[Federal Register Volume 77, Number 114 (Wednesday, June 13, 2012)]
[Rules and Regulations]
[Pages 35295-35298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14429]



40 CFR Part 180

[EPA-HQ-OPP-2012-0245; FRL-9352-4]
RIN 2070-ZA16

Methyl Bromide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes a tolerance for residues of methyl 
bromide in or on cotton, undelinted seed under the Federal Food, Drug, 
and Cosmetic Act (FFDCA) because there is a need for imported 
undelinted cottonseed for use as additional feed for dairy cattle in 
the United States.

DATES: This regulation is effective June 13, 2012. Objections and 
requests for hearings must be received on or before August 13, 2012, 
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: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0245; FRL-9352-4, is 
available either electronically through http://www.regulations.gov or 
in hard copy at the OPP Docket in the Environmental Protection Agency 
Docket Center (EPA/DC), located in EPA West, Rm. 3334, 1301 
Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading 
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Public Reading 
Room is (202) 566-1744, and the telephone number for the OPP Docket is 
(703) 305-5805. Please review the visitor instructions and additional 
information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Kimberly Nesci, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8059; email address: [email protected].


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

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not limited to those engaged in the following activities:
     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 to 
provide 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 

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 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 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-2012-0245 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 
August 13, 2012. 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 Confidential Business Information 
(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-2012-0245, 
by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of April 6, 2012 (77 FR 20752) (FRL-9345-
1), EPA issued a proposed rule pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3). The rule proposed that 40 CFR 180.124 be created to 
establish a tolerance for residues of methyl bromide, including 
metabolites and degradates in or on cotton, undelinted seed at 150 
parts per million (ppm). EPA issued a proposed rule that explained the 
basis for EPA's conclusion that there is a reasonable certainty that no 
harm will result to the general population, or to infants and children, 
from exposure to methyl bromide on cottonseed because there will be no 
human dietary exposure to methyl bromide from the use of methyl bromide 
to fumigate cottonseed. The proposal established a 60-day public 
comment period. Comments were received in response to the proposed 
rule. EPA's response to these comments is discussed in Unit III.

III. Response to Comments

    Comments were received in response to the proposed rule from a 
large dairy producer trade association, from a dairy industry expert, 
and from two other individuals. The comments from the dairy producer 
trade association and from the dairy industry expert are in support of 
the establishment of a tolerance for methyl bromide on cottonseed out 
of a concern with a shortage of domestically-grown cottonseed. These 
commenters stressed that ``cottonseed is a uniquely superior feed for 
dairy cattle because it contains high concentrations of protein, energy 
(or fat), and fiber; is highly digestible; and has proven to increase 
milk production. The commenters argued that alternative feeds are not 
``equivalent substitutes'' because they do not contain a similar mix of 
these components and because they are generally more expensive.
    The other two comments were adverse to EPA's proposed action. A 
comment from one anonymous individual objected to the establishment of 
the tolerance due to the toxic nature of methyl bromide and due to 
potential effects on the environment. EPA has determined, however, that 
there would be no human dietary exposure from the use of methyl bromide 
to fumigate cottonseed. In addition, the safety standard for approving 
tolerances under section 408 of the FFDCA focuses on potential harm to 
human health. Environmental and non-target species considerations are 
outside of the scope of this rule.
    The second comment from another individual raised several issues. 
EPA is responding to these issues by topic. First, the individual 
argues that EPA should, in collaboration with the United States 
Department of Agriculture (USDA), establish the necessity of cottonseed 
as feed for cattle by analyzing the supply and demand of cottonseed and 
available alternatives prior to approving a methyl bromide pesticide 
tolerance. The commenter also asserts that EPA implies that cottonseed 
is the only dairy cattle feed available. EPA's response to this concern 
is twofold. First, and most important, EPA's discussion of the 
decreased availability of cottonseed in the proposed rule was included 
only for the purpose of explaining the context of the Agency action. It 
did not provide the legal basis for the proposed tolerance. The legal 
standard for the establishment of a tolerance is whether the tolerance 
is safe. 21 U.S.C. 346a(b)(2)(A)(i). The degree of shortage of 
cottonseed does not affect this safety determination. Thus, both this 
comment and the comments from the trade association and dairy expert do 
not address the legal basis for establishing the proposed methyl 
bromide tolerance on cottonseed. Second, while not relevant to the 
ultimate decision on safety, EPA's statements regarding the current 
shortage of cottonseed were accurate. According to USDA, drought 
conditions in Texas have reduced cotton production by 13% between the 
2010/2011 and 2011/2012 seasons. In 2011, the average U.S. yield of 
cotton per harvested acre was the lowest it had been since 2003. 
Moreover, as noted in the proposal and as supported by the

