Guidance for Submission of Probabilistic Human Health Exposure Assessments Science Policy; Notice of Withdrawal, 34341-34342 [E9-16273]

Download as PDF 34341 Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Notices Waterbody/general area From longitude From latitude To longitude To latitude South in a straight line across the water to navigational marker C ‘‘1’’ off ‘‘Baker Island’’ in Cranberry Isles. West in a straight line across the water to ‘‘Bass Harbor Head’’ in Tremont. 69°11′27.45″ W 44°18′20.76″ N 68°11′16.54″ W 44°14′16.84″ N 68°11′16.54″ W 44°14′16.84″ N 68°20′14.35″ W 44°13′16.42″ N The area includes the municipal waters of Mount Desert, Southwest Harbor, portions of Cranberry Isles, and Tremont. The information submitted to EPA by the State of Maine certifies that there are six pumpout facilities located within this area. A list of the facilities, with locations, phone numbers, and hours of operation is appended at the end of this determination. Based on the examination of the petition and its supporting documentation, and discussions with the State and local officials, EPA has determined that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available for the area covered under this determination. This determination is made pursuant to Section 312(f)(3) of Public Law 92– 500, as amended by Public laws 95–217 and 100–4. PUMPOUT FACILITIES WITHIN PROPOSED NO DISCHARGE AREA [Southern Mount Desert Island] Mean low water depth Name Location Contact info. Hours Harbormaster .............................. 18 Harbor Dr., ............................. Mount Desert ............................... Clifton Dock Rd., Mount Desert .. 130 Shore Rd., Southwest Harbor. 11 Apple Lane, Southwest Harbor. 168 Clarke Point Rd., Southwest Harbor. 174 Clarke Point Rd., Southwest Harbor. 207–276–5737, HF 16 ........... 8 a.m.–5 p.m., 7 days ............ 10 ft. 207–967–2511, HF 9 ............. 207–244–5572, VHF 9 .......... 8 a.m.–5 p.m., 7 days ............ 8 a.m.–5 p.m., 7 days ............ 10 ft. 20 ft. 207–244–0117, VHF 9 .......... 9 a.m.–5 p.m., 7 days ............ 10 ft. 207–244–5525, VHF 9 .......... 9 a.m.–5 p.m., M–F ............... 8 ft. 207–244–5145, VHF 9 .......... 9 a.m.–5 p.m., M–F ............... 8 ft. Clifton Dock ................................. Hinckley Company ...................... Great Harbor Marina ................... Southwest Boat Marine Service .. Downeast Diesel and Marine ...... Dated: June 22, 2009. Ira W. Leighton, Acting Regional Administrator, New England Region. [FR Doc. E9–16838 Filed 7–14–09; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2008–0935; FRL–8408–5] Guidance for Submission of Probabilistic Human Health Exposure Assessments Science Policy; Notice of Withdrawal SUPPLEMENTARY INFORMATION: Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: sroberts on DSKD5P82C1PROD with NOTICES I. General Information A. Does this Action Apply to Me? EPA announces the withdrawal of the pesticide science policy document ‘‘Guidance for Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticide Programs.’’ This science policy document was developed to establish guidance for submission and review of probabilistic human health exposure assessments to the Agency’s Office of Pesticide Programs. SUMMARY: VerDate Nov<24>2008 17:21 Jul 14, 2009 Jkt 217001 This guidance has been superseded by EPA’s ‘‘Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity,’’ and by the ‘‘Guidance for Performing Aggregate Exposure and Risk Assessment.’’ FOR FURTHER INFORMATION CONTACT: David J. Miller, Health Effects Division, Office of Pesticide Programs (7509P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–5352; fax number: (703) 305– 5147; e-mail address: miller.davidj@epa.gov. This action is directed to the public in general. This action, however, may be of interest to persons who produce or formulate pesticides or who register pesticide products. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2008–0935. Publicly available docket materials are available either in the electronic docket at https:// www.regulations.gov, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https://www.epa.gov/fedrgstr. II. Background The Food Quality Protection Act of 1996 (FQPA) significantly amended the E:\FR\FM\15JYN1.SGM 15JYN1 sroberts on DSKD5P82C1PROD with NOTICES 34342 Federal Register / Vol. 74, No. 134 / Wednesday, July 15, 2009 / Notices Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). Among other changes, FQPA established a stringent health-based standard (‘‘a reasonable certainty of no harm’’) for pesticide residues in foods to assure protection from unacceptable pesticide exposure and strengthened health protections for infants and children from pesticide risks. During 1998 and 1999, EPA and the United States Department of Agriculture (USDA) established a subcommittee of the National Advisory Council for Environmental Policy and Technology (NACEPT), the Tolerance Reassessment Advisory Committee (TRAC), to address FFDCA issues and implementation. TRAC comprised more than 50 representatives of affected user, producer, consumer, public health, environmental, states, and other interested groups. The TRAC met from May 27, 1998, through April 29, 1999. In order to continue the constructive discussions about FFDCA, EPA and USDA established, under the auspices of NACEPT, the Committee to Advise on Reassessment and Transition (CARAT). The CARAT provided a forum for a broad spectrum of stakeholders to consult with and advise the Agency and the