Analysis of Lead in Sindoor and Related Religious Powders Purchased in New Jersey

Home , Manthan, Sindoor

Manthan Shah

and India

By Manthan Shah

A dissertation submitted to the

School of Public Health

and the

Graduate School—New Brunswick

Rutgers, The State University of New Jersey

In partial fulfillment of the requirements

for the degree of

Doctor of Philosophy

Written under the direction of

Professor Derek G. Shendell

And Approved by

______

New Brunswick, NJ

October, 2016

ABSTRACT OF THE DISSERTATION

Analysis of Lead in Sindoor and Related Religious Powders Purchased in New Jersey

and India

By MANTHAN SHAH

Dissertation Director:

Derek G. Shendell

Sindoor, an orange, maroon or red powder used for Hindu cultural and religious purposes, has been found to be adulterated with lead tetroxide, (Pb3O4, red lead). Red lead is often added to give the sindoor powder a deep red color. The adverse health effects caused by lead exposure have been widely documented and in children can include abdominal pain, learning disabilities reduced attention span, slowed growth and antisocial and delinquent behavior. Currently, there is no known safe level of lead exposure in children. We believe this is the first study to comprehensively assess lead (Pb) concentrations in sindoor and related powders from not only a wide geographical area in an entire state but also in those sindoor powders purchased directly from India. A total of

170 religious powders were purchased in different regions of the state (Northern, Central and Southern Jersey). Out of those 170 powders, 118 were sindoor and 52 were miscellaneous religious powders. Of the 118 powders, 95 were purchased from 66 South

Asian stores in New Jersey while 23 were purchased in India. The miscellaneous powders

were purchased in New Jersey. Laboratory analysis revealed how, among, U.S. sindoor powders, 79 (83.2%) of tested powders contained >1 g/g Pb. The median lead concentration for tested U.S. sindoor powders was 3.0 g/g Pb with a maximum Pb level of >300,000 g/g Pb. For sindoor powders purchased in India, 18 (78.3%) samples contained >1 g/g Pb. The median Pb concentrations for these sindoor powders was 12.7

g/g Pb with a maximum Pb level of >300,000 g/g Pb. Two samples, purchased from

Mumbai, contained >1% Pb. A third sample, also purchased from Mumbai, contained

0.5% g/g Pb. For miscellaneous religious powders, 29 (55.8%) powders contained >1

g/g Pb. The median Pb concentration for these powders was 1.1 g/g Pb with a maximum Pb level of 61.0 g/g Pb. Semi-quantitative x-ray fluorescence (XRF) and colormetric tests successfully identified lead in samples with higher Pb levels (i.e.,

>300,000 g/g), but were not effective for samples with lower Pb levels. In summary, these results underscore the need for hazard surveillance of sindoor.

iii

Acknowledgements

This project was possible due to the support of my academic advisor, Dr. Derek

Shendell, D.Env, MPH and co-chair of my committee Dr. William Halperin, MD, MPH,

DrPH. Dr. Shendell has supported me throughout the completion of both my MPH and now PhD. His dedication to his students is unmatched and helped me complete my degree. It was Dr. Halperin who first had the idea for this project and his passion for public health carried it forward. His focus on the public health impact of this project has exposed me to the challenges and different venues of public health action—something I can use later in my career.

I would also like to thank my colleagues at the New Jersey Department of Health, especially Dr. Margaret Lumia, Virginia Wheatly and Dr. Daniel Lefkowitz. Their interest in this project is remarkable and I am truly grateful for the time they took out of their busy schedules to help me understand what role the health department could play in the protection of consumers from toxic products, including public health outreach. I would also like to thank Donald Gerber for taking time out of his workday to help me with the XRF test.

I am also grateful to Dr. John Bogden and Frank Kemp who patiently worked with me and provided high quality laboratory analytical results of the samples.

Finally, I would like to thank my friends and family without whose support I would not have completed my doctorate. I want to specifically thank my parents who provided their encouragement and anything else I needed throughout my academic career. I’m forever grateful.

Table of Contents

Abstract of the Dissertation ii Acknowledgements iv List of Tables viii List of Figures x Chapter 1 1 Introduction 1 Background 1 Alternative Sources for Lead Exposure 2 Sindoor 3

Role of Hazard Surveillance in Identifying Lead Contamination 5 Lead Toxicokinetics 6 Sindoor Related Lead Poisoning Cascade of Prevention 8 Lead Toxicodynamics: Health Effects Due to Lead Exposure 9 U.S. Food and Drug Administration Regulations 9 New Jersey Department of Health Regulations 11 Chapter 2 14 Literature Review on Sindoor 14 Research Objectives/Aims 17 Hypotheses 18

Chapter 3 19 Methods 19 Sample Collection: New Jersey South Asian Grocery Markets 19 Sindoor Use Survey 21 Sample Collection: Markets in Mumbai and New Delhi, India 22 Sindoor Collection and Newark Liberty International Airport 23 Lead Analysis 24 XRF Lead Analysis Procedure 26 Lead Test Kit Analysis Procedure 27

Laboratory Lead Analysis Procedure 29 Data Analysis 30 Chapter 4 34 Results 34 Sindoor 34 Analysis Results for Sindoor 36 Miscellaneous Religious Powders 38 Analysis Results for Miscellaneous Religious Powders 40 Packaging Types (Sindoor and Related Powders) 40 Analysis of Powders by Lead Level Categories 44 Case Control Analysis 44 XRF Analysis Results 45 Colormetric Analysis Results 50 Sindoor Use Survey Results 58 Chapter 5 61 Discussion 61 Sindoor Collection and Analyses 61

Packaging Types 65

Lead Level Category Analysis and Case Control Analysis 66

XRF and Colormetric Analysis 68 Sindoor Use Survey 73 Study Limitations 75 Public Health Outreach, Education and Action 76 Conclusion and Future Research 84 References 86 Appendices 93 Appendix 1: Lead Threshold Levels in Household Dust, Consumer Products and Workplaces 94 Appendix 2: Maps of Sampling Areas 96

Appendix 3: Tables of Purchased Brands, Packaging Types, Manufacturers, Distributors and Other Pertinent Information By Sampling Region 99

Appendix 4: New Jersey South Asian Markets Survey Tool 105

Appendix 5: Information Sheet 108

Appendix 6: Sindoor Samples Purchased in India 110

Appendix 7: Sindoor Collection Methodology for Newark Liberty International Airport 112 Appendix 8: E-mail Exchange for United Airlines Representative 117 Appendix 9: Overview of Sampling Results by Individual Sampling Regions in New Jersey and India 122

Appendix 10: Similarities Between Food Coloring and Sindoor Containers and Locations in Stores 124 Appendix 11: Sindoor Fact Sheet 127

vii

List of Tables

Table 1: Locations of Stores of Religious Powder Purchases 34 Table 2: Descriptive Statistics for Sindoor Powders 37 Table 3: Ranges and Percentages of Detectable Lead Content in Sindoor Powders by Purchase Location 38 Table 4: Ranges of Lead Content of Miscellaneous Powders by Color 39 Table 5: Descriptive Statistics for Miscellaneous Religious Powders 39 Table 6: Religious Powder Packaging Types (Sindoor + Other Powders) 41 Table 7: Religious Powder Packaging Types (U.S. Sindoor Only) 41 Table 8: Cross-Tabulations of Lead Level Categories and Purchase Locations of Sindoor and Related Powders 43 Table 9: Cross-Tabulations of Lead Level Categories and Packaging Types of Sindoor and Related Powders 44 Table 10: Odds Ratios for New Jersey Sampling Regions 44 Table 11: Odds Ratios for U.S. and India Sampling Regions 45 Table 12: Odds Ratios for Packaging Types 45 Table 13: XRF and Lab Analysis Results for North Jersey Samples 46 Table 14: XRF and Lab Analysis Results for Central Jersey Samples 47 Table 15: XRF and Lab Analysis Results for South Jersey Samples 47 Table 16: XRF and Lab Analysis Results for Mumbai Samples 48 Table 17: XRF and Lab Analysis Results for New Delhi Samples 48 Table 18: Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value for XRF Analysis and Cell Counts by Lead Level Category 49 Table 19: North Jersey Colormetric (Leach) and Lab Analysis Results 52 Table 20: North Jersey Colormetric (Rapid) and Lab Analysis Results 52 Table 21: Central Jersey Colormetric (Leach) and Lab Analysis Results 52 Table 22: Central Jersey Colormetric (Rapid) and Lab Analysis Results 53 Table 23: South Jersey Colormetric (Leach) and Lab Analysis Results 54 Table 24: South Jersey Colormetric (Rapid) and Lab Analysis Results 54 Table 25: Mumbai Colormetric (Leach) and Lab Analysis Results 55 Table 26: Mumbai Colormetric (Rapid) and Lab Analysis Results 55

viii

Table 27: New Delhi Colormetric (Leach) and Lab Analysis Results 55 Table 28: New Delhi Colormetric (Rapid) and Lab Analysis Results 56 Table 29: Sensitivity, Specificity, Positive Predictive Values, Negative Predictive Values for Colormetric Leach Test Analysis and Cell Counts by Lead Level Category 57 Table 30: Sensitivity, Specificity, Positive Predictive Values, Negative Predictive Values for Colormetric Rapid Test Analysis 57 Table 31: Sindoor Use Survey Results 60 Table 32: North Jersey Powder Brands, Packaging Types and Lead Levels 79 Table 33: Central Jersey Powder Brands, Packaging Types and Lead 80 Levels Table 34: South Jersey Powder Brands, Packaging Types and Lead Levels 81 Table A1-1: Housing and Urban Development Lead Threshold Levels in 95 Dust Table A1-2: Consumer Product Safety Commission Limits of Lead in 95 Products Table A1-3: National Institute for Occupational Safety and Health and 95 Occupational Safety and Health Administration Lead Limits for Workers Table A3-4: North Jersey Religious Powder Brands and Packaging 100 Information Table A3-5: Central Jersey Religious Powder Brands and Packaging 101 Information Table A3-6: South Jersey Religious Powder Brands and Packaging 104 Information Table A6-7: Sindoor Samples Purchased in Mumbai, India 111 Table A6-8: Sindoor Samples Purchased in New Delhi, India 111

List of Figures

Figure 1: Sindoor Related Lead Poisoning Cascade of Prevention 8 Figure 2: Sensitivity for XRF Analysis 71 Figure 3: Negative Predictive Value for XRF Analysis 72 Figure 4: Sensitivity for Colormetric Leach Test 72 Figure 5: Negative Predictive Value for Colormetric Leach Test 72 Figure 6: Sensitivity for Colormetric Rapid Test 73 Figure 7: Negative Predictive Value for Colormetric Rapid Test Analysis 73 Figure A2-1: Overview of Sampling Areas 97 Figure A2-2: Fifteen-Mile Radius of New Jersey Medical School 97 Figure A2-3: Fifteen Mile Radius of School of Public Health 98 (Central Jersey) Figure A2-4: Fifteen Mile Radius of School of Public Health 98 (South Jersey) Figure A10-6: Proximity of Placement of Sindoor and Food 125 Coloring in Stores Figure A10-7: Similarities Between Containers for Food 126 Coloring and Sindoor

Figure A11-5: Sindoor Fact Sheet 128

x 1

Chapter 1

Introduction

Background

Lead has been one of the most widely studied neurotoxicants over the last several decades. Its adverse health effects in adults and children are well documented and the reduction in blood lead levels (BLLs) over the last several decades is considered one of the great public health achievements of the 20th century. Most of the initial focus in reducing lead exposure has been rightfully on eliminating lead from ubiquitous products such as paint and gasoline. To this end, in 1978, lead based paint was banned and by the mid-1990s lead was phased out of gasoline in the United States (CDC, 2013; EPA, 2011).

The importance of banning lead from gasoline to public health has been demonstrated by research showing a correlation between reduced BLLs in the U.S. population and the phase out of lead from gasoline (Frumkin, 2010).

Today, the most pervasive sources of elevated BLLs in adults and children are through occupational exposure and exposure via dust and chips to old lead based paint, respectively (Lanphear & Roghmann, 1996). Workers in industries such as smelting, battery manufacturing and construction tend to have higher BLLs than workers in other industries (Frumkin, 2010). Associated “take-home exposures” from these jobs, in which workers can carry lead dust on clothes, boots, etc home which may subsequently be deposited on carpeting, furniture, bedding, etc home, are not only another source of exposure for these workers but can also be for their families. In children, a majority of today’s lead exposure is due to exposure from deteriorating old lead based paint and the lead dust present on window sills, floors, etc that can form from this paint (CDC, 2013a).

See Appendix 1 for tables A1-1-A1-3 which provide various lead limits in household dust, consumer products and occupational limits set by the U.S. Department of Housing and Urban Development (HUD); Consumer Product Safety Commission (CPSC); and, the U.S. Centers for Disease Control and Prevention’s National Institute for Occupational

Safety and Health (NIOSH) and U.S. Department of Labor’s Occupational Safety and

Health Administration (OSHA), respectively.

While today’s children have much lower BLLs than children in past decades, more recent research has documented how lower BLLs than previously thought may cause adverse neurological and behavioral health effects in children (Lanphear et al,

2000; Canfield et al, 2003). Therefore, in 2012, the U.S. Centers for Disease Control and

Prevention (CDC) reduced the BLL at which it recommends intervention from 10g/dL to 5g/dL (CDC, 2012). Previously, the CDC referred to this level as the “level of concern,” but now has replaced it with “reference level” because BLLs previously thought to be safe are associated with adverse cognitive, behavioral and other deficits

(CDC, 2012). It must be noted that there is no known blood lead level considered safe, especially in young children (CDC, 2012; Canfield et al 2003). While the majority of limited resources continue to be allocated towards abating lead based paint exposure in older homes and buildings, scientists are also now focusing on alternative sources of lead exposure, especially among immigrant and minority populations.

Alternative Sources of Lead Exposure

In immigrant populations, lead exposure may also occur from cultural products brought from their native countries in addition to lead based paint or occupational exposures. Some of these alternative sources are culture specific and include utensils,

3 foods such as Mexican tamarmind candy, cosmetics such as kohl, kajal, tiro and henna

(used in Middle Eastern and South Asian cultures) and remedies such as ayurvedic medicines (used by South Asians) and Mexican digestive medicines (CDC, 2013a;

MMWR, 2013). Heavy metals end up in these products because they are either intentionally added to promote health, to increase prices for products sold by weight, or due to contamination during processing (Schmidt, 2013). In the case of Mexican candies, lead may leach into the candies from their wrappers (Schmidt, 2013). Non-culture specific items, which may be sources of lead, include glazed pots or ceramics, which can leach lead into foods (these pots/ceramics can contain lead glaze to give the pottery a smooth finish and vibrant colors); plastic and vinyl mini-blinds; and, imported candles with leaded wicks (Lin et al, 2010; Gorospe & Gerstenberger, 2006; Schmidt, 2013). In recent years, scientists, public health advocates and state health departments have begun evaluating the Indian religious and cultural powder sindoor as an alternative source of lead exposure due to a growing number of lead poisoning case reports implicating it as the source of exposure (Vassilev et al, 2004; Lin et al, 2010).

Sindoor

Sindoor, also known as kumkum or vermillion, is an orange/red colored powder used by Hindus for religious and cultural purposes (Vassilev et al, 2004). Married women may wear sindoor in the part of their hair to indicate marriage status or desire for a long life for their husbands. Women may also wear sindoor as a dot or “bindi” on their foreheads for cosmetic purposes, or, along with men, may wear it for religious purposes

(Vassilev et al, 2004). Traditionally, sindoor was made from the spices turmeric and alum, which would turn red in the presence of lime juice or lime powder (Kapoor et al,

2007). The sindoor was then moistened with water, or alum, iodine or oil (Kapoor et al,

2007). Another method was to produce sindoor was through a mixture of saffron ground with kusumbha flower (Kapoor et al, 2007). However, with the advent of mass manufacturing, sindoor is now produced in part from vermilion, the purified and powdered form of cinnabar. Cinnabar is a reddish mercuric sulfide (HgS) and is one of the main ores of mercury (Liu et al 2008). In order to give it its distinctive red color, manufacturers often use red lead, (lead tetroxide, Pb3O4) (Vassilev et al, 2004).

In late 2007, the U.S. Food and Drug Administration (FDA) issued a warning for consumers not to purchase the Swad brand of sindoor after testing by the Illinois

Department of Health indicated lead levels as high as 87% in their sindoor (CDC, 2013b).

