51628 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

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). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of the FFDCA, 

such as the exemption 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. 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 final 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 the 

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 6, 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. 

XIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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 theFederal 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: August 23, 2005. 

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 § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * 

Lactic acid, 2- 

ethylhexyl 

ester (CAS 

Reg. No. 

6283–86–9).

................ Solvent 

Inert Ingredients Limits Uses 

Lactic acid, 2- 

ethylhexyl 

ester, (2S)- 

(CAS Reg. 

No. 186817–

80–1).

................ Solvent 

* * * * * 

■ 3. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * * 

Lactic acid, 2- 

ethylhexyl 

ester (CAS 

Reg. No. 

6283–86–9).

................ Solvent 

Lactic acid, 2- 

ethylhexyl 

ester, (2S)- 

(CAS Reg. 

No. 186817–

80–1).

................ Solvent 

* * * * * 

[FR Doc. 05–17360 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2004–0326; FRL–7716–1] 

S-metolachlor; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues (free 

and bound) of S-metolachlor in or on 

certain commodities as set forth in Unit 

II. of the SUPPLEMENTARY INFORMATION. 

The Interregional Research Project 

Number 4 (IR–4), 681 U.S. Highway #1 

South, North Brunswick, NJ 08902–

3390, requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA), 

on behalf of the registrant, Syngenta 

Crop Protection, Swing Road, 

Greensboro, NC 276419. 

DATES: This regulation is effective 

August 31, 2005. Objections and 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51629 

requests for hearings must be received 

on or before October 31, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2004–

0326. All documents in the docket are 

listed in the EDOCKET index at http:// 

www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Sidney Jackson, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7610; e-mail address: 

jackson.sidney@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: 

• Crop production (NAICS 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

This listing is not intended to be 

exhaustive, but rather provides 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 and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gpo/ 

opptsfrs/home/guidelin.htm/. 

II. Background and Statutory Findings 

In the Federal Register of August 13, 

2004 (69 FR 50196) (FRL–7371–7), 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 (3E6787) by IR-4 on 

behalf of Syngenta Crop Protection, 

Swing Road, Greensboro, NC 27419. The 

petition requested that 40 CFR 180.368 

be amended by establishing tolerances 

for combined residues (free and bound) 

of the herbicide S-metolachlor [S-2- 

chloro-N-(2-ethyl-6-methylphenyl)-N-(2- 

methoxy-1-methylethyl)acetamide], its 

R-enantiomer, and its metabolites, 

determined as the derivatives, 2-(2- 

ethyl-6-methylphenyl)amino-1-propanol 

and 4-(2-ethyl-6-methylphenyl)-2- 

hydroxy-5-methyl-3-morpholinone, 

each expressed as the parent compound, 

S-metolachlor. It should be noted that 

the above chemical nomenclature for Smetolachlor differs slightly from that 

previously listed under 40 CFR 

180.368(a)(2). The Agency is 

establishing these tolerances for 

residues of S-metolachlor under a new 

paragraph, 180.368 (a)(3), using this 

nomenclature because it is more 

technically accurate in terms of the 

nature of the residues and the 

components determined by the 

analytical method. The Agency has 

determined that the tolerance 

expression as listed in paragraph (a)(2) 

should be changed and will be 

proposing that change in an upcoming 

rule. Further chemical definition of Smetolachlor can be found in Unit III. A. 

of this document. In petition, PP 

3E6787, IR-4 requested tolerances for Smetolachlor in or on the following raw 

agricultural commodities (RACs): 

1. Brassica, head and stem, subgroup 

5A at 0.5 parts per million (ppm). 

2. Cattle, fat at 0.04 ppm; cattle, 

kidney at 0.20 ppm; cattle, meat at 0.04 

ppm; cattle, meat byproducts, except 

kidney at 0.04 ppm. 

3. Corn, field, grain at 0.10 ppm; corn, 

field, stover at 6.0 ppm; corn, field, 

forage at 6.0 ppm; corn, sweet, forage at 

6.0 ppm; corn, sweet, stover at 6.0 ppm; 

corn, pop, stover at 6.0 ppm; corn, pop, 

grain at 6.0 ppm; corn, sweet, kernel 

plus cob with husk removed at 0.1 ppm. 

4. Cotton, gin byproducts at 4.0 ppm; 

cotton, undelinted seed at 0.1 ppm. 

5. Egg at 0.04 ppm. 

6. Garlic, bulb at 0.1 ppm. 

7. Goat, fat 0.04 ppm; goat, kidney at 

0.20 ppm; goat, meat at 0.04 ppm; goat, 

meat byproducts, except kidney at 0.04 

ppm. 

8. Horse, fat 0.04 ppm; horse, kidney 

at 0.20 ppm; horse, meat at 0.04 ppm; 

horse, meat byproducts, except kidney 

at 0.04 ppm. 

9. Leafy petioles subgroup 4B at 0.10 

ppm. 

10. Milk at 0.02 ppm. 

11. Onion, dry bulb at 0.1 ppm; onion, 

green at 2.0 ppm. 

12. Pea and bean, dried shelled, 

except soybean, subgroup 6C at 0.1 

ppm. 

13. Peanut 0.2 ppm; peanut, hay at 20 

ppm; peanut, meal at 0.40 ppm. 

14. Poultry, fat at 0.04 ppm; poultry, 

meat at 0.04 ppm; poultry, meat 

byproducts, except liver at 0.04 ppm. 

15. Safflower, seed at 0.1 ppm. 

16. Shallot at 0.1 ppm. 

17. Sheep, fat at 0.04 ppm; sheep, 

kidney at 0.20 ppm; sheep, meat at 0.04 

ppm; sheep, meat byproducts, except 

kidney at 0.04 ppm. 

18. Sorghum grain, stover at 4.0 ppm; 

sorghum grain, forage at 1.0 ppm; 

sorghum grain, grain at 0.3 ppm. 

19. Soybean, seed at 0.2 ppm; 

soybean, forage at 5.0 ppm; soybean, 

hay at 8.0 ppm. 

20. Vegetable, foliage of legume, 

except soybean, subgroup 7A at 15 ppm. 

21. Vegetable, fruiting, group 8 at 0.5 

ppm. 

22. Vegetable, legume, edible podded, 

subgroup 6A at 0.5 ppm. 

23. Vegetable, root, except sugar beet, 

subgroup 1B at 0.3 ppm. 

24. Vegetable, tuberous and corm, 

subgroup 1C at 0.2 ppm. 

