16316 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

SNUR notice submitters were small

firms, the number of small businesses

affected by this rule will not be

substantial.

C. Paperwork Reduction Act

There is no additional reporting

burden associated with this amendment.

The information collection requirements

in this rule have been approved by the

Office of Management and Budget

(OMB) under the provisions of the

Paperwork Reduction Act, 44 U.S.C.

3502 et seq., and have been assigned

OMB control number 2070–0012.

List of Subjects in 40 CFR Part 721

Chemicals, Environmental protection,

Hazardous materials, Recordkeeping

and reporting requirements, Significant

new uses.

Dated: March 21, 1995.

Carol M. Browner,

Administrator.

Therefore, 40 CFR Chapter I, part 721

is amended as follows:

PART 721 — [AMENDED]

1. The authority citation for part 721

continues to read as follows:

Authority: 15 U.S.C. 2604, 2607, and

2625(c).

2. By revising §721.170(c)(1) to read

as follows:

§721.170 Notification requirements for

selected new chemical substances that

have completed premanufacture review.

* * * * *

(c) * * *

(1) When EPA decides to establish

significant new use reporting

requirements under this section, EPA

may designate as a significant new use

any one or more of the activities set

forth in subpart B of this part. In

addition, EPA may designate specific

recordkeeping requirements described

under subpart C of this part that are

applicable to the substance.

* * * * *

[FR Doc. 95–7710 Filed 3–24–95; 3:32 pm]

BILLING CODE 6560–50–F

40 CFR Part 723

[OPPTS–50594B; FRL–4929–8]

RIN 2070–AC14

Premanufacture Notification

Exemptions; Revisions of Exemptions

for Polymers; Final Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is promulgating

amendments to the polymer exemption

rule to expand the exemption criteria

and exempt manufacturers of eligible

polymers from certain section 5

premanufacture notification (PMN)

requirements. EPA has determined that

the manufacture, processing,

distribution in commerce, use, and

disposal of new chemical substances

meeting the revised polymer exemption

criteria will not present an unreasonable

risk of injury to human health or the

environment under terms of the

exemption. These final amendments

reflect criteria developed and used by

EPA to assess the hazards associated

with new polymeric substances over the

past 15 years the New Chemicals

Program has been in place. EPA believes

that these amendments will encourage

the manufacture of safer polymers by

reducing industry’s reporting burden for

this category of chemical substances.

DATES: This rule will become effective

May 30, 1995. In accordance with 40

CFR 23.5 (50 FR 7271), this rule shall

be promulgated for purposes of judicial

review at 1 p.m. eastern time on April

12, 1995.

FOR FURTHER INFORMATION CONTACT:

James B. Willis, Acting Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460, Telephone: (202) 554–1404;

TDD: (202) 554–0551.

SUPPLEMENTARY INFORMATION: The

polymer exemption rule was originally

promulgated on November 21, 1984.

The supporting rationale and

background for that exemption was

published at 49 FR 46066 on November

21, 1984 and 46 FR 54688 on November

3, 1981. On February 8, 1993, EPA

proposed amendments to the 1984

polymer exemption rule (58 FR 7679).

Consult those documents for further

information on the objectives, rationale,

and procedures for the rule and the

basis for the finding that polymers

eligible for exemption will not present

an unreasonable risk of injury to human

health and the environment under terms

of the exemption. The docket control

number for this document is OPPTS–

50594B.

The amended rule allows

manufacture and distribution of

polymers meeting the exemption criteria

without submission of a PMN or an

exemption notice prior to

commencement of manufacture for a

commercial purpose under terms of the

exemption. However, manufacturers of

exempted polymers are required to

submit an annual report on exempted

polymers for which manufacture or

importation commenced for the first

time under terms of the exemption

during the preceding calendar year.

Recordkeeping requirements are

retained as part of the rule to document

compliance with the exemption criteria.

Overall, these amendments constitute a

substantial revision of the existing

polymer exemption rule.

I. Background

A. Statutory Authority

Section 5(a)(1) of TSCA requires that

persons notify EPA at least 90 days

before they manufacture or import a

new chemical substance for commercial

purposes. A ‘‘new chemical substance’’

is any substance that is not on the

Inventory of Chemical Substances

compiled by EPA under section 8(b) of

TSCA. Section 5(h)(4) of TSCA

authorizes EPA, upon application and

by rule, to exempt the manufacturer or

importer of any new chemical substance

from part or all of the provisions of

section 5 if the Agency determines that

the manufacture, processing,

distribution in commerce, use, or

disposal of the new chemical substance

will not present an unreasonable risk of

injury to human health or the

environment. In this preamble and

under the rule, references to

‘‘manufacture’’ and ‘‘manufacturer’’

include ‘‘import’’ and ‘‘importer’’,

respectively, as defined in TSCA section

3 and the PMN rule.

B. History/Rationale

In 1984, the Agency published a

TSCA section 5(h)(4) rule granting an

exemption for persons who manufacture

or import certain polymers, set forth at

40 CFR 723.250. Since promulgation of

the 1984 polymer exemption rule (the

‘‘1984 exemption’’), the Agency has

reviewed over 2,000 polymers

submitted as polymer exemption notices

in the 21–day review process in

addition to over 10,000 polymers

submitted as PMNs since the initiation

of the 90–day PMN review process in

1979. In the course of performing hazard

and risk assessments for these polymers,

the Agency has developed internal

guidelines for identifying polymeric

substances that do not present an

unreasonable risk of injury to human

health or the environment. These

guidelines are based on (1) EPA’s

ongoing review of the available

literature on the toxicity of polymers, (2)

EPA’s analyses of various samples of the

PMN polymer data base, (3) information

provided to EPA by outside groups
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16317

during and subsequent to development

of the 1984 exemption, and (4)

professional judgment of EPA staff

scientists. The final rule will bring the

1984 polymer exemption criteria into

close alignment with the internal

criteria currently being used by EPA to

assess hazards and risks of polymers.

The eligibility criteria in the final rule,

which are based on the 1984 polymer

exemption criteria, have been refined

and expanded to allow more low-risk

polymers to qualify for exemption.

While expanding the category of safer

polymers, the exemption continues to

exclude or restrict those polymers that

the Agency believes should be reviewed

under the 90–day PMN process.

Both the Agency and the polymer

industry have had 10 years of practical

experience with the polymer exemption.

Since the current exemption criteria

define what the Agency considers to be

low-risk polymers, eligible polymers

generally receive only a cursory Agency

review to validate that the polymer

meets the eligibility criteria.

