Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 2867 

flats. Although DALS are letter-size, 

they are allowed to be entered at DDUs 

when they accompany either flats or 

parcels. This final rule does not propose 

to change the current standards that 

allow the DALs to be dropped at the 

DDU and does not change price 

eligibility for flats. 

The Postal Service adopts the 

following changes to Mailing Standards 

of the United States Postal Service, 

Domestic Mail Manual (DMM), which is 

incorporated by reference in the Code of 

Federal Regulations. See 39 CFR 111.1. 

List of Subjects in 39 CFR Part 111 

Administrative practice and 

procedure, Postal Service. 

■ Accordingly, 39 CFR 111 is amended 

as follows: 

PART 111—[AMENDED] 

■ 1. The authority citation for 39 CFR 

Part 111 continues to read as follows: 

Authority: 5 U.S.C. 552(a); 39 U.S.C. 101, 

401, 403, 404, 414, 416, 3001–3011, 3201– 

3219, 3403–3406, 3621, 3622, 3626, 3632, 

3633, and 5001. 

2. Revise the following sections of 

Mailing Standards of the United States 

Postal Service, Domestic Mail Manual 

(DMM), as follows: 

* * * * * 

600 Basic Standards for All Mailing 

Services 

* * * * * 

602 Addressing 

1.0 Elements of Addressing 

* * * * * 

1.5 Return Addresses 

* * * * * 

1.5.3 Required Use of Return 

Addresses 

The sender’s domestic return address 

must appear legibly on: 

* * * * * 

[Revise text of 1.5.3 to add new item 

m as follows:] 

m. Detached addressed labels (DALs). 

* * * * * 

4.0 Detached Address Labels (DALs) 

4.1 DAL Use 

* * * * * 

4.1.2 Periodicals or Standard Mail 

Flats Saturation Mailings 

[Revise text of 4.1.2 to require that 

DALs accompanying saturation 

mailings of Periodicals or Standard Mail 

flats be automation-compatible as 

follows:] 

Saturation mailings of unaddressed 

Periodicals or Standard Mail flats may 

be mailed with detached address labels 

(DALs). DALs accompanying saturation 

mailings of Periodicals or Standard Mail 

flats must be automation-compatible 

under 201.3.0. This standard does not 

apply to DALs with simplified 

addressing. For this standard, saturation 

mailing means a mailing sent to at least 

75% of the total addresses on a carrier 

route or 90% of the residential 

addresses on a route, whichever is less. 

Deliveries are not required to every 

carrier route of a delivery unit. 

Saturation flats mailings presented with 

DALs that are not automationcompatible and barcoded do not qualify 

for saturation prices but may be entered 

at the basic carrier route price for 

Periodicals mailings or the basic 

Enhanced Carrier Route price for 

Standard Mail mailings. 

* * * * * 

4.2 Label Preparation 

4.2.1 Label Construction 

Each DAL must be made of paper or 

cardboard stock that is not folded, 

perforated, or creased, and that meets 

these measurements: 

[Revise text of 4.2.1 to modify item c 

and add new item d and new item e as 

follows:] 

* * * * * 

c. At least .007 inch thick except 

under 4.2.1.d. 

d. If more than 41⁄4 inches high or 

more than 6 inches long, must be at 

least 0.009 inch thick. 

e. Must have an aspect ratio (length 

divided by height) from 1.3 to 2.5, 

inclusive. 

4.2.2 Addressing 

[Revise text of 4.2.2 by deleting the 

current last sentence in its entirety and 

adding a new last sentence to require a 

POSTNET or Intelligent Mail barcode 

with a delivery point routing code as 

follows:] 

* * * In addition, if DALs 

accompany saturation mailings of 

Periodicals or Standard Mail flats, a 

correct delivery point POSTNET 

barcode or Intelligent Mail barcode with 

an 11-digit routing code must be 

included (see 708.4) except when using 

a simplified address. 

* * * * * 

Neva R. Watson, 

Attorney, Legislative. 

[FR Doc. E9–859 Filed 1–15–09; 8:45 am] 

BILLING CODE 7710–12–P 

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. 

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: 

harris.thomas@epa.gov. 

SUPPLEMENTARY INFORMATION: 


sroberts on PROD1PC70 with RULES
2868 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 

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: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• 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: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• 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′-epimethylamino- 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), and its 

metabolites 8,9 isomer of the B1a and B1b

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-methylamino4′-deoxyavermectin B1a and maximum 

of 10% 4′-epi-methylamino-4′- 

deoxyavermectin B1b) and its 

metabolites 8,9-isomer of the B1a and B1b

component of the parent (8,9–ZMA), or 

4′-deoxy-4′-epi-amino-avermectin B1a

and 4′-deoxy-4′-epi-amino-avermectin 

B1b; 4′-deoxy-4′-epi-amino-avermectin 

B1a (AB1a); 4′-deoxy-4′-epi-(N-formyl-Nmethyl)amino-avermectin (MFB1a); and 

4′-deoxy-4′-epi-(N-formyl)aminoavermectin B1a (FAB1a) 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 (MAB1a + MAB1b) and the 

