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Rotterdam Convention Operation of the prior informed consent procedure for banned or severely restricted chemicals Draft Decision Guidance Document Terbufos IMPORT S:\\Marin\\Agenda\\!OLEGENE.WPG IMPORT S:\\Marin\\Agenda\\!UNEP.WPG Secretariat of the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade Introduction The objective of the Rotterdam Convention is to promote shared responsibility and cooperative efforts among Parties in the international trade of certain hazardous chemicals in order to protect human health and the environment from potential harm and to contribute to their environmentally sound use, by facilitating information exchange about their characteristics, by providing for a national decision-making process on their import and export and by disseminating these decisions to Parties. The Secretariat of the Convention is provided jointly by the United Nations Environment Programme (UNEP) and the Food and Agriculture Organization of the United Nations (FAO). Candidate chemicals for inclusion in the prior informed consent (PIC) procedure under the Rotterdam Convention include those that have been banned or severely restricted by national regulatory actions in two or more Parties in two different regions. Inclusion of a chemical in the PIC procedure is based on regulatory actions taken by Parties that have addressed the risks associated with the chemical by banning or severely restricting it. Other ways might be available to control or reduce such risks. Inclusion does not, however, imply that all Parties to the Convention have banned or severely restricted the chemical. For each chemical included in Annex III of the Rotterdam Convention and subject to the PIC procedure, Parties are requested to make an informed decision whether they consent or not to the future import of the chemical. At its […] meeting, held in […] on […], the Conference of the Parties agreed to list terbufos in Annex III of the Convention and adopted the decision-guidance document with the effect that this chemical became subject to the PIC procedure. The present decision-guidance document was communicated to designated national authorities on […], in accordance with Articles 7 and 10 of the Rotterdam Convention. Purpose of the decision guidance document For each chemical included in Annex III of the Rotterdam Convention, a decision-guidance document has been approved by the Conference of the Parties. Decision-guidance documents are sent to all Parties with a request that they make a decision regarding future import of the chemical listed in the relevant category(ies) in Annex III to the Convention. Further information on import response can be found on the website of the Rotterdam Convention . Decision-guidance documents are prepared by the Chemical Review Committee. The Committee is a group of government-designated experts established in line with Article 18 of the Convention, which evaluates candidate chemicals for possible inclusion in Annex III of the Convention. Decision-guidance documents reflect the information provided by two or more Parties in support of their national regulatory actions to ban or severely restrict the chemical. They are not intended as the only source of information on a chemical nor are they updated or revised following their adoption by the Conference of the Parties. There may be additional Parties that have taken regulatory actions to ban or severely restrict the chemical and others that have not banned or severely restricted it. Risk evaluations or information on alternative risk mitigation measures submitted by such Parties may be found on the Rotterdam Convention website (www.pic.int). Under Article 14 of the Convention, Parties can exchange scientific, technical, economic and legal information concerning the chemicals under the scope of the Convention including toxicological, ecotoxicological and safety information. This information may be provided directly to other Parties or through the Secretariat. Information provided to the Secretariat will be posted on the Rotterdam Convention website. Information on the chemical may also be available from other sources. Disclaimer The use of trade names in the present document is primarily intended to facilitate the correct identification of the chemical. It is not intended to imply any approval or disapproval of any particular company. As it is not possible to include all trade names presently in use, only a number of commonly used and published trade names have been included in the document. While the information provided is believed to be accurate according to data available at the time of preparation of the present decision-guidance document, FAO and UNEP disclaim any responsibility for omissions or any consequences that may arise there from. Neither FAO nor UNEP shall be liable for any injury, loss, damage or prejudice of any kind that may be suffered as a result of importing or prohibiting the import of this chemical. The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of FAO or UNEP concerning the legal status of any country, territory, city or area or of its authorities or concerning the delimitation of its frontiers or boundaries. STANDARD CORE SET OF ABBREVIATIONS &lt; less than &lt; less than or equal to &gt; greater than &gt; greater than or equal to µg microgram ARfD acute reference dose a.i. active ingredient ADI acceptable daily intake bw body weight o C degree Celsius (centigrade) CAS Chemical Abstracts Service DNA deoxyribose nucleic acid EC European Community EC 50 median effective concentration EU European Union FAO Food and Agriculture Organization of the United Nations g gram h hour ha hectare HHP Highly Hazardous Pesticide IARC International Agency for Research on Cancer IPCS International Programme on Chemical Safety IPM Integrated Pest Management IUPAC International Union of Pure and Applied Chemistry JMPM JMPR Joint FAO/WHO Meeting on Pesticide Management 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 1000) kg kilogram Kow octanol–water partition coefficient kPa kilopascal L litre LC 50 median lethal concentration n LD 50 median lethal dose LOAEL lowest-observed-adverse-effect level m metre mg milligram ml millilitre mPa millipascal MRL maximum residue limit MOE margin of exposure ng nanogram NOAEC no-observed-adverse-effect concentration NOAEL no-observed-adverse-effect level NOEC no-observed-effect concentration NOEL no-observed-effect level OECD Organisation for Economic Co-operation and Development PEC predicted environmental concentration PMRA Canadian Pest Management Regulatory Agency Pow octanol-water partition coefficient , also referred to as Kow PPE personal protective equipment ppm parts per million (used only with reference to the concentration of a pesticide in an experimental diet. In all other contexts the terms mg/kg or mg/L are used). RfD reference dose (for chronic oral exposure; comparable to ADI) SAICM Strategic Approach to International Chemicals Management UNEP United Nations Environment Programme USEPA United States Environmental Protection Agency UV ultraviolet w/w weight for weight WHO World Health Organization wt weight Decision guidance document for a banned or severely restricted chemical Terbufos Published: 1. Identification and uses (see Annex 1 for further details) Common name Terbufos Chemical name and other names or synonyms IUPAC : S -[( tert -Butylsulfanyl)methyl] O , O -diethyl phosphorodithioate CAS : S -[[(1,1-Dimethylethyl)thio]methyl] O,O -diethyl phoshporodithioate ( UNEP/FAO/RC/CRC.17/8/Rev.1 S ection 1.2 of Canadian and Mozambican notifications ) O th er IUPAC: tert -butylsulfanylmethylsulfanyl-diethoxy-sulfanylidene-λ 5 -phosphane (P ubC hem [Internet] , computed by Lexichem TK 2.7.0) Molecular formula C 9 H 21 O 2 PS 3 ( UNEP/FAO/RC/CRC.17/8/Rev.1 S ection 3.2.1 of Canadian and Mozambican notifications ) Chemical structure ( UNEP/FAO/RC/CRC.17/8/Rev.1 S ection 3.2.1 of Canadian and Mozambican notifications ) CAS-No.(s) 13071-79-9 ( UNEP/FAO/RC/CRC.17/8/Rev.1 S ection 1.4.1 of Canadian and Mozambican notifications ) Harmonized System Customs Code 293090 (active ingredient) 380891 (formulation) ( UNEP/FAO/RC/CRC.17/8/Rev.1 S ection s 1. 4.2 of Mozambican notification ) Other numbers EC number 235-963-8 ( UNEP/FAO/RC/CRC.17/8/Rev.1 S ection s 1. 4.3 of Mozambican notification ) Category Pesticide ( UNEP/FAO/RC/CRC.17/8/Rev.1 S ection 2.3.3 of Canadian and Mozambican notifications ) Regulated category Pesticide ( UNEP/FAO/RC/CRC.17/8/Rev.1 S ection 2.3.3 of Canadian and Mozambican notifications ) Use(s) in regulated category Terbufos was registered in Mozambique as an insecticide to be used on maize, sorghum, potato and beans . Terbufos was registered in Canada as an insecticide and nematicide for use on canola, corn, mustard, rutabag a s and sugar beets. ( UNEP/FAO/RC/CRC.17/8/Rev.1 S ection 2 . 3.1 of Canadian and Mozambican notifications ) Trade names Trade names listed by Moz ambique : Moz Terbufos 15% GR , Rotam Terbufos 15% GR and Bongo. Trade names listed by Canada: Counter 5-G Soil Insecticide and Counter 15-G Lock'n Load Soil Insecticide Granular . ( UNEP/FAO/RC/CRC.17/8/Rev.1 S ection 1.3 of Canadian and Mozambican notifications and p.146 of UNEP/FAO/RC/CRC.17/INF/18 ) Contraven, Aragran, Cyanater . (PPDB [internet]; UNEP/FAO/RC/CRC.17/INF19/Rev.1 The Pesticide Manual, Sixteenth Edition (excerpt) o n the Canadian supporting documentation ) This is an indicative list. It is not intended to be exhaustive. Formulation types Moz Terbufos 15% GR, Rotam Terbufos 15% GR, Counter 5-G Soil Insecticide and Counter 15-G Lock'n Load Soil Insecticide Granular are granular formulations. Both notifications indicate “G” or “GR” for granules. ( UNEP/FAO/RC/CRC.17/8/Rev.1 S ection 1.3 of Canadian and Mozambican notifications ) Uses in other categories There is no reported use as an industrial chemical Basic manufacturers A MVAC Chemical Corporation , BASF, American Cyanamid (PPDB [internet] ) This is an indicative list of current and former manufacturers. It is not intended to be exhaustive. 2. Reasons for inclusion in the PIC procedure Terbufos is included in the PIC procedure as a pesticide. It has been listed on the basis of the final regulatory actions to ban its use notified by Canada and Mozambique. 2.1 Final regulatory action (see Annex 2 for further details) Canada According to the Pest Management Regulatory Agency, Health Canada. 2004. Re-evaluation Decision RRD2004-04: Re-evaluation of Terbufos , and Pest Management Regulatory Agency, Health Canada. 2008. Re-evaluation Note REV2008-06: Update on the use of Terbufos on s ugar b eets , t he s ale of pesticides containing terbufos was prohibited in Canada effective May 1, 2012. The use of products containing terbufos was prohibited after August 1, 2012 . The final regulatory action has been taken for the pesticide category to protect the environment. ( UNEP/FAO/RC/CRC.17/8/Rev.1 Section 2.2.1 , 2.2.2 and 2.3.1 of the Canadian notification ) Reason: Environment Mozambique Based on the decision Nr 001/DNSA/2014 , terbufos was banned by the National Directorate of Agrarian Services (The P esticide R egist er Authority) from further import and use in Mozambique. The ban of all uses and the cancellation of the products containing terbufos in the country was decided due to the toxic nature and hazardous properties of this active substance which , combined with the improper use in the country due to the local specific conditions of use , can damage human and animal health. The decision to cancel the registration of terbufos was taken as the last step of the project for Risk Reduction of H ighly H azardous P esticides ( HHPs ) , which identified HHPs that are registered in Mozambique. After consultations with different actors (public sector, private sector, civil society and others), cancelation of registrations and consequent non-approval for their use in Mozambique was approved . The regulatory action entered into force on 15 July 2014. The final regulatory action has been taken for the pesticide category to protect human health. ( UNEP/FAO/RC/CRC.17/8/Rev.1 S ection s 2.2.1 , 2.2.3 and 2.3.1 of the Mozambican notification) Reason: Human Health 2.2 Risk evaluation (see Annex 1 for further details) Canada A re-evaluation of the active ingredient terbufos and its end-use products for use on canola, corn, mustard, rutabagas was conducted under the authority of Section 19 of the Pest Control Products Regulations . The Canadian P est M anagement R egulatory A gency (PMRA) identified extremely high hazards to terrestrial organisms resulting from all currently registered uses of terbufos. Th e assessment is supported by reports of incidents in Canada and the USA . The PMRA identified extremely high hazard to aquatic organisms resulting from all currently registered uses of terbufos. Th e assessment is supported by reports of incidents of adverse effects in the USA . Similar effects may have occurred in Canada, but there is no equivalent reporting system. Risk quotients determined for applications of the end-use terbufos formulations Counter 5-G and Counter 15-G indicate risks for all groups of organisms (i.e., birds, mammals, fish and aquatic invertebrates) for all application scenarios. Based on the available toxicity data, risk is classified as high to extremely high for aquatic organisms and in most cases high to extremely high for birds. Similarly, risk to mammals is classified as low for large mam mals to high for small mammals. ( UNEP/FAO/RC/CRC.17/8/Rev.1 Section s 2. 4.2.2 and 3.2.3 of the Canadian notification) Mozambique The notification states that the ban of all uses and the cancellation of the products containing terbufos in Mozambique was decided based on the toxic nature and hazardous properties which combined with the improper use in the country due to the local specific conditions of use can damage human and animal health. Terbufos and the products containing terbufos were considered as harmful for human health taking into consideration of the local conditions of use in Mozambique and the requirements for risk mitigation measures. The notification refers to a consultancy report Reducing Risks of Highly Hazardous Pesticides in Mozambique: Step 1 – Shortlisting highly hazardous pesticides (Come &amp; van der Valk , 2014 ), which identified t erbufos formulations as Extremely hazardous Class Ia according to the JMPM criteria for HHPs based on the WHO International Classification of Pesticides by Hazards, and therefore considered and shortlisted as HHP ( Come &amp; van der Valk , 2014) Thus, terbufos and the products containing terbufos were considered harmful for the human health under the local conditions of use in Mozambique requiring risk mitigation measures. Therefore, the authorities decided to ban terbufos from future use in the country and to cancel the registration of all the products containing terbufos. 3. Protective measures that have been applied concerning the chemical 3.1 Regulatory measures to reduce exposure Canada The Pest Management Regulatory Agency, Health Canada. 2004. Re-evaluation Decision RRD2004-04: Re-evaluation of Terbufos , and Pest Management Regulatory Agency, Health Canada. 