WO1999030265A1 - Systems, methods and computer program products for determining compliance of chemical products to government regulations - Google Patents
Systems, methods and computer program products for determining compliance of chemical products to government regulations Download PDFInfo
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- WO1999030265A1 WO1999030265A1 PCT/US1998/026286 US9826286W WO9930265A1 WO 1999030265 A1 WO1999030265 A1 WO 1999030265A1 US 9826286 W US9826286 W US 9826286W WO 9930265 A1 WO9930265 A1 WO 9930265A1
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G06Q99/00—Subject matter not provided for in other groups of this subclass
Definitions
- This invention relates to computer integrated manufacturing systems, methods and computer program products, and more particularly to systems, methods and computer program products for chemical product manufacturing.
- SAP Release 2 a well known enterprise resource planning computer product
- SAP AG SAP, Release 2
- SAP, Release 2 can provide automated product sales order entry and can also track manufacturing bills of materials that are used in a chemical plant to manufacture chemical products.
- Such enterprise resource planning products allow a manufacturer to track orders, inventory and manufacturing operations for a complex chemical plant.
- TSCA Toxic Substances Control Act
- the present invention includes systems, methods and computer program products for determining compliance of a chemical product to be manufactured to government regulations that govern the manufactured product.
- the chemical compositions that are present in the chemical product to be manufactured are ascertained.
- the chemical compositions so ascertained are compared to a stored set of government regulatory standards related to the chemical compositions to determine compliance. Accordingly, compliance with complex government regulations governing chemical products can be determined.
- the chemical compositions that are present in the chemical product to be manufactured may be ascertained by obtaining a bill of materials comprising the chemical components of the chemical product to be manufactured.
- the bill of materials may be compared to a "recipe" that is used in a chemical process to manufacture the chemical product.
- the bill of materials is used to derive the chemical compositions that are present in the manufactured chemical product.
- the chemical compositions that are present in the chemical product to be manufactured may be ascertained in foreground processing in response to receipt of a customer order for a chemical product.
- ascertaining the chemical compositions that are present in the chemical product may be performed in background processing, wherein the chemical compositions that are present in a plurality of chemical products that can be manufactured in a chemical plant are ascertained.
- the chemical composition that was ascertained for the selected chemical product is retrieved.
- the chemical compositions that are present in the chemical product to be manufactured may be ascertained by identifying a manufacturing bill of materials that is associated with the chemical product and then creating a regulatory bill of materials from the manufacturing bill of materials. More specifically, a manufacturing bill of materials that includes the chemical components of the chemical product to be manufactured is obtained. For each component, a component class to which the component belongs is then assigned. Component classes may be used to allow the compliance determining system to deduce the components of the final chemical product from knowledge of how the components .are used in the manufacturing process. Accordingly, the component classes include the class of bases, additives, reactants and monomers and others. Based on the assigned component classes, the chemical compositions are determined. This determination will generally vary based on whether the chemical composition results from a reaction, a mixture or a polymerization.
- the chemical product may include impurities that are not part of the chemical product, but are nonetheless important for regulatory purposes.
- impurities may be accounted for in the chemical composition that is ascertained. More specifically, known impurities may be added to the chemical composition of the chemical product. Alternatively, impurities may be added to the bill of materials to represent impurities that are present in the chemical product in addition to the chemical compositions of the manufactured chemical product. Then, the chemical compositions present in the manufactured chemical product that is derived, including the chemical compositions of the impurities.
- the chemical compositions so ascertained are compared to a stored set of government regulatory standards relating to the chemical compositions to determine compliance. Comparison may be performed by comparing the chemical compositions so ascertained to a stored set of government regulatory standards governing the manufacturing location for the manufactured chemical product. The chemical compositions so ascertained are also compared to a stored set of government regulatory standards governing the destination location for the manufactured chemical product.
- the chemical product to manufactured may be flagged as complying with all regulations or as noncomplying. If noncomplying, the particular regulations to which the chemical composition does not comply may be flagged. According to another aspect of the invention, modifications may be proposed to noncomplying chemical products, so that the chemical product to be manufactured becomes complying. For example, an expert system may be used that can suggest substitutions for components in mixtures that are not on the inventory of existing substances for the shipped-to country.
