Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Rules and Regulations 56569 

Indian tribes, 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 by Executive Order 13175 

(65 FR 67249, November 9, 2000). This 

action also does not have federalism 

implications because it does not 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, as specified in 

Executive Order 13132 (64 FR 43255, 

August 10, 1999). This action merely 

approves a state rule implementing a 

Federal standard, and does not alter the 

relationship or the distribution of power 

and responsibilities established in the 

Clean Air Act. This rule also is not 

subject to Executive Order 13045 

‘‘Protection of Children from 

Environmental Health Risks and Safety 

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

because it is not economically 

significant. 

In reviewing SIP submissions, EPA’s 

role is to approve state choices, 

provided that they meet the criteria of 

the Clean Air Act. In this context, in the 

absence of a prior existing requirement 

for the state to use voluntary consensus 

standards (VCS), EPA has no authority 

to disapprove a SIP submission for 

failure to use VCS. It would thus be 

inconsistent with applicable law for 

EPA, when it reviews a SIP submission, 

to use VCS in place of a SIP submission 

that otherwise satisfies the provisions of 

the Clean Air Act. Thus, the 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) do not apply. This rule does 

not impose an information collection 

burden under the provisions of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

The Congressional Review Act, 5 

U.S.C. section 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 the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. 804(2). 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by November 28, 

2005. Filing a petition for 

reconsideration by the Administrator of 

this final rule does not affect the finality 

of this rule for the purposes of judicial 

review nor does it extend the time 

within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Carbon Monoxide, 

Hydrocarbons, Intergovernmental 

relations, Lead, Nitrogen oxides, Ozone, 

Particulate matter, Sulfur oxides, 

Volatile organic compounds. 

Dated: September 19, 2005. 

Lawrence E. Starfield, 

Acting Regional Administrator, Region 6. 

■ 40 CFR part 52 is amended as follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart SS—Texas 

■ 2. The table in § 52.2270(c) entitled 

‘‘EPA Approved Regulations in the 

Texas SIP’’ is amended under chapter 

106, subchapter A, by removing the 

entry for section 106.5, ‘‘Public Notice.’’

[FR Doc. 05–19358 Filed 9–27–05; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0244; FRL–773-5] 

Muscodor albus QST 20799 and the 

Volatiles Produced on Rehydration; 

Exemption from the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the Muscodor 

albus (M. albus) QST 20799 and the 

volatiles produced on its rehydration on 

all food commodities when applied or 

used for all agricultural applications, 

including seed, propagule and post 

harvest treatments. This action is in 

response to a pesticide petition 

submitted to EPA under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

as amended by the Food Quality 

Protection Act of 1996 (FQPA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of M. albus QST 20799 and 

the volatiles produced on its 

rehydration. 

DATES: This regulation is effective 

September 28, 2005. Objections and 

requests for hearings must be received 

on or before November 28, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit IX. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0244. 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., 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: 

Shanaz Bacchus, Biopesticides and 

Pollution Prevention Division (7511C), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

703–308–8097; e-mail address: 

bacchus.shanaz@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 code 111); 

56570 Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Rules and Regulations 

• 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 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 April 7, 

2004 (69 FR 18370–18375) (FRL–734-4), 

EPA issued a notice pursuant to section 

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

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

pesticide tolerance petition (PP 3F6745) 

by AgraQuest, Inc. (EPA Company No. 

69592), 1530 Drew Avenue, Davis, CA 

95616. The petition requested that 40 

CFR part 180 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of M. albus QST 20799. This notice 

included a summary of the petition 

prepared by the petitioner AgraQuest, 

Inc. There were no comments received 

in response to the notice of filing. 

Section 408(c)(2)(A)(i) of the FFDCA 

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’

Section 408(c)(2)(A)(ii) of the 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. Pursuant to 

section 408(c)(2)(B), in establishing or 

maintaining in effect an exemption from 

the requirement of a tolerance, EPA 

must take into account the factors set 

forth in section 408(b)(2)(C), which 

require 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....’’ Additionally, section 

408(b)(2)(D) of the FFDCA requires that 

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 performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of the FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness, and reliability and the 

relationship of this information 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. 

M. albus QST 20799, a fungus, was 

originally isolated from the bark of a 

cinnamon tree in Honduras. It was 

imported into the United States with 

appropriate permits issued by the U.S. 

Department of Agriculture (USDA) 

Animal and Plant Health Inspection 

Services (APHIS). It grows as a white 

sterile mycelium and does not produce 

asexual or sexual spores or other 

reproductive structures such as 

chlamydospores or sclerotia. When 

hydrated, M. albus QST 20799 produces 

a number of volatiles, mainly alcohols, 

acids, and esters, that are claimed to 

inhibit and kill plant pathogenic 

organisms that cause diseases such as 

root rot, damping off, and wilt. 

