[Federal Register Volume 62, Number 95 (Friday, May 16, 1997)]
[Rules and Regulations]
[Pages 26941-26946]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-12787]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300490; FRL-5718-1]
RIN 2070-AB78


Emamectin Benzoate; 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 
residues of the insecticide emamectin benzoate: 4''-epi-methylamino-
4''-deoxyavermectin B1 benzoate in or on the raw agricultural 
commodities head and Napa (chinese) cabbage in connection with EPA's 
granting an emergency exemption under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act authorizing use of the 
pesticide on head and Napa cabbage in Hawaii. The tolerance will expire 
and is revoked on December 31, 1998.

DATES: This regulation becomes effective May 16, 1997. Objections and 
requests for hearings must be received by EPA on or before July 15, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300490], 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-300490], must be submitted to: Public Information 
and Records Integrity Branch, Information Resources and Services 
Division (7506C), 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. 1132, CM #2, 
1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1 file 
format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300490]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Olga Odiott, Registration 
Division (7505W), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail: Sixth Floor, Crystal Station 
#1, 2800 Jefferson Davis Highway, Arlington, VA. (703) 308-6418, e-
mail: [email protected].
SUPPLEMENTARY INFORMATION: The regulations governing section 18 require 
that the Agency publish a notice of receipt in the Federal Register and 
solicit public comment on an application for a specific exemption 
proposing the use of an unregistered chemical [40 CFR 166.24]. 
Emamectin benzoate is an active ingredient not currently found in any 
registered product. Accordingly, a notice of receipt of this request 
was published in the Federal Register on April 11, 1997. One comment 
was received regarding the requirement for a groundwater monitoring 
study. EPA is not requiring such study under section 18. Based on the 
available environmental fate data, the Agency has determined that the 
use proposed by this emergency exemption will not cause unreasonable 
adverse effects on the environment. EPA, on its own initiative, 
pursuant to section 408(e) and (l)(6) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a 
tolerance for residues of the insecticide 4''-epi-methylamino-4''-
deoxyavermectin B1 benzoate, also referred to in this document as 
emamectin benzoate, in or on head and Napa cabbage at 0.025 part per 
million (ppm). This tolerance will expire and be revoked by EPA on 
December 31, 1998. After December 31, 1998, EPA will publish a document 
in the Federal Register to remove the revoked tolerance from the Code 
of Federal Regulations.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the 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. Among other things, FQPA amends FFDCA to bring all EPA pesticide 
tolerance-setting activities under section 408 with a new safety 
standard and new procedures. These activities are described below and 
discussed in greater detail in the final rule establishing the time-
limited tolerance associated with the emergency exemption for use of 
propiconazole on sorghum (61 FR 58135, November 13, 1996) (FRL-5572-9).
    New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166. Section 408(l)(6) of the FFDCA 
requires EPA to establish a time-limited tolerance or exemption from 
the requirement for a tolerance for pesticide chemical residues in food 
that will result from the use of a pesticide under an emergency 
exemption granted

[[Page 26942]]

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 Emamectin Benzoate on Head and Napa 
Cabbage and FFDCA Tolerances

