13174 Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations 

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

■ 2. The table in paragraph (a) of 

§ 180.495 is amended by: 

■ i. Alphabetically adding amaranth, 

grain, stover; cattle, liver; goat, liver; 

hop, dried cones; horse, liver; and 

sheep, liver. 

■ ii. Revising the remainder of the 

entries listed. 

The additions and revisions to the 

table in paragraph (a) read as follows: 

§ 180.495 Spinosad; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million Expiration/Revocation Date 

*****

Amaranth, grain, stover ............................................................................................................................... 10 None 

*****

Cattle, fat ..................................................................................................................................................... 50 None 

Cattle, liver ................................................................................................................................................... 10 None 

Cattle, meat ................................................................................................................................................. 2.0 None 

Cattle, meat byproducts, except liver .......................................................................................................... 5.0 None 

*****

Egg ............................................................................................................................................................... 0.30 None 

*****

Goat, fat ....................................................................................................................................................... 50 None 

Goat, liver .................................................................................................................................................... 10 None 

Goat, meat ................................................................................................................................................... 2.0 None 

Goat, meat byproducts, except liver ............................................................................................................ 5.0 None 

*****

Hop, dried cones ......................................................................................................................................... 22 None 

Horse, fat ..................................................................................................................................................... 50 None 

Horse, liver ................................................................................................................................................... 10 None 

Horse, meat ................................................................................................................................................. 2.0 None 

Horse, meat byproducts, except liver .......................................................................................................... 5.0 None 

*****

Milk ............................................................................................................................................................... 7.0 None 

Milk, fat ........................................................................................................................................................ 85 None 

*****

Poultry, fat .................................................................................................................................................... 1.3 None 

Poultry, meat ................................................................................................................................................ 0.10 None 

Poultry, meat byproducts ............................................................................................................................. 0.10 None 

*****

Sheep, fat .................................................................................................................................................... 50 None 

Sheep, liver .................................................................................................................................................. 10 None 

Sheep, meat ................................................................................................................................................ 2.0 None 

Sheep, meat byproducts, except liver ......................................................................................................... 5.0 None 

*****

* * * * * 

[FR Doc. E7–4760 Filed 3–20–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0325; FRL–8117–9] 

6-Benzyladenine; 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 biochemical 

pesticide, 6-benzyladenine (6–BA), in or 

on pear when applied/used as a plant 

regulator. Valent BioSciences 

Corporation (Valent) submitted a 

petition 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 6- 

benzyladenine. 

DATES: This regulation is effective 

March 21, 2007. Objections and requests 

for hearings must be received on or 

before May 21, 2007, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2006–0325. All documents in the 

docket are listed in the index for the 

docket. Although listed in the index, 

some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S–

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Denise Greenway, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8263; e-mail address: 

greenway.denise@epa.gov. 

SUPPLEMENTARY INFORMATION: 


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Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations 13175 

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). 

• 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? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this ‘‘Federal Register’’ document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

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. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ–

OPP–2006–0325 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 May 21, 2007. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0325, by one of 

the following methods. 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket telephone number is (703) 305–

5805. 

II. Background and Statutory Findings 

In the Federal Register of April 19, 

2006 (71 FR 20100) (FRL–8058–1), 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 6F7035) 

by Valent BioSciences Corporation 

(Valent), 870 Technology Way, 

Libertyville, IL 60048–6316. The 

petition requested that 40 CFR part 180 

(specifically, § 180.1150) be amended 

by establishing an exemption from the 

requirement of a tolerance for residues 

of 6-benzyladenine (6–BA) in or on pear 

when applied at a rate of ≤182 grams of 

active ingredient per acre per season. 

The electronic docket (EPA–HQ–OPP–

2006–0325) for this notice includes a 

summary of the petition prepared by the 

petitioner, Valent. Previously, on April 

2, 2004 (69 FR 17304; FRL–7347–6), 

EPA issued a final rule granting a 

permanent exemption from the 

requirement of a tolerance for residues 

of 6–BA in or on pistachio when 

applied at a rate of ≤60 grams of active 

ingredient per acre per season, and the 

existing permanent tolerance exemption 

for apple was amended to expand the 

uses (by adding a post-bloom-applied 

stand-alone fruitlet thinner use) and 

increase the permissible application rate 

to ≤182 grams of active ingredient per 

acre per season. Both apple and the 

subject new crop, pear, are pome fruit 

and, therefore, botanically similar. The 

two crops are grown in the same 

climatic/geographic regions, and are 

similarly cultivated. For both crops, 6–

BA is applied for the same purpose, on 

the same schedule, at the same 

application rate and with the same 86–

day pre-harvest interval restriction. 

