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Publication 100,’’ guidelines published (3) Knowing submission of false or eRulemaking Portal at: http:// by NTIS and available at https:// misleading information concerning a www.regulations.gov. Follow the dmf.ntis.gov. Such attestation must be material fact(s) in an attestation or instructions for submitting comments. based on the Accredited Certification assessment report by an Accredited The Commission does not accept Body’s review or assessment conducted Certification Body of a Person or comments submitted by electronic mail no more than three years prior to the Certified Person; (email), except through date of submission of the Person’s or (4) Failure of an Accredited www.regulations.gov. The Commission Certified Person’s completed Certification Body to cooperate in encourages you to submit electronic certification statement, and, if an audit response to a request from NTIS verify comments by using the Federal of a Certified Person by an Accredited the accuracy, veracity, and/or eRulemaking Portal, as described above. Certification Body is required by NTIS, completeness of information received in Written Submissions: Submit written no more than three years prior to the connection with an attestation under submissions in the following way: Mail/ date upon which NTIS notifies the § 1110.502 or an attestation or Hand delivery/Courier, preferably in Certified Person of NTIS’s requirement assessment report by that Body of a five copies, to: Office of the Secretary, for audit, but such review or assessment Person or Certified Person. An Consumer Product Safety Commission, or audit need not have been conducted Accredited Certification Body ‘‘fails to Room 820, 4330 East West Highway, specifically or solely for the purpose of cooperate’’ when it does not respond to Bethesda, MD 20814; telephone (301) submission under this part. NTIS inquiries or requests, or it 504–7923. (c) Where review or assessment or responds in a manner that is Instructions: All submissions received audit by an Accredited Certification unresponsive, evasive, deceptive, or must include the agency name and Body was not conducted specifically or substantially incomplete; or docket number for this proposed solely for the purpose of submission (5) Where NTIS is unable for any rulemaking. All comments received may reason to verify the accuracy of the under this part, the written attestation be posted without change, including Accredited Certification Body’s or assessment report (if an audit) shall any personal identifiers, contact attestation. describe the nature of that review or information, or other personal assessment or audit, and the Accredited [FR Doc. 2014–30199 Filed 12–29–14; 8:45 am] information provided, to: http:// Certification Body shall attest that on BILLING CODE 3510–04–P www.regulations.gov. Do not submit the basis of such review or assessment confidential business information, trade or audit, the Person or Certified Person secret information, or other sensitive or has systems, facilities, and procedures CONSUMER PRODUCT SAFETY protected information that you do not in place as required under COMMISSION want to be available to the public. If § 1110.102(a)(2). In so attesting, an furnished at all, such information Accredited Certification Body may 16 CFR Part 1307 should be submitted in writing. reference ‘‘Limited Access Death Master [Docket No. CPSC–2014–0033] Docket: For access to the docket to File (LADMF) Certification Program read background documents or Publication 100,’’ guidelines published Prohibition of Children’s Toys and comments received, go to: http:// by NTIS and available at https:// Child Care Articles Containing www.regulations.gov, and insert the dmf.ntis.gov. Specified Phthalates docket number, CPSC–2014–0033, into (d) Notwithstanding paragraphs (a) the ‘‘Search’’ box, and follow the AGENCY: Consumer Product Safety prompts. through (c) of this section, NTIS may, in Commission. FOR FURTHER INFORMATION CONTACT: its sole discretion, require that review or ACTION: Notice of Proposed Rulemaking. Kent assessment or audit by an Accredited R. Carlson, Ph.D., Toxicologist, Division Certification Body be conducted SUMMARY: Section 108 of the Consumer of Toxicology & Risk Assessment, specifically or solely for the purpose of Product Safety Improvement Act of Directorate for Health Sciences, U.S. submission under this part. 2008 (CPSIA), requires the United States Consumer Product Safety Commission, Consumer Product Safety Commission 5 Research Place, Rockville, MD 20850– § 1110.503 Acceptance of accredited (Commission or CPSC) to convene a 3213; email: [email protected]. certification bodies. Chronic Hazard Advisory Panel (CHAP) SUPPLEMENTARY INFORMATION: (a) NTIS will accept written to study the effects on children’s health attestations and assessment reports from of all phthalates and phthalate I. Background an Accredited Certification Body that alternatives as used in children’s toys A. Consumer Product Safety attests, to the satisfaction of NTIS, as and child care articles and to provide Improvement Act provided in § 1110.502. recommendations to the Commission (b) NTIS may decline to accept regarding whether any phthalates or 1. Statutory Prohibitions written attestations or assessment phthalate alternatives other than those Section 108 of the CPSIA establishes reports from an Accredited Certification already permanently prohibited should requirements concerning phthalates. Body, whether or not it has attested as be prohibited. The CPSIA requires the The term ‘‘phthalates’’ generally refers provided in § 1110.502, for any of the Commission to promulgate a final rule to ortho-phthalate diesters (phthalate following reasons: after receiving the final CHAP report. esters, phthalates), which are a class of (1) When it is in the public interest The Commission is proposing this rule organic compounds used primarily as under Section 203 of the Bipartisan pursuant to section 108(b) of the CPSIA. plasticizers for polyvinyl chloride Budget Act of 2013, and DATES: Submit comments by March 16, (PVC). Phthalates also are used as notwithstanding any other provision of 2015. solvents and stabilizers for fragrances. this part; ADDRESSES: You may submit comments, Phthalates have been used in teethers, (2) Submission of false or misleading identified by Docket No. CPSC–2014– plastic toys, home furnishings, air information concerning a material 0033, by any of the following methods: fresheners, automobile interiors, fact(s) in an Accredited Certification Electronic Submissions: Submit cosmetics, medications, medical Body’s attestation under § 1110.502; electronic comments to the Federal devices, and many other products.

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Phthalates are also found in food, list of nominees nominated by the • consider possible similar health indoor air, outdoor air, household dust, president of the National Academy of effects of phthalate alternatives used in soil, and other environmental media. Sciences (NAS). CHAP members must children’s toys and child care articles. Section 108(a) of the CPSIA ‘‘have demonstrated the ability to CPSIA section 108(b)(2)(B). The permanently prohibits the manufacture critically assess chronic hazards and CHAP’s examinations must be for sale, offer for sale, distribution in risks to human health presented by the conducted de novo, and the findings commerce, or importation into the exposure of humans to toxic substances and conclusions of any previous CHAP United States of any ‘‘children’s toy or or as demonstrated by the exposure of on this issue and other studies child care article’’ that contains animals to such substances.’’ 15 U.S.C. conducted by the Commission must be concentrations of more than 0.1 percent 2077(b)(2). Additionally, CHAP reviewed by the CHAP but are not to be of di(2-ethylhexyl) phthalate (DEHP), members must not receive considered determinative. Id. dibutyl phthalate (DBP), or butyl benzyl compensation from, or have any phthalate (BBP). Section 108(b)(1) of the substantial financial interest in, any Section 108(b)(2)(C) of the CPSIA CPSIA prohibits on an interim basis manufacturer, distributor, or retailer of requires the CHAP to complete its (i.e., until the Commission promulgates a consumer product. Id. at 15 U.S.C. examination and final report within 2 a final rule), the manufacture for sale, 2077(b)(1). Members of the CHAP may years of the CHAP’s appointment. In the offer for sale, distribution in commerce, not be employed by the federal final report, the CHAP is required to or importation into the United States of government, except the National recommend to the Commission whether ‘‘any children’s toy that can be placed Institutes of Health, the National any ‘‘phthalates (or combinations of in a child’s mouth’’ or ‘‘child care Toxicology Program, or the National phthalates)’’ in addition to those article’’ containing concentrations of Center for Toxicological Research. Id. permanently prohibited, including the more than 0.1 percent of diisononyl Section 108(b)(2) directs the CHAP to phthalates covered by the interim phthalate (DINP), diisodecyl phthalate recommend to the Commission whether prohibition or phthalate alternatives, (DIDP), or di-n-octyl phthalate (DNOP). any phthalates or phthalate alternatives should be declared banned hazardous The CPSIA defines a ‘‘children’s toy’’ as other than those permanently prohibited substances. ‘‘a consumer product designed or should be declared banned hazardous 3. Rulemaking intended by the manufacturer for a child substances. Specifically, section 12 years of age or younger for use by the 108(b)(2) directs the CHAP to: Section 108(b)(3) of the CPSIA child when the child plays.’’ Id. Section Complete an examination of the full requires the Commission to promulgate 108(g)(1)(B). A ‘‘child care article’’ is range of phthalates that are used in a final rule, pursuant to section 553 of defined as ‘‘a consumer product products for children and shall— the Administrative Procedure Act • designed or intended by the Examine all of the potential health (APA), not later than 180 days after the manufacturer to facilitate sleep or the effects (including endocrine-disrupting Commission receives the final CHAP feeding of children age 3 and younger, effects) of the full range of phthalates; • report. The Commission must or to help such children with sucking or consider the potential health effects ‘‘determine, based on such report, teething.’’ Id. Section 108(g)(1)(C). A of each of these phthalates both in whether to continue in effect the ‘‘toy can be placed in a child’s mouth isolation and in combination with other [interim] prohibition . . ., in order to if any part of the toy can actually be phthalates; ensure a reasonable certainty of no harm • examine the likely levels of brought to the mouth and kept in the to children, pregnant women, or other children’s, pregnant women’s, and mouth by a child so that it can be susceptible individuals with an sucked and chewed. If the children’s others’ exposure to phthalates, based on adequate margin of safety . . .’’ CPSIA product can only be licked, it is not a reasonable estimation of normal and section 108(b)(3)(A). Additionally, the regarded as able to be placed in the foreseeable use and abuse of such Commission must ‘‘evaluate the mouth. If a toy or part of a toy in one products; findings and recommendations of the dimension is smaller than 5 centimeters, • consider the cumulative effect of Chronic Hazard Advisory Panel and it can be placed in the mouth.’’ Id. total exposure to phthalates, both from declare any children’s product Section 108(g)(2)(B). These statutory children’s products and from other containing any phthalates to be a prohibitions became effective in sources, such as personal care products; banned hazardous product under February 2009. The interim prohibitions • review all relevant data, including section 8 of the Consumer Product remain in effect until the Commission the most recent, best-available, peer- Safety Act (15 U.S.C. 2057), as the issues a final rule determining whether reviewed, scientific studies of these Commission determines necessary to to make the interim prohibitions phthalates and phthalate alternatives protect the health of children.’’ Id. permanent. Id. Section 108(b)(1). that employ objective data collection practices or employ other objective Section 108(b)(3)(B). 2. Chronic Hazard Advisory Panel methods; B. CHAP Process Section 108(b)(2) of the CPSIA directs • consider the health effects of the CPSC to convene a CHAP ‘‘to study phthalates not only from ingestion but The CHAP held its first meeting on the effects on children’s health of all also as a result of dermal, hand-to- April 14–15, 2010. The CHAP met in phthalates and phthalate alternatives as mouth, or other exposure; public session seven times and met via used in children’s toys and child care • consider the level at which there is teleconference (also open to the public) articles.’’ Section 108(g) of the CPSIA a reasonable certainty of no harm to six times.1 The meetings were held at defines a ‘‘phthalate alternative’’ as children, pregnant women, or other the CPSC offices in Bethesda, MD, and ‘‘any common substitute to a phthalate, susceptible individuals and their also aired via webcast. A record of the alternative material to a phthalate, or offspring, considering the best available CHAP’s public meetings, including alternative plasticizer.’’ science, and using sufficient safety video recordings and information Section 28 of the Consumer Product factors to account for uncertainties submitted to the CHAP, in addition to Safety Act (CPSA), requires a CHAP to regarding exposure and susceptibility of consist of seven independent scientists children, pregnant women, and other 1 The CHAP met in one closed meeting as part of appointed by the Commission from a potentially susceptible individuals; and the peer review process, January 28–29, 2014.

