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[Federal Register Volume 75, Number 81 (Wednesday, April 28, 2010)]
[Rules and Regulations]
[Pages 22207-22211]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9779]

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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. APHIS-2008-0050]
RIN 0579-AC95

Importation of Papayas From Colombia and Ecuador

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the fruits and vegetables regulations to 
allow, under certain conditions, the importation of commercial 
shipments of fresh papayas from Colombia and Ecuador into the 
continental United States. The conditions for the importation of 
papayas from Colombia and Ecuador include requirements for field 
sanitation, hot water treatment, and fruit fly trapping in papaya 
production areas. This action allows for the importation of papayas 
from Colombia and Ecuador while continuing to provide protection 
against the introduction of injurious plant pests into the continental 
United States.

DATES: Effective Date: May 28, 2010.

FOR FURTHER INFORMATION CONTACT: Ms. Dorothy C. Wayson, Regulatory 
Coordination Specialist, Regulatory Coordination and Compliance, PPQ, 
APHIS, 4700 River Road Unit 134, Riverdale, MD 20737-1231; (301) 734-
0772.

SUPPLEMENTARY INFORMATION:

Background

    Under the regulations in ``Subpart-Fruits and Vegetables'' (7 CFR 
319.56 through 319.56-50, referred to below as the regulations), the 
Animal and Plant Health Inspection Service (APHIS) of the U.S. 
Department of Agriculture (USDA) prohibits or restricts the importation 
of fruits and vegetables into the United States from certain parts of 
the world to prevent plant pests from being introduced into and spread 
within the United States.
    On April 21, 2009, we published in the Federal Register (74 FR 
18161-18166, Docket No. APHIS-2008-0050) a proposal\1\ to amend the 
regulations in Sec.  319.56-25 to allow the importation of commercial 
consignments of fresh papayas from Colombia and Ecuador subject to a 
systems approach. Section 319.56-25 currently sets out conditions for 
the importation of papayas from Central America and Brazil; we

[[Page 22208]]