Several of the proposed tolerances 

were subsequently amended as follows: 

51630 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

Tolerances for vegetable, fruiting, group 

8 (except tabasco pepper) at 0.1 ppm; 

tomato, paste at 0.3 ppm; a separate 

regional tolerance for pepper, tabasco at 

0.5 ppm; brassica, head and stem 

increased from 0.5 to 0.6 ppm; corn, 

pop, grain decreased from 6.0 to 0.1 and 

barley straw from 0.1 to 0.5 ppm. 

Furthermore, the proposed tolerance of 

cattle, goat, horse and sheep meat 

byproducts, except kidney at 0.04 ppm 

was subsequently amended to establish 

tolerances for meat byproducts, except 

kidney and liver of cattle, goat, horse 

and sheep at 0.04 ppm and separate 

tolerances for liver of cattle, goat, horse 

and sheep at 0.1 ppm. The tolerance for 

poultry, meat byproducts, except liver at 

0.04 ppm was also amended to poultry, 

meat byproducts at 0.04 ppm. 

Additionally, IR–4 proposed to amend 

40 CFR 180.368(a)(2) by removing 

tolerances established for the combined 

residues (free and bound) of the 

herbicide S-metolachlor [S-2-chloro-N- 

(2-ethyl-6-methylphenyl)-N-(2-methoxy1-methylethyl)acetamide], and its 

metabolites, determined as the 

derivatives, 2-(2-ethyl-6- 

methylphenyl)amino-1-propanol and 4- 

(2-ethyl-6-methylphenyl)-2-hydroxy-5- 

methyl-3-morpholinone, each expressed 

as the parent compound, in or on the 

following RAC’s: Carrot, roots at 0.20 

ppm; Horseradish at 0.20 ppm; onion, 

green at 0.20; rhubarb at 0.10 ppm; 

swiss chard at 0.10 ppm; and tomato at 

0.1 ppm. The Agency concurs with this 

proposal based on the fact that these 

uses are covered by crop group and/or 

crop subgroup tolerances promulgated 

under section (a)(3) of this ruling. 

Additionally, IR–4 proposed to amend 

40 CFR 180.368(d) by establishing 

tolerances for indirect or inadvertent 

combined residues (free and bound) of 

the herbicide S-metolachlor [S-2-chloroN-(2-ethyl-6-methylphenyl)-N-(2- 

methoxy-1-methylethyl)acetamide] its 

R-enantiomer,, and its metabolites, 

determined as the derivatives, 2-(2- 

ethyl-6-methylphenyl)amino-1-propanol 

and 4-(2-ethyl-6-methylphenyl)-2- 

hydroxy-5-methyl-3-morpholinone, 

each expressed as the parent compound, 

S-metolachlor in or on the following 

RAC’s: 

1. Animal feed, nongrass, group 18 at 

1.0 ppm 

2. Barley, grain at 0.1 ppm; barley 

straw at 0.1 ppm 

3. Buckwheat, grain at 0.1 ppm 

4. Oat, forage at 0.5 ppm; oat, grain at 

0.1 ppm; oat straw at 0.5 ppm 

5. Peanut, meal at 0.4 ppm 

6. Rice, grain at 0.1 ppm; rice, straw 

at 0.5 ppm 

7. Rye, forage at 0.5 ppm; rye, grain 

at 0.1 ppm; rye straw at 0.5 ppm 

8. Wheat, forage at 0.5 ppm; wheat 

grain at 0.1 ppm; wheat straw at 0.5 

ppm 

These tolerances for the various grains 

(barley, buckwheat, oats, rice, rye, 

wheat) and nongrass animal feeds are 

being established to cover residues of Smetolachlor in these crops when 

planted as rotational crops following 

treatment of a primary crop. The Agency 

concludes that these tolerances should 

be assigned to § 180.368(d) for indirect 

and inadvertent residues, and that 

adequate data are available to set the 

rotational crop tolerance for the 

nongrass animal feeds at 1.0 ppm. In 

addition, the Agency has concluded that 

tolerances should be established on the 

hays of barley, oats, and wheat at 1.0 

ppm in paragraph (d). The peanut meal 

tolerance will be established under 

paragraph (a)(3) and is not necessary as 

proposed in (d). 

The notice proposing these tolerances 

included a summary of the petition 

prepared by Syngenta Crop Protection, 

Incorporated, the registrant. There were 

no comments received in response to 

the notice of filing. 

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. . . .’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of FFDCA 

and a complete description of the risk 

assessment process, see the final rule on 

Bifenthrin Pesticide Tolerances 

November 26, 1997 (62 FR 62961) (FRL–

5754–7). 

III. Aggregate Risk Assessment and 

Determination of Safety 

Consistent with 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, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for combined 

residues (free and bound) of Smetolachlor on commodities and at 

tolerance levels presented in Unit II. of 

this document. EPA’s assessment of 

exposures and risks associated with 

establishing the tolerance follows. 

A. Toxicological Profile 

Metolachlor is a chloroacetanilide 

herbicide that was first registered as a 

pesticide in 1976. Metolachlor (known 

as racemic metolachlor) is a mixture 

consisting of 50% each of the Renantiomer (CGA 77101) and the Senantiomer (CGA 77102). The Senantiomer is the herbicidally active 

isomer.S-metolachlor is also a racemic 

mixture comprised of 88% Senantiomer and 12% R-enantiomer. The 

Agency has determined that Smetolachlor has either comparable or 

decreased toxicity as compared to 

racemic metolachlor. 

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. The nature of the 

toxic effects caused by S-metolachlor as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies reviewed are discussed 

in Unit III.A. of the Federal Register of 

April 2, 2003 (68 FR 15945) (FRL–7299–

8). 

B. Toxicological Endpoints 

The dose at which the NOAEL from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the LOAEL 

of concern is sometimes used for risk 

assessment if no NOAEL was achieved 

in the toxicology study selected. An 

uncertainty factor (UF) is applied to 

reflect 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. An UF of 100 is routinely 

used, 10X to account for interspecies 

differences and 10X for intraspecies 

differences. 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51631 

Three other types of safety or UFs 

may be used: ‘‘Traditional UF;’’ the 

‘‘special FQPA safety factor;’’ and the 

‘‘default FQPA safety factor.’’ By the 

term ‘‘traditional UF,’’ EPA is referring 

to those additional uncertainty factors 

used prior to FQPA passage to account 

for database deficiencies. These 

traditional uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘special FQPA safety factor’’ refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children primarily as a result of the 

FQPA. The ‘‘default FQPA safety factor’’

is the additional 10X safety factor that 

is mandated by the statute unless it is 

decided that there are reliable data to 

choose a different additional factor 

(potentially a traditional UF or a special 

FQPA safety factor). 