States such as New York, Illinois, Georgia and Minnesota have also subsequently issued warnings or recalls of Swad brand sindoor (CDC, 2013b). As a result of the testing and subsequent warnings, Swad issued a nationwide recall of their sindoor in early 2008

(CDC, 2013b). Other brands (not named) of sindoor have also been associated with elevated lead levels (CDC, 2013b). Furthermore, the New Jersey Poison Information and

Education System (NJPIES) has issued warnings in the past to local municipalities with a high Indian population regarding the addition of sindoor to Indian cuisines such as rice and chicken to create or enhance the red color of the food (Hudson Reporter, 2004).

These reports were the result of a case study of a South Asian family and their 13-month old child who all had elevated BLLs due to using sindoor as food coloring and the prevention plans formulated by the New Jersey Department of Health (NJDOH) and the

Department of Preventive Medicine and Community Health at New Jersey Medical

School. The plan proposed by NJDOH was based on health and public workers’

5 education; the other was proposed by New Jersey Medical School focused on hazard surveillance of sindoor and sindoor products in retail environments and from personal importation (Vassilev et al, 2004). The differences in these prevention plans lead to the warning issued by NJPIES.

Role of Hazard Surveillance in Identifying Lead Contaminated Sindoor

In any public health endeavor, the main objective is primary prevention— eliminating exposure (contact between an organism, e.g. human, and a biological, chemical or physical agent) at the source so susceptible, vulnerable sub-populations never come into contact with the hazard of interest (Stover & Bassett, 2003; EPA, 2011b). The hierarchy of preventive medicine starts with primary prevention followed by secondary and tertiary prevention (Halperin, 2013). In the case of sindoor, examples of primary prevention include elimination of lead during manufacturing, substitution of the lead additive during manufacturing, or regulation of commercial or personal importation of sindoor products (Achebe et al, 2013). Secondary prevention involves those who are at risk for lead exposure from sindoor receiving regular blood tests to monitor their BLLs

(Achebe et al, 2013). Tertiary prevention for sindoor consumers with elevated BLLs would be treatments such as chelation therapy to reduce their BLLs (Achebe et al, 2013).

In order to focus on primary prevention, hazard surveillance of sindoor/sindoor products is paramount. Hazard surveillance is the continuous collection, analysis, interpretation and distribution of information on occupational hazards and hazard controls, normally reserved for the purpose of preventing disease in the workplace

(Greife et al, 1995). It also involves documenting historical trends of exposures and documenting current trends in the exposure of interest (Greife et al, 1995). In addition,

6 hazard surveillance entails intervening to prevent the exposure, evaluation of the effectiveness of interventions and the dissemination of this information (Greife et al,

1995).

In terms of sindoor, hazard surveillance can be used to recognize and identify lead hazards in specific brands/types of sindoor, to suggest methods to reduce or control such exposures, to define the extent and distribution of the lead hazard, to focus hazard reduction strategies on those susceptible, vulnerable sub-populations most likely at risk, to test the effectiveness of reduction methods and to increase awareness among the public and legislators regarding lead in sindoor. Figure 1 depicts a “cascade of prevention” for sindoor related lead poisoning, outlining the steps mentioned above in each tier of prevention, including hazard surveillance. The objectives of this study as described below focus on the primary prevention of lead exposure from sindoor by employing the principles of hazard surveillance on sindoor and sindoor related products.

Lead Toxicokinetics

Lead has been implicated in a myriad of health effects from a variety of exposure routes. One can be exposed to lead through inhalation of aerosolized particles, ingestion or dermal exposure (Lin et al, 2010). Infants may also be exposed to lead in utero or via breastfeeding if the mother was previously exposed to lead (Lin et al, 2010). In addition to environmental media, one may be exposed to lead from endogenous exposures. Lead competes with calcium for sites in bone and teeth and may be stored in them for decades

(Nie et al, 2009; Robson & Toscano, 2007). In both children and adults, the majority of the body burden of lead is in bone and teeth (ATSDR, 2007). During periods of physiological stress such as pregnancy or during menopause, lactation or osteoporosis

7 bone resorption increases and may cause release of lead from bone back into the blood stream (Nie et al, 2009; ATSDR, 2007). This endogenous exposure may travel through the placenta and reach the developing fetus (Liu et al, 2014).

Diet can also play a role in how much lead is absorbed by the body. For example, studies have shown an inverse correlation between the amounts of calcium consumed and lead stored in bones (Bruening et al, 1999; Robson & Toscano, 2007). Furthermore, vitamin C and iron can reduce the harmful effects of lead as vitamin C increases iron absorption and iron can prevent lead absorption (Mahaffey, K 1983; Robson & Toscano,

2007). In addition, foods high in fat can increase lead absorption and solubility

(Mahaffey K, 1983; Robson & Toscano, 2007).

tio 8

Figure 1: Sindoor Related Lead Poisoning Cascade of Prevention

Hazard surveillance is the feedback loop from one level to another

(Adapted from Integrating Preventive Medicine and Public Health into Clinical Practice PowerPoint slides by W. Halperin)

Lead Toxicodynamics: Health Effects Due to Lead Exposure

In children, lead exposure may result in irritability, learning disabilities, abdominal pain, hyperactivity, hearing loss, reduced attention span, slowed growth and antisocial and delinquent behavior (Needleman, 2004; ATSDR, 2007; Frumkin, 2010).

Children are particularly susceptible to the adverse effects of lead due to their developing organ systems, higher intake rates of environmental media such as food, air, water, etc per unit body weight and because the half-life of lead in blood is approximately 10 months in children compared to approximately 1 month in adults (Nie et al 2009;

Frumkin, 2010; Robson & Toscano, 2007). Furthermore, children tend to engage in hand- to-mouth activity and are closer to the ground, both of which can increase their exposure to lead based dust (Melnyk et al, 2000; Bearer, 1995; Frumkin, 2010). Moreover, adverse health effects in children generally occur at lower BLLs than adults (Bearer, 1995;

ATSDR, 2007). In adults lead exposure can cause hypertension, peripheral neuropathy, memory loss, declines in mental functioning and reproductive effects such as abnormal sperm formation, reduced sperm count, miscarriage and preterm birth (Goyer, 1990;

ATSDR, 2007).

U.S. Food and Drug Administration Regulations

In 1938 Congress passed the Federal Food, Drug and Cosmetic Act (FFDCA)

(Toxipedia, 2012). The purpose of this legislation is to ensure that foods are unadulterated and safe to eat, medical devices and medications are safe and effective and that cosmetics are safe. Under the FFDCA, a cosmetic is defined as any product intended to be rubbed, poured, or sprayed on the human body for the purpose of beautifying, cleansing, promoting attractiveness or altering appearance without effecting the body’s

10 structure or functions (FDA, 2014a). Examples of products that fall under this definition include skin moisturizers, lipsticks, deodorants and eye and facial makeup (FDA, 2014a).

However, sindoor’s multiple uses as a cosmetic, cultural and religious powder make it difficult to determine whether it falls under the purview of the FFDCA.

According to the legislation, cosmetic products and ingredients do not need to be approved by the U.S. Food and Drug Administration (FDA) prior to going on sale with the exception of color additives (FDA, 2014a). FDA has not set limits for lead in cosmetics, but has set limits for lead in color additives used in cosmetics—20 parts per million (FDA, 2014c). Under the law, FDA does not have authority to order a recall of a cosmetic but can request a company to recall a product (FDA, 2014a). However, FDA may engage in enforcement action against products on the market not in agreement with the law through the Department of Justice in the federal court system (FDA, 2014a). For example, in 2012, FDA sent a warning letter to Vienna Beauty Products citing them for practices conducive to microbial contamination of their cosmetics. The agency threatened enforcement action, including an injunction, if the company did not improve their manufacturing and sanitary practices (FDA, 2012).

The FFDCA also states that contaminated or misbranded cosmetics are prohibited from distribution or interstate commerce (FDA, 2014a). Under the law, contaminated or misbranded cosmetics are defined as containing any toxins, toxicants or otherwise poisonous substances, which may cause harm to the consumer under normal use of the cosmetic (FDA, 2014a). Normal use for sindoor is topical application by rubbing it on one’s skin, not ingestion (due to use as food coloring) or any other use where it may enter the body. The FFDCA also requires proper labeling of cosmetics, including name,

11 ingredients and label warnings (FDA, 2014a). Mislabeling may occur if any of the above is missing or if the product labeling does not contain directions and warnings ensuring proper use (FDA, 2014a). If sindoor is to be defined as a cosmetic, then the labeling requirements of the law are especially relevant as it is often times sold in minimally labeled packaging.

For imported cosmetics, the FDA works in conjunction with U.S. Customs and

Border Protection (CBP) to monitor such imports. During import, cosmetics are subject to inspection by CBP and cosmetics that appear to be adulterated or misbranded may be refused entry into the United States (FDA, 2014b). However, not all cosmetics are inspected by CBP and currently only those who fall under the following criteria are inspected: products marketed with therapeutic claims, cosmetics contaminated due to microbes, those which fail to meet U.S. standards for color additives, those with high risk bovine tissue and others in the FDA Import Alert list (FDA, 2014b).

New Jersey Department of Health Regulations

The NJDOH Food and Drug Safety Program has the authority to regulate wholesale facilities and take enforcement action regarding misbranded and/or adulterated cosmetics under NJ Administrative Code Title 8, Chapter 21 (N.J.A.C, 21:8). In most cases, NJDOH will find adulterated cosmetics during routine inspections or after receiving a notice from an external government agency such as a local health department,

FDA or a health department from another state such as the New York City Department of

Health and Mental Hygiene. NJDOH may also inspect a wholesale facility due to an incident case, i.e., an elevated BLL or lead poisoning, or if it is determined a cosmetic at

12 a certain wholesale facility in NJ is on a FDA Import Alert (V. Wheatly, personal communication, September 10, 2014).

The inspection consists of two main portions, the trace back and the trace forward. The trace back involves determining from where the wholesale facility purchased their products (V. Wheatly, personal communication, September 10, 2014).

This is done using invoices and any other documentation the inspector can collect. If during this phase, it is determined the original supplier for the wholesaler is in NJ, a subsequent inspection of the facility is performed (V. Wheatly, personal communication,

September 10, 2014). During this inspection, an embargo of the adulterated cosmetics may occur and/or oversight of “voluntary destruction” of the product may occur (V.

Wheatly, personal communication, September 10, 2014).

During the trace forward phase, the inspector determines to which retail locations the adulterated products were sold (V. Wheatly, personal communication, September 10,

2014). If these retailers are in NJ, then the respective local health departments of the municipalities in which these stores are located are contacted (V. Wheatly, personal communication, September 10, 2014). These local health departments will then conduct an inspection of these retail facilities for contaminated product.

If during either the trace back or trace forward phase, it is found that a supplier or retailer is located out of the State of NJ, then the FDA is first contacted since these adulterated products would have been transported via interstate commerce (V. Wheatly, personal communication, September 10, 2014). Subsequently, the state health department in which the retailer is located may be contacted either by FDA or NJDOH (V. Wheatly, personal communication, September 10, 2014).

It must be noted how NJDOH does not have any written documentation outlining their procedures. The wholesale code cited above only refers to FDA regulations for violations but does not mention NJDOH inspection procedures. Therefore, the information contained here was obtained through direct communication with a NJDOH inspector (V. Wheatly, personal communication, September 10, 2014) who is familiar with inspection procedures.

Chapter 2

Literature Review on Sindoor: In 2010, researchers (Lin, Schaider, Brabander & Woolf) tested religious powders purchased in Boston including sindoor for lead content. Researchers used an online national directory of Indian grocery stores and a New England area Indian business directory to identify fifteen random stores from which they purchased sindoor. These identified stores were within twenty miles of Children’s Hospital Boston; however, researchers only purchased religious powders if they were manufactured in India. The name of the product, manufacturer, manufacturer’s location, packaging location, lot number, expiration date, store name and purchase date were documented when available.

In order to test variability of lead content between different lots of the same product, all religious powders that contained >10g/g lead were subsequently repurchased for additional analysis. Moreover, 10% of all products were randomly repurchased and reanalyzed for lead content. Overall, fifty-five religious powders were purchased with a mean lead level of 8.2 g/g with a range of 1-39.9 g/g. However, three sindoor products were outliers, i.e. contained a mean of 559,000 g/g of lead (47% lead by weight). Lin and colleagues (2010) estimated that ingesting 20g of lead containing sindoor increases lead exposure by 10g/day and the probability of an elevated BLL by eight-fold. As a point of reference, it should be noted that Vassilev (discussed below) and colleagues found that the sindoor collected in the couple’s home contained almost 58% lead by weight.

Unlike our study, this research only examined sindoor manufactured in India. We purchased sindoor from South Asian markets regardless of country of manufacture. In

15 addition, we also tested sindoor from both New Delhi and Mumbai, India by directly purchasing them. The importance in testing sindoor from both the U.S. and India is due to potential differences in manufacturing practices between sindoor sold in India versus the

U.S.

In 2004, Vassilev, Marcus, Ayyanathan and colleagues reported on a case in which blood testing revealed elevated BLLs in a South Asian family consisting of a mother, father and 13-month old boy. A routine blood lead test discovered a BLL of

57g/dL in the child and subsequent testing of the father and mother revealed BLLs of 85 and 95 g/dL, respectively. Investigation by the local health department and NJPIES using an XRF analyzer showed that a container labeled “Sindoor, Product of India, Non-

Edible” was suspect. Subsequent analysis for lead content showed that the sindoor contained 58% acid-extractable lead by weight. Interviews with the family revealed that they had been using the sindoor as a food-coloring agent. Vassilev and colleagues then conducted a small survey of five randomly selected South Asian grocery stores in the

Newark, NJ area to check if sindoor was available. Researchers asked a store employee if sindoor was available, what the common use of the product was and if it could be used as a substitute for food coloring. Two of the stores did not have sindoor in stock and two had sindoor sold in tightly sealed plastic containers with labels that stated the name of the product and a warning stating “Non Edible.” The fifth store also had sindoor in stock but sold it in an unmarked plastic bag, which did not contain the name of the product or a warning about the potential dangers of sindoor. The general consensus among the employees was that sindoor was solely meant for religious purposes and was not intended as a food additive.

Similar to the study conducted by Vassilev et al, our study also asked store employees about common sindoor use practices during the purchase of sindoor products.

In addition, we also purchased sindoor samples from a representative sample of South

Asian grocery stores throughout major regions of New Jersey (northern, central and southern). Moreover, we analyzed samples by the packaging type, purchase location and other variables.

In 2013, physicians in India investigated a case in which a 35-year-old male presented with acute abdominal pain, constipation, nausea, vomiting and facial puffiness

(Kute et al, 2013). Investigation revealed he had been ingesting 5-10 grams of sindoor daily for religious purposes. A blood lead level test revealed a BLL of 95.91 g/dL (Kute el al, 2013). The patient was diagnosed with lead neuropathy. While the physicians could not test the sindoor for lead content due to limited resources, they reached the conclusion that the lead neuropathy was associated with sindoor due to a previous history of the patient with sindoor ingestion (Kute et al, 2013).

Circa 2013, the New York City Department of Health and Mental Hygiene (NYC

DOHMH) received a report of a two-year-old child with a BLL of 25g/dL (Steuben

County, NY, 2013). Subsequent investigation revealed that the child had been placing sindoor, which her family used for religious prayer, in her mouth. Several sindoor products were collected from the family and tested for lead content. Analysis revealed lead content from 3.2 to 330,000 ppm (Steuben County, NY, 2013). NYC DOHMH visited the stores from which the family reported purchasing the sindoor products and procured various ceremonial powders including sindoor. One sindoor product used for

“poojas” (prayers) was found to contain 570,000 ppm (57%) lead (Steuben County, NY,

2013). Lead content in the remaining products ranged from non-detectable to 36 ppm

(Steuben County, NY, 2013). NYC DOHMH ordered the retailer selling the “pooja” sindoor to recall the products and re-label the product with precautionary labels warning consumers of the product’s lead content and methods to minimize exposure (Steuben

County, NY, 2013). The wholesaler and its retail outlets were ordered to post signs warning about possible hazards of lead containing sindoor. Follow up inspection by the health department revealed a high level of fidelity with NYC DOHMH mandates

(Steuben County, NY, 2013).

