[Federal Register Volume 70, Number 204 (Monday, October 24, 2005)]
[Rules and Regulations]
[Pages 61351-61362]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-21168]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 319
[Docket No. 03-019-3]
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: Final rule.
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SUMMARY: We are adopting as a final rule, with changes, an interim rule
that amended the regulations by establishing a certification program
for articles of Pelargonium spp. and Solanum spp. imported from
countries where the bacterium Ralstonia solanacearum race 3 biovar 2
(R3B2) is known to occur. The interim rule prohibited the importation
of articles of Pelargonium spp. and Solanum spp. from countries where
R. solanacearum R3B2 is known to occur unless the articles are produced
in accordance with the certification program. This final rule amends
the regulations by modifying some of the requirements of the
certification program to make them clearer and more flexible, by
providing for the establishment of areas that are free of R.
solanacearum R3B2 within countries where the bacterium is known to
occur, and by exempting imported seeds of Pelargonium spp. and Solanum
spp. from all requirements related to R. solanacearum R3B2. The
requirements of the certification program are designed to ensure that
R. solanacearum R3B2 will not be introduced into the United States
through the importation of articles of Pelargonium spp. and Solanum
spp. This certification program is necessary to prevent the
introduction of this bacterial strain into the United States.
EFFECTIVE DATE: October 24, 2005.
FOR FURTHER INFORMATION CONTACT: Ms. Jeanne Van Dersal, Import
Specialist, Phytosanitary Issues Management Team, PPQ, APHIS, 4700
River Road Unit 140, Riverdale, MD 20737-1236; (301) 734-6653.
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 that the phytosanitary
certificates that must accompany all articles of Pelargonium spp. and
Solanum spp. imported into the United States contain an additional
declaration. (Articles of Pelargonium spp. and Solanum spp. imported
under the Canadian greenhouse-grown restricted plant program in Sec.
319.37-4(c), 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 May 2003
interim rule was necessary because introductions of R. solanacearum
R3B2, 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 May 2003
interim rule had to state either that the articles of Pelargonium spp.
and Solanum spp. were produced in a production site that had been
tested and found to be free of R. solanacearum R3B2 or that R.
solanacearum R3B2 was not known to occur in the region in which the
articles were produced.
We received comments on that interim rule requesting that we
establish a certification program for articles of Pelargonium spp. and
Solanum spp. imported from countries where R. solanacearum R3B2 is
known to occur.
In addition, an introduction of the bacterium into the United
States via infected geranium cuttings (Pelargonium spp.) was confirmed
in February 2003; during the subsequent eradication effort, APHIS found
some infected articles of Pelargonium spp.
[[Page 61352]]
that we believed were imported after the effective date of the May 2003
interim rule. This indicated to us that additional mitigations against
the risk of introducing R. solanacearum R3B2 via imported articles of
Pelargonium spp. and Solanum spp. were necessary.
Accordingly, in a subsequent interim rule effective May 24, 2004,
and published in the Federal Register on April 23, 2004 (69 FR 21941-
21947, Docket No. 03-019-2), we amended the regulations by requiring
that articles of Pelargonium spp. and Solanum spp. imported from
countries where R. solanacearum R3B2 is known to occur be grown in
accordance with a certification program. The certification program,
which includes production site construction requirements, testing
requirements, and operational requirements, is designed to ensure that
R. solanacearum R3B2 will not be introduced into the United States via
the importation of articles of Pelargonium spp. and Solanum spp. The
interim rule also required that imported articles of Pelargonium spp.
and Solanum spp. from countries where the bacterium R. solanacearum
R3B2 is known to occur be accompanied by a phytosanitary certificate
with an additional declaration stating that the articles were produced
in accordance with the requirements of the certification program. We
took this action based on our determination that the restrictions that
had been added to the regulations in the May 2003 interim rule did not
adequately mitigate the risk that imported articles of Pelargonium spp.
and Solanum spp. could introduce this bacterial strain into the United
States.
We solicited comments concerning the April 2004 interim rule for 60
days ending June 22, 2004. We received 10 comments by that date. They
were from State and foreign plant protection organizations, nursery
stock growers, industry associations, and university researchers. We
have carefully considered all of the comments we received. They are
discussed below by topic.
General Comments
Two commenters asserted that the available scientific evidence did
not support placing any restrictions on the importation of articles of
Pelargonium spp. and Solanum spp. to prevent the introduction of R.
solanacearum R3B2, further claiming that the decision to establish the
certification program in the April 2004 interim rule was driven by
politics rather than science. One of these commenters also stated that
there is no evidence that articles of Pelargonium spp. that are
infected with R. solanacearum R3B2 pose a threat to the environment in
general or potatoes in particular, noting that the recent introductions
of the bacterium that had prompted our interim rules had not resulted
in any introductions of R. solanacearum R3B2 into the environment.
(Potatoes were identified in the analysis under the heading ``Executive
Order 12866 and Regulatory Flexibility Act'' in both interim rules as
the Solanum crop that could experience the greatest magnitude of
negative economic effects if R. solanacearum R3B2 was introduced into
the United States.)
The Animal and Plant Health Inspection Service (APHIS) considers R.
solanacearum R3B2 to be a quarantine pest. The bacterium is not known
to occur in the United States; 10 years of field surveys undertaken by
APHIS and by State governments have failed to discover any evidence of
R. solanacearum R3B2 in the environment.
As mentioned above, an introduction of the bacterium into the
United States via infected geranium cuttings (Pelargonium spp.) was
confirmed in February 2003. The bacterium was subsequently eradicated;
more than 2.1 million plants at 471 greenhouses throughout the United
States were destroyed as part of the eradication effort. The
eradication effort was, as one of the commenters noted, successful at
preventing the introduction of R. solanacearum R3B2 into the wider U.S.
environment. The survey procedures used to make this determination are
described in detail in the 2004 New Pest Response Guidelines (Action
Plan) issued in response to the introduction of R. solanacearum R3B2
into the United States.\1\
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\1\ This document may be viewed on the Internet at http://
www.aphis.usda.gov/ppq/ep/ralstonia/rasltoniaactionplanv4web.pdf.
Copies of all documents related to APHIS' response to the
introduction of R. solanacearum R3B2 into the United States may also
be requested from the person listed under FOR FURTHER INFORMATION
CONTACT.
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Experiences in other countries suggest that if R. solanacearum R3B2
were to become established in the United States, it would have a
significant impact on U.S. potato production; the bacterium causes
potatoes to rot through, making them unusable and seriously affecting
potato yields. In addition, if R. solanacearum R3B2 were to be
introduced into the U.S. environment, the bacterium would be 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 a means of eradicating R. solanacearum R3B2, 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. Therefore, it is
imperative that APHIS implement measures restrictive enough to prevent
R. solanacearum R3B2 from being introduced into the United States via
the importation of potentially infected articles. The requirements of
the certification program are designed to meet that goal.
