[Federal Register: September 15, 2008 (Volume 73, Number 179)]
[Notices]
[Page 53252-53254]
[DOCID:fr15se08-77]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0372] (formerly Docket No. 2007D-0388)

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adverse Event
Reporting and Recordkeeping for Dietary Supplements as Required by the
Dietary Supplement and Nonprescription Drug Consumer Protection Act

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October
15, 2008.

ADDRESSES:  To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All comments
should be identified with the OMB control number 0910-NEW and title,
``Adverse Event Reporting and Recordkeeping for Dietary Supplements as
Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act.'' Also include the FDA docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Adverse Event Reporting and Recordkeeping for Dietary Supplements as
Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act--(OMB Control Number 0910-NEW)

    Description of Respondents: Respondents to this collection of
information are manufacturers, packers, and distributors of dietary
supplements marketed in the United States.
    On December 22, 2006, the President signed into law the Dietary
Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA)
(Public Law 109-462, 120 Stat. 3469). This law amends the Federal Food,
Drug, and Cosmetic Act (the act) with respect to serious adverse event
reporting and recordkeeping for dietary supplements and non-
prescription drugs marketed without an approved application.
    Under section 761(b)(1) of the act (21 U.S.C. 379aa-1(b)(1)), the
manufacturer, packer, or distributor whose name (under section
403(e)(1) of the act (21 U.S.C. 343(e)(1))) appears on the label of a
dietary supplement marketed in the United States is required to submit
to FDA any serious adverse event report it receives regarding use of
the dietary

supplement in the United States, accompanied by a copy of the product
label. In addition, under section 761(c)(2) of the act, the submitter
of the serious adverse event report (referred to in the statute as the
``responsible person'') is required to submit to FDA a followup report
of any related new medical information the responsible person receives
within 1 year of the initial report. Under section 761(e)(1) of the
act, responsible persons are required to maintain records related to
dietary supplement adverse event reports they receive, whether or not
the adverse event is serious. These requirements became effective on
December 22, 2007.
    As required by section 3(d)(3) of the DSNDCPA, FDA is issuing
guidance to describe the minimum data elements for serious adverse
event reports for dietary supplements. The draft guidance entitled
``Questions and Answers Regarding Adverse Event Reporting and
Recordkeeping for Dietary Supplements as Required by the Dietary
Supplement and Nonprescription Drug Consumer Protection Act,'' was
issued October 15, 2007, and is consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The draft guidance discusses how,
when, and where to submit serious adverse event reports for dietary
supplements and followup reports of new medical information. In
accordance with the statutory requirements that serious adverse event
reports for dietary supplements be submitted via MedWatch (section
761(d) of the act) and that FDA consolidate all information related to
a serious adverse event into a single report (section 761(c)(3) of the
act), the draft guidance directs the responsible person to submit
serious adverse event reports on MedWatch Form 3500A and to attach a
copy of the initial serious adverse event report on Form 3500A as part
of any followup report of new medical information. We are also
providing guidance on records maintenance and access for serious and
non-serious adverse event reports and related documents.
    In the Federal Register of October 15, 2007 (72 FR 58313), FDA
published a 60-day notice requesting public comment on the information
collection provisions. FDA received one comment related to the
information collection. The comment disagreed with FDA's proposed
estimate of the annual recordkeeping burden associated with dietary
supplement adverse events. However, the commenter did not provide an
alternative estimate or compelling information that the estimate
provided by FDA was not a reasonable upper-bound estimate. Since the
receipt of the comment, the mandatory reporting of serious adverse
events for dietary supplements to FDA has come into effect (on December
22, 2007). Thus, FDA now has data on mandatory dietary supplement
adverse event reports to use in revising our reporting burden estimate.
For the first quarter of 2008 (January 1 to April 15), FDA has received
214 mandatory reports of serious adverse events related to dietary
supplements. Therefore, FDA revises our annual burden estimate from 960
mandatory reports to 856 mandatory reports of serious adverse events
related to dietary supplements. FDA requests comments on this estimate.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual        Hours per
                    Respondents        per Response          Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
Serious adverse          71.3333                     12                856                  2              1,712
 event reports
 for dietary
 supplements
 (21 U.S.C.
 379aa-1(b)(1))
----------------------------------------------------------------------------------------------------------------
Followup                 17.83333                    12                214                  1                214
 reports of new
 medical
 information
 (21 U.S.C.
 379aa-1(c)(2))
----------------------------------------------------------------------------------------------------------------
Total                                                                                1,926
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's Center for Drug Evaluation and Research estimates it will
take respondents a total of 2 hours to collect information about a
serious adverse event associated with an over-the-counter drug marketed
without an approved application and report the information to FDA on
MedWatch Form 3500A. That time burden estimate is based on FDA's
knowledge of the adverse drug experience reports submitted to the
agency for nonprescription drug products marketed under an approved
application, including knowledge about the time needed to prepare the
reports. FDA believes that the time for a dietary supplement firm to
collect information about a serious adverse event associated with a
dietary supplement and report the information to FDA will be
approximately the same, as MedWatch Form 3500A will be used in both
cases; therefore, we also estimate this time burden at 2 hours per
report. The estimated total annual burden for dietary supplement
serious adverse event reports is shown in row 1 of table 1 of this
document.
    If a firm that has submitted a serious adverse event report
receives new medical information related to the serious adverse event
within 1 year of submitting the initial report, the firm must provide
the new medical information to FDA in a followup report. Given our
limited experience with mandatory dietary supplement adverse event
reporting, we do not have any information on the number of followup
reports of new medical information that will be submitted to FDA each
year. We expect followup medical information to be reported for some
percentage of the 856 serious adverse event reports we estimate
receiving annually. In the absence of data that would support a more
precise estimate, we will assume that 25 percent of the 856 serious
adverse event reports for dietary supplements will have a followup
report submitted. FDA requests comments on this estimate. We estimate
that each followup report will require 1 hour to assemble and submit,
including the time needed to copy and attach the initial serious
adverse event report as recommended in the draft guidance. We assume
the followup report will take less time than the initial serious
adverse event report, as the responsible person will not need to fill
out Form 3500A for the followup report. FDA requests comments on
whether the burden estimate of 1 hour is reasonable for this
information collection. The