Consequently, most polymers eligible

for the exemption present no issues and

manufacture can commence when the

21–day review period expires.

Based on the Agency’s review and

analysis of polymer exemption

applications submitted to date, EPA has

determined that an overwhelming

number of submitters correctly

determined the eligibility status of the

polymer. Consequently, the Agency

believes that it is no longer necessary for

EPA to expend its limited resources to

validate a polymer’s eligibility under

the exemption. The Agency would like

to shift the resources currently

expended on analytical screening of this

class of low-risk substances to the

substantive review of substances that

present unknown or potentially higher

risks. Moreover, the Agency believes

that industry has become sufficiently

familiar with the criteria over the past

10 years and is capable of correctly

determining the eligibility of a polymer

under the exemption. Therefore, EPA

has decided to eliminate the

requirement that a company submit an

exemption application prior to the

manufacture or importation of an

exempted polymer under terms of the

exemption. Instead, the final rule

requires submission of an annual report

on polymers for which manufacture or

importation under terms of the

exemption commenced for the first time

during the preceding calendar year.

However, to increase the level of

assurance that polymers manufactured

under the exemption meet the eligibility

criteria, EPA has prepared a draft

technical guidance document and will

hold workshops on determining

eligibility of exempted polymers for

polymer manufacturers. In addition, the

final rule requires that records

documenting an exempted polymer’s

eligibility under terms of the exemption

be maintained at the manufacturing site.

The Agency believes that expanding

the 1984 exemption criteria and

eliminating routine EPA review will

increase the number of polymeric

substances eligible for exemption,

encourage the manufacture of safer

polymers, and result in resource savings

to industry and the EPA without

decreasing or compromising the level of

risk reduction/management afforded by

a 21–day or 90–day review of these

same substances.

II. Final Amendments

A. Summary of Final Amendments

1. Definition of polymer. To be

considered for exemption, substances

must meet the definition of polymer in

the rule. EPA is amending the definition

of ‘‘polymer’’ to adopt the exact wording

of the internationally recognized

definition of polymer which was

developed at the Organization of

Economic Cooperation and

Development (OECD) Expert Group

Meetings on Polymers held in Toronto,

Canada (January, 1990), Paris, France

(October, 1991), and Tokyo, Japan

(April, 1993) and agreed upon in May,

1993 by the OECD Member Countries.

(Copies of the OECD Chairperson’s

reports are available in the docket for

this rulemaking.) The definition, which

is based on the Agency’s 1984 polymer

definition at 40 CFR 723.250, ensures

that exempt substances have the

structural characteristics common to the

category of substances on which EPA

has based its no unreasonable risk

finding. Minor revisions are included in

the definition in response to comments.

2. Classes of polymers ineligible for

exemption. Section 723.250(d) of the

1984 exemption established certain

classes of polymers that were ineligible

for exemption. As with the 1984

exemption, polymers that are designed

or reasonably anticipated to

substantially degrade, decompose, or

depolymerize will remain ineligible for

exemption in this final rule. In addition,

polymers that are prepared from

monomers or other reactants that are

included in the polymer identity must

be existing chemical substances on the

TSCA Inventory or otherwise excluded

or manufactured under terms of another

TSCA section 5 exemption. The final

rule excludes from eligibility waterabsorbing polymers with molecular

weights (MW) equal to or greater than

10,000 daltons; moreover, the term

‘‘water-absorbing’’ has been re-defined

to describe more specifically the

category of polymers that the Agency

believes should remain subject to the

full PMN review process. The final rule

also amends certain restrictions

contained in the 1984 exemption for

cationic polymers and polymers that

contain certain elements. Restriction on

polymers that contain certain reactive

functional groups have been amended

and are part of the eligibility criteria for

polymers with MW equal to or greater

than 1,000 and less than 10,000 daltons

(§720.250(e)(1)).

3. Polymers eligible for the exemption.

Polymers with number-average MW

greater than 1,000 daltons and

polyesters that are made from a

specified list of reactants remain eligible

for exemption. The final rule sets limits

on oligomer content and reactive

functional groups for polymers with

number-average MW equal to or greater

than 1,000 and less than 10,000 daltons.

In addition, polymers with numberaverage MW equal to or greater than

10,000 daltons and restricted oligomer

content are also eligible for exemption.

In the 1993 proposal, the Agency

requested comment on its proposal to

impose certain restrictions relating to

potential inhalation exposure of

respirable water-insoluble polymer

particles, along with several alternatives

for dealing with potential lung effects

associated with the inhalation of waterinsoluble particles of respirable size.

Based on comments and further analysis

of the available data, the Agency has

removed the restrictions on waterinsoluble polymers with MW of 10,000

daltons or greater, with the exception of

water-absorbing polymers which are

ineligible for exemption.

Polyesters remain eligible as in the

current exemption; however, in

response to comments that the Agency

should expand the category of polyester

polymers eligible for exemption, the

final rule includes a number of

additional substances in the list of

acceptable polyester reactants.

Finally, the following classes of

polymers are now eligible for

exemption: (a) polymers that contain

less than 32 percent carbon; (b)

biopolymers, their synthetic

equivalents, and modifications and

derivatives of biopolymers; and (c)

polymers made from reactants that

contain halogen atoms or cyano groups.

4. General provisions. In the 1993

proposal, manufacturers and importers

would have been required to submit an

abbreviated notice within 30 calendar

days following the first manufacture or

import of an eligible polymer rather
16318 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

than 21 days prior to manufacture

(import) as required in the 1984

exemption. However, the final rule

further modifies the notification

provisions and now requires only that

manufacturers of exempt polymers

submit an annual report on all

exempted polymers for which

manufacture or importation under terms

of the exemption commenced for the

first time during the preceding calendar

year. This annual report would provide

the Agency with information concerning

use of the exemption. Manufacturers are

required to maintain specific records to

document a polymer’s eligibility under

the exemption rule.

With the elimination of the obligation

to notify EPA in advance of manufacture

of an exempted polymer, the use of EPA

Form 7710–25 will not be required.

However, the final rule requires that

certain information be maintained at the

site of manufacture including chemical

identity and structure, records of

production volume for the first 3 years

of manufacture, date of commencement

of manufacture or import, certification

that the polymer meets the conditions of

the exemption, and information that

demonstrates compliance with the

exemption, including analytical data or

other information that substantiates the

manufacturer’s claim of eligibility under

criteria established for minimum

number average MW and restricted

oligomer content.