Typically, APHIS simply prohibits the importation of articles of
nursery stock that pose a risk of introducing plant pathogens such as
R. solanacearum R3B2 into the United States, as plant pathogens are
substantially more difficult to detect and neutralize than other plant
pests. However, as indicated in the analysis under the heading
``Executive Order 12866 and Regulatory Flexibility Act'' in the April
2004 interim rule, the United States imports substantial quantities of
Pelargonium spp., and we did not want to halt this trade if there was
an effective alternative. We believe the requirements of the
certification program strike a balance by allowing continued
importation of articles of Pelargonium spp. and Solanum spp. but
ensuring that such importation does not introduce R. solanacearum R3B2
into the United States.
One commenter asserted that the requirements of the certification
program are identical to the requirements of the Minimum Sanitation
Protocols for Offshore Geranium Cutting Production that APHIS issued in
response to the February 2003 introduction of R. solanacearum R3B2 via
imported geranium cuttings.\2\ The commenter asked what assurance we
have that the certification program will be effective, since some
infected geranium cuttings appeared to have entered the United States
after the Minimum Sanitation Protocols were issued.
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\2\ The Minimum Sanitation Protocols for Offshore Geranium
Cutting Production may be viewed on the Internet at http://
www.aphis.usda.gov/ppq/ep/ralstonia/ralstoniaworkplan.pdf.
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We believe that the apparent entry of infected geranium cuttings
after the Minimum Sanitation Protocols were issued was due to the
failure of one importer to properly implement the Minimum Sanitation
Protocols, rather than a deficiency in the protocols themselves. (The
Minimum Sanitation
[[Page 61353]]
Protocols contain requirements that are similar to, but more specific
than, the requirements of the certification program.) We continue to
believe that the requirements of the certification program will be
effective at preventing the introduction of R. solanacearum R3B2 into
the United States if they are properly implemented under the oversight
of APHIS and the national plant protection organization (NPPO) of the
country of origin of the imported articles. Adding the certification
program to the regulations via our April 2004 interim rule helped to
ensure that any production requirements imposed by APHIS are properly
implemented. We are making no changes to the April 2004 interim rule in
response to this comment.
One commenter stated that the workplans developed among APHIS, the
NPPOs of exporting countries, and the owners or operators of production
sites need to address operational details of production under the
certification program more specifically than the regulations
established by the April 2004 interim rule do.
We agree with this comment. The regulations describing the
certification program are intended to establish the necessary
performance standards, while the workplans cited by the commenter are
intended to describe in greater detail what needs to be done at a
specific production site or sites to meet these standards. We have
prepared a workplan for this program by combining the Minimum
Sanitation Protocols for Offshore Geranium Cutting Production with a
testing and sampling plan and a signature page, which is signed by
APHIS and the NPPO of each exporting country. The workplan requires the
inspection personnel of the exporting country's NPPO to work in
conjunction with APHIS when appropriate, and to provide the oversight
needed to demonstrate that each production site will carry out the
procedures, sampling, and testing described in the workplan.
Additionally, the workplan requires the exporting country's NPPO to
provide the proper phytosanitary certification of all host material,
which includes the additional declaration ``Tested and found free of
Ralstonia solanacearum race 3 biovar 2.''
One commenter suggested that APHIS establish a Web site that would
provide updates to the public whenever the best management practices
associated with growing articles of Pelargonium spp. and Solanum spp.
are changed.
APHIS maintains documents pertaining to R. solanacearum R3B2 on the
Plant Protection and Quarantine Web page, at http://www.aphis.usda.gov
/ppq/ep/ralstonia/index.html. That Web site hosts the documents cited
in this final rule related to the production of articles of Pelargonium
spp. and Solanum spp. for export to the United States in countries or
areas where R. solanacearum R3B2 is known to occur, along with more
general information about APHIS efforts to prevent the introduction of
the bacterium into the United States. We will continue to update that
Web page to reflect advances in scientific knowledge and amendments to
our regulations regarding R. solanacearum R3B2, including changes to
the best management practices associated with growing articles of
Pelargonium spp. and Solanum spp.
Characteristics of R. solanacearum R3B2
The April 2004 interim rule included information about the means by
which R. solanacearum R3B2 can spread and the reasons it is difficult
to eradicate. This information is presented above under the heading
``General Comments'' in the context of discussing why it was necessary
to restrict the importation of articles of articles of Pelargonium spp.
and Solanum spp.; it served a similar function in the interim rule. We
received several comments concerning this information.
One commenter stated that the spread of R. solanacearum R3B2 from
field to field via run-off water had never been substantiated to the
commenter's knowledge in Europe. This commenter cited establishment in
wild bittersweet (Solanum duclamara) and subsequent irrigation with
contaminated surface water as of more importance. Another commenter
stated that no scientific evidence suggests that R. solanacearum R3B2
can survive in water.
Once R. solanacearum R3B2 is introduced into the environment, its
primary means of spread is via contaminated run-off water or irrigation
water. This has been proven by experiences in the United Kingdom
(UK).\3\ Furthermore, the first commenter provided additional evidence
that suggests it is necessary to address the risk of transmission of
the bacterium into a production site via contaminated water.
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\3\ Summarized by John Elphinstone, Central Science Laboratory,
Department for Environment, Food, and Rural Affairs, York, UK, in
``Monitoring and control of the potato brown rot bacterium
(Ralstonia solanacearum) in the UK.'' This presentation was given at
``Planning for Ralstonia solanacearum R3B2 Detection on Solanaceous
Crops in the U.S.,'' meeting held at APHIS headquarters on June 19,
2003.
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In response to the second commenter's assertion, the bacterium does
not survive indefinitely in water, as it requires food to metabolize,
but it can survive for the limited time required for plant-to-plant
transmission via run-off water.
One commenter stated that Pelargonium spp. are not preferred hosts
for R. solanacearum R3B2, so crop losses in Pelargonium spp. due to the
bacterium are minimal and can be easily eliminated by proper production
practices. This commenter also stated that R. solanacearum R3B2 rarely
results in substantial yield losses in potatoes in cooler climates, and
a proper control program can cause it to occur only sporadically and
easily eliminate it from the production column.
We agree with the commenter's statement regarding the host status
of Pelargonium spp. for R. solanacearum R3B2; however, since infected
articles of Pelargonium spp. have introduced R. solanacearum R3B2 into
the United States, necessitating eradication efforts that were costly
both to APHIS and to U.S. nursery stock growers, we believe it is
necessary to regulate their importation from countries where R.
solanacearum R3B2 is known to occur.
With regard to the commenter's assertions about the potential
impact of R. solanacearum R3B2 on potato crops, it should be reiterated
that R. solanacearum R3B2 is a quarantine pest that is not known to
occur in the United States. It can be difficult to predict the impact
of a plant pest in a new environment. In addition, if R. solanacearum
R3B2 were introduced into the United States, APHIS would likely place a
quarantine on any areas of the United States where the bacterium was
known to occur, which would result in increased production costs for
U.S. producers of articles of Pelargonium spp. and Solanum spp. and the
possible loss of export markets for such articles. As described in the
analysis under the heading ``Executive Order 12866 and Regulatory
Flexibility Act'' in both interim rules, losses for U.S. potato
producers due to quarantines and reduced export markets could
potentially amount to hundreds of millions of dollars in the event of
an introduction of R. solanacearum R3B2 into the United States. We do
not believe that the information cited by the commenter warrants
reconsideration of R. solanacearum R3B2's status as a quarantine pest
or warrants relaxing any of the restrictions on the importation of
articles of Pelargonium spp. and Solanum spp. that we added to the
regulations in the two interim rules.
