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GUIDELINES GUIDELINES FOR CONTAMINATION PREVENTION STANDARDS FOR

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					                                                                                 GUIDELINES


        Brussels
February 5, 2003
  P/03/VT/11772

                                                                                    -ag.de
                   Mr G Chester             Syngenta graham.chester@syngenta.com
                   Mr H Felber                       hans.felber@freesurf.ch
                   Mr M Findlay             Syngenta   chneid.findlay@syngenta.com
                   Dr W Maasfeld            Bayer    wolfgang.maasfeld@bayercropscience.com
                   Dr S McEuen              DuPont   steven.f.mceuen@usa.dupont.com
                   Mr J Perkins             Dow      jmperkins@dow.com
                   Mr S Rutherford          ECPA     stuart.rutherford@ecpa.be
                   Mrs M Schneider          Syngenta marlies.schneider@syngenta.com
                   Ms C Schulze-Rosario     Syngenta corina.schulze-




                                   GUIDELINES FOR CONTAMINATION
                                  PREVENTION STANDARDS FOR TOLL
                                    MANUFACTURING OPERATIONS




                                                         ECPA
                                6, Avenue E. Van Nieuwenhuyse . 1160 Brussels . Belgium
                           Tel: +32 2 663 15 50 . Fax: +32 2 663 15 60 . VAT: BE 447.618.871
                                        -1-




Table of Contents


                                                                    Page


1. Introduction                                                        2
2. Purpose                                                             2

3. Scope                                                               2

4. Policy Statement                                                    3

5. Abbreviations/ Definitions/ Terminology                             3

6. Responsibilities                                                    4

7. Information Exchange                                                5

8. Establishing NOELs and calculating cleaning levels                  6

9. Minimum Requirements for Toll Manufacturers                         7

10. Minimum Requirements for Clients (ECPA Member Companies) Toll
    Manufacturers                                                      8

11. Recommendations                                                    8

12. Appendix 1                                                         8
                                             -2-




1. Introduction

Contamination of products with residual impurities is a potential issue and area of concern for
any multi-purpose chemical synthesis, formulation and/or packaging facility. Contamination
can result in adverse effects on sensitive, treated crops or non-target species and may
trigger regulatory issues. Incidents may also tarnish the reputation and image of the industry
as a whole.


2. Purpose

The purpose of these Guidelines is to ensure the quality of agricultural chemical products by
preventing contamination during toll manufacturing. This will be achieved by:
    Setting minimum standards for contamination prevention between clients and toll
    manufacturers
    Information exchange between toll manufacturers ( = toller) and its clients and direct
    communication between clients to allow adequate risk assessments.
These Guidelines are available to all member companies and their current and potential toll
manufacturers. Implementation of these Guidelines is mutually beneficial for the toller and its
clients. Responsibility for the implementation of contamination prevention programmes
remains with the individual companies and the toll manufacturers.


3. Scope

   This document provides guidelines for the preparation of contracts between the member
   companies and toll manufacturers to ensure proper Contamination Prevention. The only
   legally binding agreements are those between tollers and clients in contracts and/or
   agreements. These guidelines should not be seen as replacing or superseding existing
   contracts or agreements.
   Provide minimum standards regarding Contamination Prevention to be written into toll
   manufacturing agreements/contract.
   Exchange of relevant information on Contamination Prevention between member
   companies and between member companies and their tollers.
   Pertains to Contamination Prevention aspects in the synthesis, formulation, packaging
   and repackaging of agricultural chemicals.
   Limited to Contamination Prevention at toll manufacturers.
   Sets minimum standards regarding Contamination Prevention for toll manufacturers.
   Excluded from the scope of this document are:
       Contamination Prevention at farm level (e.g. tank cleaning)
       Issues related to biotechnology and seeds, e.g. GMO / non-GMO contamination
       during seed production.
       Bulk deliveries and storage of finished product at distributors and dealers. Guidelines
       for implementation of Contamination Prevention measures for handling finished
       product in bulk are considered the responsibility of the individual member companies
       and the regional Crop Protection Organisations.
                                                -3-



4. Policy Statement

The member companies will commit to the following:

   They will ensure that their products on the market do not contain residual impurities in the
   form of active ingredients not defined in the product specification, at levels which will
   prejudice safety and efficacy, or which do not meet regulatory requirements. Limits will
   be set by the individual companies for their products following an appropriate risk
   assessment.
   They will provide a named Focal Point able to speak authoritatively on behalf of the
   company on all aspects of Contamination Prevention.
   A company which has its products toll-manufactured will provide available information to
   their best knowledge to enable the succeeding client of the toller to carry out appropriate
   risk assessments and to set limits for residual impurities.


5. Definitions/ Abbreviations/ Terminology

   A / F / H / I / N / PGR / R
   Acaricide / Fungicide/ Herbicide/ Insecticide/ Nematicide / Plant Growth Regulator /
   Rodenticide

   ARIL, ACL, RIL and Release Limit. These terms are used by the different member
   companies and form the basis for the communication of the required cleaning level.

