78324 Federal Register / Vol. 79, No. 249 / Tuesday, December 30, 2014 / Proposed Rules 

Publication 100,’’ guidelines published 

by NTIS and available at https://

dmf.ntis.gov. Such attestation must be 

based on the Accredited Certification 

Body’s review or assessment conducted 

no more than three years prior to the 

date of submission of the Person’s or 

Certified Person’s completed 

certification statement, and, if an audit 

of a Certified Person by an Accredited 

Certification Body is required by NTIS, 

no more than three years prior to the 

date upon which NTIS notifies the 

Certified Person of NTIS’s requirement 

for audit, but such review or assessment 

or audit need not have been conducted 

specifically or solely for the purpose of 

submission under this part. 

(c) Where review or assessment or 

audit by an Accredited Certification 

Body was not conducted specifically or 

solely for the purpose of submission 

under this part, the written attestation 

or assessment report (if an audit) shall 

describe the nature of that review or 

assessment or audit, and the Accredited 

Certification Body shall attest that on 

the basis of such review or assessment 

or audit, the Person or Certified Person 

has systems, facilities, and procedures 

in place as required under 

§ 1110.102(a)(2). In so attesting, an 

Accredited Certification Body may 

reference ‘‘Limited Access Death Master 

File (LADMF) Certification Program 

Publication 100,’’ guidelines published 

by NTIS and available at https://

dmf.ntis.gov. 

(d) Notwithstanding paragraphs (a) 

through (c) of this section, NTIS may, in 

its sole discretion, require that review or 

assessment or audit by an Accredited 

Certification Body be conducted 

specifically or solely for the purpose of 

submission under this part. 

§ 1110.503 Acceptance of accredited 

certification bodies. 

(a) NTIS will accept written 

attestations and assessment reports from 

an Accredited Certification Body that 

attests, to the satisfaction of NTIS, as 

provided in § 1110.502. 

(b) NTIS may decline to accept 

written attestations or assessment 

reports from an Accredited Certification 

Body, whether or not it has attested as 

provided in § 1110.502, for any of the 

following reasons: 

(1) When it is in the public interest 

under Section 203 of the Bipartisan 

Budget Act of 2013, and 

notwithstanding any other provision of 

this part; 

(2) Submission of false or misleading 

information concerning a material 

fact(s) in an Accredited Certification 

Body’s attestation under § 1110.502; 

(3) Knowing submission of false or 

misleading information concerning a 

material fact(s) in an attestation or 

assessment report by an Accredited 

Certification Body of a Person or 

Certified Person; 

(4) Failure of an Accredited 

Certification Body to cooperate in 

response to a request from NTIS verify 

the accuracy, veracity, and/or 

completeness of information received in 

connection with an attestation under 

§ 1110.502 or an attestation or 

assessment report by that Body of a 

Person or Certified Person. An 

Accredited Certification Body ‘‘fails to 

cooperate’’ when it does not respond to 

NTIS inquiries or requests, or it 

responds in a manner that is 

unresponsive, evasive, deceptive, or 

substantially incomplete; or 

(5) Where NTIS is unable for any 

reason to verify the accuracy of the 

Accredited Certification Body’s 

attestation. 

[FR Doc. 2014–30199 Filed 12–29–14; 8:45 am] 

BILLING CODE 3510–04–P 

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. 

SUMMARY: Section 108 of the Consumer 

Product Safety Improvement Act of 

2008 (CPSIA), requires the United States 

Consumer Product Safety Commission 

(Commission or CPSC) to convene a 

Chronic Hazard Advisory Panel (CHAP) 

to study the effects on children’s health 

of all phthalates and phthalate 

alternatives as used in children’s toys 

and child care articles and to provide 

recommendations to the Commission 

regarding whether any phthalates or 

phthalate alternatives other than those 

already permanently prohibited should 

be prohibited. The CPSIA requires the 

Commission to promulgate a final rule 

after receiving the final CHAP report. 

The Commission is proposing this rule 

pursuant to section 108(b) of the CPSIA. 

