P.1 / ~ .

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

III. What is the Agency Authority for and the trustees of the Trust . Pursuant ENVIRONMENTAL PROTECTION

Taking This Action? to the Agreement, the Trust will arrange AGENCY

Section 6(f)(1) of FIFRA provides that for the sale of the Trust property.

a registrant of a pesticide product may Seventy-five percent of the proceeds of [OPPTS-53171A; FRL-6097-7]

at any time request that any of its the sale will be paid to the Hazardou s

pesticide registrations be amended to Substance Superfund and twenty-five Category for Persistent,

delete one or more uses The Act further percent will be paid to the Trust . This Bioaccumulative, and Toxic New

provides that, before acting on the allocation is a close approximation of Chemical Substances

request, EPA must publish a notice of the costs each party has contributed to AGENCY: Environmental Protection receipt of any such request in the cleaning up the site . The settlement Agency (EPA)

. Federal Register . Thereafter, the includes a covenant not to sue the ACTION: Policy statement. Administrator may approve such a settling parties pursuant to Sections 10 6

request. and 107(a) of CERCLA, 42 U.S.C . 9606, SUMMARY : EPA groups new chemical

IV. Procedures for Withdrawal of 9607(a). For thirty (30) days following substances with similar structural and

Request the date of publication of this notice, toxicological properties into categories

EPA will receive written comments to facilitate premanufacture assessment Registrants who choose to withdraw a relating to the settlement. EPA will and regulation . These groupings enable

request for use deletion must submit consider all comments received and both Toxic Substances Control Act such withdrawal in writing to James A

. may modify or withdraw its consent to (TSCA) section 5(a)(1) Premanufacture

Hollins, at the address given above, the settlement if comments received Notice (PMN) submitters and EPA postmarked May 2, 2000

. disclose facts or considerations which reviewers to benefit from accumulated

V. Provisions for Disposition of Existing indicate that the settlement is data and decisional precedents and have

Stocks inappropriate, improper, or inadequate . streamlined the process for Agency

The Agency has authorized the The United States' response to an review of and regulatory follow-up on

any new chemical substances. Consistent registrants to sell or distribute product comments received will be available for with TSCA section 26(c), which allows

under the previously approved labeling public inspection at the U .S. EPA action under TSCA with respect to

for a period of 18-months after approval Environmental Protection Agency, 75 categories of chemical substances o

r the re

v have beenision Hawthorne Street, San Francisco, CA mixtures, EPA is issuing this policy imposed, as~n special eview 94105 .

actions. statement regarding a category of

DATES : Comments must be submitted on persistent, bioaccumulative, and toxic

List of Subjects or before December 6, 1999 . (PBT) new chemical substances.

Environmental protection, ADDRESSES : Comments should reference DATES : This document will become

the Sanders Aviation Removal Site, effective January 3, 2000 .

Dated : October 4, 1999

. Tempe, Arizona and EPA Docket No . FOR FURTHER INFORMATION CONTACT : For

Richard D 99-06 and should be addressed to Kara general information contact: Christine D. Schmitt,

Christenson, Office of Regional Counsel, Augustyniak, Associate Director

, Environmental Assistance Divisio n

Acting Division

. Information Resources & U.S

. Environmental Protection Agency, (7408), Office of Pollution Prevention 75 Hawthorne Street, San Francisco, C A

[FR Doc . 99-28890 Filed 11-3-99: 8 :45 am] 94105. and Toxics, Environmental Protection

Agency, 401 M St., SW., Washington, BILLING CODE 6560-50-F AVAI LABILITY : The proposed settlement is DC 20460 ; telephone numbers: 202-

available for public inspection at the 554-1404 and TDD : 202-554-0551 ; eENVIRONMENTAL PROTECTION U.S. Environmental Protection Agency, mail address: TSCA-Hotline@epa .gov.

AGENCY 75 Hawthorne Street, San Francisco, CA For technical information contact :

94105 . A copy of the proposed Kenneth Moss, Chemical Control

[FRL-6458-9] settlement may be obtained from Kara Division (7405), Environmental

Sanders Aviation Superfund Site, Christenson, Office of Regional Counsel Protection Agency, 401 M St., SW. ,

U.S . Environmental Protection Agency, Washington, DC 20460 ; telephone Proposed Notice of Administrative number: 202-260-3395 ; fax number: Settlement 75 Hawthorne Street, San Francisco, CA

94105 ; and at the Tempe Public Library, 202-260-0118 ; e-mail address:

AGENCY : Environmental Protection 3500 South Rural Road, Tempe, moss .kenneth@epa .gov.

Agency (EPA) . Arizona. SUPPLEMENTARY INFORMATION : On

ACTI ON : Notice ; request for public October 5, 1998 (63 FR 53417) (FRLcomment.

FOR FURTHER INFORMATION CONTACT : Kara 5571-6), EPA published a Federal

Christenson, Office of Regional Counsel Register notice soliciting comments on

SUMMARY : In accordance with section U.S . Environmental Protection Agency, proposed criteria for identifying PBT

122(i) of the Comprehensive 75 Hawthorne Street, San Francisco, CA chemical substances and their

Environmental Response, 94105, telephone : (415) 744-1330. supporting scientific rationale . This

Compensation, and Liability Act, as Dated : October 25, 1999 . policy statement responds to comments

amended ("CERCLA"), 42 U .S.C. on the proposed criteria for identifying

9622(i), notice is hereby given of a Michael

Feeley, PBT new chemical substances and their

proposed administrative settlement for Deputy Director, Super£und Division, Region supporting scientific rationale. Please

recovery of past response costs IX. consult the October 5, 1998 (63 FR

concerning the Sanders Aviation [FR Doc . 99-28885 Filed 11-3-99 : 8 :45 am] 53417) Federal Register notice for

Superfund Site in Tempe, Arizona with BILLING CODE 6560-50-P further information on the TSCA new

the Alfred P. Sanders Trust ("Trust") chemicals program. The docket control
p. 2

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

number for this document is OPPTS- I . General Information future be a submitter of a PMN under

53171A. A . Does This Document Apply to Me? TSCA. Potentially affected entities may

include, but are not limited to the

You may be potentially affected by following :

this document if you are or may in the

Category NAICS Code SIC Codes Examples of Potentially Affected Entities

Chemical manufacturers or impo rters 325, 32411 28, 2911 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 submitt ed by

chemical manufacturers or impo rt ers as PMNs

and which are determined by EPA to meet the

PBT c riteri a desc ri bed here may be subject to

regulato ry controls under TSCA section 5(e).

This listing is not intended to be referenced in this document, any public also be suspended voluntarily by the

exhaustive, but rather provides a guide comments received during an applicable mutual consent of EPA and the PMN

for readers regarding entities likely to be comment period, and other information submitter. During the review period,

affected by this document . Other types related to this document, including any EPA may take action under TSC A

of entities not listed above could also be information claimed as Confidential section 5(e) or (f) to prohibit or limit the

affected. The four-digit Standard Business Information (CBI) . This official production, processing, distribution in

Industrial Classification (SIC) codes or record includes the documents that are commerce, use, and disposal of ne w

the six-digit North American Industrial physically located in the docket, as well chemical substances that raise health or

Classification System (NAICS) codes as the documents that are referenced in environmental concerns . If EPA has not

have been provided to assist you and those documents . The public version of taken action under TSCA section 5(e) or

others in determining whether or not the official record does not include any (f), the PMN submitter may manufacture

this document might apply to certain information claimed as CBI . The public or import the new chemical substance

entities. To determine whether you or version of the official record, which when the review period expires .

your business is affected by this includes printed, paper versions of any No later than 30 days after the PMN

document, you should carefully electronic comments submitted during submitter initiates manufacturing or

examine the applicability provisions in an applicable comment period, is importing, it must provide EPA with a

40 CFR 720 .22 . If you have any available for inspection in the TSCA notice of commencement of

questions regarding the applicability of Nonconfidential Information Center, manufacture or import . Section 8(b) of

this document to a particular entity, Rm. NE B-607, Waterside Mall, 401 M TSCA provides that, upon receipt of

consult the technical person listed in St ., SW., Washington, DC . The Center is such a notice, EPA must add th e

the "FOR FURTHER INFORMATION open from 12 noon to 4 p .m., Monday substance to the TSCA Inventory .