estimated total annual burden for followup reports of new medical
information is shown in row 2 of table 1 of this document.
    As previously noted, section 761(e)(1) of the act requires that
responsible persons maintain records related to dietary supplement
adverse event reports they receive, whether or not the adverse event is
serious. Under the statute, the records must be retained for a period
of 6 years. The draft guidance provides FDA's recommendations as to
what records industry should maintain to satisfy the statutory
recordkeeping requirement.
    The guidance recommends that the responsible person document its
attempts to obtain the minimum data elements for a serious adverse
event report. Along with these records, the guidance recommends that
the responsible person keep the following other records: (1)
Communications between the responsible person and the initial reporter
of the adverse event and with any other person(s) who provided
information about the adverse event; (2) (for serious adverse events
only) the responsible person's serious adverse event report to FDA on
MedWatch Form 3500A, with attachments; (3) any new medical information
about the adverse event received by the responsible person; (4) (for
serious adverse events only) any reports to FDA of new medical
information related to the serious adverse event report. We estimate
that assembling and filing these records, including any necessary
photocopying, will take approximately 0.5 hours per adverse event
report received by the responsible person.
    Once the documents pertaining to an adverse event report have been
assembled and filed, FDA expects the records retention burden to be
minimal, as the agency believes most establishments would normally keep
this kind of record for at least several years after receiving the
report, as a matter of usual and customary business practice. FDA
requests comment on current adverse event recordkeeping practices in
the dietary supplement industry, including the length of time such
records are typically kept.
    According to a 2001 report by the Office of the Inspector General,
between 1994-1999 FDA received 2,547 adverse event reports involving
dietary supplements, or about 500 reports per year, on average.
According to the report, the actual number of adverse events relating
to dietary supplements is likely to be at least 100 times that many, or
more than 50,000 adverse events per year. Given that we have limited
data on how many adverse events will be reported each year to the
responsible person, we are using the 50,000 per year figure as an
upper-bound estimate of reporting. This is almost certainly an
overestimate of the number of reports the firms will receive, as it is
unlikely that every adverse event that occurs will be reported to the
responsible person. FDA requests comments on this estimate.
    We estimated in the economic impact analysis of the Dietary
Supplement Good Manufacturing Practices final rule (the GMP final rule)
(72 FR 34752, June 25, 2007) that there are 1,460 manufacturers,
packers, and holders of dietary supplements (72 FR 34752 at 34920). We
assume that the estimated 50,000 adverse event reports related to
dietary supplements will be spread evenly among these firms. The
estimate of the number of manufacturers, packers, and holders of
dietary supplements from the GMP final rule is FDA's best estimate of
the number of firms that are ``responsible persons'' who must comply
with the recordkeeping requirements of the DSNDCPA; however, it is not
a precise estimate because the number of dietary supplement
establishments covered by the GMP final rule is likely to be larger
than the number of ``responsible persons,'' where a ``responsible
person'' is a dietary supplement manufacturer, packer, or distributor
whose name is listed on the label of a dietary supplement marketed in
the United States (see section 761(b)(1) of the act). Thus, FDA's
estimate for the number of respondents in table 2 may be over
inclusive. FDA requests comments on the number of firms that would be
subject to the recordkeeping requirements of the DSNDCPA.
    The estimated total annual recordkeeping burden under the statute
and this guidance is shown in table 2 of this document.

                                Table 2--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency       Total Annual
                  Recordkeepers      per Recordkeeping       Records\2\     Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
Dietary                     1,460                4.2465             50,000                0.5             25,000
 supplement
 adverse event
 records (21
 U.S.C. 379aa-
 1(e)(1))
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ For purposes of estimating the number of records and hours per record, a ``record'' means all records kept
  for an individual adverse event report received by the responsible person.

    Dated: September 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21454 Filed 9-12-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 62 (Thursday, March 31, 2016)]
[Rules and Regulations]
[Page 18526]
[FR Doc No: 2016-07310]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0397; FRL-9943-79]

Pendimethalin; Tolerance Exemptions; Technical Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; technical correction.

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SUMMARY: EPA issued a final rule in the Federal Register of December
21, 2015, concerning the addition of certain commodities to 40 CFR
180.361. Nut, tree group 14-12 was inadvertently omitted. This document
corrects that omission.

DATES: This final rule correction is effective March 31, 2016.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0397, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    The Agency included in the December 21, 2015 final rule a list of
those who may be potentially affected by this action.

II. What does this technical correction do?

    EPA issued a final rule in the Federal Register of December 21,
2015 (80 FR 79267) (FRL-9937-18) that was adding commodities including
Nut, tree group 14-12 to 40 CFR 180.361(a)(1). EPA inadvertently
omitted the language in the codified text, which would have added Nut,
tree group.

III. Why is this correction issued as a final rule?

    Section 553 of the Administrative Procedure Act (APA) (5 U.S.C.
553(b)(3)(B)) provides that, when an agency for good cause finds that
notice and public procedure are impracticable, unnecessary, or contrary
to the public interest, the agency may issue a final rule without
providing notice and an opportunity for public comment. EPA has
determined that there is good cause for making this technical
correction final without prior proposal and opportunity for comment,
because this is correcting a typographical error. EPA finds that this
constitutes good cause under 5 U.S.C. 553(b)(3)(B).

IV. Do any of the statutory and executive order reviews apply to this
action?

    No. For a detailed discussion concerning the statutory and
executive order review, refer to Unit VI of the December 21, 2015 final
rule.

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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: March 24, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is corrected 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.

0
2. In Sec.  [emsp14]180.361(a)(1), add alphabetically the entry Nut,
tree, group 14-12 to read as follows:

Sec.  [emsp14]180.361  Pendimethalin; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Nut, tree, group 14-12.....................................        0.10

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-07310 Filed 3-30-16; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: September 3, 2008 (Volume 73, Number 171)]
[Notices]
[Page 51468-51469]
[DOCID:fr03se08-63]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2008-0200; FRL-8710-3]

Board of Scientific Counselors, Water Quality Mid-Cycle
Subcommittee Meeting--2008

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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SUMMARY: Pursuant to the Federal Advisory Committee Act, Public Law 92-
463, the Environmental Protection Agency, Office of Research and
Development (ORD), gives notice of a meeting of the Board of Scientific
Counselors (BOSC) Water Quality Mid-Cycle Subcommittee.

DATES: The meeting will be held on Tuesday, September 23, 2008 from 9
a.m. to 3 p.m. Eastern Standard Time. The meeting may adjourn early if
all business is finished. Requests for the draft agenda or for making
oral presentations at the conference call will be accepted up to one
business day before the meeting.

