56644 Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Rules and Regulations 

Air Quality Standard (NAAQS) by the 

applicable attainment date of April 5, 

2010. Therefore, EPA has met the 

requirement pursuant to CAA section 

179(c) to determine, based on the area’s 

air quality as of the attainment date, 

whether the area attained the standard. 

EPA also determined that the 

Steubenville-Weirton PM2.5

nonattainment area is not subject to the 

consequences of failing to attain 

pursuant to section 179(d). 

[FR Doc. 2011–23367 Filed 9–13–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0684; FRL–8887–2] 

Sulfur Dioxide; Pesticide Tolerances 

for Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

sulfur dioxide in or on fig. This action 

is associated with the utilization of a 

crisis exemption under section 18 of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) authorizing 

use of the pesticide on figs. This 

regulation establishes a maximum 

permissible level for residues of sulfur 

dioxide, including its metabolites and 

degradates (determined by measuring 

only sulfur dioxide (SO2)), in or on fig 

at 10 parts per million (ppm). This timelimited tolerance expires on December 

31, 2014. 

DATES: This regulation is effective 

September 14, 2011. Objections and 

requests for hearings must be received 

on or before November 14, 2011, 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–2011–0684. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Libby Pemberton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9364; e-mail address: 

pemberton.libby@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. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

21 U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011–0684 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before November 14, 2011. Addresses 

for mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2011–0684, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of FFDCA, 21 U.S.C. 346a(e) 

and 346a(1)(6), is establishing a timelimited tolerance for residues of sulfur 

dioxide, including its metabolites and 

degradates (determined by measuring 

only sulfur dioxide (SO2)), at 10 ppm. 

This time-limited tolerance is effective 

until December 31, 2014. 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 


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an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

time-limited tolerances to set binding 

precedents for the application of section 

408 of FFDCA and the safety standard 

to other tolerances and exemptions. 

Section 408(e) of FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for Sulfur 

Dioxide on Figs and FFDCA Tolerances 

Excessive rain and humidity at 

flowering and early fruit development 

in the spring are critical factors in 

development of gray mold caused by 

Botrytis cinerea (B. cinerea) and these 

have been high in the areas where 

California figs are grown over the past 

two years. California estimated that gray 

mold could be responsible for a 24% 

yield loss; and there are no pre or postharvest fungicides registered to control 

B. cinerea on fresh figs. 

The Applicant asserts that an 

emergency condition exists in 

accordance with the criteria for 

approval of an emergency exemption, 

and has utilized a crisis exemption 

under FIFRA section 18 to allow the use 

of sulfur dioxide on figs for control of 

gray mold caused by B. cinerea in 

California. After having reviewed the 

submission, EPA concurs that an 

emergency condition exists. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of sulfur dioxide in or on fig. 

In doing so, EPA considered the safety 

standard in section 408(b)(2) of FFDCA, 

and EPA decided that the necessary 

tolerance under section 408(l)(6) of 

FFDCA would be consistent with the 

safety standard and with FIFRA section 

18. Consistent with the need to move 

quickly on the emergency exemption in 

order to address an urgent non-routine 

situation and to ensure that the resulting 

food is safe and lawful, EPA is issuing 

this tolerance without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of FFDCA. 

Although these time-limited tolerances 

expire on December 31, 2014, under 

section 408(l)(5) of FFDCA, residues of 

the pesticide not in excess of the 

amounts specified in the tolerance 

remaining in or on figs after that date 

will not be unlawful, provided the 

pesticide was applied in a manner that 

was lawful under FIFRA, and the 

residues do not exceed a level that was 

authorized by this time-limited 

tolerance at the time of that application. 

EPA will take action to revoke this timelimited tolerance earlier if any 

experience with, scientific data on, or 

other relevant information on this 

pesticide indicate that the residues are 

not safe. 

Because this time-limited tolerance is 

being approved under emergency 

conditions, EPA has not made any 

decisions about whether sulfur dioxide 

meets FIFRA’s registration requirements 

for use on fig or whether a permanent 

tolerance for this use would be 

appropriate. Under these circumstances, 

EPA does not believe that this timelimited tolerance decision serves as a 

basis for registration of sulfur dioxide by 

a State for special local needs under 

FIFRA section 24(c). Nor does this 

tolerance by itself serve as the authority 

for persons in any State other than 

California to use this pesticide on the 

applicable crops under FIFRA section 

18 absent the issuance of an emergency 

exemption applicable within that State. 

