EXPOSURE-BASED SCREENING TOOL TO EVALUATE ...

Center for Chemical Regulation and Food Safety

EXPOSURE-BASED SCREENING TOOL TO EVALUATE CONTAMINANT COMPLIANCE IN SPICES: ASTA SPICE SCREENING TOOL

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EXPOSURE-BASED SCREENING TOOL TO EVALUATE CONTAMINANT COMPLIANCE IN SPICES: ASTA SPICE SCREENING TOOL Prepared for American Spice Trade Association 1101 17th Street, NW Suite 700 Washington, DC 20036 USA Prepared by Exponent, Inc. 1150 Connecticut Avenue, NW Suite 1100 Washington, DC 20036 May 11, 2020 Exponent, Inc.

ASTA Spice Screening Tool

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Contents

Page

List of Figures iii

List of Tables iv

List of Acronyms v

BACKGROUND 1

ASTA SPICE SCREENING TOOL FRAMEWORK 2

Hazard characterization (Lead) 4

US Food and Drug Administration 4

Proposition 65 5

JECFA 5

Dietary Exposure Assessment 6

Concentration Data 6

Spice Usage Data 7 Diet 7 Dietary supplements 9 Intake Estimates 9

Estimating Exposures 10 Consideration of Exposure Metrics 10

Risk Characterization 12

Comparison to regulatory thresholds 12

Derivation of maximum contaminant limits 12

SCREENING CONSIDERATIONS 13

REFERENCES 14

APPENDIX A: User’s Guide 15


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List of Figures

Page

Figure 1. Framework of the ASTA Spice Screening Tool for Lead in Five Select Spices 3


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List of Tables

Page

Table 1. Current Regulatory Thresholds included in the ASTA Spice Screening tool: Lead (CASRN 7439-92-1) 4


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List of Acronyms

CFR Code of Federal Regulations

DHHS Department of Health and Human Services

FDA US Food and Drug Administration

FNDDS USDA’s Food and Nutrient Database for Dietary Studies

IRL Interim Reference Level

JECFA Joint FAO/WHO Expert Committee on Food Additives

MADL Maximum allowable dose level

NCHS National Center for Health Statistics

NHANES National Health and Nutrition Examination Survey

NSRL No significant risk level

OEHHA California’s Office of Environmental Health Hazard Assessment

PTTI Provisional total tolerable intake

PTWI Provisional tolerable weekly intake

RACC Reference Amounts Customarily Consumed

USDA US Department of Agriculture

WWEIA What We Eat in America


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BACKGROUND

Under contract with The American Spice Trade Association (ASTA), Exponent, Inc. (Exponent)

developed an exposure-based spice screening tool (ASTA Spice Screening tool) for the purpose

of evaluating exposure to contaminants in select spices in comparison with established

regulatory thresholds. The first version of the tool described in the current report has been

developed specifically for exposure to lead in dried basil, cinnamon/cassia, ginger, oregano, or

turmeric based on consumption of these spices in the US. The screening tool can be updated

in future versions to incorporate additional spices as well as additional contaminants of concern

and their associated regulatory thresholds.

The ASTA Spice Screening tool has three key components: 1) hazard characterization, 2) dietary

exposure assessment and 3) risk characterization. This report describes the data and methods

used in developing the ASTA Spice Screening tool. A user-guide on how to operate the tool is

also included.

**************************************************************************** WARNING: The ASTA Spice Screening tool is a screening tool using default assumptions. Users must always check contaminant limits derived for select food/ingredient using the tool against existing regulatory limits. The ASTA Spice Screening tool cannot be used to override these existing regulatory limits. *****************************************************************************


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ASTA SPICE SCREENING TOOL FRAMEWORK

The ASTA Spice Screening tool has three key components: 1) hazard characterization, 2) dietary

exposure assessment and 3) risk characterization. In the hazard characterization component,

current regulatory thresholds that have been established by authoritative bodies are identified

and incorporated into the tool for use in the risk characterization component. In the dietary

exposure assessment component, the ASTA Spice Screening tool estimates exposure to a

chemical contaminant in a spice (consumed either in food and/or as a dietary supplement)

based on an estimate of spice intake multiplied by the concentration of the contaminant in that

spice. Within the risk characterization component, the ASTA Spice Screening tool provides a

comparison of the estimated dietary exposure to the established regulatory thresholds.

