Final NAFTA Guidance for Conducting Terrestrial Field Dissipation Studies, 46226-46227 [E6-13042]

Download as PDF 46226 Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Notices Brassica leafy vegetables and turnip greens to control diamondback moth larvae. Information in accordance with 40 CFR part 166 was submitted as part of this request. As part of this request, the Applicant asserts that, the available alternative controls are no longer providing adequate control, and asserts that resistance to some of them may be developing. The Applicant claims that another control chemical is needed to use in rotation with registered materials, to maintain season long control of the diamondback moth in these crops, and that without adequate control, significant economic losses will be suffered. The Applicant proposes to make no more than 4 applications of pyridalyl, at a rate of up to 0.2 lbs. active ingredient (a.i.) per acre (no more than 0.8 lbs. a.i. total), on up to 32,000 acres, to Brassica leafy vegetables (including but not limited to cabbage, collard greens, mustard greens, kale) and turnip greens, in Georgia, for use year round, resulting in use of up to a total of 25,600 lbs. a.i. total. This notice does not constitute a decision by EPA on the application itself. The regulations governing section 18 of FIFRA require publication of a notice of receipt of an application for a specific exemption proposing use of a new chemical (i.e., an active ingredient) which has not been registered by the EPA. The notice provides an opportunity for public comment on the application. The Agency, will review and consider all comments received during the comment period in determining whether to issue the specific exemption requested by the Georgia Department of Agriculture. List of Subjects Environmental protection, Pesticides and pests. Dated: August 2, 2006. Lois Rossi, Director, Registration Division, Office of Pesticide Programs. [FR Doc. E6–13036 Filed 8–10–06; 8:45 am] BILLING CODE 6560–50–S hsrobinson on PROD1PC67 with NOTICES1 [EPA–HQ–OPP–2005–0129; FRL–8071–9] Final NAFTA Guidance for Conducting Terrestrial Field Dissipation Studies Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 15:03 Aug 10, 2006 I. General Information A. Does this Action Apply to Me? ENVIRONMENTAL PROTECTION AGENCY VerDate Aug<31>2005 SUMMARY: Under the North American Free Trade Agreement (NAFTA), EPA and the Canadian Pest Management Regulatory Agency (PMRA) have agreed to harmonize their testing guidelines so that one set of tests can be used for the registration of pesticides in Canada and the United States. The NAFTA harmonized guidance for terrestrial field dissipation (TFD) studies are conducted to demonstrate the transformation, transport, and fate of pesticides under representative actual use conditions. These field studies are needed to substantiate the physicochemical, mobility, and biotransformation data from laboratory studies. Environmental fate studies have shown that pesticide dissipation may proceed at different rates under field conditions and may result in degradates forming at levels different from those observed in laboratory studies. The objective of this guidance document is to help ensure that TFD studies are conducted in a manner that will provide risk assessors and risk managers with more confidence in the data generated and with a better understanding of the assumptions and limitations of the data and estimated half-lives of the pesticide. The proposed guidance document for TFD studies was published in the Federal Register on June 15, 2005 (FRL–7713–7). After reviewing the public comments for this Notice, EPA developed a final guidance document, which can be found at: https://www.epa.gov/oppefed1/ ecorisk_ders/terrestrial_field_ dissipation_guidance.pdf. EPA’s response to public comments can be found in the public docket: EPA–HQ– OPP–2005–0129. FOR FURTHER INFORMATION CONTACT: Mark Corbin, Environmental Fate and Effects Division (7507P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 605-0033; fax number: (703) 305-6309; e-mail address: corbin.mark@epa.gov. SUPPLEMENTARY INFORMATION: Jkt 208001 You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111) • Animal production (NAICS code 112) • Food manufacturing (NAICS code 311) PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 • Pesticide manufacturing (NAICS code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. 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–2005–0129. 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 Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket telephone number is (703) 305-5805. 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 A. What Action is the Agency Taking? The Terrestrial Field Dissipation study has been a basic requirement for registrants of new and existing pesticides since 1982. While laboratory environmental fate studies are designed to address one dissipation process at a time, terrestrial field dissipation studies address pesticide loss as a combined result of chemical and biological processes (e.g., hydrolysis, photolysis, microbial transformation) and physical migration (e.g., volatilization, leaching, plant uptake). Data from these studies can reduce potential overestimation of exposure and risk and can confirm assumptions of low levels of toxic degradates. Results can be used to propose scenario-specific effective risk mitigation. In general, the terrestrial field dissipation study results should allow the risk assessor to: E:\FR\FM\11AUN1.SGM 11AUN1 Federal Register / Vol. 71, No. 155 / Friday, August 11, 2006 / Notices • Compare predicted routes of dissipation identified in the laboratory with those measured in the field; • Characterize the rates of dissipation of the parent compound and formation and decline of the major and/or toxicologically significant transformation products under field conditions; • Characterize the rates and relative importance of the different transport processes, including leaching, runoff, and volatilization; • Establish the distribution of the parent compound and the major transformation products in the soil profile; • Characterize the persistence of the parent compound and major transformation products in soil, including