[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Rules and Regulations]
[Pages 2867-2873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-625]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0261; FRL-8397-9]


Emamectin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for combined residues 
of emamectin and its metabolites in or on tree nuts (crop group 14) and 
pistachios. Syngenta Crop Protection, Inc. requested these tolerances 
under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation 
also makes a technical correction reinstating hog tolerances that were 
inadvertently omitted from the previous rule.

DATES: This regulation is effective January 16, 2009. Objections and 
requests for hearings must be received on or before March 17, 2009, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2008-0261. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Thomas C. Harris, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-9423; e-mail address: 
<a href="/cdn-cgi/l/email-protection#630b0211110a104d170b0c0e0210230613024d040c15"><span class="__cf_email__" data-cfemail="610900131308124f15090e0c0012210411004f060e17">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

[[Page 2868]]

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 entities may include, but are not limited to those 
engaged in the following activities:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr. To access the OPPTS Harmonized 
Guidelines referenced in this document, go directly to the guidelines 
at http://www.epa.gpo/opptsfrs/home/guidelin.htm.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2008-0261 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 as required by 40 CFR part 178 
on or before March 17, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2008-0261, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of May 16, 2008 (73 FR 28461) (FRL-8361-6), 
EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 7F7263) 
by Syngenta Crop Protection, Inc., PO Box 18300, Greensboro, NC 27419-
8300. The petition requested that 40 CFR 180.505 be amended by 
establishing tolerances for combined residues of the insecticide 
emamectin, 4'-epi-methylamino- 4'-deoxyavermectin B1 benzoate (a 
mixture of a minimum of 90% 4'-epi-methylamino-4'-deoxyavermectin 
B<INF>1a</INF> and a maximum of 10% 4'-epi-methlyamino-4'-
deoxyavermectin B<INF>1b</INF>), and its metabolites 8,9 isomer of the 
B<INF>1a</INF> and B<INF>1b</INF> component of the parent insecticide, 
in or on the food commodities tree nuts (crop group 14) and pistachios 
at 0.02 parts per million (ppm); and almond hulls at 0.25 ppm. That 
notice referenced a summary of the petition prepared by Syngenta Crop 
Protection, Inc., the registrant, which is available to the public in 
the docket, http://www.regulations.gov. There were no comments received 
in response to the notice of filing.
    Based upon EPA review of the data supporting the petition, the 
petition was subsequently revised to establish permanent tolerances for 
the combined residues of emamectin (a mixture of a minimum of 90% 4'-
epi-methylamino-4'-deoxyavermectin B<INF>1a</INF> and maximum of 10% 
4'-epi-methylamino-4'-deoxyavermectin B<INF>1b</INF>) and its 
metabolites 8,9-isomer of the B<INF>1a</INF> and B<INF>1b</INF> 
component of the parent (8,9-ZMA), or 4'-deoxy-4'-epi-amino-avermectin 
B<INF>1a</INF> and 4'-deoxy-4'-epi-amino-avermectin B<INF>1b</INF>; 4'-
deoxy-4'-epi-amino-avermectin B<INF>1a</INF> (AB<INF>1a</INF>); 4'-
deoxy-4'-epi-(N-formyl-N-methyl)amino-avermectin (MFB<INF>1a</INF>); 
and 4'-deoxy-4'-epi-(N-formyl)amino-avermectin B<INF>1a</INF> 
(FAB<INF>1a</INF>) in/on almond, hulls at 0.20 ppm; nut, tree, group 14 
at 0.02 ppm; and pistachio at 0.02 ppm. The reason for these changes 
are explained in Unit IV.D.
    In addition, with this final rule EPA is also making a technical 
correction to restate existing permanent tolerances on hogs (fat, 
liver, meat, and meat byproducts) which were inadvertently omitted in 
the final rule for pome fruit published on April 12, 2006 in (71 FR 
18642) (FRL-7765-4). Due to the consumption of apple pomace, that final 
rule altered the tolerances for most livestock but not for hogs (except 
to delete hog, milk as noted below). While the new livestock tolerances 
were listed, the tolerances for hogs, fat, liver, meat, and meat 
byproducts were inadvertently omitted. Hog tolerances were considered 
in this risk analysis for tree nuts and pistachios. Permanent 
tolerances continue to exist as stated in the final rule published on 
July 9, 2003 in (68 FR 40791) (FRL-7316-6) for emamectin 
(MAB<INF>1a</INF> + MAB<INF>1b</INF>) and the 8,9-Z isomers (8,9-
ZB<INF>1a</INF> and 8,9-ZB<INF>1b</INF> in hog, fat at 0.003 ppm; hog, 
liver at 0.020 ppm; hog, meat at 0.002 ppm; and hog, meat byproducts 
(except liver) at 0.005 ppm. Note: As stated in the April 12, 2006 
final rule, the tolerance for hog, milk was deleted along with other 
livestock-specific milk and replaced by a tolerance for simply 
``milk.''

