Document ID: EPA-HQ-OPP-2011-0684-0001
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances for Emergency Exemptions: Sulfur Dioxide
Posted Date: 2011-09-14T04:00Z

[Federal Register Volume 76, Number 178 (Wednesday, September 14, 2011)]
[Rules and Regulations]
[Pages 56644-56648]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23359]

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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.

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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 
time-limited 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/text-idx?&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 
time-limited 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

[[Page 56645]]

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 post-harvest 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 time-limited 
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 time-limited 
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

[[Page 56646]]

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 Development-Screening 
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 time-
limited 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 post-harvest 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 non-occupational 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 post-
natal 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

[[Page 56647]]

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

[[Page 56648]]

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]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.444 is amended by:
0
i. Designating the existing text as paragraph (a) and adding a heading; 
and
0
ii. Adding paragraphs (b), (c) and (d).
    The amendments read as follows:

Sec.  [emsp14]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.

------------------------------------------------------------------------
                                                             Expiration/
                  Commodity                     Parts per    revocation
                                                 million        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