EPA proposed but is not requiring

that polymer identity be described by a

Chemical Abstracts (CA) Index Name or

CA Preferred Name, since

manufacturers are not required to

submit an exemption notice to the

Agency under the final rule. Finally, the

Agency has determined, for the reasons

outlined in the discussion below, that

the revocation provisions in the 1993

proposal are not necessary for the

Agency to make its determination that

this category of substances will not

present unreasonable risk to human

health and the environment and has

deleted these provisions in their

entirety.

B. Discussion of the Amendments and

Response to Comments

The final rule adopts many of the

proposed amendments without changes.

However, as indicated above, certain

provisions of the proposed amendments

have been revised in light of the

Agency’s consideration of comments

received. A discussion of the major

comments, the Agency’s responses, and

the amended provisions follow:

1. Definition of polymer. Under the

proposal, EPA proposed to revise the

definition of polymer in the 1984

exemption to conform with the

international definition of polymer

recently adopted by OECD Member

Countries, including the United States,

Canada, Japan, and the member nations

of the European Union. The revised

definition retains the meaning and

purpose of the 1984 exemption

definition of polymer. For purposes of

this exemption, the term ‘‘polymer’’

means ‘‘a chemical substance consisting

of molecules characterized by the

sequence of one or more types of

monomer units and comprising a simple

weight majority of molecules containing

at least 3 monomer units which are

covalently bound to at least one other

monomer unit or other reactant and

which consists of less than a simple

weight majority of molecules of the

same molecular weight. Such molecules

must be distributed over a range of

molecular weights wherein differences

in the molecular weight are primarily

attributable to differences in the number

of monomer units.’’

The term ‘‘monomer unit,’’ which

replaces the non-standard term

‘‘internal subunit’’ used in the 1984

exemption, means the reacted form of

the monomer in a polymer, i.e., the

monomer must have formed at least one

covalent bond with another like or

unlike molecule under the conditions of

the relevant polymer-forming reaction.

The fact that a monomer must be

capable of forming two or more such

bonds is not a requirement that it do so

to be considered ‘‘the reacted form;’’ one

is sufficient. Consequently, ‘‘polymer

molecules,’’ defined as containing ‘‘at

least 3 monomer units which are

covalently bound to at least one other

monomer unit or other reactant,’’

continue to require at least 4 precursor

units, as in the 1984 definition. The

difference is that, under the proposal, at

least 3 of the units must be in a

‘‘sequence,’’ and further, one of the

groupings could come from an ‘‘other

reactant’’ as well as from a monomer.

The first change (‘‘sequence’’) is slightly

more restrictive and the second (‘‘other

reactant’’) slightly less restrictive than

the present definition. The net effect of

the change, made to be consistent with

protocols of the OECD, is expected to be

minimal. The term ‘‘sequence’’ is

defined as part of the polymer definition

in the final rule. ‘‘Monomer’’ and

‘‘reactant’’ remain consistent with the

terms used for purposes of Inventory

reporting and premanufacture

notification, wherein ‘‘reactants’’

include monomers, chain transfer and

cross-linking agents, monofunctional

groups that act as modifiers, and other

end groups if incorporated into the

polymer molecule.

Comment. The Society of the Plastics

Industry (SPI) commented that the new

polymer definition should be clear and

complete. By using wording that strays

from the OECD definition, EPA has

rendered its definition unclear and

made interpretation difficult. The

definition of ‘‘polymer molecule’’ that

uses the term ‘‘monomer unit’’ cannot

be equated with the earlier definition

that used ‘‘internal subunit’’ because a

‘‘monomer unit’’ does not have to be

internal. The term ‘‘polymer molecule’’

defined at §723.250(b), requiring at least

two internal monomer units, is in

conflict with the statement in the

preamble that ‘‘at least three of the units

must be internal.’’

Response. The polymer definition in

the proposed rule represents a version

proposed before an OECD meeting held

in April 1993 in which the participants

agreed upon an interpretation of the

polymer definition. (The definition of

the term ‘‘polymer molecule’’, which is

responsible for some of the confusion,

was introduced to assist in defining

‘‘polyester,’’ which is not relevant to the

OECD definition of polymer.) EPA has

therefore made changes in the relevant

provisions of the rule.

Comment. SPI commented that the

definition of ‘‘reactant’’ is inconsistent

with the definition of ‘‘reactive

functional group’’ and is problematic

because of EPA’s dependence on

subjective intent; it recommends that

the language ‘‘reasonably be

anticipated’’ and ‘‘reasonably

ascertainable’’ be used instead of

depending on intent.

Response. The Agency does not

believe there is an inconsistency

between the definitions, nor any

particular reason why they should be

consistent, since they are describing

different things and addressing different

issues. Sodium hydroxide may be a

reactant, but it can hardly be a reactive

functional group. Furthermore, many

chemically reactive substances are not

‘‘reactants’’ in this context because they

are not intended (or reasonably

anticipated) to become chemically part

of the polymer.

2. Polymers ineligible for exemption—

(a) Exclusion of certain polymers that

are cationic or anticipated to become

cationic in aquatic environments. The

Agency continues to have ecotoxicity

concerns for cationic polymers with

specific characteristics but believes that

certain restrictions in the 1984

exemption can be modified as discussed

in the 1993 proposal. No comments

were received on this provision.

Accordingly, under the final rule, the
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16319

current restriction on cationic polymers

at §723.250(d)(1) is amended to provide

that certain cationic polymers will be

eligible for exemption if:

(i) The polymer is a solid material that

is not soluble or dispersible in water

and will be used only in the solid phase

(e.g., polymers that will be used as ion

exchange beads), or

(ii) The combined (total) functional

group equivalent weight of cationic

groups (e.g., primary, secondary and

tertiary amines, quaternary ammonium,

phosphonium, and sulfonium) in the

polymer is equal to or greater than

5,000. ‘‘Equivalent weight’’ of a

functional group means the ratio of the

molecular weight to the number of

occurrences of that functional group in

the molecule. It is the weight of

substance that contains one formulaweight of the functional group. In

addition, the definition of ‘‘cationic

polymer’’ was rephrased in the final

rule to replace the term ‘‘subunit,’’

which as discussed previously in this

unit under Definition of Polymer is

considered a non-standard term.

