[Federal Register: April 23, 2004 (Volume 69, Number 79)]
[Rules and Regulations]
[Page 21941-21947]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23ap04-1]
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Rules and Regulations
Federal Register
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[[Page 21941]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 319
[Docket No. 03-019-2]
Certification Program for Imported Articles of Pelargonium spp.
and Solanum spp. To Prevent Introduction of Potato Brown Rot
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Interim rule and request for comments.
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SUMMARY: We are amending the regulations to establish a certification
program for articles of Pelargonium spp. and Solanum spp. imported from
countries where the bacterium Ralstonia solanacearum race 3 biovar 2 is
known to occur. The requirements of the certification program are
designed to ensure that Ralstonia solanacearum race 3 biovar 2 will not
be introduced into the United States through the importation of
articles of Pelargonium spp. and Solanum spp. We have determined that
the restrictions presently in place do not adequately mitigate the risk
that imported articles of Pelargonium spp. and Solanum spp. could
introduce this bacterial strain, which causes potato brown rot, into
the United States. This action is necessary to prevent the introduction
of this bacterial strain into the United States.
DATES: This interim rule is effective May 24, 2004. We will consider
all comments that we receive on or before June 22, 2004.
ADDRESSES: You may submit comments by any of the following methods:
Postal Mail/Commercial Delivery: Please send
four copies of your comment (an original and three copies) to Docket
No. 03-019-2, Regulatory Analysis and Development, PPD, APHIS, Station
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. 03-019-2.
E-mail: Address your comment to
regulations@aphis.usda.gov. Your comment must be contained in the body
of your message; do not send attached files. Please include your name
and address in your message and ``Docket No. 03-019-2'' on the subject
line.
Agency Web site: Go to http://www.aphis.usda.gov/ppd/rad/cominst.html
for a form you can use to
submit an e-mail comment through the APHIS Web site.
Federal eRulemaking Portal: Go to http://www.regulations.gov
and follow the instructions for locating this
docket and submitting comments.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue, SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: You may view APHIS documents published in the
Federal Register and related information, including the names of groups
and individuals who have commented on APHIS dockets, on the Internet at
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
FOR FURTHER INFORMATION CONTACT: Mr. Wayne Burnett, Senior Import
Specialist, Phytosanitary Issues Management Team, PPQ, APHIS, 4700
River Road Unit 140, Riverdale, MD 20737-1236; (301) 734-6799.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 7 CFR part 319 prohibit or restrict the
importation of certain plants and plant products into the United States
to prevent the introduction of plant pests. The regulations contained
in ``Subpart--Nursery Stock, Plants, Roots, Bulbs, Seeds, and Other
Plant Products,'' Sec. Sec. 319.37 through 319.37-14 (referred to
below as the regulations), restrict, among other things, the
importation of living plants, plant parts, seeds, and plant cuttings
for propagation.
In an interim rule effective May 16, 2003, and published in the
Federal Register on May 23, 2003 (68 FR 28115-28119, Docket No. 03-019-
1), we amended the regulations by requiring an additional declaration
on the phytosanitary certificates that must accompany all articles of
Pelargonium spp. and Solanum spp. imported into the United States.
(Articles of Pelargonium spp. and Solanum spp. imported under the
Canadian greenhouse-grown restricted plant program, which are not
required to be accompanied by a phytosanitary certificate when they are
offered for importation into the United States, are exempt from this
requirement.) The interim rule was necessary because recent
introductions of Ralstonia solanacearum race 3 biovar 2, the bacterium
that causes potato brown rot, had shown that articles of Pelargonium
spp. and Solanum spp. can serve as vectors for its transmission. The
additional declaration required by the interim rule must state either
that the articles of Pelargonium spp. and Solanum spp. were produced in
a production site that has been tested and found to be free of R.
solanacearum race 3 biovar 2 or that R. solanacearum race 3 biovar 2 is
not known to occur in the region in which the articles were produced.
Comments on the interim rule were required to be received on or
before July 22, 2003. We received four comments by that date, from
representatives of industry associations and from a State government.
All of the commenters supported the interim rule. Three of the
commenters asked the Animal and Plant Health Inspection Service (APHIS)
to take additional steps to ensure that imported articles of
Pelargonium spp. and Solanum spp. do not introduce R. solanacearum race
3 biovar 2 into the United States.
