Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Rules and Regulations 18519 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0418; FRL–9379–1] 

Abamectin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation raises 

tolerances for residues of abamectin 

(also known as 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 delta-8,9- 

isomer) in or on cotton and strawberries. 

Syngenta Crop Protection Inc. requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

March 27, 2013. Objections and requests 

for hearings must be received on or 

before May 28, 2013, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0418, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Jessica Rogala, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460; telephone number: (703) 

347–0263; email address: 

rogala.jessica@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. To access the OPPTS 

harmonized test guidelines referenced 

in this document electronically, please 

go to http://www.epa.gov/oppts and 

select ‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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–2012–0418 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before May 28, 2013. Addresses for mail 

and hand delivery of objections and 

hearing requests are provided in 40 CFR 

178.25(b). 

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 (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0418, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/ 

dockets. 

II. Summary of Petitioned-For 

Tolerance 

In the Federal Register of August 22, 

2012 (77 FR 50661) (FRL–9358–9), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

petition (PP 2F8009) by Syngenta Crop 

Protection LLC, P.O. Box 18300, 

Greensboro, NC 27419–8300. The 

petition requested that 40 CFR 180.449 

be amended by increasing the 

established tolerances for residues of the 

insecticide abamectin (also known as 

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-methylpropyl)-25-(1-methylethyl) 

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

(referred to as ‘‘abamectin’’ in this 

document) in or on cotton, undelinted 

seed from 0.005 parts per million (ppm) 

to 0.015 ppm; cotton, gin by-products 

from 0.15 ppm to 1.0 ppm and 

strawberry from 0.02 ppm to 0.06 ppm. 

That document referenced a summary 

of the petition prepared by Syngenta 

Crop Protection LLC., the registrant, 

which is available in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petition, EPA is 

establishing tolerance for cotton, 

undelinted seed and strawberry at levels 

that vary from levels requested. The 

reasons for these changes are explained 

in Unit IV.D. 

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 


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reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) 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 FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for abamectin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with abamectin 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. Abamectin has 

high to moderate acute toxicity by the 

oral route (depending on the vehicle), 

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. The main target 

organ is the nervous system, and the 

reduced body weight effect is one of the 

most frequent findings. Neurotoxicity 

and developmental effects were 

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/chronic exposures. Increased 

susceptibility (qualitative and/or 

quantitative) was seen in prenatal 

developmental toxicity studies in mice 

and rabbits, and in developmental 

neurotoxicity studies in rats. Review of 

acceptable oncogenicity and 

mutagenicity studies provides no 

indication that abamectin is 

carcinogenic or mutagenic. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by abamectin 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, 

Abamectin: Human Health Risk 

Assessment at 16, section 4.0 in docket 

ID number EPA–HQ–OPP–2012–0418. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Once a pesticide’s toxicological 

profile is determined, EPA identifies 

toxicological points of departure (POD) 

and levels of concern to use in 

evaluating the risk posed by human 

exposure to the pesticide. For hazards 

that have a threshold below which there 

is no appreciable risk, the toxicological 

POD is used as the basis for derivation 

of reference values for risk assessment. 

PODs are developed based on a careful 

analysis of the doses in each 

toxicological study to determine the 

dose at which no adverse effects are 

observed (the NOAEL) and the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL). Uncertainty/ 

safety factors are used in conjunction 

with the POD to calculate a safe 

exposure level—generally referred to as 

a population-adjusted dose (PAD) or a 

reference dose (RfD)—and a safe margin 

of exposure (MOE). 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 

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 abamectin 

used for human risk assessment is 

shown in the following Table. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ABAMECTIN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (General population including infants and 

children).

NOAEL = 0.5 mg/kg/ 

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = .005 

mg/kg/day.

12-week dose-range finding study in dogs LOAEL = 1.0 mg/kg/ 

day based on Mydriasis seen 1–5 times during the first week 

of treatment. Acute neurotoxicity study in rats 

LOAEL= 1.5 mg/kg/day based on increased incidence of foot 

splay. 

Chronic dietary (All populations) NOAEL= 0.12 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

cPAD = .0004 mg/ 

kg/day.