2008. Re-evaluation Note REV2008-06: Update on the use of Terbufos on su gar b eets , prohibited the s ale of pesticides containing terbufos in Canada effective May 1, 2012. The use of products containing terbufos was prohibited after August 1, 2012 . ( UNEP/FAO/RC/CRC.17/8/Rev.1 Section 2.2.1 and 2.2.2 of the Canadian notification) Mozambique Terbufos was banned by the National Directorate of Agrarian Services from further import and use in Mozambique by the decision Nr 001/DNSA/2014. The regulatory action entered into force on 15 July 2014. ( UNEP/FAO/RC/CRC.17/8/Rev.1 Sections 2.2.1 and 2.2.3 of the Mozambican notification) 3.2 Other measures to reduce exposure Canada None reported Mozambique None reported 3.3 Alternatives Canada At the time of the regulatory action, there were effective alternatives for management of flea beetle on canola and mustard. These included one other organophosphate , two carbamates, three pyrethroids and two neonicotinoids. Products containing imidacloprid, thiamethoxam, cypermethrin, deltamethrin, lambda - cyhalothrin , carbaryl and carbofuran were registered for controlling flea beetle in canola. Alternative soil insecticides that were registered for control of corn rootworm , seedcorn maggot and wireworm in corn included carbaryl, chlorpyrifos, diazinon , tefluthrin and phorate . Azinphos-methyl, chlorpyrifos, diazinon and phorate were registered as a prophylactic treatment at planting to control cabbage maggot on rutabaga . Carbaryl, endosulfan, methoxychlor, diazinon and cypermethrin were registered for controlling flea beetle on rutabaga . ( UNEP/FAO/RC/CRC.17/8/Rev.1 Section 2.5.3.2 of the Canadian notification and pp.16-17 of UNEP/FAO/RC/CRC.17/19/Rev.1 ) Mozambique Mozambique’s Ministry of Agriculture and Food S ecurity engaged with the p roducer a ssociation to assess alternative insecticide options and to facilitate registration of lower-risk products. In parallel, the Ministry is also promoting the use of biological pest control measures. ( UNEP/FAO/RC/CRC.17/8/Rev.1 Section 2.5.3.2 of the Mozambican notification) General There are a number of alternative methods involving chemical and non-chemical strategies, including alternative technologies available, depending on the individual crop-pest complex under consideration. Countries should consider promoting, as appropriate, IPM and organic strategies as a means of reducing or eliminating the use of hazardous pesticides. SAICM's Fourth International Conference on Chemicals Management recommended that in replacing HHPs the focus should be on agroecologically-based practices. Where possible, priority should be given to the introduction of integrated pest management or integrated vector management that makes optimal use of agro-ecological approaches and reduces reliance on pesticides. This approach is explicitly supported by a broad range of international policy documents, including those of FAO, WHO, World Bank and the OECD Development Assistance Committee. SAICM's Fourth International Conference on Chemicals Management recommended that in replacing HHPs the focus should be on agroecologically-based practices. Advice may be available through National IPM focal points, the FAO, IFOAM (International Federation of Organic Movements) and agricultural research or development agencies. Where it has been made available by governments, additional information on alternatives to terbufos may be found on the Rotterdam Convention website www.pic.int . Information on such agroecologically-based practices can be found at the following websites: FAO Agroecology hub: http://www.fao.org/agroecology/en/ IPAM (International Peoples Agroecology Multiversity): HYPERLINK " http://ipam-global.org/ " http://ipam-global.org/ OISAT (Online Information Service for Non-Chemical Pest Management in the Tropics): http://www.oisat.org/ Replacing Chemicals with Biology: Phasing out Highly Hazardous Pesticides with Agroecology: HYPERLINK "http://panap.net/2015/11/replacing-chemicals-biology-phasing-highly-hazardous-pesticides-agroecology/" http://panap.net/2015/11/replacing-chemicals-biology-phasing-highly-hazardous-pesticides-agroecology/ https://saicmknowledge.org/library/replacing-chemicals-biology-phasing-out-highly-hazardous-pesticides-agroecology It is essential that before a country considers substituting a substance with alternatives, it ensures that the use is relevant to its national needs, and the anticipated local conditions of use. The hazards of the substitute materials and the controls needed for safe use should also be evaluated. 3.4 Socio-economic effects Canada A significant challenge for Canada’s PMRA was a regulatory decision that moved towards the goal of eliminating terbufos in a manner that was least disruptive to the need to protect agricultural crops from pests. To meet its challenge, the PMRA has considered the availability of alternatives and the need for a transition period for those uses for which no or limited alternatives were available. A significant challenge for industry was to develop alternativ es in the relatively short time frame of the phase-out. A significant challenge for the agricultural sector was in adopting alternatives during the transition period. ( UNEP/FAO/RC/CRC.17/8/Rev.1 Section 2.5.3.1 of the Canadian notification) Mozambique None reported 4. Hazards and Risks to human health and the environment 4.1 Hazard Classification WHO / IPCS I a — Extremely Hazardous ( WHO, 2019) IARC Not evaluated European Union Classification according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (CLP-Regulation) Acute Toxicity 2* - H300 (Fatal if swallowed) Acute Toxicity 1 - H310 (Fatal in contact with skin) Aquatic Acute 1 - H400 (Very toxic to aquatic life) Aquatic Chronic 1 - H410 (Very toxic to aquatic life with long lasting effects) US EPA 1 (highly toxic) (US EPA, 1988) 4.2 Exposure limits JMPR ( 2004 ) Acute reference dose (ARfD): 0.00 2 mg/kg bw The Meeting established an acute RfD of 0.002 mg/kg bw based on a NOAEL of 0.15 mg/kg bw per day for miosis in the study of neurotoxicity in rats given a single dose of terbufos, and a 100- fold safety factor. Since only in this study miosis was observed in the absence of inhibition of cholinesterase activity, it may be possible to refine the acute RfD after better characterization of this effect. Acceptable Daily Intake (ADI): 0-0.000 6 mg/kg bw The Meeting established an ADI of 0-0.0006 mg/kg bw based on an overall NOAEL of 0.06 mg/kg bw per day and a safety factor of 100 for inhibition of brain cholinesterase activity in a 1-year toxicity study in rats , 13-week study of neurotoxicity and two-generation study of reproduction in rats, and 1-year study in dogs. Canadian risk evaluation: Acute reference dose (ARfD): 0.00015 mg/kg bw In animal studies, the adverse effects noticeable at the lowest dose (i.e., the toxicity end point) were clinical signs observed in an acute rat neurotoxicity study (NOAEL = 0.15 mg/kg bw). The uncertainty factor was 100 (10x for interspecies ext rapolation x 10x intraspecies variability). An additional safety factor of 10x was applied to account for the steepness of the dose response and the high degree of potency (based on lethality at very low doses). The acute reference dose (A RfD) was calculated to be 0.000 15 mg/kg bw (0.15 mg/kg bw ÷ 1000). This value was considered to be protective of infants and children . Acceptable Daily Intake (ADI): 0.00015 mg/kg bw/d As the ARfD value was lower than any acceptable daily intake (ADI) derived from any of the repeat-dose toxicity studies (reflecting the high acute toxicity and use of the additional safety factor), the ADI was established at the same value as the ARfD. Thus, the ADI is 0.00015 mg/kg bw/d. Environmental Risk Quotients: Estimated environmental concentrations exceed acute and chronic effects levels in both fish and aquatic invertebrates. The risk quotients for acute effects on the majority of aquatic invertebrates tested were greater than 1, the threshold of concern. Values ranged from 10 to 409 following use on canola and from 28 to 2795 following use on corn, sugar beets or rutabaga. These risk quotients are classified as high risk to extremely high risk. The risk quotients for acute effects on fish were greater than 1, the threshold of concern. Values ranged from 4 to 106 following canola application rates and from 11 to 726 following use on corn, sugar beets or rutabaga. These risk quotients are classified as moderate risk to very high risk. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) Maximum Residue Limits JMPR ( 2005 ) Commodity MRL Symbol Banana 0.05 mg/kg Coffee beans 0.05 mg/kg (*) Edible offal (mammalian) 0.05 mg/kg (*) Eggs 0.01 mg/kg (*) Maize 0.01 mg/kg (*) Maize fodder (dry) 0.2 mg/kg Meat (from mammals other than marine mammals) 0.05 mg/kg (*) Milks 0.01 mg/kg (*) Poultry meat 0.05 mg/kg (*) Poultry, edible offal of 0.05 mg/kg (*) Sorghum 0.01 mg/kg (*) Sorghum straw and fodder, dry 0.3 mg/kg dry wt Sugar beet 0.02 mg/kg Sweet corn (corn-on-the-cob) 0.01 mg/kg (*) : At or about the limit of determination. Residue definition: For compliance with MRLs and for estimation of dietary intake in plant and animal commodities: Sum of terbufos, its oxygen analogue and their sulphoxides and sulphones, expressed as terbufos. European Union 0.01 mg/kg, except 0.0 5 mg/kg for bananas ( Reg. (EC) No 149/2008 ) https://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/mrls/?event=details&amp;pest_res_ids=384&amp;product_ids=&amp;v=1&amp;e=search.pr 4.3 Packaging and labelling The United Nations Committee of Experts on the Transportation of Dangerous Goods classifies the chemical in: Hazard Class and Packing Group: UN Number 2783 UN Hazard Class: 6.1 UN Pack Group: I Source: https://inchem.org/documents/icsc/icsc/eics1768.htm International Maritime Dangerous Goods (IMDG) Code Severe M arine P ollutant Source: https://pubchem.ncbi.nlm.nih.gov/compound/Terbufos#section=Shipment-Methods-and-Regulations Transport Emergency Card Not available Further specific guidance on appropriate symbols and label statements for terbufos products may be available in the FAO Guidelines on Good Labelling Practice for Pesticides (FAO, 2015) . 4.4 First aid NOTE: The following advice is based on information available from the World Health Organisation and the notifying countries and was correct at the time of publication. This advice is provided for information only and is not intended to supersede any national first aid protocols. Safety and first aid recommendations extracted from the IPCS/WHO chemical safety card (see complete chemical safety card at https://inchem.org/documents/icsc/icsc/eics1768.htm ) Av oid exposure of adolescents and children! Strict hygiene! F irst aid: use personal protection. I n all cases consult a doctor! Fire and explosion Acute hazards: Combustible. Prevention: no open flames. Fire fighting: In case of fire in the surroundings: all extinguishing agents allowed. Inhalation Symptoms: Blurred vision. Headache. Dizziness. Muscle spasms. Weakness. Vomiting. Diarrhoea. Abdominal pain. Prevention: Avoid inhalation of aerosol. First aid: Fresh air, rest. Refer immediately for medical attention. Skin Symptoms: EASILY ABSORBED! Blurred vision. Headache. Dizziness. Muscle spasms. Weakness. Vomiting. Diarrhoea. Abdominal pain. Prevention: Protective gloves. Protective clothing. First aid: Remove contaminated clothes. Rinse and then wash skin with water and soap. Refer immediately for medical attention. Eyes Symptoms: No information Prevention: Wear face shield First aid: Rinse with plenty of water (remove contact lenses if easily possible). Refer for medical attention. Ingestion Symptoms: Blurred vision. Headache. Dizziness. Muscle spasms. Weakness. Vomiting. Diarrhoea. Abdominal pain . Prevention: Do not eat, drink, or smoke during work. Wash hands before eating. First aid: Rinse mouth. Refer immediately for medical attention. Give a slurry of activated charcoal in water to drink. S pillage D isposal Personal protection: chemical protection suit including self-contained breathing apparatus. Do NOT let this chemical enter the environment. Collect leaking liquid in covered containers. Then store and dispose of according to local regulations. PubChem [internet] Note: Terbufos is a cholinesterase inhibitor . Signs and Symptoms of Acute Terbufos Exposure: Acute exposure to terbufos may produce the following signs and symptoms: pinpoint pupils, blurred vision, headache, dizziness, muscle spasms, and profound weakness. Vomiting, diarrhea, abdominal pain, seizures, and coma may also occur. The heart rate may decrease following oral exposure or increase following dermal exposure. Chest pain may be noted. Hypotension (low blood pressure) may be noted, although hypertension (high blood pressure) is not uncommon. Respiratory symptoms include dyspnea (shortness of breath), respiratory depression, and respiratory paralysis. Psychosis may occur. Emergency Life-Support Procedures: Acute exposure to terbufos may require decontamination and life support for the victims. Emergency personnel should wear protective clothing appropriate to the type and degree of contamination. Air-purifying or supplied-air respiratory equipment should also be worn, as necessary. Rescue vehicles should carry supplies such as plastic sheeting and disposable plastic bags to assist in preventing spread of contamination. Inhalation Exposure: 1. Move victims to fresh air. Emergency personnel should avoid self-exposure to terbufos. 2. Evaluate vital signs including pulse and respiratory rate, and note any trauma. If no pulse is detected, provide CPR. If not breathing, provide artificial respiration. If breathing is labored, administer oxygen or other respiratory support. 3. Obtain authorization and/or further instructions from the local hospital for administration of an antidote or performance of other invasive procedures. 4. Transport to a health care facility. Dermal/Eye Exposure: 1. Remove victims from exposure. Emergency personnel should avoid self- exposure to terbufos. 2. Evaluate vital signs including pulse and respiratory rate, and note any trauma. If no pulse is detected, provide CPR. If not breathing, provide artificial respiration. If breathing is labored, administer oxygen or other respiratory support. 3. Remove contaminated clothing as soon as possible. 4. If eye exposure has occurred, eyes must be flushed with lukewarm water for at least 15 minutes. 5. Wash exposed skin areas three times with soap and water. 6. Obtain authorization and/or further instructions from the local hospital for administration of an antidote or performance of other invasive procedures. 7. Transport to a health care facility. Ingestion Exposure: 1. Evaluate vital signs including pulse and respiratory rate, and note any trauma. If no pulse is detected, provide CPR. If not breathing, provide artificial respiration. If breathing is labored, administer oxygen or other respiratory support. 2. Obtain authorization and/or further instructions from the local hospital for administration of an antidote or performance of other invasive procedures. 3. Vomiting may be induced with syrup of Ipecac. If elapsed time since ingestion of terbufos is unknown or suspected to be greater than 30 minutes, do not induce vomiting and proceed to Step 4. Ipecac should not be administered to children under 6 months of age. Warning: Ingestion of terbufos may result in sudden onset of seizures or loss of consciousness. Syrup of Ipecac should be administered only if victims are alert, have an active gag-reflex, and show no signs of impending seizure or coma. If ANY uncertainty exists, proceed to Step 4. The following dosages of Ipecac are recommended: children up to 1 year old , 10 mL (1/3 oz); children 1 to 12 years old, 15 mL (1/2 oz); adults, 30 mL (1 oz). Ambulate (walk) the victims and give large quantities of water. If vomiting has not occurred after 15 minutes, Ipecac may be readministered. Continue to ambulate and give water to the victims. If vomiting has not occurred within 15 minutes after second administration of Ipecac, administer activated charcoal. 4. Activated charcoal may be administered if victims are conscious and alert. Use 15 to 30 g (1/2 to 1 oz) for children, 50 to 100 g (1-3/4 to 3-1/2 oz) for adults, with 125 to 250 mL (1/2 to 1 cup) of water. 5. Promote excretion by administering a saline cathartic or sorbitol to conscious and alert victims. Children require 15 to 30 g (1/2 to 1 oz) of cathartic; 50 to 100 g (1-3/4 to 3-1/2 oz) is recommended for adults. 6. Transport to a health care facility. Drugs and Antidotes: Specific treatment includes the antimuscarinic agent atropine and the enzyme reactivator pralidoxime . 