the 2005-06 season 
were grapefruit, Valencia oranges, and midseason oranges. Fresh 
production accounted for approximately 67 percent of total production. 
Valencia and midseason orange production was destined primarily for the 
fresh market, accounting for 79 percent of total production. Also, 62 
percent of grapefruit production in that State was utilized on the 
fresh market.
    Arizona produces Valencia and navel oranges, grapefruit, 
tangerines, and lemons. Approximately 58 percent of Arizona citrus was 
utilized on the fresh market during the 2005-06 season, including 52 
percent of the State's orange production, 65 percent of its tangerine 
production, 55 percent of its lemon production, and all of its 
grapefruit production.
    Total and domestic shipments of Florida fresh citrus demonstrated a

[[Page 65198]]

discernible improvement during the 2006-07 seasons with shipments 
increasing by 26 percent and 7 percent, respectively, over the previous 
season. Total and domestic shipments of Florida fresh citrus remained 
virtually unchanged during the 2005-06 season over the previous season, 
showing few signs of recovery from the dramatic decline between the 
2003-04 and 2004-05 seasons, when total and domestic shipments declined 
by 42 percent and 29 percent, respectively. Florida total and domestic 
fresh citrus shipments are 30 percent and 24 percent less, 
respectively, than they were prior to the 2004-05 season. While fresh 
grapefruit continues to have the largest share of total shipments of 
fresh Florida citrus including exports, oranges still account for the 
State's largest share of domestic shipments. During the 2006-07 season, 
Florida domestic shipments marginally increased to most geographical 
U.S. regions, with the noted exception of a 4 percent decline in 
shipments to the western U.S. region, which was chiefly attributable to 
the loss of market access to other citrus-producing States.

Expected Costs and Benefits

    The changes in the regulations described in this document are 
likely to primarily affect citrus producers and packinghouses in 
Florida whose operations rely on the interstate shipment of fresh 
citrus. The changes will also affect the way resources are allocated 
for citrus canker mitigation activities at both Federal and State 
levels.

Effects on Florida Fresh Citrus Shipments

    We expect the final rule to have little economic effect on the 
production of fresh citrus in Florida, but the shift from inspection 
for citrus canker in the citrus groves, tree by tree, to the inspection 
of fresh citrus samples at the packinghouse will likely result in 
increased shipments of fresh citrus to States other than commercial 
citrus-producing States. As such, the marketing effects of increased 
quantities of fresh citrus fruit on the domestic market may include 
changes in fresh market prices, processed market prices, and increased 
competition. Under this final rule, Florida citrus is still prohibited 
from distribution to other commercial citrus-producing States.
    APHIS expects the quantities of fresh citrus shipped interstate 
from Florida to reflect historic demand for Florida fresh citrus. We do 
not expect that interstate shipments of fresh citrus will increase by a 
proportion equivalent to the potential production for the fresh market 
from groves previously prohibited from shipping interstate due to 
citrus canker. Over the last decade, the proportions of Florida fresh 
citrus shipped within Florida, to other States, and internationally 
have remained fairly constant. Based on historical data from 1997-98 to 
2006-07, an average of 10 percent of Florida's commercially packed 
fresh citrus was shipped intrastate (within Florida) each season, 52 
percent was shipped to other States each season, and 39 percent was 
exported to other countries each season.
    The average proportion of Florida fresh citrus shipments to the 
domestic market (intrastate and interstate) over the last decade was 
approximately 61 percent of total shipments. The average deviation in 
the proportion of fruit shipped to the domestic market was 
approximately 3 percent (or approximately 982,000 \4/5\-bushel 
cartons).\8\ The proportion of Florida fresh citrus shipments to the 
domestic market over the last 5 seasons was approximately 62 percent of 
total shipments, with an average deviation of approximately 5 percent 
(or roughly 1.2 million \4/5\-bushel cartons).
---------------------------------------------------------------------------

    \8\ The average deviation is a measure of variability. It is 
computed for a series of data points by finding the absolute 
difference between each point and the average (mean) for the series, 
summing these differences, and dividing by the total number of data 
points.
---------------------------------------------------------------------------

