Document ID: EPA-HQ-OPP-2005-0123-0206
Agency: epa
Document Type: Proposed Rule
Title: Inorganic Bromide; Proposed Tolerance Actions
Posted Date: 2006-05-31T13:03:02Z

[Federal Register: May 31, 2006 (Volume 71, Number 104)]
[Proposed Rules]               
[Page 30845-30848]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31my06-27]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0123; FRL-8061-7]

 
Inorganic Bromide; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY:  EPA is announcing that 12 specific inorganic bromide 
tolerances have been reassessed and is proposing to revoke them because 
they are no longer needed. These twelve tolerances are for residues of 
inorganic bromide from pre-plant (non-food) use in or on raw 
agricultural commodities grown in soil fumigated with combinations of 
chloropicrin, methyl bromide, and propargyl bromide. Although methyl 
bromide is used as an agricultural pesticide, the Agency considers its 
application as a soil fumigant to be a non-food use because it is 
quickly degraded or metabolized in the soil, and subsequently 
incorporated into natural plant constituents.Methyl bromide is also 
emitted to the atmosphere. Residues of the parent compound are not 
likely to be found in foods as a result of prior treatment of fields. 
While residues of inorganic bromide may be present, these residues are 
indistinguishable from background because of inorganic bromide's 
ubiquity in the environment. In addition, the Agency has concluded that 
inorganic bromide residue from such use is not of risk concern and has 
determined those twelve tolerances to be safe. Consequently, EPA is 
proposing to revoke them because no tolerances are needed for those 
non-food uses and the Agency considers these tolerances to be 
reassessed. Furthermore, since methyl bromide, when applied as a pre-
plant soil fumigant is a non-food use, it should be added as an entry 
to 40 CFR 180.2020 noting the non-food use determination. The 
regulatory actions proposed in this document contribute toward the 
Agency's tolerance reassessment requirements under the Federal Food, 
Drug, and Cosmetic Act (FFDCA) section 408(q), as amended by the Food 
Quality Protection Act (FQPA) of 1996. By law, EPA is required by 
August 2006 to reassess the tolerances that were in existence on August 
2, 1996. The regulatory actions proposed in this document pertain to 
the proposed revocation of 12 tolerances that count as tolerance 
reassessments toward the August 2006 review deadline.

DATES:  Comments must be received on or before July 31, 2006.

ADDRESSES:  Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2005-0123, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the on-line 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 
Building); 2777 S. Crystal Drive, Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
docket telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0123. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line 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 e-
mail. The Federal regulations.gov website 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 e-mail comment directly to EPA without going through 
regulations.gov, your e-mail 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

[[Page 30846]]

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. 
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 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 Building), 2777 S. Crystal Drive, 
Arlington, VA. The hours of operation for this docket facility are from 
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. 
The docket telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT:  Steven Weiss, Special Review and 
Reregistration Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave, NW., 
Washington, DC 20460-0001; telephone number: (703) 308-8293; e-mail 
address: weiss.steven@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 e-mail. 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.