- the systems, methods and computer program products for ascertaining which chemical compositions are present in a chemical product to be manufactured may be used independent of the systems, methods and computer program products for determining compliance of the chemical product to be manufactured to government regulations that govern the manufactured product.
- the ascertaining of chemical compositions may be used to determine the total output of a chemical product from a chemical plant.
- comparing chemical compositions to a stored set of government regulatory standards relating to the chemical compositions to determine compliance may take place for a known chemical composition, the composition of which is not ascertained from a manufacturing bill of materials.
- the ascertaining and comparing aspects of the present invention may be used independently. However, preferably, the ascertaining and comparing aspects of the present invention .are used together to provide improved methods, systems .and computer program products for determining compliance of a chemical product to manufactured to government regulations that govern the manufactured chemical product.
- Figure 1 is a block diagram of systems, methods and computer program products for determining compliance of the chemical product to be manufactured to government regulations that govern the manufactured product, according to the invention.
- Figure 2 illustrates chemical composition deriving of Figure 1.
- Figures 3A and 3B which together form Figure 3 as indicated, indicate calculating a polymer regulatory bill of material of Figure 2.
- Figure 4 illustrates calculating a mixture regulatory bill of material of Figure 2.
- Figures 5A and 5B which together form Figure 5 as indicated, illustrate regulatory databases of Figure 1.
- Figures 6A, 6B and 6C which together form Figure 6 as indicated, illustrate regulatory compliance verifying of Figure 1.
- Figures 7A and 7B which together form Figure 7 as indicated, illustrate restriction checks of Figure 6.
- Figures 1-7 each element of the illustrations, and combinations of elements in the illustrations, can be implemented by general and/or special purpose hardware-based systems that perform the specified functions or steps, or by combinations of general and/or special purpose hardware and computer instructions.
- These program instructions may be provided to a processor to produce a machine, such that the instructions that execute on the processor create means for implementing the functions specified in the illustrations.
- the computer program instructions may be executed by a processor to cause a series of operational steps to be performed by the processor to produce a computer implemented process such that the instructions which execute on the processor provide steps for implementing the functions specified in the illustrations.
- Figures 1-7 support combinations of means for performing the specified functions, combinations of steps for performing the specified functions and program instruction means for performing the specified functions. Overview
- systems, methods and computer program products 100 according to the present invention are preferably implemented as a stored program that executes on a data processing system.
- a legacy data processing system such as an IBM Model S/390 may be used.
- midrange or personal system and a network of legacy, midrange and personal systems may be used.
- enterprise resource planning 110 may be a legacy system that is used for automated product sales order entry and for maintenance of manufacturing bills of materials that are used in chemical product manufacturing. As will be described below, manufacturing bills of materials may be modified to include component classes.
- An example of an enterprise resource planning system that may be used for component 110 is the aforementioned SAP system.
- Composition ascertaining 120 ascertains which chemical compositions are present in the chemical product to be manufactured. As will be described below, the chemical compositions may be ascertained in foreground or background processing.
- Compliance comparing 130 compares the chemical compositions so ascertained to a stored set of government regulatory standards relating to the chemical compositions to determine compliance.
- enterprise resource planning 110 includes automated product sales order entry 111 that is responsive to a customer order for a product 112.
- Automated product sales order entry 111 interacts with manufacturing maintenance 113 to provide computer integrated manufacturing, using techniques well known to those having skill in the art.
- Manufacturing maintenance 113 is responsive to a material master file 114 to create a manufacturing bill of materials (BOM) 115.
- BOM manufacturing bill of materials
- the manufacturing bill of materials is a list of materials that is used in the chemical manufacturing process to manufacture a product.
- manufacturing bills of materials according to the present invention include a component class 116 associated with each material component in the manufacturing bill of materials.
- the component class is used by the composition ascertaining 120 in order to ascertain which chemical compositions are present in the chemical product to be manufactured.
- composition ascertaining 120 uses the manufacturing bills of materials 115, including the component classes 116 to derive material chemical compositions, also known as regulatory bills of materials 122 that define the chemical compositions that are present in the chemical product to be manufactured. As will be described in detail below, chemical composition deriving 121 uses the component closes 116 to determine the chemical compositions 122.
- Composition ascertaining 120 also includes manual adjusting 123.
