Pesticides; Science Policy; Notice of Withdrawal, 42082-42083 [E7-14685]

Download as PDF 42082 Federal Register / Vol. 72, No. 147 / Wednesday, August 1, 2007 / Notices SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? You may be potentially affected by this action if you are engaged in pesticide and other agricultural chemical manufacturing. Potentially affected entities may include, but are not limited to: • Pesticide and other agricultural chemical manufacturing (NAICS code 325320) e.g., individuals or entities engaged in activities related to the registration of a pesticide product. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. jlentini on PROD1PC65 with NOTICES B. What Should I Consider as I Prepare My Comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When submitting comments, remember to: i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. VerDate Aug<31>2005 20:12 Jul 31, 2007 Jkt 211001 iv. Describe any assumptions and provide any technical information and/ or data that you used. v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. vi. Provide specific examples to illustrate your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. What Action is the Agency Taking? EPA is seeking public comment on the document entitled Statistical Basis of the NAFTA Method for Calculating Pesticide Maximum Residue Limits from Field Trial Data. The document, prepared by the NAFTA MRL Harmonization Working Group, serves as an added explanatory document to Canada’s PMRA and EPA’s OPP September 2005 draft document entitled Guidance for Setting Pesticide Maximum Residue Limits Based on Field Trial Data which is available at https://www.pmra-arla.gc.ca/english/ pdf/pro/pro2005-04-e.pdf. The SOP includes procedures for using the companion ‘‘NAFTA MRL calculator,’’ the Microsoft Excel spreadsheet that incorporates the decision algorithm and automates the statistical calculations as outlined by the SOP. The NAFTA MRL calculator can be downloaded from the PMRA website (https://www.pmraarla.gc.ca/english/pdf/mrl/ method_calc.xls). The September 2005 draft SOP is intended for use by residue chemistry reviewers in the United States and Canada to ensure that the same or similar data sets will result in the same or similar recommendation for MRL levels in each regulatory program. A 60– day comment period was opened for this by PMRA in September 2005 and is now closed. The comments received by PMRA were shared with EPA. Upon the September 2005 release of the draft SOP, PMRA and EPA announced that an additional explanatory document would be published at a future date. This document is now available on the PMRA website (see https://www.pmraarla.gc.ca/english/pdf/nafta/docs/ nafta_mrls-e.pdf) and EPA is seeking comment on the statistical (and nonstatistical) basis of the selected procedures and algorithms. More detailed statistical, simulation, and other support for the methods described in the September 2005 draft SOP are provided in this follow-on document PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 which is intended to provide a permanent and enduring record of the rationale, reasoning, historical context, and technical/statistical support for the MRL estimation methodologies described and discussed in the September 2005 SOP. Once the public comment period closes for this document, the statistical support document, the SOP and the associated MRL calculator will be modified as appropriate to address the comments from this current public comment period and the previous PMRA comment period for the draft SOP, and then reissued. We anticipate these documents will be released in final form in December 2007. List of Subjects Environmental protection, Administrative practice and procedure, Agricultural commodities, North American Free Trade Agreement (NAFTA), Pesticides and pests. Dated: July 26, 2007. Debra Edwards, Director, Office of Pesticide Programs. [FR Doc. E7–14889 Filed 7–31–07; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2007–0218; FRL–8130–2] Pesticides; Science Policy; Notice of Withdrawal Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: EPA announces the withdrawal of the revised version of the pesticide science policy document ‘‘Standard Operating Procedures for Incorporating Screening-Level Estimates of Drinking Water Exposure into Aggregate Risk Assessments’’ https:// www.epa.gov/oppfead1/trac/science/ screeningsop.pdf. This science policy document was developed during the implementation of the new safety standard in section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). EPA’s assessment of exposure to pesticide residues in drinking water no longer involves performing screening level assessments as described in this policy paper. Accordingly, EPA is withdrawing this science policy document. Instead, the Agency now routinely develops estimates of exposure to pesticides in drinking water using the more advanced E:\FR\FM\01AUN1.SGM 01AUN1 Federal Register / Vol. 72, No. 147 / Wednesday, August 1, 2007 / Notices methods that EPA has described in other science policy papers. 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–2007–0218. 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. jlentini on PROD1PC65 with NOTICES II. Background On August 3, 1996, FQPA was signed into law. The FQPA significantly amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and FFDCA. Among other changes, FQPA established a stringent healthbased standard (‘‘a reasonable certainty of no harm’’) for pesticide residues in foods to assure protection from unacceptable pesticide exposure and strengthened health protections for VerDate Aug<31>2005 20:12 Jul 31, 2007 Jkt 211001 infants and children from pesticide risks. During 1998 and 1999, EPA and the U.S. 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, in 2000 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 two of the FQPA science policy papers. III. Summary: Why the Policy Is No Longer Needed As a result of the new procedures for estimating concentrations of pesticide residues in drinking water, this notice announces the withdrawal of ‘‘Standard Operating Procedures for Incorporating Screening-Level Estimates of Drinking Water Exposure into Aggregate Risk PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 42083 Assessments’’ https://www.epa.gov/ fedrgstr/EPA-PEST/2000/October/Day11/p25934.htm. In assessing the risks of pesticide exposure, scientists frequently use mathematical models to predict pesticide concentrations in food, water, residential, and occupational environments. This notice pertains to how the Agency determines pesticide risk from drinking water. (For more information on the models the Agency uses to estimate concentrations of pesticides in drinking water see https:// www.epa.gov/oppefed1/models/water/ models4.htm). This approach provides a more realistic estimate of exposure through drinking water since actual drinking water consumption data and reported body weight from the Combined Survey of Food Intake by Individuals (CSFII) are used, rather than the standard assumptions used in the Drinking Water Level of Comparison approach. 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/oigearth/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 rendered obsolete by the availability of more robust data and models. List of Subjects Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests. Dated: July 20, 2007. James B. Gulliford, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. E7–14685 Filed 7–31–07; 8:45 am] BILLING CODE 6560–50–S FEDERAL COMMUNICATIONS COMMISSION Notice of Public Information Collection(s) Being Reviewed by the Federal Communications Commission, Comments Requested July 23, 2007. SUMMARY: The Federal Communications Commission, as part of its continuing E:\FR\FM\01AUN1.SGM 01AUN1

