[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Rules and Regulations]
[Page 45415-45424]
[DOCID:fr09au06-21]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0230; FRL-8084-1]

Inert Ingredients; Revocation of Tolerance Exemptions with
Insufficient Data for Reassessment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule revokes under section 408(e)(1) of the Federal
Food, Drug, and Cosmetic Act (FFDCA) the existing exemptions from the
requirement of a tolerance for residues of certain inert ingredients
because there are insufficient data to make the determination of safety
required by FFDCA section 408(b)(2), or because they are redundant and,
therefore, are not necessary. In addition, EPA has identified
substances within certain of these tolerance exemptions that meet the
definition of low-risk polymers and is establishing new tolerance
exemptions for them. The revocation actions in this document contribute
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 actions in
this document pertain to the revocation of 130 tolerance exemptions
which are counted as tolerance reassessment toward the August 2006
review deadline.

DATES: This rule is effective August 9, 2008, except amendatory
instructions dd for Sec.  180.910; jj and pp for Sec.  180.920; m, q,
bb, and kk for Sec.  180.930; and Sec.  180.960 which are effective
August 9, 2006. Objections and requests for hearings must be received
on or before October 10, 2006, and must be filed in accordance with the
instructions provided in 40 CFR part 178 (see also Unit I.C. of the
SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0230. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (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 Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

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:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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. 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.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/ fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://

http://www.gpoaccess.gov/ ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178.

You must file your objection or request a hearing on this regulation in
accordance with the instructions provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2006-0230 in the subject line on the first page of your submission. All
requests must be in writing, and must be mailed or delivered to the
Hearing Clerk on or before October 10, 2006.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0230, 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
Bldg.), 2777 S. Crystal Dr., 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<PHONE_NUMBER>.

II. Background and Statutory Findings

A. What Action is the Agency Taking?

    1. Revocation because of insufficient data. This final rule revokes
the inert ingredient tolerance exemptions with insufficient data
identified in two documents that published in the Federal Register on
May 3, 2006 (71 FR 25993; EPA-HQ-OPP-2006-0230) (FRL-8060-9) and June
7, 2006 (71 FR 32895; EPA-HQ-OPP-2006-0493) (FRL-8072-4). EPA is now in
the process of reassessing all inert ingredient exemptions from the
requirement of a tolerance (``tolerance exemptions'') established prior
to August 3, 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. EPA is revoking
130 inert ingredient tolerance exemptions because insufficient data are
available to the Agency to make the safety determination required by
FFDCA section 408(c)(2).
    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 these inert ingredients
in areas critical to reassessment. Without these data, the assessment
of possible effects to infants and children cannot be made. EPA has
insufficient data to make the safety finding of FFDCA section 408(c)(2)
and is revoking the inert ingredient tolerance exemptions identified in
this final rule.
    The Agency is revoking two other inert ingredient tolerance
exemptions with insufficient data under 40 CFR part 180 that were
identified in the preamble of the proposed revocation document (71 FR
25993; EPA-HQ-OPP-2006-0230). They were inadvertently removed from the
CFR some time ago but are considered to be active tolerance exemptions
subject to reassessment as required by FFDCA section 408(q). The
tolerance exemptions being revoked are:
    i. Sec.  180.910: ``[alpha]-Alkyl(C12-C15)-
[omega]- hydroxypoly(oxyethylene) sulfate, ammonium, calcium,
magnesium, potassium, sodium, and zinc salts; the poly(oxyethylene)
content averages 3 moles.''
    ii.Sec.  180.930: ``[alpha]-Alkyl (C12-C15)-
[omega]-hydroxypoly(oxyethylene) sulfate and its ammonium, calcium,
magnesium, potassium, sodium, and zinc salts; the poly(oxyethylene)
content averages 3 moles.''
    EPA's response to the comments received on the proposed rule is
provided in Unit II.B. In summary, the safety finding required by FFDCA
section 408(b)(2) cannot be made for certain inert ingredient tolerance
exemptions due to insufficient data. Therefore, EPA is revoking under
FFDCA section 408(e)(1) the tolerance exemptions identified in this
document under Sec. Sec.  180.910, 180.920, 180.930, and 180.940, with
the revocations effective 2 years after the date of publication of this
rule in the Federal Register.
    2. Five new tolerance exemptions for polymer chemicals. In this
final rule, EPA is establishing five tolerance exemptions under 40 CFR
180.960 for chemicals that meet the criteria for defining a low-risk
polymer under 40 CFR 723.250. No comments were received on the proposal
to establish these tolerance exemptions (71 FR 25993; EPA-HQ-OPP-2006-
0230). The establishment of these tolerance exemptions is effective on
the date of publication of this rule in the Federal Register.
    3. Revocations for administrative reasons. The Agency is revoking
seven redundant and incorrect tolerance exemptions under 40 CFR part
180, as described in this unit. No comments were received on the
proposal to revoke these tolerance exemptions (71 FR 25993; EPA-HQ-OPP-
2006-0230). These tolerance exemptions are revoked on the date of
publication of this rule in the Federal Register.
    i. In Sec.  180.920, the tolerance exemption for: ``Sodium mono-
and dimethyl naphthalenesulfonate; molecular weight (in amu) 245-260.''
    ii. In Sec.  180.930, the tolerance exemptions for: ``Ethyl vinyl
acetate (CAS Reg. No. 24937-78-8)'' and ``[alpha]-(Methylene (4-
(1,1,3,3-tetramethylbutyl)-o-phenylene)bis-[omega]-
hydroxypoly(oxyethylene) having 6-7.5 moles of ethylene oxide per
hydroxyl group.''
    iii. In Sec.  180.920 and 180.930, the tolerance exemptions for:
``Sodium butyl naphthalenesulfonate.''
    iv. In Sec.  180.910 and 180.930, the tolerance exemptions for:
``[alpha]-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70
moles of ethylene oxide; ...''.

B. EPA's Rsponses to Comments

    1. Identifying data gaps. Several commenters claim that EPA has not
communicated specific data gaps for each tolerance exemption, and has
been reticent in communicating whether testing must be conducted for
each chemical or whether inert ingredients can be grouped and data
submitted that supports all the inert ingredients within a group. EPA
disagrees. The proposed rule identified the data gaps that resulted in
the Agency being unable to make the safety finding of FFDCA section
408(c)(2). In addition, EPA discussed these topics at some depth during
both public meetings on the proposed revocation (See the Federal
Register of May 3, 2006 (71 FR 26000) (FRL-8068-5).
    In the proposed rule, EPA clearly stated that tests agreed to under
the Organization for Economic Cooperation and Development's (OECD)
Screening