retention and residue carryover in the soil to the following crop season; and • Characterize the effect(s) of different typical pesticide formulation categories, where applicable. EPA and PMRA have developed harmonized guidance for conducting terrestrial field dissipation studies so that one set of tests can be used for registration of a pesticide in Canada, the United States, and Mexico. In developing this guidance document, EPA and PMRA conducted an extensive outreach and review program, soliciting input from stakeholders and the technical community through several forums: Three symposia, one Scientific Advisory Panel (SAP) meeting, and one workshop. Working closely with its stakeholders, PMRA and EPA developed a conceptual model for designing terrestrial studies that will evaluate the overall dissipation of a pesticide in the field. The conceptual model, which is specific for each pesticide, is based on the chemical’s physicochemical properties, laboratory environmental fate studies, formulation type and intended use pattern. On June 15, 2005, the Agency published the draft harmonized guidance and conceptual model in the Federal Register and asked for comments. After reviewing all the comments, PMRA and EPA developed the final guidance, which can be found at the following address: https:// www.epa.gov/oppefed1/ecorisk_ders/ terrestrial_field_dissipation_ guidance.pdf. B. What is the Agency’s Authority for Taking this Action? This action is being taken under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). List of Subjects Environmental protection, Terrestrial field dissipation, NAFTA harmonized guidance. Dated: August 3, 2006. Steven Bradbury, Director, Environmental Fate and Effects Division, Office of Pesticide Programs. FR Doc. E6–13042 Filed 8–10–06; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [FRL–8208–2] Clean Water Act Section 303(d): Availability of Thirty Oklahoma Total Maximum Daily Loads (TMDLs) for Public Comment Environmental Protection Agency (EPA). ACTION: Notice of availability of thirty Oklahoma TMDLs for public comment. AGENCY: SUMMARY: This notice announces the availability for public comment of thirty TMDLs, and their administrative record files prepared by EPA Region 6 for certain waters listed in the Upper Canadian River and Turkey Creek Watersheds of Oklahoma, under section 303(d) of the Clean Water Act (CWA). DATES: Comments must be submitted in writing to EPA on or before September 11, 2006. ADDRESSES: Comments on the thirty TMDLs should be sent to Diane Smith, Environmental Protection Specialist, Water Quality Protection Division, U.S. Environmental Protection Agency Region 6, 1445 Ross Ave., Dallas, TX 75202–2733 or e-mail: hsrobinson on PROD1PC67 with NOTICES1 Segment Canadian River ................................................ Bear Creek ....................................................... Canadian River ................................................ Trail Creek ....................................................... Lone Creek ...................................................... Red Trail Creek ................................................ Red Creek ........................................................ Hackberry Creek .............................................. Commission Creek ........................................... Deer Creek ....................................................... smith.diane@epa.gov. For further information, contact Diane Smith at (214) 665–2145 or fax 214–665–7373. The administrative record files for the thirty TMDLs are available for public inspection at this address as well. Documents from the administrative record files may be viewed at https:// www.epa.gov/region6/6wq/npdes/tmdl/ index.htm, or obtained by calling or writing Ms. Smith at the above address. Please contact Ms. Smith to schedule an inspection. FOR FURTHER INFORMATION CONTACT: Diane Smith at (214) 665–2145. SUPPLEMENTARY INFORMATION: On March 10, 2006, EPA Region 6 made a commitment to the EPA Headquarters Office of Water under EPA’s National Water Program Fiscal Year 2006 Guidance for the program activity measure (PAM) number WQ–12, to establish or approve a total of 188 TMDLs in fiscal year (FY) 2006. Under the PAM number WQ–12, EPA expected the Oklahoma Department of Environmental Quality (ODEQ) to develop a total of 87 TMDLs in fiscal year (FY) 2006 and submit them for EPA’s approval. By the end of July 2006, ODEQ had submitted two final TMDLs for EPA’s approval and 30 draft TMDLs for EPA’s review and comments. EPA has approved the two final TMDLs submitted by ODEQ. However, a recent discussion between EPA Region 6 and ODEQ senior managers determined that although substantial progress has been made on the other TMDLs, the remainder of the TMDLs needed to meet the commitment could not be completed by the target date. Accordingly, EPA Region 6 has decided to conduct the public participation process for these thirty TMDLs and establish the final TMDLs on or before September 30, 2006, to meet the FY06 PAM commitment. EPA Seeks Comment on Thirty TMDLs By this notice EPA is seeking public comment on the following thirty TMDLs for certain waters located within Oklahoma’s Upper Canadian River and Turkey Creek Watersheds: Waterbody name Upper Canadian River Watershed: OK520620010010_00 ................................. OK520620010120_00 ................................. OK520620020010_00 ................................. OK520620020090_00 ................................. OK520620030020_00 ................................. OK520620030050_00 ................................. OK520620030110_00 ................................. OK520620040050_00 ................................. OK520620050160_00 ................................. OK520620060010_00 ................................. VerDate Aug<31>2005 15:03 Aug 10, 2006 Jkt 208001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 46227 Pollutant Fecal coliform E. coli, Enterococci, and Fecal coliform Enterococci, and Fecal coliform E. coli, Enterococci, and Fecal coliform E. coli and Enterococci E. coli, Enterococci, and Fecal coliform E. coli, Enterococci, and Fecal coliform E. coli and Enterococci E. coli and Enterococci E. coli and Enterococci E:\FR\FM\11AUN1.SGM 11AUN1