The registrant is seeking to register a 

microbial pesticide in which the 

Manufacturing Use Product (MP) 

contains M. albus QST 20799 as the 

active ingredient. End-use Products 

(EPs) will be formulated from the MP by 

addition of inerts. The EPs, which will 

be registered concurrently with the MP, 

will be shipped as dried products. The 

EPs are proposed for use as a seed and 

propagule or soil treatment to control 

root diseases in greenhouse and field 

crops, as well as for control of postharvest decay in fresh fruits and 

vegetables and cut flowers. 

1. Acute oral toxicity - rats (OPPTS 

870.1100). Three female and three male 

rats were dosed with a single dose of M. 

albus QST 20799 in distilled water at 5 

grams/kilogram body weight (g/kg bw). 

The rodents were observed for 14 days 

(Master Record Identification Number 

(MRID) 46106401). No mortality was 

observed, all animals gained weight, 

and there were no clinical signs, or 

abnormal findings at necropsy. The oral 

LD50 for males, females, and combined 

was greater than 5,000 milligram/ 

kilogram (mg/kg) (Biopesticides and 

Pollution Prevention Division (BPPD) 

Data Evaluation Record (DER) dated 

April 28, 2004, hereinafter referred to as 

‘‘BPPD DER 04/28/04’’). 

M. albus QST 20799 produces 

volatiles when it is rehydrated. 

Generally, an acute oral test is not 

required when the test material is 

volatile. Nevertheless, the Agency 

considered the patterns of use, and the 

nature of the volatiles produced under 

these conditions. M. albus QST 20799 

and its volatiles are not expected to be 

present in or on treated food 

commodities as a result of these 

proposed uses. The pesticide is 

incorporated into soil prior to planting, 

is not viable in soil once its food source 

is exhausted, and is not in direct contact 

with treated seed and propagule, or food 

or feed commodities treated post 

harvest. It is not a systemic pesticide 

and, thus, will not be translocated in 

seed and propagule, or other treated 

food and feed commodities. The 

volatiles are well-known fragrances and 

flavors of food and beverages, are shortlived, and are not expected to remain on 

treated food or feed commodities. Thus, 

acute oral tests, as conducted with the 

test material, M. albus QST 20799, are 

sufficient to evaluate in support of the 

petition of an exemption from tolerance. 

2. Acute oral toxicity/pathogenicity - 

rat study (Guideline 152–30; OPPTS 

885.3050). Twenty-two male and 22 

female rats were treated by oral gavage 

for 22 days with a white aqueous 

suspension of M. albus QST 20799 

(mean dry weight percentage: 1.82%) 

(MRID 46039404). Clinical signs were 

observed and body weights recorded 

Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Rules and Regulations 56571 

twice per day. The sacrificed rats were 

subjected to necropsy. No mortality was 

observed, all animals gained weight, 

and there were no clinical signs, or 

abnormal findings at necropsy. M. albus 

QST 20799 was not detected in kidney, 

brain, liver, heart, lungs, spleen, 

mesenteric lymph nodes, blood 

samples, or intestinal contents. M. albus 

QST 20799 does not appear to be toxic, 

infective, and/or pathogenic to rats, 

when dosed at 108 cfu (0.1 g total dry 

weight)/animal. The study results were 

considered acceptable and the active 

ingredient is considered in Toxicity 

Category IV for acute oral effects (BPPD 

DER 04/28/04). 

3. Acute pulmonary toxicity/ 

pathogenicity - rat (OPPTS 885.3150). 

Twenty-nine female and 29 male rats 

received, by intratracheal instillation, a 

dose of 3 milliliters (ml) ( 1.9 x 103 to 

2.4 x 103 cfu) of an aqueous suspension 

of M. albus QST 20799. They were 

observed for 22 days post treatment 

(MRID 46039406). However, two rats 

died early in the experiment likely due 

to the dosing procedure. Another rat 

was sacrificed at 4 days due to the 

severity of the clinical signs. Surviving 

rats were sacrificed, then subjected to 

necropsy. Recovery of viable test 

organism from blood, organs, intestinal 

contents, and feces was determined. No 

clinical signs related to the test 

organism or macroscopic abnormalities 

were noted in the rats. No test 

organisms were detected in any tissue 

sample tested. In general, M. albus QST 

20799 does not appear to be toxic, 

infective, and/or pathogenic to rats at 

this dose. This study was considered 

acceptable (BPPD DER 04/28/04). 

