Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 39545 

Pursuant to the Regulatory Flexibility 

Act (RFA) (5 U.S.C. 601 et seq.), the 

Agency hereby certifies that this action 

will not have a significant negative 

economic impact on a substantial 

number of small entities. 

In addition, the Agency has 

determined that this action will not 

have a substantial direct effect on States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive Order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This rule directly 

regulates growers, food processors, food 

handlers, and food retailers, not States. 

This action does not alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. For these 

same reasons, the Agency has 

determined that this rule does not have 

any ‘‘tribal implications’’ as described 

in Executive Order 13175, entitled 

Consultation and Coordination with 

Indian Tribal Governments (65 FR 

67249, November 9, 2000). Executive 

Order 13175 requires EPA to develop an 

accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: August 4, 2009. 

G. Jeffrey Herndon, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

§180.910 [Amended] 

■ 2. In the final rule published August 

9, 2006 (71 FR 45415), and delayed on 

August 4, 2008 (73 FR 45312), the 

effective date is delayed from August 9, 

2009, to October 9, 2009, for the 

following amendments to § 180.910: 

2.m., n., and cc. 

§180.930 [Amended] 

■ 3. In the final rule published August 

9, 2006 (71 FR 45415), and delayed on 

August 4, 2008 (73 FR 45312), the 

effective date is delayed from August 9, 

2009, to October 9, 2009, for the 

following amendments to § 180.930: 

4.t., u., and v. 

[FR Doc. E9–19057 Filed 8–6–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0806; FRL–8427–7] 

Avermectin B1 and its delta-8,9-isomer; 

Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

avermectin B1 and its delta-8,9-isomer 

in or on stone fruit crop group 12, tree 

nut crop group 14, pistachio, tuberous 

and corm vegetable crop subgroup 01C, 

goat fat, hog fat, horse fat, sheep fat, 

cattle fat, and cattle meat byproducts. 

Existing tolerances for cattle, fat and 

cattle, meat byproducts are revised. 

Existing individual crop tolerances on 

almond, plum, potato, and walnut are 

deleted and replaced by the 

establishment of new crop group 

tolerances. Existing tolerances on 

almond, hulls and plum, prune, dried 

are retained. This regulation also makes 

a technical correction to correctly 

express the existing tolerances for mint 

(replace term ‘‘mint’’ with the more 

specific terms ‘‘peppermint, tops’’ and 

‘‘spearmint, tops’’). Syngenta Crop 

Protection, Inc. and Y-TEX Corporation 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 7, 2009. Objections and requests 

for hearings must be received on or 

before October 6, 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–2008–0806. 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: 

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: 


pwalker on DSK8KYBLC1PROD with RULES
39546 Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 

• 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.gov/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–2008–0806 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 October 6, 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–2008–0806, 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 

As listed below, EPA published 

notices pursuant to section 408(d)(3) of 

FFDCA, 21 U.S.C. 346a(d)(3), 

announcing the filing of pesticide 

petitions in the Federal Register 

requesting that 40 CFR 180.449 be 

amended by establishing a tolerance for 

combined residues of the insecticide/ 

miticide avermectin B1 (a mixture of 

avermectins containing greater than or 

equal to 80% avermectin B1a (5-Odemethyl avermectin A1) and less than 

or equal to 20% avermectin B1b (5-Odemethyl-25-de (1-methylpropyl)-25-(1- 

methylethyl) avermectin A1)), and its 

delta-8,9-isomer, as listed below. 

Avermectin B1 is also referred to as 

abamectin. Each notice included a 

summary of the petition prepared by the 

registrant listed. There were no 

comments received in response to these 

notices of filing. 

September 27, 2000, 65 FR 58080, 

FRL–6746–4, PP 0F6146. This petition 

was filed by Novartis Crop Protection, 

Inc. (now Syngenta Crop Protection, 

Inc.), P.O. Box 18300, Greensboro, NC 

27419–8300 for tolerances of avermectin 

B1 and its delta-8,9-isomer in or on grass 

forage at 0.001 ppm, grass hay at 0.001 

ppm, stone fruit crop group 12 at 0.015 

ppm, tree nut crop group 14 at 0.005 

ppm, pistachio at 0.005 ppm, and the 

tuberous and corm vegetable crop 

subgroup 01C at 0.005 ppm. Tolerances 

for avocado and mint which were also 

requested in that notice were 

established earlier (see February 16, 

2005, 70 FR 7876). 