    Citrus production in Florida has been in decline in recent years 
due in part to declining citrus tree inventories and harsh weather 
conditions. Although the total quantity of Florida fresh citrus shipped 
has declined in recent years, the allocation between the various 
markets (e.g. interstate, intrastate, and export) has remained fairly 
consistent despite this downward trend in production. The proportion of 
Florida fresh citrus shipments to the domestic market prior to the 2004 
hurricane season was approximately 60 percent of total shipments, with 
an average deviation of approximately 2 percent (or approximately 
663,000 \4/5\-bushel cartons each season).
    The proportion of Florida fresh citrus shipments to the domestic 
market for the past three seasons was approximately 65 percent of total 
shipments, with an average deviation of approximately 4 percent (or 
approximately 841,000 \4/5\-bushel cartons each season) The increased 
variability in the proportion of Florida fresh citrus shipped to the 
domestic market over the last three seasons is reflective of an 
industry recovering in the wake of the 2004 and 2005 hurricane seasons. 
The average quantity of Florida fresh citrus shipped on the domestic 
market prior to 2004 was approximately 34.1 million \4/5\-bushel 
cartons each season compared to an average of 20.8 million \4/5\-bushel 
cartons over the last three seasons.
    The Florida Citrus Packers, a nonprofit cooperative association, 
commented during the public comment period that the spread of citrus 
canker had resulted in an estimated additional 20 percent of total 
fresh citrus groves in Florida declared ineligible for interstate 
shipment under the regulations in place before this final rule because 
of the presence of citrus canker. The commenter did not report a 
baseline for this ``additional 20 percent.'' The Florida Citrus Packers 
further estimated that the fresh citrus fruit produced in these groves 
represents approximately 8 million cartons of potential business 
opportunity under the revised regulations. Based on the commenter's 
estimation of an additional 20 percent of Florida's fresh citrus groves 
regaining interstate shipment eligibility under this final rule, and 
given historic distribution patterns, we project as an upper bound that 
the shipment of fresh citrus to States other than commercial citrus-
producing States is likely to be closer to 4.3 million \4/5\-bushel 
cartons per season. However, based on the preceding discussion of the 
small variability in the proportion of fruit shipped to various 
markets, it is not likely that interstate shipments will increase by 
this projected upper bound. We also note that a portion of fruit from 
these groves is expected to fail to meet quality standards for the 
fresh market and will be diverted to other channels, including the 
processed market. This issue is discussed in more detail earlier in 
this document under the heading ``Comments on the Preliminary 
Regulatory Impact Analysis and Initial Regulatory Flexibility 
Analysis.''
    In addition, while any benefits to Florida growers and packers are 
expected to be small in the short term, the RMA indicates that it will 
be very hard to certify citrus groves as canker-free in Florida in the 
future. In the long run, this rule is expected to provide increased 
benefits in comparison to the regulations in place before the 
publication of this final rule, while continuing to prevent the 
interstate spread of citrus canker.

Effects on Consumers

    Consumers in States other than commercial citrus-producing States 
will benefit from any increases in shipments of Florida fresh citrus. 
The increase in interstate shipments may lead to lower prices, 
depending on the magnitude of the change and the price elasticity of

[[Page 65199]]

demand. If the regulations in place before the publication of this 
final rule had been maintained, Florida fresh citrus shipments to the 
domestic market would have been expected to decline, because the number 
of groves eligible for certification as free of citrus canker would 
decline as a result of the spread of citrus canker. In the long run, 
under this final rule, these consumers will benefit from a sustained 
supply of Florida fresh citrus.
    In the short run, consumers within Florida may experience increased 
supplies associated with rejected lots that have been diverted 
intrastate. Florida consumers may benefit from near-term price 
declines, again, depending on the quantities diverted to the fresh 
market within Florida and the price elasticity of demand. However, in 
the long run, any increase in intrastate shipments is expected to be 
less than would occur under the regulations that had been in place 
before the publication of this final rule. Under those regulations, the 
number of groves eligible for certification as free of citrus canker 
would have declined, along with the quantity of fresh citrus approved 
for interstate movement.

Effects on Florida Packinghouses and Citrus Growers

    In terms of operational adjustments, Florida packinghouses are the 
segment of the citrus industry likely to be the most affected by the 
change in regulations since the focus of the new protocol for 
treatments and APHIS inspections will be shifted away from the citrus 
groves to the packinghouse facilities. The final rule will require 
citrus packinghouses that move regulated citrus fruit interstate to 
operate under an APHIS compliance agreement wherein the packinghouse 
operator agrees to meet all requirements of the regulations. The 
provisions in Sec.  301.75-7 pertaining to the inspection of groves for 
citrus canker as a prerequisite for the interstate movement of citrus 
are being removed.
    Citrus producers, however, will still retain the same incentives 
that currently exist to employ best management practices when producing 
citrus for the fresh market. A packinghouse charge to the grower for 
citrus that does not meet the quality requirements is known as an 
elimination charge, and is an existing industry measure for ensuring 
high quality, symptom-free fruit. With quality standards in place for 
fresh citrus, as outlined as part of the U.S. Standards in the 
Agricultural Marketing Service's regulations in 7 CFR part 51, growers 
already employ the practice of surveying for fresh citrus fruit that 
are not considered of fresh market quality. The high cost of inputs and 
production practices employed in producing citrus fruit intended for 
the fresh market yields a relatively low return to citrus growers if 
the fruit is diverted to the processed market because it is determined 
to be unsuitable for the fresh market. Production costs associated with 
citrus fruit intended for the processed market are less than costs 
associated with citrus fruit produced for the fresh market because the 
physical appearance of the fruit produced for the processed market is 
not important; consequently, the value of citrus on the processed 
market is relatively low compared to the value of citrus sold on the 
fresh market. In the long run, citrus growers will maintain self-
surveys and best management practices as long as the costs of these 
practices are less than the elimination charges and the price discount 
that is incurred when their fruit diverted from the fresh to the 
processed market. Table 2 outlines the average packinghouse charges for 
Florida fresh citrus during the 2005-06 season.