(b) Exclusion of polymers with certain

weight content of certain elements. The

rule continues to exclude from

eligibility polymers containing certain

levels of particular elements from the

exemption if the elements are present as

an integral part of the polymer structure,

or present as counterions in the

polymer. However, as proposed, the

Agency is expanding the list of

allowable elements set forth at

§§723.250(d)(2)(ii)(B) and (C) to include

chlorine, bromine, and iodine as the

monatomic counterions; and fluorine,

chlorine, bromine, and iodine as

covalently bound to carbon. The Agency

received no comments on this specific

provision.

(c) Exclusion of polymers that

degrade, decompose, or depolymerize.

The rule continues the exclusion at

§723.250(d)(3) for polymers that are

designed or reasonably anticipated to

substantially degrade, decompose, or

depolymerize, including those polymers

that could substantially decompose after

manufacture and use, even though they

are not actually intended to do so. A

description of what the Agency

considers degradation, decomposition

and depolymerization for purposes of

this exemption is contained in the final

rule. No specific comments were

received on this provision.

(d) Exclusion of polymers that are

prepared from monomers or other

reactants that are not already on the

TSCA Inventory. As proposed, polymers

that are manufactured using monomers

or other reactants that are not on the

TSCA Inventory, or that are not

manufactured under an applicable

section 5 exemption are not eligible for

exemption at §723.250(d)(4). Some

confusion surrounded the Agency’s

position on the use of non-Inventory

listed monomers or other reactants at

levels of 2 percent or less, as evidenced

at the public hearing on the proposed

rule held in Washington, D.C. on April

26–27, 1993 and written comments on

this proposal. EPA is making clear that

this provision relates specifically to

monomers or other reactants that would

be considered part of the polymer’s

identity, if the same substance was

reported in a PMN, i.e., those substances

charged to the reaction vessel or

incorporated in the polymer at levels

greater than 2 percent. The provision

will not restrict the use of non-Inventory

listed reactants that are not considered

part of the polymer identity, provided

that those reactants do not introduce

into the polymer elements, properties,

or functional groups that would render

the polymer ineligible for the

exemption. In other words, the ‘‘two

percent rule’’ affects only the identity of

the polymer, not its eligibility. This is

consistent with the 1984 exemption.

However, in practice, the use of nonInventory listed monomers or reactants

at 2 percent or less may be applicable

only to imported polymers since

chemical substances used as feedstocks

in domestic manufacture must be on the

Inventory or otherwise excluded or

exempted from the section 5

requirements. In a separate rulemaking

being published concurrently with this

document [Revisions of Premanufacture

Notification Regulations], EPA amended

the ‘‘Two Percent Rule’’ to allow

submitters greater flexibility in

determining the amount of monomer or

other reactant used in the manufacture

of a polymer. Please consult that rule for

further information.

As stated in the proposal, hazard

concerns for polymers are often based

on a concern for residual monomers or

other reactants in the polymer. Since

residual levels of monomers or other

reactants are not restricted under the

exemption and EPA is not reviewing

exempt polymers, the Agency is

restricting this exemption to those

polymers manufactured using only

Inventory-listed (or otherwise excluded

or manufactured under an applicable

section 5 exemption) constituent

monomers or other reactants that are

part of the polymer’s chemical identity.

This ensures that the Agency will

review polymers that contain new

chemical monomers or other reactants

through the full PMN process and can

regulate any new polymer that may

cause concern as a result of residual

monomers or reactants that are new

chemical substances.

Comment. The Synthetic Organic

Chemical Manufacturers Association

(SOCMA), The Dow Chemical Company

(Dow), Monsanto Company, and SPI

commented that imported polymers

should be treated as polymers produced

in the United States. That is, if the

imported polymer meets the polymer

exemption criteria but contains a nonInventory listed monomer or reactant (at

greater than 2 percent), that polymer

should be eligible for the polymer

exemption as long as the residual

monomer or reactant level is kept below

1 percent (0.1 percent if a carcinogen).

The importer may have no reason to

ever bring the monomer or other

reactant into the United States, and thus

no PMN would be filed on that material.

This would reduce the burden on those

companies importing polymers that

meet the exemption criteria since PMNs

would not have to be filed for the

monomers that these polymers contain.

The residual monomer level limit would

address any potential risk to health and

the environment.

Response. Imported polymers are

being treated the same under this

exclusion as polymers manufactured in

the United States. As stated above, the

Agency wants to be able to assess new

monomers and reactants if present as

residuals. Further, the Agency has not

considered setting a specific level for

residuals nor concluded that polymers

made with presently unknown

monomers (i.e., chemicals not on the

Inventory or exempted) will not present

an unreasonable risk to health or the

environment.

(e) Exclusion of water-absorbing

polymers with number-average MW

equal to or greater than 10,000 daltons.

The final rule excludes from the

exemption water-absorbing polymers

having MW of 10,000 daltons or greater

(§723.250(d)(5)). In the proposal, EPA

had defined a water-absorbing polymer

as a polymeric substance that, either in

whole or in part, increases its volume

when in contact with water. Numerous

comments were received by the Agency

concerning this definition and the MW

restriction. Commenters argued that this

restriction represented a very narrow

approach by the Agency since it was

based on the TSCA section 8(e) study,

designated 8(e)–1795 and FYI–470, on a

water-absorbing polyacrylate polymer

with a MW in excess of 1 million

daltons. The section 8(e) data on the

toxicity of the water-absorbing

polyacrylate polymer included a 1-year

chronic inhalation study, a 2–year

chronic/oncogenicity study, and a
16320 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

subchronic inhalation study. As

discussed in the 1993 proposal,

preliminary data from the 2–year

chronic inhalation study reported

squamous cell carcinoma and bronchioalveolar carcinomas. The exposure

concentrations were 0.05, 0.2, and 0.8

mg/m3. Preliminary pathology reports

state that cancer was observed in the

two highest concentrations. Since the

1993 proposal, the final report on the 2–

year chronic inhalation study has been

received and reviewed by the Agency.

The final report confirms the

preliminary conclusions that under the

conditions of the study, the waterabsorbing polyacrylate polymer was

carcinogenic to F344 rats, inducing lung

tumors (bronchiolar/alveolar adenomas

and adenocarcinomas) in both males

and females. Statistically significant

increased incidences of lung tumors

were seen in both male and female rats

exposed to 0.8 mg/m3 of the polymer.

The tumor incidences in males and

female rats also showed significant

trends as analyzed using the Logistic

Regression Test. At the present time

published Agency guidelines state that

cancer may be a non-threshold effect,

i.e., that dose is cumulative over a

lifetime (see Guidelines for Carcinogen

Risk Assessment, 51 FR 33998,

September 24, 1986 and Risk

Assessment Guidelines of 1986,

Document No. EPA/600/8–87/045).