4. Acute dermal toxicity - rabbits 

(Guideline 152–31; OPPTS 870–2500/ 

885–3100). To investigate dermal 

toxicity of M. albus QST 20799, five 

male and five female New Zealand 

white rabbits were treated with an 

aqueous suspension of M. albus QST 

20799. The fur representing 

approximately 10% of the total body 

surface was clipped on the dorsolumbar region of each rabbit. The test 

substance (2 ml/kg equivalent to 2 g/kg 

body weight) was applied on the skin 

site on each rabbit, then covered (MRID 

#46106402). After the dressings were 

removed in 24 hours, the rabbits were 

observed at least twice daily for survival 

and were checked for clinical signs 

hourly post treatment and twice on 

subsequent days for 14 days. Body 

weight was recorded on days 1, 8, and 

15. The Draize method was utilized to 

rate skin irritation after test substance 

removal. The rabbits were euthanized 

and gross necropsied on day 15. No 

rabbits died and no clinical signs of 

toxicity were observed throughout the 

study. No dermal irritation was noted 

on any animal. One female lost weight 

during the first week and four males and 

one female lost weight during the 

second week. Overall, all animals 

gained weight. No treatment-related 

abnormal findings were noted. The test 

organism was not toxic to rabbits. The 

acute lethal dose (LD50) was greater than 

2 mg/kg. The study is acceptable, and 

the pesticide is considered Toxicity 

Category IV for dermal effects (BPPD 

DER 04/28/04). 

5. Primary eye irritation (OPPTS 

Guideline 870.2400). Three female 

young adult New Zealand White rabbits 

were treated with M. albus QST 20799. 

A solution of 0.1 ml/eye/animal was 

applied into the conjunctival sac of one 

eye, and the eye held closed for 

approximately 1 second. The 

contralateral eye served as control. The 

eyes were examined and scored 1, 24, 

48 and 72 hours after test material 

instillation (MRID 46039407). No 

corneal opacity, iritis, or positive 

conjunctival irritation was noted on any 

rabbit during the study. M. albus QST 

20799 was practically non-irritating to 

the eyes of the rabbits. This study was 

considered acceptable and the pesticide 

placed in Toxicity Category IV for 

primary eye irritation (BPPD DER 04/28/ 

04). 

6. Data waiver requests: MP and EP. 

Requests were made to waive data for 

the following requirements for the 

TGAI/MP and EP: 

• Acute Inhalation (Guideline 152–

32; OPPTS 870.1300); 

• Acute Intravenous (IV), 

Intracerebral (IC), Intraperitoneal (IP) 

injection Toxicity/Pathogenicity 

(Guideline 152–33; OPPTS 885.3200); 

• Cell Culture (Guideline 152.39; 

OPPTS 885.3500); 

• Immune Response (Guideline 152–

38; OPPTS 885.3800); 

• Hypersensitivity Study (Guideline 

152–36); 

• Hypersensitivity Incidents 

(Guideline 152–37; OPPTS 870.3400). 

i. Acute inhalation toxicity/ 

pathogenicity. The registrant cited the 

acute pulmonary toxicity/pathogenicity 

study (see Unit III.3, above) to justify 

waiving the acute inhalation study. In 

that study the active ingredient cleared 

tissues and was not toxic, infective, or 

pathogenic to rats when instilled 

intratracheally. In addition, the 

registrant’s argument that the exposure 

during formulations of the granular EPs 

from the MP justifies granting this 

request to waive acute inhalation data 

requirements for the MP. 

However, the Agency did consider 

that exposure to all the volatiles 

produced during rehydration of the 

pesticide was not fully addressed. For 

product characterization and to 

establish that pesticide residues do not 

accumulate on treated commodities, the 

registrant provided data to the Agency 

about potential volatiles produced 

during rehydration of the active 

ingredient. These volatiles occur 

naturally in food products, and are used 

as fragrances, flavoring agents or as 

solvents. In submitted chromatograms, 

seven peaks (pks) were identified as pks 

1, 2, 3, 4, 6, 10 and 11, as discussed 

below (BPPD DER 06/ /05). 

• (Pk 1) Ethyl propionate in wine, 

white grapes and, cocoa; 

• (Pk 2) Isobutyl alcohol in food and 

beverages; 

• (Pk 3) 2-Methylbutyl acetate in 

apples; 

• (Pk 4) Isoamyl isobutyrate in honey, 

hop oil and whiskey; 

• (Pk 6) 2-Methyl-1-butanol in wine, 

kiwi, apples and alcoholic beverages. It 

is a volatile component of blue cheese 

aroma, concord grape juice essence, 

nectarines, apples, papaya fruit, 

oranges, tomatoes and is released in the 

volatile emissions from poultry manure. 

• (Pk 10) Isobutyric acid in cheese, 

fruits, vinegar and alcoholic beverages; 

(Pk 11) Phenethyl alcohol in foods 

such as olive oil, grapes, tea, apple 

juice, coffee, and alcoholic beverages 

(BPPD DER 06/ /05). 