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of 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) of FFDCA 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

[[Page 2869]]

exposure through drinking water and in residential settings, but does 
not include occupational exposure. Section 408(b)(2)(C) of FFDCA 
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. . . .''
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for combined residues of emamectin and its metabolites in/on 
almond, hulls at 0.20 ppm; nut, tree, group 14 at 0.02 ppm; and 
pistachio at 0.02 ppm. EPA's assessment of exposures and risks 
associated with establishing 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.
    Emamectin has moderate acute toxicity by the oral route and low 
acute toxicity by the dermal and inhalation routes. It is not 
irritating to the skin, nor is it a dermal sensitizer, but it is a 
severe eye irritant. The main target tissue is the nervous system, with 
neuropathology detected in many studies and several species. The dose/
response curve was very steep in several studies (most notably with CF-
1 mice and dogs), with severe effects (morbid sacrifice and 
neuropathology) sometimes seen. Although no increased sensitivity was 
seen in developmental toxicity studies in rats and rabbits, increased 
qualitative and/or quantitative sensitivity of rat pups was seen in the 
reproductive toxicity study and in the developmental neurotoxicity 
study. Review of acceptable oncogenicity and mutagenicity studies 
provide no indication that emamectin is carcinogenic or mutagenic.
    Specific information on the studies received and the nature of the 
adverse effects caused by emamectin as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document PP 7F7263 - Emamectin benzoate: Risk 
Assessment for adding new use on tree nuts and pistachios at pages 13-
22 in docket ID number EPA-HQ-OPP-2008-0261.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for emamectin used for 
human risk assessment can be found at http://www.regulations.gov in 
document PP 7F7263 - Emamectin benzoate: Risk Assessment for adding new 
use on tree nuts and pistachios at pages 19-21 in docket ID number EPA-
HQ-OPP-2008-0261.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to emamectin, EPA considered exposure under the petitioned-for 
tolerances as well as all existing emamectin tolerances in (40 CFR 
180.505). Note: As explained above, while hog tolerances were 
inadvertently omitted from the last emamectin tolerance listing, 
previously established hog tolerances continue to exist and were 
considered in this risk analysis for tree nuts and pistachios. EPA 
assessed dietary exposures from emamectin in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, EPA used tolerance 
levels and 100 percent crop treated (PCT) for tree nuts and pistachios. 
EPA relied upon anticipated residues based on field trial data and 
either 100 PCT or maximum surveyed PCT for all other commodities. See 
Unit C.1.iv. below for full listing of PCTs.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA added tree nuts 
(including pistachios) to the previous pome fruit risk assessment using 
tolerance levels and 100 PCT for tree nuts and pistachios. EPA relied 
upon anticipated residues based on field trial data and either 100 PCT 
or averaged surveyed PCT for all other commodities. See Unit III. 
C.1.iv for full listing of PCTs. Additional refinements included 
default processing factors where appropriate and chemical-specific 
processing factors for apple and pear juice based on an emamectin apple 
processing study.
    iii. Cancer. Based on the results of carcinogenicity studies in 
rats and mice, EPA classified emamectin as ``not likely to be 
carcinogenic to humans'' therefore, an exposure assessment for 
evaluating cancer risk is not needed for this chemical.
    iv. Anticipated residue and PCT information. Section 408(b)(2)(E) 
of