ADDRESSES: The meeting will be held at the Key Bridge Marriott, 1401
Lee Highway, Arlington, Virginia 22209. Submit your comments,
identified by Docket ID No. EPA-HQ-ORD-2008-0200, by one of the
following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
     E-mail: Send comments by electronic mail (e-mail) to:
<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-ORD-2008-0200.
     Fax: Fax comments to:<PHONE_NUMBER>, Attention: Docket ID
No. EPA-HQ-ORD-2008-0200.
     Mail: Send comments by mail to: Board of Scientific
Counselors, Water Quality Mid-Cycle Subcommittee--2008

Docket, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC
20460, Attention: Docket ID No. EPA-HQ-ORD-2008-0200.
     Hand Delivery or Courier: Deliver comments to: EPA Docket
Center (EPA/DC), Room B102, EPA West Building, 1301 Constitution
Avenue, NW., Washington, DC, Attention: Docket ID No. EPA-HQ-ORD-2008-
0200.

    Note: This is not a mailing address. Such deliveries are only
accepted during the docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.

    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2008-0200. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket, visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the Board of
Scientific Counselors, Water Quality Mid-Cycle Subcommittee--2008
Docket, EPA/DC, EPA West, Room B102, 1301 Constitution Ave., NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the ORD Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The Designated Federal Officer via
mail at: Susan Peterson, Mail Code 8104-R, Office of Science Policy,
Office of Research and Development, Environmental Protection Agency,
1200 Pennsylvania Avenue, NW., Washington, DC 20460; via phone/voice
mail at:<PHONE_NUMBER>; via fax at:<PHONE_NUMBER>; or via e-mail at:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

General Information

    Any member of the public interested in receiving a draft BOSC
agenda or making a presentation at the meeting may contact Susan
Peterson, the Designated Federal Officer, via any of the contact
methods listed in the FOR FURTHER INFORMATION CONTACT section above. In
general, each individual making an oral presentation will be limited to
a total of three minutes.
    Proposed agenda items for the meeting include, but are not limited
to: overview of the charge to the subcommittee, discussion of the
bibliometric analysis, report on wrap-up of the 2003 Water Quality
Multi-Year Plan (MYP), and research survey results. The meeting is open
to the public.
    Information on Services for Individuals with Disabilities: For
information on access or services for individuals with disabilities,
please contact Susan Peterson at<PHONE_NUMBER> or
<EMAIL_ADDRESS>To request accommodation of a disability,
please contact Susan Peterson, preferably at least ten days prior to
the meeting, to give EPA as much time as possible to process your
request.

    Dated: August 26, 2008.
Fred Hauchman,
Director, Office of Science Policy.
[FR Doc. E8-20386 Filed 9-2-08; 8:45 am]

BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

MEMORANDUM

DATE:        02/AUG/2007

SUBJECT:  Pendimethalin:  Chronic Dietary (Food and Drinking Water) Analysis and Risk Assessment to Support the Section 3 Registration for New Food Uses of the Herbicide on Artichoke, Asparagus, Brassica Head and Stem Vegetables, Subgroup 5A, and Grape.

PC Code:				108501

DP Number:			334173

Decision Numbers:			371520

Petition Numbers:			6E7129

Regulatory Citation:			40CFR §180.361

Chemical Class:			Dinitroaniline Herbicide

Trade Names:			Prowl® 3.3 EC, Prowl® H2O

EPA Registration Numbers:		241-337, 241-418

Reviewer:	Debra Rate, Ph.D., Biologist

		Alternative Risk Integration and Assessment (ARIA)

		Risk Integration, Minor Use, and Emergency Response Branch (RIMUERB)

		Registration Division (RD) (7505P)

Through:	William Cutchin, Acting Senior Branch Scientist

		ARIA

		RIMUERB/RD (7505P)

			And

		Douglas Dotson, Ph. D., Chemist

		Amelia Acierto, Chemist

		Dietary Exposure Science Advisory Council (DESAC)

		Health Effects Division (HED) (7509P)

Through:	Dan Rosenblatt / Barbara Madden

		RIMUERB/RD (7505P)

Executive Summary

The purpose of this memorandum is to report the results of a dietary exposure analysis for pendimethalin.  In this analysis, the chronic dietary exposure and risk estimates resulting from food and water intake were determined for the general U.S. population and various population subgroups.

A chronic dietary risk assessment was conducted using the Dietary Exposure Evaluation Model (DEEM-FCID, Version 2.03) which uses food consumption data from the US Department of Agriculture’s Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994 to 1996, and 1998.  The analysis was performed in order to determine the exposure and risk estimates which result from the addition of artichoke, globe; asparagus, Brassica head and stem vegetables, subgroup 5A, and grapes to the commodity residue list for pendimethalin.  The proposed tolerances are associated with Section 3 requests.

The chronic dietary exposure analysis was based on the following assumptions:

(1) Tolerance-level residues of pendimethalin in/on all current RACs (e-CFR 40 §180.361, Updated July 1, 2007) and proposed RACs.

(2) Empirical processing factors obtained from processing studies (when available; including citrus commodities).  Grape processing studies were not adequate, and tolerances for grape commodities (grape, raisin and grape, juice) were recommended and no processing factor was used in the dietary analysis.

(3) A processing factor of 8 for the processed commodities of wheat bran and wheat germ and 1.4 for wheat flour.

(4) DEEM 7.81 default processing factors were used for the remaining processed commodities.

(5) 100% crop treated (CT), and

(6) 0.006 ppm pendimethalin estimated drinking water concentration (EDWC).

These assumptions result in conservative estimates of dietary exposure and risk.  In calculating dietary risk estimates, ARIA has compared the chronic population-adjusted dose (cPAD) to the estimated dietary exposure.  Typically, ARIA has concerns regarding dietary risk when the estimates exceed 100% of the cPAD.  Even with the conservative assumptions noted above, risk estimates associated with dietary exposure to pendimethalin are significantly below ARIA’s level of concern.

In the chronic dietary assessment, the most highly exposed population subgroup is children 1-2 years old.  The chronic exposure estimate of 0.004749 mg/kg/day corresponds to approximately 16% of the cPAD.  Risks for the general US population were 5% of the cPAD.