    The Hawaii Department of Agriculture has requested a specific 
exemption for the use of emamectin benzoate on head and Napa cabbage to 
control the diamondback moth (Plutella xylostella). The Applicant 
states that although there are numerous insecticides registered for use 
against the diamondback moth (DBM) on cabbage in Hawaii, these 
pesticides do not provide effective control. DMB has become resistant 
to most of these insecticides and label restrictions on others render 
their control inadequate for this pest. Growers using these products 
have experienced significant yield reductions due to feeding damage by 
DBM larvae. Bacillus thuringiensis (Bt) based insecticides were once 
very effective, but in 1990 scientists at the University of Hawaii 
documented DBM resistance to first generation Bt products; more 
recently these same scientists have documented a 20-fold resistance to 
Bt toxin CryIC. Based on these trends, it is expected that the DBM will 
quickly develop resistance to these second generation Bt products if 
they are overused. Alternative control practices include the use of 
tolerant cabbage varieties, natural enemy augmentation, and the 
application of overhead irrigation. Management programs incorporating 
these practices have been adopted by many cabbage growers; however the 
growers continued to experience moderate to excessive yield losses due 
to DBM injury. Thus, without an effective control such as emamectin 
benzoate, cabbage growers in Hawaii will likely suffer severe economic 
losses. EPA has authorized under FIFRA section 18 the use of emamectin 
benzoate on cabbage for control of the DBM. After having reviewed the 
submission, EPA concurs that emergency conditions exist for this state.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of emamectin benzoate in or 
on cabbage. In doing so, EPA considered the new safety standard in 
FFDCA section 408(b)(2), and decided that the necessary tolerance under 
FFDCA section 408(l)(6) would be consistent with the new safety 
standard and with FIFRA section 18. This tolerance will permit the 
marketing of head and Napa cabbage treated in accordance with the 
provisions of the section 18 emergency exemption. Consistent with the 
need to move quickly on the emergency exemption in order to address an 
urgent non-routine situation and to ensure that the resulting food is 
safe and lawful, EPA is issuing this tolerance without notice and 
opportunity for public comment under section 408(e), as provided in 
section 408(l)(6). Although this tolerance will expire and is revoked 
on December 31, 1998, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on head and Napa cabbage after that date will not be 
unlawful, provided the pesticide is applied during the term of, and in 
accordance with all the conditions of, section 18 of FIFRA. EPA will 
take action to revoke this tolerance earlier if any experience with, 
scientific data on, or other relevant information on this pesticide 
indicate that the residues are not safe.
    EPA has not made any decisions about whether emamectin benzoate 
meets EPA's registration requirements for use on head and Napa cabbage 
or whether a permanent tolerance for this use would be appropriate. 
This tolerance does not serve as a basis for registration of emamectin 
benzoate by a State for special local needs under FIFRA section 24(c). 
Nor does this tolerance serve as the basis for any State other than 
Hawaii to use this pesticide on this crop under section 18 of FIFRA 
without following all provisions of section 18 as identified in 40 CFR 
part 166. For additional information regarding the emergency exemption 
for emamectin benzoate, contact the Agency's Registration Division at 
the address provided above.

III. Risk Assessment and Statutory Findings

    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides based primarily on toxicological studies using 
laboratory animals. These studies address many adverse health effects, 
including (but not limited to) reproductive effects, developmental 
toxicity, toxicity to the nervous system, and carcinogenicity. For many 
of these studies, a dose response relationship can be determined, which 
provides a dose that causes adverse effects (threshold effects) and 
doses causing no observed effects (the ``no-observed effect level'' or 
``NOEL'').
    Once a study has been evaluated and the observed effects have been 
determined to be threshold effects, EPA generally divides the NOEL from 
the study with the lowest NOEL by an uncertainty factor (usually 100 or 
more) to determine the Reference Dose (RfD). The RfD is a level at or 
below which daily aggregate exposure over a lifetime will not pose 
appreciable risks to human health. An uncertainty factor (sometimes 
called a ``safety factor'') of 100 is commonly used since it is assumed 
that people may be up to 10 times more sensitive to pesticides than the 
test animals, and that one person or subgroup of the population (such 
as infants and children) could be up to 10 times more sensitive to a 
pesticide than another. In addition, EPA assesses the potential risks 
to infants and children based on the weight of the evidence of the 
toxicology studies and determines whether an additional uncertainty 
factor is warranted. Thus, an aggregate daily exposure to a pesticide 
residue at or below the RfD (expressed as 100% or less of the RfD) is 
generally considered acceptable by EPA. EPA generally uses the RfD to 
evaluate the chronic risks posed by pesticide exposure. For shorter 
term risks, EPA calculates a margin of exposure (MOE) by dividing the 
estimated human exposure into the NOEL from the appropriate animal 
study. Commonly, EPA finds MOEs lower than 100 to be unacceptable. This 
100-fold MOE is based on the same rationale as the 100-fold uncertainty 
factor.
    Lifetime feeding studies in two species of laboratory animals are 
conducted to screen pesticides for cancer effects. When evidence of 
increased cancer is noted in these studies, the Agency conducts a 
weight of the evidence review of all relevant toxicological data 
including short term and mutagenicity studies and structure activity 
relationship. Once a pesticide has been classified as a potential human 
carcinogen, different types of risk assessments (e.g., linear low dose 
extrapolations or MOE calculation based on the appropriate NOEL will be 
carried out based on the nature of the carcinogenic response and the 
Agency's knowledge of its mode of action.
    In examining aggregate exposure, FFDCA section 408 requires that 
EPA take into account available and reliable information concerning 
exposure from