In addition, using the hazard characterization component and the estimated spice intake, the

ASTA Spice Screening tool can estimate the theoretical maximum contaminant level in a spice

such that detection of the contaminant below that level would result in estimated daily

exposures below the established regulatory thresholds.

A schematic of the framework for the screening tool is presented in Figure 1.


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Figure 1. Framework of the ASTA Spice Screening Tool for Lead in Five Select Spices


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Hazard characterization (Lead)

A summary of the regulatory thresholds for lead that are incorporated into the current version

of the ASTA Spice Screening tool is provided in Table 1. At ASTA’s request, regulatory

thresholds for additional contaminants can be added and incorporated into the tool.

Table 1. Current Regulatory Thresholds included in the ASTA Spice Screening tool: Lead (CASRN 7439-92-1)

Authoritative Body

Threshold Type

Subpopulation of interest

Threshold level Units

Reference

OEHHA MADL “Average consumer”

0.5 µg/day California Health and Welfare Agency, 1989

OEHHA NSRL “Average consumer”

15 µg/day OEHHA, 2001

US FDA IRL Children 3 µg/day FDA, 2019 US FDA IRL Adults 12.5 µg/day FDA, 2019 JECFA PTWI

(withdrawn) Total Population

25 µg/kg bw/week JECFA, 2011

US Food and Drug Administration

The US Food and Drug Administration (FDA) had developed a provisional total tolerable intake

(PTTI) levels of lead for particular age and sex groups (Carrington and Bolger, 1992). The PTTI

levels were established for the at-risk population groups of children, pregnant and lactating

women and adult women. In 2017, the FDA formed the Toxic Elements Working Group in part

to re-evaluate when the FDA should take action on lead levels in particular foods. The working

group calculated an interim reference level (IRL) based on the U.S. Centers for Disease Control

and Prevention blood lead level of concern of 5 µg/dL for children developed in 2012. The


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current IRLs for lead are 3 µg/day for children and 12.5 µg/day for adults and women of child-

bearing age1.

Proposition 65

California’s Office of Environmental Health Hazard Assessment (OEHHA) has developed “safe

harbor” levels for lead based on requirements in the Safe Drinking Water and Toxic

Enforcement Act of 1986. This Act was enacted as a ballot initiative in California and is known

as Proposition 65. As part of this regulation, all businesses must warn and notify California

residents about compounds in food products they purchase that are known to cause cancer,

birth defects, or other reproductive effects. OEHHA’s “safe harbor” levels are based on a no

significant risk level (NSRL) for cancer-causing chemicals and maximum allowable dose level

(MADL) for chemicals causing reproductive toxicity. According to OEHHA, exposures that are

below the safe harbor levels are exempt from the requirements of Proposition 65. Lead has

been listed by OEHHA as both cancer-causing (NSRL) and causing reproductive toxicity (MADL).

JECFA

During the Joint FAO/WHO Expert Committee on Food Additives’ (JECFA’s) 30th meeting in

1987, a provisional tolerable weekly intake (PTWI) was established for infants and children and

was later extended to all age groups at the 41st meeting in 1993. However, at the 73rd meeting

in 2011, the committee found the established PTWI to be associated with at least a 3-point

decrease in IQ among children and an increase in blood pressure among adults. The committee

determined the PTWI could no longer be health protective and withdrew the threshold. The

committee also determined that a new PTWI could not be established that would be

considered health protective (JECFA, 2011). While the ASTA Spice Screening tool includes the

withdrawn PTWI for completeness, users should be aware that it is no longer an established

1 https://www.fda.gov/food/metals-and-your-food/lead-food-foodwares-and-dietary-supplements

https://www.fda.gov/food/metals-and-your-food/lead-food-foodwares-and-dietary-supplements


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regulatory threshold. A provisional tolerable daily intake of 3.6 µg/kg bw/day derived as

PTWI/7 is used in the ASTA Spice Screening tool.

