Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates
Federal Register, Volume 79 Issue 249 (Tuesday, December 30, 2014)
Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)
Proposed Rules
Pages 78324-78343
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2014-29967
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1307
Docket No. CPSC-2014-0033
Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of Proposed Rulemaking.
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SUMMARY: Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires the United States Consumer Product Safety Commission (Commission or CPSC) to convene a Chronic Hazard Advisory Panel (CHAP) to study the effects on children's health of all phthalates and phthalate alternatives as used in children's toys and child care articles and to provide recommendations to the Commission regarding whether any phthalates or phthalate alternatives other than those already permanently prohibited should be prohibited. The CPSIA requires the Commission to promulgate a final rule after receiving the final CHAP report. The Commission is proposing this rule pursuant to section 108(b) of the CPSIA.
DATES: Submit comments by March 16, 2015.
ADDRESSES: You may submit comments, identified by Docket No. CPSC-2014-
0033, by any of the following methods:
Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: http://www.regulations.gov. Follow the instructions for submitting comments. The Commission does not accept comments submitted by electronic mail (email), except through www.regulations.gov. The Commission encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above.
Written Submissions: Submit written submissions in the following way: Mail/Hand delivery/Courier, preferably in five copies, to: Office of the Secretary, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone (301) 504-7923.
Instructions: All submissions received must include the agency name and docket number for this proposed rulemaking. All comments received may be posted without change, including any personal identifiers, contact information, or other personal information provided, to: http://www.regulations.gov. Do not submit confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If furnished at all, such information should be submitted in writing.
Docket: For access to the docket to read background documents or comments received, go to: http://www.regulations.gov, and insert the docket number, CPSC-2014-0033, into the ``Search'' box, and follow the prompts.
FOR FURTHER INFORMATION CONTACT: Kent R. Carlson, Ph.D., Toxicologist, Division of Toxicology & Risk Assessment, Directorate for Health Sciences, U.S. Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850-3213; email: kcarlson@cpsc.gov.
SUPPLEMENTARY INFORMATION:
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Background
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Consumer Product Safety Improvement Act
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Statutory Prohibitions
Section 108 of the CPSIA establishes requirements concerning phthalates. The term ``phthalates'' generally refers to ortho-phthalate diesters (phthalate esters, phthalates), which are a class of organic compounds used primarily as plasticizers for polyvinyl chloride (PVC). Phthalates also are used as solvents and stabilizers for fragrances. Phthalates have been used in teethers, plastic toys, home furnishings, air fresheners, automobile interiors, cosmetics, medications, medical devices, and many other products.
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Phthalates are also found in food, indoor air, outdoor air, household dust, soil, and other environmental media.
Section 108(a) of the CPSIA permanently prohibits the manufacture for sale, offer for sale, distribution in commerce, or importation into the United States of any ``children's toy or child care article'' that contains concentrations of more than 0.1 percent of di(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), or butyl benzyl phthalate (BBP). Section 108(b)(1) of the CPSIA prohibits on an interim basis (i.e., until the Commission promulgates a final rule), the manufacture for sale, offer for sale, distribution in commerce, or importation into the United States of ``any children's toy that can be placed in a child's mouth'' or ``child care article'' containing concentrations of more than 0.1 percent of diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), or di-n-octyl phthalate (DNOP). The CPSIA defines a ``children's toy'' as ``a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays.'' Id. Section 108(g)(1)(B). A ``child care article'' is defined as ``a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.'' Id. Section 108(g)(1)(C). A ``toy can be placed in a child's mouth if any part of the toy can actually be brought to the mouth and kept in the mouth by a child so that it can be sucked and chewed. If the children's product can only be licked, it is not regarded as able to be placed in the mouth. If a toy or part of a toy in one dimension is smaller than 5 centimeters, it can be placed in the mouth.'' Id. Section 108(g)(2)(B). These statutory prohibitions became effective in February 2009. The interim prohibitions remain in effect until the Commission issues a final rule determining whether to make the interim prohibitions permanent. Id. Section 108(b)(1).
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Chronic Hazard Advisory Panel
Section 108(b)(2) of the CPSIA directs the CPSC to convene a CHAP ``to study the effects on children's health of all phthalates and phthalate alternatives as used in children's toys and child care articles.'' Section 108(g) of the CPSIA defines a ``phthalate alternative'' as ``any common substitute to a phthalate, alternative material to a phthalate, or alternative plasticizer.''
Section 28 of the Consumer Product Safety Act (CPSA), requires a CHAP to consist of seven independent scientists appointed by the Commission from a list of nominees nominated by the president of the National Academy of Sciences (NAS). CHAP members must ``have demonstrated the ability to critically assess chronic hazards and risks to human health presented by the exposure of humans to toxic substances or as demonstrated by the exposure of animals to such substances.'' 15 U.S.C. 2077(b)(2). Additionally, CHAP members must not receive compensation from, or have any substantial financial interest in, any manufacturer, distributor, or retailer of a consumer product. Id. at 15 U.S.C. 2077(b)(1). Members of the CHAP may not be employed by the federal government, except the National Institutes of Health, the National Toxicology Program, or the National Center for Toxicological Research. Id.
Section 108(b)(2) directs the CHAP to recommend to the Commission whether any phthalates or phthalate alternatives other than those permanently prohibited should be declared banned hazardous substances. Specifically, section 108(b)(2) directs the CHAP to:
Complete an examination of the full range of phthalates that are used in products for children and shall--
Examine all of the potential health effects (including endocrine-disrupting effects) of the full range of phthalates;
consider the potential health effects of each of these phthalates both in isolation and in combination with other phthalates;
examine the likely levels of children's, pregnant women's, and others' exposure to phthalates, based on a reasonable estimation of normal and foreseeable use and abuse of such products;
consider the cumulative effect of total exposure to phthalates, both from children's products and from other sources, such as personal care products;
review all relevant data, including the most recent, best-
available, peer-reviewed, scientific studies of these phthalates and phthalate alternatives that employ objective data collection practices or employ other objective methods;
consider the health effects of phthalates not only from ingestion but also as a result of dermal, hand-to-mouth, or other exposure;
consider the level at which there is a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals and their offspring, considering the best available science, and using sufficient safety factors to account for uncertainties regarding exposure and susceptibility of children, pregnant women, and other potentially susceptible individuals; and
consider possible similar health effects of phthalate alternatives used in children's toys and child care articles.
