26322 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 

[[[(E)-[(1,3-dimethyl-5-phenoxy-1Hpyrazol-4-yl) methylene] amino]oxy] methyl]benzoate in or on honey at 0.10 

ppm. This tolerance expires and is 

revoked on the date specified in the 

following table. 

Commodity Parts per million Expiration/revocation date 

Honey ........................................................................................................................................................... 0.10 ppm 12/31/2010 

* * * * * 

[FR Doc. E7–8954 Filed 5–8–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0880; FRL–8125–5] 

Foramsulfuron; 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 foramsulfuron 

on corn, sweet (K+CWHR); corn, sweet, 

forage; corn, sweet, stover; corn, pop 

grain; and corn, pop, stover when 

applied/used as a herbicide. The 

Interregional Project Number 4 (IR-4) 

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 foramsulfuron. 

DATES: This regulation is effective May 

9, 2007. Objections and requests for 

hearings must be received on or before 

July 9, 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–2006–0880. 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 

web site 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 either in the electronic docket 

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

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S-4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The hours of 

operation of this Docket Facility are 

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: 

Shaja R. Brothers, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–3194; e-mail address: 

brothers.shaja@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). 

• 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. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

[insert appropriate cite to either another 

unit in the preamble or a section in a 

rule]. 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–2006–0880 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 July 9, 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–2006–0880, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 


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Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 26323 

• 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 Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of November 

22, 2006 (71 FR 67574) (FRL–8102–1), 

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 5E7004) 

by IR-4, 500 College Road, East, Suite 

201 W, Princeton, NJ 08540. The 

petition requested that 40 CFR 180.1219 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of foramsulfuron 

on corn, sweet (K+CWHR); corn, sweet, 

forage; corn, sweet, stover; corn, pop 

grain; and corn, pop, stover. This notice 

included a summary of the petition 

prepared by the registrant Bayer 

CropScience. There was one comment 

submitted by a private citizen who 

opposed the authorization to sell any 

pesticide that leaves a residue on food. 

The Agency has received this comment 

on numerous occasions and rejects it for 

the reason previously stated in the 

Federal Register of January 7, 2005, (70 

FR 1349) (FRL–7694–3). 

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 tolerance is ‘‘safe.’’

Section 408(c)(2)(A)(ii) 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 

requires EPA to give special 

consideration to exposure of infants and 

children to the pesticide chemical 

residue in establishing a tolerance and 

to ‘‘ensure that there is a reasonable 

certainty that no harm will result to 

infants and children from aggregate 

exposure to the pesticide chemical 

residue....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. 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 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 Agency determined the 

toxicological profile for foramsulfuron 

supports a tolerance exemption as result 

of the lack of toxicity associated with 

this chemical. For conclusive 

information on foramsulfuron’s toxicity 

profile, please view the final rule 

published in the Federal Register of 

March 29, 2002 (67 FR 15120), (FRL–

6829–8) (http://www.epa.gov/fedrgstr/ 

EPA-PEST/2002/March/Day-29/ 

p7502.htmtp). 

IV. Aggregate Exposures 

In examining aggregate exposure, 

FFDCA section 408 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). 

Due to the low toxicity, it was 

determined that a dietary aggregate 

exposure risk assessment (food and 

water) is not needed. Therefore, an 

aggregate dietary assessment was not 

conducted. For more information on 

this determination, please view the final 

rule published in the Federal Register 

of March 29, 2002 (67 FR 15120), 

(http://www.epa.gov/fedrgstr/EPAPEST/2002/March/Day-29/ 

p7502.htmtp). 

V. Cumulative Effects 

Section 408(b)(2)(D)(v) of the 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.’’

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 

foramsulfuron and any other substances, 

and foramsulfuron 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 foramsulfuron 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 website at http:// 

www.epa.gov/pesticides/cumulative/. 

VI. Safety Factor for the Protection of 

Infants and Children 

1. In general. FFDCA section 408 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

that a different margin of safety will be 

safe for infants and children. Margins of 

safety are incorporated into EPA risk 

assessments either directly through use 

of a margin of exposure (MOE) analysis 

or through using uncertainty (safety) 

factors in calculating a dose level that 

poses no appreciable risk to humans. 

Since a dietary risk assessment was not 

conducted for foramsulfuron due to its 

low toxicity, a safety factor for infants 

and children is not applicable to the 

determination of the risk due to 

exposure of infants and children to 

foramsulfuron. 

2. Prenatal and postnatal sensitivity. 

No significant toxicity or prenatal or 

postnatal toxicity was seen in any of the 

studies conducted with foramsulfuron. 

3. Conclusion. There is a complete 

toxicity database for foramsulfuron. 

Since a dietary risk assessment was not 


rmajette on PROD1PC67 with RULES
26324 Federal Register / Vol. 72, No. 89 / Wednesday, May 9, 2007 / Rules and Regulations 

conducted for foramsulfuron due to its 

low toxicity, a safety factor for infants 

and children is not applicable to the 

determination of the risk due to 

exposure of infants and children to 

foramsulfuron. 

VII. Determination of Safety 

Based on the information in this 

preamble and the final rule published in 

the Federal Register of March 29, 2002 

(67 FR 15120), EPA concludes that there 

is a reasonable certainty that no harm 

will result to the general population, or 

to infants and children from aggregate 

exposure to foramsulfuron residues. 

VIII. Other Considerations 

A. Endocrine Disruptors 

No special studies have been 

conducted to investigate the potential of 

foramsulfuron to induce estrogenic or 

their endocrine effects. However, no 

evidence of estrogenic or other 

endocrine effects have been noted in 

any of the standard toxicology studies 

that have been conducted with this 

product. Hence, there is no reason to 

suspect that any such effects would be 

likely. 

B. Analytical Method 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

C. Existing Tolerances 

There is an existing exemption for 

field corn. 

D. International Tolerances 

There are no established or proposed 

Codex maximum residue limits for 

foramsulfuron. 

IX. Conclusion 

Therefore, an exemption is 

established for foramsulfuron in/on 

corn, sweet (K+CWHR); corn, sweet, 

forage; corn, sweet, stover; corn, pop 

grain; and corn, pop, stover. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this rule has 

been exempted from review under 

Executive Order 12866, 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) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). Since tolerances and exemptions 

that are established on the basis of a 

petition under section 408(d) of FFDCA, 

such as the tolerance in this final rule, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000) do not apply 

to this rule. In addition, This rule does 

not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

(Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: April 26, 2007. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.1219 is revised to read 

as follows: 

§ 180.1219 Foramsulfuron; exemption 

from the requirement of a tolerance. 

The pesticide foramsulfuron (N,Ndimethyl-2-[3-(4,6-dimethoxypyrimidin-2- yl)ureidosulfonyl]-4- 

formylaminobenzamide) is exempted 

from the requirement of a tolerance in 

corn, field, grain; corn, field, forage; 

corn, field, stover; corn, sweet 

(K+CWHR); corn, sweet, forage; corn, 

sweet, stover; corn, pop grain; and corn, 

pop, stover when applied as a herbicide 

in accordance with good agricultural 

practices. 

[FR Doc. E7–8901 Filed 5–8–07; 8:45 am] 

BILLING CODE 6560–50–S 


rmajette on PROD1PC67 with RULES