Dietary Exposure Assessment

Dietary intake of a contaminant in a food component, such as spice, is often estimated based

on two parameters: 1) the concentration of the contaminant in the food component at the

time of consumption (Cf = µg/gfood) and 2) the amount of the food component consumed, i.e.,

the load (L = gfood/day). Under this general framework, exposure to a contaminant can be

estimated as either the product of an average consumption of a food and an average

concentration of the contaminant in or on that food, or as the product of the probability

distributions of food intakes and contaminant concentrations.

Formula 1:

Ef = (Cf)(L) Ef = Exposure to contaminant (C) from consumption of food (f)

Cf = Concentration in food component (µg/g food) L = Amount of food consumed (g food/day)

This dietary exposure model is incorporated in the ASTA Spice Screening tool to estimate daily

dietary exposure to the contaminant of interest from consumption of the spice of interest.

Based on the user’s selection of the spice of interest and user’s contaminant level entry, the

tool combines the contaminant level with the spice intake rates to generate screening-level

exposure estimates for the contaminant. The data used in the current tool are described in

detail below.

Concentration Data

The ASTA Spice Screening tool contains a screen allowing the user to enter the contaminant

concentration for the selected spice. It is the responsibility of the user to assure that the

concentration data value entered into the model is accurate and that the user understands if

the value being entered is representative of the spice being evaluated, or whether it is a worst-


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case value based on assumptions. The user would need to be able to document the reference

sources from which the concentration data were derived and supporting rationale if an

assumed worst case value is being used.

Note this step is only required when a comparison to regulatory thresholds is selected as the

evaluation method.

Spice Usage Data

Diet

Estimated daily intakes of select spices used as ingredients in foods were based on food

consumption records collected in the What We Eat in America (WWEIA) component of NHANES

conducted in 2013-2014 and 2015-2016 (NHANES 2013-2016)2. This continuous survey uses a

complex multistage probability sample designed to be representative of the civilian US

population (NCHS 2016, 2018). The NHANES datasets provide nationally representative

nutrition and health data and prevalence estimates for nutrition and health status measures in

the United States. Statistical weights are provided by the National Center for Health Statistics

(NCHS) to adjust for the differential probabilities of selection.

As part of the examination, trained dietary interviewers collected detailed information on all

foods and beverages consumed by respondents in the previous 24 hour time period (midnight

to midnight). A second dietary recall was administered by telephone three to ten days after the

first dietary interview, but not on the same day of the week as the first interview. The dietary

component of the survey is conducted as a partnership between the US Department of

Agriculture (USDA) and the US Department of Health and Human Services (DHHS). DHHS is

responsible for the sample design and data collection while USDA is responsible for the survey’s

dietary data collection methodology, maintenance of the databases used to code and process

2 The predecessor survey to NHANES, the US Department of Agriculture’s Continuing Survey of Food Intakes by Individuals

(“CSFII”), is specifically suggested for use in estimating the extent of exposure by the Proposition 65 regulations at Title 27 of the California Code of Regulations section 25721(d)(4).


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the data, and data review and processing. A total of 14,601 individuals in the survey period

2013-2016 provided two complete days of dietary recalls.

Consumption data in the NHANES survey are reported on an “as consumed basis” with

individual foods represented by an 8-digit food code. That is, if a survey participant consumed

an apple pie, the consumption amount reported in the survey for that subject would be for the

amount of pie consumed, and not for the ingredients (flour, butter, apples, sugar, cinnamon

etc.) used to make that pie. For the spice products that are used as ingredients in foods, which

are typically not recorded in the dietary diaries of survey participants, Exponent utilized USDA’s

food database that translates NHANES foods as consumed into its corresponding ingredients

(and gram amounts) or recipes. Consumption of food ingredients that corresponded to the

selected spice was estimated using the USDA recipes when the target food was a component of

the reported food (e.g., cinnamon, cloves, ginger, parsley, sesame seeds). Thus, for foods that

contained the spice of interest, only the ingredient component corresponding to the spice was

captured in the analysis. A description of mapping is described below and in Table 2.