Secretary of Agriculture on pest and pesticide management transition issues related to the tolerance reassessment process. The CARAT was intended to further the valuable work initiated by earlier advisory committees toward the use of sound science and greater transparency in regulatory decisionmaking, increased stakeholder participation, and reasonable transition strategies that reduce risks without jeopardizing American agriculture and farm communities. As a result of the 1998 and 1999 TRAC process, EPA decided that the implementation process and related policies would benefit from providing notice and comment on major science policy issues. The TRAC identified nine science policy areas it believed were key to implementation of tolerance reassessment. EPA agreed to provide one or more documents for comment on each of the nine issues by announcing their availability in the Federal Register. In a notice published in the Federal Register of October 29, 1998 (63 FR 58038) (FRL–6041–5), EPA described its intended approach. Since then, EPA has issued a series of draft and revised documents concerning the nine science policy issues. Publication of this notice is intended to update the public on the status of the science paper ‘‘Guidance for Submission of Probabilistic Human VerDate Nov<24>2008 17:21 Jul 14, 2009 Jkt 217001 Health Exposure Assessments to the Office of Pesticide Programs.’’ III. Why this Policy is No Longer Needed Historically, assessment of the potential health risks associated with exposure to pesticides has focused upon single pathways of exposure (e.g., from pesticide residues in food, water, or residential/non-occupational uses) for individual chemicals, and not on the potential for individuals to be exposed to multiple pesticides by all pathways concurrently. In 1996, the FQPA required EPA to consider potential human health risks from all pathways of dietary and non-dietary exposures to more than one pesticide acting through a common mechanism of toxicity. The ‘‘Guidance for Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticide Programs’’ was issued in 1998; https:// www.epa.gov/fedrgstr/EPA-PEST/1998/ November/Day-05/6021.pdf. The ‘‘Guidance for Submission of Probabilistic Human Health Exposure Assessments’’ provided general guidance on the conduct of probabilistic risk assessments. The guidance was intended to be used chiefly by persons conducting human health exposure assessments for purposes of registration or reregistration of pesticides. EPA is withdrawing the ‘‘Guidance for Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticide Programs’’ because it has been superseded by several other EPA policy and guidance documents. These include: (1) ‘‘General Principles for Performing Aggregate Exposure and Risk Assessments,’’ https://www.epa.gov/ pesticides/trac/science/aggregate.pdf, and (2) ‘‘Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity,’’ https://epa.gov/pesticides/ trac/science/cumulative_guidance.pdf. The ‘‘General Principles for Performing Aggregate Exposure and Risk Assessments’’ focus upon describing principles to guide the way in which aggregate exposure and risk assessment may be performed when more extensive distributional data and more sophisticated exposure assessment, methods and tools are available. The ‘‘Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity’’ provides guidance for OPP scientists for evaluating and estimating the potential human risks associated with such multi-chemical and multipathway exposures to pesticides. PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 The policies and guidance mentioned above reflect EPA’s most recent guidance, thus superseding the information in ‘‘Guidance for Submission of Probabilistic Human Health Exposure Assessments to the Office of Pesticide Programs.’’ While the information in the document we are withdrawing is not necessarily inaccurate, it is outdated. This action is also responsive to the recommendations made by EPA’s Office of Inspector General during its review of EPA’s implementation of FQPA. In its report ‘‘Opportunities to Improve Data Quality and Children’s Health through the FQPA’’ issued January 10, 2006 https://www.epa.gov/oig/reports/2006/ 20060110–2006–P–00009.pdf the Office of Inspector General Recommended that EPA should update the status of its science policy issue papers. This Federal Register notice updates the public on the status of one of the science policy papers which has been superseded by other guidance. List of Subjects Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests. Dated: June 30, 2009. James Jones, Acting Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. E9–16273 Filed 7–14–09; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2009–0467; FRL–8424–7] Lead Wheel Balancing Weights; TSCA Section 21 Petition; Notice of Receipt and Request for Comment AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: This notice announces that EPA has received a petition under section 21 of the Toxic Substances Control Act (TSCA), and requests comments on issues raised by the petition. The petition was received from the Ecology Center of Ann Arbor, Michigan and the Sierra Club et al., (petitioners) on May 29, 2009. The petition requests that EPA establish regulations prohibiting the manufacture, processing, and distribution in commerce of lead wheel balancing weights. EPA must either grant or deny the petition within 90 days of filing. DATES: Comments must be received on or before July 30, 2009 E:\FR\FM\15JYN1.SGM 15JYN1