Based on these similarities, the Agency 

has determined for the purpose of 

establishing the requested tolerance 

exemption that previously-submitted 

and reviewed information and data 

supporting the current tolerance 

exemption for apple will apply equally 

to the new crop, pear. In submitting this 

petition, therefore, Valent is relying on 

information previously submitted in 

connection with seeking and obtaining 

the tolerance exemption for the 

expanded use of 6–BA on apple, which 

was summarized in the April 2, 2004, 

final rule, and also on new data 

summarized in the cited petition 

summary (i.e., PP 6F7035). New data 

submitted to the Agency by Valent on 

October 20, 2004 and summarized by 

the company in the current petition are 

a two-generation rat reproduction study, 

which is data not required for U.S. 

registration of this biochemical active 

ingredient, but rather was conducted to 

satisfy the registration requirements of 

other countries and submitted by the 

petitioner to augment the Agency’s 6–

BA data base. 

In response to EPA’s April 19, 2006 

notice, no comments were submitted in 

accordance with the instructions for 

submitting comments set forth in the 

notice. However, one informal comment 

was received from a private citizen who 

opposed issuance of a final rule. The 

commenter expressed concern regarding 

the hazard associated with plant 

regulator use in general, stated the 

unsupported belief that more testing 

needs to be done, and was generally 

opposed to the establishment of an 

exemption from the requirement of a 

tolerance as proposed in the subject 

pesticide tolerance petition for 6–BA. 

The Agency understands and recognizes 

that some individuals believe that 

pesticides, which include plant 

regulators, should be banned 

completely. Notwithstanding such 

beliefs, pursuant to its authority under 

the FFDCA, EPA has conducted a 

comprehensive assessment of 6–BA and 

has concluded that there is a reasonable 

certainty that no harm will result from 

dietary exposure to this chemical when 

its use is limited by the specified 

maximum application rates. 

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

allows EPA to establish an exemption 


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13176 Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations 

1 USEPA. N6-Benzyladenine: Review of 

Information for an Exemption from the Requirement 

of a Tolerance. K. R. Carlson to D. Greenway; 

December 5, 2006. 

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) of the FFDCA, 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) of the FFDCA, 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. 

The toxicological profile for 6–BA 

was published by the Agency in the 

June 1994 N6-Benzyladenine 

(synonymous with the subject active 

ingredient, 6-benzyladenine) 

Reregistration Eligibility Decision (RED) 

document (http://www.epa.gov/ 

oppsrrd1/REDs/old_reds/

n6benzyladenine.pdf). The summarized 

values and categories for the various, 

previously reviewed studies for the 

technical active ingredient are presented 

here. 

1. Acute toxicity. Toxicity Category III 

was assigned to the acute oral toxicity 

study in the rat (lethal dose (LD)50 = 1.3 

grams/kilogram (g/kg)), and in the eye 

irritation study in the rabbit (moderate 

irritant). Toxicity Category IV (the least 

toxic category) was assigned to the acute 

dermal toxicity study in the rabbit (LD50

>5 g/kg), the acute inhalation toxicity 

study in the rat (lethal concentration 

(LC)50 = 5.2 milligrams/liter (mg/L)), 

and to the dermal irritation study in the 

rabbit (slight irritant). Additionally, 

from a dermal sensitization study in the 

guinea pig, it was determined that 6–BA 

is not a dermal sensitizer. There have 

been no reported incidents of 

hypersensitivity directly linked to 6–

BA. Nevertheless, to comply with 

section 6(a)(2) of the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), any incident of 

hypersensitivity associated with the use 

of this pesticide must be reported to the 

Agency. 

2. Genotoxicity. From three 

mutagenicity studies (Ames test, mouse 

micronucleus assay, and unscheduled 

DNA synthesis assay in the rat), it was 

determined that 6–BA is not mutagenic. 

3. Developmental toxicity. The no 

observed adverse effect levels (NOAEL) 

and the lowest observed adverse effect 

levels (LOAEL) for maternal and 

developmental toxicity in rats, 

respectively, were found to be 50 and 

175 milligrams/kilogram body weight/ 

day (mg/kg bwt/day), respectively. 

