PHTHALATES IN FOOD PACKAGING - Department of Toxic ...



-28575-124777500Work Plan Implementation: Phthalates in Food Packagingoctober 2019 right97790000IntroductionThe Safer Consumer Products regulations define the process and criteria used by the Department of Toxic Substances Control (DTSC) to evaluate consumer products for possible designation as Priority Products. In that process, DTSC issues a Priority Product Work Plan (Work Plan) identifying the product categories to evaluate over a three-year period. DTSC then considers the product categories through the lens of the Work Plan’s stated policy goals (Figure 1). Since issuing the 2018-2020 Work Plan, ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"l9jMEfbk","properties":{"formattedCitation":"\\super 1\\nosupersub{}","plainCitation":"1","noteIndex":0},"citationItems":[{"id":3719,"uris":[""],"uri":[""],"itemData":{"id":3719,"type":"webpage","title":"2018-2020 Priority Product Work Plan","URL":"","language":"en","author":[{"family":"DTSC","given":"(Department of Toxic Substances Control)"}],"accessed":{"date-parts":[["2019",8,7]]}}}],"schema":""} 1 DTSC has conducted a review of product categories, chemicals, and chemical classes that align with our policy goals. This document summarizes our preliminary findings on food packaging containing ortho-phthalates (OPs) and their alternatives, and describes our concerns. Publication of this document signals the beginning of a dialogue with interested stakeholders, including manufacturers, nonprofit organizations, governments, and academia, to inform DTSC on the potential listing of specific consumer products containing BPA and its alternatives as one or more Priority Products subject to the requirements of the Safer Consumer Products regulations. BackgroundFood packaging is one of the product categories identified in DTSC’s 2018-2020 DTSC Priority Product Work Plan. Ortho-phthalates (OPs) are dialkyl or alkyl esters of 1,2-benzenedicarboxylic acid and are all captured, as a group, on DTSC’s Candidate Chemical List, whether or not the individual chemicals are specifically listed. One of the major uses of OPs is as plasticizers that impart flexibility and durability to products made of polyvinyl chloride (PVC), including some food packaging products. It has been estimated that 95 percent of all OPs produced globally are used as PVC plasticizers.Foods packaged in PVC have been shown to contain OPs, and diet is considered a major source of human exposure to this class of chemicals ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"4pfOZljm","properties":{"formattedCitation":"(Rodgers, Rudel, and Just 2017)","plainCitation":"(Rodgers, Rudel, and Just 2017)","noteIndex":0},"citationItems":[{"id":4177,"uris":[""],"uri":[""],"itemData":{"id":4177,"type":"paper-conference","title":"Chapter 2 Phthalates in Food Packaging , Consumer Products , and Indoor Environments","source":"Semantic Scholar","abstract":"Phthalates are a diverse group of chemicals, including five with production volumes of over 1 million pounds per year in the United States (U.S.). They are used as plasticizers in a variety of plastics including polyvinyl chloride (PVC), medical devices (e.g., intravenous bags and tubing), food contact materials (FCMs), toys, and household goods, and as solvents in fragranced personal care and household products. Although not all phthalates have been evaluated for their toxic effects, many that are in widespread use have displayed endocrine disrupting properties on the developing reproductive system, especially in males, in laboratory, animal, and human studies. Widespread exposure to phthalates has been documented in the U.S. and in European countries, with some examples of unusually high exposures in certain populations, such as neonates with intravenous interventions in hospital settings. For the majority of the population, the primary route of exposure to the endocrine disrupting phthalates produced in the highest volume, bis(2-ethylhexyl) phthalate (DEHP) and diisononyl phthalate (DINP), is through diet. DEHP is used in food packaging, and also has been found to contaminate food sources directly. Some newer phthalates that have been introduced as alternatives to phthalates with known health concerns are also endocrine disruptors, while others have not been evaluated. Regulatory agencies are considering ways to define phthalates and assess their risk as a group based on chemical structure. K. M. Rodgers R. A. Rudel (&) Silent Spring Institute, Newton, MA, USA e-mail: rudel@ K. M. Rodgers e-mail: rodgers@ A. C. Just Department of Environmental Health, Harvard School of Public Health, Boston, MA, USA e-mail: acjust@hsph.harvard.edu S. M. Snedeker (ed.), Toxicants in Food Packaging and Household Plastics, Molecular and Integrative Toxicology, DOI: 10.1007/978-1-4471-6500-2_2, Springer-Verlag London 2014 31","author":[{"family":"Rodgers","given":"Kathryn M."},{"family":"Rudel","given":"Ruthann A."},{"family":"Just","given":"Allan C."}],"issued":{"date-parts":[["2017"]]}}}],"schema":""} (Rodgers, Rudel, and Just 2017). Biomonitoring data shows that human exposure to OPs is ubiquitous ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"q7VioWzf","properties":{"formattedCitation":"(Rodgers, Rudel, and Just 2017)","plainCitation":"(Rodgers, Rudel, and Just 2017)","noteIndex":0},"citationItems":[{"id":4177,"uris":[""],"uri":[""],"itemData":{"id":4177,"type":"paper-conference","title":"Chapter 2 Phthalates in Food Packaging , Consumer Products , and Indoor Environments","source":"Semantic Scholar","abstract":"Phthalates are a diverse group of chemicals, including five with production volumes of over 1 million pounds per year in the United States (U.S.). They are used as plasticizers in a variety of plastics including polyvinyl chloride (PVC), medical devices (e.g., intravenous bags and tubing), food contact materials (FCMs), toys, and household goods, and as solvents in fragranced personal care and household products. Although not all phthalates have been evaluated for their toxic effects, many that are in widespread use have displayed endocrine disrupting properties on the developing reproductive system, especially in males, in laboratory, animal, and human studies. Widespread exposure to phthalates has been documented in the U.S. and in European countries, with some examples of unusually high exposures in certain populations, such as neonates with intravenous interventions in