DATES: Submit comments by March 16, 

2015. 

ADDRESSES: You may submit comments, 

identified by Docket No. CPSC–2014– 

0033, by any of the following methods: 

Electronic Submissions: Submit 

electronic comments to the Federal 

eRulemaking Portal at: http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

The Commission does not accept 

comments submitted by electronic mail 

(email), except through 

www.regulations.gov. The Commission 

encourages you to submit electronic 

comments by using the Federal 

eRulemaking Portal, as described above. 

Written Submissions: Submit written 

submissions in the following way: Mail/ 

Hand delivery/Courier, preferably in 

five copies, to: Office of the Secretary, 

Consumer Product Safety Commission, 

Room 820, 4330 East West Highway, 

Bethesda, MD 20814; telephone (301) 

504–7923. 

Instructions: All submissions received 

must include the agency name and 

docket number for this proposed 

rulemaking. All comments received may 

be posted without change, including 

any personal identifiers, contact 

information, or other personal 

information provided, to: http://

www.regulations.gov. Do not submit 

confidential business information, trade 

secret information, or other sensitive or 

protected information that you do not 

want to be available to the public. If 

furnished at all, such information 

should be submitted in writing. 

Docket: For access to the docket to 

read background documents or 

comments received, go to: http://

www.regulations.gov, and insert the 

docket number, CPSC–2014–0033, into 

the ‘‘Search’’ box, and follow the 

prompts. 

FOR FURTHER INFORMATION CONTACT: Kent 

R. Carlson, Ph.D., Toxicologist, Division 

of Toxicology & Risk Assessment, 

Directorate for Health Sciences, U.S. 

Consumer Product Safety Commission, 

5 Research Place, Rockville, MD 20850– 

3213; email: kcarlson@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

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. 


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1The CHAP met in one closed meeting as part of 

the peer review process, January 28–29, 2014. 

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, peerreviewed, 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-tomouth, 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 


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2http://www.cpsc.gov/chap. 

3Nipple retention does not normally occur in 

rodents, as it does in humans. 

4That is, the effect occurring at the lowest dose. 

5A malformation of the penis. 

6 Distance between the anus and genitals, which 

is greater in males than in females. 

the final CHAP report, are available on 

the CPSC Web site.2

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 http://

www.cpsc.gov/Global/Newsroom/FOIA/

CommissionBriefingPackages/2015/

ProposedRule-Phthalates-112514.pdf. 

As discussed in this preamble, the 

Commission agrees with the staff’s 

recommendations. 

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). 

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 nonantiandrogenic 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). 

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). 

Based on this information, the CHAP 

concluded that there is a growing body 

of studies reporting associations 

between phthalate exposure and human 

health. (CHAP 2014, p. 27). Many of the 

reported health effects are consistent 

with testicular dysgenesis syndrome in 


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humans. (CHAP 2014, p. 28). However, 

the CHAP acknowledged the limitations 

of these studies, noting that the 

epidemiological studies were not 

designed specifically to provide 

information on sources of exposure or 

the relative contributions of different 

phthalates. Furthermore, the studies 

were limited by simultaneous human 

exposure to multiple phthalates and 

other environmental chemicals and by 

the study design. (CHAP 2014, pp. 2–3). 

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 EPAfunded 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 scenariobased 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 DINPcontaining toys or contact with DINPcontaining 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 singlechemical 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: 


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7The 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. 

8Having a HI greater than one does not 

necessarily mean that adverse effects will occur; 

however, this possibility cannot be ruled out. 

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. 