[[Page 26943]]

the pesticide residue in the food in question, residues in other foods 
for which there are tolerances, residues in groundwater or surface 
water that is consumed as drinking water, and other non-occupational 
exposures through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses). Dietary exposure to residues of a 
pesticide in a food commodity are estimated by multiplying the average 
daily consumption of the food forms of that commodity by the tolerance 
level or the anticipated pesticide residue level. The Theoretical 
Maximum Residue Contribution (TMRC) is an estimate of the level of 
residues consumed daily if each food item contained pesticide residues 
equal to the tolerance. The TMRC is a ``worst case'' estimate since it 
is based on the assumptions that food contains pesticide residues at 
the tolerance level and that 100% of the crop is treated by pesticides 
that have established tolerances. If the TMRC exceeds the RfD or poses 
a lifetime cancer risk that is greater than approximately one in a 
million, EPA attempts to derive a more accurate exposure estimate for 
the pesticide by evaluating additional types of information 
(anticipated residue data and/or percent of crop treated data) which 
show, generally, that pesticide residues in most foods when they are 
eaten are well below established tolerances.
    Percent of crop treated estimates are derived from federal and 
private market survey data. 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 percent of crop 
treated, the Agency is reasonably certain that exposure is not 
understated for any significant subpopulation group. Further, regional 
consumption information is taken into account through EPA's computer-
based model for evaluating the exposure of significant subpopulations 
including several regional groups, to pesticide residues.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action.

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 emamectin benzoate 
are discussed below.
    1. Acute toxicity. The Agency has determined that the NOEL of 0.075 
mg/kg/day from a 15-day feeding study in mice should be used to 
evaluate acute dietary risk. At the lowest effect level (LEL) of 0.10 
mg/kg/day, there were clinical signs of tremors and histological 
evidence of degenerative effects in the sciatic nerve. This acute 
dietary risk assessment evaluates neurological risks to all population 
subgroups.
    2. Short- and intermediate-term dermal and inhalation toxicity. The 
Agency has determined that a NOEL of 2.4 mg/kg/day from a 21-day dermal 
toxicity study in rabbits should be used to assess risks from short and 
intermediate-term dermal toxicity. At the LEL of 6.0 mg/kg/day, there 
were axonal degenerative lesions in the sciatic nerve and spinal cord. 
For the short- and intermediate-term inhalation toxicity, the Agency 
has determined that a NOEL of 0.075 mg/kg/day from the 15-day feeding 
study in mice [same study used in the acute dietary risk assessment] 
should be used to assess risks for occupational scenarios since no 
suitable inhalation toxicity study is available. At the LEL of 0.10 mg/
kg/day, there were tremors, and histological degenerative effects in 
the sciatic nerve.
    3. Chronic risk. The Agency has established a provisional RfD for 
emamectin benzoate at 0.000083 mg/kg/day. The provisional RfD was based 
on one-year and 90-day feeding studies in dogs with a NOEL of 0.25 mg/
kg/day and an uncertainty factor of 3000 based on severe neurological 
effects, the steep dose response in the dog studies, data gaps in the 
chronic studies in mice and rats, and the extra-sensitivity for infants 
and children which was seen in the developmental neurotoxicity study. 
At the LEL of 0.50 mg/kg/day, effects in both sexes consist of axonal 
degeneration in the pons; medulla, sciatic, sural, and tibial; whole 
body tremors; stiffness of hind legs; spinal cord axonal degeneration; 
and muscle fiber degeneration in females. At the highest dose tested, 
0.75 mg/kg/day, males were sacrificed after 7 weeks, and additional 
effects were mydriasis, cellular degeneration of retina, axonal 
degeneration of optic nerve, decreased body weight gain and decreased 
food consumption.
    The Agency has also determined that a non-dietary chronic toxicity 
endpoint does not exist for emamectin benzoate and a chronic risk 
assessment is not required for occupational exposures.
    4. Cancer risk. The carcinogenicity studies for emamectin benzoate 
have not been fully evaluated, therefore a cancer risk assessment is 
not possible at this time.