One commenter felt that our use of the term ``dangerous'' to
describe R. solanacearum R3B2 and our statement
[[Page 61354]]
that an introduction of R. solanacearum R3B2 into the United States
``could be devastating to U.S. potato production'' were unnecessarily
inflammatory.
Our use of the term ``dangerous'' was intended to indicate that R.
solanacearum R3B2 has the potential to cause economic damage to crops
in the United States if it is introduced and spreads to the wider
environment. Similarly, our use of the term ``devastating'' to describe
the potential impact of R. solanacearum R3B2 on U.S. potato production
was intended to reflect the fact that 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.
(These possibilities were discussed in the analysis under the heading
``Executive Order 12866 and Regulatory Flexibility Act'' in both
interim rules.) To address this commenter's concern, in the preamble to
this final rule, we will refer more directly to the potential economic
impact of R. solanacearum R3B2 when discussing the importance of
preventing its introduction into the United States. No changes to the
regulations established by the two interim rules are necessary as a
result of this comment.
We also received comments regarding two other characteristics of R.
solanacearum R3B2.
First, both interim rules restricted the importation of articles of
Pelargonium spp. and Solanum spp.; the term ``articles'' is understood
to refer to both plants and all propagative material that can be
derived from a plant, including seed. Two commenters disputed the
implied assertion that R. solanacearum R3B2 could be transmitted via
seed and asked us to exempt seed of Pelargonium spp. and Solanum spp.
imported from countries where the bacterium exists from the
requirements established by the two interim rules.
The commenters are correct that R. solanacearum R3B2 is not a
seedborne pathogen and that we should, therefore, exempt seeds from the
requirements for imported articles of Pelargonium spp. and Solanum spp.
that we established in Sec. 319.37-5(r) in the two interim rules. We
have done so in this final rule by adding a statement to the
introductory text of Sec. 319.37-5(r) stating that seeds are not
subject to that paragraph's requirements. (We are not amending the
entries for ``Pelargonium spp. not meeting the conditions for
importation in Sec. 319.37-5(r)'' and ``Solanum spp. not meeting the
conditions for importation in Sec. 319.37-5(r)'' in the table of
prohibited articles in Sec. 319.37-2(a), because the entries for
prohibited articles in that table include seed only if specifically
mentioned.)
Although we are exempting seed from the requirements of paragraph
Sec. 319.37-5(r) in this final rule, we will refer simply to
``articles of Pelargonium spp. and Solanum spp.'' in the following
discussion of comments for ease of reading.
Second, both interim rules also limited the articles that were
regulated to those of Pelargonium spp. and Solanum spp. One commenter
asked if the host range of R. solanacearum R3B2 was limited to articles
of Pelargonium spp. and Solanum spp., and stated that if it is not, the
importation of asexual propagative material from the entire host range
of the bacterium should be restricted.
We agree that other plants can serve as hosts for R. solanacearum
R3B2, and we are reviewing the available evidence regarding plants that
may serve as hosts for R. solanacearum R3B2. If necessary, we will
conduct further rulemaking to address any risks their importation may
pose. Such an action would afford the public, and foreign producers of
these species in particular, an opportunity to comment on the
suitability and effectiveness of the certification program's
requirements for production of those species. Thus, we are making no
changes to the regulations established by the two interim rules in
response to this comment.
R. solanacearum in the United States
In the April 2004 interim rule, we made the following statements
about the presence of R. solanacearum in the United States:
``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 cannot 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.''
We received several comments regarding these statements.
One commenter stated that it is not R. solanacearum race 3 biovar 1
that does not tolerate cold temperatures and that is present in the
United States, but rather R. solanacearum race 1 biovar 1.
At the time the commenter submitted this comment, during the 60
days after the publication of the April 2004 interim rule, the
commenter was correct. The races of R. solanacearum are distinguished
on the basis of their primary hosts; race 1 causes bacterial wilt on
tomatoes, while race 3 causes brown rot on potatoes. Both race 1 and
race 3 can infect hosts other than their primary hosts. R. solanacearum
race 1 biovar 1 is established in the southeast United States.
A strain of Ralstonia was discovered in samples from a greenhouse
and pond in the State of Florida in September 2004. It was eventually
identified as R. solanacearum biovar 1, but testing has to this point
produced conflicting results as to what race of the bacterium is
present in the samples. Regardless, APHIS is not treating any R.
solanacearum of biovar 1 as a quarantine pest.
In the absence of further information regarding the strain of R.
solanacearum that we discovered in Florida in September 2004, we will
refer to the strain of R. solanacearum that is present in the United
States as race 1 biovar 1 in the preamble of this final rule. However,
because the interim rules addressed R. solanacearum R3B2 and the
bacterium present in Florida has been determined not to be a biovar 2
R. solanacearum bacterium, no changes to the regulations established by
the two interim rules are necessary as a result of this comment.
Two commenters asked APHIS to present evidence that R. solanacearum
R3B2 is not present in the United States. These commenters stated that
U.S. potato growers are not required to test wilted plants for R.
solanacearum R3B2, which means that it is unknown whether R.
solanacearum R3B2 exists in U.S. potatoes. Another commenter took issue
with our statement that R. solanacearum R3B2 is not present in the
United States, since APHIS conducted a recent eradication effort
against the bacterium, and suggested that we state
[[Page 61355]]
instead that we are attempting to eradicate R. solanacearum R3B2 within
the United States.
All of the available data indicate that our eradication effort has
been successful at preventing R. solanacearum R3B2 from becoming
established within the United States. Data from surveys conducted both
by APHIS and by State governments indicate that R. solanacearum R3B2 is
not present in the United States.
Potato growers within the United States are not required by APHIS
to test their wilted plants for R. solanacearum R3B2 because the
bacterium is not known to occur in the United States. If R.
solanacearum R3B2 were known to occur in the United States, we would
establish a domestic quarantine in order to pursue its eradication or
containment. Such a quarantine would be likely to include a requirement
that potato growers submit wilted plants for testing.
Many States have potato certification programs to ensure freedom
from disease and to improve marketability for their potato crops. These
State programs require potato producers to test for disease organisms
that may occur in the production cycle if the potato plants show
symptoms such as wilting. These programs do not specifically seek to
identify R. solanacearum R3B2 infections because the bacterium is not
known to occur in the United States, but the presence of symptoms
caused by R. solanacearum R3B2 infection would indicate that a disease
is present, and the potatoes would be subsequently tested for diseases,
including R. solanacearum R3B2, until the cause of the symptoms was
determined.
As indicated above, survey data indicate that R. solanacearum R3B2
is not present in the United States; these data are what led us to the
conclusion that R. solanacearum R3B2 is not known to occur in the
United States.