Two of these commenters urged APHIS to develop a certification
program for foreign production sites in countries where R. solanacearum
race 3 biovar 2 is known to occur that wish to export articles of
Pelargonium spp. and Solanum spp. to the United States. These
commenters stated that such a program would greatly reduce the risk of
introducing R. solanacearum race 3 biovar 2 into the United States via
imported articles of Pelargonium spp. and Solanum spp. We agree with
these
[[Page 21942]]
commenters. In addition, since our May 2003 interim rule became
effective, we have encountered several difficulties that have
demonstrated to us that we need to implement a certification program
immediately.
As we discussed in the first interim rule, race 3 of the bacterium
R. solanacearum affects the potato (Solanum tuberosum L.) and causes
potato brown rot. This race of the bacterium is widely distributed in
temperate areas of the world, including some parts of the United
States. It causes potatoes to rot, making them unusable and seriously
affecting potato yields. The bacterium is extremely difficult to
eradicate both because of its many alternate hosts and because of its
ability to survive in water. Letting an infected field lie fallow or
using alternate, non-potato crops for a growing season is not
effective, as the bacterium survives in various common weeds, including
Solanum species such as nightshade. The bacterium can also be
transmitted from infected fields to other fields by streams and runoff.
At least three biovars of R. solanacearum race 3 are distinguished
on the basis of biochemical properties. Biovar 1, which is currently
established in the United States, does not tolerate cold temperatures;
its establishment is thus limited to the southern part of the United
States. However, biovar 2, which is not present in the United States,
is adapted to low temperatures and is found in temperate zones, meaning
that it could thrive in the northern States where most U.S. potatoes
are produced. If R. solanacearum race 3 biovar 2 were to become
established in the United States, it would likely have a devastating
impact on potato production.
Biovar 1 is currently established in the United States, and we have
not established an official control program for it. Therefore, in
accordance with international trade agreements, we do not place
restrictions on the importation of articles that may be infected with
biovar 1. Biovar 2, however, is not established in the United States
and is considered a pest of quarantine significance. Therefore, under
those same international agreements, we are free to place restrictions
on the importation of articles that may be infected with biovar 2.
One approach to preventing the entry of R. solanacearum race 3
biovar 2 would be to test articles of Pelargonium spp. and Solanum spp.
that are offered for importation into the United States at the port of
entry. For such an approach to be effective, our tests would need to be
able to distinguish between the biovars of the bacterium and to
identify the presence of R. solanacearum race 3 biovar 2. However,
there currently exists no standalone, specific test for R. solanacearum
race 3 biovar 2 that is practical for testing articles of Pelargonium
spp. and Solanum spp. at ports of entry. Therefore, our May 2003
interim rule required that the phytosanitary certificate accompanying
imported articles of Pelargonium spp. and Solanum spp. contain an
additional declaration either that the articles were produced in a
production site that has been tested and found to be free of R.
solanacearum race 3 biovar 2, which we believed would be effective due
to the fact that production sites can be effectively tested for the
bacterium, or that R. solanacearum race 3 biovar 2 is not known to
occur in the region in which the articles were produced.
At the time our May 2003 interim rule became effective, an
emergency program had been initiated to identify and destroy plants in
the United States that tested positive for infection with R.
solanacearum race 3 biovar 2. This program was initiated in February
2003 after R. solanacearum race 3 biovar 2 was detected at nursery
facilities that had received geraniums from Kenya. The emergency
program, which continued beyond the effective date of the interim rule,
eradicated the bacterium within the United States. We believe that some
of the plants we identified as infected during this effort entered the
United States after the effective date of the interim rule, meaning
that the additional declarations required by the interim rule do not
provide adequate protection against the risk of introduction of R.
solanacearum race 3 biovar 2 into the United States. It is clear that
additional steps should be taken to prevent the introduction of this
dangerous bacterium.
Therefore, in this interim rule, we are adding a certification
program that must be implemented at production sites in countries where
R. solanacearum race 3 biovar 2 is known to occur that produce articles
of Pelargonium spp. and Solanum spp. to be offered for importation into
the United States.
Certification Program for Production Sites
In this interim rule, we are amending the regulations to require
that articles of Pelargonium spp. and Solanum spp. grown in countries
where R. solanacearum race 3 biovar 2 is known to occur be produced in
accordance with the requirements in Sec. 319.37-5(r)(3), as revised by
this interim rule, to be eligible for importation into the United
States.
These requirements are designed to ensure that even if R.
solanacearum race 3 biovar 2 is present in the environment surrounding
the production site in which the articles of Pelargonium spp. or
Solanum spp. are produced, the bacterium will not enter the production
site. Registration and certification of production sites will allow us
to determine the production site from which any imported articles of
Pelargonium spp. and Solanum spp. originated. This will facilitate
monitoring of the program and allow for quicker reactions to any
problems we detect. Ongoing monitoring is also prescribed to ensure
that the certification program is properly implemented and fully
effective. The requirements of this certification program, contained in
Sec. 319.37-5(r)(3), are described below.
