SFDC 1001
`SFDC 1001
`
`
`
`
`
`
`
`
`
`

`
`US007356482B2
`
`(12) United States Patent
`Frankland et al.
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 7,356,482 B2
`Apr. 8, 2008
`
`1/1998 Henderson ................. .. 705/28
`3/1998 Sturgeon et a1.
`..
`.... .. 705/9
`9/1999 Eager et a1.
`.... ..
`717/147
`IS:::k1e:t;1'
`--
`..."707/104
`5/2000 Smalley et 515."...
`8/2000 Tipton et al.
`............... 700/266
`(Continued)
`
`
`
`5,712,990 A
`5,726,884 A
`5,960,200 A *
`: *
`6,067,549 A
`6,097,995 A
`
`EP
`
`FOREIGN PATENT DOCUMENTS
`874306 A2 * 10/1998
`
`OTHER PUBLICATIONS
`
`Buzzard, “dBase and SQL Mixing Metaphors”, Data Based Advisor,
`V8, n6, p. 94(7), Jun. 1990, ISSN: 0740-5200.*
`
`Primary Examiner—Mary D. Cheung
`(74) Attorney, Agent, or Firm—Ladas & Parry LLP
`
`(57)
`
`ABSTRACT
`
`An integrated system for managing changes in regulatory
`and non-regulatory requirements for business activities at an
`industrial or commercial facility. Application of this system
`to environmental, health and safety activities, and to food,
`drug, cosmetic, and medical treatment and device activities,
`are discussed as examples. The system: provides one or
`more databases that contain information on operations and
`requirements concerning an activity or area of business;
`receives
`information on regulatory and non-regulatory
`changes that affect operations of the business; converts these
`changes into changes in data entry forms, data processing
`and analysis procedures, and presentation (by printing, elec-
`tronic display and/or distribution) of data processing and
`analysis results to selected recipients, without requiring the
`services of one or more programmers to re-key and/or
`reformat the items affected by the change; and implements
`receipt of change information and dissemination of data
`processing and analysis results using the facilities of the
`Internet.
`
`59 Claims, 13 Drawing Sheets
`
`1’!
`
`(54)
`
`INTEGRATED CHANGE MANAGEMENT
`UNIT
`
`(75)
`
`Inventors: Richard Frankland, San Jose, CA
`(US); Chrismpher M‘ Mitchell’ E1
`Sranada’ CA (US)9 J°S°Ph D‘
`.
`erguson, Santa Clara, CA (US),
`Anthony T. Sziklai, Half Moon Bay,
`CA (US); Ashish K. Verma, Foster
`City, CA (US); Judith E_ popowskia
`Half Moon Bay, CA (US); Douglas H.
`Sturgeon, San Mateo, CA (US)
`
`(73) Assignee: Alternative Systems, Inc., Half Moon
`Bay, CA (US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. l54(b) by 1064 days.
`
`(21) Appl. N6: 09/797,488
`
`(22)
`
`Filed:
`
`Mar. 1, 2001
`
`(65)
`
`Prior Publication Data
`
`US 2002/0026339 A1
`
`Feb. 28, 2002
`
`(51)
`
`Int. Cl.
`(2006.01)
`G06F 17/00
`(52) U.S. Cl.
`......................................... .. 705/8; 707/102
`(58) Field of Classification Search ............ .. 705/7—11,
`705/28—29; 707/102, 200, 202—203, 205;
`588/1, 16; 700/266; 713/151—152; 719/328—329
`See application file for complete search history.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`4,803,039 A
`5,185,699 A
`5,532,928 A
`5,611,076 A *
`5,664,112 A
`
`....... .. 376/216
`2/1989 Impink, Jr. et al.
`2/1993 Reiner et al.
`............. .. 707/531
`7/1996 Stanczyk et al.
`............ .. 705/7
`.. 707/102
`3/1997 Durflinger et al.
`
`............ .. 705/28
`9/1997 Sturgeon et al.
`
`
`
`Change Layer
`CHANGES ARE IDENTIFIED DN THE INTETINET USING
`INTELLIGENT AGENTS AND PTIDVIDED FOR CONFIGURATION
`CONFIGURATION TOOLS THAT
`END USER FUNCTIONS
`ENABLE THE END USER FUNCTIONS
`ENABLED BY CONFIGURATION
`
`
`
`
`
`13
`
`‘I5
`
`TABLES, VIEWS, FUNCTIONS AND
`PROCEDURES ARE ACCESSED EIY
`END USER FUNCTIONS VIA METADATA
`
`
`
`Business Content Layer
`
`‘I7
`
`
`
`SFDC 1001
`
`SFDC 1001
`
`

`
`US 7,356,482 B2
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`6,341,287 B1
`6,377,993 B1*
`9/2000 Wiitala et al.
