[Federal Register Volume 65, Number 8 (Wednesday, January 12, 2000)]
[Rules and Regulations]
[Pages 1796-1802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-735]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300958; FRL-6398-5]
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 time-limited tolerances for 
combined residues of emamectin benzoate and its metabolites and 
photodegradates emamectin benzoate, 4'-epi-methylamino- 4'-
deoxyavermectin B1 benzoate (a mixture of a minimum of 90% 
4'-epi-methylamino-4'- deoxyavermectin B1a and a maximum of 
10% 4'-epi-methlyamino-4'deoxyavermectin B1b benzoate) and 
its metabolites 8,9 isomer of the B1a and B1b 
component of the parent insecticide (8,9 ZMA); 4'-deoxy-4'-epi-
aminoavermectin B1 (AB1a); 4'deoxy-4'-epi-(N-
formyl-N-methyl)amino-avermectin (MFB1a); and 4'-deoxy-4'-
epi-(N-formyl)amino-avermectin B1(FAB1a) (CAS 
No.137512-74-4), in or on cottonseed, cottonseed oil, cotton meal, 
hulls, and gin trash; and the milk, meat, fat, kidney, and liver of 
cattle, goats, sheep, and swine. 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 cotton. This regulation establishes maximum permissible 
levels for residues of emamectin benzoate in these food and feed 
commodities. The tolerances will expire and are revoked on December 31, 
2001.

DATES: This regulation is effective January 12, 2000. Objections and 
requests

[[Page 1797]]

for hearings, identified by docket control number OPP-300958, must be 
received by EPA on or before March 13, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VII. of the ``SUPPLEMENTARY 
INFORMATION.'' To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-300958 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Andrea Beard, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: (703) 308-9356; and e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected categories and entities may include, but are not 
limited to:


 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                      affected  entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------


    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under `` FOR FURTHER INFORMATION 
CONTACT.''

B. How Can I Get Additional Information, Including Copies of This 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register-Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-300958. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(l)(6) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is 
establishing tolerances for combined residues of the insecticide 
emamectin benzoate, in or on cottonseed at 0.002 part per million 
(ppm), cottonseed oil at 0.006 ppm, cotton meal at 0.002 ppm, cotton 
hulls at 0.004 ppm, and cotton gin trash at 0.025 ppm; and the milk, 
meat, fat, kidney, and liver of cattle, goats, sheep, and swine at 
0.002 ppm. These tolerances will expire and are revoked on December 31, 
2001. EPA will publish a document in the Federal Register to remove the 
revoked tolerances from the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.
    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 the Federal Insecticide, Fungicide, and Rodenticide 
Act (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 
the Food Quality Protection Act (FQPA). EPA has established regulations 
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Emamectin Benzoate on Cotton and FFDCA 
Tolerances

    Beet armyworm has infested cotton fields to a high degree in recent 
growing seasons. This pest had not previously been a significant pest 
in cotton, and had been controlled with available alternatives. 
However, in recent years, beet armyworm populations have reached 
devastating levels in southeastern cotton-growing areas, and registered 
alternatives have proven to provide inadequate control to prevent 
significant economic losses from occurring. The resistant tobacco 
budworm is also negatively affecting yields in these states. EPA has 
reviewed the submissions and has concluded that these pest situations 
represent urgent and non-routine problems. EPA has authorized under 
FIFRA section 18 the use of emamectin benzoate on cotton for control of 
beet armyworm and resistant tobacco budworm in Alabama, Arkansas, 
Louisiana, Mississippi, Oklahoma, and Texas. After having

[[Page 1798]]

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 emamectin benzoate in or 
on cotton commodities. 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 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 cotton 
commodities 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 the 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 emamectin 
benzoate meets EPA's registration requirements for use on cotton or 
whether permanent tolerances for this use would be appropriate. Under 
these circumstances, EPA does not believe that these tolerances serve 
as a basis for registration of emamectin benzoate 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 Alabama, Arkansas, 
Louisiana, Mississippi, Oklahoma, and Texas to use this pesticide on 
this crop under section 18 of FIFRA without following all provisions of 
EPA's regulations implementing section 18 as identified in 40 CFR part 
166. For additional information regarding the emergency exemptions for 
emamectin benzoate, contact the Agency's Registration Division at the 
address provided under `` FOR FURTHER INFORMATION CONTACT.''

