Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices 7983 

D. Labeling Issues 

1. There are many differences 

between the labeling requirements 

required by FDA’s OTC drug labeling 

requirements and EPA’s pesticide 

labeling requirements. For example, the 

formats and the order in which 

information is presented are quite 

different. FDA allows the use of the 

word ‘‘warning’’ on labels; however it is 

only allowed as an indicator of toxicity 

level on pesticide labels. Various 

required section headings are different. 

Please comment on how such labeling 

differences can be reconciled. 

2. FDA ingredient statements list the 

‘‘inactive or inert’’ ingredients more 

often and in greater detail than do EPA 

approved labels. The Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) does not require the listing 

of the identities of inert ingredients on 

the label. Are there ways to provide the 

insect repellent inert ingredients 

information in the product’s labeling to 

satisfy the drug requirements of the 

FFDCA? 

3. Is it desirable for users of these 

products to have a single integrated 

label, or would an insect repellent (EPA) 

and a sunscreen (FDA) section in the 

product’s labeling be preferable? 

4. Should the insect repellent/ 

sunscreen combination products be 

required to have a statement on the front 

panel of the label specifically 

identifying the product as containing an 

insect repellent (such as, This Product 

Contains An Insect Repellent)? Would 

this be useful to help consumers 

distinguish between sunscreen products 

that contain pesticides from the typical 

sunscreen drug products that contain no 

pesticides? 

List of Subjects 

Environmental protection, 

Administrative practice and procedure, 

Intergovernmental relations, Pesticides, 

Pests. 

Dated: February 13, 2007. 

James B. Gulliford, 

Assistant Administrator, Office of Prevention, 

Pesticides and Toxic Substances. 

[FR Doc. E7–3008 Filed 2–21–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[Docket# EPA–RO4–SFUND–2007–0129; 

FRL–8279–3] 

Starmet CMI; Barnwell, Barnwell 

County, SC; Notice of Settlement 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of settlement. 

SUMMARY: Under Section 122(g) of the 

Comprehensive Environmental 

Response, Compensation and Liability 

Act (CERCLA), the United States 

Environmental Protection Agency has 

entered into a settlement for 

reimbursement of past response costs 

with the Alaron Corporation concerning 

the Starmet CMI Superfund Site located 

in Barnwell, Barnwell County, South 

Carolina. 

DATES: The Agency will consider public 

comments on the settlement until March 

26, 2007. The Agency will consider all 

comments received and may modify or 

withdraw its consent to the settlement 

if comments received disclose facts or 

considerations which indicate that the 

settlement is inappropriate, improper, 

or inadequate. 

ADDRESSES: Copies of the settlement are 

available from Ms. Paula V. Batchelor. 

Submit your comments, identified by 

Docket ID No. EPA–RO4–SFUND–2007–

0129 or Site name Starmet CMI 

Superfund Site by one of the following 

methods: 

• www.regulations.gov: Follow the 

online instructions for submitting 

comments. 

• E-mail: Batchelor.Paula@epa.gov 

• Fax: 404/562–8842/Attn Paula V. 

Batchelor 

Mail: Ms. Paula V. Batchelor, U.S. 

EPA Region 4, WMD–SEIMB, 61 Forsyth 

Street, SW., Atlanta, Georgia 30303. ‘‘In 

addition, please mail a copy of your 

comments on the information collection 

provisions to the Office of Information 

and Regulatory Affairs, Office of 

Management and Budget (OMB), Attn: 

Desk Officer for EPA, 725 17th St., NW., 

Washington, DC 20503.’’

Instructions: Direct your comments to 

Docket ID No. EPA–R04–SFUND–2007–

0129. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at 

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 www.regulations.gov 

or e-mail. The www.regulations.gov Web 

site 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 www.regulations.gov your email address will be automatically 

captured and included as part of the 

comment that is placed in the public 

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 www.regulations.gov 

index. 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 

either electronically in 

www.regulations.gov or in hard copy at 

the U.S. EPA Region 4 office located at 

61 Forsyth Street, SW., Atlanta, Georgia 

30303. Regional office is open from 7 

a.m. until 6:30 p.m.. Monday through 

Friday, excluding legal holidays. 

Written comments may be submitted 

to Ms. Batchelor within 30 calendar 

days of the date of this publication. 

FOR FURTHER INFORMATION CONTACT: 

Paula V. Batchelor at 404/562–8887. 

Dated: February 7, 2007. 

Rosalind H. Brown, 

Chief, Superfund Enforcement & Information 

Management Branch, Superfund Division. 