B. Exposures and Risks

    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food and all other non-occupational exposures. The primary non-food 
sources of exposure the Agency looks at include drinking water (whether 
from groundwater or surface water), and exposure through pesticide use 
in gardens, lawns, or buildings (residential and other indoor uses). In 
evaluating food exposures, EPA takes into account varying consumption 
patterns of major identifiable subgroups of consumers, including 
infants and children.
    1. From food and feed uses. Emamectin benzoate is not currently 
registered for food uses and no tolerances have been established. Risk 
assessments were conducted by EPA to assess dietary exposures and risks 
from emamectin benzoate as follows:
    i. Acute risk. Acute dietary risk assessments are performed for a 
food-use pesticide if a toxicological study has indicated the 
possibility of an effect of concern occurring as a result of a one day 
or single exposure.
    Since emamectin benzoate is not currently registered for food uses, 
the use proposed by this Section 18 is the only commodity considered in 
the acute dietary risk assessment. In conducting this risk assessment, 
the Agency used the tolerance value of 0.025 ppm and assumed 100% crop 
treated. Thus, the acute dietary risk estimates are considered 
conservative and therefore protective of any acute exposure scenario. 
The acute dietary risks from this proposed Section 18 use do not exceed 
the Agency's level of concern. The resulting MOEs for the different 
population subgroups ranged from 150 to 540. Further refinement using 
anticipated residue values and percent crop-treated data would result 
in lower acute dietary risk estimates.
    ii. Chronic risk. For the chronic dietary risk assessment, the 
Agency used the tolerance value of 0.025 ppm, and assumed that all 
cabbage consumed in the U.S. will contain residues at the tolerance 
level. Thus, in making a safety determination for this tolerance, EPA 
is taking into account a conservative exposure assessment. With this 
Section 18 use of emamectin benzoate on cabbage, the TMRC estimates

[[Page 26944]]

represented 0% to 4% of the RfD (all TMRCs were <0.00001 mg/kg/day). 
The EPA has therefore concluded that the chronic dietary risks from the 
proposed Section 18 use do not exceed our level of concern.
    2. From drinking water. No Maximum Concentration Level has been 
established for residues of emamectin benzoate in drinking water. No 
Health Advisory Levels for emamectin benzoate in drinking water have 
been established.
    Because the Agency lacks sufficient water-related exposure data to 
complete a comprehensive drinking water risk assessment for many 
pesticides, EPA has commenced and nearly completed a process to 
identify a reasonable yet conservative bounding figure for the 
potential contribution of water related exposure to the aggregate risk 
posed by a pesticide. In developing the bounding figure, EPA estimated 
residue levels in water for a number of specific pesticides using 
various data sources. The Agency then applied the estimated residue 
levels, in conjunction with appropriate toxicological endpoints (RfD's 
or acute dietary NOEL's) and assumptions about body weight and 
consumption, to calculate, for each pesticide, the increment of 
aggregate risk contributed by consumption of contaminated water. While 
EPA has not yet pinpointed the appropriate bounding figure for exposure 
from contaminated water, the ranges the Agency is continuing to examine 
are all below the level that would cause emamectin benzoate to exceed 
the RfD if the tolerance being considered in this document is granted. 
The Agency has therefore concluded that the potential exposures 
associated with emamectin benzoate in water, even at the higher levels 
the Agency is considering as a conservative upper bound, would not 
prevent the Agency from determining that there is a reasonable 
certainty of no harm if the tolerance is granted.
    3. From non-dietary exposure. Emamectin benzoate is not currently 
registered for non-food uses.