hospital settings. For the majority of the population, the primary route of exposure to the endocrine disrupting phthalates produced in the highest volume, bis(2-ethylhexyl) phthalate (DEHP) and diisononyl phthalate (DINP), is through diet. DEHP is used in food packaging, and also has been found to contaminate food sources directly. Some newer phthalates that have been introduced as alternatives to phthalates with known health concerns are also endocrine disruptors, while others have not been evaluated. Regulatory agencies are considering ways to define phthalates and assess their risk as a group based on chemical structure. K. M. Rodgers R. A. Rudel (&) Silent Spring Institute, Newton, MA, USA e-mail: rudel@ K. M. Rodgers e-mail: rodgers@ A. C. Just Department of Environmental Health, Harvard School of Public Health, Boston, MA, USA e-mail: acjust@hsph.harvard.edu S. M. Snedeker (ed.), Toxicants in Food Packaging and Household Plastics, Molecular and Integrative Toxicology, DOI: 10.1007/978-1-4471-6500-2_2, Springer-Verlag London 2014 31","author":[{"family":"Rodgers","given":"Kathryn M."},{"family":"Rudel","given":"Ruthann A."},{"family":"Just","given":"Allan C."}],"issued":{"date-parts":[["2017"]]}}}],"schema":""} (Rodgers, Rudel, and Just 2017). OPs are potential endocrine disruptors that have a significant potential to adversely affect human reproductive development, especially in males ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"tGw1CxQF","properties":{"formattedCitation":"(Rodgers, Rudel, and Just 2017)","plainCitation":"(Rodgers, Rudel, and Just 2017)","noteIndex":0},"citationItems":[{"id":4177,"uris":[""],"uri":[""],"itemData":{"id":4177,"type":"paper-conference","title":"Chapter 2 Phthalates in Food Packaging , Consumer Products , and Indoor Environments","source":"Semantic Scholar","abstract":"Phthalates are a diverse group of chemicals, including five with production volumes of over 1 million pounds per year in the United States (U.S.). They are used as plasticizers in a variety of plastics including polyvinyl chloride (PVC), medical devices (e.g., intravenous bags and tubing), food contact materials (FCMs), toys, and household goods, and as solvents in fragranced personal care and household products. Although not all phthalates have been evaluated for their toxic effects, many that are in widespread use have displayed endocrine disrupting properties on the developing reproductive system, especially in males, in laboratory, animal, and human studies. Widespread exposure to phthalates has been documented in the U.S. and in European countries, with some examples of unusually high exposures in certain populations, such as neonates with intravenous interventions in hospital settings. For the majority of the population, the primary route of exposure to the endocrine disrupting phthalates produced in the highest volume, bis(2-ethylhexyl) phthalate (DEHP) and diisononyl phthalate (DINP), is through diet. DEHP is used in food packaging, and also has been found to contaminate food sources directly. Some newer phthalates that have been introduced as alternatives to phthalates with known health concerns are also endocrine disruptors, while others have not been evaluated. Regulatory agencies are considering ways to define phthalates and assess their risk as a group based on chemical structure. K. M. Rodgers R. A. Rudel (&) Silent Spring Institute, Newton, MA, USA e-mail: rudel@ K. M. Rodgers e-mail: rodgers@ A. C. Just Department of Environmental Health, Harvard School of Public Health, Boston, MA, USA e-mail: acjust@hsph.harvard.edu S. M. Snedeker (ed.), Toxicants in Food Packaging and Household Plastics, Molecular and Integrative Toxicology, DOI: 10.1007/978-1-4471-6500-2_2, Springer-Verlag London 2014 31","author":[{"family":"Rodgers","given":"Kathryn M."},{"family":"Rudel","given":"Ruthann A."},{"family":"Just","given":"Allan C."}],"issued":{"date-parts":[["2017"]]}}}],"schema":""} (Rodgers, Rudel, and Just 2017). Although robust hazard data is publicly available for only a subset of OPs, emerging data suggests that many OPs may share similar hazard traits. Various authoritative bodies have recognized members of the OP group as potential reproductive and developmental toxicants, which is the basis for listing OPs on DTSC’s Candidate Chemical list. DTSC is concerned about the potential adverse impacts to human health posed by exposures to OPs from food packaging, especially in children. One of the policy goals stated in SCP’s 2018-2020 Priority Product Work Plan is to protect children from exposures to harmful chemicals from consumer products. The American Academy of Pediatrics’ 2018 policy statement on food additives and child health designates phthalates as one of five chemical classes of emerging concern with respect to children’s health ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"EsAS8NTJ","properties":{"formattedCitation":"(Trasande et al. 2018)","plainCitation":"(Trasande et al. 2018)","noteIndex":0},"citationItems":[{"id":3950,"uris":[""],"uri":[""],"itemData":{"id":3950,"type":"article-journal","title":"Food Additives and Child Health","container-title":"Pediatrics","page":"e20181408","volume":"142","issue":"2","source":"pediatrics.","abstract":"Our purposes with this policy statement and its accompanying technical report are to review and highlight emerging child health concerns related to the use of colorings, flavorings, and chemicals deliberately added to food during processing (direct food additives) as well as substances in food contact materials, including adhesives, dyes, coatings, paper, paperboard, plastic, and other polymers, which may contaminate food as part of packaging or manufacturing equipment (indirect food additives); to make reasonable recommendations that the pediatrician might be able to adopt into the guidance provided during pediatric visits; and to propose urgently needed reforms to the current regulatory process at the US Food and Drug Administration (FDA) for food additives. Concern regarding food additives has increased in the past 2 decades, in part because of studies in which authors document endocrine disruption and other adverse health effects. In some cases, exposure to these chemicals is disproportionate among minority and low-income populations. Regulation and oversight of many food additives is inadequate because of several key problems in the Federal Food, Drug, and Cosmetic Act. Current requirements for a “generally recognized as safe” (GRAS) designation are insufficient to ensure the safety of food additives and do not contain sufficient protections against conflict of interest. Additionally, the FDA does not have adequate authority to acquire data on chemicals on the market or reassess their safety for human health. These are critical weaknesses in the current regulatory system for food additives. Data about health effects of food additives on infants and children are limited or missing; however, in general, infants and children are more vulnerable to chemical exposures. Substantial improvements to the food additives regulatory system are urgently needed, including greatly strengthening or replacing the “generally recognized as safe” (GRAS) determination process, updating the scientific foundation of the FDA’s safety assessment program, retesting all previously approved chemicals, and labeling direct additives with limited or no toxicity data.","DOI":"10.1542/peds.2018-1408","ISSN":"0031-4005, 1098-4275","note":"PMID: 30037974","language":"en","author":[{"family":"Trasande","given":"Leonardo"},{"family":"Shaffer","given":"Rachel M."},{"family":"Sathyanarayana","given":"Sheela"},{"family":"Health","given":"Council on Environmental"}],"issued":{"date-parts":[["2018",8,1]]}}}],"schema":""} (Trasande et al. 2018). Emerging concerns over the potential adverse impacts of OPs have also prompted the U.S. Environmental Protection Agency to identify certain OPs (currently authorized for use in food packaging by the FDA) as candidates for designation as high priority chemicals under the Toxic Substances Control Act ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"ipAazhu8","properties":{"formattedCitation":"(U.S. EPA 2019)","plainCitation":"(U.S. EPA 2019)","noteIndex":0},"citationItems":[{"id":4050,"uris":[""],"uri":[""],"itemData":{"id":4050,"type":"webpage","title":"List of Chemicals Undergoing Prioritization | Assessing and Managing Chemicals under TSCA | US EPA","URL":"","author":[{"family":"U.S. EPA","given":""}],"issued":{"date-parts":[["2019"]]},"accessed":{"date-parts":[["2019",5,13]]}}}],"schema":""} (U.S. EPA 2019). And concerns over OP exposure have compelled the U.S. Consumer Product Safety Commission (CPSC) and other authoritative bodies to ban the use of some OPs in certain children’s and consumer products ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"U2uMoAWD","properties":{"formattedCitation":"(Consumer Product Safety Commission 2017)","plainCitation":"(Consumer Product Safety Commission 2017)","noteIndex":0},"citationItems":[{"id":3280,"uris":[""],"uri":[""],"itemData":{"id":3280,"type":"webpage","title":"Federal Register :: Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates","URL":"","author":[{"family":"Consumer Product Safety Commission","given":""}],"issued":{"date-parts":[["2017",10,27]]},"accessed":{"date-parts":[["2019",6,17]]}}}],"schema":""} (Consumer Product Safety Commission 2017) ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"yV1GO7Nn","properties":{"formattedCitation":"(European Commission 2018)","plainCitation":"(European Commission 2018)","noteIndex":0},"citationItems":[{"id":3265,"uris":[""],"uri":[""],"itemData":{"id":3265,"type":"legislation","title":"Commission Regulation (EU) 2018/2005 of 17 December 2018 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards bis(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP) (Text with EEA relevance.)","container-title":"OJ L","volume":"322","URL":"","number":"32018R2005","language":"en","author":[{"family":"European Commission","given":""}],"issued":{"date-parts":[["2018",12,18]]},"accessed":{"date-parts":[["2019",6,20]]}}}],"schema":""} (European Commission 2018). However, the use of some OPs in food packaging is still allowed. FDA has recently proposed a rule that would rescind the authorization for specific uses of OPs in food packaging, but this rule would not affect the previously authorized uses of certain OPs as plasticizers in food packaging ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"A3LhHtH5","properties":{"formattedCitation":"(FDA 2018)","plainCitation":"(FDA 2018)","noteIndex":0},"citationItems":[{"id":7682,"uris":[""],"uri":[""],"itemData":{"id":7682,"type":"webpage","title":"83 FR 56750 - Flexible Vinyl Alliance; Filing of Food Additive Petition - Content Details - 2018-24657","URL":"","author":[{"family":"FDA","given":"U.S."}],"issued":{"date-parts":[["2018"]]},"accessed":{"date-parts":[["2019",8,21]]}}}],"schema":""} (FDA 2018).DTSC is considering whether to propose one or more food packaging products containing OPs as a potential Priority Product. To help reach a final decision, DTSC is requesting additional information from stakeholders in order to learn more about the current uses of OPs in food packaging products.Preliminary Screening ResultsSome OPs have been recognized by various authoritative bodies as carcinogens, mutagens, or reproductive and developmental toxicants; these designations were the basis for listing OPs on DTSC’s Candidate Chemical list. OPs appear to have a number of endocrine-disrupting properties on the developing human reproductive system. Recent epidemiological studies have demonstrated significant associations between maternal exposure to some OPs and adverse developmental impacts on the male fetus ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"4V1b8UOM","properties":{"formattedCitation":"(Crinnion 2010)","plainCitation":"(Crinnion 2010)","noteIndex":0},"citationItems":[{"id":3991,"uris":[""],"uri":[""],"itemData":{"id":3991,"type":"article-journal","title":"Toxic Effects of the Easily Avoidable Phthalates and Parabens","container-title":"Alternative Medicine Review","page":"190-196","volume":"15","issue":"3","source":"EBSCOhost","abstract":"Some environmental toxins like DDT and other chlorinated compounds accumulate in the body because of their fat-soluble nature. Other compounds do not stay long in the body, but still cause toxic effects during the time they are present. For serious health problems to arise, exposure to these rapidly-clearing compounds must occur on a daily basis. Two such classes of compounds are the phthalate plasticizers and parabens, both of which are used in many personal care products, some medications, and even foods and food preservation. The phthalates are commonly found in foods and household dust. Even though they have relatively short half-lives in humans, phthalates have been associated with a number of serious health problems, including infertility, testicular dysgenesis, obesity, asthma, and allergies, as well as leiomyomas and breast cancer. Parabens, which can be dermally absorbed, are present in many cosmetic products, including antiperspirants. Their estrogenicity and tissue presence are a cause for concern regarding breast cancer. Fortunately, these compounds are relatively easy to avoid and such steps can result in dramatic reductions of urinary levels of these compounds.","ISSN":"10895159","journalAbbreviation":"Alternative Medicine Review","author":[{"family":"Crinnion","given":"Walter J."