[Federal Register Volume 64, Number 41 (Wednesday, March 3, 1999)]
[Rules and Regulations]
[Pages 10227-10233]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4832]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300794; FRL-6062-4]
RIN 2070-AB78
Pyriproxyfen; Pesticide Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes time-limited tolerances for
residues of pyriproxyfen in or on almond nutmeats and hulls, and stone
fruits (Crop Group 12, see 40 CFR 180.41). This action is in response
to EPA's granting of emergency exemptions under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
the pesticide on almonds and stone fruits. This regulation establishes
maximum permissible levels for residues of pyriproxyfen in these food
commodities pursuant to section 408(l)(6) of the Federal Food, Drug,
and Cosmetic Act, as amended by the Food Quality Protection Act of
1996. The tolerances for almond nut meats and hulls will expire and are
revoked on April 30, 2002. The tolerance for stone fruits will expire
and is revoked on August 31, 2000. This document will remove a second
section (Sec. 180.534) published in the Federal Register on July 6,
1998 (63 FR 36366) which subsequently added pyriproxifen as a permanent
tolerance on cotton seed and cotton gin byproducts.
DATES: This regulation is effective March 3, 1999. Objections and
requests for hearings must be received by EPA on or before May 3, 1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300794], 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-300794], 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@epa.gov. Copies of electronic 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 electronic objections and hearing
requests must be identified by the docket control number [OPP-300794].
No Confidential Business Information (CBI) should be submitted through
e-mail. Copies of electronic objections and hearing requests on this
rule may be filed online at many Federal Depository Libraries.
FOR FURTHER INFORMATION CONTACT: For pyriproxyfen on almonds: Andrea
Beard, (703)308-9356, beard.andrea@epa.gov; for pyriproxyfen on stone
fruits: Andrew Ertman,
[[Page 10228]]
(703)308-9367, ertman.andrew@epa.gov; Office location (both): Crystal
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. Mailing address
(both) Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to
sections 408 and (l)(6) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a and (l)(6), is establishing tolerances for
residues of the insect growth regulator pyriproxyfen, in or on almond
nutmeats and hulls at 0.02 and 2.0 parts per million (ppm),
respectively, and in or on stone fruits at 0.1 ppm. The tolerances for
almond nut meats and hulls will expire and are revoked on April 30,
2002. The tolerance for stone fruits will expire and is revoked on
August 31, 2000. EPA will publish a document in the Federal Register to
remove the revoked tolerances from the Code of Federal Regulations.
EPA published in the Federal Register on July 25, 1997 (62 FR
39962) (FRL-5731-9) a time-limited tolerance for residues of
pyriproxifen in or on cotton seed and cotton gin byproducts (40 CFR
180.510). Subsequently, on July 6, 1998 (63 FR 36366) (FRL-5794-6), EPA
issued a permanent tolerance for pyriproxyfen on cotton seed and cotton
gin byproducts in response to a petition by Valent U.S.A. Corporation
(40 CFR 180.534). Through oversight, tolerances have been established
for residues of pyriproxyfen on cotton seed and cotton gin byproducts
in two different sections of 40 CFR part 180. EPA is revising
Sec. 180.510 to add the permanent tolerance of Sec. 180.534(a) and will
remove Sec. 180.534.
I. Background and Statutory Findings
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (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 in this preamble 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.
II. Emergency Exemption for Pyriproxyfen on Almonds and Stone
Fruits and FFDCA Tolerances
Almonds: The situation involving the discovery of Red Imported Fire
Ant (RIFA) mounds in California almond orchards is urgent and non-
routine, as this is a new pest which may become a serious economic pest
as well as a public health pest in California, if its spread is not
checked at this point. The Applicant states that a RIFA infestation
could cause significant economic impacts to the affected growers, as
well as other agricultural and non-agricultural interests for years to
come. There are significant potential long-term losses, as well as the
adverse impacts to other growers and entities, should RIFA infestations
become established in the area
Stone Fruits: California has requested the use of pyriproxyfen due
to the development of organophosphate-resistant San Jose scale
populations. According to the Applicant, decades of organophosphate and
carbamate insecticide usage, with no alternative modes of action have
led to a build-up of these resistant populations. Individual orchards
are now experiencing significant yield losses despite multiple
insecticide applications. There are currently no insecticides
registered for San Jose scale control in stone fruits which do not use
acetyl-cholinesterase inhibition as their mode of action. Once a scale
population takes over an orchard, it is difficult to bring it under
control. Heavy infestations kill off branches and reduce yields. EPA
has authorized under FIFRA section 18 the use of pyriproxyfen on
almonds and stone fruits for control of Red Imported Fire Ants, and
Resistant San Jose Scale, respectively in California. After having
reviewed the submission, EPA concurs that emergency conditions exist
for this state.