proposed to add Colombia and Ecuador to this systems approach. The 
proposed systems approach required that the papayas be produced and 
packed in approved areas of Colombia and Ecuador, that they be packed 
using packing procedures designed to exclude quarantine pests, and that 
fruit fly trapping, field sanitation, and hot water treatment be 
employed to remove pests of concern from the pathway.
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    \1\ To view the proposed rule and the comments we received, go 
to (http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0050).
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    We solicited comments concerning our proposal for 60 days ending 
June 22, 2009. We received six comments by that date. They were from 
State agricultural agencies, a domestic produce wholesaler, and 
Ecuador's Agency for Agricultural Product Quality Assurance. The 
comments are discussed below.
    We proposed to require that the fields where papayas in Colombia 
and Ecuador are grown be kept free of papayas that are one-half or more 
ripe and that all culled and fallen fruits be buried, destroyed, or 
removed from the farm at least twice a week. One commenter stated that 
removing fallen fruit and fruit that is more than half ripe will be 
difficult and subject to interpretation, and therefore will increase 
pest infestation risks. The commenter asked how this practice will be 
carried out.
    We disagree with the commenter's concerns about fruit removal. The 
national plant protection organizations (NPPOs) of Colombia and Ecuador 
will be responsible for ensuring that field sanitation, such as 
removing fallen and half ripe fruit is conducted. However, APHIS will 
conduct periodic reviews to ensure compliance with the regulations. The 
removal of fallen and half-ripe fruit is already a requirement for the 
importation of papayas from Central America and Brazil. To date, we 
have not received reports of any difficulties associated with this 
requirement.
    One commenter asked if studies have been done to determine when 
papayas in Colombia and Ecuador are susceptible to fruit flies. The 
commenter also asked what fruit fly lures will be used.
    Although research regarding when papayas are susceptible to fruit 
flies has not been conducted specifically for papayas from Colombia and 
Ecuador, the pest risk assessments (PRAs) that accompanied the proposed 
rule summarized the research on that topic that already exists and that 
was conducted for the currently approved program for importation of 
papayas from Central America and Brazil. Based on the findings of these 
PRAs, a risk management document (RMD) was drafted to identify measures 
to address the risks of the two fruit flies within Colombia and 
Ecuador, Anastrepha fraterculus (South American fruit fly) and 
Ceratitis capitata (Mediterranean fruit fly, or Medfly), and the fungal 
pest (Phoma caricae-papayae) within Ecuador, identified as quarantine 
pests in the PRAs. As stated in the RMD, papayas that are less than 
half ripe, or ``green,'' are poor hosts for the two fruit flies.
    Both Jackson and McPhail traps will be used for fruit fly trapping. 
Baits to be used will be specified APHIS-approved protein baits such as 
Nu-Lure or Torula yeast pellets.
    In order to mitigate the potential pest risk posed by fruit flies 
laying eggs in papayas immediately before harvest, we proposed to, 
among other things, require the treatment of papayas with a hot water 
dip. The dip requires that papayas from Colombia and Ecuador be held 
for 20 minutes in hot water at 48 [deg]C (118.4 [deg]F).
    One commenter expressed concern regarding this hot water dip 
treatment, stating that we removed the requirement for hot water 
treatment from the regulations in 7 CFR part 318 20 years ago in favor 
of vapor heat or forced air treatment. In addition, the commenter 
stated that field sanitation, trapping, and treatment with a hot water 
dip is not a probit 9 method of treating papaya for fruit flies. 
Therefore, the commenter stated that papayas should be prohibited from 
importation from Colombia and Ecuador and all other countries from 
which papaya are not treated with a probit 9 treatment.
    The hot water dip treatment that the commenter referred to was used 
as the sole mitigation measure for papayas moved interstate from Hawaii 
to the mainland United States. The treatment, which we removed from the 
regulations in part 318 in 1991, consisted of immersion in water at a 
temperature of between 41 [deg]C and 43 [deg]C for a period of 40 
minutes followed by a second immersion in water at a temperature of 
between 48 [deg]C and 50 [deg]C for a period of 20 minutes. The 
treatment failed due to a blossom end defect within the papayas that 
allowed mature fruit flies to enter the fruit rather than to a flaw in 
the treatment itself. The treatment was designed to treat fruit fly 
eggs and larvae near the surface of the fruit rather than fruit fly 
larvae within the seed cavity of the fruit where heat from the hot 
water treatment could not penetrate. We removed the treatment for 
Hawaii because we determined that we could not ensure that all papayas 
with the blossom end defect would be successfully culled at the 
packinghouse. Unlike the hot water dip that we used in Hawaii, the hot 
water dip we proposed for papayas from Colombia and Ecuador is part of 
a systems approach rather than a sole mitigation measure.
    Probit 9 is a treatment standard that requires a pest mortality 
rate of greater than 99 percent. Although the hot water dip is not 
considered a probit 9 treatment, the systems approach we proposed uses 
methods in addition to treatment to mitigate the risk associated with 
fruit flies. These methods include removing papayas that are one-half 
or more ripe as well as culled or fallen papayas from fields where 
papayas are grown, allowing the exportation of only green papayas, and 
trapping for fruit flies at a rate of 1 trap per hectare with required 
mitigation measures or suspension of exports if fruit fly populations 
reach certain levels. As stated previously, the current systems 
approach has been used successfully to mitigate the risks associated 
with papayas from Central America and Brazil. To date, no interceptions 
of fruit flies have been found on papayas entering the United States 
from these countries.
    Two commenters asked what regulatory oversight is in place to 
ensure that the elements of the systems approach will be followed. One 
of these commenters asked whether a site visit has been conducted and 
whether periodic reviews of the program will be carried out.
    APHIS has conducted a site visit and will be conducting annual 
reviews to ensure compliance with the regulations. In addition, the 
NPPOs of Colombia and Ecuador are responsible for monitoring fruit fly 
traps on a weekly basis and maintaining records of such reviews, and 
supervising and directing compliance with the requirements of the rule.
    One commenter stated that there is no objective means of assessing 
the risk associated with the importation of papayas from Colombia and 
Ecuador under the proposed systems approach or for the countries 
already approved to ship papayas under that systems approach.
    We disagree with the commenter. As we noted above, the systems 
approach has been used in Central America and Brazil and no fruit flies 
have been intercepted on papayas imported from those regions. This 
real-world experience, along with our PRAs, our RMD, and our knowledge 
of the conditions in Colombia and Ecuador, provide an adequate basis 
for regulatory decisionmaking.
    Under the current regulations in Sec.  319.56-25(f), papayas from 
Central America and Brazil must be packed in