Research Objectives/Aims:

Objective 1a: Assess lead content of various brands and types of sindoor and sindoor products sold in South Asian grocery stores and other retailers (i.e., temporary retailers such as carts or newsstands) in New Jersey. This included sindoor/sindoor products manufactured in India, imported and subsequently sold in South Asian retailers in New

Jersey or domestically produced sindoor sold in South Asian retailers in New Jersey.

Objective 1b: Assess lead content of various brands and types of sindoor and sindoor products sold in markets in Mumbai, India and New Delhi, India.

Objective 2: Determine whether there is an association between lead content and packaging and labeling of sindoor/sindoor products sold in the U.S. Types of packaging and labeling included:

 Properly sealed containers or plastic bags with warning labels describing the

potential dangers of the powders or labels describing use

 Minimally labeled containers or plastic bags (only name of product and little

to no other information)

 Religious ceremony kits, with and without warning labels

 Unmarked plastic bags or containers

Objective 3a: Determine whether XRF analyzers manufactured for determining the presence of lead based paint can be used to accurately assess whether a sindoor sample is positive or negative for lead content.

Objective 3b: Determine whether a commercially available color-metric lead testing kit can be used to accurately assess whether a sindoor sample is positive or negative for lead content.

Hypotheses:

Based on the above-mentioned study objectives, three hypotheses were rigorously assessed in this project as follows:

1. Overall, sindoor products purchased in New Jersey and those purchased directly in

India will have similar lead content, which will be at safe levels.

2. Professionally packaged sindoor products will have a lower lead content than those

found in minimally labeled containers or unmarked plastic bags.

3. XRF analyzers manufactured for the purpose of determining lead based paint will

be able to provide a rapid, qualitative field-based assessment of whether a sindoor

sample contains lead.

4. The commercially available home lead test kit will be able to provide a general

qualitative assessment of whether a sindoor sample contains lead, however not a

semi-quantitative assessment.

Chapter 3

Methods:

Sample Collection: New Jersey South Asian Grocery Markets

Online national directories were used to identify of South Asian grocery stores in

New Jersey. The directories can be accessed at:

 http://www.immihelp.com/yellowpages/browse-334-0-302-0-0.html

 http://theindianlist.com/category/11-Indian+Grocery+Stores/region/31

New+Jersey/city/586=New+Jersey

 http://www.courtesyindia.com/usa/Indian%20Grocery%20Stores%20in%20N

ew%20Jersey%28NJ%29.aspx

 http://www.indianfoodsguide.com/indian-food-guide/indian-grocery-

stores/united-states/new-jersey/iselin.html.

These online directories were all used in conjunction in an effort to get the most comprehensive list of South Asian grocery stores in the state. A Google search of South

Asian retailers was also conducted in each pre-determined region of New Jersey to ensure a comprehensive list of stores to visit. Other retailers such as newsstands or “street carts” were to be determined by convenience sampling but were not encountered during field sampling. Any stores not able to be located by the address provided by the directory were attempted to be located by a Google Maps search using a mobile device in the field. If during sampling, a South Asian store not on the prepared list of retailers was encountered or was replaced by another store, this new store was also visited (this included Arabic,

Turkish and Halal stores). We believe this comprehensive method reduced any potential selection bias.

For this study, identified South Asian retailers within a 15-mile distance of the following three locations were visited to purchase sindoor products: New Jersey Medical

School in Newark, NJ, Rutgers School of Public Health (SPH) in Piscataway, NJ and the

Rutgers campus in Camden, NJ (see Appendix 2 for maps showing proposed sampling areas). Distance from the respective Rutgers campuses was determined using Google

Maps (Mountain View, CA).

We determined this sampling strategy to be the most appropriate as the total number of sindoor brands is unknown. Therefore, a sampling method allowing for the purchase of the highest number of sindoor samples from a broad statewide sample of

Indian retailers in a practical and feasible manner was formulated. This cross-sectional sampling method also ensured that the sindoor samples purchased were a comprehensive collection of currently available brands from South Asian retailers throughout several major regions of NJ. A similar sampling strategy was employed by Lin et al (2010) and

Saper et al (2004). If sampling had been conducted by determining the number of sindoor samples required for adequate statistical power and sampling until that number was reached, the predetermined number of samples may have easily been acquired by only visiting a small number of South Asian retailers, which may not be representative of all retailers from which sindoor may be purchased. In addition, this strategy may have potentially left a high number of sindoor samples from other stores untested.

Sindoor and sindoor products were purchased regardless of country in which they were manufactured. While we intended to test for lot-to-lot and shipment variability of lead content by purchasing duplicates of the same product (i.e. identical name, color and manufacturer), resource limitations precluded this assessment. If two sindoor products

21 had the same name but were made by different manufacturers, they were considered different and both were purchased. Sindoor products were purchased in the following forms (if available): powder, liquid, lipstick or cosmetic pencil. Subsequently, during sample logging, the sample name and the store of purchase were recorded. If available, the manufacturer, manufacturer’s location, packaging location, lot number, and expiration date will be provided to the appropriate stakeholders if required as part of public health outreach, education or enforcement purposes. This specific information is not presented here, as it was not relevant for our analyses. For this dissertation, a table summarizing samples providing the aforementioned information and other packaging information is provided in Appendix 3.

Samples remained in original packaging until they were analyzed. A minimum of twenty samples were purchased from each 15-mile region. However, not all products were distinctive and included some repeat products, which were purchased unintentionally. These “repeat” products were not included in the analysis (see results below). In addition to the sindoor samples, other miscellaneous religious powders were also purchased.

Sindoor Use Survey

At the time of purchase, an employee at each South Asian market from which sindoor samples were purchased was surveyed on common sindoor use practices.

Questions included common uses of sindoor, frequency and location of application, whether it is applied to children, etc. Store employees were also asked if they self- identified as Hindu or Muslim due to evidence that Muslim individuals may use sindoor for uses other than for which it is intended due to unfamiliarity with the powder. The full

22 survey tool is located in Appendix 4. It should be noted that surveys were only utilized at stores selling sindoor. If a South Asian store was found not to sell sindoor, no attempt at completing the survey was made. If a store was visited but sindoor was not purchased

(due to presence of non-distinctive samples or lack of availability due to inventory issues), survey completion was attempted.

Sample Collection: Markets in Mumbai and New Delhi, India

In addition to purchasing samples in New Jersey, sindoor/sindoor product samples were purchased directly from markets in Mumbai, India and New Delhi, India. The doctoral candidate visited Mumbai in April/May 2014 and purchased sindoor samples from the Vile Parle East and Vile Parle West neighborhoods of Mumbai. In July 2014, an acquaintance of the doctoral candidate acted as a proxy and purchased sindoor samples in

New Delhi, India.

In both cities, sindoor samples were purchased according to the following methodology: when more than one store carried the same sindoor (i.e. identical name, and manufacturer), the sindoor was only purchased from one store. If two sindoor products had the same name but made by different manufacturers, they were considered different and both were purchased. If a merchant sold sindoor powder only by weight, 10 grams were purchased. Sindoor products were purchased in the following configurations in both cities: powder, liquid, lipstick and cosmetic pencil. In addition, the proxy in New

Delhi was sent via e-mail, an “information sheet,” which he completed for each sample during the time of purchase. The sheet included details such as name of the sindoor product, type of packaging (plastic/glass container, unmarked plastic bag, cardboard container or other), date of purchase and price of the sindoor. This information sheet can

23 be found in Appendix 5. The salient information (name of powder brand and packaging type) from these sheets can be found in Tables A3-4-A3-6.

In both Mumbai and New Delhi, due to logistical issues and limited resources, markets from which sindoor/sindoor products were purchased were determined using a convenience sample (e.g. proximity to Vile Parle East section of Mumbai). While this may limit the internal validity of the study from the perspective of determining the overall proportion of sindoor samples in markets throughout Mumbai and New Delhi with detectable levels of lead, it nonetheless provides valuable information on lead content of sindoor that may be purchased by a sizeable portion of the population, especially if lead is detected and quantified in a brand of sindoor widely available. In addition, these samples may serve as a proxy for the types of samples that may be carried into New Jersey by travelers by airplane from India. Products purchased in India remained in original packaging until they were analyzed at the New Jersey Department of

Health, Rutgers School of Public Health and New Jersey Medical School. Tables listing purchased sindoor samples by name and packaging type can be found in Appendix 6.

Sindoor Collection at Newark Liberty International Airport

Our original study objectives and protocol included plans for collection of sindoor powders from travelers flying back into the United States from Mumbai, India and New

Delhi, India. Our initial plan was to collaborate with the U.S. CDC Quarantine Station and Customs and Border Protection at Newark Liberty International Airport (EWR).

However, due to administrative, logistical and other reasons beyond our control, the collaboration never came to fruition. Subsequently, we attempted to work directly with

United Airlines since they own Terminal C at EWR. The principal investigator

24 corresponded via e-mail with the manager of Terminal C. Initially, the manager was receptive and cooperative with our efforts to conduct the study; however, after a few months the manager stopped responding to our inquiries and it was unclear if this person was even still with United Airlines and/or at EWR. Therefore, execution of this portion of the study never occurred. For completeness and interest, the sample collection methodology prepared to be employed at EWR, and the e-mail correspondences with the

EWR Terminal C manager, can be found in Appendix 7 and Appendix 8, respectively,

Lead Analysis

Lead content was analyzed using three types of methodology. The first was using a portable x-ray fluorescence (XRF) analyzer. The XRF analysis occurred at the New

Jersey Department of Health (NJDOH) in Trenton, NJ. Samples were analyzed at

NJDOH due to the Rutgers University Institutional Review Board requirement that operators must be certified to use an XRF analyzer due to potential radiation exposure concerns. Since the principal investigator is not certified, a colleague at NJDOH operated the XRF analyzer under the direction of the doctoral candidate. The second type of analysis was done via commercially available color-metric lead testing kit and performed at the dry labs at the Rutgers School of Public Health in Piscataway, NJ. The third type— the confirmatory analysis—was a laboratory based analysis and occurred at the Trace

Element and Mineral Research Laboratory in the (former) Department of Preventive

Medicine and Community Health at New Jersey Medical School in Newark, NJ. Ten randomly selected samples from each sampling region of New Jersey (North, Central and

South) and 10 from Mumbai, India and 10 from New Delhi, India, underwent all three types of lead analysis procedures.

A RMD LPA-1 XRF analyzer (Watertown, MA) was used to analyze samples at

NJDOH. It should be noted that while the RMD LAP-1 XRF analyzer is designed for use for lead based paint analysis on surfaces, it was utilized in this study to assess whether it could determine if a sindoor sample contained any lead. While it was expected that the

RMD LPA-1 XRF analyzer would not give an accurate quantitative value of a sindoor sample’s lead content, we were interested in determining whether these analyzers could provide a general qualitative indication of whether a sindoor sample is positive or negative for lead content. Often, local or state health departments may wish to conduct rapid field analysis or “spot tests” for lead in sindoor in a store or in an individual’s home. Due to limited resources—these XRF analyzers can cost tens of thousands of dollars—these departments may not have access to expensive portable XRF analyzers designed to determine lead content in consumer products such as toys or powders such as sindoor. Therefore, being able to determine whether XRF analyzers designed for other uses can provide a general positive or negative analysis of lead content in sindoor prior to more confirmatory laboratory analysis can be valuable to resource limited health departments.

Much like the XRF, the accuracy of the commercially available lead testing kit was also assessed to see if it could be a viable option for rapid field analysis or preliminary assessment of lead for health departments prior to the use of confirmatory and more resource intensive tests. The lead kit used was a First Alert Lead Test Kit

(Palatine, Illinois). This kit is designed for the testing of lead on a variety of consumer products including pottery, dishes, ceramic wear, jewelry, soil and dust (First Alert Store,

2005). It is a colormetric test, indicating the presence of lead by a change of color of the testing solution.

XRF Lead Analysis Procedure

Samples to be tested by XRF were previously removed from their original packaging and placed in a thin plastic bag (“baggie”) and labeled with their study identifier only. Prior to XRF analysis, sindoor powders were checked for homogeneity to ensure accurate analysis. If samples were not found to be homogenous (determined by the presence of clustering or clumping of powder) they were further homogenized.

It should also be noted the XRF analyzer has two modes of operation: Quick

Mode and Standard Mode. Quick Mode enables determination of whether a sample is positive, negative or inconclusive for lead based on a threshold of a predetermined lead level programmed into the XRF analyzer. The machine allows this threshold to be increased in increments of 0.1mg/cm2. This was also the approximate limit of detection for the XRF analyzer. While setting the threshold to the lowest level is ideal, the XRF analyzer may not be able to detect low lead levels in the sindoor powder as compared to a surface painted with lead based paint, or, it may take too long to analyze the samples.

Therefore, Quick Mode was used during the testing of sindoor samples, but the threshold level was set to 1.0mg/cm2. Once this level was set, any sindoor sample containing lead above the set level as recognized by the analyzer was designated as positive for containing lead. Standard mode was only used during calibration checks as described below.

Prior to XRF analysis, the analyzer was tested against a standard reference material (SRM) as a final calibration test and quality control check to ensure accuracy of

27 the XRF analyzer. For the RMD LPA-1, the SRM was a block of wood painted with confirmed lead based paint provided by the manufacturer with the instrument. The lead content of the paint on the block was also provided by the manufacturer and was compared against the reading of the analyzer to ensure it was accurately detecting lead.

This calibration check occurred by setting the analyzer in Standard Mode and reading the reference block for 40 seconds. In addition, every 18 months, NJDOH sends the XRF analyzer back to the manufacturer to have the cobalt-57 source (which generates the x- rays) replaced. This ensures timely and accurate lead readings. During this time, a leak test is also performed to ensure excess amounts of radiation are not escaping from the

XRF analyzer. This cobalth-57 source replacement and leak test last occurred in January

2015.

After the calibration check, the sindoor containing baggies were flattened on a clean and obstruction free work surface to form a continuous flat layer. The nose of the

XRF analyzer was placed firmly flat against the baggie and readings were initiated by pressing and holding the trigger until analysis was completed. Positive results were displayed as any measurement above the predetermined threshold level (1.0 mg/cm2) and negative results were displayed as any measurement below the threshold level. If the lead levels were too close to the chosen threshold level, the instrument displayed an inconclusive result by simply showing the threshold level.

Lead Test Kit Analysis Procedure

For the testing of sindoor using the First Alert kit, the two testing methods the kit was capable of performing, as indicated by the manufacturer, were employed. One was the Rapid Method and the other was the Patented Leach method (First Alert Store, 2005).

As indicated by its name, the Rapid Method testing allowed for results within a few minutes of testing (First Alert Store, 2005). However, this method only provided qualitative results and may not be as accurate as the Patented Leach method. The

Patented Leach method took about four hours to complete per sample but provided semi- quantitative results and thus, in theory, provided more accurate results (First Alert Store,

2005).

For the Rapid Method, a cotton swab stick provided in the kit was activated by dipping it into the indicator solution vial. The swab was then gently rubbed against the sindoor sample for approximately 30-60 seconds (First Alert Store, 2005). The swab turning yellow, brown or black indicated the presence of lead. No color change was indicative of the lack of presence of lead (First Alert Store, 2005).

For the Patented Leach method, the sindoor samples to be tested were first prepared prior to testing (First Alert Store, 2005). This was done by transferring 0.5 teaspoons of sindoor into a lead free container and subsequently adding 250mL of vinegar (purchased separately from colormetric kit). This solution then stood uncovered for four hours (First Alert Store, 2005). After that duration, the plastic test tube provided with the kit was filled approximately ¼ with the sindoor/vinegar solution. The cotton swab was then activated by placing it in the indicator solution and subsequently placed in the test tube solution (First Alert Store, 2005). The test tube with the sindoor/vinegar solution and cotton stab was then capped and inverted (First Alert Store, 2005). If, after

30 seconds, the solution turned yellow, brown or black, the solution and therefore the sindoor, contained leachable lead (First Alert Store, 2005). In general, a faint yellow tint indicated a lead concentration of 1-3 parts per million (ppm); light brown indicated

29 approximately 5 ppm; medium brown indicated approximately 10 ppm; dark brown indicated approximately 25 ppm and black indicated approximately >50 ppm (First Alert

Store, 2005). If the solution remained clear, no leachable lead was present (First Alert

Store, 2005). The limit of detection for the semi-quantitative Leach method is 1.0 ppm

(g/g) lead.