- manual adjusting may be used to account for impurities that may be part of the chemical composition, even though they are not officially part of the manufacturing bill of materials 115. If it is known that impurities are contained in the chemical composition, manual adjusting 123 may be used to add impurities to the chemical composition 122 to account for impurities that are present in the manufactured chemical product. Alternatively, as shown in Figure 1 , manual adjusting may be used to adjust the manufacturing maintenance 113, so that the manufacturing bill of materials 115 also includes the impurities that will be included in the chemical compositions 122.
- the chemical compositions (regulatory bills of materials) 122 are provided to compliance comparing 130.
- Compliance comparing 130 includes regulatory databases 131 that can include a list of regulations that apply to chemical products.
- the regulatory databases may be maintained 132 by adding new regulations or updating existing regulations.
- the regulatory databases 131, chemical compositions 122 and customer orders 112 are input to compliance verifying 133.
- Compliance verifying 133 compares the chemical compositions 122 to the stored set of government regulatory standards in the regulatory databases 131 for a customer order 112, in order to determine whether the chemical product to be manufactured complies with government regulations that govern the manufactured product.
- Regulatory compliance verifying 133 can produce a verified order 134 that indicates that the chemical compositions do comply with the applicable government regulations, or may produce an exceptions list 135 that indicate particular chemical compositions and/or regulations that are violated. As another alternative, modifications 136 may be suggested to render the chemical composition complying.
- enterprise resource planning 110, composition ascertaining 120 and compliance comparing 130 of compliance determining methods, systems and computer program products 100 will now be provided. In order to provide consistent terminology, definitions will first be provided.
- Material A Material is a substance or article used in or incidental to, the manufacture of other Materials or a Target Material in a chemical manufacturing process.
- Target Material A Target Material, also known as a chemical composition, is a material to be produced by a chemical manufacturing process according to a Manufacturing Bill of Material.
- a unique Target Material may be differentiated by packaging materials. For example, acetic acid may be a Material but bulk acetic acid, acetic acid in 55 gallon drums, and acetic acid in 1 quart sample jars, are three unique Target Materials.
- Manufacturing Bill of Material This is a list of materials used in a chemical manufacturing process to produce a Target Material.
- a Manufacturing Bill of Material may also be referred to as a "recipe" that is used in manufacturing. The Materials may chemically react to form a new chemical, or they may form a physical mixture. Alternatively, polymerization may take place.
- a Manufacturing Bill of Material may also contain materials that do not become part of the final target material, such as solvents and catalysts.
- a Manufacturing Bill of Material may also contain materials that are used to package the Target Material.
- Chemical Composition also referred to as a Chemical Composition: This is a list of chemicals present in a Material that are relevant for checking the Material's regulatory compliance. It will be understood that the Chemical Compositions or Regulatory Bills of Material are not true chemical analyses or chemical standards for the Material and generally are not used in assay analyses or other similar processes. Rather, the Regulatory Bill. of Material includes only those materials that are relevant for regulatory compliance verifying. Regulatory Bills of Materials are maintained for the Target Material family because the family represents the chemical makeup of the Target Material.
- Chemical Identifier This uniquely identifies a chemical substance (such as benzene, toluene or polyester), or a chemical identification of a physical mixture, such as 20% water, 80% methanol.
- Material Family also referred to as “Family”: This is a general inventory grouping of Materials used to isolate the chemical nature of the Materials in the group. Families ignore differences in Material identifications stemming from packaging, manufacturing location, etc. For example, “Family A” could represent “acetic acid”, grouping 3 materials: “bulk acetic acid”, “acetic acid in 55 gallon drums” and "acetic acid in one quart sample jars”.
- Each Family has an associated chemical identifier that indicates the primary chemical substance or mixture associated with it. This chemical identifier generally does not represent a Bill of Material.
- Component Class These are chemical classifications assigned to a Material component in a Manufacturing Bill of Material.
- the component class is used to filter components that are relevant for deriving a Regulatory Bill of Material from a Manufacturing Bill of Material.
- the following component classes may be used for derivation rules: BAS (Base); ADD (Additive); REA (Reactant); MON (Monomer); and IMP (Impurity).
- BAS Base
- ADD Additive
- REA Reactant
- MON Monitoring
- IMP Impurity
- the following Component Classes may be ignored in the derivation process, but may be used to help clarify the role a given component plays in a specific Bill of Materials: CAT (Catalyst); SOL (Solvent); PAC (Packaging); and IGN (Ignore-special component).