I.	Introduction

Dietary risk assessment incorporates both exposure and toxicity of a given pesticide.  For acute and chronic assessments, the risk is expressed as a percentage of a maximum acceptable dose.  This is the population adjusted dose (PAD), which ARIA has concluded will result in no unreasonable adverse health effects.  The PAD is equivalent to point of departure (POD, NOAEL, LOAEL, e.g.) divided by the required uncertainty factors.  Dietary risk is expressed as a percentage of the PAD.  For acute and non-cancer chronic exposures, ARIA is concerned when estimated dietary risk exceeds 100% of the PAD.  ARIA is generally concerned when estimated cancer risk exceeds one in one million (i.e., the risk exceeds 1 x 10-6).  References which discuss the acute and chronic risk assessments in more detail are available on the EPA/pesticides web site:  Available Information on Assessing Exposure from Pesticides, A User’s Guide, 21/JUN/2000, web link:  http://www.epa.gov/fedrgstr/EPA-PEST/2000/July/Day-12/6061.pdf ; or see SOP 99.6 (20/AUG/1999).

The most recent dietary risk assessment for pendimethalin was conducted by W. Drew (DP Num: 329175, W. Drew, 30/JUN/2006).

II.	Residue Information

Permanent and time-limited tolerances are currently established for combined residues of the herbicide pendimethalin, N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine, and its metabolite, 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, in/on various plant commodities, as listed in 40CFR §180.361[a] and [b] (e-CFR 40CFR §180.361, updated July 1, 2007).  In addition to the current tolerances, the recommended tolerances for the proposed new uses in/on artichoke, globe at 0.1 ppm; asparagus at 0.15 ppm; Brassica head and stem vegetables, subgroup 5A at 0.1 ppm; grapes at 0.1 ppm; raisin at 0.5 ppm and grape juice at 0.15 ppm (DP Num: 340343; D. Rate; 02/AUG/2007) were used in the analysis.

Tolerance-level residues of pendimethalin were utilized for all RACs, current and proposed, with exception of grape juice and raisins which are recommended by ARIA due to the submission of inadequate grape processing studies.  Empirical processing factors obtained from processing study data were utilized for processed commodities, when available and adequate.  Wheat processing data have not been submitted, therefore, a processing factor of 8 was used for the processed commodities wheat germ and bran and 1.4 for wheat flour (the maximum theoretical concentration factor for wheat, from Table 1 of OPPTS Residue Chemistry Test Guideline 860.1520) (DP Num: 329175, W. Drew, 30/JUN/2006; personal communication R. Loranger (19/JUL/2007)).  For the currently proposed processed commodities (grape), processing factors could not be calculated   SEQ CHAPTER \h \r 1 because residues were below the limit of quantitation (LOQ) in both the RAC and the processed fractions (DP Num: 340343; D. Rate; 02/AUG/2007).  DEEM™ 7.81 processing factors were utilized for processed commodities (other than wheat and citrus (DP Num: 238469, W. Cutchin, 21/JUL/1999)) associated with the previously registered uses for fruiting vegetables (tomato), pome fruit, and stone fruit (DP Num: 329175; W. Drew; 30/JUN/2006).  One hundred %CT was assumed for all foods in this assessment.

III.	Drinking Water Data

The drinking water residues used in this chronic dietary risk assessment were provided by the Environmental Fate and Effects Division (EFED) in a memorandum (D334061; J. Breithaupt; 08/MAY/2007), and incorporated directly into the dietary assessment.  Water residues were entered into the DEEM-FCID input file under the food categories “water, direct, all sources” and “water, indirect, all sources.”

The EDWC of 0.006 ppm (the 1 in 10 year annual mean concentration in surface water, as calculated by PRZM-EXAMS modeling) was directly entered into the exposure model to assess the contributions from drinking water.  This EDWC (resulting from a single application of pendimethalin to grapes (NY) at the rate of 6.0 lb ai/A) was the highest modeling result calculated for either surface or groundwater sources of drinking water, and is therefore conservative.

The PRZM-EXAMS Model and its description are available at the EPA internet site (web link   HYPERLINK "http://www.epa.gov/oppefed1/models/water/"  http://www.epa.gov/oppefed1/models/water/ ).

III.	DEEM-FCID Program and Consumption Information

 (DEEM-FCID™, Version 2.03), which incorporates consumption data from USDA’s Continuing Surveys of Food Intakes by Individuals (CSFII), from 1994 to 1996, and 1998.  The 1994-96 & 1998 data are based on the reported consumption of more than 20,000 individuals over two non-consecutive survey days.  Foods “as consumed” (such as apple pie) are linked to EPA-defined food commodities (such as apples, peeled fruit - cooked, fresh/unspecified, or baked; or wheat flour - cooked, fresh/unspecified, or baked) using publicly available recipe translation files developed jointly by USDA/ARS and EPA.  For chronic exposure assessment, consumption data are averaged for the entire US population, and within population subgroups.  Based on analysis of the 1994-96 & 1998 CSFII consumption data, which took into account dietary patterns and survey respondents, HED concluded that it is most appropriate to report risk for the following population subgroups: the general US population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, adults 20-49, females 13-49, and adults 50+ years old.

For chronic dietary exposure assessment, an estimate of the residue level in each food or food-form (such as orange or orange juice) on the food commodity residue list is multiplied by the average daily consumption estimate for that food/food form to produce a residue intake estimate.  The resulting residue intake estimate for each food/food form is summed with the residue intake estimates for all other food/food forms on the commodity residue list to arrive at the total average estimated exposure.  Exposure is expressed in mg/kg body weight/day and as a percent of the cPAD.  This procedure is performed for each population subgroup.

IV.	Toxicological Information

Endpoints and doses for risk assessment were selected to support previous risk assessments in 2000; evaluation of the database in accordance with the Food Quality Protection Act (FQPA) of 1996 was also completed in 2000.  Since that time, there have been changes in the way the Agency has applied the FQPA Safety Factor, based on guidance issued in 2002.

The most recent evaluation of the toxicity database for pendimethalin is summarized in the most recent risk assessment (DP Num: 344766, W. Drew, 23/MAR/2007).  The total uncertainty factor (UF) for dietary exposure is based on a 3X interspecies factor, a 10X intraspecies factor, and a 10X database UF retained pending receipt of a developmental thyroid toxicity study.

Doses and endpoints for dietary risk assessment are presented in Table 1 (below).  Although HED concluded that pendimethalin is a likely human carcinogen, a nonlinear approach to cancer risk assessment was recommended by the Cancer Assessment Review Committee (CARC).  The chronic dietary risk assessment, based on the calculated RfD, is considered to be protective of cancer risk arising from potential carcinogenic effects.  In addition, no appropriate endpoint attributable to a single dose (exposure) was identified in the available studies.  As such, a chronic dietary analysis is required, while an acute dietary analysis is not.

TABLE 1	Summary of Pendimethalin Toxicological Doses and Endpoints for Use in Dietary Exposure Assessment.