`..
`............... .. 700/106 * cited by examiner
`12/2000 Petke et al.
`
`6,122,622 A
`6,163,732 A
`
`1/2002 Sziklai et a1.
`4/2002 Brandt et a1.
`
`............. .. 707/102
`............. .. 709/227
`
`

`
`U.S. Patent
`
`Apr. 8,2008
`
`Sheet 1 of 13
`
`US 7,356,482 B2
`
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`
`U.S. Patent
`
`Apr. 8,2008
`
`Sheet 2 of 13
`
`US 7,356,482 B2
`
`
`
`IA IDENTIFIES ONE OR MORE
`
`RELEVANT CHANGES ON A NETWORK.
`
`
`
`
`
`USING PRE—DEFINED RULES
`
`22
`
`
`
`
`
`CHANGE DATA,
`CONFIGURATION RECOMMENDATIONS
`
`
`
`AND DEFAULT PARAMETERS
`
`ARE REPORTED TO SYSTEM
`
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`YES
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`
`CHANGEISI
`
`2
`
`
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`REFLECTED IN END USER FUNCTIONISJ
`
`
`

`
`U.S. Patent
`
`Apr. 8,2008
`
`Sheet 3 of 13
`
`US 7,356,482 B2
`
`iused as an item
`
`SIS WURKLIST
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`54
`
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`
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`
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`
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`
`FIG. 3
`
`

`
`U.S. Patent
`
`Apr. 8,2008
`
`Sheet 4 of 13
`
`US 7,356,482 B2
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`U.S. Patent
`
`Apr. 8,2008
`
`Sheet 5 of 13
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`US 7,356,482 B2
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`
`U.S. Patent
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`US 7,356,482 B2
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`Patent
`
`AP13 8, 2008
`
`Sheet 7 of 13
`
`US 7,356,482 B2
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`

`
`U.S. Patent
`
`Apr. 8,2008
`
`Sheet 8 of 13
`
`US 7,356,482 B2
`
`Change Agent Management Unit Main Menu
`
`Ijlireensuite
`FILE
`LOGIC
`DISTRIBUTION
`
`DATA
`
`TOOLS
`
`ADMIN
`
`HELP
`
`BUSINESS AREA
`
`PRODUCT STEWARDSHIP
`
`YOU ARE NOW CONNECTED TO PRODUCT STEWARDSHIP
`
`FIG. 8
`
`E] Ereensuite
`
`FILE
`
`LOGIC
`
`DISTRIBUTION
`
`DATA
`
`TOOLS
`
`ADMIN
`
`HELP
`
`,I EfQ>'?<I>':@ EI E»
`BUSINESS AREA
`
`El Product Stewardship
`
`{Eco} Tax Studies
`
`EH5 Life CW9
`Assessments
`
`Product Labelin
`
`Ailegation/Inquiry Tracking MSDS Management
`
`Setup Tables
`
`Chemical Shimants
`
`“"3‘?,'}i?,‘,.,§,,‘,3,f-‘§,§“i“3'
`
`TSCA Information
`
`Customer Usae Surve s
`
`Pesticide Information
`
`FIG. 9
`
`

`
`U.S. Patent
`
`Apr. 8,2008
`
`Sheet 9 of 13
`
`US 7,356,482 B2
`
`CI Wnrklist
`
`Business Area;
`
`Hazardous Materials and Wastelil
`
`Set U Waste Stream Data
`
`IE
`
`EJ
`
`Find
`
`Group: Waste Manaement
`Search:
`Worklist;
`Workiist Menu
`- DESCRIPTION
`EIIITEII IIIIIISTE STREAM
`E ENTER WASTE STREAM SOURCE CODES
`ENTER WASTE STREAM EPA NUMBERS
`ENTER WASTE STREAM STATE NUMBER
`
`MODULE TYPE
`FIIRIIII
`FORM
`FORM
`FORM
`
`MODULE NAME
`'
`HIIIIIIIEIIIIIS WIISTE PHIIFIIE
`WASTE PROFILE RCRA SOURCE CODE
`WASTE PROFILE EPA NUMBERS
`WASTE PROFILE STATE NUMBERS
`
`Business Area: Hazardous Materials and Waste :1
`Group; [Waste Management
`EJI
`Worklist Name;
`[Set Ué Waste Stream Data
`j
`
