[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