4. Subchronic toxicity. For rats of both 

sexes, the NOAEL was approximately 

111 mg/kg bwt/day and the LOAEL was 

approximately 304 mg/kg bwt/day. 

In addition to the previously reviewed 

studies discussed above, a twogeneration rat reproduction study was 

relied upon by Valent to support the 

current petition to establish an 

exemption from the requirement of a 

tolerance for residues of 6–BA in or on 

pear. The lowest-LOAEL for parental 

systemic toxicity of technical 6–BA is 

750 ppm (58.6–70.4 mg/kg bwt/day) and 

is based on reduced body weight and 

weight gain in F0 and F1 male rats1.The 

NOAEL is 400 ppm (31.5–37.5 mg/kg 

bwt/day)1 . This systemic adult 

endpoint was used in the dietary risk 

assessment. Although the systemic 

endpoint is similar to that used in 

previous occupational risk assessments, 

the previous toxicological endpoint (40 

mg/kg bwt/day) has been modified to 

more precisely reflect the composition 

of test diets, rat body weights, and food 

consumption estimates1. 

Because only systemic and no 

reproductive effects were observed, the 

LOAEL for reproductive toxicity of 

technical 6–BA in rats could not be 

determined. The NOAEL, therefore, is 

>1,500 ppm (115.7–144.2 mg/kg bwt/ 

day for males and 133.0–139.2 mg/kg 

bwt/day for females), the highest dose 

tested1. 

The LOAEL for offspring toxicity of 

technical 6–BA in rats is 750 ppm 

(66.7–68.1 mg/kg bwt/day) and is based 

on decreased body weight and weight 

gain in F1 and F2 male and female pups. 

The NOAEL is 400 ppm (35.8–36.0 mg/ 

kg bwt/day)1. 

Uncertainty factors for inter- and 

intra-species variation (10X each) and 

subchronic to chronic extrapolation (3X) 

were used to modify the toxicity 

NOAEL. 

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 

1. Food. Apple field trials yielded 

acceptable magnitude of the residue 

data. In apples, residues of 6–BA were 

consistently near the limit of 

quantitation (LOQ). However, the 

residue levels for processed 

commodities did not increase relative to 

those on the raw commodity, and were 

below the LOQ. The apple field data are 

adequate to support the tolerance 

exemption for pear, limited by a 

maximum application rate of ≤182 

grams of active ingredient per acre per 

season, because of the shared physical, 

compositional and cultural 

characteristics of the two botanically 

similar pome fruits, which also are 

grown in the same climatic/geographic 

regions. The proposed use pattern; low 

application rate, frequency and timing; 

and 86–day pre-harvest interval are 

identical for apple and pear. Because 

application precedes harvest by 

approximately 2.5 months for apple and 

pear, the potential for dietary exposure 

is reduced. Due to the low anticipated 

dietary intake of 6–BA residues relative 

to the chronic and acute population 

adjusted doses (see Unit VI.), and the 


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Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations 13177 

fact that actual exposure will probably 

be considerably less because the dietary 

exposure analysis was based on worstcase assumptions (such as 

conservatively assuming: That 100% of 

the crop is treated, that non-detected or 

<LOQ residue concentrations are 

present, and that chronic exposure from 

the few seasonal applications made 60–

86 days before harvest could occur), it 

is highly unlikely that the proposed new 

use of 6–BA on pear will result in 

adverse effects to human health. 

2. Drinking water exposure. The 

proposed use on pear is not expected to 

add potential exposure to residues of 6–

BA in drinking water. Soil leaching 

studies have suggested that 6–BA is 

relatively immobile, adsorbing to 

sediment, and is degraded in the soil. 

Migration to potable water resources, 

therefore, is highly improbable. 

However, any residues that do reach 

surface waters from field runoff should 

quickly adsorb to sediment particles and 

be partitioned from the water column. 6- 

Benzyladenine also has low solubility in 

water, 76 ±2 mg/L at 20° C, and 

detections in ground water are not 

expected. Together, these data indicate 

that residues are not expected in 

drinking water. 

B. Other Non-Occupational Exposure 

The potential for non-dietary, nonoccupational exposure to 6–BA residues 

for the general population, including 

infants and children, is unlikely because 

the uses, both those currently allowed 

and the one currently being established, 

are limited to applications in certain 

tree fruit and nut tree orchards. 

Additionally, because 6–BA is a 

naturally-occurring cytokinin plant 

regulator (having been detected in all 

higher plants tested for its presence), it 

is a normal part of the human diet. 