CPSIA section 108(b)(2)(B). The CHAP's examinations must be conducted de novo, and the findings and conclusions of any previous CHAP on this issue and other studies conducted by the Commission must be reviewed by the CHAP but are not to be considered determinative. Id.
Section 108(b)(2)(C) of the CPSIA requires the CHAP to complete its examination and final report within 2 years of the CHAP's appointment. In the final report, the CHAP is required to recommend to the Commission whether any ``phthalates (or combinations of phthalates)'' in addition to those permanently prohibited, including the phthalates covered by the interim prohibition or phthalate alternatives, should be declared banned hazardous substances.
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Rulemaking
Section 108(b)(3) of the CPSIA requires the Commission to promulgate a final rule, pursuant to section 553 of the Administrative Procedure Act (APA), not later than 180 days after the Commission receives the final CHAP report. The Commission must ``determine, based on such report, whether to continue in effect the interim prohibition . . ., in order to ensure a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety . . .'' CPSIA section 108(b)(3)(A). Additionally, the Commission must ``evaluate the findings and recommendations of the Chronic Hazard Advisory Panel and declare any children's product containing any phthalates to be a banned hazardous product under section 8 of the Consumer Product Safety Act (15 U.S.C. 2057), as the Commission determines necessary to protect the health of children.'' Id. Section 108(b)(3)(B).
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CHAP Process
The CHAP held its first meeting on April 14-15, 2010. The CHAP met in public session seven times and met via teleconference (also open to the public) six times.\1\ The meetings were held at the CPSC offices in Bethesda, MD, and also aired via webcast. A record of the CHAP's public meetings, including video recordings and information submitted to the CHAP, in addition to
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the final CHAP report, are available on the CPSC Web site.\2\
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\1\ The CHAP met in one closed meeting as part of the peer review process, January 28-29, 2014.
\2\ http://www.cpsc.gov/chap.
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At a July 26-28, 2010 meeting, the CHAP heard testimony from the public, including from federal agency representatives who discussed federal activities on phthalates. The CHAP also invited experts to present their latest research findings at the July 2010 and subsequent meetings. Members of the public who presented testimony to the CHAP at the July 2010 meeting included manufacturers of phthalates and phthalate alternatives, as well as representatives of nongovernmental organizations. In addition to oral testimony, the manufacturers and other interested parties submitted an extensive volume of toxicity and other information to the CHAP and/or the CPSC staff. All submissions given to CPSC staff were provided to the CHAP.
Although the CPSIA did not require peer review of the CHAP's work, at the CHAP's request, four independent scientists peer-reviewed the draft CHAP report. CPSC staff applied the same criteria for selecting the peer reviewers as is required for the CHAP members. Peer reviewers were nominated by the National Academy of Sciences. Peer reviewers did not receive compensation from, nor did they have a substantial financial interest in, any of the manufacturers of the products under consideration. In addition, the peer reviewers were not employed by the federal government, except the National Institutes of Health, the National Toxicology Program, or the National Center for Toxicological Research. The CHAP report was due to the Commission on April 13, 2012 based on the requirement in section 108(b)(2)(C) of the CPSIA. The CHAP submitted the final report to the Commission on July 18, 2014.
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The Proposed Rule
The Commission proposes this rule in accordance with the CPSIA's direction to follow section 553 of the APA. CPSC staff reviewed the CHAP report and provided the Commission with a briefing package that assessed the CHAP report and made recommendations for a notice of proposed rulemaking (NPR). The staff's briefing package is available on CPSC's Web site at http://www.cpsc.gov/Global/Newsroom/FOIA/CommissionBriefingPackages/2015/ProposedRule-Phthalates-112514.pdf. As discussed in this preamble, the Commission agrees with the staff's recommendations.
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CHAP Report
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Summary of the CHAP Report
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Health Effects in Animals
As staff explained in their briefing package, the CHAP reviewed all of the potential health effects of phthalates. Although phthalates are associated with a number of adverse health effects, the CHAP considered effects on male reproductive development to be the most relevant for human risk assessment. This is, in part, because these effects constitute the ``most sensitive and most extensively studied endpoint'' for phthalates. (CHAP 2014; pp. 1-2, 12-13). In support of this decision, the CHAP noted that a 2008 National Research Council (NRC) report also recommended using male reproductive development effects as the basis for a cumulative risk assessment of phthalates. (CHAP, 2014; NRC, 2008). The CHAP explained that exposing pregnant female rodents to certain phthalates causes a suite of effects on the male reproductive tract in male pups, known as the ``phthalate syndrome in rats.'' The syndrome includes: malformations of the testes, prostate, and penis (hypospadias); undescended testes; reduced anogenital distance (AGD); and retention of nipples.\3\ Male pups also have reduced fertility as adults. The incidence and severity of these effects increases with dose. In addition, the male fetus is the most sensitive, followed by juveniles and adults. The phthalate syndrome effects are due largely to the suppression of testosterone production (Foster 2006), as well as reduced expression of the insulin-like hormone 3 gene (CHAP 2014; Wilson et al. 2004; p. 16). Thus, the CHAP refers to these effects as ``antiandrogenic'' to reflect their effect on testosterone production. Not all phthalates cause antiandrogenic effects; only phthalates meeting certain structural criteria, termed ``active'' phthalates, are associated with the phthalate syndrome. (CHAP 2014; p. 16; Foster et al. 1980; Gray et al. 2000).
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\3\ Nipple retention does not normally occur in rodents, as it does in humans.
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The CHAP, citing published reports, noted (CHAP 2014, p.2) an additional reason for focusing on effects on male reproductive development: is empirical evidence demonstrates that the effects of active phthalates on male reproductive development are additive (Hannas et al. 2011b; 2012; Howdeshell et al. 2007; 2008). That is, exposures to multiple phthalates at lower doses act in concert to produce the same effect as a higher dose of a single phthalate. The additive effects of different phthalates are significant because humans are exposed to multiple phthalates simultaneously. (CHAP 2014; p. 2). The CHAP also noted that, in addition to phthalates, other chemicals, including certain pesticides and preservatives, add to the male reproductive effects of phthalates. (CHAP 2014; pp. 26-27, p. D-26; Rider et al. 2010).