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (aRfD or cRfD) where the RfD is 

equal to the NOAEL divided by an UF 

of 100 to account for interspecies and 

intraspecies differences and any 

traditional uncertainty factors deemed 

appropriate (RfD = NOAEL/UF). Where 

a special FQPA safety factor or the 

default FQPA safety factor is used, this 

additional factor is applied to the RfD 

by dividing the RfD by such additional 

factor. The acute or chronic Population 

Adjusted Dose (aPAD or cPAD) is a 

modification of the RfD to accommodate 

this type of safety factor. 

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the LOC. For example, when 

100 is the appropriate UF (10X to 

account for interspecies differences and 

10X for intraspecies differences) the 

LOC is 100. To estimate risk, a ratio of 

the NOAEL to exposures (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk). An example of how such a 

probability risk is expressed would be to 

describe the risk as one in one hundred 

thousand (1 X 10-5), one in a million (1 

X 10-6), or one in ten million (1 X 10-7). 

Under certain specific circumstances, 

MOE calculations will be used for the 

carcinogenic risk assessment. In this 

non-linear approach, a ‘‘point of 

departure’’ is identified below which 

carcinogenic effects are not expected. 

The point of departure is typically a 

NOAEL based on an endpoint related to 

cancer effects though it may be a 

different value derived from the dose 

response curve. To estimate risk, a ratio 

of the point of departure to exposure 

(MOEcancer= point of departure/ 

exposures) is calculated. A summary of 

the toxicological endpoints for Smetolachlor used for human risk 

assessment is discussed in Unit III.B. of 

the final rule published in the Federal 

Register of April 2, 2003 (68 FR 15945) 

(FRL–7299–8). Should you desire 

additional information in this regard, 

please refer to that document. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.368(a)(2)) for 

the combined residues of S-metolachlor, 

in or on a variety of RAC’s. Smetolachlor is a selective, 

chloroacetanilide herbicide that is 

applied as a preplant, preplantincorporated (PPI), pre-emergence, or 

post-emergence application, primarily 

for the control of grass weeds. Smetolachlor is registered to Syngenta 

Crop Protection, Inc., for use on a wide 

variety of crops including: Corn, cotton, 

grasses grown for seed, legume 

vegetables, peanuts, potatoes, safflower, 

sorghum, sunflower, and tomatoes and 

complement the metolachlor (racemic 

mixture) product line with Smetolachlor products that contain a 

higher percentage of active pesticidal 

ingredient. 

Permanent tolerances for the 

combined S-metolachlor residues have 

been established in/on plant 

commodities ranging from 0.1 ppm in/ 

on a variety of plant commodities to 15 

ppm in/on sugar beet tops 40 CFR 

180.368(a))(2). Permanent tolerances are 

also established for combined residues 

of racemic metolachlor in 180.368(a)(1) 

and (c) at levels of 0.02 to 30 ppm. 

The Agency has recently reviewed 

plant metabolism data on S-metolachlor 

from field tests on soybeans and corn, 

in vitro tests on corn seedlings, and 

greenhouse tests on seedlings of corn, 

sorghum, soybeans and peanuts. These 

data support the petitioners assertion 

that the metabolism of S-metolachlor in 

plants is similar to the racemic mixture, 

metolachlor. The Agency has also 

recently reviewed animal metabolism 

data on S-metolachlor. Data from a goat 

metabolism study indicated that the 

residues of concern for S-metolachlor in 

animals are the same as for metolachlor. 

For both metolachlor and S-metolachlor 

the residues of concern in plants and 

animals include the parent compound 

and its metabolites, determined as the 

derivatives CGA-37913 and CGA-49751. 

In the case of S-metolachlor tolerances, 

the residues of the R-enantiomer should 

be included in the expression. 

Risk assessments were conducted by 

EPA to assess dietary exposures from Smetolachlor in food as follows: 

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse 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 conducting 

the acute dietary risk assessment EPA 

used the LifelineTM Model, Version 2.0, 

which incorporates food consumption 

data as reported by respondents in the 

United State Department of Agriculture 

(USDA) 1994–1996 and 1998 

Nationwide Continuing Surveys of Food 

Intake by Individuals (CSFII), and 

accumulated exposure to the chemical 

for each commodity. A conservative 

Tier 1 acute dietary exposure 

assessment was conducted for all 

labeled metolachlor and all labeled and 

proposed S-metolachlor food uses using 

100% crop treated (CT) and tolerance 

level residues. 

ii. Chronic exposure. In conducting 

the chronic dietary risk assessment EPA 

used the LifelineTM Model, Version 2.0, 

which incorporates food consumption 

data as reported by respondents in the 

USDA 1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII), and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the chronic exposure 

assessments: A conservative Tier 1 

chronic dietary exposure assessment 

was conducted for all labeled 

metolachlor and all labeled and 

proposed S-metolachlor food uses using 

100% CT and tolerance level residues. 

Both the acute and chronic analyses 

assume tolerance-level residues on all 

crops with established, pending, or 

proposed tolerances for metolachlor 

and/or S-metolachlor (collectively 

referred to as metolachlor in this 

document). In cases where separate 

tolerance listings occur for both 

metolachlor and S-metolachlor on the 

same commodity, the higher value of 

the two is used in the analyses. The 

analyses also assume that 100% of the 

crops included in the assessment were 

treated with metolachlor. These 

assumptions result in overestimates of 

exposure and are, therefore, highly 

conservative with respect to dietary risk 

assessment. 

iii. Cancer. Metolachlor has been 

classified as a Group C, possible human 

carcinogen based on liver tumors in rats 

at the highest dose tested (HDT). The 

51632 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

chronic NOAEL, 15 milligram/kilogram/ 

day (mg/kg/day), that was established 

based on tumors in the rat seen at the 

HDT of 150 mg/kg/day) is comparable to 

the NOAEL of 9.7 mg/kg/day selected 

for establishing the chronic reference 

dose for metolachlor. The Agency 

concludes that the chronic dietary PAD 

is protective for cancer dietary risk. 

Therefore, a separate cancer dietary risk 

assessment was not conducted. 

2. Dietary exposure from drinking 

water. The environmental fate database 

is complete for S-metolachlor. Parent 

metolachlor/S-metolachlor appear to be 

moderately persistent to persistent, and 

range from mobile to highly mobile in 

different soils. Metolachlor and Smetolachlor are expected to have similar 

degradation pathways and rates in soil 

and water environments. 