Laboratory Lead Analysis Procedure

For the laboratory analysis, samples used for XRF and lead kit analysis were brought to the Trace Element and Mineral Research Laboratory at New Jersey Medical

School. Approximately 100 mg (0.1 g) of sindoor was required for analysis with a detection limit of approximately 0.5 g/g (Dr. J. Bogden, personal communication,

October 1, 2014). However, after reviewing the analytical results, the limit of detection appeared to be closer to 0.2 g/g lead. Samples were considered positive for lead content if they contain >1g/g lead.

Samples were transferred to plastic vials for lab analysis and marked with the same numerical identifier used during XRF and colormetric analysis. National Bureau of

Standards Standard Reference Material #1571 Orchard Leaf Sample was used as quality control (Vassilev et al, 2005). Both the sindoor powder and SRM was digested in 3:1

Nitric/Perchloric acids until a liquid slurry remained (Vassilev et al, 2005). This slurry was then transferred to 25mL volumetric flasks for the determination of lead. Sindoor samples with high lead content were analyzed using flame atomic absorption spectrophotometry (FAAS) (Vassilev et al, 2005). Sindoor samples with no detectable lead or lead content just above the detection limit were reanalyzed using a more sensitive

30 technique called electrothermal heated graphite atomizer atomic absorption spectrophotometry (HGA-AAS) (Vassilev et al, 2005).

Data Analysis

We analyzed the total number (n) and percentage (%) of sindoor/sindoor products with a detectable level of lead (>1g/g Pb) by lab analysis. Positive results for the two field tests were also reported. The 95% confidence interval for the overall percentage of all sindoor/sindoor products containing lead (>1 g/g Pb) was calculated along with the

25% and 75% quartiles, range, maximum lead level and number of high sindoor products

(>1% Pb). Sindoor products were also stratified by where they were purchased/collected and the median and geometric mean of lead concentrations (in g/g) and 95% confidence interval for percentages of samples containing detectable amount of lead for each purchase/collection location was calculated. Miscellaneous religious powders were separated by color and the above was then also calculated for each color type. For the

XRF testing, a Pearson correlation coefficient was calculated to determine any association between XRF readings and Pb content in powders. The median lead concentration for each packaging type was also calculated. Any statistically significant differences in median lead concentrations by packaging type or purchase location were tested using the Kruskal Wallis test for significance.

In addition, a chi square analysis of high (>1000 g/g Pb), moderate (20-1000

g/g Pb) low level (0.2-20 g/g Pb) and lead free (<0.2 g/g Pb) powders (sindoor + miscellaneous religious powders) was conducted in an effort to determine any association between lead level categories, purchase locations and packaging types not evident through the other cross-sectional analyses.

A case-control analysis of various lead categories was also conducted for the covariates of interest (sampling location and packaging type) for sindoor powders.

Powder samples were divided into the following categories: <1 g/g Pb, 1-20 g/g Pb

21-1000 g/g Pb and >1000 g/g Pb. For the New Jersey sampling location, South Jersey samples served as the control while Northern and Central Jersey served as the cases. For

India versus U.S. sampling locations, the U.S. samples served as the control while India samples were the cases. For the packaging types, kits served as the controls, while all other packaging types (professionally packaged with and without warning labels and unmarked bags) served as the cases. For analysis, all non-kit packaging types were grouped into one category due to sample size concerns. Odds ratios, 95% CI and p-values using Fisher’s Exact Test (2-sided) were calculated. For the 95% CI, bootstrap measurements were used due to sample size concerns. For samples purchased in Central

Jersey and for samples packaged in containers other than kits both of which contained

>1,000 g/g Pb, odds ratios were calculated manually do to the presence of a “0” count in the cells. In this case, a value of 0.5 was added to each cell prior to calculation of odds ratios. Due to small sample sizes and relatively similar lead content in each color stratum and lack of detectable lead in the moderate and high lead level categories, odds ratios for miscellaneous religious powders were not calculated.

We also compared proportions of samples with detectable levels of lead versus those without detectable levels of lead. Statistical analysis was performed using the Z test of population proportions to determine any statistically significant difference between the proportion of sindoor samples from the U.S. and India containing >1 g/g Pb.

Statistically significant differences between the proportion of sindoor samples (both total

32 and U.S. samples only) and miscellaneous powder samples containing >1 g/g Pb lead were also analyzed. For all location and color strata, the proportion of samples containing

>20 g/g Pb were also calculated.

For the field tests (colormetric and XRF tests), we used both a correlation coefficient (r) and sensitivity, specificity, positive predictive value and negative predictive value to assess effectiveness of these tests in correctly identifying lead adulterated or lead free products. The latter metrics (sensitivity, specificity, etc) were calculated for different lead content ranges. These ranges included >1 g/g Pb, 20-1000

g/g Pb, >1000 g/g Pb and >10,000 g/g Pb. Sensitivity is defined as the proportion of true positives as correctly identified by the screening test (Altman & Bland, 1994).

Specificity is defined as the proportion of true negatives as correctly identified by the screening test (Altman & Bland, 1994). Positive predictive value is typically defined as the proportion of individuals with a positive screening test who truly have the disease; so, for the purposes of this project, the focus is on confirmed lead content instead of disease

(Altman & Bland, 1994). Negative predictive value is typically defined as is the proportion of individuals with a negative screening test who truly do not have the disease; again, for this project, the focus is on confirmed lead content, not disease status (Altman

& Bland, 1994).

Qualitative data from the survey tools was analyzed to assess sindoor use practices by the South Asian population in New Jersey. Any relevant data extrapolated will be used to tailor future public health education or outreach efforts. Moreover, the names of sindoor products and other religious powders and their respective lead concentrations were assembled into a table stratified by region and disseminated to the

NJDOH Food and Drug Safety Program. This list may then by further disseminated to local and county health departments. Due to Rutgers University-Rutgers Biomedical and

Health Sciences IRB restrictions attached to this project’s approval, the names and addresses of stores from which products were purchased remain confidential outside the

Principal Investigator’s team.

Statistical analyses were conducted using Statistical Package for Social Sciences, or, SPSS, version 22 (Armonk, NY).

Chapter 4

Results

Sindoor

A total of 145 distinct sindoor samples were purchased from sixty-six total South

Asian markets in the three pre-determined regions of NJ (North Jersey, Central Jersey and South Jersey). Table 1 shows the number of stores by region and also shows the counties in which the stores were located. Of the sixty-six total stores visited, thirty-four

(51.5%) were located in Central Jersey.

Table 1: Locations of Stores of Religious Powder Purchases

This is consistent with population demographics; there is large Indian-American community in that region of the state, specifically Middlesex and Somerset counties (Wu,

2012). Samples were purchased from a total of nine counties throughout the state. South

Asian stores, which were visited but found not to sell sindoor or sold sindoor already purchased elsewhere, were included in the final count.

It is important to recognize how only stores within a 15-mile radius of a Rutgers

University campus were visited— there may be more stores in each sampling region than were visited during the course of this study. While stores selling Middle Eastern goods and foods were visited if they had replaced an existing South Asian store or were located in close proximity to a South Asian store, no sindoor or sindoor products were located at any of these establishments. These stores were not part of the final count of stores visited,

35 as they were not South Asian stores. Also sindoor products analyzed were in the powder form; lipsticks sindoor liquids and cosmetic pencils were not analyzed by the Trace

Element Laboratory due to technical issues. Of the 145 sindoor samples purchased in the

US, fifty (34.5%) samples were not analyzed by the laboratory method due to resource limitations. We hope to analyze these products at a later date as resources become available.

Of the samples analyzed by the confirmatory laboratory analysis, 33 samples were purchased North Jersey, 47 in Central Jersey and 15 were purchased in South Jersey for a total of 95 U.S. samples. Any duplicate samples purchased were identified, separated and not analyzed. For the current study, each sample analyzed was noted to be a distinctive sample (i.e. unique brand, packaging type or color). It should be noted that the samples categorized into each region of the state may also be available in other regions (i.e. they may not be exclusive to a particular region of New Jersey).

A total of 23 sindoor samples purchased from India (Mumbai and New Delhi) were analyzed. Thirteen distinct samples purchased from New Delhi and 10 purchased from Mumbai were analyzed. The total number of sindoor products purchased in India can be seen in tables A6-7 and A6-8 (Appendix 6). The final count of all sindoor samples analyzed by the laboratory method was one hundred eighteen (U.S. + India samples).

Furthermore, sindoor samples—approximately ten in each sampling region—analyzed by field methods, i.e., the colormetric and XRF methods were also analyzed the confirmatory laboratory analysis.

Analysis Results for Sindoor

As seen in Table 2, overall, for all sindoor products (those purchased in the U.S. and India), 97 (82.2%, 95% CI: 75.3%-89.0%) samples contained >1 g/g Pb. While the

FDA limit for lead in color additives for cosmetics is 20 g/g Pb, we selected 1 g/g Pb as the threshold for detection given an interest in determining the presence of any amount of lead in sindoor and related religious powders, as no safe blood lead level in children has yet been identified (CDC, 2012). The median lead level was 3.6 g/g Pb; the geometric mean was 7.5 g/g Pb with a 25% quartile Pb level of 1.41 g/g Pb, a 75% quartile Pb level of 15.8 g/g and a maximum Pb level of >300,000 Pb g/g (It should be noted how according to Dr. John Bogden, Director of the Trace Element and Mineral

Research Lab at Rutgers New Jersey Medical School, samples with a value of >300,000

g/g Pb were re-analyzed to confirm lead levels were in fact this high. Subsequent analysis revealed lead content was actually >800,000 g/g. Samples were analyzed according to the 300,000 g/g value as this was the reported value on the official analytical results). Twenty-four percent of all sindoor powders contained > 20 g/g Pb, the FDA limit. In total, five sindoor products had a Pb level of >1% or 10,000 g/g. On average, the lead content in these “high Pb” sindoor samples is similar to previously published reports, (Lin et al, 2010), which reported levels of >47% Pb by weight. Table 3 provides an overview of lead content of sindoor samples by overall sample location (U.S. and India). A similar table with overview of lead content by each individual sampling location in New Jersey (NJ, CJ, SJ) and India (Mumbai and New Delhi) can be found in

Appendix 9.

For U.S. sindoor powders, 79 (83.2%, 95% CI: 75.8%-90.6%) powders contained

>1 g/g Pb. The median lead concentration for all US sindoor powders was 3.0 g/g Pb; the geometric mean was 5.4 g/g Pb with a 25% quartile of 1.4 g/g Pb, a 75% quartile of 11.83 g/g Pb and a maximum Pb level of >300,000 g/g Pb (or higher, see above).

Nineteen percent of all U.S. sindoor samples had a lead level > 20 g/g. For powders purchased in North Jersey, 26 of 33 (78.8%, 95% CI: 64.2%-93.3%) contained >1 g/g

Pb. For Central Jersey, 40 of 47 powders (85.1%, 95% CI: 74.6%-95.6%) contained

>1g/g Pb. For powders purchased in South Jersey, 13 of 15 (86.7%, 95% CI: 69.5%-

92.0%) contained >1 g/g Pb. Overall, three sindoor samples contained >1% Pb. One of the high Pb sindoor samples was purchased in North Jersey while the remaining two were purchased in Central Jersey. It is worth reiterating how the purchase of powders in one region of the state does not generally preclude their sale in other regions of the state.

Table 2: Descriptive Statistics for Sindoor Powders

For sindoor powders purchased in India, 18 (78.3%, 95% CI: 60.5%, 96.1%) samples contained >1 g/g Pb (Table 7). The median lead concentrations for these sindoor powders was 12.7 g/g Pb; the geometric mean was 28.09 g/g Pb with a 25% quartile of 3.36 g/g Pb, a 75% quartile of 69.19 g/g Pb and a maximum Pb level of

>300,000 g/g Pb. Forty-three percent of samples had a lead level > 20 g/g. As with the

U.S. samples noted above, this value could be as high as 900,000 g/g Pb. Two samples, purchased from Mumbai, contained >1% Pb. A third sample, also purchased from

Mumbai contained 0.5% g/g Pb. Samples from New Delhi had a higher median lead level than those purchased in Mumbai, 21.6 g/g versus 5.0 g/g, respectively.

No statistically significant difference was found when comparing the proportion of samples containing >1 g/g Pb between U.S. and India sindoor powders (p- value=0.58; z-score=0.551). In addition, when comparing the median lead levels between

U.S. sindoor samples and India sindoor samples, no statistically significant difference was found (p=0.585).

Table 3: Ranges and Percentages of Detectable Lead in Sindoor by Purchase Location

Miscellaneous Religious Powders In addition to the sindoor powders, 52 miscellaneous religious powders were also analyzed. Some of these powders were part of “pooja” (prayer) kits, which also contained sindoor powders while others were stand-alone products. Also, it must again be noted how any “repeat” samples were separated and not analyzed and powders purchased in

39 one region of the state may be available in other parts of New Jersey. Due to the variation in color and smaller sample size, these religious powders were stratified according to color and not purchase location. Twenty-two samples were categorized as pink, 10 as white, nine as yellow, seven as beige/brown and four as miscellaneous in color (blue, green or orange). No miscellaneous religious powders were purchased in India. The lead level of each powder in a kit was used to determine overall median lead levels, etc for this category of samples. However, when counting frequencies of kits, all powders in each kit were counted as one unit. Table 4 provides an overview of lead content of miscellaneous powders by color.

Table 4: Ranges of Lead Content of Miscellaneous Powders by Color

Table 5: Descriptive Statistics for Miscellaneous Religious Powders

Analysis Results for Miscellaneous Religious Powders

For miscellaneous religious powders, 29 (55.8%, 95% CI: 42.3%, 69.3%) powders contained >1 g/g Pb (Table 5). The median lead concentration for these powders was 1.1 g/g Pb with a 25% quartile of 0.39 g/g Pb, a 75% quartile of 3.2 g/g

Pb and a maximum of 61.0 g/g Pb. Those samples identified as pink in color had the highest median Pb concentration, 3.0 g/g Pb, followed by the group of powders containing green, orange and blue powders (2.7 g/g).

A statistically significant difference was found when comparing the proportion of samples containing >1 g/g Pb between U.S. + India sindoor powders and the miscellaneous religious powders (p-value<0.05; z=3.62). A statistically significant difference was also found when comparing only U.S. sindoor samples and miscellaneous religious powders (p-value<0.05; z=3.59). No statistically significant difference was found between median lead levels of U.S. + India sindoor powders and miscellaneous religious powders (p=0.715).

Packaging Types (Sindoor and Related Powders)

Sindoor and other religious powders analyzed by the Trace Element Lab were also stratified by packaging type (Table 6). Packaging categories included: professionally packaged containers (bottle, bag or foil; not part of a religious kit and not containing any warning labels); professionally packaged powders with warning labels (not part of a religious kit); religious ceremony kits (with and without warning labels) and unmarked plastic bags (not professionally packaged). Warning labels included such warnings as

“fatal if consumed;” “for religious use only;” “not for human consumption;” “keep away from children;” “external use only;” “not edible;” etc.

Table 6: Religious Powder Packaging Types (Sindoor + Related Powders)

Table 7: Religious Powder Packaging Types (US Sindoor Only)

These warnings were on the outer packages in most cases and written in English.

Even if a sample did not have a discernable brand listed, it was categorized as professionally packaging if it was in a sealed plastic bottle, bag, etc. The median lead level of each packaging type for U.S. powders was similar across religious powders and also when U.S. sindoor products were analyzed separately (~2.5 g/g Pb, with unmarked plastic bags having a median Pb level of 4.0 g/g) (Table 7). In terms of frequency of products, most samples were found to be professionally packaged without warning labels, followed by professionally packaged samples with warning labels (neither one of these categories included religious kits). For religious kits, it was found that most samples did not have any sort of warning label about the dangers of consuming the powders. Only three samples were found to be in unmarked, plastic bags. Two were purchased in Central

Jersey and sealed while one was purchased in North Jersey and closed using a simple garbage bag tie. For this sample, the clerk at the store from where it was purchased simply transferred some sindoor from a large container into the plastic bag. These three samples were found to contain >1 g/g Pb. No statistically significant difference was

42 found between median lead levels for the various packaging types for both overall religious powders and the sindoor only products (all p-values >0.05).

