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Fian Louie

Fian Louie

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Posted by on in Centers of Excellence

Posted of behalf of Elise de Gandiaga and Melinda Hoang.

On November 16, 2017, California’s three state cannabis licensing authorities released California’s long-awaited regulations for commercial medicinal and adult-use cannabis, which will be legal on January 1, 2018. The Department of Public Health’s Manufactured Cannabis Safety Branch, the Department of Food and Agriculture’s CalCannabis Cultivation Licensing Division, and the Department of Consumer Affairs’ Bureau of Cannabis Control collaborated to develop the regulations outlined in California’s Medicinal and Adult-Use Cannabis Regulation and Safety Act (MAUCRSA).

Once the new regulations take effect on January 1, 2018, cannabis businesses will be allowed to apply for licenses. To help with the transition to a regulated commercial cannabis market, the Bureau of Cannabis Control (BCC), the lead agency developing regulations for medical and adult-use cannabis in California, has allowed a grace period beginning January 1, 2018 and ending July 1, 2018, which will allow licensees who have cannabis and cannabis goods held in inventory to transport and sell those products provided that they meet conditions outlined by each regulating agency.

In addition to daily retail sales limits for adult-use and medical customers and labeling requirements, some of the more notable additions or changes to the cannabis regulation include:

· Edible cannabis products cannot exceed 10 milligrams of THC in a single serving, and no product can exceed 100 milligrams of THC in a single package;
· Cannabis-containing lotions and tinctures can only contain up to 2,000 milligrams of THC for medicinal use, and up to 1,000 milligrams for adult-use;
· Cannabis products may not contain nicotine, added caffeine, seafood, dairy (except butter), or alcohol (with the exception of tincture products);
  o Exceptions include products with naturally occurring caffeine such coffee, tea, and chocolate
· Manufacturers must conduct and prepare a written hazard analysis to identify and/or evaluate known or reasonably foreseeable hazards for each type of cannabis product produced at their facility

Additionally, product testing for various contaminants must be conducted prior to releasing cannabis products for sale (BCC). Specifically, all cannabis harvested or cannabis products shall be tested for the following analytes set to a specified schedule: cannabinoids, moisture content, Category I & II Residual Solvents and Processing Chemicals, Category I & II Residual Pesticides, microbial impurities, and homogeneity, “foreign material,” terpenoids, mycotoxins, heavy metals, and water activity. Depending on the chemical, the BCC has defined specific “action levels” or pass/fail standards that the cannabis industries must meet (BCC).

Cardno ChemRisk has experience assisting companies with assessing consumer products contaminated with metals and other analytes, cross contamination of different food products, and with performing human health risk assessments and hazard evaluations. If you would like to learn more about our capabilities, or have any questions about this topic, please contact Elise de Gandiaga at This e-mail address is being protected from spambots. You need JavaScript enabled to view it

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Posted by on in Centers of Excellence
Posted on behalf of Melinda Hoang

Acrylamide is a chemical primarily used in industrial processes for its water-soluble and thickening properties, such as in the manufacturing of paper and plastic and in treating drinking water and wastewater (Lineback et al. 2012).  In 1994, the International Agency for Research on Cancer (IARC) classified acrylamide as “probably carcinogenic to humans” (IARC 1994).  Acrylamide is characterized as being neurotoxic, and its main metabolite, glycidamide, has been associated with genotoxicity.  In 2002, the Swedish National Food Administration reported the presence of high acrylamide levels in certain types of food (Tareke et al. 2002).  Acrylamide is mainly formed as part of the Maillard reaction, in which reducing sugars such as glucose and fructose react with amino acids at temperatures above 120°C in thermal food treatments such as frying, baking, and roasting (Lineback et al. 2012).  Previous studies have reported cancer as well as reproductive and developmental effects in laboratory animals exposed to acrylamide, which led California to add acrylamide to its Prop 65 list of chemicals known to the state to cause cancer or reproductive toxicity. 