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commenters familiar with the dairy industry, cottonseed is an important 
source of protein, energy, and fiber in the dairy cattle diet. It 
generally comprises up to 15 percent of the daily dietary dry matter 
intake of lactating diary cattle.
    The commenter questions two decisions and assumptions made by EPA 
in its decision to establish a tolerance: The use of fumigation trials 
on tree nuts as a surrogate for cottonseed and the assumption that 
methyl bromide would undergo chemical reactions in the digestive system 
of dairy cattle. The Agency believes that nuts are an adequate 
surrogate in the case of methyl bromide commodity fumigation. In 
controlled trials with numerous commodities, nuts had the highest 
residues of any commodity. Studies with other small seeds such as poppy 
seeds and sesame seeds showed residues of 35 ppm, in contrast to the 
nuts where a maximum residue of 138 ppm was observed. To be protective, 
the Agency chose to translate from nuts to cottonseed, since they both 
contain oils. While the Agency does not have specific studies on the 
metabolism of methyl bromide in cattle, oral metabolism studies in rats 
have indicated methyl bromide undergoes chemical transformations in the 
digestive system to compounds that are thought to be less toxic. 
Ruminants such as cattle have complex digestive systems with four 
compartments, including a fermentation chamber. Therefore, given the 
complexity of the ruminant digestive system, there is considerably more 
opportunity for digestion and detoxification of a simple molecule such 
as methyl bromide in cattle as compared to rats. Finally, the commenter 
also claims that EPA failed to consider the impact of methyl bromide 
pesticide levels in cottonseed used as feed on the health of livestock. 
EPA expects methyl bromide exposure to cattle to be very low. 
Cottonseed is very unlikely to comprise more than 15% of the dairy 
cattle diet and cottonseed and residues of methyl bromide in all other 
potential feed items are much lower than the levels anticipated in 
cottonseed. Further, residues of methyl bromide in the cottonseed will 
be very low, as the residues will largely dissipate after fumigation, 
especially given the time needed to ship cottonseed to the United 
States. For commodity fumigations with methyl bromide the Agency 
generally sets tolerances based on residue levels 24 hours after 
completion of fumigation. Commodities such as nuts and cottonseed are 
stored for much longer than 24 hours before they are distributed for 
consumption. Controlled trials with nuts as well as other commodities 
indicate that residues dissipate considerably with time. For example, 
residues in nuts dissipated to residues ranging from <0.1 to 11 ppm 
after only 1 week of storage. Mammalian oral toxicity studies available 
to the Agency indicate that much higher concentrations of methyl 
bromide in the diet would be needed to elicit any sort of toxic effect 
(the maximum reasonable dietary burden for dairy cattle is 
approximately 20 ppm (assuming upper bound residues), and the no-
observed effect level in long-term oral toxicity studies in rats is 
approximately 50 ppm).
    The commenter asserts that approving the use of methyl bromide 
fumigation on cottonseed imports will increase occupational exposure to 
methyl bromide and requests that EPA weigh the risks of occupational 
exposure against the benefits of imported cottonseed. However, under 
the existing legal framework provided by section 408 of the FFDCA EPA 
is authorized to establish pesticide tolerances or exemptions where it 
has been demonstrated that the tolerance meets the safety standard 
imposed by that statute. In making this determination, EPA is 
specifically prohibited from considering occupational exposure to a 
pesticide. 21 U.S.C. 346a(b)(2)(D)(vi). If an applicant sought to 
register methyl bromide for use in the United States, the issue of 
risks from occupational exposure would be considered by EPA in making a 
determination on registration of such a use under the Federal 
Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et seq.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate analytical method, the head-space procedure of King et 
al. is available for enforcement of methyl bromide tolerances. Samples 
are blended with water at high speed in airtight jars for 5 minutes. 
After 15 minutes, the partitioned gas phase is sampled and analyzed by 
gas chromatography with electron capture detection (GC/EC). See the 
February 22, 2002, Residue Chemistry Chapter for the methyl bromide RED 
available in Docket EPA-HQ-OPP-2005-0123.

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 United Nations 
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 methyl bromide on cottonseed.

V. Conclusion

    Based on the information, analysis, and conclusions in the April 6, 
2012 proposal (77 FR 20752) (FRL-9345-1), as well as the consideration 
of public comments discussed herein, a tolerance is established for 
residues of methyl bromide in or on cottonseed at 150 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
on EPA's own initiative. 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, entitled ``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).
    Pursuant to the requirements of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that this 
rule will not have significant negative economic impact on a 
substantial number of small entities. Establishing a pesticide 
tolerance or an

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exemption from the requirement of a pesticide tolerance is, in effect, 
the removal of a regulatory restriction on pesticide residues in food 
and thus such an action will not have any negative economic impact on 
any entities, including small entities.
    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 FFDCA section 408(n)(4). 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 

VII. 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: June 7, 2012.
Steven Bradbury,
 Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. Add Sec.  180.124 to subpart C to read as follows:

Sec.  180.124  Methyl Bromide; tolerances for residues.

    (a) General. A tolerance is established for residues of the 
fumigant methyl bromide, including metabolites and degradates, in or on 
the commodity in the table below. Compliance with the tolerance level 
specified below is to be determined by measuring only methyl bromide.

                                                               Parts per
                          Commodity                             million
Cotton, undelinted seed.....................................         150

     (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2012-14429 Filed 6-8-12; 4:15 pm]