[[Page 2870]]

FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must require pursuant to FFDCA section 
408(f)(1) 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. For the present action, 
EPA will issue such Data Call-Ins as are required by FFDCA section 
408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be 
required to be submitted no later than 5 years from the date of 
issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
    <bullet> Condition a: 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 the pesticide residue.
    <bullet> Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
    <bullet> Condition c: 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 FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency used PCT information as follows (average and maximum, 
respectively): Apples 5, 5; broccoli 10, 20; cabbage 10, 20; 
cauliflower 10, 25; celery 15, 35; cotton <1, <2.5; lettuce 10, 15; 
pears <1, <2.5; peppers 5, 10; spinach 5, 5; tomatoes 10, 15. EPA 
assumed 100 PCT (both average and maximum) for tree nuts, pistachios, 
other crops not listed above, and for all livestock commodities. 
Maximum PCT was used for analysis of acute exposure while average PCT 
was used for analysis of chronic exposure.
    In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), proprietary market surveys, and the National Pesticide Use 
Database for the chemical/crop combination for the most recent 6 years. 
EPA uses an average PCT for chronic dietary risk analysis. The average 
PCT figure for each existing use is derived by combining available 
public and private market survey data for that use, averaging across 
all observations, and rounding to the nearest 5%, except for those 
situations in which the average PCT is less than one. In those cases, 
1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA 
uses a maximum PCT for acute dietary risk analysis. The maximum PCT 
figure is the highest observed maximum value reported within the recent 
6 years of available public and private market survey data for the 
existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c 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 reliable information on the regional consumption of 
food to which emamectin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for emamectin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of emamectin. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
emamectin for acute exposures are estimated to be 0.57 parts per 
billion (ppb) for surface water and 2.7 x 10-<SUP>4</SUP> ppb for 
ground water. The EDWCs of emamectin for chronic (non-cancer) exposures 
are estimated to be 0.22 ppb for surface water and 2.7 x 10-
<SUP>4</SUP> ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the full distribution of estimated residues in surface 
water generated by the PRZM-EXAMS model was used to assess the 
contribution to drinking water. For chronic dietary risk assessment, 
the water concentration of value 0.22 ppb was used to assess the 
contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Emamectin is not registered for any specific use patterns that 
would result in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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 has not found emamectin to share a common mechanism of toxicity 
with any other substances, and emamectin does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that emamectin does not 
have a common mechanism of toxicity with other substances. For 
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 EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(c) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this

[[Page 2871]]

