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[Federal Register Volume 77, Number 67 (Friday, April 6, 2012)]
[Proposed Rules]
[Pages 20752-20756]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-8390]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0245; FRL-9345-1]
RIN 2070-ZA16

Methyl Bromide; Proposed Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: This document proposes to establish 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 feed for dairy cattle in the 
United States. This imported cottonseed has become necessary because 
cottonseed is a critical part of the dairy cattle diet and the 2011 
U.S. cotton crop was significantly below average due to severe drought 
conditions in Texas.

DATES: Comments must be received on or before June 5, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(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.
     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).

[[Page 20753]]

Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2012-0245. EPA's policy is that all comments received will be included 
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through regulations.gov or email. The 
regulations.gov Web site is an ``anonymous access'' system, which means 
EPA will not know your identity or contact information unless you 
provide it in the body of your comment. If you send an email comment 
directly to EPA without going through regulations.gov, your email 
address will be automatically captured and included as part of the 
comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: 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., 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 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: 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: nesci.kimberly@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. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or email. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified. Comments not timely-filed will not be considered 
in EPA's decision on this proposal or in any subsequent proceedings in 
this rulemaking.

II. This Proposal

    EPA on its own initiative, under FFDCA section 408(e), 21 U.S.C. 
346a(e), is proposing to establish a tolerance for residues of the 
fumigant methyl bromide, in or on cotton, undelinted seed at 150 parts 
per million (ppm) in newly proposed 40 CFR 180.124. The Animal and 
Plant Health Inspection Service, an agency of the United States 
Department of Agriculture (USDA-APHIS), supports EPA's proposal to 
establish this tolerance.
    Undelinted cottonseed, also known as fuzzy cottonseed, needs to be 
imported into the United States for use as feed for dairy cattle in the 
United States. Cottonseed is a critical part of the dairy cattle diet 
because it is high in protein, energy, and fiber. In 2011, the size of 
the U.S. cotton crop was significantly below average due to severe 
drought conditions in Texas, the leading cotton producing state in the 
United States. As a result, U.S. cottonseed has been in short supply 
since the November 2011 harvest causing hardship for U.S. dairy cattle 
farmers.
    The USDA-APHIS has, in the past, pursuant to its authorities from 
the Plant Protection Act (PPA, as amended, 7 U.S.C. 7701 et seq.), 
required imported cottonseed to be fumigated as a condition of entry 
into the United States. APHIS evaluated the use of methyl bromide for 
such fumigation and has determined through efficacy studies that methyl 
bromide does effectively mitigate potential pests of concern such as 
Fusarium oxysporum f. sp.

[[Page 20754]]

vasinfectum strains Boggabilla (VCG01112) and Cecil Plains (VCG01111) 
that imported undelinted cottonseed could harbor. These Fusarium 
strains are not known to occur in the United States. Fusarium oxysporum 
f. sp. vasinfectum causes Fusarium wilt of cotton and, if introduced, 
these foreign strains could cause significant losses to U.S. cotton 
crops. The PPA authorizes the Secretary of Agriculture (who has 
delegated this authority to APHIS) to facilitate imports of 
agricultural commodities that pose a risk of harboring plant pests, 
among other pests, in ways that will reduce the risk of dissemination 
of plant pests that could constitute a threat to crops and other plants 
or plant products and burden interstate or foreign commerce. The 
Secretary may prohibit or restrict the importation, entry, exportation, 
or movement in interstate commerce of any plant, plant product, noxious 
weed, or article if the Secretary determines that the prohibition or 
restriction is necessary to prevent the introduction of a plant pest 
into the United States or the dissemination of a plant pest within the 
United States.
    As a feed commodity, imported cottonseed that has been fumigated 
with methyl bromide requires a tolerance. Without a tolerance or 
exemption, food or feed containing pesticide residues is considered to 
be unsafe and therefore ``adulterated'' under section 402(a) of FFDCA, 
21 U.S.C. 342(a). Such food or feed may not be distributed in 
interstate commerce (21 U.S.C. 331(a)).