Drinking water assessment was 

conducted based on monitoring data 

from several sources, as well as on Tier 

1 First Index Reservoir Screening Tool 

(FIRST) and Screening Concentration In 

Groundwater (SCI-GROW) and Tier II 

modeling (PRZM/EXAMS) for selected 

vulnerable sites. This assessment is a 

worst-case scenario and demonstrates 

high end numbers. It is important to 

note that the analytical methods used to 

obtain the monitoring data are not able 

to distinguish between metolachlor and 

S-metolachlor; therefore, the estimated 

environmental concentrations (EECs) 

presented in this risk assessment are 

representative of both racemic 

metolachlor and S-metolachlor. 

EECs for metolachlor and Smetolachlor were calculated for both the 

parent compound and the 

ethanesulfonic acid (ESA) and oxanilic 

acid (OA) degradates. The PRZM/ 

EXAMS model was used to estimate the 

EECs for the surface water 

concentrations of the parent compound 

and the FIRST model was used to 

estimate the EECs for the surface water 

concentrations of the ESA and OA 

degradates. Groundwater concentrations 

were modeled using the SCI-GROW. 

Although it was determined by the 

Agency that the ESA and OA 

metabolites appear to be less toxic than 

parent metolachlor, they are included in 

the risk assessment since they were 

found in greater abundance than the 

parent in water monitoring studies. 

The EECs were estimated for the crops 

with the highest maximum seasonal 

application rates, turf (S-metolachlor 

only) and corn (racemic metolachlor 

and S-metolachlor) with a maximum 

seasonal application rate of 4.0 lbs ai 

per acre (lbs ai/acre). 

i. Surface water modeling of parent 

metolachlor/S-metolachlor. Based on 

PRZM/EXAMS modeling the maximum 

peak and annual average concentrations 

of metolachlor/S-metolachlor in surface 

water were 199 μg/l and 9.2 μg/l, 

respectively. Based on an evaluation of 

U.S. Geological Survey (USGS) National 

Water Quality Assessment (NAWQA) 

surface water monitoring data, the 

estimate of the maximum drinking 

water concentration from surface water 

sources of parent metolachlor/Smetolachlor is 77.6 μg/l, and the EEC is 

4.3 μg/l for the maximum annual timeweighted mean concentration for parent 

metolachlor/S-metolachlor. These data 

suggest that the PRZM/EXAMS 

estimates for metolachlor/S-metolachlor 

are slightly overestimating the potential 

impact of metolachlor/S-metolachlor 

use on surface water. 

ii. Surface water modeling of 

degradates. Based on FIRST modeling 

results, the estimate of the drinking 

water concentration from surface water 

sources of metolachlor ESA (ground 

application with no spray drift) is not 

likely to exceed 31.9 μg/L for the annual 

peak concentration and 22.8 μg/L for the 

annual average exposure for use on turf/ 

corn at a maximum annual application 

rate of 4.0 lbs ai per acre. Based on 

FIRST modeling results, the estimate of 

the drinking water concentration from 

surface water sources of metolachlor OA 

(ground application with no spray drift) 

is not likely to exceed 91.4 μg/L for the 

annual peak concentration and 65.1 μg/ 

L for the annual average exposure for 

use on turf/corn at a maximum annual 

application rate of 4.0 lbs ai per acre. 

iii. Groundwater modeling of parent 

metolachlor/S-metolachlor. 

Metolachlor/S-metolachlor appears to 

be mobile in different soil types. 

Metolachlor/S-metolachlor and its 

degradates have been detected in 

ground water demonstrating that it is 

likely to impact ground water resources. 

In order to augment existing monitoring 

data, the (SCI GROW) screening model 

was used to estimate ground water 

concentrations. The model estimates the 

upper bound ground water 

concentrations of pesticides likely to 

occur when the pesticide is used at the 

maximum allowable rate in areas with 

ground water vulnerable to 

contamination. The estimated 

concentration of metolachlor/Smetolachlor in drinking water from 

shallow ground water sources is 5.5 μg/ 

l for application on corn at a seasonal 

maximum rate of 4.0 lbs ai. per acre. 

This concentration is appropriate for 

both the peak and annual average 

exposures. 

From the available ground water 

monitoring data , the highest annual 

maximum concentration from the 

(NAWQA) ground water monitoring 

data for acute exposure to metolachlor/ 

S-metolachlor is 32.8 μg/l. Data 

collected in Iowa as part of the NAWQA 

program indicate that metolachlor/Smetolachlor has been detected in 

ground water at concentrations as high 

as 15.4 μg/l. However, these data are not 

used quantitatively in the risk 

assessment because the next highest 

concentration detected is 1.7 μg/l 

suggesting that the maximum 

concentration may be an outlier. 

Additionally, recent data collected by 

the Suffolk County, New York 

Department of Health Services, Bureau 

of Groundwater Resources indicate that 

both metolachlor/S-metolachlor 

(analytical methods did not determine 

the enantiomeric ratio) and its 

degradates have been detected in 

ground water. In data collected between 

1997 and 2001, metolachlor/Smetolachlor was detected in 60 well 

samples with a maximum concentration 

of 83 μg/l. No information was available 

on frequency of detection and since 

only summary statistics were provided, 

these data are not used quantitatively in 

this assessment. Nonetheless, even use 

of the 83 μg/l value as the exposure 

level in drinking water would not raise 

the aggregate risk estimate, as discussed 

in Unit III.E. of this document the level 

of concern. 

iv. Groundwater modeling of 

degradates. The EEC for metolachlor 

ESA from use on turf/corn is not 

expected to exceed 65.8 μg/l for peak 

and annual average exposures. The EEC 

for metolachlor OA from use on turf/ 

corn is not expected to exceed 31.7 μg/ 

l for peak and annual average exposures. 

These values exceed the maximum 

values detected in the Iowa NAWQA 

study (63.7 μg/l for metolachlor ESA 

and 4.4 μg/l for metolachlor OA and 

also exceed those detected in the two 

PGW studies (metolachlor ESA was 

detected at a maximum concentration of 

24 μg/l, while metolachlor OA was 

detected at a maximum concentration of 

15.6 μg/l). 

Recent data collected by the Suffolk 

County, New York Department of Health 

Services, Bureau of Groundwater 

Resources indicate that both 

metolachlor/S-metolachlor (analytical 

methods did not determine the 

enantiomeric ratio) and its degradates 

have been detected in ground water. In 

data collected between 1997 and 2001, 

metolachlor ESA was detected in 296 

wells with a maximum concentration of 

39.7 μg/l, while metolachlor OA was 

detected in 228 wells with a maximum 

concentration of 49.6 μg/l. No 

information was available on frequency 

of detection and only summary statistics 

were provided on these data. Therefore, 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51633 

these data are not used quantitatively in 

this assessment. However, these data 

suggest that the screening level SCIGROW estimates for metolachlor ESA 

and OA are slightly overestimating the 

potential impact of metolachlor/Smetolachlor use on ground water. 