Spice mapping

Due to the complexity of spices used as ingredients in foods as consumed and which are

typically not recorded in the dietary diaries of survey participants’ within NHANES, Exponent

utilized USDA databases that translate NHANES foods as consumed into its corresponding

ingredients (and gram amounts) in addition to internet-based searches for recipes that

incorporate the selected spices. Exponent first applied USDA’s Food and Nutrient Database for

Dietary Studies FNDDS version 2015-2016 recipes (which corresponds to dietary consumption

for NHANES 2015-2016 (USDA 2018) to process dietary recall data reported in NHANES 2013-

2016 and FNDDS version 2013-2014 recipes (which corresponds to dietary consumption for

NHANES 2013-2014) (USDA 2016) for foods that were only reported consumed in 2013-2014.

For spices that had reported consumption of the fresh form (i.e., basil), the dried amount was

estimated based on the water content of the fresh form. The mapping was then expanded to

include food categories expected to contain the spice based on internet recipe searches and

typical uses for the dried spices. The percent of spice within a food was based on the maximum


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percent use within a food type (e.g., pasta sauces) derived from the FNDDS recipes. Therefore,

spice consumption was estimated using recipes and only the portion of the food as consumed

that corresponded to the spice was captured in the analysis.

Dietary supplements

In addition to the intake of spices from use as an ingredient in foods, the intake of spice from

use of dietary supplements containing the spice of interest was estimated based on the 24-hour

dietary recall records in NHANES 2013-2016. Starting in the NHANES 2007-2008 cycle, NHANES

collected supplement use data along with food consumption data as part of the 24-hour dietary

recall data collection. The data collection for the 24-hour dietary supplement use is

administered by the trained dietary interviewers. During the 24-hour recall, NHANES

participants who reported taking supplements in the past 30 days in the household

questionnaire were asked if they took these supplements in the previous 24 hours, and if so,

how much of each they took. All participants in the 24-hour recall were also asked if they took

any other supplements, not reported during the 30-day supplement use household interview,

and, if so, they were asked to report how much they took. To identify supplements that

contain the selected spice, Exponent reviewed the supplements reported taken that contained

the spice in the name or in the ingredient listing. The amount of the spice in each supplement

was based on the reported value in the Dietary Supplement Ingredient Information dataset

within the NHANES Dietary Supplement Database.

Intake Estimates

For each selected spice, two-day average intake estimates from diet alone as well as from diet +

dietary supplements were derived for the total US population age 2+ y, Infants 6m to 2y,

Children 2 to 6 y, Children 6 to 12 y, Children 2-12 y, and Females 14 to 45 y. To estimate the

total spice intake from diet + supplement use by each respondent the amount of spice from

each source was added at the individual respondent level. The two-day average daily intake

was derived for each individual in the NHANES survey who reported consuming any food

and/or dietary supplement containing the selected spice on either of the survey days and each


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individual’s responses for both survey days were used to estimate his/her 2-day average daily

intake. For example, if a person reported consuming 1 gram of cinnamon on day 1 and 0.2

grams on day 2, his/her 2-day average consumption for cinnamon would be 0.6 grams ([1 +

0.2]/2). Statistically weighted values from the survey were used in the analyses. The statistical

weights compensate for variable probabilities of selection, adjust for non-response, and

provide intake estimates that are representative of the U.S. population and the selected age-

gender subgroups.

Summary statistics of the two-day average spice intake rates, i.e. mean, 90th, 95th and 99th

percentiles are derived on a per user basis. The per user approach includes only users in the

derivation of the summary statistics. In this analysis, a “user” is anyone who reported

consuming a food containing the select spice on either of the survey days. This approach is

consistent with the definition of “user” followed by the USDA. Intake estimates were derived

on both a g/day basis and a g/kg bw/day basis using each individual’s body weight. The 2-day

average intakes by each individual were estimated using Exponent’s Foods and Residues

Evaluation Program (FARE® version 13.04) software.