The CHAP also reviewed available toxicity data on six phthalate alternatives. (CHAP 2014; p. 22). The CHAP found none of the alternatives to be antiandrogenic, that is, causing effects consistent with the phthalate syndrome. Therefore, because these phthalate alternatives did not contribute to the cumulative antiandrogenic effect, the CHAP assessed the potential risks of phthalate alternatives, as well as non-antiandrogenic phthalates, in isolation. These assessments were based on the most sensitive health endpoint \4\ for each chemical, such as liver toxicity, for assessing risk. (CHAP 2014, pp. 121-142).
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\4\ That is, the effect occurring at the lowest dose.
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Health Effects in Humans
The CHAP noted that the phthalate syndrome in rats resembles the ``testicular dysgenesis syndrome'' (TDS) in humans. (CHAP 2014, pp. 2, 28). TDS includes poor semen quality, reduced fertility, testicular cancer, undescended testes, and hypospadias.\5\ After reviewing all of the available studies on associations between phthalate exposure and human health (CHAP 2014, pp. 27-33; Appendix C), the CHAP noted that two of three studies found an association between prenatal or neonatal phthalate exposure and reduced anogenital distance \6\ in male infants. Several studies also found associations between prenatal or neonatal exposure and neurobehavioral effects in children. These effects included reductions in mental and psychomotor development and increases in attention deficits and behavioral symptoms. The CHAP cited several studies that found associations between phthalate exposure in adult males and reduced sperm quality and infertility. (Reviewed in CHAP 2014, p. C-8).
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\5\ A malformation of the penis.
\6\ Distance between the anus and genitals, which is greater in males than in females.
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Based on this information, the CHAP concluded that there is a growing body of studies reporting associations between phthalate exposure and human health. (CHAP 2014, p. 27). Many of the reported health effects are consistent with testicular dysgenesis syndrome in
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humans. (CHAP 2014, p. 28). However, the CHAP acknowledged the limitations of these studies, noting that the epidemiological studies were not designed specifically to provide information on sources of exposure or the relative contributions of different phthalates. Furthermore, the studies were limited by simultaneous human exposure to multiple phthalates and other environmental chemicals and by the study design. (CHAP 2014, pp. 2-3).
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Human Phthalate Exposure
The CHAP assessed human exposure to phthalates by two different, but complementary, methods: human biomonitoring (HBM) and exposure scenario analysis. HBM relies on measurements of phthalate metabolites in human urine to estimate phthalate exposure. (CHAP 2014, pp. 34-48; Appendix D). The HBM method provides good estimates of total exposure based on empirical measurements (CHAP 2014, p. 6, 75, E1-38; Clark et al. 2011), but the method does not provide information on sources of exposure. The CHAP used two data sources for HBM--each will be described in turn. The National Human Health and Nutrition Survey (NHANES), which is conducted by the U.S. Department of Health and Human Services, periodically measures phthalates and other chemicals in human urine and blood in a statistically representative sample of thousands of U.S. residents. The CHAP used data from NHANES to estimate daily exposures to various phthalates in pregnant women and women of reproductive age. (CDC 2012). NHANES does not measure phthalate metabolites in children younger than 6 years old. Therefore, the CHAP used measurements from an NIH- and EPA-funded study of mother-child pairs, the Study for Future Families (SFF), to obtain exposure estimates for infants. (Sathyanarayana et al. 2008a; 2008b). The SFF study also provided additional data for the mothers, both before and after they gave birth.
The CHAP also found, based on the HBM studies, that ``exposure to phthalates in the United States (as worldwide) is omnipresent.'' (CHAP 2014, p. 37). Virtually all Americans are exposed simultaneously to multiple phthalates. (CHAP 2014, p. 37). Based on NHANES data, pregnant women have median exposures that are roughly similar to those of women of reproductive age. (CHAP 2014, Table 2.7, page 45). Based on the SFF data, infants have threefold to fourfold greater median exposures than their mothers. (CHAP 2014, Table 2.7, p. 45).
The second method that the CHAP used to assess human exposure was through analyzing numerous exposure scenarios. The CHAP used the scenario-based method because that method provides information on sources of exposure. (CHAP 2014, pp. 49-60, Appendix E1). Thus, the scenario-based method complements the information obtained from the HBM method, which provides estimates of total exposure. The CHAP estimated exposure from individual sources using data on phthalate levels in products and environmental media, migration rates, and product use information. (CHAP 2014, pp. 49-60; Appendices, E1, E3).
For most phthalates, the CHAP found that food, rather than children's toys or child care articles, provides the primary source of exposure to both women and children. (CHAP 2014, pp. 52-53, Table 2.1). For example, DINP exposure to infants and children is primarily from diet, although mouthing of DINP-containing toys or contact with DINP-
containing toys and child care articles may contribute to the overall exposure. (CHAP 2014, Figure 2.1, page 59; Table E1-23, page E1-32; and Table E1-24, page E1-36). The CHAP also found that personal care products (cosmetics) are a major source of exposure to diethyl phthalate (DEP) and dibutyl phthalate (DBP) (id.). Indoor air and household dust are also major sources of diethyl phthalate (DEP), dibutyl phthalate (DBP), and butyl benzyl phthalate (BBP) (id.).
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Risk
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Cumulative Risk Assessment Generally
Section 108(b)(2)(B)(iv) of the CPSIA directed the CHAP specifically to ``consider the cumulative effect of total exposure to phthalates, both from children's products and from other sources.''
Cumulative risk assessment (CRA) generally refers to the combined effects of multiple environmental stressors. (Sexton and Hattis, 2007). CRA may combine different types of hazards, such as air pollution combined with psychological stress. More commonly, CRA includes mixtures of different chemicals. Chemical mixtures may be complex mixtures, such as air pollution or combustion emissions. Mixtures may include unrelated chemicals or, in the case of phthalates, a family of closely related chemicals. Human exposure to phthalates is a ``coincidental'' exposure, meaning that different individuals are exposed to phthalates in different proportions.
