Fenpropathrin; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: January 20, 1999 (Volume 64, Number 12)]
[Rules and Regulations]
[Page 3003-3009]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20ja99-3]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300763; FRL 6047-3]
RIN 2070-AB78

Fenpropathrin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes a time-limited tolerance for
combined residues of fenpropathrin in or on soybeans. This action is in
response to EPA's granting of an emergency exemption under section 18
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on soybeans. This regulation
establishes a maximum permissible level for residues of fenpropathrin
in this food commodity pursuant to section 408(l)(6) of the Federal
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality
Protection Act (FQPA) of 1996. The tolerance will expire and is revoked
on June 30, 2000.

DATES: This regulation is effective January 20, 1999. Objections and
requests for hearings must be received by EPA on or before March 22,
1999.

ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300763], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300763], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 119, Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1
or ASCII file format. All copies of objections and hearing requests in
electronic form must be identified by the docket control number [OPP-
300763]. No Confidential Business Information (CBI) should be submitted
through e-mail. Electronic copies of objections and hearing requests on
this rule may be filed online at many Federal Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Jacqueline Gwaltney,
Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
Office location, telephone number, and e-mail address: Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA, (703) 305-6792, e-mail:
gwaltney.jackie@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408(e) and (l)(6) of the FFDCA, 21 U.S.C. 346a(e) and (l)(6),
is establishing a tolerance for combined residues insecticide/
fungicide/herbicide fenpropathrin, in or on soybeans at 0.1 part per
million (ppm). This tolerance will expire and is revoked on June 30,
2000. EPA will publish a document in the Federal Register to remove the
revoked tolerance from the Code of Federal Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the FFDCA, 21
U.S.C. 301 et seq., and the FIFRA, 7 U.S.C. 136 et seq. The FQPA
amendments went into effect immediately. Among other things, FQPA
amends FFDCA to bring all EPA pesticide tolerance-setting activities
under a new section 408 with a new safety standard and new procedures.
These activities are described below and discussed in greater detail in
the final rule establishing the time-limited tolerance associated with
the emergency exemption for use of propiconazole on sorghum (61 FR
58135, November 13, 1996) (FRL 5572-9).
New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is reliable information.'' This
includes exposure through drinking water and in residential settings,
but does not include occupational exposure. Section 408(b)(2)(C)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue.''
Section 18 of FIFRA authorizes EPA to exempt any Federal or State
agency from any provision of FIFRA, if EPA determines that ``emergency
conditions exist which require such exemption.'' This provision was not
amended by FQPA. EPA has established regulations governing such
emergency exemptions in 40 CFR part 166.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment.
Because decisions on section 18-related tolerances must proceed
before EPA reaches closure on several policy issues relating to
interpretation and implementation of the FQPA, EPA does not intend for
its actions on such tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.

[[Page 3004]]