IV. 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 emamectin 
benzoate and to make a determination on aggregate exposure, consistent 
with section 408(b)(2), for time-limited tolerances for combined 
residues of emamectin benzoate and its metabolites and photodegradates 
on cottonseed at 0.002 ppm, cottonseed oil at 0.0006 ppm, cotton meal 
at 0.002 ppm, cotton hulls at 0.004 ppm, and cotton gin trash at 0.025 
ppm; and the milk, meat, fat, kidney, and liver of cattle, goats, 
sheep, and swine at 0.002 ppm. EPA's assessment of the dietary 
exposures and risks associated with establishing the tolerances 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. The nature of the toxic effects caused by emamectin benzoate 
are discussed in Unit II.A. of the final rule on Emamectin Benzoate 
Pesticide Tolerances published in the Federal Register on May 19, 1999 
(64 FR 27192) (FRL-6079-7).

B. Toxicological Endpoint

    The toxicological endpoints for emamectin benzoate are discussed in 
Unit II.B. of the final rule on Emamectin Benzoate Pesticide Tolerances 
published in the Federal Register on May 19, 1999.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.505) for the combined residues of emamectin benzoate and its 
metabolites and photodegradates, in or on Brassica, head and stem 
(subgroup 5-A under 40 CFR 180.41), celery, and head lettuce. Risk 
assessments were conducted by EPA to assess dietary exposures and risks 
from emamectin benzoate 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. For conducting the acute dietary risk 
assessment, the population subgroups of concern are infants, children, 
and females 13 years and older. An acute dietary risk assessment was 
performed using the Dietary Exposure Evaluation Model (DEEM) system, 
Tier 3 (Monte Carlo) approach. This methodology incorporates 
distributions of residues and refined percent of crop treated (PCT) 
estimates for some crops and thus results in refined risk estimates. 
This exposure analysis was conducted using the Acute Population-
Adjusted Dose (PAD) of 0.00025 milligrams/kilograms/day (mg/kg/day). 
The analysis evaluated individual food consumption as reported in the 
USDA Continuing Surveys of Food Intake by Individuals (CSFII) conducted 
in 1989-92. The model accumulated exposure to emamectin for each 
commodity and expresses risk as a function of dietary exposure. For the 
most highly exposed population subgroup, children 1-6 years old, the 
resulting high-end exposure (at the 99.9th percentile) occupies 65% of 
the acute PAD. For the overall U.S. population, the high-end exposure 
(99.9th percentile) occupies 29% of the acute PAD. All risk estimates 
are within acceptable limits, thus there is reasonable certainty of no 
harm due to acute dietary exposure to emamectin.
    ii. Chronic exposure and risk. The chronic dietary risk assessment 
used the chronic PAD of 0.000083 mg/kg/day, and consumption reported in 
the USDA-CSFII of 1989-92, and accumulates exposure to emamectin for 
each commodity. This analysis used tolerance-level residues and 25% 
crop treated figures for broccoli, Brussels sprouts, cabbage, 
cauliflower, lettuce, and celery. For the most highly exposed 
population subgroup, children 1-6 years old, the resulting exposure 
occupies 21% of the chronic PAD. For the overall U.S. population, the 
exposure occupies 15% of the chronic PAD. All risk estimates are within 
acceptable limits, thus there is reasonable certainty of no harm due to 
chronic dietary exposure to emamectin.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual 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

[[Page 1799]]