`:I
`
`1 FORM
`
`2 FORM
`3 FORM
`
`4 FORM
`
`HAZARDOUS WASTE PROFILE
`
`WASTE PROFILE RCRA SOURCE CODES
`WASTE PROFILE EPA NUMBERS
`
`WASTE PROFILE STATE NUMBERS
`
`

`
`U.S. Patent
`
`Apr. 8,2008
`
`Sheet 10 of 13
`
`US 7,356,482 B2
`
`CI Data Entry Form - Air Emission Amount
`EIIEI
`MonitorEl
`Material Dr Chemical Volatile Dranic Comounds
`El
`Estimation Basis Estimate Based on AP-42 Emission Factors
`Emission Calculation Date select NATGAS UNCONTRDLLED_
`LBSYFll5.5D,l F282] rslt from dual
`
`
`
`Estimation Meow ]
`Process Flate M382
`
`Rate Unit of Measure l\/llVlcit/ F
`El
`
`
`tfjfi
`
`FIG. 12
`
`Warning Applet Window
`
`
`
`
`
`
`
`
`
`El Edit Form: Table Selection
`
`
`
`
`
`Form Name
`Table Name AIR EMISSION AMDUNTEI Z
`
`
`
`
`Available Fields
`Selected Fields
`
`
`
`
`
`ID
`
`FACILITY
`SOURCE LOCATION
`
`
`
`AIR PARAMETER
`
`AIR PARAMETER2
`USEROOL2
`
`USERCOL3
`
`USERCOL4
`
`USERCOL5
`
`SOURCE CATEGORY
`SOURCE PROCESS
`PARAMETER
`
`
`SOURCE EOUIPMENT UNIT
`
`
`
`
`
`SOURCE PERMITTED UNIT
`
`FORM PROPERTIES
`
`LINK TO ITEM PROPERTIES FDRMU A DISPLAY
`
`Finish
`
`
` Warnin A let Window
`
`Cancel
`
`
`
`
`

`
`U.S. Patent
`
`Apr. 8,2008
`
`Sheet 11 of 13
`
`US 7,356,482 B2
`
`D Report printing
`
`AIEI EMISSION FEES
`
`I-1
`
`G —a
`AE
`12-03
`12-03
`-
`
`19
`10
`I
`
`IIJFLJ
`
`I;J'1(_)1-».[>.5
`
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`PULLLJTANT
`FURMALDEHYDE
`BENZENE
`"3 ‘.1:
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`IIAI :'III
`
`QAS NUMBER EMIEEIONS
`59990
`1.1680
`7149203219
`.59
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`'
`
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`FURMALDEHYDE
`1998
`1998
`PARTICULATE MATTEFl—PM1U 789779
`1998 VOL/-\lllE UFlGAN|CCUl\/lPOU 5859789
`"3 BENZENE
`714 2 21
`
`llll
`": MA I'I
`1998 VDLATILEURGANECUMPOU 5859789
`
`1.1680
`.7085
`.4018
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`
`FIG. 14
`
`Cl Report Builder--Table/Views
`
`
`
`
`
`Report
`Table/View AUD_GS_AlFl_ANNUAL_EMlSSlDN_ FEE E [:3
`
`
`
`
`
`Available Fields
`
`Selected Fields
`
`FlUl\l
`
`POLLUTANT_CAS_NUMBER
`POLLUTANT_FEE
`PDLLUTANT_N/AME
`- REPORT|NG_YEAR
`RUN_DATE
`
`lflCAT|flN_NAME
`
`TUTAL_EMlSSlONS_TDNS
`
`<<
`
`
`
`
`
`
`
`FIG. 15
`
`

`
`U.S. Patent
`
`Apr. 8,2008
`
`Sheet 12 of 13
`
`US 7,356,482 B2
`
`
`
`
`
`
`
`
`
`
` [:1 Run Process Results
`Process ENE MTERIL 91LA9vE RGUANTITY
`
`Resuhs
`
`INCIDENLDATE OCATlON_NAME 9As_NuM9E9 MATER|AL_NAME QUANTITY ‘
`93/23/1999
`A99 Company
`7192414
`rwnnmc
`RELEASE
`99/99/1999
`A99 Company
`7792414
`FLUURINE
`99/29/1999
`A99 Company
`959999
`FLUUROACETYL 9
`99/99/1999
`A99 Company
`959999
`FLUOROACETYL 9
`99/29/1999
`A99 Company
`59999
`FDRMALDEHYDE
`[3 99/99/1999
`A99 Company
`59999
`FORMALDEHYDE
`[1 99/29/1999
`A99 Company
`2549921
`FDRMDTHIDN
`[9199/99/1999
`A99 Company
`2549921
`FORMUTHIUN
`I-19929/1999
`A99 Company
`3979191
`E99E919Az9LE
`99/99/1999
`A99 Company
`9979191
`FUBERIDAZOLE
`
`
`
`
`A99 Coman 22224929 FENAMIPHOS99/29/1999 9 ll
`
`
`
`
`
`
`
`
`
`
`FIG. 15
`
`[:1 Advanced lluery Builder
`
`Used Columns
`MDEINCIDENLDATE
`M9,L99A99N_NAME
`M9,9A9_N9M9E9
`MD.MATERlAL_NAME
`MDGU/-\NT|TY_LBS
`
`@A“ O Distinct
`.
