Tag Archives Prop. 65

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has asked the Carcinogen Identification Committee (CIC) to further evaluate “nitrite in combination with amines or amides” for possible inclusion on the state’s list of substances known to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65). According to OEHHA, “nitrite is a natural constituent of fresh produce, including spinach and celery, and of fresh uncured meats,” while “amines are organic compounds that contain a basic nitrogen atom with a lone electron pair” and “amides are organic compounds that can be formed from amines, and contain a nitrogen atom and an oxygen atom.” After announcing a February 7, 2014, proposal to list the chemical combination under Prop. 65, the agency received comments and scientific evidence supporting the measure but ultimately concluded that regulatory criteria “have not been met for the spectrum of…

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has extended the comment period about whether styrene meets the criteria for authoritative bodies listings under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65) until April 29, 2015. OEHHA announced its intent to list styrene as a chemical known to the state to cause cancer under the authoritative bodies listing mechanism of Prop. 65 on February 27. Styrene is used in the manufacture of various consumer products, including polystyrene packaging, synthetic rubber and food containers. Two previous attempts to list styrene as known to cause cancer under Prop. 65’s Labor Code listing mechanism failed. The agency’s latest attempt relies on findings in the National Toxicology Program’s (NTP’s) 2011 Report on Carcinogens which concluded that styrene is “reasonably anticipated to be a human carcinogen” based on studies showing that inhalation and oral exposure to the chemical…

A California appeals court has affirmed a lower court’s ruling against plaintiff Environmental Law Foundation (ELF), which alleged that the products of Beech-Nut Nutrition Corp. and other food manufacturers, distributors and retailers contained sufficient amounts of lead to trigger warnings required under the state’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65). Envtl. Law Found. v. Beech-Nut Nutrition Corp., No. A139821 (Cal. Ct. App., 1st App. D., Div. 1, order entered March 17, 2015). ELF argued that several products, including foods predominantly intended for babies and toddlers, contained more than the state’s safe-harbor level of 0.5 micrograms per day. On appeal, ELF challenged the trial court’s decision to allow Beech-Nut’s experts to average lead test results over multiple lots rather than evaluating each individually because the single highest result may have met the minimum threshold for Prop. 65 labeling. The court dismissed the challenge, finding that averaging…

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has extended the deadline for public comments on hazard identification materials on BPA and female reproductive toxicity from April 6 to April 20, 2015, in response to a request from the American Chemistry Council. OEHHA has also announced that the May 7 meeting of its Developmental and Reproductive Toxicant Identification Committee (DARTIC) to consider the addition of bisphenol A (BPA) to its list of chemicals known to the state to cause reproductive toxicity will be continued on May 21 in the same location if the committee is unable to finish its deliberations on May 7. Citing the availability of new epidemiological and toxicological data, DARTIC will assess “whether BPA has been clearly shown by scientifically valid testing according to generally accepted principles to cause female reproductive toxicity.” After adding BPA to the list of reproductive toxicants under the Safe…

A joint study by Consumer Reports and the Johns Hopkins Center for a Livable Future claims that 4-methylimidazole (4-MEI) exposures “associated with average rates of soft drink consumption pose excess cancer risks exceeding one case per 1,000,0000 exposed individuals, which is a common acceptable risk goal used by U.S. federal regulatory agencies.” Tyler Smith, et al., “Caramel Color in Soft Drinks and Exposure to 4-Methylimidazole: A Quantitative Risk Assessment,” PLOS One, February 2015. Researchers apparently used ultra-high-performance liquid chromatography-tandem mass spectrometry to estimate 4-MEI concentrations in 12 beverages purchased in California and New York City, then assessed exposure levels based on data obtained from the National Health and Nutrition Examination Survey, California Environmental Protection Agency Office of Environmental Health Hazards Assessment (OEHHA) and U.S. Census Bureau. In addition to ranking 4-MEI concentrations by brand, product and geographic location, the study authors calculated the lifetime average daily dose and lifetime excess cancer…