A summary of metolachlor EEC’s in 

surface water and ground water is 

presented in Table 1. 

TABLE 1.—METOLACHLOR EEC’S

Surface Water (peak) Surface Water (average) Ground Water 

Parent 199 9.2 5.5 

Metolachlor ESA 31.9 22.8 65.8 

Metolachlor OA 91.4 65.1 31.7 

Total EECs (ppb) 322.3 97.1 103.0 

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). 

S-metolachlor is registered (as an 

emulsifiable concentrate formulation) 

for use on lawn, turf (including sod 

farms), golf courses, sports fields, and 

ornamental gardens and marketed to 

commercial applicators. Current 

product labels include the statement, 

‘‘Not intended for homeowner purchase 

or use.’’ Therefore, a residential handler 

assessment was not conducted. 

Based on the use pattern of residential 

products, duration of post application 

exposure is expected to be short term. 

A short-term dermal endpoint was not 

selected, since no systemic toxicity was 

seen at the limit dose of 1,000 mg/kg/ 

day; therefore, a dermal risk assessment 

was not conducted. 

Post-application inhalation exposure 

is also expected to be minimal since Smetolachlor is only applied in an 

outdoor setting and the label specifies 

that residents should not re-enter 

treated areas until after sprays have 

dried. Based on these assumptions, a 

postapplication inhalation exposure was 

not calculated. 

However, the following postapplication incidental oral scenarios 

following application to lawns and turf 

have been identified: 

i. Short-term oral exposure to toddlers 

and children following hand-to-mouth 

exposure 

ii. Short-term oral exposure to 

toddlers and children following objectto-mouth exposure 

iii. Short-term oral exposure to 

toddlers and children following soil 

ingestion. The term ‘‘incidental’’ is used 

to distinguish the inadvertent oral 

exposure of small children from 

exposure that may be expected from 

treated foods or residues in drinking 

water. 

The exposure estimates for the three 

post-application scenarios (object-tomouth, hand-to-mouth, and incidental 

soil ingestion) were combined to 

represent the possible (if not likely) 

high-end oral exposure resulting from 

lawn (or similar) use. Table 2 

summarizes the results of the residential 

post-application assessment. 

TABLE 2.—SUMMARY OF SHORT-TERM RESIDENTIAL POST-APPLICATION EXPOSURE

Exposure Scenarioa S-metolachlorb Oral Dose (mg/kg/day) 

Object-to-mouth S-metolachlor 0.0092 

Hand-to-mouth S-metolachlor 0.037 

Soil ingestion S-metolachlor 0.00012 

Combined exposure S-metolachlor 0.046 

aExposure scenario represents oral exposure of children, with an assumed body weight of 15 kg. 

bS-metolachlor application rate is 2.47 lb ai/acre. 

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 

examined the common mechanism 

potential for S-metolachlor and has 

concluded that S-metolachlor should 

not be included with the 

chloroacetanilide pesticides designated 

as a ‘‘Common Mechanism Group.’’ The 

Agency’s position is that only some 

chloroacetanailides, namely acetochlor, 

alachlor and butachlor should be 

considered as a ‘‘Common Mechanism 

Group’’ due to their ability to cause 

nasal turbinate tumors. 

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 the policy 

statements released by EPA’s 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s web site at http://www.epa.gov/ 

pesticides/cumulative/. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold 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 data base on 

51634 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using UF 

(safety) in calculating a dose level that 

poses no appreciable risk to humans. In 

applying this provision, EPA either 

retains the default value of 10X when 

reliable data do not support the choice 

of a different factor, or, if reliable data 

are available, EPA uses a different 

additional safety factor value based on 

the use of traditional UFs and/or special 

FQPA safety factors, as appropriate. 

2. Prenatal and postnatal sensitivity. 

There is no indication of quantitative or 

qualitative increased susceptibility of 

rats or rabbits to in utero and/or 

postnatal exposure in the available 

toxicity data. 

3. Conclusion. There is a sufficient 

toxicity data base and exposure data are 

complete or are estimated based on data 

that reasonably accounts for potential 

exposures. The FQPA Safety Factor for 

the protection of infants and children 

has been reduced to 1X because: 

i. The toxicology data base is 

complete for the FQPA assessment. 

ii. There is no indication of 

quantitative or qualitative increased 

susceptibility of rats or rabbits to in 

utero and/or postnatal exposure to 

metolachlor in the available toxicity 

data. 

iii. A developmental neurotoxicity 

study is not required for S-metolachlor. 

iv. The dietary (food and drinking 

water) and non-dietary exposure 

(residential) assessments will not 

underestimate the potential exposures 

for infants and children from the use of 

S-metolachlor. 

E. Aggregate Risks and Determination of 

Safety 

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency 

calculates DWLOCs which are used as a 

point of comparison against EECs. 

DWLOC values are not regulatory 

standards for drinking water. DWLOCs 

are theoretical upper limits on a 

pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food and residential 

uses. In calculating a DWLOC, the 

Agency determines how much of the 

acceptable exposure (i.e., the PAD) is 

available for exposure through drinking 

water e.g., allowable chronic water 

exposure (mg/kg/day) = cPAD - (average 

food + residential exposure). This 

allowable exposure through drinking 

water is used to calculate a DWLOC. 

A DWLOC will vary depending on the 

toxic endpoint, drinking water 

consumption, and body weights. Default 

body weights and consumption values 

as used by the EPA’s Office of Water are 

used to calculate DWLOCs: 2 liter (L)/ 

70 kg (adult male), 2L/60 kg (adult 

female), and 1L/10 kg (child). Default 

body weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer. 

When EECs for surface water and 

ground water are less than the 

calculated DWLOCs, EPA concludes 

with reasonable certainty that exposures 

to the pesticide in drinking water (when 

considered along with other sources of 

exposure for which EPA has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because EPA considers the 

aggregate risk resulting from multiple 

exposure pathways associated with a 

pesticide’s uses, levels of comparison in 

drinking water may vary as those uses 

change. If new uses are added in the 

future, EPA will reassess the potential 

impacts of residues of the pesticide in 

drinking water as a part of the aggregate 

risk assessment process. 

1. Acute risk. The acute aggregate risk 

assessment addresses potential exposure 

from combined residues of metolachlor/ 

S-metolachlor on food and total residues 

of metolachlor/S-metolachlor plus ESA 

and OA degradates in drinking water 

(surface water and ground water). Using 

the exposure assumptions discussed in 

this unit for acute exposure, the acute 

dietary exposure from food to 

metolachlor/S-metolachlor will occupy 

<1% of the aPAD for the U.S. 

population and all population 

subgroups. In addition, there is 

potential for acute dietary exposure to 

metolachlor/S-metolachlor and the ESA 

and OA degradates in drinking water. 