provision, EPA either retains the default value of 10X, or uses a 
different additional safety factor when reliable data available to EPA 
support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. Prenatal exposure to 
emamectin results in increased sensitivity of offspring relative to 
adults (as seen in the rat reproductive toxicity study and the rat 
developmental neurotoxicity study). EPA has determined that the concern 
is low for the qualitative susceptibility seen in the two generation 
reproduction study because:
    i. There was a clear NOAEL for offspring toxicity.
    ii. Effects unique to offspring (decreased fertility in 
F<INF>1</INF> adults, and clinical signs (tremors and hind limb 
extensions during and following lactation)) were seen at the same dose 
that caused parental systemic toxicity (decreased body weight gain and 
histopathological lesions in the brain and spinal cord).
    iii. The decreased fertility seen in F<INF>1</INF> adults may be 
secondary to the neurotoxicity characterized by histopathological 
lesions in the brain and central nervous system (seen in both 
F<INF>0</INF> and F<INF>1</INF> generations), rather than due to a 
direct effect on the reproductive system.
    EPA has determined that the concern is also low for the qualitative 
and quantitative susceptibility seen in the developmemtal-neurotoxicity 
study (DNT) because:
    a. Although multiple offspring effects (including decreased pup 
body weight, head and body tremors, hind limb extension and splay, 
changes in motor activity and auditory startle) were seen at the 
highest dose, and no maternal effects were seen at any dose, there was 
a clear NOAEL for offspring toxicity at the low dose.
    b. The offspring LOAEL (at the mid dose) is based on a single 
effect seen on only 1-day (decreased motor activity on PND 17) and no 
other offspring toxicity was seen at the LOAEL.
     EPA has considered the differences in species sensitivity (rat 
NOAELs/LOAELs > dog NOAELs/LOAELs > mouse NOAELs/LOAELs) as well as the 
increased sensitivity of offspring relative to adults (as seen in the 
rat reproductive toxicity study and the rat developmental neurotoxicity 
study). EPA has determined that the dose selected for overall risk 
assessment (based on a 15-day study in adult mice) is lower than the 
doses that caused offspring toxicity in reproductive toxicity and 
developmental neurotoxicity studies in rats, the endpoint selected is 
the most sensitive end point (neurotoxicity) in the most sensitive 
species (mice) and thus would address the concerns for any potential 
toxicity in the offspring. Therefore, there are no residual 
uncertainties for prenatal and/or postnatal toxicity from exposure to 
emamectin.
    3. Conclusion. The 10X FQPA safety factor (SF) is retained for 
chronic assessments while a 3X FQPA SF is adequate for acute 
assessments. This conclusion is based on the following.
     The toxicology database used to assess prenatal and postnatal 
exposure to emamectin is considered adequate at this time. Note: There 
is a new data requirement under 40 CFR part 158 following the 
Immunotixicity Test Guideline (OPPTS 870.7800) which prescribes 
functional immunotoxicity testing and is designed to evaluate the 
potential of a repeated chemical exposure to produce adverse effects 
(i.e., suppression) on the immune system. Because the immune system is 
highly complex, studies assessing functional immunotoxic endpoints are 
helpful in fully characterizing a pesticide's potential immunotoxicity. 
These data will be used in combination with data from hematology, 
lymphoid organ weights, and histopathology in routine chronic or 
subchronic toxicity studies to characterize potential immunotoxic 
effects. The immunotoxicty study will be required as a condition of 
registration of the proposed emamectin tree nut use. Although there is 
a complete toxicity database for emamectin (other than new 
immunotoxicity study), exposure is estimated based on data that 
reasonably accounts for potential exposures, and increased sensitivity 
in the young is addressed by selection of a protective endpoint, EPA 
has retained a 10X FQPA SF for chronic/long-term and intermediate-term 
assessments due to the steepness of the dose-response curve, severity 
of effects at the LOAEL (death and neuropathology), the use of a short-
term study for long-term risk assessment. The 10X FQPA SF will also 
provide adequate protection for the lack of the new immunotoxicity 
study.
    The steepness of the dose-response curve and the severity of the 
effects at the LOAEL also are the basis for EPA retaining a 3X FQPA SF 
for acute assessments. A 3X FQPA factor was judged to be adequate (as 
opposed to a 10X) for the following reasons:
    i. A NOAEL was established in this study.
    ii. Although the effects of concern are seen after repeated dosing, 
the NOAEL here is used for a single exposure risk assessment
    iii. The most sensitive endpoint in the most sensitive species is 
selected.
    This risk analysis used both PCT and anticipated residues in the 
exposure analysis. For the reasons described in Unit III.C.1.iv the 
Agency is reasonably certain that the percentage of the food treated is 
not likely to be an underestimation. Use of 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.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. The acute aggregate risk assessment takes into 
account exposure from dietary (food and water) consumption. Using the 
exposure assumptions discussed in this unit for acute exposure, the 
acute dietary exposure from food and water to emamectin will occupy 45% 
of the aPAD for children 1-2 years old, the population group receiving 
the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
emamectin from food and water will utilize 44% of the cPAD for children 
1-2 years old, the population group receiving the greatest exposure. 
There are no residential uses for emamectin.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Emamectin is 
not registered for any use patterns that would result in residential 
exposure. Therefore, the short-term aggregate risk is the sum of the 
risk from exposure to emamectin through food and water and