Moreover, the proposed use rates are 

well below the toxicity NOAELs (see 

Unit III.), and the residues resulting 

from applications made in accordance 

with the proposed use rates indicate 

dietary exposures that are <1.0% of the 

chronic and acute population adjusted 

doses. Therefore, not only is there a 

great likelihood of prior exposure for 

most, if not all, individuals to 6–BA, 

due to its natural presence in food 

crops, the data submitted also 

demonstrate that any incremental 

increased exposure due to the proposed 

use would be negligible due to the lack 

of residue in comparison with the 

toxicity NOAELs. 

V. Cumulative Effects 

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.’’ These 

considerations include the possible 

cumulative effects of such residues on 

infants and children. 

EPA does not have, at this time, 

available data to suggest whether 6–BA 

has a common mechanism of toxicity 

with other substances. Unlike other 

pesticides for which EPA has followed 

a cumulative risk approach based on a 

common mechanism of toxicity, EPA 

has not made a common mechanism of 

toxicity finding as to 6–BA and any 

other substances and 6–BA does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 6–

BA has a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs 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/. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

A. U.S. Population 

When assessing the contributions of 

apple and pistachio, the Agency’s 

analysis estimated that the chronic 

exposures for the overall U.S. 

population was 0.000002 mg/kg/day 

(<1.0% of the chronic population 

adjusted dose (cPAD))1. Similarly, the 

acute dietary estimated exposure was 

0.000069 mg/kg/day (<1.0% of the acute 

population adjusted dose (aPAD)) for 

the overall U.S. population. Critical 

exposure commodity analysis showed 

that apple juice contributed the most to 

dietary exposure for the overall 

population. Dietary exposure to 6–BA 

residues in or on pear did not add 

significantly to the current dietary 

exposure to 6–BA from its use in or on 

apple or pistachio. Due to the low 

anticipated dietary intake of 6–BA 

residues relative to the chronic and 

acute population adjusted doses, and 

the fact that actual exposure will 

probably be considerably less because 

the dietary exposure analysis was made 

based on worst-case assumptions (such 

as conservatively assuming: That 100% 

of the crop is treated, that non-detected 

or <LOQ residue concentrations are 

present, and that chronic exposure from 

the few seasonal applications made 60–

86 days before harvest could occur), the 

Agency is reasonably certain that no 

dietary harm will result from aggregate 

exposure to 6–BA residues, including 

all anticipated dietary exposures 

(including the proposed new use of 6–

BA on pear) and all other exposures for 

which there is reliable information. 

B. Infants and Children 

Section 408(b)(2)(C) of the FFDCA 

provides that EPA shall apply an 

additional ten-fold 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, unless 

EPA determines that a different margin 

of exposure (safety) will be safe for 

infants and children. Margins of 

exposure (safety) are often referred to as 

uncertainty (safety) factors. In the case 

of 6–BA, the safety factor was reduced 

from 10X to 3X based on adequate data 

from a new 2-generation rat 

reproduction study, and from a rat 

developmental toxicity study, neither of 

which demonstrated unique fetal 

susceptibility (i.e., fetal or neonatal 

effects occurred only at maternally toxic 

doses)1. Additionally, genotoxicity and 

mutagenicity tests were negative. EPA 

did not reduce the uncertainty factor 

any further, however, because of the 

lack of a developmental toxicity study 

in a second species, and the resulting 

residual uncertainties for 6–BA-induced 

pre-/post-natal toxicity. The analysis 

estimated that the chronic exposures for 

the most highly exposed subgroup, nonnursing infants, was 0.000012 mg/kg/ 

day (<1.0% of the cPAD). The acute 

dietary estimated exposure was 

0.000361 mg/kg/day (<1.0% of aPAD) 

for the most highly exposed subgroup, 

non-nursing infants. Critical exposure 

commodity analysis showed that apple 

juice contributed the most to dietary 

exposure for all infants. Due to the low 

anticipated dietary intake of 6–BA 

residues relative to the chronic and 

acute PAD, and the fact that actual 

exposure will probably be considerably 

less because the dietary exposure 

analysis was made based on worst-case 

assumptions (such as conservatively 

assuming: that 100% of the crop is 

treated, that non-detected or <LOQ 

residue concentrations are present, and 

that chronic exposure from the few 

seasonal applications made 60–86 days 

before harvest could occur), it is 

reasonably certain that no dietary harm 

will result to infants and children from 

aggregate exposure to residues of 6–BA 


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13178 Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations 

resulting from all currently-registered 

uses, as well as from the proposed new 

use of 6–BA on pear. 