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the final CHAP report, are available on II. CHAP Report effects of different phthalates are the CPSC Web site.2 significant because humans are exposed A. Summary of the CHAP Report At a July 26–28, 2010 meeting, the to multiple phthalates simultaneously. CHAP heard testimony from the public, 1. Health Effects in Animals (CHAP 2014; p. 2). The CHAP also including from federal agency As staff explained in their briefing noted that, in addition to phthalates, representatives who discussed federal package, the CHAP reviewed all of the other chemicals, including certain activities on phthalates. The CHAP also potential health effects of phthalates. pesticides and preservatives, add to the invited experts to present their latest Although phthalates are associated with male reproductive effects of phthalates. research findings at the July 2010 and a number of adverse health effects, the (CHAP 2014; pp. 26–27, p. D–26; Rider subsequent meetings. Members of the CHAP considered effects on male et al. 2010). The CHAP also reviewed available public who presented testimony to the reproductive development to be the toxicity data on six phthalate CHAP at the July 2010 meeting included most relevant for human risk alternatives. (CHAP 2014; p. 22). The manufacturers of phthalates and assessment. This is, in part, because CHAP found none of the alternatives to phthalate alternatives, as well as these effects constitute the ‘‘most be antiandrogenic, that is, causing representatives of nongovernmental sensitive and most extensively studied effects consistent with the phthalate organizations. In addition to oral endpoint’’ for phthalates. (CHAP 2014; syndrome. Therefore, because these pp. 1–2, 12–13). In support of this testimony, the manufacturers and other phthalate alternatives did not contribute decision, the CHAP noted that a 2008 interested parties submitted an to the cumulative antiandrogenic effect, National Research Council (NRC) report extensive volume of toxicity and other the CHAP assessed the potential risks of also recommended using male information to the CHAP and/or the phthalate alternatives, as well as non- reproductive development effects as the CPSC staff. All submissions given to antiandrogenic phthalates, in isolation. basis for a cumulative risk assessment of CPSC staff were provided to the CHAP. These assessments were based on the phthalates. (CHAP, 2014; NRC, 2008). Although the CPSIA did not require most sensitive health endpoint 4 for The CHAP explained that exposing peer review of the CHAP’s work, at the each chemical, such as liver toxicity, for pregnant female rodents to certain CHAP’s request, four independent assessing risk. (CHAP 2014, pp. 121– phthalates causes a suite of effects on scientists peer-reviewed the draft CHAP 142). report. CPSC staff applied the same the male reproductive tract in male criteria for selecting the peer reviewers pups, known as the ‘‘phthalate 2. Health Effects in Humans as is required for the CHAP members. syndrome in rats.’’ The syndrome The CHAP noted that the phthalate Peer reviewers were nominated by the includes: malformations of the testes, syndrome in rats resembles the National Academy of Sciences. Peer prostate, and penis (hypospadias); ‘‘testicular dysgenesis syndrome’’ (TDS) reviewers did not receive compensation undescended testes; reduced anogenital in humans. (CHAP 2014, pp. 2, 28). TDS distance (AGD); and retention of includes poor semen quality, reduced from, nor did they have a substantial 3 financial interest in, any of the nipples. Male pups also have reduced fertility, testicular cancer, undescended manufacturers of the products under fertility as adults. The incidence and testes, and hypospadias.5 After consideration. In addition, the peer severity of these effects increases with reviewing all of the available studies on reviewers were not employed by the dose. In addition, the male fetus is the associations between phthalate federal government, except the National most sensitive, followed by juveniles exposure and human health (CHAP Institutes of Health, the National and adults. The phthalate syndrome 2014, pp. 27–33; Appendix C), the Toxicology Program, or the National effects are due largely to the CHAP noted that two of three studies Center for Toxicological Research. The suppression of testosterone production found an association between prenatal CHAP report was due to the (Foster 2006), as well as reduced or neonatal phthalate exposure and Commission on April 13, 2012 based on expression of the insulin-like hormone reduced anogenital distance 6 in male the requirement in section 108(b)(2)(C) 3 gene (CHAP 2014; Wilson et al. 2004; infants. Several studies also found of the CPSIA. The CHAP submitted the p. 16). Thus, the CHAP refers to these associations between prenatal or final report to the Commission on July effects as ‘‘antiandrogenic’’ to reflect neonatal exposure and neurobehavioral 18, 2014. their effect on testosterone production. effects in children. These effects Not all phthalates cause antiandrogenic included reductions in mental and C. The Proposed Rule effects; only phthalates meeting certain psychomotor development and structural criteria, termed ‘‘active’’ The Commission proposes this rule in increases in attention deficits and phthalates, are associated with the behavioral symptoms. The CHAP cited accordance with the CPSIA’s direction phthalate syndrome. (CHAP 2014; p. 16; to follow section 553 of the APA. CPSC several studies that found associations Foster et al. 1980; Gray et al. 2000). between phthalate exposure in adult staff reviewed the CHAP report and The CHAP, citing published reports, provided the Commission with a males and reduced sperm quality and noted (CHAP 2014, p.2) an additional infertility. (Reviewed in CHAP 2014, p. briefing package that assessed the CHAP reason for focusing on effects on male report and made recommendations for a C–8). reproductive development: is empirical Based on this information, the CHAP notice of proposed rulemaking (NPR). evidence demonstrates that the effects of The staff’s briefing package is available concluded that there is a growing body active phthalates on male reproductive of studies reporting associations on CPSC’s Web site at http:// development are additive (Hannas et al. www.cpsc.gov/Global/Newsroom/FOIA/ between phthalate exposure and human 2011b; 2012; Howdeshell et al. 2007; health. (CHAP 2014, p. 27). Many of the CommissionBriefingPackages/2015/ 2008). That is, exposures to multiple ProposedRule-Phthalates-112514.pdf. reported health effects are consistent phthalates at lower doses act in concert with testicular dysgenesis syndrome in As discussed in this preamble, the to produce the same effect as a higher Commission agrees with the staff’s dose of a single phthalate. The additive 4 That is, the effect occurring at the lowest dose. recommendations. 5 A malformation of the penis. 3 Nipple retention does not normally occur in 6 Distance between the anus and genitals, which 2 http://www.cpsc.gov/chap. rodents, as it does in humans. is greater in males than in females.

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humans. (CHAP 2014, p. 28). However, The second method that the CHAP Section 108(b)(2)(B)(ii) of the CPSIA the CHAP acknowledged the limitations used to assess human exposure was also directed the CHAP to ‘‘consider the of these studies, noting that the through analyzing numerous exposure potential health effects of each of [the epidemiological studies were not scenarios. The CHAP used the scenario- specified] phthalates both in isolation designed specifically to provide based method because that method and in combination with other information on sources of exposure or provides information on sources of phthalates.’’ Components of a mixture the relative contributions of different exposure. (CHAP 2014, pp. 49–60, may interact in different ways regarding phthalates. Furthermore, the studies Appendix E1). Thus, the scenario-based health risks. For example, suppose two were limited by simultaneous human method complements the information chemicals produce the same health exposure to multiple phthalates and obtained from the HBM method, which effect in animals. Furthermore, assume other environmental chemicals and by provides estimates of total exposure. that 1 mg of A affects 10 percent of the study design. (CHAP 2014, pp. 2–3). The CHAP estimated exposure from animals tested, and 1 mg of B affects 15 3. Human Phthalate Exposure individual sources using data on percent of animals. If the effects of the phthalate levels in products and mixture are ‘‘dose additive,’’ then 25 The CHAP assessed human exposure environmental media, migration rates, percent of animals would be affected. In to phthalates by two different, but and product use information. (CHAP the case of phthalates, there is evidence complementary, methods: human 2014, pp. 49–60; Appendices, E1, E3). in animal studies that the effects are biomonitoring (HBM) and exposure ‘‘dose additive.’’ (Howdeshell et al., scenario analysis. HBM relies on For most phthalates, the CHAP found that food, rather than children’s toys or 2007; Howdeshell et al., 2008; Hannas measurements of phthalate metabolites et al., 2011b; Hannas et al., 2012). In in human urine to estimate phthalate child care articles, provides the primary source of exposure to both women and other words, the whole equals the sum exposure. (CHAP 2014, pp. 34–48; of its parts. Dose additivity does not Appendix D). The HBM method children. (CHAP 2014, pp. 52–53, Table 2.1). For example, DINP exposure to necessarily apply in all cases. With provides good estimates of total other mixtures, the effects could be less exposure based on empirical infants and children is primarily from diet, although mouthing of DINP- than, or more than, dose additive. The measurements (CHAP 2014, p. 6, 75, process of performing a CRA differs in E1–38; Clark et al. 2011), but the containing toys or contact with DINP- containing toys and child care articles several respects from that of single- method does not provide information on chemical risk assessment. One key sources of exposure. The CHAP used may contribute to the overall exposure. (CHAP 2014, Figure 2.1, page 59; Table difference is the choice of health two data sources for HBM—each will be endpoint. Risk assessments for described in turn. The National Human E1–23, page E1–32; and Table E1–24, chemicals in isolation are usually based Health and Nutrition Survey (NHANES), page E1–36). The CHAP also found that on the most sensitive health effect. The which is conducted by the U.S. personal care products (cosmetics) are a most sensitive endpoint is the one that Department of Health and Human major source of exposure to diethyl is observed at the lowest dose or has the Services, periodically measures phthalate (DEP) and dibutyl phthalate greatest risk at a given dose. CRAs are phthalates and other chemicals in (DBP) (id.). Indoor air and household generally based on a health effect that is human urine and blood in a statistically dust are also major sources of diethyl common to the components of the representative sample of thousands of phthalate (DEP), dibutyl phthalate mixture. The common health endpoint U.S. residents. The CHAP used data (DBP), and butyl benzyl phthalate (BBP) is not necessarily the most sensitive from NHANES to estimate daily (id.). health endpoint for each of the mixture exposures to various phthalates in 4. Risk pregnant women and women of components. reproductive age. (CDC 2012). NHANES a. Cumulative Risk Assessment b. Cumulative Risk and Risk in does not measure phthalate metabolites Generally Isolation—Hazard Index in children younger than 6 years old. Section 108(b)(2)(B)(iv) of the CPSIA Therefore, the CHAP used As required by section 108(b)(2)(B)(ii) directed the CHAP specifically to measurements from an NIH- and EPA- of the CPSIA, the CHAP assessed the ‘‘consider the cumulative effect of total funded study of mother-child pairs, the potential risks from phthalates in exposure to phthalates, both from Study for Future Families (SFF), to isolation and in combination with other obtain exposure estimates for infants. children’s products and from other phthalates, that is, cumulative risk. The (Sathyanarayana et al. 2008a; 2008b). sources.’’ CHAP chose antiandrogenic effects on The SFF study also provided additional Cumulative risk assessment (CRA) male reproductive development as the data for the mothers, both before and generally refers to the combined effects focus of the CHAP’s cumulative risk after they gave birth. of multiple environmental stressors. assessment. Only antiandrogenic (i.e., The CHAP also found, based on the (Sexton and Hattis, 2007). CRA may active) phthalates cause male HBM studies, that ‘‘exposure to combine different types of hazards, such reproductive developmental effects and, phthalates in the United States (as as air pollution combined with therefore, only active phthalates worldwide) is omnipresent.’’ (CHAP psychological stress. More commonly, contribute to the cumulative risk of 2014, p. 37). Virtually all Americans are CRA includes mixtures of different male developmental reproductive exposed simultaneously to multiple chemicals. Chemical mixtures may be effects. (CHAP 2014, pp. 61–70). The phthalates. (CHAP 2014, p. 37). Based complex mixtures, such as air pollution CHAP applied the hazard index (HI) on NHANES data, pregnant women or combustion emissions. Mixtures may approach to assess the cumulative risk have median exposures that are roughly include unrelated chemicals or, in the for antiandrogenic effects in males. The similar to those of women of case of phthalates, a family of closely HI approach is widely used for chemical reproductive age. (CHAP 2014, Table related chemicals. Human exposure to mixtures and other cumulative risk 2.7, page 45). Based on the SFF data, phthalates is a ‘‘coincidental’’ exposure, assessments. (Kortenkamp and Faust infants have threefold to fourfold greater meaning that different individuals are 2010; NRC 2008; Teuschler and median exposures than their mothers. exposed to phthalates in different Hertzberg 1995). Calculating the HI is a (CHAP 2014, Table 2.7, p. 45). proportions. two-step process:

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1. Calculate the ‘‘hazard quotient’’ (PEAA).7 The PEAA is an estimate of for a given phthalate, there may be a (HQ) for each phthalate. The HQ is the the level of exposure at which the risk concern for antiandrogenic effects in the exposure divided by the ‘‘potency of antiandrogenic effects is considered exposed population due to the effect of estimate for antiandrogenicity’’ negligible. If the HQ is greater than one an individual phthalate.

2. The hazard index (HI) is the sum than one, there may be a concern for population due to the cumulative effects of the hazard quotients (HQs) for the antiandrogenic effects in the exposed of phthalates.8 phthalates of interest. If the HI is greater

The CHAP calculated the HI for each Results for the three sets of PEAAs for adverse effects from the cumulative individual in two populations of were roughly similar; HIs were within 2- effects of phthalates in individuals with interest: (1) Pregnant women, and (2) fold, although HIs were slightly lower a hazard index greater than one, children up to 36 months old. Pregnant for Case 3. (CHAP 2014, p. 65). representing up to 10 percent of women represent exposure to the fetus, Using NHANES data, the CHAP found pregnant women and up to 5 percent of which is considered more sensitive than that pregnant women had median HIs of infants. (CHAP 2014, p. 65). newborns, children, and adults. about 0.1 (0.09 to 0.14), while the 95th Looking at the HQs for individual The CHAP used three sets of PEAAs percentile HIs were about 5, depending phthalates, the CHAP concluded: that were derived by different on which set of PEAAs was used. ‘‘Clearly, the hazard quotient for DEHP approaches. (CHAP 2014, p. 62, 64; Roughly 10 percent of pregnant women dominates the calculation of the HI, as Table 2.15). This was done to assess the had HIs greater than one. (CHAP 2014, expected, with high exposure levels and effect of using different PEAAs on the Table 2.16). one of the lowest PEAAs.’’ (CHAP 2014, overall conclusions. The CHAP report Using SFF data, the CHAP found that p. 65). Thus, DEHP (which the CPSIA refers to these as cases 1, 2, and 3: the mothers had median HIs about 0.1 permanently prohibits from use in • Case 1: Published values used from (0.06 to 0.11), while the 95th percentiles children’s toys and child care articles) a cumulative risk assessment for were less than one (0.33 to 0.73). (CHAP contributes the most to the cumulative phthalates (Kortenkamp and Faust 2014, Table 2.16). There was little risk. (CHAP 2014, Table 2.16). This is 2010); difference between pre- and post-natal due to a combination of exposure and • Case 2: Values derived by the CHAP exposures. The CHAP report shows that potency. (CHAP 2014, p. 65). The CHAP based on relative potency comparisons up to 5 percent of women had HIs found that the median HQs for DEHP across chemicals from the same study greater than one. For infants, HIs were range from 0.1 to 0.2, with 95th (Hannas et al. 2011b); and about twofold greater than their percentiles up to 12. DEHP contributed • Case 3: Values from the CHAP’s de mothers. Infants had median HIs about between 50 (case 2) and 90 percent (case novo literature review of reproductive 0.2, while the 95th percentiles were 1) of the median HI in pregnant women and developmental endpoints based on between 0.5 and 1.0. About 5 percent of (summarized in Table 1). For the no observed adverse effect levels infants had HIs greater than one. comparison, DBP, BBP, and DINP each (NOAEL) in Table 2.1 of the CHAP Based on these results, the CHAP contributed up to 8 percent of the HI in report. concluded that there may be a concern pregnant women (Table 1).

TABLE 1—PERCENT CONTRIBUTION OF INDIVIDUAL PHTHALATES TO THE CUMULATIVE RISK a

Case 1 Case 2 Case 3

NHANES Pregnant Women: Diisobutyl phthalate, DIBP ...... 0.7 2.3 <1.1 Dibutyl phthalate, DBP ...... 7.1 7.7 1.1 Butyl benzyl phthalate, BBP ...... 0.7 7.7 1.1 Di(2-ethylhexyl) phthalate, DEHP ...... 85.7 53.8 77.8 Diisononyl phthalate, DINP ...... 0.7 7.7 2.2 SFF Infants: Diisobutyl phthalate, DIBP ...... 0.9 5.0 <0.8 Dibutyl phthalate, DBP ...... 9.1 15.0 2.5 Butyl benzyl phthalate, BBP ...... 18.2 10.0 2.5 Di(2-ethylhexyl) phthalate, DEHP ...... 81.8 55.0 91.7 Diisononyl phthalate, DINP ...... 0.9 15.0 8.3 a Calculated from data in CHAP, 2014, Table 2.16. Based on median exposures.