Acrylamide is currently receiving widespread attention in media reports due to its formation in coffee.  Many studies have analyzed acrylamide levels in different brands and types of coffee as well as potential factors that may affect acrylamide levels in coffee, such as the coffee variety, ripeness of the coffee bean, roasting process, and storage conditions (Alves et al. 2010; Lantz et al. 2006).  However, very few studies have estimated the potential acrylamide exposure from daily intake of coffee, and even fewer studies have conducted a human health risk assessment to determine the potential cancer risk from lifetime exposure to coffee.

In 2004, the U.S. FDA published an article reporting acrylamide levels in brewed coffee; however, the agency did not estimate U.S. consumers’ total daily intake of acrylamide or calculate their potential risk from lifetime exposure based on these numbers (Andrzejewski et al. 2004).  Since then, many new coffee products and non-traditional brewing methods have entered the market and gained popularity in the U.S.  While quantitative risk assessments of traditional coffee products have been conducted for populations outside the U.S., there remain data gaps for quantifying acrylamide in key coffee products distributed within the U.S., and for understanding the risk of cancer associated with exposure to these products. 

Cardno ChemRisk has assessed human exposure to many different chemicals in consumer products.  Our exposure assessment specialists are able to estimate the exposure and characterize the potential health risks associated with acrylamide exposure via coffee consumption.  If you would like to learn more about our capabilities or have any questions about this topic, please contact Rachel Novick at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .  
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Posted by on in Centers of Excellence
Posted on behalf of Lauren Gloekler.

A group of flame-retardant chemicals called polybrominated diphenyl ethers (PBDEs) have been produced in various commercial mixtures, commonly referred to as pentaBDE, octaBDE, and decaBDE (EPA 2017). These chemicals are associated with a variety of adverse health outcomes associated with IQ development, attention span, memory, and mental processing speed (Guardian 2017). Although these chemicals were voluntarily phased out in the U.S. by top manufacturers in 2004 and in 2013, they continue to be imported and found in consumer products sold in the U.S. (EPA 2017Furniture World 2004Baschuk 5/2017). Electronics recycling, or “e-waste,” can result in the PBDEs found in electronics being preserved in the plastics used in new consumer products, such as children’s toys (PR Newswire 2017Brewerton 2017). Countries like China are involved in huge e-waste recycling activities, and in 2010 Chinese imports represented 88% of all toys imported into the U.S. (Guardian 2017, U.S. Dept of Commerce 2012). 

Under the EU’s REACH law, decaBDE will be “largely prohibited” in the EU after March 2, 2019 (Gardner 2017).  In October, 2016, decaBDE was added the PBT list of chemicals to be evaluated by the U.S. EPA, under the new TSCA reform (Rizzuto 2016Parker 2016). An EPA decision regarding decaBDE is due by June, 2019 (Parker 2016). In May, 2016, the Stockholm Convention agreed that decaBDE should be phased out and eventually banned; however, several exemptions may exist that allow these and other similar chemicals to continue to be used in certain applications (Baschuk 5/2017, Baschuk 1/2017). The International POPs Elimination Network (IPEN) criticized the Stockholm decision, saying that the policy would still allow for decaBDE to be used in contaminated recycling streams, and thus in children’s toys (Baschuk 5/2017).

Several studies have confirmed the presence of PBDEs in children’s toys from China (Chen et al. 2009IPEN 2017). According to a 2017 IPEN survey, several children’s toys from 26 countries (many of which were purchased in China) were sampled for octaBDE and decaBDE (IPEN 2017). Ninety-one percent of the samples contained decaBDE, ranging from 1 ppm to 672 ppm, 43% of which were at levels higher than 50 ppm. Another study by Chen et al. measured much lower concentrations in 69 toys purchased from China; decaBDE was found in mean levels between 0.0003 ppm and 0.20 ppm in toys, with variation between the toy types (hard plastic vs. foam, etc.) (Chen et al. 2009). The authors concluded that the profiles of brominated flame retardants measured in the toys were “consistent with the patterns of their current production and consumption in China” (Chen et al. 2009). They also estimated that daily exposure in children to decaBDE (pg/kg bw-day) was 0.55-2.06 via inhalation, 439-5001 via mouthing, 0.51-0.73 via dermal contact, and 0.03-0.52 via oral ingestion (hand-to-mouth). Total daily exposure via all routes was significantly lower than the EPA RfD (reference dose) for decaBDE (7 X 106 pg/kg bw-day), and the hazard quotient for decaBDE was well below one (EPA 2009). The authors thus concluded that the data suggested a low risk of adverse health outcomes associated with children’s toys. Given that the IPEN study measured decaBDE in concentrations approximately 3,000 times higher than Chen et al., however, further study on the risk associated with decaBDE exposures in children from toys is warranted. 