CONTACT" section. through Friday, excluding legal Thereafter, other manufacturers and

B. How Can I Get Additional holidays . The telephone number of the importers may engage in activities

Information, Including Copies of This Center is 202-260-7099. involving the new substance without

Document and Other Related 3 . By phone . If you need additional submitting a PMN, unless the Agency

Documents? information about this document, you has used its Significant New Use Rul e

may also contact the person identified (SNUR) authority under TSCA section 1 . Electronically. You may obtain in the "FOR FURTHER INFORMATION 5(a)(2) to designate a use of a chemical copies of this document from the EPA CONTACT" section . substance as a "significant new use." Internet Home Page at http:// Section 5(a)(1)(B) of TSCA would then

www.epa .gov/. On the Home Page select II. Background require persons to submit a Significant

"Laws and Regulations" and then look A. Overview of the PMN Process New Use Notice (SNUN) to EPA at least

up the entry for this document under 90 days before they manufacture

,

the "Federal Register - Environmental Under section 5(a) of TSCA, persons import, or process the substance for the

Documents." You can also go directly to must notify EPA at least 90 days before use designated as significant. The

the "Federal Register" listings at http:/ manufacturing or importing a new required SNUN provides EPA with the

/www.epa.gov/fedrgstr/. To access chemical substance for non-exempt opportunity to evaluate the intended

information about the TSCA New purposes. A new chemical substance, as use, and if necessary, to prohibit or limit

Chemicals Program, go directly to the defined in section 3(9) of TSCA, is any that activity before it occurs

. Home Page for the New Chemicals chemical substance (as defined by

Program, within the Office of Pollution section 3(2)) that is not included on the B. History

Prevention and Toxics, at http:// Inventory compiled under section 8(b) Since 1979, EPA has reviewed over

www.epa.gov/opptintr/newchms/. of TSCA. 30,000 TSCA section 5 submissions for 2 . In person. The Agency has Section 5 of TSCA gives EPA 90 days new chemical substances. During the

established an official record for this to review a PMN (also referred to as a intervening years, EPA has

document under docket control number "section 5 notice") . However, the implemented various initiatives which

OPPTS-53171A . The official record review period can be extended under have enabled the Agency to review a

consists of the documents specifically TSCA section 5(c) for good cause ; it may greater number of new chemicals more
p. 3

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

efficiently . In 1988, for example, EPA's procedure for identifying additional including a summary of significant

Office of Toxic Substances (now the POPs as candidates for future comments and the Agency's response

Office of Pollution Prevention and international action . The CEG is to follows :

Toxics) first used its accumulated incorporate criteria pertaining t o

experience to group chemical persistence, bioaccumulation, toxicity A. Pigments

substances with similar and exposure in different global regions Comment 1-Pigments. Commenters

physicochemical, structural, and and should take into account the suggested that EPA not identify

toxicological properties into working potential for regional and global pigments as bioaccumulators and were

categories (USEPA, 1988, see Unit transport, including dispersion concerned that testing could end up

VI.8.) . These categories, including the mechanisms for the atmosphere and the being expensive for pigments, which are

subject one for PBT chemical hydrosphere, migratory species, and the persistent by design .

substances, are developed by EPA based need to reflect possible influences of Response . EPA assesses PMN

on available data and experience marine transport and tropical climates. chemical substances for PBT attributes

reviewing PMNs on similar substances . At its first meeting, October 26-30, 1998 on a chemical-by-chemical basis ,

Such groupings enable both PMN in Bangkok, the CEG recommended that regardless of whether or not they fall

submitters and EPA reviewers to benefit the INC consider developing a provision into a chemical use category such as

from the accumulated data and encouraging countries and regions to pigments . Not all pigments are the same

decisional precedents and facilitates the include in their new chemicals schemes and a precise definition of the term

assessment of new chemical substances . elements relating to development and "pigment" is not available . As a result,

PBT chemical substances possess introduction of new chemical POPs. The EPA does not have general "pigments"

characteristics of persistence (P) in the U.S. described its proposed TSCA new or "dyes" assessment categories; there

environment, accumulation in chemicals program policy for the are, however, more specifically

biological organisms (bioaccumulation category of PBT new chemicals, and the described categories of dyes or pigments

(B)), and toxicity (T) that make them full text of the October 5, 1998 Federal that have been described by EPA (e .g .,

priority pollutants and potential risks to Register notice was distributed to all acid or amphoteric dyes,

humans and ecosystems. Prominent delegations as a Conference Room dichlorobenzidine-based pigments, and

examples of PBT chemical substances Paper . The CEG's recommendation was others; see categories document at http :/

include the insecticide DDT and accepted at the second meeting of the /www .epa.gov/opptintr/newchms/

polychlorinated biphenyls (PCBs) . INC (January 25-29, 1999 in Nairobi) chemcat.htm) . Moreover, the fact that a

Establishment of a PBT category alerts and the INC will consider it further in substance is "persistent by design" by

potential PMN submitters to possible its deliberations. itself is not a sufficient basis for

assessment or regulatory issues This policy statement is important in identifying a PBT new chemical

associated with PBT new chemicals our new chemical assessment and TSCA substance . Persistence is only one of

review. It also provides a vehicle by regulatory programs, and represents the three criteria used to identify a chemical

which the Agency may gauge the flow first formal statement of national policy as PBT . When combined with a

of PBT chemical substances through the regarding new chemical "persistent potential to bioaccumulate, toxicity

TSCA New Chemicals Program and organic pollutants." Under our domestic concern, and sufficient release to the

measure the results of its risk screening program, the policy statement provides environment to result in potential risk

and risk management activities for PBT guidance criteria for persistence, or significant exposure, pigments may

new chemical substances; as such, it is bioaccumulation, and toxicity for new be of concern, whether or not they are

a major element in the Agency's overall chemicals and advises the industry persistent by design. If a PMN chemical

strategy to further reduce risks from PBT about our regulatory approach for is persistent by design, and becomes

pollutants

As described in the

. chemicals meeting the criteria. subject to testing requirements by EPA, Federal Register Internationally, the Federal Register it would be counterproductive to test

notice of October 5, 1998 (63 FR 53417), notice of October 5, 1998 (63 FR 53417) initially for persistence, but rather to

development of the TSCA new PBT alerted the parties involved in address the "B" and "T" criteria

chemicals policy has occurred in negotiation of the POPs Convention to instead .

coordination with U.S. national, U.S ./ the need for inclusion of a ne w

Canada binational, and international chemicals provision in the Convention.

B. Ready Biodegradability Testing

efforts to identify and control the The issuance of the final policy Comment 2-Ready biodegradability

environmental release of persistent statement will reaffirm US leadership testing. Commenters suggested that EPA organic pollutants (POPs). The proposed on this issue and serve as a model for avoid the use of strict- pass/fail criteria

TSCA PBT category has been provided other countries in taking steps to for ready biodegradability of poorl y

to the Criteria Expert Group (CEG) discourage the introduction of POPs as water-soluble substances.

established at the first session of the new chemicals and pesticides

. Response . Poor water solubility does

Intergovernmental Negotiating not necessarily lead to inability to pass

Committee (INC) for an International III. Discussion of Final Policy a ready biodegradability test, as amply

Legally Binding Instrument for Statement and Response to Comments demonstrated by the fact that many fats,

Implementing International Action on Today's policy statement adopts the oil, petroleum hydrocarbons, etc . easily

Certain Persistent Organic Pollutants, in criteria and testing strategy of the pass ready biodegradability tests . While accordance with the mandate given by Federal Register notice of October 5, strict OECD (Organization for Economic

the Governing Council of the United 1998 (63 FR 53417), with minor Co-operation and Development) pass/

Nations Environment Programme revisions. The Agency reviewed and fail criteria are given in the OPPTS

(UNEP) in paragraph 9 of its decision considered all comments received on Ready Biodegradability test guidelines