After calculating DWLOCs and 

comparing them to the EECs for surface 

water and ground water, EPA does not 

expect the aggregate exposure to exceed 

100% of the aPAD, as shown in the 

following Table 3: 

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO METOLACHLOR/S-METOLACHLOR

Population Subgroup aPAD (mg/kg) %aPAD (Food) Surface Water 

EEC (ppb) 

Ground Water 

EEC (ppb) 

Acute DWLOC 

(ppb) 

U.S. population 3.0 <1 322 103 105,000 

Infants (<1year) 3.0 <1 322 103 30,000 

Children (1–2 years) 3.0 <1 322 103 30,000 

Females (13–49 years) 3.0 <1 322 103 90,000 

2. Chronic risk. The chronic aggregate 

risk assessment addresses potential 

exposure from combined residues of 

metolachlor/S-metolachlor on food and 

total residues of metolachlor/Smetolachlor plus ESA and OA 

degradates in drinking water (surface 

water and ground water). There are no 

residential uses that result in chronic 

residential exposure to S-metolachlor. 

EPA has concluded that chronic 

exposure to metolachlor/S-metolachlor 

from food will utilize 1% of the cPAD 

for the U.S. population, 4% of the cPAD 

for children 1 to 2 years, the 

subpopulations at greatest exposure and 

1% of the cPAD for females 13 to 49 

years. In addition, there is potential for 

chronic dietary exposure to 

metolachlor/S-metolachlor and ESA and 

OA degradates in drinking water. After 

calculating DWLOCs and comparing 

them to the EECs for surface water and 

ground water, EPA does not expect the 

aggregate exposure to exceed 100% of 

the cPAD, as shown in the following 

Table 4: 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51635 

TABLE 4.–AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO METOLACHLOR/S-METOLACHLOR

Population subgroup cPAD mg/ 

kg/day 

%cPAD 

(Food) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. population 0.1 1 97 103 3,500 

Infants (<1 year) 0.1 2 97 103 1,000 

Children (1 to 2 years) 0.1 4 97 103 1,000 

Females (13 to 49 years) 0.1 1 97 103 3,000 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

S-metolachlor is currently registered 

for use that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic food and water and 

short-term residential exposures for 

metolachlor/S-metolachlor. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded that food 

and residential exposures aggregated 

result in an aggregate MOE of 1,000 for 

children 1 to 2 years. This aggregate 

MOE does not exceed the Agency’s level 

of concern for aggregate exposure to 

food and residential uses. In addition, 

short-term DWLOCs were calculated 

and compared to the EECs for chronic 

exposure of metolachlor/S-metolachlor 

and ESA and OA degradates in ground 

water and surface water. After 

calculating DWLOCs and comparing 

them to the EECs for surface water and 

ground water, EPA does not expect 

short-term aggregate exposure to exceed 

the Agency’s level of concern, as shown 

in the following Table 5: 

TABLE 5.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO METOLACHLOR/S-METOLACHLOR

Population Subgroup 

Aggregate 

MOE (Food 

+ Residential) 

Aggregate 

Level of 

Concern 

(LOC) 

Surface 

Water EEC 

(ppb) 

Ground 

Water EEC 

(ppb) 

Short-Term 

DWLOC 

(ppb) 

Children (1–2 years) 1,000 100 97 103 4,500 

4. Intermediate-term risk. An 

intermediate-term aggregate risk 

assessment considers potential exposure 

from food, drinking water, and nonoccupational (residential) pathways of 

exposure. However, for metolachlor/Smetolachlor, no intermediate-term nonoccupational exposure scenarios (greater 

than 30 days exposure) are expected to 

occur. Therefore, intermediate-term 

DWLOC values were not calculated and 

an intermediate-term aggregate risk 

assessment was not performed. 

5. Aggregate cancer risk for U.S. 

population. An aggregate cancer risk 

assessment considers potential 

carcinogenic exposure from food, 

drinking water, and non-occupational 

(residential) pathways of exposure. 

However, the NOAEL (15 mg/kg/day), 

that was established based on tumors in 

the rat (seen at the HDT of 150 mg/kg/ 

day) is comparable to the NOAEL of 9.7 

mg/kg/day selected for establishing the 

cRfD dose for metolachlor. Therefore, 

the chronic risk assessment is protective 

for cancer as well as other chronic risks. 

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, and to infants and children 

from aggregate exposure to metolachlor/ 

S-metolachlor residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The Pesticide Analytical Manual 

(PAM) Vol. II, lists a GC/NPD method 

(Method I) for determining residues in/ 

on plants and a GC/MSD method 

(Method II) for determining residues in 

livestock commodities. These methods 

determine residues of metolachlor and 

its metabolites as either CGA–37913 or 

CGA–49751 following acid hydrolysis. 

Residue data from the most recent field 

trials and processing studies were 

obtained using an adequate GC/NPD 

method (AG–612), which is a 

modification of Method I. Adequate data 

are available on the recovery of 

metolachlor through Multi-residue 

Method Testing Protocols. The FDA 

PESTDATA database indicates that 

metolachlor is completely recovered 

through Method 302, PAM Vol. I (3rd 

ed., revised 10/97). 

B. International Residue Limits 

No maximum residue limits for either 

metolachlor or S-metolachlor have been 

established or proposed by Codex, 

Canada, or Mexico for any agricultural 

commodity; therefore, no compatibility 

issues exist with respect to U.S. 

tolerances. 

V. Conclusion 

Therefore, the tolerances are 

established at 180.368 for combined 

residues (free and bound) of the 

herbicide S-metolachlor [S-2-chloro-N- 

(2-ethyl-6-methylphenyl)-N-(2-methoxy1-methylethyl)acetamide], its Renantiomer, and its metabolites, 

determined as the derivatives, 2-[2- 

ethyl-6-methylphenyl)amino]-1- 

propanol and 4-(2-ethyl-6- 

methylphenyl)-2-hydroxy-5-methyl-3- 

morpholinone, each expressed as the 

parent compound S-metolachlor, in or 

on vegetable brassica, head and stem, 

subgroup 5A at 0.6 ppm; cattle, fat at 

0.04 ppm; cattle, kidney at 0.20 ppm; 

cattle liver at 0.1 ppm; cattle, meat at 

0.04 ppm; cattle, meat byproducts, 

except kidney and liver at 0.04 ppm; 

corn, field, grain at 0.10 ppm; corn, 

field, stover at 6.0 ppm; corn, field, 

forage at 6.0 ppm; corn, sweet, forage at 

6.0 ppm; corn, sweet, stover at 6.0 ppm; 

corn, pop, stover at 6.0 ppm; corn, pop, 

grain at 0.1 ppm; corn, sweet, kernel 

plus cob with husk removed at 0.1 ppm; 

cotton, gin byproducts at 4.0 ppm; 

cotton, undelinted seed at 0.1 ppm; egg 

at 0.04 ppm; garlic, bulb at 0.1 ppm; 