C. 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.'' The Agency believes that ``available 
information'' in this context might include not only toxicity, 
chemistry, and exposure data, but also scientific policies and 
methodologies for understanding common mechanisms of toxicity and 
conducting cumulative risk assessments. For most pesticides, although 
the Agency has some information in its files that may turn out to be 
helpful in eventually determining whether a pesticide shares a common 
mechanism of toxicity with any other substances, EPA does not at this 
time have the methodologies to resolve the complex scientific issues 
concerning common mechanism of toxicity in a meaningful way. EPA has 
begun a pilot process to study this issue further through the 
examination of particular classes of pesticides. The Agency hopes that 
the results of this pilot process will increase the Agency's scientific 
understanding of this question such that EPA will be able to develop 
and apply scientific principles for better determining which chemicals 
have a common mechanism of toxicity and evaluating the cumulative 
effects of such chemicals. The Agency anticipates, however, that even 
as its understanding of the science of common mechanisms increases, 
decisions on specific classes of chemicals will be heavily dependent on 
chemical specific data, much of which may not be presently available.
    Although at present the Agency does not know how to apply the 
information in its files concerning common mechanism issues to most 
risk assessments, there are pesticides as to which the common mechanism 
issues can be resolved. These pesticides include pesticides that are 
toxicologically dissimilar to existing chemical substances (in which 
case the Agency can conclude that it is unlikely that a pesticide 
shares a common mechanism of activity with other substances) and 
pesticides that produce a common toxic metabolite (in which case common 
mechanism of activity will be assumed).
    EPA does not have, at this time, available data to determine 
whether emamectin benzoate has a common mechanism of toxicity with 
other substances or how to include this pesticide in a cumulative risk 
assessment. For the purposes of this tolerance action, therefore, EPA 
has not assumed that emamectin benzoate has a common mechanism of 
toxicity with other substances.

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

    1. Acute risk. For the U.S. population, the calculated dietary 
(food only) MOE value is 250. This MOE value does not exceed the 
Agency's level of concern for acute dietary exposures. Despite the 
potential for exposure to emamectin benzoate from drinking water, EPA 
does not expect the aggregate acute risk (food + water) to exceed the 
Agency's level of concern.
    2. Chronic risk. Using the conservative TMRC exposure assumptions 
described above, EPA has concluded that exposure to emamectin benzoate 
from food will utilize 1% of the RfD for the U.S. population. EPA 
generally has no concern for exposures below 100% of the RfD because 
the RfD represents the level at or below which daily aggregate dietary 
exposure over a lifetime will not pose appreciable risks to human 
health. Despite the potential for exposure to emamectin benzoate in 
drinking water, EPA does not expect the aggregate exposure to exceed 
100% of the RfD. EPA concludes that there is a reasonable certainty 
that no harm will result from aggregate exposure to emamectin benzoate 
residues.

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

    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 MOE analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans. EPA believes that reliable data support using the standard MOE 
and uncertainty factor (usually 100 for combined inter- and intra-
species variability)) and not the additional tenfold margin of 
exposure/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 margin of 
exposure/safety factor.
    In assessing the potential for additional sensitivity of infants 
and children to residues of emamectin benzoate, EPA considered data 
from developmental toxicity studies in rats and rabbits, developmental 
neurotoxicity studies in rats, and a two-generation reproductive 
toxicity study in rats. The developmental toxicity studies are designed 
to evaluate adverse effects on the developing organism resulting from 
maternal pesticide exposure during prenatal development. Reproduction 
studies provide information relating to pre- and post-natal effects 
from exposure to the

[[Page 26945]]

