Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

All three datasets make use of the SPTOBID variable to identify the tobacco product under study, and the STRFID (Substance Reference Identifier) variable to represent the ingredient name. STRFID must be assigned by study sponsors to be unique with regard to the attributes that describe it. If, for instance, the same ingredient varies on one or more attribute (e.g., two different manufacturers supplied the same ingredient, each with different purities, that is used in two different components of the product), STRFID must be unique for each use to reflect this difference, even if they share the same common name, and/or the same IUPAC name and CAS number. (see note 5)See IT example which illustrates this below.

The IT example below shows 4 types of tobacco listed as tobacco ingredients (STRFID) for the Tobacco Product CIG01A (SPTOBID). The variable ITSPECIF shows the specification (variety) of the first three tobaccos. ITCAT is used to indicate that Reconstituted Tobacco is a complex ingredient. (it has two more components) ITCURMTH indicates the cure method. ITCPISP is used to indicate whether complex purchased ingredients were made to the applicant's specification. TMRF indicates the Tobacco Master Reference File. Note that there are two varieties of burley tobacco in this tobacco product, thus each is given a unique STRFID value (Burley Tobacco and Burley Tobacco 2).

Dataset wrap
Nameit
Dataset2

Row

DOMAIN

STUDYIDSPTOBIDSTRFIDITSPECIFITCATITCURMTHITCPISPTMRF
1ITTOB07CIG01ABurley TobaccoNC 7LC
Air
MF5555555
2ITTOB07CIG01ABright TobaccoCC 1063
Flue

3ITTOB07CIG01AOriental TobaccoUSDA Nicotiana Collection PI 552747
Sun

4ITTOB07CIG01AReconstituted Tobacco
COMPLEX INGREDIENT
N
5ITTOB07CIG01ABurley Tobacco 2KT215LC
Air

...

Finally, the IQ domain is used to represent the quantity (target, minimum and maximum) of each ingredient identified in STRFID that the product (SPTOBID) is designed to contain, with the units for these values represented in IQUNIT. The function of each ingredient is described in IQFUNCT. Ingredients that appear in more than one component of the tobacco product are quantified separately for each component. (see note 3) IQPARENT and IQLEVEL are used to identify the component/ingredient of which the ingredient in a record is a constituent component, and and at which level in the overall hierarchy the constituent ingredient appears. The following implementation rules apply:

  • IQPARENT must correspond to a value of STRFID in the same dataset. If parent is null, the ingredient is considered a top-level component and is assigned a value of "1" in IQLEVEL.
  • Records describing ingredients that are constituent ingredients of another ingredient/component listed in the dataset will have IQPARENT value equal to the STRFID of that ingredient/component. IQLEVEL will be set to n +1, where n=the parent record's value of IQLEVEL. 
  • Every value of STRFID used in the IQ dataset that has an IQLEVEL >1 (See note 4) must >1 must have a matching value of STRFID in either:
    • The IT dataset (when IQCAT=TOBACCO INGREDIENT) or,
    • The IN dataset (when IQCAT=NON-TOBACCO INGREDIENT)
    • Therefore, IQCAT is required to relate ingredient quantity records in IQ to the associated ingredient attributes described in either IT or IN.

The use of IQLPARENT and IQLEVEL help make explicit the relationship between complex ingredients and their constituents, and can assist when totaling the quantities of an ingredient that appears in multiple components of a tobacco product. 
The concept map below illustrates the representation of the hierarchical relationships between a complex ingredient and its constituent ingredients in the IQ domain structure. 

...