 Table 2.--Estimated Average Total Packing Charges Paid by Growers, and Elimination Charges Paid by Growers for
                              Lots That Do Not Meet Quality Requirements, 2005-06 a
----------------------------------------------------------------------------------------------------------------
                                                   Domestic      Export                   Temples/
                                                  grapefruit   grapefruit    Oranges      tangelos    Tangerines
----------------------------------------------------------------------------------------------------------------
                                                                            $/Carton c
----------------------------------------------------------------------------------------------------------------
Total packing charge b.........................       $4.016       $4.395       $4.347       $4.614       $5.469
----------------------------------------------------------------------------------------------------------------
                                                                             $/Box c
----------------------------------------------------------------------------------------------------------------
Drenching charge...............................        0.181        0.189        0.181        0.184        0.188
Packinghouse elimination charges...............        0.545        0.553        0.548        0.548        0.552
Hauling charges for eliminations...............        0.505        0.534        0.515        0.531        0.534
----------------------------------------------------------------------------------------------------------------
Source: Ronald P. Muraro, University of Florida-Institute of Food and Agricultural Sciences, Citrus Research and
  Education Center, Lake Alfred, FL, August 2006.
a These packing charges are based on charges at four citrus packinghouses in the Interior production region and
  13 citrus packinghouses in the Indian River production region.
b Total packing charge refers to the charge to the grower for packed fruit, and is based upon packinghouse
  operational costs. Total packing charges are discussed in detail in the report ``Average Packinghouse Charges
  for Florida Fresh Citrus--2005-06 Season,'' (http://edis.ifas.ufl.edu).
c One box is equivalent to two \4/5\-bushel cartons.

    Focusing regulatory enforcement in the packinghouse via required 
treatments and inspection of fruit intended for interstate movement is 
expected to be a more economically efficient means of ensuring a high 
level of confidence that even a small percentage of infected fruit will 
be detected than the system in place before the publication of this 
final rule. Both packinghouses operating under compliance agreements 
with APHIS and growers seeking to minimize elimination charges and 
price discounts have incentives to ensure that only fruit free of 
visible canker lesions enter a packing facility. Packinghouse 
operations with fully integrated groves also seek to minimize the costs 
associated with fruit rejected due to low quality in general, 
especially since these operations have more control over production 
practices. (The purpose of the APHIS inspection is to ensure that fruit 
is free from visible canker lesions. Packinghouses are responsible for 
all other quality inspections.) Minimizing the charges back to the 
grower associated the drenching, elimination, and hauling of fruit 
unsuitable for the fresh market through the practice of grove surveys 
is commonly employed by growers as part of their operations. Tree 
inspections, which were previously conducted by APHIS and the Florida 
Department of Agriculture and

[[Page 65200]]

Consumer Services (FDACS), will, we believe, be conducted as self-
surveys by the industry. Given the possibility of elimination charges 
and price discounts, growers will apply the additional resources needed 
to conduct these self-surveys as long as the benefits outweigh the 
costs.
    The inspection process will be largely dependent on the physical 
layout of each particular packinghouse. Conditions that must be met in 
order for APHIS inspectors to successfully conduct the required 
inspections would translate into additional costs to the packinghouse. 
Inspections will either occur at the roll board prior to the fruit 
being packed or after the fruit is packed. In either case, adequate 
lighting will be a necessary component for the fruit inspection 
process. If the inspection occurs after fruit is packed, the 
packinghouse will be required to provide a table and personnel to 
repack the boxes after inspection. The APHIS inspection process will be 
designed with every effort to maintain the efficiency of the 
packinghouse operation.
    If a lot is rejected due to citrus canker detection, the lot will 
not be approved for interstate movement. Alternative markets for this 
fruit are the intrastate market, some international markets, or the 
processed market. The grower or packinghouse will divert the fruit to 
the market that yields the maximum return. Assuming the fruit is 
diverted to the intrastate or an international market, the grower may 
incur repacking charges associated with fruit that was packed before 
the lot was rejected in boxes or other containers approved only for 
interstate movement. These charges will likely be in addition to 
drenching and elimination charges. Since the average price that growers 
receive on the processed market is less than prices received on the 
fresh market, growers will likely suffer a loss by diverting rejected 
lots to the processed market. Growers are more likely to maximize 
returns by diverting the fruit to available fresh markets, either 
intrastate or international, depending on demand, even though they will 
likely incur repacking charges into cartons approved for intrastate or 
international movement.
    Lot size is determined by the packinghouse, and varies according to 
the size of the packinghouse, the number of packing lines per facility, 
and the varieties of fresh citrus packed. Additionally, packinghouses 
generally identify each lot run through the packinghouse with a lot 
number that can be traced back to the origin of the lot. APHIS field 
personnel estimate that under ideal circumstances, the inspection of 
1,000 pieces of fruit will take approximately 1 hour and 23 minutes 
(approximately 5 seconds per fruit). If the lot takes longer than that 
to run, the inspection is not expected to result in a delay. However, a 
base inspection level of 1,000 pieces of fruit may delay a lot that 
would require less time than 1 hour and 23 minutes to run the line. 
Packing would essentially have to halt while the inspection is 
completed before the next lot can be run. In addition, if an inspector 
finds a suspect lesion on a piece of fruit and the packer does not wish 
to immediately divert to an alternative market (such as the intrastate 
or foreign market), the movement of that lot will be delayed while 
APHIS makes a final determination on whether the lesion is a citrus 
canker lesion.
    The time it takes to run a lot of fruit varies by packinghouse, and 
is determined by numerous factors. It is reasonable to assume that an 
average time to run a lot of fruit is about 3 hours. On the average, 
then, the inspection of 1,000 pieces of fruit will not result in 
delays. If a packinghouse has its own groves and packs its own fruit, 
lot sizes are generally larger, and no delays should be expected. 
Packinghouses that do not pack their own fruit tend to run multiple 
smaller lots whose identity must be maintained to ensure proper payment 
to the respective growers. These packinghouses are more likely to 
experience delays caused by the inspection of 1,000 pieces of fruit.
    The treatment of fruit with a surface disinfectant, as reflected in 
the drenching charges in table 1, occurs under the existing regulations 
and is conducted as a standard practice to extend shelf life. It also 
is a requirement in the FDACS/Division of Plant Industry (DPI) 
compliance agreement with packers. Therefore, there is no additional 
cost associated with the change in regulations.
    The APHIS compliance agreements are not expected to present an 
entirely new situation for the packinghouses. Current compliance 
agreements with the State of Florida issued by the FDACS/DPI are 
required of all packinghouses that ship fresh citrus interstate. They 
require the packinghouses to adhere to inspection requirements prior to 
the movement of fresh citrus. According to section III.A of the FDACS 
packinghouse compliance agreement:

    Inspection of fruit for citrus canker lesions will take place 
during the washing/grading process, and a designated number of 
packed boxes will be required to be pulled, opened and made 
available for inspection by Federal or State regulatory officials.

(As stated earlier in this document, we intend to provide for sampling 
of fruit before it is packed into boxes in our compliance agreements 
with gift packing operations.)

Effects on Public Sector Resources

    According to APHIS, 10 additional inspectors will be needed to 
implement the final rule at a cost of $450,000 per year. The added cost 
for increased inspection at the packinghouse is expected to be offset 
by a reduction in certain operational expenses in other program areas. 
For example, pre-harvest grove surveys will be reduced to only those 
required for phytosanitary certification to certain countries. The 
FDACS anticipates a reduction in field staff by 65 percent from 340 to 
120 field staff members, for a cost savings of approximately $38,000 
per inspector (or $8.4 million). Florida appropriates funds to the 
FDACS from the Citrus Inspection Trust Fund to pay the costs associated 
with the salary and benefits of employees of the Bureau of Citrus 
Inspection.\9\
---------------------------------------------------------------------------

    \9\ Title XXXV Section 601.28 of the Florida Statutes.
---------------------------------------------------------------------------

    The State of Florida allocated approximately $10 million in funds 
from the Agricultural Emergency Eradication Trust Fund to the Citrus 
Health Plan line item for the 2007-08 fiscal year to be utilized for 
grove inspections (generally pre-harvest surveys), regulatory 
oversight, and nursery surveys. Approximately $11.3 million in funds 
from the Agricultural Emergency Eradication Trust Fund were allocated 
to the Citrus Canker Eradication line item the previous fiscal year, 
thus reducing emergency eradication program activities by approximately 
$1.3 million and allowing for the management of other citrus diseases 
and pests. Trust funds may be made available upon certification by the 
Commissioner that an agricultural emergency exists and that funds 
specifically appropriated for the emergency's purpose are exhausted or 
insufficient to eliminate the agricultural emergency.\10\
---------------------------------------------------------------------------

    \10\ Title XXXV Section 570.191 of the Florida Statutes.
---------------------------------------------------------------------------

    The final rule will ensure resource savings associated with 
inspectors and equipment for the State of Florida of approximately $9.7 
million per annum.

Concluding Statement on Benefits and Costs

    Before the publication of this final rule, the regulations for the 
interstate movement for regulated fruit from quarantined areas placed 
several

[[Page 65201]]

restrictions on the interstate movement of citrus fruit from Florida, 
including inspections of citrus groves to ensure that they are free of 
citrus canker, pre-harvest inspections, treatments, and movement under 
limited permit.
    The new regulations replace the existing protocol for the movement 
of citrus fruit from citrus canker quarantined areas. A packinghouse 
that ships fresh citrus interstate is required to operate under an 
APHIS compliance agreement wherein the packinghouse operator agrees to 
meet the requirements of the regulations. APHIS inspections of fresh 
citrus will occur at the packinghouse level. This final rule also 
specifies treatment requirements for all commercially packed fresh 
citrus. The required treatment, however, is already performed at the 50 
largest commercial packinghouses, as well as at any smaller 
packinghouses that pack fruit for interstate movement under the 
regulations in place before the publication of this final rule. We 
believe packinghouses will adjust to the new regulations with little to 
no economic hardship in the long run. Packinghouses currently face 
similar regulations as required by the Florida compliance agreements 
for packinghouses. Although the final rule adds a definition of 
commercial packinghouse for the purposes of implementing the rule, all 
currently operating Florida packinghouses qualify as commercial 
packinghouses under this definition; APHIS thus does not anticipate 
that commercial citrus packinghouses will incur any costs as a result 
of adding this new definition.
    Packinghouse charges to growers for eliminations and price 
discounts for fruit diverted from the fresh to the processed market are 
incentives to growers to ensure fruit sent to the packinghouse for 
packing is free of symptoms of citrus canker. Growers will self-survey 
groves as long as the benefits outweigh the cost of the procedure. The 
provisions will provide the added benefit to growers of being able to 
ship symptom-free fresh citrus from groves previously prohibited from 
interstate movement due to the presence of citrus canker in the grove.
    The final rule will also provide opportunities for commercial 
packinghouses to treat and pack interstate shipments of dooryard 
plantings of citrus fruit. Such shipments will also be inspected by 
APHIS.
    Benefits of this final rule may include the possibility of gains 
from a larger volume of Florida shipments to consumers in States other 
than commercial citrus-producing States. Producers would no longer be 
prohibited from sending to the packinghouses for interstate shipment 
fruit from citrus groves in which citrus canker has been detected. As 
long as a lot of citrus fruit is found to be symptom-free upon APHIS 
inspection, the lot will be eligible for shipment to States other than 
commercial citrus-producing States. Growers with citrus groves in which 
citrus canker has been detected will have an additional marketing 
option for their fruit. Consumers on the domestic market may benefit 
from increased market quantities and lower prices of fresh citrus if a 
greater market demand exists than is met by the current supply. We 
expect that Florida packinghouses that wish to ship interstate will 
continue to do so as long as the financial benefits to them of 
operating under these provisions exceed their costs.
    Finally, the costs to the public sector associated with the final 
regulations are expected to be marginal in comparison to the benefits 
of a more efficient system for fresh citrus fruit movement.