One commenter cited three publications that the commenter believed
could indicate that R. solanacearum R3B2 is present in the United
States:
In a 1979 finding of R. solanacearum drawn from
Pelargonium x hortorum in the United States,\4\ the race and biovar of
the bacterium were unclear, but pathogenicity tests showed that the
isolates from the plant failed to cause disease on tobacco, which the
commenter asserted was typical of R. solanacearum R3B2. However, this
finding would also be consistent with R. solanacearum race 1 biovar 1,
which APHIS has acknowledged is established in the United States.
Therefore, no definitive statement about the presence of R.
solanacearum R3B2 in the United States can be made based on this
finding.
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\4\ Strider, D.L., Jones, R.K., and Haygood, R.A. 1981.
``Southern bacterial wilt of geranium caused by Pseudomonas
solanacearum,'' Plant Disease 65: 52-53.
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The commenter pointed out that R. solanacearum R3B2 was
found on Pelargonium zonale in Wisconsin in 1999.\5\ However, the
bacterium was found only in greenhouses; APHIS eradicated the bacterium
after it was found, and there is no evidence that it was transmitted
into the wider U.S. environment.
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\5\ Hudelson, B.D. 1999. ``Southern wilt.'' University of
Wisconsin Garden Facts, May 11, 1999.
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The commenter also noted that R. solanacearum race 1
biovar 1 has been found on P. zonale in Ohio.\6\ R. solanacearum race 1
biovar 1, as noted above, is established in the United States, and
APHIS has not established an official control program for it. The
interim rules placed restrictions on the importation of articles of
Pelargonium spp. and Solanum spp. to prevent the introduction of R.
solanacearum R3B2.
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\6\ Nameth, S. 1999. ``Bacterial disease alert in geraniums.''
FlowerTECH2 4: 65-67.
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This commenter also asked for information on official control of R.
solanacearum in the United States. As described above, R. solanacearum
race 1 biovar 1 is established in the United States, and APHIS has not
established an official control program for it, nor have we established
an official control program for any other biovar of race 1. We do not
have an official control program for R. solanacearum R3B2 because that
strain of the bacterium is not known to occur in the United States.
Races 2, 4, and 5 are also not known to occur in the United States. As
mentioned earlier in this document, we are not treating the R.
solanacearum biovar 1 bacterium found in Florida as a quarantine pest.
Two commenters stated that they were not aware of any evidence that
R. solanacearum R3B2 could survive in a northern climate. Another
commenter argued that our assertion that R. solanacearum R3B2 is
adapted to low temperatures may not be justified by the available
evidence and suggested that we state instead that R3B2 ``appears to be
adapted to lower temperatures.''
Janse (1996) indicates that R3B2 is, in fact, adapted to low
temperatures.\7\ If we become aware of any new research disputing the
existing evidence, we will evaluate it and, if necessary, update the
regulations.
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\7\ Janse, J. D. 1996. ``Potato brown rot in Western Europe--
History, presence, occurrence and some remarks on possible origin,
epidemiology and control strategies.'' EPPO Bull. 26: 679-985.
---------------------------------------------------------------------------
Distribution of R. solanacearum in Other Countries
In the May 2003 interim rule, we listed the following countries as
countries where R. solanacearum R3B2 is not known to occur: Algeria,
Austria, Belarus, Bulgaria, Canada, Croatia, Cyprus, Czech Republic,
Denmark, Estonia, Finland, Greece, Ireland, Israel, Italy, Latvia,
Lithuania, Moldavia, Morocco, Norway, Poland, Portugal, Romania,
Russian Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Tunisia, and Ukraine. (We did not provide this list in the April 2004
interim rule; one commenter on that interim rule asked that we provide
it here.) Two comments on the April 2004 interim rule raised issues
related to this list.
The April 2004 interim rule exempted articles of Solanum spp. from
Canada from the requirement that the phytosanitary certificate
accompanying articles of Solanum spp. must contain an additional
declaration; Canada is the only country allowed to export articles of
Solanum spp. other than true seed to the United States, as the
importation of Solanum spp. other than seed from other countries is
prohibited due to other disease risks. One commenter asked whether R.
solanacearum R3B2 might have entered Canada after it entered the United
States in 2003.
We are aware of no evidence suggesting that R. solanacearum R3B2
has occurred in Canada, and the Canadian NPPO has not reported its
presence. All the evidence available indicates that APHIS was
successful at confining the R. solanacearum R3B2 in the United States
to a few hundred facilities and that the bacterium was not transmitted
into the wider environment in the United States, much less in Canada.
As a signatory nation to the International Plant Protection Convention
(IPPC) of the United Nations' Food and Agriculture Organization, Canada
is obligated to report any discoveries of R. solanacearum R3B2 to the
IPPC.
One commenter, the Secretaria de Agricultura, Ganader[iacute]a,
Desarrollo Rural, Pesca y Alimentaci[oacute]n of Mexico (SAGARPA,
Mexico's NPPO), requested that Mexico be added to the list of countries
where R. solanacearum R3B2 is not known to occur. The commenter stated
that the only article that states that R. solanacearum R3B2 occurs in
Mexico, a 1978 publication by Dr. Leopoldo Fucikovsky, used an oxidase
test to determine that R. solanacearum
[[Page 61356]]
R3B2 was present. The oxidase test is inadequate to establish the
presence of R. solanacearum R3B2 since the test reacts not only with R.
solanacearum R3B2 but also with phenols and other plant chemistry
components. According to the commenter, all recent studies regarding
the occurrence of R. solanacearum R3B2 have not discovered the
bacterium in Mexico. The commenter also stated that Mexico performs
surveys for R. solanacearum R3B2 using enzyme-linked immunosorbent
assays (ELISA) and polymerase chain reaction (PCR) tests and has found
no evidence of the bacterium.
SAGARPA did not provide citations for the studies it cited as
supporting its view. If SAGARPA wishes to provide us with more specific
information establishing Mexico's freedom from R. solanacearum R3B2,
such as parameters of any surveys undertaken and the results of those
surveys, we will consider it. Alternatively, SAGARPA may propose to
establish an area within Mexico as free of R. solanacearum R3B2; the
process for doing so is described in more detail under the heading
``Pest-Free Areas and Nurseries,'' which follows directly.
Pest-Free Areas and Nurseries
The April 2004 interim rule requires that articles of Pelargonium
spp. and Solanum spp. that are imported into the United States from a
country where R. solanacearum R3B2 is known to occur be produced in
accordance with the certification program established by that interim
rule. Two commenters acknowledged the necessity of placing restrictions
on the importation of articles other than seed of Pelargonium spp. and
Solanum spp. from countries where R. solanacearum R3B2 is known to
occur, but stated that the requirements of the certification program
are unnecessarily restrictive given the phytosanitary controls already
in place in certain countries that export articles of Pelargonium spp.
and Solanum spp. These two commenters asked that we recognize areas
within a country where R. solanacearum R3B2 is known to occur as areas
free of R. solanacearum R3B2.