Agencies

[Federal Register Volume 74, Number 134 (Wednesday, July 15, 2009)]
[Notices]
[Pages 34341-34342]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-16273]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0935; FRL-8408-5]


Guidance for Submission of Probabilistic Human Health Exposure 
Assessments Science Policy; Notice of Withdrawal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA announces the withdrawal of the pesticide science policy 
document ``Guidance for Submission of Probabilistic Human Health 
Exposure Assessments to the Office of Pesticide Programs.'' This 
science policy document was developed to establish guidance for 
submission and review of probabilistic human health exposure 
assessments to the Agency's Office of Pesticide Programs. This guidance 
has been superseded by EPA's ``Guidance on Cumulative Risk Assessment 
of Pesticide Chemicals That Have a Common Mechanism of Toxicity,'' and 
by the ``Guidance for Performing Aggregate Exposure and Risk 
Assessment.''

FOR FURTHER INFORMATION CONTACT: David J. Miller, Health Effects 
Division, Office of Pesticide Programs (7509P), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5352; fax number: (703) 305-5147; e-
mail address: miller.davidj@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     This action is directed to the public in general. This action, 
however, may be of interest to persons who produce or formulate 
pesticides or who register pesticide products. Since other entities may 
also be interested, the Agency has not attempted to describe all the 
specific entities that may be affected by this action. 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 Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under 
docket identification (ID) number EPA-HQ-OPP-2008-0935. Publicly 
available docket materials are available either in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the Office of Pesticide Programs (OPP) Regulatory Public 
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal 
Dr., Arlington, VA. The hours of operation of this Docket Facility are 
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal 
holidays. The Docket Facility telephone number is (703) 305-5805.
    2. Electronic access. You may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr.

II. Background

    The Food Quality Protection Act of 1996 (FQPA) significantly 
amended the

[[Page 34342]]

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the 
Federal Food, Drug, and Cosmetic Act (FFDCA). Among other changes, FQPA 
established a stringent health-based standard (``a reasonable certainty 
of no harm'') for pesticide residues in foods to assure protection from 
unacceptable pesticide exposure and strengthened health protections for 
infants and children from pesticide risks.
    During 1998 and 1999, EPA and the United States Department of 
Agriculture (USDA) established a subcommittee of the National Advisory 
Council for Environmental Policy and Technology (NACEPT), the Tolerance 
Reassessment Advisory Committee (TRAC), to address FFDCA issues and 
implementation. TRAC comprised more than 50 representatives of affected 
user, producer, consumer, public health, environmental, states, and 
other interested groups. The TRAC met from May 27, 1998, through April 
29, 1999.
    In order to continue the constructive discussions about FFDCA, EPA 
and USDA established, under the auspices of NACEPT, the Committee to 
Advise on Reassessment and Transition (CARAT). The CARAT provided a 
forum for a broad spectrum of stakeholders to consult with and advise 
the Agency and the Secretary of Agriculture on pest and pesticide 
management transition issues related to the tolerance reassessment 
process. The CARAT was intended to further the valuable work initiated 
by earlier advisory committees toward the use of sound science and 
greater transparency in regulatory decision-making, increased 
stakeholder participation, and reasonable transition strategies that 
reduce risks without jeopardizing American agriculture and farm 
communities.
    As a result of the 1998 and 1999 TRAC process, EPA decided that the 
implementation process and related policies would benefit from 
providing notice and comment on major science policy issues. The TRAC 
identified nine science policy areas it believed were key to 
implementation of tolerance reassessment. EPA agreed to provide one or 
more documents for comment on each of the nine issues by announcing 
their availability in the Federal Register. In a notice published in 
the Federal Register of October 29, 1998 (63 FR 58038) (FRL-6041-5), 
EPA described its intended approach. Since then, EPA has issued a 
series of draft and revised documents concerning the nine science 
policy issues. Publication of this notice is intended to update the 
public on the status of the science paper ``Guidance for Submission of 
Probabilistic Human Health Exposure Assessments to the Office of 
Pesticide Programs.''