- Component Classes will be described in detail below in connection with enterprise resource planning 110.
- Enterprise resource planning 110 can include automated product sales order entry 111 that responds to customer orders for a product 112.
- Manufacturing maintenance component 113 is responsive to a material master file to generate Manufacturing Bills of Materials 115.
- Blocks 111, 112, 113, 114 and 115 are well known to those having skill in the art and need not be described in detail herein.
- manufacturing maintenance 113 is used to select a Manufacturing Bill of Materials 115 from material master file 114 to provide a recipe for manufacturing a chemical product.
- a Component Classification (also referred to as a "Component Class") is assigned to each component of a Manufacturing BOM.
- Component Classes to be assigned are: ADD-One of a set of additive components added to a base material in order to form a mixture.
- CAT-Catalyst component not considered a part of the final product. IGN-Material to be ignored. IMP-Impurity.
- MON-Monomer used to form a polymer PAC-Packaging material.
- REA-A chemical reactant REA-A chemical reactant.
- Component Classifications 116 are assigned to Manufacturing BOM 115 components so that the components of the Regulatory BOM 122 can be deduced from knowledge of how the components are used in the manufacturing process.
- Chemical manufacturing processes generally fall into one of four categories: Reaction-chemical components are reacted, sometimes in the presence of catalysts and processing aids, to create a new chemical, perhaps with byproducts. Examples: the manufacture of various acids, solvents, esters, etc.
- Mixture-Different chemical components are blended to create a mixture, usually with a base chemical with various additives.
- a base chemical usually with various additives.
- Polymerization-Monomers are formed into polymers, sometimes with the aid of catalysts and the addition of various additives.
- the different processes will have certain component classifications in their BOMs that will be used to derive the proper final product components.
- the general approach for each is as follows:
- IGN-material to be ignored, such as rework material that may occasionally be fed back into the process. Also, byproducts should be marked IGN.
- ADD materials on the BOM there may be one or more ADD materials on the BOM if the process is truly a mixture of a reactant material (which would be a base material) with additives. In SAP, this may be represented in a single BOM and a routing operation. Mixture-The following component classifications should be found: ADD-the additive components of the mixture. BAS-the base material of the mixture. IGN-material to be ignored, usually rework material that may be added to the process.
- MON-the monomers which .are being used to form the polymer.
- PAC-packaging if the packaging step is also included.
- the MON components will be used to access a table from which the corresponding polymer for the given monomers will be derived. Any ADD components will also go into the final product composition BOM, along with the polymer. No BAS, REA or TAR components should appear. If they do, they will be considered an error.
- Bulk Liquid Chemical N-butyl acetate is manufactured from n-butyl alcohol and acetic acid. All materials are reactants and the regulatory component is derived assuming the final product is a non-mixture, single chemical.
- composition of the product n-butyl acetate, will be derived from the components of the Bill of Materials for its manufacture. This component will be shown as 100% of the final product.
- PROPIONIC ACID BU
- Example 4 Chemical Mixture. Alcohol Blend
- SDA 1 is created by denaturing pure eth.anol with methanol and methyl isobutyl ketone (MIBK).
- MIBK methyl isobutyl ketone
- the system will derive a composition BOM for the Family that has components 01786-00, 00012-00, and 02039-00 in their corresponding proportions.
- This example illustrates the manufacture of a plastic mixture.
- Example 6 Polyester Increased in Molecular Weight in the Solid State Building up the molecular weight of a polyester polymer in the solid state is a special case because the final operation adds no components.
- the regulatory BOM is based on the composition of the precursor.
- the family of the polyester is referenced to the family of the precursor polymer, using the composition family field.
- polyester P15418FZ family 62500217) is treated to increase its molecular weight to become polyester P15419FZ (family 62500218).
- 62500218 is referenced to 62500217 so the composition determination doesn't have to be redone. Display Single-Level BOM
- Composition Family 62500217 is Composition Family 62500217
- the classifications of the components of the precursor are shown. Using the monomers, a table will be searched to determine the final PM composition of the monomer set.
- a production engineer utilizes manufacturing maintenance 113 to create Manufacturing Bills of Material 115 including Component Classifications 116.