As part of its assessment of these emergency exemptions, EPA
assessed the potential risks presented by residues of pyriproxyfen in
or on almond nutmeats and hulls, and stone fruits. In doing so, EPA
considered the safety standard in FFDCA section 408(b)(2), and EPA
decided that the necessary tolerances 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 these tolerances
without notice and opportunity for public comment under section 408(e),
as provided in section 408(l)(6). Although the tolerance for stone
fruit will expire and is revoked on August 31, 2000, and the tolerances
for almond commodities will expire and are revoked on April 30, 2002,
under FFDCA section 408(l)(5), residues of the pesticide not in excess
of the amounts specified in the tolerances remaining in or on almond
nutmeats and hulls, or stone fruits after these dates will not be
unlawful, provided the pesticide is
[[Page 10229]]
applied in a manner that was lawful under FIFRA, and the residues do
not exceed levels that were authorized by these tolerances at the time
of that application. EPA will take action to revoke these tolerances
earlier if any experience with, scientific data on, or other relevant
information on this pesticide indicate that the residues are not safe.
Because these tolerances are being approved under emergency
conditions EPA has not made any decisions about whether pyriproxyfen
meets EPA's registration requirements for use on almonds and stone
fruits or whether permanent tolerances for this use would be
appropriate. Under these circumstances, EPA does not believe that these
tolerance serve as a basis for registration of pyriproxyfen by a State
for special local needs under FIFRA section 24(c). Nor does this
tolerance serve as the basis for any State other than California to use
this pesticide on these crops 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 exemptions for pyriproxyfen, contact the Agency's
Registration Division at the address provided under the ADDRESSES
section.
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
pyriproxyfen and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for time-limited tolerances for
residues of pyriproxyfen on almond nutmeats and hulls, and stone fruits
at 0.02, 2.0, and 0.1 ppm, respectively. EPA's assessment of the
dietary exposures and risks associated with establishing the tolerances
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 pyriproxyfen are
discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. There are no acute dietary endpoints of concern
for pyriproxyfen. No concern exists for acute dietary exposure to
pyriproxyfen residues.
2. Short - and intermediate - term toxicity. There are no endpoints
and no concern exists for short- or intermediate-term toxicity from
pyriproxyfen.
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for pyriproxyfen at 0.35 milligrams/kilogram/day (mg/kg/day). This RfD
is based on 2-year and 90-day feeding studies in rats with a NOEL of
35.1 mg/kg/day and an uncertainty factor of 100, based on intra- and
interspecies differences. At the LOEL of 141 mg/kg/day, there was a
decrease in body weight gain in females.
4. Carcinogenicity. Pyriproxyfen has been classified in Group E of
EPA's cancer classification system, indicating there is evidence of
non-carcinogenicity for humans. Therefore, there is no concern for
cancer risk from exposure to pyriproxyfen.
C. Exposures and Risks
1. From food and feed uses. Time-limited tolerances have been
established (40 CFR 180.510) for the residues of pyriproxyfen, in or on
tomatoes, pears, and citrus commodities, in association with use under
emergency exemptions. Permanent tolerances were recently established
for cotton commodities (July 6, 1998, 63 FR 36366). Risk assessments
were conducted by EPA to assess dietary exposures and risks from
pyriproxyfen as follows:
i. 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 1-day or single exposure. An acute dietary dose and endpoint was
not identified in the database. The Agency concludes that there is a
reasonable certainty of no harm from acute dietary exposure.
ii. Chronic exposure and risk. As stated above, tolerances for
cotton commodities were recently established, and there are time-
limited tolerances established in connection with use under emergency
exemptions for citrus commodities, pears, and tomatoes. The chronic
dietary (food only) risk assessment used tolerance level residues and
assumed 100% crop treated. The Novigen Dietary Exposure Evaluation
Model (DEEM) analysis was used and this analysis evaluates individual
food consumption as reported by respondents in the USDA Continuing
Surveys of Food Intake by Individuals conducted in 1989 through 1992.
The model accumulates exposure to the chemical for each commodity and
expresses risk as a function of dietary exposure. Resulting exposure
values (at the 99th percentile) and percentage of the acute RfD are
given below. Values for the 99th percentile are considered to be
conservative as OPP policy dictates exposure estimates from as low as
the 95th percentile may be utilized for risk estimates from DEEM runs.
Thus, these results are viewed as conservative estimates, and
refinement using anticipated residue values and percent crop treated
information, would result in lower estimates of acute dietary exposure
and risk. For chronic dietary (food only) risk estimates, the two most
highly exposed subgroups, Children (1-6 years old) and Children (1-7
years old) had 1.9 and 1.2% of the RfD utilized, respectively. All
other population subgroups had less than 1% of the RfD utilized, except
for Non-hispanic other than black or white, which had 1.1% of the RfD
utilized.
2. From drinking water. Tier II drinking water assessment of
pyriproxyfen was conducted, using computer models which simulate the
fate in a surface water body. The estimated environmental
concentrations (EECs) are generated for high exposure agricultural
scenarios and represent one in ten years EECs in a stagnant pond with
no outlet that receives pesticide loading from an adjacent 100%
cropped, 100% treated field. As such, these computer generated EECs
represent conservative screening levels for ponds and lakes and are
used only for screening. The EECs for surface water ranged from a peak
of 0.677 part per billion (ppb), to a 60-day average of 0.142 ppb, to a
1-year average of 0.103 ppb. These estimates are based on 2
applications at a rate of 0.11 lb. active ingredient per acre. For
ground water, a computer model was used which resulted in estimated 60-
day average concentrations of pyriproxyfen of 0.006 ppb.
i. Acute exposure and risk. An acute dietary dose and endpoint was
not identified in the database. The Agency concludes that there is a
reasonable certainty of no harm from acute exposure through drinking
water.
[[Page 10230]]
ii. Chronic exposure and risk. A human health drinking water level
of comparison (DWLOC) is the concentration in drinking water that would
be acceptable as an upper limit in light of total aggregate exposure to
that chemical from food, water, and non-occupational (residential)
sources. The DWLOC for chronic risk is the concentration in drinking
water as a part of the aggregate chronic exposure, that occupies no
more than 100% of the RfD. In conducting these calculations, default
body weights are used of 70 kg (adult male), 60 kg (adult female) and
10 kg (child); default consumption values of water are used of 2L per
day for adults and 1L per day for children. Using these assumptions and
the levels provided by the computer models, given above, the DWLOCs
were calculated to be 12,168 and 3,436 ppb, for the Overall U.S.
population, and Children (1-6 Yrs. old), respectively. Since these
levels are very significantly higher than the EECs calculated above,
EPA concludes that there is reasonable certainty of no harm if these
tolerances are established.
3. From non-dietary exposure. Pyriproxyfen is currently registered
for use on the following residential non-food sites: products for flea
and tick control, including foggers, aerosol sprays, emulsifiable
concentrates, and impregnated material (pet collars).
i. Acute exposure and risk. An acute endpoint was not identified in
the database. The Agency concludes that there is a reasonable certainty
of no harm from acute residential non-food exposure.
ii. Chronic exposure and risk. With the exception of the pet collar
use, consumer use of these residential-use products typically results
in short-term, intermittent exposures. Hence, chronic residential
exposure and risk assessments were conducted to estimate the potential
risks from pet collar uses only. The estimated chronic term Margins of
Exposure (MOEs) was 230,000 for children, and 430,000 for adults, which
indicates that potential risks from pet collar uses do not exceed
levels of concern. (An MOE of 100 or more is generally considered to be
of no concern.)
iii. Short- and intermediate-term exposure and risk. There are no
endpoints and no concern exists for short- or intermediate-term
toxicity from pyriproxyfen.
4. 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 pyriproxyfen 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,
pyriproxyfen 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 pyriproxyfen 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).
D. Aggregate Risks and Determination of Safety for U.S. Population
1. Acute risk. There are no acute endpoints of concern for
pyriproxyfen. No concern exists for acute exposure to pyriproxyfen
residues.
2. Chronic risk. Using the TMRC exposure assumptions described in
this unit, EPA has concluded that aggregate exposure to pyriproxyfen
from food will utilize 0.7%, respectively of the RfD for the U.S.
population. The major identifiable subgroup with the highest aggregate
exposure is Children (1 - 6 years old with 1.9% of the RfD utilized by
food. This is discussed further below. 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 pyriproxyfen in drinking water and from non-dietary, non-
occupational exposure, EPA does not expect the aggregate exposure to
exceed 100% of the RfD.
3. Short- and intermediate-term risk. 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.
There are no endpoints and no concern exists for short- or
intermediate-term toxicity from pyriproxyfen.
4. Aggregate cancer risk for U.S. population. Pyriproxyfen has been
classified in Group E of EPA's cancer classification system, indicating
there is evidence of non-carcinogenicity for humans. Therefore, there
is no concern for cancer risk from exposure to pyriproxyfen.
5. 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 pyriproxyfen residues.
E. Aggregate Risks and Determination of Safety for Infants and Children
1. Safety factor for infants and children-- i. In general. In
assessing the potential for additional sensitivity of infants and
children to residues of pyriproxyfen, 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 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.
ii. Developmental toxicity studies. In the developmental study in
rats, the maternal (systemic) NOEL was 100 mg/kg/day, based on
decreased bodyweight, body weight gain, food consumption, and increased
water consumption at the LOEL of 300 mg/kg/day. The developmental
(fetal) NOEL was 300 mg/kg/day, based on increased skeletal variations
and unspecified visceral variations at the LOEL of 1000 mg/kg/day.
[[Page 10231]]
In the developmental toxicity study in rabbits, the maternal
(systemic) NOEL was 100 mg/kg/day, based on abortions, soft stools,
emaciation, decreased activity, and bradypnea at the LOEL of 300 mg/kg/
day. The developmental (pup) NOEL was 300 mg/kg/day, based on decreased
viable litters available for examination at the LOEL of 1000 mg/kg/day.
iii. Reproductive toxicity study. In the 2-generation reproductive
toxicity study in rats, the maternal (systemic) NOEL was 87/96 mg/kg/
day for Males/Females, based on decreased body weights, body weight
gains, and increased liver weight associated with histopathological
findings in the liver at the LOEL of 453/498 mg/kg/day for M/F. The
developmental (pup) NOEL was 87/96 mg/kg/day, based on decreased body
weight on lactation days 14 and 21 at the LOEL of 453/498 mg/kg/day.
The reproductive NOEL was 453/498 mg/kg/day for M/F (the highest dose
tested).
iv. Pre- and post-natal sensitivity. In both rats and rabbits,
developmental studies demonstrated that the developmental findings
occurred at dose levels at which maternal toxicity was also present,
demonstrating no special pre-natal sensitivity for developing fetuses.
In the post-natal evaluation to infants and children, as shown in the
results of the rat reproduction study, the NOEL and LOEL for both
parental systemic toxicity and pup toxicity occurred at the same dose
levels, demonstrating no special post-natal sensitivity for infants and
children.
v. Conclusion. Given the fact that there is a complete toxicity
data base for pyriproxyfen, and no special pre- or post- natal
sensitivities are indicated for infants and children, an additional 10-
fold safety factor is not warranted. EPA concludes that there is
reasonable certainty of safety for infants and children exposed to
dietary residues of pyriproxyfen.
2. Acute risk. There are no acute dietary endpoints of concern for
pyriproxyfen. No concern exists for acute dietary exposure to
pyriproxyfen residues.
3. Chronic risk. Using the conservative exposure assumptions
described in this unit, EPA has concluded that aggregate exposure to
pyriproxyfen from food will utilize 1.9% of the RfD for the most highly
exposed infant and children population subgroup, Children (1 - 6 years
old). 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. The risk from drinking water is conservatively estimated
to utilize 0.35% of the RfD for infants and children, as discussed
above. Despite the potential for exposure to pyriproxyfen in drinking
water and from non-dietary, non-occupational exposure, EPA does not
expect the aggregate exposure to exceed 100% of the RfD. EPA concludes
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to pyriproxyfen residues.