       ACL:
       Acceptable Concentration Level

       ARIL:
       Acceptable Residual Impurity Level

       RIL:
       Residual Impurity Level


   Client:
   A company contracting the production of a product with a toll manufacturer

   Contamination in a product:
   A component, not defined in the product specification, at levels which will prejudice safety
   and efficacy or does not meet regulatory requirements.

   Manufacturing:
   Synthesis, and/or      formulation,      and/or   packaging   (filling,   labelling   etc.)   and/or
   repackaging.

   NOEL:
   No-Observable Effect Level:
   The highest rate in g active ingredient/ha at which the active ingredient has no
   observable, adverse effects on a given, tested species.
                                              -4-




   Preceding / succeeding Client:
   Indicates the sequence in which the products of these clients are manufactured in the
   same equipment (applies equally to synthesis, formulation, packaging and repackaging).

   Product:
   Intermediates, active ingredients, technical (manufacturing) concentrates, premixes of
   active ingredients, finished formulated products (either in bulk or in final sales pack).

                            :
   Toller / Toll manufacturer
    A company making a product for its client on a contractual basis. The term “toller” is
   synonymous with contract manufacturer.


6. Responsibilities

The succeeding client is responsible:
      To define the cleaning level(s) of the active ingredients of preceding clients’ products
      in its own product to be manufactured at the toller.
      To specify whether the cleaning level must be achieved in the succeeding product or
      in the wash/flush material. In all cases, the finished product must meet the agreed
      cleaning level.
      To establish and agree on any other requirements, e.g. segregation, labelling and
      warehousing.
      To undertake detailed site audits and other due diligence activities (including the
      cleaning process and results) and support the toller where appropriate.
      To include these in an agreement with the toller.
      To use the information obtained from the preceding client exclusively for the purposes
      of Contamination Prevention.
      To inform the toller of any special risks (e.g. highly active herbicide)
      associated with the product being brought onto the toller’s site.
      To review and if necessary update existing contracts and/or agreements with tollers
      to include the best practices as outlined in this document.

The toller is responsible:
       To meet its client’s minimum standards with regards to Contamination Prevention as
       defined in Chapter 9.
       To tell the succeeding client who to contact at the preceding client.
       To clean the equipment to agreed cleaning levels and to document and retain records
       of cleaning levels achieved.
       To meet any other requirements of the succeeding client, e.g. segregation, labelling,
       simultaneous operations, information on other products handled on the site, and
       warehousing.

The preceding client is responsible:
To provide the succeeding client whose product will be manufactured in the same equipment
with any available information as requested in accordance with Section 7.


Disclaimer

Regardless of the information provided, it is the sole responsibility of the succeeding client to
determine the cleaning levels for the product(s) in question.
                                            -5-




The resulting cleaning process and the demonstration of the cleaning result achieved, is the
responsibility of the toller.

The preceding clients supplying the information to allow the risk assessment will in no case
be responsible for any problem caused by their active ingredients in the products of the
succeeding client; such responsibility solely belongs to the succeeding client. In cases where
local legislation is stricter than these Guidelines, the legislation will take precedence.


7. Information Exchange

The toller must supply the following information to the succeeding client:
   The names of the active ingredients of the two preceding products in any part of the line.
   If restricted by secrecy agreements, who to contact at the clients for those products.
   Configuration of the manufacturing unit in which the succeeding product will be
   synthesized, formulated and/or packaged. Establish whether this configuration is
   identical to the one used to manufacture the two preceding products.
   Information on the physical lay-out of the facility that could impact Contamination
   Prevention.
   Information about parallel operations with emphasis on the degree of segregation,
   common equipment (including ancillary equipment like tools, vacuum cleaners, fork lift
   trucks) and personnel.
   Any relevant information related to changes in the production sequence relevant to
   Contamination Prevention.

The preceding client must supply to the succeeding client the following information if
requested and available for the previous products:
   Confirm the active ingredients present in its product(s)
   Registered crops and pest spectrum of the preceding product
   Method of application, e.g. post-emergence, pre-plant incorporated, seed treatment.
   NOELs: method of calculation and determination of the NOEL (e.g. growth stage of crop
   at time of treatment, application method, spray volume) on the registered crops of the
   succeeding product.
   In the case of lack of NOEL information on the relevant crop(s), similar information on
   related crops.
   The minimum and maximum label rates.
   Classification of the product according to the EPA Pesticide Regulation Notice 96–8,
   based on the worst case scenario, i.e. if the product (irrespective of the formulation) is
   applied both as low and normal application rate herbicide, then it should be indicated
   that this is a low application rate herbicide.
   Analytical standards if commercially not available.
   Samples of the product for tests to develop missing NOELs
   In case of pre-commercial products, agreement on information exchange will have to be
   determined on a case by case basis.


The succeeding client must supply the following information to the preceding clients:
   Registered crops.
   Method of application, e.g. post-emergence, pre-plant incorporated, seed treatment.
                                            -6-



   Disclaimer pertaining to information provided by preceding client:

   All information provided by a company on its active ingredients should be reasonably
   accurate, but the company will not be held liable or otherwise responsible for the
   sufficiency of such information or results of any assessment using this information. Such
   information is provided without any warranty or other representation, expressed or
   implied.

