Prohibition of Children's Toys and Child Care Articles Containing Specified Phthalates, 78324-78343 [2014-29967]

Agencies

• Consumer Product Safety Commission

[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Proposed Rules]
[Pages 78324-78343]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29967]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1307

[Docket No. CPSC-2014-0033]


Prohibition of Children's Toys and Child Care Articles Containing 
Specified Phthalates

AGENCY: Consumer Product Safety Commission.

ACTION: Notice of Proposed Rulemaking.

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SUMMARY: Section 108 of the Consumer Product Safety Improvement Act of 
2008 (CPSIA), requires the United States Consumer Product Safety 
Commission (Commission or CPSC) to convene a Chronic Hazard Advisory 
Panel (CHAP) to study the effects on children's health of all 
phthalates and phthalate alternatives as used in children's toys and 
child care articles and to provide recommendations to the Commission 
regarding whether any phthalates or phthalate alternatives other than 
those already permanently prohibited should be prohibited. The CPSIA 
requires the Commission to promulgate a final rule after receiving the 
final CHAP report. The Commission is proposing this rule pursuant to 
section 108(b) of the CPSIA.

DATES: Submit comments by March 16, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2014-
0033, by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. The Commission does not accept 
comments submitted by electronic mail (email), except through 
www.regulations.gov. The Commission encourages you to submit electronic 
comments by using the Federal eRulemaking Portal, as described above.
    Written Submissions: Submit written submissions in the following 
way: Mail/Hand delivery/Courier, preferably in five copies, to: Office 
of the Secretary, Consumer Product Safety Commission, Room 820, 4330 
East West Highway, Bethesda, MD 20814; telephone (301) 504-7923.
    Instructions: All submissions received must include the agency name 
and docket number for this proposed rulemaking. All comments received 
may be posted without change, including any personal identifiers, 
contact information, or other personal information provided, to: https://www.regulations.gov. Do not submit confidential business information, 
trade secret information, or other sensitive or protected information 
that you do not want to be available to the public. If furnished at 
all, such information should be submitted in writing.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov, and insert the 
docket number, CPSC-2014-0033, into the ``Search'' box, and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Kent R. Carlson, Ph.D., Toxicologist, 
Division of Toxicology & Risk Assessment, Directorate for Health 
Sciences, U.S. Consumer Product Safety Commission, 5 Research Place, 
Rockville, MD 20850-3213; email: kcarlson@cpsc.gov.

SUPPLEMENTARY INFORMATION:

I. Background

A. Consumer Product Safety Improvement Act

1. Statutory Prohibitions
    Section 108 of the CPSIA establishes requirements concerning 
phthalates. The term ``phthalates'' generally refers to ortho-phthalate 
diesters (phthalate esters, phthalates), which are a class of organic 
compounds used primarily as plasticizers for polyvinyl chloride (PVC). 
Phthalates also are used as solvents and stabilizers for fragrances. 
Phthalates have been used in teethers, plastic toys, home furnishings, 
air fresheners, automobile interiors, cosmetics, medications, medical 
devices, and many other products.

[[Page 78325]]

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

B. CHAP Process

    The CHAP held its first meeting on April 14-15, 2010. The CHAP met 
in public session seven times and met via teleconference (also open to 
the public) six times.\1\ The meetings were held at the CPSC offices in 
Bethesda, MD, and also aired via webcast. A record of the CHAP's public 
meetings, including video recordings and information submitted to the 
CHAP, in addition to

[[Page 78326]]

the final CHAP report, are available on the CPSC Web site.\2\
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    \1\ The CHAP met in one closed meeting as part of the peer 
review process, January 28-29, 2014.
    \2\ https://www.cpsc.gov/chap.
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    At a July 26-28, 2010 meeting, the CHAP heard testimony from the 
public, including from federal agency representatives who discussed 
federal activities on phthalates. The CHAP also invited experts to 
present their latest research findings at the July 2010 and subsequent 
meetings. Members of the public who presented testimony to the CHAP at 
the July 2010 meeting included manufacturers of phthalates and 
phthalate alternatives, as well as representatives of nongovernmental 
organizations. In addition to oral testimony, the manufacturers and 
other interested parties submitted an extensive volume of toxicity and 
other information to the CHAP and/or the CPSC staff. All submissions 
given to CPSC staff were provided to the CHAP.
    Although the CPSIA did not require peer review of the CHAP's work, 
at the CHAP's request, four independent scientists peer-reviewed the 
draft CHAP report. CPSC staff applied the same criteria for selecting 
the peer reviewers as is required for the CHAP members. Peer reviewers 
were nominated by the National Academy of Sciences. Peer reviewers did 
not receive compensation from, nor did they have a substantial 
financial interest in, any of the manufacturers of the products under 
consideration. In addition, the peer reviewers were not employed by the 
federal government, except the National Institutes of Health, the 
National Toxicology Program, or the National Center for Toxicological 
Research. The CHAP report was due to the Commission on April 13, 2012 
based on the requirement in section 108(b)(2)(C) of the CPSIA. The CHAP 
submitted the final report to the Commission on July 18, 2014.

C. The Proposed Rule

    The Commission proposes this rule in accordance with the CPSIA's 
direction to follow section 553 of the APA. CPSC staff reviewed the 
CHAP report and provided the Commission with a briefing package that 
assessed the CHAP report and made recommendations for a notice of 
proposed rulemaking (NPR). The staff's briefing package is available on 
CPSC's Web site at https://www.cpsc.gov/Global/Newsroom/FOIA/CommissionBriefingPackages/2015/ProposedRule-Phthalates-112514.pdf. As 
discussed in this preamble, the Commission agrees with the staff's 
recommendations.

II. CHAP Report

A. Summary of the CHAP Report

1. Health Effects in Animals
    As staff explained in their briefing package, the CHAP reviewed all 
of the potential health effects of phthalates. Although phthalates are 
associated with a number of adverse health effects, the CHAP considered 
effects on male reproductive development to be the most relevant for 
human risk assessment. This is, in part, because these effects 
constitute the ``most sensitive and most extensively studied endpoint'' 
for phthalates. (CHAP 2014; pp. 1-2, 12-13). In support of this 
decision, the CHAP noted that a 2008 National Research Council (NRC) 
report also recommended using male reproductive development effects as 
the basis for a cumulative risk assessment of phthalates. (CHAP, 2014; 
NRC, 2008). The CHAP explained that exposing pregnant female rodents to 
certain phthalates causes a suite of effects on the male reproductive 
tract in male pups, known as the ``phthalate syndrome in rats.'' The 
syndrome includes: malformations of the testes, prostate, and penis 
(hypospadias); undescended testes; reduced anogenital distance (AGD); 
and retention of nipples.\3\ Male pups also have reduced fertility as 
adults. The incidence and severity of these effects increases with 
dose. In addition, the male fetus is the most sensitive, followed by 
juveniles and adults. The phthalate syndrome effects are due largely to 
the suppression of testosterone production (Foster 2006), as well as 
reduced expression of the insulin-like hormone 3 gene (CHAP 2014; 
Wilson et al. 2004; p. 16). Thus, the CHAP refers to these effects as 
``antiandrogenic'' to reflect their effect on testosterone production. 
Not all phthalates cause antiandrogenic effects; only phthalates 
meeting certain structural criteria, termed ``active'' phthalates, are 
associated with the phthalate syndrome. (CHAP 2014; p. 16; Foster et 
al. 1980; Gray et al. 2000).
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    \3\ Nipple retention does not normally occur in rodents, as it 
does in humans.
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    The CHAP, citing published reports, noted (CHAP 2014, p.2) an 
additional reason for focusing on effects on male reproductive 
development: is empirical evidence demonstrates that the effects of 
active phthalates on male reproductive development are additive (Hannas 
et al. 2011b; 2012; Howdeshell et al. 2007; 2008). That is, exposures 
to multiple phthalates at lower doses act in concert to produce the 
same effect as a higher dose of a single phthalate. The additive 
effects of different phthalates are significant because humans are 
exposed to multiple phthalates simultaneously. (CHAP 2014; p. 2). The 
CHAP also noted that, in addition to phthalates, other chemicals, 
including certain pesticides and preservatives, add to the male 
reproductive effects of phthalates. (CHAP 2014; pp. 26-27, p. D-26; 
Rider et al. 2010).
    The CHAP also reviewed available toxicity data on six phthalate 
alternatives. (CHAP 2014; p. 22). The CHAP found none of the 
alternatives to be antiandrogenic, that is, causing effects consistent 
with the phthalate syndrome. Therefore, because these phthalate 
alternatives did not contribute to the cumulative antiandrogenic 
effect, the CHAP assessed the potential risks of phthalate 
alternatives, as well as non-antiandrogenic phthalates, in isolation. 
These assessments were based on the most sensitive health endpoint \4\ 
for each chemical, such as liver toxicity, for assessing risk. (CHAP 
2014, pp. 121-142).
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    \4\ That is, the effect occurring at the lowest dose.
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2. Health Effects in Humans
    The CHAP noted that the phthalate syndrome in rats resembles the 
``testicular dysgenesis syndrome'' (TDS) in humans. (CHAP 2014, pp. 2, 
28). TDS includes poor semen quality, reduced fertility, testicular 
cancer, undescended testes, and hypospadias.\5\ After reviewing all of 
the available studies on associations between phthalate exposure and 
human health (CHAP 2014, pp. 27-33; Appendix C), the CHAP noted that 
two of three studies found an association between prenatal or neonatal 
phthalate exposure and reduced anogenital distance \6\ in male infants. 
Several studies also found associations between prenatal or neonatal 
exposure and neurobehavioral effects in children. These effects 
included reductions in mental and psychomotor development and increases 
in attention deficits and behavioral symptoms. The CHAP cited several 
studies that found associations between phthalate exposure in adult 
males and reduced sperm quality and infertility. (Reviewed in CHAP 
2014, p. C-8).
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    \5\ A malformation of the penis.
    \6\ Distance between the anus and genitals, which is greater in 
males than in females.
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    Based on this information, the CHAP concluded that there is a 
growing body of studies reporting associations between phthalate 
exposure and human health. (CHAP 2014, p. 27). Many of the reported 
health effects are consistent with testicular dysgenesis syndrome in

[[Page 78327]]

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

[[Page 78328]]

    1. Calculate the ``hazard quotient'' (HQ) for each phthalate. The 
HQ is the exposure divided by the ``potency estimate for 
antiandrogenicity'' (PEAA).\7\ The PEAA is an estimate of the level of 
exposure at which the risk of antiandrogenic effects is considered 
negligible. If the HQ is greater than one for a given phthalate, there 
may be a concern for antiandrogenic effects in the exposed population 
due to the effect of an individual phthalate.
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    \7\ The PEAA is essentially similar to a ``reference dose'' 
(RfD) or ``acceptable daily intake'' (ADI), which are commonly used 
terms, except that the PEAA applies only to antiandrogenic effects. 
The RfD and ADI generally apply to the most sensitive health effect 
of a given chemical. RfD and ADI are estimates of a dose at which 
one could be exposed to for up a lifetime with a negligible risk of 
adverse effects.
[GRAPHIC] [TIFF OMITTED] TP30DE14.000

    2. The hazard index (HI) is the sum of the hazard quotients (HQs) 
for the phthalates of interest. If the HI is greater than one, there 
may be a concern for antiandrogenic effects in the exposed population 
due to the cumulative effects of phthalates.\8\
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    \8\ Having a HI greater than one does not necessarily mean that 
adverse effects will occur; however, this possibility cannot be 
ruled out.
[GRAPHIC] [TIFF OMITTED] TP30DE14.001

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

Table 1--Percent Contribution of Individual Phthalates to the Cumulative
                                 Risk a
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                                      Case 1       Case 2       Case 3
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NHANES Pregnant Women:
    Diisobutyl phthalate, DIBP...          0.7          2.3         <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,           85.7         53.8         77.8
     DEHP........................
    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,           81.8         55.0         91.7
     DEHP........................
    Diisononyl phthalate, DINP...          0.9         15.0          8.3
------------------------------------------------------------------------
\a\ Calculated from data in CHAP, 2014, Table 2.16. Based on median
  exposures.