4.5 Waste management Regulatory actions to ban a chemical should not result in creation of a stockpile requiring waste disposal. For guidance on how to avoid creating stockpiles of obsolete pesticides the following guidelines are available: FAO Guidelines on Prevention of Accumulation of Obsolete Pesticide Stocks (FAO, 1995), The Pesticide Storage and Stock Control Manual (FAO, 1996a) and Guidelines for the management of small quantities of unwanted and obsolete pesticides (FAO, 1999). In all cases waste should be disposed of in accordance with the provisions of the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal (1996), any guidelines thereunder, and any other relevant regional agreements. It should be noted that the disposal/destruction methods recommended in the literature are often not available in, or suitable for, all countries; e.g., high temperature incinerators may not be available. Consideration should be given to the use of alternative destruction technologies. Further information on possible approaches may be found in Technical Guidelines for the Disposal of Bulk Quantities of Obsolete Pesticides in Developing Countries (FAO, 1996b). Disposal Methods for this chemical PubChem [internet] R ecycle any unused portion of the material for its approved use or return it to the manufacturer or supplier. Ultimate disposal of the chemical must consider: the material's impact on air quality; potential migration in soil or water; effects on animal, aquatic, and plant life; and conformance with environmental and public health regulations. The manufacturer of terbufos 150 , Envio , recommend a d ispos al of waste product as hazardous waste via a licensed disposal contractor to an approved landfill or incinerator. The recommended disposal method for this product is incineration. Do not discharge into drains or sewers. Do not contaminate crops, grazing, rivers or dams with chemical or used containers. Comply with any local legislation applying to waste disposal. Empty containers may retain some product residues. Do not re-use containers. Triple rinse, render container unusable by crushing and/or puncturing and dispose in a safe manner via a licensed disposal contractor to an approved landfill or incinerator. Comply with any local legislation applying to waste disposal. http://envirobiochem.co.za/Resources/productPDFs/Terbufos%20150_MSDS.pdf Annexes Annex 1 Further information on the substance Annex 2 Details on Final regulatory action Annex 3 Address of designated national authorities Annex 4 References Annex 1 Further information on the substance The information presented in this Annex reflects the conclusions of the notifying parties: Canada and Mozambique. The notification from Canada was published in PIC Circular XXVII of June 2008 . The notification from Mozambique was published in PIC Circular L I of June 20 20 . Where possible, information on hazards provided by the notifying parties has been presented together, while the evaluation of the risks, specific to the conditions prevailing in the notifying Parties are presented separately. This information has been taken from the documents referenced in the notifications in support of the final regulatory actions to ban terbufos . Furthermore, information from the FAO/WHO JMPR 2004 monograph of the toxicological evaluation of te r bufos , as well as other sources such as PubChem, has been taken into account. Annex 1 – Further information on notified chemical 1. Physico-Chemical properties (UNEP/FAO/RC/CRC.17/INF 18 in The JMPR Evaluation on Terbufos, 2005 in the supporting documentation provided by Mozambique and UNEP/FAO/RC/CRC.17/INF19/Rev.1 in The Pesticide M anual, Sixteenth Edition (excerpt) of the Canadian supporting documentation) 1.1 Identity ISO : Terbufos IUPAC : S-[(tert-Butylsulfanyl)methyl] O,O-diethyl phosphorodithioate CAS : S-[[(1,1-Dimethylethyl)thio]methyl] O,O-diethyl phoshporodithioate (UNEP/FAO/RC/CRC.17/8/Rev.1 Section 1.2 of Canadian and Mozambican notifications) 1.2 Molecular Formula C 9 H 21 O 2 PS 3 1.3 Molecular weight 288.43 1.4 Colour and Texture Colourless to pale yellow with a mercaptan-like odour 1.5 Melting point Product is liquid at room temperature 1.6 Boiling Point 55 ° C at 0.02 mm Hg 1.7 Vapour Pressure 3.16 x 10 4 mm Hg at 25°C 6.98 x 10 4 mm Hg at 35°C 12.4 x 10 4 mm Hg at 45°C 1.8 Henry’s Law Constant 0.000024 atm m 3 /mole , derived from its vapor pressure, 0.00032 mm Hg 1.9 Relative density 1.11 g/mL at 20 ° C 1.10 Solubility in water 4.5mg/l (27°C) 1.11 Solubility in organic solvents Solubility was &gt;100 g/100mL solvent for each of the following solvents at 20°C: Acetone, acetonitrile, benzene, chloroform, dichloroethane, ethanol, n-heptane, dichloromethane, and toluene 1.12 Partition coefficient Log Kow = 4.71 1.13 Dissociation constant Not applicable; compound does not dissociate 1.14 Hydrolysis At pH 5 and 20-25°C, half-life 4.5 days At pH 7 and 25 ° C, half-life 5.5 days At pH 9 and 25 ° C, half-life 8.5 days At the conclusion of a four-week study, 75.1, 72.4, and 68.3% of the radioactivity at pH 5, 7, and 9, respectively, was hydrophilic, with formaldehyde constituting the principal degradation product. Organophilic products consisted of the phosphorylated series of oxidative metabolites. 1.15 Photolysis Less than 1% of the applied dose (4 ppm) of terbufos remained after 1-day exposure to natural sunlight in pond water, with the sulfoxide CL 94301 accounting for 45.2%. Formaldehyde appeared to be the principal water-soluble reaction product. Organophilic radioactivity was due mainly to the phosphorylated oxidative metabolites and a minor amount of the methylated mercaptan series. 1.16 Decomposition temperature Decomposes on prolonged heating above 120°C 1.17 Resistance to acids Hydrolysed by strong acids (pH&lt; 2) Resistance to alkalis Hydrolysed by strong alkalis (pH &gt; 9) 1.1 8 Storage stability Stable for more than two years at room temperature. 2 Toxicological properties 2.1 General 2.1.1 Mode of Action PubChem [internet] Acetylcholinesterase (AChE) inhibition Organophosphates poison insects and mammals primarily by phosphorylation of the acetylcholinesterase enzyme at nerve endings. The organophosphorus compounds owe their biological activities to the capacity of the central P atom to phosphorylate the esteratic site of the enzyme, cholinesterase, which is an essential constituent of the nervous system not only of i nsect s but also of all higher animals . 2.1.2 Symptoms of poisoning PubChem [internet] Acute exposure to terbufos may produce the following signs and symptoms: pinpoint pupils, blurred vision, headache, dizziness, muscle spasms, and profound weakness. Vomiting, diarrhea, abdominal pain, seizures, and coma may also occur. The heart rate may decrease following oral exposure or increase following dermal exposure. Chest pain may be noted. Hypotension (low blood pressure) may be noted, although hypertension (high blood pressure) is not uncommon. Respiratory symptoms include dyspnea (shortness of breath), respiratory depression, and respiratory paralysis. Psychosis may occur . Signs and symptoms of acute intoxication by organophosphorus insecticides include muscarinic, nicotinic, and central nervous system (CNS) manifestations. Symptoms may develop rapidly, or there may be a delay of several hours after exposure before they become evident. The delay tends to be longer in the case of more lipophilic compounds, which also require metabolic activation. Symptoms may increase in severity for more than one day and may last for several days. In severe cases, respiratory failure is a dominant effect. 2.1.3 Absorption, distribution, excretion and metabolism in mammals Canada Terbufos has a high dermal absorption potential . Phosphorylated terbufos metabolites (terbufos sulfoxide and terbufos sulfone) are of c omparable toxicity to terbufos ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) JMPR (2004) Rate and extent of oral absorption : r apid and fairly complete . Dermal absorption : rapidly penetrating following dermal or ocular application . Distribution : r elatively rapid and fairly complete . Potential for accumulation : little. Rate and extent of excretion : r elatively rapid and complete; most eliminated in 24–48 h; elimination in urine predominates . Metabolism in animals : s ulfoxidation and desulfuration of terbufos is followed by hydrolysis of the thiolophosphorus bond (S-P), enzymatic S-methylation and then additional S-oxidation . PubChem [internet] A metabolism study of rats indicated that 83% of a single administration of 0.8 mg/kg terbufos was excreted in the urine in the form of metabolites and 3.5% in the feces during 168 hours. No terbufos accumulated in tissues. Metabolism occurs principally by oxidation, hydrolysis by esterases, and by transfer of portions of the molecule to glutathione. Oxidation of organophosphorus insecticides may result in more or less toxic products. The glutathione transferase reactions produce products, that are, in most cases, of low toxicity . 2.2 Toxicology studies 2.2.1 Acute toxicity Canada In laboratory animals, terbufos was found to be extremely acutely toxic following acute oral, dermal and inhalation exposures. Following both single and repeated dosing, one of the most sensitive indicators of toxicity was the inhibition of acetylcholinesterase, an enzyme necessary for the proper functioning of the nervous system, or clinical signs of cholinergic toxicity. Phosphorylated terbufos metabolites (terbufos sulfoxide and terbufos sulfone) are of comparable toxicity to terbufos. One of the most remarkable features of terbufos was the steepness and potency of the dose—response with acute and short-term dosing via the oral and inhalation routes. NOAELs were very close to dose levels that elicited mortality in the test animals. Terbufos has a high dermal absorption potential; however, the steepness and potency of the dose—response observed in oral studies was lacking with repeated dermal dosing. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) Mozambique Terbufos formulations registered in Mozambique were identified as Extremely H azardous Class Ia according to the JMPM criteria for HHPs based on the WHO International Classification of P esticides by H azards. JMPR (2004) Terbufos is of very high acute toxicity when administered by the oral, dermal, or inhalation routes. LD 50 values for acute oral toxicity in rodents and dogs were similar, ranging from 1.4 to 9.2 mg/kg bw. The acute dermal LD 50 was about 1 mg/kg bw in rabbits, and the acute inhalation LC 50 in rats r anged from 0.0012 to 0.0061 mg/L . Clinical signs observed were those typical of cholinergic toxicity and, depending on the study, route and species, included tremors, salivation, exophthalmos, prostration, decreased activity, chromodacryorrhoea, diuresis, piloerection, ataxia, urogenital staining, nasal discharge, anorexia, and laboured breathing. Deaths following acute exposures occurred within minutes to hours or up to a week after administration. Pesticide Manual . 16 th E dition Acute oral LD 50 for male and female albino rats 1.6 mg/ kg and 5.4 mg/kg, respectively. Skin and eye acute percutaneous LD 50 for rats 9.8 mg/ kg, rabbits 1.0 mg/kg. Skin and eye irritant. Inhalation LC 50 (4 h) for male rats 0.0061 mg/L air; for females 0.0012 mg/L air. 2.2.2 Short term toxicity Canada In animal studies, the adverse effects noticeable at the lowest dose (i.e., the toxicity end point) were clinical signs observed in an acute rat neurotoxicity study (NOAEL of 0.15 mg/kg bw). Other relevant NOAELs used for occupational end points include a NOAEL of 0.1 mg/kg bw/d from a developmental study for short-term dermal risk assessment in which there were increased resorptions and post-implantation losses at the next dose level, a NOAEL of 0.072 mg/kg bw/d from a multigeneration reproduction study for intermediate-term dermal risk assessment in which there were reproductive and offspring toxicity at the next dose level, and a NOAEL of 0.016 mg/kg bw/d from a 21-d inhalation study for short-and intermediate-term inhalation risk assessment, in which there was inhibition of cholinesterase activity and mortality at the next dose level. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) JMPR (2004) Target/critical effect: Inhibition of brain cholinesterase activity . Lowest relevant oral NOAEL 0.059 mg/kg bw per day (13-week study of neurotoxicity in rats) . Lowest relevant dermal NOAEL : Data not available . Lowest relevant inhalation NOAEC : No appropriate data available . 2.2.3 Genotoxicity (including mutagenicity) Canada Terbufos was not found to be genotoxic to either rats or mice. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) JMPR (2004 ) Unlikely to be genotoxic. Most of the tests for mutagenicity with terbufos in vitro and in vivo gave negative results. However, in one acceptably performed study of dominant lethal mutation in vivo, results were inconclusive. In a paper from the open scientific literature, positive results were reported in an acceptably performed assay for mitotic gene conversion in yeast cells ( ade locus) with technical-grade terbufos in the presence or absence of a metabolic activation system, and also with a commercial grade of terbufos, without metabolic activation. However, insufficient purity and analytical data were provided in the paper for the materials tested. Although the results of an assay for unscheduled DNA repair synthesis in cells in primary culture were negative, only male Fischer 344 rat hepatocytes were used; an optimal protocol would also have included assessment of hepatocytes from female rats. End-point Test object Concentration/dose Results In vitro Reverse mutation S. typhimurium TA98, TA100, TA1535, TA1537, TA1538; E. coli WP2 uvrA - 50–5000 µg/plate, 1000 µg/disc in DMSO, ±S9 h Negative Point mutation Chinese hamster ovary cells (CHO-K 1 -BH 4 ), Hprt locus 10–100 µg/ml &amp; in DMSO, ±S9 Negative Chromosomal aberration Chinese hamster ovary cells 2.5–100 nl/ml in DMSO, ±S9 Negative Unscheduled DNA synthesis Primary rat (male, Fischer 344) hepatocytes 0.33–33.33 µg/well in DMSO Negative Mitotic gene conversion S. cerevisiae strain D4 ( ade and trp loci) Apparently 0.33–33 µg/tube in DMSO, ±S9 Technical-grade: positive at the ade locus (±S9); Commercial-grade: weakly positive at the ade locus (-S9)o In vivo Dominant lethal mutation (10 mating cycles) Crl : CD(SD)BR rats (10 male rats per group) 0, 0.1, 0.2, or 0.4 mg/kg bw per dayh,j,k in corn oil by gavage daily for 5 days at the start of the first mating cycle Inconclusive Chromosomal aberration Sprague-Dawley rats (20 males, 20 females per group), bone- marrow cells Single intraperitoneal doses of 0, 0.2,0.6, 1.5 (females only)m or 1.8 mg/kg bw in corn oil Negative 2.2.4 Long term toxicity and carcinogenicity Canada Terbufos was not found to be carcinogenic to either rats or mice. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) JMPR (2004) Target/critical effect : i nhibition of brain cholinesterase activity . Lowest relevant NOAEL : 0.055 mg/kg bw per day (1-year study in rats) . Carcinogenicity : n o evidence of carcinogenicity; u nlikely to pose a risk to humans . Extoxnet (1996) Slow thinking, memory loss, irritability, delayed reaction times, and anxiety have been noted in workers chronically exposed to organophosphates like terbufos. When rats were fed terbufos for 90 days, no effects were observed at doses up to 0.02 mg/kg/day. Cholinesterase inhibition occurred at higher doses. Similar results were obtained in a 1-year study with rats. No effects were observed at doses up to 0.025 mg/kg/day, with cholinesterase inhibition occurring at 0.05 mg/kg/day, the highest dose tested . Carcinogenicity: No tumors were found in mice given 1.8 mg/kg/day, the highest dose tested, for 18 months. The same results occurred in a 2-year study with rats given up to 0.40 mg/kg/day, the highest dose tested 2.2.5 Effects on reproduction Canada Terbufos did not cause fetal malformations in either rats or rabbits, but minimally increased resorptions and post-implantation losses were noted in the rat developmental study at a dose anticipated to cause cholinesterase inhibition in the maternal animals. In a reproductive toxicity study in rats, adverse effects following prolonged exposure to terbufos included reduced pregnancy rate, male fertility, litter size and viability of the young. The developmental and reproductive toxicity studies did not demonstrate any sensitivity of young animals relative to adult animals, although lack of cholinesterase measurements in these studies precluded a definitive assessment of this issue. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) JMPR (2004) Reproduction target/critical effect : d ecreases in male fertility and female pregnancy rate . Lowest relevant reproductive NOAEL : 0.086 mg/kg bw per day (rats) . Developmental target/critical effect : n ot teratogenic; r educed fetal body weight . Lowest relevant developmental NOAEL : 0.25 mg/kg bw per day (rabbits). Extoxnet (1996) Reproductive effects: I n a long-term study in rats, no chronic reproductive effects were observed after daily exposure to low doses of terbufos. In another study, when rats were fed 0.0125 or 0.05 mg/kg/day for 6 months, there was an increase in the number of litters with dead offspring at the highest dose tested. Rabbits were given doses of up to 0.4 mg/kg/day on days 7 to 19 of pregnancy. Cesarean sections were performed on day 29. No adverse effects on the offspring were seen at any dose. Toxic effects on the mothers occurred at the highest dose tested. These data suggest that terbufos is unlikely to cause reproductive effects in humans. Teratogenic effects: Available evidence indicates that terbufos does not cause birth defects. There were no birth defects in the offspring of rats given up to 0.2 mg/kg/day on days 6 to 15 of pregnancy. In a similar study on rabbits, no birth defects were observed in the offspring of rabbits given 0.25 mg/kg/day, the highest dose tested. The mothers exhibited reduced body weight gain at this dose 2.2.6 Neurotoxicity/ delayed neurotoxicity, Special studies where available Canada Terbufos did not cause any apparent delayed neurotoxicity and there was no evidence of histopathological effects on the central nervous system in any of the available studies. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) JMPR (2004) Acute neurotoxicity : Target/critical effect : m iosis . Relevant NOAEL : 0.15 mg/kg bw (rats) . 13-week study of neurotoxicity : Target/critical effect : i nhibition of brain cholinesterase activity . Relevant NOAEL : 0.059 mg/kg bw per day (rats) . Delayed neuropathy : No evidence to suggest toxicity at dietary exposures . 2.2.7 Summary of mammalian toxicity and overall evaluation Canada In laboratory animals, terbufos was found to be extremely acutely toxic following acute oral, dermal and inhalation exposures. Following both single and repeated dosing, one of the most sensitive indicators of toxicity was the inhibition of acetylcholinesterase, an enzyme necessary for the proper functioning of the nervous system, or clinical signs of cholinergic toxicity. Phosphorylated terbufos metabolites (terbufos sulfoxide and terbufos sulfone) are of comparable toxicity to terbufos. Terbufos did not cause any apparent delayed neurotoxicity and there was no evidence of histopathological effects on the central nervous system in any of the available studies. Terbufos was not found to be genotoxic nor was it carcinogenic to either rats or mice. Terbufos did not cause fetal malformations in either rats or rabbits, but minimally increased resorptions and post-implantation losses were noted in the rat developmental study at a dose anticipated to cause cholinesterase inhibition in the maternal animals. In a reproductive toxicity study in rats, adverse effects following prolonged exposure to terbufos included reduced pregnancy rate, male fertility, litter size and viability of the young. The developmental and reproductive toxicity studies did not demonstrate any sensitivity of young animals relative to adult animals, although lack of cholinesterase measurements in these studies precluded a definitive assessment of this issue. Despite the lack of demonstrated sensitivity, these studies were considered during the risk assessment due to the serious nature of end points affected. One of the most remarkable features of terbufos was the steepness and potency of the dose—response with acute and short-term dosing via the oral and inhalation routes. NOAELs were very close to dose levels that elicited mortality in the test animals. Terbufos has a high dermal absorption potential; however, the steepness and potency of the dose—response observed in oral studies was not observed with repeated dermal dosing. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) 3 Human exposure/Risk evaluation 3.1 Food Canada Acute dietary risk from foods treated with terbufos was not a concern for the general Canadian population and all population subgroups (i.e., less than 100% of the AR f D is consumed). At the 99.9th percentile of exposure, the most highly exposed population subgroups, infants (&lt;1 year old) and children (1-6 years old), consume 67 % and 52% of the AR f D, respectively, in their food. The assessment has been conducted using market basket and residue data, as well as U.S. tolerances for imported crops. Percent crop treated data were used for domestic and imported crops, and processing factors were used for relevant matrices. Bananas are the principal contributor to the acute dietary risk for terbufos. An import MRL is recommended at 0.005 ppm based on the dietary risk assessment. This proposed MRL is supported by field residue data. Chronic dietary risk from foods treated with terbufos is not a concern for the general Canadian population and all population subgroups (i.e., less than 100% of the ADI is consumed). The most highly exposed population subgroups, infants (&lt;1 year old) and children (1-6 years old), both consume 4% of the ADI in their food. The risk assessment was conducted using average residues, percent crop treated data and processing factors. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) 3.2 Air JMPR (2004) Terbufos is of very high acute toxicity when administered by the inhalation route . T he acute inhalation LC 50 in rats r anged from 0.0012 to 0.0061 mg/L . 3.3 Water JMPR (2004) The important metabolites terbufos sulfoxide and terbufos sulfone are more mobile and persistent than parent terbufos. The sulfoxide and sulfone half-lives are 116 and 96 days, respectively. These metabolites are also mobile in all tested soils and may reach ground water when terbufos is used in a location where irrigation or rain water moves through the soil profile to groundwater. In addition, terbufos and its metabolites may enter surface water as a result of run-off events. 3.4 Occupational exposure Canada Workers can be exposed to a pesticide through mixing, loading, or applying the pesticide, and re-entering a treated site. Worker risk is estimated by a MOE that determines how close the occupational exposure comes to the NOAEL taken from animal studies. For workers entering a treated site, re-entry intervals (REIs) may be calculated to determine the minimum length of time required before workers or others are allowed to enter. The risks associated with loading and applying the clay-based granular Counter 15-G (15% active ingredient) are below the PMRA' s level of concern when a Lock'n Load closed handling system and other mitigation measures are used. The clay- based granular is sold exclusively in Lock'n Load packaging, according to the registrant . The risk associated with exposure to Counter 5-G (corncob-based granular containing 5% active ingredient) during blending with seed commercially or on-farm and subsequent planting is expected to exceed the PMRA's level of concern. Chemical-specific exposure data was used to assess the closed handling system scenario (i.e., representative of Counter 15-G). The Pesticide Handlers' Exposure Database (PHED) was used to assess the open mixing and loading scenario (i.e., representative of Counter 5-G). For Counter 15-G, adequate worker protection would be afforded under the following conditions: for loading activities: Lock'n Load packaging and PPE including a long-sleeved shirt, long pants, chemical resistant apron and gloves. For application activities: closed cab, long-sleeved shirt and pants. As an interim measure pending implementation of closed cabs, coveralls over long pants and long-sleeved shirts, chemical registrant footwear and a respirator are recommended for application activities. These mitigation measures are the s ame as those in the recent US EPA re-evaluation of occupational risk to Counter 15-G. MOEs for on-farm uses of Counter 5-G (open mixing and loading scenario) exceed the PMRA's level of concern based on available exposure information (PHED). No exposure study is available for commercial seed blending; however, due in part to the larger quantity of terbufos handled, longer duration of exposure and the open - bag l oading scenario, commercial blending of Counter 5-G is also expected to exceed the PMRA's level of concern. Although the PMRA used toxicity end points and safety factors that differed from the EPA terbufos re-evaluation, use of the EPA toxicity end points and safety factors still resulted in inadequate MOEs for Counter 5-G. Furthermore, the EPA also expressed concerns over open-bag loading of terbufos on-farm. Commercial blending of terbufos is not a registered use in the U SA . Exposure to persons entering treated sites after application or exposure from drift to residential areas is considered minimal due to the application method (i.e., soil incorporation at planting with ground equipment). An REI of 48 h based on acute toxicity is sufficient to protect workers who may re-enter treated areas. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) Mozambique Field surveys on general pesticide use and exposure in Mozambique revealed that almost none of the farmers (93%) owned or wore adequate PPE having only one or no protective items at all. Only 2% of those applying HHPs wore adequate full body protection PPE . About half of the farmers (50.2%) had not received any training on the use of pesticides. The maj ority of pesticide applicators used manual sprayer s (36%), followed by electric sprayer s with batteries ( 33 % ) , and followed by inappropriate equipment such as watering can s (13.5%) or other (unknown) means (12.5%). A pproximately about half of the farmers surveyed reported that they noticed to receive pesticide on their clothes, bare skin or eyes when using pesticides. The main health symptoms associated with pesticide use by farmers noticing symptoms were headaches, skin rashes, burning eyes, vomiting, burning nose, blurred vision, dizziness and excessive sweating. Almost half of the farmers declared they did not read pesticide labels, including use instructions such as proper dosage and protective measures, the main reason being illiteracy. One out of four farmers poorly understood the hazard colour band on pesticide labels that indicates acute toxicity. 3.5 Medical data contributing to regulatory decision None reported 3.6 Public exposure JMPR (2004) There have been a number of reports of occupational and non-occupational poisoning incidents associated with exposure to terbufos. With regard to possible effects from terbufos manufacturing facilities, no "reportable incidents" have been noted and no other information was available. 3.7 Summary-overall risk evaluation As part of Mozambique’s national objective of reducing risks of the most dangerous pesticides including HHPs , Mozambique has conducted a risk evaluation of the human health effects of terbufos . T aking into consideration the results of the survey of pesticide use practices in selected cropping systems in Mozambique, (some of which are representative of potential terbufos use), which included the identification of inadequate availability and use of PPE and terbufos’ high acute toxicity (WHO hazard classification Ia – extremely hazardous), Mozambique concluded that the use of terbufos was likely to result in excessive exposure of farmers in Mozambique and that enforcing risk mitigation measures depending solely on wearing the appropriate PPE under the local conditions of use would be difficult and unlikely to protect the human health . 4 Environmental fate and effects 4.1 Fate 4.1.1 Soil Canada Terbufos is susceptible to transformation by both abiotic and biotic processes. Hydrolysis appears to be a major abiotic transformation route for parent terbufos. Hydrolysis of terbufos sulfoxide and terbufos sulfone is pH dependent and is slower than for the parent compound. The major route for biotic transformation is aerobic biotransformation with terbufos sulfoxide, terbufos sulfone and CO 2 as the major transformation products. Based on available data, terbufos will be slightly to moderately persistent in terrestrial soil systems depending on temperature and soil conditions. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) 4.1.2 Water Canada Terbufos has low solubility in water and has moderate volatility potential from moist soil or water surfaces. The physical and chemical properties of terbufos indicate that in aquatic systems it will partition into sediments. Data on transformation rates for water—sediment systems indicate half-lives of 27-41 d, with relative rapid transformation in the water phase, primarily through hydrolysis, and slower transformation in sediment-sorbed terbufos. Both major terrestrial transformation products, terbufos sulfoxide and terbufos sulfone, were significantly more persistent than parent terbufos. Based on incident reports from the U SA , it is evident that terbufos enters aquatic systems primarily via runoff from treated fields. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) 4.1.3 Air PubChem (Internet) If released to air, a vapor pressure of 0.00032 mm Hg at 20-25 °C indicates terbufos will exist solely as a vapor in the ambient atmosphere. Vapor-phase terbufos will be degraded in the atmosphere by reaction with photochemically-produced hydroxyl radicals; the half-life for this reaction in air is estimated to be 1.6 hours. Terbufos does not contain functional groups that are expected to absorb light at wavelengths &gt;290 nm, and would not be expected to be susceptible to direct photolysis by sunlight in air. Volatilization from moist soil surfaces is expected based upon a Henry's Law constant of 0.000024 atm m 3 /mole. However, adsorption to soil is expected to attenuate volatilization. Volatilization from dry soil surfaces is not expected based upon its vapor pressure. Volatilization from water surfaces is expected based upon this compound's Henry's Law constant. Estimated volatilization half-lives for a model river and model lake are 2.8 and 26 days, respectively. However, volatilization from water surfaces is expected to be attenuated by adsorption to suspended solids and sediment in the water column. 4.1.4 Bioconcentration Canada n-Octanol- water partition coefficients indicate potential for a bioaccumulation of the parent compound and limited bioaccumulation potential for terbufos sulfone or terbufos sulfoxide. Bioconcentration studies with fish indicate a potential for bioconcentration. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) 4.1.5 Persistence Canada The PMRA has concluded that terbufos does not meet persist ence criteria according to Canada’s Toxic Substances M anagement P olicy . Based on available data, terbufos is slightly to moderately persistent in terrestrial soil systems depending on temperatur e and soil conditions. In water- sediment systems, the half-lives of terbufos ranged from 27 to 41 d, with relatively rapid transformation in the water phase, and slower transformation in sediment sorbed terbufos. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) 4.2 Effects on non-target organisms 4.2.1 Terrestrial vertebrates PPDB (Internet) Mammals - Acute Oral LD 50 = 1.3 mg/kg Rat Mammals - Short term dietary NOEL =1 ppm Rat (2 year study) Birds - Acute LD 50 &gt; 185 mg/kg Anas platyrhynchos Extoxnet (1996) Terbufos is extremely toxic to birds. Its acute LD 50 is 28.6 mg/kg in bobwhite quail. Its dietary LC 50 is 143 to 157 ppm in bobwhites. Reported dietary LC 50 in Japanese quail are 194 to 265 ppm in 5-day studies. There were no effects on bird reproduction from chronic exposure to terbufos. Terbufos is expected to be extremely toxic to mammals and reptiles. 4.2.2 Aquatic species PPDB (Internet) Fish - Acute 96 hour LC 50 &gt; 0.004 mg/L Lepomis macrochirus Fish - C hronic 21 day NOEC = 0.000 6 mg/L Oncorhynchus mykiss growth Aquatic invertebrates - Acute 48 hour EC 50 = 0.00 31 mg/L Daphnia magna. Aquatic crustaceans - Acute 96 hour LC 5 0 = 0.000 22 mg/L Americamysis bahia. Algae - Acute 72 hour EC 50 , growth = 1.4 mg/L. Unknown species. Extoxnet (1996) Terbufos is extremely toxic to fish and aquatic invertebrates. The reported 96-hour LC 50 for terbufos in Daphnia magna , a small freshwater invertebrate, is 0.00031 mg/L ; in Gammarus psendogomnaens , also a freshwater invertebrate, it is 0.0002 mg/L. Reported 96-hour LC 50 values for the technical material (88%) are 0.008 to 0.0013 mg/L in rainbow trout, 0.390 mg/L in the fathead minnow, and 0.0017 to 0.0024 mg/L in bluegills. The compound has a moderate potential to accumulate in living tissue in aquatic organisms. The bluegill sunfish acumulated 680 times the ambient water concentration (in whole fish); 14 days after the fish were placed in terbufos free water between 84 and 93% of the compound was eliminated. 4.2.3 Honeybees and other arthropods PPDB (Internet) Contact acute LD 50 for honeybees (worst case from 24, 48 and 72 hour values - μg bee⁻¹) = 4.1 µg/bee Apis spp. 4.2.4 Earthworms PPDB (Internet) Acute 96 hour LC 50 = 4 mg/kg . 