The national plant protection organization of
the country in which the articles are produced (the NPPO) must enter
into a bilateral workplan with APHIS. This bilateral workplan must set
out conditions for monitoring the production of articles of Pelargonium
spp. and Solanum spp., for enforcement of the requirements in this
interim rule, and for the establishment of a trust fund.
The production site where the articles of
Pelargonium spp. and Solanum spp. intended for export to the United
States are produced must be registered with and certified by both APHIS
and the NPPO. As part of the certification process, production sites
must be initially approved and thereafter visited at least once a year
by APHIS and the NPPO to verify compliance with the requirements of
this interim rule.
The production site must conduct ongoing testing
for R. solanacearum race 3 biovar 2. Only those articles of Pelargonium
spp. or Solanum spp. that have been tested with negative results for
the presence of R. solanacearum race 3 biovar 2 may be used in
production and export. Records of the testing must be kept for two
growing seasons and made available to representatives of APHIS and of
the NPPO. All testing procedures must be approved by APHIS.
We are currently aware of two acceptable methods for testing
production facilities: An enzyme-linked immunosorbent assay (ELISA),
which can confirm that no Ralstonia spp. bacteria are present, and a
polymerase chain reaction (PCR) test that can confirm that no R.
solanacearum race 3 biovar 2 bacteria are present. Domestic greenhouses
tested for R. solanacearum race 3 biovar 2 during the recent
eradication effort typically used ELISA
[[Page 21943]]
to screen potentially symptomatic material; if the material was
infected with Ralstonia spp., the PCR test was used to determine
whether R. solanacearum race 3 biovar 2 was present. Other testing
methods may be used if APHIS determines that those methods are adequate
to confirm that production facilities are free of R. solanacearum race
3 biovar 2.
The production site must be constructed in a
manner that ensures that outside water cannot enter the production
site. The production site must be surrounded by a 1-meter buffer that
is sloped so that water drains away from the production site.
Dicotyledonous weeds must be controlled both
within the production site and around it. The production site and the
1-meter buffer surrounding the production site must be free of
dicotyledonous weeds.
All equipment that comes in contact with
articles of Pelargonium spp. or Solanum spp. within the production site
must be adequately sanitized so that R. solanacearum race 3 biovar 2
cannot be transmitted between plants or enter from outside the
production site via the equipment.
Production site personnel must adequately
sanitize their clothing and shoes and wash their hands before entering
the production site to prevent the entry of R. solanacearum race 3
biovar 2 into the production site.
Growing media for articles of Pelargonium spp.
and Solanum spp. must be free of R. solanacearum race 3 biovar 2.
Growing media and containers for articles of Pelargonium spp. and
Solanum spp. must not come in contact with soil, and soil may not be
used as a growing medium.
Water used in maintenance of the plants at the
production site must be free of R. solanacearum race 3 biovar 2. The
production site must either derive the water from an APHIS-approved
source or treat the water with an APHIS-approved treatment before use.
Growing media at the production site must not
come in direct contact with any water source, such as an emitter or a
hose end. If a drip irrigation system is used, backflow devices must be
installed to prevent any R. solanacearum race 3 biovar 2 that may be
present from spreading to the rest of the production site through the
irrigation system. Ebb and flow irrigation may not be used.
Production site personnel must be educated
regarding the various pathways through which R. solanacearum race 3
biovar 2 can be introduced into a production site and must be trained
to recognize symptoms of R. solanacearum race 3 biovar 2 infection in
articles of Pelargonium spp. or Solanum spp. in the production site.
Articles of Pelargonium spp. or Solanum spp. produced for export
within an approved production site must be handled and packed in a
manner adequate to prevent the presence of R. solanacearum race 3
biovar 2. The articles must be labeled with information indicating the
production site from which the articles originated.
If R. solanacearum race 3 biovar 2 is found in
the production site or in consignments from the production site, the
production site will be ineligible to export articles of Pelargonium
spp. or Solanum spp. to the United States. A production site may be
reinstated if a reinspection reveals that the site is free of R.
solanacearum race 3 biovar 2 and all problems in the production site
have been addressed and corrected to the satisfaction of APHIS.
The phytosanitary certificate of inspection
required by Sec. 319.37-4 that accompanies these articles must contain
an additional declaration that states ``These articles have been
produced in accordance with the requirements in 7 CFR 319.37-5(r)(3).''