51636 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

goat, fat 0.04 ppm; goat, kidney at 0.20 

ppm; goat, liver at 0.1 ppm; goat, meat 

at 0.04 ppm; goat, meat byproducts, 

except kidney and liver at 0.04 ppm; 

horse, fat 0.04 ppm; horse, kidney at 

0.20 ppm; horse liver at 0.1 ppm; horse, 

meat at 0.04 ppm; horse, meat byproducts, except kidney and liver at 

0.04 ppm; vegetable leaf petioles 

subgroup 4B at 0.10 ppm; milk at 0.02 

ppm; onion, dry bulb at 0.1 ppm; onion, 

green at 2.0 ppm; vegetable legumes, 

pea and bean, dried shelled, except 

soybean, subgroup 6C at 0.1 ppm; 

peanut at 0.2 ppm; peanut, hay at 20 

ppm; peanut, meal at 0.40 ppm; poultry, 

fat at 0.04 ppm; poultry, meat a 0.04 

ppm; poultry, meat by-products, at 0.04 

ppm; safflower, seed at 0.1 ppm; shallot, 

bulb at 0.1 ppm; sheep, fat at 0.04 ppm; 

sheep, kidney at 0.20 ppm; sheep, liver 

at 0.1 ppm; sheep, meat at 0.04 ppm; 

sheep, meat by-products, except kidney 

and liver at 0.04 ppm; sorghum grain, 

stover at 4.0 ppm; sorghum grain, forage 

at 1.0 ppm; sorghum grain, grain at 0.3 

ppm; soybean, seed at 0.2 ppm; 

soybean, forage at 5.0 ppm; soybean, 

hay at 8.0 ppm; tomato, paste at 0.3 

ppm; vegetable, foliage of legume, 

except soybean, subgroup 7A at 15 ppm; 

vegetable, fruiting, group 8, except 

tabasco pepper, at 0.1 ppm; vegetable, 

legume, edible podded, subgroup 6A at 

0.5 ppm; vegetable, root, except sugar 

beet, subgroup 1B at 0.3 ppm; and 

vegetable, tuberous and corm, subgroup 

1C at 0.2 ppm; pepper tabasco at 0.5 

ppm; nongrass, animal feed (forage, 

fodder, straw, hay), group 18 at 1.0 ppm; 

barley, grain at 0.1 ppm; barley straw at 

0.5 ppm; barley hay at 1.0 ppm; 

buckwheat, grain at 0.1 ppm; oat, forage 

at 0.5 ppm; oat, grain at 0.1 ppm; oat, 

straw at 0.5 ppm; rice, grain at 0.1 ppm; 

rice, straw at 0.5 ppm; rye, forage at 0.5 

ppm; rye, grain at 0.1 ppm; rye, straw 

at 0.5 ppm; wheat, forage at 0.5 ppm; 

wheat, grain at 0.1 ppm; wheat, straw at 

0.5 ppm and wheat, hay at 1.0 ppm. 

VI. Objections and Hearing Requests 

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of FFDCA provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. However, the period for 

filing objections is now 60 days, rather 

than 30 days. 

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2004–0326 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 

on or before October 31, 2005. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255. 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VI.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2004–0326, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., or 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). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 51637 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

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). 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. 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 final 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 6, 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. 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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: August 23, 2005. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.368 is amended: 

i. In paragraph (a)(2), in the table, by 

removing the commodities carrot, roots; 

horseradish; onion, green; rhubarb; 

swiss chard; and tomato; 

ii. By adding paragraph (a)(3); 

iii. By adding paragraph (c)(2); and 

iv. In paragraph (d) by adding text. 

The amendments read as follows: 

§ 180.368 Metolachlor; tolerances for 

residues. 

(a) * * * 

(3) Tolerances are established for the 

combined residues (free and bound) of 

the herbicide S-metolachlor [S-2-chloroN-(2-ethyl-6-methylphenyl)-N-(2- 

methoxy-1-methylethyl)acetamide], its 

R-enantiomer, and its metabolites, 

determined as the derivatives, 2-[2- 

ethyl-6-methylphenyl)amino]-1- 

propanol and 4-(2-ethyl-6- 

methylphenyl)-2-hydroxy-5-methyl-3- 

morpholinone, each expressed as the 

parent compound, in or on the 

following raw agricultural commodities: 