[FR Doc. E7–3014 Filed 2–21–07; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OW–2003–0079; FRL–OW–8280–

2] 

Aquatic Life Ambient Freshwater 

Quality Criteria—Copper 2007 Revision 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of Availability. 

SUMMARY: The Environmental Protection 

Agency (EPA) announces the 

availability of the 2007 revised 

recommended aquatic life ambient 

freshwater quality criteria for copper. 

The Clean Water Act (CWA) requires 


rwilkins on PROD1PC63 with NOTICES
7984 Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices 

EPA to develop and publish, and from 

time to time revise, criteria for water 

accurately reflecting the latest scientific 

knowledge. These criteria provide EPA’s 

recommendations to states and 

authorized tribes as they establish their 

water quality standards as state or tribal 

law or regulation. An EPA water quality 

criterion does not substitute for 

requirements of the CWA or EPA 

regulations, nor is an EPA criteria 

recommendation a regulation. It does 

not impose legally binding requirements 

on the EPA, states, authorized tribes or 

the regulated community. State and 

tribal decision makers have discretion to 

adopt approaches that differ from EPA’s 

water quality criteria recommendations 

on a case-by-case basis. Today, the 

Agency is making a revised 

recommendation about water quality 

criteria for copper. 

ADDRESSES: Copies of the criteria 

document entitled, Aquatic Life 

Ambient Freshwater Quality Criteria—

Copper 2007 Revision (EPA–822–R–07–

001) may be obtained from EPA’s Water 

Resource Center by phone at (202) 566–

1729, or by e-mail to 

center.water.resource@epa.gov or by 

conventional mail to: U.S. EPA Water 

Resource Center, 4101T, 1200 

Pennsylvania Avenue, NW., 

Washington, DC 20460. You can also 

download the criteria document and the 

fact sheet from EPA’s Web site at http:// 

www.epa.gov/waterscience/criteria/ 

copper/index.htm. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Luis Cruz, Health and Ecological 

Criteria Division (4304T), U.S. EPA, 

1200 Pennsylvania Avenue, NW., 

Washington, DC 20460; (202) 566–1095; 

cruz.luis@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Interested Entities 

Entities potentially interested in 

today’s notice are those that produce, 

use, or regulate copper. Categories and 

entities interested in today’s notice 

include: 

Category Examples of interested entities 

State/Local/Tribal 

Government.

States, Tribes and 

Municipalities. 

Industry ..................... Mining, fabricated 

metal products, 

electric equipment, 

leather products. 

This table is not exhaustive, but rather 

provides a guide for readers regarding 

the entities likely to be interested in this 

notice. Other types of entities not listed 

in the table could also be interested. 

B. How Can I Get Copies of This 

Document and Other Related 

Information? 

1. Docket 

EPA established an official public 

docket for the initial draft criteria 

document and scientific views received 

under Docket ID No. EPA–HQ–OW–

2003–0079. The official public docket 

will also consist of the 2007 revised 

criteria document and scientific views 

received. Although a part of the official 

docket, the public docket does not 

include Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Publicly available docket materials are 

available either electronically through 

http://www.regulations.gov, or in hard 

copy at the Water Docket in the EPA 

Docket Center, (EPA/DC) EPA West, 

Room B102, 1301 Constitution Ave., 

NW., Washington, DC. The EPA Docket 

Center Public Reading Room is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the Water 

Docket is (202) 566–2426. To view these 

documents and materials, please call 

ahead to schedule an appointment. 

Every user is entitled to copy 266 pages 

per day before incurring a charge. The 

Docket may charge 15 cents a page for 

each page over the 266-page limit plus 

an administrative fee of $25.00. 

2. Electronic Access 

You may access this Federal Register 

document electronically through the 

EPA’s Internet listings under the 

Federal Register at: http://www.epa.gov/ 

fedrgstr/. 

II. Background and Today’s Notice of 

Availability 

A. What Are EPA Recommended 

Ambient Water Quality Criteria? 

An EPA recommended ambient water 

quality criterion is a description of the 

amount of a pollutant or other 

measurable substance in water that, 

when met, will protect aquatic life and/ 

or human health. Water quality criteria 

are based on the factors specified in 

section 304(a) of the Clean Water Act, 

including the kind and extent of effects 

of the pollutant on human health and 

aquatic organisms. Section 304(a) of the 

Clean Water Act (CWA or the Act) 

requires EPA to develop and publish 

and, from time to time, revise, 

recommended ambient water quality 

criteria to accurately reflect the latest 

scientific knowledge. An EPA water 

criterion does not substitute for 

requirements of the CWA or EPA 

regulations, nor is an EPA criteria 

recommendation a regulation. It does 

not impose legally binding requirements 

on EPA, states, authorized tribes or the 

regulated community. State and tribal 

decision makers have discretion to 

adopt approaches that differ from EPA’s 

water quality criteria recommendations 

on a case-by-case basis. 