`/"'85
`
`RG.REPORTABLE_[1UANT|TY
`
`Available Columns
`M9.MA1E91AL919
`RO.MATEHIAL_|D
`
`UDMC4FROM_UDM_lD
`UDf\/|C.MULT|PLY_BY
`UDMC.TU_UNITS
`UUMC.TD_UUM_lD.
`EE::E
`
`HG.REPORTABLLDUANTITY-UOMC_MULTlPLY 19v 1]
`
`FIG.
`
`1 7
`
`

`
`U.S. Patent
`
`Apr. 8,2008
`
`Sheet 13 of 13
`
`US 7,356,482 B2
`
`Clllucument - Preview
`
`Select Page WIIIIIR Record
`
`Select Record
`
`Navigate Record
`
`Total Records
`
`
`
`
`
`
`
`
`OPTIONAL INFORMATION
`
`SHIPPEFI ABC WINERY
`
`Document Non Hazardous Waste label El
`Page
`
`I3 SHOW 9””
`[3 SNAP To GRID
`SHOW FIELDS
`
`Slze WldtI’l
`
`

`
`US 7,356,482 B2
`
`1
`INTEGRATED CHANGE MANAGEMENT
`UNIT
`
`FIELD OF THE INVENTION
`
`This invention relates to the integrated management of
`information affected by regulatory changes, such as changes
`in environmental, health and safety laws, and non-regulatory
`changes.
`
`BACKGROUND OF THE INVENTION
`
`Control of industrial and commercial activities by means
`of federal, state and local laws, statutes, ordinances and
`regulations (“regulations” herein) is endemic in the United
`States. Examples of activities that are regulated by such
`regulations
`include:
`environmental health and safety
`(“EH&S”; Titles 7, 10, 29, 30, 40, 42 and 49 of the Code of
`Federal Regulations and related state and local codes);
`administrative procedures applicable to government person-
`nel (Title 5); agricultural activities (Titles 7 and 9); creation,
`use, treatment and disposal of nuclear materials (Title 10);
`conversion and distribution of usable forms of energy, power
`and water (Titles 10 and 18); banking, financial and secu-
`rities activities and foreign trade Titles 12, 15, 16, 19 and
`22); space and aeronautical activities (Title 14); commercial
`trade practices (Title 16); food, drugs, cosmetics, medical
`treatments and devices (“FDCMTD”; Title 21); transporta-
`tion of persons and cargo (Titles 23 and 49); housing and
`urban development (Title 24); firearms production and trade
`(Title 27); workers compensation (Title 29); mining and
`related activities (Title 30); national defense activities (Titles
`15 and 32); navigation and navigable waters (Title 33);
`education (Title 34); activities in and on parks, forests,
`public lands and other public property (Titles 36 and 43);
`intellectual property activities (Title 37); veterans’ pensions
`and relief (Title 38); postal service activities (Title 39);
`public contracts and public property management (Titles 41
`and 48); public health (Title 42); emergency management
`and assistance (Title (44); grant of public welfare and
`assistance (Title 45); telecommunications (Title 47); and
`wildlife and fisheries activities (Title 50). Some of the most
`pervasive regulations concern EH&S and FDCMTD activi-
`ties.