Information Data Set (SIDS) program would have permitted the Agency to
evaluate the tolerance exemptions for reassessment. The proposed rule
stated that there are data gaps critical to reassessment including
acceptable repeat-dose, developmental, and reproductive toxicity
studies. EPA stated that 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). The
OECD SIDS is a well-known international program that also is used in
EPA's High Production Volume (HPV) program.
    In the proposed rule, EPA stated that for some inert ingredients,
the full SIDS may not be necessary because EPA has available a limited
number of studies and information (e.g., acute toxicity studies). The
Agency anticipates that most inert ingredients will only need the OECD
422 screening level study, but it must be noted that the results of
this study may indicate a need for further testing. EPA is reiterating
here the recommendation stated in the proposed rule that all parties
interested in supporting a chemical consult with EPA prior to embarking
on a testing strategy in order to determine the data gap and what data
the Agency already has available. In addition, the proposed rule lists
numerous broad multi-chemical tolerance exemptions, each of which could
encompass many chemicals. EPA continues to offer to work with industry
to clarify whether testing certain chemicals within a multi-chemical
tolerance exemption will suffice rather than testing each chemical in
the group. This will help reduce the number of studies conducted. EPA
is pleased to report that numerous companies have already consulted
with the Agency, and more meetings have been scheduled for the near
future.
    One commenter asserted that sufficient publicly available data
exists for several of the inert ingredients proposed for revocation.
The Agency disagrees. EPA searched Agency and publicly available data
sources, including EPA's HPV program, and found inadequate and
insufficient data for all of the inert ingredients being revoked in
this final rule.
    2. Concern about whether 2 years is sufficient time. Most
commenters expressed concern that the effective date of the revocation
action for the tolerance exemptions with insufficient data, which is 2
years from the publication of the final rule, is too short a timeframe
to identify supporters of inert ingredients, generate the data, and
complete Agency review. Some commenters asked for assurance that the
Agency will grant revocation extensions if a good-faith effort is
demonstrated by the supporter of an inert ingredient.
    The Agency determined that the safety finding of FFDCA section
408(c)(2) could not be made for the inert ingredient tolerance
exemptions with insufficient data being revoked in this final rule.
While the Agency does not anticipate dietary risks of concern for the
majority of these chemicals based on what is known of their physical-
chemical properties and the history of their use, the lack of data
requires revocation.
    EPA selected the 2-year timeframe after considering what data would
typically be needed to fill the data gaps for these inert ingredients.
As discussed in this unit, the Agency anticipates that most inert
ingredients will only need the OECD 422 screening level study to fill
the data gap. The OECD 422 is an oral 28-day repeat-dose screening
level study (with developmental and reproductive toxicity testing) that
is known to have a relatively short development time--approximately 9
months from test initiation to report completion. Two years provides
sufficient time for the study development and submission process, and
for Agency review and decisionmaking.
    The Agency is aware that unforeseen or other circumstances may make
it challenging to complete data development work within the 2-year
timeframe. The Agency envisions extending the expiration date of
individual inert ingredient tolerance exemptions on a case-by-case
basis when legitimate extenuating circumstances arise. EPA may be able
to through rulemaking delay the effective date of the revocation to
allow sufficient time for testing and data submission to be completed
when, soon after the publication of this final rule, the submitter
clearly communicates to EPA their commitment to support an inert
ingredient, demonstrates a concerted effort to develop and submit the
data within the 2-year timeframe, keeps the Agency informed of
challenging circumstances as they arise, and, most importantly,
provides the Agency with early indications of data that would support a
safety finding.
    Most commenters asserted that 2 years is an inadequate amount of
time if they need to reformulate their pesticide products with other
inert ingredients. The Agency believes that the majority of inert
ingredients affected by this final rule that are currently used in
pesticide products will be successfully supported with adequate data.
Developing the data, rather than costly reformulation, is the likely
path forward considering the relatively low cost of conducting the
screening level study (approximately $150,000). It should be noted that
for some pesticide products, no action is needed because the
registrants already have permission to use alternate inert ingredients
with tolerance exemptions that have been reassessed. The Agency will
work with registrants on a case-by-case basis if the tolerance
exemption for an inert ingredient cannot be reinstated because study
results are unacceptable.
    3. Low Risk Methodology and DCIs. Several commenters claim that EPA
has not followed the guidance of the ``Low Risk Methodology'' and
issued Data Call-In (DCI) notices requiring studies. The commenters are
referring to EPA's ``Guidance Document on Methodology for Determining
the Data Needed and the Types of Assessments Necessary to Make FFDCA
Section 408 Safety Determinations for Lower Toxicity Pesticide
Chemicals.'' Posted to EPA's website 4 years ago (June, 2002), this
non-binding guidance document was developed in cooperation with a
committee comprised of representatives of pesticide and industrial
chemical manufacturers. It generally describes the reassessment and
petition process for inert ingredients, sources of publicly available
data and information, and the types of data and information that might
be needed for risk characterization depending on various chemical-
related factors. The screening level assessments that EPA is using to
reassess inert ingredients are generally described in the guidance
document. Data are discussed in some detail in the guidance document,
including the need for repeat-dose, developmental, and reproductive
toxicity studies and the OECD 422 study. Therefore, the need for these
studies for inert ingredient reassessment has been public knowledge for
some time.
    The guidance document generally describes how DCIs are used by EPA,
but never states that the Agency would definitely issue DCIs for inert
ingredients. The mention of DCIs in the guidance document focuses on
chemicals that have significant toxicity concerns and need a more
robust (``Tier 3'') evaluation rather than a screening level
assessment. The guidance document states, ``These chemicals may have
already been classified as List 1 `inerts of toxicological concern' or
List 2 `potentially toxic inerts/high priority for testing.' Usually,
registrants whose products contain Tier 3 chemicals would be required
to provide these data via a Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA) section 3(c)(2)(B) DCI notice.'' The guidance
document wisely and purposefully built in flexibility to the general
process and states ``The policies and process described herein are not
binding on either EPA or pesticide registrants, and EPA may modify or
disregard the process described herein where circumstances warrant and
without prior notice.''
    Some commenters believe that EPA may not revoke a tolerance or
exemption for lack of supporting data unless it has first solicited
data through a DCI under FFDCA section 408(f)(1). Although FFDCA
section 408(f)(1) may be used to solicit data required to support a
tolerance or exemption, the statute provides direct authority for
revocation in the absence of such data. Section 408(q)(1)(C) of FFDCA
requires that ``100 percent of... tolerances and exemptions are
reviewed within 10 years of August 3, 1996.'' When reviewing a
tolerance exemption, FFDCA section 408(c)(2)(A)(i) provides the
following: The Administrator may establish or leave in effect an
exemption from the requirement for a tolerance for a pesticide chemical
residue in or on food only if the Administrator determines that the
exemption is safe. The Administrator shall modify or revoke an
exemption if the Administrator determines it is not safe.
    Under FFDCA section 408(c)(2)(A)(i) safety must be shown, and not
presumed: The term ``safe,'' with respect to an exemption for a
pesticide chemical residue, means that the Administrator has determined
that there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue, including all
anticipated dietary exposures and all other exposures for which there
is reliable information.
    Thus, EPA is required by August of 2006 to determine that all
tolerance exemptions are safe. And if there are insufficient data to
determine that an exemption is safe, the assessment mandated by FFDCA
section 408(q)(1)(C) requires that the Agency revoke the exemption,
regardless of whether a DCI has been issued.
    4. Request for guidance. Several commenters requested written
guidance, including process steps and schedules, on how to support
chemicals with insufficient data. EPA is now developing written
guidance that will help those interested in developing data on the
inert ingredients with insufficient data identified in this final rule.
The helpful guidance will include a recommended process with interim
steps toward the completion of the inert ingredient evaluation. For
example, the guidance will (among other things) suggest ways to:
    i. Demonstrate an intention to support an inert ingredient (such as
an official letter to the Agency).
    ii. Consult with the Agency on data gaps and chemicals to be
tested.
    iii. Show commitment by contracting with a testing laboratory.
    iv. Submit the study to the Agency.
The guidance will be made public on EPA's website and widely
distributed among industry and other interested stakeholders.
    5. Previously reassessed tolerance exemptions. Several commenters
noted that five tolerance exemptions were listed in the revocation
proposal by mistake because they had already been reassessed by the
Agency. The five tolerance exemptions are as follows:
    i. In both Sec.  180.910 and 180.930: ``[alpha]-Lauryl-[omega]-
hydroxypoly(oxyethylene), average molecular weight (in amu) of 600.''
    ii. In both Sec.  180.910 and 180.930: ``Polyglyceryl phthalate
ester of coconut oil fatty acids.''
    iii. In Sec. 180.920: ``Tall oil diesters with polypropylene glycol
(CAS Reg. No. 68648-12-4).''
    Previous Agency reassessment determinations did include four of the
above-listed tolerance exemptions, however, subsequent to those
decisions, it was determined that the inert ingredients were
erroneously included in those reassessment documents. In the case of
polyglyceryl phthalate esters of coconut oil fatty acids, the two
tolerance exemptions were initially considered to be reassessed based
primarily upon an inaccurate assumption that the molecular weights for
this inert ingredient are greater than 1,000 amu. The tolerance
exemptions are no longer considered to be reassessed because there are
no molecular weight limitation in the inert ingredient's tolerance
exemption expressions. In the case of [alpha]-Lauryl-[omega]-
hydroxypoly(oxyethylene), the two tolerance exemptions were
inappropriately included in a reassessment document as a member of a
group of polyethylene glycol fatty acid ester-type substances. The
tolerance exemptions are no longer considered to be reassessed because
they are not a part of this group. The reassessment documents that
initially erroneously included these four tolerance exemptions have
been revised and these tolerance exemptions have been removed. The
Agency then attempted to evaluate these inert ingredients but found
that insufficient data exists to make the FQPA reasonable certainty of
no harm safety finding. As a result, the Agency is revoking the four
tolerance exemptions in this final rule.
    The tolerance exemption for ``Tall oil diesters with polypropylene
glycol (CAS Reg. No. 68648-12-4)'' in Sec.  180.920 has not been
reassessed and is not part of any reassessment document.
    6. Channels of trade. Commenters raised two issues regarding
channels of trade. First, a number of commenters indicated that
existing stocks of pesticides containing ingredients whose exemptions
are to be revoked, or of chemical blends intended only for such
pesticides, may not be used up by the time the exemption expires. As
stated in this unit, the Agency envisions extending the expiration date
of individual inert ingredient tolerance exemptions on a case-by-case
basis when circumstances allow. Nevertheless, the Agency does not
anticipate serious existing stocks problems as a result of this
revocation action. The Agency believes that submission of acceptable
new studies and acceptable existing studies that were previously
unavailable to EPA will keep the need to reformulate pesticide products
to a minimum. The Agency has already received several communications
from pesticide registrants indicating their intention to submit
unpublished data in their possession, and an industry association has
stated that they are working to obtain unpublished data cited in
various publications.
    Second, one commenter raised a question regarding FFDCA section
408(l)(5), which provides that commodities containing pesticide
residues whose tolerances or exemptions that have been revoked are not
considered adulterated provided that it is shown to the satisfaction of
the Food and Drug Administration (FDA) that:
    i The residue is present as the result of an application or use of
a pesticide at a time and in a manner that was lawful under FIFRA.
    ii. The residue does not exceed a level that was authorized at the
time of that application or use to be present on the food under a
tolerance, exemption, or food additive regulation.
The commenter stated that it is highly doubtful that the agriculture
industry would be able to provide FDA sufficient documentation to meet
the standards in this provision. EPA has revoked a large number of
tolerances since the enactment of FQPA, and is not aware of widespread
difficulties in this area.
    7. Data compensation. A number of commenters have expressed concern
regarding the ability to receive compensation under FFDCA section