[[Page 78329]]

    In infants, DEHP also contributed the most to the cumulative risk. 
DEHP contributed between 50 and 90 percent of the median HI (Table 1). 
However, the relative contributions of other phthalates were somewhat 
greater in infants than in pregnant women. DINP contributed between 1 
percent (case 1) and 15 percent (case 2) of the median HI. DBP and BBP 
contributed between 2 percent and 18 percent of the HI. (Table 1).
    According to the CHAP, these results indicate that DEHP contributed 
between 50 and 90 percent of the cumulative risk from exposure to 
antiandrogenic phthalates. The HQs of DBP, BBP, and DINP were similar. 
(CHAP 2014, p. 65). DINP contributed between 1 percent and 15 percent 
of the cumulative risk. (Table 1).
    Furthermore, the CHAP noted that consumers are exposed to other 
types of chemicals, such as parabens \9\ and certain pesticides that 
also add to the total risk of antiandrogenic effects. (CHAP 2014, p. D-
26). These additional chemicals may increase the risk slightly or, as a 
worst case, double the percentage of pregnant women with an HI greater 
than one. (Id.). The CHAP did not have data to estimate the effects of 
the additional chemicals in infants. (Id.).
---------------------------------------------------------------------------

    \9\ Parabens are antimicrobials commonly used in cosmetics.
---------------------------------------------------------------------------

c. Risks in Isolation--Margin of Exposure
    As required by section 108(b)(2)(B)(ii) of the CPSIA, the CHAP also 
considered the risks of phthalates and phthalate alternatives in 
isolation. Risks in isolation are of particular importance for the 
phthalate alternatives and the non-antiandrogenic phthalates. The CHAP 
did not include these compounds in the cumulative risk assessment 
because they are not antiandrogenic, and therefore, do not contribute 
to the cumulative risk for male reproductive developmental effects. The 
CHAP used a margin of exposure (MoE) approach to assess the risks in 
isolation. (CHAP 2014, p. 4). The MoE is the ``no observed adverse 
effect level'' (NOAEL) of the most sensitive endpoint in animal studies 
divided by the estimated exposure in humans. Higher MoEs indicate lower 
risks. Generally, MoEs greater than 100 to 1,000 are adequate to 
protect public health. (CHAP 2014, p. 20).
    DIDP and DNOP are subject to the interim prohibition on phthalates 
under section 108 of the CPSIA. The CHAP concluded that they are not 
antiandrogenic; their most sensitive health effect is liver toxicity. 
(CHAP 2014, pp. 94, 104). MoEs for DIDP range from 300 (modeling using 
conservative assumptions) to 10,000 (biomonitoring). (CHAP 2014, pp. 
24, 104). DNOP was largely not detectable in biomonitoring studies; 
MoEs based on modeling (with conservative assumptions) are 1,800 or 
more. (CHAP 2014, pp. 24, 95). Because the MoEs in humans are likely to 
be very high, and thus adequate to protect public health, the CHAP did 
not find compelling data to justify maintaining the current interim 
bans on the use of DNOP and DIDP in children's toys and child care 
articles. The CHAP recommended that the interim prohibitions on DNOP 
and DIDP be lifted. (CHAP 2014, pp. 95, 104).
    In addition to noting DINP's antiandrogenic characteristics, the 
CHAP also stated that DINP is associated with liver toxicity. (CHAP 
2014, pp. 95-99). Furthermore, liver toxicity is the most sensitive 
health effect for DINP. Thus, to assess the adverse effects of DINP in 
isolation, the CHAP considered liver toxicity to calculate MoEs. The 
CHAP stated: ``Using the NOAEL of 15 mg/kg-d for systemic toxicity 
[liver toxicity], the MoE for infants ranged from 830 to 4,200. The MoE 
for women ranged from 1,600 to 15,000. MoEs exceeding 100-1000 are 
considered adequate for public health.'' (CHAP 2014, p. 99). Despite 
high MoEs associated with DINP, the CHAP nevertheless recommended a 
permanent ban on DINP in children's toys and child care articles, 
concluding that: ``DINP does induce antiandrogenic effects in animals, 
although at levels below that for other active phthalates, and 
therefore can contribute to the cumulative risk from other 
antiandrogenic phthalates.''
    Exposure data on many of the nonregulated phthalates are limited. 
Considered in isolation, MoEs for DIBP were 40,000 or more. (CHAP 2014, 
p. 111). However, DIBP contributes to the cumulative risk, due to its 
antiandrogencity.
    The CHAP noted that exposure data on phthalate alternatives are 
also limited. Estimates of mouthing exposure to children up to 3 years 
old are available for TPIB, DEHT, ATBC, and DINX. MoEs for mouthing 
exposure for TPIB, DEHT, ATBC, and DINX are greater than 5,000. (CHAP 
2014, pp. 121-142). However, DEHT, ATBC, TOTM, and DEHA are high 
production volume chemicals. (Id.). TPIB, DEHA, DEHT, ATBC, and TOTM 
are used in many types of products found in the home. Thus, as the CHAP 
noted, human exposure may occur from other sources, in addition to 
mouthing by children. (Id.).
    The CHAP found that, among the permanently banned phthalates, DBP 
and BBP had MoEs of 5,000 or more. (CHAP 2014, pp. 82-88). For DEHP, 
MoEs ranged from 30 to 3,000. (CHAP 2014, p. 91). The 95th percentile 
exposure to pregnant women had a MoE of 30, which is less than the 
minimum value of 100, based on biomonitoring. The 95th percentile 
exposure in infants had a MoE of 100, based on modeling and 170 for 
biomonitoring. (Id.). Thus, the CHAP found that some highly exposed 
pregnant women, more than 5 percent of the population, had DEHP 
exposures that may present a concern for adverse health effects. (Id., 
p. 65). Furthermore, the CHAP noted that DEHP contributes more than 
half of the cumulative risk from phthalates. (Table 1; CHAP 2014, p. 
65).

B. The CHAP's Recommendations to the Commission

1. Recommendations on Phthalates Permanently Prohibited by the CPSIA
    The CHAP did not recommend any Commission action on DBP, BBP, or 
DEHP because these phthalates are already permanently prohibited by the 
CPSIA. (CHAP 2014, pp. 83-91). However, the CHAP recommended that U.S. 
agencies responsible for DBP, BBP, and DEHP exposures from all sources 
conduct the necessary risk assessments with a view to supporting risk 
management steps. (CHAP 2014, pp. 83-91).
2. Recommendations on Phthalates Prohibited by the CPSIA on an Interim 
Basis
a. Diisononyl Phthalate (DINP)
    The CHAP recommended that DINP at levels greater than 0.1 percent 
should be permanently prohibited from use in children's toys and child 
care articles. (CHAP 2014, pp. 95-99). Although DINP is less potent 
than DEHP, or other active phthalates, the CHAP reasoned that DINP is 
antiandrogenic and contributes to the cumulative risk from phthalates. 
(Id.).
b. Di-n-octyl Phthalate (DNOP)
    The CHAP concluded: ``DNOP does not appear to possess 
antiandrogenic potential; nonetheless, the CHAP is aware that DNOP is a 
potential developmental toxicant, causing supernumerary ribs, and a 
potential systemic toxicant, causing adverse effects on the liver, 
thyroid, immune system, and kidney. However, because the MoE in humans 
is likely to be very high, the CHAP does not find

[[Page 78330]]

compelling data to justify maintaining the current interim ban on the 
use of DNOP in children's toys and child care articles. Therefore, the 
CHAP recommends that the current ban on DNOP be lifted.'' (CHAP 2014, 
p. 95).
c. Diisodecyl Phthalate (DIDP)
    The CHAP concluded: ``DIDP does not appear to possess 
antiandrogenic potential; nonetheless, the CHAP is aware that DIDP is a 
potential developmental toxicant, causing supernumerary ribs, and a 
potential systemic toxicant, causing adverse effects on the liver and 
kidney. However, because DIDP is not considered in a cumulative risk 
with other antiandrogens, its MoE in humans is considered likely to be 
relatively high. The CHAP did not find compelling data to justify 
maintaining the current interim ban on the use of DIDP in children's 
toys and child care articles. Therefore, the CHAP recommends that the 
current ban on DIDP be lifted . . .'' (CHAP 2014, pp. 100-105).
3. Recommendations on Phthalates Not Currently Prohibited by the CPSIA
    The CHAP recommended that the Commission permanently prohibit the 
use of the following phthalates at levels greater than 0.1 percent in 
children's toys and child care articles: diisobutyl phthalate (DIBP) 
(CHAP 2014, pp. 110-112), di-n-pentyl phthalate (DPENP) (id., pp. 112-
113), di-n-hexyl phthalate (DHEXP) (id., pp. 114-116), and dicyclohexyl 
phthalate (DCHP) (id., pp. 116-118). These are antiandrogenic 
phthalates that adversely affect male reproduction development. The 
CHAP noted that current exposures to DIBP, DPENP, DHEXP, and DCHP are 
low and, therefore, ``. . . do not indicate a high level of concern.'' 
(CHAP 2014, p. 8). However, because they are active phthalates, they 
contribute to the cumulative risk from other antiandrogenic phthalates. 
Allowing their use in toys and child care articles would increase the 
cumulative risk to children. The CHAP also noted that DPENP is the most 
potent antiandrogenic phthalate. (CHAP 2014, pp. 112-113).
    In addition, the CHAP recommended that the Commission prohibit the 
use of diisooctyl phthalate (DIOP) on an interim basis at levels 
greater than 0.1 percent until sufficient data are available. (CHAP 
2014, pp. 118-119). DIOP has been detected, although rarely, in child 
care products. (Chen 1998). Although toxicity data on DIOP are limited, 
the CHAP concluded, ``. . . the isomeric structure of DIOP suggests 
that DIOP is within the range of the structure-activity characteristics 
associated with antiandrogenic activity.'' (CHAP 2014, pp. 118-119).
    The CHAP did not recommend to CPSC any action on the use of di(2-
propyl) heptyl phthalate (DPHP) in toys and child care articles, at 
this time. (CHAP 2014, pp. 120-121). However, the CHAP recommended that 
appropriate federal agencies obtain toxicity and exposure data for 
DPHP. The CHAP noted that most of the toxicity data are unpublished and 
were not available to the CHAP. DPHP does not appear to be 
antiandrogenic, based on limited information. However, the CHAP noted: 
``Currently, there is an undetermined frequency and duration of 
exposures; however, analytical methods cannot differentiate DPHP 
metabolites from DIDP metabolites because they are closely related.'' 
The CHAP noted further that production levels of DPHP have increased in 
recent years, suggesting that human exposure may also be increasing. 
(Id., p. 120).
    The CHAP did not recommend Commission action on dimethyl phthalate 
(DMP) (CHAP 2014, pp. 105-107) or diethyl phthalate (DEP). (Id., pp. 
107-109). However, the CHAP recommended that the U.S. federal agencies 
responsible for DEP exposures from food, pharmaceuticals, and personal 
care products perform the necessary risk assessments with a view to 
supporting risk management steps. (Id., p. 109).
4. Recommendations on Phthalate Alternatives
    The CHAP found that data on the six phthalate alternatives reviewed 
by the CHAP are generally limited. (CHAP 2014, pp. 121-142). The CHAP 
noted that CPSC staff has found four of the alternatives--acetyl 
tributyl citrate (ATBC); di(2-ethylhexyl) terephthalate (DEHT); 1,2-
cyclohexanedicarboxylic acid, diisononyl ester (DINX); and 2,2,4-
trimethyl-1,3 pentanediol diisobutyrate (TPIB)--in many children's toys 
and child-care articles. (Dreyfus 2010). Two of the alternatives--di(2-
ethylhexyl) adipate (DEHA) and tris(2-ethylhexyl) trimellitate (TOTM)--
have not been identified by CPSC staff in toys or child care articles, 
thus far. (Dreyfus, 2010). For all of the phthalate alternatives, the 
CHAP recommended obtaining additional data on exposure from all sources 
because many of the alternatives have multiple uses. The CHAP also 
recommended obtaining additional toxicity data on TPIB, ATBC, DINX, and 
TOTM.