Agencies

[Federal Register Volume 71, Number 155 (Friday, August 11, 2006)]
[Notices]
[Pages 46226-46227]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-13042]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0129; FRL-8071-9]


Final NAFTA Guidance for Conducting Terrestrial Field Dissipation 
Studies

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: Under the North American Free Trade Agreement (NAFTA), EPA and 
the Canadian Pest Management Regulatory Agency (PMRA) have agreed to 
harmonize their testing guidelines so that one set of tests can be used 
for the registration of pesticides in Canada and the United States. The 
NAFTA harmonized guidance for terrestrial field dissipation (TFD) 
studies are conducted to demonstrate the transformation, transport, and 
fate of pesticides under representative actual use conditions. These 
field studies are needed to substantiate the physicochemical, mobility, 
and biotransformation data from laboratory studies. Environmental fate 
studies have shown that pesticide dissipation may proceed at different 
rates under field conditions and may result in degradates forming at 
levels different from those observed in laboratory studies. The 
objective of this guidance document is to help ensure that TFD studies 
are conducted in a manner that will provide risk assessors and risk 
managers with more confidence in the data generated and with a better 
understanding of the assumptions and limitations of the data and 
estimated half-lives of the pesticide. The proposed guidance document 
for TFD studies was published in the Federal Register on June 15, 2005 
(FRL-7713-7). After reviewing the public comments for this Notice, EPA 
developed a final guidance document, which can be found at: https://
www.epa.gov/oppefed1/ecorisk_ders/terrestrial_field_dissipation_
guidance.pdf. EPA's response to public comments can be found in the 
public docket: EPA-HQ-OPP-2005-0129.