APHIS recognizes areas within a country as being free of plant
pests in accordance with the requirements in International Standards
for Phytosanitary Measures (ISPM) Publication No. 4, ``Requirements for
the Establishment of Pest Free Areas,'' which was published in 1996 by
the IPPC and which is incorporated by reference into our regulations at
7 CFR 300.5.\8\ To establish a pest-free area under this standard, a
country must establish three main components: Systems to establish
freedom, phytosanitary measures to maintain freedom, and checks to
ensure that freedom has been maintained. The standard sets out
performance-based requirements relating to each of these three
components. Any country wishing to establish an area within its borders
as free of R. solanacearum R3B2 may submit the appropriate information
in accordance with ``Requirements for the Establishment of Pest Free
Areas'' and propose that APHIS recognize the area in question as an
area that is free of R. solanacearum R3B2. APHIS will evaluate whether
the components the country has established are sufficient to establish
the area as a pest-free area. At the present time, no foreign NPPO has
submitted such a proposal.
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\8\ ISPM publications can be viewed on the Internet at https://
www.ippc.int/id/13399.
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However, the regulations established by the two interim rules do
not explicitly provide for the possible recognition of an area within a
country as free of R. solanacearum R3B2. To allow for this possibility,
we are adding a new paragraph (r)(2)(ii) to the regulations in Sec.
319.37-5. This paragraph will exempt articles of Pelargonium spp. and
Solanum spp. imported from areas free of R. solanacearum R3B2 within
countries where R. solanacearum R3B2 is known to occur from the
requirements of the certification program. Instead, such articles will
be required to be accompanied by a phytosanitary certificate containing
an additional declaration that states ``This article is from an area
that has been established as free of Ralstonia solanacearum race 3
biovar 2.'' We are moving the requirements presently in paragraph
(r)(2) into a new paragraph (r)(2)(i) to accommodate this change.
These two commenters also asked that we recognize the growing
practices in certain nurseries as sufficient to ensure the freedom of
articles of Pelargonium spp. and Solanum spp. produced in those
nurseries from R. solanacearum R3B2.
One of these commenters noted that the presence of R. solanacearum
R3B2 in the UK has been minimized. All production of potato and tomato
within the European Union (EU) is under official compliance with EU
production directive 98/57/EC. The requirements of this directive have
ensured that outbreaks of potato brown rot and tomato bacterial wilt (a
disease caused in tomatoes by R. solanacearum R3B2) have been contained
at the place of production. Directive 98/57/EC also includes measures
for the safe disposal of any infected crops, therefore removing any
possibility of the pathogen's spread through trade. Furthermore, annual
surveys conducted by the UK's NPPO ensure that the current locations of
contaminated watercourses are known and that irrigation from such
sources is prohibited. As a result, only five cases of the disease have
been detected in ware potato crops, and only one case has been detected
in tomatoes. The commenter stated that there have been no findings of
R. solanacearum R3B2 in the UK since 2000.
The other commenter asked specifically that we exclude Solanum
nigrum produced under protected cultivation from the final rule. The
commenter also stated that R. solanacearum R3B2 is not known to occur
in some nurseries producing Pelargonium spp. in EU Member States. The
commenter further argued that, if growing practices are sufficient to
exclude R. solanacearum R3B2 from a production site, the testing
provisions of the certification program would be superfluous.
We believe that the requirements of the certification program are
all essential to ensuring that articles of Pelargonium spp. and Solanum
spp. that are imported into the United States from a country where R.
solanacearum R3B2 is known to occur do not introduce that bacterium
into the United States. Accordingly, we will recognize the growing
practices in certain nurseries (including protected cultivation) as
sufficient to ensure the freedom of articles produced in those
nurseries from R. solanacearum R3B2 only if those practices satisfy the
requirements of the certification program. Growers in countries where
R. solanacearum R3B2 is known to occur who believe that their
production practices satisfy the requirements of the certification
program may request to have those production practices evaluated by
APHIS.
With regard to the first commenter's description of production
practices in the UK, we consider the UK to be a country where R.
solanacearum R3B2 is known to occur, and the commenter did not dispute
that. If certain areas in the UK are believed to be free of R.
solanacearum R3B2, the NPPO of the UK may attempt to establish their
pest-free status by submitting the information required by ISPM
Publication No. 4 to APHIS for further evaluation as described above.
Otherwise, UK growers should request
[[Page 61357]]
to have their production practices recognized by APHIS as satisfying
the requirements of the certification program.
We disagree with the second commenter's assertion that testing is
superfluous in a production site that has taken measures to exclude R.
solanacearum R3B2. Just as the establishment of a pest-free area
requires checks to ensure that the area remains free of the relevant
pest, testing is an important means of ensuring that the measures a
production site has taken to exclude R. solanacearum R3B2 are being
properly implemented and thus excluding the bacterium. We are making no
changes to the April 2004 interim rule in response to these comments.
Testing for R. solanacearum R3B2
One commenter asked us to specify what criteria must be met to
determine whether an area is free of R. solanacearum R3B2 and what
tests may be used to determine that a production site is free of R.
solanacearum R3B2.
As mentioned earlier in this document, the determination that an
area is free of a pest is based on our assessment of components that
include, but are not limited to, regular checks to ensure that the area
remains free of the pest. Testing may be carried out using any means
that the country in which the proposed pest-free area is located deems
practical and that APHIS determines to be effective.
The April 2004 interim rule stated that we are currently aware of
two acceptable methods for testing production sites: An ELISA, which
can determine whether Ralstonia spp. bacteria are present, and a PCR
test that can determine whether R. solanacearum R3B2 bacteria are
present. Domestic greenhouses tested for R. solanacearum R3B2 during
the recent eradication effort typically used ELISA to screen
potentially symptomatic material; if the material was infected with
Ralstonia spp., the PCR test was used to determine whether those
bacteria were race 3, biovar 2. Other testing methods may be used if
APHIS determines that those methods are adequate to confirm that
production facilities are free of R. solanacearum R3B2.
The preamble of the April 2004 interim rule stated: ``One approach
to preventing the entry of R. solanacearum R3B2 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 R3B2. 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.'' One commenter stated that testing for R. solanacearum
R3B2 at ports of entry is quite possible; alternatively, imported
articles could be tested during postentry inspections of the nurseries
where the articles are further cultivated.
We do not dispute that such testing is possible; however, APHIS
currently lacks the infrastructure and resources to either perform the
PCR test at the port of entry or perform an ELISA at the port of entry,
hold the tested articles until the test results are available, and then
run a separate PCR test on any articles that tested positive by ELISA
for the presence of Ralstonia spp. Therefore, we have focused our
efforts on excluding R. solanacearum R3B2 from articles offered for
importation into the United States.
Specific Provisions of the Certification Program
The April 2004 interim rule added a definition of production site
to Sec. 319.37-1 that read: ``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 definition was taken from ISPM
Publication No. 5, ``Glossary of Phytosanitary Terms 2002.'' \9\
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\9\ ISPM publications can be viewed on the Internet at https://
www.ippc.int/id/13399.
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One commenter stated that this definition might cause confusion
with regard to some of the requirements of the certification program.
For example, Sec. 319.37-5(r)(3)(iv) of the certification program
established by the April 2004 interim rule requires the production site
for articles of Pelargonium spp. and Solanum spp. to be surrounded by a
1-meter buffer. The commenter suggested that, given the definition of
production site established in the April 2004 interim rule, this
requirement could be interpreted to mean that an entire farm, composed
of multiple greenhouses in which articles of Pelargonium spp. and
Solanum spp. are produced, is required to be surrounded by a buffer,
rather than the individual greenhouses. The commenter cited similar
potential problems regarding the certification program's requirement in
Sec. 319.37-5(r)(3)(v) that the buffer be kept free of dicotyledonous
weeds.