- the production engineer will have cognizance of the end product and the type of classifications that are to be added.
- Component Classifications 116 for a Manufacturing Bill of Materials 115 may be added using manufacturing maintenance 113 in background processing in response to anticipated production of a new Manufacturing Bill of Materials.
- Classifications 116 may be added in foreground processing in response to a receipt of a customer order for a product 112 by automated product sales order entry 111.
- Composition Ascertaining 120 Composition ascertaining derives the Regulatory Bill of Materials 122.
- Chemical composition deriving 121 derives from the Bill of Materials the chemical compositions present in the manufactured chemical product, to thereby produce chemical compositions 122, also referred to as Regulatory Bills of Materials.
- Manual adjusting 123 may be used to adjust the Regulatory Bills of Materials for impurities.
- Block 121 of Figure 1 chemical composition deriving (Block 121 of Figure 1) will now be described in detail.
- Block 201 the Target Material Manufacturing Bill of Materials 115 is read and those components that are relevant for ascertaining the Material's chemical composition are selected.
- a temporary table, referred to as a Derivation Table, of the selected components is then built.
- a test is then made, at Block 202, as to whether all the derivation table components are reactants (Class REA). If YES, then at Block 203 the Target Material's chemical identifier is 100% of the regulatory BOM composition and the regulatory BOM is built for the Target Material at Block 208. No further calculations need to be done.
- the new basis weight for the Target Material is recalculated, based on the selected component's weight in the original Manufacturing Bill of Materials, at Block 204.
- a test is then made at Block 205 as to whether there is at least one monomer (Class MON) in the derivation table components. If YES, the polymer regulatory BOM is calculated at Block 206. Details of calculating the polymer regulatory BOM will be provided in connection with Figure 3.
- the regulatory BOM relates to a mixture. Accordingly, at Block 207, the regulatory BOM is calculated for the simple mixture of bases, additives and/or impurities. The calculation for the mixture regulatory BOM 122 for the Target Material is then built at Block 208.
- Figures 3 A and 3B together form Figure 3 as indicated.
- Block 301 for each component in the Derivation Table, the components classified as MONomers are retrieved.
- Block 302 a temporary Polymer Derivation Table is built, substituting the monomer codes for each monomer.
- Block 303 the chemical component ratios are calculated, summing any monomers which appear more than once in the
- each monomer chemical in the Polymer Derivation Table is then translated into its generic mono'mer code that is retrieved from the Monomer Code Table.
- the monomers in the Monomer Set Table are used to find the corresponding monomer set, i.e., the set that contains all of the monomers in the Polymer Derivation Table and no additional monomers.
- the corresponding polymer chemical identifier for all the corresponding monomer chemicals is substituted in the adjusted Polymer Derivation Table.
- Example 9 Calculating a Regulatory Bill of Material 122 when all of the Working Components Table components are Reactants (Block 203 ' ):
- the Target Material's chemical identifier is 100% of the Regulatory Bill of Material composition (Block 203).
- Target Material P2345678 is a member of Family 71000600, which is 100% of Chemical Id. 11000-00.
- the sum of the remaining Components is 1000 kg.
- Chemical Regulatory BOM Percentage (Derived Chemical Weight) / (Sum of all Derived Chemical Weights in the Chemical Derivation Table).
- the sum of the remaining Components is 900 kg.
- Chemical identifier will be the sum of the percentages for the replaced monomers (Block 310).
- manual adjusting 123 may be performed on the regulatory bills of material 122 that were calculated in Figures 2-4 in order to add impurities that are present in the chemical compositions 122.
- regulatory compliance verifying 133 compares the chemical compositions 122 to a stored set of government regulatory standards that are contained in regulatory databases 131 and maintained by regulatory database maintenance 132 in order to determine compliance. Prior to describing the details of compliance comparing 130, background on regulatory compliance and overall rules for compliance will be described.
- TSCA is a complex set of laws that defines all chemicals (which include polymers) as being either “existing” or “new”.
- Existing chemicals are those which are on a list called the TSCA inventory.
- Existing chemicals were placed on the inventory either by grandfathering when TSCA was enacted or by premanufacture notification since that time.
- Existing chemicals may be used (with some exceptions) for any commercial application.