408(i) for data generated to demonstrate the safety of the ingredients
subject to this revocation. EPA has made clear that it interprets FFDCA
section 408(i) to provide exclusive use and data compensation rights in
data submitted to EPA by pesticide registrants or inert ingredient
manufacturers and sellers to support or maintain tolerances or
tolerance exemptions for inert ingredients. See the Federal Register of
April 17, 2003 (68 FR 18977) (FRL-7279-9). Accordingly, should EPA rely
upon such data to reinstate any of the listed tolerance exemptions
subject to this action, such data will be subject to the protections of
FFDCA section 408(i). The obligation for others to provide compensation
for such protected data would accrue from DCIs as well as registration
and registration review actions under FIFRA with respect to products
containing the ingredients subject to this revocation action.
    8. Cost of the rule, OMB review, and the Regulatory Flexibility
Act. Several commenters expressed the opinion that the costs of the
rule are significant, exceeding the $100 million threshold for OMB
review under Executive Order 12866. Commenters also claimed EPA's
analysis of the impact on small business did not comply with the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.). The costs
asserted by the commenters include, among other things, testing of
every ingredient subject to the tolerance exemptions to be revoked,
lost sales due to cancellation of pesticides because of the
revocations, lost value to farmers resulting from the unavailability of
these pesticides, and the cost of reformulation to change inert
ingredients. These costs have been estimated by some commenters to be
in excess of 1 billion dollars.
    EPA disagrees with this analysis. Companies will choose the lowest
cost alternative between testing, reformulation, and abandoning a
product. In most cases, testing, which EPA expects to average around
$150,000, will be by far the cheapest alternative, and EPA anticipates
very few instances in which reformulation or pesticide product
abandonment will be appropriate. EPA also anticipates that testing will
not have to be performed for every chemical affected for several
reasons. First, it is likely that some of these exemptions cover
chemicals no longer used in pesticide products. Testing would not be
conducted for such chemicals and there would be no costs for
reformulation or due to pesticide product cancellation. Second,
preliminary discussions with pesticide registrants and inert ingredient
manufacturers that would be affected by this rule suggest that there
are a significant number of unpublished studies already conducted that
would meet the data needs identified here. Third, in many instances,
similarities among these chemicals will allow EPA to rely on data
produced on one chemical to support another chemical or a whole group
of chemicals. Therefore, the overall cost of this rule will be far
below the Executive Order 12866 threshold.
    Although several commenters claimed that EPA's RFA certification of
no significant impact on a substantial number of small businesses was
deficient, little or no explanation was provided for that claim other
than to argue that EPA needed to perform a more comprehensive analysis.
EPA has reexamined this question and again concluded that there will be
no significant negative impact on a substantial number of small
entities (here, small businesses). As explained in this unit, the costs
associated with this action are most likely to be testing costs borne
by pesticide registrants. EPA has identified 1,720 pesticide
registrants and approximately 58% of this total meet the definition of
a small business. Even assuming some of these small businesses have to
conduct testing on their own, the cost of testing ($150,000) would only
be a small fraction of average annual sales for these companies
(0.60%). EPA believes, however, that it is unlikely that small
pesticide registrants will bear solely the costs of testing for an
exemption. First, for the reasons explained in this unit, EPA believes
that the number of tests conducted will be far fewer than the number of
inert ingredients covered by these revocations. Second, and more to the
point, the statute has cost-sharing provisions to ensure that the costs
are divided between all affected parties. Although EPA has not matched
up exemptions with pesticide products for pesticide registrants, EPA
expects impacts to be widely spread through the group of 1,720
registrants because the same inert ingredients are frequently used in
several pesticide products. Therefore, in all likelihood, the costs
will be divided between many registrants. In fact, EPA has information
indicating task forces are already being formed to share the cost of
producing data. One commenter asserted that small registrants did not
have the resources to participate in cost-sharing task forces. EPA's
analysis, however, suggests that the shared costs of conducting these
studies will be insignificant. Finally, with respect to RFA, EPA would
note that tolerance revocations generally are under FFDCA, and these
actions in particular, are based solely on safety grounds, and costs
may not be considered. For example, it would not be relevant under
FFDCA to contest these revocations on the ground that the tests needed
to demonstrate safety are too costly. Thus, the testing costs
associated with this rule are not actually costs that must be
considered under the RFA in determining whether there is an impact on
small entities.

C. 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 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.

D. When do These Actions Become Effective?

    1. EPA is revoking the tolerance exemptions identified in this
document that have insufficient data effective 2 years after the date
of publication of this rule in the Federal Register. Any commodities
listed in this rule treated with pesticide products containing the
inert ingredients 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 FDA that:
    i. 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.

    ii. 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.
    2. EPA is establishing new tolerance exemptions under 40 CFR
180.960 effective on the date of publication of this rule in the
Federal Register.
    3. EPA is revoking for administrative reasons the redundant and
incorrect tolerance exemptions identified in this document under 40 CFR
180.910, 180.920, and 180.930 effective on the date of publication of
this rule in the Federal Register.

E. 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 3,
1996. This document revokes 130 inert ingredient tolerance exemptions,
which count 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

    This rule establishes and revokes tolerance exemptions under
section 408(d) of FFDCA. 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 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
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 RFA (5 U.S.C. 601 et seq), the Agency hereby certifies
that this action will not have a significant negative economic impact
on a substantial number of small entities. The factual basis for this
certification is included in Unit II.B.8.
    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 (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 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.

V. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must

submit a rule report, which includes a copy of the rule, to each House
of the Congress and to the Comptroller General of the United States.
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
this final rule in the Federal Register. This final rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: July 31, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
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]