Final Regulatory Flexibility Analysis

    The Regulatory Flexibility Act requires that agencies consider the 
economic impact of rule changes on small businesses, organizations, and 
governmental jurisdictions. Section 604 of the Act requires agencies to 
prepare and make available to the public a final regulatory flexibility 
analysis (FRFA) describing any changes made to the rule as a result of 
comments received and the steps the agency has taken to minimize any 
significant economic impacts on small entities. Section 604(a) of the 
Act specifies the content of a FRFA. In this section, we address these 
FRFA requirements.

Need for and Objective of the Rule

    Based on our evaluation of production and processing procedures and 
their impact on removal of citrus canker from the fresh fruit pathway, 
along with our review of the operational feasibility of enforcing 
various mitigation measures, APHIS has concluded that the mandatory 
packinghouse inspection of processed fruit provides an effective 
safeguard to prevent the spread of citrus canker via the movement of 
commercial citrus fruit. Since regulations that were in place before 
the publication of this final rule required groves to be free of citrus 
canker in order for fruit to be eligible for interstate movement, the 
changes in this final rule are necessary in order for the packinghouse-
based treatment and inspection protocol to be implemented.

Summary of Significant Issues Raised During Comment Period on the 
Initial Regulatory Flexibility Analysis

    There were no significant issues raised in public comment on the 
initial regulatory flexibility analysis (IRFA) for this rulemaking. One 
commenter from California, however, expressed concerns that the impact 
of citrus canker on the production costs in other citrus-producing 
States would be devastating should the disease spread as a result of 
this rule. The commenter further defined these costs as the costs 
involved with copper sprays, isolation fencing, and spraying for 
disinfection. The commenter went on to declare that monitoring and 
surveying would be very expensive given the high cost of labor. The 
majority of citrus producers in California would be considered small 
entities according to the Small Business Administration (SBA) 
guidelines.
    We have addressed this comment earlier in this document under the 
heading ``Comments on the Preliminary Regulatory Impact Analysis and 
Initial Regulatory Flexibility Analysis.''

Description and Estimated Number of Small Entities Regulated

    Florida's citrus packinghouses and fresh citrus producers comprise 
the industries that we expect to be directly affected by the final 
rule. The small business size standards for citrus fruit packing, as 
identified by the SBA based upon the North American Industry 
Classification System (NAICS) code 115114 (Postharvest Crop 
Activities), is $6.5 million or less in annual receipts. According to 
the County Business Patterns report for Florida published by the U.S. 
Census Bureau, there were 71 post-harvest operations in Florida in 
2004. Although this publication reports the number of employees, the 
number of firms by employment size and the annual payroll for firms 
included in NAICS 115114, it does not report the distribution of annual 
sales for firms in this category. Neither is information on annual 
sales published in the Census of Agriculture or the Economic Census. 
There are at least 142 packinghouses currently registered in 
Florida.\11\ While the classification of these establishments by sales 
volume is not available, it is estimated that approximately 50 of the 
142 registered commercial packinghouses are large citrus packinghouses 
with the remainder being small establishments, many known as gift 
packers, in Florida. The Fresh Shippers Report, as reported

[[Page 65202]]

by the Citrus Administrative Committee, details quantities of fresh 
citrus shipments of the top 40 to 50 shippers of each season.\12\ At 
least 98 percent of Florida fresh citrus shipments are packed through 
the top 40 to 50 packinghouses in the State.\13\ During the 2005-06 
citrus season, annual sales for 21 of the top 40 shippers (52.5 
percent) were below the SBA size standard of $6.5 million. It is 
estimated that at least 85 percent of citrus packers, including small 
gift packers, are considered small according to the SBA size standards.
---------------------------------------------------------------------------

    \11\ Florida Department of Agriculture and Consumer Services, 
Division of Fruit & Vegetable Inspection. http://
www.doacs.state.fl.us/fruits.
    \12\ ``Fresh Shippers Report: 2005-06 Season Through July 31, 
2006,'' Citrus Administrative Committee, August 18, 2006. http://
www.citrusadministrativecommittee.org/.
    \13\ Ibid.
---------------------------------------------------------------------------