pesticide, information on the reproductive capability of mating 
animals, and data on systemic toxicity.
    1. Developmental toxicity studies.--a. Developmental toxicity study 
in rats. The maternal (systemic) NOEL was 2 mg/kg/day, based on 
decreased weight gain at the lowest observed effect level (LOEL) of 4 
mg/kg/day. The developmental (fetal) NOEL was 4 mg/kg/day, based on 
altered growth and extra ribs at the LOEL of 8 mg/kg/day.
    b. Developmental neurotoxicity study in rats. The maternal 
(systemic) NOEL was 2.5 mg/kg/day. The developmental (pup) NOEL was 
0.10 mg/kg/day [lowest dose tested], based on neurotoxicity findings at 
the LOEL of 0.60 mg/kg/day.
    c. Developmental study in rabbits. The maternal (systemic) NOEL was 
3 mg/kg/day, based on decreased weight gain and neurotoxicity at the 
LOEL of 6 mg/kg/day. The developmental (fetal) NOEL was 6 mg/kg/day 
[highest dose tested].
    2. Reproductive toxicity studies.--a. Reproductive toxicity study 
in rats. The parental (systemic) NOEL was 0.6 mg/kg/day, based on 
neurological lesions and decreased weight gain at the LOEL of 1.8 mg/
kg/day. The developmental (pup) NOEL was 0.6 mg/kg/day, based on 
neurological effects at the LEL of 1.8 mg/kg/day.
    The reproductive NOEL was 0.8 mg/kg/day, based on decreased 
fecundity and fertility indices at the LEL of 1.8 mg/kg/day.
    3. Pre- and post-natal sensitivity. Based on the results of the 
developmental neurotoxicity study for emamectin benzoate, the 
developmental findings [neurotoxicity], which may be due to pre- or/and 
post-natal extra-sensitivity, occurred in the absence of maternal 
effects. These results indicate extra-sensitivity for infants and 
children and an additional uncertainty factor of 3 was added to the 
provisional RfD due to these results.
    Based on the reproductive toxicity study discussed above, for 
emamectin benzoate there does not appear to be a special sensitivity 
for post-natal effects. The NOELs and LOELs for both parental animals 
and offspring occur at the same doses of 0.6 and 1.8 mg/kg/day, 
respectively.
    4. Acute risk. The acute dietary (food only) MOE for infants (< 1 
year) was calculated to be 150, and that for children (1-6 years) was 
calculated to be 150. The acute dietary (food only) MOE for females 13+ 
years old (accounts for both maternal and fetal exposure) is 420. These 
MOE calculations are based on the NOEL (0.075 mg/kg/day) from a 15-day 
feeding study in mice. This risk assessment also assumed 100% crop-
treated with tolerance level residues on all treated crops consumed, 
resulting in an over-estimate of dietary exposure. Despite the 
potential for exposure to emamectin benzoate in drinking water, EPA 
does not expect the aggregate acute exposure (food + water) to result 
in an MOE of less than 100. The large acute dietary MOE calculated for 
females 13+ years old provides assurance that there is a reasonable 
certainty of no harm for both females 13+ years and the pre-natal 
development of infants.
    5. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that the percent of the RfD that 
will be utilized by dietary (food only) exposure to residues of 
emamectin benzoate ranges from 0% for non-nursing infants less than one 
year old, up to 1% for non-nursing infants (<1 year old), children (1-6 
years old), and children (7-12 years old). Despite the potential for 
exposure to emamectin benzoate in drinking water, EPA does not expect 
the aggregate exposure to exceed 100% of the RfD. Therefore, taking 
into account the completeness and reliability of the toxicity data and 
the conservative exposure assessment, EPA concludes that there is a 
reasonable certainty that no harm will result to infants and children 
from aggregate exposure to emamectin benzoate residues.

V. Other Considerations

A. Metabolism in Plants and Animal

    Plant metabolism studies for emamectin benzoate on cabbage, head 
lettuce, and sweet corn have been submitted to the Agency, however, the 
studies have not been fully evaluated to determine the residue(s) of 
concern. For the purposes of this Section 18, the regulated residues of 
concern are the parent compound emamectin benzoate (including the 
4''hylamino-4''-deoxyavermectin B1A and the 4''-epi-methylamino-4''-
deoxyavermectin B1B components), its delta-8,9-isomer, and the 
degradation products 4''-deoxy-4''-epi-(N-formyl)-avermectin B1, 4''-
deoxy-4''-epi-(N-formyl-N-methyl)-avermectin B1, and 4''-deoxy-4''-epi-
amino avermectin B1.

B. Analytical Enforcement Methodology

    There is a practical analytical method for detecting and measuring 
levels of emamectin benzoate in or on cabbage with a limit of detection 
that allows monitoring of food with residues at or above the level set 
in this tolerance. The method has undergone succesful independent 
laboratory validation, but has not been forwarded to the EPA Analytical 
Chemistry Laboratory pending EPA's determination of emamectin benzoate 
regulable residues of concern.