}],"issued":{"date-parts":[["2010",9]]}}}],"schema":""} (Crinnion 2010). Prenatal exposures have also been related to adverse neurobehavioral outcomes in children such as increased aggression, attention deficits, depression, and impaired executive functioning and emotion control ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"jXDFvPcx","properties":{"formattedCitation":"(Crinnion 2010)","plainCitation":"(Crinnion 2010)","noteIndex":0},"citationItems":[{"id":3991,"uris":[""],"uri":[""],"itemData":{"id":3991,"type":"article-journal","title":"Toxic Effects of the Easily Avoidable Phthalates and Parabens","container-title":"Alternative Medicine Review","page":"190-196","volume":"15","issue":"3","source":"EBSCOhost","abstract":"Some environmental toxins like DDT and other chlorinated compounds accumulate in the body because of their fat-soluble nature. Other compounds do not stay long in the body, but still cause toxic effects during the time they are present. For serious health problems to arise, exposure to these rapidly-clearing compounds must occur on a daily basis. Two such classes of compounds are the phthalate plasticizers and parabens, both of which are used in many personal care products, some medications, and even foods and food preservation. The phthalates are commonly found in foods and household dust. Even though they have relatively short half-lives in humans, phthalates have been associated with a number of serious health problems, including infertility, testicular dysgenesis, obesity, asthma, and allergies, as well as leiomyomas and breast cancer. Parabens, which can be dermally absorbed, are present in many cosmetic products, including antiperspirants. Their estrogenicity and tissue presence are a cause for concern regarding breast cancer. Fortunately, these compounds are relatively easy to avoid and such steps can result in dramatic reductions of urinary levels of these compounds.","ISSN":"10895159","journalAbbreviation":"Alternative Medicine Review","author":[{"family":"Crinnion","given":"Walter J."}],"issued":{"date-parts":[["2010",9]]}}}],"schema":""} (Crinnion 2010) ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"ARrlzNLP","properties":{"formattedCitation":"(Engel et al. 2009)","plainCitation":"(Engel et al. 2009)","noteIndex":0},"citationItems":[{"id":4182,"uris":[""],"uri":[""],"itemData":{"id":4182,"type":"article-journal","title":"Prenatal phthalate exposure and performance on the Neonatal Behavioral Assessment Scale in a multiethnic birth cohort","container-title":"Neurotoxicology","page":"522-528","volume":"30","issue":"4","source":"PubMed","abstract":"We investigated the relationship between prenatal maternal urinary concentrations of phthalate metabolites and neonatal behavior in their 295 children enrolled in a multiethnic birth cohort between 1998 and 2002 at the Mount Sinai School of Medicine in New York City. Trained examiners administered the Brazelton Neonatal Behavioral Assessment Scale (BNBAS) to children within 5 days of delivery. We measured metabolites of 7 phthalate esters in maternal urine that was collected between 25 and 40 weeks' gestation. All but two phthalate metabolites were over 95% detectable. We summed metabolites on a molar basis into low and high molecular weight phthalates. We hypothesized the existence of sex-specific effects from phthalate exposure a priori given the hormonal activity of these chemicals. Overall we found few associations between individual phthalate metabolites or their molar sums and most of the BNBAS domains. However, we observed significant sex-phthalate metabolite interactions (p<0.10) for the Orientation and Motor domains and the overall Quality of Alertness score. Among girls, there was a significant linear decline in adjusted mean Orientation score with increasing urinary concentrations of high molecular weight phthalate metabolites (B=-0.37, p=0.02). Likewise, there was a strong linear decline in their adjusted mean Quality of Alertness score (B=-0.48, p<0.01). In addition, boys and girls demonstrated opposite patterns of association between low and high molecular weight phthalate metabolite concentrations and motor performance, with some indication of improved motor performance with increasing concentration of low molecular weight phthalate metabolites among boys. This is the first study to report an association between prenatal phthalate exposure and neurological effects in humans or animals, and as such requires replication.","DOI":"10.1016/j.neuro.2009.04.001","ISSN":"1872-9711","note":"PMID: 19375452\nPMCID: PMC4026936","journalAbbreviation":"Neurotoxicology","language":"eng","author":[{"family":"Engel","given":"Stephanie M."},{"family":"Zhu","given":"Chenbo"},{"family":"Berkowitz","given":"Gertrud S."},{"family":"Calafat","given":"Antonia M."},{"family":"Silva","given":"Manori J."},{"family":"Miodovnik","given":"Amir"},{"family":"Wolff","given":"Mary S."