Based upon EPA review of the data 

supporting the petition, the petition was 

subsequently amended to request 

permanent tolerances for avermectin B1

and its delta-8,9-isomer at the revised 

levels as follow: Stone fruit crop group 

12 at 0.09 ppm, tree nut crop group 14 

at 0.01 ppm, pistachios at 0.01 ppm, 

tuberous and corm vegetables crop 

subgroup 01C at 0.01 ppm, goat fat at 

0.01 ppm, hog fat at 0.01 ppm, horse fat 

at 0.01 ppm, and sheep fat at 0.01 ppm. 

The tolerance requests for grass hay and 

grass forage were withdrawn pending 

development of further data on grass 

hay. Existing individual crop tolerances 

on almond, plum, potato, and walnut 

are deleted and replaced by the 

establishment of new crop group 

tolerances. Existing tolerances on 

almond, hulls and plum, prune, dried 

are retained. The proposed tolerance 

levels were raised based on EPA’s 

analysis of the residue data, EPA’s 

assessment of the limits of quantitation 

(LOQs) of the analytical methods, 

current livestock feed items (OPPTS 

Guideline 860.100, Table 1 Feedstuffs, 

June 2008), and/or to coordinate with 

Codex Maximum Residue Limits (MRLs) 

(see Unit IV.B.). 

December 3, 2008, 73 FR 73648, FRL– 

8391–3, PP 8F7454. This petition was 

filed by Y-TEX Corporation, 1825 Big 

Horn Avenue, P.O. Box 1450, Cody, WY 

82414, and proposes to amend the 

tolerances in 40 CFR 180.449 by 

increasing the tolerances of avermectin 

B1 and its delta-8,9-isomer in or on 

cattle fat from 0.015 ppm to 0.03 ppm 

and cattle meat byproducts from 0.02 

ppm to 0.06 ppm. These tolerances 

support use of avermectin in cattle ear 

tags. 

This regulation also makes a technical 

amendment to correctly express the 

existing tolerances for mint which were 

established in the final rule published 

on February 16, 2005 (70 FR 7876) (FRL7695-7). That rule listed the tolerance as 

‘‘mint’’ at 0.010 ppm. The correct 

terminology is ‘‘peppermint, tops’’ at 

0.010 ppm and ‘‘spearmint, tops’’ at 

0.010 ppm. 

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 


pwalker on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 39547 

reliable information.’’ This includes 

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 

avermectin B1 and its delta-8,9-isomer 

on stone fruit crop group 12 at 0.09 

ppm, tree nut crop group 14 at 0.01 

ppm, pistachios at 0.01 ppm, tuberous 

and corm vegetables crop subgroup 01C 

at 0.01 ppm, goat fat at 0.01 ppm, hog 

fat at 0.01 ppm, horse fat at 0.01 ppm, 

sheep fat at 0.01 ppm, cattle fat at 0.03 

ppm, and cattle meat byproducts at 0.06 

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. 

Avermection B1 (also known as 

abamectin) has high to moderate acute 

toxicity by the oral route, high acute 

toxicity by the inhalation route, and low 

acute toxicity by the dermal route. It is 

slightly irritating to the skin, but is not 

an ocular irritant or a dermal sensitizer. 

In general, the results of available 

toxicity studies with single or repeated 

dosing indicate that the main target 

organ for avermection B1 is the nervous 

system, and that decreased body weight 

is also one of the most frequent findings. 

There was no observed estrogen, 

androgen, or thyroid mediated toxicity. 

Neurotoxicity and developmental effects 

are detected in multiple studies and 

species of test animals. The dose/ 

response curve is very steep in several 

studies, with severe effects (including 

death and morbid sacrifice) seen at dose 

levels as low as 0.4 milligrams/ 

kilogram/day (mg/kg/day) and 0.1 mg/ 

kg/day in rats and mice, respectively, 

following repeated exposures. Increased 

susceptibility (qualitative and/or 

quantitative) was seen in prenatal 

developmental toxicity studies in mice 

and rabbits, and an increase in 

quantitative and qualitative 

susceptibility was also seen in the rat 

reproductive toxicity studies. Review of 

acceptable oncogenicity and 

mutagenicity studies provide no 

indication that avermection B1 is 

carcinogenic or mutagenic. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by avermectin B1 and its 

delta-8,9-isomer as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov in document the 

‘‘Abamectin, Revised Human Health 

Risk Assessment for Proposed Uses on 

Pasture and Rangeland Grass, Stone 

Fruit Crop Group 12, Tree Nut Crop 

Group 14, Pistachio, Tuberous and 

Corm Vegetables Subgroup 01C, and 

Request for Cattle Ear Tag Use,’’ at page 

18 in docket ID number EPA–HQ–OPP– 

2008–0806. 

