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and effective in protecting the safety 

and health of workers, the environment, 

and preventing incidents. These 

evaluations or visits may be random or 

based upon the OCS lease operator’s or 

contractor’s performance. 

(b) The MMS or its authorized 

representative may evaluate your SEMS 

program, including documentation of 

contractors, independent third parties, 

and designated and qualified personnel, 

and audit reports to assess your SEMS 

program. 

(1) You must be prepared to explain 

and demonstrate the procedures and 

policies included in your SEMS 

program and produce evidence to 

support your explanation. 

(2) The MMS or its authorized 

representative may conduct a site visit 

on your facility to verify that personnel 

are following your SEMS program and 

can explain and demonstrate the 

procedures and policies included in 

your SEMS program and produce 

evidence to support their explanation 

for a specific task. 

(3) If MMS directs you to do an 

evaluation, you will be responsible for 

all costs associated with the evaluation 

of your SEMS program. 

§ 250.1914 What happens if MMS finds 

shortcomings in my SEMS program? 

If MMS determines that your SEMS 

program is not in compliance with this 

subpart, we may initiate one or more of 

the following enforcement actions: 

(a) Issue an Incident(s) of 

Noncompliance; 

(b) Require you to revise and submit 

to MMS your plan to address identified 

deficiencies in your SEMS program; 

(c) Assess civil/criminal penalties; or 

(d) Initiate probationary or 

disqualification procedures from serving 

as an OCS operator. 

§ 250.1915 What are my responsibilities 

for submitting OCS performance measure 

data? 

You must submit Form MMS–131 on 

an annual basis, for the previous 

calendar year, by March 31 of each year. 

[FR Doc. E9–14211 Filed 6–16–09; 8:45 am] 

BILLING CODE 4310–MR–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 799 

[EPA–HQ–OPPT–2007–0490; FRL–8416–8] 

RIN 2070–AJ34 

Testing of Certain Nonylphenol and 

Nonylphenol Ethoxylate Substances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Advance notice of proposed 

rulemaking. 

SUMMARY: On June 6, 2007, the 

Environmental Law and Policy Center, 

the Sierra Club, the Pacific Coast 

Federation of Fishermen’s Associations, 

the Washington Toxics Coalition, 

Physicians for Social Responsibility, 

and UNITE HERE (hereinafter 

‘‘petitioners’’), petitioned EPA under 

section 21 of the Toxic Substances 

Control Act (TSCA) to initiate 

rulemaking proceedings under section 4 

and section 6 of TSCA for the 

substances nonylphenol (NP) and 

nonylphenol ethoxylates (NPEs). EPA 

granted the petitioners’ request for 

chronic aquatic toxicity testing and a 

few other aspects of the petitioners’ 

TSCA section 4 request, but denied all 

of the petitioners’ section 6 requests. 

Subsequently, on October 24, 2007, the 

petitioners filed suit in the U.S. District 

Court for the Northern District of 

California challenging EPA’s denial of 

their TSCA section 21 petition. The 

lawsuit was mediated and, in an 

agreement signed on December 30, 

2008, the parties settled the case. EPA 

is now providing this advance notice of 

proposed rulemaking (ANPRM) for 

aquatic and sediment toxicity testing 

under TSCA section 4 for these 

substances, and is also requesting 

comment on gathering data under TSCA 

and through other means to facilitate the 

evaluation of industrial laundry worker 

exposure to NPEs. 

DATES: Comments must be received on 

or before September 15, 2009. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2007–0490, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East Bldg., 

Rm. 6428, 1201 Constitution Ave., NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2007–0490. 

The DCO is open from 8 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2007–0490. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The regulations.gov website is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the docket and made available 

on the Internet. If you submit an 

electronic comment, EPA recommends 

that you include your name and other 

contact information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. For additional information 

about EPA’s public docket, visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/dockets.htm. 

Docket: All documents in the docket 

are listed in the docket index available 

in regulations.gov. Although listed in 

the index, some information is not 

publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. Publicly available docket 

materials are available electronically at 

http://www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 


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Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

Federal holidays. The telephone number 

of the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

general information contact: Colby 

Lintner, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 554–1404; e-mail address: 

TSCA-Hotline@epa.gov. 

For technical information contact: 

John Schaeffer, Chemical Control 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (202) 564– 

8173; e-mail address: ccd.citb@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be interested in this action 

if you manufacture (defined by statute 

to include import) or process NP or 

NPEs. Potentially affected entities may 

include, but are not limited to: 

• Chemical manufacturers (including 

importers) (NAICS codes 325, 32411, 

e.g., chemical manufacturing and 

petroleum refineries) of one or more of 

the subject chemicals. 

• Surface active agent manufacturers 

(NAICS code 325613). 

• Industrial launderers (NAICS code 

81233). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

Unit II.B. and Unit II.D.1. If you have 

any questions regarding the 

applicability of this action to a 

particular entity, consult the technical 

person listed under FOR FURTHER

INFORMATION CONTACT. 

B. What Should I Consider as I Prepare 

My Comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD-ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. What is the Purpose and Background 

of this ANPRM? 