For additional information regarding the 

emergency exemption for sulfur 

dioxide, contact the Agency’s 

Registration Division at the address 

provided under FOR FURTHER

INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide residue, including all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. * * *’’ 

Consistent with the factors specified 

in FFDCA section 408(b)(2)(D), 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 sulfite sensitive individuals, 

infants and children. EPA has sufficient 

data to assess the hazards of and to 

make a determination on aggregate 

exposure expected as a result of this 

emergency exemption request and the 

time-limited tolerances for residues of 

sulfur dioxide, including its metabolites 

and degradates (determined by 

measuring only sulfur dioxide (SO2)), at 

10 ppm. EPA’s assessment of exposures 

and risks associated with establishing 

time-limited tolerances follows. 

A. 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, 

and infants and children, as well as 

sulfite sensitive individuals. 

Evaluations performed by the World 

Health Organization (WHO), the 


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International Agency for Research on 

Cancer (IARC), and the Agency for 

Toxic Substances and Disease Registry 

(ATSDR) were relied upon for the safety 

finding for sulfur dioxide made in the 

May 2007 RED assessment on inorganic 

sulfites, which includes the chemicals 

sulfur dioxide and sodium metabisulfite 

(end-use inorganic sulfite products 

contain sulfur dioxide at 99.9 to 100%, 

and sodium metabisulfite at 37.5 to 

98.5%. These assessments are based on 

peer-reviewed evaluations performed by 

the Cosmetic Ingredient Review (a 

program established in 1976 by the 

Cosmetic, Toiletry & Fragrance 

Association, now known as the Personal 

Care Products Council (PCPC), with the 

support of the U.S. Food and Drug 

Administration (FDA) and the 

Consumer Federation of America (CFA); 

the Organization for Economic 

Cooperation and DevelopmentScreening Information Data Set and 

from other open literature sources. 

People may be exposed to small 

amounts of sulfur through the food 

supply. However, since sulfur does not 

cause any relevant toxic effects, no 

quantitative dietary risk assessment is 

needed. Short-term studies show that 

sulfur is of very low acute oral toxicity 

and does not irritate the skin (it has 

been placed in Toxicity Category IV, the 

least toxic category, for these effects). 

Sulfur dioxide (21 CFR 182.3862) is 

listed as Generally Recognized as Safe 

(GRAS) by the FDA as a preservative in 

certain foods. The Select Committee on 

GRAS Substances (a committee of 

qualified scientists contracted by FDA 

to review and evaluate the safety of 

GRAS substances) concluded that: 

‘‘There is no evidence in the available 

information on sulfur dioxide that 

demonstrates, or suggests reasonable 

grounds to suspect, a hazard to the 

public when used at levels that are now 

current and in the manner now 

practiced.’’ This conclusion was based 

on the knowledge that orally 

administered sulfite is very rapidly 

oxidized to sulfate in all species 

studied. The metabolic removal of 

sulfite appears to be the critical defense 

mechanism. The WHO has emphasized 

the use of appropriate labeling for 

alerting individuals who cannot tolerate 

sulfites. After receiving and reviewing 

reports of adverse reactions in certain 

individuals following ingestion of 

sulfiting agents used as preservatives in 

food products, beverages, and fresh 

fruits and vegetables, the FDA requires 

ingredient labels to list sulfite 

concentrations in excess of 10 ppm. 

Several regulatory endpoints and 

standards for ambient air concentrations 

of sulfur dioxide have been established 

at the state, Federal and international 

levels. The endpoint selected by the 

Agency for the bystander inhalation risk 

assessment is 0.25 ppm sulfur dioxide, 

with one-hour exposure duration. The 

0.25 ppm concentration is based on an 

ambient air quality standard set by the 

California Air Resources Board. This 

endpoint is deemed most applicable to 

this exposure scenario, as it is based on 

effects of concern for bystanders (such 

as bronchoconstriction, shortness of 

breath, wheezing, and chest tightness 

during physical activity in persons with 

asthma). 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to sulfur dioxide, EPA 

considered exposure under the timelimited tolerances established by this 

action, as well as all existing sulfur 

dioxide tolerances in 40 CFR 180.444. 

Exposures to sulfites when used as an 

active or inert pesticide ingredient are 

minimal because it is known to be 

readily biodegradable, quickly oxidized, 

and rapidly excreted from the body. In 

addition, sulfur dioxide (21 CFR 

182.3862) is listed as GRAS by the FDA, 

with limitations, as a food preservative. 