4.2.5 Soil microorganisms No data available 4.2.6 Terrestrial plants No data available 5 Environmental Exposure/Risk Evaluation 5.1 Terrestrial vertebrates Canada The PMRA has identified extremely high hazards to terrestrial organisms resulting from all currently registered uses of terbufos. This assessment is supported by reports of incidents in Canada and the U SA . The estimated exposure concentrations for terrestrial organisms exceed acute effects levels for both birds and mammals. The acute risk from the direct consumption of granules is greatest for smaller species. The number of lethal doses (LD 50 s) that are available within one square meter immediately after application (LD 50 s/m 2 ) is used as the risk quotient for granular products. Risk quotients for acute effects in mammals were greater than 1 LD 50 /m 2 , the threshold of concern for tested species, following use of Counter 15-G in corn, rutabaga and sugar beets. Risk quotients ranged from 5 to 5910 LD 50 /m 2 depending on the size of the animal and the incorporation efficiency. Risk quotients for acute effects in mammals following use of Counter 5-G on canola ranged from 0.1 to 88 LD 50 /m 2 , depending on the size of the animal and the incorporation efficiency. For birds, risk quotients ranged from 7 to 11 250 LD 50 /m 2 depending on the size of the bird and the incorporation efficiency following use of Counter 15-G on corn, rutabaga or sugar beets. Risk quotients for acute effects on birds following use of Counter 5-G on canola ranged from 0.2 to 170 LD 50 /m 2 , depending on the size of the animal and the incorporation efficiency. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) 5.2 Aquatic species Canada The PMRA has identified extremely high hazard to aquatic organisms resulting from all currently registered uses of terbufos. This assessment is supported by reports of incidents of adverse effects in the U SA . Similar effects may have occurred in Canada, but there is no equivalent reporting system. Estimated environmental concentrations exceed acute and chronic effects levels in both fish and aquatic invertebrates. The risk quotients for acute effects on the majority of aquatic invertebrates tested were greater than 1, the threshold of concern. Values ranged from 10 to 409 following use on canola and from 28 to 2795 following use on corn, sugar beets or rutabaga. These risk quotients are classified as high risk to extremely high risk. The risk quotients for acute effects on fish were greater than 1, the threshold of concern. Values ranged from 4 to 106 following canola application rates and from 11 to 726 following use on corn, sugar beets or rutabaga. These risk quotients are classified as moderate risk to very high risk. ( UNEP/FAO/RC/CRC.17/INF19/Rev.1 in document PACR-2003-2 of the Canadian supporting documentation) 5.3 Honey bees No information reported 5.4 Earthworms No information reported 5.5 Soil microorganisms No information reported 5.6 Summary – overall risk evaluation The Canadian PMRA identified extremely high hazards to terrestrial organisms resulting from all currently registered uses of terbufos. The assessment is supported by reports of incidents in Canada and the U SA . The PMRA identified extremely high hazard to aquatic organisms resulting from all currently registered uses of terbufos. The assessment is supported by reports of incidents of adverse effects in the U SA . Similar effects may have occurred in Canada, but there is no equivalent reporting system. Risk quotients determined for applications of the end-use terbufos formulations Counter 5-G and Counter 15-G indicate risks for all groups of organisms (i.e., birds, mammals, fish and aquatic invertebrates) for all application scenarios. Based on the available toxicity data, risk is classified as high to extremely high for aquatic organisms and in most cases high to extremely high for birds. Similarly, risk to mammals is classified as low for large mammals to high for small mammals. Annex 2 – Details on final regulatory actions reported Country Name: Canada 1 Effective date(s) of entry into force of actions 1 August 2012 Reference to the regulatory document Pest Management Regulatory Agency, Health Canada. 2004. Re-evaluation Decision RRD2004-04: Re-evaluation of Terbufos. Pest Management Regulatory Agency, Health Canada. 2008. Re-evaluation Note REV2008-06: Update on the use of Terbufos on s ugar b eets. 2 Succinct details of the final regulatory action(s) The s ale of pesticides containing terbufos was prohibited in Canada effective May 1, 2012. The use of products containing terbufos was prohibited after August 1, 2012 . 3 Reasons for action Terbufos can cause harm to the environment. Preventing use of this chemical protects the environment and non-target organisms from the risk of exposure . 4 Basis for inclusion into Annex III The final regulatory action was based on a risk evaluation taking into account the prevailing conditions in Canada. 4.1 Risk evaluation A re-evaluation of the active ingredient terbufos and its end-use products for use on canola, corn, mustard, rutabaga and sugar beet was conducted under the authority of Section 19 of the Pest Control Products Regulations . With regards to human health, occupational, dietary and aggregate (exposures from food and drinking water) risk assessments were conducted. A deterministic assessment of the environmental risks of pest control products was also conducted. Environmental risk was characterized by the quotient method, which uses the ratio of the estimated environmental concentrations to the end point of concern for effects on non-target organisms. Quotient values less than one are considered indicative of a low hazard to non-target organisms, whereas values greater than one are considered to indicate that some degree of hazard exists for effects on non-target organisms. The risk assessments were also subject to a 60-day public consultation period to allow interested parties an opportunity to provide input into the re-evaluation decision. Terbufos has low solubility in water and has moderate volatility potential from moist soil or water surfaces. n-Octanol - water partition coefficients indicate potential for a bioaccumulation of the parent compound and limited bioaccumulation potential for terbufos sulfone or terbufos sulfoxide. Bioconcentration studies with fish indicate a potential for bioconcentration. Terbufos is susceptible to transformation by both abiotic and biotic processes. Hydrolysis appears to be a major abiotic transformation route for parent terbufos. Hydrolysis of terbufos sulfoxide and terbufos sulfone is pH dependent and is slower than for the parent compound. The major route for biotic transformation is aerobic biotransformation with terbufos sulfoxide, terbufos sulfone and CO 2 as the major transformation products. Based on available data, terbufos will be slightly to moderately persistent in terrestrial soil systems depending on temperature and soil conditions. The physical and chemical properties of terbufos indicate that in aquatic systems it will partition into sediments. Data on transformation rates for water—sediment systems indicate half-lives of 27-41 d, with relative rapid transformation in the water phase, primarily through hydrolysis, and slower transformation in sediment-sorbed terbufos. Both major terrestrial transformation products, terbufos sulfoxide and terbufos sulfone, were significantly more persistent than parent terbufos. Based on incident reports from the U SA , it is evident that terbufos enters aquatic systems primarily via runoff from treated fields. The PMRA has identified extremely high hazards to terrestrial organisms resulting from all currently registered uses of terbufos. This assessment is supported by reports of incidents in Canada and the U SA . The PMRA has identified extremely high hazard to aquatic organisms resulting from all currently registered uses of terbufos. This assessment is supported by reports of incidents of adverse effects in the U SA . Similar effects may have occurred in Canada, but there is no equivalent reporting system. Risk quotients determined for applications of the end-use terbufos formulations Counter 5-G and Counter 15-G indicate risks for all groups of organisms (i.e., birds, mammals, fish and aquatic invertebrates) for all application scenarios. Based on the available toxicity data, risk is classified as high to extremely high for aquatic organisms and in most cases high to extremely high for birds. Similarly, risk to mammals is classified as low for large mammals to high for small mammals. 4.2 Criteria used Risks to the environment Relevance to other States and Region Environmental risks are likely to be relevant in other countries with similar terbufos use pattern. 5 Alternatives See section 3.3. 6 Waste management None reported 7 Other None reported Country Name: Mozambique 1 Effective date(s) of entry into force of actions July 15 th , 2014 Reference to the regulatory document Delibera ção Nr. 001/DNSA/2014 by the National Directorate of Agriculture and Agrarian Services (The pesticide register Authority). 2 Succinct details of the final regulatory action(s) Based on the decision Nr 001/DNSA/2014 terbufos was banned by the National Directorate of Agrarian Services from further import and use in Mozambique. The ban of all uses and the cancellation of the products containing terbufos in the country was decided due to the toxic nature and hazardous properties of this active substance which combined with the improper use in the country due to the local specific conditions of use can damage human and animal health. The decision to cancel the registration of terbufos was taken as the last step of the project for Risk Reduction of HHPs , which identified HHPs that are registered in Mozambique. After consultations with different actors (public sector, private sector, civil society and others), cancelation of registrations and consequent non-approval for their use in Mozambique was approved. 3 Reasons for action Reducing the risk posed by the use of HHPs in Mozambique specially terbufos in the context of human health. 4 Basis for inclusion into Annex III The final regulatory action was based on a risk evaluation taking into account the prevailing conditions in Mozambique . 4.1 Risk evaluation The notification states that the final regulatory action was based on a risk or hazard evaluation involving prevailing conditions within the Party in order to protect human health ( UNEP/FAO/RC/CRC.17/ 8/Rev.1 , s ection 2.4 of the Mozambique notification ). With the goal of reducing the greatest risks associated with pesticide use in Mozambique, the Reducing Risks of Highly Hazardous Pesticides in Mozambique project was initiated by the Government of Mozambique, with the technical support of FAO’s Pesticides Management Unit, and funded by SAICM Quick Start Programme Trust Fund. Its ultimate goal was to develop and implement an “HHP Risk Reduction Action Plan” in Mozambique for the most dangerous pesticides and use situations, resulting over time in the implementation of a variety of risk reduction measures based on a review of use conditions. These could include the cancellation of specific registrations of HHPs, implementation of risk mitigation measures, appropriate use restrictions, development of alternative pest management strategies, promotion of good agricultural practices, and possible phase-out of specific pesti cides (UNEP/FAO/RC/CRC.17/INF/18 ). In the first step of the project, a review of all the pesticides registered in Mozambique was carried out and a shortlist of HHPs was established. This shortlist was based on an assessment of the hazards of the pesticides, based on criteria established by the FAO/WHO JMPM (FAO/WHO, 2008). During the second step of the project, a use survey was carried out in selected regions and cropping systems in Mozambique. The main goal of the survey was to identify the conditions under which pesticides are being used in the country and their contribution to potential risks for human health and the environment. The third step of the project consisted of a stakeholder consultation to further discuss the use and risks of HHPs in Mozambique and fine-tune the shortlist based on the survey results and the expertise and experience of stakeholders. As result, a short list of HHPs , including “coming close” to HHPs, which were used in the country, was established. Terbufos was shortlisted as a HHP based on the following FAO/WHO JMPM criterion for identification of HHPs: - pesticide formulations that meet the criteria of classes Ia or Ib of the WHO Recommended Classification of Pesticides by Hazard; To evaluate this criterion, all pesticide formulations registered in Mozambique were classified using the above mentioned hazard classification. The oral and dermal LD 50 value of the formulation, as provided in the registration dossier, was used as the basis for the classification. LD 50 values for the formulation w ere available or could be estimated for all registered pesticide products except for three microbial pesticides and one citronella oil based product (i.e. &gt; 99% of the total). Terbufos formulations were identified as Extremely hazardous Class Ia according to the JMPM criteria for HHPs based on the WHO International Classification of Pesticides by Hazards, and therefore considered and shortlisted as a HHP ( Come &amp; van der Valk , 2014) During the second phase of the project, field surveys on the pesticide use and exposure were carried out. The surveys (325 subsistence farmers interviewed) revealed that most of the farmers applied pesticides (95%), and that the conditions of use were likely to result in undue (excessive) exposure. Half of the farmers interviewed never received any training on pesticides use, and even the other half that did, often lacked understanding of the risks involved. Farmers were spraying vegetable crops at least 14 times per growing season. One out of three applications was involving one of the HHP containing formulation (Farmers using HHPs includes almost 30% of the interviewed farmers). Also, almost none of the farmers (93%) owned or wore adequate PPE having only one or no protective items at all. Only 2% of those applying HHPs wore adequate full body protection PPE. About half of the farmers (50.2%) had not received any training on the use of pesticides. The majority of pesticide applicators used manual sprayers (36%), followed by electric sprayers (with batteries ) ( 33 %), and followed by inappropriate equipment such as watering cans ( 13.5 %) or other (unknown) means (12.5%). Approximately about half of the farmers surveyed reported that they noticed to receive pesticide on their clothes, bare skin or eyes when using pesticides. The main health symptoms associated with pesticide use by farmers noticing symptoms were headaches, skin rashes, burning eyes, vomiting, burning nose, blurred vision, dizziness and excessive sweating. Almost half of the farmers declared they did not read pesticide labels, including use instructions such as proper dosage and protective measures, the main reason being illiteracy. One out of four farmers poorly understood the hazard colour band on pesticide labels that indicates acute toxicity. The survey results showed that the use of pesticides in general, and of HHPs in particular, was likely to result in excessive exposure of farmers in Mozambique . Therefore , enforcing risk mitigation measures depending solely on wearing the appropriate PPE under the local conditions of use was considered difficult and unlikely to give results . The third step of the project consisted of a stakeholder consultation to further discuss the use and risks of highly hazardous pesticides in Mozambique and fine-tune the shortlist based on the survey results and the expertise and experience of stakeholders. T erbufos and the products containing terbufos were considered harmful for the human health under the local conditions of use in Mozambique requiring risk mitigation measures. Therefore, the authorities decided to ban terbufos from future use in the country and to cancel the registration of all the products containing terbufos. ( UNEP/FAO/RC/CRC.17/8/Rev.1 Section 2.4.2.1 of the Mozambican notification) 4.2 Criteria used Risks to human health Relevance to other States and Region Countries with similar conditions as well as where the farmers use pesticides without protective equipment could make similar decision in order to protect the human health. 5 Alternatives See section 3.3. 