[Federal Register Volume 62, Number 21 (Friday, January 31, 1997)]
[Proposed Rules]
[Pages 4664-4666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2402]


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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

7 CFR Part 301

[Docket No. 96-063-3]


Imported Fire Ant; Approved Treatments

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend 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. Research has demonstrated 
that a 10 parts per million dosage of granular tefluthrin is 
efficacious for 18 months, which is 12 months longer than the current 
certification period for that dosage and 6 months longer than the 
current 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 would reduce the 
amount of insecticide used, which would reduce the costs incurred by 
persons moving containerized nursery stock interstate from areas 
quarantined for the imported fire ant.

DATES: Consideration will be given only to comments received on or 
before March 17, 1997.

ADDRESSES: Please send an original and three copies of your comments to 
Docket No. 96-063-3, Regulatory Analysis and Development, PPD, APHIS, 
Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please 
state that your comments refer to Docket No. 96-063-3. Comments 
received may be inspected at USDA, room 1141, South Building, 14th 
Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 
4:30 p.m., Monday through Friday, except holidays. Persons wishing to 
inspect comments are requested to call ahead on (202) 690-2817 to 
facilitate entry into the comment reading room.

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: 
[email protected].

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.''
    Currently, the appendix offers three dosage rate/certification 
period options for granular tefluthrin: 0 to 6 months for a 10 parts 
per million (ppm) dosage, 0 to 12 months for a 15 ppm dosage, and a 
continuous certification period for a 25 ppm dosage.
    Tests conducted by the Animal and Plant Health Inspection Service 
(APHIS) at its Imported Fire Ant Methods Development Station (IFAMDS) 
in Gulfport, MS, have demonstrated 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. This is 12 
months longer than the current certification period for a 10 ppm dosage 
and 6 months longer than the current certification period for a 15 ppm 
dosage. Based on that efficacy data, we have determined that 
containerized nursery stock could be certified for interstate movement 
for 18 months after treatment with granular tefluthrin at a dosage rate 
of 10 ppm.
    Therefore, we are proposing to amend the appendix to the 
regulations by increasing the certification period for the 10 ppm 
dosage of granular tefluthrin from 0-6 months to 0-18 months. In light 
of that longer certification period for the lower 10 ppm dosage, the 15 
ppm dosage, which has a certification period of 0 to 12 months, would 
no longer be necessary and would be removed. The dosage rate of 25 ppm 
would be required for certification of containerized nursery stock for 
interstate movement from quarantined areas for more than 18 months.

[[Page 4665]]

