27130 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations 

Inert ingredients Limits Uses 

*******

■ 3. Section 180.930 is amended by 

revising the following entries in the 

table of inert ingredients to read as 

follows: 

§ 180.930 Inert ingredients applied to 

animas; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and 

monohydrogen phosphate esters and the corresponding ammonium, calcium, 

magnesium, potassium, sodium, and zinc salts of the phosphate esters; the nonyl 

group is a propylene trimer isomer and the poly(oxyethylene) content averages 4– 

14 or 30 moles (CAS Reg. Nos. 51811–79–1, 59139–23–0, 67922–57–0, 68412– 

53–3, 68553–97–9, 68954–84–7, 99821–14–4, 152143–22–1, 51609–41–7, 

37340–60–6, 106151–63–7, 68584–47–4, 52503–15–8, 68458–49–1).

Not to exceed 7% of pesticide formulation.Surfactants, related adjuvants of surfactants. 

a-(p-Nonylphenol)-w-hydroxypoly(oxyethylene) sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc salts the nonyl group is propylene trimer isomer and the poly(oxyethylene) content averages 4 moles (CAS Reg. Nos. 9014– 

90–8, 9051–57–4, 9081–17–8, 68649–55–8, 68891–33–8.

Not to exceed 7% of pesticide formulation.Surfactants, related adjuvants of surfactants. 

* * * * * * * 

[FR Doc. 2012–10933 Filed 5–8–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0261; FRL–9339–6] 

Ametoctradin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of ametoctradin 

in or on multiple commodities which 

are identified and discussed later in this 

document. BASF Corporation requested 

these tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective May 

9, 2012. Objections and requests for 

hearings must be received on or before 

July 9, 2012, 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–2010–0261. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

Docket Facility is open from 8:30 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Shaunta Hill, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8961; email address: 

hill.shaunta@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: 

• 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 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://ecfr.gpoaccess.gov/cgi/t/

text/text-idx?&c=ecfr&tpl=/ecfrbrowse/

Title40/40tab_02.tpl. 

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 


sroberts on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations 27131 

identify docket ID number EPA–HQ– 

OPP–2010–0261 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 July 9, 2012. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0261, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

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. Summary of Petitioned-for Tolerance 

In the Federal Register of May 19, 

2010 (75 FR 28009) (FRL–8823–2), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 0F7695) by BASF 

Corporation, 26 Davis Drive, Research 

Triangle Park, NC. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide ametoctradin, 

including its metabolites and 

degradates, in or on brassica, head and 

stem, subgroup 5A at 12 parts per 

million (ppm); brassica, leafy greens, 

subgroup 5B at 50 ppm; grape at 5.0 

ppm; grape, raisin at 8 ppm; hop, dried 

cones at 9 ppm; onion, bulb, subgroup 

3–07A at 1.2 ppm; onion, green, 

subgroup 3–07B at 16 ppm; vegetable, 

cucurbit, group 9 at 4.5 ppm; vegetable, 

fruiting, group 8–10 at 2 ppm; vegetable, 

leafy, except brassica, group 4, at 70 

ppm, and vegetable, tuberous and corm, 

subgroup 1C at 0.05 ppm. That notice 

referenced a summary of the petition 

prepared by BASF Corporation, 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 has 

proposed different tolerance levels 

under a cooperative global review 

process. The reason 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 

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 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 ametoctradin 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with ametoctradin 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. 

In toxicity testing with ametoctradin, 

no single dose or repeated dose study 

performed by any route of exposure 

produced a significant toxic effect up to 

or within 75–80% of the limit dose 

(1000 mg/kg/day). This includes the 

studies performed with the 

ametoctradin metabolites. There was 

also no evidence of carcinogenicity or 

mutagenicity and therefore 

ametoctradin is considered ‘‘Not Likely 

to Be Carcinogenic to Humans’’. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by ametoctradin as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document ‘‘BAS 

650 F (Ametoctradin): Human Health 

Risk Assessment for the Proposed New 

Fungicide Active Ingredient,’’ at p. 10 in 

docket ID number EPA–HQ–OPP–2010– 

0261. 

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. Based on the available 

data, there were no adverse acute or 

chronic effects identified as to any 

population groups (including infants 

and children). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 


sroberts on DSK5SPTVN1PROD with RULES
27132 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations 

exposure to ametoctradin, EPA 

considered exposure under the 

petitioned-for tolerances. EPA assessed 

dietary exposures from ametoctradin 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. No such effects were 

identified in the toxicological studies 

for ametoctradin; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. No chronic 

dietary exposure assessment was 

conducted because no chronic effect of 

concern was identified in the available 

data. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that ametoctradin does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

2. Dietary exposure from drinking 

water. Exposure to ametoctradin via 

drinking water from the proposed uses 

is expected to be minimal based on its 

short half life in soil. Ametoctradin 

degradates (F01, F02, F03, F04) are 

likely to contribute much greater 

drinking water exposure because they 

are more persistent and more mobile 

than the parent. However, no adverse 

effects were observed in the submitted 

toxicological studies for ametoctradin 

regardless of the route of exposure. 

Thus, no drinking water exposure 

assessments are needed. 

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). 

Ametoctradin is not registered for 

homeowner uses; however, some of the 

proposed uses could be used by 

commercial applicators in areas that 

residential postapplication exposure 

could occur (i.e., ornamentals on golf 

courses or in residential landscapes). No 

adverse effects were observed in the 

submitted toxicological studies for 

ametoctradin regardless of the route of 

exposure. Thus, no residential handler 

or postapplication exposure assessments 

are needed. 

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 ametoctradin to 

share a common mechanism of toxicity 

with any other substances, and 

ametoctradin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that ametoctradin 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 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. 