Consequently, EPA has excluded such

polymers from the exemption and will

review them in the full PMN process to

ensure that they do not present an

unreasonable risk of injury to human

health or the environment. The subject

polymer evaluated in the study has no

reactive functionalities and no residuals

below 1,000 daltons, conditions which

might have excluded it from this

exemption, and, if present, could have

played a role in the reported

carcinogenicity. In the absence of these

factors, the Agency concluded that the

water-absorbing properties of the

polymer may have played a role in the

reported carcinogenicity findings. The

Agency intends to keep abreast of the

scientific findings related to the

inhalation toxicity of water-absorbing

high MW polymers, which for purposes

of this rule means polymers with MW

equal to or greater than 10,000 daltons,

and will consider modifying these

conclusions as the data so warrant.

The Agency examined more closely

its own databases to determine the MW

range for water-absorbing polymers and

their water-absorbing capabilities. The

polymer that was the subject of the

section 8(e) report is a so-called ‘‘super

absorbent’’ material of the type used

primarily in applications such as

disposable diapers and paper towels. It

is the Agency’s understanding that to be

applicable for these types of uses, the

polymers must absorb at least 60 – 100

times their weight of water. The Agency

also has observed that these polymers

have molecular weights (MW) in the 1

million dalton range. The Agency

recognizes that although many other

high MW polymers absorb water to

some extent, they do not belong to the

class identified as ‘‘super absorbent.’’ To

the Agency’s knowledge, data showing

adverse lung effects which include

oncogenicity do not exist on other than

the single high MW ‘‘super absorbent’’

type polymer that was the subject of this

section 8(e) study. Based on the review

of this polymer, the Agency, at this

time, is still unable to establish an exact

MW limit for water-absorbing polymers

likely to cause effects similar to those

reported in the section 8(e) study, but

believes that it is reasonable to set the

number-average MW exclusion for

water-absorbing polymers at 10,000

daltons. Based on EPA’s professional

judgment, the Agency believes that a

MW of 10,000 daltons is a reasonable

value where absorption is slow enough

that a compound can be considered to

persist in the lung. In addition, this MW

is two orders of magnitude less than the

MW of the tested polymer. The Agency

believes that polymers with a numberaverage MW less than 10,000 daltons, in

general, can be expected to be absorbed

by the lung and therefore have different

detoxification mechanisms available to

mitigate potential health hazards.

In response to comments requesting a

definition of ‘‘water absorbing’’ that

more accurately bounds the category of

polymers of concern, EPA has defined a

‘‘water-absorbing polymer’’ as a polymer

that is capable of absorbing its weight of

water. Although the tested polyacrylate

polymer absorbs 100 times its weight of

water, the Agency lowered the threshold

for exclusion in this rule to ‘‘absorbing

its weight of water’’, a threshold which

is 2 orders of magnitude less than that

of the tested polymer. The hundredfold

difference in water absorption is

believed to be appropriate based in part

on the limited data, duration of the

studies, effects noted, dose levels at

which effects were seen, extrapolation

from animal to humans, and the

professional judgment of EPA experts.

Comment. Monsanto comments that

the definition of water-absorbing is

entirely too broad. Nearly all polymers

will absorb some minute amount of

water which will alter its volume if the

measurements are precise enough. A

better approach might be to exclude

from the exemption polymers that will

absorb more than 20 percent of their

weight of water.

Response. The Agency agrees that the

definition in the proposal, which

defined a water-absorbing polymer as

any polymeric substance that, either in

whole or in part, increases its volume

when in contact with water, was too

broad and has narrowed the definition.

Comment. 3M states that the waterabsorbing exclusion is based on a single

section 8(e) report on a polyacrylate

polymer with a MW of greater than 1

million daltons. While 3M understands

the Agency’s desire to develop an

excluded class with an apparent safety

factor in terms of MW, the company

asks EPA to better define waterabsorbing and review industry and

scientific data to restrict the exclusion

to water-absorbing polymer classes and

MW ranges of true concern.

Response. As discussed above, based

on the limited data received by EPA, the

Agency was unable to establish an exact

MW limit but believes it is reasonable

to set the MW exclusion at 10,000

daltons.

3. Elimination of specific exclusions

contained in the 1984 exemption. No

comments were received on the

Agency’s proposal to remove three of

the exclusion criteria present in the

1984 exemption including (a) polymers

containing less than 32 percent carbon,

(b) biopolymers, and (c) polymers

manufactured from reactants containing

halogen atoms or cyano groups.

Therefore, these restrictions have been

deleted from the final rule as proposed.

Further discussion of this issue is

contained in the proposed rule.

4. Exemption criteria. The Agency is

amending the exemption criteria for

polymers with MW of 1,000 daltons or

greater by establishing two MW ranges

with restricted oligomer content.

Section 723.250(e)(1) sets out exemption

criteria for polymers with numberaverage MW equal to or greater than

1,000 and less than 10,000 daltons,

while §723.250(e)(2) sets out criteria for

polymers with number-average MW

equal to or greater than 10,000 daltons.

The exemption criteria for polyester

polymers manufactured using certain

specified precursors have been retained

and redesignated at §723.250(e)(3).

Under the final rule, polymers eligible

for exemption include the following:

a. Polymers with number-average MW

equal to or greater than 1,000 and less

than 10,000 daltons. Section 723.250

(e)(1) exempts polymers with number

average MW equal to or greater than

1,000 and less than 10,000 daltons (and

oligomer content less than 10 percent

below MW 500 and less than 25 percent

below MW 1,000) provided the polymer
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16321

also meets the following criterion: the

polymer can not contain reactive

functional groups except as specified in

paragraph (e)(1)(ii).

i. Restrictions on number average MW

and oligomer content. As discussed in

the proposal, a chemical must be

absorbed by an organism in order to

cause an adverse health or ecological

effect, other than direct contact effects;

further, the ability of a molecule to pass

through membranes and therefore be

absorbed by organisms generally

decreases with increasing MW (size).

Based on these principles, the Agency

concluded that low MW species content

provides an appropriate indication of

the concerns that EPA has for polymers,

namely, the content of potentially

absorbable low MW compounds. As was

proposed, the final rule includes

restrictions on the percentage of low

MW components directly derived from

the monomers or other reactants for

§723.250(e)(1) polymers. The criterion

requires that oligomer content be less

than 10 percent below MW 500 and less

than 25 percent below MW 1,000.