III. Determination of Safety and Exposure

    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.'' 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.* * *''
    Given the characteristics of methyl bromide, EPA concludes that the 
use of methyl bromide on cottonseed will result in detectable residues 
on the cottonseed itself. Although the Agency does not have controlled 
fumigation trial data for this cottonseed use, EPA has received such 
data for numerous other related commodities and use patterns. The data 
that would be most representative of potential residues in/on 
cottonseed are from methyl bromide trials with tree nuts because 
commodities with higher fat content, such as nuts and oils, tend to 
have higher residues. EPA is proposing a tolerance level of 150 parts 
per million (ppm), which is based on the highest residue found in tree 
nuts 24 hours after fumigation (138 ppm). Dissipation studies indicated 
that residues dissipate relatively quickly, which is consistent with 
the high vapor pressure of methyl bromide. Despite the tendency for 
rapid dissipation shown in numerous studies, the Agency believes there 
is still the potential for quantifiable residues in the imported 
cottonseed. However, residues are likely to be much less than the 
proposed tolerance level.
    EPA further concludes that the use of methyl bromide to fumigate 
imported cottonseed will not result in any human dietary exposure to 
methyl bromide residues. There are two potential human dietary exposure 
pathways from treated cottonseed: Cottonseed oil, an edible commodity 
produced from cottonseed, and livestock commodities from livestock fed 
treated cottonseed. Cottonseed itself is not consumed by humans, nor is 
it used to produce any other edible commodity because unrefined 
cottonseed and cottonseed meal contains a naturally occurring compound 
that is toxic to humans, gossypol.
    Cottonseed will be imported for the purpose of feeding dairy 
cattle. There is no reasonable expectation of finite residues of methyl 
bromide in livestock commodities from the use of methyl bromide to 
fumigate cottonseed. Methyl bromide residues in/on feed items are 
likely to significantly dissipate during storage due to the volatile 
nature of methyl bromide. Should there be methyl bromide residues 
remaining, the methyl bromide would likely undergo considerable changes 
in the digestive system of livestock. Methyl bromide is an alkylating 
agent and will probably undergo chemical reactions with the contents of 
the gut. These chemical reactions break down the compound into a 
bromide ion and a methyl group; thus, there will be no absorption of 
methyl bromide into the edible tissues of livestock. Further, methyl 
bromide has a very low octanol-water co-efficient. Octanol-water co-
efficient values measure the tendency for a chemical to partition into 
organic vs. aqueous environments, and is therefore commonly used to 
predict the likelihood for partitioning into fatty tissue where 
xenobiotics are more likely to persist. Chemicals that tend to 
bioaccumulate tend to have orders of magnitude higher octanol-water co-
efficient values than methyl bromide. And, although methyl bromide 
tends to be lipid soluble, the low octanol-water co-efficient value 
overwhelms this chemical characteristic. For these reasons, EPA does 
not believe there will be transfer of methyl bromide residues into the 
edible tissues of livestock. In its Reregistration Eligibility Decision 
document for methyl bromide, EPA also determined that no livestock 
commodity tolerances for methyl bromide are needed under 40 CFR 
180.6(a)(3) because there is no reasonable expectation of finite methyl 
bromide residues in livestock commodities. Any inorganic bromide 
residues on livestock feeding items resulting from fumigation of 
cottonseed with methyl bromide are covered by existing inorganic 
bromide tolerances at 40 CFR 180.124.
    Even if the imported cottonseed were to be diverted to cottonseed 
oil production, there will be no human exposure to methyl bromide in 
the cottonseed oil. In producing oil from cottonseed, the oil is 
removed by mechanical high pressure screw, by solvent extraction, or a 
combination of the two processes. Under either procedure, the seed 
kernels are first rolled into flakes and heated in a cooker or 
conditioner to reduce moisture. Once the oil is extracted, it is 
refined by adding sodium hydroxide that removes impurities and 
soapstock from the oil. Most cottonseed oil is bleached to remove 
coloring agents and is then filtered. Finally, it is deodorized with 
steam under a partial vacuum to remove any off flavors. Bromide ion 
will be removed from the oil during the final clean-up steps because 
the bromide ion is water soluble and will be washed away during the 
sodium hydroxide refining procedure. See also Docket EPA-HQ-OPP-2006-
0766 document number 0022 for further information on cottonseed 
processing. Because methyl bromide is a gas at room temperature, the 
heating procedures in cottonseed oil processing will dissipate all 
methyl bromide residues from the seed and oil. Cottonseed oil produced 
from cottonseed fumigated with methyl bromide would not contain 
residues of methyl bromide.
    Accordingly, EPA has determined that there would be no human 
dietary exposure to methyl bromide from the use of methyl bromide to 
fumigate cottonseed. If meat, milk, or cottonseed