II. Emergency Exemption for Fenpropathrin on Soybeans and FFDCA
Tolerances

The Applicant stated that the two-spotted spider mite is a serious
pest of soybeans in Delaware, and Maryland.
Delaware. During the 1997 field season in Delaware, fields were
sprayed 3-5 times with dimethoate, Lorsban and Parathion. While
dimethoate provided systemic activity, it has been ineffective in
recent years due to reduced systemic activity when fields are drought
stressed resulting in poor absorption and translocation of the chemical
into the leaf tissue. The two-spotted spider mite may also be
developing resistance to dimethoate. Since July 17, 1998, the mite
population in Delaware has begun to explode in soybean fields and
dimethoate applications have not provided control.
Maryland. Maryland's Emergency situation is very similar to
Delaware. They too used dimethoate and Lorsban with control ranging
from 0 to less than 30%. Maryland growers have experienced increasing
problems with spider mites in soybean fields. In 1997, the mite
population reached record high levels on more than 50% of the soybean
acreage and caused significant losses in yield and increased production
costs. Dimethoate has been the chemical of choice in Maryland because
of its systemic and longer residual action. However, numerous control
failures with dimethoate have been reported in 1997. Dimethoate has
been ineffective in recent years due to reduced systemic activity when
fields are drought stressed resulting in poor absorption and
translocation of the chemical into the leaf tissue. In the Eastern
Shore the problem is more intense, control failures are also believed
to be the result of dimethoate-tolerant populations caused by repeated
use of this product over the years. EPA has authorized under FIFRA
section 18 the use of fenpropathrin on soybeans for control of two-
spotted spider mite Tetranychus urticae in Delaware and Maryland. EPA
concurs that emergency conditions exist for this state.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of fenpropathrin in or on
soybeans. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerance under
FFDCA section 408(l)(6) would be consistent with the safety standard
and with FIFRA section 18. Consistent with the need to move quickly on
the emergency exemption in order to address an urgent non-routine
situation and to ensure that the resulting food is safe and lawful, EPA
is issuing this tolerance without notice and opportunity for public
comment under section 408(e), as provided in section 408(l)(6).
Although this tolerance will expire and is revoked on June 30, 2000,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerance remaining in or on soybeans
after that date will not be unlawful, provided the pesticide is applied
in a manner that was lawful under FIFRA, and the residues do not exceed
a level that was authorized by this tolerance at the time of that
application. EPA will take action to revoke this tolerance earlier if
any experience with, scientific data on, or other relevant information
on this pesticide indicate that the residues are not safe.
Because this tolerance is being approved under emergency conditions
EPA has not made any decisions about whether fenpropathrin meets EPA's
registration requirements for use on soybeans or whether a permanent
tolerance for this use would be appropriate. Under these circumstances,
EPA does not believe that this tolerance serves as a basis for
registration of fenpropathrin by a State for special local needs under
FIFRA section 24(c). Nor does this tolerance serve as the basis for any
States other than Delaware and Maryland to use this pesticide on this
crop under section 18 of FIFRA without following all provisions of
EPA's regulations implementing section 18 as identified in 40 CFR part
166. For additional information regarding the emergency exemption for
fenpropathrin, contact the Agency's Registration Division at the
address provided above.

III. Aggregate Risk Assessment and Determination of Safety

EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the Final Rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL 5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action EPA has sufficient data to assess the hazards of
fenpropathrin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
combined residues or residues of fenpropathrin on soybeans at 0.1 ppm.
EPA's assessment of the dietary exposures and risks associated with
establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The nature of the toxic effects caused by fenpropathrin are
discussed below.
1. Acute toxicity. EPA has established the Reference dose (RfD) for
fenpropathrin at 0.06 milligram/kilogram/day (mg/kg/day). This RfD is
based on the risk assessment that was done for synthetic pyrethoids
since fenpropathrin is a member of the synthetic pyrethroids class of
pesticides.
2. Chronic toxicity. EPA has established the RfD for fenpropathrin
at 0.025 mg/kg/day. Since fenpropathrin is a member of the synthetic
pyrethroids class of pesticides, the RfD is based on the risk
assessment that was done for synthetic pyrethoids.

B. Exposures and Risks

1. From food and feed uses. Tolerances have been established (40
CFR 180.180) for the combined residues fenpropathrin, in or on a
variety of raw agricultural commodities at levels ranging from 0.05 ppm
in eggs to 20 ppm in peanut hay. In addition, time-limited tolerances
have been established (40 CFR 190.466(b)) at 15 ppm in currants in
conjunction with previous section 18 requests. Risk assessments were
conducted by EPA to assess dietary exposures and risks from
fenpropathrin as follows.
2. Acute exposure and risk. Acute dietary risk assessments are
performed for a food-use pesticide if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a one day or single exposure. The acute dietary (food only) risk
assessment used the Monte Carlo analysis and provides fenpropathrin
levels on soybeans at 0.05 ppm and assumes that 1% of the total U.S.
soybean acreage was treated. Although this level is half of the soybean
tolerance, it is a reasonable estimate of anticipated residues based on
tolerances for other synthetic pyrethroids. This should be viewed as a
highly refined risk estimate. The risk assessment was applied to all
groups. The exposure estimates for the U.S. population and certain
subgroups are shown in Table 1.

