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Lambda-cyhalothrin. January 29, 1999, Pesticide Tolerances for Emergency Exemptions. Federal Register.
http://www.epa.gov/fedrgstr/EPA-PEST/1999/January/Day-29/p2208.htm
[Federal Register: January 29, 1999 (Volume 64, Number 19)]
[Rules and Regulations]
[Page 4584-4590]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ja99-17]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300780; FRL-6056-2]
RIN 2070-AB78
Lambda-cyhalothrin; 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 the
combined residues of lambda-cyhalothrin and its epimer in or on flax,
barley, canola, and sugarcane. This action is in response to EPA's
granting of an emergency exemption under section 18 of the Federal
Insecticide, Fungicide, and Rodenticide Act authorizing use of the
pesticide on flax, barley, canola, and sugarcane. This regulation
establishes maximum permissible levels for residues of lambda-
cyhalothrin 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. These tolerances will expire and are
revoked on December 31, 2000.
DATES: This regulation is effective January 29, 1999. Objections and
requests for hearings must be received by EPA on or before March 30,
1999.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number [OPP-300780], 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-300780], 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-300780].
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: By mail: Andrew Ertman, 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. 272, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9367, e-mail:
ertman.andrew@epa.gov.
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 a tolerances for
the combined residues of the insecticide lambda-cyhalothrin and its
epimer, in or on flax seed at 0.1 parts per million (ppm), barley bran
at 0.2 ppm, barley grain at 0.05 ppm, barley hay at 2.0 ppm, barley
straw at 2.0 ppm, canola seed at 0.1 ppm and sugarcane at 0.03 ppm.
These tolerances will expire and are revoked on December 31, 2000. EPA
will publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations.
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 preeamble 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
[[Page 4585]]
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 Lambda-cyhalothrin on Flax, Barley,
Canola, and Sugarcane and FFDCA Tolerances
North Dakota declared a crisis for the use of lambda-cyhalothrin on
flax to control grasshoppers. The emergency was due to a lack of
control of this pest with other registered alternatives. Grasshopper
infestations in 1998 were significantly greater than in 1997 and
conditions require treatment with lambda-cyhalothrin.
Several states declared crises for the use of lambda-cyhalothrin
on barley to control the Russian wheat aphid. Although there are
several registered alternative products available, each has
disadvantages, including lack of efficacy, that lead to the states
requesting the use of lambda-cyhalothrin. The states assert that
without the use of lambda-cyhalothrin, they will incur significant
economic losses.
Two states declared crises for the use of lambda-cyhalothrin on
canola to control flea beetles. The applicants stated that flea beetles
are significant pests of seedling canola and damage the plants by
feeding on leaf tissue, stems and pods.
Sugarcane yield loss from the sugarcane borer is estimated at 60%
unless adequately controlled. Registered alternatives can cause
secondary outbreaks of aphids due to toxicity to non-target arthropods
(parasites and predators). EPA has authorized under FIFRA section 18
the use of lambda-cyhalothrin on flax for control of grasshoppers,
barley for control of the Russian wheat aphid, canola for control of
flea beetles in several states, and sugarcane for control of the
sugarcane borer in Louisiana. After having reviewed the submissions,
EPA concurs that emergency conditions exist for these states.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of lambda-cyhalothrin in or
on flax, barley, canola, and sugarcane. 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
>
Transfer interrupted!
lerances will expire and are
revoked on December 31, 2000, under FFDCA section 408(l)(5), residues
of the pesticide not in excess of the amounts specified in the
tolerances remaining in or on flax, barley, canola, and sugarcane 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 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 lambda-
cyhalothrin meets EPA's registration requirements for use on flax,
barley, canola, and sugarcane or whether permanent tolerances for these
uses would be appropriate. Under these circumstances, EPA does not
believe that these tolerances serve as a basis for registration of
lambda-cyhalothrin by a State for special local needs under FIFRA
section 24(c). Nor do these tolerances serve as the basis for any State
other than North Dakota, Minnesota, Colorado, Idaho, and Louisiana 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 lambda-cyhalothrin, 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 lambda-
cyhalothrin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), for a time-limited tolerance for
combined residues of lambda-cyhalothrin and its epimer on flax seed at
0.1 ppm, barley bran at 0.2 ppm, barley grain at 0.05 ppm, barley hay
at 2.0 ppm, barley straw at 2.0 ppm, canola seed at 0.1 ppm, and
sugarcane at 0.03 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 lambda-cyhalothrin
are discussed in this unit.