0
2. In Sec.  180.910, the table is amended by removing the following
entries:
    a. [alpha]-Alkyl (C9-C18-[omega]-
hydroxypoly(oxyethylene) with poly(oxyethylene) content of 2-30 moles.
    b. [alpha]-(p-Alkylphenyl)-[omega]-hydroxypoly(oxyethylene)
produced by the condensation of 1 mole of alkylphenol (alkyl is a
mixture of propylene tetramer and pentamer isomers and averages
C13) with 6 moles of ethylene oxide.
    c. [alpha]-Alkyl (C6-C14)-[omega]-
hydroxypoly(oxypropylene) block copolymer with polyoxyethylene;
polyoxypropylene content is 1-3 moles; polyoxyethylene content is 4-12
moles; average molecular weight (in amu) is approximately 635.
    d. [alpha]-(p-tert-Butylphenyl)-[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 4-12 moles.
    e. [alpha]-(o,p-Dinonylphenyl)-[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 nonyl
group is a propylene trimer isomer and the poly(oxyethylene) content
averages 4-14 moles.
    f. [alpha]-(o,p-Dinonylphenyl)-[omega]-hydroxypoly (oxyethylene)
produced by condensation of 1 mole of dinonylphenol (nonyl group is a
propylene trimer isomer) with an average of 4-14 or 140-160 moles of
ethylene oxide.
    g. Dodecylbenzenesulfonic acid, amine salts.
    h. [alpha]-(p-Dodecylphenyl)-[omega]-hydroxypoly (oxyethylene)
produced by the condensation of 1 mole of dodecylphenol (dodecyl group
is a propylene tetramer isomer) with an average of 4-14 or 30-70 moles
of ethylene oxide; if a blend of products is used, the average number
of moles of ethylene oxide reacted to produce any product that is a
component of the blend shall be in the range of 4-14 or 30-70.
    i. Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, the
ethylene oxide content averages 3.5, 10, or 30 moles.
    j. [alpha]-Lauryl-[omega]-hydroxypoly(oxyethylene), average
molecular weight (in amu) of 600.
    k. [alpha]-Lauryl-[omega]-hydroxypoly(oxyethylene) sulfate, sodium
salt; the poly(oxyethylene) content is 3-4 moles.
    l. Manganous oxide.
    m. [alpha]-(p-Nonylphenyl)-[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 nonyl
group is a propylene trimer isomer and the poly (oxyethylene) content
averages 4-14 moles or 30 moles.
    n. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)
sulfate, ammonium, calcium, magnesium, potassium, sodium, and zinc
salts; the nonyl group is a propylene trimer isomer and the
poly(oxyethylene) content averages 4 moles.
    o. Polyglyceryl phthalate ester of coconut oil fatty acids.
    p. Poly(methylene-p-tert-butylphenoxy)- poly(oxyethylene) ethanol;
the poly(oxyethylene) content averages 4-12 moles.
    q. Poly(methylene-p-nonylphenoxy)poly(oxyethylene) ethanol; the
poly(oxyethylene) content averages 4-12 moles.
    r. Secondary alkyl (C11-C15)
poly(oxyethylene) acetate, sodium salt; the ethylene oxide content
averages 5 moles.
    s. Sodium diisobutylnaphthalenesulfonate.
    t. Sodium dodecylphenoxybenzenedisulfonate.
    u. Sodium isopropylisohexylnaphthalenesulfonate.
    v. Sodium lauryl glyceryl ether sulfonate.
    w. Sodium monoalkyl and dialkyl (C8-C16)
phenoxybenzenedisulfonate mixtures containing not less than 70% of the
monoalkylated product.
    x. Sodium mono- and dimethylnaphthalenesulfonates, molecular weight
(in amu) 245-260.
    y. Sodium mono-, di-, and tributyl naphthalenesulfonates.
    z. Sodium mono-, di-, and triisopropyl naphthalenesulfonate.
    aa. Sodium N-oleoyl-N-methyltaurine.
    bb. Sodium sulfite.
    cc. [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of
ethylene oxide: if a blend of products is used, the average range
number of moles of ethylene oxide reacted to produce any product that
is a component of the blend shall be in the range of 1-14 or 30-70.
    dd. [alpha]-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70
moles of ethylene oxide; if a blend of products is used, the average
number of moles of ethylene oxide reacted to produce any product that
is a component of the blend shall be in the range of 4-14 or 30-70.
    ee. Tridecylpoly(oxyethylene) acetate, sodium salt; where the
ethylene oxide content averages 6-7 moles.

Sec.  180.920  [Amended]

0
3. In Sec.  180.920, the table is amended by removing the following
entries:
    a. [alpha]-Alkyl (C12-C18)-[omega]-
hydroxypoly(oxyethylene) copolymers with poly(oxypropylene);
polyoxyethylene content averages 3-12 moles and polyoxypropylene
content 2-9 moles.
    b. [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.
    c. [alpha]-Alkyl (C12-C15)-[omega]-
hydroxypoly(oxyethylene)

sulfosuccinate, isopropylamine and N-hydroxyethyl isopropylamine salts
of; the poly(oxyethylene) content averages 3-12 moles.
    d. [alpha]-Alkyl(C10-12)-[omega]-
hydroxpoly(oxyethylene) poly(oxypropylene) copolymer; poly(oxyethylene)
content is 11-15 moles; poly(oxyproplene) content is 1-3 moles.
    e. [alpha]-Alkyl(C12-C18)-[omega]-hydroxypoly
(oxyethylene/oxypropylene) hetero polymer in which the oxyethylene
content averages 13-17 moles and the oxypropylene content averages 2-6
moles.
    f. [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.
    g. [alpha]-Alkyl (C12-C18)-[omega]-
hydroxypoly(oxyethylene/oxypropylene) hetero polymer in which the
oxyethylene content is 8-12 moles and the oxypropylene content is 3-7
moles.
    h. [alpha]-Alkyl (C12-C15)-[omega]-
hydroxypoly(oxyethylene/oxypropylene) hetero polymer in which the
oxyethylene content is 8-13 moles and the oxypropylene content is 7-30
moles.
    i. [alpha]-Alkyl (C21-C71)-[omega]-
hydroxypoly (oxyethylene) in which the poly(oxyethylene) content is 2
to 91 moles and molecular weight range from 390 to 5,000.
    j. n-Alkyl(C8-C18)amine acetate.
    k. Amine salts of alkyl (C8-C24)
benzenesulfonic acid (butylamine, dimethylaminopropylamine, mono- and
diisopropylamine, mono- , di- , and triethanolamine).
    l. N-(Aminoethyl) ethanolamine salt of dodecylbenzenesulfonic acid.
    m. N,N-Bis[[alpha]-ethyl-[omega]-hydroxypoly(oxyethylene)
alkylamine; the poly(oxyethylene) content averages 3 moles; the alkyl
groups (C14-C18) are derived from tallow, or from
soybean or cottonseed oil acids.
    n. N,N-Bis(2-hydroxyethyl)alkylamine, where the alkyl groups
(C8-C18) are derived from coconut, cottonseed,
soya, or tallow acids.
    o. N,N-Bis 2-([omega]-hydroxypolyoxyethylene) ethyl) alkylamine;
the reaction product of 1 mole N,N-bis(2-hydroxyethyl)alkylamine and 3-
60 moles of ethylene oxide, where the alkyl group (C8-
C18) is derived from coconut, cottonseed, soya, or tallow
acids.
    p. N,N-Bis-2-([omega]-hydroxypolyoxyethylene/polyoxypropylene)
ethyl alkylamine; the reaction product of 1 mole of N,N-bis(2-
hydroxyethyl alkylamine) and 3-60 moles of ethylene oxide and propylene
oxide, where the alkyl group (C8-C18) is derived
from coconut, cottonseed, soya, or tallow acids.
    q. Butoxytriethylene glycol phosphate.
    r. Cyclohexanol.
    s. [alpha]-(Di-sec-butyl)phenylpoly(oxypropylene) block polymer
with poly(oxyethylene); the poly(oxypropylene) content averages 4
moles, the poly(oxyethylene) content averages 5 to 12 moles, the
molecular.
    t. Disodium 4-isodecyl sulfosuccinate.
    u. Dodecylphenol.
    v. [alpha]-Dodecylphenol-[omega]-hydroxypoly(oxyethylene/
oxypropylene) hetero polymer where ethylene oxide content is 11-13
moles and oxypropylene content is 14-16 moles, molecular weight (in
amu) averages 600 to 965.
    w. Isopropylbenzenesulfonic acid and its ammonium, calcium,
magnesium, potassium, sodium, and zinc salts.
    x. (3-Lauramidopropyl) trimethylammonium methyl sulfate.
    y. Linoleic diethanolamide (CAS Reg. No. 56863-02-6).
    z. Methyl bis(2-hydroxyethyl)alkyl ammonium chloride, where the
carbon chain (C8-C18) is derived from coconut,
cottonseed, soya, or tallow acids.
    aa. [alpha],[alpha]'-[Methylenebis]-4-(1,1,3,3-tetramethylbutyl)-o-
phenylene bis[[omega]-hydroxypoly(oxyethylene)] having 6-7.5 moles of
ethylene oxide per hydroxyl group.
    bb. Methylnaphthalenesulfonic acid--formaldehyde condensate, sodium
salt.
    cc. Methyl poly(oxyethylene) alkyl ammonium chloride, where the
poly(oxyethylene) content is 3-15 moles and the alkyl group
(C8-C18) is derived from coconut, cottonseed,
soya, or tallow acids.
    dd. Methyl violet 2B.
    ee. Morpholine salt of dodecylbenzenesulfonic acid.
    ff. Naphthalenesulfonic acid-formaldehyde condensate, ammonium and
sodium salts.
    gg. Partial sodium salt of N-lauryl-[alpha]-iminodipropionic acid.
    hh. Poly(methylene-p-nonylphenoxy)poly(oxypropylene) propanol; the
poly(oxy-propylene) content averages 4-12 moles.
    ii. Primary n-alkylamines, where the alkyl group (C8-
C18) is derived from coconut, cottonseed, soya, or tallow
acids.
    jj. Sodium butyl naphthalenesulfonate.
    kk. Sodium 1,4-dicyclohexyl sulfosuccinate.
    ll. Sodium 1,4-dihexyl sulfosuccinate.
    mm. Sodium 1,4-diisobutyl sulfosuccinate.
    nn. Sodium 1,4-dipentyl sulfosuccinate.
    oo. Sodium 1,4-ditridecyl sulfosuccinate.
    pp. Sodium mono- and dimethyl naphthalenesulfonate; molecular
weight (in amu) 245-260.
    qq. Sulfosuccinic acid ester with N-(2,-hydroxy-propyl) oleamide,
ammonia and isopropylamine salts of.
    rr. Tall oil diesters with polypropylene glycol (CAS Reg. No.
68648-12-4).
    ss. N,N,N',N''-Tetrakis-(2-hydroxypropyl) ethylenediamine.
    tt. [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding sodium salts of the
phosphate esters; the poly(oxyethylene) content averages 6 to 10 moles.