Agencies

[Federal Register Volume 72, Number 147 (Wednesday, August 1, 2007)]
[Notices]
[Pages 42082-42083]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-14685]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0218; FRL-8130-2]


Pesticides; Science Policy; Notice of Withdrawal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY:  EPA announces the withdrawal of the revised version of the 
pesticide science policy document ``Standard Operating Procedures for 
Incorporating Screening-Level Estimates of Drinking Water Exposure into 
Aggregate Risk Assessments'' https://www.epa.gov/oppfead1/trac/science/
screeningsop.pdf. This science policy document was developed during the 
implementation of the new safety standard in section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality 
Protection Act of 1996 (FQPA). EPA's assessment of exposure to 
pesticide residues in drinking water no longer involves performing 
screening level assessments as described in this policy paper. 
Accordingly, EPA is withdrawing this science policy document. Instead, 
the Agency now routinely develops estimates of exposure to pesticides 
in drinking water using the more advanced

[[Page 42083]]

methods that EPA has described in other science policy papers.

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-2007-0218. 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

    On August 3, 1996, FQPA was signed into law. The FQPA significantly 
amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
and 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 U.S. 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, in 
2000 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 two of the FQPA science policy papers.

III. Summary: Why the Policy Is No Longer Needed

    As a result of the new procedures for estimating concentrations of 
pesticide residues in drinking water, this notice announces the 
withdrawal of ``Standard Operating Procedures for Incorporating 
Screening-Level Estimates of Drinking Water Exposure into Aggregate 
Risk Assessments'' https://www.epa.gov/fedrgstr/EPA-PEST/2000/October/
Day-11/p25934.htm.
    In assessing the risks of pesticide exposure, scientists frequently 
use mathematical models to predict pesticide concentrations in food, 
water, residential, and occupational environments. This notice pertains 
to how the Agency determines pesticide risk from drinking water. (For 
more information on the models the Agency uses to estimate 
concentrations of pesticides in drinking water see https://www.epa.gov/
oppefed1/models/water/models4.htm). This approach provides a more 
realistic estimate of exposure through drinking water since actual 
drinking water consumption data and reported body weight from the 
Combined Survey of Food Intake by Individuals (CSFII) are used, rather 
than the standard assumptions used in the Drinking Water Level of 
Comparison approach.
    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/oigearth/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 rendered obsolete by the availability of more robust data and 
models.

List of Subjects

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


    Dated: July 20, 2007.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.
[FR Doc. E7-14685 Filed 7-31-07; 8:45 am]
BILLING CODE 6560-50-S
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