Exposure Scenario	Dose Used in Risk Assessment, UF	FQPA SF, Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary	No appropriate endpoint attributable to a single dose (exposure) was identified in the available studies.

Chronic Dietary

(All populations)	NOAEL = 10 mg/kg/day

Total UF = 300X

Chronic RfD =

NOAEL ÷ UF =

0.03 mg/kg/day	FQPA SF = 1X

cPAD =

Chronic RfD ÷ FQPA SF = 0.03 mg/kg/day	56-day thyroid study in rats; 14-day intra thyroid metabolism study in rats;

92-day thyroid function study in rats.

LOAEL= 31 mg/kg/day, based on hormonal and histopathological changes in the thyroid.

Cancer	Pendimethalin is considered to be a possible human carcinogen.  The chronic dietary assessment using the cPAD is considered to be protective of cancer effects.  	2-year chronic/carcinogenicity study in rats.

UF = Uncertainty Factor.

FQPA SF = FQPA Safety Factor.

NOAEL = No Observed Adverse Effect Level.

LOAEL = Lowest Observed Adverse Effect Level.

PAD = Population Adjusted Dose (a = acute, c = chronic).

RfD = Reference Dose.

V.	Results/Discussion

As stated above, ARIA is concerned when dietary risk exceeds 100% of the PAD.  The results of the pendimethalin chronic dietary assessment reported in Table 2 are for the general US Population, all infants (<1 year old), children 1-2, children 3-5, children 6-12, youth 13-19, females 13-49, adults 20-49, and adults 50+ years.

The most highly exposed population subgroup is children 1-2 years old, with an estimated chronic exposure of 0.004749 mg/kg/day, corresponding to approximately 16% of the cPAD.  Exposure and risk estimates for the general US population (0.001548 mg/kg/day, 5% of the cPAD) and all other population subgroups were lower.

The summarized results of the chronic dietary exposure analysis are listed in Table 2 (below).

TABLE 2	Summary of Chronic Dietary Exposure and Risk Estimates for Pendimethalin.

Population Subgroup*

[Years of Age]	DEEM Chronic Dietary Analysis

	cPAD (mg/kg/day)	Exposure Estimate (mg/kg/day)	% cPAD

General US Population	0.03	0.001548	5

All Infants [<1]	0.03	0.003081	10

Children [1-2]	0.03	0.004749	16

Children [3-5]	0.03	0.003819	13

Children [6-12]	0.03	0.002304	8

Youths [13-19]	0.03	0.001417	5

Adults [20-49]	0.03	0.001166	4

Adults [50+]	0.03	0.001065	4

Females [13-49]	0.03	0.001164	4

* Values for the population with the highest risk are in bold type.

VII.	Characterization of Inputs/Outputs

The assumptions made in this assessment are conservative, and are very likely to result in exposure and risk values that considerably overestimate actual dietary exposure to pendimethalin.

VIII.	Conclusions

Based on conservative assumptions, dietary risk estimates for pendimethalin do not exceed ARIA’s level of concern for the general US population, or any of the population subgroups, including those comprised of infants and children.

IX.	List of Attachments

Attachment 1:  Commodity Contribution List for Pendimethalin.

Attachment 2:  Results of Pendimethalin Chronic Dietary Exposure Analysis.

cc:	D. Rate and W. Cutchin

ATTACHMENT 1:

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for PENDIMETHALIN                      1994-98 data

Residue file: E:\pendimethalin\DEEM for Secondary\FINAL\c108501 D334173 073107.R98

                                                           Adjust. #2 NOT used

Analysis Date 07-31-2007             Residue file dated: 07-31-2007/14:14:09/8

Reference dose (RfD) = 0.03  (NOEL) = 10 mg/kg bw/day

Comment:FQPA Safety Factor = 1X; DBUFs = 300X; no acute dose/endpoint

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

Food Crop                                       Residue       Adj.Factors      Comment

EPA Code  Grp  Food Name                          (ppm)

                                                             #1         #2

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

18000020 18   Alfalfa, seed                      0.100000   1.000      1.000

14000030 14   Almond                             0.100000   1.000      1.000

14000031 14   Almond-babyfood                    0.100000   1.000      1.000

14000040 14   Almond, oil                        0.100000   1.000      1.000

14000041 14   Almond, oil-babyfood               0.100000   1.000      1.000

11000070 11   Apple, fruit with peel             0.100000   1.000      1.000

11000080 11   Apple, peeled fruit                0.100000   1.000      1.000

11000081 11   Apple, peeled fruit-babyfood       0.100000   1.000      1.000

11000090 11   Apple, dried                       0.100000   8.000      1.000

11000091 11   Apple, dried-babyfood              0.100000   8.000      1.000

11000100 11   Apple, juice                       0.100000   1.300      1.000

11000101 11   Apple, juice-babyfood              0.100000   1.300      1.000

11000110 11   Apple, sauce                       0.100000   1.000      1.000

11000111 11   Apple, sauce-babyfood              0.100000   1.000      1.000

12000120 12   Apricot                            0.100000   1.000      1.000

12000121 12   Apricot-babyfood                   0.100000   1.000      1.000

12000130 12   Apricot, dried                     0.100000   6.000      1.000

12000140 12   Apricot, juice                     0.100000   1.000      1.000

12000141 12   Apricot, juice-babyfood            0.100000   1.000      1.000

95000160 O    Artichoke, globe                   0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

95000190 O    Asparagus                          0.150000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

06020370 6B   Bean, lima, succulent              0.100000   1.000      1.000

06030380 6C   Bean, lima, seed                   0.100000   1.000      1.000

14000590 14   Brazil nut                         0.100000   1.000      1.000

05010610 5A   Broccoli                           0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

05010611 5A   Broccoli-babyfood                  0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

05010620 5A   Broccoli, Chinese                  0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

05010640 5A   Brussels sprouts                   0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

14000680 14   Butternut                          0.100000   1.000      1.000

05010690 5A   Cabbage                            0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

05010710 5A   Cabbage, Chinese, napa             0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

05010720 5A   Cabbage, Chinese, mustard          0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

01010780 1AB  Carrot                             0.500000   1.000      1.000

01010781 1AB  Carrot-babyfood                    0.500000   1.000      1.000

01010790 1AB  Carrot, juice                      0.500000   1.000      1.000

14000810 14   Cashew                             0.100000   1.000      1.000

05010830 5A   Cauliflower                        0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