FOR FURTHER INFORMATION CONTACT: Mark Corbin, Environmental Fate and 
Effects Division (7507P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 605-0033; fax number: (703) 305-6309; e-
mail address: corbin.mark@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111)
     Animal production (NAICS code 112)
     Food manufacturing (NAICS code 311)
     Pesticide manufacturing (NAICS code 32532)
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. 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-2005-0129. 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 Building), 2777 S. 
Crystal Drive, Arlington, VA. The hours of operation of this Docket 
Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays. The Docket telephone number is (703) 305-5805.
    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

A. What Action is the Agency Taking?

    The Terrestrial Field Dissipation study has been a basic 
requirement for registrants of new and existing pesticides since 1982. 
While laboratory environmental fate studies are designed to address one 
dissipation process at a time, terrestrial field dissipation studies 
address pesticide loss as a combined result of chemical and biological 
processes (e.g., hydrolysis, photolysis, microbial transformation) and 
physical migration (e.g., volatilization, leaching, plant uptake). Data 
from these studies can reduce potential overestimation of exposure and 
risk and can confirm assumptions of low levels of toxic degradates. 
Results can be used to propose scenario-specific effective risk 
mitigation.
    In general, the terrestrial field dissipation study results should 
allow the risk assessor to:

[[Page 46227]]

     Compare predicted routes of dissipation identified in the 
laboratory with those measured in the field;
     Characterize the rates of dissipation of the parent 
compound and formation and decline of the major and/or toxicologically 
significant transformation products under field conditions;
     Characterize the rates and relative importance of the 
different transport processes, including leaching, runoff, and 
volatilization;
     Establish the distribution of the parent compound and the 
major transformation products in the soil profile;
     Characterize the persistence of the parent compound and 
major transformation products in soil, including retention and residue 
carryover in the soil to the following crop season; and
     Characterize the effect(s) of different typical pesticide 
formulation categories, where applicable.
    EPA and PMRA have developed harmonized guidance for conducting 
terrestrial field dissipation studies so that one set of tests can be 
used for registration of a pesticide in Canada, the United States, and 
Mexico. In developing this guidance document, EPA and PMRA conducted an 
extensive outreach and review program, soliciting input from 
stakeholders and the technical community through several forums: Three 
symposia, one Scientific Advisory Panel (SAP) meeting, and one 
workshop. Working closely with its stakeholders, PMRA and EPA developed 
a conceptual model for designing terrestrial studies that will evaluate 
the overall dissipation of a pesticide in the field. The conceptual 
model, which is specific for each pesticide, is based on the chemical's 
physicochemical properties, laboratory environmental fate studies, 
formulation type and intended use pattern. On June 15, 2005, the Agency 
published the draft harmonized guidance and conceptual model in the 
Federal Register and asked for comments. After reviewing all the 
comments, PMRA and EPA developed the final guidance, which can be found 
at the following address: https://www.epa.gov/oppefed1/ecorisk_ders/
terrestrial_field_dissipation_guidance.pdf.

B. What is the Agency's Authority for Taking this Action?

    This action is being taken under the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA).

List of Subjects

    Environmental protection, Terrestrial field dissipation, NAFTA 
harmonized guidance.


    Dated: August 3, 2006.
Steven Bradbury,
Director, Environmental Fate and Effects Division, Office of Pesticide 
Programs.
FR Doc. E6-13042 Filed 8-10-06; 8:45 am]
BILLING CODE 6560-50-S
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