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-, intermediate-, 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 avermectin B1 and its 

delta-8,9-isomer used for human risk 

assessment can be found at http:// 

www.regulations.gov in the document 

‘‘Abamectin, Revised Human Health 

Risk Assessment for Proposed Uses on 

Pasture and Rangeland Grass, Stone 

Fruit Crop Group 12, Tree Nut Crop 

Group 14, Pistachio, Tuberous and 

Corm Vegetables Subgroup 01C, and 

Request for Cattle Ear Tag Use,’’ at page 

25 in docket ID number EPA–HQ–OPP– 

2008–0806. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to avermectin B1 and its delta8,9-isomer, EPA considered exposure 

under the petitioned-for tolerances as 

well as all existing avermectin B1 and its 

delta-8,9-isomer tolerances in (40 CFR 

180.449). EPA assessed dietary 

exposures from avermectin B1 and its 

delta-8,9-isomer 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 a probabilistic 

distribution of anticipated residues 

derived from field trial data for all 

commodities. Default processing factors 

and maximum surveyed percent crop 

treated (PCT) were used as available. 

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 


pwalker on DSK8KYBLC1PROD with RULES
39548 Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 

used point estimates of anticipated 

residues derived from field trial data for 

all commodities. Default processing 

factors and average surveyed percent 

crop treated (PCT) were used as 

available. Also, residues of avermectin 

B1 and its delta-8,9-isomer in foods 

exposed in a food-handling 

establishment were assumed to be 

0.0002 ppm which is one-half the Limit 

of Detection (LOD). See Unit C.1.iv. 

below for full listing of PCTs. 

iii. Cancer. Based on the absence of a 

significant increase in tumor incidence 

in two rodent studies, EPA classified 

avermectin B1 as ‘‘not likely to be 

carcinogenic to humans’’ and, thus, an 

exposure assessment for evaluating 

cancer risk is unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. Section 

408(b)(2)(E) of 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: 

• 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): 

Commodity 

Percent Crop Treated 

(PCT) 

Average Maximum 

Almond 50 75 

Apple 5 10 

Avocado 40 60 

Cantaloupe 15 30 

Celery 40 65 

Cottonseed oil 5 5 

Cucumber 5 10 

Grape 5 15 

Grape, raisin 5 15 

Grapefruit 60 80 

Honeydew 15 30 

Hop 85 100 

Lemon 30 50 

Lettuce 10 15 

Orange 20 40 

Pear 65 80 

Pepper 25 100 

Potato 1 2.5 

Pumpkin 2.5 5 

Spinach 20 45 

Squash 5 10 

Strawberry 35 45 

Tangerine 40 45 

Tomato 15 100 

Walnut 5 20 

Watermelon 5 10 

EPA assumed 100 PCT (both average 

and maximum) for 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 the U.S. 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 <1. 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 avermectin B1 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 avermectin B1 and its major soil 

degradate (a mixture of an 8-alphahydroxy and a ring opened aldehyde 

derivative) in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of avermectin 

B1 and its major soil degradate (a 

mixture of an 8-alpha-hydroxy and a 

ring opened aldehyde derivative). 

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) for surface 

water and Screening Concentration in 


pwalker on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 39549 

Ground Water (SCI-GROW) models for 

ground water, the estimated drinking 

water concentrations (EDWCs) of 

avermectin B1 and its major soil 

degradate (a mixture of an 8-alphahydroxy and a ring opened aldehyde 

derivative) for acute exposures are 

estimated to be 0.464 parts per billion 

(ppb) for surface water and 0.00184 ppb 

for ground water; and for chronic 

exposures for non-cancer assessments 

are estimated to be 0.211 ppb for surface 

water and 0.00184 ppb for ground 

water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

acute dietary risk assessment, the water 

concentration value of 0.464 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 0.211 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). 