III. CPSC Staff's Assessment of the CHAP Report

    CPSC staff assessed the CHAP report, examining whether the CHAP met 
the requirements of the CHAP's charge and whether the CHAP report was 
otherwise scientifically sound in its methodology, findings and 
recommendations.

A. Charge to the CHAP

    Section 108(b)(2)(B) of the CPSIA required the CHAP to ``. . . 
complete an examination of the full range of phthalates that are used 
in products for children. . . .'' To meet its charge, the CHAP reviewed 
all of the available toxicity data on 14 phthalates. The 14 phthalates 
included the six phthalates set forth in the CPSIA and eight additional 
phthalates selected on the basis of toxicity (i.e., male developmental 
reproductive effects) and exposure potential (e.g., availability of 
human biomonitoring data). The CPSIA also required the CHAP to consider 
the following:
     ``Examine all of the potential health effects (including 
endocrine disrupting effects) of the full range of phthalates.'' The 
CHAP examined all of the health effects associated with phthalates, 
including carcinogenicity, liver toxicity, and reproductive/
developmental toxicity. (CHAP 2014, pp. 13-29; Appendices A-C). As 
discussed in detail below, the CHAP conducted its cumulative risk 
assessment based on male developmental reproductive effects. The 
phthalate syndrome is due largely to the inhibition of testosterone 
production in the male fetus, which is a type of endocrine disruption. 
The CHAP's cumulative risk assessment focused on male developmental 
reproductive effects. (CHAP 2014, pp. 69-70).
     ``Consider the potential health effects of each of these 
phthalates both in isolation and in combination with other 
phthalates.'' To assess the potential health effects of phthalates in 
isolation, the CHAP used the MoE based on the most sensitive endpoint 
for each phthalate. (CHAP 2014, pp. 69-70). To assess the potential 
health effects of phthalates in combination, the CHAP conducted a 
cumulative risk assessment, based on male developmental reproductive 
effects. (Id.).
     ``Examine the likely levels of children's, pregnant 
women's, and others' exposure to phthalates, based on a reasonable 
estimation of normal and foreseeable use and abuse of such products.'' 
The CHAP assessed exposure by two complementary methods. Biomonitoring 
studies provide good

[[Page 78331]]

estimates of total exposure to phthalates but do not provide 
information on the sources of exposure. (CHAP 2014, pp. 34-48). The 
scenario-based approach estimates exposure to specific products and 
sources of exposure, including toys, child care articles, and personal 
care products. (CHAP 2014, pp. 49-60; Appendices E1-E3).
     ``Consider the cumulative effect of total exposure to 
phthalates, both from children's products and from other sources, such 
as personal care products.'' The CHAP conducted a cumulative risk 
assessment, based on total phthalate exposure, as estimated from 
biomonitoring studies. (CHAP 2014; pp. 61-68; Appendix D).
     ``Review all relevant data, including the most recent, 
best-available, peer-reviewed, scientific studies of these phthalates 
and phthalate alternatives that employ objective data collection 
practices or employ other objective methods.'' The CHAP reviewed all of 
the available data on phthalates, including publications in peer-
reviewed scientific journals; reports submitted by manufacturers to the 
U.S. EPA; \10\ and authoritative reviews from agencies such as the 
Agency for Toxic Substances and Disease Registry (ATSDR), the European 
Chemical Agency (ECHA), the International Agency for Research on Cancer 
(IARC), Center for the Evaluation of Research on Human Reproduction 
(CERHR), National Toxicology Program (NTP); and the National Research 
Council (NRC). (CHAP, 2014, p. 12). In addition, the CHAP invited 
scientific experts to present their latest research in areas such as 
biomonitoring, epidemiology, phthalate syndrome, toxicology of 
phthalates mixtures, phthalates mode of action, and species 
differences. The CHAP also invited a co-author of an NRC report (NRC, 
2009) to present the NRC panel's perspective on risk assessment 
methodology, especially as applied to phthalates risk assessment. 
Furthermore, the CHAP heard testimony from federal agency scientists, 
as well as scientists representing manufacturers of phthalates 
alternatives.
---------------------------------------------------------------------------

    \10\ For example, toxicity data submitted under Sec.  8(e) of 
the Toxic Substances Control Act.
---------------------------------------------------------------------------

     ``Consider the health effects of phthalates not only from 
ingestion but also as a result of dermal, hand-to-mouth, or other 
exposures.'' The CHAP estimated phthalate exposure by two methods. 
Biomonitoring studies estimated total exposure, regardless of source or 
route of exposure. (CHAP 2014, pp. 34-48). The scenario-based approach 
estimated exposure to specific products and sources of exposure by all 
routes of exposure, including oral, dermal, inhalation, and hand-to-
mouth. (CHAP 2014, pp. 49-60; Appendices E1-E3).
     ``Consider the level at which there is a reasonable 
certainty of no harm to children, pregnant women, or other susceptible 
individuals and their offspring, considering the best available 
science, and using sufficient safety factors to account for 
uncertainties regarding exposure and susceptibility of children, 
pregnant women, and other potentially susceptible individuals.'' For 
antiandrogenic phthalates, the CHAP derived reference doses (PEAAs) 
that were specific for male developmental reproductive effects. (CHAP 
2014, Table 2.15). For non-antiandrogenic phthalates and phthalate 
alternatives, the CHAP selected appropriate NOAELs that were based on 
the most sensitive endpoint. (Id., pp. 79-142, Appendices A-B). The 
CHAP also recommended the use of additional uncertainty factors (safety 
factors) for selected compounds where the database was limited (ATBC 
and DEHA).
     ``Consider possible similar health effects of phthalate 
alternatives used in children's toys and child care articles.'' The 
CHAP considered all health effects associated with six phthalate 
alternatives and, where sufficient data were available, estimated the 
potential health risks based on the most sensitive health endpoint. 
(CHAP, 2014, pp. 121-142, Appendices A-B).
    Furthermore, section 108(b)(2)(B) required the CHAP to perform its 
examination de novo. ``The findings and conclusions of any previous 
Chronic Hazard Advisory Panel on this issue and other studies conducted 
by the Commission shall be reviewed by the panel but shall not be 
considered determinative.'' Although the CHAP considered previous CHAP 
reports and CPSC staff reports, the CHAP also conducted its own review 
of the scientific literature (including studies conducted by phthalate 
manufacturers) and invited experts to present their most recent 
research. (CHAP, 2014, p. 12).
    Finally, section 108(b)(2)(C) required the CHAP to ``make 
recommendations to the Commission regarding any phthalates (or 
combinations of phthalates) in addition to those identified in 
subsection (a) or phthalate alternatives that the panel determines 
should be declared banned hazardous substances.'' The CHAP completed 
its charge by making recommendations to prohibit additional phthalates 
(id., pp. 110-117), make the interim prohibition of DINP permanent 
(id., pp. 95-99), lift the interim prohibitions of DNOP (id., pp. 91-
94) and DIDP (id., pp. 100-104), and prohibit DIOP on an interim basis 
(id., pp. 118-119).
    The staff concluded that the CHAP fully met the charge in section 
108 of the CPSIA.

B. Selection of Phthalates and Phthalates Alternatives

    The CHAP selected phthalates for inclusion in its examination based 
on the following non-exclusive criteria: inclusion in the CPSIA, 
availability of human biomonitoring data, potential for exposure, and 
evidence of male developmental reproductive toxicity. (CHAP, 2014, pp. 
22-23):
     Six phthalates subject to the CPSIA--DBP, BBP, DEHP, DNOP, 
DINP, and DIDP;
     Availability of biomonitoring data--DMP, DEP, DIBP, in 
addition to the six phthalates subject to the CPSIA;
     Increasing production, which suggests increasing 
exposure--DPHP; and
     Ability to induce male developmental reproductive 
effects--DIBP, DPENP, DHEXP, and DCHP. (Id., p. 16).
    The CPSC staff concurs with the CHAP's selection of phthalates 
because the 14 phthalates that the CHAP reviewed include phthalates 
with high exposure potential and phthalates that contribute to the 
cumulative risk for male developmental reproductive effects.
    The CHAP selected six phthalate alternatives for study, either 
because they were known to be used in children's toys and child care 
articles (ATBC, DEHT, DINX, TPIB) (Dreyfus 2010) or because they were 
considered likely to be used (DEHA, TOTM) (CHAP, 2014; p. 23; Versar/
SRC, 2010a). CPSC staff recognizes that there is a broad range of 
potential phthalate alternatives (Versar/SRC, 2010a), including 
phthalates that are not prohibited by the CPSIA. Nonetheless, CPSC 
staff agrees with the CHAP's choice of phthalate alternatives because 
it includes all of the non-phthalate plasticizers known to be used in 
toys and child care articles (Dreyfus 2010; TAB B), as well as other 
commonly used plasticizers. After the CHAP completed its report, CPSC 
staff identified DPHP in children's toys; DPHP is an emerging phthalate 
that was included in the CHAP report.