The government of the country in which the
articles are produced must enter into a trust fund agreement with APHIS
before each growing season. The government of the country in which the
articles are produced or its designated representative is required to
pay in advance all estimated costs that APHIS expects to incur through
its involvement in overseeing the execution of the requirements of
Sec. 319.37-5(r)(3). These costs will include administrative expenses
incurred in conducting the services enumerated in Sec. 319.37-5(r)(3)
and all salaries (including overtime and the Federal share of employee
benefits), travel expenses (including per diem expenses), and other
incidental expenses incurred by the inspectors in performing these
services. (Specific provisions for making payments to this trust fund
may be found in the rule portion of this document.)
We believe the additional requirements in this certification
program will prevent the introduction of R. solanacearum race 3 biovar
2 into the United States while allowing the continued importation of
articles of Pelargonium spp. and Solanum spp.
Other Comments
One commenter suggested that we consider requiring importers of
articles of Pelargonium spp. and Solanum spp. to post a bond, which
would be used to reimburse domestic growers who may be adversely
affected by the introduction of R. solanacearum race 3 biovar 2 via
such articles. We believe that the certification program we are
establishing in this interim rule is a more direct and more effective
means of ensuring that articles of Pelargonium spp. and Solanum spp.
that are offered for importation will not serve as a pathway for the
introduction of R. solanacearum race 3 biovar 2.
Two commenters urged APHIS to continue with its review of the
nursery stock regulations, to prevent introductions of both R.
solanacearum race 3 biovar 2 and other plant pests. We agree that this
review is essential to safeguarding plant health, and we will continue
our work on it.
Other Changes
As discussed above, our May 2003 interim rule required that the
phytosanitary certificate accompanying all articles of Pelargonium spp.
and Solanum spp. from countries where R. solanacearum race 3 biovar 2
is not known to occur contain an additional declaration to that effect.
In this interim rule, we are amending the regulations established by
the May 2003 interim rule to exempt articles of Solanum spp. from
Canada from this requirement. Canada is the only country in which R.
solanacearum race 3 biovar 2 is not known to occur that is currently
eligible to export articles of Solanum spp. to the United States; the
importation of articles of Solanum spp. from all other countries where
R. solanacearum race 3 biovar 2 is not known to occur is prohibited in
Sec. 319.37-2(a), due to risks posed by other plant pests. Therefore,
the burden of the requirement for the additional declaration on the
phytosanitary certificate accompanying articles of Solanum spp. from
countries where R. solanacearum race 3 biovar 2 is not known to occur
has fallen solely on Canadian exporters of these articles. We do not
believe requiring the additional declaration for articles of Solanum
spp. exported from Canada provides additional protection against the
introduction of R. solanacearum race 3 biovar 2. Therefore, this
interim rule provides an exemption from that requirement for those
articles.
The regulations established by our May 2003 interim rule referred
to ``production facilities'' where articles were produced for export to
the United States. The term we typically use to refer to such entities
is ``production site,'' so we have amended the provisions established
in our May 2003 interim rule so that they now refer to ``production
sites'' rather than ``production facilities.'' In addition, we
[[Page 21944]]
have added a definition of the term production site to Sec. 319.37-1,
i.e.: ``A defined portion of a place of production utilized for the
production of a commodity that is managed separately for phytosanitary
purposes. This may include the entire place of production or portions
of it. Examples of portions of places of production are a defined
orchard, grove, field, greenhouse, screenhouse, or premises.'' This is
the same definition we provide in Sec. 319.56-1 of our fruits and
vegetables regulations, except that we have added greenhouse and
screenhouse to the list of examples. We believe this change will
improve the clarity of the regulations.
In addition, we have made several editorial changes to the
provisions established by our May 2003 interim rule:
The original regulations referred to ``regions''
where R. solanacearum race 3 biovar 2 is not known to occur. The
preferred term in this context is ``country.'' We use the term
``country'' in revised Sec. 319.37-5(r).
The additional declaration required by the
original Sec. 319.37-5(r)(2) was required to read ``Ralstonia
solanacearum race 3 biovar 2 is not known to occur in the country of
origin of the articles in this shipment.'' To be consistent with the
phrasing of other, similar additional declarations in the regulations,
we have shortened this to read ``Ralstonia solanacearum race 3 biovar 2
is not known to occur in the country of origin'' in this interim rule.
We had referred in the original Sec. 319.37-
5(r)(2) and (r)(3) to R. solanacearum race 3 biovar 2 either being
known or not known to occur in the country of origin ``at the time of
arrival at the port of first arrival in the United States.'' We do not
believe this language is necessary to ensure phytosanitary security; if
a consignment of articles was shipped to the United States from a
country where R. solanacearum race 3 biovar 2 was not known to occur,
but where the bacterium was found while the articles were in transit,
we would use our authority under the Plant Protection Act to prevent
the entry of the articles. Thus, we have omitted that language in
revised Sec. 319.37-5(r).