Combined data from three reproduction studies and two developmental neurotoxicity studies (please see the discussion on 

Chronic Dietary Endpoint) 

LOAEL = 0.2 mg/kg/day based on decreased pup body weight 

in pups at 0.2 mg/kg/day. 

Incidental oral short-term and 

Intermediate term (1 to 6 

months).

NOAEL= 0.12 mg/ 

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

LOC for MOE = 300 Combined data from three reproduction studies and two developmental neurotoxicity studies (please see the discussion on 

Chronic Dietary Endpoint) 

LOAEL = 0.2 mg/kg/day based on decreased pup body weight. 


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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR ABAMECTIN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Dermal All Durations ................. Dermal study 

NOAEL = 0.12 

mg/kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

LOC for MOE = 300 Combined data from three reproduction studies and two developmental neurotoxicity studies (please see the discussion on 

Chronic Dietary Endpoint) 

LOAEL = 0.2 mg/kg/day based on decreased pup body weight. 

Inhalation short-term .................

All durations ..............................

Inhalation study 

NOAEL = 0.12 

mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 3x 

LOC for MOE = 300 Combined data from three reproduction studies and two developmental neurotoxicity studies (please see the discussion on 

Chronic Dietary Endpoint) 

LOAEL = 0.2 mg/kg/day based on decreased pup body weight. 

Cancer (Oral, dermal, inhalation).Classification: Not likely to be carcinogenic to humans based on the absence of significant increase in tumor 

incidence in two adequate rodent carcinogenicity studies. 

FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = 

milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = 

chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to abamectin, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

abamectin tolerances in 40 CFR 180.449. 

EPA assessed dietary exposures from 

abamectin 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. Such effects were identified 

for abamectin. In estimating acute 

dietary exposure, EPA used 2003–2008 

food consumption information from the 

U.S. Department of Agriculture (USDA) 

2003–2008 National Health and 

Nutrition Examination Survey, What We 

Eat in America (NHANES/WWEIA). As 

to residue levels in food, a refined acute 

dietary (food and drinking water) 

exposure assessment was conducted. 

Tolerance level residues were used for 

bulb onions, chives, dry beans, and 

okra. Acute anticipated residues for the 

remaining commodities were derived 

from field trial data. Empirical and 

default processing factors were used. 

EPA also relied on available percent 

crop treated (PCT) information for 

registered uses of abamectin including 

strawberry and cotton. EPA relied on 

available data in estimating PCT) for 

existing uses of abamectin. Surface 

drinking water concentrations were 

estimated using the Tier II PRZM/ 

EXAMS (Pesticide Root Zone Model/ 

Exposure Analysis Modeling System) 

computer model and a national default 

percent cropped area (PCA) value of 

87%. The model predicts that the 

maximum concentration of total 

residues of abamectin in surface water 

(the 1-in-10-year peak exposure) is not 

likely to exceed 2.3 ppb from the use of 

aerial/ground applications to dry beans 

in Michigan. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used 2003–2008 food consumption 

data from the USDA 2003–2008 

NHANES/WWEIA. As to residue levels 

in food, EPA a refined chronic dietary 

exposure assessment was conducted. 

Tolerance level residues were used for 

bulb onions, chives, dry beans, and and 

okra. Average residues from field trials 

were used for the remaining crops. 

Empirical and default processing factors 

were also used. EPA used available PCT 

information registered use of abamectin 

including strawberry and cotton. 

Drinking water was represented by a 

single point estimate of average 

abamectin residues (the 1-in-ten-year 

annual mean). The estimated surface 

water concentration of 1.3 parts per 

billion (ppb) was based on the 

application to dry beans in Michigan. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that abamectin does not pose 

a cancer risk to humans. Therefore, a 

quantitative dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

iv. Anticipated residue and 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 


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18522 Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Rules and Regulations 

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 estimated the PCT for 

existing uses as follows: The following 

maximum PCT estimates were used in 

the acute dietary risk assessment for the 

following crops that are currently 

registered for abamectin: Almonds: 

75%; apples: 10%; apricots: 5%; 

avocados: 60%; cantaloupes: 30%; 

celery: 65%; cherries: 2.5%; cotton: 

20%; cucumbers: 10%; grapefruit: 80%; 

grapes: 25%; honeydew: 35%; lemons: 

55%; lettuce: 20%; oranges: 45%; 

peaches: 2.5%; pears: 80%; pecans: 

2.5%; peppers: 25%; potatoes: 2.5%; 

prunes: 10%; pumpkins: 10%; spinach: 

45%; squash: 10%; strawberries: 45%; 

tangerines: 65%; tomatoes: 20%; 

walnuts: 20%; and watermelons: 10%. 

