DOC

UNITED

By Margaret Cox,2014-06-28 11:12
11 views 0
UNITED ...

UNITED

    RC NATIONS

     UNEP/FAO/RC/CRC.2/12/Add.3

     Distr.: General United Nations 1 December 2005

     Environment Programme English only

    Food and Agriculture Organization

    of the United Nations

Rotterdam Convention on the Prior Informed

    Consent Procedure for Certain Hazardous

    Chemicals and Pesticides in International Trade

    Chemical Review Committee

    Second meeting

    Geneva, 1317 February 2006

    Item 5 (b) of the provisional agenda*

    Inclusion of chemicals in Annex III of the Rotterdam Convention:

    review of notifications of final regulatory actions to ban

    or severely restrict a chemical: cyhexatin

    Cyhexatin: additional information

    Note by the secretariat

    The annex to the present note contains the fact sheet issued following the removal of

    cyhexatin from the voluntary prior informed consent procedure, along with the amended decision

    guidance document containing the new information.

    * UNEP/FAO/RC/CRC.2/1.

K0584428 131205

    For reasons of economy, this document is printed in a limited number. Delegates are kindly requested to bring their copies to meetings and not to request additional copies.

UNEP/FAO/RC/CRC.2/12/Add.3

Annex

    List of documents annexed to UNEP/FAO/PIC/CRC.2/12/Add.3

    ? FACT Sheet on no longer inclusion of Cyhexatin in the PIC Procedure

    ? Revised Decision Guidance Document for Cyhexatin

    CYHEXATIN IS NO LONGER INCLUDED IN THE PIC PROCEDURE

    The FAO/UNEP Joint Group of Experts on PIC in to ban the use of cyhexatin. They were also March 1994 developed a policy for removing requested to indicate whether they were aware of chemicals from the PIC procedure, based on this information in making their decision to ban reported actions of national authorities which had cyhexatin and, if not, whether this information originally issued the bans or severe restrictions on would have any impact on its present regulatory which the decision to include the chemical had been status. Responses were received from Cyprus, taken. This policy is described on page 2 of this fact Hungary, Sweden and the United Kingdom. sheet. The original DGD on cyhexatin was revised

    (toxicology section) to reflect the conclusions of the Cyhexatin was originally included in the PIC

    1994 JMPR. The section on regulatory actions was procedure in 1991 because it was banned or severely

    restricted in 5 countries because of teratology amended to indicate that some countries were aware

    of the new data but in some instances had not been concerns. Two manufacturers producing cyhexatin

    developed additional data on its teratogenic approached by the new manufacturers with a request

    to consider the new information to support a potential. This new/additional information was

    registration application. Other governments reported considered by the 1991 and 1994 FAO/WHO Joint

    that they had reinstated its use based on the new Meeting on Pesticide Residues (JMPR). The 1994

    information. JMPR stated that "After taking into consideration

     the results of all the studies on teratogenicity in The revised DGD was circulated to all DNAs in rabbits, the Meeting concluded that cyhexatin is not September 1995, together with a covering letter teratogenic to this species." highlighting the conclusions of the 1994 JMPR and

    drawing their attention to the present regulatory The FAO/UNEP Joint Group of Experts at it's

    status in countries on which its entry into PIC was eighth meeting agreed that the developments

    based. DNAs in importing countries were invited to relating to cyhexatin seemed to represent a situation

    reconsider their decision in the light of the new where the information on which the regulatory

    evidence and the removal of the chemical from the actions were based was flawed. A more recent

    PIC procedure. international review of all the available information

     on this particular aspect had changed the previous PIC Circular V, the Update of PIC Circular V and conclusion. PIC Circular VI (July and December 1995 and July

    1996) referenced the altered status of cyhexatin and The procedure for removing a chemical from the

    the timeframe for its removal from the procedure. PIC procedure was therefore brought to the attention of the Designated National Authorities in Cyprus, As of 1 September 1996 import responses for Hungary, Sweden, the United Kingdom and the cyhexatin were no longer circulated and USA in order to determine if, in the light of new or cyhexatin would no longer be considered subject additional information which indicated that the to the PIC procedure. A copy of the revised DGD scientific basis (teratogenic effects in rabbits) for can however be obtained upon request from the their regulatory decision might have been flawed, FAO/UNEP Joint Secretariat. they would reconsider their decision

    WHERE CAN FURTHER INFORMATION BE OBTAINED?