VII. Other Considerations 

A. Endocrine Disruptors 

EPA is required under 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 is no 

scientific basis for including, as part of 

the program, the androgen and thyroid 

hormone 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 

wildlife evaluations. As the science 

develops and resources allow, screening 

of additional hormone systems may be 

added to the Endocrine Disruptor 

Screening Program (EDSP). When the 

appropriate screening and/or testing 

protocols being considered under the 

Agency’s EDSP have been developed, 6–

BA may be subjected to additional 

screening and/or testing to better 

characterize any possible effects related 

to endocrine disruption. Based on 

available data, no endocrine systemrelated effects have been identified with 

consumption of 6–BA. To date, there is 

no evidence to suggest that 6–BA affects 

the immune system, functions in a 

manner similar to any known hormone, 

or that it acts as an endocrine disruptor. 

B. Analytical Methods 

The Agency is establishing an 

exemption from the requirement of a 

tolerance for the reasons stated above. 

For the same reasons, the Agency has 

concluded that an analytical method is 

not required for enforcement purposes 

for 6–BA. Nonetheless, analytical 

methods for apple (a pome fruit 

botanically similar to the new crop, 

pear), both raw agricultural and 

processed commodities, and for 

pistachio have been developed and 

submitted by the registrant. The 

analytical method for apple is expected 

to be fully applicable (have the same 

sensitivity) to pear because the two 

pome fruits are physically and 

compositionally comparable, and 

therefore should present similar 

sequestration and matrix interference 

characteristics. 

C. Codex Maximum Residue Level 

Currently, there are no Codex, 

Canadian or Mexican maximum residue 

levels for residues of 6–BA in or on 

pear. 

VIII. Conclusions 

Based on the toxicology information 

submitted and reviewed previously and 

summarized in the June 1994 N6- 

Benzyladenine RED, in combination 

with the newly submitted two 

generation rat reproduction study and 

other information available to the 

Agency, there is a reasonable certainty 

that no harm will result to the U.S. 

population, including infants and 

children, from aggregate exposure to 

residues of 6–BA under reasonably 

foreseeable circumstances, when 6–BA 

is used as a biochemical pesticide in 

accordance with its label and good 

agricultural practices. This includes all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. The Agency has 

arrived at this conclusion based on the 

data submitted previously and 

summarized in the RED, as well as that 

data submitted to support this tolerance 

exemption, demonstrating negligible 

dietary exposure in comparison with the 

toxicity NOAELs. As a result, EPA is 

establishing an exemption (albeit, 

limited by a maximum application rate) 

from the tolerance requirements 

pursuant to section 408(c) and (d) of the 

FFDCA for residues of 6–BA in or on 

pear. 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of a 

tolerance 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 exemption from the 

requirement of a 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 the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 


cprice-sewell on PROD1PC66 with RULES
Federal Register / Vol. 72, No. 54 / Wednesday, March 21, 2007 / Rules and Regulations 13179 

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. 

X. 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: February 25, 2007. 

Janet L. Andersen, 

Director, Biopesticides and Pollution 

Prevention 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 180.1150 is revised to read 

as follows: 

§ 180.1150 6-Benzyladenine; exemption 

from the requirement of a tolerance. 

The biochemical plant regulator 6- 

benzyladenine (6–BA) is exempt from 

the requirement of a tolerance in or on 

apple and pear when applied at a rate 

of ≤182 grams of active ingredient per 

acre per season, and in or on pistachio 

when applied at a rate of ≤60 grams of 

active ingredient per acre per season. 

[FR Doc. 07–1386 Filed 3–20–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0208; FRL–8117–1] 

Thifensulfuron Methyl; Pesticide 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of thifensulfuron 

methyl in or on rice, grain; rice, straw; 

sorghum, grain, forage; sorghum, grain, 

grain; and sorghum, grain, stover. E. I. 

DuPont de Nemours and Company 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

March 21, 2007. Objections and requests 

for hearings must be received on or 

before May 21, 2007, and must be filed 

in accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPP–2006–0208. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S-4400, 

One Potomac Yard (South Bldg.), 2777 

S. Crystal Dr., Arlington, VA. The 

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305–

5805. 

FOR FURTHER INFORMATION CONTACT: 

Vickie Walters, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5704; e-mail address: 

walters.vickie@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), 

e.g., agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 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 


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