   It is understood that whenever information is exchanged between the preceding and
   succeeding company, this is done under confidentiality conditions. Individual partners will
   decide on the need for a separate secrecy agreement on a case by case basis


8. Establishing NOELs and calculating cleaning levels

   Consult the US EPA Pesticide regulation Notice 96-8 (See Appendix 1). Products sold in
   the USA must conform to the values listed within this notice. These values may serve as
   guidance in other geographies at the company’s discretion. If biological data dictate that
   the cleaning level should be lower than the value indicated in the EPA Notice, the
   biological values should take precedence.

    Calculation of cleaning levels equals

              Cleaning level in ppm = (106 x NOEL) / (SF x AR)

    Definitions:

    AR = maximum Application Rate of the succeeding product in gram or ml of formulated
    product/ ha.

    NOEL = No Observable Effect Level in gram active ingredient per ha

    SF = Safety Factor

   The NOEL used in the cleaning level calculation is based on the biological effects of the
   active ingredient(s) of the preceding product on the most sensitive crop on which the
   succeeding product is registered.

   In determining NOELs, all relevant information should be assessed and where possible,
   existing data from field trials or glass house tests should be used. When companies
   exchange the relevant information on their active ingredients, they need to provide details
   on how the NOEL was determined.

   The Safety Factors are the individual decision of the [succeeding] company. Safety
   factors typically range from 2 to 10.
                                            -7-




9. Minimum Requirements for Tollers

These items are to be incorporated in the agreement / contract between the client and the
toller.

Details and additional requirements may be added by individual clients.

   Tollers must co-operate in a full technical audit for Contamination Prevention
   Tollers must follow the requirements defined in section 7: “Information Exchange”.
   Tollers must be able to trace materials and must retain all relevant records as defined by
   the client to enable traceability.
   Adequate analytical capability must be available to meet the client’s requirements
   regarding the cleaning levels. The analytical facilities are either in-house or at an agreed
   and approved location (contract laboratory or at the client’s analytical laboratory). In the
   case of involving a contract laboratory, the analytical data should be retained at the
   facilities of the toller.
   Written change-over procedures, including the clean-out procedures and a check-list to
   be followed as agrred with the client.
   Contamination Prevention training of existing personnel and newly recruited personnel
   (before being allowed to participate in the manufacturing process), and permanent
   records of the training.
   Segregation of simultaneous operations based on the outcome of the client’s risk
   assessment.
   Complete, permanent labelling of the facilities, all equipment (including ancillary
   equipment), raw material, ‘in-process’ and ‘finished’ product containers and waste
   conta iners in accordance with the client’s requirements.
   Well defined procedures based on the outcome of the risk assessment for the use of
   shared equipment (flexi hoses, pumps, tools, pallets etc.), e.g. restricted movement,
   labelling, traceability of the history of this equipment (previous products and cleaning
   level).
   No change in configuration of the manufacturing equipment without written notification to
   the succeeding client.
   No change in the manufacturing sequence without written notification to the succeeding
   client.
   No recycling of samples, i.e. samples cannot be returned in the process, without the
   approval of the client.
   No rework (blending, recycling) without the approval of the client. Client may insist on a
   written procedure for rework
   Clear identification of finished product by minimum labelling (Batch/Lot number, product
   name) in case of packed product without its final label (e.g. country/ product label,
   transport label).
   Good housekeeping practices maintained consistently.
   During operations, re-use of containers (IBCs, ISOs, Big Bags) previously used for other
   products is prohibited, unless the client specifies differently.
   The retention time and storage conditions of retain samples specified by the client must
   be followed.
   The toller must appoint a person responsible for implementation of the Contamination
   Prevention Guidelines at the toller’s site.
                                              -8-



10. Minimum Requirements for Clients (the Member Companies)

     The ECPA member companies , the clients, will provide a named Focal Point able to
     speak authoritatively on behalf of the company on all aspects of Contamination
     Prevention.
     The ECPA member companies will incorporate these Guidelines into their toll
     manufacturing contracts



11. Recommendations for Tolling Operations

     The ECPA member companies recommend that herbicides, especially highly-active
     herbicides 1), be separated from non-herbicides ( A/ F/ I/ N/R) in simultaneous operations.
     The amount of segregation required is to be determined by each individual company
     based on the products involved and its own risk assessment.

     The ECPA member companies advise against campaigning herbicides , especially
     highly-active herbicides1), in sequence in the same equipment with non-herbicides ( A/ F/
     I/ N/ R).

     The ECPA member companies recommend adequate risk assessments whenever
     highly-active herbicides1) are campaigned in sequence or produced simultaneously with
     normal rate herbicides
1)
  For description of highly active herbicides see the definitions used in EPA Pesticide
Regulation Notice 96-8 see Appendix 1.



                                         Appendix 1

                     EPA Pesticide Regulation Notice 96 –8, October 31, 1996

				
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