The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) has announced a May 7, 2015, meeting of its Developmental and Reproductive Toxicant Identification Committee (DARTIC) to consider the addition of bisphenol A (BPA) to the list of chemicals known to the state to cause reproductive toxicity. Citing the availability of new epidemiological and toxicological data, DARTIC will assess “whether BPA has been clearly shown by scientifically valid testing according to generally accepted principles to cause female reproductive toxicity.” OEHHA has also made available hazard identification materials on BPA and female reproductive toxicity and requested public comments by April 6, 2015. After adding BPA to the list of reproductive toxicants under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65) in April 2013, OEHHA delisted the substance following a court injunction. In January 2015, the court ruled that the agency could list BPA under Prop. 65…

A California state court has lifted an injunction that barred bisphenol A (BPA) from placement on the list of reproductive toxicants mandated under Proposition 65, the 1986 law requiring warnings to the public about exposure to chemicals “known to the state to cause cancer or reproductive toxicity.” Am. Chemistry Council v. Office of Envtl. Health Hazard Assessment, No. 34-2013- 00140720 (Super. Ct. Cal., Cty. of Sacramento, order entered December 18, 2014). BPA joined the Prop. 65 list in April 2013, but a court granted the injunction barring its inclusion one week later. The court assessed whether the Office of Environmental Health Hazard Assessment (OEHHA) abused its discretion in finding substantial evidence that the regulatory criteria to list BPA were met. It found the American Chemical Council’s (ACC’s) argument that an entry to the list must be supported by “clear evidence that the chemical is known, not merely suspected, to cause cancer…

The California Environmental Protection Agency’s (Cal/EPA’s) Office of Environmental Health Hazard Assessment (OEHHA) is requesting public input for ways of improving the implementing regulations of the state’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65). More specifically, the agency invites stakeholders’ ideas about (i) alternative risk levels for chemicals in foods; (ii) revisions to the Naturally Occurring regulation; (iii) revisions and a restructuring of the Safe Use Determination process; (iv) clarification of the regulatory provisions on averaging exposures; (v) chemicals for priority consideration in the development of or update of Safe Harbor levels; (vi) new interpretive guidance; and (vii) the use of data on postnatal developmental exposures. OEHHA must receive comments and supporting documentation by 5 p.m. on November 17, 2014.   Issue 538

According to a news source, the Center for Environmental Health has filed a lawsuit under California’s Safe Drinking Water and Toxic Enforcement Act (Prop. 65), alleging that Reed’s Ginger Products fails to warn consumers about the caramel-coloring chemical 4-methylimidazole (4-MEI) purportedly present in its soft drinks. Ctr. for Envtl. Health v. Reed’s, Inc., (Cal. Super. Ct., Alameda Cty., filing date unknown). In a June 26, 2014, 60-day notice, the center claimed that the company had violated the law since January 2012, stating, “No clear and reasonable warning is provided with these products regarding the carcinogenic hazards associated with 4-MEI exposure.” Prop. 65, a voter-approved law, requires warnings to consumers about exposures to substances known to the state to cause cancer or reproductive hazards and allows private individuals or organizations to enforce it. See Courthouse News Service, September 11, 2014.   Issue 537

Food and Drug Administration (FDA) representatives are slated to present findings of the agency’s analysis of more than 200 foods containing Class III and Class IV caramels for 4-methylimidazole (4-MEI), a chemical byproduct of manufacturing processes, during the American Chemical Society National Meeting & Exposition, August 10-14, 2014, in San Francisco, California. According to the session abstract, FDA’s analysis estimated dietary exposure to 4-MEI for six U.S. populations: infants younger than age 1; 1-year-olds; children ages 2 and older; children ages 2 to 5; children ages 6 to 12; and teenage boys ages 12 to 18. Consumer Reports has urged the agency to set standards for 4-MEI in foods and called on manufacturers to disclose the types of caramel color in their products so that consumers can avoid 4-MEI. The compound was added to California’s Proposition 65 list of substances known to the state to cause cancer in 2011 based…

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