[[Page 2872]]

will not be greater than the chronic aggregate risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Emamectin is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, the 
intermediate-term aggregate risk is the sum of the risk from exposure 
to emamectin through food and water, which has already been addressed, 
and will not be greater than the chronic aggregate risk..
    5. Aggregate cancer risk for U.S. population. Emamectin is 
classified as ``not likely to be carcinogenic to humans'' and is, 
therefore, not expected to pose a cancer risk.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to emamectin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    1. Enforcement method for plant commodities. A high performance 
liquid chromatography method with fluorescence detection (HPLC/FLD 
Method 244-92-3) is available for the enforcement of established 
tolerances for residues of emamectin and its metabolites in/on plants. 
The method was validated by EPA and submitted to the FDA for inclusion 
in the Pesticide Analytical Manual (PAM), Vol. II.
    The data collection method for nuts is an liquid chromotography/
mass spectrometry/mass spectrometry (LC/MS/MS) method (Syngenta Method 
RAM 465/01, modified). Residues of emamectin (B<INF>1a</INF> and B1b), 
8,9-Z isomer of B<INF>1a</INF>, AB<INF>1a</INF>, FAB<INF>1a</INF> and 
MFB<INF>1a</INF> in/on almond and pecan nutmeats and almond hulls are 
determined. The reported method limit of quantitation (LOQ) is 0.001 
ppm for each analyte in nutmeats and almond hulls.
    2. Enforcement method for livestock commodities. An analytical 
method is available for enforcement of tolerances for residues of 
emamectin and its metabolites in/on ruminant commodities. Method 244-
95-1 is an HPLC/FLD method which determines residues of emamectin 
(MAB<INF>1a</INF> and MAB<INF>1b</INF>) and the 8,9-Z isomers in 
livestock commodities. The LOQs are 0.0005 ppm for each analyte 
(MAB<INF>1a</INF> + 8,9-ZB<INF>1a</INF> and MAB<INF>1b</INF> + 8,9-
ZB<INF>1b</INF>) in whole and skim milk and 0.002 ppm for each analyte 
(MAB<INF>1a</INF> + 8,9-ZB<INF>1a</INF> and MAB<INF>1a</INF> + 8,9-
2B<INF>1a</INF>) in fat, liver, kidney, and meat. The method has been 
validated by EPA and forwarded to FDA for publication in PAM II.
    3. Multiresidue methods testing. Data previously submitted by the 
petitioner show that residues of emamectin are not likely to be 
recovered by FDA multiresidue methods. The petitioner submitted data 
pertaining to the multiresidue methods testing of emamectin 
(B<INF>1a</INF> and B<INF>1b</INF> components), AB<INF>1a</INF>, 
FAB<INF>1a</INF>, MFB<INF>1a</INF> and the 8,9-Z isomer (B<INF>1a</INF> 
component). The data have been forwarded to FDA for inclusion in PAM, 
Vol. I.
    Based on the methods described above, EPA has concluded that 
adequate enforcement methodology is available to enforce the tolerance 
expression. As indicated, the methods in this Unit have been forwarded 
to the Food and Drug Administration for inclusion in PAM I. or II. 
Alternately, methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; e-mail address: 
<a href="/cdn-cgi/l/email-protection#87f5e2f4eee3f2e2eae2f3efe8e3f4c7e2f7e6a9e0e8f1"><span class="__cf_email__" data-cfemail="1d6f786e747968787078697572796e5d786d7c337a726b">[email protected]</span></a>.

B. International Residue Limits

    There are no international harmonization issues associated with 
proposed uses on tree nuts and pistachios as there are currently no 
Codex, Canadian, or Mexican maximum residue limits (MRLs) or tolerances 
for residues of emamectin on tree nuts and pistachios.

C. Response to Comments

    No comments were received to the Notice of Filing.

