[Federal Register Volume 60, Number 75 (Wednesday, April 19, 1995)]
[Notices]
[Pages 19589-19590]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9535]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00405; FRL-4943-5]
Publication of Addenda for Data Reporting E, K, and N
Requirements for Pesticide Assessment Guidelines
Agency: Environmental Protection Agency (EPA).
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Action: Notice of availability.
Summary: This notice announces the availability of a new addenda which
includes a Data Reporting Guideline (DRG) for those environmental
chemistry methods associated with Subdivision E, K, and N. This DRG is
not intended to introduce any new data requirements or revisions into
the existing guidelines. Its purpose is to further clarify technical
aspects of the existing Pesticide Assessment Guidelines and to provide
a format for organizing and submitting soil and water methods and their
supporting data in order to facilitate their review. EPA recognizes
there are sections of the DRG that do not apply to specific soil and
water methods; therefore, registrants should exercise scientific
judgement in deciding which sections apply to their methods.
ADDRESSES: Copies of this addenda to the Guidelines can be obtained
from the National Technical Information Services (NTIS) at the
following address: NTIS, ATTN: Order Desk, 5285 Port Royal Road,
Springfield, VA 22161, Telephone: 703-487-4650.
EPA's written response to Public Comments can be obtained from the
pesticide public docket at the following address: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticides Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20640. In person or by telephone: Rm. 1132, Crystal Mall
#2, 1921 Jefferson Davis Highway, Arlington, VA, (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Donald A. Marlow, Chief, Analytical
Chemistry Branch (7503W), Biological and Economic Analysis Division,
Office of Pesticide Programs, 401 M St., SW., Washington, DC 20460.
Office location and telephone number: Crystal Station 1, Rm. CS 44J1,
2800 Crystal Drive, Arlington, VA, 703-308-8198.
Supplementary Information: The Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) requires the registration of all pesticides
that are manufactured for use in the United States. In order to obtain
a registration from EPA, manufacturers must demonstrate that their
pesticides do not cause any unreasonable adverse effects to human
health and the environment. It is now considered appropriate to provide
available soil and water residue methods to EPA because of the
increased public concern regarding the contamination of the environment
with pesticides. They will validate some of those methods and may
assemble them into a new manual in order to make them available to
address potential environmental problems. This DRG provides more
detailed technical guidance regarding those analytical methods and
amends Pesticide Assessment Guidelines E, K, and N referred to earlier.
These methods may be validated in an EPA laboratory to determine if
they identify and quantify the pesticide parent compound,
toxicologically significant metabolites(s) and degradate(s) at the
level indicated. The results from the soil and water method validation
program may be used to support regulatory decisions regarding the
reliability and validity of the chemistry data sent to the Agency with
exposure, environmental fate, and ecological effects studies.
The Data Reporting Guideline (DRG) provides the registrant with a
detailed format for submitting soil and water methods to the Agency.
Each method should be complete and meet the technical requirements
identified in the DRG. Those methods should be sent to the Agency to
support specific exposure, environmental fate, and ecological effects
studies during the normal registration and reregistration cycle. Each
study for which environmental chemistry methods are needed has been
clearly identified below. Soil and water methods should be clearly
written and capable of being repeated by chemists in Federal and state
laboratories.
The Agency has developed a new Data Reporting Guideline for the
Pesticide Assessment Guidelines (E, K, and N) and these requirements
impact the studies identified below:
Subdivision E--Hazard Evaluation
Series 71-5--Simulated and Actual Field Testing for Mammals and
Birds
Series 72-7--Simulated and Actual Field Testing for Aquatic
Organisms
Subdivision K--Reentry Protection
Series 132-1--Soil Dislodgeable Residue Dissipation Studies
Subdivision N--Environmental Fate
Series 164-1--Terrestrial Field Dissipation Studies*
Series 164-2--Aquatic Field Dissipation Studies
Series 164-3--Forest Field Dissipation Studies
Series 164-5--Long Term Soil Dissipation Studies*
Series 165-3--Accumulation Studies in Irrigation Crops
Series 166-1--Groundwater Study
*In practice these studies are considered to be equivalent
because they evaluate the persistent nature of pesticide residues in
soil.
These addenda supercede the paragraphs in the respective guidelines
and the other addenda issued by the Pesticide Program regarding soil
and water methods sent to the Agency for the studies identified above.
While these addenda to the Guidelines are not mandatory, data
submitters are strongly encouraged to follow the format to assure that
reports will be consistent, thereby increasing the efficiency of
pesticide registration, reregistration, and other regulatory
activities.
The specific citation for this addenda with the NTIS ordering
number and price are as follows:
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Document Title NTIS Accession No. EPA Document No. Hardcopy Price
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Pesticide Assessment Guideline
Subdivision E:
[[Page 19590]]
Hazard Evaluation
Series 71-5 PB83-153908 540/09-82-024 $19.50
Series 72-7 PB83-153908 540/09-82-024 $19.50
Addendum No. 2 Data Reporting
Guideline for Soil and Water
Methods to Support Hazard
Evaluation Studies
Subdivision K:
Reentry Protection
Series 132-1b PB85-120962 540/09-84-001 $19.50
The Data Reporting Guideline
for Soil and Water Methods
will be attached to the new
Reentry Protection Guideline.
Subdivision N:
Environmental Fate
Series 164-1 B83-153973 540/09-82-021 $27.00
Series 164-2 B83-153973 540/09-82-021 $27.00
Series 164-3 B83-153973 540/09-82-021 $27.00
Series 164-5 B83-153973 540/09-82-021 $27.00
Series 165-3 B83-153973 540/09-82-021 $27.00
Series 166-1--Guidance to be
issued by EPA in the near
future.
Addendum No 9. Data Reporting
Guideline for Soil and Water
Methods to Support
Environmental Fate Studies
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Orders may be placed by mail or telephone. All orders should
specify whether the document is requested in hardcopy or microfiche
form since prices vary for hardcopy but they will cost $9.00 for
microfiche. There is an additional $4.00 to $8.00 handling charge for
each order, depending on the total cost of the order. Payment may be
made by using an existing NTIS deposit account; charging to VISA,
Mastercard, American Express or check or money order. The order should
cite the document title, NTIS ordering number for the document, kind of
document (microfiche or hardcopy), and the price.
List of Subjects
Environmental protection.
Dated: April 7, 1995.
Allen L. Jennings,
Director, Biological and Economic Analysis Division, Office of
Pesticide Programs.
[FR Doc. 95-9535 Filed 4-18-95; 8:45 am]
BILLING CODE 6560-50-F