As such, sulfites are found in many 

foods, primarily as a result of the GRAS 

preservative use. It is estimated that 

sulfite concentrations of >100 ppm may 

be found in dried fruits (excluding dark 

raisins and prunes), lemon and lime 

juices, wine, molasses, and sauerkraut 

juice. Dried potatoes, grape juice, wine 

vinegar, gravies, fruit topping, and 

maraschino cherries may contain 

between 50 and 100 ppm sulfur dioxide. 

Foods containing between 10 ppm and 

50 ppm include pectin, fresh shrimp, 

corn syrup, sauerkraut, pickled foods, 

corn starch, hominy, frozen potatoes, 

maple syrup, imported jams and jellies, 

and fresh mushrooms (CIR 2003). 

Preliminary data developed by the 

Interregional Research Project No. 4 (IR– 

4) from the concluded experimental 

phase of a study now being conducted 

on figs was submitted with this 

exemption request. The design of the 

IR–4 study is sufficient in its scope 

having followed the protocol put 

forward for determining the magnitude 

of the residue on fresh figs from the use 

of sulfur dioxide. This study shows that 

following application made at a 10x 

exaggerated rate of 250 ppm sulfur 

dioxide/hour, samples analyzed from 1 

hour up to 28 days after treatment were 

all found to have residue levels of sulfur 

dioxide below the limit of detection 

(LOD) of 10 ppm. In view of the data 

provided by IR–4, a linear extrapolation 

from the 10x exaggerated rate to a 1x 

application rate determined that a 1x 

rate is likely to result in residue levels 

of sulfur dioxide of 2.5 ppm or lower 

when following the use-pattern in this 

crisis exemption. 

2. Drinking water exposure. Based on 

environmental fate information for 

sulfur dioxide and the requested postharvest use pattern (in closed 

chambers), concentrations of concern 

are not expected in drinking water. 

3. Inhalation exposure. Based on the 

Probabilistic Exposure and Risk Model 

for Fumigants, version 2.1.1 (PERFUM2) 

the requested use is expected to limit 

bystander exposure potential to sulfur 

dioxide concentrations at or below 0.25 

ppm. This bystander exposure scenario 

is considered ‘‘worst-case,’’ in that it 

assumes the ventilation stack is at the 

edge of the treatment warehouse, and 

the warehouse is in close proximity to 

the fumigation facility property line. 

4. Other non-occupational exposure. 

In examining aggregate exposure, 

section 408 of 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). Currently there are no residential 

uses for sulfur dioxide, as the use of 

inorganic sulfites is limited to 

postharvest fumigation of grapes. 

Environmental sources of sulfur dioxide 

exposure include the combustion of 

fossil fuels, smelting of sulfide ores, 

volcanic emissions, and other natural 

sources. Sulfur dioxide is also used to 

manufacture hydrosulfites, to bleach 

wood pulp and paper, to process, 

disinfect, and bleach food, for waste and 

water treatment, and in metal, ore, and 

oil refining (ATSDR 2004). Sufficient 

information is available from public 

sources to adequately characterize 

sulfur dioxide. 

C. Safety Factor for Infants and Children 

There is sufficient toxicological 

information for sulfur dioxide to 

address risks to infants and children. 

The available information indicates that 

there is no evidence of increased 

quantitative or qualitative susceptibility 

of the offspring after in utero or postnatal exposure. Based on the lack of 

significant toxicity in existing 

toxicological testing of sulfur dioxide 

and FDA’s classification of sulfites as 

GRAS, EPA has not performed a 

quantative risk assessment for sulfur 

dioxide using safety factors. For the 

same reason, and given the absence of 


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any evidence of pre- or post-natal 

sensitivity to sulfur dioxide, EPA 

concludes that there is reliable data to 

support not using an additional safety 

factor to protect infants and children. 