    FAO Joint Secretary to PIC UNEP Joint Secretary to PIC Plant protection Service, UNEP Chemicals (IRPTC) Plant Production and Protection Division, FAO P.O. Box 356 Viale delle Terme di Caracalla 15 chemin des Anémones, Châtelaine Rome 00100, Italy CH-1219 Geneva, Switzerland Tel: (+39 6) 5225 3441 Tel: (+41 22) 979 9172 Fax: (+39 6) 5225 6347 Fax: (+41 22) 797 3460 E-mail: gerold.wyrwal@fao.org E-mail: atuxen@unep.ch

     niek.vandergraaff@fao.org jwillis@unep.ch 2

UNEP/FAO/RC/CRC.2/12/Add.3

POLICY FOR THE REMOVAL OF COMPOUNDS FROM THE PIC PROCEDURE - Taken from the

    report of the Seventh Meeting of the FAO/UNEP Joint Group of Experts on PIC, Section 8, p. 19

    1. Companies can seek to have an inclusion or The aim is to have a clear statement that the

    proposed inclusion in PIC reviewed in cases new scientific data relevant to the basis for the

    where: original ban or severe restriction have been

     evaluated by independent scientific authorities

     (i) new scientific evidence is generated and the original decision reconsidered. It was

    demonstrating that the health or recognized that it was difficult to develop a

    environmental concerns that led to the ban fixed procedure that would address every

    or severe restriction which prompted situation and that, while the proposed

    inclusion in PIC are no longer procedure was to serve as a guide to the process

    substantiated; and of removing a compound from the PIC, each

     proposal would have to be considered on a

     (ii) that evidence has been submitted for case-by-case basis.

    scientific review by national governments

    on whose actions the compound originally The Meeting considered the following

    entered the PIC procedure. scenarios in attempting to provide guidance in

     the operation of the proposed procedure: 2. The availability of an international peer review

    such as the JMPR, IPCS, etc., would be of A compound would be removed from the

    interest in revising the DGD. The need would procedure where:

    be considered on a case-by-case basis.

     ? those countries which imposed the original 3. On the basis of the outcome of the scientific ban or severe restriction, on the basis of

    reviews by national governments, companies which the compound entered the PIC

    are invited to submit (in writing) a reasoned procedure, have reviewed the new

    case for consideration by the Group when they scientific data and reversed their decision;

    believe removal from PIC or from

    consideration for inclusion is warranted. ? some countries have reviewed the

     scientific data and removed the ban or 4. In those situations where national governments severe restriction but others were not

    are not interested in reviewing the new data or interested in reviewing the new data.

    for commercial reasons, the manufacturer does

    not wish to resubmit the data for consideration, On the basis of these actions the relevant DGD

    a letter from the responsible national authority would be revised and reissued. It was

    or manufacturer stating these facts is required. suggested that there be a phased approach to

    A response must be received from all countries removing the compound from the procedure

    which indicated a ban or severe restriction that and that the revised DGD remain in circulation

    served as the basis for the compound's for one year, after which the compound would

    inclusion in PIC. be deleted from the list of compounds subject

     to the PIC procedure.

     (i) The Secretariat will prepare a revised

    DGD which includes the new information A compound would remain in the procedure

    and the updated regulatory status in where:

    countries.

     ? those countries which imposed the original

     (ii) DNAs of importing countries will be ban or severe restriction, on the basis of

    invited to reconsider decisions made in the which the compound entered the PIC

    light of the new evidence. procedure, have reviewed the new

     scientific data, some have removed the 5. Compounds may be removed from the PIC ban or severe restriction but others have

    procedure when all original bans are reviewed reaffirmed their previous decision.

    or when countries concur that the basis for the

    ban or severe restriction is no longer valid.

     FAO/UNEP, 1 January 1997

    3

UNEP/FAO/RC/CRC.2/12/Add.3

     OPERATION OF THE PRIOR INFORMED

     CONSENT PROCEDURE FOR BANNED OR

     SEVERELY RESTRICTED CHEMICALS

     IN INTERNATIONAL TRADE

     Revised

     DECISION GUIDANCE DOCUMENT

     Cyhexatin

     JOINT FAO/UNEP PROGRAMME

     FOR THE OPERATION OF PRIOR INFORMED CONSENT

     United Nations Environment Programme

     Food and Agriculture Organization

     of the United Nations

    1

UNEP/FAO/RC/CRC.2/12/Add.3

OPERATION OF THE PRIOR INFORMED CONSENT PROCEDURE FOR BANNED OR

    SEVERELY RESTRICTED CHEMICALS IN INTERNATIONAL TRADE

     Revised

     DECISION GUIDANCE DOCUMENT

     Cyhexatin

    JOINT FAO/UNEP PROGRAMME FOR THE OPERATION OF

    PRIOR INFORMED CONSENT

    Food and Agriculture Organization of the United Nations

    United Nations Environment Programme

    Rome-Geneva 1995

    2

UNEP/FAO/RC/CRC.2/12/Add.3

     DISCLAIMER

     The inclusion of this

3

UNEP/FAO/RC/CRC.2/12/Add.3

     (ii)