Sec.  180.930  [Amended]

0
4. In Sec.  180.930, the table is amended by removing the following
entries:
    a. [alpha]-Alkyl (C9-C18)-[omega]-hydroxy
poly(oxyethylene): the poly(oxyethylene) content averages 2-20 moles.
    b. [alpha]-Alkyl (C12-C15)-[omega]-
hydroxypoly(oxyethylene/oxypropylene) hetero polymer in which the
oxyethylene content is 8-13 moles and the oxypropylene content is 7-30
moles.
    c. [alpha]-Alkyl (C8-C10)
hydroxypoly(oxypropylene) block polymer with polyoxyethylene;
polyoxypropylene content averages 3 moles and polyoxyethylene content
averages 5-12 moles.
    d. [alpha]-Alkyl (C6-C14)-[omega]-
hydroxypoly(oxypropylene) block copolymer with polyoxyethylene;
polyoxypropylene content is 1-3 moles; polyoxyethylene content is 7-9
moles; average molecular weight (in amu) approximately 635.
    e. [alpha]-(p-Alkylphenyl)-[omega]-hydroxypoly (oxyethylene)
produced by the condensation of 1 mole of alkylphenol (alkyl is a
mixture of propylene tetramer and pentamer isomers and averages
C13) with 6 moles of ethylene oxide.
    f. Amine salts of alkyl (C8-C24)
benzenesulfonic acid (butylamine; dimethylamino propylamine; mono- and
diisopropyl- amine; and mono- , di-, and triethanolamine).
    g. [alpha]-(p-tert- Butylphenyl)-[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 4-12 moles.
    h. [alpha]-(o,p-Dinonylphenyl)-[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 nonyl
group is a propylene trimer isomer and the poly(oxyethylene) content
averages 4-14 moles.
    i. [alpha]-(o,p-Dinonylphenyl)-[omega]-hydroxypoly (oxyethylene),
produced by the condensation of 1 mole of dinonylphenol (nonyl group is
a propylene trimer isomer) with an average of 4-14 moles of ethylene
oxide.
    j. Dodecylbenzenesulfonic acid, amine salts.
    k. [alpha]-(p-Dodecylphenyl)-[omega]-hydroxypoly (oxyethylene)
produced by the condensation of 1 mole of dodecylphenol (dodecyl group
is a propylene tetramer isomer) with an average of 4-14 or 30-70 moles
of ethylene oxide; if a blend of products is used, the average number
of moles of ethylene oxide reacted to produce any product that is a
component of the blend shall be in the range of 4-14 or 30-70 moles.
    l. Ethylene oxide adducts of 2,4,7,9-tetramethyl-5-decynediol, the
ethylene oxide content averages 3.5, 10, or 30 moles.
    m. Ethyl vinyl acetate (CAS Reg. No. 24937-78-8).
    n. [alpha]-Lauryl-[omega]-hydroxypoly(oxyethylene), average
molecular weight (in amu) of 600.
    o. [alpha]-Lauryl-[omega]-hydroxypoly(oxyethylene), sulfate, sodium
salt; the poly(oxyethylene) content is 3-4 moles.
    p. Manganous oxide.
    q. [alpha]-(Methylene (4-(1,1,3,3-tetramethylbutyl)-o-phenylene)
bis-[omega]-hydroxypoly(oxyethylene) having 6-7.5 moles of ethylene
oxide per hydroxyl group.
    r. Mono-, di-, and trimethylnaphthalenesulfonic acids-formaldehyde
condensates, sodium salts.
    s. Naphthalenesulfonic acid and its sodium salt.
    t. [alpha]-(p-Nonylphenyl)-[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 nonyl
group is a propylene trimer isomer and the poly(oxyethylene) content
averages 4-14 moles.
    u. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)
sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and
zinc salts; the nonyl group is a propylene trimer isomer and the
poly(oxyethylene) content averages 4 moles.
    v. [alpha]-(p-Nonylphenyl)-[omega]-hydroxypoly(oxyethylene)
sulfate, and its ammonium, calcium, magnesium, monoethanolamine,
potassium, sodium, and zinc salts; the nonyl group is a propylene
trimer isomer and the poly(oxyethylene) content averages 4-14 or 30-90
moles of ethyiene oxide.
    w. Polyglyceryl phthalate esters of coconut oil fatty acids.
    x. Poly(methylene-p-tert-butylphenoxy)poly(oxyethylene) ethanol;
the poly(oxyethylene) content averages 4-12 moles.
    y. Poly(methylene-p-nonylphenoxy)poly(oxyethylene) ethanol; the
poly(oxyethylene) content averages 4-12 moles.
    z. Poly(methylene-p-nonylphenoxy)poly(oxypropylene) propanol; the
poly(oxypropylene) content averages 4-12 moles.
    aa. Secondary alkyl (C11-C15)
poly(oxyethylene) acetate, sodium salt; the ethylene oxide content
averages 5 moles.
    bb. Sodium butylnaphthalenesulfonate.
    cc. Sodium diisobutylnaphthalenesulfonate.
    dd. Sodium isopropylisohexylnaphthalenesulfonate.
    ee. Sodium isopropylnaphthalenesulfonate.
    ff. Sodium monoalkyl and diakyl (C8-C13)
phenoxybenzenedisulfonate mixtures containing not less than 70% of the
monoalkylated product.
    gg. Sodium mono- and dimethylnaphthalenesulfonate, molecular weight
(in amu) 245-260.
    hh. Sodium mono-, di-, and tributylnaphthalenesulfonates.
    ii. Sodium N-oleoyl-N-methyl taurine.
    jj. [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p
(1,1,3,3-tetramethylbutyl)phenol with a range of 1-14 or 30-70 moles of
ethylene oxide: if a blend of products is used, the average range
number of moles of ethylene oxide reacted to produce any product that
is a component of the blend shall be in the range of 1-14 or 30-70.
    kk. [alpha]-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-[omega]-
hydroxypoly(oxyethylene) produced by the condensation of 1 mole of p-
(1,1,-3,3-tetramethylbutyl) phenol with an average of 4-14 or 30-70
moles of ethylene oxide; if a blend of products is used, the average
number of moles of ethylene oxide reacted to produce any product that
is a component of the blend shall be in the range of 4-14 or 30-70.
    ll. Tridecylpoly(oxyethylene) acetate sodiums salt; where the
ethylene oxide content averages 6-7 moles.

Sec.  180.940  [Amended]

0
5. Section 180.940 is amended as follows:

0
a. The table in paragraph (a) is amended by removing the following
entries:
    i. [alpha]-Alkyl(C10-C14)-[omega]-
hydroxypoly (oxyethylene) poly(oxypropylene) average molecular weight
(in amu), 768 to 837.
    ii. [alpha]-Alkyl(C12-C18)-[omega]
hydroxypoly (oxyethylene) poly(oxypropylene) average molecular weight
(in amu), 950 to 1120.

0
b. The table in paragraph (b) is amended by removing the following
entries:
    i. [alpha]-Lauroyl-[omega]-hydroxypoly (oxyethylene) with an
average of 8-9 moles ethylene oxide, average molecular weight (in amu),
400.
    ii. Oxirane, methyl-, polymer with oxirane, ether with (1,2-
ethanediyldinitrilo)tetrakis [propanol] (4:1).