We had used the term ``plants'' in the
additional declaration required by the original Sec. 319.37-5(r)(3),
rather than the term ``articles,'' which is the term we used elsewhere
in the regulatory text. This interim rule corrects that error.
Immediate Action
Immediate action is necessary to prevent the importation of
articles of Pelargonium spp. and Solanum spp. that come from countries
where R. solanacearum race 3 biovar 2 is known to occur and that have
been produced in production sites that may not be free of that
bacterium. Because the importation of these articles may serve as a
pathway for the introduction of R. solanacearum race 3 biovar 2 into
the United States, and because the existing restrictions do not
adequately mitigate the risk that imported articles of Pelargonium spp.
and Solanum spp. that are infected with R. solanacearum race 3 biovar 2
could introduce this bacterial strain into the United States, allowing
the importation of these articles to continue without further
restrictions would pose an unacceptable risk of introducing R.
solanacearum race 3 biovar 2 into the United States.
This rule is being made effective 30 days after publication because
importers, exporters, NPPOs, and others will need 30 days to prepare
for the changes in operations that will become necessary on the
effective date of this rule. Because prior notice and other public
procedures with respect to this action are impracticable and contrary
to the public interest under these circumstances, we find good cause
under 5 U.S.C. 553 to make this rule effective 30 days after
publication in the Federal Register.
We will consider comments we receive during the comment period for
this interim rule (see DATES above). After the comment period closes,
we will publish another document in the Federal Register. The document
will include a discussion of any comments we receive and any amendments
we are making to the rule.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be not significant for the purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of
Management and Budget.
In this interim rule, APHIS is amending the regulations to
establish a certification program for articles of Pelargonium spp. and
Solanum spp. imported from countries where the bacterium Ralstonia
solanacearum race 3 biovar 2 is known to occur. The requirements of the
certification program are designed to ensure that Ralstonia
solanacearum race 3 biovar 2 will not be introduced into the United
States through the importation of articles of Pelargonium spp. and
Solanum spp. APHIS has determined that the restrictions presently in
place do not adequately mitigate the risk that imported articles of
Pelargonium spp. and Solanum spp. could introduce this bacterial
strain, which causes potato brown rot, into the United States. This
action is necessary to prevent the introduction of this bacterial
strain into the United States.
The production site certification program will impact approximately
11 different nurseries. Two of these nurseries are located in
Guatemala, three in Mexico, one in China, two in Kenya, and three in
Costa Rica. The average cost of upgrading these 11 production sites to
comply with the production site requirements in this interim rule has
been estimated at approximately $70,000 per site.\1\ However, many of
these production sites have already upgraded their facilities due to
the outbreak of R. solanacearum race 3 biovar 2 in early 2003. Thus, to
the extent that these upgrades fulfill the production site requirements
contained in this rule, compliance costs for some production sites
would be lower than this estimate.
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\1\ Society of American Florists.
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Pelargonium (geranium) spp.
Based on growers' receipts, U.S. floriculture and nursery crop
sales totaled $14 billion in 2002. Total sales of U.S. geraniums were
estimated at $204 million for 2002.\2\ The United States imported $44
million worth of cuttings and slips of which geraniums comprised some
unknown part.\3\ Geraniums are the most popular bedding plant in North
America; approximately 20,000 growers cultivate these plants.
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\2\ Electronic Outlook Report from the Economic Research
Service, Floriculture and Nursery Crops Outlook, September 12, 2002,
Alberto Jerardo.
\3\ World Trade Atlas 2002, U.S. imports of unrooted cuttings
and slips of plants, code 0602100000.
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APHIS has determined that the 2003 R. solanacearum race 3 biovar 2
outbreak occurred when geranium cuttings arrived from Kenya carrying
the R. solanacearum race 3 biovar 2 bacterium. The R. solanacearum race
3 biovar 2 outbreak in 2003 led to the disposal of 1.9 million
geraniums; the disposed plants had a total value of approximately $1.5
to $2 million.
Solanum spp.