6 Waste management None reported 7 Other None reported Annex 3 – Addresses of designated national authorities CANADA (From PIC website: 13 October 2021) Role: DNA P* Name: Mr. Jason Flint Job title: Director General Department: Policy and Operations Directorate Institution: Pest Management Regulatory Agency Postal address: 2720 Riverside Drive K1A 0K9 Ottawa Quebec Canada Phone: +1 613 736 3660 Fax: +1 613 736 3695 Email: jason.flint@ hc-sc.gc .ca MOZAMBIQUE (From PIC website: 13 October 2021) Role: DNA P * Name: Mr. Khalid Cassam Department: Plant Protection Department Institution: Ministry of Agriculture and Rural Development Postal address: c/o INIA P.O. Box 3658 Maputo Mozambique Phone: +258 1 46 05 91 Fax: +258 1 46 01 95 Email: [email protected] * P Pesticides Annex 4 – References Regulatory actions Canada Health Canada , 2008. Re-evaluation Note REV2008-06: Update on the use of Terbufos on Sugar Beets. Pe st Management Regulatory Agency. Health Canada, 2003. Proposed Acceptability for Continuing Registration PACR 2003-02: Re-evaluation of Terbufos. Pe st Management Regulatory Agency. Health Canada, 2004. Re-evaluation Decision RRD2004-04: Re-evaluation of Terbufos. Pe st Management Regulatory Agency. The Pesticide Manual, 16 th Edition: Extract on Terbufos. As cited in: UNEP/FAO/RC/CRC.17/ INF/19/Rev. 1 . Mozambique Delibera ção Nr. 001/DNSA/2014 by the National Directorate of Agriculture and Agrarian Services (The pesticide register Authority). Come A.M. &amp; van der Valk H., 2014. Reducing Risks of Highly Hazardous Pesticides in Mozambique: Step 1 – Shortlisting highly hazardous pesticides, Consultancy report undertaken under the Project EP/MOZ/101/UEP. Come A.M.; Dona L.L.; Mancini F. &amp; van der Valk H., 2014. Reducing Risks of Highly Hazardous Pesticides in Mozambique: Step 2 – Survey of pesticide use practices in selected cropping systems. FAO/ WHO , 2008 . Report of the 2nd Joint Meeting on Pesticide Management and the 4th Session of the FAO Panel of Experts on Pesticide Management. 6-8 October 2008, Geneva. Food and Agriculture Organization of the United Nations, Rome &amp; World Health Organization, Geneva. (p. 14–18) : https://www.fao.org/fileadmin/templates/agphome/documents/Pests_Pesticides/Code/Report.pdf Lahr J., R. Kruijne &amp; J. Groenwold, 2014. Hazards of pesticides imported into Mozambique, 2002-2011. Wageningen, Alterra Wageningen UR (University &amp; Research centre). JMPR, 2004 . Pesticide residues in food – 2003. Joint Meeting of the FAO Panel of Experts on Pes- ticide Residues in Food and the Environment and the WHO Core Assessment Group. Evaluations 2003. Part II Toxicological. IPCS, World Health Organization, Geneva (WHO/PCS/04.1). https://inchem.org/documents/jmpr/jmpmono/v2003pr13.htm JMPR, 2005. Evaluation on Terbufos, 2005. Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group . http://www.fao.org/fileadmin/templates/agphome/documents/Pests _ Pesticides/JMPR/Evaluatio n05/2005_Terbufos1.pdf. PPDB [Internet] Pesticide Properties Database Terbufos (Ref: AC 92100), [cited 2021 Oct. 27 for this document ]. Available from: http://sitem.herts.ac.uk/aeru/ppdb/en/Reports/621.htm Other Documents Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal 1996. Ava ilable at: www.basel.int Extoxnet (1996): Extension Toxicology Network, Pesticide Information Profiles: Terbufos. http://extoxnet.orst.edu/pips/terbufos.htm PubChem [Internet]. Bethesda (MD): National Library of Medicine (US), National Center for Biotechnology Information; 2004-. PubChem Compound Summary for CID 25670, Terbufos; [cited 2021 Oct. 27]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Terbufos US EPA , 1988. Terbufos Pesticide Factsheet No.5.2. https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=2000TZ8L.txt WHO , 2019. WHO recommended classification of pesticides by hazard and guidelines to classification, 2019 edition. https://www.who.int/publications/i/item/9789240005662 Relevant guidelines and reference documents Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal 1996. Available at: www.basel.int FAO , 1995 . Guidelines on Prevention of Accumulation of Obsolete Pesticide Stocks. FAO, Rome. Available at: http://www.fao.org/3/a-v7460e.pdf FAO , 1996a . The Pesticide Storage and Stock Control Manual, Rome. Available at: http://www.fao.org/agriculture/crops/obsolete-pesticides/resources0/en/ FAO , 1996b . Technical guidelines on disposal of bulk quantities of obsolete pesticides in developing countries. Available at: http://www.fao.org/agriculture/crops/thematic-sitemap/theme/pests/code/list-guide-new/en/ FAO , 1999 . Guidelines for the management of small quantities of unwanted and obsolete pesticides, Rome. Available at: http://www.fao.org/agriculture/crops/thematic-sitemap/theme/pests/code/list-guide-new/en/ FAO, 2015: Guidelines on Good Labelling Practice for Pesticides (Revised). Rome. Available at: https://www.fao.org/3/i4854e/i4854e.pdf Workplan for the preparation of draft decision guidance documents Tasks to be carried out Responsible persons Deadlines Draft an internal proposal based on the information available to the Committee Chair Drafter 10 December 2021 Send the draft internal proposal to the drafting group members for comments via email Secretariat 10 December 20 21 Replies Drafting group members 10 January 2022 Update the internal proposal on the basis of comments from drafting group members Chair Drafter 10 February 2022 Send the updated internal proposal to the Committee members and observers for comments via email Secretariat 10 February 2022 Replies Committee members and observers 10 March 2022 Draft a decision guidance document on the basis of the comments of the Committee members and observers Chair Drafter 8 April 2022 Send the draft decision guidance document to the drafting group members for comments via email Secretariat 8 April 2022 Replies Drafting group members 22 April 2022 Finalize the draft decision guidance document on the basis of the comments of the drafting group members Chair Drafter 12 May 2022 Send the draft decision guidance document to the Secretariat Chair Drafter 12 May 2022 Submit the draft decision guidance document to the Committee at its eighteenth meeting Secretariat September or October 2022 Excerpt from the Handbook of the Chemical Review Committee Working paper on preparing internal proposals and decision guidance documents for banned or severely restricted chemicals 1.2 Working paper on preparing internal proposals and decision guidance documents for banned or severely restricted chemicals Reference: UNEP/FAO/RC/CRC. 14/10 This document provides guidance to intersessional drafting groups of the Chemical Review Committee (CRC) in the preparation of decision guidance documents for banned or severely restricted chemicals. It is designed to clarify the purpose of each section of the decision guidance document and to characterize the information to be included. The working paper, originally developed by the interim CRC, was adopted at the first meeting of the CRC. Subsequent meetings of the CRC have reviewed and amended this working paper based on the experience gained in drafting decision guidance documents. This most recent version was approved by the fourteenth meeting of the CRC with the understanding that it would continue to evolve in the light of future experience. Purpose This working paper is to serve as guidance to drafting groups established by the Chemical Review Committee for the preparation of decision guidance documents for banned or severely restricted chemicals in accordance with Article 5 of the Rotterdam Convention. This working paper is intended: To clarify the purpose of each section of the decision guidance document; To characterize the information to be included; To define acceptable sources of information for each section. This working paper is expected to evolve as further experience is gained in the preparation of decision guidance documents. It is to be used by drafting groups preparing decision guidance documents for both pesticides and industrial chemicals. In this version of the working paper those sections which are potentially different for industrial chemicals and pesticides have been highlighted. If required, future versions of the working paper may be split into two separate working documents, one for pesticides and one for industrial chemicals. A separate working paper has been developed for the preparation of decision guidance documents for severely hazardous pesticide formulations in accordance with Article 6 of the Rotterdam Convention. In order to further facilitate the work of the drafting groups an electronic template of a draft decision guidance document has been prepared as a companion document to this working paper. General guidance In preparing each decision guidance document a standard cover/title page will be added as will a version of the standard introductory text developed at the fourth session of the interim Chemical Review Committee. This text provides a brief summary of the process through which the individual decision guidance document was developed and includes three separate sections an introduction, purpose and disclaimer. In cases where a decision guidance document includes more than one chemical ( e.g . asbestos), a table of contents will facilitate the use of the document. Similarly the insertion of footers identifying the chemical should be included on each page. A standard list of “core” abbreviations has been prepared based on experience in drafting decision guidance documents to date. It is intended that this core list should serve as the basis for decision guidance documents for both industrial chemicals and pesticides and that it should be augmented by abbreviations used in the individual decision guidance documents relevant to the chemical(s) in question. This core list of abbreviations is appended to this working paper (appendix 1). As a general rule it is preferable that acronyms used only once in the text be spelled out rather than included in the list of abbreviations. In preparing a decision guidance document, it may be that not all sections are relevant to the chemical under consideration. It is preferable, in this case, to include a phrase along the lines of ‘not applicable’, rather than deleting the section or leaving it blank. This clearly indicates that the drafting group had considered that section. 1. Identification and uses Purpose: To provide an unequivocal identification of the chemical subject to the PIC procedure and its use as either a pesticide or an industrial chemical, or both. This basic information should be obtainable from the submitted notifications and the supporting material available to the Committee prior to its decision to develop a decision guidance document. CAS numbers for all forms of the chemical covered in the relevant notifications of final regulatory action should be included here. The scope of the chemical identified in this section (chemical description and associated CAS numbers) must be consistent with the recommendation by the Chemical Review Committee (CRC) for inclusion of the chemical in Annex III of the Convention. Should additional CAS numbers be found during the development of the decision guidance document, they should be brought to the attention of the CRC. If they do not broaden the scope of the original notification, they could be included here. Chemical structural formula should be included if practicable. Structural formula may be found in standard references documents on pesticides e.g . The Pesticide Manual. Notes: Updated or additional information on trade names, formulation types and basic manufacturers for products moving in international trade may be identified through the responses to the call for information on on-going manufacture, use and trade of the chemical. The list of trade names, formulation types and manufacturers should, where possible, distinguish old products from those that are known to be moving in international trade. It is clear that a list of both manufacturers and trade names will be constantly changing, for this reason a generic disclaimer along the following lines should be considered: Under trade names: This is an indicative list of trade names. It is not intended to be exhaustive. Under basic manufacturers: This is an indicative list of current and former manufacturers of XXX. It is not intended to be exhaustive . In accordance with article 7, when a chemical may be used as both a pesticide and an industrial chemical (a dual-use chemical), the decision guidance document should provide information on uses in both categories. A statement on “reported use in X category” or “no reported uses in X category” should be given (where X is either an industrial chemical for a pesticide decision guidance document or a pesticide for an industrial chemical). 2. Reasons for inclusion in the PIC procedure Purpose: To provide a generic statement that clearly identifies the use category (pesticide or industrial chemical) and whether the chemical is subject to a ban or severe restriction in the notifying countries. References to any previous listing(s) under the PIC procedure should also be included, where relevant. For dual-use chemicals, it will also be important to note when the PIC obligations do not apply to the use category that was not regulated. Example: [Chemical X] is included in the PIC procedure as a pesticide. It is has been listed on the basis of the final regulatory actions to severely restrict its use, notified by [Country 1] , and to ban its use, notified by [Country 2] . No final regulatory actions relating to industrial chemical uses have been notified. List notifying countries alphabetically. 2.1. Final regulatory action Purpose: To provide a brief statement/summary of the final regulatory action(s) as reported by the notifying countries and the reasons for the actions taken ( e.g ., occupational health concerns, environmental concerns). The text should reflect the reasoning used by the regulatory authority to underpin the national regulatory action(s) – for example, as presented in national law, regulation, gazette, legal journal, code. Specific reference to the relevant directive or regulation for the reported regulatory action(s) should be included in annex 2. The reason(s) stated should set the stage for the subsequent description of the underlying risk evaluation. National authorities should ensure that any technical legal references, if they are used, are accurate. 2.2. Risk evaluation Purpose: To provide a brief summary (no more than 1-2 pages) highlighting the key reported finding(s) of the national risk evaluation(s) that led to the regulatory action(s). The text should reflect the reason(s) identified in the final regulatory action(s) by the notifying countries and include information on the uses that were permitted prior to the regulatory action. In the interests of brevity, the text may include references to Convention Annexes I and II for additional details. Note: Depending on the chemical and the finding(s) of the national risk evaluations, this section may provide information on an individual country basis, or, where there are multiple country notifications based on common human health or environmental concerns, the information may be summarized and combined. It would also be useful to highlight the differences in regulatory actions, if they are not already obvious. 3. Protective measures that have been applied concerning the chemical Purpose: To highlight measures taken to reduce exposure, in the first instance through regulatory controls or measures and secondly through other measures (administrative, non-legal/voluntary codes of practice, field practice, etc.) recalling that: A ban in the regulated category of use eliminates all exposure (occupational or environmental); and A severe restriction in the regulated category of use allows continued use in a manner that reduces risk to an “acceptable” level. 3.1. Regulatory measures to reduce exposure Purpose: To provide information on the regulatory measures taken to ban or severely restrict the chemical and associated products. for bans , the risk has been eliminated and therefore a simple explanation of the risk management strategy to deal with existing stocks may be enough; and for severe restrictions , briefly describe the regulatory measures taken/set in place to reduce the risk to acceptable levels - e.g . by restricting access to trained/certified applicators or requiring purchasers to be licensed. 