Section 108(b)(2)(B)(ii) of the CPSIA also directed the CHAP to ``consider the potential health effects of each of the specified phthalates both in isolation and in combination with other phthalates.'' Components of a mixture may interact in different ways regarding health risks. For example, suppose two chemicals produce the same health effect in animals. Furthermore, assume that 1 mg of A affects 10 percent of animals tested, and 1 mg of B affects 15 percent of animals. If the effects of the mixture are ``dose additive,'' then 25 percent of animals would be affected. In the case of phthalates, there is evidence in animal studies that the effects are ``dose additive.'' (Howdeshell et al., 2007; Howdeshell et al., 2008; Hannas et al., 2011b; Hannas et al., 2012). In other words, the whole equals the sum of its parts. Dose additivity does not necessarily apply in all cases. With other mixtures, the effects could be less than, or more than, dose additive. The process of performing a CRA differs in several respects from that of single-chemical risk assessment. One key difference is the choice of health endpoint. Risk assessments for chemicals in isolation are usually based on the most sensitive health effect. The most sensitive endpoint is the one that is observed at the lowest dose or has the greatest risk at a given dose. CRAs are generally based on a health effect that is common to the components of the mixture. The common health endpoint is not necessarily the most sensitive health endpoint for each of the mixture components.
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Cumulative Risk and Risk in Isolation--Hazard Index
As required by section 108(b)(2)(B)(ii) of the CPSIA, the CHAP assessed the potential risks from phthalates in isolation and in combination with other phthalates, that is, cumulative risk. The CHAP chose antiandrogenic effects on male reproductive development as the focus of the CHAP's cumulative risk assessment. Only antiandrogenic (i.e., active) phthalates cause male reproductive developmental effects and, therefore, only active phthalates contribute to the cumulative risk of male developmental reproductive effects. (CHAP 2014, pp. 61-
70). The CHAP applied the hazard index (HI) approach to assess the cumulative risk for antiandrogenic effects in males. The HI approach is widely used for chemical mixtures and other cumulative risk assessments. (Kortenkamp and Faust 2010; NRC 2008; Teuschler and Hertzberg 1995). Calculating the HI is a two-step process:
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Calculate the ``hazard quotient'' (HQ) for each phthalate. The HQ is the exposure divided by the ``potency estimate for antiandrogenicity'' (PEAA).\7\ The PEAA is an estimate of the level of exposure at which the risk of antiandrogenic effects is considered negligible. If the HQ is greater than one for a given phthalate, there may be a concern for antiandrogenic effects in the exposed population due to the effect of an individual phthalate.
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\7\ The PEAA is essentially similar to a ``reference dose'' (RfD) or ``acceptable daily intake'' (ADI), which are commonly used terms, except that the PEAA applies only to antiandrogenic effects. The RfD and ADI generally apply to the most sensitive health effect of a given chemical. RfD and ADI are estimates of a dose at which one could be exposed to for up a lifetime with a negligible risk of adverse effects.
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The hazard index (HI) is the sum of the hazard quotients (HQs) for the phthalates of interest. If the HI is greater than one, there may be a concern for antiandrogenic effects in the exposed population due to the cumulative effects of phthalates.\8\
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\8\ Having a HI greater than one does not necessarily mean that adverse effects will occur; however, this possibility cannot be ruled out.
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The CHAP calculated the HI for each individual in two populations of interest: (1) Pregnant women, and (2) children up to 36 months old. Pregnant women represent exposure to the fetus, which is considered more sensitive than newborns, children, and adults.
The CHAP used three sets of PEAAs that were derived by different approaches. (CHAP 2014, p. 62, 64; Table 2.15). This was done to assess the effect of using different PEAAs on the overall conclusions. The CHAP report refers to these as cases 1, 2, and 3:
Case 1: Published values used from a cumulative risk assessment for phthalates (Kortenkamp and Faust 2010);
Case 2: Values derived by the CHAP based on relative potency comparisons across chemicals from the same study (Hannas et al. 2011b); and
Case 3: Values from the CHAP's de novo literature review of reproductive and developmental endpoints based on the no observed adverse effect levels (NOAEL) in Table 2.1 of the CHAP report.
Results for the three sets of PEAAs were roughly similar; HIs were within 2-fold, although HIs were slightly lower for Case 3. (CHAP 2014, p. 65).
Using NHANES data, the CHAP found that pregnant women had median HIs of about 0.1 (0.09 to 0.14), while the 95th percentile HIs were about 5, depending on which set of PEAAs was used. Roughly 10 percent of pregnant women had HIs greater than one. (CHAP 2014, Table 2.16).
Using SFF data, the CHAP found that the mothers had median HIs about 0.1 (0.06 to 0.11), while the 95th percentiles were less than one (0.33 to 0.73). (CHAP 2014, Table 2.16). There was little difference between pre- and post-natal exposures. The CHAP report shows that up to 5 percent of women had HIs greater than one. For infants, HIs were about twofold greater than their mothers. Infants had median HIs about 0.2, while the 95th percentiles were between 0.5 and 1.0. About 5 percent of infants had HIs greater than one.
Based on these results, the CHAP concluded that there may be a concern for adverse effects from the cumulative effects of phthalates in individuals with a hazard index greater than one, representing up to 10 percent of pregnant women and up to 5 percent of infants. (CHAP 2014, p. 65).
Looking at the HQs for individual phthalates, the CHAP concluded: ``Clearly, the hazard quotient for DEHP dominates the calculation of the HI, as expected, with high exposure levels and one of the lowest PEAAs.'' (CHAP 2014, p. 65). Thus, DEHP (which the CPSIA permanently prohibits from use in children's toys and child care articles) contributes the most to the cumulative risk. (CHAP 2014, Table 2.16). This is due to a combination of exposure and potency. (CHAP 2014, p. 65). The CHAP found that the median HQs for DEHP range from 0.1 to 0.2, with 95th percentiles up to 12. DEHP contributed between 50 (case 2) and 90 percent (case 1) of the median HI in pregnant women (summarized in Table 1). For comparison, DBP, BBP, and DINP each contributed up to 8 percent of the HI in pregnant women (Table 1).