`Generation and use of hazardous sub stances in the United
`
`States has grown steadily in the last 53 years and is now
`estimated to be over 300 million metric tons per year.
`According to one definition, a “hazardous substance” is any
`substance or mixture of substances that may cause substan-
`tial personal
`injury or substantial
`illness during or as a
`proximate result of any customary or reasonably foreseeable
`handling or use, including reasonably foreseeable ingestion
`by children, if the substance: (1) is a toxic agent or repro-
`ductive toxin; (2) is corrosive; (3) is an irritant; (4) is a
`strong sensitizer; (5) is flammable, combustible or explo-
`sive; (6) is pyrophoric; (7) is a carcinogen, hepatotoxin,
`nephrotoxin or neurotoxin; (8) is an agent that acts on the
`hematopoietic system;
`(9) is an agent that damages the
`lungs, skin, eyes or mucous membranes; (10) is a com-
`pressed gas; (11) is an organic peroxide; (12) is an oxidizer;
`(13) is unstable, reactive or water-reactive; (14) generates
`pressure through decomposition, heat or other means; (15) is
`sufliciently radioactive to require labeling as such; (16) is a
`toy or other article intended for use by children and presents
`an electrical, mechanical or thermal hazard; or (17)
`is
`specially listed as a hazardous substance by a state or federal
`agency having jurisdiction over such substances.
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`At the federal level, special purpose hazardous substance
`laws and regulations, focusing on a particular hazardous
`substance or narrow class of such materials, have been
`applied for more than a century. In 1866, a federal law
`regulating transportation and storage of explosive and flam-
`mable materials was promulgated. This was followed in
`1899, 1910, 1938, 1944 and 1947 by passage of the Refuse
`Act, the first Insecticide Act, the Food, Drug and Cosmetic
`Act,
`the Safe Drinking Water Act, and the Insecticide,
`Fungicide and Rodenticide Act, respectively. In 1955 and
`1966, the Clean Air Act and the Federal Hazardous Sub-
`stances Act appeared, respectively. Since 1969, the pace of
`introduction of new laws regulating hazardous substances
`has increased, and approximately 15 new major federal laws
`and voluminous regulations have been introduced in this
`area. These laws often have overlapping jurisdiction and are
`not always consistent with one another. Several states, such
`as California, have passed their own hazardous substance
`laws before the corresponding federal hazardous substance
`laws were adopted. These laws still apply in those states and
`in many cases supersede their Federal counterparts. These
`laws statutes, ordinances, regulations and related constraints
`are constantly changing and require corresponding changes
`in data entry, data analysis and presentation of the results.
`The Safe Drinking Water Act
`(“SDWA”), originally
`passed in 1944 and amended several times since then, covers
`all drinking water supplies in all states. Primary standards,
`to prevent adverse effects on human health, and secondary
`standards and covering certain aesthetic effects such as odor
`and turbidity of processed drinking water, are set down in
`terms of maximum permissible concentrations of specified
`contaminants in water delivered to any public drinking water
`system. From a regulatory standpoint, SDWA falls under the
`broader mandate of the Clean Water Act (“CWA”), whose
`ultimate goal is maintenance of the “chemical, physical, and
`biological integrity of the nation’s waters.”
`CWA, with its most recent amendment, the Water Quality
`Act (“WQA”) of 1987, establishes mandatory effluent limi-
`tation guidelines for all facilities which discharge waste into
`water bodies, or allow waste to enter and potentially con-
`taminate subsurface water sources, like aquifers. CWA cre-
`ated the National Pollutant Discharge Elimination System
`(“NPDES”)
`to regulate elfluents,
`influents
`(waterborne
`wastes received by a treatment facility) and sludge. The
`primary enforcement mechanism of NPDES is the NPDES
`permit. CWA directs control authorities at the federal and
`state level to administer and enforce permit compliance.
`NPDES permits include terms and conditions ranging from
`required monitoring of point source discharges to the imple-
`mentation of control technologies to minimize outfall.
`The Clean Air Act (“CAA”), passed in 1955 and amended
`several times since that time (most recently, in 1990), covers
`emission of pollutants into the ambient air and atmosphere.
