Declarations, Discrete Organic Chemicals and Toxins: Paper 12

Introduction

It is well known that entry into force of the Chemical Weapons Conventiontriggers the requirement for each State Party to provide a series of declarationswithin 30 days of EIF. These declarations include the extraordinarily complexmeasures that encompass the industrial use of chemicals that appear on theschedules 1, 2 and 3 of the Convention. The national declarations are duewithin a very tight timeframe and depend upon the National Authorities havingthe legal power to obtain from each user the information required to constructthe national declarations. Each National Authority must be able to:

- determine whether any scheduled chemicals are used in its industry;

- determine whether the amounts involved exceed the specified thresholds;and

- develop the basis for declaration of aggregate quantities.

It is well known that formal entry into force takes place 180 days afterthe deposit of the 65th instrument of ratification. This is likely to bein place by the fall of this year, e.g. if we assure that 65 ratificationshave been received by the first of September then EIF will occur at theend of February 1996 with declarations being due around the 28th March ofthat year.



Declarations

Apart from problems with toxins, the chemical industry will mainly be concernedwith those chemicals that appear on Schedules 2 and 3. Table 1 providesinformation on annual declaration and verification thresholds while Table2 shows declaration requirements (initial, annual and planned) with thespecified deadlines for receipt by the Organization for the Prohibitionof Chemical Weapons. This means that whatever the ratification process employednationally from the CWC, the implementation process must provide the legalcapacity to collect industrial data of concern to the CWC by the end of1995 for initial States Parties so that the data can be verified at thenational level and transformed into the form necessary for the declarationhandbook of the OPCW.

Table 1. *

ANNUAL DECLARATION AND VERIFICATION THRESHOLDS

                           DECLARATION                VERIFICATION                     Schedule 2A*         1 kilogram                 10 kilograms                      Schedule 2A         1 kilogram                 1 tonne                           Schedule 2B         1 tonne                    10 tonnes                         Schedule 3          30 tonnes                  230 tonnes                     unscheduled DOCs       200 tonnes                 200 tonnes                   DOCs that contain PSF    30 tonnes                  200 tonnes                

Schedule 2 declarations are for production, processing, consumption,importation and exportation.

Schedule 3 declarations are for production, importation and exportation.

DOCs and PSF-DOCs are for production only.

* from R.G. Sutherland and J.P. Tracey, The Chemical Weapons Convention.How will it affect Canadian Industry?, Canadian Chemical News Vol. 47 No.5, 17-20, May 1995.

Table 2 **

DECLARATION REQUIREMENTS AND DEADLINES

FOR NATIONAL DATA TO THE OPCW***

                     SCHEDULE 2 CHEMICALS   SCHEDULE 3 CHEMICALS    DOCs and PSF-DOCs     Initial             Aggregate National      Aggregate National        Declarations for    Declaration         Data  EIF + 30 days     Data  EIF + 30 days     plant sites  EIF +                        Declarations for        Declarations for        30 days                                   plant sites  EIF + 30   plant sites  EIF + 30                                             days                    days                                          Annual              Aggregate National      Aggregate National        Annual update       Declarations        Data  Year End + 90     Data  Year End + 90     Year End + 90 days    (Past activities)   days Declarations for   days Declarations for                                             plant sites  Year End   plant sites  Year End                                             + 90 days               + 90 days                                     Annual              Declarations for        Declarations for                              Declarations        plant sites  Begin of   plant sites  Begin of                         (anticipatory       year less 60   days     year less 60   days                           activities)                                                                               Additional          Change after annual     Change After Annual                           Planned Activities  Anticipatory            Anticipatory                                                      Declarations   Change   Declarations  Change                                              less 5 days             less 5 days                                   Declarations on     Declarations for        Declarations for                              Past Production     plant sites  EIF + 30   plant sites  EIF + 30                         of Scheduled        days                    days                                          Chemical for CW                                                                           purposes                                                                                 

*** As this table refers to the timetable when the National Authoritymust report National data to the OPCW, industry must provide declarationinformation much sooner than the dates indicated above.

** from R.G. Sutherland and J.P. Tracey, The Chemical Weapons Convention.How will it affect Canadian Industry?, Canadian Chemical News Vol. 47 No.5, 17-20, May 1995.

It should be noted that this handbook may not be of direct utility to industryand that a National Authority will likely have to develop its own approachto data collection from industry.

There are various levels of complexity concerning these declarations. Schedule2 involves production, processing, consumption, import and export of therelevant substances. Schedule 3 involves production, import and export whiledata on production is all that is required for discrete organic chemicals.

The declarations will include "aggregate national data"for each schedule 2 and 3 chemical and declaration of plant sites wherechemicals of interest to the Convention are employed. There is a debateas to what "aggregate" means; there will be many siteswhere scheduled chemicals are produced below reporting thresholds for plantsites and these plants do not require to be declared but will the NationalAuthority require information on all production to develop a national declarationor will aggregate data only include declared plants? If the latter, thenmuch production of scheduled chemicals would not be accounted for.