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 PCT as required by section 408(b)(2)(F), 
EPA may require registrants to submit data on PCT.
    The Agency used PCT figures of: 25% for broccoli, Brussels sprouts, 
cabbage, cauliflower, lettuce, and celery.
    The Agency believes that the three conditions in section 
408(b)(2)(F), discussed 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 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 emamectin benzoate may be applied in a 
particular area.
    2. From drinking water. There are no established Maximum 
Contaminant Levels (MCLs) of health advisory levels for residues of 
emamectin in drinking water. The Agency currently lacks sufficient 
water-related exposure data to complete a comprehensive drinking water 
exposure analysis and risk assessment for emamectin. Because the Agency 
does not have comprehensive and reliable monitoring data, drinking 
water concentration estimates must be made by reliance on some sort of 
simulation or modeling. None of the drinking water models used by the 
Agency include consideration of the impact that processing of raw 
water, for distribution as drinking water, would likely have on the 
removal of pesticides from the source water. The primary use of these 
models by the Agency at this stage is to provide a coarse screen for 
sorting out pesticides for which it is highly unlikely that drinking 
water concentrations would ever exceed human health levels of concern.
    In the environment, emamectin and its primary degradates are 
expected to be relatively immobile due to the high degree of sorption 
to soil particles. Estimated concentrations for surface water exceeded 
those for ground water; therefore, surface water values were used for 
risk calculations. The estimated environmental concentration (EEC) for 
acute drinking water exposure is 0.107 part per billion (ppb), derived 
from the PRZM/EXAMS model which estimates pesticide concentrations in a 
farm pond. The highest EEC for chronic drinking water exposure is 
0.0203 ppb from the PRZM/EXAMS model. These drinking water estimates 
are considered to include both emamectin and its metabolites of 
concern.
    In the absence of monitoring data for pesticides, drinking water 
levels of comparison (DWLOCs) are calculated and compared to the model 
estimates of a pesticide's concentration in water. DWLOCs are 
theoretical upper limits for a pesticide's concentration in drinking 
water in light of total aggregate exposure to a pesticide in food, 
drinking water, and residential uses. A DWLOC will vary depending on 
the toxic endpoint, with drinking water consumption, and body weights. 
Different populations will have different DWLOCs. DWLOCs are used in 
the risk assessment process as a surrogate measure of potential 
exposure associated with pesticide exposure through drinking water. 
DWLOC values are not regulatory standards for drinking water. The 
estimates for drinking water levels, derived from the models mentioned 
in the preceding paragraph, are all well below the DWLOCs calculated 
for all population subgroups. Since DWLOCs address total aggregate 
exposure to emamectin they are further discussed in the aggregate risk 
sections below.
    3. From non-dietary exposure. Emamectin benzoate is currently not 
registered for use on any residential non-food sites. The proposed and 
existing uses of emamectin are not expected to result in residential 
exposure. Therefore, a non-dietary risk assessment was not conducted.
    4. Cumulative exposure to substances with a 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.''
    Emamectin benzoate is synthetically derived from avermectin, which 
is derived from the antibiotic-producing actinomycetes, the source of 
all of the antibiotic fungicides. Streptomyces avermitilus produces the 
insecticide avermectin, which is a mixture of two homologs, avermectin 
B1a and B1b, which have equal biological 
activity. Currently, the only member of this class which is registered 
for agricultural uses is avermectin. Avermectin and ivermectin are 
structurally similar to emamectin. 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. Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, emamectin benzoate 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 emamectin 
benzoate has a common mechanism of toxicity with other substances. For 
more information regarding EPA's efforts to determine which chemicals 
have a common mechanism of toxicity and to evaluate the cumulative 
effects of such chemicals, see the final rule for Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997).

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

    1. Acute risk. There are currently no registered residential uses 
of emamectin or uses which may result in residential exposure. 
Therefore, acute aggregate risk consists of exposure from food and 
drinking water sources only. As discussed earlier, exposure to 
emamectin residues in food will occupy no more than 29% of the acute 
PAD for adult population subgroups, and no more than 65% of the acute 
PAD for infant/children subgroups. Estimated concentrations of 
emamectin residues in surface and ground water are lower than the 
DWLOCs calculated by the Agency. The drinking water estimates were 
calculated using drinking water models,

[[Page 1800]]

and are considered conservative. Therefore, EPA does not expect chronic 
aggregate risk to emamectin residues from food and water sources to 
exceed levels of concern for acute aggregate risk, and thus finds 
reasonable certainty that no harm will result from aggregate acute 
exposure to emamectin.
    2. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to emamectin benzoate 
from food will utilize 15% of the chronic PAD for the U.S. population. 
The major identifiable subgroup with the highest aggregate exposure is 
children 1 to 6 years old, at 21% of the chronic PAD. This is discussed 
below. EPA generally has no concern for exposures below 100% of the PAD 
because the PAD represents the level at or below which daily aggregate 
dietary exposure over a lifetime will not pose appreciable risks to 
human health. As stated above, the estimated drinking water levels, 
calculated using EPA models, and thus considered conservative, were 
lower than all DWLOCs. Thus, despite the potential for exposure to 
emamectin benzoate in drinking water, EPA does not expect the aggregate 
exposure to exceed 100% of the chronic PAD, and thus concludes that 
there is reasonable certainty that no harm will result from chronic 
aggregate exposure to emamectin.
    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. Since there are no registered residential uses or 
other uses that would be expected to result in residential exposure, 
there is no exposure expected in these scenarios, and thus this risk 
assessment is not necessary.
    4. Aggregate cancer risk for U.S. population. Based on the 
available data available for emamectin, there is no evidence of 
carcinogenicity, and thus this risk assessment is not necessary.
    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 emamectin benzoate residues.