Under the final rule, companies are

free to manufacture any exempted

polymer with any residual reactant

content desired, as long as the

percentages of low MW species do not

exceed the levels specified in the

exemption criteria.

Comment. SPI commented that

number-average MW is a poor criterion

for determining the amount of low MW

oligomers present, and that the weight

percentages of material with MW below

500 and 1,000 daltons are a better

indicator of concern.

Response. While the Agency agrees

that the number-average MW is by itself

a less than perfect measure of the

amount of low MW species present, a

high statistical correlation of the two

values was established by EPA in the

course of preparing the criteria for the

1984 exemption, and EPA’s experience

since then has reinforced the

correlation. In addition, the most

frequently used method for determining

the number-average MW, size-exclusion

chromatography, also yields the

percentages of material in given MW

ranges. It should also be noted that

because the Agency has concerns for

possible lung effects associated with

certain water-absorbing polymers with

MW greater than 10,000 daltons,

determination of number-average MW is

needed for more than one criterion.

ii. Allowable reactive functional

groups. The final rule excludes from

eligibility under the §723.250(e)(1)

criterion certain polymers that contain

reactive functional groups (groups that

are intended or can reasonably be

anticipated to undergo further reaction).

The final rule also amends certain

restrictions in the 1984 exemption.

As discussed in the proposal,

polymers that contain reactive

functional groups may be capable of

reacting with tissues or other chemical

constituents of living organisms.

Absorption of polymers containing

reactive functional groups is also

plausible since reactive groups can

cause sufficient irritation to disrupt

normal cell membrane barriers and

facilitate penetration.

There are no restrictions on polymers

containing certain reactive functional

groups that generally lack reactivity in

biological settings. Under

§723.250(e)(1)(ii)(A), polymers

containing only the following reactive

functional groups remain eligible for the

exemption without restrictions on

equivalent weight: carboxylic acid

groups, aliphatic hydroxyl groups,

unconjugated olefinic groups that are

considered ‘‘ordinary’’ (i.e., not

specially activated either by being part

of a larger functional group, such as a

vinyl ether, or by other activating

influences, for example, strongly

electron-withdrawing sulfone group

with which the olefinic groups interact),

butenedioic acid groups, and conjugated

olefinic groups in naturally-occurring

fats, oils, and carboxylic acids.

Certain other functional groups are

also implicitly permitted. Obviously,

carboxylic esters, ethers, amides,

urethanes, and sulfones are among

them, although not listed above, because

polyesters, -ethers, -amides, -urethanes,

and -sulfones are among the types of

polymers allowed under the exemption.

As long as these groups have not been

modified to enhance their reactivity (for

example, dinitrophenyl esters of

carboxylic acids would be considered

reactive; see also the related discussion

of ‘‘ordinary’’ above), they are assumed

not to be reactive. Please consult the

draft technical guidance document for

further discussion of this issue.

Further, as discussed in the proposal,

EPA believes that the following groups

generally lack or have low reactivity in

biological settings and has therefore

included them in §723.250(e)(1)(ii)(A):

blocked isocyanates (including

ketoxime-blocked isocyanates), thiols,

unconjugated nitrile groups, and

halogens (except reactive halogencontaining groups such as benzylic or

allylic halides).

iii. Allowable equivalent weights for

other reactive functional groups. In the

1984 exemption, the Agency established

equivalent weight criteria which

allowed low concentrations of reactive

functional groups to be present in the

polymer molecules. At that time EPA

believed that a level of less than 1 gramformula weight of reactive functional

groups in 10,000 grams of polymer was

sufficient to ensure that the reactive

functional group was substantially

diluted by polymeric material. Based on

the Agency’s experience in reviewing

polymers since the 1984 exemption was

promulgated, EPA now believes that the

reactive functional group equivalent

weight can be lowered accordingly,

because of EPA’s lower level of concern.

For example, data generated by

companies through the PMN program

(either as section 5(e) testing or via

voluntary programs) and reviewed by

EPA now indicate that epoxy resins

with epoxide equivalent weights greater

than 800 are negative in the Ames assay;

and numerous so-called ‘‘engineering’’

plastics containing substantial

concentrations of anhydride functional

groups derived from maleic anhydride

are essentially inert to water and other

reagents that might ordinarily react with

them by virtue of the overall insolubility

and hydrophobicity of the polymer. The

final rule establishes equivalent weights

of 1,000 and 5,000 daltons for specific

reactive functional groups, as discussed

below.

Section 723.250(e)(1)(ii)(B) sets forth

allowable equivalent weights at 1,000

for the combined weight of certain

polymer reactive functional groups

(other than those of lower concern

identified in §723.250(e)(1)(ii)(A),

which are not restricted), based on the

Agency’s lower level of concern for

these reactive groups. These groups will

include the following: acid halides; acid

anhydrides; aldehydes; hemiacetals;

methylolamides, -amines or -ureas;

alkoxysilanes with alkoxy greater than

C2; allyl ethers, conjugated olefins;

cyanates; epoxides; imines; and

unsubstituted positions ortho or para to

phenolic hydroxyl.

All other reactive functional groups

(except those that are unrestricted) are

required at §723.250(e)(1)(ii)(C) to have

a combined equivalent weight of 5,000

daltons or greater, including pendant

acrylates and methacrylates, aziridines,

carbodiimides, halosilanes,

hydrosilanes, hydrazines, isocyanates,

isothiocyanates, alpha or beta lactones,

methoxy or ethoxy silanes, vinyl

sulfones or analogous compounds, and

any other reactive functional group not

listed at §§723.250(e)(1)(ii)(A) or (B).

EPA requested comment on the

complexity of this specific provision

and was concerned that smaller

businesses or those with limited

technical resources would have trouble

interpreting the exemption criteria for

reactive functional groups, if the groups
16322 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

are complicated, and might choose not

to use the exemption for eligible

polymers. Such persons would, of

course, have the option of using 5,000

as the equivalent weight if they are

uncertain whether a particular reactive

functional group is listed under

§§723.250(e)(1)(ii)(A) and (B). No

adverse comments were received on the

Agency’s specific approach. Therefore,

the final rule includes this provision as

proposed.

EPA believes that restrictions on

reactive functional groups are not

necessary for polymers with a numberaverage MW equal to or greater than

10,000 because, as stated in the

proposed rule, polymers of this size are

not expected to be absorbed by

biological systems.

b. Polymers with number-average MW

equal to 10,000 daltons or greater.