[[Page 3005]]

Table 1. Acute Dietary Exposure Summary
------------------------------------------------------------------------
Theoretical
Maximum Residue
Population Subgroup1 Contribution,2 mg/ % of RfD
kg/day
------------------------------------------------------------------------
U.S. Population (48 States)..... 0.010 17

All Infants (< 1 yr)........... 0.025 42

Nursing Infants (< 1 yr)....... 0.044 73

Children (1-6 yr).............. 0.020 33

Children (7-12 yr)............. 0.012 20

Females (13+).................. 0.007 12
------------------------------------------------------------------------
\1\ The subgroups listed above are: (1) the U.S. population (48 states),
(2) infants and children, (3) females (13+ years of age), and (4)
other subgroups (in this case, none) for which the percentage of the
RfD occupied is greater than that occupied by the subgroup U.S.
population (48 states).
\2\ The theoretical maximum residue contribution is at the 99.9th
percentile.

3. Chronic exposure and risk. In conducting this chronic dietary
risk assessment, EPA made a conservative assumption that 100% of
soybeans and all other commodities having fenpropathrin tolerances will
contain fenpropathrin residues. The existing fenpropathrin tolerances
result in a Theoretical Maximum Residue Contribution (TMRC) that is
equivalent to the percentages of the RfD shown in Table 2.

Table 2. Chronic Dietary Exposure Summary
------------------------------------------------------------------------
Theoretical
Maximum Residue
Population Subgroup1 Contribution, mg/ % of RfD
kg/day
------------------------------------------------------------------------
U.S. Population (48 States) All 0.0026 10
Seasons.

U.S. Population (48 States) 0.0028 11
Autumn Season.

Northeast Region............... 0.0027 11

Midwest Region................. 0.0027 11

Pacific Region................. 0.0027 11

Non-hispanic Other Than Black 0.0030 12
or White.

All Infants (<1 yr)............ 0.0066 27

Non-nursing Infants (<1 yr).... 0.0084 34

Children (1-6 yr).............. 0.0065 26

Children (7-12 yr)............. 0.0044 17

Females (13+ yr, Nursing)....... 0.0027 11
------------------------------------------------------------------------
\1\ The subgroups listed above are: (1) the U.S. population (48 states),
(2) infants and children, and (3) other subgroups for which the
percentage of the RfD occupied is greater than that occupied by the
subgroup U.S. population (48 states).

4. From drinking water. Fenpropathrin is relatively persistent and
not mobile. There are no established Maximum Contaminant Levels or
health advisory levels for fenpropathrin . Acute and chronic exposure
to fenpropathrin residues in drinking water do not exceed EPA's level
of concern.
5. Acute exposure and risk. Based on the acute dietary (food)
exposure estimates, acute drinking water levels of concern (DWLOCs) for
fenpropathrin were calculated and are summarized in Table 3. The acute
exposure to fenpropathrin residues in drinking water do not exceed
EPA's level of concern.

Table 3. Drinking Water Levels of Concern for Acute Dietary Exposure
----------------------------------------------------------------------------------------------------------------
Max. Water
Population1 RfD, mg/kg/day TMRC (Food Exposure2, DWLOC,3,4,5 <greek-
Exposure), mg/kg/day mg/kg/day m>g/L
----------------------------------------------------------------------------------------------------------------
U.S. Population (48 States)..... 0.06 0.0102 0.0498 1,700

Females, 13+..................... 0.06 0.0067 0.0533 1,600

Nursing Infants (< 1 yr)......... 0.06 0.0440 0.0160 160
----------------------------------------------------------------------------------------------------------------
\1\ Populations listed are the U.S. population (48 states), females 13+ years, infants/children, and any
subpopulations whose exposure exceeds that of the U.S. population (48 states). Within each subpopulation, the
group with the highest exposure is listed.
\2\ Maximum Water Exposure (mg/kg/day) = RfD (mg/kg/day) - TMRC from DEEM (mg/kg/day).
\3\ DWLOC(<greek-m>g/L) = Max water exposure (mg/kg/day) * body wt (kg) / (10-3 mg/<greek-m>g) * water consumed
daily (L/day).
\4\ HED Default body wts for males, females, and children are 70 kg, 60 kg, and 10 kg, respectively.
\5\ HED Default Daily Drinking Rates are 2 L/Day for Adults and 1 L/Day for children.