[[Page 22209]]

cartons stamped ``Not for importation into or distribution in Hawaii'' 
due to the presence in these areas of the papaya fruit fly (Toxotrypana 
curvicauda). This pest does not occur in Hawaii, where the majority of 
U.S. commercial papaya production takes place. However, in the proposed 
rule, we proposed to remove this box marking requirement for Central 
America and Brazil; we determined that our permitting process would 
allow us to effectively implement the distribution limitations. 
Likewise, we did not propose to require that boxes containing papayas 
from Colombia or Ecuador be marked.
    One commenter stated that we should retain the requirement for 
marking all shipments of papaya from Central America and Brazil with a 
statement that they may not be imported into or distributed within 
Hawaii and that we should apply the requirement to shipments of papayas 
from Colombia and Ecuador, or the protection for Hawaii could be lost.
    We disagree with the commenter. Currently, no papayas from foreign 
countries are allowed to enter into Hawaii. In addition, because papaya 
fruit fly occurs in Florida and other mainland papaya-producing areas, 
papayas from the continental United States are also prohibited from 
entering Hawaii, meaning that papayas from Colombia and Ecuador 
imported into the continental United States would not be allowed to be 
moved to Hawaii even if the papayas had entered domestic commerce. As 
stated in the proposed rule, our permitting process will allow us to 
effectively implement the distribution limitation, as it currently does 
for many other commodities that are not allowed to be imported into 
Hawaii. Therefore, we have determined that the box marking is not 
necessary.
    We proposed to allow imports of papayas only from certain areas 
within Colombia and Ecuador, which we proposed to list in Sec.  319.56-
25(b). One commenter stated that, since the pest risk analysis for 
Ecuador analyzed the risk from papaya imports on a national level, 
there is no technical reason for the rule to refer to specific areas of 
production.
    In the proposed rule, we stated that restricting imports of papayas 
to those produced in approved areas of Colombia and Ecuador would 
ensure that papayas intended for the continental United States are 
grown and packed in papaya production and packing areas of Colombia and 
Ecuador where fruit fly traps are maintained and where the other 
elements of the systems approach are in place. In addition, we stated 
that grower registration would allow for traceback and removal from the 
export program of production sites with confirmed pest problems, and 
the papaya orchards would be monitored by the NPPO to ensure that pest 
and disease-excluding sanitary procedures are employed.
    Since the publication of the proposed rule, however, we have 
determined that, as long as the risk mitigation measures we proposed 
are adhered to, there is no technical reason to restrict the 
importation of commercial shipments of papaya to those produced in 
specific areas within Ecuador. Likewise, there is no technical reason 
to restrict the importation of commercial shipments of papaya to those 
produced in specific areas within Colombia. We are retaining the grower 
registration requirement for both countries, which will allow the 
foreign NPPOs and APHIS to monitor compliance with fruit fly trapping 
and the other elements of the systems approach. Therefore, we are 
removing the origin restrictions for these countries, as grower 
registration makes limiting imports to specific production areas 
unnecessary.
    In Sec.  319.56-25(b), we proposed to require that papayas from 
Colombia and Ecuador be grown by growers registered with the NPPO of 
the exporting country. One commenter asked why the proposed rule 
required that papaya growers in Colombia and Ecuador be registered with 
the NPPO of the exporting country when this is not required for papaya 
growers in other countries producing papayas for export to the United 
States under the same program.
    Based upon our experience with pest exclusion programs and 
activities since the existing papaya program was put into place, we 
have determined it would be prudent and, indeed, necessary, to increase 
our focus on traceback capabilities. Therefore, we are requiring grower 
registration for all new fruit and vegetable imports, including the 
importation of papayas from Colombia and Ecuador. We did not have a 
policy requiring grower registration at the time the existing papaya 
program was put into place. However, the origin restrictions on papayas 
from Brazil and Central America function in the same manner as grower 
registration, allowing APHIS to monitor compliance with the regulations 
in approved growing areas in those countries.
    We also proposed to allow only the ``Solo'' type of papayas to be 
imported into the United States from Colombia and Ecuador. One 
commenter stated that there is no reason to restrict papaya imports to 
the cultivar Solo as other cultivars are already available in the 
United States, and these cultivars are also produced within Ecuador.
    The pest risk assessment only evaluated the risks associated with 
the importation of papayas weighing 2 kilograms or less, which are 
considered ``Solo'' papayas. The size limitation was put in place 
because the hot water dip treatment has not been tested on larger 
papayas. If Colombia or Ecuador desires to export other papaya 
varieties, they may propose to do so, and we will analyze the risks 
associated with the importation of such varieties.
    One commenter expressed concern regarding the potential financial 
impact of the rule on U.S. papaya growers.
    As explained in the proposed rule, we expect that papayas supplied 
by Colombia and Ecuador would largely compete against imports from 
Mexico and elsewhere. In addition, given that the U.S. market for fresh 
papaya is already dominated by imports, the addition of Colombia and 
Ecuador is unlikely to significantly affect sales by U.S. producers.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been determined to be not significant for the 
purposes of Executive Order 12866 and, therefore, has not been reviewed 
by the Office of Management and Budget.
    We have prepared a Final Regulatory Flexibility analysis in 
accordance with Section 604 of the Regulatory Flexibility Act for this 
action. The analysis identifies papaya producers, importers, and 
wholesalers; fresh fruit and vegetable wholesalers; grocery stores; 
warehouse clubs and superstores; and fruit and vegetable markets as the 
small entities most likely to be affected by this action and considers 
the effects on domestic papaya production associated with the 
importation of papaya from Colombia and Ecuador. Based on the 
information presented in the analysis, the Administrator has certified 
that this action will not have a significant economic impact on a 
substantial number of small entities. The Final Regulatory Flexibility 
analysis may be viewed on the Regulations.gov Web site (see footnote 1 
for instructions for accessing Regulations.gov). Copies of the Final 
Regulatory Flexibility analysis are also available from the person 
listed under FOR FURTHER INFORMATION CONTACT.