7 The PEAA is essentially similar to a ‘‘reference health effect of a given chemical. RfD and ADI are 8 Having a HI greater than one does not dose’’ (RfD) or ‘‘acceptable daily intake’’ (ADI), estimates of a dose at which one could be exposed necessarily mean that adverse effects will occur; which are commonly used terms, except that the to for up a lifetime with a negligible risk of adverse however, this possibility cannot be ruled out. PEAA applies only to antiandrogenic effects. The effects. RfD and ADI generally apply to the most sensitive

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In infants, DEHP also contributed the health effect is liver toxicity. (CHAP in addition to mouthing by children. most to the cumulative risk. DEHP 2014, pp. 94, 104). MoEs for DIDP range (Id.). contributed between 50 and 90 percent from 300 (modeling using conservative The CHAP found that, among the of the median HI (Table 1). However, assumptions) to 10,000 (biomonitoring). permanently banned phthalates, DBP the relative contributions of other (CHAP 2014, pp. 24, 104). DNOP was and BBP had MoEs of 5,000 or more. phthalates were somewhat greater in largely not detectable in biomonitoring (CHAP 2014, pp. 82–88). For DEHP, infants than in pregnant women. DINP studies; MoEs based on modeling (with MoEs ranged from 30 to 3,000. (CHAP contributed between 1 percent (case 1) conservative assumptions) are 1,800 or 2014, p. 91). The 95th percentile and 15 percent (case 2) of the median more. (CHAP 2014, pp. 24, 95). Because exposure to pregnant women had a MoE HI. DBP and BBP contributed between the MoEs in humans are likely to be of 30, which is less than the minimum 2 percent and 18 percent of the HI. very high, and thus adequate to protect value of 100, based on biomonitoring. (Table 1). public health, the CHAP did not find The 95th percentile exposure in infants According to the CHAP, these results compelling data to justify maintaining had a MoE of 100, based on modeling indicate that DEHP contributed between the current interim bans on the use of and 170 for biomonitoring. (Id.). Thus, 50 and 90 percent of the cumulative risk DNOP and DIDP in children’s toys and the CHAP found that some highly from exposure to antiandrogenic child care articles. The CHAP exposed pregnant women, more than 5 phthalates. The HQs of DBP, BBP, and recommended that the interim percent of the population, had DEHP DINP were similar. (CHAP 2014, p. 65). prohibitions on DNOP and DIDP be exposures that may present a concern DINP contributed between 1 percent lifted. (CHAP 2014, pp. 95, 104). for adverse health effects. (Id., p. 65). and 15 percent of the cumulative risk. In addition to noting DINP’s Furthermore, the CHAP noted that (Table 1). antiandrogenic characteristics, the DEHP contributes more than half of the Furthermore, the CHAP noted that CHAP also stated that DINP is cumulative risk from phthalates. (Table consumers are exposed to other types of associated with liver toxicity. (CHAP 1; CHAP 2014, p. 65). 9 chemicals, such as parabens and 2014, pp. 95–99). Furthermore, liver certain pesticides that also add to the B. The CHAP’s Recommendations to the toxicity is the most sensitive health Commission total risk of antiandrogenic effects. effect for DINP. Thus, to assess the (CHAP 2014, p. D–26). These additional adverse effects of DINP in isolation, the 1. Recommendations on Phthalates chemicals may increase the risk slightly CHAP considered liver toxicity to Permanently Prohibited by the CPSIA or, as a worst case, double the calculate MoEs. The CHAP stated: The CHAP did not recommend any percentage of pregnant women with an ‘‘Using the NOAEL of 15 mg/kg-d for Commission action on DBP, BBP, or HI greater than one. (Id.). The CHAP did systemic toxicity [liver toxicity], the DEHP because these phthalates are not have data to estimate the effects of MoE for infants ranged from 830 to already permanently prohibited by the the additional chemicals in infants. 4,200. The MoE for women ranged from CPSIA. (CHAP 2014, pp. 83–91). (Id.). 1,600 to 15,000. MoEs exceeding 100– However, the CHAP recommended that c. Risks in Isolation—Margin of 1000 are considered adequate for public U.S. agencies responsible for DBP, BBP, Exposure health.’’ (CHAP 2014, p. 99). Despite and DEHP exposures from all sources high MoEs associated with DINP, the As required by section 108(b)(2)(B)(ii) conduct the necessary risk assessments CHAP nevertheless recommended a of the CPSIA, the CHAP also considered with a view to supporting risk permanent ban on DINP in children’s the risks of phthalates and phthalate management steps. (CHAP 2014, pp. 83– toys and child care articles, concluding alternatives in isolation. Risks in 91). that: ‘‘DINP does induce antiandrogenic isolation are of particular importance for effects in animals, although at levels 2. Recommendations on Phthalates the phthalate alternatives and the non- below that for other active phthalates, Prohibited by the CPSIA on an Interim antiandrogenic phthalates. The CHAP and therefore can contribute to the Basis did not include these compounds in the cumulative risk from other a. Diisononyl Phthalate (DINP) cumulative risk assessment because antiandrogenic phthalates.’’ they are not antiandrogenic, and The CHAP recommended that DINP at therefore, do not contribute to the Exposure data on many of the levels greater than 0.1 percent should be cumulative risk for male reproductive nonregulated phthalates are limited. permanently prohibited from use in developmental effects. The CHAP used Considered in isolation, MoEs for DIBP children’s toys and child care articles. a margin of exposure (MoE) approach to were 40,000 or more. (CHAP 2014, p. (CHAP 2014, pp. 95–99). Although assess the risks in isolation. (CHAP 111). However, DIBP contributes to the DINP is less potent than DEHP, or other 2014, p. 4). The MoE is the ‘‘no cumulative risk, due to its active phthalates, the CHAP reasoned observed adverse effect level’’ (NOAEL) antiandrogencity. that DINP is antiandrogenic and of the most sensitive endpoint in animal The CHAP noted that exposure data contributes to the cumulative risk from studies divided by the estimated on phthalate alternatives are also phthalates. (Id.). limited. Estimates of mouthing exposure exposure in humans. Higher MoEs b. Di-n-octyl Phthalate (DNOP) indicate lower risks. Generally, MoEs to children up to 3 years old are greater than 100 to 1,000 are adequate available for TPIB, DEHT, ATBC, and The CHAP concluded: ‘‘DNOP does to protect public health. (CHAP 2014, p. DINX. MoEs for mouthing exposure for not appear to possess antiandrogenic 20). TPIB, DEHT, ATBC, and DINX are potential; nonetheless, the CHAP is DIDP and DNOP are subject to the greater than 5,000. (CHAP 2014, pp. aware that DNOP is a potential interim prohibition on phthalates under 121–142). However, DEHT, ATBC, developmental toxicant, causing section 108 of the CPSIA. The CHAP TOTM, and DEHA are high production supernumerary ribs, and a potential concluded that they are not volume chemicals. (Id.). TPIB, DEHA, systemic toxicant, causing adverse antiandrogenic; their most sensitive DEHT, ATBC, and TOTM are used in effects on the liver, thyroid, immune many types of products found in the system, and kidney. However, because 9 Parabens are antimicrobials commonly used in home. Thus, as the CHAP noted, human the MoE in humans is likely to be very cosmetics. exposure may occur from other sources, high, the CHAP does not find

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compelling data to justify maintaining that DIOP is within the range of the III. CPSC Staff’s Assessment of the the current interim ban on the use of structure-activity characteristics CHAP Report DNOP in children’s toys and child care associated with antiandrogenic CPSC staff assessed the CHAP report, articles. Therefore, the CHAP activity.’’ (CHAP 2014, pp. 118–119). examining whether the CHAP met the recommends that the current ban on The CHAP did not recommend to requirements of the CHAP’s charge and DNOP be lifted.’’ (CHAP 2014, p. 95). CPSC any action on the use of di(2- whether the CHAP report was otherwise c. Diisodecyl Phthalate (DIDP) propyl) heptyl phthalate (DPHP) in toys scientifically sound in its methodology, The CHAP concluded: ‘‘DIDP does not and child care articles, at this time. findings and recommendations. (CHAP 2014, pp. 120–121). However, appear to possess antiandrogenic A. Charge to the CHAP potential; nonetheless, the CHAP is the CHAP recommended that Section 108(b)(2)(B) of the CPSIA aware that DIDP is a potential appropriate federal agencies obtain required the CHAP to ‘‘. . . complete an developmental toxicant, causing toxicity and exposure data for DPHP. examination of the full range of supernumerary ribs, and a potential The CHAP noted that most of the systemic toxicant, causing adverse toxicity data are unpublished and were phthalates that are used in products for effects on the liver and kidney. not available to the CHAP. DPHP does children. . . .’’ To meet its charge, the However, because DIDP is not not appear to be antiandrogenic, based CHAP reviewed all of the available considered in a cumulative risk with on limited information. However, the toxicity data on 14 phthalates. The 14 other antiandrogens, its MoE in humans CHAP noted: ‘‘Currently, there is an phthalates included the six phthalates is considered likely to be relatively undetermined frequency and duration set forth in the CPSIA and eight high. The CHAP did not find of exposures; however, analytical additional phthalates selected on the compelling data to justify maintaining methods cannot differentiate DPHP basis of toxicity (i.e., male the current interim ban on the use of metabolites from DIDP metabolites developmental reproductive effects) and DIDP in children’s toys and child care because they are closely related.’’ The exposure potential (e.g., availability of articles. Therefore, the CHAP CHAP noted further that production human biomonitoring data). The CPSIA recommends that the current ban on levels of DPHP have increased in recent also required the CHAP to consider the following: DIDP be lifted . . .’’ (CHAP 2014, pp. years, suggesting that human exposure • 100–105). may also be increasing. (Id., p. 120). ‘‘Examine all of the potential health effects (including endocrine disrupting 3. Recommendations on Phthalates Not The CHAP did not recommend effects) of the full range of phthalates.’’ Currently Prohibited by the CPSIA Commission action on dimethyl The CHAP examined all of the health phthalate (DMP) (CHAP 2014, pp. 105– The CHAP recommended that the effects associated with phthalates, Commission permanently prohibit the 107) or diethyl phthalate (DEP). (Id., pp. including carcinogenicity, liver toxicity, use of the following phthalates at levels 107–109). However, the CHAP and reproductive/developmental greater than 0.1 percent in children’s recommended that the U.S. federal toxicity. (CHAP 2014, pp. 13–29; toys and child care articles: diisobutyl agencies responsible for DEP exposures Appendices A–C). As discussed in phthalate (DIBP) (CHAP 2014, pp. 110– from food, pharmaceuticals, and detail below, the CHAP conducted its 112), di-n-pentyl phthalate (DPENP) personal care products perform the cumulative risk assessment based on (id., pp. 112–113), di-n-hexyl phthalate necessary risk assessments with a view male developmental reproductive (DHEXP) (id., pp. 114–116), and to supporting risk management steps. effects. The phthalate syndrome is due dicyclohexyl phthalate (DCHP) (id., pp. (Id., p. 109). largely to the inhibition of testosterone 116–118). These are antiandrogenic 4. Recommendations on Phthalate production in the male fetus, which is phthalates that adversely affect male Alternatives a type of endocrine disruption. The reproduction development. The CHAP CHAP’s cumulative risk assessment noted that current exposures to DIBP, The CHAP found that data on the six focused on male developmental DPENP, DHEXP, and DCHP are low and, phthalate alternatives reviewed by the reproductive effects. (CHAP 2014, pp. therefore, ‘‘. . . do not indicate a high CHAP are generally limited. (CHAP 69–70). level of concern.’’ (CHAP 2014, p. 8). 2014, pp. 121–142). The CHAP noted • ‘‘Consider the potential health However, because they are active that CPSC staff has found four of the effects of each of these phthalates both phthalates, they contribute to the alternatives—acetyl tributyl citrate in isolation and in combination with cumulative risk from other (ATBC); di(2-ethylhexyl) terephthalate other phthalates.’’ To assess the antiandrogenic phthalates. Allowing (DEHT); 1,2-cyclohexanedicarboxylic potential health effects of phthalates in their use in toys and child care articles acid, diisononyl ester (DINX); and 2,2,4- isolation, the CHAP used the MoE based would increase the cumulative risk to trimethyl-1,3 pentanediol diisobutyrate on the most sensitive endpoint for each children. The CHAP also noted that (TPIB)—in many children’s toys and phthalate. (CHAP 2014, pp. 69–70). To DPENP is the most potent child-care articles. (Dreyfus 2010). Two assess the potential health effects of antiandrogenic phthalate. (CHAP 2014, of the alternatives—di(2-ethylhexyl) phthalates in combination, the CHAP pp. 112–113). adipate (DEHA) and tris(2-ethylhexyl) conducted a cumulative risk In addition, the CHAP recommended trimellitate (TOTM)—have not been assessment, based on male that the Commission prohibit the use of identified by CPSC staff in toys or child developmental reproductive effects. diisooctyl phthalate (DIOP) on an care articles, thus far. (Dreyfus, 2010). (Id.). interim basis at levels greater than 0.1 For all of the phthalate alternatives, the • ‘‘Examine the likely levels of percent until sufficient data are CHAP recommended obtaining children’s, pregnant women’s, and available. (CHAP 2014, pp. 118–119). additional data on exposure from all others’ exposure to phthalates, based on DIOP has been detected, although sources because many of the alternatives a reasonable estimation of normal and rarely, in child care products. (Chen have multiple uses. The CHAP also foreseeable use and abuse of such 1998). Although toxicity data on DIOP recommended obtaining additional products.’’ The CHAP assessed exposure are limited, the CHAP concluded, ‘‘. . . toxicity data on TPIB, ATBC, DINX, and by two complementary methods. the isomeric structure of DIOP suggests TOTM. Biomonitoring studies provide good