The definition of production site established in the April 2004
interim rule states that the production site may include ``the entire
production site or portions of it. Examples of portions of places of
production are a defined orchard, grove, field, greenhouse,
screenhouse, or premises.'' Under this definition, on a farm that is
managed as a single production site for phytosanitary purposes but is
composed of multiple greenhouses, each individual greenhouse in the
farm is considered to be a portion of the production site. (Individual
greenhouses are considered to be individual production sites only if
they are managed separately for phytosanitary purposes, as provided for
in the definition.) Thus, the production site in this case would not
include all the land of the farm on which the greenhouses are located
but rather all the portions of the farm in which production of articles
of Pelargonium spp. and Solanum spp. takes place--the individual
greenhouses. Thus, each individual greenhouse on such a farm would be
required to have a 1-meter buffer that is kept free of dicotyledonous
weeds.
We are making no changes to the definition of production site in
response to this comment. However, we are revising paragraphs
(r)(3)(iv) and (r)(3)(v), which refer to the production site in the
context of the requirements the commenter mentioned, to clarify that
these requirements apply to each greenhouse on the production site
rather than the entire production site. We believe these changes
addresses the commenter's concern.
Paragraph (r)(3)(iii) of the certification program established in
Sec. 319.37-5 by the April 2004 interim rule required that production
sites conduct ongoing testing for R. solanacearum R3B2 and that only
those articles of Pelargonium spp. and Solanum spp. that have been
tested with negative results for the presence of R. solanacearum R3B2
may be used in production and export. One commenter was concerned that
this requirement could be interpreted to mean that each article
exported to the United States must be tested.
We did not intend to require that each article used in production
and export be tested individually; rather, we intended to require that
each article that has been used in production and export be part of a
group of articles that has been tested in accordance with a protocol
sufficient to determine, with a high degree of certainty, whether the
articles in the group are infected with R. solanacearum R3B2. Details
of the
[[Page 61358]]
testing and the statistical plan for the testing protocol are specified
in the workplan developed by APHIS, the foreign NPPO, and the owner or
operator of the production site.
The commenter is correct in stating that the language in the April
2004 interim rule is ambiguous on this point. Therefore, we are
amending paragraph (r)(3)(iii) to state that only articles of
Pelargonium spp. and Solanum spp. from a group of articles that has
been tested according to an APHIS-approved testing protocol with
negative results for the presence of R. solanacearum R3B2 may be used
in production and export.
Paragraph (r)(3)(iv) of the certification program established by
the April 2004 interim rule required that the production site be
constructed in a manner that ensures that outside water cannot enter
the production site. One commenter pointed out that water is necessary
to grow plants, and this water must be brought into the production site
from outside the production site; the interim rule technically excluded
such water. The commenter suggested changing the requirement to state
that the production site must be constructed in a manner that ensures
that runoff water from areas surrounding the production site cannot
enter the production site.
We agree with this comment and have changed paragraph (r)(3)(iv) of
the certification program established by the April 2004 interim rule as
the commenter suggests.
Paragraph (r)(3)(viii) of the certification program established by
the April 2004 interim rule prohibited growing media and containers for
articles of Pelargonium spp. and Solanum spp. from coming into contact
with soil and prohibited the use of soil as a growing medium for
articles of Pelargonium spp. and Solanum spp. One commenter
hypothesized that pasteurized soil might in the future be considered an
adequate growing medium and asked that, to ensure that the
certification program could accommodate such a future development, we
remove the prohibitions relating to soil and refer instead to APHIS-
approved growing media in paragraph (r)(3)(viii).
We agree that it would be best to provide such flexibility in the
regulations in the case that pasteurized soil becomes an acceptable
growing medium. Therefore, we have changed paragraph (r)(3)(viii) of
the certification program established by the April 2004 interim rule as
the commenter requested. However, it is important to reiterate that
soil of any kind will not be considered an APHIS-approved growing
medium at this time.
Paragraph (r)(3)(ix) of the certification program established by
the April 2004 interim rule required that water used in maintenance of
the plants at the production site be free of R. solanacearum R3B2. It
also required that the production site derive the water from an APHIS-
approved source or treat the water with an APHIS-approved treatment
before use. Two commenters expressed concerns about this requirement.
One stated that no nurseries in the UK use surface water in the
production of articles of Pelargonium spp., and infected Solanum
dulcamara outside of contaminated watercourses have not been identified
during official inspections over many years. Therefore, no water-borne
route of transmission for R. solanacearum R3B2 into UK nurseries has
been identified. The second commenter stated that rain water, tap
water, or water from deep wells is used in the production of articles
of Pelargonium spp. in the Netherlands, Belgium, and Germany.
If the water sources cited by the commenters can be proven to be
free of R. solanacearum R3B2, APHIS will approve the sources for use in
the production of articles of Pelargonium spp. and Solanum spp. under
the certification program; approval will be granted in the workplan
developed among APHIS, the NPPO of the exporting country, and the owner
or operator of the production site. We are making no changes to the
April 2004 interim rule in response to these comments.
Paragraph (r)(3)(x) of the certification program established by the
April 2004 interim rule prohibited the use of ebb-and-flow irrigation
in the production of articles of Pelargonium spp. and Solanum spp.
under the certification program. We prohibited the use of ebb-and-flow
irrigation because it exposes all the articles grown using such an
irrigation system to any R. solanacearum R3B2 that may be present in
any one article in the system. One commenter stated that ebb-and-flow
irrigation should not be prohibited in production facilities located in
areas within a country where R. solanacearum R3B2 is not known to
occur.
We agree that this requirement would be unjustified if an exporting
country where R. solanacearum R3B2 is known to occur established, in
accordance with the ``Requirements for the Establishment of Pest Free
Areas'' referred to above, that an area within that country is free of
R. solanacearum R3B2. In fact, under this final rule, production
facilities in such a pest-free area would be eligible to export
articles of Pelargonium spp. and Solanum spp. under paragraph Sec.
319.37-5(r)(2)(ii) of the regulations, which requires only that the
phytosanitary certificate accompanying the articles contain an
additional declaration that states that the articles are from an area
that has been established as free of R. solanacearum R3B2 in accordance
with ISPM No. 4, ``Requirements for the Establishment of Pest Free
Areas.'' However, as discussed above, APHIS has received no requests to
establish such pest-free areas at this time.
Paragraph (r)(3)(xii) of the certification program established by
the April 2004 interim rule required that articles of Pelargonium spp.
and Solanum spp. produced for export within an approved production site
be handled and packed in a manner adequate to prevent the presence of
R. solanacearum R3B2. One commenter recommended that the word
``presence'' be changed to ``introduction,'' or that the word
``introduction'' be added to this requirement.
The intent of the certification program is to prevent the
introduction of R. solanacearum R3B2 into the United States. Therefore,
we agree with this commenter, and we have changed the word ``presence''
to ``introduction'' in paragraph (r)(3)(xii) of the certification
program established by the April 2004 interim rule as the commenter
suggests.