EPA is publishing this ANPRM as a 

follow-up to its response to certain 

TSCA section 4 test rule development 

requests made to EPA by the petitioners 

under TSCA section 21. Under TSCA 

section 21, any person may petition EPA 

to initiate a rulemaking proceeding for 

the issuance, amendment, or repeal of a 

rule under TSCA sections 4, 6, or 8 or 

an order under TSCA sections 5(e) or 

6(b)(2). In the petition filed under TSCA 

section 21 in June 2007, the petitioners’ 

requested that EPA require 

manufacturers and importers to conduct 

certain health and safety studies under 

TSCA section 4, and also requested 

certain TSCA section 6(a) actions for NP 

and NPEs (Ref. 1). 

In its response to the TSCA section 21 

petition (Ref. 2), EPA agreed that there 

may be a need for aquatic chronic 

toxicity testing for the short-chain NPEs. 

However, as EPA noted in its response, 

the particulars of a proposed testing 

program to evaluate aquatic toxicity of 

NPEs are uncertain, including which, 

and how many test chemicals and test 

species to include. In regard to an 

additional TSCA section 4 request, EPA 

denied that epidemiological testing is 

necessary, but did conclude that there 

may be a need for data to determine 

exposure to industrial laundry workers. 

However, EPA believes that additional 

information is needed to resolve: 

1. Whether an exposure study (or 

studies) of industrial laundry workers’ 

exposure to NPEs is warranted, and if 

so, 

2. What kind of exposure study(ies) 

should be performed. 

The TSCA section 21 petition and EPA’s 

response, described in a Federal 

Register document that published on 

September 5, 2007, are available in the 

docket for this action (Refs. 1 and 2). 

On October 24, 2007, the petitioners 

filed suit in the U.S. District Court for 

the Northern District of California (Ref. 

56) challenging EPA’s denial of the 

requests in the TSCA section 21 

petition. This lawsuit was mediated 

and, in an agreement signed on 

December 30, 2008, the parties settled 

the case (Ref. 57). As part of the 

settlement, the parties agreed to ask the 

Court to dismiss the case with prejudice 

within 10 days of the publication of this 

ANPRM. Copies of the original filing 

and the final settlement agreement are 

available in the docket for this action 

(Refs. 56 and 57). 

The purpose of this ANPRM is to 

solicit public input and obtain 

additional information relevant to 

whether and what kind of testing to 

propose concerning aquatic toxicity 

testing of NP and NPEs, and also to 

solicit comment relevant to establishing 

the necessity for, and the type of studies 

useful to, determining exposure of 

industrial laundry workers to NPEs. 

EPA is also soliciting comment on the 

cost of the proposed testing and the 


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capacity of laboratories to conduct the 

testing. 

B. What are the Chemical Substances of 

Concern to EPA in this ANPRM? 

The chemicals of concern in this 

ANPRM are NPEs, especially the shortchain NPEs, and NP. NP has little direct 

use itself, but is used as an intermediate 

to produce other chemicals, especially 

long-chain NPEs (Ref. 3). NPEs are 

manufactured by combining NP with 

ethylene oxide in an iterative process 

forming a mixture of NPEs of various 

chain lengths of 4 to 80 ethoxylate (EO) 

groups (e.g., NP4EO to NP80EO) (Refs. 

3 and 4). Commercially, the commonly 

used NPEs have chain lengths of 8 to 12 

EO groups (Ref. 5). Commercial 

mixtures of NPEs may contain a mixture 

of NPEs of various chain lengths; and 

NPEs may occur in either straight, or, 

more typically, branched forms. 

Different chain lengths have different 

properties and determine the particular 

industrial application and uses of the 

NPE substances. Common uses of NPEs 

include such consumer products as 

laundry detergents, shampoos, 

household cleaners and latex paints. 

Industrial uses include their use as 

surfactants, detergents, wetting agents 

and defoamers, among other uses (Refs. 

3, 4, 6, and 7). 

C. What Testing is EPA Considering in 

this ANPRM? 

As described in this ANPRM, the 

testing EPA is considering is focused on 

aquatic toxicity testing for the shortchain NPEs, i.e., NP with one or two EO 

groups attached (NP1EO and NP2EO) 

and NP. As discussed in more detail in 

this unit, NP1EO, NP2EO, and NP occur 

in the environment mainly as 

degradation products of the longerchain NPEs. In its response to the 

petitioners, EPA agreed that data 

concerning the toxic effects of the shortchain NPEs appear to be limited for 

aquatic organisms. In addition, for NP 

and short-chain NPEs, EPA concluded 

that there may be insufficient data to 

evaluate the effects of these substances 

on sediment-dwelling organisms. Data 

that are available indicate that these 

substances are highly toxic to fish and 

invertebrates, causing lethality on an 

acute basis and effects on growth, 

reproduction, and survival with lowlevel chronic exposures (Refs. 31 and 

32). While data exist that are indicative 

of these effects, for the short-chain 

NPEs, and also for sediment-dwelling 

organisms, data may be insufficient for 

EPA to adequately evaluate the risk to 

aquatic and sediment-dwelling 

organisms from exposures to NP and 

short-chain NPEs. EPA also recognizes 

that at least part of the toxic mode of 

action for these substances may include 

disruption of the organism’s endocrine 

system. For purposes of risk assessment, 

the testing EPA is considering in this 

ANPRM may adequately account for 

these effects. However, as additional 

data and test methods become available, 

EPA may propose testing protocols to 

better address endocrine disruption 

effects specifically. 

