[Federal Register Volume 69, Number 87 (Wednesday, May 5, 2004)]
[Rules and Regulations]
[Pages 24916-24936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-10067]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 319
[Docket No. 98-035-5]
RIN 0579-AB75
Importation of Orchids of the Genus Phalaenopsis From Taiwan in
Growing Media
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations governing the importation of
plants and plant products to add orchids of the genus Phalaenopsis from
Taiwan to the list of plants that may be imported in an approved
growing medium subject to specified growing, inspection, and
certification requirements. We are taking this action in response to a
request by Taiwan and after determining that Phalaenopsis spp. plants
established in growing media can be imported without resulting in the
introduction into the United States or the dissemination within the
United States of a plant pest or noxious weed.
EFFECTIVE DATE: June 4, 2004.
FOR FURTHER INFORMATION CONTACT: Mr. William Thomas, Import Specialist,
Phytosanitary Issues Management, PPQ, APHIS, 4700 River Road Unit 140,
Riverdale, MD 20737-1236; (301) 734-6799.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 7 CFR part 319 prohibit or restrict the
importation into the United States of certain plants and plant products
to prevent the introduction of plant pests and noxious weeds. The
regulations 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 or Quarantine 37) contain, among
other things, prohibitions and restrictions on the importation of
plants, plant parts, and seeds for propagation.
The regulations in Quarantine 37 currently allow the importation of
orchids from all countries of the world, provided that the plants are
(1) free of sand, soil, earth, and other growing media, (2) accompanied
by phytosanitary certificate of inspection, (3) imported under a permit
issued by the Animal and Plant Health Inspection Service (APHIS), and
(4) imported into a Federal plant inspection station listed in Sec.
319.37-14(b), where they are subject to inspection by APHIS. Such
plants are imported bare-rooted into the United States, and are rooted
and potted for sale by U.S. nurseries.
On September 1, 1998, we published in the Federal Register (63 FR
46403-46406, Docket No. 98-035-1) a proposal to amend the regulations
by allowing the importation of orchids of the genus Phalaenopsis
established in an approved growing medium, subject to specified
growing, inspection, and certification requirements. We proposed this
action in response to a request from Taiwan and after determining that
the degree of pest risk posed by these plants is no greater than the
pest risk associated with the importation of bare-rooted Phalaenopsis
spp. orchids, which may already be imported under the regulations. We
accepted comments on our proposal for a total of 90 days, ending
December 1, 1998.\1\
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\1\ The comment period on the proposed rule was extended from 60
to 90 days in a notice published in the Federal Register on October
29, 1998 (63 FR 57932, Docket 98-035-02).
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In response to comments received on the proposed rule (discussed in
detail later in this document), APHIS narrowed the application of the
rule to Phalaenopsis spp. orchids from Taiwan and entered into
consultation with the U.S. Fish and Wildlife Service (FWS) to assess
the potential effects of the proposed action on endangered or
threatened species, as required under section 7 of the Endangered
Species Act of 1973, as amended (16 U.S.C. 1531 et seq.). On April 7,
2003, FWS concluded the section 7 consultation process by concurring
with APHIS's determination that the importation of Phalaenopsis spp.
orchids from Taiwan in growing media will not adversely affect
federally listed or proposed endangered or threatened species or their
habitats. The section 7 consultation for this rule is described later
in this document.
Upon receiving concurrence from FWS, APHIS completed an
environmental assessment in accordance with: (1) The National
Environmental Policy Act of 1969, as amended (NEPA) (42 U.S.C. 4321 et
seq.), (2) regulations of the Council on Environmental Quality for
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4)
APHIS's NEPA Implementing Procedures (7 CFR part 372). On May 9, 2003,
we published in the Federal Register (68 FR 24915, Docket No. 98-035-3)
a notice announcing the availability of the environmental assessment,
and solicited comments on the environmental assessment for 30 days
ending June 9, 2003. On June 11, 2003, we published in the Federal
Register (68 FR 34898-37899, Docket No. 98-035-4) another notice that
extended the comment period on the environmental assessment for an
additional 30 days ending July 9, 2003.
2003 Risk Analysis
Also in response to public comments, APHIS updated the risk
assessment that was prepared in support of this rulemaking action. The
original risk assessment, referred to elsewhere in this document as the
1997 risk assessment, identified pests that are known to be associated
with Phalaenopsis spp. plants in Taiwan and assessed the risk posed by
those pests in the absence of the mitigative effects of the
requirements of Sec. 319.37-8(e), which are designed to establish and
maintain a pest-free production environment and ensure the use of pest-
free seeds or parent plants. However, as noted by commenters, the 1997
risk assessment did not contain a thorough description of how the
mitigation measures required under the regulations in Sec. 319.37-8(e)
reduce the risk posed by the specific quarantine pests of Phalaenopsis
spp. orchids that were identified in the risk assessment. Because the
original risk assessment was prepared in April 1997, APHIS believes it
was appropriate to update the risk document that supported this rule in
several ways in order to address commenters' concerns regarding its
adequacy. These changes were necessary to provide the most transparent
communication of risk possible at this time.
First, we revised the 1997 risk assessment to bring it up to date
with current APHIS guidelines for pathway-initiated risk assessments.
As a result of this update, some of the risk ratings that were
identified in the 1997 risk assessment have changed.\2\ These changes
are a result of the fact that the new risk assessment guidelines employ
the use of a different risk rating system
[[Page 24917]]
that was not used by APHIS at the time the 1997 risk assessment was
drafted. Using the current guidelines, the individual risk elements
that compose the overall estimated consequences and likelihood of
introduction associated with the importation of the commodity are
assigned a rating of low (1 point), medium (2 points), or high (3
points) for each known quarantine pest. Cumulative risk values for
consequences and likelihood of introduction are then calculated by a
summation of their component risk estimates, and the overall pest risk
potential posed by the identified pests is calculated by adding
together the ratings for consequences and likelihood of introduction
for each pest. The interpretation scale was modified based on agency
experience with other importations, and a ``risk score'' is no longer
used. Instead, descriptions of pest biology augment the presentation of
the risk ratings. For a detailed description of the current process,
please refer to APHIS's Guidelines for Pathway-Initiated Risk
Assessments.\3\
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\2\ In the 2003 risk analysis, the baseline pest risk potential
for 5 of the identified pests has been reassessed as ``medium''
rather than ``high.''
\3\ Version 5.02, available on the Internet at: http://www.aphis.usda.gov/ppq/pra/commodity/cpraguide.pdf.
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Next, we searched for any additional research and data published
since the 1997 risk assessment was prepared that could have a bearing
on the findings of the risk assessment and updated the document
accordingly. Specifically, the fungus Colletotrichum phalaenopsidis,
which was listed in the 1997 assessment as a quarantine significant
pest that could follow the Phalaenopsis spp. orchid import pathway, was
removed from further consideration because it has been synonymized with
(considered to be the same species as) C. gloeosporioides (Penz.),
which is widely distributed in the United States.
Finally, we added a substantial discussion of how the risk
mitigation measures contained in Sec. 319.37-8(e) mitigate the risks
posed by the six quarantine pests that were identified as likely to
follow the commodity import pathway. This part of the analysis is
referred to as ``risk management,'' and is contained in part III of the
revised risk document. Note that, due to the addition of risk
management to the risk document, we now refer to the document as a
``risk analysis.'' Risk analysis is the combined product of risk
assessment (an analysis of pests associated with the commodity) and
risk management (an analysis of the effectiveness of the measures
chosen in mitigating the risk posed by the pests identified in the risk
assessment). The revised risk analysis, ``Risk Analysis of the
Importation of Moth Orchid, Phalaenopsis spp. Plants in Approved
Growing Media From Taiwan into the United States,'' was completed May
6, 2003. The revised risk analysis is referred to throughout this
document as the 2003 risk analysis, and is available on the Internet at
http://www.aphis.usda.gov/ppq/pim/.
Determination by the Secretary
In this document, APHIS is adopting its proposal to allow the
importation of orchids of the genus Phalaenopsis established in an
approved growing medium as a final rule, with the changes discussed in
this document. Specifically, we are allowing the importation of
Phalaenopsis spp. plants in growing media from Taiwan only.
Under Sec. 412(a) of the Plant Protection Act, the Secretary of
Agriculture may prohibit or restrict the importation and entry of any
plant or plant product if the Secretary determines that the prohibition
or restriction is necessary to prevent the introduction into the United
States or the dissemination within the United States of a plant pest or
noxious weed.
The Secretary has determined that it is not necessary to prohibit
the importation of orchids of the genus Phalaenopsis from Taiwan that
are established in an approved growing medium in order to prevent the
introduction into the United States or the dissemination within the
United States of a plant pest or noxious weed. This determination is
based on the findings of the risk documents referred to earlier in this
document, and the Secretary's judgment that the application of the
measures required under Sec. 319.37-8(e) will prevent the introduction
or dissemination of plant pests into the United States.
Regulatory Requirements
Under this final rule, Phalaenopsis spp. plants imported in growing
media are subject to the requirements of Sec. 319.37-8(e), which:
Specifies the types of growing media that may be used;
Requires plants to be grown in accordance with written
agreements between APHIS and the plant protection service of the
country where the plants are grown and between the foreign plant
protection service and the grower;
Requires the plants to be rooted and grown in a greenhouse
that meets certain requirements for pest exclusion and that is used
only for plants being grown in compliance with Sec. 319.37-8(e);
Restricts the source of the seeds or parent plants used to
produce the plants, and requires grow-out or treatment of parent plants
imported into the exporting country from another country;
Specifies the sources of water that may be used on the
plants, the height of the benches on which the plants must be grown,
and the conditions under which the plants must be stored and packaged;
and
Requires that the plants be inspected in the greenhouse
and found free of evidence of plant pests no more than 30 days prior to
the exportation of the plants.
A phytosanitary certificate issued by the plant protection service
of the country in which the plants were grown that declares that the
above conditions have been met must accompany the plants at the time of
importation. These conditions have been used successfully to mitigate
the risk of pest introduction associated with the importation into the
United States of approved plants established in growing media.
Discussion of Public Comments on the Proposed Rule
We received 40 comments on the proposed rule by the close of the
comment period. The comments were from orchid growers and sellers,
Members of Congress, farm bureaus, Federal and State government agency
representatives, university researchers, agricultural research
scientists, and orchid, nursery, landscape, and floriculture
associations and societies. Thirty-five of the commenters opposed some
aspect of the rule, and the remaining five requested that APHIS extend
the comment period on the proposal, which we did, for 30 days (see 63
FR 57932). The comments are discussed below, by topic.
We also received a letter from the Small Business Administration
(SBA) regarding our proposal, which we considered along with public
comments received by the close of the comment period. Several issues
raised by SBA were also raised by other commenters; therefore, we
discuss all comments, including the SBA letter, below.
We also received 19 comments in response to our May 2003 notice of
the availability of the environmental assessment. Many of those
comments pertain to the 2003 risk analysis or to the proposed rule for
this action. Comments that pertained to the environmental assessment
are addressed in the final environmental assessment, and the
accompanying finding of no significant impact, which may be viewed on
the Internet at http://www.aphis.usda.gov/ppd/es/ppqdocs.html. Comments
that pertained
[[Page 24918]]
to the 2003 risk analysis or the proposed rule are addressed below,
along with comments submitted during the comment period for the
proposed rule.
Availability of Resources and Verification of Compliance
One commenter stated that due to budget cuts and downsizing in
Federal agencies, it is unclear whether APHIS can continue to conduct
adequate inspections, especially in the face of an increase in the
amount of plant material entering the United States.
While some Federal agencies have been subject to budget cuts and
downsizing, APHIS's appropriated funding for Agricultural Quarantine
Inspection (AQI) Programs has doubled since 1998, from approximately
$27.2 million to $55 million in 2002. Funds collected via AQI user fees
have increased from $140.5 million in 1998 to $260 million in 2002. The
inspections required under this rule will not be affected by the
transfer of APHIS personnel to the Department of Homeland Security
(DHS). All plants imported under this rule are required to be imported
into Federal plant inspection stations,\4\ which continue to be staffed
by APHIS, not DHS, inspectors. APHIS has reviewed its resources and
believes it has adequate resources available to ensure compliance with
the conditions of the final rule.
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\4\ A list of Federal plant inspection stations is contained in
7 CFR 319.37-14(b).
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One commenter stated that the conditions imposed by Sec. 319.37-8
cannot be verified by APHIS because the cost of attempting to verify
compliance is a significant expense and would require an unprecedented
level of cooperation from other governments and their agencies, many of
whom are ill-equipped to do their jobs or may be influenced by corrupt
elements. The commenters stated that if APHIS does not physically
conduct the reviews required by the regulations, the Agency must
demand, receive, and review documentation from the exporting country
and its growers that is sufficient to satisfy the Agency that the
conditions of Sec. 319.37-8 have been complied with.
Under the regulations in Sec. 319.37-8, there must be an agreement
between APHIS and a foreign entity for enforcement of the regulations
in that section. In this case, the agreement will technically be
between the American Institute in Taiwan and the Taiwanese Economic and
Cultural Representative's Office, and will involve the plant protection
organization of Taiwan and APHIS (this agreement is referred to
elsewhere in this document as ``U.S.-Taiwan agreement''). Each grower
who wishes to export to the United States under the regulations must
enter into an agreement with the plant protection organization of
Taiwan whereby he or she must agree to comply with the provisions of
the regulations in Sec. 319.37-8 and to allow APHIS inspectors, and
representatives of Taiwan's plant protection organization, access to
the growing facility as necessary to monitor compliance with the
provisions of that section. Taiwan's plant protection organization is
responsible for ongoing oversight of the program. APHIS inspectors will
monitor for compliance with the regulations by making periodic visits
to production sites, as is the case with current and past plants in
growing media programs, such as the following:
In the Netherlands, two to four greenhouses (companies)
have participated in the plants in growing media program each year
since 1990. Both ferns and Anthurium have been grown and exported to
the United States. Currently, three greenhouses are in the program.
APHIS plant health specialists inspect the greenhouses 4 to 12 times a
year for noncompliance with program requirements, including the absence
of plant pests. No greenhouses have been found to be noncompliant and
no plant pests have been found on any of these visits.
In Israel, one greenhouse growing ferns and African
violets participated in the plants in growing media program between
1990 and 1994. This facility was inspected by APHIS plant health
specialists three to five times a year. Again, no greenhouses were
found to be noncompliant and no plant pests were found.
Based on our experience with these programs, we are confident that
the safeguards work, and that we can verify compliance regularly.
One commenter stated that, under Sec. 319.37-8(g)(4)(ii),
sufficient APHIS resources must be available to implement or ensure
implementation of appropriate mitigation measures. The commenter cited
a report by the U.S. General Accounting Office (GAO) that APHIS is
unable to determine the extent to which its inspection programs
actually work. The commenter posited that, given the GAO report, APHIS
is unable to determine the extent to which its inspection programs
actually work, and therefore, cannot determine that sufficient APHIS
resources are available to implement or ensure implementation of the
appropriate mitigation measures.