}],"issued":{"date-parts":[["2009",7]]}}}],"schema":""} (Engel et al. 2009) ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"lMSW0Rpz","properties":{"formattedCitation":"(Col\\uc0\\u243{}n et al. 2000)","plainCitation":"(Colón et al. 2000)","noteIndex":0},"citationItems":[{"id":4218,"uris":[""],"uri":[""],"itemData":{"id":4218,"type":"article-journal","title":"Identification of phthalate esters in the serum of young Puerto Rican girls with premature breast development.","container-title":"Environmental Health Perspectives","page":"895-900","volume":"108","issue":"9","source":"PubMed Central","abstract":"Premature breast development (thelarche) is the growth of mammary tissue in girls younger than 8 years of age without other manifestations of puberty. Puerto Rico has the highest known incidence of premature thelarche ever reported. In the last two decades since this serious public health anomaly has been observed, no explanation for this phenomenon has been found. Some organic pollutants, including pesticides and some plasticizers, can disrupt normal sexual development in wildlife, and many of these have been widely used in Puerto Rico. This investigation was designed to identify pollutants in the serum of Puerto Rican girls with premature thelarche. A method for blood serum analysis was optimized and validated using pesticides and phthalate esters as model compounds of endocrine-disrupting chemicals. Recovery was > 80% for all compounds. We performed final detection by gas chromatography/mass spectrometry. We analyzed 41 serum samples from thelarche patients and 35 control samples. No pesticides or their metabolite residues were detected in the serum of the study or control subjects. Significantly high levels of phthalates [dimethyl, diethyl, dibutyl, and di-(2-ethylhexyl)] and its major metabolite mono-(2-ethylhexyl) phthalate were identified in 28 (68%) samples from thelarche patients. Of the control samples analyzed, only one showed significant levels of di-isooctyl phthalate. The phthalates that we identified have been classified as endocrine disruptors. This study suggests a possible association between plasticizers with known estrogenic and antiandrogenic activity and the cause of premature breast development in a human female population.","ISSN":"0091-6765","note":"PMID: 11017896\nPMCID: PMC2556932","journalAbbreviation":"Environ Health Perspect","author":[{"family":"Colón","given":"I"},{"family":"Caro","given":"D"},{"family":"Bourdony","given":"C J"},{"family":"Rosario","given":"O"}],"issued":{"date-parts":[["2000",9]]}}}],"schema":""} (Colón et al. 2000). Epidemiological studies support an association between OP exposure and impaired testicular function in adult men ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"bavHyR7N","properties":{"formattedCitation":"(Serrano et al. 2014)","plainCitation":"(Serrano et al. 2014)","noteIndex":0},"citationItems":[{"id":3434,"uris":[""],"uri":[""],"itemData":{"id":3434,"type":"article-journal","title":"Phthalates and diet: a review of the food monitoring and epidemiology data","container-title":"Environmental Health","page":"43","volume":"13","source":"PubMed Central","abstract":"Phthalates are associated with a variety of health outcomes, but sources that may be targeted for exposure reduction messaging remain elusive. Diet is considered a significant exposure pathway for these compounds. Therefore, we sought to identify primary foods associated with increased exposure through a review of the food monitoring survey and epidemiological data. A search in PubMed and Google Scholar for keywords \"phthalates\" and \"diet\" \"food\" \"food stuffs\" \"dietary intake\" \"food intake\" and \"food concentration\" resulted in 17 studies measuring phthalate concentrations in United States (US) and international foods, three epidemiological association studies, and three interventions. We report on food groups with high (≥300?μg/kg) and low (<50?μg/kg) concentrations and compare these to foods associated with phthalate body burden. Based on these data, we estimated daily intakes of di-2-ethylhexyl phthalate (DEHP) of US women of reproductive age, adolescents and infants for typical consumption patterns as well as healthy and poor diets. We consistently observed high DEHP concentrations in poultry, cooking oils and cream-based dairy products (≥300?μg/kg) across food monitoring studies. Diethyl phthalate (DEP) levels were found at low concentrations across all food groups. In line with these data, epidemiological studies showed positive associations between consumption of meats, discretionary fat and dairy products and DEHP. In contrast to food monitoring data, DEP was found to be associated with intake of vegetables in two studies. DEHP exposure estimates based on typical diets were 5.7, 8.1, and 42.1?μg/kg-day for women of reproductive age, adolescents and infants, respectively, with dairy as the largest contributor to exposure. Diets high in meat and dairy consumption resulted in two-fold increases in exposure. Estimates for infants based on a typical diet exceeded the Environmental Protection Agency’s reference dose of 20?μg/kg-day while diets high in dairy and meat consumed by adolescents also exceeded this threshold. The review of the literature demonstrated that DEHP in some meats, fats and dairy products is consistently found in high concentrations and can contribute to exposure. Guidance on future research in this area is provided that may help to identify methods to reduce dietary phthalate exposures.","DOI":"10.1186/1476-069X-13-43","ISSN":"1476-069X","note":"PMID: 24894065\nPMCID: PMC4050989","title-short":"Phthalates and diet","journalAbbreviation":"Environ Health","author":[{"family":"Serrano","given":"Samantha E"},{"family":"Braun","given":"Joseph"},{"family":"Trasande","given":"Leonardo"},{"family":"Dills","given":"Russell"},{"family":"Sathyanarayana","given":"Sheela"}],"issued":{"date-parts":[["2014",6,2]]}}}],"schema":""} (Serrano et al. 2014). OPs have been associated with increased weight, insulin resistance, asthma and allergies, uterine fibroids, and breast cancer ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"uW3nUBAt","properties":{"formattedCitation":"(Crinnion 2010)","plainCitation":"(Crinnion 2010)","noteIndex":0},"citationItems":[{"id":3991,"uris":[""],"uri":[""],"itemData":{"id":3991,"type":"article-journal","title":"Toxic Effects of the Easily Avoidable Phthalates and Parabens","container-title":"Alternative Medicine Review","page":"190-196","volume":"15","issue":"3","source":"EBSCOhost","abstract":"Some environmental toxins like DDT and other chlorinated compounds accumulate in the body because of their fat-soluble nature. Other compounds do not stay long in the body, but still cause toxic effects during the time they are present. For serious health problems to arise, exposure to these rapidly-clearing compounds must occur on a daily basis. Two such classes of compounds are the phthalate plasticizers and parabens, both of which are used in many personal care products, some medications, and even foods and food preservation. The phthalates are commonly found in foods and household dust. Even though they have relatively short half-lives in humans, phthalates have been associated with a number of serious health problems, including infertility, testicular dysgenesis, obesity, asthma, and allergies, as well as leiomyomas and breast cancer. Parabens, which can be dermally absorbed, are present in many cosmetic products, including antiperspirants. Their estrogenicity and tissue presence are a cause for concern regarding breast cancer. Fortunately, these compounds are relatively easy to avoid and such steps can result in dramatic reductions of urinary levels of these compounds.","ISSN":"10895159","journalAbbreviation":"Alternative Medicine Review","author":[{"family":"Crinnion","given":"Walter J."