[Federal Register Volume 64, Number 19 (Friday, January 29, 1999)]
[Rules and Regulations]
[Pages 4584-4590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2208]


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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: [email protected]. 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: 
[email protected].
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 
section 408(l)(6). Although these tolerances 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  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)--cyano-3-phenoxybenzyl-(Z)-
(1R,3R)-3-(2-chloro-3,3,3-trifluoroprop-1-enyl)-2,2-
dimethylcyclopropanecarboxylate and (R)--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)-
-cyano-3-phenoxybenzyl-(Z)-(1S,3S)-3-(2-chloro-3,3,3-
trifluoroprop-1-enyl)-2,2-dimethylcyclo-propanecarboxylate and (R)-
-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 
g/L for acute surface water and 0.003 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 g/L for infants and children up to 120 g/L for the 
U.S.

[[Page 4587]]

population (48 states). These levels are substantially higher than the 
surface water EEC (0.095 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 g/L for 
infants and children to 32 g/L for the U.S. population. These 
levels are substantially higher than the highest chronic water EEC 
(0.003 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 g/L 
for the U.S. population, well above the maximum acute EEC of 0.095 
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 g/L for the U.S. population, well above 
the maximum chronic EEC of 0.003 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 g/L for the infants and 
children, well above the maximum acute EEC of 0.095 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 g/L for the infants and 
children, well above the maximum chronic EEC of 0.003 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  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, 
[email protected]. 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:
    [email protected].

    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