- New chemicals on the other hand, generally must be reviewed by the Environmental Protection Agency (EPA) and approved prior to use for commercial applications. The review process is called PreManufacture Notification (PMN).
- PMN PreManufacture Notification
- a first aspect of regulatory compliance verifying 133 is to ensure that all of the chemicals (or all of the components in mixtures) used, manufactured or sold in the U.S. .are on the TSCA inventory. This can be accomplished by determining the composition of the products and checking them against a computerized list of chemicals on the TSCA inventory in the regulatory database 131.
- TSCA Research and Development exemption This states that a company need not make a premanufacture notification for any chemicals that are used solely for research and development purposes. However, there are restrictions on how these chemicals must be handled and managed. Briefly, research and development chemicals may be used, sampled and even evaluated as long as they .are not placed into commerce. Thus, orders for these chemicals, which are not on the TSCA inventory, must be checked to ensure that only certain customers can order them. The links between approved customers and the R&D products can be made in regulatory compliance verifying 133 .and orders entered by nonapproved customers may be blocked.
- TSCA TSCA-tetrachloric acid
- a manufacturer must notify the EPA each time it samples or sells any of certain listed chemicals into another country for the first time. Keeping up with dozens of such chemicals and over a hundred countries may be difficult. Making this requirement more difficult is that the rule does not have a minimum limit for impurities or additives. Thus, it may be important to know the exact composition of each and every product so that proper notifications can be made.
- TSCA TSCA
- a manufacturer may need to identify any products that contain those chemicals in order to determine its reporting liabilities. This aspect may not result in an order block, but may rely on the compositional data to determine what reports must be made. Similar laws have been enacted in Canada, the European Union, Australia, Japan, China, South Korea and the Philippines. The Regulatory Compliance Verifying 133 interacts with all of these nations by checking both the ship-from country and the ship-to country .and against the inventories of each country. Generally, all of these inventories may be different.
- Pesticides are regulated by FIFRA and not by the general TSCA law.
- the Regulatory Compliance Verifying 133 identifies any materials or products that are pesticides and checks their compliance with pesticide laws in the world.
- the sale of pesticides may be restricted to specific customers by linking the material identity to the customer location number and other customers would be blocked if they attempt to order a restricted chemical.
- the Drug Enforcement Administration administers the CDCA.
- This regulation requires a manufacturer to maintain certain records, to establish a list of approved customers for certain chemicals, to notify DEA immediately of any new potential customers and to hold their orders for 15 days while the DEA investigates them, and to notify and hold all export orders for those certain chemicals.
- the regulatory compliance verifying block 133 can ensure that all customers for these chemicals are approved prior to shipment.
- CWC Chemical Warfare Convention
- the regulatory compliance verifying block may also be able to limit the sale of any chemical to one or more specific customers. This may be used when toll manufacturing a chemical for a customer or if the chemical is subject to a secrecy agreement.
- the regulatory databases 131 include listings of chemicals that are regulated by these various regulations. These databases may be provided by outside suppliers or may be generated internally by studying the regulations. An example of the regulatory databases is shown in Figure 5 A and Figure 5B which together form Figure 5 as indicated. Since the present invention is independent of the details in the regulatory databases 131, a detailed description of each database need not be provided. A detailed description of a regulatory database, such as a TSCA database, may be found in National Inventories, as available from Chemical Abstracts Service, the disclosure of which is hereby incorporated herein by reference.
- Regulated countries 520, 504, 512 This list includes countries that have enacted regulations governing the import of chemicals across their borders. If a ship-from or ship-to country is not regulated, then no regulatory checks are required for that country. The rules check both the ship-from and the ship-to countries on the order.
- Export Notification Lists 514 The U.S. government has two chemical inventory lists dealing with chemicals that are exported to other countries. One list is the Annual Export Notification List. If a chemical on this list is shipped to any country during the year, the EPA requires a formal notification the first time it is shipped every year. The other list is the One-Time Export Notification List, which means that if a chemical on this list is shipped to any country at any time, the EPA requires a formal notification the first time a manufacturer every records a shipment. These notifications may be sent as automatic faxes to the EPA. The logic can avoid sending false notifications: no notifications are sent if the logic detects any other type of order exception.