The portion of the GAO report cited by the commenter (GAO report
RCED-97-102) deals primarily with issues surrounding the allocation of
APHIS inspectors at ports in the United States according to risk-based
criteria. The report acknowledges that ``APHIS faces a difficult
mission'' in ensuring that tons of cargo and millions of passengers
entering the United States do not bring in harmful pests or diseases,
and found that APHIS should ``allocate its limited inspection resources
to the ports of entry with the highest risks of pest and disease
introduction.'' These findings should not be construed to mean that
APHIS ``is unable to determine the extent to which its inspection
programs actually work.'' As stated earlier in this document, APHIS has
reviewed its resources and believes it has adequate resources available
to ensure compliance with the conditions of the final rule.
One commenter expressed concern that Taiwan will receive plants
moved from China, relabel them, and ship them directly to the United
States.
The regulations require that the plant protection organization of
Taiwan ensure that the plants exported to the United States meet the
requirements contained in Sec. 319.37-8(e). It is in an exporting
country's interest to ensure that the requirements of importing
countries are strictly followed. If falsified documentation is
discovered, it could impact severely on the exporter, and possibly the
exporting country's plant protection service, and could result in the
loss of export markets.
One commenter questioned what will happen if parties are caught out
of compliance, including in the event of pest-or disease-infested
shipments.
If APHIS determines that Phalaenopsis spp. orchids imported from
Taiwan in growing media contain quarantine or actionable pests, APHIS
may hold all imports until an investigation can be completed and
appropriate measures initiated, including stopping imports from a
specific producer or shutting down the entire program, if the
circumstances show that such an action is warranted.
Trade and Equivalence
One commenter expressed concern that APHIS's pest prevention
mission is being compromised in favor of trade facilitation, and stated
that the proposed action appears to be linked in trade negotiations
that resulted in agreements for U.S. exports of other commodities.
APHIS makes decisions as to whether to allow the importation of
agricultural products and commodities based on an evaluation of facts,
data, and available scientific evidence. While the order of processing
particular requests may be
[[Page 24919]]
influenced by trade considerations, and the components of a risk
management program may be a product of negotiations between APHIS and
its foreign counterparts, the ultimate determination as to whether a
commodity can be safely imported is based on a determination that the
product can be imported without introducing a plant pest or noxious
weed into the United States.
One commenter stated that U.S. producers should have equivalent
access to the export market, and claimed that producers have
considerable difficulty exporting, even within the NAFTA region. The
commenter claimed that adoption of the proposed rule would make the
``playing field'' even less level. Another commenter stated that there
is no indication whatsoever that reciprocal arrangements with Taiwan or
any other country are anticipated, and that no nation should be allowed
to export to the United States without U.S. growers being able to
export plants back under the same conditions.
Other countries make decisions as to whether to allow the
importation of U.S. products only when formally requested. If U.S.
producers of orchids wish to export to other countries, those persons
may submit a request to APHIS, and APHIS will take that request to the
appropriate country's plant protection organization for their
consideration. Upon receipt of a request, APHIS may contact the
requestor and ask for additional information prior to making a proposal
to the designated export country.
In any case, measures applied to mitigate the risk posed by a
particular plant or plant part exported from one country to another are
determined by the particular risks posed in each case. Because of
climatic conditions and other factors, the risks posed to Taiwan by
Phalaenopsis spp. orchid imports from the United States are not likely
the same risks posed by imports of Taiwan-grown Phalaenopsis spp.
orchids into the United States. The risk posed by imported plants is
dependent on the pests associated with the commodity in the country of
origin and the pests' potential impact on the importing country. As
such, reciprocal trade could occur under the same phytosanitary
conditions if the pest dynamics in each country are the same.
One commenter questioned whether other countries could make a
similar request to import other potted orchids that are now grown in
the United States, provided the countries meet APHIS's sanitary and
certification standards.
Any country may request that APHIS consider allowing the
importation of a new commodity. Whether APHIS grants that request is
tied to the findings of a risk analysis and a determination by the
Secretary of Agriculture as to whether the commodity can be imported
without resulting in the introduction into the United States or the
dissemination within the United States of a plant pest or noxious weed.
One commenter questioned whether APHIS is obliged to grant every
request to import an agricultural commodity into the United States as
long as it is pest-free and will benefit the American consumer, without
regard to the effects on small, minority- or family-operated businesses
in the United States.
APHIS is bound by Federal statutes and executive orders that
require us to consider the economic effects of our actions, as well as
to identify and assess the costs and benefits of regulatory
alternatives, including alternatives that reduce economic effects on
small entities. However, pursuant to Sec. 7701(3) of the PPA, APHIS
regulates exports, imports, and interstate commerce in agricultural
products and other commodities that pose a risk of harboring plant
pests or noxious weeds in ways that will reduce, to the extent
practicable, as determined by the Secretary, the risk of dissemination
of plant pests or noxious weeds. The determination to allow an import
under the PPA is based on the Secretary's determination that the
importation of a commodity will not result in the introduction into or
dissemination within the United States of a plant pest or noxious weed.
One commenter stated that APHIS is not acting in accordance with
its mission by ``enhancing the competitive positions of the countries
currently exporting orchids to the United States.'' The commenter
stated that, instead of being concerned for the well-being of foreign
interests, APHIS should work to enhance the competitiveness of U.S.
businesses.
The quote cited by the commenter is taken from APHIS's initial
regulatory flexibility analysis (IRFA), which is contained in the
proposed rule. The IRFA identifies the economic effects that could be
associated with adoption of the proposed rule, but the text cited is
not part of APHIS's rationale for making the proposal; rather, it was
considered as a possible consequence of adopting this rule. As stated
earlier in this document, the Secretary considers many factors in
making a determination to allow the import of a previously prohibited
article, such as potential environmental effects and the economic
effects associated with the introduction of a plant pest or noxious
weed. The determination to allow an import under the PPA, however, is
ultimately based on the Secretary's determination that the importation
of a commodity will not result in the introduction into or
dissemination within the United States of a plant pest or noxious weed.
This approach is consistent with APHIS's obligations under the PPA and
international trade agreements.
Part of APHIS's mission is to facilitate exports, and we strive to
do so. Success in this area is somewhat tied to factors out of our
control, but we make every effort to assist domestic industry in
securing access to export markets.
One commenter stated that imports should have to meet the same
standards as U.S. products, including growing conditions, pest freedom,
pesticides applied, etc. The commenter stated that the proposed rule
would allow the importation of orchid plants subject to fewer
restrictions than apply to interstate shipments.
We are unclear as to what standards the commenter refers. There are
no Federal restrictions on the interstate movement of orchids, and as
such, there are no specific ``standards'' that apply to how they are
grown or shipped. Phalaenopsis spp. plants imported from Taiwan in
growing media would have to meet the strict phytosanitary conditions
contained in Sec. 319.37-8(e), while domestically produced orchids are
not subject to any Federal regulation whatsoever. While individual
producers may adopt specific standards for how their plants are
produced, and individual States may impose requirements that apply to
the intrastate movement of plants, those standards are not Federal
standards, are not applicable in every State, and cannot be applied to
plants being imported into the United States.
Risk Assessment
General
Several commenters stated that because the 1997 risk assessment
only considered the importation of orchids from Taiwan, it cannot be
used to evaluate the risks associated with importation of orchids from
any other area, as APHIS proposed. The commenters noted that pests and
pathogens are not the same from country to country, and that a pest
risk assessment and management strategy for Phalaenopsis spp. orchids
is needed for each exporting country.
We agree with the commenter's statement. In this final rule, we are
only authorizing the importation of
[[Page 24920]]
Phalaenopsis spp. orchids in approved growing media from Taiwan--the
region considered in the 1997 risk assessment and the 2003 risk
analysis.
One commenter stated that APHIS should reexamine its 1997 pest risk
assessment, analysis procedures, and policies to ensure that they are
consistent with current levels of scientific knowledge and standards.
The commenter stated that the 1997 risk assessment should form ``a link
between scientific data and decision makers,'' but also that
decisionmakers must have accurate and adequate scientific data upon
which to base their decisions--which, the commenter argued, is not the
case in this rulemaking. The commenter further claimed that the risk
assessors' conclusion is simply an opinion--one not supported by any
scientific rigor--and does not even appear to have been used by the
decisionmakers.
As noted elsewhere in this document, we have updated the 1997 risk
assessment to bring it up to current standards. This update included
(1) inserting the data from the 1997 risk assessment into the risk
assessment document format currently used by APHIS, (2) searching for
additional research and data published since the 1997 risk assessment
was prepared that could have a bearing on the findings of the risk
analysis, and (3) adding a substantial discussion of how the risk
mitigation measures selected reduce the risk posed by quarantine pests
of Phalaenopsis spp. orchids that can be expected to follow the import
pathway. We believe that by making the link between the identified
quarantine pests and the mitigation measures more apparent, we have
addressed the commenter's concern about the need for a link between
scientific data and decisionmakers. The 2003 risk analysis is based on
the best data available to us at the time the analysis was drafted, and
it provides a clear and rational basis as to why Phalaenopsis spp.
orchids imported from Taiwan in growing media will not result in the
introduction of plant pests or noxious weeds into the United States.
Several commenters stated that the 1997 risk assessment should
incorporate a rigorous study of conditions and practices at foreign
nurseries and all existing inspection reports of imported bare-root
orchid plants. The commenters expressed concern that imports of
Phalaenopsis spp. orchids in growing media could result in the
introduction of new insects and diseases into the United States, and
stated that such pests would pose a grave threat to both indigenous
species and commercially cultivated plants.
The 1997 risk assessment and the risk assessment portion of the
2003 risk analysis are based on (1) a search of all available
scientific literature and (2) APHIS's pest interception records for
imported plants of the genus Phalaenopsis and the plant family
Orchidaceae. As such, we examined data on prior bare-root orchid
imports and visited some of the production sites that would export as a
result of the final rule. Furthermore, any exports of Phalaenopsis spp.
orchids by Taiwan would be contingent on an inspection of the
production sites by APHIS and the execution of the U.S-Taiwan agreement
described earlier in this document. We believe our 2003 risk analysis
provides an adequate analysis of the risks posed by quarantine pests,
and documents how the measures in Sec. 319.37-8(e) remove those pests
from the import pathway.
Several commenters stated that basing a risk assessment on a
literature search has some inherent weaknesses. One of the commenters
stated that literature searches do not catch all pests due to the fact
that pests have different common names, and because only the title
words of literature are searched. Several commenters also stated that
insufficient scientific literature and biological information regarding
orchid pests exists to justify reliance upon a literature search, as
orchids are not a major agricultural commodity and research has not
been conducted to the necessary depth for every pest on every orchid
species. Several commenters noted that orchids are a niche crop, and
that as such, have not had the extensive research that more widely
produced crops typically endure. One commenter stated that APHIS should
conduct field tests and preclearance surveys on the imported plants in
addition to a literature search. Another commenter claimed that the
risk potential for all the pest species identified may be high, yet due
to a lack of information, the potential effects of orchid importation
cannot be adequately addressed at this time. Another commenter stated
that the 1997 risk assessment may not consider all potential pests, and
therefore, the mitigation measures would also have to mitigate any risk
posed by unknown organisms. The commenter stated that the risk
mitigations are not designed to protect against all potential
unidentified pests.
The purpose of conducting an analysis of the risk posed by imported
agricultural commodities is to evaluate available scientific evidence
and to provide an evaluation of the risk associated with the
importation of those commodities. As such, APHIS can only make the
determination to allow the importation of the commodity based on the
current state of scientific knowledge. In developing the list of pests
that are analyzed in the 1997 risk assessment and 2003 risk analysis,
we began with a list of pests provided to us by Taiwan. We then
consulted applicable scientific literature (including field surveys
done to date) and reviewed APHIS's records to determine what pests were
intercepted on imported plants of the genus Phalaenopsis. Literature
searches are unique to each risk analysis, and typically begin with
broad searches of both abstracts of publications and the entire text of
publications, depending on the database being searched. These initial
searches typically use scientific species, genus, and family names, as
well as known common names of plants. As analysts learn more about the
pests involved and their nomenclature, additional pest-specific
searches are conducted.
We believe these sources provide an adequate means to identify and
assess pests of concern. Further, we disagree with commenters'
contentions that orchids are niche crops. While orchids may not be one
of the top-selling products in the entire floriculture industry, they
rate highly among other potted flowering plants, according to data
collected by the National Agricultural Statistics Service. (See http://www.usda.gov/nass/ for more information.)
While we do not believe there is a shortage of appropriate
scientific information in this specific case, if APHIS were to regulate
the trade of agricultural commodities based on the risk posed by
unknown factors, such an action could be viewed as highly arbitrary,
which could potentially affect the export markets for our own
domestically produced commodities. Under the PPA, APHIS protects
American agriculture while facilitating the trade of agricultural
commodities. There is always some uncertainty associated with the risk
posed by imported agricultural products, and if zero risk were the
standard applied, there would be no international trade in agricultural
products. While we can never be certain that our methods, regulations,
and policies will exclude pests 100 percent of the time, our goal is to
do just that, to the extent practicable. We are confident that the
measures required under this rule will reduce the risk posed by
Phalaenopsis spp. plants imported from Taiwan in approved growing
media. Our judgment is supported by the fact that bare-rooted
Phalaenopsis spp. plants and the growing media in which they will be
[[Page 24921]]
imported have separately been imported from throughout the world for
many years with no known associated pest problems. Given that the
plants in growing media will be subject to a number of additional
requirements (the effects of which are considered and evaluated in the
risk management section of the 2003 risk analysis) that do not apply to
bare-rooted plants, we believe that the risk posed by known and unknown
pests is appropriately reduced, to the extent practicable, by the
measures in Sec. 319.37-8(e).
One commenter claimed that a pest should have been included in the
pest list, but was not because it has multiple common names, including
``spiraling whitefly,'' ``keys whitefly,'' and ``spiral whitefly.''
While the commenter did not specify the scientific name of the
pest, we assume he is referring to Aleurodicus dispersus. There is no
available evidence to show that this pest attacks orchids in Taiwan.
Our process for searching for pests associated with a given commodity
is described earlier in this document.
One commenter stated that APHIS should reassess the role that the
propagative material pathway is playing in new pest introductions,
claiming that the U.S. nursery and greenhouse industry has suffered
from continuing pest incursions associated with plant material imports.
The commenter claimed that the current system associated with imported
propagative material is failing and that expanding the list of plant
material allowed entry established in growing media using as a baseline
the risk associated with bare-root materials--regardless of the
acceptability of that current risk--is reckless.