II. Background

A. What Action is the Agency Taking?

    Previously, EPA had established tolerances for residues of 
inorganic bromide for soil treatment with methyl bromide. However, EPA 
has classified methyl bromide as a non-food use pesticide with regard 
to its soil fumigant uses and proposes to revoke tolerances for 
inorganic bromide. The Agency stated that although methyl bromide is 
used as an agricultural pesticide, it is considered a non-food use 
chemical for soil fumigation uses since it is quickly degraded or 
metabolized in the soil, and subsequently incorporated into natural 
plant constituents. Methyl bromide is also emitted to the atmosphere. 
Residues of the parent compound are not likely to be found in foods as 
a result of prior treatment of fields. While residues of inorganic 
bromide may be present, these residues are indistinguishable from 
background because of inorganic bromide's ubiquity in the environment. 
Therefore, tolerances are not required for soil fumigant uses of methyl 
bromide, and tolerances currently established for residues of inorganic 
bromide resulting from methyl bromide soil fumigation (40 CFR 180.199) 
should be revoked. Supporting documents are available in the docket of 
this proposed rule.
    Tolerances and tolerance exemptions established under part 180 
apply to residues from only preharvest application, unless otherwise 
specified, in accordance with 40 CFR 180.1(i). On April 17, 2003 (68 FR 
18935) (FRL-7180-2), EPA made pesticide tolerance nomenclature changes 
including a nomenclature change in 40 CFR part 180 regarding the term 
``preharvest'' such that in 40 CFR 180.199(c) the regional tolerance 
for ``ginger, roots, pre-H and post-H'' was revised to ``ginger, roots, 
postharvest.'' Nevertheless, the tolerance expression in 40 CFR 
180.199(c) applies to the raw agricultural commodity grown in soil 
fumigated with combinations of methyl bromide and chloropicrin, and 
therefore the regional tolerance on ginger, roots, postharvest should 
be revoked because that tolerance is no longer needed for soil fumigant 
use and use on ginger, roots, post-harvest is covered by a tolerance 
under 40 CFR 180.123.
    Considering all the above factors (that the only residue of concern 
in pre-plant soil fumigation with methyl bromide is methyl bromide per 
se and there being no reasonable expectation of methyl bromide residues 
in most crops planted and grown in the fumigated soil, and that 
inorganic bromide is not of risk concern), as well as the low 
likelihood of identifying control samples for tolerance enforcement 
which would be bromide-free, the conclusion that soil fumigation uses 
of methyl bromide should be considered non-food uses means that the 
tolerances for residues of inorganic bromide resulting from such use 
are therefore unnecessary. Accordingly, EPA believes that the 12 
tolerances in 40 CFR 180.199(a) for residues of inorganic bromides in 
or on

[[Page 30847]]

broccoli, cauliflower, eggplants, muskmelons, peppers, pineapples, 
strawberries, and tomatoes; in 40 CFR 180.199(b) on asparagus, lettuce, 
and onions (dry bulb); and in 40 CFR 180.199(c) on ginger, roots are 
not required under FFDCA and can be revoked. The Agency considers the 
twelve tolerances to be reassessed and counts them toward meeting the 
tolerance reassessment requirements listed in FFDCA section 408(q).
    Furthermore, since methyl bromide, when applied as a pre-plant soil 
fumigant is a non-food use, it should be added as an entry to 40 CFR 
180.2020 noting the non-food use determination.

B. What is the Agency's Authority for Taking this Action?

    A ``tolerance'' represents the maximum level for residues of 
pesticide chemicals legally allowed in or on raw agricultural 
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by the FQPA of 1996, Public Law 104-170, authorizes the 
establishment of tolerances, exemptions from tolerance requirements, 
modifications in tolerances, and revocation of tolerances for residues 
of pesticide chemicals in or on raw agricultural commodities and 
processed foods. Without a tolerance or exemption, food 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 may not be distributed in interstate commerce (21 U.S.C. 331(a)). 
For a food-use pesticide to be sold and distributed, the pesticide must 
not only have appropriate tolerances under FFDCA, but also must be 
registered under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not 
registered in the United States must have tolerances in order for 
commodities treated with those pesticides to be imported into the 
United States.

C. When do These Actions Become Effective?

    EPA is proposing that revocation of these tolerances become 
effective on the date of publication of the final rule in the Federal 
Register. The Agency has determined that there is no reasonable 
expectation that residues of the pesticides listed in this proposed 
rule will be found on the commodities discussed in this proposed rule 
and therefore the lack of the tolerances does not prevent sale of the 
commodities.

D. What Is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2006 to reassess the tolerances 
in existence on August 2, 1996. As of May 18, 2006, EPA has reassessed 
over 8,130 tolerances. This document proposes to revoke a total of 12 
tolerances and counts them toward the August 2006 review deadline of 
FFDCA section 408(q), as amended by FQPA in 1996.