Commodity Parts per million 

*****

Cattle, fat .............. 0.04 

Cattle, kidney ........ 0.2 

Cattle, liver ............ 0.1 

Cattle, meat .......... 0.04 

Cattle, meat byproducts, except 

kidney and liver 0.04 

Corn, field, stover 6.0 

Corn, pop, stover .. 6.0 

Corn, sweet, stover 6.0 

Corn, field, forage 6.0 

Corn, sweet, forage .................... 6.0 

Corn, sweet, kernel 

plus cob with 

husks removed .. 0.1 

Corn, field, grain ... 0.1 

Corn, pop, grain .... 0.1 

Cotton, gin byproducts .................... 4.0 

Cotton, undelinted 

seed .................. 0.1 

Egg ....................... 0.04 

Garlic, bulb ........... 0.1 

Goat, fat ................ 0.04 

Goat, kidney ......... 0.2 

Goat, liver ............. 0.1 

Goat, meat ............ 0.04 

Goat, meat byproducts, except kidney and liver ..... 0.04 

*****

Horse, fat .............. 0.04 

Horse, kidney ........ 0.2 

Horse, liver ........... 0.1 

Horse, meat .......... 0.04 

Horse, meat byproducts, except, 

kidney and liver 0.04 

*****

Milk ....................... 0.02 

Onion, dry bulb ..... 0.1 

Onion, green ......... 2.0 

Peanut .................. 0.2 

Peanut, hay .......... 20.0 

Peanut, meal ........ 0.4 

Poultry, fat ............ 0.04 

Poultry, meat ........ 0.04 

Poultry, meat byproducts ............ 0.04 

*****

Safflower, seed ..... 0.1 

Shallot, bulb .......... 0.1 

Sheep, fat ............. 0.04 

51638 Federal Register / Vol. 70, No. 168 / Wednesday, August 31, 2005 / Rules and Regulations 

Commodity Parts per million 

Sheep, kidney ....... 0.2 

Sheep, liver ........... 0.1 

Sheep, meat ......... 0.04 

Sheep, meat byproducts, except 

kidney and liver 0.04 

Sorghum, grain, 

forage ................ 1.0 

Sorghum, grain, 

stover ................ 4.0 

Sorghum, grain, 

grain .................. 0.3 

Soybean, forage ... 5.0 

Soybean, hay ........ 8.0 

Soybean, seed ...... 0.2 

*****

Tomato, paste ....... 0.3 

Vegetable, brassica, head and 

stem, subgroup 

5A ...................... 0.6 

Vegetable, foliage 

of legume, except soybean, 

subgroup 7A ...... 15.0 

Vegetable, fruiting 

group 8, (except 

tabasco pepper) 0.1 

Vegetable, leaf 

petioles, subgroup 4B ........... 0.1 

Vegetable, legume, 

edible podded, 

subgroup 6A ...... 0.5 

Vegetable, legume, 

pea and bean, 

dried shelled, 

(except soybean) 

subgroup 6C ..... 0.1 

Vegetable, root, 

(except sugar 

beet) subgroup 

1B ...................... 0.3 

Vegetables, tuberous and corm, 

subgroup 1C ..... 0.2 

* * * * * 

(c) * * * 

(2) Tolerances with regional 

registration as defined in § 180.1(n) are 

established for the combined residues 

(free and bound) of the herbicide Smetolachlor [S-2-chloro-N-(2-ethyl-6- 

methylphenyl)-N-(2-methoxy-1- 

methylethyl)acetamide], its Renantiomer, and its metabolites, 

determined as the derivatives, 2-[2- 

ethyl-6-methylphenyl)amino]-1- 

propanol and 4-(2-ethyl-6- 

methylphenyl)-2-hydroxy-5-methyl-3- 

morpholinone, each expressed as the 

parent compound, in or on the 

following raw agricultural commodities: 

Commodity Parts per million 

Pepper, tabasco ... 0.5 

(d) Indirect or inadvertent residues. 

Tolerances are established for the 

indirect or inadvertent combined 

residues (free and bound) of the 

herbicide S-metolachlor [S-2-chloro-N- 

(2-ethyl-6-methylphenyl)-N-(2-methoxy1-methylethyl)acetamide], its Renantiomer, and its metabolites, 

determined as the derivatives, 2-[2- 

ethyl-6-methylphenyl)amino]-1- 

propanol and 4-(2-ethyl-6- 

methylphenyl)-2-hydroxy-5-methyl-3- 

morpholinone, each expressed as the 

parent compound, in or on the 

following raw agricultural commodities: 

Commodity Parts per million 

Barley, grain ......... 0.1 

Barley, hay ............ 1.0 

Barley, straw ......... 0.5 

Buckwheat, grain .. 0.1 

Nongrass, animal 

feed (forage, 

fodder, straw, 

hay) group 18 .... 1.0 

Oat, forage ............ 0.5 

Oat, grain .............. 0.1 

Oat, hay ................ 1.0 

Oat, straw ............. 0.5 

Rice, grain ............ 0.1 

Rice, straw ............ 0.5 

Rye, forage ........... 0.5 

Rye, grain ............. 0.1 

Rye, straw ............. 0.5 

Wheat, forage ....... 0.5 

Wheat, grain ......... 0.1 

Wheat, hay ........... 1.0 

Wheat, straw ......... 0.5 

[FR Doc. 05–17367 Filed 8–30–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 261 

[FRL–7961–3] 

Hazardous Waste Management 

System; Identification and Listing of 

Hazardous Waste; Final Amendment 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA, also the Agency or we in 

this preamble) today is granting a 

petition to modify an exclusion (or 

delisting) from the lists of hazardous 

waste previously granted to BMW 

Manufacturing Co., LLC (BMW) in 

Greer, South Carolina. This action 

responds to a petition for amendment 

submitted by BMW to eliminate the 

total concentration limits in its 

wastewater treatment sludge covered by 

its current conditional exclusion. 

EPA received public comments on the 

November 26, 2004, Proposed Rule (69 

FR 68851) and took into account all 

public comments before granting this 

final rule. The Agency re-evaluated the 

specific information initially provided 

by the petitioner in its original request 

and delistings granted to other 

automobile manufactures for their F019 

waste. This final decision eliminates the 

total concentration limits for barium, 

cadmium, chromium, lead, nickel, and 

cyanide from its conditionally excluded 

wastewater treatment sludge from the 

requirements of the hazardous waste 

regulations under the Resource 

Conservation and Recovery Act (RCRA). 

The waste will still be subject to local, 

State, and Federal regulations for 

nonhazardous solid wastes. 

DATES: Effective August 31, 2005. 

ADDRESSES: The RCRA regulatory 

docket for this final rule is located at the 

EPA Library, U.S. Environmental 

Protection Agency, Region 4, Sam Nunn 

Atlanta Federal Center, 61 Forsyth 

Street, SW., Atlanta, Georgia 30303, and 

is available for viewing from 9:00 a.m. 

to 4:00 p.m., Monday through Friday, 

excluding Federal holidays. The public 

may copy material from any regulatory 

docket at no cost for the first 100 pages, 

and at a cost of $0.15 per page for 

additional copies. For copying at the 

South Carolina Department of Health 

and Environmental Control, please see 

below. 

FOR FURTHER INFORMATION CONTACT: For 

general and technical information 

concerning this final rule, please contact 

Kris Lippert, RCRA Enforcement and 

Compliance Branch (Mail Code 4WD–

RCRA), U.S. Environmental Protection 

Agency, Region 4, Sam Nunn Atlanta 

Federal Center, 61 Forsyth Street, SW., 

Atlanta, Georgia 30303, (404) 562-8605, 

or call, toll free (800) 241–1754, and 

leave a message, with your name and 

phone number, for Ms. Lippert to return 

your call. Questions may also be emailed to Ms. Lippert at 

lippert.kristin@epa.gov. You may also 

contact Cindy Carter, Appalachia III 

District, South Carolina Department of 

Health and Environmental Control 

(SCDHEC), 975C North Church Street, 

Spartanburg, South Carolina. If you 

wish to copy documents at SCDHEC, 

please contact Ms. Carter for copying 

procedures and costs. 

SUPPLEMENTARY INFORMATION: The 

information in this section is organized 

as follows: 

I. Overview Information 

A. What Action Is EPA Finalizing? 

B. Why Is EPA Approving This Petition for 

Amendment? 

C. What Are the Terms of This Exclusion? 

D. When Is the Final Amendment 

Effective? 

E. How Does This Action Affect States?