Analysis of Powders by Lead Level Categories

Cross-tabulations of the various lead categories, sampling locations and packaging types and the analyzed study powders (sindoor + related powders) were performed. For the cross-tabulations, purchase locations in New Jersey and India were combined in one category each—“U.S.” and “India”—since we were interested in comparing U.S. samples as a whole to India samples as a whole. Cross-tabulations revealed the following: three samples were found to contain >1000 g/g Pb. For moderate lead level samples (20-1000 g/g Pb), twice as many were purchased in the

U.S. versus India (n=14 and n=7, respectively). The vast majority (n=101) of low lead samples (0.2-20 g/g, or below the current FDA guideline) were purchased in the U.S., compared to only 13 purchased in India.

For India samples, the three high lead level samples were from Mumbai. No high lead samples were found in New Delhi. For moderate level India samples, all sindoor samples were purchased in New Delhi (n=7). Low level samples were almost equitably split between the two sampling regions of India (n=7 for Mumbai and n=6 for New

Delhi). When we compared high, moderate and low samples to lead free samples for purchase location, we observed how no lead free samples were collected in India. While some of the samples had low levels, i.e <1.0 g/g Pb, no samples were found to be lead free as per our definition (<0.2 g/g Pb). Chi square analysis revealed a statistically significant difference in the number of lead free powders and powders containing 0.2-

20g/g Pb purchased in the U.S. versus those purchased in India (p<0.05). Table 8 shows the cross-tabulations between the lead level categories and purchase locations.

Table 8: Cross-Tabulations of Lead Level Categories and Purchase Locations of Sindoor and Related Powders

Regarding packaging type, for U.S. samples, a majority count (n) for low, moderate and high lead level categories were found to be in professional packages

(standalone products, not kits), some of which included warning labels and some of which did not: n=58 for low lead sindoor; n=9 for moderate level religious powders and n=3 for high lead sindoor; n=8 for lead free sindoor. No high lead level religious powders were found in prayer kits; these were standalone products. However, 10 of 18 lead free samples were found in kits along with five moderate lead level samples and 39 low-level samples. Overall, a majority (58%) of the tested powders across lead level categories was found to be in professional containers; some with warning labels and others without, but not in kits). Chi square analysis did not reveal any statistically significant associations between lead level categories of religious powders and packaging type (p>0.05). Table 9 shows the cross-tabulation between lead level categories and packaging types.

Table 9: Cross-Tabulations of Lead Level Categories and Packaging Types for Sindoor and Related Products

Case Control Analysis of Powders

The odds ratios obtained from the case control analysis did not reveal statistically significant associations between low, moderate and high lead level categories and purchase locations or packaging types as compared to the control covariates (tables 10-

12). It should be noted the majority of associations indicated a protective relationship between covariates and the various lead level categories. However, none of these relationships were statistically significant.

Conversely, some odds ratios for purchase location indicated an elevated risk of purchasing samples containing 1-20 g/g Pb in India, North Jersey and Central Jersey compared to the U.S. and South Jersey, respectively. However, these associations were not statistically significant (all p-values >0.05). In addition, the odds ratio for purchasing a sindoor sample with >1,000 g/g Pb in North Jersey compared to purchasing a sindoor sample with this lead content in South Jersey was one. This indicated no association between purchasing the high lead sindoor and either one of the two sampling locations.

As with the other odds ratios, this effect was not statistically significant (p>0.05).

Table 10: Odds Ratios for New Jersey Sampling Regions (Sindoor Only)

Table 11: Odds Ratios for U.S. and India Sampling Regions (Sindoor Only)

Table 12: Odds Ratios for Packaging Types (Sindoor Only)

XRF Analysis Results

Ten religious powders (sindoor and miscellaneous powders) for each sampling location in New Jersey and India were randomly chosen for XRF analysis (Tables 13-17).

Central Jersey had twelve samples analyzed because three samples from one kit were analyzed. Each sample was analyzed in triplicate for quality control purposes. The data presented here are the averages of the three readings for each sample.

Overall, there was a non-existent to moderate and inconsistent correlation between XRF readings and lead content as determined by the laboratory analysis. For

North Jersey, the Pearson product moment correlation coefficient was r=-0.23 if a higher

Pb content powder (NJ09-253.9 g/g Pb) was included in the analysis while r=-0.02 if the higher Pb content powder was removed from the analysis. These higher content powders were removed from the analysis since outliers can skew the correlation coefficient in a particular direction. For Central Jersey, the correlation coefficient was r=0.62 if a higher Pb content powder (CJ90-247.3 g/g Pb) was included in the analysis and r=0.48 if it was removed from the analysis. For South Jersey, r=-0.25. No high Pb lead content samples were present and therefore analyzed via XRF for the South Jersey region.

For the India samples, the Pearson correlation coefficient for Mumbai was r=1, indicating a perfect association between XRF readings and lead content. However, it should be noted that three samples analyzed in this region contained very high lead levels

(Mum21: 5110.9 g/g Pb; Mum22: >300,000 g/g Pb; Mum23: >300,000 g/g Pb).

When these high levels were excluded from the analysis, the r=0.24, indicating a weaker association. For New Delhi samples, r=0.26, also indicating a weaker association between XRF readings and actual lead content of the powders. The correlation coefficient did not change when higher lead containing powders were removed from the analysis for this city.

Table 13: XRF and Lab Analysis Results for North Jersey Samples

Table 14: XRF and Lab Analysis Results for Central Jersey Samples

Table 15: XRF and Lab Analysis Results for South Jersey Samples

Table 16: XRF and Lab Analysis Results for Mumbai Samples

Table 17: XRF and Lab Analysis Results for New Delhi Samples

In addition to correlation coefficients, since we had information on the true lead content of the religious powders via the confirmatory laboratory analysis, we decided to view the field tests as clinical tests and perform sensitivity, specificity, positive predictive value and negative predictive value calculations to better understand the effectiveness of these tests in real world situations an inspector may encounter in the field. We found high

(100%) and consistent sensitivity, specificity, positive predictive value and negative predictive value calculations for the samples containing extremely high levels of lead

(>300,000 g/g). For the lower level samples, we found the abovementioned metrics to be relatively low and inconsistent. For example, sensitivity ranged from 0-67%, while negative predictive value ranged from 18-80%. However, it is important to note that generally sensitivity, negative predictive and other values increased as lead content in powders increased. Table 18 shows the calculated metrics for each lead level category along with individual cell counts in the 2x2 tables used to calculate the metrics.

Table 18: Sensitivity, Specificity, Positive Predictive Values and Negative Predictive Values for XRF Analysis and Cell Counts for Each Lead Level Category

Colormetric Analysis Results

The same ten samples, which were analyzed by XRF for each New Jersey and

India region, were also analyzed by colormetric analysis using the Rapid and Patented

Leach methods, respectively (Tables 19-28). As with the XRF analysis, each sample was analyzed in triplicate for both the Rapid and Patented Leach methods. The tables presented here show consistent color changes between the triplicates. If no consistent color change was observed, then the result of each triplicate is shown.

For a majority of the samples analyzed, no discernible color change could be observed for either colormetric analysis method. In most cases, when color change was observed, it was very slight/faint (mostly yellow). For the Leach method, this faint color change was mostly observed on the applicator tip and not in the indicator solution itself

(the manufacturer has reported color change should be observed in solution, and did not specify observing it on the applicator tip). After analysis, these slight color changes revealed that generally the slight yellow and brown color changes corresponded to lead levels as specified by the manufacturer. However, no consistent pattern of color change based on lead content was observed, i.e. some powders with low lead levels showed a slight color change while powders with higher lead content revealed no color changes.

For many of the samples in which a slight color change was observed using one colormetric method, a color change was not observed with the other method. Similarly, for some of the samples, a slight color change was not observed for each triplicate test— it was only observed for one or two of the tests. This phenomenon was more frequent for the Rapid method versus the Leach method. In addition, for some of the samples, color changes other than what the manufacturer describes in the operations manual, e.g.,

51 yellow, brown and black) were observed, specifically, magenta. Possible reasons are in the discussion section below.

Definitive, dark brown or black color changes for both the Rapid and Leach methods were only observed for two Mumbai samples, each of which according to the laboratory analysis, contained >300,000 g/g Pb. It should be noted the XRF analysis also indicated extremely high lead levels in these two samples. According to the manufacturer, this type of color change indicates a lead concentration of approximately

2500 g/g Pb (brown) or >5000 g/g Pb (black). During the colormetric analysis, it was noted how these two Mumbai samples did not feel as “fine” as other powders.

Table 19: North Jersey Colormetric (Leach) and Lab Analysis Results

Table 20: North Jersey Colormetric (Rapid) and Lab Analysis Results

Table 21: Central Jersey Colormetric (Leach) and Lab Analysis Results

Table 22: Central Jersey Colormetric (Rapid) and Lab Analysis Results

Table 23: South Jersey Colormetric (Leach) and Lab Analysis Results

Table 24: South Jersey Colormetric (Rapid) and Lab Analysis Results

Table 25: Mumbai Colormetric (Leach) and Lab Analysis Results

Table 26: Mumbai Colormetric (Rapid) and Lab Analysis Results

Table 27: New Delhi Colormetric (Leach) and Lab Analysis Results

Table 28: New Delhi Colormetric (Rapid) and Lab Analysis Results

Similar to the XRF results, we found high (100%) and consistent sensitivity, specificity, positive predictive value and negative predictive value calculations for the samples containing extremely high levels of lead (>300,000 g/g) for both the Rapid and

Leach colormetric tests. For the lower lead level samples, we found the above-mentioned metrics to be relatively low and inconsistent. For example, for the colormetric leach test sensitivity ranged from 0-67%, while specificity ranged from 88-100%. Tables 29 and 30 show the calculated sensitivity, specificity, positive predictive value and negative predicative value for each lead level category along with the cells counts in each 2x2 table used to calculate the metrics. As with the XRF test, the metrics generally increased for both the colormetric tests as lead content increased in the powders. It should be noted that for data for which each triplicate test is presented, averages of the sensitivity, specificity, etc were calculated and presented in the tables below.

Table 29: Sensitivity, Specificity, Positive Predictive Values and Negative Predictive Values for Colormetric Leach Test Analysis and Cell Counts for Each Lead Level Category

Table 30: Sensitivity, Specificity, Positive Predictive Values and Negative Predictive Values for Colormetric Rapid Test Analysis and Cell Counts for Each Lead Level Category

Sindoor Use Survey Results

A total of thirty-eight sindoor use surveys were collected from store clerks/managers from stores in which sindoor was purchased (Table 31). Of these 38, 18

(47%) were collected in North Jersey, 17 (45%) in Central Jersey and four (11%) in

South Jersey. This correlates approximately with the number of stores in each region. In

North Jersey, one survey was only partially completed due to a language barrier while another could not be completed due to store clerks’ refusal to participate. A third store in

North Jersey was visited multiple times in an effort to purchase sindoor but during each visit, the store clerk stated they were out of stock and awaiting shipments of the products.

However, the clerk was willing to answer the questionnaire and therefore it was completed. In Central Jersey, clerks at three stores refused to answer the questionnaire.

The survey could not be distributed at a fourth store for miscellaneous reasons. Other discrepancies between the number of stores visited and the number of completed surveys can be attributed to visiting stores found not to sell sindoor. No refusals for participation occurred in South Jersey. No sindoor use surveys were collected in either Mumbai or

New Delhi. If after stating their religion and gender, a respondent indicated they did not use sindoor, the survey was ended. One completed survey in the Central Jersey sampling region was voided since the respondent formerly self-identified as Hindu but had subsequently converted to Sikhism; she had used sindoor in the past but no longer used it.

However, her answers reflected former use, therefore, in an attempt to avoid any information bias, this survey was discarded from subsequent analysis.

Most respondents identified as Hindu (74.5%). Of respondents who identified their religion as “other,” 66% identified as Sikh; only three respondents identified as

Muslim. Not surprisingly, only those identifying as Hindu stated they used sindoor.

Respondents who identified as other religions stated they did not use sindoor. Most respondents who identified as Hindu stated that sindoor was only to be used for religious purposes and could not be used as a food additive. Most self-identified Hindu respondents also stated how a separate powder (not sindoor) was to be used at other cultural events such as Holi (It must be noted how two did state that sindoor could be used in Holi celebrations. One of these two did not appear to know the difference between sindoor and Holi powder).

More respondents indicated they did not apply sindoor to children compared to those who did. For those who did apply to children, frequency ranged from everyday to only 1-2 times a year. Ages of their children ranged from 7 years old to 20 years of age.

No respondents reported applying sindoor to infants or toddlers. Application site was reported to be the forehead and the part of the hair. Based on the survey responses, no one gender was more likely to apply sindoor to children. Three respondents indicated they did not apply sindoor to children since it was strictly to be applied only to idols.

One self-identified Muslim respondent in Central Jersey was not sure if sindoor could be used for food coloring or Holi. However, another self-identified Muslim in

North Jersey stated that sindoor could not be used for food coloring or cosmetic purposes.

Twenty-eight respondents stated that sindoor was to be used for religious purposes, with twenty stating application to religious idols as a specific use. For those who stated they applied sindoor to their bodies, all (n=20) indicated they applied it to their foreheads

(application on part of hair was a separate question).

Table 31: Sindoor Use Survey Results (N=38)

In terms of gender, there was almost double the amount of males versus females

(25 and 14, respectively). Of the 14 women respondents, 11 self-identified as Hindu and

10 of these 11 used sindoor in some capacity. There was an equitable split between those who applied it to the part of their hair and those who did not. Only two female respondents indicated they used sindoor for cosmetic purposes e.g., as a bindi and separate from the part of the hair. Most women indicated how only married females applied sindoor to the part of the hair.

Chapter 5

Discussion

Sindoor Collection and Analyses

We believe this is not only the first study to comprehensively analyze lead content in sindoor from a wide variety of South Asian retail markets throughout major regions of a state containing a large South Asian population but also the first to assess powders purchased directly in India. Previous studies assessed sindoor from a relatively small radius in a particular city (Lin et al, 2010; Vassilev et al, 2004). Due to the sizable South

Asian population in New Jersey and the presence of a large contingent of South Asian stores, we believe New Jersey has a strong influence on the overall manufacturing and import of South Asian products in the United States, and therefore we speculate the results presented here are strongly representative of lead levels in sindoor for other parts of the county.

Overall the results of the confirmatory lead analysis revealed that sindoor samples in both New Jersey and India contain high levels of lead and are readily available. The lead levels reported here correlate with lead levels found in sindoor powders from previously reported cases of sindoor related lead poisoning in young children (Lin et al,

2010; Vassilev et al, 2004) and therefore pose a real world public health threat, not only theoretical. During the conception of this research project, we hypothesized that sindoor products purchased in New Jersey would have very low to non-detectable levels of lead

(i.e “safe levels”). We also hypothesized that a greater proportion of samples from India, compared to the US, would contain >1 g/g Pb. We arrived at these hypotheses due to the fact that FDA and local media had previously increased awareness of lead adulterated

62 sindoor. The analysis of the final laboratory data disproves both these hypotheses. The results of this study also successfully meet one of the main goals of hazard surveillance— to recognize and identify lead hazards in specific brands/types of sindoor (Tables 32-34).

This identification will allow for the commencement of other public health action from removal of lead adulterated products to education as discussed below.

As stated earlier, the current FDA limit for Pb in color additives of cosmetics is

20 g/g (ppm). While the classification of sindoor as a cosmetic is somewhat ambiguous, the US Centers for Disease Control and Prevention (CDC), another federal government agency, states that its website that sindoor may be used as a cosmetic or in religious ceremonies (CDC, 2013b). This somewhat clarifies and possibly justifies FDA’s possible authority over sindoor products. As the results indicate, a fair amount of US sindoor samples (n=18) contain Pb equal to or greater than the limit. In addition to these levels, a majority of samples were found to contain detectable levels of lead (>1 g/g but less than

20 g/g). While these levels were below the FDA limit, these powders can still pose a hazard, as there is no known safe exposure level to lead, especially in children (CDC,

2012). Moreover, even though FDA has previously issued general warnings for sindoor

(in 2007, leading to voluntary recalls by the distributor), these results clearly indicate that hazard still exists in the U.S. and therefore a continued need for hazard surveillance. It is our belief that this continued problem warrants a more active effort from FDA in preventing these products from entering the country. Since the purpose of lead tetroxide

(Pb3O4), the ingredient responsible for elevated lead levels in sindoor products, is that of a color additive (to provide the deep red color to the powders), we believe sindoor brands found be above the FDA limit should be placed on the import list. This will alert FDA

63 staff of any sindoor brands they need to be especially vigilant about when conducting inspections and will allow for detainment of lead adulterated products—primary prevention in the preventive medicine hierarchy.