NPEs and NP as a class of compounds 

are considered to be inherently, though 

not readily, biodegradable and, 

compared to some other surfactants, are 

relatively resistant to biodegradation 

(Refs. 4 and 6). In the environment and 

in wastewater treatment facilities 

(WWTFs), the long-chain NPEs degrade 

relatively quickly when compared to 

short-chain NPEs and NP (Refs. 8–12). 

Short-chain NPEs are more resistant to 

further degradation to NP (Ref. 13). With 

sufficient time NP is ultimately 

degraded to CO2 and water 

(mineralization), but this process is 

much longer that the degradation of 

NPEs to NP (Refs. 3 and 13–15). As a 

result, although most NPEs are used and 

released as long-chain NPEs, 

concentrations of short-chain NPEs and 

NP are relatively high compared to the 

long-chain NPEs in WWTF effluent and 

in environmental samples (Refs. 3, 4, 

and 16–24). 

The following studies are illustrative of 

sampling results for these compounds in 

U.S. waterways: 

• A study by Rice et al. (2003) 

examined a 74 mile stretch of the 

Cuyahoga River, Ohio. They found that 

urbanized areas typically contain higher 

levels of NP and NPEs, with maximum 

concentrations found in water samples 

near WWTF discharge sites. At the 

sampling site closest to the Akron 

WWTF discharge location, 2.1 miles 

downstream, they found NP, NP1EO, 

NP2EO, and NP3EO at concentrations of 

0.47, 0.60, 1.50, and 2.40 microgram/ 

Liter (μg/L), respectively. However, the 

combined NP to NPE3EO concentrations 

in water samples at 7 additional sites 

along the river were much lower, with 

total concentrations ranging from only 

0.13 to 1.0 μg/L (Ref. 22). 

• Similarly, Barber et al. (2000) 

found detectable levels of combined NP, 

NP1EO, and NP2EO of 3.36 μg/L (fall 

samples) and 3.20 μg/L (spring samples) 

in the Des Plaines River, which is 

dominated by wastewater. However, 

these compounds were not detected 

further downstream in the Illinois River 

(the Des Plaines and Kankakee Rivers 

combine to form the Illinois R.), which 

receives much less WWTF effluent (Ref. 

25). 

More extensive surveys of NPEs in U.S. 

waterways have also been undertaken: 

• A comprehensive monitoring 

study of NP and NPEs in 30 U.S. rivers 

sponsored by the Chemical 

Manufacturers Association (now the 

American Chemistry Council (ACC)), 

was designed with the stated goal of 

characterizing the upper range of 

environmental NP and NPE 

concentrations in U.S. rivers (Refs. 21 

and 49). This study found average levels 

of NP(3–17)EO (combined), NP2EO, 

NP1EO, and NP of 2.0 μg/L, 0.10 μg/L, 

0.09 μg/L, and 0.12 μg/L, respectively, 

in water samples. The highest levels 

found were approximately 15 μg/L for 

NP(3–17)EO and 1 μg/L for each of the 

other substances measured. Most of the 

water samples contained non-detectable 

levels of NP and NPEs (level of 

detection approximately 0.1 μg/L for 

NP, NP1EO and NP2EO, and 1.6 μg/L 

for total NP(3–17)EO) (Ref. 21). 

• In another study of 139 U.S. 

streams in 30 states conducted by the 

U.S. Geological Survey, NP, NP1EO, and 

NP2EO were 3 of 95 organic wastewater 

contaminants sampled for. Samples 

were taken downstream of areas 

anticipated to contain pollution from 

intense urbanization and livestock 

production. NP was one of the most 

frequently detected compounds (51%). 

NP1EO and NP2EO were also detected, 

though slightly less frequently (46% and 

37%, respectively). For NP, NP1EO, and 

NP2EO the maximum detected 

concentration levels were 40 μg/L, 20 

μg/L, and 9 μg/L, respectively, with the 

median estimated concentration of each 

substance being about 0.8 μg/L for NP, 

and 1 μg/L for NP1EO and NP2EO (Ref. 

18). 

NP and NPEs have also been reported 

in sediments. Because of their 

significant hydrophobicity, which 

increases with decreasing chain length, 

and relative resistance to degradation, 

which also increases with decreasing 

chain length, NPEs and especially NP 

and the short-chain NPEs tend to 

preferentially partition from water and 

accumulate in sediments at levels much 

higher than those reported in water 

(Refs. 3, 4, 6, 26, and 27). For example, 

Naylor et al. (1992) found that in 

sediment samples NP and NP1EO 

predominated (average levels of 162 μg/ 

kilogram (kg) and 18.1 μg/kg, 

respectively), with the highest sediment 

levels being about 3,000 μg/kg for NP 

and 175 μg/kg for NP1EO (Ref. 21). 

Bennett and Metcalfe (1998, 2000) 

found NP to be widely distributed in 

lower Great Lakes sediments with 

concentrations as high as 37,000 μg/kg 

in sediments near sewage treatment 

plants (Refs. 28 and 29). Rice et al. 