Table 1--Percent Contribution of Individual Phthalates to the Cumulative
Risk a
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Case 1 Case 2 Case 3
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NHANES Pregnant Women:
Diisobutyl phthalate, DIBP... 0.7 2.3 ``Examine all of the potential health effects (including endocrine disrupting effects) of the full range of phthalates.'' The CHAP examined all of the health effects associated with phthalates, including carcinogenicity, liver toxicity, and reproductive/
developmental toxicity. (CHAP 2014, pp. 13-29; Appendices A-C). As discussed in detail below, the CHAP conducted its cumulative risk assessment based on male developmental reproductive effects. The phthalate syndrome is due largely to the inhibition of testosterone production in the male fetus, which is a type of endocrine disruption. The CHAP's cumulative risk assessment focused on male developmental reproductive effects. (CHAP 2014, pp. 69-70).
``Consider the potential health effects of each of these phthalates both in isolation and in combination with other phthalates.'' To assess the potential health effects of phthalates in isolation, the CHAP used the MoE based on the most sensitive endpoint for each phthalate. (CHAP 2014, pp. 69-70). To assess the potential health effects of phthalates in combination, the CHAP conducted a cumulative risk assessment, based on male developmental reproductive effects. (Id.).
``Examine the likely levels of children's, pregnant women's, and others' exposure to phthalates, based on a reasonable estimation of normal and foreseeable use and abuse of such products.'' The CHAP assessed exposure by two complementary methods. Biomonitoring studies provide good
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estimates of total exposure to phthalates but do not provide information on the sources of exposure. (CHAP 2014, pp. 34-48). The scenario-based approach estimates exposure to specific products and sources of exposure, including toys, child care articles, and personal care products. (CHAP 2014, pp. 49-60; Appendices E1-E3).
``Consider the cumulative effect of total exposure to phthalates, both from children's products and from other sources, such as personal care products.'' The CHAP conducted a cumulative risk assessment, based on total phthalate exposure, as estimated from biomonitoring studies. (CHAP 2014; pp. 61-68; Appendix D).
``Review all relevant data, including the most recent, best-available, peer-reviewed, scientific studies of these phthalates and phthalate alternatives that employ objective data collection practices or employ other objective methods.'' The CHAP reviewed all of the available data on phthalates, including publications in peer-
reviewed scientific journals; reports submitted by manufacturers to the U.S. EPA; \10\ and authoritative reviews from agencies such as the Agency for Toxic Substances and Disease Registry (ATSDR), the European Chemical Agency (ECHA), the International Agency for Research on Cancer (IARC), Center for the Evaluation of Research on Human Reproduction (CERHR), National Toxicology Program (NTP); and the National Research Council (NRC). (CHAP, 2014, p. 12). In addition, the CHAP invited scientific experts to present their latest research in areas such as biomonitoring, epidemiology, phthalate syndrome, toxicology of phthalates mixtures, phthalates mode of action, and species differences. The CHAP also invited a co-author of an NRC report (NRC, 2009) to present the NRC panel's perspective on risk assessment methodology, especially as applied to phthalates risk assessment. Furthermore, the CHAP heard testimony from federal agency scientists, as well as scientists representing manufacturers of phthalates alternatives.
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\10\ For example, toxicity data submitted under Sec. 8(e) of the Toxic Substances Control Act.
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``Consider the health effects of phthalates not only from ingestion but also as a result of dermal, hand-to-mouth, or other exposures.'' The CHAP estimated phthalate exposure by two methods. Biomonitoring studies estimated total exposure, regardless of source or route of exposure. (CHAP 2014, pp. 34-48). The scenario-based approach estimated exposure to specific products and sources of exposure by all routes of exposure, including oral, dermal, inhalation, and hand-to-
mouth. (CHAP 2014, pp. 49-60; Appendices E1-E3).
``Consider the level at which there is a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals and their offspring, considering the best available science, and using sufficient safety factors to account for uncertainties regarding exposure and susceptibility of children, pregnant women, and other potentially susceptible individuals.'' For antiandrogenic phthalates, the CHAP derived reference doses (PEAAs) that were specific for male developmental reproductive effects. (CHAP 2014, Table 2.15). For non-antiandrogenic phthalates and phthalate alternatives, the CHAP selected appropriate NOAELs that were based on the most sensitive endpoint. (Id., pp. 79-142, Appendices A-B). The CHAP also recommended the use of additional uncertainty factors (safety factors) for selected compounds where the database was limited (ATBC and DEHA).
``Consider possible similar health effects of phthalate alternatives used in children's toys and child care articles.'' The CHAP considered all health effects associated with six phthalate alternatives and, where sufficient data were available, estimated the potential health risks based on the most sensitive health endpoint. (CHAP, 2014, pp. 121-142, Appendices A-B).
Furthermore, section 108(b)(2)(B) required the CHAP to perform its examination de novo. ``The findings and conclusions of any previous Chronic Hazard Advisory Panel on this issue and other studies conducted by the Commission shall be reviewed by the panel but shall not be considered determinative.'' Although the CHAP considered previous CHAP reports and CPSC staff reports, the CHAP also conducted its own review of the scientific literature (including studies conducted by phthalate manufacturers) and invited experts to present their most recent research. (CHAP, 2014, p. 12).
Finally, section 108(b)(2)(C) required the CHAP to ``make recommendations to the Commission regarding any phthalates (or combinations of phthalates) in addition to those identified in subsection (a) or phthalate alternatives that the panel determines should be declared banned hazardous substances.'' The CHAP completed its charge by making recommendations to prohibit additional phthalates (id., pp. 110-117), make the interim prohibition of DINP permanent (id., pp. 95-99), lift the interim prohibitions of DNOP (id., pp. 91-
94) and DIDP (id., pp. 100-104), and prohibit DIOP on an interim basis (id., pp. 118-119).
The staff concluded that the CHAP fully met the charge in section 108 of the CPSIA.