The presence of high lead level sindoor powders from India (specifically

Mumbai) is alarming since these products are a proxy for the types of products that may be carried into the United States by passengers traveling from India since flights regularly arrive to Newark Liberty International Airport from Mumbai, India and New Delhi,

India. It is also possible that these travelers use sindoor in a different manner (i.e more frequently, more often on younger children, etc) that those individuals who purchase sindoor from New Jersey stores. From our experience purchasing these powders in India, they are often times sold in unmarked plastic bags, increasing the possibility of unintended ingestion or mistaken off-label use such as during Holi celebrations

(inhalation or unintended ingestion can increase markedly during these celebrations as powders are actively made airborne by being thrown at other individuals. These powders are often thrown at an individual’s face, increasing the opportunity for accidental ingestion and inhalation). It should be noted that Holi powders with the same deep red color and texture as the sindoor powders were observed during field sample collection of sindoor powders.

Previous in vitro studies of lead absorption further emphasize the potential hazards of lead exposure in children. For example, Lin et al (2010) showed that the mean bioaccessibility of high lead sindoor in children of approximately 50%. Lin et al defined high lead sindoor as having lead content >47%, similar to findings in this study.

According to the Integrated Exposure Uptake Biokinetic (IEUBK) model used by Lin and

64 colleagues, ingestion of 20 g/day of the high lead sindoor can increase lead exposure by

10g/day.

In addition to sindoor, lead was also detected in other, readily available, miscellaneous religious powders. This is congruent with the findings of other published reports (Lin et al, 2010). Though Pb content in these powders was not as high as sindoor powders (maximum Pb concentration was 61 g/g compared to >300,000 g/g in sindoor), they still pose a risk since they were above the FDA limit of 20 g/g and may be applied to/used around children. Like sindoor powders, these powders can easily become suspended in air and therefore breathed in or ingested through hand-to-mouth activity or other means of accidental ingestion. Of the various colors tested, those powders, which were pink, contained the greatest amount of lead. We speculate that this may be due to the close resemblance between the colors pink and red and the penchant of manufacturers to add “red lead” to these colors in order to attain a “deeper and fuller” color. Following the pink powder, a green powder had the second highest lead content

(39.9 g/g). Due to the color of this powder, we find were surprised to find the presence of lead at the indicated levels. A possible reason for the presence of lead include cross contamination since this green powder was part of the kit that included other religious powders (however, this seems unlikely since other powders in this kit did not contain lead this high; the second highest concentration in this kit was approximately 17 g/g

Pb). Cross contamination may have been due to previous manufacture of sindoor in the same apparatus or the presence of a different, unknown reason. These results also indicate a need for hazard surveillance of non-sindoor religious powders.

Packaging Types

Our analysis revealed no pattern or trend in lead content that could be discerned from packaging types of the religious powders. Unsurprisingly, most of the religious powders were sold in professionally packaged containers. We speculate that since a majority of the stores from which the sindoor was purchased were large chain or franchise stores they would require proper packaging and labeling of their products. It should be noted that the three samples sold in unmarked plastic bags were from either a single “mom and pop” shop or a niche store that sold religious materials; none of the stores were major chains (as far as we know, the religious specialty stores have two locations in the state). While these products were below the FDA limit, they may still be considered misbranded as they were sold in unmarked bags. If they are in fact misbranded, the NJDOH Food and Drug Safety Program has reason and authority to force these products off the shelves. It is also important to consider the sindoor use practices of customers who shop at the religious specialty stores. These individuals may be more religious and therefore use sindoor at a greater frequency or apply it to their children more often than their counterparts who shop at larger chain stores, increasing their exposure to the toxicant.

Packaging also plays an important role when one considers unintended use of religious powders (sindoor and non-sindoor products alike). Previous reports (Vassilev et al, 2004) have described lead poisoning in both children and adults due to “off-label” use of sindoor such as for food coloring. From the anecdotal observations made during the fieldwork portion of this study, it is easy to understand how individuals not familiar with the intended use of these powders may ingest them as part of their diet. As shown in

Appendix 10, food coloring, sindoor and other religious powders are often packaged in very similar containers and made by the same brand. Food coloring and other food items are also often placed in the same location as other religious products and powders. The close proximity of all these products can easily confuse customers (especially non-Hindu customers who may be less familiar with the intended use of a powder) as to what products should be used for food preparations and what products should solely be used for external religious use. Based on these observations, we would suggest that local health department inspectors inform storeowners and managers on the importance of properly separating products with disparate uses and the importance of proper signage.

Lead Level Category Analysis and Case Control Analysis

We conducted an analysis of powders by lead level category of the samples in an attempt to discover any variables (purchase location and packaging type) which were more likely to be associated with sindoor and related powders with a certain range of lead level: lead free, low (0.2-20 g/g Pb), moderate (20-1000 g/g Pb) and high lead levels

(>1,000 g/g Pb). This analysis showed Northern and Central Jersey purchase locations were most associated with high and moderate lead level samples (data not shown in tables). These results are not surprising as they are congruent with the number of South

Asian stores and therefore the number of sindoor products available for purchase in each respective sampling area. As previously stated, the availability of a sindoor product in one region of the state does not necessarily preclude its availability in another region.

Moreover, it must be noted how associations between areas of purchase and lead levels may simply be a function of the number of samples available in each region, i.e., the higher number of samples provides more of an opportunity to find a sample with a certain

67 lead level. One should also not misconstrue these results to believe stores in Northern and

Central New Jersey somehow have “lower standards” than stores in Southern New

Jersey, and thus they allowed for the sale of high or moderate lead adulterate sindoor powders.

For the India samples, higher lead level sindoor was only purchased in Mumbai, all moderate level samples were purchased in New Delhi and no collected India samples were found to be lead free. These finding have important implications regarding public health. Mumbai and New Delhi are both major cities from which daily flights to the U.S. originate. This increases the probability for sindoor carried into the U.S. by passengers to potentially contain lead levels above the FDA limit of 20 g/g Pb. These findings may thus be an important starting point for policy discussions regarding further regulation of lead adulterated cultural powders carried into the U.S. by travelers. It is important to note though we did not find any high lead levels samples in New Delhi, this does not mean they are not available in New Delhi; our sampling methodology may not have provided the opportunity to purchase samples with higher lead levels.

Like the other analyses, this analysis also generally did not reveal any statistically significant association between lead level range and packaging type. However, it must be noted higher lead level sindoor products were found to be standalone products and not part of religious kits. As stated above, sindoor use practices of individuals who use these kits may be different than individuals who use standalone products—they may use sindoor more frequently or more often on children. For this reason, the fact that no higher lead containing powders were found to be part of these kits is positive news. On the other hand, the fact that some low level powders and moderate level powders were found to be

68 in these kits suggested individuals with potentially greater sindoor use may still be exposed to lead levels. While the majority of powders found in kits contained levels below FDA’s limit in cosmetics, no lead level in children has been found to be safe, so a potential for adverse health effects may still exist. While the lack of statistical association between packaging type and lead content has implications for primary prevention, the cross-tabulation revealed important information, which may be used to reduce exposure.

For example, since only standalone products were found to contain very high lead levels, individuals may be better served by only purchasing religious kits since no high lead samples were found in that packaging type. However, the lack of any concrete association between lead levels and packaging types may force public health authorities to simply remove all products from stores instead of systemically focusing on products that meet certain criteria as would be done if any association between packaging type and lead content was found. Case control analysis did not reveal any statistically significant differences between those sindoor powders categorized as controls (<1 g/g) and those assigned as cases (1-20 g/g, 21-1000 g/g and >1000 g/g Pb lead level categories).

XRF and Colormetric Analysis

Overall, the analysis of the XRF testing results revealed how the RMD LPA-1

XRF analyzer (a common analyzer used by local/county health departments to detect lead based paint) cannot be used as a rapid field test for sindoor by inspectors. We are surprised by this conclusion, as we believed it would be able to provide a general qualitative indicator of whether a sample contained lead. No consistent correlation between this study’s XRF readings and Pb content was revealed. While a correlation coefficient of r=1 (indicating a perfect association between XRF readings and Pb content)

69 was calculated for the Mumbai samples analyzed, we believe these readings were skewed by samples containing very high levels of lead (Mum21, Mum 22 and Mum23).

Therefore, while these results only apply to this specific model of XRF analyzer, it may be speculated how the results may also be applicable to other lead based paint analyzers if they function in the same manner as the RMD LPA-1 used in this study.

Furthermore, while in our methods section we stated that a positive lead reading would be 1.0 mg/cm2 or higher, no consistent reading even below that threshold was observed for powders containing lead in any range (even for samples containing Pb as high as 5110 g/g). The analyzer only consistently indicated high lead content for the samples containing >300,000 g/g Pb. In addition, we found consistently high sensitivity, specificity, positive predictive value and negative predictive value only for samples with

>300,000 g/g lead. Overall, while the XRF analyzer did accurately qualitatively identify samples containing very high amount of lead, due to the rarity of these samples, this XRF analyzer manufactured for the detection of lead based paint does not appear to be a practical field test for inspectors.

It is also important to note the results obtained in this study may be the result of sample processing. In the present study, samples were analyzed in their original powder form through a plastic baggie. If sindoor samples were mixed with confirmed lead-free paint, which was then painted onto a surface (i.e., resuspended onto a hard surface), the

XRF analyzer model used in this study (RMD LPA-1) may have been more accurate in assessing lead content since it was designed to be used on surfaces such as walls.

However, this procedure was not done in this study since we were interested in the viability of this XRF as a rapid field tool for health department inspectors. In summary, if

70 financially feasible, health departments and others could use a more current, sophisticated model XRF analyzer specifically manufactured for use with consumer products such as powders in order to detect lower, yet more common, amounts of lead in sindoor and other religious powders.

As with the XRF test, we believe this that particular colormetric test (both Rapid and Leach methods) is not a viable field tool for inspectors. The primary reason for this includes the fact that for most samples, even one containing lead even as high as half a percent, no color change was observed. Furthermore, while for both the Rapid and

Patented Leach Methods, the slight yellow or brown color changes corresponded with manufacturer specifications, we believe the identification of faint color changes was too subjective and inconsistent to be of any practical use for lead adulteration identification.

In addition, we are unsure if observed color changes were simply due to the color of the powder “running off” into the applicator tip and not an actual color change of the indicator solution. Due to the lack of any color change on the powders containing higher amount of lead, we believe that the slight yellow or brown/black color changes are due to

“run off” and any correspondence with manufacturer’s specification is coincidence. The subjective nature of the color identification may also explain some of the inconsistencies in color observation between the triplicate tests.

Moreover, as previously mentioned, for some of the samples, color changes not mentioned by the manufacturer such as to magenta were observed. We speculate that may be due to interaction of the indicator solution and any salts or other compounds in the powders. Taken together, these conclusions partially disprove our hypothesis (as with the

XRF analyzer), since the colormetric test can only consistently identify for samples

71 containing >300,000 g/g Pb. Like the XRF test, we found consistently high sensitivity, specificity, positive predictive value and negative predictive value only for samples with

>300,000 g/g lead for both the Rapid and Leach colormetric tests. For both the XRF and colormetric tests, the high sensitivity and negative predictive value for high lead samples is especially encouraging since we believe these two metrics to be the most important for any sort of screening test. The ability of a test to correctly identify positive samples and to accurately distinguish negative samples is important for these type of field tests since not correctly identifying lead adulterated products or incorrectly identifying lead free products can endanger public health. For rapid field tests, in general, the adverse outcome of a false positive is much less than a false negative. For both the XRF and colormetric tests, Figures 2-7 generally show sensitivity and negative predictive values increasing as the lead level categories of lead content for the religious powders increased.

Figure 2: Sensitivity for XRF Analysis

Figure 3: Negative Predictive Values for XRF Analysis

Figure 4: Sensitivity for Colormetric Leach Test

Figure 5: Negative Predictive Values for Colormetric Leach Test Analysis Results

Figure 6: Sensitivity for Colormetric Rapid Test

Figure 7: Negative Predictive Values for Colormetric Rapid Test Analysis

Sindoor Use Survey

Generally, the results of the surveys indicated most respondents knew the proper use of sindoor while also revealing small amounts of misinformation about its use. For example, of all the respondents, only one, a self-identified Muslim stated that sindoor could be used for food coloring. This is consistent with previously published reports

(Vassilev et al 2004). At the same time, two Hindu respondents stated that sindoor could be used in Holi celebrations. The surveys also revealed that the application site for

74 children and adults most frequently mentioned was the forehead. This is very conducive to hand-to-mouth action for children and therefore accidental ingestion of the powder. In adults, this has the potential to lead to unintended contamination of cooking materials if an individual rubs their forehead and then prepares food or touches a child, etc. Overall, the fact that most respondents stated that sindoor could not be used for food coloring or any other miscellaneous use underscores the mostly passive nature of sindoor related lead poisoning. These results along with previously reported case studies demonstrate the ease of unintended, accidental ingestion, especially in children.

Moreover, while not included in the survey, anecdotally, we have observed that a bare finger is used a vast majority of the time for application of sindoor instead of an application tool (i.e. swab, etc). This can lead to accidental ingestion if food is prepared afterward and hands are not properly washed. In addition, many religious ceremonies involve eating of a food item, providing another opportunity for passive, unintended ingestion. While these observations are currently simply anecdotal, they may prove vital to future hypothesis generation for other exposure studies and health education efforts to abate accidental ingestion (i.e. focusing on places of worship, where this type of behavior is more likely to occur, etc).

In terms of religion, our survey reconfirmed what was already stated in the literature—sindoor is only used by Hindus. However, the CDC claims that sindoor may also be used by Sikhs (CDC 2013b). This discrepancy may simply be a result of the small number of Sikhs in our sample (n=4); if we had sampled more Sikhs, we may have arrived at a similar conclusion.

Study Limitations

There are certain limitations of this study. First, not all collected powder samples were tested for lead content due to resource limitations. However, due to the number of samples tested and the wide geographic region of the stores from which samples were purchased, we believe our results are fairly representative of the lead content of sindoor products throughout the state. In addition, lot-to-lot variability of lead content in powders was not examined. Relatively, for the samples with low lead content, lead concentration could significantly change based on contamination, instruments used for manufacture, etc. However, significant changes in lead content are unlikely for the samples containing high levels.

While associations between lead content and the cost of the sindoor/other religious powder samples were not assessed, statistically significant associations were not expected to be found. The price for the standalone products was similar across the stores visited (approximately $2-3 U.S. per sample). For religious kits, the cost was higher

(ranging from approximately $6-35 U.S. per kit, depending on the size of the kit and the contents included); however, most (except two) of the powders tested in the kits had similar, low lead levels (see tables 32-34). In future research, a complete, thorough analysis should be conducted before any definitive statement of association (positive or negative) between the two variables—lead content and sindoor cost—can be made for either standalone products or religious kits. On the sindoor practices survey, a question should have been asked about whether an applicator tool is used when sindoor is applied to the body or if hands are used. In addition, a question should have focused on if respondents were aware of any health concerns with sindoor use. These questions would

76 have provided more information of the chance for accidental ingestion and a cross- section of awareness to the potential hazard of using sindoor. Furthermore, while we believe study survey respondents are representative of typical sindoor users, differences in sindoor use between customers and store owners/clerks could exist, especially due to the relatively small sample size (n=38) of our survey data.

Finally, it should be noted how any statistically significant differences (or lack of association) observed between lead content and sampling location or packaging type may be a result of the relatively small sample size in each location or packaging type strata.

Associations found to be statistically significant in each stratum with current sample sizes may be found to be not statistically significant (or remain significant) with a larger sample size for each stratum.

Public Health Outreach, Education and Action

As previously stated, one of the steps of effective hazard surveillance is to focus hazard reduction strategies on those subpopulations most likely at risk—i.e. South Asian individuals self-identifying as Hindu. These strategies involve removing adulterated products from shelves and raising awareness through culturally appropriate education of storeowners, consumers, religious figures, physicians and other stakeholders. From a public health perspective, these primary level actions are the most effective in abating the potential hazard introduced by sindoor and other religious powders.