The following average PCT estimates 

were used in the chronic dietary risk 

assessment for the following crops that 

are currently registered for abamectin: 

Almonds: 50%; apples: 5%; apricots: 

5%; avocados: 40%; cantaloupes: 15%; 

celery: 40%; cherries: 1%; cotton: 5%; 

cucumbers: 5%; grapefruit: 60%; grapes: 

10%; honeydew: 20%; lemons: 35%; 

lettuce: 10%; oranges: 25%; peaches: 

1%; pears: 70%; pecans: 1%; peppers: 

10%; potatoes: 1%; prunes: 2.5%; 

pumpkins: 2.5%; spinach: 20%; squash: 

5%; strawberries: 30%; tangerines: 60%; 

tomatoes: 10%; walnuts: 10%; and 

watermelons: 5%. 

An emulsifiable concentrate (EC) 

formulation is currently registered for 

abamectin for use on cotton and 

strawberry. The petitioner has requested 

that the existing tolerance levels be 

increased to support the registration of 

cotton and strawberry for a suspension 

concentrate (SC) formulation. The 

residue field trials submitted indicate 

that the SC formulation result in higher 

pesticide residues than that of the EC 

formulation. However, the Agency does 

not expect that the registration of a 

different formulation will impact the 

PCT estimates. 

In most cases, EPA uses available data 

from USDA 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 6–7 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 abamectin 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 abamectin in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of abamectin. 

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 were used to estimate 

the drinking water concentrations 

(EDWCs) of abamectin. For acute 

exposures, the EDWCs are estimated to 

be 2.3 parts per billion (ppb) for surface 

water and 1.6 × 10¥3 ppb for ground 

water. The EDWCs of abamectin for 

chronic exposures are estimated to be 

1.3 ppb for surface water and 1.6 × 10¥3

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 2.3 ppb was used 

to assess the contribution to drinking 

water. For chronic dietary risk 

assessment, the water concentration of 

value 1.3 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). 

Abamectin is currently registered for 

the following uses that could result in 

residential exposures: Granular baits 

used to treat lawns and indoor bait 

products. EPA assessed residential 

exposure using the following 

assumptions: Adults were assessed for 

short-term residential handler exposure. 

Residential post-application exposure to 

adults and children is unlikely for all 

registered uses of abamectin. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

http://www.epa.gov/pesticides/trac/ 

science/trac6a05.pdf. 

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.’’ 

OPP’s Guidance For Identifying 

Pesticide Chemicals and Other 

Substances that have a Common 

Mechanism of Toxicity (USEPA, 1999) 

describes the weight of the evidence 

approach for determining whether or 

not a group of pesticides share a 

common mechanism of toxicity. This 

guidance defines mechanism of toxicity 

as the major steps leading to a toxic 

effect following interaction of a 

pesticide with biological targets. All 

steps leading to an effect do not need to 

be specifically understood. Rather, it is 

the identification of the crucial events 

following chemical interaction that are 

required in order to describe a 

mechanism of toxicity. For example, a 

mechanism of toxicity may be described 

by knowing the following: A chemical 

binds to a given biological target in 

vitro, and causes the receptor-related 

molecular response; in vivo it also leads 


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to the molecular response and causes a 

number of intervening biological and 

morphological steps that result in an 

adverse effect. In this context a common 

mechanism of toxicity pertains to two or 

more pesticide chemicals or other 

substances that cause a common toxic 

effect to human health by the same, or 

essentially the same, sequence of major 

biochemical events. Hence, the 

underlying basis of the toxicity is the 

same, or essentially the same, for each 

chemical. In the case of the macrocyclic 

lactone pesticides (e.g., abamectin, 

emamectin, and avermectin), there is a 

wealth of data on the insecticidal 

mechanism of action for avermectin: Its 

insecticidal actions are mediated by 

interaction with the glutamate-gated 

chloride channels and GABAA gated 

chloride channels. This is presumed to 

be the insecticidal mechanism of action 

of emamectin and abamectin as well. 