3.2. Other measures to reduce exposure This section is primarily intended for additional information from the notifying country(ies) on chemicals that have been severely restricted e.g. chemicals where for which virtually all use has been prohibited. For most banned chemicals this section would not be completed. The exception is where there was relevant chemical specific information from either the notifying country or international sources on possible risk mitigation measures. Purpose: To provide information about non-regulatory measures (including technical and field-level arrangements) for severely restricted chemicals taken/set in place to reduce exposure and ensure that risk remains at an acceptable level for the uses that are permitted to continue. Information could include, for example changing the type of formulation or application equipment used, specifying the personal protective equipment or clothing required. Where available, information from the notifying country or international sources of information on chemical specific risk mitigation measures may also be referenced. Examples may include publications from the International Labo u r Organization or International Standards Organization. It is not intended that generic information on handling hazardous chemicals would be included in this section. Note: In order to maintain the timeliness and accuracy of this information, it is preferable to include references to additional sources of information (electronic links, etc) for a specific chemical on the Rotterdam Convention website. New sources of such information could also be included in a series of up-dates that could be distributed to designated national authorities along with the PIC circular. 3.3. Alternatives Purpose: To provide countries with brief information about alternatives that have been identified by the notifying country or countries and others where available. It is not be feasible for the decision guidance document to contain a comprehensive list of specific pest crop complexes and recommended pesticides or non-chemical alternatives, particularly for pesticides that have a broad spectrum of activity. As the available alternatives are constantly evolving, identifying sources of information is likely to be more useful and more reliable than a list of specific recommendations. Notifying countries may provide information about chemical and non-chemical alternatives that are being used within their jurisdictions. Detailed information can be included in annex 2. Information from sources other than the notifying country might be referenced here with details on where the information might be found provided to DNAs through the PIC Circular and the Rotterdam Convention website (see following note). Note: While recognizing that a range of chemical and non-chemical alternatives may be available, this section should include a generic statement on the need for caution in considering them or using them and should remind parties of the need to ensure that they are appropriate to national circumstances. In order to maintain the timeliness and accuracy of this information, it is preferable to include references to additional sources of information (electronic links, etc.) for a specific chemical on the Rotterdam Convention website. Such new sources of such information could be included in a series of up-dates that could be distributed to designated national authorities along with the PIC circular and also used in workshops. The following is an example of standard text for this section related to pesticides. There are a number of alternative methods involving chemical and non-chemical strategies, including alternative technologies available, depending on the individual crop-pest complex under consideration. Countries should consider promoting, as appropriate, integrated pest management (IPM) and organic strategies as a means of reducing or eliminating the use of hazardous pesticides. SAICM’s Fourth International Conference on Chemicals Management recommended that in replacing highly hazardous pesticides the focus should be on agroecologically-based practices. Advice may be available through National IPM focal points, the FAO, IFOAM (International Federation of Organic Movements) and agricultural research or development agencies. Where it has been made available by governments, additional information on alternatives to XXXX may be found on the Rotterdam Convention website www.pic.int . Information on such agroecologically-based practices can be found at the following websites: FAO Agroecology hub: http://www.fao.org/agroecology/en/ IPAM (International Peoples Agroecology Multiversity): http://ipamglobal.org/ OISAT (Online Information Service for Non-Chemical Pest Management in the Tropics): http://www.oisat.org/ Replacing Chemicals with Biology: Phasing out Highly Hazardous Pesticides with Agroecology: http://panap.net/2015/11/replacing-chemicals-biology-phasing-highly-hazardous-pesticides-agroecology/ It is essential that before a country considers substituting alternatives, it ensure that the use is relevant to its national needs and the anticipated local conditions of use. The hazards of the substitute materials and the controls needed for safe use should also be evaluated. For industrial chemicals , the final paragraph above should be used, to indicate the need to consider the hazards associated with possible alternatives. National alternatives should be included, and if international organizations have discussed alternatives in reviews etc. this information could also be included. 3.4. Social and economic effects This section would only be completed where Notifying Countries have undertaken specific studies of the social and economic effects related to their final regulatory action(s) and wish to report on their findings. Note: Most countries do not undertake rigorous social and economic studies that are relevant beyond their own jurisdictions, but they may provide information on alternatives when a country took an action to restrict a chemical. This information is optional. When reported, there will need to be a caveat that countries consider the results of this information in the context of their own national conditions. 4. Hazards and risks to human health and/or the environment 4.1 Hazard Classification Purpose: To provide a brief summary of internationally recognized classifications applied to the chemical(s) for which the decision guidance document has been prepared. This section should focus on internationally recognized standards such as IARC, WHO/IPCS classification systems. The standard reference for LD 50 values is the most recent edition of the WHO/IPCS publication, recommended classification of pesticides by hazard and guidelines to classification . The WHO classification schemes for pesticides as well as its formulations are based on oral or dermal toxicity. According to the WHO guideline, the route which indicate greater hazard would be chosen for its classification. As far as possible, information on the WHO hazard classification of liquid and solid formulations should be included. The US EPA and European Union classification systems have been included as they are widely used by many countries as a reference. All references should include the date when they were established. Note: It is not intended that national standards be included here, notifying countries should include their national classification schemes in Annex 2. The following is an example of how this information might be presented: 4. Hazards and Risks to human health and the environment 4.1 Hazard Classification WHO / IPCS Technical product a.i.: Insert classification e.g. Class Ia (extremely hazardous) Classification based on oral or dermal toxicity in rats LD 50: (WHO reference) Formulations a.i. (%) Hazard class Liquid Solid IARC Group 3: the agent is not classified as to its carcinogenicity to humans. (IARC reference) European Union Classification of the active substance is (Commission Directive reference): T (toxic) Xi (Irritant) N (dangerous for the environment) R 24/25 (Toxic in contact with skin/ if swallowed) R 36 (Irritating to eyes) R 50/53 (Very toxic to aquatic organisms / may cause long-term adverse effects in the aquatic environment) US EPA Toxicity Class I (formulation) (EPA reference) 4.2. Exposure limits Purpose: To provide a brief summary of internationally recognized exposure limits as applied to the chemical(s) subject to the decision guidance document. This section should focus on those exposure limits that are internationally recognized, e.g ., Codex levels in food, WHO drinking water guidelines, etc. All references should include the date when they were established and the date of any subsequent review by the FAO/WHO Joint Meeting on Pesticide Residues (JMPR), etc. It is not intended to capture occupational exposure limits such as Threshold Limit Values (TLVs) for pesticides largely because of the widely differing ways in which they may be calculated Note: It is not intended that national standards be included here as their applicability to other countries is limited without a good understanding of how the limits were derived. Notifying countries could include them in Annex 2 if they feel it is appropriate and necessary. If no international exposure limits are available, the words ‘not applicable for this chemical’ could be inserted. 4.3 Packaging and labelling Purpose: To provide a quick reference to existing standards for packaging and labelling of the chemical. This section should focus on internationally recognized classifications established by the United Nations Committee of Experts on the Transport of Dangerous Goods, and on the Globally Harmonized System of Classification and Labelling of Chemicals (if used), the International Maritime Dangerous Goods Code, etc., along with relevant explanatory text if applicable ( i.e. for specific requirements). Note: In the case of pesticides, this section should include a generic statement on the availability of further specific guidance on appropriate symbols and label statements for individual pesticides and formulations in the FAO Guidelines on Good Labelling Practice for Pesticides . 4.3 Packaging and labelling The United Nations Committee of Experts on the Transportation of Dangerous Goods classifies the chemical in: Hazard Class and Packing Group: International Maritime Dangerous Goods (IMDG) Code Transport Emergency Card 4.4. First aid Purpose: To provide a quick reference to internationally recognized information on the treatment of chemical poisoning (pesticides and industrial chemicals) available at the time of publication of the decision guidance document. Reference should be generic and include the most recent WHO/IPCS recommendation. It should note any aspects specific to the chemical cited in the decision guidance document. A reference to the WHO website for other relevant information might also be included www.inchem.org Notes: For chemicals that are not acutely toxic, this section may not be relevant and could be completed with the statement “ not applicable to this chemical ”. Recognizing that a range of first-aid treatments may be available, this section should include a generic statement on the need for caution and should remind parties of the need to ensure that this information is in compliance with any national standards that may exist. 4.5. Waste management Purpose: To ensure that countries are aware of the need for appropriate management of wastes and to provide references to relevant guidance and other sources of information. This section should include references to appropriate internationally recognized guidelines such as those developed by FAO for pesticides. Particular attention should be drawn to the relevant terms of international agreements – the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal. Notifying countries may wish to note specific actions taken to avoid the creation of stockpiles, including arrangements to permit use of existing stocks during a phase-out period. Annex 1 . Further information on the chemical Annex 1 contains information submitted by the notifying countries based on the national assessments which were used to support the reported final regulatory action. The results of international reviews such as those of WHO/IPCS/JMPR/IARC should also be included in this section where available and considered relevant. Subsequent evaluations or reviews of the chemical from Parties, other than those that submitted the notifications of final regulatory actions may be submitted to the secretariat for posting on the Rotterdam Convention website. Purpose: To provide an overall summary of information on the chemical for which the reported regulatory action(s) have been taken, including physico-chemical properties of the substance and/or product(s) and the results of toxicological and ecotoxicity studies. The decision guidance document is not intended to be a scientific treatise on a chemical. The emphasis should be on the concerns that formed the basis of the reported final regulatory action(s). For example, if the sole basis of the reported regulatory action(s) is unacceptable occupational exposure, this annex section should focus on human health effects rather than environmental aspects. The principal headings in this annex generally reflect those used by OECD countries and the European Union in their monographs. This approach will assist all countries, especially developing countries, which may have used an OECD/European Union monograph as the basis for the risk evaluation supporting their final regulatory action(s). The generic headings and general guidance on content should facilitate consistency in the format and content of decision guidance documents. The introduction to the annex should describe its content. This should include reference to any relevant international reviews ( e.g . those of OECD, IPCS/WHO or IARC) and how this information has been incorporated into the document. For example whether or not the results of an international assessment (toxicological or ecotoxicological) are substantively different from those of the notifying countries should be noted. In the case of mammalian toxicity a summary of the two evaluations highlighting the similarities or differences as appropriate may be included in section 2.2.7 of this annex (see below). The level of detail within the subheadings may be adjusted to accommodate the information used to support the notified regulatory action and available to the drafting group. (See appendix 2 to the present note for a list of the headings and subheadings and an indication of the points that may be included under each.) Specific sections on exposure/risk evaluation have been included for both human health and environmental fate and effects. These sections should include specific information from notifying countries on the basis for their final regulatory action. General comments Tabular summaries of information should be used wherever possible; this should not, however, be at the expense of a clearly stated analysis that explains how the data were used in the risk evaluation that formed the basis for the reported regulatory action. The level of detail will be a function of the information that is available and will need to be determined on a case by case basis. As a guiding principle, however, the focus should be on those end points that were the basis for the risk evaluation underlying the notified final regulatory action. For example, in those instances where a chemical was found to be a reproductive toxin and this was the basis for the regulatory action, greater detail would be expected on the supporting studies e.g . NOEL/NOAEL/LOEL, than on end points for which the results may have been negative ( i.e. , simply stating “was not carcinogenic”). In the case of universally recognized regulatory guidelines or limits such as the acceptable daily intake (ADI) or acute reference dose (ARfD), details on the supporting studies on which they are based should be included. LD 50 and LC 50 data can vary widely for a chemical. In order to avoid apparent discrepancies in the information reported, it may be better to report a range of values wherever possible, particularly where the results from more than one source are combined. In reporting toxicity data reference should be made to the duration of exposure for all studies reported, including acute toxicity studies, where it is available or known. In some cases, the notifying parties may reach different conclusions on individual end points related to human health or the environment. Furthermore, the situation may arise where there has been an evaluation of the chemical at the international level e.g . by the OECD, WHO/IPCS or IARC that has reached conclusions that differ from those of the findings of the notifying parties. In such cases the following approaches should be considered: It is intended that these differences be clearly indicated in the decision guidance document, where they concern “pivotal end points” within the risk evaluation, that is those end points upon which the final regulatory action was based. Where there are differences in interpretation of data concerning specific end points, but the differences do not affect the outcome of the final regulatory action or the conclusions of the international review, the degree to which these details will be reflected in the decision guidance document will need to be considered on a case-by-case basis. Section 2.2.7 Summary of mammalian toxicity and overall evaluation – this section provides an opportunity to summarize the conclusions of the toxicological evaluations from the notifying countries as well as any relevant international reviews e.g . WHO/IPCS/IARC. Where information from an international evaluation such as an IPCS Environmental Health Criteria document is included, the reference in the text should be to this document, rather than to the individual papers quoted therein. Where information from the risk evaluations by the notifying Parties is included, it is sufficient if this source is indicated, rather than the specific studies or reviews referred to. Specific comments - details of proposed subheading may be found in appendix 2 1. Physico-chemical properties This section characterizes the chemical, based on national evaluations and recognized information sources e.g . Pesticides Manual, A World Compendium (Crop Protection Publications - ISBN 0 948404 79 5) 2. Toxicological properties 2.1. General information This section should provide brief information on the mode of action, symptoms of poisonings and on absorption, distribution, excretion and metabolism in mammals. It can be retrieved from the notifications as well as from internationally recognized sources such as the Pesticide Manual or WHO/IPCS/JMPR/IARC evaluations. 