    The final rule will implement a new protocol for inspections and 
treatments that will likely result in additional costs to 
packinghouses. Examples of additional costs include providing adequate 
lighting and space for fruit inspection and labor to repack boxes which 
have been unpacked during inspection. Essentially, the inspection and 
treatment process is an additional quality control measure. In the 
short run, it is likely that commercial packinghouses will increase 
packing charges to cover any additional costs associated with the final 
rule, passing some of the cost of the rule onto the growers. However, 
packinghouse average costs may rise with the imposition of this quality 
control measure due to increases in the average variable costs 
associated with maintaining a consistent level of output. Examples of 
expected increases in average variable costs include higher labor costs 
associated with repacking of 4/5-bushel cartons or an inspection 
process that slows or shuts down the packing line for any period of 
time. The inspection process will add one more layer to the production 
process. As the base level for inspection increases, so does inspection 
time. Therefore, as inspection sample size increases, the efficiency 
and productivity of the packinghouse, especially the smaller 
packinghouses and gift packers, could become hindered. Overall, the 
industry will benefit; inspection for citrus canker lesions at the 
packinghouse will maintain sales to interstate markets more efficiently 
than would be possible under the current grove inspections.
    The final rule will also affect producers of fresh citrus in 
Florida. Most, if not all, of the Florida citrus producers that will be 
affected by the final rule are small, based on 2002 Census of 
Agriculture data and SBA guidelines for entities classified within the 
farm categories Orange Groves (NAICS 111310) and Citrus (except Orange) 
Groves (NAICS 111320). SBA classifies producers in these categories 
with total annual sales of not more than $750,000 as small entities. 
According to 2002 Census data, there were a total of 7,653 citrus farms 
in Florida in 2002. Of this number, approximately 94 percent had annual 
sales in 2002 of less than $500,000, which is well below the SBA's 
small entity threshold of $750,000.\14\ While it is likely this final 
rule will result in higher packinghouse charges to the grower, costs 
associated with the final rule are expected to be minimal. Citrus 
growers previously prohibited from interstate shipment of fresh citrus 
due to citrus canker detection in their groves will have an additional 
marketing opportunity for their fruit provided the fruit meets the 
requirements to pass APHIS inspection.
---------------------------------------------------------------------------

    \14\ Source: SBA and 2002 Census of Agriculture.
---------------------------------------------------------------------------

Description and Estimate of Compliance Requirements

    Florida's packinghouses that ship fresh citrus interstate would be 
subject to compliance agreements with APHIS, as described in section IV 
of the full final regulatory impact analysis.

Description of Steps Taken To Minimize Significant Economic Impacts on 
Small Entities

    APHIS does not believe small entities will suffer significant 
economic losses as a result of this final rule. APHIS intends to devise 
a compliance agreement that is suitable for both large and small 
commercial packinghouses, especially with respect to the inspection 
process. Citrus growers will continue to have the same incentives to 
employ best management practices that will yield citrus fruit meeting 
the quality standards required at the packinghouse.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with State and local 
officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are inconsistent with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

National Environmental Policy Act

    An environmental assessment and finding of no significant impact 
have been prepared for this final rule. The environmental assessment 
provides a basis for the conclusion that the interstate movement of 
citrus fruit under the conditions specified in this rule will not have 
a significant impact on the quality of the human environment. Based on 
the finding of no significant impact, the Administrator of the Animal 
and Plant Health Inspection Service has determined that an 
environmental impact statement need not be prepared.
    The environmental assessment and finding of no significant impact 
were prepared in accordance with: (1) The National Environmental Policy 
Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) 
regulations of the Council on Environmental Quality for implementing 
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA 
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA 
Implementing Procedures (7 CFR part 372).
    The environmental assessment and finding of no significant impact 
may be viewed on the Regulations.gov Web site.\15\ Copies of the 
environmental assessment and finding of no significant impact are also 
available for public inspection at USDA, Room 1141, South Building, 
14th Street and Independence Avenue, SW., Washington, DC, between 8 
a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons 
wishing to inspect copies are requested to call ahead on (202) 690-2817 
to facilitate entry into the reading room. In addition, copies may be 
obtained by writing to the individual listed under FOR FURTHER 
INFORMATION CONTACT.
---------------------------------------------------------------------------

    \15\ Go to http://www.regulations.gov/fdmspublic/component/
main?main=DocketDetail&d=APHIS-2007-0022. The environmental 
assessment and finding of no significant impact will appear in the 
resulting list of documents.
---------------------------------------------------------------------------

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 0579-0325.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to

[[Page 65203]]

provide increased opportunities for citizen access to Government 
information and services, and for other purposes. For information 
pertinent to E-Government Act compliance related to this rule, please 
contact Mrs. Celeste Sickles, APHIS' Information Collection 
Coordinator, at (301) 734-7477.

