[Federal Register Volume 62, Number 108 (Thursday, June 5, 1997)]
[Rules and Regulations]
[Pages 30739-30741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14725]
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Rules and Regulations
Federal Register
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This section of the FEDERAL REGISTER contains regulatory documents
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Federal Register / Vol. 62, No. 108 / Thursday, June 5, 1997 / Rules
and Regulations
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 301
[Docket No. 96-063-4]
Imported Fire Ant; Approved Treatments
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the imported fire ant regulations to lengthen
the certification period for containerized nursery stock treated with a
10 parts per million dosage of the insecticide tefluthrin in its
granular formulation and to remove the 15 parts per million dosage rate
for granular tefluthrin. These changes are based on research showing
that a 10 parts per million dosage of granular tefluthrin is
efficacious for 18 months, which is 12 months longer than the original
certification period for that dosage and 6 months longer than the
original certification period for a 15 parts per million dosage.
Lengthening the certification period for the 10 parts per million
dosage and removing the 15 parts per million dosage will reduce the
amount of insecticide used, which will reduce the costs incurred by
persons moving containerized nursery stock interstate from areas
quarantined for the imported fire ant.
EFFECTIVE DATE: July 7, 1997.
FOR FURTHER INFORMATION CONTACT: Mr. Ronald P. Milberg, Operations
Officer, Program Support, PPQ, APHIS, 4700 River Road Unit 134,
Riverdale, MD 20737-1236, (301) 734-5255; or E-mail:
rmilberg@aphis.usda.gov.
SUPPLEMENTARY INFORMATION:
Background
Imported fire ants, Solenopsis invicta Buren and Solenopsis
richteri Forel, are aggressive, stinging insects that, in large
numbers, can seriously injure or even kill livestock, pets, and humans.
The imported fire ant feeds on crops and builds large, hard mounds that
damage farm and field machinery.
The regulations in ``Subpart--Imported Fire Ant'' (7 CFR 301.81
through 301.81-10, referred to below as the regulations) quarantine
infested States or infested areas within States and impose restrictions
on the interstate movement of certain regulated articles from those
quarantined States or areas for the purpose of preventing the
artificial spread of the imported fire ant.
Sections 301.81-4 and 301.81-5 of the regulations provide, among
other things, that regulated articles requiring treatment prior to
interstate movement must be treated in accordance with the methods and
procedures prescribed in the appendix to the subpart, which sets forth
the treatment provisions of the ``Imported Fire Ant Program Manual.''
In a proposed rule published in the Federal Register on January 31,
1997 (62 FR 4664-4666, Docket No. 96-063-3), we proposed to amend the
regulations to lengthen the certification period for containerized
nursery stock treated with a 10 parts per million (ppm) dosage of the
insecticide tefluthrin in its granular formulation and to remove the 15
ppm dosage for granular tefluthrin.
We solicited comments concerning the proposed rule for 45 days
ending March 17, 1997. We received 3 comments by that date. The
comments we received were from a State agricultural agency, a nursery
and landscape industry trade organization, and an agricultural products
manufacturer. One commenter strongly supported the proposed rule, while
the two remaining commenters questioned the accuracy and validity of
the statistical analysis used to support the proposed lengthening of
the certification period for a 10 ppm dosage of granular tefluthrin.
One of the two commenters who opposed an 18-month certification
period for a 10 ppm dosage of granular tefluthrin stated that his own
statistical analysis of the raw data led him to conclude that a 10 ppm
dosage rate can be expected to provide protection from fire ant
infestation for only 13.4 months, rather than the 18 months cited by
the Animal and Plant Health Inspection Service (APHIS). The second
commenter stated that APHIS had utilized a flawed regression equation
and that data had been inappropriately omitted from the regression
analysis; this commenter suggested that a second analysis be conducted
that included data points for a 0 ppm dosage and a regression of the
square root of the dependent variable (months) on the log of the dose
(ppm).
We continue to believe that the testing and analysis conducted by
APHIS at its Imported Fire Ant Methods Development Station (IFAMDS) in
Gulfport, MS, were properly conducted and support our conclusion that
granular tefluthrin incorporated at a dosage rate of 10 ppm into soil
or potting media for containerized nursery stock is efficacious for 18
months. IFAMDS researchers used regression analysis (SPSS Inc., ``SPSS/
PC+TM Base System User's Guide: Version 6,'' Chicago, IL,
1992) of all valid data points from dozens of different field trials of
tefluthrin conducted between 1988 and 1995. That regression analysis
indicated that, on average, 18 months of residual activity could be
expected from tefluthrin at a dose rate of 10 ppm based on dry weight
bulk density of the potting media.
However, because two of the commenters disputed the validity of the
regression analysis used to support the proposed rule, researchers at
IFAMDS sought to corroborate the results of the regression analysis by
reevaluating the data from the tefluthrin field trials using the exact
same method that was used to obtain the variable dose rate schedule for
granular bifenthrin, another insecticidal formulation currently
approved for use in the imported fire ant program.
Specifically, the IFAMDS researchers used simple arithmetic means
of various data points from a variety of trials to determine the
average residual activity of tefluthrin at various dose rates, then
averaged all data from the trials that included a 10 ppm dose rate. A
compilation of the data collected in those trials yielded six valid
data points--12, 16, 16, 17, 20, and 31 months--that were used to
arrive at an average residual activity of 18.6 months
[[Page 30740]]
for granular tefluthrin incorporated in potting media at a 10 ppm
dosage rate.
