Certification Program for Imported Articles of Pelargonium, 61351-61362 [05-21168]
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Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Rules and Regulations
List of Subjects in 7 CFR Part 301
Agricultural commodities, Plant
diseases and pests, Quarantine,
Reporting and recordkeeping
requirements, Transportation.
I Accordingly, we are amending 7 CFR
part 301 as follows:
PART 301—DOMESTIC QUARANTINE
NOTICES
1. The authority citation for part 301
continues to read as follows:
I
2. In § 301.51–3, paragraph (c), under
the heading New Jersey, the entry for
Hudson County is removed and the
entry for Middlesex and Union Counties
is revised to read as follows:
I
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Quarantined areas.
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(c) * * *
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13:23 Oct 21, 2005
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Final rule.
AGENCY:
New Jersey
Middlesex and Union Counties. That
portion of the counties bounded by a
line drawn as follows: Beginning at the
intersection of St. Georges Avenue and
Wood Avenue; then east on Wood
Avenue to Curtis Street; then north on
Curtis Street to East Baltimore Avenue;
then east on East Baltimore Avenue to
Dill Avenue; then north on Dill Avenue
to Grant Street; then southeast on Grant
Street to Alberta Avenue; then northeast
on Alberta Avenue to County Road 616
(Park Avenue); then southeast on
County Road 616 (Park Avenue) to U.S.
Route 1; then north on U.S. Route 1 to
Allen Street; then southeast on Allen
Street to the east side of the New Jersey
Turnpike right-of-way; then south along
the east side of the New Jersey Turnpike
right-of-way to Marshes Creek; then
southeast along Marshes Creek to the
Rahway River; then west along the
south side of the Rahway River to Cross
Creek; then south along Cross Creek
through the wetlands to Peter J. Sica
Industrial Drive; then east and south on
Peter J. Sica Industrial Drive to
Roosevelt Avenue (State Route 602);
then west on Roosevelt Avenue to Port
Reading Avenue (State Route 604); then
west southwest on Port Reading Avenue
to the Conrail railroad; then north and
west along the Conrail railroad right-ofway to the NJ Transit railroad right-ofway; then north and northwest along the
NJ Transit railroad right-of-way to the
south branch of the Rahway River; then
VerDate Aug<31>2005
Done in Washington, DC, this 18th day of
October 2005.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 05–21169 Filed 10–21–05; 8:45 am]
BILLING CODE 3410–34–P
Authority: 7 U.S.C. 7701–7772 and 7781–
7786; 7 CFR 2.22, 2.80, and 371.3.
Section 301.75–15 also issued under Sec.
204, Title II, Pub. L. 106–113, 113 Stat.
1501A–293; sections 301.75–15 and 301.75–
16 also issued under Sec. 203, Title II, Pub.
L. 106–224, 114 Stat. 400 (7 U.S.C. 1421
note).
§ 301.51–3
west along the south branch of the
Rahway River to St. Georges Avenue;
then north on St. Georges Avenue to the
point of beginning.
*
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Jkt 208001
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:
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October 24, 2005.
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61351
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:
FOR FURTHER INFORMATION CONTACT:
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,’’
§§ 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 § 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.
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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
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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
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
1 This document may be viewed on the Internet
at https://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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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.
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
2 The Minimum Sanitation Protocols for Offshore
Geranium Cutting Production may be viewed on the
Internet at https://www.aphis.usda.gov/ppq/ep/
ralstonia/ralstoniaworkplan.pdf.
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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 https://www.aphis.usda.gov
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13:23 Oct 21, 2005
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/ppq/ep/ralstonia/. 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.
In response to the second
commenter’s assertion, the bacterium
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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61353
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 runoff 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
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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
§ 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 § 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 § 319.37–5(r)’’ and ‘‘Solanum spp.
not meeting the conditions for
importation in § 319.37–5(r)’’ in the
table of prohibited articles in § 319.37–
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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 § 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
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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
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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
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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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.
• 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.
• 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.
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
5 Hudelson, B.D. 1999. ‘‘Southern wilt.’’
University of Wisconsin Garden Facts, May 11,
1999.
6 Nameth, S. 1999. ‘‘Bacterial disease alert in
geraniums.’’ FlowerTECH2 4: 65–67.
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.
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61355
disputing the existing evidence, we will
evaluate it and, if necessary, update the
regulations.
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, Ganaderıa, Desarrollo
´
Rural, Pesca y Alimentacion 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
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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
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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.
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 § 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)
8 ISPM publications can be viewed on the Internet
at https://www.ippc.int/id/13399.
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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 pestfree status by submitting the
information required by ISPM
Publication No. 4 to APHIS for further
evaluation as described above.
Otherwise, UK growers should request
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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
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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
§ 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
One commenter stated that this
definition might cause confusion with
regard to some of the requirements of
the certification program. For example,
§ 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 1meter 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 § 319.37–
9 ISPM publications can be viewed on the Internet
at https://www.ippc.int/id/13399.
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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 § 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
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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
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13:23 Oct 21, 2005
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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 ebband-flow irrigation in the production of
articles of Pelargonium spp. and
Solanum spp. under the certification
program. We prohibited the use of ebband-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
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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
§ 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.
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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
§ 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
§ 319.37–5 and all salaries (including
overtime and the Federal share of
employee benefits), travel expenses
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13:23 Oct 21, 2005
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(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 § 319.56–
2cc, or importing Hass avocados from
Mexico under § 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
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61359
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
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Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Rules and Regulations
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
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13:23 Oct 21, 2005
Jkt 208001
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
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Fmt 4700
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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.
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.
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;
10 Society
of American Florists.
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.