- New York Bulk Shipment List The state of New York (USA) has a list of chemicals requiring New York customers who store the chemicals in bulk tanks to register the chemical/tank with the state government. If a chemical component is in the NYBS list, then the customer location must be approved for the location to clear the order. Note that customers are linked to the NYBS chemicals even if the customer does not currently store the chemical in a bulk tank. (They may drum the chemical instead.) This is to avoid continually flagging exceptions. In these cases, it is noted that the rule does not apply to the customer's use of the chemical.
- Sales-Restricted Products 532 A product may be restricted for sale to any customer for regulatory precautions. Since this check applies to the product and not to the chemical components, the Family GMN 520 is flagged for sales restrictions. The customer must be linked to the Family GMN and be approved to allow the sale.
- a test is made as to whether the shipped-from country is regulated. This test determines if a country from which the order is shipped is regulated by a law such as TSCA. If the shipped-from country is regulated, then a test is made at Block 603 as to whether a chemical in the shipped-from country is restricted. In particular, countries that have inventories may also exempt some chemicals from inventory listing if they are regulated by other laws enforced at the same time. Examples are chemicals for foods, drugs, cosmetics, pesticides, tobacco, nuclear and chemicals. These are sent for restriction checks at Block 604. Restriction checks will be described in detail in connection with Figure 7.
- Block 604 a test is made as to whether the chemical is on the shipped-from country's inventory. If NO, an exception is issued at Block 135. If YES, then tests are made as to whether the shipped-to country is regulated at Block 606. If YES, then at Block 607, a test is made as to whether the chemical in the shipped-to country is restricted. If YES, restriction checks of Figure 7 .are performed at Block 604. If NO, a test is made as to whether the chemical is on a shipped-to country's inventory at Block 608, and if NO, an exception 135 is produced.
- a test is then made at Block 610 as to whether the Family is sales-restricted.
- a manufacturer may have many reasons for restricting the sales of certain chemicals to selected customers only.
- One reason may be toll manufacturing agreements.
- Other reasons may be restriction on use only to customers who are able to use the chemical safely and only in safe applications.
- Yet another restriction may be a secrecy agreement.
- the sales restrictions may not be based on regulations but rather may be based on a manufacturer's policy.
- Block 609 a test is made at Block 609 as to whether Family or customer cross-references exist that tie the restriction to a particular customer. If NO, then .an exception is created at Block 135. If YES, a test is made at Block 611 as to whether the customer is sales-restricted. If YES, an exception is made at Block 135.
- compositional information in the database may be used to determine the amounts of SARA chemicals on hand or disposed at a plant site.
- Compositional information can be used to manage reporting of RCRA wastes and EPCRA releases.
- the compositional information and bills of materials can also be reviewed periodically for opportunities to change to processes that are more environmentally friendly, i.e. "green chemistry". Accordingly, rather th.an merely flagging an exception, modifications 136 may be proposed.
- R&D or commercial volume accumulators are updated as necessary if there were no exceptions.
- an export notification check is performed by checking whether the chemicals are being shipped from the U.S. to a foreign country.
- TSCA Section 12(b) requires that the EPA be notified under certain conditions when specified chemicals are exported for the first time to each country, sometimes annually and sometimes once. See 40 CFR 707.65. Chemicals subject to TSCA Section 4 regulations are notified only once per country. Other chemicals subject to Section 5 or 6 regulations are to be notified each year for each country. Accordingly, a test is made at Block 625 as to which requirement a chemical is subject. If YES, a test is made at Block 626 as to whether this country has been notified yet. If NO, at Block 627, a notification letter is created to produce an export notification to the EPA and export notification flags are updated.
- Block 628 a test is made at Block 628 as to whether the chemical is on the other control list. If YES, a test is made at Block 629 if the country has ever been notified, and at Block 627 a notification may be sent.
- Block 703 a test is made at Block 703 as to whether a chemical is banned in a country. The only case that is presently in effect is the outright ban of cadmium compounds in Sweden. If YES, an exception is created at Block 135.
- a test is made as to whether the chemical is an ozone- depleting agent.
- the Montreal Protocol is an international treaty that proposes to reduce the emissions of ozone-depleting substances, such as some of the freons, from further reducing ozone in the atmosphere.
- the U.S. regulations are located in 40 CFR ⁇ 82.