Estimating Exposures

In the ASTA Spice Screening tool, exposure to a contaminant in a selected spice (estimated daily

exposure) is estimated as the product of an arithmetic mean, 90th, 95th or 99th percentile spice

intake estimate and the contaminant concentration in that spice that have been entered by the

user. In addition, the option to apply the FDA’s Reference Amounts Customarily Consumed

(RACC) for spices and herbs of 0.5 grams (21 CFR §101.12) is available to replace the intake

estimates based on consumption data from NHANES.

Consideration of Exposure Metrics

FDA Regulatory Thresholds


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Typically, the FDA evaluates exposure at the per user mean and 90th percentile of consumers of

the food. The ASTA Spice Screening tool provides per user mean, 90th, 95th, and 99th percentile

intake estimates to allow for an estimate of worst-case exposure scenarios.

Proposition 65

According to Proposition 65 regulations, exposure estimation should be conducted on a

product by product basis and is not intended to be a cumulative, total diet exposure scenario.

Therefore, the exposure estimates derived from the ASTA Spice Screening tool are directly

applicable to a Proposition 65 assessment. Furthermore, exposure estimates and risk

characterization according to OEHHA should be based on the average consumer. As stated in

the Proposition 65 regulations at Title 27 of the California Code of Regulations section

25821(c)(2) “For exposures to consumer products, the level of exposure shall be calculated using

the reasonably anticipated rate of intake or exposure for average users of the consumer

product, and not on a per capita basis for the general population.” For that reason, low or high-

end consumers are not intended for consideration in the Proposition 65 risk process nor are

non-consumers. This screening tool provides arithmetic mean consumption estimates among

consumers of the select spices (i.e., per user). Where the consumption data is not normally

distributed (i.e., bell-shaped) but rather skewed (e.g., lognormal), as is typically the case for

consumption distributions, the arithmetic mean is not the most appropriate estimate of typical

consumption. If the data are skewed, the highest (and lowest) statistical values in the

distribution curve can distort the estimate of an average if the arithmetic mean is used. Rather,

for log normally distributed consumption data, estimates based on the geometric mean are

most appropriate since the geometric mean is less influenced by the highest and lowest

statistical values. Finally, the current screening tool does not incorporate any measure of the

frequency of consumption of the spice, which is an important component of estimating usual

consumption, especially for food products that are consumed infrequently.


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Risk Characterization

Comparison to regulatory thresholds

In the risk characterization component of the tool, risk estimates are derived using the

following two approaches depending on the regulatory threshold selected:

1) Exposure as a percent of the threshold: The screening-level estimated daily exposures, on

a per user basis, are compared to the established regulatory threshold. Screening-level risk

estimates are expressed as a % of the threshold (i.e., % of IRL or PTDI). The exposure estimates

provided in the ASTA Spice Screening tool are based on intake of an individual spice and not

aggregated across all spice consumption or the total diet.

2) Exposure compared to warning threshold based on established “safe harbor” levels: The

screening-level estimated daily exposures, on a mean per user basis, are compared to the

established safe harbor levels (i.e., the MADL and NSRL). Screening-level risk estimates are

expressed as either being above or below the safe harbor level.

Derivation of maximum contaminant limits

Based on intake estimates for the selected spice and the regulatory thresholds for a

contaminant, a screening level contaminant limit, i.e. maximum contaminant concentration in

the select spice to not exceed, in order to ensure exposure to the contaminant remaining

below the regulatory threshold, can be derived. However, when contaminant limits exist for

certain food/ingredients, such as those established by FCC, Codex, FDA, such limits must be

followed and the ASTA Spice Screening tool cannot be used to justify contaminant levels

exceeding existing limits. Further, the derived maximum contaminant limit in the ASTA Spice

Screening tool is based on the estimated daily exposure to a contaminant from an individual

spice and does not consider additional exposure to the same contaminant from other dietary

sources which would need to be considered in comparison to a regulatory threshold based on

the total diet.