B. Toxicological Endpoint
1. Acute toxicity. The acute dietary RfD is 0.005 milligrams/
kilogram/day (mg/kg/day) based on a chronic toxicity study in dogs. The
systemic No Observed Adverse Effect Level (NOAEL) was determined to be
0.5 mg/kg/day based on gait abnormalities. An uncertainty factor of 100
was applied.
2. Short- and intermediate-term toxicity. The short- and
intermediate-term dermal toxicity NOAEL was determined to be 10.0 mg/
kg/day based on mortality, clinical signs and effects on body weight
and food consumption in a 21-day dermal rat study. An acceptable MOE
will be <gr-thn-eq> 100.
3. Chronic toxicity. EPA has established the Reference Dose (RfD)
for lambda-cyhalothrin at 0.001 mg/kg/day. This RfD is based on a No
Observed Adverse Effect Level (NOAEL) of 0.1 mg/kg/day in a chronic
toxicity study in dogs. Symptoms included neurotoxicity, ataxia and
convulsions. An uncertainty factor of 100 was applied.
4. Carcinogenicity. Lambda-cyhalothrin has been classified by the
Agency as a group D carcinogen (``not classifiable as to human
carcinogenicity'').
[[Page 4586]]
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established under
40 CFR 180.438 for residues of lambda-cyhalothrin and its epimer
expressed as: a 1:1 mixture of (S)-<greek-a>-cyano-3-phenoxybenzyl-(Z)-
(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)-<greek-a>-cyano-3-
phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and its epimer a 1:1 mixture of (S)-
<greek-a>-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclo-propanecarboxylate and (R)-
<greek-a>-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclo-propanecarboxylate in numerous
plant commodities at levels ranging from 0.01 to 6.0 ppm; in the fat of
cattle, goats, hogs, horses, and sheep at 3.0 ppm; in the meat and meat
byproducts of cattle, goats, hogs, horses, and sheep at 0.2 ppm;
milkfat at 5.0 ppm (reflecting 0.2 ppm in whole milk); and in poultry
fat, meat, meat byproducts, and eggs at 0.01 ppm. Food additive
tolerances have been established for residues of lambda-cyhalothrin in
all food items (other than those already covered by a higher tolerance
as a result of use on growing crops) in food handling establishments
(0.01 ppm), dried hops (10.0 ppm), corn grain flour (0.15 ppm),
sunflower oil (0.30 ppm), and wheat bran (0.2 ppm). Feed additive
tolerances for residues of lambda-cyhalothrin on sunflower hulls (0.50
ppm), tomato pumice (6.0 ppm), and wheat bran (0.2 ppm) have been
established under 40 CFR 180.438. Risk assessments were conducted by
EPA to assess dietary exposures and risks from lambda-cyhalothrin 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 (food) risk assessment was performed that used a
tier three analysis (i.e., Monte Carlo) of the Novigen DEEM (Dietary
Exposure Evaluation Model) system, which employed both percent crop
treated data and processing data in the calculation. Flax was added to
the analysis at the 100% crop treated level. The residue value for flax
was taken from canola which is another seed oil. The DEEM analysis
evaluates individual food consumption as reported by respondents in the
USDA Continuing Surveys of Food Intake by Individuals (CSFII) conducted
in 1989 through 1991. The model accumulates exposure to the chemical
for each commodity and expresses risk as a function of dietary
exposure.
Resulting exposure values (at the 99.9th percentile) and
percentage of the acute RfD occupied range from 28% for nursing infants
(<1 year old) up to 72% for non-nursing infants (<1 year old). EPA
generally has no concern for exposures below 100% of the RfD (when the
FQPA safety factor has been removed, as it has in this case).
ii. Chronic exposure and risk. A tier three DEEM chronic exposure
analysis was performed using anticipated residues, percent crop
treated, and processing data. The analysis evaluates individual food
consumption as reported by respondents in the USDA CSFII conducted in
1989 through 1991. The model accumulates exposure to the chemical for
each commodity and expresses risk as a function of dietary exposure.