`This may include hazardous wastes that are liquid or gas-
`eous when discharge occurs. National Ambient Air Quality
`Standards (“NAAQSs”) are set forth for seven chemicals or
`chemical groups: SOX, CO, NOX, O3, Pb, hydrocarbons and
`total suspended particulates. Additionally, emission stan-
`dards are set forth for asbestos, beryllium, mercury and vinyl
`chloride. Primary Standards are set forth to protect human
`health, and Secondary Standards are set to protect or limit
`damage to other entities, such as flora, fauna and personal
`and real property. The federal government in effect delegates
`responsibility to achieve these standards to the individual
`states, which are required to present and implement State
`Implementation Plans to achieve the target air quality stan-
`dards in various identified air basins in the states.
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`The primary enforcement mechanism of CAA is the CAA
`permit. Permits covering emission source construction,
`modification, and operation follow the NPDES scheme,
`adopting strict measures for controlling and reducing emis-
`sions of airborne waste at the source. CAA permits include
`terms and conditions ranging from the application of abate-
`ment devices and other control technologies for emission
`reduction,
`to required monitoring at all source emission
`point sources and non-point sources (i.e., fugitive emission
`locations). Permits based on economic incentive strategies,
`such as marketable emission allowances, were added to the
`federal regulatory program maze under the 1990 amend-
`ments. Although these additions were intended to stimulate
`compliance via market-based vehicles (like emission allow-
`ance futures trading), these permits have not, as yet, been
`broadly implemented.
`The Toxic Substances Control Act (“TSCA”), originally
`passed in 1965, together with the Federal Hazardous Sub-
`stances Act (“FHSA”) passed in 1966 and the Resource
`Recovery Act (“RRA”) passed in 1970, were the initial
`federal laws governing generation and handling of toxic and
`other hazardous substances. Most provisions of the RRA and
`the FHSA have been incorporated in the Resource Conser-
`vation and Recovery Act, discussed below. Under TSCA, the
`Environmental Protection Agency (“E.P.A.”) reviews any
`chemical substance that is or will be produced in sufficient
`quantity that it may cause significant acute or chronic human
`exposure. Testing is performed with respect to human health
`and the environment and focuses particularly on possible
`risk of serious harm to humans from (1) cancer, (2) genetic
`mutations and (3) birth defects. If the EPA finds that the risk
`to human health or to the environment is sufficiently great,
`the EPA may: (1) limit the amount of the chemical to be
`manufactured or used;
`(2) prohibit a particular use;
`(3)
`require placement of warning labels on all containers of the
`chemical; (4) require placement of public notices of use; and
`(5) regulate commercial use and/or disposal of the chemical.
`Any person, including a company, that manufactures or
`imports more than 10,000 pounds or more of a chemical
`named on an E.P.A. Chemical Substances Inventory List is
`subject to the reporting requirements under TSCA. These
`reporting requirements include: (1) updating of a list of all
`chemicals present on a site, at four-year intervals or more
`frequently; (2) submission (to the E.P.A.) of a Pre-manu-
`facture Notice and relevant test data for any new chemical,
`at
`least 90 days before manufacturing or importing the
`chemical; (3) submission of a Notice Of Intent To Import or
`To Export a listed chemical, within seven days after entering
`into a contract to import or export the chemical, if the
`chemical is known to be mutagenic, teratogenic or carcino-
`genic or is known to cause chronic health or environmental
`problems;
`(4) reporting of a significant new use for a
`chemical already on the E.P.A. list; (5) reporting of known
`significant adverse reactions caused by handling or dis-
`charge of any chemical used by the reporting entity; (6)
`submission of any unpublished health and/or safety studies
`on certain chemicals used by the reporting entity; (7) noti-
`fication of any substantial risk of injury to human health or
`the environment, due within 15 days after the reporting
`entity first receives information on the risk; (8) submission
`of information on production of, use of and exposure to
`certain chemicals to an Interagency Testing Committee for
`analysis by the Committee;
`(9) submission of specified
`comprehensive information on a fixed format reporting
`form; (10) submission of results of tests, if any, performed
`by the reporting entity on certain hepta-halogenated
`dibenzo-p-dioxins and dibenzofurans, within 90 days after a
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`test, if a positive result is obtained; and (11) submission of
`a Notification of PCB Activity form by any storer, trans-
`porter or disposer of polychlorinated biphenyl (“PCB”)
`waste. TSCA also sets forth certain requirements for labeling
`of, disposal of and recordkeeping for certain chemicals, such
`as PCBs.