19/13 C(http://irptc.unep.ch/pops/ the October 5, 1998 (63 FR 53417) (see http ://www.oecd.org//ehs/test/

gcpops _ e .html). The CEG is an open- notice . A complete copy of all degrad .htm and Testing Strategy for PBT

ended technical working group with a comments received is available in the Chemical Substances, Unit IV .B. of this mandate to present to the INC proposals public docket for this document . A document), the Agency recognizes the

for science-based criteria and a discussion of the policy statement, limitations in applying such criteria
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Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 60197

rigidly given that many substances of test guideline) or the new "slow-stir" longer. EPA's current suggested

concern as potential PBTs are unlikely method currently under development by approach to finding water half-life is to

to pass ready biodegradability tests . A the OECD, can be used. However, if the use the Ultimate Survey Model (USM)

variety of critical aspects beyond the chemical manufacturer still views these in the EPI BIOWIN program (Boethling

pass/fail result will be considered when methods as inappropriate for a given et al ., 1994, see Unit VI.5 .) . Estimation

evaluating potential new chemical PBTs chemical, it would be advisable to of bulk compartment half-lives fro m

or when testing decisions are made proceed to more definitive testing to USM model data requires several

about specific PMN substances. These address bioaccumulation potential (i.e ., assumptions, including that (1 )

more critical aspects include those the Fish BCF study) . This approach can biodegradation is the only significant

related to chemical structure (e.g ., be applied to other testing endpoints as fate process in water, soil, sediment ; (2) degree of branching) and bioavailability well ; for example, based on water and soil half-lives are the same ;

(e .g ., uptake of a substance by fish or physicochemical properties of a and (3) sediment is dominated by

microorganisms), and their influence on particular PMN chemical substance, a anaerobic conditions and therefore

both biodegradation and company might forgo a lower tier acute sediment half-life is four times longer

bioaccumulation . Daphnia toxicity study in favor of the than water half-life .

C. Bioconcentration Factor and Kow chronic study because it would yield

E. Computer Models and the Use of the best information for the screening

Comment 3-Bioconcentration factor. level risk assessment Models vs. Actual Data

. Commenters requested clarification on Comment 5-Use of octanol solubility Comment 7-Use of models vs. actual how bioconcentration factor (BCF) will data alone. Commenters wanted to data. Commenters support the use of the

be estimated using calculations based know if octanol or fat solubility data can Mackay/EQC model, but stressed th e

on octanol-water partition coefficient. be used before determining which importance of having a process for using

Response. The octanol-water partition chemical substances have the potential actual data in place of the model

.

coefficient (Kow) is correlated with the for bioaccumulation . Response . This is a reasonable

potential for a chemical to Response . By itself, solubility in suggestion . The EQC model is based on

bioaccumulate in organisms; the BCF octanol (as a surrogate for fat) is not a the fugacity approach and subsequently

can be predicted from log Kow, via good predictor of potential applied to numerous environmental

computer programs based on structure bioaccumulation in fish . Kow is processes. It uses an "evaluative activity relationship (SAR) . The Agency correlated with the potential for a environment" in which environmental

process for predicting bioaccumulation chemical to bioaccumulate in parameters such as bulk compartment

factors (BAFs) and BCFs, along with organisms ; the bioconcentration factor dimensions and volumes (e .g ., total

literature references, is described in (BCF) can be predicted from log Kow, area, volume of soil and sediment, etc .) some detail in the proposed rule for via SAR. Kow is a coefficient which are standardized, so that overall

lowering of reporting thresholds for serves as a surrogate for the partitioning persistence for chemicals with different

certain PBT toxic chemicals subject to of chemicals between water and fat, and properties and rates of transformation

reporting under section 313 (Toxic cannot be accurately estimated via may be compared on an equal basis . In

Release Inventory, or TRI) of the separate determinations of solubility in general, measured values of toxicity,

Emergency Planning and Community pure octanol and water (i .e ., by chemical properties, compartmental

Right-to-Know Act (EPCRA) of 1986 calculating the ratio of the pure-solvent transformation half-lives, etc ., provided

(January 5, 1999 (64 FR 688) (FRL- solubilities) (Sijm et al., 1999, see Unit the data are of acceptable quality, are 6032-3), see page 704) . VI. 1 .) . The Agency uses and preferred over those that are predicte d Comment 4-Log Kow and low recommends the use of computer or estimated via a model or computer

solubility chemicals. Commenters models to predict Kow where there are program .

suggested that the October 5, 1998 (63 no measured data

. Comment 8-Modeling of air releases. FR 53417) Federal Register notice Commenters noted that the October 5,

identified methods for calculating log g g 1998 (63 FR 53417)

D. Environmental Half-Life

Federal Register Kow that are not appropriate for organic Comment 6-Calculation of half-life . notice considered only biodegradation

pigments, which are insoluble in Commenters wanted to know how half- and aqueous hydrolysis and asked about

octanol. They wanted to know how EPA life is calculated in the review of PBT fate of a chemical upon release to air

.

handles low octanol or water soluble new chemicals. They suggested that EPA estimate chemicals . Response. Multimedia fate models atmospheric oxidation using AOPWIN . Response . EPA believes that the like the Environmental Quality Criteria Response . Although the testing

methods cited in the October 5, 1998 (63 (EQC) model (Mackay et al ., 1996, see strategy for this policy statement focuses

FR 53417) Federal Register notice for Unit VI.2 .) require compartmental half- on biodegradability, all relevant

experimental measurement of the lives for air, water, soil and sediment, transport and transformation processes

octanol/water partition coefficient which cannot necessarily be interpreted will be considered in evaluating the

(Kow), or SAR to predict Kow, are as half-lives for any specific process potential for a PMN substance to behave

appropriate, and the results of either can such as biodegradation . Data on air half- as a PBT. Transformation processes not then be used to predict the Fish BCF. lives for input to models would be mentioned in the Federal Register

Chemicals are unlikely to be accorded either measured or derived from the notice but which may be important for

special treatment in the new chemicals Atmospheric Oxidation Program (AOP specific PMN substances includ e

review process solely because of low or AOPWIN) or similar methodology . atmospheric oxidation and photolysis,

solubility in octanol or water alone . The Studies by Boethling et al. (1995, see photolysis in water, and redo x

test guidelines (OPPTS 830 .7570 or Unit VI.3 .) and Federle et al . (1997, see transformations (of which there are 830.7560) cited in the October 5, 1998 Unit VI.4 .) suggest that half-lives in bulk various types) in water, soil, an d

(63 FR 53417) Federal Register notice soil may be assumed for screening sediment . Although EPA believes that

are viewed as the most appropriate for purposes to be about the same as for for most organic chemicals,

measuring Kow, and alternatively, the surface water, and that sediment half- biodegradation in water, soil, and

shake-flask method (OPPTS 830 .7550 lives may be assumed to be 3-4 times sediment will be the most important
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60198 Federal Register/Vol. 64, No . 213/Thursday, November 4, 1999/Notices

transformation process, each suspected for PBT chemicals look more like the current proposed criteria do not

PBT chemical substance will be "check-the-box" than "weight of consider any health and safety benefits

evaluated on its use and disposal evidence" and wanted to know how of a PBT chemical substance

. patterns . EPA will make professional judgment Response. New chemicals identified

Clearly the atmosphere is an and use SAR and assessment methods to as potential PBT chemicals are assessed

important environmental medium, and identify PBT new chemicals. on a case-by-case basis. Section 5(e) of is especially relevant where a substance Response . These tools (professional TSCA authorizes EPA to control

is emitted directly to the atmosphere or judgment, SAR, computer models, commercial activities involving a new

transported there via volatilization or assessment methods, etc .) would be chemical substance for which available aerosolization. We know by deduction applied to potential PBT chemical information is insufficient to permit a

that it is only, or at least chiefly, substances in the same way they are reasoned evaluation of potential health

through the atmosphere that POPs like applied to any other chemical substance and environmental effects if EPA

dioxins and Polychlorinated biphenyls in the PMN review process. Using determines either (1) that th e

(PCBs) reach remote locations, and it predictive tools (in the absence of test manufacture (including import)

,

will be an important factor in data) and professional judgment, EPA processing, distribution in commerce,

determining the ultimate fate of many leans towards a "reasonable worst case" use, or disposal of the substance may

PMN substances as well . It is through when there is lack of chemical-specific present an unreasonable risk of injury to

multimedia fate models such as EQC data. Industry always has the option of health or the environment ("risk-based"

that atmospheric fate will be considered assisting and enhancing the Agency's finding), or (2) that the substance is or

in developing an overall prediction of determinations by submitting will be produced in substantial

environmental persistence for suspected scientifically valid test data . There are a quantities, and such substance either

PBT substances. Where measured data number of existing documents enters or may reasonably be anticipated

are not available, appropriate estimation describing the PMN process and the to enter the environment in substantial

methods such as that in the AOPWIN critical role played by SAR and quantities or there is or may b e

program will be used to generate professional judgment in that process, significant or substantial human

screening-level estimates of atmospheric including the Chemistry Assistance exposure to the substance ("exposurehalf-lives. Manual for Premanufacture Notification based" finding) . The restrictions under

F. Use of "Weight of Evidence" and Submitters (USEPA, 1997, see Unit TSCA section 5(e) are imposed pending

Professional Judgment VI.6 .) and parts of the report on the joint the development of the test data or othe r

U.S./European Union study that information needed to evaluate the new Comment 9-Laboratory vs. field evaluated the predictive power of the substance's health or environmental behavior of chemicals. Commenters SAR (USEPA, 1994, see Unit VI.7 .) . EPA effects. EPA draws on information and

indicated that EPA needs to incorporate believes that, where no or insufficient data submitted with the PMN form ,

any differences between lab and field actual toxicity data exist upon which to other information available to the

behavior of chemicals into its analysis base a decision, toxicity estimates Agency, and modeling (e .g ., exposure,

of new chemical substances, generated by SARs and other predictive release, SAR, etc.).

acknowledge the limitations of techniques may constitute sufficient The Agency will consider P and B and

screening-level biodegradation tests, evidence to be used in human health T, individually and together, and

and acknowledge the value of using and environmental hazard and exposure in making risk-based

professional judgment when environmental fate assessment as judgments. Risk, specific to the PMN

interpreting data from extended (> 60 components in certain risk substance as well as its risk relative to

day) degradation studies. determinations under TSCA (see also substitutes currently on the market, i s Response . EPA recognizes that the Federal Register of December 1, predicted as a function of the potential

laboratory tests at best provide a 1993 (58 FR 63507) for a similar hazard of the substance and the

snapshot of expected environmental statement related to meeting section 313 expected exposure . In other instances, behavior, which ideally is studied in the listing criteria under EPCRA of 1986) . as discussed in the October 5, 1998 (63 field. But since field testing is nearly Comment 11-Implement PBTpolicy FR 53417) Federal Register notice, always impractical for PMN chemical within risk assessment framework . during PMN review EPA may determine

substances, it is necessary to conduct Commenters suggested that EPA risk that a new substance will be produced

laboratory tests and to apply scientific management decisions should not be in substantial quantities and "may

judgment in extrapolating from lab to made solely on hazard information ; reasonably be anticipated to enter the field . EPA similarly acknowledges the these PBT criteria should be environment in substantial quantities or

limitations of ready biodegradability implemented within a risk assessment there is or may be significant or

and other screening tests as indicators of framework . They indicated that toxicity substantial human exposure to the

ultimate environmental behavior . has been largely overlooked in the PBT substance," and that the available

Finally, it is well known that even this scheme and no criteria have been information is insufficient to determine

policy statement's higher tier (Testing provided for toxicity. Commenters the effects of the substance. For such

Tiers 2 and 3) environmental fate suggested that EPA needs to take into exposure-based determinations on

guidelines, despite being designed to account P and B and T before requiring suspected PBT new chemicals, EPA will

provide test conditions closer to those further testing or identifying a chemical use a case-by-case approach for making

expected in the field, become less as a"true" PBT, and asked whether findings by applying considerations

reliable when tests are run for longer persistence and log Kow would be beyond P and B (i .e ., toxicity or

than the maximum duration specified in sufficient to determine that a PBT PMN physical/chemical properties), and

the guidelines. EPA will give chemical substance may pose a consider P and B aspects as factors

appropriate weight to these and other significant risk . Commenters also which might argue for regulatory action

complexities in its assessments. suggest that EPA should except non- under TSCA section 5(e) at lower levels Comment 10-"Check the box" vs. toxic and low exposure/release of production or exposure/release than "weight of evidence ." Commenters substances from consideration under are described in the general guidelines

noted that the TSCA PMN requirements this category and were concerned that for the new chemicals program's
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Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 60199

exposure-based policy (USEPA, 1988, G . Scientific Justification for PBT persistence in water, soil, and sediment,

USEPA, 1989, see Unit VI.8 . and 9.) . Technical Criteria the criteria were grouped around halfOverall, companies are not being Comment 12-Support for lower lives of 1 to 2 months and 6 months,

prevented from developing and using threshold criteria for "P" and "B." and for persistence in air, either 2 or 5

new substances that are judged to be Commenters believed that there is little days . Bioaccumulation criteria were

potential PBT chemicals, but EPA may precedent, scientific justification, grouped around BAF/BCF values of

require certain controls (e .g ., limiting evidence or data to support the lower 1,000 and 5,000 . The preamble to the

the release of the PMN chemical to the regulatory threshold of bioaccumulation EPCRA proposed rule states "Bearing in

environment) or testing as a result of its factor of 1,000 and environmental mind that one of Congress' articulated

assessments. persistence of 2 months. They suggested purposes for EPCRA section 313 was to

In order to be so identified as a PBT that EPA needs a rationale for these provide local communities wit h

new chemical based on a risk-based criteria beyond " . .

.are characterized by relevant information on the release and

finding, all three criteria must be a tendency to accumulate in other waste management activities of

satisfied . The Agency has adopted a 1 to organisms ." chemicals in their community that may

3 rating system for each of P, B, and T . Response . There is no "bright line" present a hazard, EPA determined that

If chemical has a low Kow (i.e ., "B1," that clearly identifies a bioaccumulation the criteria that were most consistent

with BCF estimated as less than 1,000), factor of 1,000 or a half-life of 2 months with these purposes were, for

the B1 rating does not support the new as the best bioaccumulation or persistence, half-lives of 2 months for

chemical's identification as a potential persistence criterion from a scientific water, sediment, and soil, and 2 days in

"PBT chemical." For example, some perspective . However, it is not accurate air, and for bioaccumulation,

surfactants could be P3B1T3 ; they are to state that there is no precedent or bioaccumulation/bioconcentration

highly persistent in the environment basis for using these values . As outlined factor values of 1,000 or greater" (64 FR

and chronically toxic to organisms, but in EPA's recent proposal to lower the 692 ; January 5, 1999). EPA is making a

with low bioaccumulation potential . reporting thresholds for PBT chemicals similar determination for the PBT new

However, Agency action may still be that are subject to reporting under chemicals policy under TSCA . The

taken under TSCA on chemicals not section 313 of EPCRA (64 FR 688 ; PMN process is one of EPA's

meeting all of the PBT criteria, if they January 5, 1999), similar values have cornerstone Pollution Prevention

otherwise meet the risk or exposure- been proposed by several authorities, programs and plays a critical gatekeeper

based elements of TSCA section 5(e) . including the Ontario, Canada Ministry role in making sure that all new

Similarly, calcium would also not be of Environment and Energy (MOEE) for chemical substances do not present

considered a PBT chemical, as it would its Candidate Substances List for Bans unreasonable risks when they ar e

be ranked P3B3T1 ; it is persistent in the or Phaseouts (MOEE, 1992, see Unit commercialized. Given this, and the

VI.10 .) ; the Canadian initiative for uncertainty which often accompanies

environment, it bioaccumulates, but it is Accelerated Reduction/Elimination of Agency review of a PMN chemical

not considered toxic . Although the

Agency does not promote the Toxics (ARET) (ARET, 1995 and ARET, substance due to lack of data, the TSCA

1994, see Unit VI. 11 . and 12.); the new chemicals program is and must be

environmental discharge of more International Joint Commission (IJC)'s conservative by nature, which suggests

persistent materials, the environmenta l

"desirability" Great Lakes Water Quality Agreement that a half-life shorter than 6 months

of a given chemical often (GLWQA) (IJC, 1993, see Unit VI.13 .) ; and a BCF criterion lower than 5,000-

depends on a balance of various factors, and the United Nations Economic values that were selected solely or

including toxicity and ability of the Commission for Europe Convention on primarily to isolate substances already

chemical to bioaccumulate . Like the Long-Range Transboundary Air widely acknowledged to be POPs are

previous surfactant example, the Pollution (UNECE-LRTAP), which did appropriate for regulatory scrutiny of

Agency may nonetheless take action on adopt 2 months as the persistence new chemicals under TSCA . Note that

a P3B3T1 chemical (not calcium per se), criterion of record for water (UNECE- the CEG, at the October 26-30, 1998

most likely under its exposure-based LRTAP, 1998, see Unit VI.14 .) . Bangkok meeting described in Unit II.B.

authority . In determining the thresholds for this of this document, developed indicativ e

The toxicity rating for a PBT chemical policy statement, EPA concluded that it numerical values as bracketed criteria

applies to repeated exposures which would be appropriate to reflect the text which included persistence of 2 vs .

result in human or environmental levels of concern that the various PBT 6 months in water and log Kow of 4 vs .

toxicity, including, for example, chemicals presented, based on the 5 (equivalent to a BCF of approximately

systemic toxicity, mutagenic damage, differing degrees to which the chemicals 1,000 vs. 5,000, respectively) .

reproductive toxicity, or developmental persist and bioaccumulate . The Agency A series of PMNs submitted to EPA in

toxicity. An example of this is chronic ultimately chose to adopt a two-tier 1990 (Zeeman et al ., 1999, see Unit

toxicity towards aquatic organisms of approach, and to establish two separate VI .15 .) illustrates (1) why EPA believes

organotins from contaminated marine thresholds to reflect the chemicals' that the persistence criterion for

environments, which ultimately varying potentials to persist and bioaccumulating substances in soil,

resulted in the regulation of use of bioaccumulate, as well as to reflect the water, or sediment should be set

tributyl tin in marine anti-fouling Agency's belief that the different levels substantially lower than 6 months; and

paints. Repeated exposures result from of regulatory action under TSCA are (2) that concern for potential exposures

a PBT chemical after it has been warranted for the two tiers. As to persistent and bioaccumulative toxics

released into the environment, usually discussed in detail in the preamble to must extend beyond the UNEP's 1 2

via contaminated water, sediments, or the mentioned EPCRA proposed rule, widely acknowledged POPs . The

food. The classic PBT problems (i .e ., EPA found that generally the criteria substances in question were alkylated

PCBs and Dichloro diphenyl selected by various U .S. and diphenyls, for which EPA expected

trichloroethane (DDT)) have been international regulatory bodies for either discharge to receiving streams and

associated with food chain persistence or bioaccumulation rivers. The submitter supplied data on

contamination. clustered around two values. For use and disposal, aquatic toxicity, and
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60200 Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notice s

biodegradability . The submitted or exposure-based findings under TSCA that persistence alone is not sufficient to

environmental fate data and EPA section 5(e) . cause a substance to bioaccumulate .

estimates of biodegradability based on Comment 14-Relationship of P, B, and Response. EPA did not intend that the

structural analogs suggested that half- T criteria . Commenters suggested that sentence be read to mean that

lives in water would be well below 6 the October 5, 1998 (63 FR 53417) persistence alone is sufficient to result

months, but not necessarily lower than notice is inaccurate when it states that in bioaccumulation . The point that was

2 months. As a result of concerns 2 months is adequate for detecting many intended to be conveyed was that a

expressed by EPA, use was limited to long-term toxic effects as well as any certain level of persistence is a

sites where resulting water tendency for a substance to necessary condition for

concentrations could be limited to 1 bioaccumulate in aquatic organisms . bioaccumulation to occur. There are

microgram per liter or less; Commenters pointed out that the other conditions that affect

concomitantly, the submitter was also persistence criterion is not related to bioaccumulation, such as bioavailability

informed of EPA's belief that a potential detection of long-term toxicity . and the metabolic transformation rate in

for long-term risk existed, but that EPA Response . The statement in question the target species . These and other

could not quantify this risk since was intended simply to note that the 2 factors will be evaluated by EPA in the

assessments typically evaluated releases months half-life in water persistence determination of the PBT concern level

over a period of only 1 year. In 1998, criterion closely tracks the duration of for PMN chemical substances.

results of monitoring revealed that the long-term environmental toxicity or H. Relationship of TSCA PBT Policy to PMN substances had been found in fish bioaccumulation tests. If a new Other Agency and International PBT

fillets and sediment samples from the chemical substance is predicted to or Initiatives

receiving stream. If, for these 1990 measurably demonstrates chroni c

PMNs, EPA were to have had in place toxicity, potential to bioaccumulate, and Comment 16-Finalize overall Agency

the 2 month persistence criterion multimedia strategy first . Commenters

described in today's policy statement, environmental persistence over that suggested that the PBT classification

further scrutiny under the new same time period (2 months), it would criteria being proposed for TSCA

chemicals program would have been meet the minimum TSCA PBT criteria . section 5(e) may have broade r

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

warranted, and beyond simply for identifying POPs warranting application, e .g ., international or other

informing the PMN submitter of the international action (e

.g

., in programs Agency PBT initiatives, and may be

potential for long-term risk, the Agency like UNECE-LRTAP and UNEP Global used to establish precedent in other

would likely have required further Negotiations on POPs) have not been programs. In addition to the TSCA

testing to obtain an experimental value selected based on the duration of October 5, 1998 (63 FR 53417) Federal

for environmental persistence of the toxicity or bioaccumulation tests. There

Register notice, there have been three

chemicals. This in turn would have cutoffs or "fence lines" for other notices published in Federal

given the Agency a better picture ofthe are no Register dealing with (1) the promotion

behavior of the chemicals in the environmental persistence criteria that of voluntary waste minimization efforts

environment and the environmental emerge as immutable quantities solely to reduce the generation of those PBT

half-life relative to the 2 month value . from scientific analysis; the choice of chemicals which are found in hazardous

Comment 13-Deny commercialization screening criteria is a policy decision waste regulated under the Resourc

e

to lower threshold PBT chemicals. Some guided by the anticipated scope of a Conservation and Recovery Act (RCRA)

commenters supported exercising the negotiation or regulatory activity . In the (63 FR 60332 ; November 9, 1998 (FRL-

"Precautionary Principle" by not case of the PMN program, 2 months 6186-7)), (2) the Agency draft

allowing commercialization under a represents a reasonable screening level Multimedia PBT Strategy (63 FR 63926 ;

TSCA 5(e) consent order or SNUR value for "persistence" which is more November 17, 1998 (FRL-6045-2)), and

pending testing of the PMN chemicals than the 1-month period in a ready (3) the lowering of reporting thresholds

which meet the P=2 month and biodegradation study and less than the for certain PBT toxic chemicals subject

BCF=1,000 criteria . They suggested that 6 month value widely agreed to to reporting under section 313 (Toxic

these chemicals should be banned internationally (U .S.-Canada binational Release Inventory, or TRI) of EPCRA of

instead, pending the necessary testing . agreement to control the discharge or 1986 (64 FR 688 ; January 5, 1999) .

Response . Whereas a half-life of 2 release of POPs in the Great Lakes These commenters stated that the TSCA

months and BCF of 1,000 can be Basin, UNECE-LRTAP, North American notice is premature, occurring before

justified as lower-tier cutoffs in a Free Trade Agreement Commission for adoption of the overall Agency strategy,

deliberately conservative TSCA new Environmental Cooperation (NAFTA- and is inconsistent with other

chemicals program that is designed to CEC), etc .) as reflecting the persistence initiatives, domestic and international,

prevent commercialization of of known POPs chemicals (e .g ., DDT, which have lists of chemicals and more

potentially risky substances, it would hexachlorobenzene) . As mentioned in selective criteria (i .e ., specific t o

not be appropriate to automatically the previous response, there is environmental media, fate an d

trigger a "ban pending testing" at these international support, through the CEG, transformation processes) . Commenters

cutoffs given the uncertainties about for persistence values of 2 or 6 months recommended that EPA finalize the

substance properties, release, and in water. Agency strategy first, before proceeding

environmental behavior that normally Comment 15-Relationship of P and B. with the TSCA, RCRA, and TRI actions,

characterize PMN review . The Agency Commenters suggested that the October and that there should be coordination

believes that the available predictive 5, 1998 (63 FR 53417) notice's among them all with uniform PBT

tools and current knowledge of POPs statement, "Generally, persistent criteria as part of the Agency strategy .

lend support for this two-phased bioaccumulators are chemical Response. The PBT Multimedia

approach to screening of PBT chemicals substances that partition to water, Strategy formalizes an Agency process

and collection of information "sufficient sediment or soil and are not removed at for integration of program activitie s

to permit a reasoned evaluation of rates adequate to prevent their involving these types of substances

.

potential health and environmental bioaccumulation in aquatic or terrestrial While the strategy intends to coordinate

effects" if EPA makes the requisite risk- species," should be revised to reflect Agency PBT-related activities under its
p. 8

Federal Register/Vol. 64, No. 213/Thursday, November 4, 1999/Notices 6 0201

framework, the strategy does not chemicals program policy for the could be required in addition to PBT

establish rigid criteria with respect to category of PBT new chemicals, and the testing.

PBTs. Program offices must operate full text of the October 5, 1998 (63 FR Comment 19-Equivalent tests.

within the parameters of their legislative 53417) Federal Register notice was Commenters suggested that all tests

mandates and established regulatory distributed to all delegations as a referenced in the testing strategy should

and policy frameworks. For some Conference Room Paper. The CEG's also state "or an equivalent test."

programs such as the Toxics Release recommendation was accepted at the Response . EPA realizes that often

Inventory, the TSCA New Chemicals second meeting of the INC Qanuary 25- there are a number of different but

Program and the RCRA National Waste 29, 1999 in Nairobi) and the INC will acceptable means to providing testing

Minimization Plan, actions involving consider it further in its deliberations . information. However, EPA's

PBTs are a historical reality and their

I. Testing Strategy acceptance of a guideline not specified

experience has, in fact, largely shaped in this policy statement and/or use of

the strategy . Therefore, EPA does not Comment 18-Toxicity testing. data generated under such guidelines

intend to halt all ongoing work Commenters asked whether toxicity was depends on multiple factors including

involving PBTs until the strategy is considered at each testing tier or only in the specifics of the test substance,

"finalized ." With respect to the PMN tier 3 . It was not clear to them when purpose of the testing, familiarity with

process, it is important to understand toxicity testing would be requested, nor specific procedures and equipment,

and acknowledge its fundamental what results will be considered validation of the method, etc . Typical

purpose, which is to allow EPA to acceptable by the Agency . TSCA 5(e) consent orders require that

evaluate the hazards, exposures, and Response . Each of P and B and T are testing performed pursuant to the order

risks of new chemicals, and the weighed in the Agency's assessment. must be conducted according to TSCA

opportunity to protect against The testing strategy outlined in this Good Laboratory Practice Standards at

unreasonable risks, if any. The structure policy statement is intended to build the 40 CFR part 792 and usin g

of that process and the tools used to case, starting with testing to establish methodologies generally accepted at the

implement it flow logically from its persistence and bioaccumulation, and time the study is initiated . Before

statutory purpose and suggest that the then determining toxicity and starting to conduct any such study, the

category approach outlined in this confirming a chemical's status as a PBT PMN submitter must obtain approval of

policy statement is the most appropriate chemical in tier 3 . Once a chemical test protocols from EPA by submitting

means of addressing potential concerns becomes distributed in the environment written protocols. Published test

for substances possessing PBT at low concentrations, the combination guidelines specified in the Test Strategy

characteristics. It is EPA's intention that of persistence and bioconcentration in section (see Unit IV . B. of this

the strategy be a living document . organisms can result in residues high document) provide general guidance for

Therefore, the strategy will be updated enough to approach a toxic dose . The development of test protocols, but are

based upon public comment; it will not first two tiers focus on P and B because not themselves acceptable protocols .

be "finalized" in the more traditional of the critical role these aspects play i n

sense of a rulemaking . EPA does agree PBT determinations and because of their J. Applicability of PBT Criteria to Metals

that consistency is a laudable goal relatively lower cost to determine P and Comment 20-PBT criteria are not

where the criteria are meant to be used B. Thus, chronic toxicity testing, which appropriate for metals. Commenters

for similar purposes and is seriously is expected to be the most expensive suggested that the application of

considering comments within the testing, is reserved until tier 3 where it Persistence and Bioaccumulation

context of the strategy regarding serves to establish PBT status. Although criteria appropriate for organic

establishment of consistent criteria for the early tier P and B testing may either chemicals does not make sense for

priority PBTs. obviate the need for toxicity testing or metals and metal compounds. They also

Comment 17-Carefully communicate result in more directed and cost- suggested that EPA needs criteria to

lower thresholds. Commenters suggested effective toxicity testing, the need for identify potential problems generated by

that EPA should use only the toxicity testing is considered in each organometals .

environmental persistence of 6 months/ testing tier and will be obtained in Response . The approach and the

BCF of 5,000 screening levels for lower tiers where needed on a case- criteria are sufficiently flexible to apply

consistency among EPA and U.S./ specific basis. As with all new to organic chemicals, inorganic metals

international programs and should chemicals reviewed by the Agency and organometallics . It is important to

carefully communicate proposed lower under TSCA, the potential toxicity of distinguish between criteria for

criteria internationally . the chemical is determined from test identifying potential PBTs, on the one

Response . As discussed in the data, if any, or by analogy to structurally hand, and on the other : (1) the means of

response to Comment 12, EPA believes similar chemicals . If a company knows generating information on the P, B, and

that a lower tier of 2 month/BCF of or suspects prior to testing that their T endpoints for comparison to th e

1,000 is appropriate for risk screening chemical is likely to be persistent and criteria, and (2) the applicability of

activities under TSCA. Communication bioaccumulative, consideration should existing test guidelines for generating

is occurring in the international forum . be given to conducting chronic toxicity such information experimentally .

Unit II.B. of this document discusses the testing in the first tier. For any EPA understands that metals are

CEG for POPs, established under UNEP suspected PBT chemicals for which a intrinsically not degradable in the sense

mandate . At its first meeting, on October risk finding has not been made, but of ultimate degradation of organics

30, 1998 in Bangkok, the CEG which meet production, release, and (although they may undergo biologically

recommended that the INC consider exposure thresholds under the Agency's as well as chemically induced changes

developing a provision encouraging exposure-based policy (USEPA, 1988, in, e .g ., oxidation state), and therefore

countries and regions to include in their USEPA, 1989, see Unit VI .8 . and 9.), the are persistent by definition, bu t

new chemicals schemes elements standard screening level battery of nevertheless may not b e

relating to development and testing (or an appropriate subset thereof) bioaccumulative . It is widely accepted

introduction of new chemical POPs. The currently utilized for exposure-based that elemental metals are persistent by

U.S . described its proposed TSCA new cases in the new chemicals program definition, since they may take different
P. 9

60202 Federal Register/Vol . 6 4, No . 213/Thursday, November 4, 1999/Notices

forms that can be interconverted, but the do this, but the Agency will consider all IV . Final TSCA New Chemicals

elemental metal itself cannot be available and relevant data, and will use Program Policy for PBT Chemical

destroyed . All elemental metals its professional judgment in considering Substances

therefore meet the 6 month half-life issues like bioavailability of metals . A. Evaluation Criteria and Process for

criterion. Given this, it is not correct Using lead as an example, many New PBT Chemical Substances

that EPA's proposed persistence criteria processes commonly observed in th e

cannot be applied to metals . It may be environment can result in the presence EPA is adopting the following specific

more accurate to state that the of bioavailable (ionic) lead where it can identification criteria and associated

persistence criteria are not themselves be bioaccumulated by organisms . These process for use in evaluating new

very helpful in screening or assessing processes may occur in soil and aquatic chemical substances .

metals and metal compounds with environments with low pH and low

respect to the potential for risk, whether levels of organic matter . Under these NEW CHEMICALS PROGRAM PBT

from direct exposure or through

bioaccumulation

. Relative to conditions, the solubility of lead is CATEGORY CRITERIA AND PROCESS

applicability of test guidelines, the same enhanced and, in the absence of sorbin g

level of judgment will be brought to bear surfaces and colloids, lead ion can TSCA Section 5(e) Action

such that, for example, EPA would not remain in solution for a sufficient 5(e) Orde r

require ready biodegradability testing period to be taken up by biota . Lead Pending Test- 5(e) Ban

for a metal or metal salt . (EPA may, sorption to soil organic matter has been ing/Significant Pending

however, request such testing for shown to be pH dependent

. Decreasing New Rule Testing2

organometallics, which, depending on pH can lead to increasing (SNUR)

chemical structure, could still show concentrations of lead in soil and water . Persistence > 2 months . . . . . . > 6 months

significant degradation in such tests.) Microbial transformations in soil, water, (transEPA understands that bioavailability and sediment are also important in formation

is important in determining the determining the overall fate of metals half-life).

potential for risk, and notes that the and metal compounds, and therefore the Bioaccumu- >_ 1,000 . . . . . . . . . . . . >_ 5,000

lation

same generalization applies to any potential for formation of bioavailable (Fish BC F

substance whether metallic or not . forms. Metals are generally taken into or BAF)3.

Metals and organometallic compounds cells by nutrient metal transport Toxicity Develop toxicity Develop toxare no different from other organic data where icity data

chemicals with respect to the systems, and these are not sufficiently necessary4 . where

applicability of the proposed criteria for specific to completely exclude nonessential metals , in persistent, bioaccumulative, , some of which may essary4

y g and toxic substances, except that Kow be toxic and/or bioaccumulative . In this

determination may not be relevant for situation, nutrient metals can be 'Exposure/release controls included in

Y order; testing required .

metals (although the fish BCF study is displaced from their binding sites by 2Deny commercialization; testing results

relevant) . Similarly, it is not necessary undesirable, toxic metals, which then may justify removing chemical from "high risk

to develop different criteria or gain access to the cell interior with concern" .

assessment strategies for pigments (see concomitant exclusion of the essential 3Chemicals must also meet criteria for KW (< 1000) and cross-sectional diameter (< 20A ,

first comments/responses in this policy metal (Stumm and Morgan, 1996 see or < 20 x 10-8 cm) .

statement) or any other specific classes Unit VI.16 .) . Toxic metal ions are then 'Based upon various factors, including conof organics. What is necessary is to free to react with critical enzymes or cems for persistence, bioaccumulation, other

consider what is known about the otherwise disrupt cellular functions if physical/chemical factors, and toxicity based on existing data .

behavior of substances like metals they reach certain levels . EPA concludes Chemical substances suspected as during the TSCA PMN review process, that under many environmenta l

both in the assessment of whether a conditions, metals and metal persistent bioaccumulators under the

given chemical substance meets the compounds may be available to express criteria listed in the table in Unit W .A.

established criteria and in subsequent y of this document may need to undergo

toxicity and to bioaccumulate, and that testing on "P" and "B" endpoints

testing decisions. For any untested PMN these effects are not necessaril limite d

chemical substance, if there are no close y which, if confirmed, would be followed analogs with data and no clear evidence to metals that are not essential nutrients. by appropriate toxicity testing to

that available estimation methods are It is appropriate, therefore, to be identify PBT chemical substances ."

unreliable for this or closely related concerned about the potential for risk Control action under TSCA section 5(e)

substances, then the estimation methods from these effects . It is the policy of the may be needed in varying degrees,

can be assumed to apply and the TSCA New Chemicals Program that if based upon the level of risk concern .

resulting data compared to PBT criteria . the metal in a metal compound cannot Agency control actions taken under

Put another way, a metal or become available as a result of biotic or TSCA section 5(e) for chemical

organometallic (or, similarly, a pigment) abiotic processes then the metal will not substances meeting these criteria would

that is judged sufficiently persistent and be available to express its toxicity, and be based upon the level of certainty for

meets the criteria for bioaccumulation by extension, to bioaccumulate . If the the PBT properties of a PMN substance

potential and toxicity is of concern for intact metal compound is not toxic and (e .g ., measured vs. estimated values),

"PBTness" regardless of theoretical the metal is not available from the metal the magnitude of Agency concerns, and

arguments or generalizations . compound, then such a chemical would conditions of expected use and releas e

The key is how persistence and not be a strong candidate for regulation of the chemical . For example, new

bioaccumulation potential are under TSCA section 5(e). chemical substances meeting the PBT

determined in the PMN process, and by criteria listed under "5(e) Order Pending

implication, how bioavailability is Testing/Significant New Use Rule

determined . This policy statement (SNUR)" could be addressed via a

leaves unspecified how EPA intends to negotiated consent agreement under
P. 1 0

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

which necessary testing is "triggered" chemical substance for which EPA has chemical properties, persistence an d

by specific production limits. While the made the above described risk and/or bioaccumulative qualities of hydrolysis

PMN submitter would be allowed to exposure-based findings under section products, and the nature of the expected

commercialize the substance, certain 5(e)(1)(A)(i) and (ii) of TSCA . The tests releases.

controls could be stipulated, including are tiered ; depending upon the Tier 2. Biodegradability should be

annual TRI-type reporting on circumstances, such as magnitude of determined according to the Shake-flask

environmental releases of the PMN environmental releases, results of die-away test (OPPTS 835 .3170 test

substance and specific limits on testing, or SAR, testing could begin guideline) . This test is based on the

exposures, releases, or uses . The "ban above Tier 1 or additional, higher levels principle of aerobic incubation of the

pending testing" criteria are equivalent of testing may be required. As discussed test chemical in natural water with and

to those that have been used in the response to Comment 19 in Unit without suspended sediment, requires a

internationally to identify POPs. For the 111.1 . of this document, testing must be chemical-specific analytical method,

chemical substances meeting these conducted according to TSCA Good and allows for the development of a

criteria, the concern level is higher and Laboratory Practice Standards at 40 CFR first-order rate constant and half-life . It

the Agency would look carefully at any part 792 and using methodologies provides information on persistence that

and all environmental releases. Because generally accepted at the time the study is relevant to the natural environmen t

of the increased concern, more stringent is initiated . Before starting to conduct and is intermediate in cost between

control action would be a likely any such study under the terms of a ready biodegradability tests (tier 1) and

outcome, up to a ban on commercial Consent Order under TSCA section 5(e), sediment/water microcosm

production until data are submitted the PMN submitter must obtain biodegradation test (tier 3) .

which allow the Agency to determine approval of test protocols from EPA by Bioaccumulation potential should be

that the level of risk can be submitting written protocols. Published determined by experimental

appropriately addressed by less test guidelines specified in Unit IV .B. of measurement of the bioconcentration

restrictive measures. The control actions this document provide general guidance factor (BCF), using the Fish

described in the table in Unit IV .A. of for development of test protocols, but bioconcentration test (OPPTS 850 .1730

this document represent just one body are not themselves acceptable protocols . test guideline (public draft)) . Measured

of possible decisions and should not be Tier 1 .

If, based upon available test BCF should be based on 100 percent

considered as exclusive of other risk data, SAR, and professional judgment, active ingredient and measured

management options. the Agency identifies a new chemical concentration(s)

.

substance as a possible PBT chemical

B. Testing Strategy for PBT Chemical Kow should be life If i

s the measured biodegradation half- substance, Lo g

Substances determined experimentally, using either > 60 days and measured BCF is

Where EPA is unable to adequately the liquid chromatography (OPPTS > 1,000, tier 3 testing will normally be

determine the potential for 830.7570 test guideline) or generator required. If only one condition is met,

bioaccumulation, persistence in the column (OPPTS 830 .7560 test guideline) releases and exposure are further

environment, and toxicity which may method . Hydrolysis in water (OPPTS considered to determine if additional

result from exposure of humans and 835 .2110 test guideline) should be testing is required .

environmental organisms to a possible determined if, based upon SAR, Tier 3. Toxicity/advanced

PBT chemical substance, the Agency susceptibility to hydrolysis is suspected . environmental fate testing . Human

may conclude, pursuant to sections Ready biodegradability should be health hazards should be determined in

5(e) (1) (A) (i) and 5(e) (1) (A) (ii) (I) and (II) determined according to either one of the combined repeated dose ora l

of TSCA, that the information available the following test guidelines: toxicity with the reproductive/

to the Agency is insufficient to permit 1 . Ready biodegradability (OPPTS developmental toxicity screening test

a reasoned evaluation of the human 835 .3110 test guideline) 6 methods (OECD No . 422 test guideline) in rats .

health and environmental effects of that (choose one) : DOC Die-Away, CO2 Other health testing will be considered

PMN substance, that the manufacturing, Evolution, Modified MITI (I), Closed where appropriate .

processing, distribution in commerce, Bottle, Modified OECD Screening, Environmental fate testing should be

use, or disposal of the substance may Manometric Respirometry . conducted according to the Sediment/

present an unreasonable risk of injury to 2 . Sealed-vessel CO2 production test water microcosm biodegradation test

human health or the environment, and/ (OPPTS 835 .3120 test guideline) . (OPPTS 835.3180 test guideline) . The

or that the PMN substance will be If the measured log Kow is < 4.2 principle of this method is the

produced in substantial quantities and (equivalent to an estimated BCF of determination of the test chemical's fate,

that there may be significant or 1,000) or if the test chemical passes including transport and transformation,

substantial human exposure to the (pass criteria are described in the test in core chambers containing intact

substance or the PMN substance may guidelines) the ready biodegradability benthic sediment and overlying site

reasonably be anticipated to enter the test (i .e ., not persistent in the water. The method permits more

environment in substantial quantities. environment), no further PBT-related accurate and reliable extrapolation to

Accordingly, the Agency may find it testing is required . If the measured log natural aquatic environments than is

appropriate to prohibit or otherwise Kow is greater than or equal to 4 .2, and possible with lower tier test methods.

limit the manufacture, import, the chemical does not pass the ready Chronic toxicity to fish (rainbow

processing, distribution in commerce, biodegradability test, no further testing trout) and daphnids should b e

use, or disposal of the PMN substance will normally be deemed necessary in determined according to 40 CF R

in the United States pending the tier 1 ; the Agency would likely require 797 .1600 (same as OPPTS test guideline

development of information necessary tier 2 testing . If hydrolysis testing is 850 .1400 (public draft)) and 40 CF R

for a reasoned evaluation of these conducted and results in a half-life of < 797 .1330 (same as OPPTS test guideline

effects. The following testing strategy 60 days, further testing may not be 850 .1300 (public draft)), respectively .

describes test data which EPA believes needed, but the need for testing must be Additional testing to evaluate other

are needed to evaluate the persistence, determined after consideration of factors biota (e .g ., avian, sediment dwelling

bioaccumulation, and toxicity of a PBT specific to the case, such as physical/ organisms) or other effects (e .g .,
P. 11

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

endocrine disrupting potential) will be biodegradability assessment . 15. Zeeman, M., D Rodier, and JV considered where appropriate . Chemosphere 30: 741-752. Nabholz. 1999 . Chapter 2 . Ecological

V. Intended Legal Affect of this Policy 4 . Federle TW, SD Gasior and BA Risks of a New Industrial Chemical

.

Statement Nuck. 1997 . Extrapolating Under TSCA. In Ecological Risk

mineralization rates from the ready C02 Assessment in the Federal Government

The policy discussed in this screening test to activated sludge, river (Executive Office of the President,

document provides general guidance on water, and soil

. Environ. Toxicol. Chem. National Science and Technology the Agency's use of a category grouping 16 : 127-134. Council, Committee on Environment for PBT new chemical substances to 5. Boethling RS, Howard PH, Meylan and Natural Resources, Ed .) . CENR/5- facilitate the PMN assessment process W, Stiteler W, Beauman J, Tirado N. 99/001, May, 1999, pp 2-1 to 2-30 . for PMN submitters and EPA reviewers. 1994 . Group contribution method for 16. Stumm, W. and JJ Morgan. 1996 . EPA uses groupings of new chemical predicting probability and rate of Aquatic Chemistry, 3rd ed . New York : substances with similar structural and aerobic biodegradation. Environ. Sci. Wiley.

toxicological properties to allow PMN Technol. 28: 459-465.

submitters and EPA reviewers to benefit 6. USEPA. March, 1997 . Chemistry List of Subjects

from accumulated data and decisional Assistance Manual for Premanufacture Environmental protection, Chemical

precedents, as well as streamlined Notification Submitters . EPA 744-R- substances, Hazardous substances, procedural requirements related to the 97-003 . Also available as Reporting and recordkeeping

review of and follow-up for new Premanufacture Notification : Chemistry requirements. chemical substances. Assistance for Submitters, by Steven C. As guidance, the policy presented in DeVito and Carol A . Farris (ISBN : 0- Dated: October 22, 1999 .

this document is not binding on either 471-19151-5) through the publisher, Susan H. Wayland ,

EPA or any outside parties, and this John Wiley and Sons, at 1-800-22 5

document is not intended, nor can it be 5945 or the TSCA Hot Line, at 202-554- DeputyAssistantAdministratorfor

relied upon, to create any rights 1404 .

Prevention, Pesticides and Toxic Substances.

enforceable by any party in litigation 7 . USEPA. March, 1994 . U.S. EPA/EC [FR Doc . 99-28888 Filed 11-3-99 ; 8 :45 am]

with the United States. Although this Joint Project on the Evaluation of BILLING CODE 6560-56-F

guidance provides a starting point for (Quantitative) Structure Activity

assessing PBT new chemical substances, Relationships . EPA 743-R-94-001 .

EPA will depart from its policy where 8. USEPA. 1988 . Letter from Charles ENVIRONMENTAL PROTECTION

the facts or circumstances warrant. In L. Elkins to Geraldine V. Cox (Chemical AGENCY

such cases, EPA will explain why a Manufacturers Association) . Office of [FRL-6469-6] different course was taken . Similarly, Toxic Substances, USEPA (Septembe r

outside parties remain free to assert that 22, 1988) . Notice of Proposed Assessment of

this policy is not appropriate for a 9 . USEPA. 1989 . Letter from Charles Clean Water Act Class II Administrative

specific PMN or that the circumstances L . Elkins to Geraldine V. Cox (Chemical Penalty and Oppo rtunity To Comment surrounding a specific PMN Manufacturers Association) . Office of

demonstrate that this policy should not Toxic Substances, USEPA (August 31, AGENCY : Environmental Protection

be applied. Although the Agency has 1989) . Agency (EPA).

provided an opportunity for public 10. Ministry of Environment and ACTION : Notice.

comment on the guidance provided in Energy for Ontario (MOEE) . 1992 .

this policy statement and is likely to Candidate substances list for bans or SUMMARY: EPA is providing notice of a

request additional feedback if changes phase-outs . Report perpared by the proposed administrative penalty for

are necessary at some point in the Hazardous Contaminants Branch and alleged violations of the Clean Water

future, the Agency may revise, clarify, the Water Resources Branch, MOEE . Act. EPA is also providing notice of

or update the text of this guidance Ontario, Canada, ISBN 0-7729-9764-0 . opportunity to comment on the

without public notice. 11. Accelerated Reduction/ proposed penalty.

Elimination of Toxics (ARET) EPA is authorized under section VI. References Secretariat. 1995 . Environment leaders 311(b) (6) of the Clean Water Act, 33

The OPPTS harmonized test 1 . Voluntary commitments to action on U .S.C. 1321(b) (6), to assess a civil

guidelines referenced in this document toxics through ARET . March 95. penalty after providing the person

are available on EPA's World Wide Web 12 . Accelerated Reduction/ subject to the penalty notice of the

site (http ://www.epa.gov/ Elimination of Toxics (ARET) proposed penalty and the opportunity

OPPTS_Harmonized/). Secretariat. 1994 . The ARET substance for a hearing, and after providin g

1 . Sijm, D.T.H.M., Schuurmann, G., selection process and guidelines. interested persons public notice of the

de Vries, P.J., Opperhuizen, A. Aqueous January 94 . proposed penalty and a reasonable

Solubility, Octanol Solubility, and 13 . International Joint Commission opportunity to comment on its issuance . Octanol/Water Partition Coefficient of (IJC) . 1993 . A strategy for the virtual Under section 311(b)(6), any owner,

Nine Hydrophobic Dyes. Environ. elimination of persistent toxic operator, or person in charge of a vessel,

Toxicol. and Chem. 18 :1109-1117. substances. Vol. 1, report of the Virtual onshore facility, or offshore facility in

2 . Mackay, D., Di Guardo, A., Elimination Task Force to the IJC. violation of the regulations issued under

Paterson, S., Cowan, C.E. 1996 . Windsor, Ontario, Canada, 72 pp. section 311(j) of the Clean Water Act, 33

Evaluating the environmental fate of a 14 . United Nations Economic U.S.C. 1321(j), ("Oil Pollutio n

variety of types of chemicals using the Commission for Europe, Convention on Prevention Regulations"-40 CFR part

EQC model. Environ. Toxicol. Chem. Long-Range Transboundary Air 112) may be assessed a civil penalty of

15 :1627-1637 . Pollution (UNECE-LRTAP). 1998 . Draft up to $137,500 by EPA in a "Class II "

3 . Boethling RS, PH Howard, JA composite negotiating text for a protocol administrative penalty proceeding . Beauman and ME Larosche . 1995 . on persistent organic pollutants . Class II proceedings under section

Factors for intermedia extrapolation in UNECE, EB.AIR/1998/2, 31 March 1998 . 311(b)(6) of the Clean Water Act are