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estimates of total exposure to phthalates dermal, inhalation, and hand-to-mouth. and prohibit DIOP on an interim basis but do not provide information on the (CHAP 2014, pp. 49–60; Appendices (id., pp. 118–119). sources of exposure. (CHAP 2014, pp. E1–E3). The staff concluded that the CHAP 34–48). The scenario-based approach • ‘‘Consider the level at which there fully met the charge in section 108 of estimates exposure to specific products is a reasonable certainty of no harm to the CPSIA. and sources of exposure, including toys, children, pregnant women, or other B. Selection of Phthalates and child care articles, and personal care susceptible individuals and their Phthalates Alternatives products. (CHAP 2014, pp. 49–60; offspring, considering the best available Appendices E1–E3). science, and using sufficient safety The CHAP selected phthalates for • ‘‘Consider the cumulative effect of factors to account for uncertainties inclusion in its examination based on total exposure to phthalates, both from regarding exposure and susceptibility of the following non-exclusive criteria: children’s products and from other children, pregnant women, and other inclusion in the CPSIA, availability of sources, such as personal care potentially susceptible individuals.’’ For human biomonitoring data, potential for products.’’ The CHAP conducted a antiandrogenic phthalates, the CHAP exposure, and evidence of male cumulative risk assessment, based on derived reference doses (PEAAs) that developmental reproductive toxicity. total phthalate exposure, as estimated (CHAP, 2014, pp. 22–23): were specific for male developmental • from biomonitoring studies. (CHAP reproductive effects. (CHAP 2014, Table Six phthalates subject to the 2014; pp. 61–68; Appendix D). 2.15). For non-antiandrogenic CPSIA—DBP, BBP, DEHP, DNOP, DINP, • ‘‘Review all relevant data, including and DIDP; phthalates and phthalate alternatives, • the most recent, best-available, peer- the CHAP selected appropriate NOAELs Availability of biomonitoring data— reviewed, scientific studies of these that were based on the most sensitive DMP, DEP, DIBP, in addition to the six phthalates and phthalate alternatives endpoint. (Id., pp. 79–142, Appendices phthalates subject to the CPSIA; • Increasing production, which that employ objective data collection A–B). The CHAP also recommended the suggests increasing exposure—DPHP; practices or employ other objective use of additional uncertainty factors and methods.’’ The CHAP reviewed all of (safety factors) for selected compounds the available data on phthalates, • Ability to induce male where the database was limited (ATBC developmental reproductive effects— including publications in peer-reviewed and DEHA). scientific journals; reports submitted by DIBP, DPENP, DHEXP, and DCHP. (Id., • ‘‘Consider possible similar health manufacturers to the U.S. EPA; 10 and p. 16). effects of phthalate alternatives used in authoritative reviews from agencies The CPSC staff concurs with the children’s toys and child care articles.’’ such as the Agency for Toxic Substances CHAP’s selection of phthalates because The CHAP considered all health effects and Disease Registry (ATSDR), the the 14 phthalates that the CHAP European Chemical Agency (ECHA), the associated with six phthalate reviewed include phthalates with high International Agency for Research on alternatives and, where sufficient data exposure potential and phthalates that Cancer (IARC), Center for the Evaluation were available, estimated the potential contribute to the cumulative risk for of Research on Human Reproduction health risks based on the most sensitive male developmental reproductive (CERHR), National Toxicology Program health endpoint. (CHAP, 2014, pp. 121– effects. (NTP); and the National Research 142, Appendices A–B). The CHAP selected six phthalate Council (NRC). (CHAP, 2014, p. 12). In Furthermore, section 108(b)(2)(B) alternatives for study, either because addition, the CHAP invited scientific required the CHAP to perform its they were known to be used in experts to present their latest research in examination de novo. ‘‘The findings and children’s toys and child care articles areas such as biomonitoring, conclusions of any previous Chronic (ATBC, DEHT, DINX, TPIB) (Dreyfus epidemiology, phthalate syndrome, Hazard Advisory Panel on this issue and 2010) or because they were considered toxicology of phthalates mixtures, other studies conducted by the likely to be used (DEHA, TOTM) phthalates mode of action, and species Commission shall be reviewed by the (CHAP, 2014; p. 23; Versar/SRC, 2010a). differences. The CHAP also invited a co- panel but shall not be considered CPSC staff recognizes that there is a author of an NRC report (NRC, 2009) to determinative.’’ Although the CHAP broad range of potential phthalate present the NRC panel’s perspective on considered previous CHAP reports and alternatives (Versar/SRC, 2010a), risk assessment methodology, especially CPSC staff reports, the CHAP also including phthalates that are not as applied to phthalates risk assessment. conducted its own review of the prohibited by the CPSIA. Nonetheless, Furthermore, the CHAP heard testimony scientific literature (including studies CPSC staff agrees with the CHAP’s from federal agency scientists, as well as conducted by phthalate manufacturers) choice of phthalate alternatives because scientists representing manufacturers of and invited experts to present their most it includes all of the non-phthalate phthalates alternatives. recent research. (CHAP, 2014, p. 12). plasticizers known to be used in toys • ‘‘Consider the health effects of Finally, section 108(b)(2)(C) required and child care articles (Dreyfus 2010; phthalates not only from ingestion but the CHAP to ‘‘make recommendations to TAB B), as well as other commonly used also as a result of dermal, hand-to- the Commission regarding any plasticizers. After the CHAP completed mouth, or other exposures.’’ The CHAP phthalates (or combinations of its report, CPSC staff identified DPHP in estimated phthalate exposure by two phthalates) in addition to those children’s toys; DPHP is an emerging methods. Biomonitoring studies identified in subsection (a) or phthalate phthalate that was included in the estimated total exposure, regardless of alternatives that the panel determines CHAP report. should be declared banned hazardous source or route of exposure. (CHAP C. Selection of Health Endpoint 2014, pp. 34–48). The scenario-based substances.’’ The CHAP completed its approach estimated exposure to specific charge by making recommendations to After reviewing all of the available products and sources of exposure by all prohibit additional phthalates (id., pp. toxicity data on 14 phthalates, the routes of exposure, including oral, 110–117), make the interim prohibition CHAP selected male developmental of DINP permanent (id., pp. 95–99), lift reproductive toxicity as the critical 10 For example, toxicity data submitted under the interim prohibitions of DNOP (id., endpoint for its cumulative risk § 8(e) of the Toxic Substances Control Act. pp. 91–94) and DIDP (id., pp. 100–104), assessment. (CHAP 2014, pp. 13). CPSC

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staff supports the selection of male ‘‘sufficient evidence’’ in animal studies. Research Council (NRC, 2008) developmental reproductive toxicity for (CPSC, 1992). recommended this approach for several reasons. Male developmental Other authors also have selected male phthalates cumulative risk assessment. reproductive effects in animals are developmental reproductive effects as Two other publications on phthalates’ associated with many of the most the basis of cumulative risk assessments cumulative risk also used the HI common phthalates. For most of the of phthalates. The U.S. Environmental approach. (Benson, 2009; Christensen et active phthalates, these effects are the Protection Agency (EPA) convened a al., 2014). ExxonMobil scientists 11 also most sensitive health effect; that is, National Research Council (NRC) recommended the HI approach to CPSC these effects are observed at lower doses committee to consider approaches to in 2010, before the CHAP met for the than other adverse health effects (see assessing the cumulative risk of first time. CPSC staff and contractor reports at phthalates; the committee The CHAP found that up to 10 http://www.cpsc.gov/chap). Male recommended using male percent of pregnant women and up to 5 developmental reproductive effects developmental reproductive effects as percent of infants, those with the (phthalate syndrome) are of particular the basis for a cumulative risk highest exposure, have a HI greater than concern because they may adversely assessment. (NRC, 2008). Additionally, one. The portion of the population with affect human reproduction. two subsequent publications conducted a HI greater than one may be at risk for Furthermore, the phthalate syndrome in cumulative risk assessments based on the adverse effects of phthalates. (EPA, animals bears a striking resemblance to male developmental reproductive 1993). This does not necessarily mean the testicular dysgenesis syndrome in effects. (Benson, 2009; Christensen et that anyone will suffer adverse effects; humans. (Skakkebaek et al., 2001). al., 2014). however, one cannot rule out the The availability of empirical evidence CPSC staff recognizes that a number possibility of adverse effects. The also supports the choice to base the of other health effects are associated greater the HI, the greater the risk. cumulative risk assessment on male with phthalates. (Reviewed in Babich, Although the HI approach is widely developmental reproductive effects 2010). Although some phthalates are accepted, the CHAP introduced a novel because such evidence eliminates the associated with cancer, cancer is only process to calculate the HI. The CHAP need to make critical assumptions that associated with a relatively small calculated hazard quotients (HQ) and a might not be borne out. Specifically, number of phthalates, and many of the HI for each individual in the population empirical evidence demonstrates that cancers induced by phthalates are of of interest (i.e., pregnant women or mixtures of active phthalates interact in uncertain relevance to humans. (CHAP, infants), and then derived distributions a dose-additive fashion with respect to 2001; CPSC, 2002; Klaunig et al., 2003). of the HI. This was necessary because developmental male reproductive Other effects, such as liver toxicity, are each individual is exposed to phthalates effects. (Howdeshell et al., 2007, 2008; common to most phthalates; but there in differing proportions. For example, Hannas et al., 2011b, 2012). Thus, it was are little or no data available on mode some individuals may be exposed not necessary for the CHAP to make any of action or the effects of mixtures. almost exclusively to a single phthalate, assumptions regarding the effects of Thus, there is less scientific basis for while others may be exposed to several phthalate mixtures. Most other health performing a cumulative risk phthalates in roughly equal proportion. effects of phthalates have not been assessment with liver toxicity as the After calculating the HQs and HIs for all studied with mixtures; performing a critical endpoint. individuals, the CHAP then generated cumulative risk assessment on any other Finally, a growing number of frequency distributions for the HI. This endpoint would require assumptions epidemiological studies have reported process allowed the CHAP to estimate regarding the mode of action and associations of phthalate exposure with the average and 95th percentile of the possible mixture effects. adverse health effects in humans. (As HI, as well as the portion of the population with a HI greater than one. Furthermore, the male developmental cited in CHAP 2014, pp. 27–33, The alternative to the CHAP’s reproductive effects of phthalates are Appendix C). Many of these adverse approach would be to calculate hazard well-studied. (Reviewed in Foster, health effects are consistent with the quotients using summary data on 2006). These effects, which were first effects in animal studies. The staff metabolite levels, that is, median and reported in 1980 (Foster et al., 1980), concludes that the epidemiological 95th percentile levels (e.g., Benson, persist into adulthood, even in the studies, though not conclusive on their 2009). This would have allowed the absence of further exposure (Barlow and own, provide supporting evidence that CHAP to estimate median and 95th Foster, 2003; Barlow et al., 2004; the animal studies are relevant to percentile hazard quotients for each McIntyre et al., 2001). Similar effects humans. phthalate. Under this approach, the have been reported in multiple Therefore, CPSC staff supports using median hazard quotients are summed to mammalian species, including guinea male developmental reproductive calculate the average HI, which would pigs (Gray et al., 1982), mice, (Gray et effects as the basis for the CHAP’s be roughly similar to the median hazard al., 1982; Moody et al., 2013; Ward et cumulative risk assessment due to the quotient calculated as above. However, al., 1998), rabbits (Higuchi et al., 2003), importance of the endpoint; the summing the 95th percentile values and ferrets (Lake et al., 1976). Hamsters abundance of data, the known additive would overestimate the 95th percentile were resistant due to slow metabolism nature of phthalate mixtures regarding HI. Therefore, the CHAP introduced this of the phthalate ester to the monoester, male developmental reproductive novel process to calculate the hazard which is believed to be the active effects, and NRC’s recommendation. quotients and HI more accurately, metabolite. Hamsters responded to the D. Methodology especially at the upper-bound (e.g., 95th monoester, however. (Gray et al., 1982). percentile) exposures. Had the CHAP The observation of similar effects in 1. Hazard Index not applied this novel approach, the multiple species demonstrates that these The CHAP chose the hazard index result would have been an overestimate effects are not unique to rats. Based on (HI) approach for its cumulative risk assessment because that index is widely the CPSC chronic hazard guidelines, the 11 ‘‘Approach to Cumulative Risk,’’ presented to CPSC staff regards active phthalates as accepted for this purpose. (Teuschler the CPSC staff, March 2010. http://www.cpsc.gov/ ‘‘probably toxic to humans,’’ based on and Hertzberg, 1995). The National PageFiles/125812/CummRiskExxon03232010.pdf.