12000900 12   Cherry                             0.100000   1.000      1.000

12000901 12   Cherry-babyfood                    0.100000   1.000      1.000

12000910 12   Cherry, juice                      0.100000   1.500      1.000

12000911 12   Cherry, juice-babyfood             0.100000   1.500      1.000

14000920 14   Chestnut                           0.100000   1.000      1.000

10001060 10   Citrus citron                      0.100000   1.000      1.000

10001070 10   Citrus hybrids                     0.100000   1.000      1.000

10001080 10   Citrus, oil                        0.500000   1.000      1.000

15001200 15   Corn, field, flour                 0.100000   1.000      1.000

15001201 15   Corn, field, flour-babyfood        0.100000   1.000      1.000

15001210 15   Corn, field, meal                  0.100000   1.000      1.000

15001211 15   Corn, field, meal-babyfood         0.100000   1.000      1.000

15001220 15   Corn, field, bran                  0.100000   1.000      1.000

15001230 15   Corn, field, starch                0.100000   1.000      1.000

15001231 15   Corn, field, starch-babyfood       0.100000   1.000      1.000

15001240 15   Corn, field, syrup                 0.100000   1.500      1.000

15001241 15   Corn, field, syrup-babyfood        0.100000   1.500      1.000

15001250 15   Corn, field, oil                   0.100000   1.000      1.000

15001251 15   Corn, field, oil-babyfood          0.100000   1.000      1.000

15001260 15   Corn, pop                          0.100000   1.000      1.000

15001270 15   Corn, sweet                        0.100000   1.000      1.000

15001271 15   Corn, sweet-babyfood               0.100000   1.000      1.000

95001280 O    Cottonseed, oil                    0.100000   1.000      1.000

95001281 O    Cottonseed, oil-babyfood           0.100000   1.000      1.000

11001290 11   Crabapple                          0.100000   1.000      1.000

08001480 8    Eggplant                           0.100000   1.000      1.000

14001550 14   Filbert                            0.100000   1.000      1.000

14001560 14   Filbert, oil                       0.100000   1.000      1.000

03001640 3    Garlic                             0.100000   1.000      1.000

03001650 3    Garlic, dried                      0.100000   1.000      1.000

03001651 3    Garlic, dried-babyfood             0.100000   1.000      1.000

95001750 O    Grape                              0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

95001760 O    Grape, juice                       0.150000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

95001761 O    Grape, juice-babyfood              0.150000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

95001770 O    Grape, leaves                      0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

95001780 O    Grape, raisin                      0.500000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

95001790 O    Grape, wine and sherry             0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

10001800 10   Grapefruit                         0.100000   1.000      1.000

10001810 10   Grapefruit, juice                  0.100000   1.000      1.000

14001850 14   Hickory nut                        0.100000   1.000      1.000

05011960 5A   Kohlrabi                           0.100000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