}],"issued":{"date-parts":[["2010",9]]}}}],"schema":""} (Crinnion 2010) ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"IOPFwAUW","properties":{"formattedCitation":"(Stahlhut et al. 2007)","plainCitation":"(Stahlhut et al. 2007)","noteIndex":0},"citationItems":[{"id":4299,"uris":[""],"uri":[""],"itemData":{"id":4299,"type":"article-journal","title":"Concentrations of urinary phthalate metabolites are associated with increased waist circumference and insulin resistance in adult U.S. males","container-title":"Environmental Health Perspectives","page":"876-882","volume":"115","issue":"6","source":"PubMed","abstract":"BACKGROUND: Phthalates impair rodent testicular function and have been associated with anti-androgenic effects in humans, including decreased testosterone levels. Low testosterone in adult human males has been associated with increased prevalence of obesity, insulin resistance, and diabetes.\nOBJECTIVES: Our objective in this study was to investigate phthalate exposure and its associations with abdominal obesity and insulin resistance.\nMETHODS: Subjects were adult U.S. male participants in the National Health and Nutrition Examination Survey (NHANES) 1999-2002. We modeled six phthalate metabolites with prevalent exposure and known or suspected antiandrogenic activity as predictors of waist circumference and log-transformed homeostatic model assessment (HOMA; a measure of insulin resistance) using multiple linear regression, adjusted for age, race/ethnicity, fat and total calorie consumption, physical activity level, serum cotinine, and urine creatinine (model 1); and adjusted for model 1 covariates plus measures of renal and hepatic function (model 2). Metabolites were mono-butyl phthalates (MBP), mono-ethyl phthalate (MEP), mono-(2-ethyl)-hexyl phthalate (MEHP), mono-benzyl phthalate (MBzP), mono-(2-ethyl-5-hydroxyhexyl) phthalate (MEHHP), and mono-(2-ethyl-5-oxohexyl) phthalate (MEOHP).\nRESULTS: In model 1, four metabolites were associated with increased waist circumference (MBzP, MEHHP, MEOHP, and MEP; p-values </= 0.013) and three with increased HOMA (MBP, MBzP, and MEP; p-values </= 0.011). When we also adjusted for renal and hepatic function, parameter estimates declined but all significant results remained so except HOMA-MBP.\nCONCLUSIONS: In this national cross-section of U.S. men, concentrations of several prevalent phthalate metabolites showed statistically significant correlations with abdominal obesity and insulin resistance. If confirmed by longitudinal studies, our findings would suggest that exposure to these phthalates may contribute to the population burden of obesity, insulin resistance, and related clinical disorders.","DOI":"10.1289/ehp.9882","ISSN":"0091-6765","note":"PMID: 17589594\nPMCID: PMC1892109","journalAbbreviation":"Environ. Health Perspect.","language":"eng","author":[{"family":"Stahlhut","given":"Richard W."},{"family":"Wijngaarden","given":"Edwin","non-dropping-particle":"van"},{"family":"Dye","given":"Timothy D."},{"family":"Cook","given":"Stephen"},{"family":"Swan","given":"Shanna H."}],"issued":{"date-parts":[["2007",6]]}}}],"schema":""} (Stahlhut et al. 2007) . Some OPs appear to act as metabolic disruptors or obesogens, and increases in waist circumference and body mass index have been linked to OP exposures in men and in adolescent and adult females ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"GPKBVavQ","properties":{"formattedCitation":"(Hatch et al. 2008)","plainCitation":"(Hatch et al. 2008)","noteIndex":0},"citationItems":[{"id":4298,"uris":[""],"uri":[""],"itemData":{"id":4298,"type":"article-journal","title":"Association of urinary phthalate metabolite concentrations with body mass index and waist circumference: a cross-sectional study of NHANES data, 1999-2002","container-title":"Environmental Health: A Global Access Science Source","page":"27","volume":"7","source":"PubMed","abstract":"BACKGROUND: Although diet and activity are key factors in the obesity epidemic, laboratory studies suggest that endocrine disrupting chemicals may also affect obesity.\nMETHODS: We analyzed associations between six phthalate metabolites measured in urine and body mass index (BMI) and waist circumference (WC) in National Health and Nutrition Examination Survey (NHANES) participants aged 6-80. We included 4369 participants from NHANES 1999-2002, with data on mono-ethyl (MEP), mono-2-ethylhexyl (MEHP), mono-n-butyl (MBP), and mono-benzyl (MBzP) phthalate; 2286 also had data on mono-2-ethyl-5-hydroxyhexyl (MEHHP) and mono-2-ethyl-5-oxohexyl (MEOHP) phthalate (2001-2002). Using multiple regression, we computed mean BMI and WC within phthalate quartiles in eight age/gender specific models.\nRESULTS: The most consistent associations were in males aged 20-59; BMI and WC increased across quartiles of MBzP (adjusted mean BMI = 26.7, 27.2, 28.4, 29.0, p-trend = 0.0002), and positive associations were also found for MEOHP, MEHHP, MEP, and MBP. In females, BMI and WC increased with MEP quartile in adolescent girls (adjusted mean BMI = 22.9, 23.8, 24.1, 24.7, p-trend = 0.03), and a similar but less strong pattern was seen in 20-59 year olds. In contrast, MEHP was inversely related to BMI in adolescent girls (adjusted mean BMI = 25.4, 23.8, 23.4, 22.9, p-trend = 0.02) and females aged 20-59 (adjusted mean BMI = 29.9, 29.9, 27.9, 27.6, p-trend = 0.02). There were no important associations among children, but several inverse associations among 60-80 year olds.\nCONCLUSION: This exploratory, cross-sectional analysis revealed a number of interesting associations with different phthalate metabolites and obesity outcomes, including notable differences by gender and age subgroups. Effects of endocrine disruptors, such as phthalates, may depend upon endogenous hormone levels, which vary dramatically by age and gender. Individual phthalates also have different biologic and hormonal effects. Although our study has limitations, both of these factors could explain some of the variation in the observed associations. These preliminary data support the need for prospective studies in populations at risk for obesity.","DOI":"10.1186/1476-069X-7-27","ISSN":"1476-069X","note":"PMID: 18522739\nPMCID: PMC2440739","title-short":"Association of urinary phthalate metabolite concentrations with body mass index and waist circumference","journalAbbreviation":"Environ Health","language":"eng","author":[{"family":"Hatch","given":"Elizabeth E."