`
`(“OSHA”),
`The Occupational Safety and Health Act
`passed in 1970, covers the conditions under which employ-
`ees work. The regulations issued under OSHA make this Act
`among the most detailed of all workplace laws. The relevant
`parts of OSHA prescribe standards for the protection and
`welfare of employees exposed to workplace hazards. An
`employer must establish a written hazard communication
`plan to advise its employees of hazards associated with
`chemicals the employees handle, and incorporate into this
`plan the use of container labels, warning signs, Material
`Safety Data Sheets (“MSDSs”) and training programs. The
`centerpiece of the OSHA Hazard Communication Standard
`is the MSDS, required for each hazardous substance manu-
`factured or used on the site. The MSDS includes all relevant
`
`information pertaining to a hazardous substance, from its
`ingredients to physical properties, health hazards, exposure
`limits, storage incompatibilities, safe handling and use pre-
`cautions and much more. An employer must report, within
`48 hours, any incident
`that results in a fatality, or in
`hospitalization of five or more employees. The OSHA Log
`and Summary of Occupational Injuries and Illnesses form is
`used to record all work-related injuries and illnesses for each
`calendar year. Many such records must be maintained by the
`employer for the duration of employment of an employee,
`plus 30 years. An employer must develop and implement a
`written emergency plan and make the plan available in the
`workplace, whenever an OSHA standard requires it. An
`employer must also develop and implement a written safety
`and health program and a medical surveillance program for
`employees involved in hazardous waste operations, includ-
`ing emergency response procedures.
`The Occupational Health and Safety Administration
`(“O.S.H.A.”) under the Department of Labor
`(D.O.L.)
`develops and enforces all OSHA standards. The O.S.H.A.
`primary enforcement activity is the inspection, or audit
`procedure. Facilities covered by one or more OSHA stan-
`dard are subject to voluntary (routine) inspections, as well as
`non-voluntary inspections based on a warrant to search.
`The Hazardous Materials Transportation Act (“HMTA”),
`passed in 1974, is administered jointly by the Department of
`Transportation (“D.O.T.”), established in 1966, and the
`E.P.A., established in 1969. The HMTA sets forth 15 hazard
`classes of materials (e.g., flammable liquids, high explo-
`sives, poisons) plus five classes of “other regulated materi-
`als” and sets forth laws and corresponding regulations on:
`(1) identification, listing, labeling and placarding of these
`hazardous substances; (2) recordkeeping requirements for
`handling these hazardous substances,
`including Uniform
`Hazardous Material Manifests for shipment of hazardous
`wastes; (3) requirements for generators and transporters of
`hazardous substances and for owners and operators of
`specially defined treatment, storage and disposal facilities
`(“TSDFs”) for these hazardous substances; (4) permit and
`pretransport notification requirements and transportation
`routing for all facilities that generate or transport these
`hazardous substances;
`(5) requirements for tracking the
`movement of these hazardous substances; (6) containers to
`be used for transport; (7) incident notification and other
`procedures for handling and reporting accidental and inten-
`tional discharges of hazardous substances; and (8) testing
`and standards for operators of transport vehicles for hazard-
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`US 7,356,482 B2
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`5
`ous substances. Hazardous wastes and other hazardous sub-
`
`stances are not distinguished under the HMTA. A “genera-
`tor” of a hazardous waste is defined simply as “any person
`whose act first causes a hazardous waste to become subject
`to regulation”. Transportation modes covered include move-
`ment of the hazardous substance by air, rail, water and
`highway. The D.O.T. is authorized to inspect generator and
`transporter facilities, vehicles and records to insure compli-
`ance.
`
`The Resource Conservation and Recovery Act (“RCRA”),
`passed in the present form in 1976, was originally part of the
`Clean Air Act, passed in 1966. The RCRA establishes
`“cradle-to-grave” responsibility for hazardous solid waste
`handled by a generator, by a TSDF operator, or by a
`hazardous waste transporter or recycler. Under RCRA, a
`solid waste is a “hazardous waste”, if: (1) the waste arises
`from specified manufacturing practices; (2) the waste is one
`of a group of specified wastes; (3) the waste contains any of
`a group of specified chemicals; or (4) the waste has specified
`toxicity, chemical reactivity, ignitability or corrosive char-
`acteristics. Household wastes are generally exempted from
`RCRA coverage. Generators of more than 1,000 kilograms
`per month of ordinary hazardous wastes or of more than 1
`kgm per month of extremely hazardous waste must operate
`under a RCRA permit covering registration, container label-
`ing, recordkeeping and other requirements. “Small quantity
`generators”, who generate 100-1,000 kgms per month of
`hazardous wastes and no more than 1 kgm per month of
`extremely hazardous wastes, are covered by simpler require-
`ments. Generators of still smaller amounts of the hazardous
`
`wastes or the extremely hazardous wastes are often exempt
`from regulation under RCRA.