    ABBREVIATIONS WHICH MAY BE USED IN THIS DOCUMENT

    (N.B.: Chemical elements and pesticides are not included in this list)

ADI acceptable daily intake

    ai active ingredient

b.p. boiling point

    bw body weight

?C degree Celsius (centigrade)

    CCPR Codex Committee on Pesticide Residues

    DNA Designated National Authority

EC emulsion concentrate

    EEC European Economic Community

    EPA U.S. Environmental Agency

    ERL extraneous residue limit

    FAO Food and Agriculture Organization of the United Nations

g gram

    ?g microgram

    GAP good agricultural practice

    GL guideline level

ha hectare

    IARC International Agency for Research on Cancer i.m. intramuscular

    i.p. intraperitoneal

    IPCS International Programme on Chemical Safety IRPTC International Register of Potentially Toxic Chemicals

JMPR Joint FAO/WHO Meeting on Pesticide Residues (Joint Meeting of the FAO Panel of

    Experts on Pesticide Residues in Food and the Environment and a WHO

    Expert Group on Pesticide Residues)

k kilo- (x 103)

    kg kilogram

l litre

     lethal concentration, 50% LC50

    LD lethal dose, median 50

m metre

    mg milligram

     (iii)

4

UNEP/FAO/RC/CRC.2/12/Add.3

ml millilitre

    m.p. melting point

    MRL Maximum Residue Limit

    MTD Maximum tolerated dose

ng nanogram

    NOEL no observed effect level

    NOAEL no observed adverse effect level NS Not Stated

OP organophosphorus pesticide

PHI pre-harvest interval

    ppb parts per billion

    ppm ppm (used only in reference to the concentration of a pesticide in an

    experimental diet. In all other contexts the terms mg/kg or mg/l are used.)

    ppt parts per trillion

sp gr specific gravity

    STEL Short Term Exposure Limit

    TADI Temporary Acceptable Daily Intake TLV Threshold Limit Value

    TMDI theoretical maximum daily intake TMRL Temporary Maximum Residue Limit TWA Time Weighted Average

    UNEP United Nations Environment Programme

WHO World Health Organization

    WP wettable powder

    wt weight

< less than

    << much less than

    < less than or equal to

> greater than

    > greater than or equal to 5

UNEP/FAO/RC/CRC.2/12/Add.3

6

UNEP/FAO/RC/CRC.2/12/Add.3

     Revised July 1995

     CYHEXATIN

     PRIOR INFORMED CONSENT

     revised DECISION GUIDANCE DOCUMENT

1. IDENTIFICATION

1.1 Common Name: Cyhexatin

1.2 Chemical Type: Organotin compound

1.3 Use: Acaricide

1.4 Chemical Name: Tricyclohexylhydroxystannane or tricyclohexyltin hydroxide

1.5 CAS No: 13121-70-5

1.6 Trade Names: Pennstyl, Techn'acid, Dowco 213, Plictran, Acarstin

    1.7 Mode of Action as a Pesticide: Photoplasmic poison

    1.8 Formulation Types: Wettable powder 25%, 50%, flowable concentrate 600g/l, dust 1.5%, technical

    grade 95%

1.9 Basic Producers: Oxon Italia (Italy), Elf Atochem (France), Chemia SpA (Italy)

    2. SUMMARY OF CONTROL ACTIONS

2.1 General: Cyhexatin entered the PIC procedure on the basis of control actions (bans) in Cyprus (1988),

    Hungary (1987), Sweden (1987) and the United Kingdom (1987). The USA found unacceptable

    margins of safety for female workers of child-bearing age who mix and load or apply cyhexatin or who

    harvest treated crops, which caused the registrant to voluntarily cancel all products containing

    cyhexatin.

     As of March 1995 registration had been reinstated in Cyprus and Hungary. In the United Kingdom

    and Sweden bans are still in effect. If a request for registration is received from the manufacturer the

    new information will be evaluated and the regulatory status in these countries reconsidered (see Annex

    1).

    2.2 Reasons for the Control Action: All countries reported that evidence of teratogenic effects in

    mammalian species was the basis for their actions. 2.3 Uses Banned: All uses of

    cyhexatin have been banned in countries reporting control actions.

2.4 Uses Reported to be Continued in Effect: No previously registered uses were reported to have been

    retained by the countries identifying control actions.

2.5 Alternatives: Alternatives noted by countries reporting import decisions under the PIC procedure are

    listed in Annex 3.

    2.6 Contacts for Further Information: Designated National Authorities (DNAs) in countries which took

    the decision to prohibit import of cyhexatin may be a further source of information (Annex 3). Further

    information may also be obtained through national or regional pest management centres.

7

Report this document

For any questions or suggestions please email
cust-service@docsford.com