C. Selection of Health Endpoint

    After reviewing all of the available toxicity data on 14 
phthalates, the CHAP selected male developmental reproductive toxicity 
as the critical endpoint for its cumulative risk assessment. (CHAP 
2014, pp. 13). CPSC

[[Page 78332]]

staff supports the selection of male developmental reproductive 
toxicity for several reasons. Male developmental reproductive effects 
in animals are associated with many of the most common phthalates. For 
most of the active phthalates, these effects are the most sensitive 
health effect; that is, these effects are observed at lower doses than 
other adverse health effects (see CPSC staff and contractor reports at 
https://www.cpsc.gov/chap). Male developmental reproductive effects 
(phthalate syndrome) are of particular concern because they may 
adversely affect human reproduction. Furthermore, the phthalate 
syndrome in animals bears a striking resemblance to the testicular 
dysgenesis syndrome in humans. (Skakkebaek et al., 2001).
    The availability of empirical evidence also supports the choice to 
base the cumulative risk assessment on male developmental reproductive 
effects because such evidence eliminates the need to make critical 
assumptions that might not be borne out. Specifically, empirical 
evidence demonstrates that mixtures of active phthalates interact in a 
dose-additive fashion with respect to developmental male reproductive 
effects. (Howdeshell et al., 2007, 2008; Hannas et al., 2011b, 2012). 
Thus, it was not necessary for the CHAP to make any assumptions 
regarding the effects of phthalate mixtures. Most other health effects 
of phthalates have not been studied with mixtures; performing a 
cumulative risk assessment on any other endpoint would require 
assumptions regarding the mode of action and possible mixture effects.
    Furthermore, the male developmental reproductive effects of 
phthalates are well-studied. (Reviewed in Foster, 2006). These effects, 
which were first reported in 1980 (Foster et al., 1980), persist into 
adulthood, even in the absence of further exposure (Barlow and Foster, 
2003; Barlow et al., 2004; McIntyre et al., 2001). Similar effects have 
been reported in multiple mammalian species, including guinea pigs 
(Gray et al., 1982), mice, (Gray et al., 1982; Moody et al., 2013; Ward 
et al., 1998), rabbits (Higuchi et al., 2003), and ferrets (Lake et 
al., 1976). Hamsters were resistant due to slow metabolism of the 
phthalate ester to the monoester, which is believed to be the active 
metabolite. Hamsters responded to the monoester, however. (Gray et al., 
1982). The observation of similar effects in multiple species 
demonstrates that these effects are not unique to rats. Based on the 
CPSC chronic hazard guidelines, the CPSC staff regards active 
phthalates as ``probably toxic to humans,'' based on ``sufficient 
evidence'' in animal studies. (CPSC, 1992).
    Other authors also have selected male developmental reproductive 
effects as the basis of cumulative risk assessments of phthalates. The 
U.S. Environmental Protection Agency (EPA) convened a National Research 
Council (NRC) committee to consider approaches to assessing the 
cumulative risk of phthalates; the committee recommended using male 
developmental reproductive effects as the basis for a cumulative risk 
assessment. (NRC, 2008). Additionally, two subsequent publications 
conducted cumulative risk assessments based on male developmental 
reproductive effects. (Benson, 2009; Christensen et al., 2014).
    CPSC staff recognizes that a number of other health effects are 
associated with phthalates. (Reviewed in Babich, 2010). Although some 
phthalates are associated with cancer, cancer is only associated with a 
relatively small number of phthalates, and many of the cancers induced 
by phthalates are of uncertain relevance to humans. (CHAP, 2001; CPSC, 
2002; Klaunig et al., 2003). Other effects, such as liver toxicity, are 
common to most phthalates; but there are little or no data available on 
mode of action or the effects of mixtures. Thus, there is less 
scientific basis for performing a cumulative risk assessment with liver 
toxicity as the critical endpoint.
    Finally, a growing number of epidemiological studies have reported 
associations of phthalate exposure with adverse health effects in 
humans. (As cited in CHAP 2014, pp. 27-33, Appendix C). Many of these 
adverse health effects are consistent with the effects in animal 
studies. The staff concludes that the epidemiological studies, though 
not conclusive on their own, provide supporting evidence that the 
animal studies are relevant to humans.
    Therefore, CPSC staff supports using male developmental 
reproductive effects as the basis for the CHAP's cumulative risk 
assessment due to the importance of the endpoint; the abundance of 
data, the known additive nature of phthalate mixtures regarding male 
developmental reproductive effects, and NRC's recommendation.

D. Methodology

1. Hazard Index
    The CHAP chose the hazard index (HI) approach for its cumulative 
risk assessment because that index is widely accepted for this purpose. 
(Teuschler and Hertzberg, 1995). The National Research Council (NRC, 
2008) recommended this approach for phthalates cumulative risk 
assessment. Two other publications on phthalates' cumulative risk also 
used the HI approach. (Benson, 2009; Christensen et al., 2014). 
ExxonMobil scientists \11\ also recommended the HI approach to CPSC in 
2010, before the CHAP met for the first time.
---------------------------------------------------------------------------

    \11\ ``Approach to Cumulative Risk,'' presented to the CPSC 
staff, March 2010. https://www.cpsc.gov/PageFiles/125812/CummRiskExxon03232010.pdf.
---------------------------------------------------------------------------

    The CHAP found that up to 10 percent of pregnant women and up to 5 
percent of infants, those with the highest exposure, have a HI greater 
than one. The portion of the population with a HI greater than one may 
be at risk for the adverse effects of phthalates. (EPA, 1993). This 
does not necessarily mean that anyone will suffer adverse effects; 
however, one cannot rule out the possibility of adverse effects. The 
greater the HI, the greater the risk.
    Although the HI approach is widely accepted, the CHAP introduced a 
novel process to calculate the HI. The CHAP calculated hazard quotients 
(HQ) and a HI for each individual in the population of interest (i.e., 
pregnant women or infants), and then derived distributions of the HI. 
This was necessary because each individual is exposed to phthalates in 
differing proportions. For example, some individuals may be exposed 
almost exclusively to a single phthalate, while others may be exposed 
to several phthalates in roughly equal proportion. After calculating 
the HQs and HIs for all individuals, the CHAP then generated frequency 
distributions for the HI. This process allowed the CHAP to estimate the 
average and 95th percentile of the HI, as well as the portion of the 
population with a HI greater than one.
    The alternative to the CHAP's approach would be to calculate hazard 
quotients using summary data on metabolite levels, that is, median and 
95th percentile levels (e.g., Benson, 2009). This would have allowed 
the CHAP to estimate median and 95th percentile hazard quotients for 
each phthalate. Under this approach, the median hazard quotients are 
summed to calculate the average HI, which would be roughly similar to 
the median hazard quotient calculated as above. However, summing the 
95th percentile values would overestimate the 95th percentile HI. 
Therefore, the CHAP introduced this novel process to calculate the 
hazard quotients and HI more accurately, especially at the upper-bound 
(e.g., 95th percentile) exposures. Had the CHAP not applied this novel 
approach, the result would have been an overestimate

[[Page 78333]]

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

[[Page 78334]]

reproductive effects in animals are appropriate for estimating risks to 
humans.

IV. Commission Assessment of the CHAP Report's Recommendations for the 
Proposed Rule

    As discussed in the staff's briefing package, staff assessed the 
recommendations of the CHAP. The Commission agrees with the staff's 
assessment and provides the following explanation.

A. Interim Prohibited Phthalates: DINP, DIDP, and DNOP

    Section 108(b)(3)(A) of the CPSIA requires the Commission to 
determine, based on the CHAP report, whether to continue in effect the 
interim prohibitions on children's toys that can be placed in a child's 
mouth and child care articles containing DINP, DIDP, and DNOP ``to 
ensure a reasonable certainty of no harm to children, pregnant women, 
or other susceptible individuals with an adequate margin of safety.'' 
For each phthalate, the Commission must decide whether to make the 
interim prohibitions permanent.
    Consistent with the CHAP and the statutory framework, the 
Commission considered both cumulative risk and risk in isolation. For 
active phthalates, that is, phthalates causing male developmental 
reproductive effects, the Commission considered the cumulative risk, 
which was based on the HI. Consistent with the CHAP report and the CPSC 
chronic hazard guidelines (CPSC, 1992), the Commission considers that 
the acceptable risk is exceeded when the HI is greater than one (CPSC, 
1992). Thus, the Commission considers that an HI <1 is necessary ``to 
ensure a reasonable certainty of no harm to children, pregnant women, 
or other susceptible individuals with an adequate margin of safety.''
    For non-antiandrogenic phthalates and phthalate alternatives, the 
Commission considered the MoE, as estimated by the CHAP. MoEs greater 
than 100-1,000 are generally considered adequate to protect human 
health (EPA, 1993). As discussed above, the staff considers a MoE of 
100 or more to be adequate if a NOAEL has been identified in animal 
studies (CPSC, 1992), which is the case for most of the compounds 
discussed by the CHAP. Thus, for the phthalates discussed in this 
section, the Commission considers a MoE of 100 or greater to be 
necessary ``to ensure a reasonable certainty of no harm to children, 
pregnant women, or other susceptible individuals with an adequate 
margin of safety.''
1. Di-n-octyl Phthalate (DNOP)
    The CHAP recommended that the interim prohibition on DNOP not be 
continued (CHAP 2014, pp. 91-95). The CHAP concluded: ``DNOP does not 
appear to possess antiandrogenic potential'' (CHAP, 2014, pp. 24, 95), 
and therefore, DNOP does not contribute to the cumulative risk from 
other phthalates. Thus, the CHAP considered DNOP risks in isolation 
because DNOP is not antiandrogenic. As with virtually all chemicals, 
DNOP is associated with toxicological effects, including liver toxicity 
and developmental effects. The CHAP did not use biomonitoring data to 
estimate DNOP exposure because DNOP metabolites were undetectable in 
most individuals. Using the scenario-based approach, the CHAP estimated 
exposures to infants and toddlers ranging from 4.5 to16 [micro]g/kg-d. 
The margins of exposure (MoEs) \12\ ranged from 2,300 to 8,300. The 
CHAP considered an MoE of at least 100 to be adequate to protect human 
health from the potential effects of DNOP. The CHAP concluded that the 
MoE for DNOP was sufficiently high and that continuing the interim 
prohibition was unnecessary. Therefore, the CHAP recommended removing 
the interim prohibition on children's toys and child care articles 
containing DNOP.
---------------------------------------------------------------------------

    \12\ The margin of exposure (MoE) is the ratio of the NOAEL to 
the estimated exposure.
---------------------------------------------------------------------------