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(2003) measured sediment 

concentrations of NPEs and NP of 1,020 

μg/kg dry weight in the Cuyahoga River, 

Ohio (Combined NP and NP(1–5)EO) 

(Ref. 22). Furthermore, in contrasting 

their observations with other published 

results, Rice et al. (2003) concluded that 

sediment levels of NPEs in the 

Cuyahoga River are low compared to 

some other areas; they noted, for 

example much higher levels were 

reported for the Detroit, Rouge, and 

Chicago Rivers (e.g., maximum reported 

levels of NP and/or NPEs from 49,000 to 

60,000 μg/kg). In a marine/estuarine 

environment (Bernard Bayou, 

Mississippi), sediment concentrations 

ranged from 78 to 915 μg/kg for NP 

(average 509 μg/kg), and 5 to 89 μg/kg 

for NP1EO (average 11 μg/kg) (Ref. 49). 

In WWTFs the degradation process of 

NPEs may vary depending on the 

efficiency of the WWTF and even 

according to the season of the year. 

However, even in cases where 

biodegradation of the long-chain NPEs 

is slowed (e.g., in winter or where 

wastewater treatment is poor), studies 

indicate that NP and the short-chain 

NPEs are still the predominant 

substances found after treatment (Refs. 

3, 9, and 30). 

D. What are the Issues for Comment 

Concerning Aquatic Toxicity Testing? 

EPA has identified a number of 

issues, on which it is specifically 

soliciting comment in regard to 

proposing aquatic toxicity testing for NP 

and NPEs. However, this is not intended 

as an exclusive list of issues and 

commenters are encouraged to provide 

comments on any issue pertaining to the 

aquatic toxicity of NP and NPE shortchain isomers, and the testing that may 

be necessary or appropriate. The issues 

on which EPA is specifically soliciting 

comments are: 

• Selection of test substance identity 

and purity; 

• Selection of extent of acute and 

chronic aquatic tests and test species; 

• Selection of particular aquatic 

toxicity tests and test species for NPEs; 

• Testing of NP in a saltwater fish 

species; 

• Testing of NP and NPEs in 

freshwater and marine sediment; and 

• Proposed testing for NP1EO and 

NP2EO as it relates to development of 

water quality criteria. 

In the discussions in this unit, EPA 

indicates its preliminary considerations 

regarding these issues: 

1. Selection of test substance identity 

and purity. Currently, the aquatic 

toxicity testing EPA is considering 

would focus on testing NP and the 

short-chain NPEs, i.e., nonylphenol 

with one or two ethoxylates groups 

attached. EPA is soliciting comment on 

the most appropriate selection and 

purity of NP and NPEs to test. At this 

time, considering presently available 

data on NP and NPEs, EPA believes that 

testing of NP (phenol, 4-nonylbranched: CAS number 84852–15–3) 

and NP1EO and/or NP2EO of 95% 

purity (laboratory grade) is appropriate 

for purposes of sufficiently predicting 

environmental risks from NP and NPEs 

as a chemical category. As noted in Unit 

II.C., NP1EO, NP2EO and NP occur in 

the environment mainly as degradation 

products of the longer-chain NPEs and, 

because of their relative resistance to 

degradation compared to the longerchain NPEs, these short-chain NPEs are 

commonly found in the aquatic 

environment (Refs. 22, 25, and 31). NPE 

toxicity also seems to increase with 

decreasing chain length (Refs. 32–34). 

Available toxicity studies indicate that 

the short-chain NPEs, for example, are 

about 100 times more toxic than the 

long-chain NPEs, and NP appears to be 

about 1.5 to two times more toxic than 

the short-chain NPEs (Refs. 3 and 35). In 

the environment, the alkylphenols are 

combinations of various isomers and 

congeners, including NP, which is a mix 

of substances in which the nonyl group 

may be branched or linear and which 

may be attached to the phenol ring 

ortho, meta, or para to the hydroxyl 

group (Ref. 4). The most predominant 

commercial NP substance for which 

EPA has developed aquatic life ambient 

water quality criteria is phenol, 4-nonylbranched (CAS number 84852–15–3), 

but tests on NP with CAS number 

25154–52–3 (phenol, nonyl) were also 

used in developing these criteria (Ref. 

4). Determining which test substance to 

specify for testing is a more complex 

issue in regard to the short-chain 

ethoxylates. On the TSCA inventory, 

both NP1EO (CAS number 27986–36–3) 

and NP2EO (CAS number 27176–93–8) 

are described with the term 

‘‘unspecified isomer lot.’’ EPA has also 

identified NP1EO (CAS number 104– 

35–8) and NP2EO (CAS number 27176– 

93–8) whose name and CAS numbers 

indicate linear forms of these substances 

(although the actual structure may be 

branched); the NP1EO so identified is 

not present on the TSCA inventory; the 

NP2EO is. 

With regard to who might ultimately 

be responsible for testing of these 

substances, the approach that EPA is 

considering proposing is that all 

manufacturers and processors of NP and 

NPEs of any chain length would be 

responsible for the testing. However, 

EPA solicits comment on such an 

approach. 

2. Selection of extent of acute and 

chronic aquatic tests and test species. 