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of the 95th percentile exposures and the the CHAP’s use of these approaches to pigs (Gray et al., 1982), mice, (Gray et percentage of pregnant women and assess exposure for the reasons al., 1982; Moody et al., 2013; Ward et infants with HI greater than one. explained below. al., 1998), rabbits (Higuchi et al., 2003), The CHAP used exposure estimates and ferrets (Lake et al., 1976) (Lake et 2. Margin of Exposure from biomonitoring data as the basis for al. 1976). Hamsters were resistant to The CHAP chose the margin of its cumulative risk assessment. CPSC male developmental reproductive exposure (MoE) approach to assess staff considers biomonitoring to provide effects due to slow metabolism of the potential health risks for phthalates and the best available estimates of total phthalate ester to the monoester, which phthalate alternatives in isolation. The exposure because biomonitoring is is believed to be the active metabolite. CHAP chose this approach, in part, due based on empirical measurements in Hamsters responded to the monoester, to the recommendation of a NRC report individuals. Furthermore, the NHANES however. (Gray et al. 1982). The on risk assessment methodology (NRC, study is a large statistically observation of similar effects in multiple 2009). Like the HI approach, the MoE is representative sample. In contrast, the species demonstrates that these effects also widely accepted. (Id.). alternative approach, scenario-based are not unique to rats. This is not The MoE is the ratio of the no estimates, are subject to a number of surprising because male reproductive observed adverse effect level (NOAEL) assumptions and uncertainties. (CHAP, development is essentially similar in all to the estimated exposure. Generally, a 2014, Appendix E). The method for mammalian species (NRC, 2008). MoE of 100 to 1,000 is needed to protect estimating exposure from biomonitoring In contrast to these findings, a single public health (EPA, 1993). The data has been in use since 2000 and was study in marmosets that exposed minimum value of the MoE depends on developed by an industry scientist. pregnant females to DBP did not lead to the compound. If a NOAEL has been (David, 2000). The CHAP devoted any adverse effects in male offspring established in animal (rather than considerable effort to discussing (McKinnell et al., 2009). However, as human) studies, a MoE of 100 or greater potential errors and bias in this with most primate studies, this study is sufficient to protect public health methodology, having invited two was limited by small numbers. (CPSC, 1992). If a NOAEL has not been experts (Stahlhut and Lorber) to address Similarly, in two recent studies in established, and a LOAEL (lowest this issue at the December 2010 which fetal rat and mouse testes, or fetal observed adverse effect level) is used meeting. As discussed in the CHAP human testicular tissue, were instead, or if the available toxicity data report, any errors in this methodology transplanted into laboratory animals for the chemical of interest is are relatively small and are unbiased and exposed to phthalates (Heger et al., inadequate, then a MoE of 1,000 may be (CHAP 2014, pp. 73–75). ‘‘Unbiased’’ 2012; Mitchell et al., 2012), only the rat required. Based on the knowledge that means that any errors are equally likely testes responded to the phthalates. adequate animal data are available and to lead to overestimation or However, the human fetal tissue was NOAELS have been established for most underestimation of risk. generally past 14 weeks of gestation, of the phthalates, staff believes, The staff notes that the CHAP used which is outside the window of consistent with the CHAP report, that a the latest data available at the time the maximum sensitivity. Nevertheless, MoE of 100 is sufficient for most of the CHAP performed its analysis. Phthalate given the potential significance of these compounds in the CHAP report. The exposures in the U.S. population, as studies, the CHAP invited the principal CHAP recommended an additional measured by biomonitoring, have investigators of both studies uncertainty factor for the phthalate remained essentially constant for about (Boekelheide and Sharpe) to present alternatives ATBC and DEHA. Staff a 10-year period. (CDC, 2012; EPA, their findings at the November 2011 concurs that an additional uncertainty 2013). However, the most recent report CHAP meeting. Both of these scientists factor for ATBC and DEHA is from CDC shows that phthalate stated that their studies were very appropriate because of limitations in the exposures are beginning to change as preliminary and that it would be available toxicity data. one might expect, as products are premature to use their results to support The MoE approach is conceptually reformulated in light of concerns about public health decisions. similar to the CPSC staff’s default phthalate toxicity. (CDC, 2013). The Finally, a growing number of approach for assessing non-cancer risks CDC report shows that exposure to DBP, epidemiological studies have reported (CPSC, 1992) and would lead to similar BBP, and DEHP is declining, while associations of phthalate exposure with conclusions about risk. CPSC staff exposures to DINP and DIBP are adverse health effects in humans. approves of the CHAP’s selection of the increasing. The decline in DEHP (CHAP 2014, pp. 27–33). Many of these MoE approach to assess the risks of exposure may be due, in part, to effects are consistent with male phthalates and phthalate alternatives in concerns about its toxicity and developmental effects observed in isolation because the MoE approach replacement with other plasticizers. animal studies. The human studies, leads to the same conclusion as the Exposure to DEP and DBP has declined although not conclusive on their own, staff’s default methodology. somewhat, possibly due to provide supporting evidence that the reformulation of cosmetics and other animal studies are relevant to humans. 3. Exposure Assessment products. (Zota et al., 2014). Staff has (CPSC, 1992). The consistency of the The CHAP assessed exposure by two not assessed the effect of changing results of the epidemiological studies complementary methods. Biomonitoring phthalate exposures on the HI. with the animal studies provides studies provide good estimates of total additional support for the relevance of exposure to phthalates but do not 4. Human Relevance of Animal Data the animal studies to humans. provide information on the sources of One source of uncertainty in any risk To summarize, active phthalates exposure. (CHAP 2014, pp. 34–48). The assessment is the use of animal data as cause testicular effects in multiple scenario-based approach estimates the basis for estimating the risk to animal species. The animal studies are exposure to specific products and humans. Male developmental further supported by the results of sources of exposure, including toys, reproductive effects have been well- epidemiological studies. CPSC staff child care articles, and personal care studied in rats. In addition, similar concludes that the weight of the products. (CHAP 2014, pp. 49–60; effects have been reported in multiple evidence overwhelmingly supports the Appendices E1–E3). Staff concurs with mammalian species, including guinea conclusion that male developmental

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reproductive effects in animals are 1. Di-n-octyl Phthalate (DNOP) permanent.’’ (CHAP, 2014, pp. 95–99). appropriate for estimating risks to The CHAP recommended that the DINP is associated with adverse effects humans. interim prohibition on DNOP not be on male development (antiandrogenicity). In addition, DINP IV. Commission Assessment of the continued (CHAP 2014, pp. 91–95). The CHAP concluded: ‘‘DNOP does not acts in concert with other CHAP Report’s Recommendations for antiandrogenic phthalates, including the the Proposed Rule appear to possess antiandrogenic potential’’ (CHAP, 2014, pp. 24, 95), and permanently banned phthalates, thereby As discussed in the staff’s briefing therefore, DNOP does not contribute to contributing to the cumulative risk. package, staff assessed the the cumulative risk from other Multiple published studies confirm recommendations of the CHAP. The phthalates. Thus, the CHAP considered the antiandrogenicity of DINP Commission agrees with the staff’s DNOP risks in isolation because DNOP (Adamsson et al., 2009; Boberg et al., assessment and provides the following is not antiandrogenic. As with virtually 2011; Borch et al., 2004; Clewell et al., explanation. all chemicals, DNOP is associated with 2013; Gray et al., 2000; Hannas et al., toxicological effects, including liver 2011b; Hass et al., 2003; Masutomi et A. Interim Prohibited Phthalates: DINP, al., 2003; reviewed in NRC, 2008). Even DIDP, and DNOP toxicity and developmental effects. The CHAP did not use biomonitoring data to though DINP is less potent, by perhaps Section 108(b)(3)(A) of the CPSIA estimate DNOP exposure because DNOP twofold to tenfold, than DEHP (Gray et requires the Commission to determine, metabolites were undetectable in most al., 2000; Hannas et al., 2011b), DINP based on the CHAP report, whether to individuals. Using the scenario-based contributes to the cumulative risk from continue in effect the interim approach, the CHAP estimated all antiandrogenic phthalates. The prohibitions on children’s toys that can exposures to infants and toddlers CHAP estimated that DINP contributes 1 be placed in a child’s mouth and child ranging from 4.5 to16 mg/kg-d. The percent to 8 percent of the cumulative care articles containing DINP, DIDP, and margins of exposure (MoEs) 12 ranged risk to pregnant women and 1 percent DNOP ‘‘to ensure a reasonable certainty from 2,300 to 8,300. The CHAP to 15 percent in infants (Table 1). The of no harm to children, pregnant considered an MoE of at least 100 to be CHAP found that 10 percent of pregnant women, or other susceptible individuals adequate to protect human health from women and up to 5 percent of infants with an adequate margin of safety.’’ For the potential effects of DNOP. The have a HI greater than one. The CHAP each phthalate, the Commission must CHAP concluded that the MoE for also estimated that allowing the use of decide whether to make the interim DNOP was sufficiently high and that DINP in children’s toys and child care prohibitions permanent. continuing the interim prohibition was articles would increase DINP exposure to infants by about 13 percent. (CHAP Consistent with the CHAP and the unnecessary. Therefore, the CHAP recommended removing the interim 2014, Table E1–21). statutory framework, the Commission The Commission notes that the CHAP prohibition on children’s toys and child considered both cumulative risk and assessed the risks of DINP both in risk in isolation. For active phthalates, care articles containing DNOP. The Commission considers that a MoE isolation and in combination with other that is, phthalates causing male phthalates. Considered in isolation, staff developmental reproductive effects, the of 100 or greater is sufficient to protect human health with respect to DNOP. concluded that DINP would not present Commission considered the cumulative a hazard to consumers because the MoE risk, which was based on the HI. The Commission agrees with the CHAP’s assessment of the potential (830 to 15,000) is well in excess of 100. Consistent with the CHAP report and (CHAP, 2014, p. 99). This is consistent the CPSC chronic hazard guidelines health risks from DNOP because the MoEs are greater than 100. DNOP levels with previous work. (CHAP, 2001; (CPSC, 1992), the Commission considers CPSC, 2002). However, the Commission that the acceptable risk is exceeded are so low that they are not detectable in about 90 percent of humans. (CHAP agrees with the CHAP that DINP is when the HI is greater than one (CPSC, antiandrogenic and contributes to the 1992). Thus, the Commission considers 2014, Table 2.6). Furthermore, DNOP is not antiandrogenic, and therefore, cumulative risk. Specifically, the CHAP that an HI <1 is necessary ‘‘to ensure a found that 10 percent of pregnant reasonable certainty of no harm to DNOP does not contribute to the cumulative risk from antiandrogenic women and up to 5 percent of infants children, pregnant women, or other have a HI greater than one. Therefore, as susceptible individuals with an phthalates. The Commission concludes that continuing the prohibition of DNOP discussed previously, the Commission adequate margin of safety.’’ concludes that the cumulative risk of For non-antiandrogenic phthalates is not necessary to ensure a reasonable certainty of no harm to children, male developmental reproductive and phthalate alternatives, the effects should be considered ‘‘to ensure Commission considered the MoE, as pregnant women, or other susceptible individuals with an adequate margin of a reasonable certainty of no harm to estimated by the CHAP. MoEs greater safety. Accordingly, under the proposed children, pregnant women, or other than 100–1,000 are generally considered rule, children’s toys that can be placed susceptible individuals with an adequate to protect human health (EPA, in a child’s mouth and child care adequate margin of safety.’’ 1993). As discussed above, the staff The Commission agrees with the articles containing DNOP would no considers a MoE of 100 or more to be CHAP’s recommendation to make longer be prohibited. adequate if a NOAEL has been permanent the prohibition on DINP identified in animal studies (CPSC, 2. Diisononyl Phthalate (DINP) because the Commission concludes that 1992), which is the case for most of the DINP is currently subject to an allowing the use of DINP in children’s compounds discussed by the CHAP. interim prohibition. The CHAP toys and child care articles would Thus, for the phthalates discussed in recommended that ‘‘the interim further increase the cumulative risk to this section, the Commission considers prohibition on the use of DINP in male developmental reproductive a MoE of 100 or greater to be necessary children’s toys and child care articles at development. Multiple studies indicate ‘‘to ensure a reasonable certainty of no levels greater than 0.1 percent be made that DINP is antiandrogenic and harm to children, pregnant women, or contributes to the cumulative risk from other susceptible individuals with an 12 The margin of exposure (MoE) is the ratio of phthalates. As discussed previously, the adequate margin of safety.’’ the NOAEL to the estimated exposure. Commission considers that a HI <1 is