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Selection of Phthalates and Phthalates Alternatives
The CHAP selected phthalates for inclusion in its examination based on the following non-exclusive criteria: inclusion in the CPSIA, availability of human biomonitoring data, potential for exposure, and evidence of male developmental reproductive toxicity. (CHAP, 2014, pp. 22-23):
Six phthalates subject to the CPSIA--DBP, BBP, DEHP, DNOP, DINP, and DIDP;
Availability of biomonitoring data--DMP, DEP, DIBP, in addition to the six phthalates subject to the CPSIA;
Increasing production, which suggests increasing exposure--DPHP; and
Ability to induce male developmental reproductive effects--DIBP, DPENP, DHEXP, and DCHP. (Id., p. 16).
The CPSC staff concurs with the CHAP's selection of phthalates because the 14 phthalates that the CHAP reviewed include phthalates with high exposure potential and phthalates that contribute to the cumulative risk for male developmental reproductive effects.
The CHAP selected six phthalate alternatives for study, either because they were known to be used in children's toys and child care articles (ATBC, DEHT, DINX, TPIB) (Dreyfus 2010) or because they were considered likely to be used (DEHA, TOTM) (CHAP, 2014; p. 23; Versar/
SRC, 2010a). CPSC staff recognizes that there is a broad range of potential phthalate alternatives (Versar/SRC, 2010a), including phthalates that are not prohibited by the CPSIA. Nonetheless, CPSC staff agrees with the CHAP's choice of phthalate alternatives because it includes all of the non-phthalate plasticizers known to be used in toys and child care articles (Dreyfus 2010; TAB B), as well as other commonly used plasticizers. After the CHAP completed its report, CPSC staff identified DPHP in children's toys; DPHP is an emerging phthalate that was included in the CHAP report.
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Selection of Health Endpoint
After reviewing all of the available toxicity data on 14 phthalates, the CHAP selected male developmental reproductive toxicity as the critical endpoint for its cumulative risk assessment. (CHAP 2014, pp. 13). CPSC
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staff supports the selection of male developmental reproductive toxicity for several reasons. Male developmental reproductive effects in animals are associated with many of the most common phthalates. For most of the active phthalates, these effects are the most sensitive health effect; that is, these effects are observed at lower doses than other adverse health effects (see CPSC staff and contractor reports at http://www.cpsc.gov/chap). Male developmental reproductive effects (phthalate syndrome) are of particular concern because they may adversely affect human reproduction. Furthermore, the phthalate syndrome in animals bears a striking resemblance to the testicular dysgenesis syndrome in humans. (Skakkebaek et al., 2001).
The availability of empirical evidence also supports the choice to base the cumulative risk assessment on male developmental reproductive effects because such evidence eliminates the need to make critical assumptions that might not be borne out. Specifically, empirical evidence demonstrates that mixtures of active phthalates interact in a dose-additive fashion with respect to developmental male reproductive effects. (Howdeshell et al., 2007, 2008; Hannas et al., 2011b, 2012). Thus, it was not necessary for the CHAP to make any assumptions regarding the effects of phthalate mixtures. Most other health effects of phthalates have not been studied with mixtures; performing a cumulative risk assessment on any other endpoint would require assumptions regarding the mode of action and possible mixture effects.
Furthermore, the male developmental reproductive effects of phthalates are well-studied. (Reviewed in Foster, 2006). These effects, which were first reported in 1980 (Foster et al., 1980), persist into adulthood, even in the absence of further exposure (Barlow and Foster, 2003; Barlow et al., 2004; McIntyre et al., 2001). Similar effects have been reported in multiple mammalian species, including guinea pigs (Gray et al., 1982), mice, (Gray et al., 1982; Moody et al., 2013; Ward et al., 1998), rabbits (Higuchi et al., 2003), and ferrets (Lake et al., 1976). Hamsters were resistant due to slow metabolism of the phthalate ester to the monoester, which is believed to be the active metabolite. Hamsters responded to the monoester, however. (Gray et al., 1982). The observation of similar effects in multiple species demonstrates that these effects are not unique to rats. Based on the CPSC chronic hazard guidelines, the CPSC staff regards active phthalates as ``probably toxic to humans,'' based on ``sufficient evidence'' in animal studies. (CPSC, 1992).
Other authors also have selected male developmental reproductive effects as the basis of cumulative risk assessments of phthalates. The U.S. Environmental Protection Agency (EPA) convened a National Research Council (NRC) committee to consider approaches to assessing the cumulative risk of phthalates; the committee recommended using male developmental reproductive effects as the basis for a cumulative risk assessment. (NRC, 2008). Additionally, two subsequent publications conducted cumulative risk assessments based on male developmental reproductive effects. (Benson, 2009; Christensen et al., 2014).
CPSC staff recognizes that a number of other health effects are associated with phthalates. (Reviewed in Babich, 2010). Although some phthalates are associated with cancer, cancer is only associated with a relatively small number of phthalates, and many of the cancers induced by phthalates are of uncertain relevance to humans. (CHAP, 2001; CPSC, 2002; Klaunig et al., 2003). Other effects, such as liver toxicity, are common to most phthalates; but there are little or no data available on mode of action or the effects of mixtures. Thus, there is less scientific basis for performing a cumulative risk assessment with liver toxicity as the critical endpoint.
Finally, a growing number of epidemiological studies have reported associations of phthalate exposure with adverse health effects in humans. (As cited in CHAP 2014, pp. 27-33, Appendix C). Many of these adverse health effects are consistent with the effects in animal studies. The staff concludes that the epidemiological studies, though not conclusive on their own, provide supporting evidence that the animal studies are relevant to humans.
Therefore, CPSC staff supports using male developmental reproductive effects as the basis for the CHAP's cumulative risk assessment due to the importance of the endpoint; the abundance of data, the known additive nature of phthalate mixtures regarding male developmental reproductive effects, and NRC's recommendation.
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Methodology
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Hazard Index
The CHAP chose the hazard index (HI) approach for its cumulative risk assessment because that index is widely accepted for this purpose. (Teuschler and Hertzberg, 1995). The National Research Council (NRC, 2008) recommended this approach for phthalates cumulative risk assessment. Two other publications on phthalates' cumulative risk also used the HI approach. (Benson, 2009; Christensen et al., 2014). ExxonMobil scientists \11\ also recommended the HI approach to CPSC in 2010, before the CHAP met for the first time.
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\11\ ``Approach to Cumulative Risk,'' presented to the CPSC staff, March 2010. http://www.cpsc.gov/PageFiles/125812/CummRiskExxon03232010.pdf.