    The Commission considers that a MoE of 100 or greater is sufficient 
to protect human health with respect to DNOP. The Commission agrees 
with the CHAP's assessment of the potential health risks from DNOP 
because the MoEs are greater than 100. DNOP levels are so low that they 
are not detectable in about 90 percent of humans. (CHAP 2014, Table 
2.6). Furthermore, DNOP is not antiandrogenic, and therefore, DNOP does 
not contribute to the cumulative risk from antiandrogenic phthalates. 
The Commission concludes that continuing the prohibition of DNOP is not 
necessary to ensure a reasonable certainty of no harm to children, 
pregnant women, or other susceptible individuals with an adequate 
margin of safety. Accordingly, under the proposed rule, children's toys 
that can be placed in a child's mouth and child care articles 
containing DNOP would no longer be prohibited.
2. Diisononyl Phthalate (DINP)
    DINP is currently subject to an interim prohibition. The CHAP 
recommended that ``the interim prohibition on the use of DINP in 
children's toys and child care articles at levels greater than 0.1 
percent be made permanent.'' (CHAP, 2014, pp. 95-99). DINP is 
associated with adverse effects on male development 
(antiandrogenicity). In addition, DINP acts in concert with other 
antiandrogenic phthalates, including the permanently banned phthalates, 
thereby contributing to the cumulative risk.
    Multiple published studies confirm the antiandrogenicity of DINP 
(Adamsson et al., 2009; Boberg et al., 2011; Borch et al., 2004; 
Clewell et al., 2013; Gray et al., 2000; Hannas et al., 2011b; Hass et 
al., 2003; Masutomi et al., 2003; reviewed in NRC, 2008). Even though 
DINP is less potent, by perhaps twofold to tenfold, than DEHP (Gray et 
al., 2000; Hannas et al., 2011b), DINP contributes to the cumulative 
risk from all antiandrogenic phthalates. The CHAP estimated that DINP 
contributes 1 percent to 8 percent of the cumulative risk to pregnant 
women and 1 percent to 15 percent in infants (Table 1). The CHAP found 
that 10 percent of pregnant women and up to 5 percent of infants have a 
HI greater than one. The CHAP also estimated that allowing the use of 
DINP in children's toys and child care articles would increase DINP 
exposure to infants by about 13 percent. (CHAP 2014, Table E1-21).
    The Commission notes that the CHAP assessed the risks of DINP both 
in isolation and in combination with other phthalates. Considered in 
isolation, staff concluded that DINP would not present a hazard to 
consumers because the MoE (830 to 15,000) is well in excess of 100. 
(CHAP, 2014, p. 99). This is consistent with previous work. (CHAP, 
2001; CPSC, 2002). However, the Commission agrees with the CHAP that 
DINP is antiandrogenic and contributes to the cumulative risk. 
Specifically, the CHAP found that 10 percent of pregnant women and up 
to 5 percent of infants have a HI greater than one. Therefore, as 
discussed previously, the Commission concludes that the cumulative risk 
of male developmental reproductive effects should be considered ``to 
ensure a reasonable certainty of no harm to children, pregnant women, 
or other susceptible individuals with an adequate margin of safety.''
    The Commission agrees with the CHAP's recommendation to make 
permanent the prohibition on DINP because the Commission concludes that 
allowing the use of DINP in children's toys and child care articles 
would further increase the cumulative risk to male developmental 
reproductive development. Multiple studies indicate that DINP is 
antiandrogenic and contributes to the cumulative risk from phthalates. 
As discussed previously, the Commission considers that a HI <1 is

[[Page 78335]]

necessary ``to ensure a reasonable certainty of no harm to children, 
pregnant women, or other susceptible individuals with an adequate 
margin of safety.'' Therefore, to ensure a reasonable certainty of no 
harm with an adequate margin of safety to children, pregnant women, or 
other susceptible individuals (i.e., male fetuses), the proposed rule 
would permanently prohibit children's toys and child care articles 
containing more than 0.1 percent of DINP.
    The statute's interim prohibition on DINP applies only to 
children's toys that can be placed in a child's mouth,\13\ which is 
narrower in scope than the permanent prohibitions on DEHP, DBP, and BBP 
in all children's toys.\14\ The CHAP recommended that DINP be 
permanently prohibited in all children's toys but did not explain why 
the CHAP recommended expanding the prohibition on DINP to include all 
children's toys. However, the CHAP's recommendation is consistent with 
the scope of the permanently prohibited phthalates.
---------------------------------------------------------------------------

    \13\ CPSIA Sec.  108(b)(1).
    \14\ CPSIA Sec.  108(a).
---------------------------------------------------------------------------

    The proposed rule would permanently prohibit DINP in all children's 
toys and child care articles, rather than only children's toys that can 
be mouthed. The Commission believes that the expansion in scope is 
appropriate because exposure occurs from handling children's toys, as 
well as from mouthing. (CHAP, 2014, Appendix E1). The additional 
exposure from handling toys would add to the cumulative risk. 
Therefore, the Commission concludes that expanding the scope of the 
DINP prohibition to include all children's toys is necessary to ensure 
a reasonable certainty of no harm to children with an adequate margin 
of safety.
    The European Commission (EC) directive on phthalates in toys and 
child care articles also distinguished between all children's toys and 
toys that can be mouthed, prohibiting DBP, BBP, and DEHP in all 
children's toys, and prohibiting DINP, DNOP, and DIDP in toys that can 
be mouthed. (EC, 2005). The directive cited greater uncertainty about 
hazards presented by DINP, DNOP, and DIDP as the reason for this 
distinction. (EC, 2005, paragraph 11). As discussed in the CHAP report, 
there are multiple studies related to the male developmental 
reproductive effects of DINP, many of which were published after 2005, 
the date of the ECdirective. Thus, the Commission concludes that 
because the CHAP report addresses uncertainties regarding the potential 
hazard associated with DINP, an expansion of the prohibition on DINP to 
all children's toys is appropriate.
    Additionally, we expect that expanding the scope to all children's 
toys would have a minimal effect on manufacturers because few products 
would need to be reformulated to comply with the broader scope. (See 
Tab A of the staff's briefing package.) In practice, children's toys 
and toys that can be placed in a child's mouth all require testing for 
phthalates. The testing costs are the same in either case. The only 
change caused by expanding the scope to all children's toys is that 
toys too large to be mouthed could not be made with DINP.
3. Diisodecyl Phthalate (DIDP)
    The CHAP recommended that the interim prohibition on DIDP not be 
continued. (CHAP, 2014, pp. 100-105). DIDP is not associated with 
antiandrogenicity. Thus, DIDP does not contribute to the cumulative 
risk from the antiandrogenic phthalates. As with virtually all 
chemicals, DIDP is associated with toxicological effects, including 
liver toxicity and developmental effects. The CHAP assessed the 
potential risks from DIDP in isolation. The CHAP concluded that the MoE 
for DIDP is relatively high (>100) and that there is no compelling 
reason to continue the interim prohibition.
    The CHAP concluded: ``DIDP does not appear to possess 
antiandrogenic potential'' (CHAP, 2014, pp. 24, 104); therefore, DIDP 
does not contribute to the cumulative risk (CHAP 2014, p. 104). 
However, the CHAP stated that it is aware that DIDP is associated with 
other health effects in animal studies, including chronic liver and 
kidney toxicity and developmental effects (e.g., supernumerary ribs). 
(CHAP 2014, pp. 100-105). The CHAP considered DIDP risks in isolation 
because DIDP is not antiandrogenic. The lowest NOAEL for DIDP was 15 
mg/kg-d, based on liver effects. Using biomonitoring data, the CHAP 
estimated that human exposures range from 1.5 to 26 [micro]g/kg-d. The 
MoEs range from 2,500 to 10,000 for median DIDP exposures and 586 to 
3,300 for upper-bound exposures. Therefore, the CHAP recommended that 
the interim prohibition on children's toys and child care articles 
containing DIDP be lifted.
    As discussed previously, the Commission considers that a MoE of 100 
or greater is sufficient to protect human health with respect to DIDP. 
The Commission agrees with the CHAP's assessment of the potential 
health risks from DIDP because the MoEs are much greater than 100. DIDP 
exposure would need to increase by more than 250 times to exceed the 
acceptable level. Furthermore, DIDP is not antiandrogenic; and 
therefore, DIDP does not contribute to the cumulative risk from 
antiandrogenic phthalates. The Commission concludes that continuing the 
prohibition of DIDP is not necessary to ensure a reasonable certainty 
of no harm to children, pregnant women, or other susceptible 
individuals with an adequate margin of safety. Accordingly, under the 
proposed rule, children's toys and child care articles containing DIDP 
would no longer be prohibited.

B. Phthalates Not Prohibited by the CPSIA

    The CPSIA requires the Commission to ``evaluate the findings and 
recommendations of the Chronic Hazard Advisory Panel and declare any 
children's product containing any phthalates to be a banned hazardous 
product under section 8 of the Consumer Product Safety Act (15 U.S.C. 
2057), as the Commission determines necessary to protect the health of 
children.'' CPSIA section 108(b)(3)(B). The CHAP reviewed the potential 
health risks associated with eight phthalates that were not prohibited 
by the CPSIA. The CHAP recommended permanent prohibitions on four 
additional phthalates: DIBP, DPENP, DHEXP, and DCHP. The CHAP 
recommended an interim prohibition of DIOP. The CHAP did not recommend 
prohibitions on DMP, DEP, or DPHP; although the CHAP recommended 
additional study on DEP and DPHP.
    Consistent with the CHAP report, the Commission considered both 
cumulative risk and risk in isolation. For active phthalates, that is, 
phthalates causing male developmental reproductive effects, the 
Commission considered the cumulative risk, which was based on the HI. 
Consistent with the CHAP report and the CPSC chronic hazard guidelines 
(CPSC 1992), the Commission considers that the acceptable risk is 
exceeded when the HI is greater than one (CPSC 1992). Thus, the 
Commission considers that a HI <1 is necessary ``to protect the health 
of children.''
    For non-antiandrogenic phthalates and phthalate alternatives, the 
Commission considered the MoE, as estimated by the CHAP. MoEs greater 
than 100 to 1,000 are generally considered adequate to protect human 
health (EPA 1993). As discussed previously, staff considers a MoE of 
100 or more to be adequate if a NOAEL has been identified in animal 
studies (CPSC 1992), which is the case for most of the

[[Page 78336]]

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

[[Page 78337]]

4. Dicyclohexyl Phthalate (DCHP)
    The CHAP recommended that dicyclohexyl phthalate (DCHP) should be 
permanently banned from use in children's toys and child care articles 
at levels greater than 0.1 percent. (CHAP pp. 116-118). DCHP is 
associated with adverse effects on male reproductive development and 
contributes to the cumulative risk from antiandrogenic phthalates.
    The Commission agrees with the CHAP's recommendation for DCHP. 
Based on previous CPSC staff and contractor reviews (Versar/SRC, 2010b) 
and the CHAP's review, the Commission concludes that there is 
sufficient evidence to conclude that DCHP is antiandrogenic and is able 
to contribute to the cumulative risk (e.g., Foster et al., 1980). The 
Commission also concludes that, by applying the CPSC chronic hazard 
guidelines (CPSC, 1992), this phthalate is considered ``probably 
toxic'' to humans, based on sufficient evidence in animal studies. Up 
to five percent of infants and up to 10 percent of pregnant women 
exceed the negligible risk level (HI >1). Allowing the use of DCHP in 
children's toys and child care articles would further increase the 
cumulative risk. As discussed previously, the Commission considers that 
a HI <1 is necessary ``to protect the health of children.'' Although 
the CPSC staff has not detected DCHP in toys and child care articles 
during routine compliance testing thus far, prohibiting the use of DCHP 
would prevent its use as a substitute for other banned phthalates. The 
Commission concludes that this action is necessary to protect the 
health of children because it would prevent future use of this 
antiandrogenic phthalate in toys and child care articles.
5. Diisooctyl Phthalate (DIOP)
    The CHAP recommended an interim prohibition for diisooctyl 
phthalate (DIOP). (CHAP 2014, pp. 118-119). DIOP has a chemical 
structure consistent with other antiandrogenic phthalates.
    DIOP is a high production volume chemical (EPA 2006), that is, over 
a million pounds are produced or imported each year (Versar/SRC, 
2010d). DIOP is approved for use in food contact applications. (CHAP 
2014, pp. 118-119). DIOP was identified in a small number of child care 
articles in the past (Chen, 2002); although it has not been detected by 
CPSC in children's toys and child care articles since the CPSIA was 
enacted in 2008.
    The possible antiandrogenicity of DIOP is a potential concern (CHAP 
2014, pp. 118-119). However, the CHAP concluded that there is not 
sufficient evidence to support a permanent prohibition. The only 
developmental study on DIOP is an older study in which DIOP was 
administered by intraperitoneal injection, which is not relevant to 
consumer exposures. The study's authors reported the presence of soft 
tissue abnormalities, a type of birth defect; but there were 
insufficient details to assess whether the abnormalities could be 
related to the phthalate syndrome. (Versar/SRC, 2010d). The primary 
reason for suspecting antiandrogenic activity is DIOP's structural 
similarity to other active phthalates (CHAP 2014, p. 119).
    The CHAP did not recommend a permanent prohibition because the CHAP 
concluded that existing data are insufficient to support a permanent 
ban. Although the CHAP recommended an interim prohibition, the CPSIA 
did not provide for an interim prohibition as an option for the 
Commission's rule under section 108. CPSIA section 108(b)(3). As 
discussed above, insufficient data exists to determine that a permanent 
prohibition of DIOP is necessary to protect the health of children. 
Thus, the Commission is not proposing any prohibition of products 
containing DIOP.

C. Scope of Phthalate Prohibitions

    Currently, under section 108(a) of the CPSIA, the permanent 
phthalate prohibitions apply to ``any children's toy or child care 
article that contains concentrations of more than 0.1 percent'' of the 
permanently prohibited phthalates. In addition, under section 108(b)(1) 
of the CPSIA, the interim phthalate prohibitions apply to ``any 
children's toy that can be placed in a child's mouth or child care 
article that contains concentrations of more than 0.1 percent.'' 
Section 108(g)(1)(B) of the CPSIA defines a ``children's toy'' as ``a 
consumer product designed or intended by the manufacturer for a child 
12 years of age or younger for use by the child when the child plays.'' 
Section 108(g)(1)(C) of the CPSIA defines a ``child care article'' as 
``a consumer product designed or intended by the manufacturer to 
facilitate sleep or the feeding of children age 3 and younger, or to 
help such children with sucking or teething.'' Finally, section 
108(g)(2)(B) states that a ``toy can be placed in a child's mouth if 
any part of the toy can actually be brought to the mouth and kept in 
the mouth by a child so that it can be sucked and chewed. If the 
children's product can only be licked, it is not regarded as able to be 
placed in the mouth. If a toy or part of a toy in one dimension is 
smaller than 5 centimeters, it can be placed in the mouth.''
    Section 108(b)(3)(B) of the CPSIA requires the Commission to 
``evaluate the findings and recommendations'' of the CHAP and consider 
whether to prohibit ``any children's product containing any 
phthalates'' if the Commission determines that this is ``necessary to 
protect the health of children.'' Action by the Commission under this 
subsection could result in extending the phthalates prohibition beyond 
children's toys and child care articles and could be taken for any or 
all of the phthalates the proposed rule would prohibit, including those 
that are permanently prohibited, were subject to the interim 
prohibition, or that would be prohibited by the proposed rule. A 
``children's product'' is defined as a ``a consumer product designed or 
intended primarily for children 12 years of age or younger.'' 15 U.S.C. 
2052(a)(2). Children's products that are not children's toys or child 
care articles that might contain phthalates, for example, include 
rainwear, footwear, backpacks, some school supplies, apparel containing 
elastic waistbands, and printed T-shirts and sweatshirts.
    The CHAP report did not specifically discuss the possibility of 
expanding the scope of the phthalates prohibitions to children's 
products. That inquiry was not part of the CHAP's charge. CPSIA section 
108(b)(2). However, all of the CHAP's recommendations to prohibit 
certain phthalates apply to ``children's toys and child care 
articles.''
    In the CHAP's scenario-based exposure assessment, the CHAP 
initially considered assessing exposures to phthalates for some 
children's products that were not toys or child care articles.\15\ The 
CHAP ultimately decided, however, to limit its analysis to exposure 
activity scenarios that were thought to contribute significantly to 
human exposure. Specifically, these exposure activity scenarios 
included mouthing of teethers and toys, and dermal exposure to play 
pens and changing pads (CHAP 2014, Table 2.1). The CHAP found that most 
phthalate exposure comes from food and beverages (CHAP, 2014, pp. 50-
52). Mouthing teethers and toys may also contribute to total exposure 
(See also, CHAP 2014, Table E1-24).
---------------------------------------------------------------------------

    \15\ CPSC staff meeting with Dr. Lioy. May 3, 2011. https://www.cpsc.gov//PageFiles/157051/Meeting%20Log%20050311.pdf.
---------------------------------------------------------------------------

    The Commission is not proposing to expand the scope of the 
phthalates prohibitions to include all children's products. The 
Commission does not

[[Page 78338]]

have sufficient information to assess the impact on the health of 
children from expanding the phthalates prohibition from children's toys 
and child care articles to include other children's products. In 
addition, the limited information available suggests that increased 
exposure to phthalates from most children's products outside children's 
toys and child care articles would be negligible. The Commission 
believes this for two reasons. First, the broader category of all 
children's products is likely to contain proportionately fewer products 
that contain phthalates. (Laursen et al., 2003). Second, the exposure 
activity patterns, in combination with the primary exposure route 
(dermal), would generally lead to lower exposures than with children's 
toys (CHAP, 2001, 2014; CPSC, 2002).
    Based on the limited available data, the Commission notes that most 
children's products are not made of PVC and are not expected to contain 
phthalates. For example, most textiles contain less than 0.01 percent 
phthalates (Laursen et al., 2003). Thus, with a few possible 
exceptions, such as PVC sandals (CHAP, 2001; T[oslash]nning et al., 
2009), the Commission does not expect other children's products to 
contribute significantly to phthalate exposure.
    Determining the relative importance of various exposure activity 
pathways (e.g., playing with plastic toys, sitting on a vinyl couch) 
can be challenging. For example, much more data are available on 
exposure from mouthing teethers and toys than dermal exposure (CHAP 
2014, Appendix E1; (CHAP, 2001). Thus, regarding DINP, the CHAP 
concluded: ``Although dermal uptake of DINP may occur through prolonged 
contact of DINP-containing products with skin or mouth, data on the 
prevalence of DINP in consumer products are not available and there is 
a fundamental uncertainty concerning the magnitude of dermal DINP 
uptake. Therefore, estimation of potential dermal exposure to humans 
remains speculative.'' (CHAP, 2001, p. 3).
    The Commission agrees that oral exposure to phthalates is generally 
considered more important than dermal exposure. (CHAP, 2001; Wormuth et 
al., 2006). Studies of children's mouthing activity demonstrate that 
children age 3 or younger primarily mouth their fingers, pacifiers, 
teethers, and toys. (EPA, 2011; Greene, 2002; Juberg et al., 2001). 
Mouthing of other articles is infrequent. (Id.). Mouthing times for 
pacifiers, teethers, and plastic toys are 12-15-fold and 20-64-fold 
higher than all other objects, including other children's products. 
(EPA, 2011). Mouthing activity declines rapidly after age 3 years. 
(Greene, 2002).
    Because the Commission believes that increased exposure to 
phthalates from most children's products would be negligible, the 
Commission concludes that expanding the phthalate prohibition beyond 
children's toys and child care articles is not warranted.

D. Concentration Limit

    Section 108(a) and (b)(1) of the CPSIA sets a concentration limit 
of 0.1 percent for the permanently and interim-prohibited phthalates in 
children's toys and child care articles. This is a statutory limit. 
However, if the Commission chooses to prohibit additional phthalates, 
the agency could choose to set a different limit for the additional 
phthalates, as well as for any interim-prohibited phthalates that are 
being permanently prohibited under this rulemaking. As discussed in the 
CHAP report:

    The CPSIA prohibits the use of certain phthalates at levels 
greater than 0.1%, which is the same level used by the European 
Commission. When used as plasticizers for polyvinyl chloride (PVC), 
phthalates are typically used at levels greater than 10%. Thus, the 
0.1% limit prohibits the intentional use of phthalates as 
plasticizers in children's toys and child care articles but allows 
trace amounts of phthalates that might be present unintentionally. 
There is no compelling reason to apply a different limit to other 
phthalates that might be added to the current list of phthalates 
permanently prohibited from use in children's toys and child care 
articles.

    (CHAP, 2014, p. 79). The CHAP found no compelling reason to support 
lowering or raising the concentration limit. The Commission agrees with 
the CHAP that the 0.1 percent limit is not risk-based; rather, the 
limit is based on practical considerations, that is, the desire to 
prohibit intentional phthalate use while allowing trace levels.
    Therefore, the Commission concludes that there is no risk-based 
justification to change the limit from the 0.1 percent level specified 
in the CPSIA. In the absence of any information to support a different 
limit, the proposed rule would maintain the limit at 0.1 percent for 
the proposed prohibitions on DINP, DIBP, DPENP, DHEXP, and DCHP.
    Deriving a risk-based limit would require additional analysis 
beyond the CHAP's scenario-based exposure assessment. This would be 
difficult because exposure by a given scenario is not necessarily 
proportional to the phthalate concentration in the product. The sources 
of uncertainty and data gaps in the CHAP's scenario-based assessment 
(CHAP 2014, Appendix E1) would still apply. Thus, it would be difficult 
to derive a risk-based level.
    The Commission considers that the 0.1 percent limit is practical. A 
lower limit would make it more difficult to perform the testing 
required of third party laboratories, which may lead to increased 
testing costs. Compliance testing would also be more difficult.

V. Description of the Proposed Rule

Section 1307.1--Scope and Application

    Proposed Sec.  1307.1 describes the actions that the proposed rule 
would prohibit. This provision tracks the language in section 108(a) of 
the CPSIA regarding the permanent prohibition and prohibits the same 
activities: manufacture for sale, offer for sale, distribution in 
commerce, or importation into the United States of a children's toy or 
child care article that contains any of the prohibited phthalates.

Section 1307.2--Definitions

    Proposed Sec.  1307.2 provides the same definitions of ``children's 
toy'' and ``child care article'' found in section 108(g) of the CPSIA. 
``Children's toy'' means a consumer product designed or intended by the 
manufacturer for a child 12 years of age or younger for use by the 
child when the child plays. ``Child care article'' means a consumer 
product designed or intended by the manufacturer to facilitate sleep or 
the feeding of children age 3 and younger, or to help such children 
with sucking or teething. Although these definitions are stated in the 
CPSIA, the proposed rule text would restate them for convenience.

Section 1307.3--Prohibition on Children's Toys and Child Care Articles 
Containing Specified Phthalates

    Proposed Sec.  1307.3(a) states which products would be prohibited. 
For convenience, the proposed section would provide both the items that 
are subject to the CPSIA's existing permanent prohibition and the items 
that would be subject to prohibition under the proposed rule. Stating 
all prohibitions in this section will allow a reader of the CFR to be 
aware of all the CPSC's restrictions concerning phthalates.
    Proposed paragraph (a) sets out the CPSIA's existing permanent 
prohibition that makes it unlawful to manufacture for sale, offer for 
sale, distribute in commerce, or import into the United States any 
children's toy or child care article that contains concentrations of 
more than 0.1 percent of DEHP, DBP, or BBP. The restriction on these 
products

[[Page 78339]]

is currently in place as a result of section 108(a) of the CPSIA. This 
statutory prohibition is not affected by the proposed rule but is 
merely restated in the proposed regulatory text.
    Proposed paragraph (b) would prohibit the manufacture for sale, 
offer for sale, distribution in commerce, or importation into the 
United States of any children's toy or child care article that contains 
concentrations of more than 0.1 percent of DINP, DIBP, DPENP, DHEXP, or 
DCHP. As explained above, in accordance with section 108(b)(2) of the 
CPSIA, the Commission appointed a CHAP that considered the effects on 
children's health of phthalates and phthalate alternatives as used in 
children's toys and child care articles. After completing its work, the 
CHAP presented the Commission with a report of its findings and 
recommendations. After reviewing the CHAP's report and making the 
appropriate determinations and evaluations, the Commission is proposing 
a rule in accordance with section 108(b)(3) of the CPSIA.
    For the reasons explained in Section IV of this preamble, the 
Commission concludes that prohibiting children's toys and child care 
articles that contain more than 0.1 percent of DINP would ensure a 
reasonable certainty of no harm to children, pregnant women, or other 
susceptible individuals with an adequate margin of safety. DINP is 
currently subject to the CPSIA's interim prohibition. CPSIA section 
108(b)(1). Proposed Sec.  1307.3(b) would change the scope of 
regulation of DINP from the current interim scope of ``children's toys 
that can placed into a child's mouth'' \16\ (and child care articles) 
to also include all children's toys. Based on the recommendations in 
the CHAP report, the Commission is not proposing to continue the 
interim prohibitions on DIDP and DnOP.
---------------------------------------------------------------------------

    \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 the toy can actually be 
brought to the mouth and kept in the mouth by a child so that it can 
be sucked and chewed. If the children's product can only be licked, 
it is not regarded as able to be placed in the mouth. If a toy or 
part of a toy in one dimension is smaller than 5 centimeters, it can 
be placed in the mouth.''
---------------------------------------------------------------------------

    Additionally, proposed Sec.  1307.3(b) would prohibit children's 
toys and child care articles containing four phthalates that are not 
currently subject to restrictions under the CPSIA: DIBP, DPENP, DHEXP, 
and DCHP. For the reasons stated in section IV of this preamble, the 
Commission concludes that prohibiting children's toys and child care 
articles containing more than 0.1 percent of DIBP, DPENP, DHEXP, or 
DCHP is necessary to protect the health of children.

VI. Effective Date

    The APA generally requires that the effective date of a rule be at 
least 30 days after publication of the final rule. 5 U.S.C. 553(d). The 
Commission is proposing an effective date of 180 days after publication 
of the final rule in the Federal Register.
    As discussed in Tab A of the staff's briefing package, the proposed 
rule is expected to have a minimal impact on manufacturers. The 
proposed rule would prohibit four additional phthalates--DIBP, DPENP, 
DHEXP, and DCHP--which currently are not widely used in children's toys 
and child care articles. Only DIBP has been detected in a small portion 
of toys tested by the staff. The proposed rule would also make the 
interim prohibition on DINP permanent and expand the scope from 
children's toys that can be place in a child's mouth to all children's 
toys (along with child care articles). Based on staff's testing 
results, to meet the proposed rule, a relatively small percentage of 
non-mouthable toys would need to be reformulated to remove DINP. To 
meet the statutory testing and certification requirements if the 
proposed rule were in place, testing laboratories would need to expand 
their procedures to include the four additional prohibited phthalates, 
which the staff believes would require minimal effort by testing 
laboratories. Therefore, none of the prohibitions in the proposed rule 
is likely to require more than 180 days for manufacturers and testing 
laboratories to become compliant. For these reasons, the Commission 
proposes an effective date of 180 days after publication of the final 
rule in the Federal Register.

VII. Notice of Requirements

    The CPSA establishes certain requirements for product certification 
and testing. Children's products subject to a children's product safety 
rule under the CPSA must be certified as complying with all applicable 
CPSC-enforced requirements. 15 U.S.C. 2063(a). Certification of 
children's products subject to a children's product safety rule must be 
based on testing conducted by a CPSC-accepted third party conformity 
assessment body. Id. 2063(a)(2). The Commission must publish a notice 
of requirements (NOR) for the accreditation of third party conformity 
assessment bodies (or laboratories) to assess conformity with a 
children's product safety rule to which a children's product is 
subject. Id 2063(a)(3). Thus, the proposed rule for 16 CFR part 1307, 
``Prohibition of Children's Toys and Child Care Articles Containing 
Specified Phthalates,'' when issued as a final rule, would be a 
children's product safety rule that requires the issuance of an NOR. 
The Commission previously published in the Federal Register an NOR for 
the phthalate-containing products prohibited by section 108 on August 
10, 2011. (76 FR 49286). The codified listing for the NOR can be found 
at 16 CFR 1112.15(b)(31). If the Commission finalizes the proposed rule 
with prohibitions restricting phthalates that are not covered by the 
current NOR, the Commission would issue a new NOR that would include 
the additional phthalates. The NOR would notify manufacturers and 
testing laboratories of the additional requirements and would include a 
revised test method. Any revisions to the existing NOR will be done in 
a separate future rulemaking.

VIII. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) requires an agency to prepare 
a regulatory flexibility analysis for any rule subject to notice and 
comment rulemaking requirements under the APA or any other statute, 
unless the agency certifies that the rulemaking will not have a 
significant economic impact on a substantial number of small entities. 
U.S.C. 603 and 605. Small entities include small businesses, small 
organizations, and small governmental jurisdictions. After considering 
the economic impacts of this proposed rule on small entities, the 
Commission certifies that the proposed rule would not have a 
significant economic impact on a substantial number of small entities.

A. Background

    As discussed above, the proposed rule would fulfill a requirement 
in section 108 of the CPSIA that the Commission issue a rule to 
determine whether the interim prohibitions established in section 
108(b)(1) of the CPSIA should be made permanent and whether any 
children's product containing any phthalates that were not prohibited 
by the CPSIA should be declared a banned hazardous product. The 
proposed rule would lift the interim prohibitions for two of the three 
phthalates (DIDB and DNOP) and would permanently prohibit children's 
toys and child care articles containing more than 0.1 percent of the 
third phthalate (DINP). The proposed rule would also prohibit 
children's toys and child care articles containing more than 0.1 
percent of any of four specified phthalates that were not prohibited by

[[Page 78340]]

the CPSIA (DIBP, DPENP, DHEXP, and DCHP).

B. Small Entities To Which the Rule Would Apply

    Small entities would be subject to the proposed rule if they 
manufacture or import children's toys or child care articles that 
contain phthalates. These companies are already subject to the 
restrictions imposed by the CPSIA on children's toys and child care 
articles containing certain phthalates. The draft proposed rule would 
neither increase, nor decrease, the number of small entities to which 
the phthalate restrictions apply. More detailed information about the 
entities that likely manufacture or import children's toys and child 
care articles and would be considered small businesses under the 
criteria established by the Small Business Administration (SBA) is 
provided at Tab A of the staff's briefing package.

C. Potential Impact on Small Businesses

1. Impact From Meeting Substantive Requirements of the Proposed Rule
    The proposed rule would impact which plasticizers are available to 
manufacturers for use in children's toys and child care articles. We 
discuss the anticipated impact from each aspect of the Commission's 
proposed action.
    Lifting restriction on DNOP and DIDP. The proposed rule would end 
the CPSIA's interim restrictions on the use of DNOP and DIDP in 
children's toys and child care articles. Manufacturers would be free to 
use these two phthalates. Ending restrictions for these phthalates 
would benefit manufacturers if DNOP and DIDP are less costly than the 
alternatives or they impart other desirable attributes to the final 
product.
    Altering restriction on DINP. The proposed rule would broaden the 
restrictions on DINP. The interim ban prohibits children's toys that 
can be placed in a child's mouth and child care articles that contain 
more than 0.1 percent of DINP. The proposed rule would extend the 
prohibition to all children's toys and child care articles regardless 
of whether the toy can be placed in a child's mouth. Manufacturers who 
were using DINP in toy components that could not be placed in a child's 
mouth would have to find an alternative for DINP in these applications. 
The Commission expects the impact of changing the prohibition on the 
use DINP to include children's toys that cannot be placed in a child's 
mouth would be limited to a small number of firms. A review of samples 
tested by CPSC staff indicated that of 725 samples that were found to 
contain phthalates through infrared screening techniques, fewer than 5 
samples (or less than 1 percent) contained DINP but were probably too 
large to be placed in a child's mouth. (See Tab B of staff's briefing 
package). The percentage of all children's toys that could be impacted 
by broadening the restrictions on the use of DINP to all children's 
toys would be substantially less than 1 percent because the only 
samples reviewed in this analysis were those that were already found to 
contain phthalates using infrared screening techniques. This would be a 
small subset of all children's toys.
    Restricting four additional phthalates. The proposed rule would 
also prohibit children's toys and childcare articles containing four 
additional phthalates: DIBP, DPENP, DHEXP, and DCHP. The prohibition on 
the use of these additional phthalates is not expected to have a 
significant impact on a substantial number of manufacturers because the 
CHAP found that three of these phthalates (DPENP, DHEXP, and DCHP) are 
not currently used in children's products and that although the fourth 
(DIBP) has been found in some toys, it ``is not widely used in toys and 
child care articles.'' (CHAP 2014, pp. 111,113,116, and 117). This 
aspect of the proposed rule is intended to prevent these phthalates 
from being used in children's toys and child care articles in the 
future.
    Summary of impact from meeting substantive requirements of 
proposal. For the reasons described above, the Commission expects that 
few, if any, manufacturers would need to alter their formulations to 
comply with the proposed rule.
2. Impact From Third Party Testing to the Proposed Rule
    The CPSIA requires manufacturers of children's products subject to 
a children's product safety rule to certify that their children's 
products comply with all applicable children's product safety rules 
based on the results of third party tests. 15 U.S.C. 2063(a)(2). Third 
party testing is only required for those components of children's toys 
and child care articles that are accessible and that could contain one 
or more of the prohibited phthalates. These third party testing 
requirements are set forth in the CPSIA and are unaffected by the 
proposed rule.
    The CPSIA permanently prohibits children's toys and child care 
articles that contain concentrations of more than 0.1 percent of DEHP, 
DBP or BBP. This restriction is unaffected by the proposed rule. Thus, 
manufacturers of children's toys and child care articles currently must 
comply with the third party testing requirements to certify that their 
products do not contain more than 0.1 percent of DEHP, DBP, or BBP. 
Manufacturers of children's toys and child care articles currently must 
also certify, based on the results of third party tests, that their 
products do not contain more than 0.1 percent of the phthalates subject 
to the interim prohibitions (DINP, DIDP, and DNOP), unless the product 
is a children's toy that cannot be placed in a child's mouth. (The 
prohibitions on DEHP, DBP, and BBP apply regardless of whether a toy 
can be placed in a child's mouth).
a. Scope of Products That Must Be Tested
    The proposed rule would not affect the scope of products subject to 
the third party testing requirement because even in the absence of the 
proposed rule, manufacturers of children's toys and child care articles 
that may contain accessible phthalates are required to certify those 
products based on third party testing.
    Lifting restriction on DNOP and DIDP. Because the proposed rule 
would remove the interim prohibitions for DIDP and DNOP, manufacturers 
of children's toys and child care articles would no longer be required 
to certify that their products do not contain these phthalates. 
However, third party testing of children's toys and child care articles 
would still be required to ensure that these products do not contain 
concentrations of more than 0.1 percent for DEHP, DBP, and BBP.
    Altering restriction on DINP. Under the proposed rule, 
manufacturers of children's toys that can be placed in a child's mouth 
and child care articles would need to continue to test to ensure that 
their products do not exceed concentrations of more than 0.1 percent 
for DINP. Additionally, under the proposed rule, manufacturers would 
have to certify, based on third party tests, that toys that cannot be 
placed in a child's mouth do not contain DINP. However, as noted above, 
these manufacturers are already required to test their products for 
DEHP, DBP, and BBP. The extension of the DINP prohibition would not 
require testing of additional products; the extension simply adds 
another phthalate for which certification is required when testing 
children's toys and child care articles that cannot be placed in the 
mouth.
    Restricting four additional phthalates. Under the proposed rule, 
manufacturers of children's toys and child care articles