[[Page 22210]]

Executive Order 12988

    This final rule allows fresh papayas to be imported into the 
continental United States from Colombia and Ecuador. State and local 
laws and regulations regarding papayas imported under this rule will be 
preempted while the fruit is in foreign commerce. Fresh fruits are 
generally imported for immediate distribution and sale to the consuming 
public, and remain in foreign commerce until sold to the ultimate 
consumer. The question of when foreign commerce ceases in other cases 
must be addressed on a case-by-case basis. No retroactive effect will 
be given to this rule, and this rule will not require administrative 
proceedings before parties may file suit in court challenging this 
rule.

Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.), the information collection or recordkeeping requirements 
included in this rule have been approved by the Office of Management 
and Budget (OMB) under OMB control number 0579-0358.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the Internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this rule, please contact Mrs. Celeste Sickles, 
APHIS' Information Collection Coordinator, at (301) 851-2908.

List of Subjects in 7 CFR Part 319

    Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant 
diseases and pests, Quarantine, Reporting and recordkeeping 
requirements, Rice, Vegetables.

0
Accordingly, we are amending 7 CFR part 319 as follows:

PART 319--FOREIGN QUARANTINE NOTICES

0
1. The authority citation for part 319 continues to read as follows:

    Authority: 7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 
and 136a; 7 CFR 2.22, 2.80, and 371.3.

0
2. Section 319.56-25 is revised to read as follows:

Sec.  319.56-25  Papayas from Central America and South America.