2.2 Toxicity studies This section lays out the toxicological profile of the chemical as assessed by the notifying countries at the time of their final regulatory actions(s). It should also include a comparative summary of any IPCS/WHO international evaluations, such as those of WHO/IPCS/JMPR, where they are available and considered relevant. This summary should be included in section 2.2.7 Summary of mammalian toxicity and overall evaluation. In the interests of brevity, where multiple studies for the same end point exist, the drafting group should report in a summary form, rather than report on each individual study. The level of detail will need to be considered on a case-by-case basis. It is generally accepted that where a review document has been used as the source of the information, the review document is cited rather than the individual studies. Under the heading Summary of mammalian toxicity and overall evaluation (section 2.2.7), the drafting group should provide a concise summary of key end points, in order to facilitate comparisons among different evaluations and to improve understanding of those end points considered in the human exposure/risk evaluation section (see the preceding section on General comments). 3. Human exposure/risk evaluation This section highlights in greater detail those human exposure and risk factors that led to the regulatory control action(s), focusing on the major exposure routes ( i.e. food, air, water and occupation). Information concerning epidemiological studies or poisoning incidents that were considered by the notifying country in taking the reported regulatory action could be inserted under the subheading Medical data (section 3.5). Note: Where the reported regulatory actions are based on environmental effects, it is anticipated that this section of the decision guidance document would be minimal. 4. Environmental fate and effects This section provides information on the environmental fate characteristics ( Fate , section 4.1) of the chemical and the results of ecotoxicity studies ( Effects on non-target organisms , section 4.2). Note : Specific subheadings for the parameters of persistence and bio-concentration have been included to facilitate the identification of chemicals with the characteristics of persistent organic pollutants (POPs) . 5 . Environmental exposure/risk evaluation This section highlights in greater detail those environmental fate factors that led to the regulatory control action(s) and should include a summary of the overall risk evaluation. Note: Where the reported regulatory actions are based on human health concerns ( e.g ., risks to workers), it is anticipated that this section of the decision guidance document would be minimal. Annex 2. Details on final regulatory actions reported Annex 2 reports expand upon the information presented regarding the final regulatory action(s) of each notifying country. This annex should reflect the information provided in the notification of regulatory action form and presented to the Chemical Review Committee for review. The annex represents an opportunity for notifying countries to provide increased detail on aspects of the regulatory decision that they may wish to include. Annex 3. Addresses of designated national authorities This annex should provide detailed information on how to contact the designated national authorities of the notifying countries, including the name of a contact person; mailing address; telephone, fax and telex numbers; and email address. Annex 4. References This annex includes a list of the sources of information cited in the decision guidance document. Where information from a review document has been used, the reference should be to the review document, rather than to the individual papers within the review. Original papers should only be cited where they have been considered individually, rather than as a component of the review. List References under headings as appropriate. The following is an example for a reference list: Regulatory actions Decision by the Norwegian Agricultural Inspection Service (NAIS) 22.10.2002 (200200430 IP/hmo). Supporting documentation provided by Country X Environmental Health Criteria No. 165: Inorganic Lead. IPCS/WHO 1995 ( an example of a review document) Supporting documentation provided by Country Y Sebastien P, Begin R, &amp; Masse S (1990) Mass number and size of lung fibres in the pathogenesis of asbestosis in sheep. Int J Exp Pathol, 71: 1-10. (individual paper cited if the original paper was used in the preparation of the DGD) Others WHO (2003): Health Risk of Persistent Organic Pollutants from Long-Range Transboundary Air Pollution. Relevant guidelines and reference documents FAO/WHO Food Standards (2010). CODEX Alimentarius. FAO (2006) Framework of FAO Guidelines on Pesticide Management in support of the Code of Conduct. http://www.fao.org/ag/AGP/AGPP/Pesticid/Code/Guidelines/Framework.htm Appendix I: Standard Core Set of Abbreviations STANDARD CORE SET OF ABBREVIATIONS &lt; less than &lt; less than or equal to &gt; greater than &gt; greater than or equal to µg microgram m micrometre ARfD acute reference dose a.i. active ingredient ADI acceptable daily intake AOEL acceptable operator exposure level b.p. boiling point bw body weight o C degree Celsius (centigrade) CAS Chemical Abstracts Service cc cubic centimetre cm centimetre DNA deoxyribonucleic acid DT 50 dissipation time 50% EC European Community EC 50 median effective concentration ED 50 median effective dose EEC European Economic Community EHC Environmental Health Criteria EU European Union FAO Food and Agriculture Organization of the United Nations g gram h hour ha hectare i.m. intramuscular i.p. intraperitoneal IARC International Agency for Research on Cancer IC 50 median inhibitory concentration ILO International Labour Organisation IPCS International Programme on Chemical Safety IPM Integrated Pest Management IUPAC International Union of Pure and Applied Chemistry 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 1000) kg kilogram Koc soil organic partition coefficient Kow octanol–water partition coefficient kPa kilopascal L litre LC 50 median lethal concentration LD 50 median lethal dose LOAEL lowest-observed-adverse-effect level LOEL lowest-observed-effect level m metre m.p. melting point mg milligram ml millilitre mPa millipascal MRL maximum residue limit MTD maximum tolerated dose ng nanogram NOAEC no-observed-adverse-effect concentration NOAEL no-observed-adverse-effect level NOEC no-observed-effect concentration NOEL no-observed-effect level OECD Organisation for Economic Co-operation and Development PEC predicted environmental concentration Pow octanol-water partition coefficient, also referred to as Kow PPE personal protective equipment ppm parts per million (used only with reference to the concentration of a pesticide in an experimental diet. In all other contexts the terms mg/kg or mg/L are used). RfD reference dose (for chronic oral exposure; comparable to ADI) SMR standard(ized) mortality ratio STEL short-term exposure limit TER toxicity exposure ratio TLV threshold limit value TWA time-weighted average UNEP United Nations Environment Programme USEPA United States Environmental Protection Agency UV ultraviolet VOC volatile organic compound w/w weight for weight WHO World Health Organization wt weight Appendix 2: Headings for Annex I and a list of information points that could be included under each Physico-chemical properties Toxicological properties General Mode of action Symptoms of poisoning Absorption, distribution, excretion and metabolism in mammals Rate and extent of absorption Distribution Potential for accumulation Rate and extent of excretion Metabolism in animals Toxicologically significant compounds (animals, plants and environment) 2.2. Toxicology studies 2.2.1. Acute toxicity Rat LD 50 oral Rat LD 50 dermal Rat LC 50 inhalation Skin irritation Eye irritation Skin sensitization (test method used and result) 2.2.2. Short term toxicity Target /critical effect Oral Dermal Inhalation 2.2.3. Genotoxicity (including mutagenicity) 2.2.4. Long term toxicity and carcinogenicity Target /critical effect Relevant NOAEL/NOEL Carcinogenicity 2.2.5. Effects on reproduction Reproduction target/critical effect Lowest relevant reproductive NOAEL/NOEL Developmental target/critical effect Lowest relevant developmental NOAEL / NOEL 2.2.6. Neurotoxicity/delayed neurotoxicity Acute neurotoxicity Subchronic neurotoxicity Special studies (where available) could include human immunotoxicity studies 2.2.7. Summary of mammalian toxicity and overall evaluation include summary of key findings of relevant international reviews e.g . WHO/IPCS/IARC evaluations Human exposure/risk evaluation 3.1. Food 3.2. Air 3.3. Water 3.4. Occupational 3.5. Medical data contributing to regulatory decision – could include: Report on medical surveillance on manufacturing plant personnel Report on clinical cases and poisoning incidents Observations on exposure of the general population and epidemiological studies Environmental fate and effects 4.1. Fate 4.1.1. Soil Field dissipation Aerobic and anaerobic degradation Rate of degradation Adsorption/desorption Mobility 4.1.2. Water Route and rate of degradation 4.1.3. Air Fate and behaviour 4.1.4. Bioconcentration and bioaccumulation 4.1.5. Persistence 4.2. Effects on non-target organisms 4.2.1. Terrestrial vertebrates Acute/chronic toxicity mammals Acute/chronic toxicity birds Dietary toxicity birds Reproductive toxicity birds Other 4.2.2. Aquatic species Fish Invertebrates Algal species Aquatic plants Other 4.2.3. Honey bees and other arthropods 4.2.4. Earthworms 4.2.5. Soil microorganisms 4.2.6. Terrestrial plants 5. Environmental exposure/risk evaluation Specific reference as appropriate to the following 5.1. Terrestrial vertebrates Mammals/birds 5.2. Aquatic species Fish/invertebrates/algal species/aquatic plants 5.3. Honey bees Other arthropods 5.4. Earthworms 5.5. Soil microorganisms 5.6. Summary – overall risk evaluation. ROTTERDAM CONVENTION Secretariat of the Rotterdam Convention Secretariat of the Rotterdam Convention United Nations Environment Programme Food and Agriculture Organization of the United Nations International Environment House 1 Viale delle Terme di Caracalla, 00153 Rome, Italy 11–13, Chemin des Anémones, CH 1219 Châtelaine, Geneva, Switzerland Tel: +39 06 5705 2061 ¦ Fax: +39 06 5705 3224 ¦ E-mail: [email protected] Tel: +41 (0) 22 917 8271 ¦ Fax: +41 (0) 22 917 8098 ¦ E-mail: [email protected] Rome, 10 February 2022 Subject: Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for Certain Hazardous Chemicals and Pesticides in International Trade - internal proposal for terbufos Dear Chemical Review Committee members and observers, The Chemical Review Committee at its seventeenth meeting (from 20 to 24 September 2021, online) agreed to the establishment and composition of an intersessional drafting group with the mandate of drafting a decision guidance document (DGD) for terbufos. The Committee also approved a workplan with the tentative schedule for developing the draft DGD. The meeting report is available on the Convention’s website: www.pic.int/crc17. The internal proposal for terbufos, developed by the intersessional drafting group with CRC members Mr. Jonah Ormond as the chair and Mr. Martin Lacroix as the drafter, is now available for your review. In providing your comments on the internal proposal, you are kindly requested to be concise and indicate clearly the particular page and section to which you refer. The working paper on preparing internal proposals and decision guidance documents for banned and severely restricted chemicals provides guidance and is seen as a dynamic document that evolves in the light of experience gained in the process. According to the work plan, you are kindly requested to provide your comments on the internal proposal for terbufos no later than 10 March 2022, by email, to the Secretariat (Yun Zhou at [email protected] and Aleksandar Mihajlovski at [email protected]). All comments will be considered by the intersessional drafting group in preparing the draft DGD, which will be circulated as a meeting document for consideration by the Chemical Review Committee at its 18th session scheduled for October 2022. A summary of all comments received on the internal proposal will be made available to the Committee. To: Chemical Review Committee members and observers SECRETARIAT FOR THE ROTTERDAM CONVENTION 2 If you have any questions regarding this process, please do not hesitate to contact the Secretariat. Yours sincerely, Rémi Nono Womdim Executive Secretary of the Rotterdam Convention Enclosures  Internal proposal for terbufos  Working paper on preparing internal proposals and decision guidance documents for banned and severely restricted chemicals  Workplan for the preparation of draft decision guidance documents Saatja: Kei Ohno Woodall <[email protected]> Saadetud: 10.02.2022 01:07 Adressaat: Kei Ohno Woodall <[email protected]> Teema: Rotterdam Convention - Invitation for comments on terbufos draft DGD internal proposal by 10 March 2022 Dear Sir/Madam, Please find attached a letter inviting comments on the internal proposal of draft decision guidance document for terbufos. The seventeenth meeting of the Chemical Review Committee was held from 20 to 24 September 2021, online. The meeting report is available on the Conventions website: . At the meeting, the Committee adopted decision CRC-17/2, by which it adopted the rationale for the Committees conclusion that the notifications of final regulatory action submitted by Canada and Mozambique in respect of terbufos in the pesticide category met the criteria of Annex II to the Convention and recommended that the Conference of the Parties list terbufos in Annex III to the Convention as a pesticide. In accordance with the workplan adopted at the meeting, the intersessional drafting group has prepared an internal proposal of the draft decision guidance document on terbufos. Parties and observers are invited to review the attached draft and submit comments by e-mail to and no later than 10 March 2022. For your reference, the working paper on preparing internal proposals and decision guidance documents for banned and severely restricted chemicals and the workplan for the preparation of draft decision guidance documents are also attached. If you have any questions regarding this invitation, please contact the Secretariat. Best regards, Kei --- Kei Ohno Woodall Secretariat of the Basel, Rotterdam and Stockholm Conventions United Nations Environment Programme Office address: 11-13, chemin des Anémones, 1219 Châtelaine, Genève, Switzerland Postal address: c/o Avenue de la Paix 8-14, 1211 Genève 10, Switzerland Tel.: &#43;41 22 917 8201 Email: