HeinOnline -- 64 Fed. Reg. 60194 1999

60194 Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 

III. What is the Agency Authority for 

Taking This Action? 

Section 6(f)(1) ofFIFRA provides that 

a registrant of a pesticide product may 

at any time request that any of its 

pesticide registrations be amended to 

delete one or more uses. The Act further 

provides that. before acting on the 

request. EPA must publish a notice of 

receipt of any such request in the 

Federal Register. Thereafter. the 

Administrator may approve such a 

request. 

IV. Procedures for Withdrawal of 

Request 

Registrants who choose to withdraw a 

request for use deletion must submit 

such withdrawal in writing to James A. 

Hollins. at the address given above. 

postmarked May 2. 2000. 

V. Provisions for Disposition of Existing 

Stocks 

The Agency has authorized the 

registrants to sell or distribute product 

under the previously approved labeling 

for a period of 18-months after approval 

of the revision. unless other restrictions 

have been imposed. as in special review 

actions. 

List of Subjects 

En vironmen tal protection. 

Dated: October 4.1999. 

Richard D. Schmitt, 

A cting Director, Information Resou rces & 

Services Division. 

[FR Doc. 99-28890 Filed 11-3-99; 8 :45 am] 

BILLING CODE 6560-50-F 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL--6458--9] 

Sanders Aviation Superfund Site, 

Proposed Notice of Administrative 

Settlement 

AGENCY: En vironmen tal Protection 

Agency (EPA). 

ACTION: Notice; request for public 

comment. 

SUMMARY: In accordance with section 

122(i) of the Comprehensive 

Environmental Response. 

Compensation. and Liability Act. as 

amended ("CERCLA"). 42 U.S.C. 

9622(i). notice is hereby given of a 

proposed administrative settlement for 

recovery of past response costs 

concerning the Sanders Aviation 

Superfund Site in Tempe. Arizona with 

the Alfred P. Sanders Trust ("Trust") 

and the trustees of the Trust. Pursuant 

to the Agreemen t. the Tru st will arrange 

for the sale of the Tru st property. 

Seventy-five percent of the proceeds of 

the sale will be paid to the Hazardous 

Substance Superfund and twenty-five 

percent will be paid to the Trust. This 

allocation is a close approximation of 

the costs each party has contributed to 

cleaning up the site. The settlement 

includes a covenant not to sue the 

settling parties pursuant to Sections 106 

and 107(a) ofCERCLA. 42 U.S.C. 9606. 

9607(a). For thirty (30) days following 

the date of publication of this notice. 

EPA will receive written comments 

relating to the settlemen t. EPA 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. 

The United States' response to any 

comments received will be available for 

public inspection at the U.S. 

Environmental Protection Agency. 75 

Hawthorne Street. San Francisco. CA 

94105. 

DATES: Comments must be submitted on 

or before December 6. 1999. 

ADDRESSES: Comments should reference 

the Sanders Aviation Removal Site. 

Tempe. Arizona and EPA Docket No. 

99-06 and should be addressed to Kara 

Christenson. Office of Regional Counsel. 

U.S. En vironmen tal Protection Agency. 

75 Hawthorne Street. San Francisco. CA 

94105. 

AVAILABILITY: The proposed settlemen t is 

available for public inspection at the 

U.S. En vironmen tal Protection Agency. 

75 Hawthorne Street. San Francisco. CA 

94105. A copy of the proposed 

settlement may be obtained from Kara 

Christenson. Office of Regional Counsel 

U.S. En vironmen tal Protection Agency. 

75 Hawthorne Street. San Francisco. CA 

94105; and at the Tempe Public Library. 

3500 South Rural Road. Tempe. 

Arizona. 

FOR FURTHER INFORMATION CONTACT: Kara 

Christenson. Office of Regional Counsel 

U.S. En vironmen tal Protection Agency. 

75 Hawthorne Street. San Francisco. CA 

94105. telephone: (415) 744-1330. 

Dated: October 25,1999. 

Michael Feeley, 

Deputy Director, Supeifund Division, Region 

IX. 

[FR Doc. 99-28885 Filed 11-3-99; 8:45 am] 

BILLING CODE 6560-50-P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[OPPTS-53171A; FRL--6097-7] 

Category for Persistent, 

Bioaccumulative, and Toxic New 

Chemical Substances 

AGENCY: En vironmen tal Protection 

Agency (EPA). 

ACTION: Policy statement. 

SUMMARY: EPA groups new chemical 

substances with similar structural and 

toxicological properties into categories 

to facilitate premanufacture assessment 

and regulation. These groupings enable 

both Toxic Substances Control Act 

(TSCA) section 5(a)(1) Premanufacture 

Notice (PMN) submitters and EPA 

reviewers to benefit from accumulated 

data and decisional precedents and have 

streamlined the process for Agency 

review of and regulatory follow-up on 

new chemical substances. Consistent 

with TSCA section 26(c). which allows 

EPA action under TSCA with respect to 

categories of chemical substances or 

mixtures. EPA is issuing this policy 

statemen t regarding a category of 

persistent. bioaccumulative. and toxic 

(PBT) new chemical substances. 

DATES: This document will become 

effective January 3. 2000. 

FOR FURTHER INFORMATION CONTACT: For 

general information con tact: Christine 

Augustyniak. Associate Director. 

Environmental Assistance Division 

(7408). Office of Pollu tion Preven tion 

and Toxics. En vironmen tal Protection 

Agency. 401 M St.. SW .• Washington. 

DC 20460; telephone numbers: 202-

554-1404 and TDD: 202-554-0551; email address: TSCA-Hotline@epa.gov. 

For technical information con tact: 

Kenneth Moss. Chemical Control 

Division (7405). Environmental 

Protection Agency. 401 M St.. SW .• 

Washington. DC 20460; telephone 

number: 202-260-3395; fax number: 

202-260-0118; e-mail address: 

moss.kenneth@epa.gov. 

SUPPLEMENTARY INFORMATION: On 

October 5.1998 (63 FR 53417) (FRL5571-6). EPA published a Federal 

Register notice soliciting commen ts on 

proposed criteria for iden tifying PBT 

chemical substances and their 

su pporting scien tific rationale. This 

policy statement responds to comments 

on the proposed criteria for iden tifying 

PBT new chemical substances and their 

su pporting scien tific rationale. Please 

consult the October 5.1998 (63 FR 

53417) Federal Register notice for 

further information on the TSCA new 

chemicals program. The docket control 
HeinOnline -- 64 Fed. Reg. 60195 1999

Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 60195 

number for this document is OPPTS53171A. 

Category 

Chemical manufacturers or importers 

This listing is not in tended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this document. Other types 

of entities not listed above could also be 

affected. The four-digit Standard 

Industrial Classification (SIC) codes or 

the six-digit North American Industrial 

Classification System (NAICS) codes 

have been provided to assist you and 

others in determining whether or not 

this document might apply to certain 

entities. To determine whether you or 

your bu siness is affected by this 

document, you should carefully 

examine the applicability provisions in 

40 CFR 720.22. If you have any 

questions regarding the applicability of 

this document to a particular entity, 

consult the technical person listed in 

the "FOR FURTHER INFORMA TION 

CONTACT" section. 

B. How Can I Get Additional 

Information, Including Copies of This 

Docum ent and Other Related 

Docum ents? 

l. Electronically. You may obtain 

copies of this document from the EPA 

Internet Home Page at http:// 

www.epa.gov/. On the Home Page select 

"Laws and Regulations" and then look 

up the entry for this document under 

the "Federal Register - En vironmen tal 

Documents." You can also go directly to 

the "Federal Register" listings at http:/ 

/www .epa.gov/fedrgstr/. To access 

information about the TSCA New 

Chemicals Program, go directly to the 

Home Page for the New Chemicals 

Program, within the Office of Pollution 

Prevention and Toxics, at http:// 

www.epa.gov/opptintr/newchms/. 

2. In person. The Agency has 

established an official record for this 

document under docket control number 

OPPTS-53171A. The official record 

consists of the documen ts specifically 

I. General Information 

A. Does This Document Apply to Me? 

You may be potentially affected by 

this document if you are or may in the 

NAICS Code SIC Codes 

325,32411 28,2911 

referenced in this document, any public 

comments received during an applicable 

comment period, and other information 

related to this document, including any 

information claimed as Confiden tial 

Bu siness Information (CBI). This official 

record includes the documents that are 

physically located in the docket, as well 

as the documents that are referenced in 

those documents. The public version of 

the official record does not include any 

information claimed as CBL The public 

version of the official record, which 

includes printed, paper versions of any 

electronic comments submitted during 

an applicable comment period, is 

available for inspection in the TSCA 

Nonconfiden tial Information Cen ter, 

Rm. NE B-607, Waterside Mall, 401 M 

St., SW., Washington, DC. The Center is 

open from 12 noon to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The telephone number of the 

Center is 202-260-7099. 

3. By phone. If you need additional 

information about this document, you 

may also con tact the person iden tified 

in the "FOR FURTHER INFORMATION 

CONTACT" section. 

II. Background 

A. Overview of the PMN Process 

Under section 5(a) of TSCA, persons 

must notify EPA at least 90 days before 

manufacturing or importing a new 

chemical substance for non-exempt 

purposes. A new chemical substance, as 

defined in section 3(9) of TSCA, is any 

chemical substance (as defined by 

section 3(2)) that is not included on the 

Inventory compiled under section 8(b) 

ofTSCA. 

Section 5 of TSCA gives EPA 90 days 

to review a PMN (also referred to as a 

"section 5 notice"). However, the 

review period can be extended under 

TSCA section 5(c) for good cause; it may 

future be a submitter of a PMN under 

TSCA. Potentially affected entities may 

include, bu t are not limited to the 

following: 

Examples of Potentially Affected Entities 

Anyone who plans to manufacture or import a 

new chemical substance (as defined in TSCA 

Section 3) for a non-exempt commercial purpose is required to provide the EPA with a 

PMN at least 90 days prior to the activity. Any 

TSCA chemical substance that is not on the 

TSCA Inventory is classified as a new chemical. New chemical substances submitted by 

chemical manufacturers or importers as PMNs 

and which are determined by EPA to meet the 

PST criteria described here may be subject to 

regulatory controls under TSCA section 5(e). 

also be suspended voluntarily by the 

mutual consent of EPA and the PMN 

submitter. During the review period, 

EPA may take action under TSCA 

section 5(e) or (f) to prohibit or limit the 

production, processing, distribution in 

commerce, use, and disposal of new 

chemical substances that raise health or 

environmental concerns. If EPA has not 

taken action under TSCA section 5(e) or 

(f), the PMN submitter may manufacture 

or import the new chemical substance 

when the review period expires. 

No later than 30 days after the PMN 

submitter initiates manufacturing or 

importing, it must provide EPA with a 

notice of commencement of 

manufacture or import. Section 8(b) of 

TSCA provides that, upon receipt of 

such a notice, EPA must add the 

substance to the TSCA Inventory. 

Thereafter, other manufacturers and 

importers may engage in activities 

involving the new substance without 

submitting a PMN, unless the Agency 

has used its Significant New Use Rule 

(SNUR) authority under TSCA section 

5(a)(2) to designate a use ofa chemical 

substance as a "significant new use." 

Section 5(a)(I)(B) of TSCA would then 

require persons to submit a Significant 

New Use Notice (SNUN) to EPA at least 

90 days before they manufacture, 

import, or process the substance for the 

use designated as significant. The 

required SNUN provides EPA with the 

opportunity to evaluate the intended 

use, and if necessary, to prohibit or limit 

that activity before it occurs. 

B. History 

Since 1979, EPA has reviewed over 

30,000 TSCA section 5 submissions for 

new chemical substances. During the 

intervening years, EPA has 

implemented various initiatives which 

have enabled the Agency to review a 

greater number of new chemicals more 
HeinOnline -- 64 Fed. Reg. 60196 1999

60196 Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 

efficiently. In 1988, for example, EPA's 

Office of Toxic Substances (now the 

Office of Pollution Preven tion and 

Toxics) first used its accumulated 

experience to grou p chemical 

substances with similar 

physicochemical, structural, and 

toxicological properties into working 

categories (USEPA, 1988, see Unit 

VI.8.). These categories, including the 

subject one for PBT chemical 

substances, are developed by EPA based 

on available data and experience 

reviewing PMNs on similar substances. 

Such groupings enable both PMN 

submitters and EPA reviewers to benefit 

from the accumulated data and 

decisional precedents and facilitates the 

assessmen t of new chemical substances. 

PBT chemical substances possess 

characteristics of persistence (P) in the 

environment, accumulation in 

biological organisms (bioaccumulation 

(B)), and toxicity (T) that make them 

priority pollutants and potential risks to 

humans and ecosystems. Prominent 

examples of PBT chemical substances 

include the insecticide DDT and 

polychlorinated biphenyls (PCBs). 

Establishmen t of a PBT category alerts 

potential PMN submitters to possible 

assessment or regulatory issues 

associated with PBT new chemicals 

review. It also provides a vehicle by 

which the Agency may gauge the flow 

of PBT chemical substances through the 

TSCA New Chemicals Program and 

measure the results of its risk screening 

and risk management activities for PBT 

new chemical substances; as such, it is 

a major elemen t in the Agency's overall 

strategy to further reduce risks from PBT 

pollutants. 

As described in the Federal Register 

notice of October 5,1998 (63 FR 53417), 

developmen t of the TSCA new PBT 

chemicals policy has occurred in 

coordination with U.S. national, U.S.! 

Canada binational, and international 

efforts to iden tify and con trol the 

en vironmen tal release of persisten t 

organic pollutants (POPs). The proposed 

TSCA PBT category has been provided 

to the Criteria Expert Group (CEG) 

established at the first session of the 

In tergovernmen tal Negotiating 

Committee (INC) for an International 

Legally Binding Instrument for 

Implementing International Action on 

Certain Persisten t Organic Pollu tan ts, in 

accordance with the mandate given by 

the Governing Council of the United 

Nations Environment Programme 

(UNEP) in paragraph 9 of its decision 

19/13 C (http://irptc.unep.ch/pops/ 

gcpops _e.html). The CEG is an openended technical working group with a 

mandate to present to the INC proposals 

for science-based criteria and a 

procedure for identifying additional 

POPs as candidates for future 

international action. The CEG is to 

incorporate criteria pertaining to 

persistence, bioaccumulation, toxicity 

and exposure in different global regions 

and should take into account the 

potential for regional and global 

transport, including dispersion 

mechanisms for the atmosphere and the 

hydrosphere, migratory species, and the 

need to reflect possible influences of 

marine transport and tropical climates. 

At its first meeting, October 26-30, 1998 

in Bangkok, the CEG recommended that 

the INC consider developing a provision 

encouraging countries and regions to 

include in their new chemicals schemes 

elemen ts relating to develop men t and 

introduction of new chemical POPs. The 

U.S. described its proposed TSCA new 

chemicals program policy for the 

category of PBT new chemicals, and the 

full text of the October 5,1998 Federal 

Register notice was distribu ted to all 

delegations as a Conference Room 

Paper. The CEG's recommendation was 

accepted at the second meeting of the 

INC (January 25-29, 1999 in Nairobi) 

and the INC will consider it further in 

its deliberations. 

This policy statement is important in 

our new chemical assessment and TSCA 

regulatory programs, and represents the 

first formal statement of national policy 

regarding new chemical "persisten t 

organic pollutants." Under our domestic 

program, the policy statement provides 

guidance criteria for persistence, 

bioaccumulation, and toxicity for new 

chemicals and advises the industry 

about our regulatory approach for 

chemicals meeting the criteria. 

Internationally, the Federal Register 

notice of October 5,1998 (63 FR 53417) 

alerted the parties involved in 

negotiation of the POPs Con ven tion to 

the need for inclu sion of a new 

chemicals provision in the Convention. 

The issuance of the final policy 

statemen t will reaffirm US leadership 

on this issue and serve as a model for 

other countries in taking steps to 

discourage the introduction of POPs as 

new chemicals and pesticides. 

III. Discussion of Final Policy 

Statement and Response to Comments 

Today's policy statement adopts the 

criteria and testing strategy of the 

Federal Register notice of October 5, 

1998 (63 FR 53417), with minor 

revisions. The Agency reviewed and 

considered all comments received on 

the October 5, 1998 (63 FR 53417) 

notice. A complete copy of all 

comments received is available in the 

public docket for this document. A 

discu ssion of the policy statemen t, 

including a summary of significan t 

comments and the Agency's response 

follows: 

A. Pigments 

Comment I-Pigments. Commenters 

suggested that EPA not identify 

pigments as bioaccumulators and were 

concerned that testing could end up 

being expensive for pigments, which are 

persisten t by design. 

Response. EPA assesses PMN 

chemical substances for PBT attributes 

on a chemical-by-chemical basis, 

regardless of whether or not they fall 

into a chemical use category such as 

pigments. Not all pigments are the same 

and a precise definition of the term 

"pigment" is not available. As a result, 

EPA does not have general "pigments" 

or "dyes" assessment categories; there 

are, however, more specifically 

described categories of dyes or pigments 

that have been described by EPA (e.g., 

acid or amphoteric dyes, 

dichlorobenzidine-based pigments, and 

others; see categories document at http:/ 

/www.epa.gov/opptintr/newchms/ 

chemcat.htm). Moreover, the fact that a 

substance is "persistent by design" by 

itself is not a sufficient basis for 

identifying a PBT new chemical 

substance. Persistence is only one of 

three criteria used to identify a chemical 

as PBT. When combined with a 

potential to bioaccumulate, toxicity 

concern, and sufficient release to the 

environment to result in potential risk 

or significan t exposure, pigmen ts may 

be of concern, whether or not they are 

persisten t by design. If a PMN chemical 

is persistent by design, and becomes 

su bject to testing requ iremen ts by EPA, 

it would be counterproductive to test 

initially for persistence, but rather to 

address the "B" and "T" criteria 

instead. 

B. Ready Biodegradability Testing 

Comment 2-Ready biodegradability 

testing. Commenters suggested that EPA 

avoid the use of strict pass/fail criteria 

for ready biodegradability of poorly 

water-soluble substances. 

Response. Poor water solubility does 

not necessarily lead to inability to pass 

a ready biodegradability test, as amply 

demonstrated by the fact that many fats, 

oil, petroleum hydrocarbons, etc. easily 

pass ready biodegradability tests. While 

strict OECD (Organization for Economic 

Co-operation and Development) pass/ 

fail criteria are given in the OPPTS 

Ready Biodegradability test guidelines 

(see http://www .oecd .org//ehs/test/ 

degrad.h tm and Testing Strategy for PBT 

Chemical Substances, Unit IV.B. of this 

document), the Agency recognizes the 

limitations in applying such criteria 
HeinOnline -- 64 Fed. Reg. 60197 1999

Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 60197 

rigidly given that many substances of 

concern as potential PBTs are unlikely 

to pass ready biodegradability tests. A 

variety of critical aspects beyond the 

pass/fail result will be considered when 

evaluating potential new chemical PBTs 

or when testing decisions are made 

about specific PMN substances. These 

more critical aspects include those 

related to chemical structure (e.g., 

degree of branching) and bioavailability 

(e.g., uptake of a substance by fish or 

microorganisms), and their influence on 

both biodegradation and 

bioaccumulation. 

C. Bioconcentration Factor and Kow 

Com m ent 3 -Bioconcentration factor. 

Commen ters requ ested clarification on 

how bioconcen tration factor (BCF) will 

be estimated using calculations based 

on octanol-water partition coefficient. 

Response. The octanol-water partition 

coefficient (Kow) is correlated with the 

poten tial for a chemical to 

bioaccumulate in organisms; the BCF 

can be predicted from log Kow, via 

computer programs based on structure 

activity relationship (SAR). The Agency 

process for predicting bioaccumulation 

factors (BAFs) and BCFs, along with 

literature references, is described in 

some detail in the proposed rule for 

lowering ofreporting thresholds for 

certain PBT toxic chemicals subject to 

reporting under section 313 (Toxic 

Release Inventory, or TRI) of the 

Emergency Planning and Community 

Right-to-Know Act (EPCRA) of 1986 

(January 5,1999 (64 FR 688) (FRL6032-3), see page 704). 

Comment 4-Log Kow and low 

solubility chemicals. Commenters 

suggested that the October 5,1998 (63 

FR 53417) Federal Register notice 

identified methods for calculating log 

Kow that are not appropriate for organic 

pigments, which are insoluble in 

octanol. They wan ted to know how EPA 

handles low octanol or water soluble 

chemicals. 

Response. EPA believes that the 

methods cited in the October 5,1998 (63 

FR 53417) Federal Register notice for 

experimen tal measuremen t of the 

octanollw ater parti tion coefficien t 

(Kow), or SAR to predict Kow, are 

appropriate, and the results of either can 

then be u sed to predict the Fish BCF. 

Chemicals are unlikely to be accorded 

special treatmen t in the new chemicals 

review process solely becau se of low 

solubility in octanol or water alone. The 

test guidelines (OPPTS 830.7570 or 

830.7560) cited in the October 5,1998 

(63 FR 53417) Federal Register notice 

are viewed as the most appropriate for 

measuring Kow, and alternatively, the 

shake-flask method (OPPTS 830.7550 

test guideline) or the new "slow-stir" 

method currently under development by 

the OECD, can be used. However, if the 

chemical manufacturer still views these 

methods as inappropriate for a given 

chemical, it would be advisable to 

proceed to more definitive testing to 

address bioaccumulation potential (i.e., 

the Fish BCF study). This approach can 

be applied to other testing endpoints as 

well; for example, based on 

physicochemical properties of a 

particular PMN chemical substance, a 

company might forgo a lower tier acute 

Daphnia toxicity study in favor of the 

chronic study because it would yield 

the best information for the screening 

level risk assessment. 

Com m ent 5-Use of octanol solubility 

data alone. Commenters wanted to 

know if octanol or fat solubility data can 

be used before determining which 

chemical substances have the potential 

for bioaccumulation. 

Response. By itself, solubility in 

octanol (as a surrogate for fat) is not a 

good predictor of poten tial 

bioaccumulation in fish. Kow is 

correlated with the potential for a 

chemical to bioaccumulate in 

organisms; the bioconcentration factor 

(BCF) can be predicted from log Kow, 

via SAR. Kow is a coefficient which 

serves as a surrogate for the partitioning 

of chemicals between water and fat, and 

cannot be accurately estimated via 

separate determinations of solubility in 

pure octanol and water (i.e., by 

calculating the ratio of the pure-solven t 

solubilities) (Sijm et aI., 1999, see Unit 

VI.l.). The Agency uses and 

recommends the use of computer 

models to predict Kow where there are 

no measured data. 

D. Environmental Half-Life 

Com m ent 6-Calculation of half-life. 

Commenters wanted to know how halflife is calculated in the review of PBT 

new chemicals. 

Response. Multimedia fate models 

like the Environmental Quality Criteria 

(EQc) model (Mackay et aI., 1996, see 

Unit VI.2.) require compartmental halflives for air, water, soil and sediment, 

which cannot necessarily be interpreted 

as half-lives for any specific process 

such as biodegradation. Data on air halflives for input to models would be 

either measured or derived from the 

Atmospheric Oxidation Program (AOP 

or AOPWIN) or similar methodology. 

Studies by Boethling et al. (1995, see 

Unit VI.3.) and Federle et al. (1997, see 

Unit VI.4.) suggest that half-lives in bulk 

soil may be assumed for screening 

purposes to be abou t the same as for 

surface water, and that sediment halflives may be assumed to be 3-4 times 

longer. EPA's current suggested 

approach to finding water half-life is to 

use the Ultimate Survey Model (USM) 

in the EPI BIOWIN program (Boethling 

et aI., 1994, see Unit VI.5.). Estimation 

of bulk compartment half-lives from 

USM model data requires several 

assumptions, including that (1) 

biodegradation is the only significant 

fate process in water, soil, sediment; (2) 

water and soil half-lives are the same; 

and (3) sediment is dominated by 

anaerobic conditions and therefore 

sedimen t half-life is four times longer 

than water half-life. 

E. Computer Models and the Use of 

Models vs. A ctual Data 

Comment 7-Use of models vs. actual 

data. Commen ters su pport the use of the 

Mackay/EQC model, but stressed the 

importance of having a process for using 

actu al data in place of the model. 

Response. This is a reasonable 

suggestion. The EQC model is based on 

the fugacity approach and subsequently 

applied to numerous environmental 

processes. It uses an "evalu ative 

environment" in which environmental 

parameters such as bulk compartment 

dimensions and volumes (e.g., total 

area, volume of soil and sediment, etc.) 

are standardized, so that overall 

persistence for chemicals with different 

properties and rates of transformation 

may be compared on an equal basis. In 

general, measured values of toxicity, 

chemical properties, compartmental 

transformation half-lives, etc., provided 

the data are of acceptable quality, are 

preferred over those that are predicted 

or estimated via a model or computer 

program. 

Com m ent 8-Modeling of air releases. 

Commenters noted that the October 5, 

1998 (63 FR 53417) Federal Register 

notice considered only biodegradation 

and aqueous hydrolysis and asked about 

fate of a chemical upon release to air. 

They suggested that EPA estimate 

atmospheric oxidation using AOPWIN. 

Response. Although the testing 

strategy for this policy statement focuses 

on biodegradability, all relevant 

transport and transformation processes 

will be considered in evaluating the 

potential for a PMN substance to behave 

as a PBT. Transformation processes not 

men tioned in the Federal Register 

notice but which may be important for 

specific PMN substances include 

atmospheric oxidation and photolysis, 

photolysis in water, and redox 

transformations (of which there are 

various types) in water, soil, and 

sedimen t. Although EPA believes that 

for most organic chemicals, 

biodegradation in water, soil, and 

sediment will be the most important 
HeinOnline -- 64 Fed. Reg. 60198 1999

60198 Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 

transformation process, each su spected 

PBT chemical substance will be 

evaluated on its use and disposal 

patterns. 

Clearly the atmosphere is an 

important environmental medium, and 

is especially relevant where a substance 

is emitted directly to the atmosphere or 

transported there via volatilization or 

aerosolization. We know by deduction 

that it is only, or at least chiefly, 

through the atmosphere that POPs like 

dioxins and Polychlorinated biphenyls 

(PCBs) reach remote locations, and it 

will be an important factor in 

determining the ultimate fate of many 

PMN substances as well. It is through 

multimedia fate models such as EQC 

that atmospheric fate will be considered 

in developing an overall prediction of 

en vironmen tal persistence for su spected 

PBT substances. Where measured data 

are not available, appropriate estimation 

methods such as that in the AOPWIN 

program will be used to generate 

screening-level estimates of atmospheric 

half-lives. 

F. Use of "Weight of Evidence" and 

Professional Judgment 

Com m ent 9-Laboratory vs. field 

behavior of chem icals. Commenters 

indicated that EPA needs to incorporate 

any differences between lab and field 

behavior of chemicals into its analysis 

of new chemical substances, 

acknowledge the limitations of 

screening-level biodegradation tests, 

and acknowledge the value of using 

professional judgment when 

interpreting data from extended (> 60 

day) degradation studies. 

Response. EPA recognizes that 

laboratory tests at best provide a 

snapshot of expected environmental 

behavior, which ideally is studied in the 

field. But since field testing is nearly 

always impractical for PMN chemical 

substances, it is necessary to conduct 

laboratory tests and to apply scien tific 

judgment in extrapolating from lab to 

field. EPA similarly acknowledges the 

limitations ofready biodegradability 

and other screening tests as indicators of 

ultimate environmental behavior. 

Finally, it is well known that even this 

policy statemen t's higher tier (Testing 

Tiers 2 and 3) environmental fate 

guidelines, despite being designed to 

provide test conditions closer to those 

expected in the field, become less 

reliable when tests are run for longer 

than the maximum duration specified in 

the guidelines. EPA will give 

appropriate weigh t to these and other 

complexities in its assessments. 

Com m ent I 0- "Check the box" vs. 

"weight of evidence." Commenters 

noted that the TSCA PMN requirements 

for PBT chemicals look more like 

"check-the-box" than "weight of 

evidence" and wanted to know how 

EPA will make professional judgment 

and use SAR and assessment methods to 

identify PBT new chemicals. 

Response. These tools (professional 

judgment, SAR, computer models, 

assessment methods, etc.) would be 

applied to poten tial PBT chemical 

substances in the same way they are 

applied to any other chemical substance 

in the PMN review process. Using 

predictive tools (in the absence of test 

data) and professional judgment, EPA 

leans towards a "reasonable worst case" 

when there is lack of chemical-specific 

data. Industry always has the option of 

assisting and enhancing the Agency's 

determinations by submitting 

scientifically valid test data. There are a 

number of existing documents 

describing the PMN process and the 

critical role played by SAR and 

professional judgmen t in that process, 

including the Chemistry Assistance 

Manual for Premanufacture Notification 

Submitters (USEPA, 1997, see Unit 

VI.6.) and parts of the report on the joint 

U.S.lEuropean Union study that 

evaluated the predictive power of the 

SAR (USEPA, 1994, see Unit VI.7.). EPA 

believes that, where no or insufficient 

actual toxicity data exist upon which to 

base a decision, toxicity estimates 

generated by SARs and other predictive 

techniques may constitute sufficient 

evidence to be used in human health 

and environmental hazard and 

environmental fate assessment as 

components in certain risk 

determinations under TSCA (see also 

the Federal Register of December 1, 

1993 (58 FR 63507) for a similar 

statemen t related to meeting section 313 

listing criteria under EPCRA of 1986). 

Com ment II-Implement PBT policy 

within risk assessment framework. 

Commenters suggested that EPA risk 

management decisions should not be 

made solely on hazard information; 

these PBT criteria should be 

implemented within a risk assessment 

framework. They indicated that toxicity 

has been largely overlooked in the PBT 

scheme and no criteria have been 

provided for toxicity. Commenters 

suggested that EPA needs to take into 

account P and Band T before requiring 

further testing or iden tifying a chemical 

as a "true" PBT, and asked whether 

persistence and log Kow would be 

sufficient to determine that a PBT PMN 

chemical substance may pose a 

significan t risk. Commen ters also 

suggest that EPA should except nontoxic and low exposurelrelease 

substances from consideration under 

this category and were concerned that 

the curren t proposed criteria do not 

consider any health and safety benefits 

of a PBT chemical substance. 

Response. New chemicals identified 

as poten tial PBT chemicals are assessed 

on a case-by-case basis. Section 5(e) of 

TSCA au thorizes EPA to con trol 

commercial activities involving a new 

chemical substance for which available 

information is insufficient to permit a 

reasoned evalu ation of poten tial health 

and en vironmen tal effects if EP A 

determines either (1) that the 

manufacture (including import), 

processing, distribu tion in commerce, 

use, or disposal of the substance may 

present an unreasonable risk of injury to 

health or the en vironmen t ("risk-based" 

finding), or (2) that the substance is or 

will be produced in substantial 

quantities, and such substance either 

enters or may reasonably be anticipated 

to enter the environment in substantial 

qu an tities or there is or may be 

significant or substantial human 

exposure to the substance ("exposurebased" finding). The restrictions under 

TSCA section 5(e) are imposed pending 

the development of the test data or other 

information needed to evaluate the new 

substance's health or environmental 

effects. EPA draws on information and 

data submitted with the PMN form, 

other information available to the 

Agency, and modeling (e.g., exposure, 

release, SAR, etc.). 

The Agency will consider P and Band 

T, individually and together, and 

exposure in making risk-based 

judgments. Risk, specific to the PMN 

substance as well as its risk relative to 

substitutes currently on the market, is 

predicted as a function of the potential 

hazard of the substance and the 

expected exposure. In other instances, 

as discussed in the October 5, 1998 (63 

FR 53417) Federal Register notice, 

during PMN review EPA may determine 

that a new substance will be produced 

in substantial quantities and "may 

reasonably be anticipated to enter the 

environment in substantial quantities or 

there is or may be significan tor 

substantial human exposure to the 

substance," and that the available 

information is insufficient to determine 

the effects of the substance. For such 

exposure-based determinations on 

suspected PBT new chemicals, EPA will 

use a case-by-case approach for making 

findings by applying considerations 

beyond P and B (i.e., toxicity or 

physical/chemical properties), and 

consider P and B aspects as factors 

which might argue for regulatory action 

under TSCA section 5(e) at lower levels 

of production or exposurelrelease than 

are described in the general guidelines 

for the new chemicals program's 
HeinOnline -- 64 Fed. Reg. 60199 1999

Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 60199 

exposure-based policy (USEP A, 1988, 

USEPA, 1989, see Unit VL8. and 9.). 

Overall, companies are not being 

prevented from developing and using 

new substances that are judged to be 

poten tial PBT chemicals, bu t EPA may 

require certain controls (e.g., limiting 

the release of the PMN chemical to the 

environment) or testing as a result of its 

assessments. 

In order to be so iden tified as a PBT 

new chemical based on a risk-based 

finding, all three criteria must be 

satisfied. The Agency has adopted a 1 to 

3 rating system for each ofP, B, and T. 

If chemical has a low Kow (i.e., "B1," 

with BCF estimated as less than 1,000), 

the B1 rating does not support the new 

chemical's identification as a potential 

"PBT chemical." For example, some 

surfactants could be P3B1 T3; they are 

highly persisten t in the en vironmen t 

and chronically toxic to organisms, but 

with low bioaccumulation potential. 

However, Agency action may still be 

taken under TSCA on chemicals not 

meeting all of the PBT criteria, if they 

otherwise meet the risk or exposurebased elemen ts of TSCA section 5(e). 

Similarly, calcium would also not be 

considered a PBT chemical, as it would 

be ranked P3B3T1; it is persistent in the 

environment, it bioaccumulates, but it is 

not considered toxic. Although the 

Agency does not promote the 

environmental discharge of more 

persisten t materials, the en vironmen tal 

"desirability" of a given chemical often 

depends on a balance of variou s factors, 

including toxicity and ability of the 

chemical to bioaccumulate. Like the 

previous surfactant example, the 

Agency may nonetheless take action on 

a P3B3T1 chemical (not calcium per se), 

most likely under its exposure-based 

au thority. 

The toxicity rating for a PBT chemical 

applies to repeated exposures which 

result in human or environmental 

toxicity, including, for example, 

systemic toxicity, mutagenic damage, 

reproductive toxicity, or developmental 

toxicity. An example of this is chronic 

toxicity towards aquatic organisms of 

organotins from contaminated marine 

environments, which ultimately 

resulted in the regulation of use of 

tributyl tin in marine anti-fouling 

paints. Repeated exposures result from 

a PBT chemical after it has been 

released in to the en vironmen t, u su ally 

via contaminated water, sediments, or 

food. The classic PBT problems (i.e., 

PCBs and Dichloro diphenyl 

trichloroethane (DDT)) have been 

associated with food chain 

contamination. 

G. Scientific justification for PBT 

Technical Criteria 

Comment 12-Supportfor lower 

threshold criteriafor "P" and "B." 

Commen ters believed that there is little 

preceden t, scien tific ju stification, 

evidence or data to support the lower 

regulatory threshold ofbioaccumulation 

factor of 1,000 and environmental 

persistence of2 months. They suggested 

that EPA needs a rationale for these 

criteria beyond " ... are characterized by 

a tendency to accumulate in 

organisms." 

Response. There is no "bright line" 

that clearly identifies a bioaccumulation 

factor of 1,000 or a half-life of2 months 

as the best bioaccumulation or 

persistence criterion from a scientific 

perspective. However, it is not accurate 

to state that there is no precedent or 

basis for using these values. As outlined 

in EPA's recent proposal to lower the 

reporting thresholds for PBT chemicals 

that are subject to reporting under 

section 313 ofEPCRA (64 FR 688; 

January 5,1999), similar values have 

been proposed by several au thorities, 

including the Ontario, Canada Ministry 

of Environment and Energy (MOEE) for 

its Candidate Substances List for Bans 

or Phaseouts (MOEE, 1992, see Unit 

VI.lO.); the Canadian initiative for 

Accelerated Reduction/Elimination of 

Toxics (ARET) (ARET, 1995 and ARET, 

1994, see Unit VI.ll. and 12.); the 

International Joint Commission (IJC)'s 

Great Lakes Water Quality Agreement 

(GLWQA) (IJC, 1993, see Unit VI.l3.); 

and the United Nations Economic 

Commission for Europe Convention on 

Long-Range Transboundary Air 

Pollution (UNECE-LRTAP), which did 

adopt 2 months as the persistence 

criterion ofrecord for water (UNECELRTAP, 1998, see Unit VI.l4.). 

In determining the thresholds for this 

policy statement, EPA concluded that it 

would be appropriate to reflect the 

levels of concern that the various PBT 

chemicals presented, based on the 

differing degrees to which the chemicals 

persist and bioaccumulate. The Agency 

ultimately chose to adopt a two-tier 

approach, and to establish two separate 

thresholds to reflect the chemicals' 

varying poten tials to persist and 

bioaccumulate, as well as to reflect the 

Agency's belief that the differen t levels 

of regulatory action under TSCA are 

warranted for the two tiers. As 

discussed in detail in the preamble to 

the mentioned EPCRA proposed rule, 

EPA found that generally the criteria 

selected by variou s U.S. and 

international regulatory bodies for either 

persistence or bioaccumulation 

clustered around two values. For 

persistence in water, soil, and sediment, 

the criteria were grouped around halflives of 1 to 2 months and 6 months, 

and for persistence in air, either 2 or 5 

days. Bioaccumulation criteria were 

grouped around BAF/BCF values of 

1,000 and 5,000. The preamble to the 

EPCRA proposed rule states "Bearing in 

mind that one of Congress' articulated 

purposes for EPCRA section 313 was to 

provide local communities with 

relevant information on the release and 

other waste management activities of 

chemicals in their community that may 

present a hazard, EPA determined that 

the criteria that were most consistent 

with these purposes were, for 

persistence, half-lives of2 months for 

water, sediment, and soil, and 2 days in 

air, and for bioaccumulation, 

bioaccu m u lation/bioconcen tration 

factor values of 1,000 or greater" (64 FR 

692; January 5,1999). EPA is making a 

similar determination for the PBT new 

chemicals policy under TSCA. The 

PMN process is one of EPA's 

cornerstone Pollu tion Preven tion 

programs and plays a critical gatekeeper 

role in making sure that all new 

chemical substances do not present 

unreasonable risks when they are 

commercialized. Given this, and the 

uncertainty which often accompanies 

Agency review of a PMN chemical 

substance due to lack of data, the TSCA 

new chemicals program is and must be 

conservative by nature, which suggests 

that a half-life shorter than 6 months 

and a BCF criterion lower than 5,000-

values that were selected solely or 

primarily to isolate substances already 

widely acknowledged to be POPs are 

appropriate for regulatory scrutiny of 

new chemicals under TSCA. Note that 

the CEG, at the October 26-30,1998 

Bangkok meeting described in Unit ILB. 

of this documen t, developed indicative 

numerical values as bracketed criteria 

text which included persistence of 2 vs. 

6 months in water and log Kow of 4 vs. 

5 (equivalent to a BCF of approximately 

1,000 vs. 5,000, respectively). 

A series ofPMNs submitted to EPA in 

1990 (Zeeman et aI., 1999, see Unit 

VI.l5.) illustrates (1) why EPA believes 

that the persistence criterion for 

bioaccumulating substances in soil, 

water, or sediment should be set 

substantially lower than 6 months; and 

(2) that concern for potential exposures 

to persistent and bioaccumulative toxics 

must extend beyond the UNEP's 12 

widely acknowledged POPs. The 

substances in question were alkylated 

diphenyls, for which EPA expected 

discharge to receiving streams and 

rivers. The submitter supplied data on 

use and disposal, aquatic toxicity, and 
HeinOnline -- 64 Fed. Reg. 60200 1999

60200 Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 

biodegradability. The submitted 

environmental fate data and EPA 

estimates of biodegradability based on 

structural analogs suggested that halflives in water would be well below 6 

months, but not necessarily lower than 

2 months. As a result of concerns 

expressed by EPA, use was limited to 

sites where resulting water 

concentrations could be limited to 1 

microgram per liter or less; 

concomitantly, the submitter was also 

informed of EPA's belief that a potential 

for long-term risk existed, but that EPA 

could not quantify this risk since 

assessmen ts typically evalu ated releases 

over a period of only 1 year. In 1998, 

results of monitoring revealed that the 

PMN substances had been found in fish 

fillets and sediment samples from the 

receiving stream. If, for these 1990 

PMNs, EPA were to have had in place 

the 2 mon th persistence criterion 

described in today's policy statement, 

further scrutiny under the new 

chemicals program would have been 

warranted, and beyond simply 

informing the PMN submitter of the 

poten tial for long-term risk, the Agency 

would likely have required further 

testing to obtain an experimental value 

for en vironmen tal persistence of the 

chemicals. This in turn would have 

given the Agency a better picture of the 

behavior of the chemicals in the 

environment and the environmental 

half-life relative to the 2 month value. 

Comment I3-Deny commercialization 

to lower threshold PBT chem icals. Some 

com men ters su pported exercising the 

"Precautionary Principle" by not 

allowing commercialization under a 

TSCA 5(e) consent order or SNUR 

pending testing of the PMN chemicals 

which meet the P=2 month and 

BCF=l,OOO criteria. They suggested that 

these chemicals should be banned 

instead, pending the necessary testing. 

Response. Whereas a half-life of2 

months and BCF of 1,000 can be 

ju stified as lower-tier cu toffs in a 

deliberately conservative TSCA new 

chemicals program that is designed to 

prevent commercialization of 

potentially risky substances, it would 

not be appropriate to automatically 

trigger a "ban pending testing" at these 

cutoffs given the uncertainties about 

substance properties, release, and 

environmental behavior that normally 

characterize PMN review. The Agency 

believes that the available predictive 

tools and curren t knowledge of POPs 

lend support for this two-phased 

approach to screening of PBT chemicals 

and collection of information "sufficient 

to permit a reasoned evalu ation of 

poten tial health and en vironmen tal 

effects" if EPA makes the requisite riskor exposure-based findings under TSCA 

section 5(e). 

Com ment I4-Relationship of P, B, and 

T criteria. Commenters suggested that 

the October 5, 1998 (63 FR 53417) 

notice is inaccurate when it states that 

2 months is adequate for detecting many 

long-term toxic effects as well as any 

tendency for a substance to 

bioaccumulate in aquatic organisms. 

Commenters pointed out that the 

persistence criterion is not related to 

detection of long-term toxicity. 

Response. The statement in question 

was intended simply to note that the 2 

months half-life in water persistence 

criterion closely tracks the duration of 

long-term environmental toxicity or 

bioaccumulation tests. If a new 

chemical substance is predicted to or 

measurably demonstrates chronic 

toxicity, potential to bioaccumulate, and 

environmental persistence over that 

same time period (2 months), it would 

meet the minimum TSCA PBT criteria. 

It is true that, in general, half-life cutoffs 

for identifying POPs warranting 

international action (e.g., in programs 

like UNECE-LRTAP and UNEP Global 

Negotiations on POPs) have not been 

selected based on the duration of 

toxicity or bioaccumulation tests. There 

are no cu toffs or "fence lines" for 

environmental persistence criteria that 

emerge as immutable quantities solely 

from scientific analysis; the choice of 

screening criteria is a policy decision 

guided by the anticipated scope of a 

negotiation or regulatory activity. In the 

case of the PMN program, 2 months 

represents a reasonable screening level 

value for "persistence" which is more 

than the I-month period in a ready 

biodegradation study and less than the 

6 month value widely agreed to 

internationally (U.S.-Canada binational 

agreement to control the discharge or 

release of POPs in the Great Lakes 

Basin, UNECE-LRTAP, North American 

Free Trade Agreement Commission for 

Environmental Cooperation (NAFTACEC), etc.) as reflecting the persistence 

of known POPs chemicals (e.g., DDT, 

hexachlorobenzene). As mentioned in 

the previous response, there is 

international support, through the CEG, 

for persistence values of2 or 6 months 

in water. 

Comment IS-Relationship ofPand B. 

Commenters suggested that the October 

5,1998 (63 FR 53417) notice's 

statemen t, "Generally, persisten t 

bioaccumulators are chemical 

substances that partition to water, 

sedimen t or soil and are not removed at 

rates adequ ate to preven t their 

bioaccumulation in aquatic or terrestrial 

species," should be revised to reflect 

that persistence alone is not sufficient to 

cause a substance to bioaccumulate. 

Response. EPA did not intend that the 

sentence be read to mean that 

persistence alone is sufficient to result 

in bioaccumulation. The point that was 

intended to be conveyed was that a 

certain level of persistence is a 

necessary condition for 

bioaccumulation to occur. There are 

other conditions that affect 

bioaccumulation, such as bioavailability 

and the metabolic transformation rate in 

the target species. These and other 

factors will be evaluated by EPA in the 

determination of the PBT concern level 

for PMN chemical substances. 

H. Relationship of TSCA PBT Policy to 

Other Agency and International PBT 

Initiatives 

Com m ent I6-Finalize overall Agency 

m ultim edia strategy first. Commenters 

suggested that the PBT classification 

criteria being proposed for TSCA 

section 5(e) may have broader 

application, e.g., international or other 

Agency PBT initiatives, and may be 

u sed to establish preceden t in other 

programs. In addition to the TSCA 

October 5,1998 (63 FR 53417) Federal 

Register notice, there have been three 

other notices published in Federal 

Register dealing with (1) the promotion 

of volun tary waste minimization efforts 

to reduce the generation of those PBT 

chemicals which are found in hazardous 

waste regulated under the Resource 

Conservation and Recovery Act (RCRA) 

(63 FR 60332; November 9,1998 (FRL6186-7)), (2) the Agency draft 

Multimedia PBT Strategy (63 FR 63926; 

November 17, 1998 (FRL-6045-2)), and 

(3) the lowering of reporting thresholds 

for certain PBT toxic chemicals subject 

to reporting under section 313 (Toxic 

Release In ven tory, or TRI) of EPCRA of 

1986 (64 FR 688; January 5, 1999). 

These commenters stated that the TSCA 

notice is premature, occurring before 

adoption of the overall Agency strategy, 

and is inconsistent with other 

initiatives, domestic and international, 

which have lists of chemicals and more 

selective criteria (i.e., specific to 

en vironmen tal media, fate and 

tran sform ation processes). Com men ters 

recommended that EPA finalize the 

Agency strategy first, before proceeding 

with the TSCA, RCRA, and TRI actions, 

and that there should be coordination 

among them all with uniform PBT 

criteria as part of the Agency strategy. 

Response. The PBT Multimedia 

Strategy formalizes an Agency process 

for integration of program activities 

in volving these types of substances. 

While the strategy intends to coordinate 

Agency PBT -related activities under its 
HeinOnline -- 64 Fed. Reg. 60201 1999

Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 60201 

framework, the strategy does not 

establish rigid criteria with respect to 

PBTs. Program offices must operate 

within the parameters of their legislative 

mandates and established regulatory 

and policy frameworks. For some 

programs such as the Toxics Release 

Inventory, the TSCA New Chemicals 

Program and the RCRA National Waste 

Minimization Plan, actions involving 

PBTs are a historical reality and their 

experience has, in fact, largely shaped 

the strategy. Therefore, EPA does not 

intend to halt all ongoing work 

in volving PBTs un til the strategy is 

"finalized." With respect to the PMN 

process, it is important to understand 

and acknowledge its fundamental 

purpose, which is to allow EPA to 

evaluate the hazards, exposures, and 

risks of new chemicals, and the 

opportunity to protect against 

unreasonable risks, if any. The structure 

of that process and the tools used to 

implement it flow logically from its 

statutory purpose and suggest that the 

category approach ou tlined in this 

policy statemen t is the most appropriate 

means of addressing potential concerns 

for substances possessing PBT 

ch aracteristics. It is EPA's in ten tion th at 

the strategy be a living document. 

Therefore, the strategy will be updated 

based upon public comment; it will not 

be "finalized" in the more traditional 

sense of a rulemaking. EPA does agree 

that consistency is a laudable goal 

where the criteria are meant to be used 

for similar purposes and is seriou sly 

considering comments within the 

con text of the strategy regarding 

establishment of consistent criteria for 

priority PBTs. 

Comment I7-CareJully communicate 

lower thresholds. Commenters suggested 

that EPA should use only the 

environmental persistence of 6 months/ 

BCF of 5,000 screening levels for 

consistency among EPA and u.s.! 

international programs and should 

carefully communicate proposed lower 

criteria internationally. 

Response. As discussed in the 

response to Comment 12, EPA believes 

that a lower tier of2 month/BCF of 

1,000 is appropriate for risk screening 

activities under TSCA. Communication 

is occurring in the international forum. 

Unit ILB. of this document discusses the 

CEG for POPs, established under UNEP 

mandate. At its first meeting, on October 

30, 1998 in Bangkok, the CEG 

recommended that the INC consider 

developing a provision encouraging 

countries and regions to include in their 

new chemicals schemes elemen ts 

relating to developmen t and 

introduction of new chemical POPs. The 

U.s. described its proposed TSCA new 

chemicals program policy for the 

category of PBT new chemicals, and the 

full text of the October 5,1998 (63 FR 

53417) Federal Register notice was 

distributed to all delegations as a 

Conference Room Paper. The CEG's 

recommendation was accepted at the 

second meeting of the INC (January 25-

29, 1999 in Nairobi) and the INC will 

consider it further in its deliberations. 

1. Testing Strategy 

Comment I8-Toxicity testing. 

Commenters asked whether toxicity was 

considered at each testing tier or only in 

tier 3. It was not clear to them when 

toxicity testing would be requested, nor 

what results will be considered 

acceptable by the Agency. 

Response. Each ofP and Band Tare 

weighed in the Agency's assessmen t. 

The testing strategy ou tlined in this 

policy statement is intended to build the 

case, starting with testing to establish 

persistence and bioaccumulation, and 

then determining toxicity and 

confirming a chemical's statu s as a PBT 

chemical in tier 3. Once a chemical 

becomes distribu ted in the en vironmen t 

at low concentrations, the combination 

of persistence and bioconcen tration in 

organisms can result in residues high 

enough to approach a toxic dose. The 

first two tiers focus on P and B because 

of the critical role these aspects play in 

PBT determinations and because of their 

relatively lower cost to determine P and 

B. Thus, chronic toxicity testing, which 

is expected to be the most expensive 

testing, is reserved until tier 3 where it 

serves to establish PBT status. Although 

the early tier P and B testing may either 

obviate the need for toxicity testing or 

result in more directed and costeffective toxicity testing, the need for 

toxicity testing is considered in each 

testing tier and will be obtained in 

lower tiers where needed on a casespecific basis. As with all new 

chemicals reviewed by the Agency 

under TSCA, the potential toxicity of 

the chemical is determined from test 

data, if any, or by analogy to structurally 

similar chemicals. If a company knows 

or suspects prior to testing that their 

chemical is likely to be persisten t and 

bioaccumulative, consideration should 

be given to conducting chronic toxicity 

testing in the first tier. For any 

suspected PBT chemicals for which a 

risk finding has not been made, but 

which meet production, release, and 

exposure thresholds under the Agency's 

exposure-based policy (USEP A, 1988, 

USEPA, 1989, see Unit VL8. and 9.), the 

standard screening level battery of 

testing (or an appropriate subset thereof) 

curren tly utilized for exposure-based 

cases in the new chemicals program 

could be required in addition to PBT 

testing. 

Com m ent I9-Equivalent tests. 

Commenters suggested that all tests 

referenced in the testing strategy should 

also state "or an equivalent test." 

Response. EPA realizes that often 

there are a number of different but 

acceptable means to providing testing 

information. However, EPA's 

acceptance of a guideline not specified 

in this policy statement and/or use of 

data generated under such guidelines 

depends on multiple factors including 

the specifics of the test substance, 

purpose of the testing, familiarity with 

specific procedures and equipment, 

validation of the method, etc. Typical 

TSCA 5(e) consent orders require that 

testing performed pursu an t to the order 

must be conducted according to TSCA 

Good Laboratory Practice Standards at 

40 CFRpart 792 and using 

methodologies generally accepted at the 

time the study is initiated. Before 

starting to conduct any such study, the 

PMN submitter must obtain approval of 

test protocols from EPA by submitting 

written protocols. Published test 

guidelines specified in the Test Strategy 

section (see Unit IV. B. of this 

document) provide general guidance for 

development of test protocols, bu tare 

not themselves acceptable protocols. 

1 Applicability oj PBT Criteria to Metals 

Comment 20-PBT criteria are not 

appropriateJor metals. Commenters 

suggested that the application of 

Persistence and Bioaccumulation 

criteria appropriate for organic 

chemicals does not make sense for 

metals and metal compounds. They also 

suggested that EPA needs criteria to 

iden tify poten tial problems generated by 

organometals. 

Response. The approach and the 

criteria are sufficiently flexible to apply 

to organic chemicals, inorganic metals 

and organometallics. It is important to 

distinguish between criteria for 

iden tifying poten tial PBTs, on the one 

hand, and on the other: (1) the means of 

generating information on the P, B, and 

T endpoints for comparison to the 

criteria, and (2) the applicability of 

existing test guidelines for generating 

such information experimentally. 

EPA understands that metals are 

intrinsically not degradable in the sense 

of ultimate degradation of organics 

(although they may undergo biologically 

as well as chemically induced changes 

in, e.g., oxidation state), and therefore 

are persistent by definition, but 

nevertheless may not be 

bioaccumulative. It is widely accepted 

that elemental metals are persistent by 

definition, since they may take different 
HeinOnline -- 64 Fed. Reg. 60202 1999

60202 Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 

forms that can be interconverted, but the 

elemen tal metal itself cannot be 

destroyed. All elemen tal metals 

therefore meet the 6 month half-life 

criterion. Given this, it is not correct 

that EPA's proposed persistence criteria 

cannot be applied to metals. It may be 

more accurate to state that the 

persistence criteria are not themselves 

very helpful in screening or assessing 

metals and metal compounds with 

respect to the potential for risk, whether 

from direct exposure or through 

bioaccumulation. Relative to 

applicability of test guidelines, the same 

level of judgment will be brought to bear 

such that, for example, EPA would not 

require ready biodegradability testing 

for a metal or metal salt. (EPA may, 

however, request such testing for 

organometallics, which, depending on 

chemical structure, could still show 

significant degradation in such tests.) 

EPA understands that bioavailability 

is important in determining the 

potential for risk, and notes that the 

same generalization applies to any 

substance whether metallic or not. 

Metals and organometallic compounds 

are no differen t from other organic 

chemicals with respect to the 

applicability of the proposed criteria for 

iden tifying persisten t, bioaccum ulative, 

and toxic substances, except that Kow 

determination may not be relevant for 

metals (although the fish BCF study is 

relevant). Similarly, it is not necessary 

to develop differen t criteria or 

assessmen t strategies for pigmen ts (see 

first commentsiresponses in this policy 

statemen t) or any other specific classes 

of organics. What is necessary is to 

consider what is known about the 

behavior of substances like metals 

during the TSCA PMN review process, 

both in the assessment of whether a 

given chemical substance meets the 

established criteria and in subsequent 

testing decisions. For any untested PMN 

chemical substance, if there are no close 

analogs with data and no clear evidence 

that available estimation methods are 

unreliable for this or closely related 

substances, then the estimation methods 

can be assumed to apply and the 

resulting data compared to PBT criteria. 

Put another way, a metal or 

organometallic (or, similarly, a pigment) 

that is judged sufficiently persistent and 

meets the criteria for bioaccumulation 

poten tial and toxicity is of concern for 

"PBTness" regardless of theoretical 

arguments or generalizations. 

The key is how persistence and 

bioaccumulation potential are 

determined in the PMN process, and by 

implication, how bioavailability is 

determined. This policy statemen t 

leaves unspecified how EPA intends to 

do this, but the Agency will consider all 

available and relevant data, and will use 

its professional judgment in considering 

issues like bioavailability of metals. 

Using lead as an example, many 

processes commonly observed in the 

environment can result in the presence 

ofbioavailable (ionic) lead where it can 

be bioaccumulated by organisms. These 

processes may occur in soil and aqu atic 

environments with low pH and low 

levels of organic matter. Under these 

conditions, the solubility of lead is 

enhanced and, in the absence of sorbing 

surfaces and colloids, lead ion can 

remain in solu tion for a sufficien t 

period to be taken up by biota. Lead 

sorption to soil organic matter has been 

shown to be pH dependent. Decreasing 

pH can lead to increasing 

concentrations of lead in soil and water. 

Microbial transformations in soil, water, 

and sediment are also important in 

determining the overall fate of metals 

and metal compounds, and therefore the 

poten tial for formation of bioavailable 

forms. Metals are generally taken into 

cells by nutrient metal transport 

systems, and these are not sufficiently 

specific to completely exclude 

nonessential metals, some of which may 

be toxic and/or bioaccumulative. In this 

situation, nutrient metals can be 

displaced from their binding sites by 

undesirable, toxic metals, which then 

gain access to the cell interior with 

concomitan t exclu sion of the essen tial 

metal (Stumm and Morgan, 1996 see 

Unit VI.l6.). Toxic metal ions are then 

free to react with critical enzymes or 

otherwise disrupt cellular functions if 

they reach certain levels. EPA concludes 

that under many environmental 

conditions, metals and metal 

compounds may be available to express 

toxicity and to bioaccumulate, and that 

these effects are not necessarily limited 

to metals that are not essential nutrients. 

It is appropriate, therefore, to be 

concerned abou t the poten tial for risk 

from these effects. It is the policy of the 

TSCA New Chemicals Program that if 

the metal in a metal compound cannot 

become available as a result of biotic or 

abiotic processes then the metal will not 

be available to express its toxicity, and 

by extension, to bioaccumulate. If the 

intact metal compound is not toxic and 

the metal is not available from the metal 

compound, then such a chemical would 

not be a strong candidate for regulation 

under TSCA section 5(e). 

IV. Final TSCA New Chemicals 

Program Policy for PBT Chemical 

Substances 

A. Evaluation Criteria and Process for 

New PBT Chemical Substances 

EPA is adopting the following specific 

iden tification criteria and associated 

process for use in evaluating new 

chemical substances. 

NEW CHEMICALS PROGRAM PBT 

CATEGORY CRITERIA AND PROCESS 

TSCA Section 5(e) Action 

5(e) Order 

Pending Test- 5(e) Ban 

ing/Significant Pending 

New Use Rule Testing2 

(SNUR)1 

Persistence > 2 months ...... > 6 months 

(transformation 

half-life). 

Bioaccumu- 21,000 ............ 25,000 

lation 

(Fish BCF 

or BAF)3. 

Toxicity ....... Develop toxicity Develop toxdata where icity data 

necessary4 where 

necessary4 

1 Exposure/release controls included in 

order; testing required. 

2Deny commercialization; testing results 

may justify removing chemical from "high risk 

concern". 

3Chemicals must also meet criteria for MW 

« 1000) and cross-sectional diameter « 20A , 

or < 20 x 10-8 cm). 

4Based upon various factors, including concerns for persistence, bioaccumulation, other 

physical/chemical factors, and toxicity based 

on existing data. 

Chemical substances suspected as 

persistent bioaccumulators under the 

criteria listed in the table in Unit IV.A. 

of this document may need to undergo 

testing on "P" and "B" endpoints 

which, if confirmed, would be followed 

by appropriate toxicity testing to 

identify "PBT chemical substances." 

Control action under TSCA section 5(e) 

may be needed in varying degrees, 

based upon the level of risk concern. 

Agency control actions taken under 

TSCA section 5(e) for chemical 

substances meeting these criteria would 

be based upon the level of certain ty for 

the PBT properties of a PMN substance 

(e.g., measured vs. estimated values), 

the magnitude of Agency concerns, and 

conditions of expected use and release 

of the chemical. For example, new 

chemical substances meeting the PBT 

criteria listed under "5(e) Order Pending 

Testing/Significant New Use Rule 

(SNUR)" could be addressed via a 

negotiated consent agreement under 
HeinOnline -- 64 Fed. Reg. 60203 1999

Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 60203 

which necessary testing is "triggered" 

by specific production limits. While the 

PMN submitter would be allowed to 

commercialize the substance, certain 

controls could be stipulated, including 

annual TRI-type reporting on 

en vironmen tal releases of the PMN 

substance and specific limits on 

exposures, releases, or uses. The "ban 

pending testing" criteria are equivalent 

to those that have been used 

internationally to identify POPs. For the 

chemical substances meeting these 

criteria, the concern level is higher and 

the Agency would look carefully at any 

and all environmental releases. Because 

of the increased concern, more stringent 

control action would be a likely 

outcome, up to a ban on commercial 

production until data are submitted 

which allow the Agency to determine 

that the level of risk can be 

appropriately addressed by less 

restrictive measures. The control actions 

described in the table in Unit IV.A. of 

this document represent just one body 

of possible decisions and should not be 

considered as exclusive of other risk 

management options. 

B. Testing Strategy for PBT Chern ical 

Substances 

Where EPA is unable to adequately 

determine the potential for 

bioaccumulation, persistence in the 

environment, and toxicity which may 

result from exposure of humans and 

environmental organisms to a possible 

PBT chemical substance, the Agency 

may conclude, pursuant to sections 

5(e)(l)(A)(i) and 5(e)(1)(A)(ii)(I) and (II) 

ofTSCA, that the information available 

to the Agency is insufficient to permit 

a reasoned evaluation of the human 

health and en vironmen tal effects of that 

PMN substance, that the manufacturing, 

processing, distribu tion in commerce, 

use, or disposal of the substance may 

presen t an unreasonable risk of injury to 

human health or the environment, and/ 

or that the PMN substance will be 

produced in substantial quantities and 

that there may be significant or 

substantial human exposure to the 

substance or the PMN substance may 

reasonably be anticipated to enter the 

environment in substantial quantities. 

Accordingly, the Agency may find it 

appropriate to prohibit or otherwise 

limit the manufacture, import, 

processing, distribu tion in commerce, 

use, or disposal of the PMN substance 

in the United States pending the 

developmen t of information necessary 

for a reasoned evalu ation of these 

effects. The following testing strategy 

describes test data which EPA believes 

are needed to evalu ate the persistence, 

bioaccumulation, and toxicity of a PBT 

chemical substance for which EPA has 

made the above described risk and/or 

exposure-based findings under section 

5(e)(l)(A)(i) and (ii) of TSCA. The tests 

are tiered; depending upon the 

circumstances, such as magnitude of 

environmental releases, results of 

testing, or SAR, testing could begin 

above Tier 1 or additional, higher levels 

of testing may be required. As discussed 

in the response to Comment 19 in Unit 

IILL of this document, testing must be 

conducted according to TSCA Good 

Laboratory Practice Standards at 40 CFR 

part 792 and using methodologies 

generally accepted at the time the study 

is initiated. Before starting to conduct 

any such study under the terms of a 

Consent Order under TSCA section 5(e), 

the PMN submitter must obtain 

approval of test protocols from EPA by 

submitting written protocols. Published 

test guidelines specified in Unit IV.B. of 

this document provide general guidance 

for develop men t of test protocols, bu t 

are not themselves acceptable protocols. 

Tier 1. If, based upon available test 

data, SAR, and professional judgmen t, 

the Agency iden tifies a new chemical 

substance as a possible PBT chemical 

substance, Log Kow should be 

determined experimentally, using either 

the liquid chromatography (OPPTS 

830.7570 test guideline) or generator 

column (OPPTS 830.7560 test guideline) 

method. Hydrolysis in water (OPPTS 

835.2110 test guideline) should be 

determined if, based upon SAR, 

susceptibility to hydrolysis is suspected. 

Ready biodegradability should be 

determined according to either one of 

the following test guidelines: 

l. Ready biodegradability (OPPTS 

835.3110 test guideline) 6 methods 

(choose one): DOC Die-Away, CO2 

Evolution, Modified MIT! (I), Closed 

Bottle, Modified OECD Screening, 

Manometric Respirometry. 

2. Sealed-vessel CO2 production test 

(OPPTS 835.3120 test guideline). 

If the measured log Kow is < 4.2 

(equivalent to an estimated BCF of 

1,000) or if the test chemical passes 

(pass criteria are described in the test 

guidelines) the ready biodegradability 

test (i.e., not persisten t in the 

environ men t), no further PBT -related 

testing is required. If the measured log 

Kow is greater than or equal to 4.2, and 

the chemical does not pass the ready 

biodegradability test, no further testing 

will normally be deemed necessary in 

tier 1; the Agency would likely require 

tier 2 testing. If hydrolysis testing is 

conducted and results in a half-life of < 

60 days, further testing may not be 

needed, but the need for testing must be 

determined after consideration of factors 

specific to the case, such as physical/ 

chemical properties, persistence and 

bioaccum ulative qu alities of hydrolysis 

products, and the nature of the expected 

releases. 

Tier 2. Biodegradability should be 

determined according to the Shake-flask 

die-away test (OPPTS 835.3170 test 

guideline). This test is based on the 

principle of aerobic incubation of the 

test chemical in natural water with and 

without suspended sediment, requires a 

chemical-specific analytical method, 

and allow s for the develop men t of a 

first-order rate constant and half-life. It 

provides information on persistence that 

is relevant to the natural environment 

and is in termediate in cost between 

ready biodegradability tests (tier 1) and 

sediment!water microcosm 

biodegradation test (tier 3). 

Bioaccumulation potential should be 

determined by experimen tal 

measuremen t of the bioconcen tration 

factor (BCF), using the Fish 

bioconcentration test (OPPTS 850.1730 

test guideline (public draft)). Measured 

BCF should be based on 100 percen t 

active ingredien t and measured 

concen tration(s). 

If the measured biodegradation halflife is > 60 days and measured BCF is 

> 1,000, tier 3 testing will normally be 

required. If only one condition is met, 

releases and exposure are further 

considered to determine if additional 

testing is required. 

Tier3. Toxicity/advanced 

environmental fate testing. Human 

health hazards should be determined in 

the combined repeated dose oral 

toxicity with the reproductive/ 

developmental toxicity screening test 

(OECD No. 422 test guideline) in rats. 

Other health testing will be considered 

where appropriate. 

Environmental fate testing should be 

conducted according to the Sediment! 

water microcosm biodegradation test 

(OPPTS 835.3180 test guideline). The 

principle of this method is the 

determination of the test chemical's fate, 

including transport and transformation, 

in core cham bers con taining in tact 

benthic sediment and overlying site 

water. The method permits more 

accurate and reliable extrapolation to 

natural aquatic environments than is 

possible with lower tier test methods. 

Chronic toxicity to fish (rain bow 

trout) and daphnids should be 

determined according to 40 CFR 

797.1600 (same as OPPTS test guideline 

850.1400 (public draft)) and 40 CFR 

797.1330 (same as OPPTS test guideline 

850.1300 (public draft)), respectively. 

Additional testing to evaluate other 

biota (e.g., avian, sediment dwelling 

organisms) or other effects (e.g., 
HeinOnline -- 64 Fed. Reg. 60204 1999

60204 Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 

endocrine disrupting potential) will be 

considered where appropriate. 

V. Intended Legal Affect of this Policy 

Statement 

The policy discu ssed in this 

document provides general guidance on 

the Agency's use of a category grou ping 

for PBT new chemical substances to 

facilitate the PMN assessmen t process 

for PMN submitters and EPA reviewers. 

EPA uses groupings of new chemical 

substances with similar structural and 

toxicological properties to allow PMN 

submitters and EPA reviewers to benefit 

from accumulated data and decisional 

preceden ts. as well as streamlined 

procedural requirements related to the 

review of and follow -u p for new 

chemical substances. 

As guidance. the policy presented in 

this document is not binding on either 

EPA or any outside parties. and this 

document is not intended. nor can it be 

relied upon. to create any rights 

enforceable by any party in litigation 

with the United States. Although this 

guidance provides a starting point for 

assessing PBT new chemical substances. 

EPA will depart from its policy where 

the facts or circumstances warrant. In 

such cases. EPA will explain why a 

different course was taken. Similarly. 

outside parties remain free to assert that 

this policy is not appropriate for a 

specific PMN or that the circumstances 

surrounding a specific PMN 

demonstrate that this policy should not 

be applied. Although the Agency has 

provided an opportunity for public 

comment on the guidance provided in 

this policy statemen t and is likely to 

request additional feedback if changes 

are necessary at some poin t in the 

future. the Agency may revise. clarify. 

or update the text of this guidance 

without public notice. 

VI. References 

The OPPTS harmonized test 

guidelines referenced in this document 

are available on EPA's World Wide Web 

site (http://www.epa.gov/ 

OPPTS -Harmonized/). 

1. Sijm. D.T.H.M .• Schuurmann. G .• 

de Vries. P.J .• Opperhuizen. A. Aqueous 

Solubility. Octanol Solubility. and 

Octanol/Water Partition Coefficient of 

Nine Hydrophobic Dyes. Environ. 

Toxicol. and Chem. 18:1109-1117. 

2. Mackay. D .• Di Guardo. A .• 

Paterson. S .• Cowan. C.E. 1996. 

Evaluating the environmental fate of a 

variety of types of chemicals u sing the 

EQC model. Environ. Toxicol. Chem. 

15:1627-1637. 

3. Boethling RS. PH Howard. JA 

Beauman and ME Larosche. 1995. 

Factors for in termedia extrapolation in 

biodegradability assessmen t. 

Chemosphere 30: 741-752. 

4. Federle TW. SD Gasior and BA 

Nuck. 1997. Extrapolating 

mineralization rates from the ready C02 

screening test to activated sludge. river 

water. and soil. Environ. Toxicol. Chem. 

16: 127-134. 

5. Boethling RS. Howard PH. Meylan 

W. Stiteler W. Beauman J. Tirado N. 

1994. Group contribution method for 

predicting probability and rate of 

aerobic biodegradation. Environ. Sci. 

Technol. 28: 459-465. 

6. USEPA. March. 1997. Chemistry 

Assistance Manual for Premanufacture 

Notification Su bmi tters. EPA 744-R97-003. Also available as 

Premanufacture Notification: Chemistry 

Assistance for Submitters. by Steven C. 

DeVito and Carol A. Farris (ISBN: 0-

471-19151-5) through the publisher. 

John Wiley and Sons. at 1-800-225-

5945 or the TSCA Hot Line. at 202-554-

1404. 

7. USEPA. March. 1994. U.S. EPA/EC 

Join t Project on the Evalu ation of 

(Quantitative) Structure Activity 

Relationships. EPA 743-R-94-001. 

8. USEPA. 1988. Letter from Charles 

L. Elkins to Geraldine V. Cox (Chemical 

Manufacturers Association). Office of 

Toxic Substances. USEPA (September 

22. 1988). 

9. USEPA. 1989. Letter from Charles 

L. Elkins to Geraldine V. Cox (Chemical 

Manufacturers Association). Office of 

Toxic Substances. USEPA (August 31. 

1989). 

10. Ministry of En vironmen t and 

Energy for Ontario (MOEE). 1992. 

Candidate substances list for bans or 

phase-outs. Report perpared by the 

Hazardous Contaminants Branch and 

the Water Resources Branch. MOEE. 

Ontario. Canada. ISBN 0-7729-9764-0. 

11. Accelerated Reduction/ 

Elimination of Toxics (ARET) 

Secretariat. 1995. En vironmen t leaders 

1. Voluntary commitments to action on 

toxics through ARET. March 95. 

12. Accelerated Reduction/ 

Elimination of Toxics (ARET) 

Secretariat. 1994. The ARET substance 

selection process and guidelines. 

January 94. 

13. International Joint Commission 

(IJC). 1993. A strategy for the virtu al 

elimination of persisten t toxic 

substances. Vol. 1. report of the Virtual 

Elimination Task Force to the IJC. 

Windsor. Ontario. Canada. 72 pp. 

14. United Nations Economic 

Commission for Europe. Convention on 

Long-Range Transboundary Air 

Pollution (UNECE-LRTAP). 1998. Draft 

composite negotiating text for a protocol 

on persisten t organic pollu tan ts. 

UNECE. EB.AIRl1998/2. 31 March 1998. 

15. Zeeman. M .• D Rodier. and N 

Nabholz. 1999. Chapter 2. Ecological 

Risks ofa New Industrial Chemical. 

Under TSCA. In Ecological Risk 

Assessment in the Federal Government 

(Execu tive Office of the Presiden t. 

National Science and Technology 

Council. Committee on Environment 

and Natural Resources. Ed.). CENRl5-

99/001. May. 1999. pp 2-1 to 2-30. 

16. Stumm. W. and JJMorgan. 1996. 

Aquatic Chemistry. 3rd ed. New York: 

Wiley. 

List of Subjects 

En vironmen tal protection. Chemical 

substances. Hazardous substances. 

Reporting and recordkeeping 

requ iremen ts. 

Dated: October 22.1999. 

Susan H. Wayland, 

Deputy Assistant Administratorfor 

Prevention, Pesticides and Toxic Substances. 

[FR Doc. 99-28888 Filed 11-3-99; 8:45 am] 

BILLING CODE 6560-50-F 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL--6469--6] 

Notice of Proposed Assessment of 

Clean Water Act Class II Administrative 

Penalty and Opportunity To Comment 

AGENCY: En vironmen tal Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: EPA is providing notice of a 

proposed administrative penalty for 

alleged violations of the Clean Water 

Act. EPA is also providing notice of 

opportunity to comment on the 

proposed penalty. 

EPA is authorized under section 

3ll(b )(6) of the Clean Water Act. 33 

U.S.C. l32l(b)(6). to assess a civil 

penalty after providing the person 

subject to the penalty notice of the 

proposed penalty and the opportunity 

for a hearing. and after providing 

interested persons public notice of the 

proposed penalty and a reasonable 

opportunity to comment on its issuance. 

Under section 311(b)(6). any owner. 

operator. or person in charge of a vessel. 

onshore facility. or offshore facility in 

violation of the regulations issued under 

section 311 U) of the Clean Water Act. 33 

U.S.C. l32lU). ("Oil Pollution 

Prevention Regulations"--40 CFR part 

112) may be assessed a civil penalty of 

up to $137.500 by EPA in a "Class II" 

administrative penalty proceeding. 

Class II proceedings under section 

3ll(b )(6) of the Clean Water Act are