6. Chronic exposure and risk. Based on the chronic dietary (food)
exposure estimates, chronic DWLOCs for fenpropathrin were calculated
and are summarized in Table 4. The chronic exposure to fenpropathrin
residues in drinking water do not exceed EPA's level of concern.

Table 4. Drinking Water Levels of Concern for Chronic Dietary Exposure
----------------------------------------------------------------------------------------------------------------
RfD, TMRC (Food Max. Water
Population1 mg/kg/ Exposure), Exposure2, DWLOC,3,4,5
day mg/kg/day mg/kg/day <greek-m>g/L
----------------------------------------------------------------------------------------------------------------
U.S. Population (48 States) Autumn Season.................... 0.02
5 0.0028 0.022 780

Females (13+ yr, Nursing).................................... 0.02
5 0.0027 0.022 670

[[Page 3006]]

Non-nursing Infants (<1 yr).................................. 0.02
5 0.0084 0.017 170

Non-hispanic Other Than Black or White....................... 0.02
5 0.0030 0.022 770
----------------------------------------------------------------------------------------------------------------
\1\ Populations listed are the U.S. population (48 states), females 13+ years, infants/children, and any
subpopulations whose exposure exceeds that of the U.S. population (48 states). Within each subpopulation, the
group with the highest exposure is listed.
\2\ Maximum Water Exposure (mg/kg/day) = RfD (mg/kg/day) - TMRC from DEEM (mg/kg/day).
\3\ DWLOC(<greek-m>g/L) = Max water exposure (mg/kg/day) * body wt (kg) / (10<INF>-3 mg/<greek-m>g) * water consumed
daily (L/day).
\4\HED Default body wts for males, females, and children are 70 kg, 60 kg, and 10 kg, respectively.
\5\ HED Default Daily Drinking Rates are 2 L/Day for Adults and 1 L/Day for children.

7. From non-dietary exposure. Fenpropathrin has no registered
residential uses. There are registered uses for non-food sites,
however, exposures are expected for workers only (i.e., greenhouse
use).
8. Cumulative exposure to substances with common mechanism of
toxicity. Section 408(b)(2)(D)(v) requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA does not have, at this time, available data to determine
whether fenpropathrin has a common mechanism of toxicity with other
substances or how to include this pesticide in a cumulative risk
assessment. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity,
fenpropathrin does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has not assumed that fenpropathrin has a common mechanism of
toxicity with other substances. For more information regarding EPA's
efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
the Final Rule for Bifenthrin Pesticide Tolerances (62 FR 62961,
November 26, 1997).

C. Aggregate Risks and Determination of Safety for U.S. Population

1. Acute risk. Using the food exposure assumptions, and taking into
account the completeness and reliability of the toxicity data, EPA
concludes that dietary (food only) exposure to fenpropathrin will
utilize 17% of the acute RfD for the U.S. population. In the absence of
additional safety factors, EPA generally has no concern for exposures
below 100% of the RfD because the acute RfD represents the level at or
below which an acute exposure will not pose an appreciable risk to
human health. Despite the potential for exposure to fenpropathrin in
drinking water and through occupational (e.g., commercial greenhouse)
use, EPA does not expect the aggregate exposure to exceed 100% of the
RfD.
2. Chronic risk. Using the food exposure assumptions, and taking
into account the completeness and reliability of the toxicity data, EPA
concludes that dietary (food only) exposure to fenpropathrin will
utilize 10% of the chronic RfD for the U.S. population. In the absence
of additional safety factors, EPA generally has no concern for
exposures below 100% of the RfD because the chronic RfD represents the
level at or below which daily aggregate dietary exposure over a
lifetime will not pose appreciable risks to human health. Despite the
potential for exposure to fenpropathrin in drinking water, EPA does not
expect the aggregate exposure to exceed 100% of the RfD. The non-food
sites (e.g., greenhouse uses) for which fenpropathrin is registered
would not fall under a chronic scenario. There is a reasonable
certainty that no harm will result to the U.S. population from chronic
aggregate exposure to fenpropathrin residues.
Short- and intermediate-term aggregate exposure takes into account
chronic dietary food and water (considered to be a background exposure
level) plus indoor and outdoor residential exposure. No endpoint was
selected for short-and intermediate-term dermal or inhalation
exposures. This risk assessment is not required.
3. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
from aggregate exposure to fenpropathrin residues.