APHIS recognizes that the underlying structure of the regulations
for nursery stock and other propagative material are different from the
corresponding regulations for fruits and vegetables. Fruits and
vegetables are prohibited entry into the United States unless the
regulations specifically provide otherwise. In contrast, nursery stock
and other propagative plant material (except plants imported in growing
media) are allowed importation subject to inspection at a plant
inspection station unless the regulations specifically provide
otherwise. While APHIS conducts risk analyses in each case where the
importation of a new fruit or vegetable is proposed, risk analyses are
only conducted for nursery stock and propagative material in response
to a demonstrated pest problem or in response to a new request to
import plants in growing media. The regulations in Sec. 319.37-8(g)
currently provide that APHIS will allow the importation of plants in
growing media if it determines, using risk analysis, that the plants
pose the same or less risk than bare-rooted plants which are already
allowed importation under the current regulations in Quarantine 37. In
this case, restricting the entry of Phalaenopsis spp. orchids in
growing media is not necessary because the measures in Sec. 319.37-
8(e) reduce the risk posed by those plants to a level at or below that
of bare-root plants.
APHIS recognizes that there is a need to reconsider the underlying
structure of the nursery stock regulations in order to better address
the risk posed by propagative material and has been considering ways to
approach the issue for several years. We are in the process of drafting
an advanced notice of proposed rulemaking on the subject of revising
Quarantine 37; however, we are not able to provide a projected
publication date at this point.
One commenter expressed confusion as to why the title of the 1997
risk assessment indicates that seedlings are under consideration, yet
neither the body of the 1997 risk assessment nor proposed rule address
the distinction between seedlings and adult plants.
The reference to seedlings in the title of the 1997 risk assessment
was made in error. While Taiwan requested that we allow the importation
of Phalaenopsis spp. seedlings in growing media, the 1997 risk
assessment and 2003 risk analysis actually consider the risk posed by
all plants regardless of whether they were grown from seed or whether
they are a specific size or age.
One commenter stated that some of the pests identified in the 1997
risk assessment could affect other plants besides orchids and that
APHIS should have discussed potential effects on those species in the
proposed rule.
Risk analyses conducted by APHIS are designed to assess the risk of
introducing quarantine pests into the United States, regardless of the
domestic plants that can serve as hosts for those pests. The 1997 risk
assessment considered potential effects on other plants in its
estimates of consequences of introduction, as does the 2003 risk
analysis. We acknowledge that some pests attack other hosts besides
orchids; however, the Secretary's determination to allow the
importation of Phalaenopsis spp. orchids from Taiwan in growing media
was derived from the conclusions of the 2003 risk analysis, which shows
that importations of those plants will not result in the introduction
of pests into the United States.
One commenter stated that the importation of propagative material
presents different levels of risk than does trade in major food
commodity crops, which are well-studied. The commenter stated that more
is known about the pests associated with fruits and vegetables,
including those that are incidental, but that little is known about
crops such as orchids, and therefore, informed decisionmaking is not
possible. The commenter claimed that if a pest is allowed to enter and
become established, there may not be enough knowledge about its
background, enemies, physiology, hosts, and so on, to enable us to
control it quickly.
We agree with the commenter's statement that propagative material
presents different risks than do food commodities, primarily because of
the nature of the commodity. Pests associated with fruits and
vegetables can be the same species as those associated with propagative
plants. Nevertheless, as stated elsewhere in this document, we believe
there are sufficient data available to conclude that the importation of
Phalaenopsis spp. orchids in growing media from Taiwan will not result
in the introduction of plant pests into the United States.
One commenter stated that the 1997 risk assessment should consider
the risk posed by microbial species that may inhabit the growing media.
The commenter also claimed that all risk assessments must include
experiments on the genetic consequences on ``founder populations'' of
these alien species, as genetic changes and the evolution of new
recombinants as a result of small population size can be extremely
important in the ability of alien species to adapt to new habitats.
The 1997 risk assessment and 2003 risk analysis for this action
take into account all pests that are known to be associated with
Phalaenopsis spp. orchids, and consider the unique risk posed by the
plant imported in growing media. As stated elsewhere in this document,
determinations as to whether a new agricultural commodity can be safely
imported are based on the current state of knowledge and based on the
information available, there is no reason to believe that the
importation of Phalaenopsis spp. orchids in growing media from Taiwan
will result in the introduction of plant pests such as the commenter
has suggested (including microbial species). As such, we do not believe
the experiments suggested by the commenter are necessary.
One commenter stated that if pests are excluded from risk
mitigation because they are not expected to remain with the commodity
during harvest and
[[Page 24922]]
shipping, according to APHIS guidelines, references must be cited to
support the pest's inability to follow the pathway.
The risk assessments (1997 and 2003) for this action assume that
all known pests are expected to follow the pathway if risk mitigation
measures are not applied. However, most of the pests listed in table 2
of the 2003 risk analysis (table 1 of the 1997 risk assessment) are
excluded from further consideration because of two factors: (1) The
pests do not meet the Food and Agriculture Organization of United
Nations (FAO) definition of a ``quarantine pest'' for the United
States, or (2) the pests have not been specifically linked in
scientific literature or APHIS interception records with orchids of the
genus Phalaenopsis. This winnowing of the list of pests is documented
in detail in section E, ``Analysis of Quarantine Pests'' in the 2003
risk analysis.
One commenter stated that none of the conditions required by Sec.
319.37-8(e) address the risks presented by Phalaenopsis spp. orchids
that have flower spikes. The commenter noted that flower spikes
increase pest risk because they provide a habitat for thrips, blossom
mites, blossom midges, and other blossom-infesting organisms.
There are no quarantine pests of the types cited by the commenter
that have been specifically linked in scientific literature or APHIS
pest interception records with orchids of the genus Phalaenopsis.
Further, the operators of greenhouses in which plants imported under
the regulations in Sec. 319.37-8(e) are required to apply measures
necessary to eliminate pest infestation of plants being grown in an
approved greenhouse, including infestations by pests such as those
cited by the commenter. In the event that any such quarantine pests are
confirmed to be associated with Phalaenopsis spp. plants in the future
either in program greenhouses, in scientific literature, or via
inspections by APHIS, we would adopt revised conditions that address
the risk posed by those pests.
One commenter stated that the World Trade Organization's Sanitary
and Phytosanitary Agreement provides that members shall take into
account relevant ecological and environmental conditions and quarantine
or other treatment, and claimed that APHIS's 1997 risk assessment does
not consider relevant ecological and environmental conditions.
Specifically, the commenter noted that (1) pesticide use in other
countries is less restrictive, (2) there are more chemical pesticides
available, and (3) due to the long U.S. pesticide registration process,
new pesticides in other countries are years ahead of sales in the
United States. The commenter claimed that because of these factors, the
presence of serious pathogens is masked and pests rapidly become
resistant to pesticides. The commenter claimed that the risk assessment
should provide for consideration as to whether introduced plant pests
will arrive as resistant strains, since control of such strains is
difficult, if not impossible.
There is no specific scientific evidence that any of the quarantine
pests affecting Phalaenopsis spp. are resistant to pesticides.
Furthermore, APHIS has taken into account relevant ecological and
environmental conditions in its risk analysis. We are confident that
the measures required under the regulations in Sec. 319.37-8(e) will
reduce the risk posed by Phalaenopsis spp. plants imported from Taiwan
in growing media, regardless of whether or not the pests are resistant
to pesticides. Our judgment is supported by the fact that these plants
have been imported bare-rooted for many years, with no known associated
pest problems. Given that the plants in growing media will be subject
to a number of additional requirements that do not apply to bare-rooted
plants, we believe that the risk posed by all plant pests is
appropriately reduced by the measures in Sec. 319.37-8(e).
One commenter claimed that the establishment of introduced pest
species is far more likely in Hawaii than in other States, as Hawaii's
climate and ecology are very similar to the proposed point of origin
for this plant material, Taiwan. The commenter stated that, for this
reason, Hawaii's State quarantine measures have historically focused on
plants coming from within the 30[deg] parallels, yet the 1997 risk
assessment for the proposed rule does not account for this. The
commenter claimed that failure to address this point results in APHIS
treating Hawaii's verdant ecosystems the same as those of urban
environments without suitable hosts.
APHIS's 2003 risk analysis is designed to assess the risk posed by
all known pests that could be introduced into the United States via
Phalaenopsis spp. plants imported from Taiwan in growing media. The
intent of the regulatory approach chosen is to ensure that pests are
not introduced into the United States, regardless of the destination of
the plants. Specifically, in this case, the risk assessment identifies
the climatological conditions in which identified pests could survive
and the estimates of consequences of introduction of those pests
reflect what is known about climate-host interaction and host range for
the pests. While the consequences of the introduction of the identified
pests into Hawaii differ from the consequences associated with
introductions into urban environments, the risk assessment also
considers introductions into a suitable habitat and introductions near
suitable hosts. Nonetheless, given the application of mitigation
measures that will be required under this final rule, there is a very
low likelihood that an identified pest would be introduced into Hawaii
via Phalaenopsis spp. plants imported in growing media from Taiwan.
Risk Ratings
Two commenters argued that the risk rating for climate-host
interaction should be assessed as high for all pest species because
plant hardiness zone 11 includes more than just the southern part of
Florida, which is the only area cited in the risk assessment. The
commenters noted that plant hardiness zone 11 also includes Hawaii,
Guam, American Samoa, Northern Mariana Islands, U.S. Virgin Islands,
Federated States of Micronesia, and Puerto Rico, and stated that given
this error the 2003 risk analysis does not adequately address the
potential risks posed to these States and territories.
We have corrected the 2003 risk analysis to show that plant
hardiness zone 11 includes other States and territories besides
Florida. However, this does not affect the risk ratings for climate-
host interaction \5\ in the 2003 risk analysis. As described in APHIS's
``Guidelines for Pathway-Initiated Pest Risk Assessments'' (available
on the Internet at http://www.aphis.usda.gov/ppq/pra/commodity/cpraguide.pdf), risk ratings for climate-host interaction are based on
the number of plant hardiness zones where a pest can establish, not the
number of States that are contained within a specific plant hardiness
zone. If a pest can establish in a specific U.S. plant hardiness zone,
the risk assessment takes that into consideration, regardless of the
number of States and territories that fall within the particular plant
hardiness zone.
---------------------------------------------------------------------------
\5\ ``Climate-host interaction'' is one of several risk elements
that factor into the overall ``consequences of introduction'' risk
rating in commodity risk assessments.
---------------------------------------------------------------------------
For the purposes of commodity risk assessments, if a pest can
establish in a single plant hardiness zone (e.g., zone 11, which occurs
in parts of more than one State), the risk rating for climate host-
interaction is ``low.'' If a pest can establish in two or three plant
hardiness zones (e.g., zones 9, 10, and 11), the risk rating for
climate-host interaction is medium. If a pest can establish in four
[[Page 24923]]
or more plant hardiness zones, the risk rating for climate-host
interaction is high. Given these facts, the risk ratings for climate-
host interaction for each identified pest in the 2003 risk analysis are
appropriate.
One commenter stated that the information given in the 2003 risk
analysis does not accurately reflect the potential host range of the
quarantine mealybug pest Planococcus minor. The commenter pointed out
that the 2003 risk analysis characterizes the host range of P. minor
(according to Cox, 1989) as including more than 30 species in over 10
families, but that according to ScaleNet (http://www.sel.barc.usda.gov
/scalenet/scalenet.htm), the host range of P. minor includes more than
100 species in over 60 families, with many hosts being genera grown in
the ornamental industry.
APHIS agrees that the host range of Planococcus minor includes many
hosts, but the mitigation measures are designed to reduce or eliminate
this pest from production facilities and remove it from the pathway of
the importation. Given that the risk rating for host range of
Planococcus minor is already high, we do not see any need to revise our
risk analysis based on this comment, since making such a change would
not affect the estimates of risk or the overall conclusions of the risk
analysis.
One commenter noted that the host range for pathogens
Cylindrosporium phalaenopsis and Sphaerulina phalaenopsis was assumed
to be only Phalaenopsis. The commenter claimed that host range, if not
known, should not be assumed to be restricted to orchids. The commenter
stated that if only one host is known it may be because plant
pathologists do not have the time or funds to undertake costly cross-
inoculation studies.
As stated elsewhere in this document, APHIS makes determinations as
to whether a new agricultural commodity can be safely imported based on
data and research available to us. There is no evidence to suggest that
the host range of the pests cited by the commenter is incorrectly rated
in the risk assessment. Furthermore, ``cross-inoculation'' is not
sufficient in this case. A complete demonstration of Koch's Postulates
to establish pathogenicity is the standard for host range testing that
plant pathologists have relied on since the start of modern plant
pathology.
One commenter stated that the host range of Phomopsis orchidolphila
is nothing more than the extent of scientific observations and not a
biological limit. The commenter noted that not all species of orchids
have been tested and not found to be a host of this pathogen, and
claimed that, contrary to the 2003 risk analysis, it is very likely
that other orchid genera will be hosts of P. orchidophila but have not
been observed yet.
While APHIS agrees that many orchid genera are closely related,
hybrids are common, and members of the Orchidaceae may be susceptible
to a variety of pests, APHIS makes determinations as to whether a new
agricultural commodity can be safely imported based on data and
research available to us. There is no evidence to suggest that the host
range of the pest cited by the commenter is incorrectly rated in the
risk assessment. We are aware of no evidence that the importation of
bare-rooted plants has led to the introduction of Phomopsis
orchidolphila, so there is no reason to suspect that the lower-risk
plants produced under this system are likely to be infected.
One commenter stated that the dispersal potential of mollusks
should be rated high in the 2003 risk analysis because of difficulty of
finding them on the roots of orchid plants.
APHIS acknowledges that mollusks may be difficult to detect on
orchid plants, which is why the overall risk rating for the mollusks
Acusta (= Bradybaena) tourranensis and Bradybaena spp. is ``medium.''
The overall rating would not change if the rating for dispersal
potential was changed to medium or high, and, in any event, the risk
management measures contained in Sec. 319.37-8(e) would appropriately
reduce the risk posed by mollusks including Acusta (= Bradybaena)
tourranensis and Bradybaena spp. regardless of whether the overall risk
rating is ``medium'' or ``high.'' The ability of the measures to reduce
the risk posed by mollusks, including A. tourranensis, is discussed in
detail in the risk management section of the 2003 pest risk analysis.
One commenter stated that the dispersal potential of Planococcus
minor should be rated as high because finished, flowering orchids have
not previously moved in international commerce, and that a lack of
interceptions on bare-root plants is proof of nothing. The commenter
claimed that the presence of mealybugs is a major cause of rejections
of potted flowering orchid plants.