At room temperature a 10 gram 

sample of the EP, Arabesque, rehydrated 

1:1 with water, produced low 

concentrations of the volatiles ranging 

from 0.15 parts per billion (ppb) for 2- 

Methylbutyl acetate and Isoamyl 

isobutyrate to 20.5 ppb for Isobutyric 

acid. The inhalation LC50 was reported 

from published literature for most of the 

volatiles and found to be within 

acceptable threshold levels. Volatiles 

dissipating from the rehydrated 

pesticide are well below those reported 

inhalation LC50 values. All the volatiles 

are reported as naturally occurring in 

foods as fragrances and flavors, and they 

dissipate shortly after rehydration, 

without compromising efficacy in the 

time required for storage or other 

treatments related to proposed 

agricultural practices. However, the 

inhalation LC50 was not reported for 

Ethyl propionate, 2-Methylbutyl acetate, 

and Isoamyl isobutyrate. The Agency is 

of the opinion that the exposure to these 

substances may not pose a dietary risk 

via inhalation, because they are shortlived, well-characterized flavors and 

fragrances, which occur naturally in 

consumed food and feed commodities. 

This data requirement is satisfied for the 

purposes of the exemption from 

tolerance. 

56572 Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Rules and Regulations 

ii. Acute IV/IP/IC study. In an acute 

oral toxicity/pathogenicity study (see 

Unit III.1 and 2 above) with the 

technical grade active ingredient 

(TGAI), no clinical signs of toxicity were 

observed in rats and no viable M. albus 

QST 20799 was recovered from blood, 

organs, or intestinal contents. Data from 

the registrant’s in-house study show that 

M. albus is not viable at temperatures of 

34 °C and above, and, therefore, would 

not be expected to survive at 

mammalian body temperatures. Based 

on the low toxicity potential indicated 

by these observations, the request to 

waive the acute IP study was granted. 

iii. Cell culture. This study is required 

for a virus and is not required for a 

fungal active ingredient such as M. 

albus QST 20799. The request to waive 

this data requirement is granted. 

iv. Immune response. The lack of 

pathogenicity seen in the acute oral 

toxicity/pathogenicity study with the 

TGAI indicates the immune system was 

not adversely affected by M. albus QST 

20799. Based on these considerations, 

the justifications to support the request 

to waive data requirements for the 

immune response studies for the TGAI/ 

MP are acceptable. 

v. Hypersensitivity study. No 

incidents of hypersensitivity have 

occurred during the research, 

development, or testing of M. albus QST 

20799 or the ArabesqueTM end product. 

A hypersensitivity study is not required 

at this time, but may be required in the 

future if there are reports of 

hypersensitivity incidents associated 

with this active ingredient used in 

pesticides. 

vi. Hypersensitivity incidents 

(Guideline 152–37; OPPTS 870.3400). 

The registrant requested to waive 

reports of hypersensitivity incidents, 

because no incidents of hypersensitivity 

associated with the TGAI or proposed 

components of the EP have been 

reported to date. However, the registrant 

agreed to report hypersensitivity 

incidents, should they occur in the 

future. This guideline requirement is 

satisfied at this time. In order to comply 

with FIFRA requirements under Section 

6(a)(2), any incident of hypersensitivity 

associated with the use of this pesticide 

must be reported to the Agency. This 

data requirement is not waived. 

7. Subchronic, chronic toxicity and 

oncogenicity, and residue data. Based 

on the data generated in accordance 

with the Tier I data requirements set 

forth in 40 CFR 158.740(c), the Tier II 

and Tier III data requirements were not 

triggered and, therefore, not required in 

connection with this action. In addition, 

because the Tier II and Tier III data 

requirements were not required, the 

residue data requirements set forth in 40 

CFR 158.740(b) also were not required. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of the FFDCA directs EPA 

to consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

A. Dietary Exposure 

Use of M. albus QST 20799 and its 

EPs is not likely to cause any harm via 

consumption of food or feed treated 

with the microbe, which is not applied 

directly to food as discussed below. 

1. Food. Residues of M. albus QST 

20799 and its volatiles are not expected 

on treated food commodities from the 

proposed use patterns. After pesticides 

containing M. albus QST 20799 are 

incorporated into soil prior to planting, 

the fungal active ingredient survives 

poorly in the soil once the food supply 

is depleted. Even though the fungal 

active ingredient itself, does not survive 

in soil, the volatiles produced by the 

microbe appear to control the target soil 

pests. Thus, neither the fungus nor its 

volatiles are in direct contact with, or 

expected to remain on, treated food 

commodities. 

Similarly, treatment using pesticides 

containing M. albus Strain QST 20799 

after food is harvested (i.e., post harvest) 

does not involve contact with the 

treated commodities. Post-harvest 

treatment involves exposure of the food 

to the pesticide in warehouses or in 

shipping containers. Here, the 

rehydrated pesticides containing the 

fungal active ingredient are in sachets or 

containers, and are not in direct contact 

with the food or feed. During the period 

of treatment, volatiles released from the 

microbe inhibit the growth of 

organisms, which cause disease on food 

commodities, when they are being 

stored after harvest. 

Furthermore, the active ingredient is 

not a systemic pesticide. Thus, 

detectable residues of M. albus QST 

20799, the microbe, are not expected on 

treated seed and propagules or food or 

feed commodities. The volatiles do 

occur naturally as flavors and fragrances 

in food and feed commodities. Hence, 

they are not expected to be present on 

treated seed and propagules, food or 

feed, solely as a result of treatment with 

this pesticide. 