0
c. The table in paragraph (c) is amended by removing the following
entries:
    i. [alpha]-Alkyl(C10-C14)-[omega]-hydroxypoly
(oxyethylene) poly (oxypropylene) average molecular weight (in amu),
768 to 837.
    ii. [alpha]-Alkyl(C11-C15)-[omega]-
hydroxypoly (oxyethylene) with ethylene oxide content 9 to 13 moles.
    iii. [alpha]-Alkyl(C12-C15)-[omega]-
hydroxypoly (oxyethylene) polyoxypropylene, average molecular weight
(in amu), 965.
    iv. [alpha]-Alkyl(C12-C18)-[omega]-
hydroxypoly (oxyethylene) poly(oxypropylene) average molecular weight
(in amu), 950 to 1120.
    v. [alpha]-Lauroyl-[omega]-hydroxypoly (oxyethylene) with an
average of 8-9 moles ethylene oxide, average molecular weight (in amu),
400.
    vi. Naphthalene sulfonic acid, sodium salt.
    vii. Naphthalene sulfonic acid sodium salt, and its methyl,
dimethyl and trimethyl derivatives.
    viii. Naphthalene sulfonic acid sodium salt, and its methyl,
dimethyl and trimethyl derivatives alkylated at 3% by weight with
C6-C9 linear olefins.

    ix. Oxirane, methyl-, polymer with oxirane, ether with (1,2-
ethanediyldinitrilo)tetrakis [propanol] (4:1).

Sec.  180.960  [Amended]

6. In Sec.  180.960, the table is amended by alphabetically adding the
following entries:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                  Polymer                              CAS No.
------------------------------------------------------------------------
                                * * * * *
[alpha]-(o,p-Dinonylphenyl)-[omega]-        9014-93-1
 hydroxypoly(oxyethylene) produced by
 condensation of 1 mole of dinonylphenol
 (nonyl group is a propylene trimer
 isomer) with an average of 140-160 moles
 of ethylene oxide
------------------------------------------------------------------------
                                * * * * *
[alpha]-(p-Dodecylphenyl)-[omega]-          9014-92-0
 hydroxypoly(oxyethylene) produced by the   26401-47-8
 condensation of 1 mole of dodecylphenol
 (dodecyl group is a propylene tetramer
 isomer) with an average of 30-70 moles of
 ethylene oxide
------------------------------------------------------------------------
                                * * * * *
[alpha]-(p-Nonylphenyl)-[omega]-            None
 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
 nonyl group is a propylene trimer isomer
 and the poly(oxyethylene) content
 averages 30 moles
------------------------------------------------------------------------
[alpha]-(p-Nonylphenyl)-[omega]-            None
 hydroxypoly(oxyethylene) sulfate, and its
 ammonium, calcium, magnesium,
 monoethanolamine, potassium, sodium, and
 zinc salts; the nonyl group is a
 propylene trimer isomer and the
 poly(oxyethylene) content averages 30-90
 moles of ethylene oxide
------------------------------------------------------------------------
                                * * * * *
[alpha]-[p-(1,1,3,3-                        9036-19-5
 Tetramethylbutyl)phenyl]-[omega]-          9002-93-1
 hydroxypoly(oxyethylene) produced by the
 condensation of 1 mole of p-(1,1,3,3-
 tetramethylbutyl)phenol with a range of
 30-70 moles of ethylene oxide
------------------------------------------------------------------------
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E6-12877 Filed 8-8-06; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Notices]
[Page 42887-42888]
[DOCID:fr25au09-60]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

August 18, 2009.
    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG09-85-000.
    Applicants: Ashtabula Wind II, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Ashtabula Wind II, LLC.
    Filed Date: 08/17/2009.
    Accession Number: 20090817-5141.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: EG09-86-000.
    Applicants: Elk City Wind, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of Elk City Wind, LLC.
    Filed Date: 08/17/2009.
    Accession Number: 20090817-5181.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: EG09-87-000.
    Applicants: FPL Energy Stateline II, Inc.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of FPL Energy Stateline II, Inc.
    Filed Date: 08/17/2009.
    Accession Number: 20090817-5182.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: EG09-88-000.
    Applicants: FPL Energy Illinois Wind, LLC.
    Description: Notice of Self-Certification of Exempt Wholesale
Generator Status of FPL Energy Illinois Wind, LLC.
    Filed Date: 08/17/2009.
    Accession Number: 20090817-5183.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER09-659-002.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits revisions to the
Agreement between Southwest Power Pool, Inc and Entergy Services, Inc.
    Filed Date: 08/17/2009.
    Accession Number: 20090818-0035.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: ER09-1064-004.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corp. reports
that clean tariff sheets composing Attachment A to that filing
inadvertently failed to incorporate all the changes reflected in the
redline tariff sheets etc.
    Filed Date: 08/11/2009.
    Accession Number: 20090811-0050.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 01, 2009.

    Docket Numbers: ER09-1252-001.
    Applicants: Midwest Independent Transmission System, MidAmerican
Energy Company.
    Description: Midwest Independent Transmission System Operator, Inc
et al. submits the instant Compliance Filing.
    Filed Date: 08/17/2009.
    Accession Number: 20090818-0036.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: ER09-1253-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits proposed revisions to Attachment P of the Midwest ISO's Open
Access Transmission, Energy and Operating Reserve Markets Tariffs, FERC
Electric Tariff, Fourth Revised Volume 1.
    Filed Date: 08/17/2009.
    Accession Number: 20090818-0034.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: ER09-1590-000.
    Applicants: Xcel Energy Services Inc.
    Description: Southwestern Public Service Company et al. submits the
proposed cancellation of the New Century Operating Companies Open
Access Transmission Tariff, Second Revised Volume 1.
    Filed Date: 08/17/2009.
    Accession Number: 20090818-0001.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: ER09-1591-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Company submits Service Schedule C for
inclusion in the Contract for Interchange Service with Seminole
Electric Coop, Inc.
    Filed Date: 08/17/2009.
    Accession Number: 20090817-4003.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: ER09-1592-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Co submits a Wholesale Work
Performance Agreement with Shelter Cove Resort Improvement District 1.
    Filed Date: 08/17/2009.
    Accession Number: 20090818-0008.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: ER09-1593-000.
    Applicants: Florida Power & Light Company.
    Description: Florida Power & Light Co submits a new Service
Agreement 269, Service Agreement for Long-Term Firm Point-to-Point
Transmission Service with Georgia Transmission Corporation.
    Filed Date: 08/17/2009.
    Accession Number: 20090818-0007.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: ER09-1594-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Co submits Service Schedule C for
inclusion in the Agreement for Interchange Service with City of
Lakeland, Florida.
    Filed Date: 08/17/2009.
    Accession Number: 20090818-0005.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: ER09-1595-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Co submits Service Schedule C for
inclusion in the Contract for Interchange Service with Florida Power
Corp.
    Filed Date: 08/17/2009.
    Accession Number: 20090818-0004.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: ER09-1596-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc submits
proposed revisions to its Market Administration and Control Area
Services Tariff.
    Filed Date: 08/17/2009.

    Accession Number: 20090818-0003.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: ER09-1597-000.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Co submits Service Schedule C for
inclusion in the Contract for Interchange Service with Reedy Creek
Improvement District.
    Filed Date: 08/17/2009.
    Accession Number: 20090818-0002.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: ER09-1598-000.
    Applicants: Nevada Power Company.
    Description: Nevada Power Company submits FERC Rate Schedule 52--
Supplemental Power Service Agreement with City of Boulder City, NV et
al.
    Filed Date: 08/17/2009.
    Accession Number: 20090818-0038.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Take notice that the Commission received the following open access
transmission tariff filings:

    Docket Numbers: OA07-36-005; OA08-46-004.
    Applicants: South Carolina Electric & Gas Company.
    Description: Attachment K Compliance Filing of South Carolina
Electric & Gas Company, et al.
    Filed Date: 08/17/2009.
    Accession Number: 20090817-5192.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: OA08-20-003.
    Applicants: Tampa Electric Company.
    Description: Compliance Filing of Tampa Electric Company.
    Filed Date: 08/17/2009.
    Accession Number: 20090817-5187.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: OA08-22-003.
    Applicants: Florida Power Corporation.
    Description: Compliance Filing of Florida Power Corporation.
    Filed Date: 08/17/2009.
    Accession Number: 20090817-5188.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: OA08-29-002.
    Applicants: Florida Power & Light Company.
    Description: Florida Power & Light Company Order No. 890 Attachment
K Compliance Filing.
    Filed Date: 08/17/2009.
    Accession Number: 20090817-5190.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: OA08-36-004.
    Applicants: Cleco Power LLC.
    Description: Attachment K Compliance Filing of Cleco Power LLC.
    Filed Date: 08/17/2009.
    Accession Number: 20090817-5191.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: OA08-37-004.
    Applicants: Southern Company Services, Inc.
    Description: Compliance Filing of Southern Company Services, Inc.
under OA08-37.
    Filed Date: 08/17/2009.
    Accession Number: 20090817-5204.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: OA08-50-005; OA08-51-004.
    Applicants: Duke Energy Carolinas, LLC, Progress Energy Carolinas,
Inc.
    Description: Compliance Filing of Duke Energy Carolinas, LLC, et
al.
    Filed Date: 08/17/2009.
    Accession Number: 20090817-5185.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.