Determinations as to whether a new agricultural commodity can be
safely imported are based on data and research available to us. There
is no evidence to suggest that the dispersal potential of the pest
cited by the commenter is incorrectly rated in the risk assessment, and
the commenter provided no data to suggest otherwise. Further, potted
orchids plants have not been previously allowed importation into the
United States from any location. The commenter's claim that ``mealybugs
are a major cause of rejections of potted flowering orchid plants,''
pertains to interstate movements of potted plants that are not subject
to the same measures as Phalaenopsis spp. imported from Taiwan. There
are no Federal regulations governing the interstate movement of
Phalaenopsis spp. plants.
One commenter stated that it is incorrect to assume that the spores
of S. phalaenopsis, P. orchidophila, and C. phalaenopsis are not
dispersed over long distances since spores are carried by rain
splashes. The commenter stated that observation of the roadsides in
Hawaii shows that spores are likely to be widely dispersed, either by
rain splashes, or in the air, and claimed that the dispersal rating for
these pathogens should be rated as high.
Our risk rating for the dispersal potential of S. phalaenopsis, P.
orchidophila, and C. phalaenopsis is based on the need for both
adequate rain and wind to disseminate these spores. While the anecdotal
observation cited by the commenter suggests that these combined
conditions occur in native U.S. habitats, the dispersal potential
rating in the risk analysis also considers the dispersal potential
derived from plants within greenhouses, production facilities, and
interiorscapes where proper watering practices and reduced airflow are
expected to limit the conditions that favor spore dispersal.
One commenter claimed the 2003 risk analysis' prediction that no
more than 10 shipping containers per year are expected to be imported
from Taiwan is an understatement, as permission to import this
commodity into the United States is likely to be linked with an
increase in production and subsequent increases in volume of imports.
The commenter claimed that the pest risk concerning the quantity of
product should be properly assessed as high, not low.
Our estimate that no more than 10 shipping containers per year are
expected to be imported from Taiwan is based on information provided to
us by Taiwan. We believe this estimate and the risk rating for
``quantity imported annually'' contained in 2003 risk analysis are
appropriate.
Pest List
Two commenters stated that, in the 1997 risk assessment, 18 of the
26 mollusk and arthropod quarantine pests do not have species
identification and
[[Page 24924]]
are identified to family or genus level only. The commenters claimed
that the risk assessment, therefore, does not comply with APHIS's own
regulatory requirement that all quarantine pests be catalogued. One of
the commenters also claimed that APHIS regulations require that an
evaluation be made of the history of past plant pest interceptions or
introductions, but that the 1997 risk assessment does not contain such
an evaluation.
The 2003 risk analysis catalogues all known pests that have been
documented as being associated with Phalaenopsis spp. plants, and
identifies all pests that are of quarantine significance. Contrary to
one of the commenters' statements, the pests that were identified to
family or genus level were selected because they appear in APHIS
interception records for orchids; however, for the purposes of this
action, APHIS did not select pests for further consideration in the
risk assessment unless those specific pests were directly linked by
scientific literature or pest interception records with the particular
host species being imported. In this case, there is no evidence
available to clearly establish that the pests identified to family or
genus level are pests of Phalaenopsis spp. orchids.
Several commenters stated that the 1997 risk assessment is based on
an incomplete catalog of quarantine pests, and a few commenters
identified specific pests that they claimed APHIS should consider in
its risk assessment. Another commenter submitted a list of pests of
orchids that were found during Hawaiian State plant inspections.
As stated elsewhere in this document, APHIS is confident that the
2003 risk analysis considers all pests known to be associated with
Phalaenopsis spp. orchids. We reviewed lists of pests provided by
commenters and found that our list of pests is complete. The lists
provided did not contribute any new quarantine pests of Phalaenopsis
spp. orchids from Taiwan.
Several commenters claimed that only two mollusk taxa are discussed
in the 2003 risk analysis, but many other species have potential to be
imported with growing media, including Achatinidae (e.g., Achatina
fulica, the giant African snail), species of Succinea (family
Succineidae), Meghimatium species (slugs in the family Philomycidae),
as well as various species of Subulinidae (especially species in the
genus Opeas), Veronicellidae, Camaenidae, Helicarionidae, and
Ariophantidae. The commenter claimed that many of these species are
actionable by APHIS.
There is no scientific evidence that any mollusks of quarantine
significance are associated with Phalaenopsis spp. orchids in Taiwan
besides those considered in the 2003 risk analysis. Further, even if
one of the mollusks cited by the commenter was associated with
Phaelanopsis spp. orchids in Taiwan, the mitigation measures required
under this final rule would be sufficient to mitigate the risk posed by
the pest.
One commenter stated the 1997 pest risk assessment omits pathogenic
roundworms, nematodes, phytopathogenic bacteria, and plant viruses
vectored by insects, and stated that the pest risk assessment is
focused only on ``the organisms for which biological information is
available.'' The commenter claimed that the 1997 risk assessment does
not comply with the requirement in Sec. 319.37-8(g)(2)(v) that any
nonindigenous or native plant pest that may be able to vector another
plant pest be identified and assessed. The commenter stated that
undetected bacteria contained within orchids established in growing
media or orchids serving as symptomless carriers of viruses are
possibilities that must be addressed in the risk assessment.
As stated earlier in this document, APHIS is confident that our
1997 risk assessment and our 2003 risk analysis consider all pests
known to be associated with Phalaenopsis spp. orchids. The commenter
did not identify any specific pests for APHIS to evaluate. Further,
based on the findings of our risk analysis, we believe that the
measures contained in Sec. 319.37-8(e) will effectively remove all
known quarantine pests from the import pathway. APHIS does not
currently have any evidence to support the conclusion that any of the
pests identified in the risk analysis are vectors of animal or plant
diseases, therefore, we would not be justified in regulating the
importation of Phalaenopsis spp. plants in growing media as if they
posed a risk of introducing pests that serve as vectors of animal or
plant diseases.
One commenter stated that the species identifications for four
fungal pathogens (Colletotrichum phalaenopsis, Cylindrosporium
phalaenopsis, Phomopsis orchidophila, and Sphaerulina phalaenopsis) are
incorrect, and therefore, the risk ratings for those pests are
incorrect. The commenter stated that none of the species were found in
the Permuterm Subject Index for 1985 to 1998 (January and February for
1998), published by the Institute for Scientific Information, and
questioned how the four fungal pathogens were identified to the species
level in the 1997 risk assessment when there has been no species
identification of these four fungal pathogens in the last 13 years. The
commenter claimed that the four fungal pathogens should properly have
been identified only to genus, the host range of these four genera
should have been appraised as high, and, as a consequence, the risk
rating for these four fungal pathogens should be assessed as high.
To produce the pest list for the risk assessments on Phalaenopsis
spp. orchids from Taiwan, the risk assessors relied on published
scientific literature on pests of quarantine significance from that
area. The references that supported the inclusion on the list of the
four fungi \6\ were from periodicals listing fungal taxa (genus,
species, and author), hosts (scientific names), and their geographical
distributions. One of the references was a book which was a list of
plant pests reported in Taiwan (published by Taiwan's plant protection
organization). Another reference was the scientific journal Mycologia.
Fungus names and host names were provided to the species level. Fungus
names and authors of names were verified by using USDA-ARS National
Fungus Collection's Database on Fungi operated from Beltsville, MD.
Even if the pests were not reported or intercepted recently (i.e., in
the last 13 years) APHIS would still consider that they occur in that
area unless official notification by Taiwan was made declaring
``eradication.''
---------------------------------------------------------------------------
\6\ Colletotrichum phalaenopsidis, which was listed in the 1997
risk assessment, was removed from futher consideration because it
has been synonymized with C. gloeosporioides (Penz.), which is
widely distributed in the United States.
---------------------------------------------------------------------------
One commenter stated that the mealybugs Pseudococcus importatus
McKenzie and Pseudococcus microcirculus McKenzie are host specific to
orchids and that Pseudococcus orchidicola Takahashi has a wide host
range and could become a pest on many other plant species if
established.
The mealybugs cited by the commenter have not been linked
specifically with Phalaenopsis spp. orchids in any scientific
literature or by interception records. For this reason, they were not
specifically considered in the 1997 risk assessment or 2003 risk
analysis.
One commenter stated that it is critical that risk analysis be
conducted at the species level, and claimed that the extrapolation of
data regarding one species across an entire genus is not acceptable.
The commenter noted that, for an expert to accurately predict the
potential impact of an exotic pest in the
[[Page 24925]]
United States, we must know what factors are responsible for its impact
(or lack of impact) in the country of origin. The commenter stated that
adding species of plants within the requested genus further complicates
and reduces the probability of successful prediction of risk.
In conducting the risk analysis for this action, we searched for
information that linked specific pests with any plant in the genus
Phalaenopsis in Taiwan, and we assumed that those pests found could
affect any plants in the genus. We disagree that analysis needs to be
conducted at the species level, since an analysis at the species level
would have likely yielded far fewer pests, and a less-accurate
prediction of the risk. In fact, our risk analysis would yield similar
results if it were composed of a series of species-specific risk
analyses; the same pests we have identified would have been cited in a
series of documents, rather than in one document. If anything, the
approach we have chosen may overestimate the risk posed by imports of
certain species of Phalaenopsis spp. orchids in growing media, as
identified pests may not actually be associated with the specific
species and varieties of Phalaenopsis that may be imported under this
final rule.
One commenter stated that imported orchids pose a risk of
introducing an unknown virus, which has no symptoms of infection until
potted Phalaenopsis spp. orchids are mature and stressed. The commenter
claimed that a major outbreak of this virus has occurred in Japan from
potted Phalaenopsis spp. orchids imported from Taiwan, and that the
virus is well established in Taiwan. The commenter also claimed that it
is likely that the virus has arrived on the mainland and in Hawaii on
bare-rooted Phalaenopsis spp. orchids shipped from Taiwan.
As stated elsewhere in this document, we can only make
determinations as to whether a new agricultural commodity can be safely
imported based on available scientific evidence, and we are not aware
of any evidence that supports the commenter's suggestion that a
previously unknown disease or virus has been documented to affect
Phalaenopsis spp. orchids. Given that the commenter did not identify
the disease in question, we have no basis to revise our risk analysis
in response to this comment.
Risk Management
General
One commenter expressed concern as to why APHIS proposed this
action given the fact that the 1997 risk assessment found that seven
quarantine pests could be expected to follow the import pathway, and
that the risk posed by each pest was rated ``high.'' The commenter
stated that it would take an unwise ``leap of faith'' to assume that
the mitigation measures will reduce identified high risks to acceptable
levels.
First, as explained earlier in this document, through the process
of updating the risk assessment to bring it up to current standards,
the baseline pest risk potential for five of the identified pests has
been reassessed as ``medium.'' Only one (Spodoptera litura) of the
original seven identified quarantine pests remains rated as ``high;''
the other pest (Colletotrichum phalaenopsidis) listed in the 1997 risk
assessment was removed from further consideration because it was
synonymized with C. gloeosporioides (Penz.), which is widely
distributed in the United States. Second, as stated elsewhere in this
document, in response to commenters' concerns that the measures chosen
may not mitigate the risk posed by the pests identified, we have
updated the 1997 risk assessment to include a thorough discussion of
how the risks posed by the pests of concern, including the risk posed
by Spodoptera litura, are mitigated by the measures in Sec. 319.37-
8(e).
Several commenters stated that no manner of risk mitigation can be
completely effective, nor can there be any guarantees that a
surreptitious pest in an imported Phalaenopsis plant or its growing
medium will not spread to other plants, including food crops and
indigenous flora. One commenter questioned whether APHIS will be held
accountable for any introduction of new pests that occur if the
proposed rule is adopted.
As stated elsewhere in this document, while we can never be certain
that our methods, regulations, and policies will exclude pests 100
percent of the time, our goal is to do just that, to the extent
practicable. We are confident that the measures required under this
rule will effectively remove all identified quarantine pests from the
import pathway. Again, if zero tolerance for pest risk were the
standard applied to international trade in agricultural products, it is
likely that no country would ever be able to export an agricultural
commodity to any other country. There will always be some degree of
pest risk associated with the movement of agricultural products;
however, as stated in the PPA, APHIS will ``facilitate exports,
imports, and interstate commerce in agricultural products and other
commodities that pose a risk of harboring plant pests or noxious weeds
in ways that will reduce, to the extent practicable, as determined by
the Secretary, the risk of dissemination of plant pests or noxious
weeds.''
In the highly unlikely event that a new pest is introduced into the
United States as a result of the importation of Phalaenopsis spp.
orchids from Taiwan in growing media, responsibility for managing that
situation would reside with APHIS, in cooperation with States and
industry.
One commenter stated that mitigation measures to control the
growing environment can only be effective if enough is known about the
specific diseases and pest species associated with the import in the
country of origin. The commenter claimed that, in this case, the lack
of available biological information raises doubts as to how effective
any mitigation efforts will be.
As stated elsewhere in this document, we identified all known
quarantine pests of Phalaenopsis spp. orchids and evaluated the ability
of the mitigation measures to mitigate the risk posed by those
particular pests. We believe sufficient biological information is
available to determine that these plants can be safely imported into
the United States.
One commenter stated that monitoring reduces pest risk by lowering
the level of pest infestation, which does not negate the presence of
pests. The commenter claimed that lowered pest levels are more
difficult to detect upon inspection at the nursery and at the port of
entry, yet the pest still has the capability to be introduced and
established in a new environment.
While it is true that the mitigation measures required under this
rule are intended to reduce pest introduction into the United States,
the level of pest infestation of all imported plants is generally very
low to begin with. While very low levels of pest infestation are harder
to detect than high levels of pest infestation, we believe that the
reductions in pest levels resulting from the application of the
measures specified in Sec. 319.37-8(e) will not affect our ability to
prevent the introduction of plant pests into the United States. As with
other systems approaches, the measures in Sec. 319.37-8(e) provide an
overlapping series of safeguards which, even if one of the measures
fails, still ensures that the risk of pest introduction is reduced to
the extent practicable.
One commenter stated that the mitigative effects of the
requirements in Sec. 319.37-8(e) are not sufficient to reduce the risk
posed by plants imported in
[[Page 24926]]
growing media to the same level as that posed by bare-rooted plants or
plants imported on other approved epiphytic growing media.
As stated in our proposed rule, and based on the findings of the
2003 risk analysis, we believe the mitigation measures required under
this rule are sufficient to reduce the risk posed by Phalaenopsis spp.
orchids imported in growing media to the same level, or a lower level,
than that posed by bare-rooted plants. Plants that are currently
allowed to be imported with bare roots are subject only to inspection
at the port of entry, while plants imported in media under the
conditions of Sec. 319.37-8(e) are subject to additional conditions
that reduce the risk that those plants could become infested with pests
prior to export to the United States or introduce pests into the United
States.
