Inert Ingredient; Revocation of a Tolerance Exemption with Insufficient Data for Reassessment

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: June 7, 2006 (Volume 71, Number 109)]
[Proposed Rules]
[Page 32895-32899]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn06-35]

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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2006-0493; FRL-8072-4]

Inert Ingredient; Revocation of a Tolerance Exemption with
Insufficient Data for Reassessment

AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.

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SUMMARY: This document proposes under section 408(e)(1) of the Federal
Food, Drug, and Cosmetic Act (FFDCA) to revoke the existing exemption
from the requirement of a tolerance for residues of one inert
ingredient because there are insufficient data to make the
determination of safety required by FFDCA section 408(b)(2). The inert
ingredient tolerance exemption under 40 CFR 180.920 is ``[alpha]-Alkyl
(C₁₀-C₁₆)-[omega]-hydroxypoly(oxyethylene)
mixture of dihydrogen phosphate and monohydrogen phosphate esters and
the corresponding ammonium, calcium, magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the phosphate esters; the
poly(oxyethylene) content averages 3-20 moles.'' The revocation action
in this document contributes towards 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 in this document pertains to the
revocation of one tolerance exemption which is counted as tolerance
reassessment toward the August 2006 review deadline.

DATES: Comments must be received on or before July 7, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0493, 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-
2006-0493. 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

[[Page 32896]]

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 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
Building), 2777 S. Crystal Drive, 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 telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Kerry Leifer, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-8811; e-mail address: leifer.kerry@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:
? rop 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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II. If you have
any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

II. Background and Statutory Findings

A. What Action is the Agency Taking?

On May 3, 2006, EPA published a proposed rule in the Federal
Register (71 FR 25993; FRL-8060-9) to revoke exemptions from the
requirement of a tolerance for certain inert ingredients used in
pesticide products. Unfortunately, one inert ingredient tolerance
exemption was inadvertently omitted from this Federal Register proposed
rule: ``[alpha]-Alkyl (C₁₀-C₁₆)-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, monoethanolamine, potassium, sodium, and zinc salts of the
phosphate esters; the poly(oxyethylene) content averages 3-20 moles.''
Therefore, in this proposed rule, EPA is proposing to revoke this one
inert ingredient tolerance exemption because sufficient data are not
available to the Agency to make the safety determination required by
FFDCA section 408(c)(2).
As described in the Federal Register of May 3, 2006, described in
this unit, EPA is now in the process of reassessing all inert
ingredient exemptions from the requirement of a tolerance (``tolerance
exemptions'') established prior to August 2, 1996, as required by FFDCA
section 408(q). Under FFDCA section 408(q), tolerance reassessment may
lead to regulatory action under FFDCA section 408(e)(1). When taking
action under FFDCA section 408(e)(1), EPA may leave a tolerance
exemption in effect only if the Agency determines that the tolerance
exemption is safe. As is the case for the inert ingredient tolerance
exemptions identified in the May 3 Federal Register, EPA has
insufficient data available to make the safety determination required
by FFDCA section 408(c)(2) for this one inert ingredient and is
proposing to revoke the tolerance exemption.
In making the FFDCA reassessment safety determination, EPA
considers the validity, completeness, and reliability of the data that
are available to the Agency, FFDCA section 408 (b)(2)(D), and the
available information concerning the special susceptibility of infants
and children (including developmental effects from in utero exposure),
FFDCA section 408 (b)(2)(C). Data gaps exist for this inert ingredient
in areas critical to reassessment. Without these data, the assessment
of possible effects to infants and children cannot be made. Thus, EPA
has insufficient data to make the safety finding of FFDCA section
408(c)(2) and is revoking the inert ingredient tolerance exemption
identified in this document.
In developing risk assessment documents for inert ingredient
tolerance exemptions, EPA currently reviews data submitted to the
Agency as well as information from reputable, publicly available
sources. For example, studies may be available in professional (peer-
reviewed) journals, and chemical assessments may be available on the
Internet from U.S. Government agencies (e.g., EPA, the Agency for Toxic
Substances and Disease Registry, National Institutes of Health, Food
and Drug Administration (FDA)) and international organizations (e.g.,
World Health Organization, Organization for Economic Cooperation and
Development (OECD)). In some cases, representatives from chemical and
pesticide manufacturing industry associations endeavored to locate data
to support reassessment of surfactant chemicals. Nonetheless,
sufficient valid and reliable data were not available to make the
requisite FFDCA safety finding.
EPA could not have made the requisite FFDCA safety finding unless,
at the very least, a set of basic toxicity studies had been available
to the Agency. It is possible that the tests agreed to under OECD's
Screening Information Data Set (SIDS) program would have sufficed.
Especially important to inert ingredient reassessment is an acceptable
repeat-dose study. The preferred test for repeat-dose toxicity is the
``Combined Repeated Dose Toxicity Study with the Reproduction/
Developmental Toxicity Screening Test'' (OECD Test Guideline 422). More
information about the OECD SIDS and EPA's High Production Volume (HPV)
programs is found at http://www.epa.gov/oppt/chemrtk/sidsappb.htm.
For the inert ingredient subject to this proposed rule and the inert
ingredients identified in the May 3 Federal Register, the full OECD
SIDS may not have been necessary in some cases because EPA has
available a limited number of studies and information on the inert
ingredient in question (e.g., acute toxicity studies). In other cases,
the limited toxicity information available to the Agency may