D. Aggregate Risks and Determination of Safety for Infants and Children

1. Safety factor for infants and children--In general. In assessing
the potential for additional sensitivity of infants and children to
residues of fenpropathrin, EPA considered data from developmental
toxicity studies in the rat and rabbit and a 2-generation reproduction
study in the rat. The developmental toxicity studies are designed to
evaluate adverse effects on the developing organism resulting from
maternal pesticide exposure during gestation. Reproduction studies
provide information relating to pre- and post-natal effects from
exposure to the pesticide on the reproductive capability of mating
animals and data on systemic toxicity.
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for pre-and post-natal toxicity and the
completeness of the database unless EPA determines that a different
margin of safety will be safe for infants and children. Margins of
safety are incorporated into EPA risk assessments either directly
through use of a margin of exposure (MOE) analysis or through using
uncertainty (safety) factors in calculating a dose level that poses no
appreciable risk to humans. EPA believes that reliable data support
using the standard MOE and uncertainty factor (usually 100 for combined
inter- and intra-species variability)) and not the additional tenfold
MOE/uncertainty factor when EPA has a complete data base under existing
guidelines and when the severity of the effect in infants or children
or the potency or unusual toxic properties of a compound do not raise
concerns regarding the adequacy of the standard MOE/safety factor.

[[Page 3007]]

2. Developmental toxicity studies--i. Rats. In the developmental
study in rats, the maternal (systemic) no observed adverse effect level
(NOAEL) was 6 mg/kg/day. The maternal lowest adverse effect level
(LOAEL) of 10 mg/kg/day was based on death, moribundity, ataxia,
hypersensitivity, spastic jumping, tremors, prostration, convulsions,
hunched posture, squinting eyes, chromodacryorrhea, and lacrimation.
The developmental (fetal) NOAEL was >10 mg/kg/day, the highest dose
tested (HDT).
ii. Rabbits. In the developmental toxicity study in rabbits, the
maternal (systemic) NOAEL was 4 mg/kg/day. The maternal LOAEL of 12 mg/
kg/day was based on anorexia, grooming, and flicking of the forepaws.
The developmental (fetal) NOAEL was >36 mg/kg/day at the HDT.
3. Reproductive toxicity study-- Rats. In the 3-generation
reproductive toxicity study in rats, the parental (systemic) NOAEL was
3 mg/kg/day. The parental (systemic) LOAEL of 8.9 mg/kg/day was based
on body tremors with spasmodic muscle twitches, increased sensitivity
and maternal lethality. The developmental NOAEL was 3.0 mg/kg/day. The
developmental LOAEL of 8.9 mg/kg/day was based on body tremors and
increased pup mortality. The reproductive NOAEL was 8.9 mg/kg/day. The
reproductive LOAEL of 26.9 mg/kg/day was based on decreased
F1B pup weight and increased pup loss in the F2B
generation.
4. Conclusion. There is a complete toxicity database for
fenpropathrin and exposure data is complete or is estimated based on
data that reasonably accounts for potential exposures.
5. Acute risk. Using the food exposure assumptions described above
(Acute Dietary Risk), and taking into account the completeness and
reliability of the toxicity data, EPA concludes that dietary (food
only) exposure to fenpropathrin will utilize 73% of the acute RfD for
the U.S. population subgroup nursing infants (< 1 yr). This is the
maximally exposed subgroup in the infants and children categories. In
the absence of additional safety factors, EPA generally has no concern
for exposures below 100% of the RfD because the acute RfD represents
the level at or below which an acute exposure will not pose an
appreciable risk to human health. Despite the potential for exposure to
fenpropathrin in drinking water, EPA does not expect the aggregate
exposure to exceed 100% of the RfD.
6. Chronic risk. Using the food exposure assumptions described
above (Chronic Dietary Risk), and taking into account the completeness
and reliability of the toxicity data, EPA concludes that the percentage
of the RfD that will be utilized by dietary (food only) exposure to
residues of fenpropathrin ranges from 9.6% for nursing infants (<1 yr)
up to 34% for non-nursing infants (< 1 yr). In the absence of
additional safety factors, EPA generally has no concern for exposures
below 100% of the RfD because the RfD represents the level at or below
which daily aggregate dietary exposure over a lifetime will not pose
appreciable risks to human health. Despite the potential for exposure
to fenpropathrin in drinking water, EPA does not expect the aggregate
exposure to exceed 100% of the RfD. The non-food sites (e.g.,
greenhouse use) for which fenpropathrin is registered would not fall
under a chronic scenario.
7. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to infants and children from aggregate exposure to fenpropathrin
residues.

IV. Other Considerations

Adequate enforcement methodology (example - gas chromotography) is
available to enforce the tolerance expression. The method may be
requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide
Programs, Environmental Protection Agency, 401 M St., SW., Washington,
DC 20460. Office location and telephone number: Rm 101FF, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA 22202, (703-305-5229).

A. Magnitude of Residues

Crop residue studies of fenpropathrin in/on soybeans were not
available for review. In lieu of soybean residue data, EPA considered
residue data from grapes and peanuts. Pyrethroid insecticides are non-
systemic; therefore, residues of fenpropathrin in soybean seed are not
expected to be as high as those on ``exposed'' crop commodities (e.g.,
grapes). Because of this, EPA also used data from other pyrethroid
insecticides (fenvalerate, lambda-cyhalothrin, permethrin,
tralomethrin) that are registered for use on soybeans to determine the
appropriate tolerance for soybean seed. Residue data from the above-
ground parts of peanut commodities were used to determine appropriate
tolerances for soybean forage and hay. Because a soybean processing
study was not available for review, the maximum theoretical
concentration factors were used to derive tolerances for the soybean
processed commodities aspirated grain fractions, meal, hulls, and
refined oil from the soybean seed tolerance.

Residues of fenpropathrin are not expected to exceed the following
values for soybean:
<bullet> Aspirated grain fractions----20 ppm
<bullet> Soybean, forage----15 ppm
<bullet> Soybean, hay----20 ppm
<bullet> Soybean, seed----0.1 ppm

or the following values for processed soybean commodities:

<bullet> Soybean, hulls----1.0 ppm
<bullet> Soybean, meal----0.2 ppm
<bullet> Soybean, oil, refined----1.5 ppm

Existing tolerances for fenpropathrin in animal commodities are
listed in 40 CFR 180.466. Secondary residues in animal commodities are
not expected to exceed existing tolerances.

V. Conclusion

Therefore, the tolerance is established for combined residues or
residues of fenpropathrin in soybeans at 0.1 ppm.

VI. Objections and Hearing Requests

The new FFDCA section 408(g) provides essentially the same process
for persons to ``object'' to a tolerance regulation issued by EPA under
new section 408(e) and (l)(6) as was provided in the old section 408
and in section 409. However, the period for filing objections is 60
days, rather than 30 days. EPA currently has procedural regulations
which govern the submission of objections and hearing requests. These
regulations will require some modification to reflect the new law.
However, until those modifications can be made, EPA will continue to
use those procedural regulations with appropriate adjustments to
reflect the new law.
Any person may, by March 22, 1999, file written objections to any
aspect of this regulation and may also request a hearing on those
objections. Objections and hearing requests must be filed with the
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of
the objections and/or hearing requests filed with the Hearing Clerk
should be submitted to the OPP docket for this rulemaking. The
objections submitted must specify the provisions of the regulation
deemed objectionable and the grounds for the objections (40 CFR
178.25). Each objection must be accompanied by the fee prescribed by 40
CFR 180.33(i). If a hearing is requested, the objections must include a
statement of the factual issues on which a hearing is requested, the
requestor's contentions on such issues, and a summary of any evidence
relied upon by the requestor (40 CFR 178.27). A request for a hearing
will be granted if

[[Page 3008]]

the Administrator determines that the material submitted shows the
following: There is genuine and substantial issue of fact; there is a
reasonable possibility that available evidence identified by the
requestor would, if established, resolve one or more of such issues in
favor of the requestor, taking into account uncontested claims or facts
to the contrary; and resolution of the factual issues in the manner
sought by the requestor would be adequate to justify the action
requested (40 CFR 178.32). Information submitted in connection with an
objection or hearing request may be claimed confidential by marking any
part or all of that information as CBI. Information so marked will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2. A copy of the information that does not contain CBI must be
submitted for inclusion in the public record. Information not marked
confidential may be disclosed publicly by EPA without prior notice.