One commenter claimed that the success of the proposed rule depends
upon the cooperation and enforcement of the exporting country, which in
many cases simply are inadequate or underfunded. The commenter claimed
that compliance with the conditions spelled out in Sec. 319.37-8(e)
could only be assured if an inspector were on-site every hour of every
day in every ``certified'' greenhouse--and perhaps not even then--and
stated that signing an agreement does not guarantee that it will be
followed. The commenter stated that APHIS should take extra precautions
to enter only into agreements that have a high likelihood of compliance
and claimed that there is no such assurance in this case.
The regulations in Sec. 319.37-8 require that for orchid producers
of Taiwan to export Phalaenopsis spp. orchids to the United States,
there must be an agreement in place that stipulates provisions for how
the regulations will be enforced. Furthermore, each grower who wishes
to export to the United States under the regulations must enter into an
agreement with the plant protection organization of Taiwan whereby he
or she must agree to comply with the provisions of the regulations in
Sec. 319.37-8 and to allow APHIS inspectors, and representatives of
Taiwan's plant protection service, access to the growing facility as
necessary to monitor compliance with the provisions of this section.
We disagree with the commenter that these agreements do not provide
for verification that the conditions specified in the regulations will
be followed. As noted elsewhere in this document, APHIS monitors
production sites to ensure compliance with the regulations. If the
regulations are not followed, inspections of the production sites and
inspections of the imported plants at the ports of entry in the United
States will reveal as much, and APHIS may hold all imports until an
investigation can be completed and appropriate measures initiated,
including stopping imports from a specific producer or shutting down
the entire program, if the circumstances show that such an action is
warranted. For this reason, the plant protection organization of Taiwan
and growers have an economic incentive to follow the regulations.
Two commenters stated that none of the conditions required by Sec.
319.37-8(e) mitigates the risk of contamination of plants in growing
media by fungal spores. The commenters stated that while the 1997 risk
assessment identifies 12 fungal pests of Phalaenopsis spp. orchids, 3
of these fungi have teleomorphic or sexual stages, which produce spores
that will contaminate growing media, be discharged into air currents,
and quickly travel throughout a greenhouse. The commenter stated that
since fungal spores are microscopic in size, they cannot be detected
via inspection.
The fact that plants will be required to be grown in greenhouses
for a minimum of 4 months, propagated from clean mother stock, and
watered with clean water sources reduces the risk that undetected
infections will occur. Many fungal spores are able to travel by air and
water, but it is unlikely that the spores will gain entry into a
greenhouse, spread to plants intended for export, and infect the
plants, and that the subsequent symptoms of infection will escape
detection during both the 4-month pre-export quarantine period and port
of entry inspection. APHIS agrees that unlike leaf-spot symptoms,
microscopic fungal spores are not likely to be detected via inspection,
but the risk analysis accounts for this within its risk element rating
for the ability of the pest to evade detection. If greenhouses are
contaminated by fungal spores, plants are likely to show symptoms or
signs of infection prior to export to the United States, or at an
inspection station in the United States. If fungal infection is
detected in the greenhouse, surrounding plants would be removed from
the greenhouse and remedial measures would be applied to ensure that
the fungal spores do not reinfest clean plants. If fungal infection is
detected at the port of entry into the United States, the plants would
be refused entry, and APHIS may hold all imports until an investigation
can be completed and appropriate measures initiated, including stopping
imports from a specific producer or shutting down the entire program,
if the circumstances show that such an action is warranted.
Furthermore, Phalaenopsis spp. plants have been imported bare-
rooted for years, subject simply to inspection at a port of entry.
Bare-rooted plants are more likely to be infected with a fungal pest
than plants grown under the stringent conditions of Sec. 319.37-8(e),
yet there have been no major problems with Phalaenopsis spp. plants
imported with bare roots.
One commenter stated that APHIS should employ postentry risk
management to reduce the risk posed by Phalaenopsis imported in growing
media. The commenter claimed that in this case, an effective post-
harvest disinfestation treatment is needed for Thrips palmi.
As stated elsewhere in this document, we are confident that the
measures contained in Sec. 319.37-8(e) will mitigate the risk posed by
orchids of the genus Phalaenopsis imported in growing media from
Taiwan. The effectiveness of these measures renders postentry risk
management other than inspection unnecessary. Thrips palmi has not been
documented as being specifically associated with Phalaenopsis spp.
plants. Should Thrips palmi or any other quarantine-significant pest be
detected in shipments of Phalaenopsis spp. plants in the future, or in
the event that such a pest is linked to Phalaenopsis in scientific
literature, we may reevaluate whether the measures we have chosen
mitigate the risk posed by the particular pests discovered.
One commenter claimed that there is a lack of plant virus control
by growers in Taiwan because they do not sterilize tools between
plants.
Our 2003 risk analysis did not identify any quarantine-significant
viruses that are associated with Phalaenopsis spp. orchids in Taiwan.
Nonetheless, growers will be required to perform specific sanitary
measures under the requirements of the rule and the bilateral workplan
that APHIS enters into with the plant protection organization of
Taiwan.\7\ Greenhouse
[[Page 24927]]
operating procedures will specify that sterilization of tools between
plants must occur.
---------------------------------------------------------------------------
\7\ A bilateral workplan is a written agreement between APHIS
and a foreign plant protection organization that clarifies the
responsibilities of each organization in enforcing APHIS regulations
that pertain to preclearance export programs. The workplan also
clarifies how specific aspects of the program operate, and may
include directives as to how certain pest problems must be remedied.
The workplan goes into more detail regarding the day to day
operation of the programs than do the regulations in the CFR, and,
because of their separation from the CFR, workplans are flexible and
can be revised as needed based on changing circumstances in the
exporting country. The workplan is enforceable, and failure of the
exporting country to abide by the conditions of the workplan is
grounds for suspension, and possibly cancellation, of the export
program.
---------------------------------------------------------------------------
One commenter stated that laboratory testing is necessary to
confirm the absence of pests such as latent viruses and nematodes, and
that it is necessary to keep a log of pesticide applications that
indicates pesticides used, dosage, and date of application.
Based on the findings of the 2003 risk analysis, we believe there
is no basis to require laboratory testing of plants intended for export
to the United States. We are confident that the measures required under
the regulations are sufficient to address the risk posed by
Phalaenopsis spp. orchids from Taiwan. Further, the bilateral workplan
for the export program will require growers to keep a log of pesticide
applications as suggested by the commenter. This type of requirement is
standard in APHIS's plants in growing media import programs.
Two commenters claimed that pest control during the growing period
and an efficacious disinfestation treatment prior to shipment are
necessary to ensure pest-free orchid plants. The commenters claimed
that the systems approach should include an effective postproduction
treatment.
Based on the findings of the 2003 risk analysis, we believe there
is no basis to require plants intended for export to the United States
to be subjected to a specific post-harvest treatment regimen. Further,
it is the responsibility of the growers of these plants in the
exporting country to apply pesticides and fungicides as necessary to
ensure that plants are pest-free.
One commenter claimed that the program requirements will not
address the dispersal potential of identified mollusk pests, and
claimed that 46 cm benches are not high enough. The commenter claimed
that, in Hawaii, slugs and snails easily travel 90 cm to infest plants
on benches of that height.
If the height of benches were the only risk-mitigating factor to
protect against the infestation of Phalaenopsis spp. orchids by
mollusks (i.e., if plants were not grown in greenhouses subject to the
requirements of Sec. 319.37-8(e)), then we would agree with the
commenter that the risk posed by those pests may have been too great.
However, plants are subject to a series of mitigation measures intended
to keep mollusks out of the greenhouse, and, in the unlikely event that
they enter the greenhouse, they are subject to additional control
measures. Should we find evidence that mollusks are present in program
greenhouses, we may require additional risk mitigation for those pests,
such as attaching copper flashing to vertical structural components.
One commenter claimed that the regulations should include explicit
requirements for greenhouse sanitation such as those imposed on
imported geraniums.
The regulations do require that plants be grown in a greenhouse in
which sanitary procedures sufficient to exclude plant pests and
diseases are always applied. The bilateral workplan for the program
will specify measures that are believed by APHIS to be necessary to
meet this requirement.
One commenter stated that the regulations should include a
requirement that prohibits packing at night under lights and packing
outside of the pest exclusionary greenhouse.
The bilateral workplan will require plants to be packed inside the
greenhouse. We see no need to require that plants not be packed at
night since plants will be packed in greenhouses that exclude
quarantine pests.
Inspection at the Port of Entry
One commenter stated that inspection should be considered the first
line of defense, and not considered to be a ``catch all'' for pests
that are able to exist on the plant in potting media despite proposed
safeguards. The commenter stated that Hawaii's pest interceptions on
orchid plants from 1988 to 1998 indicate that it is difficult to
intercept pests on orchid plants, as evidenced by the fact that, only
later, while under Hawaii's mandatory 60-day quarantine in secure
quarantine facilities, did pests develop into larger populations that
became observable, or develop to a detectable state, or produce signs
(i.e., exit holes) that could be detected. The commenter stated that
the Hawaii Department of Agriculture has intercepted a large number of
pests on bare-rooted orchids, and expressed concern as to whether those
pests could be found on potted materials when inspectors from two
separate agencies (foreign and APHIS) could not find these pests on
bare-rooted materials.
It is significant to note that inspection is the last in a series
of safeguards required under this final rule to ensure that
Phalaenopsis spp. orchids imported in growing media do not introduce
plant pests into the United States, including Hawaii. It is also
significant to note that the pests detected by Hawaii's inspectors were
found on bare-rooted plants, which, in contrast to plants imported
under this final rule, are allowed importation subject only to
inspection. As a practical matter, under this rule, inspection at the
port of entry is not the ``first line of defense,'' since it is the
last phytosanitary measure applied to Phalaenopsis spp. from Taiwan. As
such, it is the last remaining means by which to ensure, to the extent
possible, that plants are pest-free prior to release into domestic
commerce. The various other measures required under Sec. 319.37-8(e)
are intended to ensure that the plants are free of pests prior to
arrival at a port of entry into the United States.
One commenter stated that inspection at the port of entry is not an
effective mitigation measure, especially given the list of pests that
have become established in the United States in recent years,
apparently associated with the living plant or cut flower/decorative
plant material pathways.
APHIS believes that inspection, as a mitigation measure, is more
effective in some cases than others. For instance, if a pest associated
with a commodity is large and not mobile, we would likely consider
inspection sufficient mitigation for the risk posed by the pest. In a
case where a pest is difficult to detect via inspection, we would
employ inspection in combination with other measures that reduce the
likelihood that the plants being inspected are infested with the pest.
In this case, the regulations in Sec. 319.37-8(e) place several
restrictions on plants imported under this final rule. Inspection is
just one in a series of measures that, taken together, reduce the
likelihood that plants released into U.S. commerce will contain pests
that could harm U.S. agriculture or the natural environment.
One commenter questioned at what rate orchids would be inspected
upon arrival at U.S. ports of entry.
For at least the first year of the program, APHIS would inspect a
large percentage (greater than 50 percent) of each shipment of
Phalaenopsis spp. orchids imported in growing media from Taiwan. In
subsequent years, the rate of sampling may increase or decrease
depending on the results of previous inspections (i.e., based on how
well the program appears to be working). In the event that pests are
found, APHIS may hold all imports until an investigation can be
completed and appropriate measures initiated, including stopping
imports from a specific producer or shutting down the entire program,
if the circumstances show that such an action is warranted.
Screening and Doors
Three commenters stated that screens of 0.6 mm mesh are inadequate
to keep out certain important pests. One of the
[[Page 24928]]
commenters claimed that the melon aphid and the silverleaf whitefly
will pass through screens with mesh sizes of 0.281 mm, and that
quarantine pests of Phalaenopsis spp. orchids, including Dichromothrips
spp., Frankliniella intonsa, Frankliniella schultezi, and Thrips palmi
will not be excluded with hole sizes as small as 0.073 mm. The
commenter also stated that the required 0.6 mm opening will not exclude
aphids, whiteflies, thrips, and crawlers of mealybug, including
Planococcus minor, soft scales, and armored scales, including
Parlatoria spp., as well as young nymphal stages of leafhoppers. The
commenter noted that Dichromothrips spp., Frankliniella intonsa,
Frankliniella schultezi, Planococcus minor, Parlatoria spp., and Thrips
palmi are identified quarantine pests of Phalaenopsis spp. orchids, and
that Planococcus minor is one of the identified quarantine pests of
Phalaenopsis spp. orchids that is most likely to travel with the plant
and has the greatest potential for economic damage.
The screen mesh size required under the regulations in Sec.
319.37-8(e) is sufficient to exclude all life stages of all quarantine
pests of Phalaenopsis spp. orchids identified in our risk analysis,
except for the crawler stage of Planococcus minor. That said, the
likelihood that P. minor could invade a greenhouse and infest
Phalaenopsis grown in media is very low. The crawler, which is not
highly mobile, would have to either crawl through a screen, up a bench,
and onto plants'--or be blown in the air through a screen and fall
directly on a plant below. Nonetheless, even if P. minor invaded a
greenhouse, it would likely be detected during greenhouse or port of
entry inspections, thus greatly reducing the chance that it could be
introduced into the United States via imported Phalaenopsis spp.
plants.
One commenter stated that equipping entryways with automatic
closing doors is of little protection, unless double door systems are
used and the production areas are under positive pressure. Another
commenter stated that during the short period when a door is opened,
flying insects, such as adults of the nocturnal, high-risk pest cluster
caterpillar (Spodoptera litura) are capable of entering the greenhouse,
especially if it is lighted. The commenter claimed that if a mated
female moth entered the greenhouse, she would be capable of laying
fertile eggs on potted orchids.
APHIS acknowledges that pests may be able to gain access to
greenhouses, but it is the responsibility of the person growing the
plants to ensure that does not happen. Regular inspections of growing
premises are intended to ensure that plants are grown in a pest-free
environment, and our past experience with this type of program provides
evidence that this approach is successful.
Regarding Spodoptera litura specifically: If a mated adult female
entered the greenhouse and laid eggs on plants, given that those eggs
are relatively large and are typically laid in one location, the eggs
would likely be detected by a simple visual inspection. If the eggs
went undetected and hatched, the damage caused by the larvae would be
detectable during the growing period or at the port of entry.
One commenter stated that ants and other pests that move
underground will not be excluded by mesh screens and automatic doors.
The commenter stated that ants intercepted on bare-root orchids in the
past are generalist predators and, if established, some species would
most certainly become pests in urban, agricultural, and natural
environments. The commenter cited, as an example, the introduced ant
Linepithema humile (Mayr), which has had a devastating effect on many
native and endangered plant and animal species in Hawaii.