For substances that are broadly 

distributed in the environment, as is the 

case for NP and NPEs, EPA’s OPPT, in 

assessing hazard to substances which 

are considered highly toxic, and EPA’s 

Office of Water (OW), in determining 

ambient water quality criteria, typically 

review test data for both freshwater and 

saltwater organisms (fish, invertebrates, 

and plants) in order to adequately 

predict aquatic toxicity to 

environmental species (Refs. 36–38 and 

50 to 51). To further elucidate the 

aquatic toxicity of NP and NPEs, EPA is 

considering proposing a number of 

aquatic and sediment toxicity tests in 

fish, invertebrates and algae. Specific 

testing is discussed in more detail in 

this unit. 

The petitioners requested testing of 

mixtures. EPA responded that, for 

purposes of evaluating the effects of 

mixtures of NP and NPEs, an 

assumption of additive toxicity was 

reasonable and a more pragmatic way to 

account for the toxicity of mixtures of 

these substances to aquatic organisms 

(Refs. 1 and 2). This is because if effects 

are additive, the effects of mixtures can 

be effectively predicted from toxicity 

studies done on single substances. Two 

recent papers have examined the issue 

of additive toxicity for NP and NPEs. 

These papers present test results for 

mixtures of NP and the short-chain 

NPEs on fathead minnows and two 

species of daphnids, planktonic 

freshwater crustaceans also known as 

water fleas (Refs. 52 and 53). TenEyk 

and Markee (2007) concluded from 

testing with fathead minnows 

(Pimephales promelas) and water fleas 

(Ceriodaphnia dubia) that both potential 

additivity and synergism (where toxicity 

of the mixture is greater than additive) 

were observed (Ref. 52). Conversely, in 

tests with another water flea species 

(Daphnia magna), Sun and Gu (2005) 

concluded that potential antagonism 

(where toxicity of the mixture was less 

than additive) was seen (Ref. 53). EPA 

notes that these testing results indicate 

the substantial difference in the 

conclusions regarding the type of 

interaction (antagonism vs. additivity 

vs. synergism) that can potentially occur 

due to any number of factors related to 

biology, chemistry, experimental 

variables, etc. However, in considering 

the limitations associated with the study 

designs, EPA notes that, in both studies, 

the deviations observed from a simple 

additivity interaction are sufficiently 

small (a factor of approximately two or 

less) as to make additivity a reasonable 


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assumption for any evaluation of these 

compounds at this time. Two–fold is 

well within the range of inter-laboratory 

variability that one might expect in the 

results of testing a single chemical in 

the same species from one laboratory to 

another, and is far lower than the 

variability observed for toxicity of the 

same chemical to different aquatic 

species, which, in the case of NP, can 

exceed 100–fold (Refs. 32 and 55). 

Therefore, it is EPA’s current view 

that testing of individual NP and NPE 

substances as EPA is considering 

proposing in this ANPRM, will provide 

sufficient information needed to 

evaluate the toxicity of mixtures of these 

substances (for example, by using a 

toxic equivalent factor (TEF) approach). 

However, EPA is soliciting comment on 

whether testing intended to address the 

potential for additive toxicity should be 

conducted consistent with the protocol 

used in the TenEyck and Markee study 

(Ref. 52), as suggested by the petitioners. 

EPA is also soliciting comment on 

alternative approaches to investigating 

the potential toxicity of mixtures of NP 

and the various short-chain NPEs. 

3. Selection of particular aquatic 

toxicity tests and test species for NPEs. 

To further determine the aquatic 

toxicity of NPEs, EPA is considering 

proposing chronic testing in freshwater 

fish, both warm and coldwater species 

(e.g., fathead minnow, Pimephales 

promelas, and rainbow trout, 

Oncorhynchus mykiss); chronic testing 

in a freshwater invertebrate (e.g., 

Daphnia magna); and testing in 

freshwater algae (e.g., 

Pseudokirchneriella subcapitata; 

formerly Selenastrum capricornutum). 

EPA is also considering testing in a 

saltwater fish (e.g., sheepshead minnow, 

(Cyprinodon variegatus), chronic testing 

in a saltwater invertebrate (e.g., mysid 

shrimp, Mysidopsis bahia), and testing 

in saltwater algae (e.g., Skeletonema 

costatum)). In order to set appropriate 

test concentration levels, and to 

develop-acute-to-chronic ratios, EPA is 

also considering acute testing be 

performed by the same laboratory doing 

the chronic fish and invertebrate testing. 

4. Testing of NP in a saltwater fish 

species. EPA has developed water 

quality criteria (WQC) for NP (Ref. 4). 

However, as EPA noted in that 

document, the WQC for NP (CAS 

number 84852–15–3) was developed 

without adequate chronic toxicity data 

for a saltwater fish species. EPA is 

therefore considering proposing that 

acute and chronic toxicity testing of NP 

be performed in a single laboratory in 

order to fill that missing chronic toxicity 

data need, and also to calculate an 

acute-to-chronic ratio. EPA is 

considering proposing that the 

sheepshead minnow be the test species 

for this possible testing requirement. 