    Commercial consignments of the Solo type of papaya may be imported 
into the United States only in accordance with this section and all 
other applicable provisions of this subpart.
    (a) The papayas were grown and packed for shipment to the 
continental United States (including Alaska), Puerto Rico, and the U.S. 
Virgin Islands in one of the following locations:
    (1) Brazil: State of Espirito Santo; all areas in the State of 
Bahia that are between the Jequitinhonha River and the border with the 
State of Espirito Santo and all areas in the State of Rio Grande del 
Norte that contain the following municipalities: Touros, Pureza, Rio do 
Fogo, Barra de Maxaranguape, Taipu, Ceara Mirim, Extremoz, Ielmon 
Marinho, Sao Goncalo do Amarante, Natal, Maciaba, Parnamirim, Veracruz, 
Sao Jose de Mipibu, Nizia Floresta, Monte Aletre, Areas, Senador 
Georgino Avelino, Espirito Santo, Goianinha, Tibau do Sul, Vila Flor, 
and Canguaretama e Baia Formosa.
    (2) Costa Rica: Provinces of Guanacaste, Puntarenas, San Jose.
    (3) El Salvador: Departments of La Libertad, La Paz, and San 
Vicente.
    (4) Guatemala: Departments of Escuintla, Retalhuleu, Santa Rosa, 
and Suchitep[eacute]quez.
    (5) Honduras: Departments of Comayagua, Cort[eacute]s, and Santa 
B[aacute]rbara.
    (6) Nicaragua: Departments of Carazo, Granada, Leon, Managua, 
Masaya, and Rivas.
    (7) Panama: Provinces of Cocle, Herrera, and Los Santos; Districts 
of Aleanje, David, and Dolega in the Province of Chiriqui; and all 
areas in the Province of Panama that are west of the Panama Canal; or
    (b) The papayas were grown by a grower registered with the national 
plant protection organization (NPPO) of the exporting country and 
packed for shipment to the continental United States (including Alaska) 
in Colombia or Ecuador.
    (c) Beginning at least 30 days before harvest began and continuing 
through the completion of harvest, all trees in the field where the 
papayas were grown were kept free of papayas that were one-half or more 
ripe (more than one-fourth of the shell surface yellow), and all culled 
and fallen fruits were buried, destroyed, or removed from the farm at 
least twice a week.
    (d) The papayas were held for 20 minutes in hot water at 48 [deg]C 
(118.4 [deg]F).
    (e) When packed, the papayas were less than one-half ripe (the 
shell surface was no more than one-fourth yellow, surrounded by light 
green), and appeared to be free of all injurious insect pests.
    (f) The papayas were safeguarded from exposure to fruit flies from 
harvest to export, including being packaged so as to prevent access by 
fruit flies and other injurious insect pests. The package containing 
the papayas does not contain any other fruit, including papayas not 
qualified for importation into the United States.
    (g) Beginning at least 1 year before harvest begins and continuing 
through the completion of harvest, fruit fly traps were maintained in 
the field where the papayas were grown. The traps were placed at a rate 
of 1 trap per hectare and were checked for fruit flies at least once 
weekly by plant health officials of the NPPO. Fifty percent of the 
traps were of the McPhail type and 50 percent of the traps were of the 
Jackson type. The NPPO kept records of fruit fly finds for each trap, 
updated the records each time the traps were checked, and made the 
records available to APHIS inspectors upon request. The records were 
maintained for at least 1 year.
    (1) If the average Jackson fruit fly trap catch was greater than 
seven Mediterranean fruit flies (Ceratitis capitata) (Medfly) per trap 
per week, measures were taken to control the Medfly population in the 
production area. If the average Jackson fruit fly trap catch exceeds 14 
Medflies per trap per week, importations of papayas from that 
production area must be halted until the rate of capture drops to an 
average of 7 or fewer Medflies per trap per week.
    (2) In Colombia, Ecuador, or the State of Espirito Santo, Brazil, 
if the average McPhail trap catch was greater than seven South American 
fruit flies (Anastrepha fraterculus) per trap per week, measures were 
taken to control the South American fruit fly population in the 
production area. If the average McPhail fruit fly trap catch exceeds 14 
South American fruit flies per trap per week, importations of papayas 
from that production area must be halted until the rate of capture 
drops to an average of 7 or fewer South American fruit flies per trap 
per week.
    (h) All activities described in paragraphs (a) through (h) of this 
section were carried out under the supervision and direction of plant 
health officials of the NPPO.
    (i) All consignments must be accompanied by a phytosanitary 
certificate issued by the NPPO of the exporting country stating that 
the papayas were grown, packed, and shipped in accordance with the 
provisions of this section.

(Approved by the Office of Management and Budget under control numbers 
0579-0128 and 0579-0358)

[[Page 22211]]

    Done in Washington, DC, this 31\st\ day of March 2010.

Gregory Parham
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-9779 Filed 4-27-10: 8:45 am]
BILLING CODE 3410-34-S
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