Based on the complete database, there 

were no adverse effects noted in the 

developmental toxicity or reproductive 

toxicity studies. 

3. Conclusion. Based on review of the 

available ametoctradin toxicological 

studies, no toxicological points of 

departure where selected for 

ametoctradin and thus, an additional 

safety factor to protect children is not 

needed. That decision is based on the 

following findings: 

i. The toxicity database for 

ametoctradin is complete. 

ii. There is no indication that 

ametoctradin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

ametoctradin results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2-generation 

reproduction study. 

iv. There are no concerns identified 

with regard to exposure to ametoctradin 

and thus there are no uncertainties 

identified in the exposure databases. 

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 aPAD and cPAD. For 

linear cancer risks, EPA calculates the 

lifetime probability of acquiring cancer 

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 appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, ametoctradin is not 

expected to pose an acute risk. 

2. Chronic risk. No adverse effect 

resulting from a chronic exposure was 

identified and no chronic endpoint was 

selected. Therefore, ametoctradin is not 

expected to pose a chronic risk. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Because no short-term 

adverse effect was identified, 

ametoctradin is not expected to pose a 

short-term risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because no intermediate-term adverse 

effect was identified, ametoctradin is 

not expected to pose a intermediateterm risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

ametoctradin is not expected to pose a 

cancer risk to humans. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population or to infants and children 

from aggregate exposure to ametoctradin 

residues. 


sroberts on DSK5SPTVN1PROD with RULES
Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations 27133 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

using liquid chromatography tandem 

mass spectrometry (LC/MS/MS) is 

available to enforce the tolerance 

expression. The method 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 U.N. 

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 

ametoctradin. 

C. Revisions to Petitioned-for Tolerances 

Ametoctradin is a candidate for global 

registration in the USA, Australia, and 

Canada and import tolerance 

establishment in the European Union 

(EU) for varying uses. Under a 

cooperative joint review process, 

harmonized MRLs were proposed by the 

Agency, the Pesticide Management 

Regulatory Agency of Canada (PMRA), 

and the EU. 

Although much effort was made to 

harmonize with the EU proposed 

import-MRLs, there remained a few 

crops (celery, broccoli, cucumber and 

hops) where the proposed global 

registration recommended MRLs 

differed. This is primarily because EU’s 

practice for setting MRLs is to lower the 

MRL as much as possible hence they try 

to assign MRLs to selected individual 

crops within a crop group as opposed to 

assigning a crop group MRL which is 

normally higher than all the estimated 

MRLs for individual crops. This 

approach is impractical for North 

American Free Trade Agreement 

(NAFTA) regions as there are other 

crops within a crop group petitioned for 

registration. 

The Organization for Economic Cooperation and Development’s (OECD) 

MRL calculation procedures used to 

estimate the proposed MRLs. The MRLs 

were derived using the average of 

individual residue data points from 

each field trial conducted at maximum 

applications rates and the lowest PHI, 

and assuming the presence of adjuvants 

(as indicated on the proposed labels). In 

estimating MRLs for crop groups, the 

highest estimated MRL for individual 

representative crops were selected. 

For some crops, field trials were 

conducted at concentrated and diluted 

solutions. In these cases, MRLs were 

chosen using only the residue data for 

applications with concentrated solution 

if the concentrated solution residue data 

showed significant differences from the 

whole residue dataset (concentrated and 

diluted solution applications). 

V. Conclusion 

Therefore, tolerances are established 

for residues of ametoctradin, including 

its metabolites and degradates, in or on 

brassica, head and stem, subgroup 5A at 

9.0 ppm; brassica, leafy greens, 

subgroup 5B at 50 ppm; grape at 4.0 

ppm; grape, raisin at 8.0 ppm; hop, 

dried cones at 10 ppm; onion, bulb, 

subgroup 3–07A at 1.5 ppm; onion, 

green, subgroup 3–07B at 20 ppm; 

spinach at 50 ppm; vegetable, cucurbit, 

group 9 at 3.0 ppm; vegetable, fruiting, 

group 8–10 at 1.5 ppm; vegetable, leafy, 

except brassica, group 4, except spinach 

at 40 ppm; and vegetable, tuberous and 

corm, subgroup 1C at 0.05 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) (Pub. L. 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 


sroberts on DSK5SPTVN1PROD with RULES
27134 Federal Register / Vol. 77, No. 90 / Wednesday, May 9, 2012 / Rules and Regulations 

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: April 27, 2012. 

Steven Bradbury, 

Director, 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. Add § 180.663 to read as follows: 

§ 180.663 Ametoctradin; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

ametoctradin, 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 

ametoctradin (5-ethyl-6- 

octyl[1,2,4]triazolo[1,5-a]pyrimidin-7- 

amine). 

Commodity Parts per 

million 

Brassica, head and stem, subgroup 5A ................................. 9.0 

Brassica, leafy greens, subgroup 

5B ............................................ 50 

Grape .......................................... 4.0 

Grape, raisin ............................... 8.0 

Commodity Parts per 

million 

Hop, dried cones ........................ 10.0 

Onion, bulb, subgroup 3–07A .... 1.5 

Onion, green, subgroup 3–07B .. 20.0 

Spinach ....................................... 50.0 

Vegetable, cucurbit, group 9 ...... 3.0 

Vegetable, fruiting, group 8–10 .. 1.5 

Vegetable, leafy, except Brassica, group 4, except spinach 40.0 

Vegetable, tuberous and corm, 

subgroup 1C ........................... 0.05 

(b) Section 18 emergency exemptions. 

[Reserved] 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2012–10950 Filed 5–8–12; 8:45 am] 

BILLING CODE 6560–50–P 


sroberts on DSK5SPTVN1PROD with RULES