    Docket Numbers: OA08-59-007.
    Applicants: Entergy Services, Inc.
    Description: Entergy Operating Companies submits compliance filing
to amend Attachment K to Entergy's Open Access Transmission Tariff.
    Filed Date: 08/17/2009.
    Accession Number: 20090818-0037.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 08, 2009.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-20354 Filed 8-24-09; 8:45 am]

BILLING CODE 6717-01-P


1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Chemical: S metolachlor PC Code: 108800 DP Barcode: DP324973, DP327861 MEMORANDUM DATE: May 31, 2006 SUBJECT: Transmittal Memo for the Ecological Risk Assessment for the Use of Smetolachlor on Pumpkins and Winter Squash ( IR 4, DP 324973) and on Pumpkins in New York State ( S18, DP 327861)

FROM: Paige Doelling Brown, Ph. D., Fisheries Biologist James Hetrick, Ph. D., Senior Chemist Nancy Andrews, Ph. D, Branch Chief Environmental Risk Branch 1 Environmental Fate and Effects Division ( 7507P)

TO: Joanne Miller, Product Manager, Herbicide Branch ( 23) Barbara Madden, Risk Integration, Minor Use, Emergency Response Branch Daniel Rosenblatt, Team Leader, Emergency Response Team Registration Division ( 7507P)

Attached is the Environmental Fate and Effects Division's ( EFED) ecological risk assessment for the proposed use of S metolachlor ( PC 108800) on the minor crops of pumpkins and winter squash ( IR 4, DP 324973). This risk assessment also applies to the specific exemption request for use on pumpkins in New York ( S18, 327861), as the rates proposed are similar, and do not exceed the maximum rate evaluated in the IR 4 assessment. 2 S metolachlor is proposed as a post plant, pre emergence herbicide, applied via groundspray. The application rate is 1.0 1.33 pt formulated product per acre ( equivalent to 0.95 1.27 lb ai/ A). Actual rate is dependent on percent organic matter in the soil, and the product is applied once. A 400 ft buffer for " sensitive plants" is included in the current label, and was presumed to apply to the proposed crops.

Sufficient fate and toxicity data were available to conduct a screening level assessment. Smetolachlor ( PC 108800) is chemically similar to metolachlor ( PC 108801, also known as racemic metolachlor), but is a separate registration. The Agency has determined that the environmental fate ( D23688) and ecotoxicity data ( D233184) for S metolachlor are comparable. For the purpose of this assessment, data for S metolachlor are used when available, and gaps are filled with data for racemic metolachlor. Two degradates, metolachlor ethane sulfonic acid ( ESA) and metolachlor oxanilic acid ( OA) have been identified as potentially of toxicological concern, and were considered in the assessment.

S metolachlor is a chloroactanilide herbicide, classified as a seedling shoot growth inhibitor. It inhibits biosynthesis in plants, although the specific biochemical target has not been identified. It is slightly toxic to practically nontoxic to birds, and moderately toxic to fish. OA is slightly toxic to both fish and aquatic invertebrates. ESA is slightly toxic to fish, and practically nontoxic to aquatic invertebrates. Neither is as active against aquatic or terrestrial plants as the parent. S metolachlor is persistent and highly mobile in soil. S metolachlor and the major degradates OA and ESA have been detected in surface and groundwater, especially in the Midwest, where it is used extensively for corn.

Key findings of this assessment include   S metolachlor and its degradation products are persistent and mobile in terrestrial and aquatic environments.

  Non target organisms most at risk from S metolachlor use are terrestrial plants near the use site( s). Non endangered plant and endangered plant LOCs are exceeded by at least an order of magnitude and sometimes up to three orders of magnitude in any areas receiving runoff alone or runoff and spray drift from treated fields ( TerrPlant modeling).

  Based on spray drift alone, risk quotients ( RQs) for plants fall below the non endangered species level of concern ( LOC) at a downwind distance from the treated field of 250 300 ft ( based on the more sensitive seedling emergence endpoint). This potential zone of impact is within the required 400 ft buffer established on the label for application distances from sensitive plants. However, the endangered plant risk LOC is still exceeded as far as 600 ft away from the application point ( AgDrift Tier I modeling).

  No significant effects on terrestrial plants are expected from the degradates ESA and OA, based on the available toxicity data and estimated environmental concentrations ( EECs). 3   Degradation of plant communities ( hedgerows, wetlands, riparian corridors) surrounding the treated fields could have effects on the wildlife residing in or dependent on them.

  Both non endangered plant and endangered plant risk LOCs were exceeded for freshwater vascular plants, freshwater non vascular plants, and saltwater plants. Currently, there are no listed non vascular aquatic plant species. Listed aquatic vascular plants are reported with terrestrial plants in the endangered species appendix.

  Use of S metolachlor could reduce primary productivity in aquatic systems located near the use site. The importance of primary productivity occurring within a given ecosystem varies widely. However, differential selection pressure for algal species could have cascading effects up the food chain and/ or may affect community composition.

  There were no acute risk or chronic risk concerns for direct effects to non endangered birds. However, acute endangered species LOCs for small insectivorous and herbivorous birds were exceeded at the higher application rate ( 1.27 lb ai/ A). Acute endangered species LOCs for small herbivorous birds were exceeded at the lower application rate ( 0.95 lb ai/ A).

  There were no non endangered or endangered species acute risk concerns for small mammals based on the conditions modeled. Chronic risk LOCs for mammals were exceeded in some situations evaluated. Chronic effects noted in guideline studies include reduced survivability of offspring.

  There were no risk concerns for acute or chronic direct effects to endangered or nonendangered aquatic animals in freshwater or saltwater environments. 4 Endangered Species   Endangered species taxa potentially affected by the proposed use of S metolachlor on pumpkins and winter squash include plants, amphibians, birds, reptiles, and mammals. Table 1 shows the possible direct and indirect effects for various taxa, as well as the number of species identified as occurring in the same counties as the proposed crops.

Table 1 Endangered Species Summary Evaluation Organism LOCATES Category (# of species) Direct Effects Indirect Effects Monocots ( 61) Monocots Other 1 ( 22)

Dicots Dicots ( 576) Yes Effects at both proposed application rates of 1.33 and 1.0 pt/ A 2 Possible Effects on birds or mammals could affect pollinator or dispersal species Birds ( 26) Reptiles ( 8)

Birds Terrestrial Phase Amphibians ( 18) Yes Acute effects, herbivores and insectivores, small size class, at 1.33 and 1.0 pt/ A 2 Mammals Mammals ( 12) Yes Chronic effects, herbivores and invertivores, all size classes, at 1.33 and 1.0 pt/ A 2 Possible Modification of plant community could affect food and shelter FW Aquatic Plants FW Aquatic Plants 3 Yes LOC exceedences for both algae and vascular plants SW Aquatic Plants SW Aquatic Plants 3 Yes LOC exceedences Possible Modification of primary productivity in the system could affect survival or fecundity of individuals. Modification of riparian vegetation could affect water temperature, allochthonous input, sedimentation, or bank stability 1 Cycads, Conifers, Fern Allies. These genera have no direct corollary test organism, and have been evaluated based on the most sensitive plant endpoint. 2 formulated product 3 Number of species affected included in count of monocots and dicots 5 Data Requirements No specific toxicity studies are required, although providing the following toxicity studies to the Agency may reduce uncertainty in the risk assessment.

  No valid S metolachlor guideline studies on saltwater animals ( fish ( 72 3a) or invertebrates ( 72 3b, 72 3c) were available. Gaps were filled with data on racemic metolachlor. New data are not expected to change risk conclusions.

  The avian oral studies ( 71 4) and avian dietary studies ( 71 2) only establish a greater than value for the LC50. While RQs generated using this value do not approach the non endangered species acute risk LOCs, the dose based RQs generated from the oral study may exceed the endangered species acute risk LOC for small birds. Additional data may or may not reduce uncertainty in this portion of the assessment. The oral study would have to establish an LC50 of approximately 3500 mg/ kg bw to clear all LOCs.


[Federal Register: June 18, 2008 (Volume 73, Number 118)]
[Notices]
[Page 34829-34831]
[DOCID:fr18jn08-145]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration, DOT.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Paperwork Reduction Act of 1995 and its
implementing regulations, the Federal Railroad Administration (FRA)
hereby announces that it is seeking approval of the following
information collection activities. Before submitting these information
collection requirements for clearance by the Office of Management and
Budget (OMB), FRA is soliciting public comment on specific aspects of
the activities identified below.