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The CHAP found that up to 10 percent of pregnant women and up to 5 percent of infants, those with the highest exposure, have a HI greater than one. The portion of the population with a HI greater than one may be at risk for the adverse effects of phthalates. (EPA, 1993). This does not necessarily mean that anyone will suffer adverse effects; however, one cannot rule out the possibility of adverse effects. The greater the HI, the greater the risk.
Although the HI approach is widely accepted, the CHAP introduced a novel process to calculate the HI. The CHAP calculated hazard quotients (HQ) and a HI for each individual in the population of interest (i.e., pregnant women or infants), and then derived distributions of the HI. This was necessary because each individual is exposed to phthalates in differing proportions. For example, some individuals may be exposed almost exclusively to a single phthalate, while others may be exposed to several phthalates in roughly equal proportion. After calculating the HQs and HIs for all individuals, the CHAP then generated frequency distributions for the HI. This process allowed the CHAP to estimate the average and 95th percentile of the HI, as well as the portion of the population with a HI greater than one.
The alternative to the CHAP's approach would be to calculate hazard quotients using summary data on metabolite levels, that is, median and 95th percentile levels (e.g., Benson, 2009). This would have allowed the CHAP to estimate median and 95th percentile hazard quotients for each phthalate. Under this approach, the median hazard quotients are summed to calculate the average HI, which would be roughly similar to the median hazard quotient calculated as above. However, summing the 95th percentile values would overestimate the 95th percentile HI. Therefore, the CHAP introduced this novel process to calculate the hazard quotients and HI more accurately, especially at the upper-bound (e.g., 95th percentile) exposures. Had the CHAP not applied this novel approach, the result would have been an overestimate
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of the 95th percentile exposures and the percentage of pregnant women and infants with HI greater than one.
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Margin of Exposure
The CHAP chose the margin of exposure (MoE) approach to assess potential health risks for phthalates and phthalate alternatives in isolation. The CHAP chose this approach, in part, due to the recommendation of a NRC report on risk assessment methodology (NRC, 2009). Like the HI approach, the MoE is also widely accepted. (Id.).
The MoE is the ratio of the no observed adverse effect level (NOAEL) to the estimated exposure. Generally, a MoE of 100 to 1,000 is needed to protect public health (EPA, 1993). The minimum value of the MoE depends on the compound. If a NOAEL has been established in animal (rather than human) studies, a MoE of 100 or greater is sufficient to protect public health (CPSC, 1992). If a NOAEL has not been established, and a LOAEL (lowest observed adverse effect level) is used instead, or if the available toxicity data for the chemical of interest is inadequate, then a MoE of 1,000 may be required. Based on the knowledge that adequate animal data are available and NOAELS have been established for most of the phthalates, staff believes, consistent with the CHAP report, that a MoE of 100 is sufficient for most of the compounds in the CHAP report. The CHAP recommended an additional uncertainty factor for the phthalate alternatives ATBC and DEHA. Staff concurs that an additional uncertainty factor for ATBC and DEHA is appropriate because of limitations in the available toxicity data.
The MoE approach is conceptually similar to the CPSC staff's default approach for assessing non-cancer risks (CPSC, 1992) and would lead to similar conclusions about risk. CPSC staff approves of the CHAP's selection of the MoE approach to assess the risks of phthalates and phthalate alternatives in isolation because the MoE approach leads to the same conclusion as the staff's default methodology.
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Exposure Assessment
The CHAP assessed exposure by two complementary methods. Biomonitoring studies provide good estimates of total exposure to phthalates but do not provide information on the sources of exposure. (CHAP 2014, pp. 34-48). The scenario-based approach estimates exposure to specific products and sources of exposure, including toys, child care articles, and personal care products. (CHAP 2014, pp. 49-60; Appendices E1-E3). Staff concurs with the CHAP's use of these approaches to assess exposure for the reasons explained below.
The CHAP used exposure estimates from biomonitoring data as the basis for its cumulative risk assessment. CPSC staff considers biomonitoring to provide the best available estimates of total exposure because biomonitoring is based on empirical measurements in individuals. Furthermore, the NHANES study is a large statistically representative sample. In contrast, the alternative approach, scenario-
based estimates, are subject to a number of assumptions and uncertainties. (CHAP, 2014, Appendix E). The method for estimating exposure from biomonitoring data has been in use since 2000 and was developed by an industry scientist. (David, 2000). The CHAP devoted considerable effort to discussing potential errors and bias in this methodology, having invited two experts (Stahlhut and Lorber) to address this issue at the December 2010 meeting. As discussed in the CHAP report, any errors in this methodology are relatively small and are unbiased (CHAP 2014, pp. 73-75). ``Unbiased'' means that any errors are equally likely to lead to overestimation or underestimation of risk.
The staff notes that the CHAP used the latest data available at the time the CHAP performed its analysis. Phthalate exposures in the U.S. population, as measured by biomonitoring, have remained essentially constant for about a 10-year period. (CDC, 2012; EPA, 2013). However, the most recent report from CDC shows that phthalate exposures are beginning to change as one might expect, as products are reformulated in light of concerns about phthalate toxicity. (CDC, 2013). The CDC report shows that exposure to DBP, BBP, and DEHP is declining, while exposures to DINP and DIBP are increasing. The decline in DEHP exposure may be due, in part, to concerns about its toxicity and replacement with other plasticizers. Exposure to DEP and DBP has declined somewhat, possibly due to reformulation of cosmetics and other products. (Zota et al., 2014). Staff has not assessed the effect of changing phthalate exposures on the HI.
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Human Relevance of Animal Data
One source of uncertainty in any risk assessment is the use of animal data as the basis for estimating the risk to humans. Male developmental reproductive effects have been well-studied in rats. In addition, similar effects have been reported in multiple mammalian species, including guinea pigs (Gray et al., 1982), mice, (Gray et al., 1982; Moody et al., 2013; Ward et al., 1998), rabbits (Higuchi et al., 2003), and ferrets (Lake et al., 1976) (Lake et al. 1976). Hamsters were resistant to male developmental reproductive effects due to slow metabolism of the phthalate ester to the monoester, which is believed to be the active metabolite. Hamsters responded to the monoester, however. (Gray et al. 1982). The observation of similar effects in multiple species demonstrates that these effects are not unique to rats. This is not surprising because male reproductive development is essentially similar in all mammalian species (NRC, 2008).