III. Why this Policy is No Longer Needed

    Historically, assessment of the potential health risks associated 
with exposure to pesticides has focused upon single pathways of 
exposure (e.g., from pesticide residues in food, water, or residential/
non-occupational uses) for individual chemicals, and not on the 
potential for individuals to be exposed to multiple pesticides by all 
pathways concurrently. In 1996, the FQPA required EPA to consider 
potential human health risks from all pathways of dietary and non-
dietary exposures to more than one pesticide acting through a common 
mechanism of toxicity.
    The ``Guidance for Submission of Probabilistic Human Health 
Exposure Assessments to the Office of Pesticide Programs'' was issued 
in 1998; https://www.epa.gov/fedrgstr/EPA-PEST/1998/November/Day-05/6021.pdf. The ``Guidance for Submission of Probabilistic Human Health 
Exposure Assessments'' provided general guidance on the conduct of 
probabilistic risk assessments. The guidance was intended to be used 
chiefly by persons conducting human health exposure assessments for 
purposes of registration or reregistration of pesticides.
    EPA is withdrawing the ``Guidance for Submission of Probabilistic 
Human Health Exposure Assessments to the Office of Pesticide Programs'' 
because it has been superseded by several other EPA policy and guidance 
documents. These include: (1) ``General Principles for Performing 
Aggregate Exposure and Risk Assessments,'' https://www.epa.gov/pesticides/trac/science/aggregate.pdf, and (2) ``Guidance on Cumulative 
Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of 
Toxicity,'' https://epa.gov/pesticides/trac/science/cumulative_guidance.pdf.
    The ``General Principles for Performing Aggregate Exposure and Risk 
Assessments'' focus upon describing principles to guide the way in 
which aggregate exposure and risk assessment may be performed when more 
extensive distributional data and more sophisticated exposure 
assessment, methods and tools are available.
    The ``Guidance on Cumulative Risk Assessment of Pesticide Chemicals 
That Have a Common Mechanism of Toxicity'' provides guidance for OPP 
scientists for evaluating and estimating the potential human risks 
associated with such multi-chemical and multi-pathway exposures to 
pesticides.
    The policies and guidance mentioned above reflect EPA's most recent 
guidance, thus superseding the information in ``Guidance for Submission 
of Probabilistic Human Health Exposure Assessments to the Office of 
Pesticide Programs.'' While the information in the document we are 
withdrawing is not necessarily inaccurate, it is outdated.
    This action is also responsive to the recommendations made by EPA's 
Office of Inspector General during its review of EPA's implementation 
of FQPA. In its report ``Opportunities to Improve Data Quality and 
Children's Health through the FQPA'' issued January 10, 2006 https://www.epa.gov/oig/reports/2006/20060110-2006-P-00009.pdf the Office of 
Inspector General Recommended that EPA should update the status of its 
science policy issue papers. This Federal Register notice updates the 
public on the status of one of the science policy papers which has been 
superseded by other guidance.

List of Subjects

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

    Dated: June 30, 2009.
James Jones,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.
[FR Doc. E9-16273 Filed 7-14-09; 8:45 am]
BILLING CODE 6560-50-S
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