10001970 10   Kumquat                            0.100000   1.000      1.000

03001980 3    Leek                               0.200000   1.000      1.000

10001990 10   Lemon                              0.100000   1.000      1.000

10002000 10   Lemon, juice                       0.100000   1.000      1.000

10002001 10   Lemon, juice-babyfood              0.100000   1.000      1.000

10002010 10   Lemon, peel                        0.100000   1.000      1.000

10002060 10   Lime                               0.100000   1.000      1.000

10002070 10   Lime, juice                        0.100000   1.000      1.000

10002071 10   Lime, juice-babyfood               0.100000   1.000      1.000

11002100 11   Loquat                             0.100000   1.000      1.000

14002130 14   Macadamia nut                      0.100000   1.000      1.000

12002300 12   Nectarine                          0.100000   1.000      1.000

08002340 8    Okra                               0.100000   1.000      1.000

03002370 3    Onion, dry bulb                    0.100000   1.000      1.000

03002371 3    Onion, dry bulb-babyfood           0.100000   1.000      1.000

03002380 3    Onion, dry bulb, dried             0.100000   9.000      1.000

03002381 3    Onion, dry bulb, dried-babyfood    0.100000   9.000      1.000

03002390 3    Onion, green                       0.200000   1.000      1.000

10002400 10   Orange                             0.100000   1.000      1.000

10002410 10   Orange, juice                      0.100000   1.000      1.000

10002411 10   Orange, juice-babyfood             0.100000   1.000      1.000

10002420 10   Orange, peel                       0.100000   1.000      1.000

06022550 6B   Pea, succulent                     0.100000   1.000      1.000

06022551 6B   Pea, succulent-babyfood            0.100000   1.000      1.000

06012570 6A   Pea, edible podded, succulent      0.100000   1.000      1.000

06022590 6B   Pea, pigeon, succulent             0.100000   1.000      1.000

12002600 12   Peach                              0.100000   1.000      1.000

12002601 12   Peach-babyfood                     0.100000   1.000      1.000

12002610 12   Peach, dried                       0.100000   7.000      1.000

12002611 12   Peach, dried-babyfood              0.100000   7.000      1.000

12002620 12   Peach, juice                       0.100000   1.000      1.000

12002621 12   Peach, juice-babyfood              0.100000   1.000      1.000

95002630 O    Peanut                             0.100000   1.000      1.000

95002640 O    Peanut, butter                     0.100000   1.890      1.000

95002650 O    Peanut, oil                        0.100000   1.000      1.000

11002660 11   Pear                               0.100000   1.000      1.000

11002661 11   Pear-babyfood                      0.100000   1.000      1.000

11002670 11   Pear, dried                        0.100000   6.250      1.000

11002680 11   Pear, juice                        0.100000   1.000      1.000

11002681 11   Pear, juice-babyfood               0.100000   1.000      1.000

14002690 14   Pecan                              0.100000   1.000      1.000

08002700 8    Pepper, bell                       0.100000   1.000      1.000

08002701 8    Pepper, bell-babyfood              0.100000   1.000      1.000

08002710 8    Pepper, bell, dried                0.100000   1.000      1.000

08002711 8    Pepper, bell, dried-babyfood       0.100000   1.000      1.000

08002720 8    Pepper, nonbell                    0.100000   1.000      1.000

08002721 8    Pepper, nonbell-babyfood           0.100000   1.000      1.000

08002730 8    Pepper, nonbell, dried             0.100000   1.000      1.000

95002750 O    Peppermint                         0.200000   1.000      1.000

95002760 O    Peppermint, oil                    1.000000   1.000      1.000

14002820 14   Pistachio                          0.100000   1.000      1.000

12002850 12   Plum                               0.100000   1.000      1.000

12002851 12   Plum-babyfood                      0.100000   1.000      1.000

12002860 12   Plum, prune, fresh                 0.100000   1.000      1.000

12002861 12   Plum, prune, fresh-babyfood        0.100000   1.000      1.000

12002870 12   Plum, prune, dried                 0.100000   5.000      1.000

12002871 12   Plum, prune, dried-babyfood        0.100000   5.000      1.000

12002880 12   Plum, prune, juice                 0.100000   1.400      1.000

12002881 12   Plum, prune, juice-babyfood        0.100000   1.400      1.000

95002890 O    Pomegranate                        0.100000   1.000      1.000

01032960 1C   Potato, chips                      0.100000   1.000      1.000

01032970 1C   Potato, dry (granules/ flakes)     0.100000   6.500      1.000

01032971 1C   Potato, dry (granules/ flakes)-b   0.100000   6.500      1.000

01032980 1C   Potato, flour                      0.100000   6.500      1.000

01032981 1C   Potato, flour-babyfood             0.100000   6.500      1.000

01032990 1C   Potato, tuber, w/peel              0.100000   1.000      1.000

01032991 1C   Potato, tuber, w/peel-babyfood     0.100000   1.000      1.000

01033000 1C   Potato, tuber, w/o peel            0.100000   1.000      1.000

01033001 1C   Potato, tuber, w/o peel-babyfood   0.100000   1.000      1.000

10003070 10   Pummelo                            0.100000   1.000      1.000

11003100 11   Quince                             0.100000   1.000      1.000

15003230 15   Rice, white                        0.100000   1.000      1.000

15003231 15   Rice, white-babyfood               0.100000   1.000      1.000

15003240 15   Rice, brown                        0.100000   1.000      1.000

15003241 15   Rice, brown-babyfood               0.100000   1.000      1.000

15003250 15   Rice, flour                        0.100000   1.000      1.000

15003251 15   Rice, flour-babyfood               0.100000   1.000      1.000

15003260 15   Rice, bran                         0.100000   1.000      1.000

15003261 15   Rice, bran-babyfood                0.100000   1.000      1.000

03003380 3    Shallot                            0.200000   1.000      1.000

15003440 15   Sorghum, grain                     0.100000   1.000      1.000

15003450 15   Sorghum, syrup                     0.100000   1.000      1.000

06003470 6    Soybean, seed                      0.100000   1.000      1.000

06003480 6    Soybean, flour                     0.100000   1.000      1.000

06003481 6    Soybean, flour-babyfood            0.100000   1.000      1.000

06003490 6    Soybean, soy milk                  0.100000   1.000      1.000

06003491 6    Soybean, soy milk-babyfood or in   0.100000   1.000      1.000

06003500 6    Soybean, oil                       0.100000   1.000      1.000

06003501 6    Soybean, oil-babyfood              0.100000   1.000      1.000

95003520 O    Spearmint                          0.200000   1.000      1.000

95003530 O    Spearmint, oil                     1.000000   1.000      1.000

95003590 O    Strawberry                         0.100000   1.000      1.000

95003591 O    Strawberry-babyfood                0.100000   1.000      1.000

95003600 O    Strawberry, juice                  0.100000   1.000      1.000

95003601 O    Strawberry, juice-babyfood         0.100000   1.000      1.000

95003620 O    Sugarcane, sugar                   0.100000   1.000      1.000

95003621 O    Sugarcane, sugar-babyfood          0.100000   1.000      1.000

95003630 O    Sugarcane, molasses                0.100000   1.000      1.000

95003631 O    Sugarcane, molasses-babyfood       0.100000   1.000      1.000

20003640 20   Sunflower, seed                    0.100000   1.000      1.000

20003650 20   Sunflower, oil                     0.100000   1.000      1.000

20003651 20   Sunflower, oil-babyfood            0.100000   1.000      1.000

10003690 10   Tangerine                          0.100000   1.000      1.000

10003700 10   Tangerine, juice                   0.100000   1.000      1.000

08003740 8    Tomatillo                          0.100000   1.000      1.000

08003750 8    Tomato                             0.100000   1.000      1.000

08003751 8    Tomato-babyfood                    0.100000   1.000      1.000

08003760 8    Tomato, paste                      0.100000   5.400      1.000

08003761 8    Tomato, paste-babyfood             0.100000   5.400      1.000

08003770 8    Tomato, puree                      0.100000   3.300      1.000

08003771 8    Tomato, puree-babyfood             0.100000   3.300      1.000

08003780 8    Tomato, dried                      0.100000  14.300      1.000

08003781 8    Tomato, dried-babyfood             0.100000  14.300      1.000

08003790 8    Tomato, juice                      0.100000   1.500      1.000

14003910 14   Walnut                             0.100000   1.000      1.000

86010000 O    Water, direct, all sources         0.006000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

86020000 O    Water, indirect, all sources       0.006000   1.000      1.000   PP#6E7

  Full comment: PP#6E7129

15004010 15   Wheat, grain                       0.100000   1.000      1.000

15004011 15   Wheat, grain-babyfood              0.100000   1.000      1.000

15004020 15   Wheat, flour                       0.100000   1.400      1.000

15004021 15   Wheat, flour-babyfood              0.100000   1.400      1.000

15004030 15   Wheat, germ                        0.100000   8.000      1.000

15004040 15   Wheat, bran                        0.100000   8.000      1.000

15004050 15   Wild rice                          0.100000   1.000      1.000

ATACHEMNT 2:

U.S. Environmental Protection Agency                                 Ver. 2.00

DEEM-FCID Chronic analysis for PENDIMETHALIN                    (1994-98 data)

Residue file name: E:\pendimethalin\DEEM for Secondary\FINAL\c108501 D334173 073107.R98

                                                 Adjustment factor #2 NOT used.