Dataset wrap
NameIQ
Rowcaps
Rows 1, 1013, 1316:Show three top-level components of a cigarette product: tobacco filler, filter, and cigarette paper, respectively. Their target, minimum and maximum quantities expressed in units of mg/cigarette are shown in IQTARG, IQMIN, IQMAX and IQUNIT. Because there is no parent component other than the finished product itself, IQPARENT is null, and IQLEVEL = 1, indicating that these are top-level ingredients/components of the finished product.
Rows 2-5:Show the quantities of four types of tobacco used in the product. IQPARENT=Tobacco Filler and IQLEVEL=2, together indicating that these are constituents of the tobacco filler, a top level-component of the cigarette product.
Rows 6-7-8:Show the three constituent tobacco ingredients that comprise reconstituted tobacco in row 5 (IQPARENT=Reconstituted Tobacco). The quantities of these tobaccos pertain to the quantity at which they appear in the reconstituted tobacco ONLY. Therefore, the total quantity of the individual tobaccos used in this tobacco product is the sum of these three plus the sum of the quantities shown in rows 1-3.  IQLEVEL=3 to show that these ingredients are at the 3rd level of the hierarchy (constituents of an ingredient with IQLEVEL=2).
Rows 9-10:Show the quantities of two non-tobacco ingredients, Methylcellulose and 1,3-Butanediol, Both which are further constituent ingredients of Reconstituted Tobacco as indicated by IQPARENT. IQFUNCT shows that Methylcellulose functions as a binder and 1,3-Butanediol functions as a humectant. IQLEVEL=3 to show that these ingredients are at the 3rd level of the hierarchy.
Rows 811-912:Show the quantities of two constituent ingredients that both function as a flavorant in the tobacco filler (as indicated by IQFUNCT= Flavor and IQPARENT=Tobacco Filler).
Rows 1114-1215:Show the quantities of two constituent ingredients that function as filtration and binderplasticizer, respectively, in the filter portion of the cigarette (Cellulose Filter A, a top-level component shown in row 13).
Rows 1417-1922:Show the quantities and function functions of five six constituent ingredients of the top-level component FSC Paper B (the cigarette paper shown in row 16).
Dataset2
RowDOMAINSTUDYIDSPTOBIDSTRFIDIQCATIQPARENTIQLEVELIQFUNCTIQTARGIQMINIQMAXIQUNIT
1IQTOB07CIG01ATobacco FillerTOBACCO INGREDIENT
1
672.5661.3683.7mg/cigarette
2IQTOB07CIG01ABurley TobaccoTOBACCO INGREDIENTTobacco Filler2
191721mg/cigarette
3IQTOB07CIG01ABright TobaccoTOBACCO INGREDIENTTobacco Filler2
300295305mg/cigarette
4IQTOB07CIG01AOriental TobaccoTOBACCO INGREDIENTTobacco Filler2
115113117mg/cigarette
5IQTOB07CIG01AReconstituted TobaccoTOBACCO INGREDIENTTobacco Filler2
231229233mg/cigarette
6IQTOB07CIG01ABurley Tobacco 2TOBACCO INGREDIENTReconstituted Tobacco3
191820mg/cigarette
7IQTOB07CIG01ABright TobaccoTOBACCO INGREDIENTReconstituted Tobacco3
103101105mg/cigarette
8IQTOB07CIG01AOriental TobaccoTOBACCO INGREDIENTReconstituted Tobacco3
656367mg/cigarette
9IQTOB07CIG01AMethylcelluloseNON-TOBACCO INGREDIENTReconstituted Tobacco3Binder201921mg/cigarette
710IQTOB07CIG01A1,3-ButanediolNON-TOBACCO INGREDIENTReconstituted Tobacco3Humectant242325mg/cigarette
811IQTOB07CIG01ACocoa ExtractNON-TOBACCO INGREDIENTTobacco Filler2Flavor76.757.25mg/cigarette
912IQTOB07CIG01AButyric AcidNON-TOBACCO INGREDIENTTobacco Filler2Flavor0.50.550.45mg/cigarette
1013IQTOB07CIG01ACellulose Filter ANON-TOBACCO INGREDIENT
1Filter164163165mg/cigarette
1114IQTOB07CIG01ACellulose AcetateNON-TOBACCO INGREDIENTCellulose Filter A2Filtration155154156mg/cigarette
1215IQTOB07CIG01ATriacetinNON-TOBACCO INGREDIENTCellulose Filter A2Plasticizer9810mg/cigarette
1316IQTOB07CIG01AFSC Paper BNON-TOBACCO INGREDIENT
1Cigarette Paper (Wrapper)504951mg/cigarette
1417IQTOB07CIG01ACellulose PulpNON-TOBACCO INGREDIENTFSC Paper B2Fiber302931mg/cigarette
1518IQTOB07CIG01ACalcium CarbonateNON-TOBACCO INGREDIENTFSC Paper B2Filler151416mg/cigarette
1619IQTOB07CIG01ASodium AlginateNON-TOBACCO INGREDIENTFSC Paper B2Reduced ignition propensity21.752.25mg/cigarette
1720IQTOB07CIG01ATrisodium CitrateNON-TOBACCO INGREDIENTFSC Paper B2Combustion Modifier0.50.450.55mg/cigarette
1821IQTOB07CIG01ACationic StarchNON-TOBACCO INGREDIENTFSC Paper B2Binder0.50.450.55mg/cigarette
1922IQTOB07CIG01ASeam AdhesiveNON-TOBACCO INGREDIENTFSC Paper B2Adhesive21.752.25mg/cigarette

...