Paragraph (r)(3)(xiii) of the certification program established by
the April 2004 interim rule stated that if R. solanacearum R3B2 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. The paragraph
further stated that a production site may be reinstated if a
reinspection reveals that the production site is free of R.
solanacearum R3B2 and all problems in the production site have been
addressed and corrected to the satisfaction of APHIS.
One commenter asked us to rewrite this paragraph to provide for the
possibility of individual greenhouses in a production site to be
declared ineligible to export articles of Pelargonium spp. or Solanum
spp. to the United States if articles of Pelargonium spp. or Solanum
spp. infected with R. solanacearum R3B2 can be traced back to an
individual greenhouse in a production site, rather than declaring the
entire production site ineligible.
[[Page 61359]]
We believe it is safe to declare an individual greenhouse among
several greenhouses ineligible to export articles of Pelargonium spp.
or Solanum spp. to the United States only if the greenhouse is managed
separately for phytosanitary purposes and thus qualifies as a
production site itself, as specified in the definition of production
site that the April 2004 interim rule added to Sec. 319.37-1.
Otherwise, production practices in a production site composed of
multiple greenhouses could spread R. solanacearum R3B2 from one
greenhouse to another, meaning that it would not be safe to allow
importation from any greenhouse in a production site in which one
greenhouse produced articles of Pelargonium spp. or Solanum spp.
infected with R. solanacearum R3B2. We are making no changes to the
April 2004 interim rule in response to this comment.
One commenter stated that production sites should have to be tested
with negative results three times over a 90-day period in order to be
considered eligible for reinstatement into the certification program.
This commenter further requested that details of the testing that would
be required for reinstatement and other requirements for reinstatement
be included in the regulations.
The three-test, 90-day standard the commenter suggests is a
reasonable standard, but it may not be appropriate in all cases. We
prefer to specify conditions for production site testing and
reinstatement in the workplan developed among APHIS, the NPPO of the
exporting country, and the operator of the production site, in order to
take into account local production conditions and capabilities. We are
making no changes to the April 2004 interim rule in response to this
comment.
Paragraph (r)(3)(xv) of the certification program established by
the April 2004 interim rule required that the government of the country
in which articles other than seed of Pelargonium spp. or Solanum spp.
are produced 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 Sec. 319.37-5 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.
One commenter stated that the trust fund requirement adds an
economic cost to the production of articles of Pelargonium spp. or
Solanum spp. that does not contribute to the maintenance of plant
health and is therefore not justifiable.
The trust fund requirement is common practice under many other
APHIS import regulations (e.g., importing Fuji apples from Japan and
the Republic of Korea under Sec. 319.56-2cc, or importing Hass
avocados from Mexico under Sec. 319.56-2ff). The trust fund is
intended to ensure that the government of the country in which the
articles are produced or its designated representative bears the cost
of the certification program, rather than U.S. taxpayers. (The
government of the country in which the articles are produced is, of
course, free to pass this cost on to production sites producing
articles of Pelargonium spp. or Solanum spp. for export to the United
States.) Requiring that APHIS subsidize the production of articles of
Pelargonium spp. or Solanum spp. grown in foreign countries for export
to the United States would, we believe, be a misallocation of APHIS'
limited resources. We are making no changes to the April 2004 interim
rule in response to this comment.
Two commenters expressed concern about the administration of the
trust fund. One stated that there is no assurance that the governments
of countries in which articles of Pelargonium spp. or Solanum spp. are
produced will participate in setting up the trust fund; without such
assurance, exporters might not be able to participate due to
governmental reluctance. The other asked that APHIS itself, rather than
the exporting country, establish and administer the trust fund so that
it will cover the APHIS costs without making it uneconomical for
exporting companies to continue production.
APHIS does, in fact, establish and administer the trust fund in the
certification program established in the April 2004 interim rule. The
government of the country in which the articles are produced or its
designated representative deposits money into the fund in response to
APHIS estimates of costs and in response to actual costs as determined
by APHIS. As noted above, the government of the country in which the
articles are produced is free to pass this cost on to production sites
producing articles of Pelargonium spp. or Solanum spp. for export to
the United States. We are making no changes to the April 2004 interim
rule in response to these comments.
In the section of the April 2004 interim rule in which we responded
to comments, we described one comment as suggesting that APHIS impose
an import bond on all imports of articles of Pelargonium spp. or
Solanum spp. Two commenters on the April 2004 interim rule stated that
we should require an import bond; one suggested that an import bond
would be appropriate if compensation is not provided for articles of
Pelargonium spp. or Solanum spp. destroyed during eradication efforts.
We continue to believe that the certification program we
established in that 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 R3B2.
Other Comments
One commenter recommended that, rather than place restrictions on
the importation of articles of Pelargonium spp. or Solanum spp., we
simply prohibit the importation of all nursery stock. We do not believe
such an action is necessary or warranted.
One commenter suggested that R. solanacearum R3B2 should be removed
from the list of select agents in 7 CFR 331.3(a). We continue to
believe, based on input from USDA's Agricultural Research Service,
Forest Service, and Cooperative State Research, Education, and
Extension Service and consultation with the American Phytopathological
Society, that R. solanacearum R3B2 poses a severe threat to plant
health or plant products, and the commenter
[[Page 61360]]
provided no evidence to the contrary. In any case, removing R.
solanacearum R3B2 from that list is beyond the scope of this
rulemaking.
One commenter urged APHIS to continue with its review of the
nursery stock regulations, to prevent introductions of both R.
solanacearum R3B2 and other plant pests. We agree that this review is
essential to safeguarding plant health, and we published an advance
notice of proposed rulemaking soliciting comments on approaches to
revising the nursery stock regulations on December 10, 2004 (69 FR
71736-71744, Docket No. 03-069-1).
Three commenters addressed various aspects of the eradication
effort that APHIS undertook after the presence of R. solanacearum R3B2
was confirmed in the United States in February 2003, including
reinstatement procedures for facilities where R. solanacearum R3B2 was
present, the speed with which the eradication effort was conducted, the
treatment of individual greenhouses as production sites, and the fact
that APHIS did not pay compensation to the owners of plants destroyed
during this eradication effort.
The effort to eradicate R. solanacearum R3B2 within the United
States was conducted under the authority granted to APHIS in the Plant
Protection Act (7 U.S.C. 7714), which states that if the Secretary
considers it necessary in order to prevent the dissemination of a plant
pest or noxious weed that is new to or not known to be widely prevalent
or distributed within and throughout the United States, the Secretary
may hold, seize, quarantine, treat, apply other remedial measures to,
destroy, or otherwise dispose of any plant that is moving into or
through the United States or interstate, or has moved into or through
the United States or interstate, and the Secretary has reason to
believe is infested with a plant pest or noxious weed at the time of
the movement. The Plant Protection Act further states that if that
situation should occur, the Secretary may order the owner of any plant
to destroy the plant without cost to the Federal Government and in the
manner the Secretary considers appropriate.
The May 2003 and April 2004 interim rules placed restrictions on
the importation of articles of Pelargonium spp. or Solanum spp. in
order to address the risk that such importation could introduce R.
solanacearum R3B2 into the United States; the domestic eradication
effort is beyond the scope of this rulemaking.