As previously discussed in Unit III, 

data submitted to the Agency indicate 

that some of the volatiles produced by 

the fungus are Ethyl propionate, 

Isobutyl alcohol, 2-Methylbutyl acetate, 

Isoamyl isobutyrate, 2-Methyl-1- 

butanol, Isobutyric acid, Phenethyl 

alcohol. Many of these compounds are 

found in fruit aromas, fresh leaves, wine 

and rum aromas, blue cheese aroma, 

natural essential oils and olive and 

vegetable oil. Data submissions to the 

Agency indicate that residues of the 

volatiles do not appear to adhere to the 

treated commodities, nor leave any 

detectable residues on treated apples. 

Based on the nature of the volatiles, and 

their natural occurrence in some food 

commodities, they are not expected to 

be detectable residues solely as a result 

of treatment with M. albus QST 20799. 

From the above discussion it is clear 

that during any of the proposed uses, 

residues of the microbe or its volatiles 

are not expected on treated 

commodities. Normal washing, peeling, 

cooking, or processing of treated fruits 

and vegetables would further reduce 

any possible residues of M. albus QST 

20799 or its volatiles. Finally, as 

discussed in Unit III, the acute oral tests 

demonstrate low toxicity potential via 

dietary exposure to this Toxicity 

Category IV pesticide. Hence, even if the 

pesticide was present in or on food 

commodities, exposure via the dietary 

route is not expected to cause any harm. 

Therefore, the Agency has decided 

that dietary exposure from the proposed 

uses of M. albus QST 20799 and its 

volatiles is not likely to adversely affect 

the U.S. adult population, infants and 

children. 

2. Drinking water exposure. Exposure 

to M. albus QST 20799 in drinking 

water is not likely to adversely affect 

U.S. adult population, infants and 

children, if the pesticide is used as 

labeled. The active ingredient belongs to 

the group referred to as ‘‘mycelia 

sterilia’’ which do not produce spores. 

This feature of the microbe allows for a 

short life cycle of M. albus QST 20799. 

Since M. albus Strain QST 20799 occurs 

as a sterile mycelium and has no spores 

or resting structure, it is unlikely to be 

capable of substantial growth in soil 

after its food base in the product has 

been exhausted. Thus, transfer of M. 

albus Strain QST 20799 from soil to 

groundwater is unlikely. Even if such a 

transfer were to occur, the fungus would 

not tolerate the conditions drinking 

water treatment would provide, e.g., 

chlorination, pH adjustments, high 

temperatures, and/or processing 

conditions. 

The proposed uses of pesticides 

containing this active ingredient, 

suggest that neither the parent fungus, 

nor its volatiles are likely to persist or 

Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Rules and Regulations 56573 

accumulate in drinking water when the 

active ingredient is used as labeled. 

Potential risks via exposure to drinking 

water or runoff are adequately mitigated 

by, among other things, percolation 

through soil. Thus, exposure via 

drinking water from the proposed use of 

this active ingredient is not likely to 

adversely affect the U.S. population of 

adult humans, infants and children. 

B. Other Non-Occupational Exposure 

Non-occupational dermal and 

inhalation exposure is unlikely, since 

the use sites are commercial and 

agricultural. Pesticide drift is expected 

to be minimal, since the EP is 

incorporated into the soil for preplanting treatment, or is used in 

enclosed containers for post-harvest 

treatment. Soil survivability of M. albus 

Strain QST 20799 is poor, and it has no 

spores or resting structure. The volatile 

compounds produced by M. albus 

Strain QST 20799 dissipate rapidly in 

the environment. The acute pulmonary 

toxicity study demonstrated no 

treatment-related adverse effects when 

the active ingredient was instilled into 

rats intratracheally. No hypersensitivity 

incidents have been reported for either 

the TGAI/MP or EPs. 

1. Dermal exposure. The low toxicity 

potential observed in the acute dermal 

studies discussed above (Unit III), the 

low exposure potential based on low 

application rates, and the lack of 

persistence of the active ingredient, 

leads EPA to conclude that this 

pesticide poses minimal risk to human 

populations via non-occupational 

dermal exposure. The volatiles 

produced by the active ingredient 

dissipate rapidly, and are thus not likely 

to adhere to, or penetrate, clothing, or 

adhere to the skin of the nonoccupationally exposed population. 

Moreover, potential non-occupational 

dermal exposure to M. albus Strain QST 

20799 is unlikely because the use sites 

are commercial and agricultural. The 

pesticide is granular in nature and the 

methods of application minimize 

pesticide drift. As previously discussed 

in Units III and IV, a lack of 

hypersensitivity incidents and the poor 

survivability of the fungus in soil 

indicate M. albus Strain QST 20799 

poses minimal risk to populations via 

non-occupational dermal exposure. 