Previous Direct Final Rule

    On October 15, 1996, we published in the Federal Register (61 FR 
53601-53603, Docket No. 96-063-1) a direct final rule to amend the 
regulations in the same way as proposed in this document, i.e., to 
lengthen the certification period for 10 ppm dosage of granular 
tefluthrin and remove the 15 ppm dosage rate. In response to that 
direct final rule, we received two adverse comments. Therefore, in 
accordance with our published policy on direct final rules, we withdrew 
the direct final rule prior to its effective date in a document 
published in the Federal Register on December 13, 1996 (61 FR 65459, 
Docket No. 96-063-2).
    Both of the adverse comments we received stated that the research 
conducted at IFAMDS did not demonstrate that a 10 ppm dosage of 
tefluthrin will provide 18 months of control. The commenters focused on 
the regression equation used to chart the data generated by that 
research. While they acknowledged that the regression equation did 
indeed show that a 10 ppm dosage of tefluthrin would provide 18 months 
of control, they questioned the validity of the equation itself.
    The tefluthrin trials conducted by IFAMDS covered 46 individual 
tests conducted over 15 different projects using a 1.5 percent granular 
formulation of the insecticide incorporated with nursery potting media. 
The dosage rates tested in those projects ranged from 2.5 ppm to 86.3 
ppm. Those dosage rates were shown to provide residual activity--i.e., 
fire ant control--for periods ranging from greater than 1 month for the 
2.5 ppm dosage to 43 months for the 86.3 ppm dosage. When those 
research results were charted and the generated regression equation of 
Y = 16.29 + 0.19X was applied, the data indicated that a 10 ppm dosage 
of tefluthrin would provide greater than 18 months of control. Based on 
that research, APHIS personnel at IFAMDS recommended that the 
regulations be amended to reflect a 0-18 month certification period for 
a 10 ppm dosage of tefluthrin and a continuous certification period for 
a 25 ppm dosage, which is what we attempted to do in the October 1996 
direct final rule that was withdrawn due to our receipt of adverse 
comments.
    The adverse comments we received were based on two arguments. The 
first argument is that the regression equation used by APHIS to support 
an 18-month certification period for a 10 ppm dosage of tefluthrin also 
predicts that a 0 ppm dosage--i.e., no insecticidal treatment at all--
would provide greater than 16 months of control. We believe that this 
argument is a misinterpretation of the facts in that the commenters are 
merely pointing to the chart used to represent the results of the 
tefluthrin trials and noting that the regression line to the data 
points, when extended to 0 on the X axis (dose rate/ppm), intersects 
the Y axis (months residual activity) at 16. That line is unsupported 
by data points at 0 on the X axis and cannot reasonably be represented 
as unequivocally supporting a 16-month certification period for a 0 ppm 
dosage. We believe that such an interpretation is an extreme inference 
that misrepresents the function of regression equation methodology and 
mischaracterizes the nature of the conclusions that can be logically 
drawn from the research conducted by IFAMDS.
    The second argument employed in the adverse comments is that the 
regression equation is inappropriate because it fails to consider that 
the equation was generated using the least squares technique to fit the 
best line to the data points. That means, one comment stated, that 
roughly half of the data points will fall above the regression line and 
half will fall below. Thus, the comment continued, the data can be 
interpreted as showing tefluthrin applied at 10 ppm would fail to 
provide 18 months of control 50 percent of the time and at 25 ppm would 
fail to provide 18 months of control 33 percent of the time. We 
continue to believe that the methodology used is valid and appropriate 
and provides a rational basis for our proposal to amend the regulations 
to reflect a 0-18 month certification period for a 10 ppm dosage of 
tefluthrin and a continuous certification period for a 25 ppm dosage. 
The methodology used in the tefluthrin trials has been used by IFAMDS 
in conducting trials for the other insecticidal chemicals and 
formulations that are currently approved for use--and are being used to 
good effect--in the imported fire ant program.
    A recent example of the application of this methodology to the 
imported fire ant program was the approval of reduced rates of granular 
bifenthrin for incorporation in containerized nursery stock. (Those 
reduced rates were added to the regulations by a direct final rule 
published in the Federal Register of October 28, 1993 [58 FR 57952-
57955, Docket No. 93-082-1].) The regression equation used for 
bifenthrin in that case could be interpreted as predicting that a 0 ppm 
dosage of granular bifenthrin would provide approximately 13 months of 
control; that a 15 ppm dosage would fail to provide 24 months of 
control 50 percent of the time; and that a 25 ppm dosage would fail to 
provide 24 months of control 20 percent of the time. Granular 
bifenthrin has been used as an efficacious and dependable component of 
the imported fire ant program since that direct final rule became 
effective on December 27, 1993; the research conducted by IFAMDS leads 
us to fully expect that tefluthrin applied at the rates proposed in 
this document would be similarly effective in preventing the spread of 
the imported fire ant.
    Therefore, having considered the adverse comments received in 
response to the previous direct final rule, we still believe that 
efficacy data generated by IFAMDS and the methodology used to develop 
the data provide an appropriate scientific basis for our proposed 
lengthening of the certification period for a 10 ppm dosage of granular 
tefluthrin.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed 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 proposed rule would amend 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 would reduce the 
amount of insecticide used, which would 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 could result from this proposed 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 these are necessarily shipping restricted products requiring the 
application of granular tefluthrin or alternative chemicals out of the 
regulated areas. Moreover, most nurseries under compliance agreements 
currently use treatments other than tefluthrin. Therefore, it is 
difficult to estimate how many small entities would be affected by this 
proposed rule

[[Page 4666]]

change, but they may number in the hundreds.
    Costs for most users of granular tefluthrin would be reduced 
because of the increased period of certification. Under the current 
regulations, a dose rate of 15 ppm is required for a certification 
period up to 12 months and a dose rate of 25 ppm is required for a 
certification period greater than 12 months. Thus, a cost savings of 
from 33 to 60 percent would be realized by 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 could mean a savings of about 
$1.33 to $2.40 in the application of one pound of granular tefluthrin.
    We do not anticipate that there would 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 would 
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 proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Paperwork Reduction Act

    This proposed 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 would be amended as follows:

PART 301--DOMESTIC QUARANTINE NOTICES

    1. The authority citation for part 301 would continue to read as 
follows:

    Authority: 7 U.S.C. 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. would be 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, MD 20737-1236.
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III. Regulatory Procedures

* * * * *
    C. Approved Treatments.
* * * * *

3. Plants--Balled or in Containers

* * * * *
    c. Tefluthrin: Granular Formulation.
* * * * *
    Dosage: * * *

------------------------------------------------------------------------
   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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* * * * *
    Done in Washington, DC, this 27th day of January 1997.
Terry L. Medley,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 97-2402 Filed 1-30-97; 8:45 am]
BILLING CODE 3410-34-P