VII. Public Record and Electronic Submissions

EPA has established a record for this rulemaking under docket
control number [OPP-300763] (including any comments and data submitted
electronically). A public version of this record, including printed,
paper versions of electronic comments, which does not include any
information claimed as CBI, is available for inspection from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in Room 119 of the Public Information and Records
Integrity Branch, Information Resources and Services Division (7502C)
Office of Pesticide Programs, Environmental Protection Agency, Crystal
Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments may be sent directly to EPA at:
opp-docket@epamail.epa.gov.

Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.

VIII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

This final rule establishes a tolerance/exemption from the
tolerance requirement under FFDCA section 408 (l)(6). The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since tolerances and exemptions that are established
under FFDCA section 408 (l)(6), such as the tolerance/exemption in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. Nevertheless, the Agency has previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance acations published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.

B. Executive Order 12875

Under Executive Order 12875, entitled Enhancing the
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may
not issue a regulation that is not required by statute and that creates
a mandate upon a State, local, or tribal government, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by those governments. If the mandate is unfunded, EPA
must provide to OMB a description of the extent of EPA's prior
consultation with representatives of affected State, local, and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local, and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create an unfunded Federal mandate on State,
local, or tribal governments. The rule does not impose any enforceable
duties on these entities. Accordingly, the requirements of section 1(a)
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

Under Executive Order 13084, entitled Consultation and Coordination
with Indian Tribal Governments (63 FR 27655, May 19,1998), EPA may not
issue a regulation that is not required by statute, that significantly
or uniquely affects the communities of Indian tribal governments, and
that imposes substantial direct compliance costs on those communities,
unless the Federal government provides the funds necessary to pay the
direct compliance costs incurred by the tribal governments. If the
mandate is unfunded, EPA must provide to OMB, in a separately
identified section of the preamble to the rule, a description of the
extent of EPA's prior consultation with representatives of affected
tribal governments, a summary of the nature of their concerns, and a
statement supporting the need to issue the regulation. In addition,
Executive Order 13084 requires EPA to develop an effective process
permitting elected officials and other representatives of Indian tribal
governments ``to provide meaningful and timely input in the development
of regulatory policies on matters that significantly or uniquely affect
their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. This action does not involve
or impose any requirements that affect Indian tribes. Accordingly, the
requirements of

[[Page 3009]]

section 3(b) of Executive Order 13084 do not apply to this rule.

IX. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

Dated: January 6, 1999.

James Jones,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:

PART 180 -- [AMENDED]

1. The authority citation for part 180 continues to read as
follows:

Authority: 21 U.S.C. 346a and 371.

2. In Sec. 180.466, by alphabetically adding the following
commodities to the table in paragraph (b) to read as follows:

Sec. 180.466 Fenpropathrin; tolerances for residues.

* * * * *
(b)* * *

------------------------------------------------------------------------
Expiration/
Commodity Parts per million Revocation Date
------------------------------------------------------------------------

* * * * *
Soybean, forage................. 15 6/30/00

Soybean, hay.................... 20 6/30/00

Soybean, hulls.................. 1.0 6/30/00

Soybean, meal................... 0.2 6/30/00

Soybean, oil, refined........... 1.5 6/30/00

Soybean, seed................... 0.1 6/30/00
------------------------------------------------------------------------

* * * * *

[FR Doc. 99-1254 Filed 1-19-99; 8:45 am]
BILLING CODE 6560-50-F

Fenpropathrin; Pesticide Tolerances for Emergency Exemptions

Local Navigation