One avenue of public health action at the primary level involves removing lead adulterated products from store shelves to ensure they never reach individuals’ homes. To this effect, we have met with the New Jersey Department of Health Food and Drug Safety

Program (FDSP) and have agreed to collaborate on public health action. Due to FDSP’s

77 limited resources and regulatory authority, FDSP leadership informed us that collaboration with US FDA is required to remove adulterated products from store shelves; FDSP can only easily remove mislabeled cosmetics from store shelves or if they receive notice of adulteration from an outside agency (personal communication, L.

Muetter and V. Wheatly, January 8, 2016). We will be sending FDA an abstract of the findings of this study and a table of the names of all tested powders and their associated lead content (Tables 32-34) in an effort to inform them of the potential hazard and the gauge their interest in a collaboration. It should be noted that this same table has already been disseminated to the FDSP who will further forward to local and county health departments. Inspectors at these health departments can then use these tables (and associated pictures of some powders containing very high levels of lead) during their routine inspections to inform storeowners that they may be carrying adulterated products.

However, the response of each local health department may vary depending on their individual priorities. For example, the health department in Middlesex County, NJ may be more inclined to instruct their inspectors to remove adulterated products from store shelves due to their high South Asian population while a health department in Atlantic

County, NJ may take a more passive approach such as simply hanging signs warning of the potential hazard in South Asia stores (V. Wheatly, personal communication, January

14, 2016). A more comprehensive and uniform response requires assistance from and collaboration with FDA. Furthermore, as part of our nascent public health outreach strategy, a sindoor fact sheet created by the principal investigator has been placed on the

NJDOH FDSP website (Appendix 11).

Due to previously published case reports of sindoor associated lead poisoning in children and the number of powders found to be above the FDA limit of lead in color additives in cosmetics, we are optimistic in receiving FDA assistance in either raising awareness or removing these adulterated products from commerce. In addition to removing adulterated products from store shelves, FDA can raise awareness by issuing warnings to the pubic (as they have previously done in 2007) or by issuing an import alert. Ultimately, FDA involvement may also lead to contact with distributors and/or manufacturers of adulterated powders, allowing potential abatement of lead at the source.

For legal reasons, if FDA wishes to remove products from shelves, they will have to collect their own samples, maintain a chain of custody and conduct the lead testing in their lab in Jamaica, Queens, NY (L. Muetter, personal communication, January 8, 2016).

From a legal perspective, the results we will provide to FDA are considered

“informational” and would not have standing in a court of law (L. Muetter, personal communication, January 8, 2016).

Table 32: North Jersey Religious Powder Brands, Packaging Type and Respective Lead Concentrations

Table 33: Central Jersey Religious Powder Brands, Packaging Type and Respective Lead Concentrations

Table 34: South Jersey Religious Powder Brands, Packaging Type and Respective Lead Concentrations

In addition to physically removing adulterated products from store shelves, raising awareness through education is also an important step in reducing the hazard. For example, during routine inspections, local and county health inspectors can educate owners/managers of South Asian stores of the brands of religious powders found to contain higher levels of lead. Local health departments can also advise storeowners to hang signs near religious powders to warn consumers of the potential adulteration of powders and to educate them on the importance of not applying the powders to small children because of potential hand-to-mouth activity and the importance of washing hands after sindoor application for both adults and children.

As a complement to involving storeowners, it is important to involve other stakeholders, especially those who are part of the South Asian Hindu community. As is a basic tenant of health education, populations targeted for public health action/at risk populations are more likely to respond to public health intervention such as education if a member of their own community disseminates the message (ATSDR 2005). To this effect, we believe members of the Hindu community should have a prominent role in propagating educational materials and general awareness of the potential hazard. These members can act as “cultural contacts,” a bridge between members of the community and public health officials (ATSDR 2005).

One of the groups to involve is religious leaders/priests from Hindu places of worship throughout New Jersey. Due to the role sindoor plays in religious ceremonies, sindoor use is likely to be prominent in these locations. In addition, those who use sindoor in places of worship may be more religious than their peers and educational

83 outreach from a priest or other religious authority figure may be especially effective.

Initial outreach to religious figures would have to be conducted in a culturally appropriate manner, ideally by a member of the South Asian Community and viable alternatives (i.e. names of products found not to contain high levels of lead) would have to be presented.

As was observed during field collection, one of the biggest hurdles in any sort of public health outreach is anticipated to be the fact many Hindu individuals have used religious powders throughout their lives without any discernable adverse health effects and therefore may believe the potential hazard to be overblown and therefore intervention unnecessary.

Another group to involve in public health education is South Asian/ Hindu physicians. Due to their medical training and positions of authority, this group should be effective in communicating the hazard. Anecdotally, it has been observed how South

Asian individuals go to South Asian physicians due to cultural compatibility and familiarity. South Asian physicians are aware of cultural sensitivities and proclivities and can present the potential hazard of religious powders in a culturally appropriate manner.

We propose collaborating with the New Jersey Chapter of the American Association of

Physicians of Indian Origin (AAPI). This chapter is further divided into sub-chapters for certain specific counties in the state including Hudson, Essex, Monmouth and Ocean counties. The AAPI also includes the Indian Medical Society of New Jersey. The director of the Mid-Atlantic region of the AAPI (which includes the sub-chapters mentioned above) will be contacted and provided with the same summary and results and table(s) we provided to NJDOH and to FDA. If interest is reciprocated by the director, we plan on asking him to contact, on our behalf, presidents of the sub-chapters as his endorsement is

84 more likely to engender their collaboration. We hope that mutual interest in this hazard will lead to meetings between investigators of this study and member physicians in order to examine the findings of this study and methods of health communication to the target- population.

In addition to contacting physicians of South Asian origin, the New Jersey Poison

Information and Education System will be contacted. While NJPIES is generally aware of this potential hazard from a previous case (Vassilev et al, 2004), we believe they need to aware of the results of this study due to its comprehensive nature. NJPIES has several public education programs focusing on poison safety (NJPIES 2015). These programs range from programs for children to programs for parents and seniors. In addition to education program, education materials are also provided by NJPIES. Ultimately, the fact sheet provided to NJDOH FDSP will also be on the NJPIES website and sindoor awareness will become part of the poison education programs to adults and children. To facilitate this, contact with Dr. Bruce Ruck, PharmD, RPh, Director of Drug Information

Services & Professional Education, was initiated.

Conclusion and Future Research

Due to logistical issues, we were not able to carry out the airport portion of this study. For future research on this subject matter, we would strongly advocate for the examination of sindoor and other religious powders carried into the US by travelers from

India. Comprehensive hazard surveillance of lead adulterated religious powders requires assessment of this potential mode of entry into the US and New Jersey as a major port of entry. This approach may reveal how sindoor import via passenger luggage is or is not a

85 significant contributor to the prevalence of lead adulterated powders and thus may allow for the focus of limited public health resources.

Analysis of other types of religious powders, especially pink colored powders, also revealed lead content at various levels. A more comprehensive study of these powders in

New Jersey is required to determine the scope and extent of the potential hazard. In addition, powders used during the cultural festival of Holi also need to be examined for lead. These powders are often red—among other colors, given this study revealed sindoor powders in other colors can also contain lead—and therefore may contain lead tetroxide as a color additive. (Due to the reasons mentioned above, exposure to powders through inhalation and unintentional non-dietary ingestion is also possible during Holi and therefore may pose even a greater risk to health than sindoor). Children, who in general are more sensitive to toxicants than adults, most often participate in these celebrations.

Air monitoring of dust/airborne powders near breathing zones of children participating in

Holi activities may also be done as a compliment to assessing lead content in powders.

This may provide a more complete picture of the total aggregate, real world exposure to potentially lead adulterated products in a sensitive, vulnerable sub-population. We also believe an exposure survey for specific populations, such as those using religious powders at places of worship, needs to be conducted to determine any potential differences in sindoor use practices between these individuals and the general South

Asian population.

References

Achebe, C.R., Sweeney, O.T., Jani, N., Marcus, S., & Halperin, W. (2013, April).

Conceptualization of sindoor related lead poisoning prevention using sentinel health

event approach. Poster presented at the NJ Public Health Symposium, Piscataway,

NJ.

Agency for Toxic Substance and Disease Registry [ATSDR]. (2005). Chapter 4:

Involving and Communicating with the Community. Retrieved January 13, 2016,

from http://www.atsdr.cdc.gov/hac/phamanual/ch4.html

Altman, D.G., & Bland, J.M. (1994). Diagnostic tests 1: sensitivity and specificity.

British Medical Journal, 308, 1552.

Altman, D.G., & Bland, J.M. (1994). Diagnostic tests 2: predictive values. British

Medical Journal, 309, 102.

ATSDR. (2007). Lead Toxicity: What are the physiologic effects of lead exposure?

Retrieved March 8, 2014, from

http://www.atsdr.cdc.gov/csem.asp?csem=7&po=10

ATSDR (2007.) Lead Toxicity: What are the U.S. standards for lead levels? Retrieved

September 28, 2014 from http://www.atsdr.cdc.gov/csem/csem.asp?csem=

=7&po=8

Bearer, C.F. (1995). How are children different from adults? Environmental Health

Perspectives, 103, 7-12.

Bruening, K., Kemp, F.W., Simone, N., Holding, Y., Louria, D.B., & Bogden, J.D.

(1999). Dietary calcium intakes of urban children at risk of lead poisoning.

Environmental Health Perspectives, 107(6), 431-435.

Canfield, R.L., Henderson, C.R. Jr, Cory-Slechta, D.A., Cox, C., Jusko, T.A. &

Lanphear, B.P. (2003). Intellectual impairment in children with blood lead

concentrations below 10microg per deciliter. New England Journal of Medicine,

348(16), 1517-1526.

Centers for Disease Control and Prevention [CDC]. (2013a). Lead: Prevention Tips.

Retrieved March 5, 2014, from http://www.cdc.gov/nceh/lead/tips.htm

CDC. (2012). Lead: What do parents need to know to protect their children?

Retrieved March 10, 2014, from http://www.cdc.gov/nceh/lead/

ACCLPP/blood_lead_levels.htm

CDC. (2013b). Sindoor Alert. Retrieved February 18, 2014, from

http://www.cdc.gov/nceh/lead/tips/sindoor.htm

Environmental Protection Agency [EPA]. (2011). Fuel and fuel additives: Basic

information. Retrieved March 27, 2014 from, http://www.epa.gov/otaq

/fuels/basicinfo.htm

EPA. (2011b). Vocabulary Catalog. Retrieved February 21, 2016 from,

https://ofmpub.epa.gov/sor_internet/registry/termreg/searchandretrieve/glossariesan

dkeywordlists/search.do?details=&glossaryName=IRIS%20Glossary#formTop

First Alert Store. (2005). Lead test kit. Retrieved August 18, 2014 from,

http://www.firstalertstore.com/store/images/pdf/LT1-

First_Alert_Lead_Test_Kit.pdf

Frumkin, H. (2010). Environmental health: from global to local (2nd ed). San Francisco,

CA: Jossey-Bass.

Gorospe, E.C., & Gertstenberger, S.L. (2008). Atypical sources of childhood lead

poisoning in the United States: A systematic review from 1966-2006. Clinical

Toxicology, 46, 728-737.

Goyer, R. (1990). Lead Toxicity: From overt to subclinical to subtle health effects.

Environmental Health Perspectives, 86, 177-181.

Greife, A., Halperin, W., Groce, D., O'Brien, D., Pedersen, D., Myers, J., & Jenkins, L.

(1995). Hazard surveillance: Its role in primary prevention of occupational disease

and injury. Applied Occupational and Environmental Hygiene, 10(9), 737-742.

Halperin W. Integrating Preventive Medicine and Public Health into Clinical Practice

[PowerPoint slides].

Halperin, W. (2013) Public health approach to industrial chemical assessments “6

paradigms” [PowerPoint slides].

Hudson Reporter. (2004). Concerns about sindoor in Indian cuisine High traces of

lead found in popular food coloring. Retrieved February 22, 2014, from

http://hudsonreporter.com/view/full_story/2397259/article-Concerns-about-sindoor-

in-Indian-cuisine-High-traces-of-lead-found-in-popular-food-coloring

Kapoor, V.P., Katiyar, K., Pushpangadan, P., & Singh, N. (2008). Development of

natural dye based sindoor. Natural Product Radiance, 7(1), 22-29.

Kute, V.B., Shrimali, J.D., Balwani, M.R., Godhani, U.R., Vanikar, A.V., Shah, P.R.,

Gumber, M.R., Patel, H.V., & Trivedi, H.L. (2013). Lead neuropathy due to

sindoor in India. Renal Failure, 35(6), 885-887.

Lanphear, B.P., Dietrich, K., Auinger, P., Cox, C. (2000). Cognitive deficits associated

with blood lead concentrations <10microg/dL in US children and adolescents.

Public Health Reports, 115(6), 521-529.

Lanphear, B & Roghmann, K. (1996). Pathways of lead exposure in urban children.

Environmental Research, 74, 67-73.

Lin, C.G., Schaider, L.A., Brabender, D.J., & Woolf, A.D. (2010). Pediatric lead

exposure from imported Indian spices and cultural powders. Pediatrics, 125(4),

e828-e835.

Liu, J., Gao, D., Chen, Y., Jing, J., Hu, Q., & Chen, Y. (2014). Lead exposure at each

stage of pregnancy and neurobehavioral development of neonates.

NeuroToxicology, 44, 1-7.

Liu, J., Shi J.Z., Y, L.M., Goyer, R.A., Waalkes, M.P. (2008). Mercury in traditional

medicines: Is cinnabar toxicologically similar to common mercurials? Experimental

Biology and Medicine, 233(7), 810-817.

Mahaffey, K.H. (1982). Biotoxicity of lead: influence of various factors. Federation

Proceedings, 42(6), 1730-1734.

Mayo Clinic. (2011). Lead Poisoning. Retrieved March 5, 2014, from

http://www.mayoclinic.org/diseases-conditions/lead-

poisoning/basics/definition/con-20035487

Melnyk, L.J., Berry, M.R., Sheldon, L.S., Freeman, N.C., Pellizari, E.D., & Kinman,

R.N. (2000). Dietary exposure of children in lead-laden environments. Journal of

Exposure Analysis and Environmental Epidemiology. 10, 723-731.

Morbidity and Mortality Weekly Report, Centers for Disease Control and Prevention.

(2013). Childhood Lead Exposure Associated with the Use of Kajal, an Eye

Cosmetic from Afghanistan — Albuquerque, New Mexico, 2013. Retrieved March

5, 2014, from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6246a3.htm

Needleman, H. (2004). Lead Poisoning. Annual Review of Medicine, 55, 209-222.

Nie, H., Sanchez, B.N., Wilker, E., Weisskopf, M., Schwartz, J., Sparrow, D. & Hu, H.

(2002). Bone lead an endogenous exposure in an environmentally exposed elderly

population: the normative aging study. Journal of Occupational and

Environmental Medicine, 51(7), 848-857.

Saper, R.B., Kales, S.F., Paquin, J., Burns, M.J., Eisenberg, D.M., Davis, R.B., &

Phillips, R.S. (2004). Heavy metal content of ayurvedic herbal medicine

products. Journal of the American Medical Association, 292(23), 2868-2873.

Schmidt, C.W. (2013). Unsafe harbor? Elevated blood lead levels in refugee children.

Environmental Health Perspectives, 121(6), A190-A195.

Steuben County, New York. (2013). In the field of environmental health.

Retrieved June 7, 2013, from

http://www.steubencony.org/Files/Documents/inthefield_summer

_13_web.pdf

Stover, G.N., & Bassett, M.T. (2003). Practice is the Purpose of Public Health. American

Journal of Public Health, 93(11), 1799-1801.

Robson, M, G., & Toscano, W.A. (2007). Risk assessment for environmental health (1st

ed). San Francisco, CA: Jossey-Bass.

Toxipedia. (2012). Federal Food, Drug and Cosmetic Act of 1938. Retrieved March 15,

2014, from http://www.toxipedia.org/display/toxipedia/Federal+Food,+Drug

,+and+Cosmetic+Act+of+1938

United States Consumer Product Safety Commission. Total Lead Content. Retrieved

September 25, 2014 from http://www.cpsc.gov/en/Business-

Manufacturing/Business-Education/Lead/Total-Lead-Content/

U.S. Department of Housing and Urban Development [HUD]. Clearance. Retrieved

September 25, 2014 from http://portal.hud.gov/hudportal/HUD?src

=/program_offices/comm_planning/affordablehousing/training/web

/leadsafe/keyrequirements/clearance

U.S. Food and Drug Administration [FDA]. (2014a). FDA authority over cosmetics.