We are not aware of how the ant Linepithema humile (Mayr) was
introduced into Hawaii, but we have no reason to believe that its
introduction had anything to do with imports of plants in growing
media, or imports of orchids specifically. Ants that are associated
with vegetation are worker ants, which are not generally reproductive,
and which therefore present little risk of establishment if imported
into the United States. Ants generally only pose a risk of becoming
established in the United States if a queen were imported in a plant in
growing media. Given the fact that signs of ant infestation of
Phalaenopsis spp. plants in growing media would be relatively obvious
in the greenhouse in Taiwan and at the port of entry into the United
States, and given the fact that media must be safeguarded against pest
introduction prior to entry into the greenhouse, we do not believe the
risks posed by ants require additional risk mitigation. Again, if
pests, including ants, are detected in a program greenhouse, remedial
measures must be applied, and the infestation must be eliminated.
One commenter stated that rusts, such as Coleosporium merillii,
Uromyces spp., Puccinia spp., and Uredo spp. have spores able to
penetrate through mesh screens.
The commenter is correct that rust fungi have spores that could
penetrate mesh screens, however, according to our risk analysis, there
are no known quarantine significant rusts that are associated with
Phalaenopsis spp. orchids in Taiwan. In general, greenhouse mesh
screens are not intended to prevent the entry of fungal spores,
although the decrease in air flow associated with screening may provide
some benefits. The exclusion of diseases begins with the use of only
clean stock plants and media, and continues via the rapid detection and
removal of symptomatic plant tissues. Other mitigation measures that
are part of good plant production practices, such as sanitation and
proper watering, are expected to be more effective in reducing or
eliminating diseases than manipulation of the mesh screen size.
One commenter questioned whether 0.8 mm mesh size screens would be
sufficient, rather than 0.6 mm screens.
Given the pests known to be associated with Phalaenopsis spp.
plants in Taiwan, and the fact that other APHIS plants in growing media
programs have been successful in keeping plants pest-free using 0.6 mm
screens, we believe that size mesh is necessary.
Greenhouse Inspections and Pest Freedom
One commenter stated that the requirement that a greenhouse be
``found free from evidence of plant pests and diseases * * * no more
than 30 days prior to the date of export to the United States'' is
inadequate. The commenter stated that, during that period of time, any
number of pests could become established and develop in the greenhouse,
and then be imported into the United States.
The requirement that plants be inspected no more than 30 days prior
to export grew out of the practical reality of inspecting the plants.
Greenhouses ship plants periodically--sometimes several different
shipments in one month--and it is often not feasible for inspectors to
visit greenhouses and perform inspections for each shipment of plants
during the day or week they are shipped. Rather, the inspectors inspect
and approve plants for export within the next 30 days, which allows the
owner of the plants to ship certified plants as needed during that time
frame. If plants that are inspected and certified are not shipped
within 30 days, they must be reinspected. While it is possible that
plants could become infested with a pest during the short time between
inspection and shipment from the greenhouse, it is highly unlikely, as
[[Page 24929]]
shown by our years of experience in allowing imports of plants in
growing media under the regulations in Sec. 319.37-8(e). Furthermore,
as noted earlier in this document, it is in the interest of producers
to ship only pest-free plants, or else risk that the plants be refused
entry into the United States upon inspection at a plant inspection
station.
Two commenters stated that even under near-optimal conditions of
chemical pest control, it is unlikely that a greenhouse can be kept
pest-free over extended periods of time.
In section D of the risk management portion of the 2003 risk
analysis, we describe the historical performance of existing programs
for the export to the United States of plants in growing media. Our
review of those programs found that during the approximately 200
inspectional site visits made to greenhouses participating in plants in
growing media programs, no pests were found. While it is possible that
pests could infest program greenhouses, the regulations in Sec.
319.37-8(e) and the bilateral workplans for such export programs are
designed to ensure that plants are not infested with pests of
quarantine significance.
One commenter questioned how often greenhouses would be inspected
in Taiwan.
Approved greenhouses will be inspected at least monthly by
officials of Taiwan's plant protection organization to monitor for
compliance with the regulations, and APHIS personnel will make multiple
inspections during the first year of the program, followed by at least
one inspection per year in subsequent years.
Risk Associated With Growing Media
One commenter stated that fungal plant pathogens of Phalaenopsis
orchids, including Colletotrichum phalaenopsis, Cylindrosporium
phalaenopsis, Phomopsis orchidophila, and Sphaerulina phalaenopsis,
could be introduced into the United States unless the media and pots
were removed to expose roots.
We disagree that it will be necessary to remove growing media from
plants to detect these fungal diseases,\8\ which can cause leaf-
spotting or canker symptoms on affected plant parts. These are not
primarily root-affecting fungi. Orchids routinely produce roots that
protrude from associated media, and these will be visible to
inspectors. Furthermore, inspectors at APHIS's plant inspection
stations (into which all plants in growing media must be imported) do
remove growing media from plants to inspect their root systems for soil
or other pests.
---------------------------------------------------------------------------
\8\ Colletotrichum phalaenopsidis was removed from further
consideration in the 2003 risk analysis because it has been
synonymized with C. gloeosporioides (Penz.), which is widely
distributed in the United States.
---------------------------------------------------------------------------
One commenter stated that the proposal, if adopted, will create
another avenue for the illegal importation of wild-collected plants,
because it will inhibit inspection of the root systems of imported
plants. The commenter stated that one of the major factors in
determining whether a plant is wild-collected instead of artificially
propagated is the nature and condition of the root system.
As stated elsewhere in this document, it is in the interest of the
exporting country to ensure that the conditions of the regulations are
met. Failure to abide by the conditions could result in rejection of
shipments of plants, as well as suspension of the program. As such,
Taiwan's plant protection organization is responsible for verifying
that plants are artificially propagated and in compliance with the
program--otherwise Taiwan risks suspension of the program. If APHIS
finds one quarantine pest in a shipment of imported plants, we may hold
all imports until an investigation can be completed and appropriate
measures initiated, including stopping imports from a specific producer
or shutting down the entire program, if the circumstances show that
such an action is warranted. We wish to make it clear that we will
accept certifications made by the plant protection organization of
Taiwan as true unless there is a reason to believe that certifications
are being made improperly. Regardless, as stated in response to the
previous comment, inspectors at APHIS's plant inspection stations (into
which all plants in growing media must be imported) do remove growing
media from plants to inspect their root systems.
Several commenters stated that increased risk of pest introduction
comes not from Phalaenopsis spp. plants but from the medium in which
they are shipped, which, they alleged, the 1997 risk assessment did not
consider. The commenters stated that the likelihood of importing pests
and diseases is greatly increased where plants are already established
in sphagnum, or any other growing medium, as bare root plants allow a
more thorough inspection of plant roots and easier detection of any
pests or diseases which may be present. One commenter stated that the
mounding of media around the bases of plants obscures not only the
roots but also the lower leaf axils where additional pests occur. The
commenter stated that the medium also provides harborage for dormant
pest stages and may delay pest and disease symptoms. One commenter
stated that insects and other pests that feed on roots are found in
substrates during part of their life cycle may not be noticed by the
APHIS inspector during inspection. The commenters also stated that
there may be an unacceptable risk of pest introduction associated with
even bare-root orchids.
The 1997 risk assessment and 2003 risk analysis take into account
the fact that growing media has an effect on pests' ability to find
suitable shelter and an effect on the ability of inspectors to detect
certain pests that may be obscured by growing media. Specifically, the
risk assessment took these factors into consideration in its estimates
of the likelihood of introduction (see table 6 and preceding text in
the 2003 risk analysis). The risk posed by growing media in and of
itself was not considered in the risk assessment, because the specific
types of growing media are already approved and listed in Sec. 319.37-
8(e)(1) of the regulations, and have been successfully imported into
the United States for years.\9\ Such media does not present a risk of
pest introduction into the United States. In particular, sphagnum moss,
which APHIS expects to be the growing medium of choice for growers in
Taiwan, is exported in bulk and in association with plants imported
under the regulations in Sec. 319.37-8(e) from countries all over the
world.
---------------------------------------------------------------------------
\9\ See section D of the risk management section of the 2003
risk analysis for additional detail.
---------------------------------------------------------------------------
Based on many years of inspections of bare-rooted Phalaenopsis spp.
orchids, we do not believe that it is necessary to impose any
additional restrictions on their entry. Our interception records shows
that, since 1988, there have been fewer than 50 interceptions of
quarantine significant pests on orchids of the genus Phalaenopsis from
Taiwan. This number compares favorably with numbers of interceptions
for other imported plants. It suggests that the risk posed by these
plants is low, and that pests are generally not associated with
Phalaenopsis spp. orchids
Several commenters claimed that the importation of Phyllosticta or
Guignardia species in vandaceous orchids imported from southeast Asia
is already happening, and that potting media will only make it worse.
There is no interception evidence that either of the pests cited by
the commenter is associated with Phalaenopsis spp. orchids in Taiwan or
would be associated with imports of
[[Page 24930]]
those plants in growing media. Furthermore, there is no evidence that
the unidentified Phyllosticta and Guignardia species are even of
quarantine concern on vandaceous orchids.
Several commenters claimed that immature stages of biting midges
(Ceratopoginidae = Culicoides spp., Forcipomyia spp.) that are present
in Taiwan could be imported in sphagnum moss. The commenters claimed
that given the size of the midges, the mitigation measures required by
the rule cannot prevent them from entering greenhouses where plants
intended for export to the United States are grown. The commenters
claimed the midges can vector arboviruses, filarial worms, other
parasites, and in addition, could be major pests to humans in areas
such as Hawaii which have climatic conditions to support their
survival.
APHIS believes that there is a very low likelihood that biting
midges that can vector animal diseases will be imported in Phalaenopsis
spp. plants from Taiwan. First, the growing medium in which the plants
are potted is very unlikely to contain midges when it enters the
greenhouse, and even if it did, under the regulations, in Sec. 319.37-
8(e)(2)(ii) measures must be applied to ensure that pests are excluded
from the greenhouse, and that action is taken against pests that do
enter the greenhouse. While the regulations do not require any specific
pest-control measures such as pesticide applications to be applied in
the greenhouse, it is the responsibility of the greenhouse owner to
ensure that plants exported to the United States are free of all pests,
including biting midges. Furthermore, it is the responsibility of
Taiwan's plant protection organization to verify that growers follow
the conditions of the regulations. This involves ensuring that the
growing media (likely sphagnum moss imported from another country) is
safeguarded against pest infestation at all times prior to entry of the
media into the greenhouse, and that, in the highly unlikely event that
pests enter the greenhouse, they are dealt with accordingly.
Furthermore, sphagnum moss has been imported into the United States
for years, and there is no evidence to suggest that media used for
commercial plant production has been or will be a pathway for entry of
biting midges into the United States.
One commenter questioned whether sphagnum moss must be sterilized
or pasteurized, and claimed that the regulations should include such a
requirement.
Based on years of importations and inspections of various types of
approved growing media, including sphagnum moss, we are confident that
approved media, by virtue of their natural composition, are
inhospitable to most pest species. Further, under the conditions of the
bilateral workplan for this program, media will have to be safeguarded
against pest infestation prior to entry into the greenhouse.
One commenter claimed that snail eggs may be laid in growing media
and are not visible to inspectors.
While it is possible to detect the presence of snail eggs visually
under certain circumstances, it is highly unlikely, given the measures
required under Sec. 319.37-8(e), that quarantine significant snails
will have access to plants.
Several commenters expressed confusion over what type of growing
medium will be used. The commenters stated that the proposed rule
discusses sphagnum moss in several places but speaks of ``other
approved media'' such as coconut fiber and tree fern. The commenters
claimed that the pest risk associated with each medium will vary based
on various factors, including the source of the medium, its age, and
state of decomposition, among others.
Under this final rule, plants may be imported in any approved
growing medium listed in Sec. 319.37-8(e)(1), although sphagnum moss
will likely be the most commonly used type. The following growing media
are also approved: Baked expanded clay pellets, cork, glass wool,
organic and inorganic fibers, peat, perlite, polymer stabilized starch,
plastic particles, phenol formaldehyde, polyethylene, polystyrene,
polyurethane, rock wool, sphagnum moss, ureaformaldehyde, vermiculite,
or volcanic rock, or any combination of these media. Growing media must
not have been previously used.
Several commenters expressed concern that the importation of
Phalaenopsis spp. orchids in sphagnum moss could have serious
ecological consequences in Hawaii. One commenter stated that scientists
have found that one transplanted Sphagnum species that is native to
Hawaii has spread vigorously when moved out of its natural habitat. The
commenter expressed concern that this could happen with imported
species of sphagnum as well. Another commenter stated that sphagnum
moss used domestically as a growing medium consistently contains
damaging insects and noxious weeds.
Sphagnum moss is an approved growing medium and is listed in Sec.
319.37-8(e)(1). There are already nine genera and one order of plants
that may be imported into any U.S. State (including Hawaii) in sphagnum
moss. Ferns from Taiwan are known to be imported in sphagnum moss, and
are already eligible for importation into Hawaii. At present, we have
no reason to believe that unused sphagnum moss that is produced
according to standard industry practice presents any risk of pest
introduction in and of itself, nor does it behave as a weed.
Nonetheless, growing media are subject to inspection at any point in
the production process, from rooting to importation into the United
States, to ensure against pest infestation.
One commenter stated that when sphagnum is of low quality or
advancing age, it proves to be an attractive home for all manner of
insect and arthropod life as well as fungi, algae, etc. The commenter
stated that, while these plants would not be coming from the wild, it
is disingenuous to suggest that the addition of a growing medium will
not increase the risk of pest introduction.
As stated elsewhere in this document, the regulations require that
sphagnum moss used as growing media must not have been previously used.
We do not deny that the pest risk posed by bare-rooted Phalaenopsis
plants would be lower than that posed by Phalaenopsis imported in
growing media if the plants in media were not subject to the mitigation
measures in Sec. 319.37-8(e). However, when the mitigation measures
are applied to such plants, the risk they pose drops to a level equal
to or below that posed by bare-rooted plants. Plants imported in
growing media are subject to many additional requirements that do not
apply to bare-rooted plants. These requirements are designed to
mitigate the added risk posed by the addition of growing media. As
stated elsewhere in this document, the risk management section of the
2003 risk analysis provides a detailed discussion of how the measures
ensure that pests are removed from the import pathway.
One commenter stated that the current plants in growing media
program is very limited as to country of origin, and that plants grown
under the existing program have failed to guard against pest intrusion.
The commenter stated that citing the debatable success of the existing
program is misleading. The commenter stated that APHIS failed to
consider that the first five genera approved for importation in growing
media are all short term crops compared to the genera proposed in 1993
(Alstroemeria, Ananas, Anthurium, and Nidularium) and claimed that
APHIS
[[Page 24931]]
also did not consider that the first five genera came from countries
north of 30[deg] north latitude while noting that the genera proposed
in 1993 and Phalaenopsis (as proposed) may be imported from any foreign
country. The commenter stated that short term crops grown in northern
areas present a lower pest risk than what was proposed in 1993 or what
is being considered in the proposed rule.