},{"family":"Nelson","given":"Jessica W."},{"family":"Qureshi","given":"M. Mustafa"},{"family":"Weinberg","given":"Janice"},{"family":"Moore","given":"Lynn L."},{"family":"Singer","given":"Martha"},{"family":"Webster","given":"Thomas F."}],"issued":{"date-parts":[["2008",6,3]]}}}],"schema":""} (Hatch et al. 2008) ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"0iODBILD","properties":{"formattedCitation":"(Serrano et al. 2014)","plainCitation":"(Serrano et al. 2014)","noteIndex":0},"citationItems":[{"id":3434,"uris":[""],"uri":[""],"itemData":{"id":3434,"type":"article-journal","title":"Phthalates and diet: a review of the food monitoring and epidemiology data","container-title":"Environmental Health","page":"43","volume":"13","source":"PubMed Central","abstract":"Phthalates are associated with a variety of health outcomes, but sources that may be targeted for exposure reduction messaging remain elusive. Diet is considered a significant exposure pathway for these compounds. Therefore, we sought to identify primary foods associated with increased exposure through a review of the food monitoring survey and epidemiological data. A search in PubMed and Google Scholar for keywords \"phthalates\" and \"diet\" \"food\" \"food stuffs\" \"dietary intake\" \"food intake\" and \"food concentration\" resulted in 17 studies measuring phthalate concentrations in United States (US) and international foods, three epidemiological association studies, and three interventions. We report on food groups with high (≥300?μg/kg) and low (<50?μg/kg) concentrations and compare these to foods associated with phthalate body burden. Based on these data, we estimated daily intakes of di-2-ethylhexyl phthalate (DEHP) of US women of reproductive age, adolescents and infants for typical consumption patterns as well as healthy and poor diets. We consistently observed high DEHP concentrations in poultry, cooking oils and cream-based dairy products (≥300?μg/kg) across food monitoring studies. Diethyl phthalate (DEP) levels were found at low concentrations across all food groups. In line with these data, epidemiological studies showed positive associations between consumption of meats, discretionary fat and dairy products and DEHP. In contrast to food monitoring data, DEP was found to be associated with intake of vegetables in two studies. DEHP exposure estimates based on typical diets were 5.7, 8.1, and 42.1?μg/kg-day for women of reproductive age, adolescents and infants, respectively, with dairy as the largest contributor to exposure. Diets high in meat and dairy consumption resulted in two-fold increases in exposure. Estimates for infants based on a typical diet exceeded the Environmental Protection Agency’s reference dose of 20?μg/kg-day while diets high in dairy and meat consumed by adolescents also exceeded this threshold. The review of the literature demonstrated that DEHP in some meats, fats and dairy products is consistently found in high concentrations and can contribute to exposure. Guidance on future research in this area is provided that may help to identify methods to reduce dietary phthalate exposures.","DOI":"10.1186/1476-069X-13-43","ISSN":"1476-069X","note":"PMID: 24894065\nPMCID: PMC4050989","title-short":"Phthalates and diet","journalAbbreviation":"Environ Health","author":[{"family":"Serrano","given":"Samantha E"},{"family":"Braun","given":"Joseph"},{"family":"Trasande","given":"Leonardo"},{"family":"Dills","given":"Russell"},{"family":"Sathyanarayana","given":"Sheela"}],"issued":{"date-parts":[["2014",6,2]]}}}],"schema":""} (Serrano et al. 2014). Biomonitoring studies have consistently demonstrated widespread human exposures to OPs, although it has been reported that exposures to OPs in the U.S. population appear to be decreasing in recent years based on trends in the available biomonitoring data. It is unclear if this decrease in OP exposure is associated with the replacement of products that previously contained OPs with new products that do not have them, the use of alternatives in products that previously contained OPs, or both.Next StepsRecent studies have demonstrated that OPs are being used in some food packaging products ADDIN ZOTERO_ITEM CSL_CITATION {"citationID":"thrioA39","properties":{"formattedCitation":"(Carlos, de Jager, and Begley 2018)","plainCitation":"(Carlos, de Jager, and Begley 2018)","noteIndex":0},"citationItems":[{"id":3301,"uris":[""],"uri":[""],"itemData":{"id":3301,"type":"article-journal","title":"Investigation of the primary plasticisers present in polyvinyl chloride (PVC) products currently authorised as food contact materials","container-title":"Food Additives & Contaminants: Part A","page":"1214-1222","volume":"35","issue":"6","source":" (Crossref)","abstract":"PVC is a common food contact material that is usually plasticised to increase its flexibility. Phthalates are one class of chemical compounds that are often used as plasticisers in PVC in a wide range of industries. They may be used in packaging materials for foods and can also be found in components of certain food processing equipment such as conveyor belts and tubing. Transfer of plasticisers from packaging to foods can occur. In recent years, there has been increased interest in understanding the health effects of phthalates, as well as the possible human exposure levels. However, there is limited information available about the routes of exposure to phthalates. In July 2014, the Chronic Hazard Advisory Panel (CHAP) produced a report for the U.S. Consumer Product Safety Commission detailing the potential health hazards of phthalates and phthalate alternatives. This report listed diet as one factor contributing greater than or equal to 10% of total phthalate exposure. As a result of this report, the U.S. Food and Drug Administration (FDA) is interested in determining the types of the primary plasticiser present in food packaging and processing materials as well as their concentrations. An investigation was conducted of 56 different samples of PVC food packaging and food processing materials available in the US market using a solvent extraction and GC-MS analysis. Nine different plasticisers including three phthalates, di(2-ethylhexyl) phthalate, diisononyl phthalate and diisodecyl phthalate, were identified in the products tested. The plasticiser concentrations ranged from 1 to 53% depending on the types of food contact materials and the type of plasticiser. Overall, it appears that manufacturers are switching away from phthalates as their primary plasticiser to alternate compounds such as ESBO, ATBC, DEHT, DINCH, DEHA and DINA.","DOI":"10.1080/19440049.2018.1447695","ISSN":"1944-0049, 1944-0057","journalAbbreviation":"Food Additives & Contaminants: Part A","language":"en","author":[{"family":"Carlos","given":"Katherine S."