[[Page 32897]]

indicate a need for further testing. EPA always recommends that parties
interested in supporting an inert ingredient consult with the Agency
prior to embarking on a testing strategy in order to determine existing
data gaps and if testing certain chemicals within a multi-chemical
exemption would serve to represent the entire exemption.
In summary, the safety finding required by FFDCA section 408(b)(2)
cannot be made for the one inert ingredient tolerance exemption due to
insufficient data. Therefore, EPA is revoking under FFDCA section
408(e)(1) the tolerance exemption identified at the end of this
document under 40 CFR 180.920 with the revocation effective 2 years
after the date of publication of the final rule in the Federal Register.
The inert ingredient tolerance exemption that is the subject of
this revocation proposal is found in 40 CFR 180.920 and reads as
follows: ``[alpha]-Alkyl (C₁₀-C₁₆)-[omega]-
hydroxypoly (oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, monoethanolamine, potassium, sodium, and zinc salts of the
phosphate esters; the poly(oxyethylene) content averages 3-20 moles.''
It is noted that the chemical described in this tolerance exemption is
included in a broader tolerance exemption also found in 40 CFR 180.920
that was proposed for revocation for insufficient data in the May 3
Federal Register, which reads as follows: ``[alpha]-Alkyl
(C₁₀-C₁₆)-[omega]-hydroxypoly (oxyethylene)poly
(oxypropylene) mixture of di- and monohydrogen phosphate esters and the
corresponding ammonium, calcium, magnesium, monoethanolamine,
potassium, sodium, and zinc salts of the phosphate esters; the combined
poly(oxyethylene) poly(oxypropylene) content averages 3-20 moles.'' The
public has had an opportunity to comment on the proposed revocation of
the broader tolerance exemption since May 3. Because the public has had
an opportunity since May 3 to comment on the broader exemption that
encompasses this more narrow tolerance exemption, a 30-day comment
period is provided for this proposed revocation of the more narrow
tolerance exemption.

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 FQPA, 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 FFDCA
section 402(a), 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 Federal
Insecticide, Fungicide, and Rodenticide Act (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 revoking the tolerance exemption identified in this proposed
rule that has insufficient data effective 2 years after the date of
publication of the final rule in the Federal Register. Any commodities
listed in this rule treated with pesticide products containing the
inert ingredient and in the channels of trade following the tolerance
revocation shall be subject to FFDCA section 408(1)(5), as established
by FQPA. Under this section, any residues of this pesticide chemical in
or on such food shall not render the food adulterated so long as it is
shown to the satisfaction of FDA 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.
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 revokes one inert ingredient tolerance exemption,
which counts as a tolerance reassessment toward the August 2006 review
deadline under FFDCA section 408(q), as amended by FQPA in 1996.

III. Are the Actions Consistent with International Obligations?

The tolerance revocation in this rule 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 (RED) documents. EPA has developed guidance concerning
submissions for import tolerance support which was published in the
Federal Register of June 1, 2000 (65 FR 35069) (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

The Office of Management and Budget (OMB) has exempted this type of
action from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this rule
has been exempted from review under Executive Order 12866 due to its
lack of significance, this 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 rule
does not contain any information collections subject to OMB approval
under the Paperwork Reduction Act (PRA), 44

[[Page 32898]]

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 on May 4, 1981 (46 FR 24950) and on December 17, 1997 (62 FR
66020) (FRL-5753-1), 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
pesticide chemical listed in this rule, the Agency hereby certifies
that this 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/Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) concern
and require more analysis. (This Agency document is available in the
docket of this rule). Furthermore, for the pesticide chemical named in
this rule, the Agency knows of no extraordinary circumstances that
exist as to the present rule that would change the EPA's previous
analysis.
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 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 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 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 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 31, 2006.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is 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. In Sec. 180.920, the table is amended by revising the entry in
the table to read as follows:

Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

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Inert Ingredients Limits Uses
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* * * * *
[alpha]-Alkyl (C10-C16)-[omega]-hydroxypoly(oxyethylene) Expires June 9, 2008 Surfactant; related
mixture of dihydrogen phosphate and monohydrogen phosphate adjuvants of
esters and the corresponding ammonium, calcium, magnesium, surfactants
monoethanolamine, potassium, sodium, and zinc salts of the
phosphate esters; the poly(oxyethylene) content averages 3-20
moles........................................................
* * * * *
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[FR Doc. E6-8826 Filed 6-6-06; 8:45 am]
BILLING CODE 6560-50-S

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Inert Ingredient; Revocation of a Tolerance Exemption with Insufficient Data for Reassessment

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