As stated elsewhere in this document, the risk analysis conducted
in support of this rulemaking action assesses the risk posed by known
quarantine pests of Phalaenopsis spp. orchids that are present in
Taiwan. The findings of the risk analysis have led the Secretary to
determine that Phalaenopsis spp. orchids imported in growing media from
Taiwan can be safely imported into the United States. Furthermore, the
risk analysis is independent of previous analyses of other plants in
growing media, though we do cite the success of the program as evidence
that the program is effective in producing pest-free plants for export
to the United States.
One commenter stated that a potted plant is difficult to inspect
because unlike bare-root plants, a potted plant cannot be turned upside
down or turned in such a way to make it easier for the inspector to see
tiny signs of infestations, such as entry holes on the plant's stems.
The commenter stated that entry holes of weevils and other internal
feeders are difficult to detect because the holes are generally small
and may be hidden in protected areas of the plants, such as where the
leaf and stem meet, or on the stem near the media level.
A plant potted in growing media can be removed from media such that
the roots can be inspected for signs of pest infestation. This is
common practice in APHIS's plant inspection stations, and will be
practiced as part of the inspection of plants imported under this final
rule. Additionally, inspectors do inspect all accessible parts of the
plant, including the leaf and root interface. Furthermore, while
inspection at the port of entry is the last mitigation measure employed
under the growing media program, it is only one in a series of measures
that are collectively designed to reduce the risk that quarantine pests
that are known to infest Phalaenopsis spp. orchids could be introduced
into the United States.
One commenter stated that, in the 1997 risk assessment for the
proposed rule, only the weediness potential of Phalaenopsis spp.
orchids was assessed, and that there was no assessment of the weediness
potential of sphagnum moss. The commenter stated that this oversight
renders the proposal arbitrary, capricious, and an abuse of discretion,
because sphagnum moss can contain viable weed seeds which may sprout
and grow after the orchids are potted.
The commenter is correct that the 1997 risk assessment did not
assess the weediness potential of sphagnum moss itself, as sphagnum
moss is allowed to be imported without restriction from all parts of
the world, as is the case with bare-rooted Phalaenopsis plants. As
such, we conducted the 1997 risk assessment in accordance with our
regulations to specifically address the unique risk posed by
Phalaenopsis plants imported in growing media--that is, the risk caused
by the interaction of plant and the media'which, in this case, is tied
to the fact that growing media increases the risk posed by an imported
plant by providing harborage for pests that would not likely be present
on bare-root plants, or that would be easier to inspect for if the
plants were imported with bare roots. The measures contained in Sec.
319.37-8(e) are designed to mitigate the risk posed by those pests, as
described and evaluated in the risk management portion of the 2003 risk
analysis.
One commenter stated that inspection of growing media is necessary
to ensure that snails are not present in imported orchids, and alleged
the current regulations do not provide for such inspection. The
commenter stated that snails, including the quarantine pest Bradybaena
spp., are known to occur on roots of potted orchids, and that others
have observed Sublina octona and the bush snail, Bradybena similaris,
occurring on orchids in Hawaii and stunting potted orchid plants. The
commenter stated that interception records from the Hawaii Department
of Agriculture report snails even on bare-rooted Phalaenopsis spp.
orchids from Taiwan.
The risk analysis identified only one quarantine pest of
Phalaenopsis spp. orchids in Taiwan that is a mollusk: Acusta
tourranensis.\10\ The risk posed by this snail and related pests is
mitigated by the measures contained in Sec. 319.37-8(e), as explained
in detail in the risk management portion of the 2003 risk analysis.
---------------------------------------------------------------------------
\10\ For purposes of the 2003 risk analysis, Acusta
(=Bradybaena) tourranensis and Bradybaena spp. are analyzed
together.
---------------------------------------------------------------------------
One commenter stated that the greenhouses in which Phalaenopsis
spp. orchids would be grown are likely to be invaded by Frankliniella
schultezi, Spodoptera litura, Thrips palmi, and other quarantine pests,
and that Phalaenopsis spp. orchids potted in sphagnum moss provide an
excellent habitat for the pupal or resting stage of those pests, which
could pupate in the growing media, thereby infesting it.
There are no quarantine significant thrips that have been confirmed
to be associated with Phalaenopsis spp. plants in Taiwan. We have
responded to the commenter's concern regarding the risk posed by S.
litura earlier in this document.
Preemption
Several commenters expressed concern or confusion as to whether the
proposed regulations would preempt Hawaiian quarantine restrictions on
the importation of Phalaenopsis spp. orchids from Taiwan. One commenter
requested that the rule include a special exemption for Hawaii and
stated that all orchid plants imported into Hawaii should still be
subject to the mandatory 60-day quarantine. Two commenters stated that
such an exemption would not suffice, as plants which contain pests
could be imported into the mainland and then be moved interstate into
Hawaii. The Department of Agriculture of the State of Hawaii (HDOA)
commented on the proposal, and specifically objected to the adoption of
the rule, which it believes would increase the risk of introducing more
plant pests in the State. HDOA stated that a number of the pests do not
yet occur in Hawaii, but have been documented to have passed through
APHIS inspection in Hawaii only to be stopped by a more thorough Hawaii
Department of Agriculture quarantine requirement.
This final rule preempts applicable State regulations, as the
Federal Government is responsible for regulating foreign and interstate
commerce. States have authority to regulate intrastate commerce. In
this case, we do not believe it is necessary to provide an exception
for the rule for Hawaii, given the fact that plants imported in growing
media are subject to the requirements of Sec. 319.37-8(e), these
plants present a level of pest risk equal to or below that posed by
bare-rooted plants.
HDOA also stated that Federal preemption limits States' ability to
protect themselves from risks that the Federal government does not
acknowledge. HDOA expressed concern as to whether APHIS is facilitating
international trade at the expense of its mission to prevent the
introduction or dissemination of pests.
APHIS is charged with regulating the importation and interstate
movement of plants and plant products according to
[[Page 24932]]
the best available science. Our authority does not allow us to make
exceptions to our regulatory policy unless they are science-based. In
this case, we are confident that this final rule is based on sound
scientific data.
One commenter stated that plants imported into Hawaii should be
subject to a mandatory 60-day quarantine.
APHIS disagrees with the commenter that any further risk management
is necessary beyond what we originally proposed. The 2003 risk analysis
shows that the risks posed by the identified pests are mitigated by the
measures contained in Sec. 319.37-8(e).
Safeguarding Report
One commenter noted that at the time comments were being accepted
on the proposed rule, the National Plant Board and APHIS were
initiating a review of U.S. pest safeguarding systems. The commenter
stated that it would be premature to make further modifications to
Quarantine 37 pending the results of that review, and suggested that
APHIS withdraw the proposal pending completion of that review, and re-
propose it in light of future results.
The ``Safeguarding American Plant Resources'' report was completed
in July 1999, and efforts to implement its recommendations are ongoing.
The report is posted on the Internet at http://www.safeguarding.org/.
The report did not contain any recommendations specific to the
importation of plants in growing media, though it did recommend that
APHIS consider revisions to Quarantine 37 under which decisions to
allow the importation of propagative material would be made based on
risk analysis as is the case with Quarantine 56 (7 CFR 319.56 through
319.56-8). Given that plants in growing media are the only propagative
materials that are always subject to risk analysis as a condition of
determining their enterability, we see no reason to further delay
modifications to the regulations in Sec. 319.37-8.
OMB Designation of Significance
One commenter stated that the proposed rule would result in
increased inspection and regulatory activity by APHIS and that the
conclusion that the rule is ``not significant for the purposes of
Executive Order 12866'' is incorrect. The commenter claimed that review
by the Office of Management and Budget (OMB) is necessary.
The determination that the proposed rule was ``not significant for
the purposes of Executive Order 12866'' was made by OMB. This final
rule has been determined to be significant for the purposes of
Executive Order 12866 and, therefore, has been reviewed by OMB.
Economics
General
Several commenters claimed that adoption of this rule would result
in unfair ``dumping'' of cheap imports in the United States and that
there must be assurances that such dumping will not occur.
As stated elsewhere in this document, determinations as to whether
a new agricultural commodity can be safely imported are based on the
findings of risk analysis. The regulation of ``dumping'' is
administered by (1) the U.S. Department of Commerce (with respect to
the determination of dumping margins), and (2) the International Trade
Commission (with respect to determinations of injury). APHIS has no
authority to adopt regulations to guard against ``dumping'' of imported
plants.
Several commenters claimed that Phalaenopsis spp. orchids shipped
specifically from Taiwan would have an unfair marketing advantage over
domestically grown plants due to growers being subsidized and the
plants may be shipped on subsidized airlines.
APHIS has no reason to believe that Phalaenopsis producers or
shippers are subsidized by Taiwan. However, even if they were, as
stated elsewhere in this document, APHIS's determinations as to whether
a new agricultural commodity can be safely imported are not affected by
factors such as economic competitiveness.
One commenter claimed that this rule is unnecessary because
Hawaiian orchid growers can supply the epiphytic orchids needed by
Hawaiian citizens and the Hawaiian visitor industry. Another commenter
stated that because imported plants would spend an extended period of
time in transit and would require shorter acclimation time, plants
offered for sale will be in a stressed condition resulting in shorter
bloom life and reduced overall quality, which would be a disservice to
consumers. The commenter claimed that since the plants may not appear
stressed at the time of sale, the latent damage would lead to overall
dissatisfaction of the consumer, which in turn would be damaging to the
Phalaenopsis industry.
APHIS is bound under international trade agreements to remove
technical barriers to trade in the event that such barriers are found
by scientific analysis to be unnecessary. In this case, we have
conducted a risk analysis that found that all quarantine pests
associated with Phalaenopsis spp. orchids in Taiwan are effectively
removed from the import pathway by the measures required under Sec.
319.37-8(e). As such, the Secretary of Agriculture has determined that
it is not necessary to prohibit the importation of orchids of the genus
Phalaenopsis from Taiwan in approved growing media. Considerations such
as quality and consumer preference are not factors considered by APHIS
or USDA in general when authorizing the importation of new commodities.
These considerations are addressed by retailers and consumers who
purchase plants in a free market; if imported plants are of
insufficient quality or are perceived in a particular light due to
their origin, the need for those imports will be dictated by the
marketplace.
Economic and Regulatory Flexibility Analysis
Several commenters claimed that, contrary to the initial regulatory
flexibility analysis that APHIS has prepared and published, the
proposed rule will have a significant economic impact on a substantial
number of small entities, and the economic analysis for the proposal
greatly underestimates the consequences that will be associated with
adoption of the proposal. The commenters claimed that adoption of the
proposed rule would harm or perhaps destroy the domestic orchid
industry, especially the industry in Hawaii, which will be unable to
compete with new, cheaper imports. Commenters stated that the economic
effect of the rule on small and family operated nurseries needs study
and claimed that those types of businesses should be nurtured, not
threatened, by government policies, especially in economically
depressed areas.
Our initial regulatory flexibility analysis did not make a
determination as to whether adoption of the proposed rule would have a
significant economic effect on a substantial number of small entities.
Our final regulatory analysis, however, found this final rule will
likely have a significant adverse economic impact on many U.S. growers
of potted Phalaenopsis plants, many of whom are probably small
entities. Our analysis also found that an adverse impact on U.S.
growers of orchids other than Phalaenopsis spp. orchids, many of whom
are also probably small in size, is possible, but less certain. As
noted elsewhere in this document, determinations as to whether a new
agricultural commodity can be safely imported are not affected by
factors such as economic competitiveness.
One commenter stated that the intent of the Regulatory Flexibility
Act is not to limit regulations having adverse
[[Page 24933]]
economic impacts on small entities; rather the intent is to have
agencies (1) focus special attention on the effects their proposed
actions would have on small entities, (2) disclose to the public which
alternatives they considered to lessen adverse impacts, (3) consider
public comments on impacts and alternatives, and (4) state reasons for
not adopting an alternative that has less of an adverse impact on small
entities. The commenter stated that APHIS must fully comply with the
Regulatory Flexibility Act, and must consider the impact of
``inevitable proposals'' for importing flowering potted orchids from
other orchid genera. The commenter claimed that if APHIS issues a final
rule for this action, the Agency must state in detail all of the
reasons it has for making no changes in the regulations, the only
alternative that can ``minimize the significant economic impact on
small entities.''
APHIS believes that it has complied with the requirements of the
Regulatory Flexibility Act. In our proposed rule, APHIS proposed to
allow the importation of Phalaenopsis in growing media from all
countries of the world. We also explained that we considered two
alternatives to the proposed rule: (1) to make no changes to the
regulations; and (2) to limit the scope of the rule to potted
Phalaenopsis plants from Taiwan only, not all countries. In light of
the comments we received on the proposed rule, we reconsidered the
selection of alternatives for our final rule. As such, we are adopting
the second alternative to our proposal as a final rule because our risk
analysis for this action applies only to imports of Phalaenopsis from
Taiwan, and as such should not be used as a technical justification for
imports of Phalaenopsis from other countries. We rejected the first
alternative because, given APHIS's obligations under the Plant
Protection Act and international trade agreements, we do not believe
continuing to prohibit the importation of Phalaenopsis in growing media
from Taiwan is justified, since we have determined that Phalaenopsis
from Taiwan can be imported in growing media without introducing plant
pests or noxious weeds into the United States.
Regarding the ``inevitable proposals'' referred to by the
commenter, we have considered the potential effects associated with
importing Phalaenopsis in growing media from Taiwan. An analysis of
future revisions and potential imports from other countries is not
appropriate at this time, as any such changes to the regulations would
have to be the subject of a future rulemaking action.
One commenter stated that there is a mass-market domestic trade
that establishes Phalaenopsis spp. orchids, and other epiphytic
orchids, in pots, and then sells these potted epiphytic orchids,
primarily at wholesale. The commenter claimed that adoption of the
proposed rule will severely compromise, even devastate, domestic orchid
growers' participation in this mass-market trade, noting that Hawaiian
orchid growers import about half of the orchid plants that they use to
establish potted epiphytic orchids.
Our regulatory impact analysis and final regulatory flexibility
analysis consider the potential economic effects of the adoption of
this rule on persons who import orchid plants into Hawaii and pot them
for sale in the domestic market. As noted earlier in this document, our
final regulatory analysis found this final rule will likely have a
significant adverse economic impact on many U.S. growers of potted
Phalaenopsis plants, many of whom are probably small entities. Our
analysis also found that an adverse impact on U.S. growers of orchids
other than Phalaenopsis spp. orchids, many of whom are also probably
small in size, is possible, but less certain.