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

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

Case 1 Case 2 Case 3 

NHANES Pregnant Women: 

Diisobutyl phthalate, DIBP ................................................................................................................ 0.7 2.3 <1.1 

Dibutyl phthalate, DBP ..................................................................................................................... 7.1 7.7 1.1 

Butyl benzyl phthalate, BBP ............................................................................................................. 0.7 7.7 1.1 

Di(2-ethylhexyl) phthalate, DEHP ..................................................................................................... 85.7 53.8 77.8 

Diisononyl phthalate, DINP .............................................................................................................. 0.7 7.7 2.2 

SFF Infants: 

Diisobutyl phthalate, DIBP ................................................................................................................ 0.9 5.0 <0.8 

Dibutyl phthalate, DBP ..................................................................................................................... 9.1 15.0 2.5 

Butyl benzyl phthalate, BBP ............................................................................................................. 18.2 10.0 2.5 

Di(2-ethylhexyl) phthalate, DEHP ..................................................................................................... 81.8 55.0 91.7 

Diisononyl phthalate, DINP .............................................................................................................. 0.9 15.0 8.3 

a Calculated from data in CHAP, 2014, Table 2.16. Based on median exposures. 


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9Parabens are antimicrobials commonly used in 

cosmetics. 

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.). 

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 nonantiandrogenic 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 


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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 


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10For example, toxicity data submitted under 

§ 8(e) of the Toxic Substances Control Act. 

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, peerreviewed, 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 coauthor 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. 

• ‘‘Consider the health effects of 

phthalates not only from ingestion but 

also as a result of dermal, hand-tomouth, 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 


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11 ‘‘Approach to Cumulative Risk,’’ presented to 

the CPSC staff, March 2010. http://www.cpsc.gov/

PageFiles/125812/CummRiskExxon03232010.pdf. 

staff supports the selection of male 

developmental reproductive toxicity for 

several reasons. Male developmental 

reproductive effects in animals are 

associated with many of the most 

common phthalates. For most of the 

active phthalates, these effects are the 

most sensitive health effect; that is, 

these effects are observed at lower doses 

than other adverse health effects (see 

CPSC staff and contractor reports at 

http://www.cpsc.gov/chap). Male 

developmental reproductive effects 

(phthalate syndrome) are of particular 

concern because they may adversely 

affect human reproduction. 

Furthermore, the phthalate syndrome in 

animals bears a striking resemblance to 

the testicular dysgenesis syndrome in 

humans. (Skakkebaek et al., 2001). 

The availability of empirical evidence 

also supports the choice to base the 

cumulative risk assessment on male 

developmental reproductive effects 

because such evidence eliminates the 

need to make critical assumptions that 

might not be borne out. Specifically, 

empirical evidence demonstrates that 

mixtures of active phthalates interact in 

a dose-additive fashion with respect to 

developmental male reproductive 

effects. (Howdeshell et al., 2007, 2008; 

Hannas et al., 2011b, 2012). Thus, it was 

not necessary for the CHAP to make any 

assumptions regarding the effects of 

phthalate mixtures. Most other health 

effects of phthalates have not been 

studied with mixtures; performing a 

cumulative risk assessment on any other 

endpoint would require assumptions 

regarding the mode of action and 

possible mixture effects. 

Furthermore, the male developmental 

reproductive effects of phthalates are 

well-studied. (Reviewed in Foster, 

2006). These effects, which were first 

reported in 1980 (Foster et al., 1980), 

persist into adulthood, even in the 

absence of further exposure (Barlow and 

Foster, 2003; Barlow et al., 2004; 

McIntyre et al., 2001). Similar effects 

have been reported in multiple 

mammalian species, including guinea 

pigs (Gray et al., 1982), mice, (Gray et 

al., 1982; Moody et al., 2013; Ward et 

al., 1998), rabbits (Higuchi et al., 2003), 

and ferrets (Lake et al., 1976). Hamsters 

were resistant due to slow metabolism 

of the phthalate ester to the monoester, 

which is believed to be the active 

metabolite. Hamsters responded to the 

monoester, however. (Gray et al., 1982). 

The observation of similar effects in 

multiple species demonstrates that these 

effects are not unique to rats. Based on 

the CPSC chronic hazard guidelines, the 

CPSC staff regards active phthalates as 

‘‘probably toxic to humans,’’ based on 

‘‘sufficient evidence’’ in animal studies. 

(CPSC, 1992). 

