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Wheat Bran; Proposed Revocation of the Inert Ingredient Tolerance Exemption
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: April 19, 2006 (Volume 71, Number 75)]
[Proposed Rules]
[Page 20045-20048]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19ap06-32]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0232; FRL-8065-7]
Wheat Bran; Proposed Revocation of the Inert Ingredient Tolerance Exemption
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: This document proposes to revoke, under the Federal Food,
Drug, and Cosmetic Act (FFDCA) section 408(e)(1), the existing
exemption from the requirement of a tolerance for residues of the inert
ingredient ``wheat bran'' under 40 CFR 180.910. The regulatory action
proposed in this document contributes toward the Agency's tolerance
reassessment requirements under 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 action proposed in this document pertains to
the proposed revocation of one tolerance which would be counted as a
tolerance reassessment toward the August 2006 review deadline.
DATES: Comments must be received on or before June 19, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0232, by one of the following methods:
[[Page 20046]]
? Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
? Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502C), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
? Hand Delivery: OPP Regulatory Public Docket, Environmental
Protection Agency, Rm. 119, Crystal Mall #2, 1801 S. Bell St.,
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.
? Important Note: OPP will be moving to a new location the
first week of May 2006. As a result, from Friday, April 28 to Friday,
May 5, 2006, the OPP Regulatory Public Docket will NOT be accepting any
deliveries at the Crystal Mall #2 address and this facility
will be closed to the public. Beginning on May 8, 2006, the OPP
Regulatory Public Docket will reopen at 8:30 a.m. and deliveries will
be accepted in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA 22202. The mail code for the mailing
address will change to (7502P), but will otherwise remain the same. The
OPP Regulatory Public Docket telephone number and hours of operation
will remain the same after the move.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0232. 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
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 at
the location identified under ``Delivery'' and ``Important Note.'' 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: Karen Angulo, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 306-0404; e-mail address: angulo.karen@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
http://www.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 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 and Statutory Findings
A. What Action is the Agency Taking?
The Agency is proposing to revoke the inert ingredient tolerance
exemption for ``wheat bran'' under 40 CFR 180.910. This action
completes EPA's revocation of the wheat bran tolerance exemption as
initially discussed in the Federal Register Notice of January 15, 2002, (67
[[Page 20047]]
FR 1925) (FRL-6807-8). In that Notice, EPA identified several inert
ingredients as allergen-containing food commodities, including wheat
bran, and stated that their tolerance exemptions needed to be removed.
Unfortunately, wheat bran's tolerance exemption was not revoked in the
final rule (May 24, 2002, 67 FR 36534) (FRL-6834-8) because of an
administrative error. No comments were received on the proposed or the
final rule. Therefore, wheat bran's tolerance exemption was not revoked
in the final rule for any reason but omission.
As background, EPA revoked the inert ingredient tolerance
exemptions identified in the Federal Register of May 24, 2002 (67 FR
36534) (FRL-6834-8), in order to be protective of sub-populations that
are known to be sensitive to allergen-containing food commodities. This
action was done in concordance with the current science and medical
understanding of the allergenic potential of these food commodities.
The Federal Food, Drug, and Cosmetic Act (FFDCA) section 201(qq)
defines a ``major food allergen'' as one of eight foods or a food
ingredient that contains protein derived from one of the following
foods: Milk, eggs, fish crustacean shellfish, tree nuts, peanuts,
wheat, and soybeans. These foods and food ingredients are known to
contain the allergenic protein that can cause allergic responses in
some people, such as celiac disease. FFDCA section 202(6) states: ``(A)
celiac disease is an immune-mediated disease that causes damage to the
gastrointestinal tract, central nervous system, and other organs; (B)
the current recommended treatment is avoidance of glutens in foods that
are associated with celiac disease.'' As part of the Food Allergen
Labeling and Consumer Protection Act (FALCPA), which amended FFDCA in
2004, the U.S. Food and Drug Administration is now in the process of
defining the term ``gluten-free'' and is expected to issue the
definition in a final rule in 2008.
EPA fully intended to revoke the tolerance exemption for wheat bran
under 40 CFR 180.910 with the other allergen-containing food commodity
tolerance exemptions in the 2002 proposed and final rules identified
above. Therefore, the Agency is now moving to complete its original
intended action and is proposing herein to revoke the exemption from
the requirement of a tolerance for wheat bran under 40 CFR 180.910.
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 the revocation of the current wheat bran tolerance
exemption under 40 CFR 180.910 become effective on the date of
publication of the final rule in the Federal Register. Any commodities
listed in this proposal treated with pesticide products containing the
inert ingredient wheat bran, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as
established by FQPA. Under this section, any residues of these
pesticide chemicals in or on such food shall not render the food
adulterated so long as it is shown to the satisfaction of the Food and
Drug Administration that: (1) The residue is present as the result of
an application or use of the pesticide at a time and in a manner that
was lawful under FIFRA, and (2) the residue does not exceed the level
that was authorized at the time of the application or use to be present
on the food under a tolerance or exemption from tolerance. Evidence to
show that food was lawfully treated may include records that verify the
dates when the pesticide was applied to such food.
D. What Is the Contribution to Tolerance Reassessment?
By law, EPA is required by August 2006, to reassess the tolerances
and exemptions from tolerances that were in existence on August 2,
1996. This document proposes to revoke one inert ingredient tolerance
exemption, which will be counted in a final rule as a tolerance
reassessments toward the August 2006, review deadline under FFDCA
section 408(q), as amended by FQPA in 1996.
III. Are the Proposed Actions Consistent with International Obligations?
The tolerance revocation in this proposal is not discriminatory and
is 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 a specific
tolerance established under FFDCA section 408.
[[Page 20048]]
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, 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 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 Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), the Agency previously assessed whether establishment of
tolerances, exemptions from tolerances, raising of tolerance levels,
expansion of exemptions, or revocations 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. These analyses for tolerance
establishments and modifications, and for tolerance revocations were
published in the Federal Register on May 4, 1981 (46 FR 24950) and on
December 17, 1997 (62 FR 66020), respectively, and were provided to the
Chief Counsel for Advocacy of the Small Business Administration. Taking
into account this analysis, and available information concerning the
pesticides listed in this proposed rule, the Agency hereby certifies
that this proposed action will not have a significant negative economic
impact on a substantial number of small entities. Specifically, the
Agency has concluded in a memorandum dated May 25, 2001 that for import
tolerance revocation there is a negligible joint probability of certain
defined conditions holding simultaneously which would indicate an RFA/
SBREFA concern and require more analysis. (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 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 (59 FR 22951,
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: April 5, 2006.
Meredith F. Laws,
Acting Director, Registration Division, 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.
Sec. 180.910 [Amended]
2. Section 180.910 is amended by removing from the table the entry
for ``Wheat bran.''
[FR Doc. E6-5877 Filed 4-18-06; 8:45 am]
BILLING CODE 6560-50-S