Discrete Organic Chemicals (DOCs)

Over many years, the negotiators of the CWC struggled with the problemsof ensuring that the verification regime would cover all relevant facilitieswhile not interfering unduly with legitimate chemical production activities.The major problem being the fact that there are many chemical productionsites that could, in principal, be used produce scheduled chemicals butnever had done so nor were likely to. At the same time, the possible riskthat such plants could pose to the Convention had to be recognized. Thesolution to that problem was the development of Part IX of the VerificationAnnex, "Regime for Other Chemical Production Facilities",and the development of two categories of "unscheduled discrete organicchemicals".

For the purposes of the Convention, a DOC is defined as "all compoundsof carbon except for its oxides, sulfides, and metal carbonates, identifiableby chemical name, by structural formula, if known, and by Chemical AbstractsService registry number if assigned". A subclass is underlinedin Part IX of the Verification Annex by reference to plants which produceby synthesis discrete organic chemicals containing the elements phosphorus,sulfur or fluorine (PSF-plants). The only exceptions from declarations being"plant sites that exclusively produce explosives or hydrocarbons".

The above is an extremely broad category which only excludes inorganic carboncompounds, hydrocarbons and explosives but one must note that the latterplant sites would only be exempt if the facility produced hydrocarbons orexplosives "exclusively".

DOCs are subject to limited reporting in that only production at chemicalproduction facilities above a given threshold established on the basis ofpast production. There is a definitional problem; the CWC generally definesproduction as "its formation through chemical reaction"while Part IX of the Verification Annex discusses the production of DOCs"by synthesis". The former is wider than the latter butone should recall the initial definition of a toxic chemical in ArticleII of the Convention which states "... regardless of whether theyare produced in facilities, in munitions or elsewhere". The schedulescontains lists of toxic chemicals identified for implementation purposesand these schedules must not be regarded as limitations on the CWC; onceagain it would appear that there is a misunderstanding by some of the "GeneralPurpose Criterion". As many industrial processes are moving fromthe purely chemical to biochemical and/or biological production it wouldbe a serious mistake to attempt to exclude them from the reporting treewhere such processes could produce chemicals that either are currently consideredas presenting a risk to the Convention or may have to be added to the schedulesat a later date.



Toxins

Two toxins, ricin and saxitoxin, currently appear on Schedule 1 of the ChemicalWeapons Convention and are likely presently the only substances on thatschedule to have some industrial (pharmaceutical and medical) use besidesthe nitrogen mustards. The difference is in the fact that these toxins arecurrently isolated from natural sources rather than being available by synthesisfrom simpler precursors. It should be noted that rapid developments in biologicallymediated processes may allow toxin synthesis in the future. The propertiesand uses of these toxins appear in Tables 3 and 4.

If we use the general purpose criteria, there is no doubt that toxins arecovered by the CWC and the definition of a toxic chemical utilized in theConvention "any chemical which through its chemical action on lifeprocesses can cause death, temporary incapacitation or permanent harm ...regardless of their origin or of their method of production ...".In this sense the presence of ricin and saxitoxin on the schedules is merelya marker and any toxin previously used or considered for military use couldbe added to schedule 1.



Table 3

Saxitoxin, C10H17N7O4

CAS No. 35523-8908

NIOSH:RTECS No. UY8708500

Merck 8344

Synonyms: 2,6-diamino-4-((aminocarbonyl) oxy)methyl-3a,4,8,9-tetrahydro-1H,10H-pyrrolo(1,2-c)purine-10,10-diol (3aS-(3a-a-a-4-a,10aR*)).

Physical Properties: MW: 299, [a]p + 130o, it is a white amorphoussolid (the hydrochloride salt is crystalline) and is a hydrate. Informationon physical properties is found in J. Bordner et. al, J.A.CS., 1975, 97,6008.

Synthesis: It is a natural neurotoxin sometimes found in Alaska butterclams, toxic mussels, and plankton. Its chemical synthesis has been reportedby H. Tanino et al., J.A.C.S., 1977, 99, 2818.

Toxicity: It is one of the most potent neurotoxins known; its LD50ipr is 5 ug/kg (mouse). Data is also available on Saxitoxin hydrochloride(C10H17N7O4 . 2HCl, MW372, CAS No. 35554-08-6, NIOSH/RTECS UY8708600. Bothare deadly poisons by ingestion, intravenous and intraperitoneal routes.

Uses: It is used as a neuromuscular blocking agent, and in nervefibre research.

Suppliers: Two suppliers are listed in the USA.



Table 4

Ricin

CAS No. 9009-86-3

NIOSH/RTECS No. VJ 26250000

Merck 8211

Synonyms: Ricin A,. Ricin B, RCA (Ricin Communis Agglutin) RCA60, RCA120,Ricin D, RCL 111, RCA11.

Physical Properties: It is a white powder obtained from castor beans.It is normally preformulated due to its great toxicity; RCA60 and RCA120refer to molecular weights of 60000 and 120000 respectively.