4. Short- or intermediate-term risk. There are no endpoints and no
concern exists for short- or intermediate-term toxicity from
pyriproxyfen.
5. 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 pyriproxyfen
residues.
IV. Other Considerations
A. Metabolism In Plants and Animals
For the purposes of these uses under section 18, the nature of the
residue in plants is adequately understood, and the residue to be
regulated is parent pyriproxyfen per se [4-phenoxyphenyl (RS)-2-(2-
pyridyloxy)propyl ether. There are no detectable residues expected in
animal commodities as a result of these uses.
B. Analytical Enforcement Methodology
Adequate analytical methodology is available to enforce the
tolerance expression, in residue analytical method RM-33P-2 using gas
chromatography with a nitrogen-phosphorus detector. This has been
validated by EPA and 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, (703) 305-5229.
C. Magnitude of Residues
Residues of pyriproxyfen are not expected to exceed 0.02 ppm in/on
almond nutmeat, 2.0 ppm in/on almond hulls, and 0.1 ppm in/on stone
fruits; no detectable residues are expected to occur in animal
commodities, as a result of these emergency exemption uses.
D. International Residue Limits
There are no Canadian, Mexican, or Codex maximum residue limits
(MRLs) for residues of pyriproxyfen in/on almond nutmeats or hulls, or
stone fruits.
E. Rotational Crop Restrictions
There are no applicable rotational crop restrictions for these
emergency exemption uses.
V. Conclusion
Therefore, the tolerances are established for residues of
pyriproxyfen in almond nutmeats and hulls at 0.02 and 2.0 ppm,
respectively, and on stone fruits 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 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 May 3, 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 under the ``ADDRESSES'' section (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). EPA is authorized to waive any fee requirement
``when in the judgement of the Administrator such a waiver or refund is
equitable and not contrary to the purpose of this subsection. For
additional information regarding tolerance objection fee waivers,
contact James Tompkins, 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: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy.,
Arlington, VA, (703) 305-5697, tompkins.jim@epa.gov. Requests for
waiver of tolerance objection fees should be sent to James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection
[[Page 10232]]
Agency, 401 M St., SW., Washington, DC 20460.
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 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 regulation under docket
control number [OPP-300794] (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 Hwy., Arlington, VA.
Objections and hearing requests may be sent by e-mail directly to
EPA at:
opp-docket@epa.gov.
E-mailed objections and hearing requests must be submitted as an
ASCII file avoiding the use of special characters and any form of
encryption.
The official record for this regulation, as well as the public
version, as described in this unit 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 record which
will also include all comments submitted directly in writing. The
official 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 under section 408 of the
FFDCA. 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
on the basis of a petition under FFDCA section 408(l)(6), such as the
tolerance 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 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 actions 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 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
[[Page 10233]]
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 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 the Comptroller General of the United
States. EPA will submit a report containing this rule and other
required information to 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: February 11, 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. Section 180.510 is revised to read as follows:
Sec. 180.510 Pyriproxyfen; tolerances for residues.
(a) General. Tolerances are established for combined residues of
the insecticide pyriproxyfen in or on the following agricultural
commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cotton, gin byproducts.................... 2.0
Cottonseed................................ 0.05
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the residues of the insect growth regulator
pyriproxyfen, in connection with the use of the pesticide under section
18 emergency exemptions granted by EPA. The tolerances will expire on
the dates specified in the following table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Almond hulls.................... 2.0 4/30/02
Almond nutmeats................. 0.02 4/30/02
Citrus fruit.................... 0.3 7/31/99
Citrus juice.................... 1.0 7/31/99
Citrus oil...................... 300 7/31/99
Citrus pulp, dried.............. 1.0 7/31/99
Pears........................... 0.2 7/31/99
Stone fruits (Crop Group 12).... 0.1 8/31/00
Tomatoes........................ 0.1 7/31/99
------------------------------------------------------------------------
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
Sec. 180.534 [Removed]
3. Section 180.534 is removed.
[FR Doc. 99-4832 Filed 3-2-99; 8:45 am]
BILLING CODE 6560-50-F