Section 723.250(e)(2) exempts polymers

with number average MW equal to

10,000 daltons or greater (and oligomer

content less than 2 percent below MW

500 and less than 5 percent below MW

1,000). The Agency established this

separate category for polymers with

number-average MW equal to or greater

than 10,000 daltons because high MW

polymers are not expected to be readily

absorbable by any route of exposure

because of their molecular size. As

stated earlier in this unit, polymers with

a number-average MW of less than

10,000 daltons, in general, can be

expected to be absorbed by the lung and

therefore have different detoxification

mechanisms available to mitigate

potential health hazards.

In the 1993 proposal, EPA proposed

as a condition of the exemption that the

submitter evaluate the potential for

inhalation exposure to respirable

particles of water-insoluble polymers

and, if warranted, provide adequate

notification and appropriate protective

measures to exposed workers. At that

time, EPA had expressed concern for

potential health effects that may be

caused by inhalation of respirable

particles of water-insoluble high MW

polymers of 10,000 daltons or greater

based on section 8(e) data which are

discussed below. In the 1984

exemption, the Agency also discussed a

similar concern for potential health

risks but in the preamble to the 1984

final polymer exemption rule, EPA

concluded that such exposure to

polymer particulates was generally

limited and expected to be of low risk

[49 FR 46082, November 21, 1984].

Following publication of the 1993

proposal, the Agency received

numerous adverse comments regarding

EPA’s proposed conditions on this

category of high MW polymers which,

as a class in general, is considered to be

one of the safest categories of chemicals

in commerce.

To address these comments, the

Agency reviewed in detail its

experience with polymers in the New

Chemicals Program and in particular reexamined its database of polymers

submitted under the 1984 polymer

exemption rule to determine what

percentage of these polymers afforded

the potential for inhalation exposure. In

particular, the Agency examined 553

polymer exemption notices received

since 1991 and found that of the 18

polymers that fit the proposed

exemption criteria for water-insoluble

polymers, only 1 polymer presented a

possible inhalation risk based on

particle size and use considerations.

The exemption application for this

polymer was converted to a PMN to

allow a full review in the 90–day PMN

review process. The Agency’s review

did not result in a finding that the

manufacture, processing, use, or

disposal of the polymer ‘‘may present’’

an unreasonable risk to human health

and the polymer was dropped from

further review. In view of the Agency’s

experience over the last 3 years and its

judgment that exposure patterns will

not change appreciably, the Agency has

concluded that there is an exceedingly

low probability that potential exposure

to high MW water-insoluble polymers,

as a class, will result in unreasonable

risk of injury to human health or the

environment. In the 1993 proposal, EPA

stated that it received TSCA section 8(e)

data, designated 8(e)–0668, reporting

irreversible lung damage linked with

inhalation of respirable particles of

water-insoluble polymers with MW of

70,000 daltons or greater. Of these data,

the central study was contained in

section 8(e)–0668. The subject chemical

was a toner used in copy machines. This

submission included chronic inhalation

studies in both rats and hamsters and

concluded that both species suffered

similar lung damage when respirable

dusts were inhaled at levels that also

produced ‘‘lung overloading.’’ In

addition, studies were performed on

clearance rates that demonstrated that

impaired clearance occurred without

regard to particle concentration once

overloading had taken place. Other

section 8(e) data on water-insoluble

high MW polymers did not include

chronic studies, but were shorter term

studies that resulted in a similar type of

lung damage. The 1993 proposal

contains a full discussion concerning

these data and the issues the data raised

for the Agency.

In the 1993 proposal, EPA proposed

an exposure level for respirable polymer

dust of 0.5 mg/m3 as an 8–hour time

weighted average to provide an

adequate margin of safety given the

Agency’s interpretation of the section

8(e) data and believed that this level

was technologically feasible. EPA

assumed that most companies would be

in compliance with the Occupational

and Safety and Health Administration’s

(OSHA) existing Permissible Exposure

Limit (PEL) for respirable Particulates

Not Otherwise Regulated (PNOR), as an

8–hour time weighted average of 5 mg/

m3 and that EPA’s proposed lower limit

of 0.5 mg/m3 could be attained through

additional engineering controls, work

practices, good housekeeping practices,

or different respiratory protection.

While EPA is not imposing conditions

on this category of high MW polymers

as part of the final rule, the Agency

believes that manufacturers and users of

polymers and chemical substances, in

general, where feasible should take

appropriate action to mitigate exposure

to all respirable particles. In addition,

EPA has raised the general issue of

particulate inhalation exposure to the

attention of the ‘‘ONE’’ Committee,

which is an intra-agency committee of

OSHA, National Institute for

Occupational Safety and Health, the

Mine Safety and Health Administration,

and EPA representatives, formed in

1988 as a focal point for coordination

and information exchange related to

occupational issues. When further

research is conducted in the area of

particulate inhalation exposure and the

data gaps are addressed (see ‘‘Inhalation

Toxicity of High Molecular Weight

Polymers, Workshop Proceedings, by

Technical Resources, Inc., 1993), EPA

may refine the eligibility criteria further

for the polymer exemption or may

impose new restrictions, if necessary.

Comment. The American Fiber

Manufacturers Association (AFMA)

comments that it was unwarranted to

impose restrictive evaluation criteria for

products based on the limited data

available. AFMA stated that since EPA

has already restricted the introduction

of polymers containing chemically

reactive groups and water-absorbing

polymers, the remaining polymers

should not present any special hazard

dependent solely upon MW. This

restriction should be eliminated.

Response. As stated previously, EPA

has concluded that there is an

exceedingly low probability that

potential exposure to high MW waterinsoluble polymers as a class will result

in unreasonable risk of injury to human

health or the environment.

Consequently, the final rule does not

impose restrictive evaluation criteria on

this class of polymers.
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16323

Comment. AFMA commented that the

1991 EPA workshop on Inhalation

Toxicity of High MW Polymers

recommended against using MW as a

predictor of inhalation toxicity, stating

that the workshop concluded that

knowledge of MW alone does not

provide enough information about the

material for use in predicting inhalation

toxicity and that lung toxicity seen in

animals with excessive lung burdens of

high MW polymers is likely the result

of a particle overload mechanism. The

Workshop did not believe there is a

relationship between MW and particle

overloading that would justify use of

MW for the proposed criteria

determinant.

Response. The Workshop was

advisory in nature and the opinions of

the participants are not necessarily

those of EPA. Nevertheless, EPA has

reconsidered its own experience with

such polymers and the available data for

water-insoluble polymers and

concluded that the proposed MW

criteria were unduly limited and its

reliance on MW as a restricting factor is

unnecessary. Therefore, the limitation

on water-insoluble polymers has been

removed.