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SCREENING CONSIDERATIONS

The ASTA Spice Screening tool was developed for the purpose of allowing risk assessors and

managers the ability to rapidly evaluate potential risks that may be associated with

contaminants in spices. A screening tool generally uses readily available data and simple

models where conservative assumptions are intentional and deliberate in order to allow for

these rapid decisions. This type of assessment supports a decision-making process where

contaminant levels that are not of public health concern can be set aside while identifying

those that warrant further assessment with more refined data. However, it is important to

note that while the estimated dietary exposure from a single spice may be conservative, risk

decisions when comparing to thresholds based on the total diet (e.g., the FDA’s IRL for lead)

need to consider the potential for exposure to the contaminant from other spices as well as

other food and beverage sources in the diet.

The ASTA Spice Screening tool relies on an exposure-based framework. For screening purposes,

estimates of spice intake are purposely and conservatively overestimated such that the

estimated daily exposures or the theoretical maximum contaminant limits calculated by the

current screening tool provide conservative results. As a screening tool, the conservative

results are designed to in turn, provide for conservative risk management decisions that are

protective of public health and serves to identify those exposure scenarios for which a more

refined analysis, focused on refined data inputs, may be needed


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REFERENCES

National Center for Health Statistics (NCHS). 2018. National Health and Nutrition Examination Survey Data 2015-2016. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available from: https://wwwn.cdc.gov/nchs/nhanes/search/datapage.aspx?Component=Dietary&CycleBeginYear=2015.

National Center for Health Statistics (NCHS). 2016. National Health and Nutrition Examination Survey Data 2013-2014. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. Available from: https://wwwn.cdc.gov/nchs/nhanes/ContinuousNhanes/Default.aspx?BeginYear=2013.

Office of Environmental Health Hazard Assessment (OEHHA). 2001. NO SIGNIFICANT RISK LEVELS (NSRLS) FOR THE PROPOSITION 65 CARCINOGENS LEAD AND LEAD COMPOUNDS (ORAL). California Environmental Protection Agency. Available from: https://oehha.ca.gov/media/downloads/crnr/leadoralnsrl.pdf

U.S. Department of Agriculture (USDA). 2018. USDA Food and Nutrient Database for Dietary Studies (FNDDS), 2015-2016. Beltsville, MD: US Department of Agriculture, Agricultural Research Service, Food Surveys Research Group. Available via: https://www.ars.usda.gov/northeast-area/beltsville-md/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/fndds-download-databases/.

U.S. Department of Agriculture (USDA). 2016. USDA Food and Nutrient Database for Dietary Studies (FNDDS), 2013-2014. Beltsville, MD: US Department of Agriculture, Agricultural Research Service, Food Surveys Research Group. Available via: https://www.ars.usda.gov/northeast-area/beltsville-md/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/fndds-download-databases/.

Joint FAO/WHO Expert Committee on Food Additives (JECFA). 2011. Evaluation of certain food additives and contaminants. 73rd Meeting of the Joint FAO/WHO Expert Committee on Food Additives. World Health Organization, Technical Report Series. Geneva.

https://wwwn.cdc.gov/nchs/nhanes/search/datapage.aspx?Component=Dietary&CycleBeginYear=2015

https://wwwn.cdc.gov/nchs/nhanes/search/datapage.aspx?Component=Dietary&CycleBeginYear=2015

https://wwwn.cdc.gov/nchs/nhanes/ContinuousNhanes/Default.aspx?BeginYear=2013

https://oehha.ca.gov/media/downloads/crnr/leadoralnsrl.pdf

https://www.ars.usda.gov/northeast-area/beltsville-md/beltsville-human-nutrition-research-center/food-surveys-research-group/docs/fndds-download-databases/





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APPENDIX A: User’s Guide

Administrative Screen: Before using the ASTA Spice Screening tool, the user is required to

read and “accept” the End user agreement.