5. Testing of NP and NPEs in 

freshwater and marine sediment. EPA 

noted in its response to the NP-NPE 

TSCA section 21 petition that 

information on the toxicity of NP in 

sediment, in both freshwater and 

marine/estuarine habitats, is limited and 

that it would consider additional testing 

under TSCA section 4 to obtain needed 

data. EPA is considering proposing 

acute and chronic sediment toxicity 

testing in freshwater and marine species 

of benthic invertebrates for NP, NP1EO, 

and/or NP2EO, where adequate data are 

lacking. Specifically, EPA is considering 

proposing the amphipod (Hyalella 

azteca) as the freshwater test species 

(acute and chronic testing) (Ref. 39). 

EPA is also requesting, as per the 

discussion in Unit II.D.2., comment on 

whether to require section 4 testing of 

NPE and NP on a sediment organism, 

e.g., Hyalella azteca, in order to fill the 

information gaps on additive toxicity. 

Regarding the marine environment, EPA 

is considering proposing testing in two 

species: acute testing in a marine 

amphipod (Rhepoxynius abronius), 

which, besides being a purely marine 

species, has a large data base of toxicity 

testing available; and acute and chronic 

testing in an estuarine amphipod, 

(Leptocheirus plumulosus) (Refs. 40 and 

41). EPA would consider using the 

results from both Leptocheirus and 

Rhepoxynius to estimate chronic 

toxicity to Rhepoxynius, for which a 

chronic toxicity test method is not 

available. 

6. Proposed testing for NP1EO and 

NP2EO as it relates to development of 

water quality criteria. EPA has derived 

recommended ambient water quality 

criteria (AWQCs) only for NP (Ref. 4). 

An EPA-recommended AWQC is a level 

of a pollutant or other measurable 

substance in water that, when met, will 

protect aquatic life and/or human 

health. EPA publishes recommended 

AWQCs pursuant to Section 304(a) of 

the Clean Water Act, which directs EPA 

to publish criteria accurately reflecting 

the latest scientific knowledge on such 

factors as ‘‘the kind and extent of all 

identifiable effects . . . expected from 

the presence of pollutants in any body 

of water.’’ 33 U.S.C 1314(a)(1)(A). As 

discussed in this unit, NP is more 

persistent and toxic, and frequently 

more abundant in the environment, than 

NPEs. Because of its relative persistence 

and toxicity compared to NPEs, most 

research has focused on NP as a 

chemical substance of concern. For 

these same reasons, development of data 

for NP was considered of priority 

importance for derivation of AWQCs. 

(Development of AWQC generally 

involves extensive and specific test data 

(Refs. 4 and 38)). In this ANPRM, EPA 

is considering proposing more limited 

testing that would sufficiently 

characterize the toxicity of NP1EO and 

NP2EO to enable a reasoned assessment 

of risk from these substances. However, 

the data developed could also be useful 

to OW should they pursue development 

of NPE AWQCs. 

E. What are the Issues Concerning 

Exposure of NPEs to Industrial Laundry 

Workers? 

The petitioners requested that EPA 

conduct an epidemiology study of 

industrial laundry workers who may be 

exposed to NP and NPEs in detergents. 

As noted in EPA’s response to the 

petition, before an epidemiology study 

can be effectively designed or 

conducted, there needs to be sufficient 

exposures to a substance to warrant a 

study of human health effects 

potentially attributable to those 

exposures. As noted in the comments 

submitted by the Uniform and Textile 

Service Association (UTSA) and the 

Textile Rental Services Association 

(TRSA), approximately 90% of 

industrial laundries use injected liquid 

detergent (Ref. 42). Given the low 

volatility (Ref. 43) and negligible dermal 

absorption of NP and NPE (Ref. 44), EPA 

does not expect that where liquid 

detergents are used these industrial 

laundry operations will present a 

significant exposure potential to 

workers. However, as agreed to in the 

Settlement Agreement (Ref. 57), EPA is 

soliciting comment on that conclusion 

in this ANPRM. Additionally, EPA is 

soliciting information on specific 

circumstances or scenarios which may 

result in workers being exposed. 

Examples included exposure scenarios 

resulting from spills. EPA would be 

interested in the extent to which those 

types of exposures would present risks 

to workers. EPA would also be 

interested in receiving comments on the 

best ways to obtain data or information 

on such exposures. 

For the approximately 10% of 

industrial laundry operations and an 

unknown number of institutional 

laundry operations that may use 

powdered detergent, EPA believes there 

is potential for inhalation exposure to 

dust containing NP and NPE by workers 

and that the number of potentially 

exposed workers involved could be 

substantial (Ref. 45). As these concerns 

are based on estimates, not actual 

exposure monitoring data, they would 

not support a conclusion that there are 

sufficient exposures to warrant an 


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epidemiology study. However, EPA 

considers that obtaining additional 

exposure information may be warranted 

to reasonably assess the potential for 

risk associated with this exposure 

scenario in particular. 

EPA has examined the regulatory 

status, as well as other studies, of 

various components of detergents that 

are used in consumer, industrial, and 

institutional laundry operations (Refs. 