- the U.S. recently signed the Chemical Warfare Convention. Implementing legislation has not been implemented yet. Once implemented, it can be used in this test.
- Block 706 a test is made as to whether the chemical is an essential drug precursor.
- the Drug Enforcement Administration (Department of Justice) permits the export of certain chemicals that are useful for the manufacture and processing of elicit drugs. See 21 CFR ⁇ 1307ff. If YES, then at Block 707, a test is made as to whether a customer is approved for a drug precursor chemical. If not, the order is flagged for 15 days at Block 708 and DEA is notified.
- Block 709 a test is made as to whether the chemical is for R&D use only.
- TSCA specifically 40 CFR ⁇ 710.4(c)(3), exempts certain chemicals from listing on the National Inventory of Commercial Chemical Substances under certain conditions. Other regulations may do the same. Often, the amount of R&D substance which may be manufactured is restricted. See also Canadian Environment Protection Act (CEP A) Section 218(l)(a).
- CEP A Canadian Environment Protection Act
- Block 710 if the chemical is R&D-use only, then a test is made at Block 710 as to whether the chemical has R&D annual limits in the shipped-to region. If YES, a test is made at Block 711 as to whether the ordered quantity is greater than the annual limit. If YES, an exception is created at Block 135.
- Block 714 a test is made as to whether the chemical has commercial manufacture/import limits.
- the U.S. and Japan do not limit import or manufacture of R&D chemicals, but other regulatory countries may.
- Canada and the European Union impose limits on the .amount of chemicals that may be manufactured or used for commercial purposes until toxicity and property testing is submitted to the agencies and is approved.
- These limits are both annual and cumulative. See, for example, EU directive 67/548/EEC. Accordingly, if there is a cumulative limit, then at Block 717, a test is made on the ordered quantity, and if YES, an exception 135 is created.
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- Business, Economics & Management (AREA)
- Physics & Mathematics (AREA)
- General Business, Economics & Management (AREA)
- General Physics & Mathematics (AREA)
- Engineering & Computer Science (AREA)
- Theoretical Computer Science (AREA)
- Management, Administration, Business Operations System, And Electronic Commerce (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP98964722A EP1038252A4 (en) | 1997-12-11 | 1998-12-10 | Systems, methods and computer program products for determining compliance of chemical products to government regulations |
BR9813528-7A BR9813528A (en) | 1997-12-11 | 1998-12-10 | Processes to determine the conformity of a chemical to be manufactured and of chemical compositions of a chemical with government regulations and to derive chemical compositions that are present in a chemical to be manufactured and data processing system and computer program product to determine the compliance of a chemical to be manufactured with government regulations |
JP2000524751A JP2001526428A (en) | 1997-12-11 | 1998-12-10 | System, method and computer program product for determining chemical product compliance with government regulations |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/989,040 US6163732A (en) | 1997-12-11 | 1997-12-11 | System, method and computer program products for determining compliance of chemical products to government regulations |
US08/989,040 | 1997-12-11 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1999030265A1 true WO1999030265A1 (en) | 1999-06-17 |
Family
ID=25534693
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1998/026286 WO1999030265A1 (en) | 1997-12-11 | 1998-12-10 | Systems, methods and computer program products for determining compliance of chemical products to government regulations |
Country Status (6)
Country | Link |
---|---|
US (1) | US6163732A (en) |
EP (1) | EP1038252A4 (en) |
JP (1) | JP2001526428A (en) |
CN (1) | CN1285069A (en) |
BR (1) | BR9813528A (en) |
WO (1) | WO1999030265A1 (en) |
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- 1998-12-10 BR BR9813528-7A patent/BR9813528A/en not_active IP Right Cessation
- 1998-12-10 WO PCT/US1998/026286 patent/WO1999030265A1/en active Application Filing
- 1998-12-10 EP EP98964722A patent/EP1038252A4/en not_active Withdrawn
- 1998-12-10 CN CN98813551A patent/CN1285069A/en active Pending
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Also Published As
Publication number | Publication date |
---|---|
US6163732A (en) | 2000-12-19 |
EP1038252A4 (en) | 2005-05-11 |
EP1038252A1 (en) | 2000-09-27 |
JP2001526428A (en) | 2001-12-18 |
CN1285069A (en) | 2001-02-21 |
BR9813528A (en) | 2000-10-03 |
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