11 Electronic
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Federal Register / Vol. 70, No. 204 / Monday, October 24, 2005 / Rules and Regulations
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.
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.
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 § 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
13 National Agricultural Statistical Service
(NASS) data on U.S. potato production, 2002;
Foreign Agricultural Service data on potato exports,
2002.
14 British Department of Environment, Food and
Rural Affairs, Service Delivery Unit, Plant Health
Division.
15 NASS, Agricultural Statistics Board, U.S.
Department of Agriculture, 2001 Floriculture Crops.
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13:23 Oct 21, 2005
Jkt 208001
as small due to the $250,000
discrepancy.
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.
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.
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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61361
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:
I
PART 319—FOREIGN QUARANTINE
NOTICES
1. The authority citation for part 319
is revised to read as follows:
I
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.
2. Section 319.37–5 is amended as
follows:
I a. By revising paragraph (r),
introductory text, to read as set forth
below.
I b. By revising paragraph (r)(2) to read
as set forth below.
I c. In paragraph (r)(3), in the
introductory text, by adding the words
‘‘or area’’ after the word ‘‘country.’’
I d. By revising the second sentence of
paragraph (r)(3)(iii) to read as set forth
below.
I e. By revising paragraphs (r)(3)(iv) and
(r)(3)(v) to read as set forth below.
I 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.
I g. In paragraph (r)(3)(xii), by removing
the word ‘‘presence’’ and adding the
word ‘‘introduction’’ in its place.
I
§ 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
§ 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
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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
§ 300.5 of this chapter, the
phytosanitary certificate required by
§ 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 1meter 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
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13:23 Oct 21, 2005
Jkt 208001
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 71
Docket No. FAA–2005–22047; Airspace
Docket No. 05-ANM–10
RIN 2120–AA66
Revision of VOR Federal Airway V–
343; MT
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
AGENCY:
SUMMARY: This action extends Federal
Airway V–343 from the Bozeman, MT,
Very High Frequency Omni-directional
Range/Tactical Air Navigation
(VORTAC) to the initial approach fix for
the Area Navigation (RNAV) runway 15
approach to the Bert Mooney Airport
(BTM), MT. Specifically, this action will
enhance the management of air traffic
arrivals at BTM.
EFFECTIVE DATE: 0901 UTC, December
22, 2005.
FOR FURTHER INFORMATION CONTACT: Ken
McElroy, Airspace and Rules, Office of
System Operations Airspace and AIM,
Federal Aviation Administration, 800
Independence Avenue, SW.,
Washington, DC 20591; telephone: (202)
267–8783.
SUPPLEMENTARY INFORMATION:
Background
On August 23, 2005, the FAA
published in the Federal Register a
notice of proposed rulemaking (NPRM)
to revise VOR Federal Airway V–343 by
extending the airway to the initial
approach for the BTM airport (70 FR
49222). Interested parties were invited
to participate in this rulemaking effort
by submitting written comments on the
proposal. No comments were received.
With the exception of editorial changes,
this amendment is the same as that
published in the NPRM.
The Rule
This action amends Title 14 Code of
Federal Regulations (14 CFR) part 71 to
revise VOR Federal Airway V–343 by
extending the airway from the Bozeman,
MT, VORTAC to the initial approach fix
for the RNAV runway 15 approach to
the BTM, MT.
Domestic VOR Federal airways are
published in paragraph 6010(a) of FAA
Order 7400.9N dated September 1, 2005,
and effective September 15, 2005, which
is incorporated by reference in 14 CFR
71.1. The Federal airways listed in this
document will be published
subsequently in the order.
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. Therefore, this regulation: (1) Is
not a ‘‘significant regulatory action’’
under Executive Order 12866; (2) is not
a ‘‘significant rule’’ under Department of
Transportation (DOT) Regulatory
Policies and Procedures (44 FR 11034;
February 26, 1979); and (3) does not
warrant preparation of a regulatory
evaluation as the anticipated impact is
so minimal. Since this is a routine
matter that will only affect air traffic
procedures and air navigation, it is
certified that this rule, when
promulgated, will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
Adoption of the Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
I
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for part 71
continues to read as follows:
I
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.9N,
Airspace Designations and Reporting
Points, dated September 1, 2005, and
effective September 15, 2005, is
amended as follows:
I
Paragraph 6010(a)
Airways.
*
*
*
Domestic VOR Federal
*
*
V–343 [Revised]
From Dubios, ID; Bozeman, MT, INT
Bozeman, MT, 302° and Whitehall, MT, 342°
Radials.
*
*
*
*
*
Issued in Washington, DC, October 17,
2005.
Edith V. Parish,
Acting Manager, Airspace and Rules.
[FR Doc. 05–21144 Filed 10–21–05; 8:45 am]
BILLING CODE 4910–13–P
E:\FR\FM\24OCR1.SGM
24OCR1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\1\ This document may be viewed on the Internet at https://
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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\ The Minimum Sanitation Protocols for Offshore Geranium
Cutting Production may be viewed on the Internet at https://
www.aphis.usda.gov/ppq/ep/ralstonia/ralstoniaworkplan.pdf.
---------------------------------------------------------------------------
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 https://www.aphis.usda.gov
/ppq/ep/ralstonia/. 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\5\ Hudelson, B.D. 1999. ``Southern wilt.'' University of
Wisconsin Garden Facts, May 11, 1999.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\6\ Nameth, S. 1999. ``Bacterial disease alert in geraniums.''
FlowerTECH2 4: 65-67.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
\8\ ISPM publications can be viewed on the Internet at https://
www.ippc.int/id/13399.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\9\ ISPM publications can be viewed on the Internet at https://
www.ippc.int/id/13399.
---------------------------------------------------------------------------
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 tha