46, 47, and 48). Exposure limits for 

subtilisins, enzymes used in detergent 

formulations, have been established by 

the American Conference of Industrial 

Hygienists (ACGIH) and the National 

Institute for Occupational Safety and 

Health (NIOSH). Air monitoring to 

ensure the levels are maintained is 

recommended and personal monitoring 

equipment for subtilisins or other 

common enzyme detergents is available 

(Ref. 47). In addition, the Organization 

for Economic Co-operation and 

Development (OECD) Screening 

Information Data Set (SIDS) report on 

linear alkyl sulfonates, another common 

laundry detergent component, suggests 

that the hazard warnings and routine 

practices (protective equipment use and 

rinsing of residuals from contact) will 

sufficiently limit exposure and 

subsequent absorption (Ref. 48). The 

potential for exposure to NP based 

chemicals in detergents should already 

be mitigated by the policies in place for 

the other detergent components. 

However, based on EPA’s draft 

engineering report (Ref. 45), EPA 

believes that specific monitoring for NP 

or NPE, using the analogous 

methodology for monitoring enzyme 

exposure, may be warranted to ensure 

that these routine practices are also 

protecting from NP exposures. 

Accordingly, while EPA denied the 

petitioners’ specific request for an 

epidemiology study, EPA is soliciting 

comment on the best means to obtain 

information on NP and NPE exposures 

of laundry workers, especially where 

powdered detergents are used (e.g., 

whether through requiring an exposure 

study, workplace exposure monitoring, 

the voluntary submission of existing 

monitoring data, or other means). In 

addition, although EPA does not believe 

it has evidence sufficient to support the 

same level of concern for liquid 

detergents as for powdered detergents, 

EPA is soliciting comment on whether 

and how to obtain data on specific 

scenarios that may result in exposure to 

laundry workers from liquid detergents, 

as well as powdered detergents. 

F. What is the Agency’s Authority for 

Taking this Action? 

EPA is issuing this ANPRM on certain 

health and environmental effects testing 

for certain NP and NPE chemical 

substances under TSCA section 4(a) (15 

U.S.C. 2603(a)). 

Section 2(b)(1) of TSCA (15 U.S.C. 

2601(b)) states that it is the policy of the 

United States that ‘‘adequate data 

should be developed with respect to the 

effect of chemical substances and 

mixtures on health and the environment 

and that the development of such data 

should be the responsibility of those 

who manufacture [which is defined by 

statue to include import] and those who 

process such chemical substances and 

mixtures[.]’’ To implement this policy, 

TSCA section 4(a) provides that EPA 

shall require by rule that manufacturers 

and processors of chemical substances 

and mixtures conduct testing if the 

Administrator finds that: 

(1)(A)(i) the manufacture, distribution in 

commerce, processing, use, or disposal of a 

chemical substance or mixture, or that any 

combination of such activities, may present 

an unreasonable risk of injury to health or the 

environment, 

(ii) there are insufficient data and 

experience upon which the effects of such 

manufacture, distribution in commerce, 

processing, use, or disposal of such substance 

or mixture of any combination of such 

activities on health or the environment can 

reasonable be determined or predicted, and 

(iii) testing of such substances or mixture 

with respect to such effects is necessary to 

develop such data; or 

(B)(i) a chemical substance or mixture is or 

will be produced in substantial quantities, 

and (I) it enters or may reasonably be 

anticipated to enter the environment in 

substantial quantities or (II) there is or may 

be significant or substantial human exposure 

to such substance or mixture, 

(ii) there are insufficient data and 

experience upon which the effects of the 

manufacture, distribution in commerce, 

processing, use, or disposal of such substance 

or mixture or of any combination of such 

activities on health or the environment can 

reasonable be determined or predicted, and 

(iii) testing of such substance or mixture 

with respect to such effects is necessary to 

develop such data; and 

(2) in the case of a mixture, the effects 

which the mixture’s manufacture, 

distribution in commerce, processing, use or 

disposal or any combination of such 

activities may have on health or the 

environment may not be reasonably and 

more efficiently determined or predicted by 

testing the chemical substances which 

comprise the mixture[.] 

(15 U.S.C. 2603(a)) 

If EPA makes these findings for a 

chemical substance or mixture, the 

Administrator shall require that testing 

be conducted on that chemical 

substance or mixture. The purpose of 

the testing would be to develop data 

about the substance’s or mixture’s 

health and environmental effects for 

which there is an insufficiency of data 

and experience, and which are relevant 

to a determination that the manufacture, 

distribution in commerce, processing, 

use, or disposal of the substance or 

mixture, or any combination of such 

activities, does or does not present an 

unreasonable risk of injury to health or 

the environment. (15 U.S.C. 2603(a)) 

Once the Administrator has made the 

relevant findings under TSCA section 

4(a), EPA may require any type of health 

or environmental effects testing 

necessary to address unanswered 

questions about the effects of the 

chemical substance. EPA need not limit 

the scope of testing required to the 

factual basis for the TSCA section 

4(a)(1)(A) or (B) findings as long as EPA 

also finds that there are insufficient data 

and experience upon which the effects 

of the manufacture, distribution in 

commerce, processing, use, or disposal 

of such substance or mixture or of any 

combination of such activities on health 

or the environment can reasonably be 

determined or predicted, and that 

testing is necessary to develop such 

data. This approach is explained in 

more detail in EPA’s TSCA section 

4(a)(1)(B) Final Statement of Policy 

published in the Federal Register issue 

of May 14, 1993 (58 FR 28736, 28738– 

28739) (B Policy). 