One commenter stated that APHIS has failed to comply with the
Regulatory Flexibility Act, as amended by the Small Business Regulatory
Enforcement Fairness Act, because its economic analysis is rudimentary
and superficial. The commenter claimed that the economic analysis
ignores or diminishes the value of statistics that are available about
the orchid industry in the United States, and that it makes an
assumption that ``cheaper foreign imports would likely benefit plant
retailers and importers'' without examining whether or not the
statement might actually be true, or, for that matter, whether or not
more ``cheap foreign imports'' would result from adoption of the
proposal.
We believe our final regulatory flexibility analysis complies with
the requirements of the Regulatory Flexibility Act, as amended.
Further, our analysis makes use of all the relevant data that we could
locate, including information provided to us by commenters.
We believe it is reasonable in this case to assume that the
expected low prices of imported Phalaenopsis plants from Taiwan will
lead to an expanded market for those plants, at the expense of more
expensive domestically produced plants. While cheaper imports may not
benefit retailers if importers do not pass on savings, it is certain
that importers will benefit from adoption of this rule.
One commenter stated that APHIS's economic analysis should not
attempt to draw conclusions and inferences regarding the proposed
action, given that data on potted orchids are ``scarce'' and data on
potted Phalaenopsis ``are virtually nonexistent.'' The commenter
claimed that the limitations on the data used in the analysis are
significant; there are far more growers, far more space devoted to
production, and greater gross sales than APHIS acknowledges in its
analysis. The commenter noted that there is no industry sharing of data
at present, and as a result, no accurate information on the state of
the industry.
While economic data on potted orchids may be scarce, we have
considered the data that are available. In any event, APHIS cannot
prohibit imports of plants and plant products based on a lack of
information regarding domestic production of those plants and plant
products.
One commenter stated that the American Orchid Society's (AOS)
estimate (cited in the proposed rule's economic analysis) that half of
all orchids grown in the United States are Phalaenopsis is incorrect.
The commenter claimed that while the percentage is significant, the AOS
figure overstates the importance of the genus.
For the purposes of our analysis, we make the assumption that this
estimate is appropriate, as the basis for the assumption is based on
the judgment of an expert on the domestic orchid industry, and there is
no substantive evidence to suggest that the expert's opinion is
incorrect.
One commenter stated that, contrary to what was said in the
economic analysis for the proposed rule, the majority of domestic
orchids growers do not sell their plants primarily wholesale to general
merchandise retailers and specialty stores.
The commenter did not provide any evidence to support his claim,
and since revisions to the economic analysis for the rule based on this
comment would not affect the overall conclusions of the analysis, we
are making no changes in response to this comment.
One commenter stated that APHIS's economic analysis should consider
the impact of the proposed rule on other orchids grown domestically
such as dendrobium, cattleya, vanda, etc., since orchid buyers do not
always distinguish what kind of orchid they are buying, as long they
are cheap and attractive. Another commenter stated that potted
Phalaenopsis spp. orchids imported from Taiwan will compete against all
other potted plants as well--although to a lesser degree.
[[Page 24934]]
In our final regulatory flexibility analysis, we acknowledge that
adoption of this final rule may have adverse economic effects on
producers of other plants besides Phalaenopsis spp. orchids; however,
the extent of the effect on those producers could not be determined.
One commenter stated that the economic analysis failed to analyze
or consider extra costs that growers, importers, or retailers might
face in case a pest is introduced into the United States via these
imports.
Our regulatory impact analysis does not consider potential economic
impacts associated with the introduction of a new pest into the United
States because, based on the findings of our risk analysis, we believe
such an occurrence to be highly unlikely. If we expected pest
introductions to occur in association with this proposal, an assessment
of the associated costs would be appropriate--but we would never have
formally proposed the action in the first place.
One commenter stated that importers of potted orchids will benefit
from adoption of the proposed rule, but it is a leap of faith to
suppose that the rule will lead to increased sales volume benefitting
retailers and consumers. The commenter claimed that, at retail flower
shops and other mass marketers of floriculture products, the
competition for shelf space is fierce and that orchids are minor items
for most retail outlets. The commenter stated that owners might be
inclined to pocket the savings from lower prices and earn a greater
margin per square foot of shelf space devoted to potted orchids. The
commenter claimed that it is naive to suggest that retail sales volume
will increase or that retailers will pass their lower costs on to
consumers.
As noted in our regulatory impact analysis, the availability of
cheaper foreign imports would benefit plant importers in the United
States. Importers would benefit from the income that the increased
business activity would produce. U.S. retailers would also benefit if
they kept the savings from lower wholesale prices for themselves
instead of passing those savings on to their customers in the form of
lower retail prices. Even if retailers did pass the savings on to their
customers, they may still benefit, because the lower retail prices on
potted plants may create an environment that leads to increased sales
volume and revenue elsewhere. Consumers would benefit if retailers
passed the savings on to them.
When a lower priced import is introduced, both consumer and
producer surplus, as well as total surplus, are affected; consumers are
better off because they pay a lower price for the good, and producers
are hurt because they get a lower price. However, trade in the product
always increases total surplus. In this case, the lack of information
and uncertainties regarding certain data (e.g., the volume of
Phalaenopsis spp. orchid imports from Taiwan) has precluded a monetary
quantification of the gains and losses for U.S. producers and
consumers, and the net welfare effect to U.S. society. However,
regardless of the specific dollar amounts, the net welfare effect of
imports of Phalaenopsis from Taiwan to U.S. society will be positive.
One commenter stated that, given this rule's potential negative
economic effects on small entities, APHIS should consider employing
quotas on the number of imported plants it will allow from Taiwan to
protect the domestic orchid industry from competition.
APHIS regulates the importation of agricultural products based on
risk, and has no authority to issue quotas on the importation of
agricultural products, since such quotas would be based on economic
considerations.
One commenter stated that there would be a negative impact on
Hawaii's tourism industry if biting fly Forcipomyia taiwana or other
non-native biting flies were to become established in Hawaii.
We do not believe this action will have an impact on Hawaii's
tourism industry because there is no evidence to suggest that the pests
cited by the commenter will enter the United States in association with
Phalaenopsis spp. plants imported in approved growing media from
Taiwan.
Fish and Wildlife Consultation/Effects on Endangered Species
Several commenters stated that APHIS must enter into formal
consultation with the U.S. Fish and Wildlife Service (FWS), as required
by section 7 of the Endangered Species Act (ESA) for all Federal
actions that may affect species listed under the ESA. The commenters
stated that the importation of orchids in growing media may affect
species of native Hawaiian orchids listed as threatened or endangered
under the ESA and that the importation of sphagnum moss could be
detrimental to these orchid species by altering the critical conditions
required by Hawaiian orchids for successful germination, growth, and
reproduction. This could come about through the introduction of the
alien arthropods, snails, and fungi that have been identified in the
1997 risk assessment conducted by APHIS and summarized in the proposed
rule.
In response to comments received on the proposed rule, APHIS
narrowed the application of the rule to Phalaenopsis spp. orchids from
Taiwan as the only point of origin and entered into informal section 7
consultation with FWS, as required under the ESA, to seek its
concurrence with APHIS's determination that the proposed rule may
affect, but is not likely to adversely affect, species proposed or
listed by FWS as endangered or threatened. On April 7, 2003, FWS
concluded the section 7 consultation process by concurring with APHIS's
determination that the importation of Phalaenopsis spp. orchids from
Taiwan in approved growing media will not adversely affect federally
listed or proposed endangered or threatened species or their habitats.
One commenter claimed that APHIS did not provide FWS with
sufficient information to make a valid determination of the impact of
the rule on endangered or threatened species. The commenter noted that
comments made by Hawaii's Department of Agriculture were not mentioned
in the Biological Evaluation provided to FWS in support of the rule,
and claimed that, since the Biological Evaluation was the document used
by FWS to concur with APHIS's finding of ``not likely to adversely
affect,'' APHIS should reconsider its findings.
APHIS provided FWS with all of the information that we had related
to imports of Phalaenopsis spp. orchids in growing media from Taiwan.
FWS concluded that the information that we gave them was sufficient to
produce a finding that the importation of Phalaenopsis spp. orchids
from Taiwan in approved growing media will not adversely affect
federally listed or proposed endangered or threatened species or their
habitats.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be significant for the purposes of Executive
Order 12866 and, therefore, has been reviewed by the Office of
Management and Budget.
We have prepared an economic analysis for this rule. The economic
analysis provides a cost-benefit analysis, as required by Executive
Order 12866, and an analysis of the potential economic effects of this
final rule on
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small entities, as required by the Regulatory Flexibility Act. The
economic analysis is summarized below. Copies of the full analysis are
available by contacting the person listed under FOR FURTHER INFORMATION
CONTACT, or on the Internet at http://www.aphis.usda.gov/ppd/rad/98-035-5_final_economic_analysis.pdf.
Under the Plant Protection Act (7 U.S.C. 7701-7772), the Secretary
of Agriculture is authorized to regulate the importation of plants,
plant products, and other articles to prevent the introduction of
injurious plant pests.
Summary of Economic Analysis
The regulations in 7 CFR part 319 prohibit or restrict the
importation into the United States of certain plants and plant products
to prevent the introduction of plant pests. The current regulations
allow the importation of orchids from all countries of the world, but
only under certain conditions, including the condition that the plants
be free of sand, soil, earth, and other growing media.
We are amending the regulations to add orchids of the genus
Phalaenopsis from Taiwan to the list of plants that may be imported in
an approved growing medium, subject to specified growing, inspection,
and certification requirements. We are taking this action in response
to a request by Taiwan, and after determining that Phalaenopsis spp.
plants established in growing media can be imported without resulting
in the introduction into, or dissemination within, the United States of
plant pests or noxious weeds.
Our economic analysis examines this final rule's economic impacts,
as required by Executive Order 12866, and considers the potential
economic effects of the rule on small entities, as required by section
604 of the Regulatory Flexibility Act. The analysis takes into account
public comments received in response to the proposal. Comments were
received primarily from Hawaiian orchid growers and organizations
representing those growers.
The economic impact of potted plant imports from Taiwan on Hawaiian
and other domestic growers is uncertain because information on relative
costs of production and transportation costs is unknown. However,
Taiwan's interest in access to the potted plant markets, as well as
certain other information, suggest that imports will displace sales by
at least some domestic growers. Accordingly, it is very possible that
domestic growers would lose sales to Taiwanese producers if the rule is
adopted.
The percentage of all potted orchid plants produced in the United
States that fall within the Phalaenopsis genus is unknown but it is
estimated to be significant, perhaps as high as 90 percent. In Hawaii,
unlike the situation on the U.S. mainland, potted plants of
Phalaenopsis spp. are only a small segment of the overall potted orchid
plant market. (Phalaenopsis spp. plants are produced primarily by the
larger growers, and many Hawaiian growers are small-scale producers
that tend to grow primarily specialty orchids.) The data suggest that,
on average, Hawaiian growers of Phalaenopsis spp. would not be price
competitive with imports from Taiwan. However, the rule's impact on
Hawaii's small scale producers, given their niche in the specialty
market, is unclear.
The data suggest that growers of Phalaenopsis spp. in California
and Florida would also not be price competitive with the Taiwanese
imports. The number of producers of potted Phalaenopsis spp. plants in
those two States is unknown, but it is believed to be significant. In
California in 2002, there were 41 producers of potted orchid plants of
all genera, including Phalaenopsis spp.; Florida also had 41 producers
of all genera that year.
Excluding Hawaii, California, and Florida, there were 101 large
growers of potted orchid plants in all of the other States in 2002,
with no one State accounting for more than 10 producers. The number of
producers of potted Phalaenopsis spp. plants in those States is unknown
but they, too, stand to be undercut in price by the Taiwanese imports.
The data are less conclusive on whether growers of all potted
orchid plants--not just Phalaenopsis spp.--would be affected. Most U.S.
growers of potted orchid plants are small entities.
The impact on producers is unclear. The rule is expected to provide
net social benefits to consumers (domestic importers, wholesalers,
retailers, as well as final consumers) that would exceed potential
losses to domestic growers. The rule is expected to increase net social
welfare.
Executive Order 12988
This final rule allows plants of the genus Phalaenopsis to be
imported in approved growing media into the United States from Taiwan.
State and local laws and regulations regarding Phalaenopsis spp. plants
imported under this rule will be preempted while the plants are in
foreign commerce. Potted plants are generally imported for immediate
distribution and sale to the consuming public, and remain in foreign
commerce until sold to the ultimate consumer. The question of when
foreign commerce ceases in other cases must be addressed on a case-by-
case basis. No retroactive effect will be given to this rule, and this
rule will not require administrative proceedings before parties may
file suit in court challenging this rule.
National Environmental Policy Act
An environmental assessment and finding of no significant impact
have been prepared for this final rule. The assessment provides a basis
for the conclusion that the importation of orchids of the genus
Phalaenopsis will not have a significant impact on the quality of the
human environment. Based on the finding of no significant impact, the
Administrator of the Animal and Plant Health Inspection Service has
determined that an environmental impact statement need not be prepared.
The environmental assessment and finding of no significant impact
were prepared in accordance with: (1) The National Environmental Policy
Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2)
regulations of the Council on Environmental Quality for implementing
the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA
regulations implementing NEPA (7 CFR part 1b), and (4) APHIS's NEPA
Implementing Procedures (7 CFR part 372).
The environmental assessment may be viewed on the Internet at
http://www.aphis.usda.gov/ppd/es/ppqdocs.html. You may request paper
copies of the environmental assessment from the person listed under FOR
FURTHER INFORMATION CONTACT. Please refer to the title of the
environmental assessment when requesting copies. The environmental
assessment is also available for review in our reading room, which is
located in room 1141 of the USDA South Building, 14th Street and
Independence Avenue, SW., Washington, DC. Normal reading room hours are
8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure
someone is there to help you, please call (202) 690-2817 before coming.
Paperwork Reduction Act
This final rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects in 7 CFR Part 319
Bees, Coffee, Cotton, Fruits, Honey, Imports, Logs, Nursery Stock,
Plant diseases and pests, Quarantine,
[[Page 24936]]
Reporting and recordkeeping requirements, Rice, Vegetables.
0
Accordingly, we are amending 7 CFR part 319 as follows:
PART 319--FOREIGN QUARANTINE NOTICES
0
1. The authority citation for part 319 continues to read as follows:
Authority: 7 U.S.C. 450 and 7701-7772; 21 U.S.C. 136 and 136a; 7
CFR 2.22, 2.80, and 371.3.
Sec. 319.37-8 [Amended]
0
2. In Sec. 319.37-8, paragraph (e), the introductory text of the
paragraph is amended by adding the words ``Phalaenopsis spp. from
Taiwan,'' immediately after the word ``Peperomia,''.
Done in Washington, DC, this 29th day of April 2004.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 04-10067 Filed 5-4-04; 8:45 am]
BILLING CODE 3410-34-P