The existing lambda-cyhalothrin tolerances (published, pending,
and including the necessary Section 18 tolerances) result in
Anticipated Residue Contributions (ARCs) that are equivalent to the
percentages of the Chronic RfD ranging from 2% for nursing infants (<1
year old) up to 19% for children (1-6 years old). As noted above, the
Agency generally has no concern for exposures below 100% of the RfD
(when the FQPA safety factor has been removed).
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated (PCT) for assessing chronic dietary risk
only if the Agency can make the following findings: That the data used
are reliable and provide a valid basis to show what percentage of the
food derived from such crop is likely to contain such pesticide
residue; that the exposure estimate does not underestimate exposure for
any significant subpopulation group; and if data are available on
pesticide use and food consumption in a particular area, the exposure
estimate does not understate exposure for the population in such area.
In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of percent crop treated as required by the section 408(b)(2)(F), EPA
may require registrants to submit data on PCT.
The Agency used a tier three DEEM analysis provided by the
petitioner. This analysis was performed using anticipated residues,
percent crop treated, and processing data.
The Agency believes that the three conditions, discussed in section
408 (b)(2)(F) in this unit concerning the Agency's responsibilities in
assessing chronic dietary risk findings, have been met. The PCT
estimates are derived from Federal and private market survey data,
which are reliable and have a valid basis. Typically, a range of
estimates are supplied and the upper end of this range is assumed for
the exposure assessment. By using this upper end estimate of the PCT,
the Agency is reasonably certain that that the percentage of the food
treated is not likely to be underestimated. The regional consumption
information and consumption information for significant subpopulations
is taken into account through EPA's computer-based model for evaluating
the exposure of significant subpopulations including several regional
groups. Use of this consumption information in EPA's risk assessment
process ensures that EPA's exposure estimate does not understate
exposure for any significant subpopulation group and allows the Agency
to be reasonably certain that no regional population is exposed to
residue levels higher than those estimated by the Agency. Other than
the data available through national food consumption surveys, EPA does
not have available information on the regional consumption of food to
which lambda-cyhalothrin may be applied in a particular area.
2. From drinking water. Estimated Environmental Concentrations
(EECs) for lambda-cyhalothrin residues were determined to be 0.095
<greek-m>g/L for acute surface water and 0.003 <greek-m>g/L for chronic
surface water.
i. Acute exposure and risk. [As mentioned previously, the acute
risk for ``food only'' does not exceed EPA's level of concern. Drinking
water levels of concern (DWLOC) for acute dietary exposure range from
14 <greek-m>g/L for infants and children up to 120 <greek-m>g/L for the
U.S.
[[Page 4587]]
population (48 states). These levels are substantially higher than the
surface water EEC (0.095 <greek-m>g/L). Therefore, the risk from acute
aggregate exposure to lambda-cyhalothrin does not exceed EPA's level of
concern.
ii. Chronic exposure and risk. As is the case with acute risk, the
chronic risk for ``food only'' does not exceed EPA's level of concern.
DWLOC for chronic dietary exposure range from 8 <greek-m>g/L for
infants and children to 32 <greek-m>g/L for the U.S. population. These
levels are substantially higher than the highest chronic water EEC
(0.003 <greek-m>g/L). Chronic residential exposures to lambda-
cyhalothrin are not expected for current registered uses. Therefore,
chronic aggregate exposure to lambda-cyhalothrin does not exceed EPA's
level of concern.
3. From non-dietary exposure. Lambda-cyhalothrin is currently
registered for use on several non-food sites that include general pest
control (crack/crevice/spot), termiticide, landscape, turf ornamentals,
commercial ornamentals, golf course turf, and unoccupied agricultural
premises. A risk assessment was performed for post application
activities on lawns treated with lambda-cyhalothrin previously. At the
time that this assessment was completed, exposures from lawn use were
considered to be a ``worst case'' estimate of exposure from high-end of
the registered residential uses.
i. Chronic exposure and risk. Chronic residential exposures to
lambda-cyhalothrin are not expected for currently registered uses and
thus a risk assessment is not required.
ii. Short- and intermediate-term exposure and risk. Short-term
exposure and risk assessments were conducted by the Agency. The oral
MOEs for infants and children was 3,500; the dermal MOEs were 1.5
million for the U.S. population and 7,810 for infants and children; and
the inhalation MOEs were 15,000 for the U.S. population and 4,800 for
infants and children. All of the above MOEs are well above the
acceptable short term MOE of 100.