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49. Radian Corp. 1990. Nonylphenol 

and nonylphenol ethoxylates in river 

water and bottom sediments: January 

1989–August 1990. Final Report to 

Alkylphenol and Ethoxylates Panel, 

Chemical Manufacturers Association. 

50. Smrchek, J.; Clements, R.; 

Morcock, R; and Rabert, W. 1993. 

Assessing ecological hazard under 

TSCA: methods and evaluation of data. 

Pp. 22–39. In: Landis W.G.; Hughes, J.S.; 

and Lewis, M.A. (eds). Environmental 

Toxicology and Risk Assessment, ASTM 

STP 1179. American Society for Testing 

and Materials, Philadelphia, 

Pennsylvania. 

51. Smrchek, J.; Zeeman, M.; and 

Clements, R. Ecotoxicology and the 

assessment ecological of chemicals at 

the US EPA’s Office of Pollution 

Prevention and Toxics: current activities 

and future needs. Pp. 127–158. In: Pratt, 

J.R.; Bowers, N.; and Stauffer, J.R. (eds). 

Making Environmental Science, 

Ecoprint, Portland, OR. 271 pp. 1995. 

52. TenEyck, M.C.; and Markee, T.P. 

2007. Toxicity of nonylphenol, 

nonylphenol monoethoxylate, and 

nonylphenol diethoxylate and mixtures 

of these compounds to Pimephales 

promelas (fathead minnow) and 

Ceriodaphnia dubia. Archives of 

Environmental Contamination and 

Toxicology. 53:599–606. 

53. Sun, H. and Gu, X. 2005. 

Comprehensive toxicity study of 

nonylpheno and short-chain 

nonylphenol polyethoxylates on 

Daphnia magna. Bulletin of 

Environmental Contamination and 

Toxicology. 75:677–683. 

54. Zeeman, M.; Nabholz, J.V.; and 

Clements, R.G. 1993. The development 

of SAR/QSAR for use under EPA’s 

Toxic Substances Control Act (TSCA): 

an introduction. Pp. 523–539. In: 

Gorsuch, J.W.; Dwyer, F.J.; Ingersoll, 

C.G.; and LaPoint, T.W. (eds). 

Environmental Toxicology and Risk 

Assessment-2nd Volume, ASTM STP 

1216. American Society for Testing and 

Materials, Philadelphia, Pennsylvania. 

55. Vaal, M.A.; Van Leeuwen, C.J.; 

Hoekstra, J.A.; and Hermens, J.L. 2000. 

Variation in sensitivity of aquatic 

species to toxicants: practical 

consequences for effect assessment of 

chemical substances. Environmental 

Management. 25:415–423. 

56. Complaint for Declaratory and 

Injunctive Relief, Sierra Club et al. v. 

Johnson, U.S. District Court for the 

Northern District of California, Case No. 

C07–05435–MCC, October 24, 2007. 

57. Settlement Agreement, Sierra Club 

et al. v. Johnson, U.S. District Court for 

the Northern District of California, Case 

No. C07–05435–MCC, December 30, 

2008. 

IV. Do Any Statutory and Executive 

Order Reviews Apply to This Action? 

Under Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993), 

it has been determined that this is a 

‘‘significant regulatory action’’ because 

the initiation of a new rulemaking 

proceeding may raise novel legal or 

policy issues. Accordingly, EPA 

submitted this action to the Office of 

Management and Budget (OMB) for 

review under Executive Order 12866 

and any changes made in response to 

OMB recommendations have been 

documented in the docket for this 

action. 

Because this action does not propose 

or impose any requirements, other 

statutory and Executive Order reviews 

that apply to rulemaking do not apply. 

Should EPA subsequently determine to 

pursue a rulemaking, EPA will address 

the statutes and Executive Orders as 

applicable to that rulemaking. 

Nevertheless, the Agency welcomes 

comments and/or information that 

would help the Agency to assess any of 


dwashington3 on PROD1PC60 with PROPOSALS-1
28662 Federal Register / Vol. 74, No. 115 / Wednesday, June 17, 2009 / Proposed Rules 

the following: The potential impact of a 

rule on small entities pursuant to the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.); availability of 

voluntary consensus standards pursuant 

to section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA), Public Law 104– 

113, section 12(d) (15 U.S.C. 272 note); 

environmental health or safety effects 

on children pursuant to Executive Order 

13045, entitled Protection of Children 

from Environmental Health Risks and 

Safety Risks (62 FR 19985, April 23, 

1997); or human health or 

environmental effects on minority or 

low-income populations pursuant to 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994). The Agency will 

consider such comments during the 

development of any subsequent 

rulemaking. 

List of Subjects in 40 CFR Part 799 

Environmental protection, Chemicals, 

Hazardous substances, Nonylphenol, 

Nonylphenol ethoxylates, Reports and 

recordkeeping requirements. 

Dated: June 10, 2009. 

James Jones, 

Acting Assistant Administrator, Office of 

Prevention, Pesticides and Toxic Substances. 

[FR Doc. E9–14250 Filed 6–16–09; 8:45 am] 

BILLING CODE 6560–50–S 


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