References

    Belasque, J. and J. Rodriguez Neto (2000). ``Survival of the 
citrus canker bacterium in non-infected orange fruits.'' Summa 
Phytopathologica 26(1): 128 (Resumo 153).
    Borchert, D., C. Thayer, L. Brown, N. Jones and R. Magarey 
(2007). Citrus Canker Ad Hoc Project, USDA-APHIS-PPQ-CPHST-PERAL 
(internal document).
    Brown, G.E. and T.S. Schubert (1987). ``Use of Xanthomonas 
campestris pv. vesicatoria to evaluate surface disinfectants for 
canker quarantine treatment of citrus fruit.'' Plant Disease 71(4): 
319-323.
    Canteros, B. I. (undated). Effect of low concentrations of 
sodium hypochlorite in external disinfection of organic fruits as 
quarantine treatment for citrus canker. INTA Final Report.
    CRARM (Presidential/Congressional Commission on Risk Assessment 
and Risk Management). 1997a. Framework for Environmental Health Risk 
Assessment, Final Report, Volume 1. Washington, DC: The 
Presidential/Congressional Commission on Risk Assessment and Risk 
Management.
    CRARM (Presidential/Congressional Commission on Risk Assessment 
and Risk Management). 1997b. Risk Assessment and Risk Management in 
Regulatory Decisionmaking, Final Report, Volume 2. Washington, DC: 
The Presidential/Congressional Commission on Risk Assessment and 
Risk Management.
    Dalla Pria, M., R.C.S. Christiano, E.L. Furtado, L. Amorim and 
A. Bergamin Filho (2006). ``Effect of temperature and leaf wetness 
duration on infection of sweet oranges by Asiatic citrus canker.'' 
Plant Pathology 55: 657-663.
    Fulton, H.R. and J.J. Bowman (1929). ``Infection of fruits by 
Pseudomonas citri.'' J. Agric. Res. 39: 403-426.
    Golmohammadi, M., J. Cubero, J. Pe[ntilde]alver, J.M. Quesada, 
M.M. Lopez, and P. Llop (2007). ``Diagnosis of Xanthomonas 
axonopodis pv. citri, causal agent of citrus canker, in commercial 
fruits by isolation and PCR-based methods.'' Journal of Applied 
Microbiology ISSN 1364-5072.
    Gottwald, Timothy. Report of lecture given on Citrus 
Packinghouse Day at Citrus Research and Education Center. Cited in 
www.theledger.com. 08/19/06.
    Gottwald, T.R. and J.H. Graham (1992). ``A device for precise 
and nondisruptive stomatal inoculation of leaf tissue with bacterial 
pathogens.'' Phytopathology 82: 930-935.
    Graham, J.H., T.R. Gottwald, T.D. Riley and M.A. Bruce (1992b). 
``Susceptibility of citrus fruit to bacterial spot and citrus 
canker.'' Phytopathology 82(4): 452-457.
    Graham, J.H., T.R. Gottwald, T.D. Riley, J. Cubero and D.L. 
Drouillard (2000). Survival of Xanthomonas campestris pv. citri 
(Xcc) on various surfaces and chemical control of Asiatic citrus 
canker (ACC). International Citrus Canker Research Workshop, Ft. 
Pierce, FL.
    Koizumi, M. (1972). ``Studies on the symptoms of citrus canker 
formed on Satsuma mandarin fruit and existence of causal bacteria in 
the affected tissues.'' Bull. Hort. Res. Sta., Japan, Ser. B 12: 
229-244.
    Peltier, G.L. and W.J. Frederich (1926). ``Effects of weather on 
the world distribution and prevalence of citrus canker and citrus 
scab.'' Journal of Agricultural Research 32(2): 147-164.
    Riley, T. (2007). E-mail dated 1/24/2007 from T. Riley, Lead 
Plant Pathologist, APHIS Citrus Health Response Program to L.M. 
Ferguson Re: Citrus Canker lesion sizes/Xac viability.
    Timmer, L.W., S.E. Zitko and T.R. Gottwald (1996). ``Population 
dynamics of Xanthomonas campestris pv. citri on symptomatic and 
asymptomatic citrus leaves under various environmental conditions.'' 
Proceedings of the International Society of Citriculture 1: 448-451.
    USDA-National Agricultural Statistics Service (2007). Commercial 
Citrus Inventory 2006. Prepared with Florida Department of 
Agriculture and Consumer Services.
    Verdier, E., E. Zefferino and S. Mendez (2006). ``Xanthomonas 
axonopodis pv. citri survival in Citrus fruit submitted to post 
harvest treatment using detecting by semi-selective culture media 
and bioassay.'' Unpublished (submitted with public comments to 2006 
citrus canker interim rule).
    Verniere, C.J., T.R. Gottwald and O. Pruvost (2003). ``Disease 
development and symptom expression of Xanthomonas axonopodis pv. 
citri in various citrus plant tissues.'' Phytopathology 93: 832-843.

List of Subjects

7 CFR Part 301

    Agricultural commodities, Plant diseases and pests, Quarantine, 
Reporting and recordkeeping requirements, Transportation.

7 CFR Part 305

    Irradiation, Phytosanitary treatment, Plant diseases and pests, 
Quarantine, Reporting and recordkeeping requirements.

0
Accordingly, we are amending 7 CFR parts 301 and 305 as follows:

PART 301--DOMESTIC QUARANTINE NOTICES

0
1. The authority citation for part 301 continues to read as follows:

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 7 CFR 2.22, 2.80, 
and 371.3.
    Section 301.75-15 issued under Sec. 204, Title II, Public Law 
106-113, 113 Stat. 1501A-293; sections 301.75-15 and 301.75-16 
issued under Sec. 203, Title II, Public Law 106-224, 114 Stat. 400 
(7 U.S.C. 1421 note).


0
2. Section 301.75-1 is amended as follows:
0
a. In the definitions for ``certificate'' and ``limited permit'', by 
adding the words ``stamp, form, or other'' after the words ``An 
official''.
0
b. By adding new definitions of ``commercial packinghouse'' and ``lot'' 
to read as set forth below.


Sec.  301.75-1  Definitions.