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

    1. Safety factor for infants and children--i. In general. The 
determination of the 3X safety factor to account for the potential for 
increased sensitivity of infants and children to residues of 
imidacloprid is discussed in Unit II.E.1.i. of the final rule on 
Emamectin Benzoate Pesticide Tolerances published in the Federal 
Register on May 19, 1999.
    ii. Developmental toxicity studies. Developmental toxicity is 
discussed in Units II.A.8. and II.A.16. and II.E.1. of the Federal 
Register document published on May 19, 1999.
    iii. Reproductive toxicity study. Reproductive toxicity is 
discussed in Units II.A.10. and II.E.1. of the Federal Register 
document published on May 19, 1999.
    iv. Prenatal and postnatal sensitivity. Prenatal and postnatal 
sensitivity is discussed in Unit II.E.1. of the Federal Register 
document published on May 19, 1999.
    v. Conclusion. There is a complete toxicity data base for emamectin 
benzoate and exposure data are complete or are estimated based on data 
that reasonably accounts for potential exposures.
    2. Acute risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to emamectin benzoate 
from food will utilize no more than 65% of the acute PAD for infants 
and children. EPA generally has no concern for exposures below 100% of 
the PAD because the PAD represents the level at or below which daily 
aggregate dietary exposure will not pose appreciable risks to human 
health.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to emamectin benzoate 
from food will utilize 21% of the PAD for the most highly exposed 
infant and children subgroup, children 1 to 6 years old. EPA generally 
has no concern for exposures below 100% of the PAD because the PAD 
represents the level at or below which daily aggregate dietary exposure 
will not pose appreciable risks to human health. Despite the potential 
for exposure to emamectin benzoate in drinking water and from non-
dietary, nonoccupational exposure, EPA does not expect the aggregate 
exposure to exceed 100% of the PAD.
    4. Short- or intermediate-term risk. Since there are no registered 
residential uses or other uses that would be expected to result in 
residential exposure, there is no exposure expected in these scenarios, 
and thus this risk assessment is not necessary.
    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 emamectin benzoate 
residues.

V. Other Considerations

A. Metabolism in Plants and Animals

    The nature of the residues of emamectin benzoate in plants is 
adequately understood. The tolerance expression for emamectin benzoate 
must contain the following: emamectin, 8,9 ZMA and metabolites/
photodegradates AB1a, MFB1a, and 
FAB1a. Metabolites/photodegradates 8AOXOMA and 8AOHMA are 
also of toxicological concern, but based upon their relative levels to 
the emamectin and the other four emamectin-like residues (8,9 ZMA, 
AB1a, MFB1a, and FAB1a), these are not 
needed in the tolerance expression or dietary risk assessment. No 
metabolism data in livestock and poultry have been provided. For the 
purposes of this section 18 request, the residue of concern in 
livestock is emamectin, and 8,9 isomer of B1a and 
B1b.

B. Analytical Enforcement Methodology

    Adequate enforcement methodology is available for both plant and 
livestock commodities; it is a HPLC method using fluorescence as the 
means of detection. The methods described in MRID 44795001 are adequate 
to enforce the tolerance expression.
    The method may be requested from: Calvin Furlow, PIRIB, IRSD 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460; telephone number: (703) 305-5229; 
e-mail address: [email protected].

C. Magnitude of the Residues

    Residues of emamectin and its metabolites and photodegradates are 
not expected to exceed 0.002 ppm in/on cottonseed, 0.006 ppm in 
cottonseed oil, 0.002 ppm cotton meal, 0.004 ppm in cotton hulls, and 
0.025 ppm in gin trash; and 0.002 ppm in the meat, milk, fat, liver, 
and kidney of cattle, goats, sheep, and swine as a result of this 
section 18 use. Secondary residues are expected in animal commodities 
as gin trash containing measurable residues is among the feed items 
associated with this section 18 use. Secondary residues in milk, meat, 
fat, kidney and liver of cattle, goats, sheep, and swine are not 
expected to exceed 0.002 ppm. Residues are not expected in poultry 
commodities, since cotton gin trash is not a significant feed item of 
poultry, and exposure would be negligible.

D. Rotational Crop Restrictions

    Based on available information, the confined rotational crop data 
base is adequate and no plantback restrictions are needed on labels.

