United States      Prevention, Pesticides     EPA712-C-96-187
          Environmental Protection    and Toxic Substances     August 1996
          Agency        (7101)
&EPA    Residue Chemistry
          Test Guidelines
          OPPTS 860.1560
          Reasonable Grounds in
          Support of the Petition

     This guideline is one  of a  series  of test  guidelines that have been
developed by the Office of Prevention, Pesticides and Toxic Substances,
United States Environmental  Protection Agency for use  in the testing of
pesticides and toxic substances, and the  development of test data that must
be submitted to the Agency  for review under Federal regulations.

     The Office of Prevention, Pesticides and Toxic Substances (OPPTS)
has  developed this guideline through  a process of harmonization that
blended the testing  guidance  and requirements that  existed in the Office
of Pollution Prevention and  Toxics  (OPPT) and appeared in Title  40,
Chapter I,  Subchapter R of the Code of Federal Regulations  (CFR),  the
Office of Pesticide Programs (OPP) which appeared in publications of the
National Technical  Information Service (NTIS) and the guidelines pub-
lished by the Organization  for Economic Cooperation and Development

     The purpose of harmonizing these  guidelines  into a single set of
OPPTS guidelines is to minimize  variations among the testing procedures
that must be performed to meet the data  requirements of the U. S. Environ-
mental Protection Agency  under  the Toxic  Substances  Control Act  (15
U.S.C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act
(7U.S.C. I36,etseq.).

     Final  Guideline Release: This guideline  is available from the U.S.
Government Printing Office, Washington, DC 20402 on The Federal Bul-
letin   Board.   By  modem  dial   202-512-1387,  telnet   and   ftp:
fedbbs.access.gpo.gov    (IP,    internet:     http://
fedbbs.access.gpo.gov, or call 202-512-0132 for disks  or paper copies.
This guideline is also available electronically in ASCII and PDF (portable
document format) from the EPA  Public Access Gopher  (gopher.epa.gov)
under the heading "Environmental Test  Methods and Guidelines."

OPPTS 860.1560  Reasonable grounds in support of the petition.
     (a) Scope—(1) Applicability. This guideline is intended to meet test-
ing  requirements  of both  the  Federal  Insecticide,  Fungicide,  and
Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.)  and the Federal Food,
Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 301, et seq.}.

     (2) Background. The source material  used in developing this har-
monized OPPTS guideline is OPP 171-7 Reasonable Grounds in Support
of the Petition (Pesticide Assessment Guidelines, Subdivision O: Residue
Chemistry, EPA Report 540/9-82-023, October 1982). This OPPTS guide-
line  should be  used in conjunction with OPPTS 860.1000, Background.

     (b) Reasonable grounds in support of the petition—section G  of
a petition. (1) The petitioner should present the rationale of how the resi-
due data support the proposed tolerance.  The presentation should include:

     (i)  Brief discussions on the adequacy of the analytical method with
respect to sensitivity and determination of the total toxic residue.

     (ii) An explanation of any aberrant residue values reported.

     (iii) An explanation for the omission or substitution of requirements
set forth in these guidelines.

     (iv) Any other residue  considerations pertinent to the proposed use.

     (v) Where  appropriate, a discussion should be furnished on the  status
of other components of the formulation.

     (2) In those instances where the dietary risk from use of the pesticide
is likely to be unacceptable, assuming tolerance level residues on the  entire
crop, the petitioner  should provide any information or data that could  be
used to  estimate a more realistic dietary exposure. In the case of concerns
with chronic risk, determination of the average residue obtained in crop
field trials would be useful. Also, information  on actual or projected mar-
ket shares for existing or proposed  uses, respectively, can be submitted
for review by OPP's Biological and Economic Analysis Division.