The Agency also conducted intermediate-term exposure and risk
assessments. The oral MOEs for infants and children was 700; the dermal
MOEs were 1.5 million for the U.S. population and 7,810 for infants and
children; and the inhalation MOEs were 15,000 for the U.S. population
and 4,800 for infants and children. All of the above MOEs are well
above the acceptable short term MOE of 100.
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 lambda-cyhalothrin 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,
lambda-cyhalothrin 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 lambda-cyhalothrin 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. The acute risk for ``food only'' does not exceed the
Agency's level of concern, taking up 32% of the RfD for the U.S.
population. The DWLOC for acute dietary exposure is 120 <greek-m>g/L
for the U.S. population, well above the maximum acute EEC of 0.095
<greek-m>g/L.
2. Chronic risk. Using the ARC exposure assumptions described in
this unit, EPA has concluded that aggregate exposure to lambda-
cyhalothrin from food will utilize 7% of the RfD for the U.S.
population. The major identifiable subgroup with the highest aggregate
exposure is discussed 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. The DWLOCs for chronic risk were
calculated to be 32 <greek-m>g/L for the U.S. population, well above
the maximum chronic EEC of 0.003 <greek-m>g/L. Chronic residential
exposures to lambda-cyhalothrin are not expected for currently
registered uses and thus a risk assessment is not required.
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.
i. Short-term aggregate risk (food + water + residential). MOEs
for dietary and residential exposures are well above the acceptable
short-term MOE of 100 and the short-term aggregate DWLOCs are higher
than average surface water EECs. Therefore, short-term aggregate risk
does not exceed EPA's level of concern.
ii. Intermediate-term aggregate risk (food + water + residential).
MOEs for dietary, residential exposures are well over the acceptable
short-term aggregate MOE of 100 and the intermediate-term aggregate
drinking water DWLOCs are higher than average surface water EECs.
Therefore, intermediate-term aggregate risk does not exceed EPA's level
of concern.
4. Aggregate cancer risk for U.S. population. Because lambda-
cyhalothrin has been classified as a group D carcinogen, ``not
classifiable as to human carcinogenicity,'' this risk assessment is not
required.
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 lambda-cyhalothrin 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 lambda-cyhalothrin, 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
[[Page 4588]]
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. From the developmental
toxicity study in rats, the maternal (systemic) NOAEL was 10 mg/kg/day.
The maternal Lowest Observed Adverse Effect Level (LOAEL) of 15 mg/kg/
day was based on decreased body weight gain and decreased food
consumption. The developmental (fetal) NOAEL was > 15 mg/kg/day at the
highest dose tested (HDT).
From the developmental toxicity study in rabbits, the maternal
(systemic) NOAEL was 10 mg/kg/day. The maternal LOAEL of 30 mg/kg/day
was based on decreased body weight gain. The developmental (fetal)
NOAEL was > 30 mg/kg/day (HDT).
iii. Reproductive toxicity study. From the 3-generation
reproductive toxicity study in rats, both the parental (systemic) and
reproductive (pup) NOAELs were 1.5 mg/kg/day. Both the parental
(systemic) and reproductive (pup) LOAELs were 5 mg/kg/day. They were
based on a significant decrease in parental body weight (systemic) or a
significant decrease in pup body weight (reproductive). The
developmental NOAEL was 5 mg/kg/day (HDT).
iv. Pre- and post-natal sensitivity. The toxicology data base for
lambda-cyhalothrin is complete with respect to current toxicological
data requirements. There are no pre- or post-natal toxicity concerns
for infants and children, based on the results of the rat and rabbit
developmental toxicity studies and the 3-generation reproductive
toxicity study in rats.
v. Conclusion. Based on the above, EPA concludes that reliable data
support the use of the standard hundredfold margin of uncertainty
factor and that an additional uncertainty factor is not warranted at
this time.
2. Acute risk. The acute risk for ``food only'' does not exceed the
Agency's level of concern, taking up from 28% of the RfD for nursing
infants <1 year old to 72% for non-nursing infants <1 year old. The
DWLOC for acute dietary exposure is 14 <greek-m>g/L for the infants and
children, well above the maximum acute EEC of 0.095 <greek-m>g/L.
