United States       Prevention, Pesticides     EPA712-C-95-016
          Environmental Protection    and Toxic Substances     August 1995
          Agency         (7101)
&EPA    Residue Chemistry
          Test Guidelines
          OPPTS 860.1650
          Submittal of Analytical
          Reference Standards
                "Public Draft'

     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.).

     Public Draft Access Information: This draft guideline is part of a
series of related harmonized guidelines that  need to  be considered as a
unit. For copies: These guidelines are available electronically from the
EPA Public Access Gopher (gopher.epa.gov) under the heading "Environ-
mental Test Methods and Guidelines" or in paper by contacting the OPP
Public    Docket    at    (703)    305-5805    or    by    e-mail:

     To Submit Comments: Interested persons are invited to submit com-
ments. By mail: Public Docket and Freedom of Information Section, Office
of Pesticide Programs, Field  Operations Division (7506C), Environmental
Protection Agency,  401  M  St.  SW.,  Washington, DC 20460. In  person:
bring to: Rm. 1132, Crystal Mall #2, 1921 Jefferson Davis Highway, Ar-
lington, VA. Comments may also be submitted  electronically by sending
electronic mail (e-mail) to: guidelines@epamail.epa.gov.

     Final  Guideline Release:  This document 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:  federal.bbs.gpo.gov
3001, or call 202-512-1530 for disks or  paper  copies.  This guideline is
available in ASCII and PDF (portable document format).

OPPTS 860.1650 Submittal of analytical reference standards.
     (a) Scope.

     (1) Applicability. This guideline is intended to meet testing require-
ments  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 test guideline is the OPP guideline 171-13 (see reference
in paragraph (d)(l) of this guideline). This guideline should be used in
conjunction with OPPTS guideline 860.1000, Background, which provides
general information and overall guidance for the  860 series  on Residue

     (b) Purpose.  The purpose of the requirements for submitting analyt-
ical reference standards is to:

     (1) Insure proper analytical reference  grade  materials are available
for the Agency to  validate residue and environmental chemistry analytical

     (2) Insure that Federal  and State  enforcement  laboratories  have a
known consistent source of analytical reference standards  to validate meth-
ods employed in enforcement and monitoring activities.

     (c) Submittal of analytical reference standards..

     (1) To avoid delay in processing petitions for new pesticides, 5 gram
samples of the active ingredient analytical grade standard and  1 gram, or
a reasonable amount  of all metabolites that are  named in the tolerance
expression (part of the total toxic residue (TTR))  should be submitted to
the Pesticide and Industrial Chemicals Repository  (MD-8), U.S. Environ-
mental Protection Agency, Research Triangle Park, North Carolina 27711,
U.S.A. Registrants shall also send 1 gram, or a reasonable amount, of any
stable  derivative that is used to identify and quantitate the target com-
pounds to the EPA repository.

     (2) The letter of transmittal should include the assay of the standards,
the analytical methods used, a  statement of principal impurities, purifi-
cation  procedures, storage  requirements and special precautions for safe
handling.  A copy  of the transmittal letter should be inserted in Section
A of the petition. Larger quantities  of standards are usually required once
the tolerance  is established.  Replacement of  standards may be  required
periodically if supplies are exhausted or  if decomposition occurs during
storage. For non-acutely toxic metabolites which are difficult to synthesize,
quantities less than 1 gram will be acceptable.

    (3) Material Safety Data Sheets (MSDS) must accompany all analyt-
ical standards as specified by Occupational Safety and Health Administra-
tion (OSHA) in 29 CFR 1910.1200.

This requirement is in addition to the requirement for submittal of analyt-
ical standards for the Pure Active Ingredient (PAI) and Technical Grade
Active Ingredient (TGAI)  for  Product Chemistry purposes (see OPPTS
guideline 830.1900).

    (d) Reference.

    (1) U.S.  Environmental  Protection  Agency, Pesticide Assessment
Guidelines, Subdivision O,  Residue Chemistry. EPA  Report No.  540/9-
82-023, October, 1982 (Available  from National Technical Information
Service, Springfield, VA)