Once acceptance is completed the user is taken to the “Step 1” screen.


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Step 1 Screen: In this screen, user will begin the screening assessment by selecting the spice,

contaminant, and type of risk characterization to be conducted.

Drop down menus for user selection


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Step 2 Screen: Select type and source of spice intake

In Step 2, the user will select the type and source of spice intake. Any of the options can be

selected alone or in combination with each other. Selection of these sources will determine

which spice use data is used in the calculation of the dietary exposure for comparison to the

threshold or of the maximum contaminant level. The user can include exposure to the

contaminant from diet alone (i.e., use of the spice as an ingredient in foods as consumed)

and/or diet + dietary supplements containing the spice. In addition, the user can select the

FDA’s RACC as a default spice intake of 0.5 grams to be used in the following calculations of

dietary exposure.

The user will not be allowed to move to Step 3 unless at least one of the options is selected.


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Step 3 Screen: Selection of Regulatory Threshold

In Step 3, the user will select the regulatory threshold for comparison to the estimated dietary

exposure in the risk characterization step.


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Step 4 Screen: Enter contaminant level

In Step 4, the user will enter the contaminant level into the box with the orange font in parts

per billion (ppb or µg/kg spice) for the spice that was selected in Step 1.


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Step 5 Screen: Selection of populations

In Step 5, default population(s) will be pre-selected for the user based on the user’s selection of

the regulatory threshold in Step 4. The default population will be the recommended population

group(s) for which the risk characterization should be conducted based on the established

thresholds and known sensitive populations (e.g., women of child-bearing age). The user can

either keep the default selection and/or add additional subpopulations for evaluation.


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Step 6 Screen: Risk characterization results (Proposition 65 Example)

Step 6 provides the results of the risk characterization based on the user’s selections. In a Proposition 65 comparison evaluation, the estimated daily exposure to the contaminant in the spice selected is compared to the safe harbor levels and the tool provides a “Below/Above” comparison. Note that the estimated daily exposures in the ASTA Spice Screening tool are based on arithmetic means and 2-day average intake rates and are therefore, conservative estimates of the usual intake rate for a food that is infrequently consumed with a skewed consumption distribution. Note: The result tables generated by the ASTA Spice Screening tool can be copy/pasted into a Word document and/or printed from the Excel Workbook.


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Step 6: Risk characterization results (FDA Example)

Step 6 provides the results of the risk characterization based on the user’s selections. In a comparison evaluation based on the FDA’s IRL for lead, the estimated daily exposure to lead in the spice selected is compared to the IRL and the tool provides the exposure estimate as a percent of the IRL. Note that the estimated daily exposures in the ASTA Spice Screening tool are from consumption of an individual spice while the FDA’s IRL is for lead exposure in the total diet. For that reason, comparison of the estimated daily exposure from an individual spice to the regulatory thresholds (i.e., the IRL or the PTDI) should result in estimates that are “relatively low” compared to the threshold to allow room for exposure to the same contaminant from other dietary sources. Note: The result tables generated by the ASTA Spice Screening tool can be copy/pasted into a Word document and/or printed from the Excel Workbook.


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Step 6: Derivation of Maximum Contaminant Limits (Proposition 65 Example)

Step 6 provides the results of the derivation of maximum contaminant limits based on the user’s selections. In a Proposition 65 evaluation, the maximum limit is the maximum concentration (ppb) of the contaminant in the spice that would result in estimated daily exposure below the safe harbor level.

When contaminant limits exist for certain food/ingredients, such as those established by FCC, Codex, FDA, such limits must be followed and the ASTA Spice Screening tool cannot be used to justify contaminant concentration exceeding existing limits. Further, the derived maximum limit in the ASTA Spice Screening tool is based on the estimated daily exposure to a contaminant from an individual spice and does not consider additional exposure to the same contaminant from other dietary sources which would need to be considered in comparison to a regulatory threshold based on the total diet.

Note: The result tables generated by the ASTA Spice Screening tool can be copy/pasted into a Word document and/or printed from the Excel Workbook.

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