DATES: Comments must be received no later than August 18, 2008.

ADDRESSES: Submit written comments on any or all of the following
proposed activities by mail to either: Mr. Robert Brogan, Office of
Safety, Planning and Evaluation Division, RRS-21.1, Federal Railroad
Administration, 1200 New Jersey Ave., SE., Room Number W33-497,
Washington, DC 20590, or Ms. Nakia Poston, Office of Information
Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey
Ave., SE., Room Number W34-204, Washington, DC 20590. Commenters
requesting FRA to acknowledge receipt of their respective comments must
include a self-addressed stamped postcard stating, ``Comments on OMB
control number 2130-New.'' Alternatively, comments may be transmitted
via facsimile to<PHONE_NUMBER> or<PHONE_NUMBER>, or via e-mail to Mr.
Brogan at<EMAIL_ADDRESS>or to Ms. Poston at
<EMAIL_ADDRESS>Please refer to the assigned OMB control number
or information collection title in any correspondence submitted. FRA
will summarize comments received in response to this notice in a
subsequent notice and include them in its information collection
submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Office of Planning
and Evaluation Division, RRS-21.1, Federal Railroad Administration,
1200 New Jersey Ave., SE., Room Number W33-497, Washington, DC 20590
(telephone:<PHONE_NUMBER>) or Ms. Nakia Poston, Office of Information
Technology, RAD-20, Federal Railroad Administration, 1200 New Jersey
Ave., SE., Room Number W34-204, Washington, DC 20590 (telephone: (202)
493-6073). (These telephone numbers are not toll-free.)

SUPPLEMENTARY INFORMATION: The Paperwork Reduction Act of 1995 (PRA),
Public Law No. 104-13, Sec.  2, 109 Stat. 163 (1995) (codified as
revised at 44 U.S.C. 3501-3520), and its implementing regulations, 5
CFR Part 1320, require Federal agencies to provide 60-days notice to
the public for comment on information collection activities before
seeking approval by OMB. 44 U.S.C. 3506(c)(2)(A); 5 CFR 1320.8(d)(1),
1320.10(e)(1), 1320.12(a). Specifically, FRA invites interested
respondents to comment on the following summary of proposed information
collection activities regarding (i) whether the information collection
activities are necessary for FRA to properly execute its functions,
including whether the activities will have practical utility; (ii) the
accuracy of FRA's estimates of the burden of the information collection
activities, including the validity of the methodology and assumptions
used to determine the estimates; (iii) ways for

FRA to enhance the quality, utility, and clarity of the information
being collected; and (iv) ways for FRA to minimize the burden of
information collection activities on the public by automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses). See 44 U.S.C. 3506(c)(2)(A)(i)-(iv); 5 CFR
1320.8(d)(1)(i)-(iv). FRA believes that soliciting public comment will
promote its efforts to reduce the administrative and paperwork burdens
associated with the collection of information mandated by Federal
regulations. In summary, FRA reasons that comments received will
advance three objectives: (i) Reduce reporting burdens; (ii) ensure
that it organizes information collection requirements in a ``user
friendly'' format to improve the use of such information; and (iii)
accurately assess the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    Below is a brief summary of proposed new information collection
activities that FRA will submit for clearance by OMB as required under
the PRA:
    Title: Factors for Selection of Railroads for Evaluation of Bridge
Management Practices.
    OMB Control Number: 2130-New.
    Abstract: Abstract: The Federal Railroad Administration (FRA) has
conducted a Railroad Bridge Safety Program at various levels of effort
ever since the enactment of the Railroad Safety Act of 1970. FRA is
authorized under that act to issue regulations addressing a wide
variety of subjects regarding railroad safety, but FRA has found that
bridge safety has been well served by a non-regulatory policy.
    The resulting Statement of Agency Policy on the Safety of Railroad
Bridges, published in the Federal Register in 2000, is based on the
findings of a survey conducted by FRA in 1992 and 1993. That survey
showed that a large majority of railroads were managing their bridges
in a manner which promoted the immediate safety of those bridges. FRA
therefore adopted that Bridge Safety Policy, which incorporates non-
regulatory guidelines. The non-regulatory guidelines of the Bridge
Safety Policy are promulgated as Appendix C of the Federal Track Safety
Standards, Title 49 Code of Federal Regulations, Part 213.
    Since the initial bridge management survey was completed, FRA has
continued to conduct evaluations of the bridge management practices of
the Nation's railroads. Regular, continuing contact has been in place
between FRA and the larger railroads (Class I and major passenger
carriers). However, the selection of smaller railroads (Class III short
lines and smaller Class II regional railroads) has been on an ad hoc
basis. FRA has based decisions to evaluate individual smaller railroads
on recommendations from FRA regional staff, complaints from the public,
and the small number of bridge-related train accidents.
    The Government Accountability Office (GAO) in 2006 and 2007
conducted a study to evaluate the safety and serviceability of our
Nation's railroad bridges and tunnels. GAO reported to the Congress on
that study in August 2007. That report, ``RAILROAD BRIDGES AND
TUNNELS--Federal Role in Providing Safety Oversight and Freight
Infrastructure Investment Could Be Better Targeted'' includes the
following recommendation:

    To enhance the effectiveness of its bridge and tunnel safety
oversight function, we recommend that the Secretary of
Transportation direct the Administrator of the Federal Railroad
Administration to devise a systematic, consistent, risk-based
methodology for selecting railroads for its bridge safety surveys to
ensure that it includes railroads that are at higher risk of not
following the FRA's bridge safety guidelines and of having bridge
and tunnel safety issues.'' FRA agrees with that recommendation, and
is implementing it.

    A vital part of that methodology is the development of information
on which to base the factors by which railroads will be selected for
surveys and evaluations. The factors developed by FRA, in conjunction
with the railroads themselves, include such statistics as the length of
a railroad in miles, the number, types and total length of its bridges,
its level of traffic, the presence of hazardous material traffic, the
operation of passenger trains, and the railroad's record of train
accidents. Several of those factors, particularly regarding the
railroad's bridge population, are not found in data already held or
collected by FRA.
    An attempt to characterize the selection factors without
incorporating that data on a railroad's bridge population would
seriously compromise the accuracy and usefulness of the information.
FRA has, therefore, determined that the effectiveness of its bridge
safety program depends on this data, and has identified two options for
collecting it. In one case, FRA inspectors could visit each railroad in
turn, interview the managers of the railroad, and record the
information presented. In the other case, FRA could request that each
railroad provide its data to FRA in a convenient format.
    FRA believes that the second option, self-reporting by the
railroads, is more convenient for the responding universe, and that it
represents the most efficient use of agency resources. Railroad
managers will be able to gather the data on their own time schedules,
within reason, and FRA would not have to devote employee time and
travel expenses to visit the responding railroads.
    FRA will use the data received in this project to rank individual
railroads for scheduling bridge program evaluations by FRA's Bridge
Safety Staff. The data will be analyzed against weighting factors, and
railroads will be prioritized according to the resulting scores. The
weighting factors are presently being reviewed by a committee of the
American Short Line and Regional Railroad Association (ASLRRA). FRA
will consider the recommendation of ASLRRA in this regard, and will
make the weighting factors available to the respondent universe and the
public as part of this project.
    It should be noted that a high selection ranking of any railroad by
FRA will not necessarily indicate that the railroad has a bridge safety
problem. That determination, one way or the other, will only be made by
FRA during its evaluation of that railroad's bridge management
practices.
    Form Number(s): FRA F 6180.129.
    Affected Public: Railroads.
    Respondent Universe: 567 Railroads.
    Frequency of Submission: On occasion.
    Reporting Burden:

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total annual    Total annual
               Form No.                     Respondent universe       Total annual responses   Average time per response   burden hours     burden cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form FRA F 6180.129...................  567 Railroads.............  475 forms................  3 hours..................           1,425         $57,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Annual Burden: 1,425 hours.
    Status: Regular Review.
    Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b),
1320.8(b)(3)(vi), FRA informs all interested parties that it may not
conduct or sponsor, and a respondent is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.

    Authority: 44 U.S.C. 3501-3520.

    Issued in Washington, DC on June 11, 2008.
D.J. Stadtler,
Director, Office of Financial Management, Federal Railroad
Administration.
[FR Doc. E8-13690 Filed 6-17-08; 8:45 am]

BILLING CODE 4910-06-P