In contrast to these findings, a single study in marmosets that exposed pregnant females to DBP did not lead to any adverse effects in male offspring (McKinnell et al., 2009). However, as with most primate studies, this study was limited by small numbers.
Similarly, in two recent studies in which fetal rat and mouse testes, or fetal human testicular tissue, were transplanted into laboratory animals and exposed to phthalates (Heger et al., 2012; Mitchell et al., 2012), only the rat testes responded to the phthalates. However, the human fetal tissue was generally past 14 weeks of gestation, which is outside the window of maximum sensitivity. Nevertheless, given the potential significance of these studies, the CHAP invited the principal investigators of both studies (Boekelheide and Sharpe) to present their findings at the November 2011 CHAP meeting. Both of these scientists stated that their studies were very preliminary and that it would be premature to use their results to support public health decisions.
Finally, a growing number of epidemiological studies have reported associations of phthalate exposure with adverse health effects in humans. (CHAP 2014, pp. 27-33). Many of these effects are consistent with male developmental effects observed in animal studies. The human studies, although not conclusive on their own, provide supporting evidence that the animal studies are relevant to humans. (CPSC, 1992). The consistency of the results of the epidemiological studies with the animal studies provides additional support for the relevance of the animal studies to humans.
To summarize, active phthalates cause testicular effects in multiple animal species. The animal studies are further supported by the results of epidemiological studies. CPSC staff concludes that the weight of the evidence overwhelmingly supports the conclusion that male developmental
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reproductive effects in animals are appropriate for estimating risks to humans.
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Commission Assessment of the CHAP Report's Recommendations for the Proposed Rule
As discussed in the staff's briefing package, staff assessed the recommendations of the CHAP. The Commission agrees with the staff's assessment and provides the following explanation.
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Interim Prohibited Phthalates: DINP, DIDP, and DNOP
Section 108(b)(3)(A) of the CPSIA requires the Commission to determine, based on the CHAP report, whether to continue in effect the interim prohibitions on children's toys that can be placed in a child's mouth and child care articles containing DINP, DIDP, and DNOP ``to ensure a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety.'' For each phthalate, the Commission must decide whether to make the interim prohibitions permanent.
Consistent with the CHAP and the statutory framework, the Commission considered both cumulative risk and risk in isolation. For active phthalates, that is, phthalates causing male developmental reproductive effects, the Commission considered the cumulative risk, which was based on the HI. Consistent with the CHAP report and the CPSC chronic hazard guidelines (CPSC, 1992), the Commission considers that the acceptable risk is exceeded when the HI is greater than one (CPSC, 1992). Thus, the Commission considers that an HI 100) and that there is no compelling reason to continue the interim prohibition.
The CHAP concluded: ``DIDP does not appear to possess antiandrogenic potential'' (CHAP, 2014, pp. 24, 104); therefore, DIDP does not contribute to the cumulative risk (CHAP 2014, p. 104). However, the CHAP stated that it is aware that DIDP is associated with other health effects in animal studies, including chronic liver and kidney toxicity and developmental effects (e.g., supernumerary ribs). (CHAP 2014, pp. 100-105). The CHAP considered DIDP risks in isolation because DIDP is not antiandrogenic. The lowest NOAEL for DIDP was 15 mg/kg-d, based on liver effects. Using biomonitoring data, the CHAP estimated that human exposures range from 1.5 to 26 microg/kg-d. The MoEs range from 2,500 to 10,000 for median DIDP exposures and 586 to 3,300 for upper-bound exposures. Therefore, the CHAP recommended that the interim prohibition on children's toys and child care articles containing DIDP be lifted.
As discussed previously, the Commission considers that a MoE of 100 or greater is sufficient to protect human health with respect to DIDP. The Commission agrees with the CHAP's assessment of the potential health risks from DIDP because the MoEs are much greater than 100. DIDP exposure would need to increase by more than 250 times to exceed the acceptable level. Furthermore, DIDP is not antiandrogenic; and therefore, DIDP does not contribute to the cumulative risk from antiandrogenic phthalates. The Commission concludes that continuing the prohibition of DIDP is not necessary to ensure a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals with an adequate margin of safety. Accordingly, under the proposed rule, children's toys and child care articles containing DIDP would no longer be prohibited.
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Phthalates Not Prohibited by the CPSIA
The CPSIA requires the Commission to ``evaluate the findings and recommendations of the Chronic Hazard Advisory Panel and declare any children's product containing any phthalates to be a banned hazardous product under section 8 of the Consumer Product Safety Act (15 U.S.C. 2057), as the Commission determines necessary to protect the health of children.'' CPSIA section 108(b)(3)(B). The CHAP reviewed the potential health risks associated with eight phthalates that were not prohibited by the CPSIA. The CHAP recommended permanent prohibitions on four additional phthalates: DIBP, DPENP, DHEXP, and DCHP. The CHAP recommended an interim prohibition of DIOP. The CHAP did not recommend prohibitions on DMP, DEP, or DPHP; although the CHAP recommended additional study on DEP and DPHP.
Consistent with the CHAP report, the Commission considered both cumulative risk and risk in isolation. For active phthalates, that is, phthalates causing male developmental reproductive effects, the Commission considered the cumulative risk, which was based on the HI. Consistent with the CHAP report and the CPSC chronic hazard guidelines (CPSC 1992), the Commission considers that the acceptable risk is exceeded when the HI is greater than one (CPSC 1992). Thus, the Commission considers that a HI 1). Allowing the use of DIBP in children's toys and child care articles would further increase the cumulative risk. As discussed previously, the Commission considers that a HI 1). Allowing the use of DPENP in children's toys and child care articles would further increase the cumulative risk. As discussed previously, the Commission considers that a HI 1). Allowing the use of DHEXP in children's toys and child care articles would further increase the cumulative risk. As discussed previously, the Commission considers that a HI 1). Allowing the use of DCHP in children's toys and child care articles would further increase the cumulative risk. As discussed previously, the Commission considers that a HI
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