V. Cumulative Effects From Substances 

With a Common Mechanism of Toxicity 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found inorganic sulfites 

to share a common mechanism of 

toxicity with any other substances, and 

sulfur dioxide does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that sulfur dioxide does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

The residue levels expected from this 

use on figs are relatively low when 

compared to concentrations of sulfites 

in many common foods and viewed as 

GRAS by the FDA. Given the low fig use 

rate, low expected residue levels, and 

relatively low consumption of figs, the 

safety finding made in the May 2007 

RED assessment for the post-harvest use 

on grapes may be extended to include 

the proposed tolerance level of 10 ppm 

on figs. EPA concludes that there is a 

reasonable certainty that no harm will 

result to the general population, or to 

sulfite sensitive individuals, infants and 

children, from aggregate exposure to 

residues of sulfur dioxide, including its 

metabolites and degradates. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

For the determination of residues in 

food, the FDA has published a 

titrimetric method of analysis capable of 

providing a 10 ppm LOD. It is 

delineated in 21 CFR part 101 Appendix 

A and is based on the Association of 

Official Agricultural Chemists official 

method for sulfites. For this procedure, 

sulfur dioxide is steam distilled from 

the crop sample and trapped in 

hydrogen peroxide to produce sulfuric 

acid. The sulfuric acid is then titrated 

against aqueous sodium hydroxide and 

expressed as sulfur dioxide. The sulfur 

dioxide concentrations are converted to 

sulfite residues with molecular weight 

conversions. Adequate recovery data are 

available to support the use of this 

procedure as a tolerance enforcement 

method. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for sulfur dioxide in/on figs. 

VIII. Conclusion 

Therefore, a time-limited tolerance is 

established for residues of sulfur 

dioxide, including its metabolites and 

degradates, (determined by measuring 

only sulfur dioxide (SO2)), at 10 ppm. 

This tolerance is effective until 

December 31, 2014. 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under sections 408(e) and 408(l)(6) of 

FFDCA. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

titled 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 in accordance with 

sections 408(e) and 408(l)(6) of FFDCA, 

such as the tolerances in this final rule, 

do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

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

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal governments, 

on the relationship between the national 

government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

X. 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 


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56648 Federal Register / Vol. 76, No. 178 / Wednesday, September 14, 2011 / Rules and Regulations 

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 2, 2011. 

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 180.444 is amended by: 

■ i. Designating the existing text as 

paragraph (a) and adding a heading; and 

■ ii. Adding paragraphs (b), (c) and (d). 

The amendments read as follows: 

§ 180.444 Sulfur dioxide; tolerances for 

residues. 

(a) General. * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of sulfur dioxide, including its 

metabolites and degradates in or on the 

specified agricultural commodities, 

resulting from use of the pesticide 

pursuant to FFIFRA section 18 

emergency exemptions. Compliance 

with the tolerance levels specified 

below is to be determined by measuring 

only sulfur dioxide (SO2). The 

tolerances expire on the date specified 

in the table. 

Commodity Parts per 

million 

Expiration/ 

revocation 

date 

Fig ................. 10 12/31/14 

(c) Tolerances with regional 

registrations. [Reserved] 

(d) Indirect or inadvertent residues. 

[Reserved] 

[FR Doc. 2011–23359 Filed 9–13–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0104; FRL–8883–9] 

Atrazine, Chloroneb, Chlorpyrifos, 

Clofencet, Endosulfan, et al.; 

Tolerance Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is revoking certain 

tolerances in follow-up to canceled uses 

for chloroneb, chlorpyrifos, clofencet, 

endosulfan, ethyl parathion, 

methidathion, methyl parathion, and 

N,N-diethyl-2-(4- 

methylbenzyloxy)ethylamine, 

modifying certain tolerances for 

atrazine, setting a revocation date for 

specific endosulfan tolerances, and 

making minor revisions to tolerance 

expressions for a few of the 

aforementioned pesticide ingredients. 

Also, EPA is removing expired 

tolerances for methidathion, and ethyl 

and methyl parathion. 

DATES: This regulation is effective 

September 14, 2011. Objections and 

requests for hearings must be received 

on or before November 14, 2011, 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–2011–0104. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

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

available in hard copy, at the OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

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

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

to 4 p.m., Monday through Friday, 

excluding legal holidays. The Docket 

Facility telephone number is (703) 305– 

5805. 

FOR FURTHER INFORMATION CONTACT: 

Joseph Nevola, Pesticide Re-evaluation 

Division (7508P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8037; e-mail address: 

nevola.joseph@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. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

C. How can I file an objection or hearing 

request? 

Under the Federal Food, Drug, and 

Cosmetic Act (FFDCA) section 408(g), 

21 U.S.C. 346a, any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2011- 0104 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before November 14, 2011. Addresses 

for mail and hand delivery of objections 


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