Ambient water quality criteria 

developed under section 304(a) provide 

guidance to states and tribes in adopting 

water quality criteria into their water 

quality standards under section 303(c) 

of the CWA. Once adopted by a state or 

tribe, the water quality standards are 

then a basis for developing regulatory 

controls on the discharge or release of 

pollutants and other alterations of water 

quality. EPA’s section 304(a) criteria 

also provide a scientific basis for EPA to 

develop any necessary federal water 

quality regulations under section 303(c) 

of the CWA. 

B. What Is the Relationship Between the 

Water Quality Criteria and Your State or 

Tribal Water Quality Standards? 

The revised recommended criteria in 

today’s notice are based on the factors 

specified in section 304(a) of the Clean 

Water Act, including the kind and 

extent of effects of the pollutant on 

human health and aquatic organisms. 

EPA’s recommended criteria are used by 

the states and tribes in developing their 

regulatory criteria under section 303(c) 

of the CWA. Under the Clean Water Act, 

regulatory water quality criteria must 

protect the designated use, independent 

of the economic and technical feasibility 

of meeting the criteria. Economic and 

technical feasibility factors are 

considered by states and tribes when 

they adopt designated uses into their 

water quality standards under section 

303(c) of the Act and when states, tribes, 

and EPA consider variance requests. 

Moreover, states and tribes may also 

consider alternative scientifically 

defensible approaches to adopting 

criteria into their water quality 

standards. 

Section 303(c)(1) of the CWA requires 

states and authorized tribes to review 

and modify, if appropriate, their water 

quality standards at least once every 

three years. Water quality standards 

consist of designated uses, water quality 

criteria to protect those uses, a policy 

for antidegradation, and general policies 

for application and implementation. 

States and authorized tribes must adopt 

water quality criteria that protect 

designated uses. Protective criteria, 

based on a sound scientific rationale, 

contain appropriate factors to protect 

the designated uses. Criteria may be 


rwilkins on PROD1PC63 with NOTICES
Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices 7985 

either narrative or numeric. States and 

authorized tribes have four options 

when adopting water quality criteria for 

parameters for which EPA has 

published section 304(a) criteria. They 

may: (1) Establish numerical values 

based on recommended CWA section 

304(a) criteria; (2) Establish numerical 

values based on CWA section 304(a) 

criteria modified to reflect site-specific 

conditions; (3) Establish numerical 

values based on other scientifically 

defensible methods; or (4) Establish 

narrative criteria or criteria based upon 

biomonitoring methods where 

numerical criteria cannot be determined 

or to supplement numerical criteria. See 

40 CFR 131.11(b). 

Pursuant to 40 CFR 131.21, water 

quality criteria that states and 

authorized tribes adopted and submitted 

to EPA before May 30, 2000, are in effect 

for CWA purposes. The criteria remain 

in effect unless and until EPA 

promulgates federal regulations that 

supersede them or EPA approves a 

revised state criteria. See, e.g., the 

National Toxics Rule, 40 CFR 131.36; 

Water Quality Standards for Idaho, 40 

CFR 131.33. New or revised water 

quality criteria that states and 

authorized tribes adopted into law or 

regulation and submit to EPA on or after 

May 30, 2000, are in effect for CWA 

purposes only after EPA approves them. 

C. What Is the History of Today’s 

Revised Criteria? 

EPA notified the public of its 

intentions to revise the recommended 

aquatic life criteria for copper in the 

Federal Register on October 29, 1999 

(63 FR 58406). On December 31, 2003 

EPA published a Federal Register Notice 

announcing the availability of the 

document Notice of Availability of Draft 

Aquatic Life Criteria Document for 

Copper and Request for Scientific Views 

(68 FR 75552). The initial draft criteria 

document contained recommendations 

for both freshwater and saltwater 

criteria derivations; however, EPA has 

since determined that the biotic ligand 

model requires further development 

before it is suitable for use to evaluate 

saltwater data. On March 9, 2004 EPA 

published a Federal Register Notice (69 

FR 11012) announcing the reopening of 

the period to submit scientific views in 

response to requests from the public. 

Comments received were supportive of 

using the BLM for deriving freshwater 

criteria for copper. Issues related to 

criteria derivation process were 

answered, as well as corrections in 

matters of scientific relevance related to 

the applicability of the BLM. 