8,9–Z isomers (8,9–ZB1a and 8,9–ZB1b 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 


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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 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-observedadverse-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 chemicalspecific 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 


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2870 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 

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 CallIns 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: 

• 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. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• 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 10-4

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 10-4 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 nonoccupational, 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 


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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 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 F1 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 F1

adults may be secondary to the 

neurotoxicity characterized by 

histopathological lesions in the brain 

and central nervous system (seen in 

both F0 and F1 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. Shortterm, intermediate-term, and chronicterm 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 


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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 (B1a and B1b), 8,9–Z isomer 

of B1a, AB1a, FAB1a and MFB1a 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 (MAB1a and 

MAB1b) and the 8,9–Z isomers in 

livestock commodities. The LOQs are 

0.0005 ppm for each analyte (MAB1a + 

8,9–ZB1a and MAB1b + 8,9–ZB1b) in 

whole and skim milk and 0.002 ppm for 

each analyte (MAB1a + 8,9–ZB1a and 

MAB1a + 8,9–2B1a) 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 (B1a and B1b components), 

AB1a, FAB1a, MFB1a and the 8,9–Z 

isomer (B1a 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: 

residuemethods@epa.gov. 

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 B1a and B1b

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 B1a and maximum of 

10% 4′-epi-methylamino-4′- 

deoxyavermectin B1b) and its 

metabolites 8,9–isomer of the B1a and 

B1b component of the parent (8,9–ZMA), 

or 4′-deoxy-4′-epi-amino-avermectin B1a

and 4′-deoxy-4′-epi-amino-avermectin 

B1b; 4′-deoxy-4′-epi-amino-avermectin 

B1a (AB1a); 4′-deoxy-4′-epi-(N-formyl-Nmethyl)amino-avermectin (MFB1a); and 

4′-deoxy-4′-epi-(N-formyl)aminoavermectin B1a (FAB1a). 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 preharvest 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′-epimethylamino-4′-deoxyavermectin B1a

and maximum of 10% 4′-epimethylamino-4′-deoxyavermectin B1b) 

and its metabolites 8,9-isomer of the B1a

and B1b component of the parent (8,9– 

ZMA), or 4′-deoxy-4′-epi-aminoavermectin B1a and 4′-deoxy-4′-epiamino-avermectin B1b; 4′-deoxy-4′-epiamino-avermectin B1a (AB1a); 4′-deoxy4′-epi-(N-formyl-N-methyl)aminoavermectin (MFB1a); and 4′-deoxy-4′- 

epi-(N-formyl)amino-avermectin B1a

(FAB1a) 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 (MAB1a + 

MAB1b) and the 8,9–Z isomers (8,9–ZB1a

and 8,9–ZB1b) 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 


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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Rules and Regulations 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. 

■ 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), 346a and 371. 

■ 2. Section § 180.505 is amended by 

alphabetically adding the following 

commodities to the tables in paragraphs 

(a)(1) and (2) to read as follows: 

§ 180.505 Emamectin; tolerances for 

residues. 

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

Commodity Parts per 

million 

Almond, hulls ............................ 0.20 

*****

Nut, tree, group 14 ................... 0.02 

Pistachio ................................... 0.02 

*****

* * * * * 

(2) * * * 

Commodity Parts per 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 414 

[CMS–1561–IFC] 

RIN 0938–AP59 

Medicare Program; Changes to the 

Competitive Acquisition of Certain 

Durable Medical Equipment, 

Prosthetics, Orthotics and Supplies 

(DMEPOS) by Certain Provisions of the 

Medicare Improvements for Patients 

and Providers Act of 2008 (MIPPA) 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Interim final rule with comment 

period. 

SUMMARY: This interim final rule with 

comment period implements certain 

provisions of section 154 of the 

Medicare Improvements for Patients and 

Providers Act of 2008 (MIPPA) related 

to the durable medical equipment, 

prosthetics, orthotics, and supplies 

(DMEPOS) Competitive Acquisition 

Program. Specifically, this rule: 

Implements certain MIPPA provisions 

that delay implementation of Round 1 of 

the program; requires CMS to conduct a 

second Round 1 competition (the 

‘‘Round 1 rebid’’) in 2009; and mandates 

certain changes for both the Round 1 

rebid and subsequent rounds of the 

program, including a process for 

providing feedback to suppliers 

regarding missing financial 

documentation and requiring 

contractors to disclose to CMS 

information regarding subcontracting 

relationships. 

DATES: Effective date: These regulations 

are effective on February 17, 2009. 

Comment date: To be assured 

consideration, comments must be 

received at one of the addresses 

provided below, no later than 5 p.m. on 

March 17, 2009. 

ADDRESSES: In commenting, please refer 

to file code CMS–1561–IFC. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (please choose only one of the 

ways listed): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ and enter the filecode to 

find the document accepting comments. 


sroberts on PROD1PC70 with RULES