Avermectin B1 is currently registered 

for the following uses that could result 

in residential exposures: Residential 

lawn application for fire ant control, 

and residential indoor crack and crevice 

application for cockroaches and ants. 

EPA assessed residential exposure as 

follows. Exposure and risk estimates for 

homeowners applying crack and crevice 

baits were estimated using the Standard 

Operating Procedure (SOP) for 

Residential Exposure Assessments. The 

unit exposure from the wettable 

powder, open mixing and loading 

scenario listed in the SOP for 

Residential Exposure Assessments was 

used as a surrogate for estimating 

dermal and inhalation exposure for an 

activity that involves the use of a small 

syringe-type duster to make bait 

placements along the baseboards and 

into cracks and crevices. The method 

used for estimating residential 

applicator exposure is believed to 

produce a high-end estimate of 

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 avermectin B1 to 

share a common mechanism of toxicity 

with any other substances, and 

avermectin B1 does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that avermectin B1 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 

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. 

Increased susceptibility was seen in 

prenatal developmental toxicity studies 

in mice and rabbits following in utero 

exposure to avermectin B1. There was 

also an increase in susceptibility in the 

rat reproductive toxicity study and the 

rat developmental neurotoxicity study. 

3. Conclusion. EPA has retained an 

additional FQPA SF for chronic/longterm and short/intermediate-term 

assessments due to the steepness of the 

dose-response curve and severity of 

effects (death) at the LOAEL. For all risk 

assessments involving repeat exposures, 

the selected toxicity endpoint is based 

on the decrease in pup body weight 

seen in the developmental neurotoxicity 

study and three reproduction studies in 

the rat. Although the study identified a 

NOAEL for the effects observed in the 

pups, the data clearly indicate that the 

decrease in pup body weight seen at 0.2 

mg/kg/day rapidly progresses to death at 

the next higher tested dose level (0.4 

mg/kg/day) in both reproduction and 

developmental neurotoxicity studies. 

The combined data from several 

reproduction toxicity and 

developmental neurotoxicity studies 

have documented a very narrow dose 

range from NOAEL (0.12 mg/kg/day) to 

adverse effect (0.2 mg/kg/day) to severe 

adverse effect (0.4 mg/kg/day). Dose 

spacing is commonly greater than the 2x 

between NOAEL and LOAEL here, and 

the 3x difference between the NOAEL 

and the dose that induced mortality in 

the pups in the developmental 

neurotoxicity study provides little 

margin of safety for such a severe effect. 

Nonetheless, EPA has determined that 

reliable data show the safety of infants 

and children would be adequately 

protected if the 10X FQPA safety (SF) 

were reduced to 3X for chronic/long 

term and short/intermediate-term 

assessments and reduced to 1X for acute 

assessments. This conclusion is based 

on the following findings: 

i. Retaining an additional 3x FQPA 

safety factor effectively provides a 10x 

margin between the dose which causes 

death (0.4 mg/kg/day) and the NOAEL 

adjusted by the additional safety factor 

(0.12 mg/kg/day/3x = 0.04 mg/kg/day). 

A dose spacing of 10x between a 

NOAEL and LOAEL is as broad, if not 

broader, than the dose spacing generally 

used in animal testing and thus removes 

the residual concern with the steepness 

of the dose response curve and the 

severe effects seen here. 

ii. This adjusted point of departure 

(0.04 mg/kg/day) would also address the 

concerns for the increased susceptibility 

seen at higher doses in the twogeneration reproduction study in rats 

(LOAEL = 0.4 mg/kg/day), prenatal 

developmental study in CD-1 mice 

(LOAEL = 0.75 mg/kg/day), the prenatal 

developmental toxicity study in rabbits 

(LOAEL = 2 mg/kg/day), and the onegeneration reproduction study (LOAEL 

= 0.2 mg/kg/day). 

iii. The toxicity database for 

avermectin B1 is complete, except for 

immunotoxicity studies. EPA began 

requiring functional immunotoxicity 

testing of all food and non-food use 

pesticides on December 26, 2007. To 

address the issue of an immunotoxicity 

data gap and the associated database 

uncertainty factor, the Agency examined 

the entire database of avermectin B1 and 

determined that an additional 

uncertainty factor is not needed to 

account for potential immunotoxicity. 

Avermectin B1 has not been found to 

induce effects associated with 

immunotoxicity and avermectin B1 does 

not belong to a class of chemicals that 

would be expected to be immunotoxic. 