Thus, the Agency does not expect 

pesticides containing M. albus QST 

20799 to pose a non-occupational 

dermal exposure hazard. 

2. Inhalation exposure. Nonoccupational inhalation exposure to the 

active ingredient itself is not likely to 

cause an inhalation hazard. No 

treatment-related effects associated with 

the active ingredient were observed in 

the pulmonary tests reported above. The 

volatiles are produced on rehydration 

and are expected to dissipate during 

storage and shipment of treated 

commodities. They are also not likely to 

persist in the environment after 

application, as discussed above. 

Furthermore, these volatiles are known 

as fragrances or flavors associated with 

food. Based on the low potential for 

non-occupational inhalation exposure, 

the Agency does not expect these 

pesticides containing M. albus QST 

20799 and its volatiles to pose an 

inhalation hazard. 

In summary, the potential aggregate 

exposure via treatment of soil, seed and 

propagules, fruits and vegetables, and 

cut flowers with M. albus Strain QST 

20799 is not likely to pose a hazard via 

aggregate exposure. This includes 

hazards derived from (a) dietary 

exposure from the treated food/feed 

commodities, (b) drinking water 

potentially exposed secondary to 

treatment of sites with this pesticide; 

and (c) dermal and inhalation nonoccupational and occupational exposure 

of populations exposed to M. albus 

Strain QST 20799. 

V. Cumulative Effects 

Section 408(b)(2)(D)(v) of the FFDCA 

requires the Agency to consider the 

cumulative effect of exposure to M. 

albus QST 20799 and to other 

substances that have a common 

mechanism of toxicity. These 

considerations include the possible 

cumulative effects of such residues on 

infants and children. Based on tests in 

mammalian systems, M. albus QST 

20799 and its volatiles do not appear to 

be toxic or pathogenic to humans. No 

other registered pesticide contains M. 

albus QST 20799 as an active 

ingredient. The pesticide is proposed to 

be used in a manner which will not 

directly contact treated food or feed 

commodities. It will not be translocated 

in seed and propagule because it is not 

systemic. One of the proposed uses, as 

a methyl bromide replacement, is a soil 

treatment. 

The volatiles, which are produced by 

the rehydrated fungus, appear to 

dissipate and are not absorbed by 

treated food commodities, thus leaving 

no detectable residues. The volatiles are 

also well-known components of 

fragrance and flavor associated with 

food, and are only produced for short 

periods when the fungus is rehydrated. 

Based on the low toxicity potential of M. 

albus QST 20799 and its volatiles (see 

Unit III above), and the low exposure 

scenario when the proposed pesticides 

are used as labeled, no cumulative or 

incremental effect is expected from its 

use. 

VI. Determination of Safety for U.S 

Population, Infants and Children 

There is reasonable certainty that no 

harm will result to the U.S. population, 

including infants and children, from 

aggregate exposures to residues of M. 

albus QST 20799, as a result of its 

proposed uses. This includes all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. As discussed 

previously, there appears to be no 

potential for harm, from this fungus in 

its use as an antifungal agent on treated 

food commodities via dietary exposure 

since the organism is non-toxic and 

non-pathogenic to animals and humans. 

The Agency has arrived at this 

conclusion based on the very low levels 

of mammalian toxicity for acute oral, 

pulmonary, and dermal effects with no 

toxicity or infectivity at the doses tested 

(see Unit III. above). Moreover, potential 

non-occupational inhalation or dermal 

exposure is not expected to pose any 

adverse effects to exposed populations 

via aggregate and cumulative exposure 

(see Units IV. and V.) 

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

that EPA shall apply an additional tenfold margin of exposure (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 

toxicity and exposure, unless EPA 

determines that a different margin of 

exposure (safety) will be safe for infants 

and children. Margins of exposure 

(safety), which are often referred to as 

uncertainty factors, are incorporated 

into EPA risk assessment either directly, 

or through the use of a margin of 

exposure analysis, or by using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk. In this instance, based 

on all the available information (as 

discussed in detail above), the Agency 

concludes that the fungus, M. albus QST 

20799, is non-toxic to mammals, 

including infants and children. Because 

there are no threshold effects of concern 

to infants, children and adults when M. 

albus QST 20799 is used as labeled, the 

Agency has determined that the 

additional margin of safety is not 

necessary to protect infants and 

children, and that not adding any 

additional margin of safety will be safe 

for infants and children. As a result, 

EPA has not used a margin of exposure 

(safety) approach to assess the safety of 

M. albus QST 20799. 

56574 Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Rules and Regulations 

VII. Other Considerations 

A. Endocrine Disruptors 

EPA is required under section 408(p) 

of the FFDCA, as amended by FQPA, to 

develop a screening program to 

determine whether certain substances 

(including all pesticide active and other 

ingredients) ‘‘may have an effect in 

humans that is similar to an effect 

produced by a naturally-occurring 

estrogen, or other such endocrine effects 

as the Administrator may designate.’’