},{"family":"Jager","given":"Lowri S.","non-dropping-particle":"de"},{"family":"Begley","given":"Timothy H."}],"issued":{"date-parts":[["2018",6,3]]}}}],"schema":""} (Carlos, de Jager, and Begley 2018). However, the available data is limited in scope, and it is unclear what types of food packaging still contains OPs. The supply chain of OP’s manufacturing and use aer also unclear to DTSC, especially within the food packaging sector. Finally, it is unclear what chemical alternatives for OPs are currently available and being used in specific food packaging applications. SCP hopes to resolve a number of these data gaps in an upcoming workshop.Public EngagementDTSC is asking stakeholders to address the questions listed in Themes 1-3 below. A public comment period will begin on November 19, 2019. Written comments can be submitted via the online information management system CalSAFER. The comment period will close on December 19, 2019, at 11:59 p.m. In addition, DTSC will hold a public workshop with stakeholders and invited participants on November 19, 2019 in Sacramento, California. Further details about this workshop will be available on our Workshops and Events Webpage. This stakeholder engagement process will help inform additional research that may result in the proposal of one or more Priority Products. Please monitor our Priority Products Work Plan Implementation webpage for updates on this topic.Questions to StakeholdersTheme 1. ManufacturingWho manufacturers food packaging in the United States?Who manufactures food packaging that contains OPs?Are there any food packaging manufacturers in California that make products with OPs? Which OPs are currently used in food packaging and what products are they used in?What alternatives to OPs are being used as plasticizers in food packaging?Theme 2. Market PresenceWho are the consumers of food packaging, generally; who in California purchases and uses packaging that may contain OPs to package foods?How much food packaging containing OPs, and what types, are on the market in California and Nationally?Who makes bottle caps and gaskets sold in California that contain OPs?Do you have any specific data on the market presence of food packaging containing OPs and the supply chain?Theme 3. Supply chainWho manufactures and supplies the OPs or OP-containing starting materials (e.g., plastisol) to food packaging manufacturers?Are there intermediaries (converters) involved who take materials (e.g., PVC film) and assemble them into a more final food package product. and who are they?Are there manufacturers of food packaging that contains OPs located outside the United States, and if so who are they, and where are they located?references cited ADDIN ZOTERO_BIBL {"uncited":[],"omitted":[],"custom":[]} CSL_BIBLIOGRAPHY Carlos, Katherine S., Lowri S. de Jager, and Timothy H. Begley. 2018. “Investigation of the Primary Plasticisers Present in Polyvinyl Chloride (PVC) Products Currently Authorised as Food Contact Materials.” Food Additives & Contaminants: Part A 35 (6): 1214–22.Colón, I, D Caro, C J Bourdony, and O Rosario. 2000. “Identification of Phthalate Esters in the Serum of Young Puerto Rican Girls with Premature Breast Development.” Environmental Health Perspectives 108 (9): 895–900.Consumer Product Safety Commission. 2017. “Federal Register?:: Prohibition of Children’s Toys and Child Care Articles Containing Specified Phthalates.” October 27, 2017. , Walter J. 2010. “Toxic Effects of the Easily Avoidable Phthalates and Parabens.” Alternative Medicine Review 15 (3): 190–96.Engel, Stephanie M., Chenbo Zhu, Gertrud S. Berkowitz, Antonia M. Calafat, Manori J. Silva, Amir Miodovnik, and Mary S. Wolff. 2009. “Prenatal Phthalate Exposure and Performance on the Neonatal Behavioral Assessment Scale in a Multiethnic Birth Cohort.” Neurotoxicology 30 (4): 522–28.European Commission. 2018. Commission Regulation (EU) 2018/2005 of 17 December 2018 Amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as Regards Bis(2-Ethylhexyl) Phthalate (DEHP), Dibutyl Phthalate (DBP), Benzyl Butyl Phthalate (BBP) and Diisobutyl Phthalate (DIBP) (Text with EEA Relevance.). OJ L. Vol. 322. , U.S. 2018. “83 FR 56750 - Flexible Vinyl Alliance; Filing of Food Additive Petition - Content Details - 2018-24657.” 2018. , Elizabeth E., Jessica W. Nelson, M. Mustafa Qureshi, Janice Weinberg, Lynn L. Moore, Martha Singer, and Thomas F. Webster. 2008. “Association of Urinary Phthalate Metabolite Concentrations with Body Mass Index and Waist Circumference: A Cross-Sectional Study of NHANES Data, 1999-2002.” Environmental Health: A Global Access Science Source 7 (June): 27.Rodgers, Kathryn M., Ruthann A. Rudel, and Allan C. Just. 2017. “Chapter 2 Phthalates in Food Packaging , Consumer Products , and Indoor Environments.” Serrano, Samantha E, Joseph Braun, Leonardo Trasande, Russell Dills, and Sheela Sathyanarayana. 2014. “Phthalates and Diet: A Review of the Food Monitoring and Epidemiology Data.” Environmental Health 13 (June): 43.Stahlhut, Richard W., Edwin van Wijngaarden, Timothy D. Dye, Stephen Cook, and Shanna H. Swan. 2007. “Concentrations of Urinary Phthalate Metabolites Are Associated with Increased Waist Circumference and Insulin Resistance in Adult U.S. Males.” Environmental Health Perspectives 115 (6): 876–82.Trasande, Leonardo, Rachel M. Shaffer, Sheela Sathyanarayana, and Council on Environmental Health. 2018. “Food Additives and Child Health.” Pediatrics 142 (2): e20181408.U.S. EPA. 2019. “List of Chemicals Undergoing Prioritization | Assessing and Managing Chemicals under TSCA | US EPA.” 2019. . ................
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