Synthesis: Castor oil seeds are pressed to remove the commerciallyvaluable castor oil. The oil cake residue is mainly protein and it is thesource of the poisonous albumin called ricin which is a polymeric protein.The ricin is destroyed by steam treatment of the oil seed cake that is thenused for animal feeds or fertilizer.

Toxicity: Amongst the most poisonous substances known. The lowestpublished lethal concentration (LDLo) is 300 ug/kg. It is a deadly poisonby ingestion or inhalation. The effect of inhalation/ingestion is violentpurging which leads to collapse and death; it causes destruction of redblood cells; as few as 5 castor beans have resulted in the death of children.

Uses: It is used in biochemical research and in medicine. Ricin conjugatedwith mono- or polyclonal antibodies is being investigated as a possiblecancer treatment.

Suppliers: Two suppliers are listed for the USA. However 22 suppliersof castor oil are listed in 12 countries. These are: Canada (1), PRC (1),Mexico (1), India (3), Japan (5), Australia (2), Belgium (2), France (1),UK (1), Italy (1), Portugal (2) and Spain (2).

The CWC regulations would place inspection requirements on all facilitiesthat produce these toxins in addition to the reporting requirements forproduction above 100 grams and the possibility of on-site monitoring. Theproduction limitation is 10 kilograms per facility. There are also traderestrictions to transfers between States Parties.

At the moment there are still many ambiguities as to how toxins will behandled both nationally and internationally under the CWC. Nationally decisionsmust be taken as to reporting cut-offs. Clearly a measure of aggregate productionwould require a knowledge of all production centres not only those thatproduce more than 100 grams; it is likely that all toxin production is alreadymonitored under existing national legislation.



Ricin

Ricin is a by-product of the processing of castor oil and, in principle,the latter could be considered as a schedule 2 product,; castor oil plantswould then be liable to those associated monitoring regimes since a schedule1 chemical, ricin, could be isolated and/or diverted to uses not permittedunder the Convention. Castor oil is extracted from the seed by pressingand any producer could isolate large quantities of ricin if they chose.

Ricin is widely used in medical and pharmaceutical research; it appearsto have potential in AIDS therapy and in certain tumor therapies. Thereis also interest in modified ricins by biotechnology companies. There area large number of producers worldwide and there will be some who exceedthe proposed thresholds.



Saxitoxin

Saxitoxin is used in nervous system experiments and has been used in mixturesto improve the function of several anesthetics. There are several commercialproducers but, in most cases, the level of production is well under thethreshold, ie. ca. 1 gram. If biotechnological routes become available then,it could be produced commercially in much larger quantities.

In general terms there is the likelihood that with the move of producingchemicals from purely chemical synthesis to routes that incorporate biochemicaland/or biological methodologies of biotechnology that the capacity of industryto fabricate toxins by "unnatural" routes will increase markedly.The use of toxins will be exhaustively monitored nationally and the CWCshould ensure that the toxins are adequately reported for arms control purposes.



Conclusion

With the placement of the toxins Ricin and Saxitoxin on Schedule 1 of theCWC and, recalling the general purpose criterion, guidance is given on howtoxins either previously considered for military use or being consideredin the future for use, should be covered under the Convention. There arespecific requirements to declare national aggregate data for chemicals inSchedules 1, 2 and 3 and for the production of DOCs for the previous calendaryear. There are still uncertainties about the definition of "aggregatenational data" and so its scope for an individual chemical. Isthe basis for aggregate date based only on facilities producing chemical(s)above the threshold or does the production for all facilities count? Thetwo toxins in schedule 1 constitute a useful example; these toxins are likelyonly produced in facilities that (a) produce less than 100 grams or (b)more than 100 grams but less than 10 kg per year. If a State Party has suchfacilities which will mostly be research and development laboratories formedical, pharmaceutical or research purposes, then there is a requirementto declare national aggregate quantities. This might imply on the nationallevel the knowledge of all facilities, not only those over the 100 gramthreshold, because of the 10 kg threshold for reporting national aggregatequantities.

It would also appear that there is a need for the State Party under theprovisions of Article VII to establish a national system that will allowthe National Authority to fulfil its declaration obligations for aggregatequantities, in this example for the two toxins produced outside of the SingleSmall Scale Facility in Schedule 1.

Until the definition and scope of "aggregate national data"is resolved, a State Party, in the preparation of regulations for its nationalimplementation legislation on reporting of production data, should considerthe introduction of reporting thresholds below those required by the CWC.This would allow National Authorities to provide more accurate "nationalaggregate data" to the OPCW. The current experience of many countriesin the development of surveys of chemicals, facilities including laboratoriesshow the need for lower national threshold quantities and the recent terroristactivities in Tokyo underline the need to be able to track any small quantitiesof what were once called "super-toxic lethal chemicals".A national reporting threshold of less than 100 grams for Schedule 1 laboratoriesin the areas of research and development in the use of such chemicals forresearch, medicine and pharmaceutical purposes would allow a National Authoritya comprehensive overview in an arena which poses the greatest risk to thepurposes of the Convention.



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