Document ID: EPA-HQ-OPP-2006-0232-0001
Agency: epa
Document Type: Proposed Rule
Title: Wheat Bran; Proposed Revocation of the Inert Ingredient Tolerance Exemption
Posted Date: 2006-04-19T04:00Z

[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 (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: 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