Therefore, based on the above 

considerations, EPA does not believe 

that conducting a special Harmonized 

Guideline series 870.7800 

immunotoxicity study will result in a 

NOAEL less than the NOAELs of 0.5 

and 0.12 mg/kg/day already set for 

avermectin B1 acute and repeated 


pwalker on DSK8KYBLC1PROD with RULES
39550 Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 

exposures, respectively. An additional 

uncertainty factor (UFDB) for database 

uncertainties associated with 

immunotoxicity does not need to be 

applied at this time. 

iv. With respect to acute dietary 

exposure, the endpoint selected for risk 

assessment is based on mydriasis 

observed in dogs. The additional 3x 

factor applied to chronic and other 

exposure scenarios is not applicable to 

acute exposure because steepness of the 

dose and severity of effects were not 

seen in the studies where mydriasis 

occurred. In addition, reduced body 

weight is not considered a single dose 

effect and would not be appropriate as 

a toxicity endpoint for acute exposure 

scenarios. 

v. There are no residual concerns with 

respect to the exposure databases. The 

chronic and acute dietary food exposure 

assessment utilizes reliable data on 

anticipated residues and percent crop 

treated as well as default processing 

factors. The dietary drinking water 

assessment utilized modeling results 

which included conservative 

assumptions for the parent and all 

degradates of concern. Conservative 

assumptions were used in the water 

models. Therefore, the water exposure 

assessment will not underestimate the 

potential risks for infants and children. 

Likewise, the use of maximum 

application rates and central-to-high 

end inputs results in calculated 

residential exposures that should not 

underestimate the risks to infants and 

children from these requested uses. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the acute population adjusted dose 

(aPAD) and chronic population adjusted 

dose (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-, intermediate-, 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 

avermectin B1 and its delta-8,9-isomer 

will occupy 27% of the aPAD for 

children 1 to 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 avermectin B1

and its delta-8,9-isomer from food and 

water will utilize 47% of the cPAD for 

children 1 to 2 years old, the population 

group receiving the greatest exposure. 

Based on the explanation in Unit 

III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of avermectin B1 and its delta8,9-isomer is not expected. 

3. Short- and intermediate-term risk. 

Short- and intermediate-term aggregate 

exposure takes into account short-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

High-end estimates of residential 

exposure were used, while average 

values were used for food and drinking 

water exposure. Avermectin B1 is 

currently registered for uses that could 

result in short- and intermediate-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short- and intermediateterm residential exposures to 

avermectin B1 and its delta-8,9-isomer. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short- and intermediate-term 

food, water, and residential exposures 

result in aggregate MOEs of 500 for 

children 1 to 2 years old, the population 

group receiving the greatest exposure. 

4. Aggregate cancer risk for U.S. 

population. Based on the absence of a 

significant increase in tumor incidence 

in two rodent studies, EPA classified 

avermectin B1 as ‘‘not likely to be 

carcinogenic to humans’’ and it is, 

therefore, not expected to pose a cancer 

risk. 

5. 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 avermectin 

B1 and its delta-8,9-isomer residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methods for 

avermectin B1 in plant and livestock 

commodities are available in PAM II. 

The methods have been validated for 

citrus and processed fractions (Method 

I), ginned cottonseed (Method IA), and 

bovine tissues and milk (Method II). 

These methods determine residues in 

plant and livestock commodities at 

limits of quantitation of 0.02 ppm for 

meat and meat byproducts and ≤0.01 

ppm for other plant/livestock 

commodities. The limits of detection of 

the methods for plant and livestock 

commodities is 0.001 ppm for each 

analyte, equivalent to 0.002 ppm for two 

analyte peaks (i.e., avermectin B1a and 

its delta-8,9-isomer in one peak and 

avermectin B1b and its delta-8,9-isomer 

in the other peak). 

The plant methods used for data 

collection adequately measure the 

residues of concern. The methods have 

been validated at 0.001, 0.002, or 0.005 

ppm (depending on the commodity and 

the method) for each of two analyte 

peaks (avermectin B1a and its delta-8,9- 

isomer in one peak and avermectin B1b

and its delta-8,9-isomer in the other 

peak), which means that the LOQs of 

the data collection methods would be 

0.002, 0.004 or 0.01 ppm. 