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necessary ‘‘to ensure a reasonable hazard associated with DINP, an need to increase by more than 250 times certainty of no harm to children, expansion of the prohibition on DINP to to exceed the acceptable level. pregnant women, or other susceptible all children’s toys is appropriate. Furthermore, DIDP is not individuals with an adequate margin of Additionally, we expect that antiandrogenic; and therefore, DIDP safety.’’ Therefore, to ensure a expanding the scope to all children’s does not contribute to the cumulative reasonable certainty of no harm with an toys would have a minimal effect on risk from antiandrogenic phthalates. adequate margin of safety to children, manufacturers because few products The Commission concludes that pregnant women, or other susceptible would need to be reformulated to continuing the prohibition of DIDP is individuals (i.e., male fetuses), the comply with the broader scope. (See not necessary to ensure a reasonable proposed rule would permanently Tab A of the staff’s briefing package.) In certainty of no harm to children, prohibit children’s toys and child care practice, children’s toys and toys that pregnant women, or other susceptible articles containing more than 0.1 can be placed in a child’s mouth all individuals with an adequate margin of percent of DINP. require testing for phthalates. The safety. Accordingly, under the proposed The statute’s interim prohibition on testing costs are the same in either case. rule, children’s toys and child care DINP applies only to children’s toys that The only change caused by expanding articles containing DIDP would no can be placed in a child’s mouth,13 the scope to all children’s toys is that longer be prohibited. which is narrower in scope than the toys too large to be mouthed could not permanent prohibitions on DEHP, DBP, be made with DINP. B. Phthalates Not Prohibited by the and BBP in all children’s toys.14 The CPSIA 3. Diisodecyl Phthalate (DIDP) CHAP recommended that DINP be The CPSIA requires the Commission permanently prohibited in all children’s The CHAP recommended that the to ‘‘evaluate the findings and toys but did not explain why the CHAP interim prohibition on DIDP not be recommendations of the Chronic Hazard recommended expanding the continued. (CHAP, 2014, pp. 100–105). Advisory Panel and declare any prohibition on DINP to include all DIDP is not associated with children’s product containing any children’s toys. However, the CHAP’s antiandrogenicity. Thus, DIDP does not phthalates to be a banned hazardous recommendation is consistent with the contribute to the cumulative risk from product under section 8 of the scope of the permanently prohibited the antiandrogenic phthalates. As with Consumer Product Safety Act (15 U.S.C. phthalates. virtually all chemicals, DIDP is 2057), as the Commission determines The proposed rule would associated with toxicological effects, necessary to protect the health of permanently prohibit DINP in all including liver toxicity and children.’’ CPSIA section 108(b)(3)(B). children’s toys and child care articles, developmental effects. The CHAP The CHAP reviewed the potential health rather than only children’s toys that can assessed the potential risks from DIDP risks associated with eight phthalates be mouthed. The Commission believes in isolation. The CHAP concluded that that were not prohibited by the CPSIA. that the expansion in scope is the MoE for DIDP is relatively high The CHAP recommended permanent appropriate because exposure occurs (>100) and that there is no compelling prohibitions on four additional from handling children’s toys, as well as reason to continue the interim phthalates: DIBP, DPENP, DHEXP, and from mouthing. (CHAP, 2014, Appendix prohibition. DCHP. The CHAP recommended an E1). The additional exposure from The CHAP concluded: ‘‘DIDP does not interim prohibition of DIOP. The CHAP handling toys would add to the appear to possess antiandrogenic did not recommend prohibitions on cumulative risk. Therefore, the potential’’ (CHAP, 2014, pp. 24, 104); DMP, DEP, or DPHP; although the Commission concludes that expanding therefore, DIDP does not contribute to CHAP recommended additional study the scope of the DINP prohibition to the cumulative risk (CHAP 2014, p. on DEP and DPHP. include all children’s toys is necessary 104). However, the CHAP stated that it Consistent with the CHAP report, the to ensure a reasonable certainty of no is aware that DIDP is associated with Commission considered both harm to children with an adequate other health effects in animal studies, cumulative risk and risk in isolation. margin of safety. including chronic liver and kidney For active phthalates, that is, phthalates The European Commission (EC) toxicity and developmental effects (e.g., causing male developmental directive on phthalates in toys and child supernumerary ribs). (CHAP 2014, pp. reproductive effects, the Commission care articles also distinguished between 100–105). The CHAP considered DIDP considered the cumulative risk, which all children’s toys and toys that can be risks in isolation because DIDP is not was based on the HI. Consistent with mouthed, prohibiting DBP, BBP, and antiandrogenic. The lowest NOAEL for the CHAP report and the CPSC chronic DEHP in all children’s toys, and DIDP was 15 mg/kg-d, based on liver hazard guidelines (CPSC 1992), the prohibiting DINP, DNOP, and DIDP in effects. Using biomonitoring data, the Commission considers that the toys that can be mouthed. (EC, 2005). CHAP estimated that human exposures acceptable risk is exceeded when the HI The directive cited greater uncertainty range from 1.5 to 26 mg/kg-d. The MoEs is greater than one (CPSC 1992). Thus, about hazards presented by DINP, range from 2,500 to 10,000 for median the Commission considers that a HI <1 DNOP, and DIDP as the reason for this DIDP exposures and 586 to 3,300 for is necessary ‘‘to protect the health of distinction. (EC, 2005, paragraph 11). As upper-bound exposures. Therefore, the children.’’ discussed in the CHAP report, there are CHAP recommended that the interim For non-antiandrogenic phthalates multiple studies related to the male prohibition on children’s toys and child and phthalate alternatives, the developmental reproductive effects of care articles containing DIDP be lifted. Commission considered the MoE, as DINP, many of which were published As discussed previously, the estimated by the CHAP. MoEs greater after 2005, the date of the ECdirective. Commission considers that a MoE of than 100 to 1,000 are generally Thus, the Commission concludes that 100 or greater is sufficient to protect considered adequate to protect human because the CHAP report addresses human health with respect to DIDP. The health (EPA 1993). As discussed uncertainties regarding the potential Commission agrees with the CHAP’s previously, staff considers a MoE of 100 assessment of the potential health risks or more to be adequate if a NOAEL has 13 CPSIA § 108(b)(1). from DIDP because the MoEs are much been identified in animal studies (CPSC 14 CPSIA § 108(a). greater than 100. DIDP exposure would 1992), which is the case for most of the

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compounds discussed by the CHAP. is necessary to protect the health of this activity. EPA would review the Thus, for the phthalates discussed in children because it would prevent potential health risks of DPENP and this section, the Commission considers current and future use of this could impose restrictions. If EPA issues a MoE of 100 or greater to be necessary antiandrogenic phthalate in toys and a final rule, the likelihood that ‘‘to protect the health of children.’’ child care articles. manufacturers would produce DPENP 1. Diisobutyl Phthalate (DIBP) 2. Di-n-pentyl Phthalate (DPENP) may be reduced. However, a SNUR would not prevent the importation of The CHAP recommended that The CHAP recommended that di-n- products containing DPENP into the diisobutyl phthalate (DIBP) should be pentyl phthalate (DPENP) should be United States. Therefore, the permanently banned from use in permanently banned from use in Commission believes that the proposed children’s toys and child care articles at children’s toys and child care articles at prohibition of children’s toys and child levels greater than 0.1 percent. (CHAP levels greater than 0.1 percent (CHAP care articles containing concentrations 2014, pp. 110–112). DIBP is associated pp. 112–113). DPENP is associated with of more than 0.1 percent of DPENP is with adverse effects on male adverse effects on male reproductive still necessary to protect the health of reproductive development and development and contributes to the children. contributes to the cumulative risk from cumulative risk from antiandrogenic antiandrogenic phthalates. Furthermore, phthalates. Furthermore, DPENP is the 3. Di-n-hexyl Phthalate (DHEXP) DIBP has been found in some toys and most potent of the antiandrogenic The CHAP recommended that di-n- child care articles during compliance phthalates. The Commission agrees with hexyl phthalate (DHEXP) should be testing by CPSC. (See TAB B of staff’s the CHAP’s recommendation for permanently banned from use in briefing package). DPENP. Based on previous CPSC staff children’s toys and child care articles at DIBP is similar in toxicity to DBP and contractor toxicity reviews (Patton, levels greater than 0.1 percent (CHAP (CHAP 2014, pp. 24, 110–111), which is 2010) and the CHAP’s review, the pp. 114–116). DHEXP is associated with one of the phthalates subject to the Commission concludes that there is adverse effects on male reproductive CPSIA’s permanent prohibition. DIBP sufficient evidence to conclude that development and may contribute to the was shown to be antiandrogenic in DPENP is antiandrogenic and is able to cumulative risk from antiandrogenic numerous studies and it acts in concert contribute to the cumulative risk. The phthalates. with other antiandrogenic phthalates Commission also concludes that, (Howdeshell et al., 2008). The CHAP applying the CPSC chronic hazard The Commission agrees with the found that current exposures to DIBP guidelines (CPSC, 1992), this phthalate CHAP’s recommendation for DHEXP. are low. When considered in isolation, is considered ‘‘probably toxic’’ to Based on previous CPSC staff and DIBP has a MoE of 3,600 or more (CHAP humans, based on sufficient evidence in contractor toxicity reviews (Patton, 2014, p. 111). DIBP contributes roughly animal studies. Furthermore, DPENP is 2010) and the CHAP’s review, the 1 percent to 2 percent of the cumulative roughly twofold to threefold more Commission concludes that there is risk from phthalate exposure to potent than DEHP. (Hannas et al., sufficient evidence to conclude that pregnant women and 1 percent to 5 2011a). Although CPSC staff has not DHEXP is antiandrogenic and is able to percent in infants (Table 7). However, detected DPENP in children’s toys or contribute to the cumulative risk (e.g., the CHAP based its recommendation on child care articles, metabolites of Foster et al., 1980). The Commission cumulative risk. DPENP have been detected in humans also concludes that, by applying the The Commission agrees with the (Silva et al., 2010), indicating that some CPSC chronic hazard guidelines (CPSC, CHAP’s recommendation for DIBP. exposure to DPENP does occur. 1992), this phthalate may be considered Based on previous CPSC staff and Moreover, prohibiting the use of DPENP ‘‘probably toxic’’ to humans based on contractor toxicity reviews (Versar/SRC, would prevent its use as a substitute for sufficient evidence in animal studies. 2010c) and the CHAP’s review, the other banned phthalates. Up to five Up to five percent of infants and up to Commission finds that there is sufficient percent of infants and up to 10 percent 10 percent of pregnant women exceed evidence to conclude that DIBP is of pregnant women exceed the the negligible risk level (HI >1). antiandrogenic and is able to contribute negligible risk level (HI >1). Allowing Allowing the use of DHEXP in to the cumulative risk. The Commission the use of DPENP in children’s toys and children’s toys and child care articles also concludes that, applying the CPSC child care articles would further would further increase the cumulative chronic hazard guidelines (CPSC, 1992), increase the cumulative risk. As risk. As discussed previously, the this phthalate is considered ‘‘probably discussed previously, the Commission Commission considers that a HI <1 is toxic’’ to humans based on sufficient considers that a HI <1 is necessary ‘‘to necessary ‘‘to protect the health of evidence in animal studies. Five percent protect the health of children.’’ children.’’ Although CPSC staff has not to 10 percent of the population exceeds Therefore, the proposed rule would detected DHEXP in toys and child care the negligible risk level (HI >1). permanently prohibit children’s toys articles during routine compliance Allowing the use of DIBP in children’s and child care articles containing more testing thus far, prohibiting children’s toys and child care articles would than 0.1 percent of DPENP. The toys and child care articles containing further increase the cumulative risk. As Commission concludes that this action DHEXP would prevent its use in these discussed previously, the Commission is necessary to protect the health of products as a substitute for other considers that a HI <1 is necessary ‘‘to children because it would prevent banned phthalates. Therefore, the protect the health of children.’’ In current and future use of this proposed rule would permanently addition, CPSC staff has identified DIBP antiandrogenic phthalate in toys and prohibit children’s toys and child care in a small portion of toys and child care child care articles. articles containing more than 0.1 articles during routine compliance Recently, the EPA proposed a percent of DHEXP. The Commission testing. Therefore, the proposed rule significant new use rule (SNUR) for concludes that this action is necessary would permanently prohibit children’s DPENP (EPA, 2012). If finalized, the to protect the health of children because toys and child care articles containing rule would require any company it would prevent future use of this more than 0.1 percent of DIBP. The planning to manufacture or import antiandrogenic phthalate in toys and Commission concludes that this action DPENP to notify EPA before beginning child care articles.

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4. Dicyclohexyl Phthalate (DCHP) 2014, pp. 118–119). However, the CHAP one dimension is smaller than 5 The CHAP recommended that concluded that there is not sufficient centimeters, it can be placed in the dicyclohexyl phthalate (DCHP) should evidence to support a permanent mouth.’’ Section 108(b)(3)(B) of the CPSIA be permanently banned from use in prohibition. The only developmental requires the Commission to ‘‘evaluate children’s toys and child care articles at study on DIOP is an older study in the findings and recommendations’’ of levels greater than 0.1 percent. (CHAP which DIOP was administered by the CHAP and consider whether to pp. 116–118). DCHP is associated with intraperitoneal injection, which is not relevant to consumer exposures. The prohibit ‘‘any children’s product adverse effects on male reproductive study’s authors reported the presence of containing any phthalates’’ if the development and contributes to the soft tissue abnormalities, a type of birth Commission determines that this is cumulative risk from antiandrogenic defect; but there were insufficient ‘‘necessary to protect the health of phthalates. details to assess whether the children.’’ Action by the Commission The Commission agrees with the abnormalities could be related to the under this subsection could result in CHAP’s recommendation for DCHP. phthalate syndrome. (Versar/SRC, extending the phthalates prohibition Based on previous CPSC staff and 2010d). The primary reason for beyond children’s toys and child care contractor reviews (Versar/SRC, 2010b) suspecting antiandrogenic activity is articles and could be taken for any or all and the CHAP’s review, the Commission DIOP’s structural similarity to other of the phthalates the proposed rule concludes that there is sufficient active phthalates (CHAP 2014, p. 119). would prohibit, including those that are evidence to conclude that DCHP is The CHAP did not recommend a permanently prohibited, were subject to antiandrogenic and is able to contribute permanent prohibition because the the interim prohibition, or that would to the cumulative risk (e.g., Foster et al., CHAP concluded that existing data are be prohibited by the proposed rule. A 1980). The Commission also concludes insufficient to support a permanent ban. ‘‘children’s product’’ is defined as a ‘‘a that, by applying the CPSC chronic Although the CHAP recommended an consumer product designed or intended hazard guidelines (CPSC, 1992), this interim prohibition, the CPSIA did not primarily for children 12 years of age or phthalate is considered ‘‘probably provide for an interim prohibition as an younger.’’ 15 U.S.C. 2052(a)(2). toxic’’ to humans, based on sufficient option for the Commission’s rule under Children’s products that are not evidence in animal studies. Up to five section 108. CPSIA section 108(b)(3). As children’s toys or child care articles that percent of infants and up to 10 percent discussed above, insufficient data exists might contain phthalates, for example, of pregnant women exceed the to determine that a permanent include rainwear, footwear, backpacks, negligible risk level (HI >1). Allowing prohibition of DIOP is necessary to some school supplies, apparel the use of DCHP in children’s toys and protect the health of children. Thus, the containing elastic waistbands, and child care articles would further Commission is not proposing any printed T-shirts and sweatshirts. increase the cumulative risk. As prohibition of products containing The CHAP report did not specifically discussed previously, the Commission DIOP. discuss the possibility of expanding the considers that a HI <1 is necessary ‘‘to C. Scope of Phthalate Prohibitions scope of the phthalates prohibitions to protect the health of children.’’ children’s products. That inquiry was Although the CPSC staff has not Currently, under section 108(a) of the not part of the CHAP’s charge. CPSIA detected DCHP in toys and child care CPSIA, the permanent phthalate section 108(b)(2). However, all of the articles during routine compliance prohibitions apply to ‘‘any children’s CHAP’s recommendations to prohibit testing thus far, prohibiting the use of toy or child care article that contains certain phthalates apply to ‘‘children’s DCHP would prevent its use as a concentrations of more than 0.1 toys and child care articles.’’ substitute for other banned phthalates. percent’’ of the permanently prohibited In the CHAP’s scenario-based The Commission concludes that this phthalates. In addition, under section exposure assessment, the CHAP initially action is necessary to protect the health 108(b)(1) of the CPSIA, the interim considered assessing exposures to of children because it would prevent phthalate prohibitions apply to ‘‘any phthalates for some children’s products future use of this antiandrogenic children’s toy that can be placed in a that were not toys or child care phthalate in toys and child care articles. child’s mouth or child care article that articles.15 The CHAP ultimately contains concentrations of more than decided, however, to limit its analysis to 5. Diisooctyl Phthalate (DIOP) 0.1 percent.’’ Section 108(g)(1)(B) of the exposure activity scenarios that were The CHAP recommended an interim CPSIA defines a ‘‘children’s toy’’ as ‘‘a thought to contribute significantly to prohibition for diisooctyl phthalate consumer product designed or intended human exposure. Specifically, these (DIOP). (CHAP 2014, pp. 118–119). by the manufacturer for a child 12 years exposure activity scenarios included DIOP has a chemical structure of age or younger for use by the child mouthing of teethers and toys, and consistent with other antiandrogenic when the child plays.’’ Section dermal exposure to play pens and phthalates. 108(g)(1)(C) of the CPSIA defines a changing pads (CHAP 2014, Table 2.1). DIOP is a high production volume ‘‘child care article’’ as ‘‘a consumer The CHAP found that most phthalate chemical (EPA 2006), that is, over a product designed or intended by the exposure comes from food and million pounds are produced or manufacturer to facilitate sleep or the beverages (CHAP, 2014, pp. 50–52). imported each year (Versar/SRC, feeding of children age 3 and younger, Mouthing teethers and toys may also 2010d). DIOP is approved for use in or to help such children with sucking or contribute to total exposure (See also, food contact applications. (CHAP 2014, teething.’’ Finally, section 108(g)(2)(B) CHAP 2014, Table E1–24). states that a ‘‘toy can be placed in a pp. 118–119). DIOP was identified in a The Commission is not proposing to child’s mouth if any part of the toy can small number of child care articles in expand the scope of the phthalates actually be brought to the mouth and the past (Chen, 2002); although it has prohibitions to include all children’s kept in the mouth by a child so that it not been detected by CPSC in children’s products. The Commission does not toys and child care articles since the can be sucked and chewed. If the CPSIA was enacted in 2008. children’s product can only be licked, it 15 CPSC staff meeting with Dr. Lioy. May 3, 2011. The possible antiandrogenicity of is not regarded as able to be placed in http://www.cpsc.gov//PageFiles/157051/ DIOP is a potential concern (CHAP the mouth. If a toy or part of a toy in Meeting%20Log%20050311.pdf.