Insecticidal mechanism of action does 

not indicate a common mechanism of 

toxicity for human health. Further, 

mammals lack glutamate-gated chloride 

channels; the toxic actions of 

avermectin appear to be mediated via 

interaction with GABAA and possibly 

glycine gated chloride channels. There 

is evidence that avermectin B1a binds to 

GABAA receptors and activates Cl¥ flux 

into neurons (Abalis et al., 1986; Huang 

and Casida, 1997). However, there is a 

paucity of data regarding the resultant 

alterations in cellular excitability of 

mammalian neurons and neural 

networks (i.e., changes in cellular 

excitability and altered network 

function as documented with 

pyrethroids), as well as in vivo 

measurements of altered excitability 

associated with adverse outcomes. 

Thus, while the downstream steps 

leading to toxicity via disruption of 

GABAA receptor function for avermectin 

can be postulated, experimental data 

supporting these actions are lacking. In 

addition, specific data demonstrating 

GABAA receptor interaction in 

mammalian preparations are lacking for 

abamectin and emamectin. Moreover, 

the specificity of such interaction on the 

adverse outcome would need to be 

shown experimentally. GABAA

receptors have multiple binding sites 

which have been proposed to relate to 

adverse outcomes. For example, Dawson 

et al (2000) showed for a group of 

avermectin-like compounds that rank 

order for anticonvulsant activity did not 

parallel the rank order for affinity at the 

3H ivermectin site. The authors 

hypothesized that these findings may be 

related to differential affinity or efficacy 

at subtypes of the GABAA receptor. 

Other reports have indicated species 

differences in abamectin effects on 

GABAA receptor function in the mouse 

as compared to the rat (Soderlund et al., 

1987). 

In conclusion, although GABAA

receptor mediated neurotoxicity may be 

a common mechanism endpoint for the 

macrocyclic lactone pesticides, data 

demonstrating the interactions of 

emamectin and abamectin with 

mammalian GABAA receptors are not 

available, and data in mammalian 

preparations linking alterations in 

GABAA receptor function to disruptions 

in neuronal excitability in vitro and in 

vivo, and ultimately adverse outcome, 

are also currently lacking for this class 

of compounds. In the absence of such 

data, the key biological steps leading to 

the adverse outcome (i.e., the 

mammalian mechanism of action) 

cannot be established and by extension 

a common mechanism of toxicity cannot 

be established. 

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 Web site 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. 

The abamectin toxicity database is 

adequate to evaluate potential increased 

susceptibility of infants and children, 

and includes developmental toxicity 

studies in rat, mice, and rabbits; two 1- 

generation rat reproductive toxicity 

studies in rat; a 2-generation 

reproductive toxicity study in rat; and 

two developmental neurotoxicity 

studies in the rat. No developmental 

effects were seen in the rat 

developmental toxicity study. However, 

increased quantitative susceptibility 

was noted in the prenatal 

developmental toxicity studies in mice 

and rabbits, the rat reproductive toxicity 

studies, and the developmental 

neurotoxicity studies in rat. 

3. Conclusion. In previous abamectin 

risk assessments, the 10X FQPA safety 

factor was retained as a database 

uncertainty factor for the lack of a 

developmental neurotoxicity study. 

Two developmental neurotoxicity 

studies have now been submitted and 

reviewed and the findings in these 

studies were considered in the 

identification of toxicological points of 

departure and uncertainty/safety factors. 

EPA has determined that reliable data 

show the safety of infants and children 

would be adequately protected if the 

FQPA SF were reduced to 1X for the 

acute dietary assessment and 3X for all 

assessments other than acute dietary. 