III. Are The Proposed Actions Consistent with International 
Obligations?

    The tolerance revocations in this proposal are not discriminatory 
and are designed to ensure that both domestically-produced and imported 
foods meet the food safety standard established by FFDCA. The same food 
safety standards apply to domestically produced and imported foods.
    EPA is working to ensure that the U.S. tolerance reassessment 
program under FQPA does not disrupt international trade. EPA considers 
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in 
reassessing them. MRLs are established by the Codex Committee on 
Pesticide Residues, a committee within the Codex Alimentarius 
Commission, an international organization formed to promote the 
coordination of international food standards. It is EPA's policy to 
harmonize U.S. tolerances with Codex MRLs to the extent possible, 
provided that the MRLs achieve the level of protection required under 
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the 
tolerance reassessment section of individual Reregistration Eligibility 
Decision documents. EPA has developed guidance concerning submissions 
for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3). 
This guidance will be made available to interested persons. Electronic 
copies are available on the internet at http://www.epa.gov. On the Home 

Page select ``Laws, Regulations, and Dockets,'' then select 
``Regulations and Proposed Rules'' and then look up the entry for this 
document under ``Federal Register--Environmental Documents.'' You can 
also go directly to the ``Federal Register'' listings at http://www.epa.gov/fedrgstr
.

IV. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to revoke specific 
tolerances established under FFDCA section 408. The Office of 
Management and Budget (OMB) has exempted this type of action (i.e., 
tolerance revocation for which extraordinary circumstances do not 
exist) 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, 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) (Public Law 104-4). Nor 
does it require any special considerations as required by 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 other 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 Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
et seq.), the Agency previously assessed whether revocations of 
tolerances might significantly impact a substantial number of small 
entities and concluded that, as a general matter, these actions do not 
impose a significant economic impact on a substantial number of small 
entities. This analysis was published on December 17, 1997 (62 FR 
66020), and was provided to the Chief Counsel for Advocacy of the Small 
Business Administration. Taking into account this analysis, and the 
fact that there is no reasonable expectation that residues of the 
pesticides listed in this proposed rule will be found on the 
commodities discussed in this proposed rule (so that the lack of the 
tolerance could not prevent sale of the commodity), the Agency hereby 
certifies that this proposed action will not have a significant 
negative economic impact on a substantial number of small entities. In 
a memorandum dated May 25, 2001, EPA determined that eight conditions 
must all be satisfied in order for an import tolerance or tolerance 
exemption revocation to adversely affect a significant number of small 
entity importers, and that there is a negligible

[[Page 30848]]

joint probability of all eight conditions holding simultaneously with 
respect to any particular revocation. (This Agency document is 
available in the docket of this proposed rule). Furthermore, for the 
pesticide named in this proposed rule, the Agency knows of no 
extraordinary circumstances that exist as to the present proposal that 
would change the EPA's previous analysis. Any comments about the 
Agency's determination should be submitted to the EPA along with 
comments on the proposal, and will be addressed prior to issuing a 
final rule. 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 section 408(n)(4) of FFDCA. 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 6, 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: May 19, 2006.
James Jones,
Director, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR part 180 be amended 
asfollows:

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.

Sec.  180.199  [Removed]

    2. Section 180.199 is removed.
    3. Section 180.2020 is amended by adding alphabetically the 
following entry to the table to read as follows.

Sec.  180.2020  Non-food determinations.

* * * * *

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          Pesticide Chemical            Chemical CAS Reg. No.            Limits                    Uses
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Methyl Bromide                                         74-83-9  When applied as a pre-   All pre-plant soil uses
                                                                 plant soil fumigant
                                                  * * * * * * *
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[FR Doc. E6-8398 Filed 5-30-06; 8:45 am]

BILLING CODE 6560-50-S