Other authors also have selected male 

developmental reproductive effects as 

the basis of cumulative risk assessments 

of phthalates. The U.S. Environmental 

Protection Agency (EPA) convened a 

National Research Council (NRC) 

committee to consider approaches to 

assessing the cumulative risk of 

phthalates; the committee 

recommended using male 

developmental reproductive effects as 

the basis for a cumulative risk 

assessment. (NRC, 2008). Additionally, 

two subsequent publications conducted 

cumulative risk assessments based on 

male developmental reproductive 

effects. (Benson, 2009; Christensen et 

al., 2014). 

CPSC staff recognizes that a number 

of other health effects are associated 

with phthalates. (Reviewed in Babich, 

2010). Although some phthalates are 

associated with cancer, cancer is only 

associated with a relatively small 

number of phthalates, and many of the 

cancers induced by phthalates are of 

uncertain relevance to humans. (CHAP, 

2001; CPSC, 2002; Klaunig et al., 2003). 

Other effects, such as liver toxicity, are 

common to most phthalates; but there 

are little or no data available on mode 

of action or the effects of mixtures. 

Thus, there is less scientific basis for 

performing a cumulative risk 

assessment with liver toxicity as the 

critical endpoint. 

Finally, a growing number of 

epidemiological studies have reported 

associations of phthalate exposure with 

adverse health effects in humans. (As 

cited in CHAP 2014, pp. 27–33, 

Appendix C). Many of these adverse 

health effects are consistent with the 

effects in animal studies. The staff 

concludes that the epidemiological 

studies, though not conclusive on their 

own, provide supporting evidence that 

the animal studies are relevant to 

humans. 

Therefore, CPSC staff supports using 

male developmental reproductive 

effects as the basis for the CHAP’s 

cumulative risk assessment due to the 

importance of the endpoint; the 

abundance of data, the known additive 

nature of phthalate mixtures regarding 

male developmental reproductive 

effects, and NRC’s recommendation. 

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. 

The CHAP found that up to 10 

percent of pregnant women and up to 5 

percent of infants, those with the 

highest exposure, have a HI greater than 

one. The portion of the population with 

a HI greater than one may be at risk for 

the adverse effects of phthalates. (EPA, 

1993). This does not necessarily mean 

that anyone will suffer adverse effects; 

however, one cannot rule out the 

possibility of adverse effects. The 

greater the HI, the greater the risk. 

Although the HI approach is widely 

accepted, the CHAP introduced a novel 

process to calculate the HI. The CHAP 

calculated hazard quotients (HQ) and a 

HI for each individual in the population 

of interest (i.e., pregnant women or 

infants), and then derived distributions 

of the HI. This was necessary because 

each individual is exposed to phthalates 

in differing proportions. For example, 

some individuals may be exposed 

almost exclusively to a single phthalate, 

while others may be exposed to several 

phthalates in roughly equal proportion. 

After calculating the HQs and HIs for all 

individuals, the CHAP then generated 

frequency distributions for the HI. This 

process allowed the CHAP to estimate 

the average and 95th percentile of the 

HI, as well as the portion of the 

population with a HI greater than one. 

The alternative to the CHAP’s 

approach would be to calculate hazard 

quotients using summary data on 

metabolite levels, that is, median and 

95th percentile levels (e.g., Benson, 

2009). This would have allowed the 

CHAP to estimate median and 95th 

percentile hazard quotients for each 

phthalate. Under this approach, the 

median hazard quotients are summed to 

calculate the average HI, which would 

be roughly similar to the median hazard 

quotient calculated as above. However, 

summing the 95th percentile values 

would overestimate the 95th percentile 

HI. Therefore, the CHAP introduced this 

novel process to calculate the hazard 

quotients and HI more accurately, 

especially at the upper-bound (e.g., 95th 

percentile) exposures. Had the CHAP 

not applied this novel approach, the 

result would have been an overestimate 


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of the 95th percentile exposures and the 

percentage of pregnant women and 

infants with HI greater than one. 