D. What Is Copper? 

Copper is an abundant trace element 

found in the earth’s crust and is a 

naturally occurring element that is 

generally present in surface waters. 

Copper is a micronutrient at low 

concentrations and recognized as 

essential to virtually all plants and 

animals. Historically, elevated levels of 

copper have been linked to adverse 

effects on aquatic organisms and 

concerns have prompted its inclusion as 

a priority pollutant. Currently, there are 

629 rivers and streams listed as 

impaired for copper and 5 for 

contaminated sediments due to copper. 

E. What Is New About the Revised 

Criteria? 

The aquatic life criteria document 

titled, ‘‘Aquatic Life Ambient 

Freshwater Quality Criteria—Copper 

2007 Revision’’ (EPA–822–R–07–001), 

contains revised recommendations for 

freshwater aquatic life criteria for 

copper. These revised criteria 

recommendations are based in part on 

new data that have become available 

since EPA’s last comprehensive criteria 

updates for copper, ‘‘Ambient Water 

Quality Criteria for Copper—1984’’

(EPA–440/5–84–031). EPA derived the 

freshwater criteria recommendations 

presented in this draft document based 

on the principles set forth in EPA’s 1985 

Guidelines for Deriving Numerical 

National Aquatic Life Criteria for 

Protection of Aquatic Organisms and 

Their Uses. In addition to incorporating 

new data, the freshwater criterion 

maximum concentration (CMC or ’’acute 

criterion’’) also relies on a new scientific 

model, the biotic ligand model (BLM), 

in the criteria derivation procedures. 

The freshwater criterion continuous 

concentration (CCC or ‘‘chronic 

criterion’’) is based on a BLM derived 

acute value divided by a final acutechronic ratio. Where used, the 

application of the BLM will replace the 

need for site-specific modifications, 

such as Water Effect Ratio, to account 

for site-specific chemistry influences on 

metal toxicity. 

F. How Do BLM-Derived Criteria Differ 

From Hardness-Dependent Criteria? 

The biotic ligand model is a metal 

bioavailability model based on recent 

information about the chemical 

behavior and physiological effects of 

metals in aquatic environments. Earlier 

freshwater aquatic life criteria for 

copper published by the Agency were 

based on empirical relationships of 

toxicity to water hardness. That is, a 

relationship was established linking the 

criteria concentrations with water 

hardness. These hardness-dependent 

criteria, however, represented combined 

effects of different water quality 

variables (such as pH and alkalinity) 

correlated with hardness. Unlike the 

empirically derived hardness-dependent 

criteria, the BLM explicitly accounts for 

individual water quality variables and 

addresses variables that EPA had not 

previously factored into the hardness 

relationship. Where the previous 

freshwater aquatic life criteria were 

hardness-dependent, these revised 

criteria are dependent on a number of 

water quality parameters (e.g., calcium, 

magnesium, dissolved organic carbon) 

described in the document. BLM-based 

criteria can be more stringent than the 

current hardness-based copper criteria 

and in certain cases the current 

hardness-based copper criteria may be 

overly stringent for particular water 

bodies. 

More information on the development 

and application of the biotic ligand 

model is available in the criteria 

document as well as in The Biotic 

Ligand Model: Technical Support 

Document for Its Application to the 

Evaluation of Water Quality Criteria for 

Copper (EPA 822–R–03–027) and 

Integrated Approach to Assessing the 

Bioavailability and Toxicity of Metals in 

Surface Waters and Sediments (EPA–

822–E–99–001). 

G. What Are the New Revised Criteria 

for Copper? 

The available toxicity data, when 

evaluated using the procedures 

described in the ‘‘Guidelines for 

Deriving Numerical National Water 

Quality Criteria for the Protection of 

Aquatic Organisms and Their Uses’’

indicate that freshwater aquatic life 

should be protected if the 24-hour 

average and four-day average 

concentrations do not respectively 

exceed the acute and chronic criteria 

concentrations calculated by the Biotic 

Ligand Model. 

A return interval of 3 years between 

exceedances of the criterion continues 

to be EPA’s general recommendation. 

However, the resilience of ecosystems 

and their ability to recover differ greatly. 

Therefore, scientific derivation of 

alternative frequencies for exceeding 

criteria may be appropriate. 

Dated: February 15, 2007. 

Ephraim King, 

Director, Office of Science and Technology. 

[FR Doc. E7–3007 Filed 2–21–07; 8:45 am] 

BILLING CODE 6560–50–P 


rwilkins on PROD1PC63 with NOTICES