Both our original regression analysis and the subsequent arithmetic
means analysis indicated that, on average, 18 months of residual
activity could be expected from tefluthrin at a dose rate of 10 ppm. We
recognize that the 18-month certification period is based on an average
and, as is the case with any average, there may be instances in which
tefluthrin incorporated at 10 ppm may not provide a full 18 months of
residual activity. We believe, however, that any increased risk that
may be present in such instances is mitigated by the certification
requirements and movement restrictions of the regulations.
Additionally, granular tefluthrin is approved for use only for the
treatment of containerized nursery stock, and most persons moving
containerized nursery stock out of the regulated areas do so as
participants in the Imported-Fire-Ant-Free Nursery program, which
combines the control aspect of insecticidal formulations with
detection, exclusion, and enforcement provisions in order to prevent
the artificial spread of the imported fire ant.
Therefore, based on the rationale set forth in the proposed rule
and in this document, we are adopting the provisions of the proposal as
a final rule without change.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. For this
action, the Office of Management and Budget has waived its review
process required by Executive Order 12866.
This rule amends the regulations by lengthening the certification
period for containerized nursery stock treated with a 10 ppm dosage of
granular tefluthrin and by removing the 15 ppm dosage rate for granular
tefluthrin. Lengthening the certification period for the 10 ppm dosage
and removing the 15 ppm dosage will reduce the amount of insecticide
used, which will reduce the costs incurred by persons moving
containerized nursery stock interstate from areas quarantined for the
imported fire ant.
The number of current users of granular tefluthrin--and the number
of potential new users that may result from this rule change--is not
known, but most are assumed to be small entities (wholesalers of
nursery stock having fewer than 100 employees, and retail nurseries
having less than $5 million in annual revenue). Several thousand
nursery wholesalers and retailers have signed compliance agreements
under the imported fire ant regulations, but not all of them are
necessarily shipping restricted products out of the regulated areas
that require the application of granular tefluthrin or alternative
chemicals. Moreover, most nurseries under compliance agreements
currently use treatments other than tefluthrin. Therefore, it is
difficult to estimate how many small entities will be affected by this
rule change, but they may number in the hundreds.
Costs for most users of granular tefluthrin will be reduced because
of the increased period of certification. Because the regulations had
required a dose rate of 15 ppm for a certification period of 0--12
months and a dose rate of 25 ppm for a certification period greater
than 12 months, the 18-month certification period for the 10 ppm dose
rate will result in a cost savings of from 33 to 60 percent for
purchasers of granular tefluthrin who ship their products out of the
restricted areas between 12 and 18 months after treatment. The current
retail price of granular tefluthrin is about $4.00 per pound, but
prices can vary considerably depending upon whether or not it is
purchased in bulk. A 33 to 60 percent cost savings realized by applying
tefluthrin at a 10 ppm dose rate rather than a 15 or 25 ppm dose rate
is expected to result in a savings of about $1.33 to $2.40 in the
application of one pound of granular tefluthrin.
We do not anticipate that there will be a significant economic
impact on small entities that distribute agricultural chemicals.
Distributors of agricultural chemicals are diversified businesses that
sell a wide variety of chemicals, fertilizers, and other farm and
nursery supplies. We also do not expect any significant economic impact
on any other small entities.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12372
This program/activity is listed in the Catalog of Federal Domestic
Assistance under No. 10.025 and is subject to Executive Order 12372,
which requires intergovernmental consultation with State and local
officials. (See 7 CFR part 3015, subpart V.)
Executive Order 12988
This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. This rule: (1) Preempts all State and local laws and
regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
This rule contains no 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 301
Agricultural commodities, Plant diseases and pests, Quarantine,
Reporting and recordkeeping requirements, Transportation.
Accordingly, 7 CFR part 301 is amended as follows:
PART 301--DOMESTIC QUARANTINE NOTICES
1. The authority citation for part 301 continues to read as
follows:
Authority: 7 U.S.C. 147a, 150bb, 150dd, 150ee, 150ff, 161, 162,
and 164-167; 7 CFR 2.22, 2.80, and 371.2(c).
2. In part 301, Subpart--Imported Fire Ant, in the appendix to the
subpart, paragraph III.C.3.c. is amended by revising the dosage table
to read as follows:
Subpart--Imported Fire Ant
* * * * *
Appendix to Subpart ``Imported Fire Ant''--Portion of ``Imported Fire
Ant Program Manual'' 8
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\8\ A copy of the entire ``Imported Fire Ant Program Manual''
may be obtained from the Animal and Plant Health Inspection Service,
Plant Protection and Quarantine, Domestic and Emergency Operations,
4700 River Road Unit 134, Riverdale, Maryland 20737-1236.
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III. Regulatory Procedures
* * * * *
C. Approved Treatments.
* * * * *
3. Plants--Balled or in Containers
* * * * *
c. Tefluthrin: Granular Formulation.
* * * * *
Dosage: * * *
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Granular tefluthrin dosage (parts per Certification period (months
million) after treatment)
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10 ppm.................................. 0-18 months.
25 ppm.................................. Continuous.
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* * * * *
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Done in Washington, DC, this 30th day of May 1997.
Donald W. Luchsinger,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-14725 Filed 6-4-97; 8:45 am]
BILLING CODE 3410-34-P