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have sufficient information to assess the children’s products. (EPA, 2011). would still apply. Thus, it would be impact on the health of children from Mouthing activity declines rapidly after difficult to derive a risk-based level. expanding the phthalates prohibition age 3 years. (Greene, 2002). The Commission considers that the from children’s toys and child care Because the Commission believes that 0.1 percent limit is practical. A lower articles to include other children’s increased exposure to phthalates from limit would make it more difficult to products. In addition, the limited most children’s products would be perform the testing required of third information available suggests that negligible, the Commission concludes party laboratories, which may lead to increased exposure to phthalates from that expanding the phthalate increased testing costs. Compliance most children’s products outside prohibition beyond children’s toys and testing would also be more difficult. children’s toys and child care articles child care articles is not warranted. V. Description of the Proposed Rule would be negligible. The Commission D. Concentration Limit believes this for two reasons. First, the Section 1307.1—Scope and Application broader category of all children’s Section 108(a) and (b)(1) of the CPSIA Proposed § 1307.1 describes the products is likely to contain sets a concentration limit of 0.1 percent actions that the proposed rule would proportionately fewer products that for the permanently and interim- prohibit. This provision tracks the contain phthalates. (Laursen et al., prohibited phthalates in children’s toys 2003). Second, the exposure activity and child care articles. This is a language in section 108(a) of the CPSIA patterns, in combination with the statutory limit. However, if the regarding the permanent prohibition primary exposure route (dermal), would Commission chooses to prohibit and prohibits the same activities: generally lead to lower exposures than additional phthalates, the agency could manufacture for sale, offer for sale, with children’s toys (CHAP, 2001, 2014; choose to set a different limit for the distribution in commerce, or CPSC, 2002). additional phthalates, as well as for any importation into the United States of a Based on the limited available data, interim-prohibited phthalates that are children’s toy or child care article that the Commission notes that most being permanently prohibited under contains any of the prohibited children’s products are not made of PVC this rulemaking. As discussed in the phthalates. and are not expected to contain CHAP report: Section 1307.2—Definitions phthalates. For example, most textiles The CPSIA prohibits the use of certain contain less than 0.01 percent phthalates at levels greater than 0.1%, which Proposed § 1307.2 provides the same phthalates (Laursen et al., 2003). Thus, is the same level used by the European definitions of ‘‘children’s toy’’ and with a few possible exceptions, such as Commission. When used as plasticizers for ‘‘child care article’’ found in section PVC sandals (CHAP, 2001; T

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is currently in place as a result of DCHP is necessary to protect the health 16 CFR part 1307, ‘‘Prohibition of section 108(a) of the CPSIA. This of children. Children’s Toys and Child Care Articles statutory prohibition is not affected by Containing Specified Phthalates,’’ when VI. Effective Date the proposed rule but is merely restated issued as a final rule, would be a in the proposed regulatory text. The APA generally requires that the children’s product safety rule that effective date of a rule be at least 30 Proposed paragraph (b) would requires the issuance of an NOR. The days after publication of the final rule. prohibit the manufacture for sale, offer Commission previously published in 5 U.S.C. 553(d). The Commission is for sale, distribution in commerce, or the Federal Register an NOR for the proposing an effective date of 180 days importation into the United States of phthalate-containing products after publication of the final rule in the any children’s toy or child care article prohibited by section 108 on August 10, Federal Register. that contains concentrations of more 2011. (76 FR 49286). The codified As discussed in Tab A of the staff’s listing for the NOR can be found at 16 than 0.1 percent of DINP, DIBP, DPENP, briefing package, the proposed rule is DHEXP, or DCHP. As explained above, CFR 1112.15(b)(31). If the Commission expected to have a minimal impact on finalizes the proposed rule with in accordance with section 108(b)(2) of manufacturers. The proposed rule the CPSIA, the Commission appointed a prohibitions restricting phthalates that would prohibit four additional are not covered by the current NOR, the CHAP that considered the effects on phthalates—DIBP, DPENP, DHEXP, and children’s health of phthalates and Commission would issue a new NOR DCHP—which currently are not widely that would include the additional phthalate alternatives as used in used in children’s toys and child care children’s toys and child care articles. phthalates. The NOR would notify articles. Only DIBP has been detected in manufacturers and testing laboratories After completing its work, the CHAP a small portion of toys tested by the presented the Commission with a report of the additional requirements and staff. The proposed rule would also would include a revised test method. of its findings and recommendations. make the interim prohibition on DINP Any revisions to the existing NOR will After reviewing the CHAP’s report and permanent and expand the scope from be done in a separate future rulemaking. making the appropriate determinations children’s toys that can be place in a and evaluations, the Commission is child’s mouth to all children’s toys VIII. Regulatory Flexibility Act proposing a rule in accordance with (along with child care articles). Based section 108(b)(3) of the CPSIA. on staff’s testing results, to meet the The Regulatory Flexibility Act (RFA) For the reasons explained in Section proposed rule, a relatively small requires an agency to prepare a IV of this preamble, the Commission percentage of non-mouthable toys regulatory flexibility analysis for any concludes that prohibiting children’s would need to be reformulated to rule subject to notice and comment toys and child care articles that contain remove DINP. To meet the statutory rulemaking requirements under the more than 0.1 percent of DINP would testing and certification requirements if APA or any other statute, unless the ensure a reasonable certainty of no harm the proposed rule were in place, testing agency certifies that the rulemaking will to children, pregnant women, or other laboratories would need to expand their not have a significant economic impact susceptible individuals with an procedures to include the four on a substantial number of small adequate margin of safety. DINP is additional prohibited phthalates, which entities. U.S.C. 603 and 605. Small currently subject to the CPSIA’s interim the staff believes would require minimal entities include small businesses, small prohibition. CPSIA section 108(b)(1). effort by testing laboratories. Therefore, organizations, and small governmental Proposed § 1307.3(b) would change the none of the prohibitions in the proposed jurisdictions. After considering the scope of regulation of DINP from the rule is likely to require more than 180 economic impacts of this proposed rule current interim scope of ‘‘children’s toys days for manufacturers and testing on small entities, the Commission that can placed into a child’s mouth’’ 16 laboratories to become compliant. For certifies that the proposed rule would (and child care articles) to also include these reasons, the Commission proposes not have a significant economic impact all children’s toys. Based on the an effective date of 180 days after on a substantial number of small recommendations in the CHAP report, publication of the final rule in the entities. the Commission is not proposing to Federal Register. A. Background continue the interim prohibitions on VII. Notice of Requirements DIDP and DnOP. As discussed above, the proposed rule The CPSA establishes certain would fulfill a requirement in section Additionally, proposed § 1307.3(b) requirements for product certification 108 of the CPSIA that the Commission would prohibit children’s toys and child and testing. Children’s products subject issue a rule to determine whether the care articles containing four phthalates to a children’s product safety rule under interim prohibitions established in that are not currently subject to the CPSA must be certified as section 108(b)(1) of the CPSIA should be restrictions under the CPSIA: DIBP, complying with all applicable CPSC- made permanent and whether any DPENP, DHEXP, and DCHP. For the enforced requirements. 15 U.S.C. children’s product containing any reasons stated in section IV of this 2063(a). Certification of children’s phthalates that were not prohibited by preamble, the Commission concludes products subject to a children’s product the CPSIA should be declared a banned that prohibiting children’s toys and safety rule must be based on testing hazardous product. The proposed rule child care articles containing more than conducted by a CPSC-accepted third would lift the interim prohibitions for 0.1 percent of DIBP, DPENP, DHEXP, or party conformity assessment body. Id. two of the three phthalates (DIDB and 2063(a)(2). The Commission must DNOP) and would permanently prohibit 16 Section 108(g)(2)(B) of the CPSIA states that ‘‘a toy can be placed in a child’s mouth if any part of publish a notice of requirements (NOR) children’s toys and child care articles the toy can actually be brought to the mouth and for the accreditation of third party containing more than 0.1 percent of the kept in the mouth by a child so that it can be sucked conformity assessment bodies (or third phthalate (DINP). The proposed and chewed. If the children’s product can only be laboratories) to assess conformity with a rule would also prohibit children’s toys licked, it is not regarded as able to be placed in the mouth. If a toy or part of a toy in one dimension children’s product safety rule to which and child care articles containing more is smaller than 5 centimeters, it can be placed in a children’s product is subject. Id than 0.1 percent of any of four specified the mouth.’’ 2063(a)(3). Thus, the proposed rule for phthalates that were not prohibited by

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the CPSIA (DIBP, DPENP, DHEXP, and 725 samples that were found to contain toys and child care articles currently DCHP). phthalates through infrared screening must comply with the third party testing techniques, fewer than 5 samples (or requirements to certify that their B. Small Entities To Which the Rule less than 1 percent) contained DINP but products do not contain more than 0.1 Would Apply were probably too large to be placed in percent of DEHP, DBP, or BBP. Small entities would be subject to the a child’s mouth. (See Tab B of staff’s Manufacturers of children’s toys and proposed rule if they manufacture or briefing package). The percentage of all child care articles currently must also import children’s toys or child care children’s toys that could be impacted certify, based on the results of third articles that contain phthalates. These by broadening the restrictions on the party tests, that their products do not companies are already subject to the use of DINP to all children’s toys would contain more than 0.1 percent of the restrictions imposed by the CPSIA on be substantially less than 1 percent phthalates subject to the interim children’s toys and child care articles because the only samples reviewed in prohibitions (DINP, DIDP, and DNOP), containing certain phthalates. The draft this analysis were those that were unless the product is a children’s toy proposed rule would neither increase, already found to contain phthalates that cannot be placed in a child’s nor decrease, the number of small using infrared screening techniques. mouth. (The prohibitions on DEHP, entities to which the phthalate This would be a small subset of all DBP, and BBP apply regardless of restrictions apply. More detailed children’s toys. whether a toy can be placed in a child’s information about the entities that likely Restricting four additional phthalates. mouth). manufacture or import children’s toys The proposed rule would also prohibit children’s toys and childcare articles a. Scope of Products That Must Be and child care articles and would be Tested considered small businesses under the containing four additional phthalates: criteria established by the Small DIBP, DPENP, DHEXP, and DCHP. The The proposed rule would not affect Business Administration (SBA) is prohibition on the use of these the scope of products subject to the provided at Tab A of the staff’s briefing additional phthalates is not expected to third party testing requirement because package. have a significant impact on a even in the absence of the proposed substantial number of manufacturers rule, manufacturers of children’s toys C. Potential Impact on Small Businesses because the CHAP found that three of and child care articles that may contain 1. Impact From Meeting Substantive these phthalates (DPENP, DHEXP, and accessible phthalates are required to Requirements of the Proposed Rule DCHP) are not currently used in certify those products based on third children’s products and that although party testing. The proposed rule would impact the fourth (DIBP) has been found in Lifting restriction on DNOP and DIDP. which plasticizers are available to some toys, it ‘‘is not widely used in toys Because the proposed rule would manufacturers for use in children’s toys and child care articles.’’ (CHAP 2014, remove the interim prohibitions for and child care articles. We discuss the pp. 111,113,116, and 117). This aspect DIDP and DNOP, manufacturers of anticipated impact from each aspect of of the proposed rule is intended to children’s toys and child care articles the Commission’s proposed action. prevent these phthalates from being would no longer be required to certify Lifting restriction on DNOP and DIDP. used in children’s toys and child care that their products do not contain these The proposed rule would end the articles in the future. phthalates. However, third party testing CPSIA’s interim restrictions on the use Summary of impact from meeting of children’s toys and child care articles of DNOP and DIDP in children’s toys substantive requirements of proposal. would still be required to ensure that and child care articles. Manufacturers For the reasons described above, the these products do not contain would be free to use these two Commission expects that few, if any, concentrations of more than 0.1 percent phthalates. Ending restrictions for these manufacturers would need to alter their for DEHP, DBP, and BBP. phthalates would benefit manufacturers formulations to comply with the Altering restriction on DINP. Under if DNOP and DIDP are less costly than proposed rule. the proposed rule, manufacturers of the alternatives or they impart other children’s toys that can be placed in a desirable attributes to the final product. 2. Impact From Third Party Testing to child’s mouth and child care articles Altering restriction on DINP. The the Proposed Rule would need to continue to test to ensure proposed rule would broaden the The CPSIA requires manufacturers of that their products do not exceed restrictions on DINP. The interim ban children’s products subject to a concentrations of more than 0.1 percent prohibits children’s toys that can be children’s product safety rule to certify for DINP. Additionally, under the placed in a child’s mouth and child care that their children’s products comply proposed rule, manufacturers would articles that contain more than 0.1 with all applicable children’s product have to certify, based on third party percent of DINP. The proposed rule safety rules based on the results of third tests, that toys that cannot be placed in would extend the prohibition to all party tests. 15 U.S.C. 2063(a)(2). Third a child’s mouth do not contain DINP. children’s toys and child care articles party testing is only required for those However, as noted above, these regardless of whether the toy can be components of children’s toys and child manufacturers are already required to placed in a child’s mouth. care articles that are accessible and that test their products for DEHP, DBP, and Manufacturers who were using DINP in could contain one or more of the BBP. The extension of the DINP toy components that could not be prohibited phthalates. These third party prohibition would not require testing of placed in a child’s mouth would have testing requirements are set forth in the additional products; the extension to find an alternative for DINP in these CPSIA and are unaffected by the simply adds another phthalate for applications. The Commission expects proposed rule. which certification is required when the impact of changing the prohibition The CPSIA permanently prohibits testing children’s toys and child care on the use DINP to include children’s children’s toys and child care articles articles that cannot be placed in the toys that cannot be placed in a child’s that contain concentrations of more than mouth. mouth would be limited to a small 0.1 percent of DEHP, DBP or BBP. This Restricting four additional phthalates. number of firms. A review of samples restriction is unaffected by the proposed Under the proposed rule, manufacturers tested by CPSC staff indicated that of rule. Thus, manufacturers of children’s of children’s toys and child care articles