Analysis Date 07-31-2007/14:15:55     Residue file dated: 07-31-2007/14:14:09/8

Reference dose (RfD, Chronic) = .03 mg/kg bw/day

NOEL (Chronic) = 10 mg/kg bw/day

COMMENT 1: FQPA Safety Factor = 1X; DBUFs = 300X; no acute dose/endpoint

======================================================================== =======

                    Total exposure by population subgroup

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

                                                    Total Exposure

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

          Population                         mg/kg       Margin of   Percent

           Subgroup                       body wt/day   Exposure 1/  of RfD

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

U.S. Population (total)                     0.001548        6,459        5.2%

U.S. Population (spring season)             0.001546        6,467        5.2%

U.S. Population (summer season)             0.001528        6,544        5.1%

U.S. Population (autumn season)             0.001545        6,474        5.1%

U.S. Population (winter season)             0.001576        6,344        5.3%

Northeast region                            0.001622        6,166        5.4%

Midwest region                              0.001585        6,309        5.3%

Southern region                             0.001440        6,944        4.8%

Western region                              0.001615        6,192        5.4%

Hispanics                                   0.001691        5,913        5.6%

Non-hispanic whites                         0.001519        6,585        5.1%

Non-hispanic blacks                         0.001521        6,574        5.1%

Non-hisp/non-white/non-black                0.001771        5,648        5.9%

All infants (< 1 year)                      0.003081        3,246       10.3%

Nursing infants                             0.001503        6,653        5.0%

Non-nursing infants                         0.003680        2,717       12.3%

Children 1-6  yrs                           0.004001        2,500       13.3%

Children 7-12 yrs                           0.002170        4,609        7.2%

Females 13-19 (not preg or nursing)         0.001321        7,571        4.4%

Females 20+ (not preg or nursing)           0.001095        9,132        3.7%

Females 13-50 yrs                           0.001252        7,989        4.2%

Females 13+ (preg/not nursing)              0.001343        7,448        4.5%

Females 13+ (nursing)                       0.001469        6,807        4.9%

Males 13-19 yrs                             0.001507        6,637        5.0%

Males 20+ yrs                               0.001158        8,634        3.9%

Seniors 55+                                 0.001064        9,398        3.5%

Children 1-2 yrs                            0.004749        2,106       15.8%

Children 3-5 yrs                            0.003819        2,618       12.7%

Children 6-12 yrs                           0.002304        4,341        7.7%

Youth 13-19 yrs                             0.001417        7,057        4.7%

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Pendimethalin	Dietary Exposure Assessment	DP Num: 	334173

PC Code:  108501			Page   PAGE  1  of   NUMPAGES  11

DRAFT Confidential, Internal, and Deliberative Material

Pendimethalin	Dietary Exposure Assessment	DP Num: 	334173

                       PC Code:  108501			Page:   PAGE  1  of 12


[Federal Register Volume 79, Number 155 (Tuesday, August 12, 2014)]
[Proposed Rules]
[Pages 47043-47044]
[FR Doc No: 2014-18954]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1983-0002; FRL-9914-91-Region 8]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Partial Deletion of the California Gulch
Superfund Site

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule; notice of intent.

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

SUMMARY: The Environmental Protection Agency (EPA) Region 8 is issuing
a Notice of Intent to Delete the Operable Unit 4, (OU4) Upper
California Gulch; Operable Unit 5 (OU5), ASARCO Smelters/Slag/Mill
Sites; and Operable Unit 7 (OU7), Apache Tailing Impoundment, of the
California Gulch Superfund Site (Site), located in Lake County,
Colorado, from the National Priorities List (NPL) and requests public
comments on this proposed action. The NPL, promulgated pursuant to
section 105 of the Comprehensive Environmental Response, Compensation,
and Liability Act (CERCLA) of 1980, as amended, is an appendix of the
National Oil and Hazardous Substances Pollution Contingency Plan (NCP).
The EPA and the State of Colorado, through the Colorado Department of
Public Health and the Environment, have determined that all appropriate
response actions at OU4, OU5 and OU7 under CERCLA, other than
operation, maintenance, and five-year reviews, have been completed.
However, this deletion does not preclude future actions under
Superfund.

    This partial deletion pertains to all of OU4, OU5 and OU7. Operable
Unit 2 (OU2), Malta Gulch Tailing Impoundments and Lower Malta Gulch
Fluvial Tailing; Operable Unit 8 (OU8), Lower California Gulch;
Operable Unit 9 (OU9), Residential Populated Areas; and Operable Unit
10 (OU10), Oregon Gulch, were previously partially deleted from the
NPL. Operable Unit 1 (OU1), the Yak Tunnel; Operable Unit 3 (OU3),
D&RGW Slag Piles and Easement; Operable Unit 6 (OU6), Stray Horse
Gulch; Operable Unit 11 (OU11), Arkansas River Floodplain; and Operable
Unit 12 (OU12), Site-wide Surface and Groundwater Quality, are not
being considered for deletion as part of this action and will remain on
the NPL.

DATES: Comments must be received by September 11, 2014.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-1983-0002, by mail to Linda Kiefer, Remedial Project Manager,
Environmental Protection Agency, Region 8, Mail Code 8EPR-SR, 1595
Wynkoop Street, Denver, CO 80202-1129. Comments may also be submitted
electronically or through hand delivery/courier by following the
detailed instructions in the ADDRESSES section of the direct final rule
located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Linda Kiefer, Remedial Project
Manager, Environmental Protection Agency, Region 8, Mail Code 8EPR-SR,
1595 Wynkoop Street, Denver, CO 80202-1129,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the ``Rules and Regulations'' Section of
today's Federal Register, we are publishing a direct final Notice of
Partial Deletion for all of OU4, OU5 and OU7 of the California Gulch
Superfund Site without prior Notice of Intent for Partial Deletion
because EPA views this as a noncontroversial revision and anticipates
no adverse comment. We have explained our reasons for this partial
deletion in the preamble to the direct final Notice of Partial
Deletion, and those reasons are incorporated herein. If we receive no
adverse comment(s) on this partial deletion action, we will not take
further action on this Notice of Intent for Partial Deletion. If we
receive adverse comment(s), we will withdraw the direct final Notice of
Partial Deletion and it will not take effect. We will, as appropriate,
address all public comments in a subsequent final Notice of Partial
Deletion based on this Notice of Intent for Partial Deletion. We will
not institute a second comment period on this Notice of Intent for
Partial Deletion. Any parties interested in commenting must do so at
this time.
    For additional information, see the direct final Notice of Partial
Deletion which is located in the Rules section of this Federal
Register.

List of Subjects in 40 CFR Part 300

    Environmental protection, Reporting and recordkeeping requirements,
Superfund.

    Authority: 33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O.
13626, 77 FR 56749, 3 CFR, 2013 Comp., p.306; E.O. 12777, 56 FR
54757, 3 CFR, 1991 Comp., p.351; E.O. 12580, 52 FR 2923, 3 CFR, 1987
Comp., p.193.

    Dated: July 31, 2014.
Shaun L. McGrath,
Regional Administrator, Region 8.
[FR Doc. 2014-18954 Filed 8-11-14; 8:45 am]
BILLING CODE 6560-50-P