The 1990 Pestrak database indicates 

that avermectin B1 and its metabolites 

are not recovered or not likely to be 

recovered by FDA multiresidue 

methods. Therefore, the multiresidue 

methods can not be used to determine 

residues for dietary exposure 

assessment and can not be used as the 

primary enforcement method. 

B. International Residue Limits 

The Codex tolerance expressions for 

plants are consistent with the U.S. 

tolerance expression. 

C. Response to Comments 

No comments were received to the 

Notices of Filing. 

D. Revisions to Petitioned-For 

Tolerances 

The correct commodity definitions are 

obtained from the ‘‘Food and Feed 

Commodity Vocabulary’’, which can be 

found at http://www.epa.gov/pesticides/ 

foodfeed. Some proposed tolerance 

levels were raised based on EPA’s 

analysis of the residue data, EPA’s 

assessment of the limits of quantitation 

of the analytical methods, current 

livestock feed items (OPPTS Guideline 

860.100, Table 1 Feedstuffs, June 2008), 

and/or to coordinate with Codex 

Maximum Residue Limits (MRLs). 

V. Conclusion 

Therefore, tolerances are established 

for combined residues of avermectin B1

(a mixture of avermectins containing 

greater than or equal to 80% avermectin 

B1a (5-O-demethyl avermectin A1) and 

less than or equal to 20% avermectin 

B1b (5-O-demethyl-25-de (1- 


pwalker on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 74, No. 151 / Friday, August 7, 2009 / Rules and Regulations 39551 

methylpropyl)-25-(1-methylethyl) 

avermectin A1)), and its delta-8,9-isomer 

in/on cattle, fat at 0.03 ppm; cattle, meat 

byproducts at 0.06 ppm; fruit, stone, 

group 12 at 0.09 ppm; goat, fat at 0.01 

ppm; hog, fat at 0.01 ppm; horse, fat at 

0.01 ppm; nut, tree, group 14 at 0.01 

ppm; pistachio at 0.01 ppm; sheep, fat 

at 0.01 ppm; and vegetable, tuberous 

and corm subgroup 01C at 0.01 ppm. 

Existing tolerances for cattle, fat and 

cattle, meat byproducts are revised. 

Existing individual crop tolerances on 

almond, plum, potato, and walnut are 

deleted and replaced by the 

establishment of new crop group 

tolerances. Existing tolerances on 

almond, hulls and plum, prune, dried 

are retained. The expression for existing 

mint tolerances is corrected by deleting 

the term mint and replacing with 

peppermint, tops at 0.010 ppm and 

spearmint, tops at 0.010 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 Safety 

Risks (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 

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: July 28, 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. In § 180.449, the table to paragraph 

(a) is amended by revising the entries 

for cattle, fat and cattle, meat 

byproducts; by removing the entries for 

almond, plum, mint, potato and walnut; 

and by adding alphabetically, the 

remaining entries in the table to read as 

follows: 

180.449 Avermectin B1 and its delta-8,9- 

isomer; tolerances for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Cattle, fat ...................................... 0.03 

Cattle, meat byproducts ............... 0.06 

* * * * * 

Fruit, stone, group 12 ................... 0.09 

Goat, fat ........................................ 0.01 

* * * * * 

Hog, fat ......................................... 0.01 

* * * * * 

Horse, fat ...................................... 0.01 

* * * * * 

Nut, tree, group 14 ....................... 0.01 

* * * * * 

Peppermint, tops .......................... 0.010 

Pistachio ....................................... 0.01 

* * * * * 

Sheep, fat ..................................... 0.01 

* * * * * 

Spearmint, tops ............................ 0.010 

Vegetable, tuberous and corm, 

subgroup 01C ........................... 0.01 

* * * * * 

FR Doc. E9–19006 Filed 8–6–09; 8:45 am 

BILLING CODE 6560–50–S 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 63 

[WC Docket No. 04–36; FCC 09–40] 

IP-Enabled Services 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule. 

SUMMARY: This document amends the 

Commission’s rules so that providers of 

interconnected Voice over Internet 

Protocol (VoIP) service will be required 

to comply with the same discontinuance 

rules as domestic non-dominant 

telecommunications carriers. These 

rules protect consumers of 

interconnected VoIP service from the 

abrupt discontinuance, reduction or 

impairment of their service by requiring 


pwalker on DSK8KYBLC1PROD with RULES