Retrieved February 11, 2014, from http://www.fda.gov/Cosmetics

/GuidanceRegulation/LawsRegulations/ucm074162.htm#Can_FDA_order

U.S. FDA. (2014b). Information for cosmetics importers. Retrieved February 11, 2014,

from http://www.fda.gov/Cosmetics /International Activities/Importers

/ucm2005215.htm

U.S. FDA. (2012). Inspections, compliance, enforcement & criminal investigations.

Retrieved October 4, 2014 from http://www.fda.gov/ICECI/EnforcementActions/

WarningLetters/2012/ucm313452.htm

U.S. FDA. (2014c). Lipstick & lead: questions & answers. Retrieved September 25,

2014, from http://www.fda.gov/cosmetics/ productsingredients/

products/ucm137224.htm#q2

Vassilev, Z.P., Marcus, S.M., Ayyanathan, K., Ciuffo, V., Bogden, J.D., Kemp, F.W.,

Ruck, B., Jennis, T., Jani, N., & Halperin, W. (2005). Case of elevated blood lead

in a South Asian family that has used sindoor for food coloring. Clinical

Toxicology, 43, 301-303.

Appendices

Appendix 1: Lead Threshold Levels in Household Dust, Consumer Products and Workplaces

Table A1-1: U.S. Department of Housing and Urban Development Lead Threshold Levels in Dust

Table A1-2: Consumer Product Safety Commission Limits of Lead in Products

*ppm=parts per million

Table A1-3: NIOSH and OSHA Lead Limits for Workers

Appendix 2: Maps of Sampling Areas

Figure A2-1: Overview of the three sampling areas within 15 miles of each Rutgers Campus in North, Central and South Jersey

Figure A2-2: Fifteen-mile radius of New Jersey Medical School (North Jersey)

Figure A2-3: Fifteen-mile radius of School of Public Health (Central Jersey)

Figure A2-4 Fifteen-mile radius of School of Public Health (South Jersey)

Appendix 3: Tables of Purchased Brands, Packaging Types, Manufacturers, Distributors and Other Pertinent Information by Sampling Region

100

Table A3-4: North Jersey Religious Powder Brands and Packaging Information

101

Table A3-5: Central Jersey Religious Powder Brands and Packaging Information (Part I of III)

102

Table A3-5: Central Jersey Religious Powder Brands and Packaging Information (Part II of III)

103

Table A3-5: Central Jersey Religious Powder Brands and Packaging Information (Part III of III)

104

Table A3-6: South Jersey Religious Powder Brands and Packaging Information

105

Appendix 4: New Jersey South Asian Markets Survey Tool

106

Hi, my name is ______and I am working with Rutgers University to conduct a study to learn about sindoor use practices in individuals and lead content in sindoor. Sometimes when sindoor is made, lead is added to it to give sindoor its red color. As you may know, lead is a heavy metal than can cause health problems in both adults and children if it gets into the body such as learning disabilities and lead poisoning. If you don’t mind, I would like to ask you a few questions about how you use sindoor.

Do you consent to this interview? A. Yes B. No If yes, please initial here: ______

[Note to study staff: If store employee consents to interview, they MUST sign IRB sanctioned consent form.]

The following questions will be asked to better understand how you use or how you are planning to use the sindoor.

1. Do you identify yourself to be a Muslim or Hindu? A. Muslim B. Hindu

2. Do you use or are you planning on using the sindoor for religious purposes? Y/N If yes: How often do you use it for religious purposes? ______

What is the role of the sindoor when it is used for religious purposes? ______

Do you apply it to the body? (Y/N) ______If yes: Where on the body do you apply it? ______

3. Do you use or are you planning on using the sindoor for cosmetic purposes (as a bindi or other purpose)? Y/N If yes: What type of cosmetic purpose do you use sindoor for? Where on the body do you apply it? ______

How often do you use it for cosmetic purposes?

Note: If individual mentions wearing sindoor in the part of their hair in question 2or 3, then you can skip question 4. Otherwise, proceed to question 4.

107

4. Do you use or are you planning on using the sindoor on the part of your hair? Y/N (If no, skip to question 6) If yes: How often do you use it on the part of your hair? (# days/week)

______

5. If you have children, do you apply or are you planning on applying sindoor to your child/children’s skin? Y/N If yes, proceed to choices below. Otherwise skip to question 7

A. How old is (are) the child (children)? ______B. What is (are) the gender(s) of the child (children)? ______C. What is (are) the year(s) of birth of the child (children)? ______D. Where on their body do you apply it? ______E. How often do you apply sindoor to the child’s (children’s) skin? a. 1-2 times a week b. 3-4 times a week c. 5 times or more a week

6. Do you use or are you planning on using the sindoor as a food additive? Y/N (If no, skip to question 9) If yes: For what cooking purpose do you use sindoor (as a food coloring, etc)?

How often do you use sindoor as a food additive? ______On which foods or types of foods do you use sindoor as a food additive?

______

7. Are there any other purposes for which you use sindoor that we have not asked? Y/N (If no, skip to question 9) If yes: Please explain: ______How often do you use it for this purpose? ______

Misc. info relating to this other purpose:

______

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Appendix 5: Information Sheet

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Name of Sindoor: ______

Type of packaging (circle one): Plastic/glass container

Unmarked plastic bag

Cardboard packaging

Other: ______

Location: ______

Price of sindoor: ______

Date of purchase: ______

Name of Sindoor: ______

Type of packaging (circle one): Plastic/glass container

Unmarked plastic bag

Cardboard packaging

Other: ______

Location: ______

Price of sindoor: ______

Date of purchase: ______

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Appendix 6: Sindoor Samples Purchased in India

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Table A6-7: Sindoor Samples Purchased in Mumbai, India

Table A6-8: Sindoor Samples Purchased in New Delhi, India

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Appendix 7: Sindoor Collection Methodology for Newark Liberty International Airport

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Sample Collection: Newark Liberty International Airport

An in-person survey of passengers arriving on commercial flights from India to

Newark Liberty International Airport regarding their sindoor use practices will be administered and a small sample of sindoor will be collected, if the passenger allows, for subsequent analysis for lead content. The surveying of passengers and collection of sindoor samples will occur at the “Meet and Greet” area directly outside the baggage claim areas of terminal C for United Airlines flights 83 and 49, which arrive from New

Delhi and Mumbai, respectively. Both flights arrive daily; flight 83 arrives at EWR at approximately 4:45am and flight 49 arrives at approximately 5:25am. United Airlines has already agreed to conduct the survey and sindoor collection in terminal C of EWR airport

(see Appendix 7 for email exchanges between doctoral candidate and the United Airlines representative).

To conduct the survey of passengers, study staff will meet three days a week over the course of approximately two months for the two daily direct flights (United 83 and

United 49). The survey tool will be translated into three languages: Hindi, Punjabi and

Gujarati by associates of the doctoral student who are fluent in the three languages.

Surveys will also be back translated into English to ensure accuracy. If the passenger does not speak English, the passenger will be provided the survey as a written questionnaire to complete in one of the aforementioned languages. This survey tool is a modified version of the survey to be used for New Jersey South Asian retailers. During the study period, study staff will be wearing shirts with the Rutgers University logo and nametags to make themselves easily identifiable to passengers as researchers affiliated with the university.

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Due to uncertainties and practical limitations such as the possibility of a low number of passengers carrying sindoor, systematic random sampling of passengers for study participation will not be conducted since this approach could greatly limit the number of sindoor samples obtained. Instead, subject selection will be done through nonrandom (convenience) sampling in which study staff will approach passengers based on their ease of accessibility as they enter the “Meet and Greet” area outside terminal C.

In addition, those passengers who are wearing sindoor will also be targeted, as their chance of carrying sindoor is higher than those not wearing it. While there may be a higher chance of women wearing sindoor, study staff will attempt to survey an approximately equal number of men and women. Furthermore, it is understood that selection bias, specifically volunteer bias, may occur as those passengers who choose to participate may be different than those who do not consent to participate in the study.

During sample collection, if multiple passengers have the same sindoor (same name and manufacturer) then those samples will still be collected, as this will allow for evaluation of lead content analysis of different samples (lot-to-lot variability) of the same brand of sindoor.

At the end of the survey and with passenger consent, a sindoor sample will be collected from each study participant for subsequent lead analysis. If a passenger consents, their name and contact information will also be collected to inform them of test results. If passengers choose to be informed of the lead analysis results for their sindoor samples, they will be given a choice of being contacted by phone, USPS mail or e-mail.

Depending on their preference, the appropriate contact information will be collected.

Furthermore, if available, the brand, distributor and lot number of sindoor collected from

115 passengers will be documented, e.g. type of packaging and type and extent of labeling

(ingredients, expiration date, manufacturer, distributor, lot number etc) in which the sindoor is found; a lack of labeling information will also be noted recorded in study notebooks on clipboards. Study staff will also document date of interview and the flight on which the passenger arrived. The total number of passengers who are asked to participate and the number who consent will be recorded along with the number of passengers who refuse.

For collection of sindoor samples, sterile plastic bags (“baggies”) will be used to place 2-3 grams of the sindoor. Baggies will be pre-marked with a line indicating to what level they should be filled for the estimated weight required for laboratory analysis. A disposal “popsicle stick” collection utensil will be used to transfer the sindoor from its packaging into the baggies. The collection utensils will be checked for any inherent lead content prior to commencement of the study. After collection of each sindoor sample, the collection tool will be discarded and a new collection tool will be used for the next sample as to avoid any cross contamination from previous samples. The trash container in which the collection tools are placed will be brought to Rutgers SPH for subsequent disposal. Baggies will be kept in their packaging prior to use, while the collection utensil will be kept in a sterile plastic bag when it is not being used. Study staff will also be provided with gloves, which will act as personal protective equipment. Gloves will be changed before the collection of each sindoor sample to prevent cross contamination.

Plastic baggies will be labeled with the initials of the study staff member who collected the sample and a numerical marker that will correspond to the study subject and their sindoor sample. The numerical identifier and its corresponding sindoor sample will be

116 carefully documented in the study notebooks. At the end of each sampling period, all vials with collected sindoor, study notebooks and other study equipment will be given to doctoral candidate who will store research material and equipment in a locked cabinet in the dry labs at the Rutgers School of Public Health in Piscataway, NJ.

Based on sample size calculations for 80% statistical power, approximately 63 sindoor samples will need to be collected from passengers. Sample size was calculated using the following formula for determining sample size when comparing two means:

2 2 2 2 N=2σ ((Z(1-) )/Δ , where (Z(1-) =7.9 and Δ=(number of standard deviations as derived from Cohen’s effect size*calculated standard deviation)2.

Z scores for Z (1- and Z were determined for 80% statistical power using a Z-table.

As can be seen for the formula, the standard deviations cancel out and consequently are not required for the final sample size calculation. Cohen’s effect size stipulates that for a

“medium” difference in means between two groups of samples, one should use one-half of a standard deviation unit (0.5) when calculating sample size. For the sample size calculation, we are assuming a medium effect size and therefore, a value of 0.5 was used in the above formula.

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Appendix 8: E-mail Exchange Between Doctoral Candidate and United Airlines Representative

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From: [email protected] [mailto:[email protected]] Sent: Monday, July 14, 2014 2:31 PM To: Briody, Maureen Subject: Rutgers Survey

Hi Ms. Briody,

My name is Manthan Shah and I am a doctoral student at the Rutgers School of Public Health. I am interested in conducting a survey in the Meet and Greet Area of Terminal C of passengers arriving to Newark from India on United flights and want to inquire about obtaining permission to conduct such a survey. Specifically, my survey would focus on determining whether passengers are carrying a cultural powder with them called sindoor. Sindoor has previously been found to contain lead and this powder has been linked to numerous high blood lead levels and adverse health effects in both adults and children in New Jersey and other parts of the country. Please see below for more information on the survey I wish to conduct.

Christopher Perez (terminal B duty manager) and Felecia Davidson (from Port Authority) suggested I contact you in order to get the process of obtaining permission from United started.

Please let me know the next step in this process at your earliest convenience.

Thank you, Manthan Shah

Title: A survey of sindoor use practices and lead content in sindoor products imported into a U.S. Port of Entry  Background: Sindoor is an orange/red colored powder used in Hindu culture for religious and cultural purposes. Sometimes when sindoor is made, lead is added to it to give sindoor its red color. Lead is a heavy metal than can cause health problems such as learning disabilities, other cognitive deficiencies, behavioral issues and lead poisoning in both adults and children if it gets into the body.  Objectives: o Assess sindoor use practices in travelers arriving from India through at a port of entry o Determine the lead content in various brands and types of sindoor imported into New Jersey by travelers from India o Determine whether there is an association between lead content and type of packaging and labeling of sindoor/sindoor products from the various sources.  Persons to be Interviewed: Random passengers arriving from India into Newark who are carrying sindoor. A sample of sindoor will be obtained to test for lead content.  Participation: Interview is 100% voluntary, passengers will sign a consent form, and will receive a 10$ gift certificate for participating. Participation is anonymous, however

119 the passengers can provide their contact information if they would like to know the results of the lead testing.  Interview length: 5-10 minutes  Interviewers: Rutgers doctoral student, possibly 1 CDC staff  Where: Meet and Greet area in Terminal C  How long: 2-3 days a week for 1 month

From: "Briody, Maureen" To: "[email protected]" Date: 07/14/2014 03:47 PM Subject: RE: Rutgers Survey

I am sorry it took a while to reply I was away and also needed to get permission When would you plan to begin ?

From: [email protected] [mailto:[email protected]] Sent: Monday, July 14, 2014 3:49 PM To: Briody, Maureen Subject: RE: Rutgers Survey

Hi Ms. Briody,

I would like to start within the next 3 weeks or so. Would that be possible?

Thanks, Manthan Shah

From: "Briody, Maureen" To: "[email protected]" Date: 07/14/2014 05:08 PM Subject: RE: Rutgers Survey

Sure,, Just let me know what day

[email protected] wrote:

Ok great. I would be surveying passengers from United Airlines flights 83 (from Delhi) and 49 (from Mumbai) which I believe arrive at 4:45 and 5:25 respectively. The survey would go on for a month or so.

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From: "Briody, Maureen" To: "[email protected]" Date: 07/14/2014 06:14 PM Subject: Re: Rutgers Survey

No problem.. there is are a few places to catch the them after they leave

[email protected] wrote: So the fact that the flights arrive so early in the morning should not be a problem?

No no problem at all for us.. people might be too grumby to talk to you. :-). But most likely not

From: [email protected] [mailto:[email protected]] Sent: Friday, August 08, 2014 9:39 AM To: Briody, Maureen Subject: Re: Rutgers Survey

Hi Ms. Briody,

I wanted to let you know that my survey will start in October. I am thinking that we can further discuss logistics as the date gets closer.

Thanks, Manthan

From: "Briody, Maureen" To: "[email protected]" Date: 08/09/2014 12:39 PM Subject: RE: Rutgers Survey

Thank you .. appreciate the update

From: [email protected] [mailto:[email protected]] Sent: Wednesday, August 20, 2014 1:48 PM

To: Briody, Maureen Subject: Re: Rutgers Survey

Hi Ms. Briody,

I just wanted to let you know that while CDC is aware of my survey, they will not be participating. I thought I would let you know to avoid any potential confusion.

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As I stated before, my survey will begin around October.

Thank you, Manthan

From: "Briody, Maureen" To: "[email protected]" Date: 08/20/2014 03:10 PM Subject: RE: Rutgers Survey

OK just let me know a week ahead Thanks!

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Appendix 9: Overview of Lead Analysis Results of Sindoor Powders by Individual Sampling locations in New Jersey and India

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Table A9-9: Overview of Lead Analysis Results by Sampling Location

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Appendix 10: Similarities in Food Coloring and Sindoor Containers and Locations in Stores

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Figure A10-6: Food coloring and religious powders are often placed in close proximity to each other

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Figure A10-7: Similarities in containers for food coloring and sindoor

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Appendix 11: Sindoor Fact Sheet

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Figure A11-5: Sindoor fact sheet created by the principal investigator