* * * * *
    Commercial packinghouse. An establishment in which space and 
equipment are maintained for the primary purpose of packing citrus 
fruit for commercial sale. A commercial packinghouse must be registered 
as a packinghouse with the State in which it operates or hold a 
business license for treating and packing fruit.
* * * * *
    Lot. The inspectional unit for fruit composed of a single variety 
of fruit that has passed through the entire packing process in a single 
continuous run not to exceed a single workday (i.e., a run started one 
day and completed the next is considered two lots).
* * * * *
0
3. Section 301.75-7 is amended as follows:
0
a. Paragraphs (a)(1), (a)(2), (a)(5), and (a)(6) are revised to read as 
set forth below.
0
b. An OMB citation is added at the end of the section to read as set 
forth below.


Sec.  301.75-7  Interstate movement of regulated fruit from a 
quarantined area.

    (a) * * *
    (1) Every lot of regulated fruit to be moved interstate must be 
inspected by an APHIS employee at a commercial packinghouse for 
symptoms of citrus canker. Any lot found to contain fruit with visible 
symptoms of citrus canker will be ineligible for interstate movement 
from the quarantined area. The number of fruit to be inspected will be 
the quantity that is sufficient to detect, with a 95 percent level of 
confidence, any lot of fruit containing 0.38 percent or more fruit with 
visible canker lesions.\1\
---------------------------------------------------------------------------

    \1\ If conditions warrant changing the number of fruit to a 
quantity that gives a statistically significant level of confidence 
of detecting lots containing a different percentage, determined by 
the Administrator, of fruit with visible canker lesions, APHIS will 
provide for public participation in that process through the 
publication of a notice in the Federal Register.
---------------------------------------------------------------------------

    (2) The owner or operator of any commercial packinghouse that 
wishes to move citrus fruit interstate from the quarantined area must 
enter into a compliance agreement with APHIS in accordance with Sec.  
301.75-13.
* * * * *

[[Page 65204]]

    (5)(i) Each lot of regulated fruit found to be eligible for 
interstate movement must be accompanied by a limited permit issued in 
accordance with Sec.  301.75-12. Regulated fruit to be moved interstate 
must be packaged in boxes or other containers that are approved by 
APHIS and that are used exclusively for regulated fruit that is 
eligible for interstate movement. The boxes or other containers in 
which the fruit is packaged, and any shipping documents accompanying 
the boxes or other containers, must be clearly marked with the 
statement ``Limited Permit: USDA-APHIS-PPQ. Not for distribution in AZ, 
CA, HI, LA, TX, and American Samoa, Guam, Northern Mariana Islands, 
Puerto Rico, and Virgin Islands of the United States.'' Only fruit that 
meets all of the requirements of this section may be packed in boxes or 
other containers that are marked with this statement;
    (ii) Provided, that until August 1, 2008, fruit that meets all the 
requirements of this section may be packed in bags that are clearly 
marked with the statement ``Not for distribution in AZ, CA, HI, LA, TX, 
and American Samoa, Guam, Northern Mariana Islands, Puerto Rico, and 
Virgin Islands of the United States,'' as long as the bags of fruit are 
packed in boxes that are marked as required by paragraph (a)(5)(i) of 
this section. Fruit that does not meet all the requirements of this 
section may not be packed in either bags or boxes that are marked with 
this statement.
    (6) A lot of fruit that is determined to be ineligible for 
interstate movement under paragraph (a)(1) of this section may not be 
reconditioned and submitted for reinspection.
* * * * *
(Approved by the Office of Management and Budget under control 
number 0579-0325)

0
4. Section 301.75-11 is amended as follows:
0
a. In paragraph (a), by revising the introductory text to read as set 
forth below.
0
b. By redesignating paragraph (a)(3) as paragraph (a)(4) and adding a 
new paragraph (a)(3) to read as set out below.
0
c. In newly redesignated paragraph (a)(4) by adding the words ``, 
peroxyacetic acid,'' after the word ``hypochlorite''.
0
d. In paragraph (d)(3), by removing the word ``or''.
0
e. In paragraph (d)(4), by removing the period at the end of the 
paragraph and adding the word ``; or'' in its place.
0
f. By adding a new paragraph (d)(5) to read as set forth below.


Sec.  301.75-11  Treatments.

    (a) Regulated fruit. Regulated fruit for which treatment is 
required by this subpart must be treated in at least one of the 
following ways at a commercial packinghouse whose owner operates under 
a compliance agreement under Sec.  301.75-7(a)(2):
* * * * *
    (3) Peroxyacetic acid. The regulated fruit must be thoroughly 
wetted for at least 1 minute with a solution containing 85 parts per 
million peroxyacetic acid.
* * * * *
    (d) * * *
    (5) A solution containing 85 parts per million peroxyacetic acid 
(indoor use only).

PART 305--PHYTOSANITARY TREATMENTS

0
5. The authority citation for part 305 continues to read as follows:

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 21 U.S.C. 136 and 
136a; 7 CFR 2.22, 2.80, and 371.3.
0
6. Section 305.11 is amended by adding a new paragraph (c) to read as 
follows:


Sec.  305.11  Miscellaneous chemical treatments.

* * * * *
    (c) CC3 for citrus canker. The fruit must be thoroughly wetted for 
at least 1 minute with a solution containing 85 parts per million 
peroxyacetic acid.

    Done in Washington, DC, this 14th day of November 2007.
J. Burton Eller,
Acting Under Secretary for Marketing and Regulatory Programs.
 [FR Doc. E7-22549 Filed 11-16-07; 8:45 am]
BILLING CODE 3410-34-P