C. Magnitude of Residues

    Regulable residues of emamectin benzoate are not expected to exceed 
0.025 ppm in/on cabbage as a result of this Section 18 use. Secondary 
residues are not expected in animal commodities as no feed items are 
associated with this Section 18 use.

D. International Residue Limits

    No CODEX, Canadian, or Mexican maximum residue limits/tolerances 
have been established for emamectin benzoate at this time.

VI. Conclusion

    Therefore, a tolerance in connection with the FIFRA section 18 
emergency exemptions is established for residues of emamectin benzoate 
in or on head and Napa cabbage at 0.025 ppm.

VII. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by July 15, 1997 file written objections to any 
aspect of this regulation (including the revocation provision) and may 
also request a hearing on those objections. Objections and hearing 
requests must be filed with the Hearing Clerk, at the address given 
above (40 CFR 178.20). A copy of the objections and/or hearing requests 
filed with the Hearing Clerk should be submitted to the OPP docket for 
this rulemaking. The objections submitted must specify the provisions 
of the regulation deemed objectionable and the grounds for the 
objections (40 CFR 178.25). Each objection must be accompanied by the 
fee prescribed by 40 CFR 180.33(I). If a hearing is requested, the 
objections must include a statement of the factual issues on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the requestor (40 CFR 178.27). A

[[Page 26946]]

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 Confidential Business Information (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.

VIII. Public Docket

    A record has been established for this rulemaking under docket 
control number [OPP-300490]. A public version of this record, which 
does not include any information claimed as CBI, is available for 
inspection from 8 a.m. to 4:30 p.m., Monday through Friday, excluding 
legal holidays. The public record is located in Room 1132 of the Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7506C), Office of Pesticide Programs, Environmental 
Protection Agency, Crystal Mall #2, 1921 Jefferson Davis Highway, 
Arlington, VA.
    The official record for this rulemaking, as well as the public 
version, as described above, is kept in paper form. Accordingly, in the 
event there are objections and hearing requests, EPA will transfer any 
copies of objections and hearing requests received electronically into 
printed, paper form as they are received and will place the paper 
copies in the official rulemaking record. The official rulemaking 
record is the paper record maintained at the address in ``ADDRESSES'' 
at the beginning of this document.

IX. Regulatory Assessment Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and, since this 
action does not impose any information collection requirements as 
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is 
not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty or contain 
any unfunded mandate as described in the Unfunded Mandates Reform Act 
of 1995 (Pub. L. 104-4), or require prior consultation with State 
officials as specified by Executive Order 12875 (58 FR 58093, October 
28, 1993), or special considerations as required by Executive Order 
12898 (59 FR 7629, February 16, 1994).
    Because FFDCA section 408(l)(6) permits establishment of this 
regulation without a notice of proposed rulemaking, the regulatory 
flexibility analysis requirements of the Regulatory Flexibility Act, 5 
U.S.C. 604(a), do not apply. Nonetheless, the Agency has previously 
assessed whether establishing tolerances or exemptions from tolerance, 
raising tolerance levels, or expanding exemptions adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse impact. (46 FR 24950, May 4, 1981).
    Under 5 U.S.C. 801(a)(1)(A) of the Small Business Regulatory 
Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121, 110 
Stat. 847), EPA submitted 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 General Accounting 
Office prior to publication of the rule in today's 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 record 
keeping requirements.

    Dated: May 8, 1997.

James Jones,

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. Section 180.505 is added to read as follows:


Sec. 180.505  Emamectin benzoate; tolerances for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. A time-limited tolerance is 
established for residues of the insecticide emamectin benzoate: 4''-
epi-methylamino-4''-deoxyavermectin B1 benzoate in connection with use 
of the pesticide under section 18 emergency exemptions granted by EPA. 
The tolerance will expire and is revoked on the date specified in the 
following table.

----------------------------------------------------------------------------------------------------------------
                                                                                          Expiration/ Revocation
                           Commodity                               Parts per million               Date         
----------------------------------------------------------------------------------------------------------------
Cabbage (head and Napa).......................................                    0.025       December 31, 1998.
----------------------------------------------------------------------------------------------------------------

    (c) Tolerances with regional restrictions. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 97-12787 Filed 5-15-97; 8:45 am]
BILLING CODE 6560-50-F