Following the recommendations of its 

Endocrine Disruptor Screening and 

Testing Advisory Committee (EDSTAC), 

EPA determined that there was 

scientific basis for including, as part of 

the program, the androgen and thyroid 

systems, in addition to the estrogen 

hormone system. EPA also adopted 

EDSTAC’s recommendation that the 

program include evaluations of 

potential effects in wildlife. For 

pesticide chemicals, EPA will use 

FIFRA and, to the extent that effects in 

wildlife may help determine whether a 

substance may have an effect in 

humans, FFDCA authority, to require 

the wildlife evaluations. As the science 

develops and resources allow, screening 

of additional hormone systems may be 

added to the Endocrine Disruptor 

Screening Program (EDSP). 

At this time, the Agency is not 

requiring information on the endocrine 

effects of this active ingredient, M. albus 

QST 20799. The Agency has considered, 

among other relevant factors, available 

information concerning whether the 

microorganism may have an effect in 

humans similar to an effect produced by 

a naturally occurring estrogen or other 

endocrine effects. There is no known 

metabolite that acts as an ‘‘endocrine 

disruptor’’ produced by this 

microorganism. The submitted toxicity/ 

infectivity or pathogenicity studies in 

the rodent (required for microbial 

pesticides) indicate that, following oral, 

pulmonary and dermal routes of 

exposure, the immune system is still 

intact and able to process and clear the 

active ingredient (see Unit III.). In 

addition, based on the low potential 

exposure level associated with the 

proposed labeled uses of the pesticide, 

the Agency expects no adverse effects to 

the endocrine or immune systems. 

Thus, there is no impact via endocrinerelated effects on the Agency’s safety 

finding set forth in this Final Rule for 

M. albus QST 20799. 

B. Analytical Method(s) 

The acute oral studies discussed 

above demonstrate that neither the 

active ingredient nor the volatiles 

produced by the rehydrated fungus pose 

a dietary risk. In addition, the active 

ingredient is not likely to come into 

contact with the treated food 

commodities. The volatiles from the 

rehydrated fungal active ingredient 

dissipate quickly. They do not appear to 

leave any detectable residues on treated 

food commodities, when used as 

labeled. Furthermore, the low 

application rate and non-persistence on 

food during soil applications suggests 

very low exposure potential via the 

dietary route. Since residues are not 

expected on treated commodities, the 

Agency has concluded that an analytical 

method to detect residues of this 

pesticide on treated food commodities 

for enforcement purposes is not needed. 

Nevertheless, the Agency has 

concluded that for analysis of the 

pesticide itself, microbiological and 

biochemical methods exist and are 

acceptable for enforcement purposes for 

product identity of M. albus QST 20799, 

and the volatiles produced by the 

rehydrated fungus. Other appropriate 

methods are required for quality control 

to assure that product characterization, 

the control of human pathogens and 

other unintentional metabolites or 

ingredients are within regulatory limits, 

and to ascertain storage stability and 

viability of the pesticidal active 

ingredient. 

C. Codex Maximum Residue Level 

There is no Codex maximum residue 

level for residues of M. albus QST 

20799. 

VIII. Conclusions 

The results of the studies discussed 

above are sufficient to comply with the 

requirements of the FQPA. They 

support an exemption from the 

requirement of a tolerance for residues 

of M. albus QST 20799, on treated food 

or feed commodities. In addition, the 

Agency is of the opinion that, if the 

microbial active ingredient is used as 

labeled, aggregate and cumulative 

exposures are not likely to pose any 

undue hazard. The volatiles produced 

when the fungus is rehydrated also do 

not pose an incremental dietary and 

non-dietary risk to the adult human U.S. 

population, children and infants. 

Therefore, an exemption from tolerance 

is granted in response to pesticide 

petition 3F6745. 

IX. Objections and Hearing Requests 

Under section 408(g) of the FFDCA, as 

amended by the 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 the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the 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 the FFDCA, as was 

provided in the old sections 408 and 

409 of the 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–2005–0244 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 November 28, 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. 

Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Rules and Regulations 56575 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit IX.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–2005–0244, to: Public Information 

and Records Integrity Branch, 

Information Technology and Resource 

Management 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 e-mail 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). 

X. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the tolerance 

requirement under section 408(d) of the 

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 

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 the FFDCA, 

such as the tolerance 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. The 

Agency hereby certifies that this rule 

will not have significant negative 

economic impact on a substantial 

number of small entities. In addition, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government, as 

specified in Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999). Executive Order 

13132 requires EPA to develop an 

accountable process to ensure 

‘‘meaningful and timely input by State 

and local officials in the development of 

regulatory policies that have federalism 

implications.’’ ‘‘Policies that have 

federalism implications’’ is defined in 

the Executive order to include 

regulations that have ‘‘substantial direct 

effects on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ This 

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. 