[[Page 20755]]

oil were imported rather than the cottonseeds themselves, no tolerance 
would be necessary. Because there will be no human dietary exposure to 
the methyl bromide in cottonseeds, EPA concludes that a methyl bromide 
tolerance in cottonseed, at the level proposed, will be safe for the 
general population, including infants and children.

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 air-tight 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

    A tolerance is proposed for residues of methyl bromide in 
cottonseed at 150 ppm based on the finding that there would be no human 
dietary exposure to methyl bromide from treated cottonseed and no 
exposure to children.

VI. Statutory and Executive Order Reviews

    EPA, at its own initiative, proposes to establish a tolerance under 
FFDCA section 408(d). 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 proposed rule has been exempted from 
review under Executive Order 12866 due to its lack of significance, 
this proposed 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). This 
proposed rule does not contain any information collections subject to 
OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et 
seq., or impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4). Nor does it require any special considerations 
under Executive Order 12898, entitled ``Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations'' (59 FR 7629, February 16, 1994); or OMB review or any 
Agency action under Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not involve any technical 
standards that would require Agency consideration of voluntary 
consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), the Agency hereby certifies that this proposed action will not 
have significant negative economic impact on a substantial number of 
small entities. Establishing a pesticide tolerance or 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. In addition, the Agency has determined that 
this action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled 
``Federalism'' (64 FR 43255, August 10, 1999). Executive Order 13132 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by State and local officials in the development of 
regulatory policies that have federalism implications.'' ``Policies 
that have federalism implications'' is defined in the Executive order 
to include regulations that have ``substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government.'' This proposed rule directly regulates 
growers, food processors, food handlers, and food retailers, not 
States. This action does not alter the relationships or distribution of 
power and responsibilities established by Congress in the preemption 
provisions of FFDCA section 408(n)(4). For these same reasons, the 
Agency has determined that this proposed rule does not have any 
``tribal implications'' as described in Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000). Executive Order 13175, requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by tribal officials in the development of regulatory policies that have 
tribal implications.'' ``Policies that have tribal implications'' is 
defined in the Executive order to include regulations that have 
``substantial direct effects on one or more Indian tribes, on the 
relationship between the Federal Government and the Indian tribes, or 
on the distribution of power and responsibilities between the Federal 
Government and Indian tribes.'' This proposed rule will not have 
substantial direct effects on tribal governments, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes, as specified in Executive Order 13175. 
Thus, Executive Order 13175 does not apply to this proposed rule.

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 2, 2012.
Steve Bradbury,
Director, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be 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. Add Sec.  180.124 to subpart C to read as follows:

[[Page 20756]]

Sec.  180.124  Methyl bromide; tolerance 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
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Cotton, undelinted seed....................................          150
------------------------------------------------------------------------

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

[FR Doc. 2012-8390 Filed 4-5-12; 8:45 am]
BILLING CODE 6560-50-P
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