[Federal Register Volume 64, Number 12 (Wednesday, January 20, 1999)]
[Rules and Regulations]
[Pages 3003-3009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1254]


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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.

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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: [email protected]. 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: 
[email protected].

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 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(g/L) = Max water exposure (mg/kg/day) * body wt (kg) / (10-3 mg/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     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(g/L) = Max water exposure (mg/kg/day) * body wt (kg) / (10-3 mg/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:
      Aspirated grain fractions----20 ppm
      Soybean, forage----15 ppm
      Soybean, hay----20 ppm
      Soybean, seed----0.1 ppm

or the following values for processed soybean commodities:

      Soybean, hulls----1.0 ppm
      Soybean, meal----0.2 ppm
      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:
    [email protected].


    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