3. Chronic risk. Using the exposure assumptions described in this
unit, EPA has concluded that aggregate exposure to lambda-cyhalothrin
from food will utilize from 2% of the RfD for nursing infants <1 year
old to 19% of the RfD for 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 DWLOC for
chronic dietary exposure is 8 <greek-m>g/L for the infants and
children, well above the maximum chronic EEC of 0.003 <greek-m>g/L.
Chronic non-dietary, non-occupational exposures to lambda-cyhalothrin
are not expected for currently registered uses and thus a risk
assessment for this exposure portion was not conducted.
4. Short- or intermediate-term risk. The short- and intermediate-
term risk estimates for infants and children do not exceed the Agency's
level of concern.
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 lambda-cyhalothrin
residues.
IV. Other Considerations
A. Metabolism In Plants and Animals
Data on plant metabolism show that lambda-cyhalothrin is
metabolized by cleavage of the ester linkage to form cyclopropane
carboxylic acids and the corresponding phenoxybenzoic acid and/or 3-
phenoxybenzyl alcohol. The residues to be regulated are lambda-
cyhalothrin and its epimer as specified in 40 CFR 180.438.
Studies of lambda-cyhalothrin metabolism in ruminants and poultry
have been reviewed. In addition to the plant metabolites, lambda-
cyhalothrin animal metabolites include 3-(2-chloro-3,3,3-trifluoroprop-
1-enyl)-2-hydroxymethyl-2-methylcyclopropane-carboxylic acid (OH-CPA)
and 4-hydroxy-3-phenoxybenzoic acid (4'-OH-3-PBAcid).
Lambda-cyhalothrin is the major component of the residue, except
in the kidney and liver of ruminants and liver of poultry. In addition
to the plant metabolites, 3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2-
hydroxymethyl-2-methylcyclopropane-carboxylic acid (OH-CPA) and 4-
hydroxy-3-phenoxybenzoic acid (4'-OH-3PBAcid) may be present in
significant quantities. A residue transfer study in which cows were fed
dietary levels of 8, 25 or 80 ppm lambda-cyhalothrin demonstrated that,
at <ls-thn-eq> 8 ppm, OH-CPA levels in tissue would not exceed 0.01
ppm. The Agency has determined that animal metabolites do not need to
appear in the tolerance expression at this time. As with plants, the
residues to be regulated are lambda-cyhalothrin and its epimer.
B. Analytical Enforcement Methodology
Adequate enforcement methodology 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, (703) 305-5229.
C. Magnitude of Residues
Residues are not expected to exceed 0.1 ppm in flax seed; 0.05 ppm
in barley grain; 0.2 ppm in barley, bran; 2 ppm in barley, straw; 2 ppm
in barley, hay; 0.10 in canola seed; and 0.03 ppm in sugarcane as a
result of these section 18 uses.
D. International Residue Limits
No Codex MRLs for residues of lambda-cyhalothrin have been
established (only cyhalothrin). No Canadian MRLs have been established
for residues of lambda-cyhalothrin. Mexico has not established
tolerances for residues of lambda-cyhalothrin on flax, only on
cottonseed (0.05 ppm). Therefore, harmonization is not an issue.
V. Conclusion
Therefore, the tolerance is established for combined residues of
lambda-cyhalothrin and its epimer in flax seed at 0.1 parts per million
(ppm), barley bran at 0.2 ppm, barley grain at 0.05 ppm, barley hay at
2.0 ppm, barley straw at 2.0 ppm, and canola seed 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 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 30, 1999, file written objections to any
aspect of this regulation and may also request a
[[Page 4589]]
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 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-300780] (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
specficed 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 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
[[Page 4590]]
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 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 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 13, 1999.
Peter Caulkins,
Acting 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. 180.438, by revising the table in paragraph (b) to read
as follows:
Sec. 180.438 Lambda-cyhalothrin; tolerances for residues.
* * * * *
(b) Section 18 emergency exemptions. ***
------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Barley, bran.................................. 0.2 12/31/00
Barley, grain................................. 0.05 12/31/00
Barley, hay................................... 2.0 12/31/00
Barley, straw................................. 2.0 12/31/00
Canola, seed.................................. 0.1 12/31/00
Flax, seed.................................... 0.1 12/31/00
Sugarcane..................................... 0.03 12/31/00
------------------------------------------------------------------------
* * * * *
[FR Doc. 99-2208 Filed 1-28-99; 8:45 am]
BILLING CODE 6560-50-F