[[Page 1801]]

 E. International Residue Limits

    There are no Codex, Canadian, or Mexican MRLs for emamectin.

VI. Conclusion

    Therefore, tolerances are established for combined residues of 
emamectin benzoate, 4'-epi-methylamino- 4'-deoxyavermectin 
B1 benzoate (a mixture of a minimum of 90% 4'-epi-
methylamino-4'- deoxyavermectin B1a and a maximum of 10% 4'-
epi-methlyamino-4'deoxyavermectin B1b benzoate) and its 
metabolites 8,9 isomer of the B1a and B1b 
component of the parent insecticide (8,9 ZMA); 4'-deoxy-4'-epi-
aminoavermectin B1 (AB1a); 4'deoxy-4'-epi-(N-
formyl-N-methyl)amino-avermectin (MFB1a); and 4'-deoxy-4'-
epi-(N-formyl)amino-avermectin B1 (FAB1a) in 
cottonseed at 0.002 ppm, cottonseed oil at 0.0006 ppm, cotton meal at 
0.002 ppm, cotton hulls at 0.004 ppm, and cotton gin trash at 0.025 
ppm; and in the milk, meat, fat, liver, and kidney of cattle, goats, 
sheep, and swine at 0.002 ppm.

VII. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-300958 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before March 13, 
2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
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 willnot 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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The 
Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The telephone number for the 
Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    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 the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VII.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by the docket control number OPP-300958, 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 or 
by courier, bring a copy to the location of the PIRIB described in Unit 
I.B.2. You may also send an electronic copy of your request via e-mail 
to: [email protected]. Please use an ASCII file format and avoid the 
use of special characters and any form of encryption. Copies of 
electronic objections and hearing requests will also be accepted on 
disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not 
include any CBI in your electronic copy. You may also submit an 
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
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(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VIII. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408. 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) (Public Law 104-4). Nor does it require any prior consultation 
as specified by Executive Order 13084, entitled

[[Page 1802]]

Consultation and Coordination with Indian Tribal Governments (63 FR 
27655, May 19, 1998); 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 or any Agency action under 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note). Since tolerances and exemptions that are established on the 
basis of a FIFRA section 18 petition under FFDCA section 408, 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. In addition, the Agency has 
determined that this action will not have a substantial direct effect 
on States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government, as specified in Executive Order 13132, 
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 
13132 requires EPA to develop an accountable process to ensure 
``meaningful and timely input by State and local officials in the 
development of regulatory policies that have federalism implications.'' 
``Policies that have federalism implications'' is defined in the 
Executive Order to include regulations that have ``substantial direct 
effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.'' This final 
rule directly regulates growers, food processors, food handlers and 
food retailers, not States. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of FFDCA section 408(n)(4).

IX. Submission to Congress and the General Accounting Office

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 22, 1999.

James Jones,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 321(q), 346(a) and 371.


    2. In Sec. 180.505, by alphabetically adding the following 
commodities to the table in paragraph (b) to read as follows:


Sec. 180.505  Emamectin Benzoate; tolerances for residues.

*    *    *    *    *
     (b) * * *

------------------------------------------------------------------------
                                                             Expiration/
                   Commodity                     Parts per    Revocation
                                                  million        date
------------------------------------------------------------------------
 
                  *        *        *        *        *
Cattle, fat...................................        0.002     12/31/01
 
Cattle, meat..................................        0.002     12/31/01
 
Cattle, meat byproduct........................        0.002     12/31/01
 
Cotton gin byproduct..........................        0.025     12/31/01
 
Cotton hulls..................................        0.004     12/31/01
 
Cotton, meal..................................        0.002     12/31/01
 
Cottonseed....................................        0.002     12/31/01
 
Cottonseed oil................................        0.006     12/31/01
 
Goats, fat....................................        0.002     12/31/01
 
Goats, meat...................................        0.002     12/31/01
 
Goats, meat byproduct.........................        0.002     12/31/01
 
Hogs, fat.....................................        0.002     12/31/01
 
Hogs, meat....................................        0.002     12/31/01
 
Hogs, meat byproduct..........................        0.002     12/31/01
 
Sheep, fat....................................        0.002     12/31/01
 
Sheep, meat...................................        0.002     12/31/01
 
Sheep, meat byproduct.........................        0.002     12/31/01
------------------------------------------------------------------------

*    *    *    *    *

[FR Doc. 00-735 Filed 1-11-00; 8:45 am]
BILLING CODE 6560-50-F