The genus Solanum comprises a large group of both tender and hardy,
herbaceous shrubby climbing plants. Several species can be found in
North America either growing wild or as decorative plants, but two--
potatoes and eggplants--are grown as vegetables. The R. solanacearum
race 3 biovar 2 bacterium, which is widely distributed
[[Page 21945]]
in temperate regions, causes the disease potato brown rot. In 2002, 1.3
million acres of U.S. potatoes were harvested; the potato harvest was
valued at $3.2 billion, and $123 million worth of U.S. potatoes were
exported to the rest of the world.\4\ The value of potato fields
infected with R. solanacearum race 3 biovar 2 could be drastically
reduced if not completely eliminated. The bacterium causes potatoes to
have unsightly brown rings in the vegetable, making them worthless for
human consumption. Most likely, U.S. producers with fields infected
with this bacterium would be required to quarantine their fields and
destroy the potatoes to prevent the spread of the disease.
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\4\ National Agricultural Statistical Service (NASS) data on
U.S. potato production, 2002; Foreign Agricultural Service data on
potato exports, 2002.
---------------------------------------------------------------------------
The United Kingdom has experienced five outbreaks of potato brown
rot that have caused minor impacts to overall potato production.\5\
Certain areas in South America have seen potato losses from 5 percent
to 100 percent due to potato brown rot. If potato brown rot were to
become established in the United States, the potato industry could
potentially lose hundreds of millions of dollars due to direct losses
and indirect losses from quarantines and diminished export markets.
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\5\ British Department of Environment, Food and Rural Affairs,
Service Delivery Unit, Plant Health Division.
---------------------------------------------------------------------------
This interim rule will allow imports of articles of Pelargonium
spp. and Solanum spp. to continue as long as the articles have been
produced in accordance with the certification program requirements in
Sec. 319.37-5(r)(3) and are accompanied by a phytosanitary certificate
stating that they have been produced in accordance with these
requirements. This interim rule will help safeguard U.S. agriculture
against the possible introduction of R. solanacearum race 3 biovar 2.
Impact on Small Entities
The Regulatory Flexibility Act requires that APHIS consider the
economic impact of its rules on small entities. The Small Business
Administration (SBA) classifies nursery and tree production businesses
as small entities (North American Industry Classification System
category 111421) if their annual sales receipts are $750,000 or less.
In 2001, 1,691 floriculture operations out of a total of 10,965
operations had sales of $500,000 or more.\6\ Therefore, at least 85
percent of all floriculture operations can be classified as small; it
is likely that an even higher percentage can be classified as small due
to the $250,000 discrepancy.
---------------------------------------------------------------------------
\6\ NASS, Agricultural Statistics Board, U.S. Department of
Agriculture, 2001 Floriculture Crops.
---------------------------------------------------------------------------
The costs of complying with the production site certification
requirements are not expected to significantly affect costs or revenues
of small-entity floriculture operators in the United States. Some
portion of the cost of site certification may be passed onto U.S.
buyers of geranium cuttings in the form of higher prices, but this
effect is expected to be minor.
The rule will have a negative impact on offshore operations due to
the costs involved in complying with the additional nursery site
certification requirements. Experts in the industry have estimated that
updating the 11 offshore nursery sites will cost approximately $770,000
total, or $70,000 per site. It is difficult to determine the impact
without knowing average revenues generated at these 11 nursery sites.
While the costs for production sites to comply with the
requirements will result in a negative impact on offshore production
sites, the requirements will help ensure that future nursery shipments
entering the United States are free of R. solanacearum race 3 biovar 2.
The 2003 R. solanacearum race 3 biovar 2 outbreak alone cost the
floriculture industry $1.5 to $2 million in geranium plant losses. The
R. solanacearum race 3 biovar 2 outbreak could have jeopardized not
only the entire U.S. geranium industry, which is estimated to be worth
$204 million per year, but also the potato industry, which is estimated
to be worth $3.2 billion per year, if it had not been contained and
eradicated.\7\ It is evident that the potential benefits of certifying
offshore production sites that produce Pelargonium spp. and Solanum
spp. outweigh the costs.
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\7\ Electronic Outlook Report from the Economic Service,
Floriculture and Nursery Crops Outlook, September 12th, 2002,
Alberto Jerardo; and NASS data U.S. potato production, 2002, along
with FAS data on potato exports 2002.
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Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts all State and local laws and
regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(j) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection and
recordkeeping requirements included in this interim rule have been
submitted for emergency approval to the Office of Management and Budget
(OMB). OMB has assigned control number 0579-0246 to the information
collection and recordkeeping requirements.
We plan to request continuation of that approval for 3 years.
Please send written comments on the 3-year approval request to the
following addresses: (1) Office of Information and Regulatory Affairs,
OMB, Attention: Desk Officer for APHIS, Washington, DC 20503; and (2)
Docket No. 03-019-2, Regulatory Analysis and Development, PPD, APHIS,
Station 3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238.
Please state that your comments refer to Docket No. 03-019-2 and send
your comments within 60 days of publication of this rule.