D. Revisions to Petitioned-For Tolerances

    Modifications were made to the petition as originally submitted. 
The original petition proposed nut tolerances on emamectin and its 
metabolites 8,9 isomer of the B<INF>1a</INF> and B<INF>1b</INF> 
component of the parent insecticide. EPA had previously determined that 
there are additional metabolites of concern. Therefore, the complete 
nut tolerances expression is set on emamectin (a mixture of a minimum 
of 90% 4'-epi-methylamino-4'-deoxyavermectin B<INF>1a</INF> and maximum 
of 10% 4'-epi-methylamino-4'-deoxyavermectin B<INF>1b</INF>) and its 
metabolites 8,9-isomer of the B<INF>1a</INF> and B<INF>1b</INF> 
component of the parent (8,9-ZMA), or 4'-deoxy-4'-epi-amino-avermectin 
B<INF>1a</INF> and 4'-deoxy-4'-epi-amino-avermectin B<INF>1b</INF>; 4'-
deoxy-4'-epi-amino-avermectin B<INF>1a</INF> (AB<INF>1a</INF>); 4'-
deoxy-4'-epi-(N-formyl-N-methyl)amino-avermectin (MFB<INF>1a</INF>); 
and 4'-deoxy-4'-epi-(N-formyl)amino-avermectin B<INF>1a</INF> 
(FAB<INF>1a</INF>). In addition, while the tolerance for almond hulls 
was proposed at 0.25 ppm, since residues were quantifiable in/on almond 
hulls from all tests, the Agency's Guidelines for Setting Tolerances 
Based on Field Trials were utilized for determining the appropriate 
tolerance level for hulls. Based on the actual residue data from the 
28-day pre-harvest interval samples, the calculated tolerance for 
almond hulls is 0.20 ppm.

V. Conclusion

    Therefore, tolerances are established for combined residues of 
emamectin (a mixture of a minimum of 90% 4'-epi-methylamino-4'-
deoxyavermectin B<INF>1a</INF> and maximum of 10% 4'-epi-methylamino-
4'-deoxyavermectin B<INF>1b</INF>) and its metabolites 8,9-isomer of 
the B<INF>1a</INF> and B<INF>1b</INF> component of the parent (8,9-
ZMA), or 4'-deoxy-4'-epi-amino-avermectin B<INF>1a</INF> and 4'-deoxy-
4'-epi-amino-avermectin B<INF>1b</INF>; 4'-deoxy-4'-epi-amino-
avermectin B<INF>1a</INF> (AB<INF>1a</INF>); 4'-deoxy-4'-epi-(N-formyl-
N-methyl)amino-avermectin (MFB<INF>1a</INF>); and 4'-deoxy-4'-epi-(N-
formyl)amino-avermectin B<INF>1a</INF> (FAB<INF>1a</INF>) in/on almond, 
hulls at 0.20 ppm; nut, tree, group 14 at 0.02 ppm; and pistachio at 
0.02 ppm. In addition, permanent tolerances continue to exist as stated 
in the final rule published on July 9, 2003 in (68 FR 40791) (FRL-7316-
6) for emamectin (MAB<INF>1a</INF> + MAB<INF>1b</INF>) and the 8,9-Z 
isomers (8,9-ZB<INF>1a</INF> and 8,9-ZB<INF>1b</INF>) in hog, fat at 
0.003 ppm; hog, liver at 0.020 ppm; hog, meat at 0.002 ppm; and hog, 
meat byproducts (except liver) at 0.005 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. 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). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and SafetyRisks 
(62 FR 19885, April 23, 1997). 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

[[Page 2873]]

seq., nor does it require any special considerations under Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations (59 FR 7629, 
February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, 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.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not 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).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report 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).

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 6, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section Sec.  180.505 is amended by alphabetically adding the 
following commodities to the tables in paragraphs (a)(1) and (2) to 
read as follows:


Sec.  180.505  Emamectin; tolerances for residues.

    (a) * * * (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Almond, hulls..............................................         0.20
                                * * * * *
Nut, tree, group 14........................................         0.02
Pistachio..................................................         0.02
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (2) * * *

 
------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
                                * * * * *
Hog, fat...................................................        0.003
Hog, liver.................................................        0.020
Hog, meat..................................................        0.002
Hog, meat byproducts (except liver)........................        0.005
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. E9-625 Filed 1-15-09; 8:45 am]
BILLING CODE 6560-50-S


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