Cardno ChemRisk has assessed human exposure to many chemicals (including phthalates and lead) in children’s products. Our exposure assessment specialists are able to estimate the exposure and the potential health risk from many consumer products and provide creative and pragmatic solutions. If you have any questions or would like more information about this topic or related issues, please contact Lauren Gloekler at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or Rachel Novick at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .
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Posted by on in Centers of Excellence

Posted on behalf of Rachel Novick and Alison Bowman. 

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Posted by on in Centers of Excellence
Posted on behalf of Angela Perez, PhD and Fian Louie

In a report published by the Coalition for Safer Food Processing and Packaging (CSFPP), 30 cheese products, including dry cheese found in macaroni and cheese packets, were tested for 13 phthalates. Di(2-ethylhexyl) phthalate, or DEHP, was found at detectable levels in 93 percent of all samples tested, making it the most frequently detected phthalate. A synopsis of the CSFPP report was recently published in the New York Times on July 12, 2017.

DEHP is one of the most extensively used phthalates worldwide. The majority of DEHP is used as a plasticizer for flooring, waterproofing, cable sheathing/insulation, PVC, epoxy and polyurethane products; it is also used in fragrance bases for perfumery and cosmetic products. Several phthalates, including DEHP and many others that were tested by the CSFPP, are legal through the FDA for use as indirect food additives or as paper and paperboard components (for example, see: 21 CFR 176).

Cardno ChemRisk previously performed a risk assessment of DEHP in which 47 varieties of cheese sold in California from 31 companies were tested. Based on the sampling results, we performed a human health risk assessment to compare the potential human exposure levels to Prop 65 levels set at the time of the project. Based on our results, we concluded that the DEHP concentrations measured in California cheeses did not exceed the Proposition 65 NSRL (No Significant Risk Level, or the daily intake level posing a 1/100,000 lifetime risk of cancer).

Per the recent CSFPP report, the concentration of DEHP across all 30 products tested ranged from less than one microgram per kilogram (µg/kg) product weight to 165 µg/kg product weight, or parts per billion. The average DEHP concentration was 50 micrograms DEHP per kilogram product weight (assuming the products below the LOQ are zero). The NSRL adopted for DEHP under Proposition 65 is 310 micrograms per day (µg/day) for oral exposure (Cal/EPA 2002). The MADLs (Maximum Allowable Dose Level, or the level at which a chemical would have no observable effect even if an individual were exposed to 1,000 times that level) adopted for DEHP are 410 µg/day for adults, and 58 µg/day for infant boys (29 days-24 months) via oral exposure (Cal/EPA 2005; OAG). To put this in perspective, a cheese packet in a box of macaroni is approximately 1/3 cup or about 38 grams. Assuming an individual eats an entire box of macaroni and cheese and that the cheese mix contains the maximum concentration of DEHP reported by CSFPP for this product category (165 µg/kg product weight), then that person would consume a total of 6 µg of DEHP. This is nearly 10 times less than the MADL for infant boys and over 50 times less than the NSRL for adults.

For any questions, or if you need further information, regarding our risk assessment capabilities, please contact Drs. Angela Perez or Rachel Novick.
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Cardno ChemRisk is a respected scientific consulting firm headquartered in San Francisco with locations and consultants across the U.S. While our website provides a formal look at our capabilities, the Cardno ChemRisk View provides an informal voice too. Various Cardno ChemRisk consultants will be sharing news and views about current trends, happenings and methodologies in the industry. We’ll also highlight activities of interest at Cardno ChemRisk, within confidentiality restrictions of course.

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