This interim rule establishes a certification program for articles
of Pelargonium spp. and Solanum spp. imported from countries where the
bacterium Ralstonia solanacearum race 3 biovar 2 is known to occur. In
order to comply with the requirements of the certification program,
exporting production sites and importers will need to obtain the
necessary additional declaration on the phytosanitary certificate
accompanying the imported articles of Pelargonium spp. and Solanum spp.
and submit documentation for the compliance agreement and trust fund
required by this interim rule. We are soliciting comments from the
public (as well as affected agencies) concerning our information
collection and recordkeeping requirements. These comments will help us:
(1) Evaluate whether the information collection is necessary for
the proper performance of our agency's functions, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
information collection, including the validity of the methodology and
assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic,
[[Page 21946]]
mechanical, or other technological collection techniques or other forms
of information technology; e.g., permitting electronic submission of
responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average 0.5049 hours per response.
Respondents: Growers and State plant regulatory officials.
Estimated annual number of respondents: 15.
Estimated annual number of responses per respondent: 67.33.
Estimated annual number of responses: 1,010.
Estimated total annual burden on respondents: 510 hours. (Due to
averaging, the total annual burden hours may not equal the product of
the annual number of responses multiplied by the reporting burden per
response.)
Copies of this information collection can be obtained from Mrs.
Celeste Sickles, APHIS' Information Collection Coordinator, at (301)
734-7477.
Government Paperwork Elimination Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the Government Paperwork Elimination Act (GPEA), which
requires Government agencies in general to provide the public the
option of submitting information or transacting business electronically
to the maximum extent possible. For information pertinent to GPEA
compliance related to this interim rule, please contact Mrs. Celeste
Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.
List of Subjects in 7 CFR Part 319
Bees, Coffee, Cotton, Fruits, Honey, Imports, Logs, Nursery stock,
Plant diseases and pests, Quarantine, Reporting and recordkeeping
requirements, Rice, Vegetables.
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 and 7701-7772; 21 U.S.C. 136 and 136a; 7
CFR 2.22, 2.80, and 371.3.
0
2. In Sec. 319.37-1, a new definition of production site is added in
alphabetical order to read as follows:
Sec. 319.37-1 Definitions.
* * * * *
Production site. A defined portion of a place of production
utilized for the production of a commodity that is managed separately
for phytosanitary purposes. This may include the entire place of
production or portions of it. Examples of portions of places of
production are a defined orchard, grove, field, greenhouse,
screenhouse, or premises.
* * * * *
0
3. In Sec. 319.37-5, paragraph (r) and the OMB control number citation
at the end of the section are revised to read as follows:
Sec. 319.37-5 Special foreign inspection and certification
requirements.
* * * * *
(r) Any restricted article of Pelargonium spp. or Solanum spp.
presented for importation into the United States may not be imported
unless it meets the following requirements:
(1) Any restricted article of Pelargonium spp. or Solanum spp.
imported from Canada under the provisions of the greenhouse-grown
restricted plant program as described in Sec. 319.37-4(c) must be
presented for importation at the port of first arrival in the United
States with a certificate of inspection in the form of a label in
accordance with Sec. 319.37-4(c)(1)(iv).
(2) For any article of Pelargonium spp. or Solanum spp. that does
not meet the requirements of paragraph (r)(1) of this section and is
from a country where Ralstonia solanacearum race 3 biovar 2 is not
known to occur, the phytosanitary certificate of inspection required by
Sec. 319.37-4 must contain an additional declaration that states
``Ralstonia solanacearum race 3 biovar 2 is not known to occur in the
country of origin''; Provided, that this additional declaration is not
required on the phytosanitary certificate of inspection accompanying
articles of Solanum spp. from Canada that do not meet the requirements
of paragraph (r)(1) of this section.
(3) Any article of Pelargonium spp. or Solanum spp. that is from a
country where Ralstonia solanacearum race 3 biovar 2 is known to occur
must meet the following requirements:
(i) The national plant protection organization of the country in
which the articles are produced (the NPPO) must have entered into a
bilateral workplan with APHIS. This bilateral workplan must set out
conditions for monitoring the production of articles of Pelargonium
spp. and Solanum spp., for enforcement of the requirements of this
paragraph (r)(3), and for the establishment of a trust fund as provided
for in paragraph (r)(3)(xv) of this section.
(ii) The production site where the articles of Pelargonium spp. and
Solanum spp. intended for export to the United States are produced must
be registered with and certified by both APHIS and the NPPO. As part of
the certification process, production sites must be initially approved
and thereafter visited at least once a year by APHIS and the NPPO to
verify compliance with the requirements of this paragraph (r)(3).