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 wellstudied in rats. In addition, similar 

effects have been reported in multiple 

mammalian species, including guinea 

pigs (Gray et al., 1982), mice, (Gray et 

al., 1982; Moody et al., 2013; Ward et 

al., 1998), rabbits (Higuchi et al., 2003), 

and ferrets (Lake et al., 1976) (Lake et 

al. 1976). Hamsters were resistant to 

male developmental reproductive 

effects due to slow metabolism of the 

phthalate ester to the monoester, which 

is believed to be the active metabolite. 

Hamsters responded to the monoester, 

however. (Gray et al. 1982). The 

observation of similar effects in multiple 

species demonstrates that these effects 

are not unique to rats. This is not 

surprising because male reproductive 

development is essentially similar in all 

mammalian species (NRC, 2008). 

In contrast to these findings, a single 

study in marmosets that exposed 

pregnant females to DBP did not lead to 

any adverse effects in male offspring 

(McKinnell et al., 2009). However, as 

with most primate studies, this study 

was limited by small numbers. 

Similarly, in two recent studies in 

which fetal rat and mouse testes, or fetal 

human testicular tissue, were 

transplanted into laboratory animals 

and exposed to phthalates (Heger et al., 

2012; Mitchell et al., 2012), only the rat 

testes responded to the phthalates. 

However, the human fetal tissue was 

generally past 14 weeks of gestation, 

which is outside the window of 

maximum sensitivity. Nevertheless, 

given the potential significance of these 

studies, the CHAP invited the principal 

investigators of both studies 

(Boekelheide and Sharpe) to present 

their findings at the November 2011 

CHAP meeting. Both of these scientists 

stated that their studies were very 

preliminary and that it would be 

premature to use their results to support 

public health decisions. 

Finally, a growing number of 

epidemiological studies have reported 

associations of phthalate exposure with 

adverse health effects in humans. 

(CHAP 2014, pp. 27–33). Many of these 

effects are consistent with male 

developmental effects observed in 

animal studies. The human studies, 

although not conclusive on their own, 

provide supporting evidence that the 

animal studies are relevant to humans. 

(CPSC, 1992). The consistency of the 

results of the epidemiological studies 

with the animal studies provides 

additional support for the relevance of 

the animal studies to humans. 

To summarize, active phthalates 

cause testicular effects in multiple 

animal species. The animal studies are 

further supported by the results of 

epidemiological studies. CPSC staff 

concludes that the weight of the 

evidence overwhelmingly supports the 

conclusion that male developmental 


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12The margin of exposure (MoE) is the ratio of 

the NOAEL to the estimated exposure. 

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 mg/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. 

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 


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13CPSIA § 108(b)(1). 

14CPSIA § 108(a). 

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. 

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 mg/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 


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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-npentyl 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-nhexyl 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. 


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15CPSC staff meeting with Dr. Lioy. May 3, 2011. 

http://www.cpsc.gov//PageFiles/157051/

Meeting%20Log%20050311.pdf. 

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). 

The Commission is not proposing to 

expand the scope of the phthalates 

prohibitions to include all children’s 

products. The Commission does not 


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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<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 interimprohibited 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 § 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 § 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 § 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 


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16Section 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.’’ 

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 § 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. 

Additionally, proposed § 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 CPSCenforced 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 


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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 


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17Fifty 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. 

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. 

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. 

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This section provides a list of the 

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Reproductive Toxicology (Elmsford, NY) 

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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: 

■ 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). 

§ 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 § 1307.3. 

§ 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. 

§ 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 

SECURITIES AND EXCHANGE 

COMMISSION 

17 CFR Parts 230 and 240 

[Release No. 33–9693; 34–73876; File No. 

S7–12–14] 

RIN 3235–AL40 

Changes to Exchange Act Registration 

Requirements To Implement Title V 

and Title VI of the Jobs Act 

AGENCY: Securities and Exchange 

Commission. 

ACTION: Proposed rule. 

SUMMARY: We are proposing 

amendments to our rules to implement 

Title V and Title VI of the Jumpstart Our 

Business Startups Act (the ‘‘JOBS Act’’). 

The proposed amendments would 


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