`The goals of RCRA include: (1) protecting the health,
`safety and environment of the public; (2) regulating the
`generation,
`treatment, disposal and storage of hazardous
`wastes; (3) reducing environmental pollution from waste
`disposal; (4) encouraging recycling and/or re-use of hazard-
`ous wastes; and (5) eliminating certain landfill and other
`solid waste disposal practices. A Notification of Hazardous
`Waste Activity must be submitted by a generator, transporter
`or operator of a hazardous waste TSDF to apply for an
`E.P.A. identification number and for any applicable E.P.A.
`permits for on-site treatment, storage or disposal. Hazardous
`waste generators are required to conduct their own studies to
`determine if a specific hazardous waste can be treated to
`reduce its volume or toxicity, with records of such studies
`being submitted each year to the E.P.A. and being main-
`tained for three years.
`A Uniform Hazardous Waste Manifest, developed by the
`E.P.A. under RCRA and under HMTA, must be used by
`persons who transport hazardous waste for off-site treat-
`ment, storage or disposal, and a copy of each Manifest must
`be maintained as part of a facility’s operating record. Own-
`ers or operators of a TSDF who receive hazardous waste
`without a proper Manifest must submit an Unauthorized
`Waste Report to the E.P.A. within 15 days after such an
`incident occurs. Upon closure of a hazardous waste facility,
`records of hazardous waste disposal and the amounts thereof
`must be submitted to the E.P.A. and to local land use control
`authorities.
`
`A hazardous waste generator must demonstrate that it has
`the financial ability to cover liability claims involving sud-
`den or non-sudden discharges from the facility. An owner or
`operator must monitor and inspect all on-site tanks that treat
`or accumulate hazardous waste. A spill or other discharge
`must be reported to the National Response Center
`(“N.R.C.”) within 24 hours after the incident occurs, and a
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`detailed report on such incident must be submitted to the
`E.P.A. within 30 days after the incident. RCRA is enforced
`concurrently with applicable state statutes.
`The Comprehensive Environmental Response, Compen-
`sation and Liability Act (“CERCLA”) was passed in 1980 in
`response to the discovery of several hazardous waste dis-
`posal sites that would have to be cleaned up at government
`expense. CERCLA was intended to: (1) provide a system for
`identifying and cleaning up chemical and hazardous sub-
`stance releases; (2) establish a fund to pay for cleanup of
`release sites, where those responsible cannot or will not pay
`for the cleanup; and (3) enable the federal government to
`collect the costs of cleanup from the responsible parties. The
`federal government set aside $1.8 billion in the first Super-
`fund for hazardous waste site clean-up purposes. CERCLA
`includes on its hazardous substance list all hazardous wastes
`
`under RCRA, all hazardous air pollutants regulated under
`the CAA, all water pollutants regulated under the CWA, and
`most substances regulated under TSCA.
`In 1986, the Superfund Amendments and Reauthorization
`Act (“SARA”) added another $6.2 billion to the Superfund
`for clean-up purposes SARA also enacted Community-
`Right-to-Know requirements into law. Title III of SARA
`contains the Community Right-to-Know requirements and
`provides for: (1) Emergency Response Planning; (2) Acci-
`dental Release Notification;
`(3) Facility Hazardous Sub-
`stance Inventory Reporting; and (4) Facility Toxic Sub-
`stance Release Reporting.
`Sections 301-303 of Title III enacted the requirement for
`Emergency Response Planning. Emergency Response Plan-
`ning as enacted by SARA required the creation of commit-
`tees at both State (State Emergency Response Committee, or
`S.E.R.C.) and Local (Local Emergency Plarming Commit-
`tee, or L.E.P.C.) levels. Owner/operators of facilities with
`specified hazardous substances on site in quantities in excess
`of specified thresholds are required to prepare and submit
`Emergency Response Plans to the L.E.P.C. having jurisdic-
`tion over the facility. Elements