That decision is based on the following 

findings: 

i. The toxicity database for abamectin 

is complete except for immunotoxicity 

testing. Recent changes to 40 CFR part 

158 imposed new data requirements for 

immunotoxicity testing (OPPTS 

Guideline 870.7800) for pesticide 

registration. However, the toxicity 

database for abamectin provides no 

indication of immunotoxicity and 

abamectin does not belong to a class of 

chemicals that would be expected to be 

immunotoxic. Therefore, EPA does not 

believe that conducting an 

immunotoxicity study will result in a 

NOAEL less than the NOAELs of 0.5 

mg/kg/day and 0.12 mg/kg/day already 

set for abamectin acute and repeated 

exposures, respectively, and an 

additional uncertainty factor is not 

needed to account for lack of an 

immunotoxicity study. 

ii. Signs of neurotoxicity ranging from 

decrease in foot splay reflex, mydriasis 

(i.e.,excessive dilation of the pupil), 

curvature of the spine, decreased foreand hind-limb grip strength, tip-toe gate, 

tremors, ataxia, or spastic movements of 

the limbs were reported in various 

studies with different durations of 

abamectin exposure in rats, mice, and 

dogs. However, the results of two 

submitted rat developmental 

neurotoxicity studies did not show any 

evidence of neurotoxicity. 

iii. For all risk assessments involving 

repeated exposures to abamectin, EPA 

determined that a 3X safety factor 

would be appropriate, based on the 

severity of effects (decrease in pup body 

weight and mortality) and the steepness 

of the dose-response curve seen in the 

developmental neurotoxicity study and 

three reproductive toxicity studies in 

the rat. These 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 


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greater than 2X between NOAEL and 

LOAEL, 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 the 

severity of the effects seen. 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 of the steepness of 

the dose-response curve and the severe 

effects noted. Additionally, this 

adjusted point of departure (0.04 mg/kg/ 

day) would address the concerns for the 

increased susceptibility seen at higher 

doses in the 2-generation reproduction 

study in rats (LOAEL = 0.4 mg/kg/day), 

prenatal developmental study in mice 

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

developmental toxicity study in rabbits 

(LOAEL = 2 mg/kg/day), and the 1- 

generation rat reproduction study 

(LOAEL = 0.2 mg/kg/day). 

With respect to acute dietary 

exposure, the endpoint selected for risk 

assessment is based on mydriasis 

observed in dogs. EPA determined that 

the additional 3X factor applied to 

chronic and other exposure scenarios is 

not applicable to acute exposure for the 

following reasons: 

a. The concerns noted for steepness of 

the dose-response curve and the severity 

of effects were not seen in the studies 

where mydriasis occurred. 

b. The reduced body weights noted in 

studies following repeated exposure to 

abamectin are not a single dose effect. 

c. The increased susceptibility seen in 

the prenatal developmental toxicity 

studies, reproductive toxicity studies, 

and the developmental neurotoxicity 

studies were seen at a dose lower 

(LOAEL 0.2 mg/kg/day) than the dose 

(LOAEL 1.0 mg/kg/day) that caused 

mydriasis. Therefore, EPA has 

determined that it would be appropriate 

if the FQPA SF were reduced to 1X for 

the acute dietary assessment. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute and chronic dietary exposure 

assessments were refined and utilized 

tolerance level or anticipated residues, 

default or empirical processing factors, 

and PCT estimates. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to abamectin in 

drinking water. These assessments will 

not underestimate the exposure and 

risks posed by abamectin. Residential 

post-application exposure to adults and 

children is unlikely for all registered 

uses of abamectin 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute percent adjusted 

dose (PAD) and chronic percent 

adjusted dose (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer 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 appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

abamectin will occupy 24% 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 abamectin from 

food and water will utilize 53% of the 

cPAD for children 1–2 years old the 

population group receiving the greatest 

exposure. 

3. Short-term and intermediate-term 

risk. Short-term and intermediate-term 

aggregate exposure takes into account 

short- and intermediate-term residential 

exposure plus chronic exposure to food 

and water (considered to be a 

background exposure level). Abamectin 

is currently registered for uses that 

could result in short- and/or 

intermediate-term residential exposure, 

and the Agency has determined that it 

is appropriate to aggregate chronic 

exposure through food and water with 

short- and/or intermediate-term 

residential exposures to abamectin . 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in an 

aggregate MOE of 1800 for the general 

population Residential post-application 

exposure to adults and children is 

unlikely for all registered uses of 

abamectin. Because EPA’s level of 

concern for abamectin is an MOE of 300 

or below, this MOE is not of concern. 

4. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

abamectin is not expected to pose a 

cancer risk to humans. 

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 abamectin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodologies 

are available in Pesticide Analytical 

Manual II (PAM II) for citrus and 

processed fractions (Method I), ginned 

cottonseed (Method IA), and bovine 

tissues and milk (Method II). 

Additionally, Method M–073 and M– 

936–95–2 have been validated by the 

Agency and submitted for inclusion in 

PAM II as enforcement methods. These 

five methods are adequate for 

enforcement of the tolerances on plants 

and livestock. Method M–073 and M 

936–95–2 may be requested from: Chief, 

Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: 

residuemethods@epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

Organization food standards program, 

and it is recognized as an international 

food safety standards-setting 

organization in trade agreements to 

which the United States is a party. EPA 

may establish a tolerance that is 

different from a Codex MRL; however, 

FFDCA section 408(b)(4) requires that 

EPA explain the reasons for departing 

from the Codex level. The Codex has not 

established a MRL for abamectin. 

D. Revisions to Petitioned-For 

Tolerances 

Based upon review of the data 

supporting the petition, EPA revised the 

proposed tolerance for cotton, 

undelinted seed from 0.015 ppm to 0.02 

ppm and strawberry from 0.06 to 0.05 

ppm. The established tolerances are 

based on residue data using the EC 


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Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Rules and Regulations 18525 

formulation. Residues from crop field 

trials using the suspension concentrate 

(SC) formulation of abamectin plus 

adjuvant are higher than the established 

tolerances on cotton and strawberry, 

which are based on the EC formulation; 

therefore, higher tolerances are needed 

for use of the SC formulation on cotton 

and strawberry. EPA revised the 

tolerance level based on analysis of the 

residue field trial data using the 

Agency’s Tolerance Spreadsheet in 

accordance with the Agency’s Guidance 

for Setting Pesticide Tolerances Based 

on Field Trial Data. Additionally, The 

Agency has revised the tolerance 

expression to clarify: 

1. That, as provided in FFDCA section 

408(a)(3), the tolerance covers 

metabolites and degradates of abamectin 

not specifically mentioned; and 

2. That compliance with the specified 

tolerance levels is to be determined by 

measuring only the specific compounds 

mentioned in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of abamectin (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- 

methylpropyl)-25-(1-methylethyl) 

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

in or on undelinted cotton seed at 0.02 

ppm, cotton gin byproducts at 1.0 ppm, 

and strawberry at 0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under FFDCA section 408(d) 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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: March 18, 2013. 

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 is amended in paragraph 

(a) by: 

■ i. Revising the introductory text. 

■ ii. Revising in the table, the tolerance 

levels for Cotton, gin byproducts; 

Cotton, undelinted seed; and Strawberry 

to read as follows. 

§ 180.449 Avermectin B1 and its delta-8,9- 

isomer; tolerances for residues. 

(a) General. Tolerances are 

established for residues of abamectin, 

including its metabolites and 

degradates, in or on the commodities in 

the following table. Compliance with 

the tolerance levels specified in the 

following table is to be determined by 

measuring only avermectin B1 a mixture 

of avermectins containing greater than 

or equal to 80% avermectin B1 a (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 in or on the following 

commodities: 

Commodity Parts per 

million 

* * * * * * * 

Cotton, gin byproducts ......................................................................................................................................................... 1.0 

Cotton, undelinted seed ....................................................................................................................................................... 0.02 


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18526 Federal Register / Vol. 78, No. 59 / Wednesday, March 27, 2013 / Rules and Regulations 

Commodity Parts per 

million 

* * * * * * * 

Strawberry ............................................................................................................................................................................ 0.05 

* * * * * * * 

[FR Doc. 2013–06916 Filed 3–26–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 721 

[EPA–HQ–OPPT–2012–0842; FRL–9382–2] 

RIN 2070–AB27 

Significant New Use Rules on Certain 

Chemical Substances; Technical 

Amendment 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; technical 

amendment. 