(iii) The production site must conduct ongoing testing for R.
solanacearum race 3 biovar 2. Only those articles of Pelargonium spp.
or Solanum spp. that have been tested with negative results for the
presence of R. solanacearum race 3 biovar 2 may be used in production
and export. Records of the testing must be kept for two growing seasons
and made available to representatives of APHIS and of the NPPO. All
testing procedures must be approved by APHIS.
(iv) The production site must be constructed in a manner that
ensures that outside water cannot enter the production site. The
production site must be surrounded by a 1-meter buffer that is sloped
so that water drains away from the production site.
(v) Dicotyledonous weeds must be controlled both within the
production site and around it. The production site and the 1-meter
buffer surrounding the production site must be free of dicotyledonous
weeds.
(vi) All equipment that comes in contact with articles of
Pelargonium spp. or Solanum spp. within the production site must be
adequately sanitized so that R. solanacearum race 3 biovar 2 cannot be
transmitted between plants or enter from outside the production site
via the equipment.
(vii) Production site personnel must adequately sanitize their
clothing and shoes and wash their hands before entering the production
site to prevent the entry of R. solanacearum race 3 biovar 2 into the
production site.
(viii) Growing media for articles of Pelargonium spp. and Solanum
spp. must be free of R. solanacearum race 3 biovar 2. Growing media and
containers for articles of Pelargonium spp. and Solanum spp. must not
come in contact with soil, and soil may not be used as a growing
medium.
(ix) Water used in maintenance of the plants at the production site
must be free of R. solanacearum race 3 biovar 2. The production site
must either derive the water from an APHIS-approved source or treat the
water with an APHIS-approved treatment before use.
(x) Growing media at the production site must not come in direct
contact with any water source, such as an
[[Page 21947]]
emitter or a hose end. If a drip irrigation system is used, backflow
devices must be installed to prevent any R. solanacearum race 3 biovar
2 that may be present from spreading to the rest of the production site
through the irrigation system. Ebb and flow irrigation may not be used.
(xi) Production site personnel must be educated regarding the
various pathways through which R. solanacearum race 3 biovar 2 can be
introduced into a production site and must be trained to recognize
symptoms of R. solanacearum race 3 biovar 2 infection in articles of
Pelargonium spp. or Solanum spp. in the production site.
(xii) Articles of Pelargonium spp. or Solanum spp. produced for
export within an approved production site must be handled and packed in
a manner adequate to prevent the presence of R. solanacearum race 3
biovar 2. The articles must be labeled with information indicating the
production site from which the articles originated.
(xiii) If R. solanacearum race 3 biovar 2 is found in the
production site or in consignments from the production site, the
production site will be ineligible to export articles of Pelargonium
spp. or Solanum spp. to the United States. A production site may be
reinstated if a reinspection reveals that the production site is free
of R. solanacearum race 3 biovar 2 and all problems in the production
site have been addressed and corrected to the satisfaction of APHIS.
(xiv) The phytosanitary certificate of inspection required by Sec.
319.37-4 that accompanies these articles must contain an additional
declaration that states ``These articles have been produced in
accordance with the requirements in 7 CFR 319.37-5(r)(3).''
(xv) The government of the country in which the articles are
produced must enter into a trust fund agreement with APHIS before each
growing season. The government of the country in which the articles are
produced or its designated representative is required to pay in advance
all estimated costs that APHIS expects to incur through its involvement
in overseeing the execution of paragraph (r)(3) of this section. These
costs will include administrative expenses incurred in conducting the
services enumerated in paragraph (r)(3) of this section and all
salaries (including overtime and the Federal share of employee
benefits), travel expenses (including per diem expenses), and other
incidental expenses incurred by the inspectors in performing these
services. The government of the country in which the articles are
produced or its designated representative is required to deposit a
certified or cashier's check with APHIS for the amount of the costs
estimated by APHIS. If the deposit is not sufficient to meet all costs
incurred by APHIS, the agreement further requires the government of the
country in which the articles are produced or its designated
representative to deposit with APHIS a certified or cashier's check for
the amount of the remaining costs, as determined by APHIS, before the
services will be completed. After a final audit at the conclusion of
each shipping season, any overpayment of funds would be returned to the
government of the country in which the articles are produced or its
designated representative or held on account until needed.
(Approved by the Office of Management and Budget under control
numbers 0579-0049, 0579-0176, 0579-0221, and 0579-0246.)
Done in Washington, DC, this 20th day of April, 2004.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 04-9262 Filed 4-22-04; 8:45 am]
BILLING CODE 3410-34-P