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would have to certify that their products Therefore, the per-test cost of the XI. Environmental Considerations do not contain DIBP, DPENP, DHEXB, additional phthalate standards would be The Commission’s regulations and DCHP in concentrations of greater less than $0.35 per test. provide a categorical exclusion for the than 0.1 percent based on third party D. Conclusion Commission’s rules from any tests. However, as noted above, these requirement to prepare an The CPSIA established prohibitions manufacturers are already subject to environmental assessment or an third party testing for DEHP, DBP, and on children’s toys and child care articles containing phthalates. The CPSIA also environmental impact statement BBP. because they ‘‘have little or no potential Summary of impact of proposal on put in place requirements for third party testing and certification of children’s for affecting the human environment.’’ scope of testing. Because children’s toys 16 CFR 1021.5(c)(2). Because this rule and child care articles that may contain products. As discussed above, because these requirements area already in place falls within the categorical exclusion, no phthalates are already subject to the environmental assessment or CPSIA’s testing requirement to by statute and will continue regardless of the proposed rule, the Commission environmental impact statement is determine the presence of any of the required. phthalates that are prohibited by section expects that the proposed rule’s impact 108(a) of the CPSIA, the proposed rule on small business would not be XII. List of References would not affect the scope of products significant. Therefore, the Commission This section provides a list of the certifies that the proposed rule would that are subject to third party testing. documents referenced in this preamble. not have a significant economic impact b. Proposed Rules’s Impact on Cost of on a substantial number of small Adamsson A, Salonen V, Paranko J, Toppari Testing entities. J. 2009. Effects of maternal exposure to di-isononylphthalate (DINP) and 1,1- Under the proposed rule, IX. Paperwork Reduction Act dichloro-2,2-bis(p-chlorophenyl)ethylene manufacturers would need to test for the (p,p′-dde) on steroidogenesis in the fetal The proposed rule does not include presence of four phthalates that they rat testis and adrenal gland. any information-collection currently do not have to test for under Reproductive Toxicology (Elmsford, NY) requirements. Accordingly, this rule is the CPSIA’s permanent and interim 28:66–74. not subject to the Paperwork Reduction prohibitions. According to the Babich MA. 2010. Overview of phthalates Act, 44 U.S.C. 3501–3520. toxicity. U.S. Consumer Product Safety Directorate for Laboratory Sciences, Commission, Bethesda, MD 20814. April including the additional phthalates that X. Preemption 2010. http://www.cpsc.gov/PageFiles/ would be prohibited by the proposed Section 26(a) of the CPSA, 15 U.S.C. 126521/phthalover.pdf. rule, DIBP, DPENP, DHEXP, and DCHP 2075(a), provides that where a Barlow NJ, Foster PM. 2003. Pathogenesis of is not expected to increase significantly male reproductive tract lesions from ‘‘consumer product safety standard gestation through adulthood following in the cost to manufacturers for having a under [the Consumer Product Safety Act products third party test their products utero exposure to di(n-butyl) phthalate. (CPSA)]’’ is in effect and applies to a Toxicol. Pathol. 31:397–410. for phthalates. The same equipment and product, no state or political Barlow NJ, McIntyre BS, Foster PMD. 2004. procedures for sample preparation and subdivision of a state may either Male reproductive tract lesions at 6, 12, extraction could be used. Although the establish or continue in effect a and 18 months of age following in utero data analysis procedure would need to requirement dealing with the same risk exposure to di(n-butyl) phthalate. be modified to include the new of injury unless the state requirement is Toxicological Pathology 32:79–90. phthalates, each of the additional Benson R. 2009. Hazard to the developing identical to the federal standard. male reproductive system from phthalates can be isolated at unique (Section 26(c) of the CPSA also provides elution times by gas chromatography cumulative exposure to phthalate that states or political subdivisions of esters—dibutyl phthalate, diisobutyl and should not be difficult for qualified states may apply to the Commission for phthalate, butylbenzyl phthalate, conformity assessment bodies to an exemption from this preemption diethylhexyl phthalate, dipentyl identify and quantify. (See Tab B of the under certain circumstances.) Section phthalate, and diisononyl phthalate. staff’s briefing package.) 108(f) of the CPSIA is entitled, Regul. Toxicol. Pharmacol. 53:90–101. Third party conformity assessment ‘‘Treatment as Consumer Product Safety Boberg J, Christiansen S, Axelstad M, Kledal bodies will have to obtain eight TS, Vinggaard AM, Dalgaard M, et al. Standards; Effect on State Laws.’’ That 2011. Reproductive and behavioral phthalate analytic standard materials for provision states that the permanent and calibration purposes for use during effects of diisononyl phthalate (DINP) in interim prohibitions and any rule perinatally exposed rats. Reproductive phthalate testing. This is a net increase promulgated under section 108(b)(3) Toxicology (Elmsford, NY) 31:200–209. of two over the six that are currently ‘‘shall be considered consumer product Borch J, Ladefoged O, Hass U, Vinggaard AM. required. These additional analytic safety standards under the Consumer 2004. Steroidogenesis in fetal male rats standards are expected to cost very Product Safety Act.’’ That section is reduced by DEHP and DINP, but little, especially on a per-test basis. The further states: ‘‘Nothing in this section endocrine effects of DEHP are not analytic standards cost about $3.50 per modulated by DEHA in fetal, prepubertal of the Consumer Product Safety Act (15 and adult male rats. Reproductive gram (based on prices by some suppliers U.S.C. 2051 et seq.) shall be construed on the Internet), but less than 50 Toxicology (Elmsford, NY) 18:53–61. to preempt or otherwise affect any State CDC. 2012. Fourth national report on human milligrams of a standard is required per requirement with respect to any exposure to environmental chemicals. test batch. Therefore, the additional two phthalate alternative not specifically Updated tables, February 2012. standards that would be required by the regulated in a consumer product safety CDC. 2013. Fourth national report on human proposed rule would increase the cost standard under the Consumer Product exposure to environmental chemicals. 17 per test batch by about $0.35. Multiple Safety Act.’’ CPSIA section 108(f). This Updated tables, September 2013. samples can be tested in one test batch. provision indicates that the preemptive CHAP. 2001. Report to the U.S. Consumer Product Safety Commission by the effect of section 26(a) of the CPSA 17 Fifty milligrams of a standard that costs $3.50 Chronic Hazard Advisory Panel on per gram would be 17.5 cents. Two additional would apply to the proposed rule which diisononyl phthalate (DINP). Bethesda, standards over what is now required would be does not include any requirements MD. June 2001. http://www.cpsc.gov/ required by the draft proposed rule. regarding phthalate alternatives. PageFiles/98260/dinp.pdf.

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CHAP. 2014. Report to the U.S. Consumer following in utero exposure to phthalate Klaunig JE, Babich MA, Baetcke KP, Cook JC, Product Safety Commission by the esters. Int. J. Androl. 29:140–147; Corton JC, David RM, et al. 2003. Ppara Chronic Hazard Advisory Panel on discussion 181–145. agonist-induced rodent tumors: Modes of phthalates and phthalate alternatives. Gray LE, Jr.,, Ostby J, Furr J, Price M, action and human relevance. Critical Chen S–B. 1998. Laboratory sciences report Veeramachaneni DN, Parks L. 2000. Reviews in Toxicology 33:655–780. on the migration of diisononyl phthalate Perinatal exposure to the phthalates Kortenkamp A, Faust M. 2010. Combined from polyvinyl chloride children’s DEHP, BBP, and DINP, but not DEP, exposures to anti-androgenic chemicals: products. DMP, or DOTP, alters sexual Steps towards cumulative risk Christensen KL, Makris SL, Lorber M. 2014. differentiation of the male rat. assessment. Int. J. Androl. 33:463–474. Generation of hazard indices for Toxicological Sciences 58:350–365. Lake BG, Brantom PG, Gangolli SD, cumulative exposure to phthalates for Gray TJ, Rowland IR, Foster PM, Gangolli SD. Butterworth KR, Grasso P. 1976. Studies use in cumulative risk assessment. 1982. Species differences in the on the effects of orally administered di- Regul. Toxicol. Pharmacol. 69:380–389. testicular toxicity of phthalate esters. (2-ethylhexyl) phthalate in the ferret. Clark KE, David RM, Guinn R, Kramarz KW, Toxicol. Lett. 11:141–147. Toxicology 6:341–356. Lampi MA, Staples CA. 2011. Modeling Greene MA. 2002. Mouthing times from the Laursen SE., Hansen J, Dr

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common target tissues via diverse Research Corporation, North Syracuse, to this part. Specifically, as defined in mechanisms of toxicity. Int. J. Androl. NY 13212. Prepared for the U.S. the CPSIA: 33:443–462. Consumer Product Safety Commission, (a) Children’s toy means a consumer Sathyanarayana S, Calafat AM, Liu F, Swan Bethesda, MD 20814. October 2010. product designed or intended by the SH. 2008a. Maternal and infant urinary http://www.cpsc.gov/PageFiles/125779/ phthalate metabolite concentrations: Are dchp.pdf manufacturer for a child 12 years of age they related? Environ. Res. 108:413–418. Ward JM, Peters JM, Perella CM, Gonzalez FJ. or younger for use by the child when the Sathyanarayana S, Karr CJ, Lozano P, Brown 1998. Receptor and nonreceptor- child plays. E, Calafat AM, Liu F, et al. 2008b. Baby mediated organ-specific toxicity of di(2- (b) Child care article means a care products: Possible sources of infant ethylhexyl)phthalate (DEHP) in consumer product designed or intended phthalate exposure. Pediatrics 121:e260– peroxisome proliferator-activated by the manufacturer to facilitate sleep or 268. receptor alpha-null mice. Toxicol. the feeding of children age 3 and Schutze A, Palmke C, Angerer J, Weiss T, Pathol. 26:240–246. younger, or to help such children with Bruning T, Koch HM. 2012. Wilson VS, Lambright C, Furr J, Ostby J, Quantification of biomarkers of Wood C, Held G, et al. 2004. Phthalate sucking or teething. environmental exposure to ester-induced gubernacular lesions are § 1307.3 Prohibition of children’s toys and di(isononyl)cyclohexane-1,2- associated with reduced insl3 gene ® child care articles containing specified dicarboxylate (DINCH ) in urine via expression in the fetal rat testis. Toxicol. phthalates. hplc-ms/ms. J. Chromatogr. B. Analyt. Lett. 146:207–215. Technol. Biomed. Life Sci. 895–896:123– Wormuth M, Scheringer M, Vollenweider M, (a) As provided in section 108(a) of 130. Hungerbuhler K. 2006. What are the the CPSIA, the manufacture for sale, Sexton K, Hattis D. 2007. Assessing sources of exposure to eight frequently offer for sale, distribution in commerce, cumulative health risks from exposure to used phthalic acid esters in Europeans? or importation into the United States of environmental mixtures—three Risk Anal. 26:803–824. any children’s toy or child care article fundamental questions. Environmental Zota AR, Calafat AM, Woodruff TJ. 2014. that contains concentrations of more Health Perspectives 115:825–832. Temporal trends in phthalate exposures: than 0.1 percent of di-(2-ethyhexyl) Silva MJ, Furr J, Samandar E, Preau JL, Jr., Findings from the national health and phthalate (DEHP), dibutyl phthalate Gray LE, Needham LL, et al. 2010. nutrition examination survey, 2001– Urinary and serum metabolites of di-n- 2010. Environmental Health Perspectives (DBP), or benzyl butyl phthalate (BBP) pentyl phthalate in rats. Chemosphere 122:235–241. is prohibited. 82:431–436. (b) In accordance with section Skakkebaek NE., Rajpert-De Meyts E, Main List of Subjects in 16 CFR Part 1307 108(b)(3) of the CPSIA, the manufacture KM. 2001. Testicular dysgenesis Consumer protection, Imports, Infants for sale, offer for sale, distribution in syndrome: An increasingly common and children, Law enforcement, and commerce, or importation into the developmental disorder with Toys. United States of any children’s toy or environmental aspects. Hum. Reprod. child care article that contains 16:972–978. For the reasons discussed in the Teuschler LK, Hertzberg RC. 1995. Current preamble, the Commission proposes to concentrations of more than 0.1 percent and future risk assessment guidelines, amend Title 16 of the Code of Federal of diisononyl phthalate (DINP), policy, and methods development for Regulations by adding part 1307 to read diisobutyl phthalate (DIBP), di-n-pentyl chemical mixtures. Toxicology 105:137– as follows: phthalate (DPENP), di-n-hexyl phthalate 144. ■ 1. Add Part 1307 to read as follows (DHEXP), or dicyclohexyl phthalate T

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