SUMMARY: EPA issued direct final 

significant new use rules (SNURS) in 

the Federal Register of December 20, 

2012 for 9 chemical substances which 

were the subject of premanufacture 

notices (PMNs). For the chemical 

substance identified generically as 

aromatic sulfonic acid amino azo dye 

salts (PMN P–12–276) a typographical 

error has been identified. This 

document is being issued to correct the 

typographical error. 

DATES: This final rule is effective March 

27, 2013. 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2012–0842, is 

available at http://www.regulations.gov 

or at the Office of Pollution Prevention 

and Toxics Docket (OPPT Docket), 

Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC. The Public 

Reading Room is open from 8:30 a.m. to 

4:30 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Please review the visitor 

instructions and additional information 

about the docket available at http:// 

www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Kenneth 

Moss, Chemical Control Division 

(7405M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460–0001; telephone 

number: (202) 564–9232; email address: 

moss.kenneth@epa.gov. 

For general information contact: The 

TSCA-Hotline, ABVI-Goodwill, 422 

South Clinton Ave., Rochester, NY 

14620; telephone number: (202) 554– 

1404; email address: TSCAHotline@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me? 

The Agency included in the final rule 

a list of those who may be potentially 

affected by this action. 

II. What does this technical amendment 

do? 

When promulgating the significant 

new uses for aromatic sulfonic acid 

amino azo dye salts, EPA inadvertently 

listed the respirator as M100 in the 

workplace protective equipment 

requirements for § 721.63. EPA did not 

intend to include this requirement when 

promulgating the significant new uses 

for aromatic sulfonic acid amino azo 

dye salts; the Agency intended the 

respirator to be designated as N100. 

This technical amendment corrects that 

workplace protective equipment 

requirement for § 721.63. 

The preamble for FR Doc. 2012–30695 

published in the Federal Register issue 

of December 20, 2012 (77 FR 75390) 

(FRL–9372–8) is corrected as follows: 

1. On page 75394, first column, line 

16, correct M100 to read N100. 

III. Why is this technical amendment 

issued as a final rule? 

Section 553 of the Administrative 

Procedure Act (APA) (5 U.S.C. 

553(b)(3)(B)) provides that, when an 

Agency for good cause finds that notice 

and public procedure are impracticable, 

unnecessary or contrary to the public 

interest, the Agency may issue a final 

rule without providing notice and an 

opportunity for public comment. EPA 

has determined that there is good cause 

for making this technical amendment 

final without prior proposal and 

opportunity for comment, because 

notice and comment are unnecessary. 

The respirator designation of M100 that 

is being removed was never intended to 

be included in the SNUR; M100 is a 

designation for a 3M Corporation series 

of respiratory face shield, not a 

respirator; the Agency intended it to be 

a National Institute for Occupational 

Safety and Health (NIOSH)-certified 

N100 respirator. The PMN submitter 

who brought the error to EPA’s attention 

is familiar with the issue, and EPA is 

not aware of and does not expect there 

to be persons who would be adversely 

affected by the change as there are no 

companies making plans based on the 

erroneous notice and no harm resulting 

from replacing the erroneous 

requirement for a M100 respirator with 

that of a N100 respirator. EPA finds that 

this constitutes good cause under 5 

U.S.C. 553(b)(3)(B). 

IV. Do any of the statutory and 

executive order reviews apply to this 

action? 

This technical amendment changes an 

erroneous respirator designation that 

was placed in § 721.10633(a)(2)(i) when 

the final rule published in the Federal 

Register of December 20, 2012, 

promulgating significant new uses of 

aromatic sulfonic acid amino azo dye 

salts. The December 20, 2012 final rule 

addresses these requirements for that 

action (see Unit IX. of the preamble to 

that action). This technical amendment 

does not otherwise amend or impose 

any other requirements. 

As such, this technical amendment is 

not a ‘‘significant regulatory action’’ 

subject to review by the Office of 

Management and Budget (OMB) under 

Executive Order 12866, entitled 

Regulatory Planning and Review (58 FR 

51735, October 4, 1993), nor does this 

technical amendment contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (44 U.S.C. 3501 et seq.). 

Because the Agency has made a ‘‘good 

cause’’ finding that this technical 

amendment is not subject to notice and 

comment requirements under the APA 

or any other statute (see Unit III. of this 

document), it is not subject to the 

regulatory flexibility provisions of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.), or to sections 202 


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