Therefore, for the reasons given in the interim rule and in this
document, we are adopting the interim rule as a final rule, with the
changes discussed in this document.
This final rule also affirms the information contained in the
interim rule concerning Executive Orders 12372 and 12988 and the
Paperwork Reduction Act.
Effective Date
Pursuant to the administrative procedure provisions in 5 U.S.C.
553, we find good cause for making this rule effective less than 30
days after publication in the Federal Register. The interim rule
adopted as final by this rule was effective on May 24, 2004. This rule
clarifies certain requirements in the certification program established
by the interim rule and amends other requirements to provide additional
options. Immediate action is necessary to amend the certification
program in order to ensure that its requirements are easily understood
and to make the certification program more flexible. 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 not significant for the purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of
Management and Budget.
In the April 2004 interim rule, APHIS amended the regulations to
establish a certification program for articles of Pelargonium spp. and
Solanum spp. imported from countries where the bacterium R.
solanacearum R3B2 is known to occur. The interim rule prohibited the
importation of articles of Pelargonium spp. and Solanum spp. from
countries where R. solanacearum R3B2 is known to occur unless the
articles are produced in accordance with the certification program.
This final rule amends the regulations by modifying some of the
requirements of the certification program to make them clearer and more
flexible, by providing for the establishment of areas that are free of
R. solanacearum R3B2 within countries where R. solanacearum R3B2 is
known to occur, and exempting imported seeds of Pelargonium spp. and
Solanum spp. from all requirements related to R. solanacearum R3B2. The
requirements of the certification program are designed to ensure that
R. solanacearum R3B2 will not be introduced into the United States
through the importation of articles of Pelargonium spp. and Solanum
spp. This certification program is necessary to prevent the
introduction of this bacterial strain into the United States.
The production site certification program impacts 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 the April 2004 interim rule has
been estimated at approximately $70,000 per site.\10\ However, many of
these production sites had already upgraded their facilities due to the
outbreak of R. solanacearum R3B2 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 have
been lower than this estimate.
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\10\ 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.\11\ The United States imported $44
million worth of cuttings and slips of which geraniums comprised some
unknown part.\12\ Geraniums are the most popular bedding plant in North
America; approximately 20,000 growers cultivate these plants.
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\11\ Electronic Outlook Report from the Economic Research
Service, Floriculture and Nursery Crops Outlook, September 12, 2002,
Alberto Jerardo.
\12\ 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 R3B2 outbreak
occurred when geranium cuttings arrived from Kenya carrying the R.
solanacearum R3B2 bacterium. The R. solanacearum R3B2 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
R3B2 bacterium, which is widely distributed in temperate regions,
causes the disease potato brown rot. In 2002, 1.3 million acres of U.S.
potatoes were harvested;
[[Page 61361]]
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.\13\ The value
of potato fields infected with R. solanacearum R3B2 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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\13\ National Agricultural Statistical Service (NASS) data on
U.S. potato production, 2002; Foreign Agricultural Service data on
potato exports, 2002.
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The UK has experienced five outbreaks of potato brown rot that have
caused minor impacts to overall potato production.\14\ 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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\14\ British Department of Environment, Food and Rural Affairs,
Service Delivery Unit, Plant Health Division.
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The April 2004 interim rule allowed imports of articles of
Pelargonium spp. and Solanum spp. to continue as long as the articles
are 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
those requirements. The interim rule helped safeguard U.S. agriculture
against the possible introduction of R. solanacearum R3B2.
Impact on Small Entities
The Regulatory Flexibility Act requires that agencies consider the
economic impact of their 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.\15\ 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.
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\15\ NASS, Agricultural Statistics Board, U.S. Department of
Agriculture, 2001 Floriculture Crops.
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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 interim rule had 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 cost approximately $770,000
total, or $70,000 per site. However, this final rule makes changes to
the production site requirements to allow affected entities some
flexibility in meeting them. 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 resulted in a negative impact on offshore production
sites, the requirements help to ensure that future nursery shipments
entering the United States are free of R. solanacearum R3B2. The 2003
R. solanacearum R3B2 outbreak alone cost the floriculture industry $1.5
to $2 million in geranium plant losses. The R. solanacearum R3B2
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.\16\ It is
evident that the benefits of certifying offshore production sites that
produce Pelargonium spp. and Solanum spp. outweigh the costs.
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\16\ 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.
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, the interim rule amending 7 CFR part 319 that was
published at 69 FR 21941-21947 on April 23, 2004, is adopted as a final
rule with the following changes:
PART 319--FOREIGN QUARANTINE NOTICES
0
1. The authority citation for part 319 is revised 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 319.37-5 is amended as follows:
0
a. By revising paragraph (r), introductory text, to read as set forth
below.
0
b. By revising paragraph (r)(2) to read as set forth below.
0
c. In paragraph (r)(3), in the introductory text, by adding the words
``or area'' after the word ``country.''
0
d. By revising the second sentence of paragraph (r)(3)(iii) to read as
set forth below.
0
e. By revising paragraphs (r)(3)(iv) and (r)(3)(v) to read as set forth
below.
0
f. In paragraph (r)(3)(vii), by removing the words ``must not come in
contact with soil, and soil may not be used as a growing medium'' and
adding the words ``must not come in contact with growing media that
could transmit R. solanacearum race 3 biovar 2 and must be grown in an
APHIS-approved growing medium'' in their place.
0
g. In paragraph (r)(3)(xii), by removing the word ``presence'' and
adding the word ``introduction'' in its place.
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 requirements of this paragraph (r). Seeds are not
subject to the requirements of this paragraph (r).
(1) * * *
(2) (i) 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 or area 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
[[Page 61362]]
requirements of paragraph (r)(1) of this section.
(ii) 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 an area that has been established as free of Ralstonia
solanacearum race 3 biovar 2 in accordance with International Standards
for Phytosanitary Measures Publication No. 4, ``Requirements for the
Establishment of Pest Free Areas,'' which is incorporated by reference
at Sec. 300.5 of this chapter, the phytosanitary certificate required
by Sec. 319.37-4 must contain an additional declaration that states
``This article is from an area that has been established as free of
Ralstonia solanacearum race 3 biovar 2.''
(3) * * *
(iii) * * * Only articles of Pelargonium spp. and Solanum spp. from
a group of articles that has been tested according to an APHIS-approved
testing protocol with negative results for the presence of R.
solanacearum race 3 biovar 2 may be used in production and export. * *
*
(iv) Each greenhouse on the production site must be constructed in
a manner that ensures that runoff water from areas surrounding the
greenhouses cannot enter the greenhouses. The greenhouses must be
surrounded by a 1-meter buffer that is sloped so that water drains away
from the greenhouses.
(v) Dicotyledonous weeds must be controlled both within each
greenhouse on the production site and around it. The greenhouses on the
production site and the 1-meter buffer surrounding them must be free of
dicotyledonous weeds.
* * * * *
Done in Washington, DC, this 18th day of October 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 05-21168 Filed 10-21-05; 8:45 am]
BILLING CODE 3410-34-P