[[Page 78341]]

would have to certify that their products do not contain DIBP, DPENP, 
DHEXB, and DCHP in concentrations of greater than 0.1 percent based on 
third party tests. However, as noted above, these manufacturers are 
already subject to third party testing for DEHP, DBP, and BBP.
    Summary of impact of proposal on scope of testing. Because 
children's toys and child care articles that may contain phthalates are 
already subject to the CPSIA's testing requirement to determine the 
presence of any of the phthalates that are prohibited by section 108(a) 
of the CPSIA, the proposed rule would not affect the scope of products 
that are subject to third party testing.
b. Proposed Rules's Impact on Cost of Testing
    Under the proposed rule, manufacturers would need to test for the 
presence of four phthalates that they currently do not have to test for 
under the CPSIA's permanent and interim prohibitions. According to the 
Directorate for Laboratory Sciences, including the additional 
phthalates that would be prohibited by the proposed rule, DIBP, DPENP, 
DHEXP, and DCHP is not expected to increase significantly the cost to 
manufacturers for having a products third party test their products for 
phthalates. The same equipment and procedures for sample preparation 
and extraction could be used. Although the data analysis procedure 
would need to be modified to include the new phthalates, each of the 
additional phthalates can be isolated at unique elution times by gas 
chromatography and should not be difficult for qualified conformity 
assessment bodies to identify and quantify. (See Tab B of the staff's 
briefing package.)
    Third party conformity assessment bodies will have to obtain eight 
phthalate analytic standard materials for calibration purposes for use 
during phthalate testing. This is a net increase of two over the six 
that are currently required. These additional analytic standards are 
expected to cost very little, especially on a per-test basis. The 
analytic standards cost about $3.50 per gram (based on prices by some 
suppliers on the Internet), but less than 50 milligrams of a standard 
is required per test batch. Therefore, the additional two standards 
that would be required by the proposed rule would increase the cost per 
test batch by about $0.35.\17\ Multiple samples can be tested in one 
test batch. Therefore, the per-test cost of the additional phthalate 
standards would be less than $0.35 per test.
---------------------------------------------------------------------------

    \17\ Fifty milligrams of a standard that costs $3.50 per gram 
would be 17.5 cents. Two additional standards over what is now 
required would be required by the draft proposed rule.
---------------------------------------------------------------------------

D. Conclusion

    The CPSIA established prohibitions on children's toys and child 
care articles containing phthalates. The CPSIA also put in place 
requirements for third party testing and certification of children's 
products. As discussed above, because these requirements area already 
in place by statute and will continue regardless of the proposed rule, 
the Commission expects that the proposed rule's impact on small 
business would not be significant. Therefore, the Commission certifies 
that the proposed rule would not have a significant economic impact on 
a substantial number of small entities.

IX. Paperwork Reduction Act

    The proposed rule does not include any information-collection 
requirements. Accordingly, this rule is not subject to the Paperwork 
Reduction Act, 44 U.S.C. 3501-3520.

X. Preemption

    Section 26(a) of the CPSA, 15 U.S.C. 2075(a), provides that where a 
``consumer product safety standard under [the Consumer Product Safety 
Act (CPSA)]'' is in effect and applies to a product, no state or 
political subdivision of a state may either establish or continue in 
effect a requirement dealing with the same risk of injury unless the 
state requirement is identical to the federal standard. (Section 26(c) 
of the CPSA also provides that states or political subdivisions of 
states may apply to the Commission for an exemption from this 
preemption under certain circumstances.) Section 108(f) of the CPSIA is 
entitled, ``Treatment as Consumer Product Safety Standards; Effect on 
State Laws.'' That provision states that the permanent and interim 
prohibitions and any rule promulgated under section 108(b)(3) ``shall 
be considered consumer product safety standards under the Consumer 
Product Safety Act.'' That section further states: ``Nothing in this 
section of the Consumer Product Safety Act (15 U.S.C. 2051 et seq.) 
shall be construed to preempt or otherwise affect any State requirement 
with respect to any phthalate alternative not specifically regulated in 
a consumer product safety standard under the Consumer Product Safety 
Act.'' CPSIA section 108(f). This provision indicates that the 
preemptive effect of section 26(a) of the CPSA would apply to the 
proposed rule which does not include any requirements regarding 
phthalate alternatives.

XI. Environmental Considerations

    The Commission's regulations provide a categorical exclusion for 
the Commission's rules from any requirement to prepare an environmental 
assessment or an environmental impact statement because they ``have 
little or no potential for affecting the human environment.'' 16 CFR 
1021.5(c)(2). Because this rule falls within the categorical exclusion, 
no environmental assessment or environmental impact statement is 
required.

XII. List of References

    This section provides a list of the documents referenced in this 
preamble.

Adamsson A, Salonen V, Paranko J, Toppari J. 2009. Effects of 
maternal exposure to di-isononylphthalate (DINP) and 1,1-dichloro-
2,2-bis(p-chlorophenyl)ethylene (p,p'-dde) on steroidogenesis in the 
fetal rat testis and adrenal gland. Reproductive Toxicology 
(Elmsford, NY) 28:66-74.
Babich MA. 2010. Overview of phthalates toxicity. U.S. Consumer 
Product Safety Commission, Bethesda, MD 20814. April 2010. https://www.cpsc.gov/PageFiles/126521/phthalover.pdf.
Barlow NJ, Foster PM. 2003. Pathogenesis of male reproductive tract 
lesions from gestation through adulthood following in utero exposure 
to di(n-butyl) phthalate. Toxicol. Pathol. 31:397-410.
Barlow NJ, McIntyre BS, Foster PMD. 2004. Male reproductive tract 
lesions at 6, 12, and 18 months of age following in utero exposure 
to di(n-butyl) phthalate. Toxicological Pathology 32:79-90.
Benson R. 2009. Hazard to the developing male reproductive system 
from cumulative exposure to phthalate esters--dibutyl phthalate, 
diisobutyl phthalate, butylbenzyl phthalate, diethylhexyl phthalate, 
dipentyl phthalate, and diisononyl phthalate. Regul. Toxicol. 
Pharmacol. 53:90-101.
Boberg J, Christiansen S, Axelstad M, Kledal TS, Vinggaard AM, 
Dalgaard M, et al. 2011. Reproductive and behavioral effects of 
diisononyl phthalate (DINP) in perinatally exposed rats. 
Reproductive Toxicology (Elmsford, NY) 31:200-209.
Borch J, Ladefoged O, Hass U, Vinggaard AM. 2004. Steroidogenesis in 
fetal male rats is reduced by DEHP and DINP, but endocrine effects 
of DEHP are not modulated by DEHA in fetal, prepubertal and adult 
male rats. Reproductive Toxicology (Elmsford, NY) 18:53-61.
CDC. 2012. Fourth national report on human exposure to environmental 
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List of Subjects in 16 CFR Part 1307

    Consumer protection, Imports, Infants and children, Law 
enforcement, and Toys.

    For the reasons discussed in the preamble, the Commission proposes 
to amend Title 16 of the Code of Federal Regulations by adding part 
1307 to read as follows:

0
1. Add Part 1307 to read as follows

PART 1307--PROHIBITION OF CHILDREN'S TOYS AND CHILD CARE ARTICLES 
CONTAINING SPECIFIED PHTHALATES

Sec.
1307.1 Scope and application.
1307.2 Definitions.
1307.3 Prohibition on children's toys and child care articles 
containing specified phthalates.

    Authority: The Consumer Product Safety Improvement Act of 2008, 
Pub. L. 110-314, Sec. 108, 122 Stat. 3016 (August 14, 2008); Pub. L. 
112-28, 125 Stat. 273 (August 12, 2011).


Sec.  1307.1  Scope and application.

    This part prohibits the manufacture for sale, offer for sale, 
distribution in commerce or importation into the United States of any 
children's toy or child care article containing any of the phthalates 
specified in Sec.  1307.3.


Sec.  1307.2  Definitions.

    The definitions of the Consumer Product Safety Act (CPSA) (15 
U.S.C. 2052)(a)) and the Consumer Product Safety Improvement Act of 
2008 (CPSIA) (Pub. L. 110-314, 108)(g)) apply to this part. 
Specifically, as defined in the CPSIA:
    (a) Children's toy means a consumer product designed or intended by 
the manufacturer for a child 12 years of age or younger for use by the 
child when the child plays.
    (b) Child care article means a consumer product designed or 
intended by the manufacturer to facilitate sleep or the feeding of 
children age 3 and younger, or to help such children with sucking or 
teething.


Sec.  1307.3  Prohibition of children's toys and child care articles 
containing specified phthalates.

    (a) As provided in section 108(a) of the CPSIA, the manufacture for 
sale, offer for sale, distribution in commerce, or importation into the 
United States of any children's toy or child care article that contains 
concentrations of more than 0.1 percent of di-(2-ethyhexyl) phthalate 
(DEHP), dibutyl phthalate (DBP), or benzyl butyl phthalate (BBP) is 
prohibited.
    (b) In accordance with section 108(b)(3) of the CPSIA, the 
manufacture for sale, offer for sale, distribution in commerce, or 
importation into the United States of any children's toy or child care 
article that contains concentrations of more than 0.1 percent of 
diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl 
phthalate (DPENP), di-n-hexyl phthalate (DHEXP), or dicyclohexyl 
phthalate (DCHP) is prohibited.

    Dated: December 17, 2014.
Alberta E. Mills,
Acting Secretary, U.S. Consumer Product Safety Commission.
[FR Doc. 2014-29967 Filed 12-29-14; 8:45 am]
BILLING CODE 6355-01-P