XI. 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: September 20, 2005. 

James Jones, 

Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

56576 Federal Register / Vol. 70, No. 187 / Wednesday, September 28, 2005 / Rules and Regulations 

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 180.1260 is added to 

subpart D to read as follows: 

§ 180.1260 Muscodor albus QST 20799 and 

the volatiles produced on rehydration; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established on all food/ 

feed commodities, for residues of 

Muscodor albus QST 20799, and the 

volatiles produced on its rehydration, 

when the pesticide is used for all 

agricultural applications, including 

seed, propagule and post harvest 

treatments. 

[FR Doc. 05–19259 Filed 9–27–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 310 

[SFUND–2005–0009; FRL–7976–2] 

RIN 2050–AE36 

Reimbursement to Local Governments 

for Emergency Responses to 

Hazardous Substances Releases 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; technical correction. 

SUMMARY: EPA issued a final rule in the 

Federal Register of February 18, 1998, 

to streamline procedures used to 

reimburse local governments for 

emergency response costs. Local 

governments may be reimbursed for 

certain costs they incur in taking 

temporary emergency measures related 

to releases of hazardous substances, 

pollutants and contaminants. This 

document is being issued to correct the 

address to mail the completed 

application and supporting data 

provided and the telephone numbers 

listed in Appendix II to the regulations. 

DATES: This technical correction is 

effective on September 28, 2005. 

ADDRESSES: Docket: 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., 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 

Superfund Docket, EPA/DC, EPA West, 

Room B102, 1301 Constitution Ave., 

NW., Washington, DC. The Public 

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

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

excluding legal holidays. The telephone 

number for the Public Reading Room is 

(202) 566–1744, and the telephone 

number for the Superfund Docket is 

(202) 566–0276. 

FOR FURTHER INFORMATION CONTACT: 

Lynn Beasley, Regulation and Policy 

Development Division, Office of 

Emergency Management, Office of Solid 

Waste and Emergency Response 

(5104A), Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460; telephone 

number: (202) 564–1965; fax number: 

(202) 564–2625; e-mail address: 

beasley.lynn@epa.gov. For further 

information regarding specific aspects of 

the final rule for reimbursement to local 

governments, contact: Lisa Boynton, 

Local Governments Reimbursement 

Project Officer, Program Operations and 

Coordination Division, Office of 

Emergency Management, Office of Solid 

Waste and Emergency Response 

(5104A), Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460; telephone 

number: (202) 564–2487; fax number: 

(202) 564–8211; e-mail address: 

boynton.lisa@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does This Action Apply to Me? 

Type of entity Examples of affected 

entities 

Local or Tribal Governments.Governing bodies of 

county, parish, municipality, city, 

town, township, 

federally recognized Indian tribe 

or general purpose 

unit of local government. 

This table is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

regulated by this action. This table lists 

the types of entities that EPA is now 

aware could potentially be regulated by 

this action. Other types of entities not 

listed in the table could also be 

regulated. If you have questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed in the preceding FOR FURTHER

INFORMATION CONTACT section. 

B. How Can I Access Electronic Copies 

of This Document and Other Related 

Information? 

The instructions provided under the 

Federal Register document of February 

18, 1998, 63 FR 8284, are no longer 

current. The current information is as 

follows: 

• Docket ID No. SFUND–2005–0009. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. 

• Agency Web site: http:// 

www.epa.gov/edocket. EDOCKET, EPA’s 

electronic public docket and comment 

system. 

• E-mail: superfund.docket@epa.gov. 

• Fax: (202) 566–0224. 

Mail: Superfund Docket, 

Environmental Protection Agency, 

Mailcode: 5202T, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460. 

In addition to using EDOCKET at 

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/. 

II. What Does This Correction Do? 

On February 18, 1998, (63 FR 8284) 

EPA published streamlined procedures 

for use by local governments seeking 

reimbursement for emergency response 

costs. Local governments may be 

reimbursed for certain costs they incur 

in taking temporary emergency 

measures related to releases of 

hazardous substances pollutants and 

contaminants. Those procedures are 

found in 40 CFR part 310. Section 

310.15(d) gives the address to mail the 

completed application and supporting 

data for reimbursement. Appendix II to 

40 CFR part 310 provides EPA Regions 

and NRC Telephone Lines. The mailing 

address and some of the telephone 

numbers are now incorrect. This 

technical correction provides the 

corrected address to mail the completed 

application and supporting data and the 

EPA Regions and NRC phone numbers. 

III. Why Is This Correction Issued as a 

Final Rule? 

Section 553 of the Administrative 

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

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

Agency for good cause finds that notice 

and public procedure are impracticable, 

unnecessary or contrary to the public 

interest, the agency may issue a final 

rule without providing notice and an 

opportunity for public comment. EPA 

has determined that there is good cause 

for making today’s technical correction 

final without prior proposal and 

opportunity for comment, because EPA 

is merely correcting information that