Comment. AFMA cited a report

(attached to AFMA’s comments) where

polypropylene fibers were tested in

subchronic inhalation studies. Under

the conditions of the study, these high

MW water-insoluble polymers are not

fibrogenic, yet would be needlessly and

improperly regulated by EPA as

proposed.

Response. The report cited by AFMA

is a 90–day inhalation study of

polypropylene fibers, not respirable

particulate dust. The toxicity of fibers

involves factors such as length and

diameter which are unique to fibers and

not applicable to respirable dust. The

study therefore, has limited relevancy to

the polymer exemption criteria.

Comment. AFMA states that data filed

under TSCA section 8(e) HQ– 0487–

0668 and section 8(e) HQ–0983–0492 S

both involve polymers which fall below

the proposed 10,000 MW cut-off. Both

polymers appear to be biologicallyactive (acutely toxic) with reactive

functional groups associated with them,

rendering each ineligible for PMN

exemption regardless of their MW. In

both cases, MW would be an

inappropriate primary determinant of

toxicity.

Response. EPA agrees that these

polymers would not be eligible for the

exemption under the criterion which

restricts reactive functional groups.

Further, these studies were not used by

the Agency in assessing concerns for

high MW water-insoluable polymer.

Comment. AFMA stated that data on

the pulmonary toxicity of xerographic

toner, as filed in TSCA section 8(e)HQ–

0487–0668, should not be used in

determining polymer toxicity criteria.

The ‘‘toner’’ tested was a mixture of

materials, not a single polymer.

Approximately 10 percent of this

mixture is reported to be carbon black.

EPA should defend its rationale for

including this mixture in the database

for water-insoluble polymers. AFMA

contends it is inappropriate for EPA to

restrict use of an entire class of

polymers based on extrapolation of the

results of a toxicity study on a mixture.

Response. It is EPA’s understanding

that the carbon black was encased in the

polymer and therefore not bioavailable.

Only the polymer was available for

contact with the experimental animal.

Thus EPA does not consider the carbon

black to be a factor in the toxicity

described in TSCA 8(e)HQ487–0668. As

discussed previously in this unit and in

the preamble to the proposed rule, EPA

did not rely solely on this particular

study but also considered other data

albeit shorter term studies. Based on

EPA’s experience in evaluating

polymers as discussed above, EPA has

decided to proceed as described in this

rulemaking.

Comment. AFMA states that the

inhalation data on super-absorbent

polymers are inappropriate for use in

determining exemption criteria in the

water-insoluble polymer section of the

proposed rule. It appears that TSCA

section 8(e) filings reporting pulmonary

toxicity [as reported hazardous in

8(e)HQ–0382–0438 S, section, 8(e)HQ–

0683–0484 S, 8(e)HZ–1291–1795, and

FYI–OTS–1285– 0470] were used by

EPA to propose conditions on waterinsoluble polymers as part of the

exemption. However, EPA has not

provided relevant data to show that

similar pulmonary toxicity would occur

in water-insoluble and water-absorbent

polymers. Accordingly, AFMA believes

it inappropriate for EPA to use toxicity

data obtained from water-absorbent

polymers in a manner that affects the

exemption eligibility of water-insoluble

polymers. AFMA believes that in the

absence of adequate supporting data,

these polymers should be treated as

nuisance particulates.

Response. EPA agrees that use of the

data on super-absorbent polymers are

not appropriate for use in determining

exemption criteria for water-insoluble

polymers. Further, in its proposal, EPA

did not use the data on super-absorbent

polymers in determining exemption

criteria of water-insoluble polymers.

Comment. Elf Atochem commented

that by setting a 0.5 mg/m3 dust

concentration level (a factor of 10 less

than OSHA’s PEL of 5 mg/m3), the

acceptability of new polymers would be

greatly reduced. To maintain

consistency between Federal agencies,

EPA should raise its workplace

exposure level to be consistent with the

OSHA standard. In addition, Exxon

commented that the imposition of

inhalation standards that are

inconsistent not only with OSHA PEL

levels but with existing polymers

creates yet another disincentive for

pursuing polymer exemptions.

Response. EPA agrees that

consistency among Federal regulations

regarding workplace exposure is

desirable. EPA has elected not to

establish an exposure limit for

respirable particles at this time for

reasons given above. However, TSCA

provides authority to ‘‘protect human

health and the environment’’ and

authorizes EPA to establish limits on

worker exposure for new chemical

substances where such exposure may

present an unreasonable risk of injury to

human health. EPA has removed the

proposed limitations on water-insoluble

polymers for the reasons stated above.

However, the Agency believes that

manufacturers and users of polymers

and other chemical substances should

take appropriate actions to mitigate

exposure to all respirable particles as

part of good industrial hygiene

practices.

c. Polyester polymers manufactured

solely from reactants listed at

§723.250(e)(3). The Agency has had

sufficient experience in reviewing

polymer exemption notices for polyester

polymers that are prepared using

reactants specified in the 1984

exemption rule that the Agency does not

believe such polymers present an

unreasonable risk of injury to human

health or the environment. Accordingly,

these polyester polymers continue to be

eligible for exemption. As discussed in

the 1993 proposal, EPA is deleting

footnote No. 2 in §723.250(e)(3), which

is no longer applicable, because under

the final rule all monomers and

reactants used to manufacture the

polymer must be on the TSCA

Inventory.

There are many polyester polymer

reactants that are not included in the

1984 polyester exemption list, and the

Agency requested comments on

expanding the list of potential polyester

reactants. Several companies identified

reactants for Agency review. Agency

scientists, using structure-activity

relationships and their expert judgment,

evaluated the candidate reactants and

identified no health or ecological

concerns for these reactants. Based on
16324 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

the Agency’s evaluation, the following

substances have been added to Table 1

of this regulation: canola oil; castor oil

fatty acids; dehydrated castor-oil fatty

acids; C16–18 and C18–unsatd. fatty acids;

C18–unsatd. fatty acids, dimers; oxidized

linseed oil; conjugated sunflower oil

fatty acid; C16–18 and C18–unsatd.

glycerides; butanedioic acid, dimethyl

ester; butanedioic acid, diethyl ester;

pentanedioic acid, dimethyl ester;

pentanedioic acid, diethyl ester;

hexanedioic acid, dimethyl ester;

hexanedioic acid, diethyl ester;

heptanedioic acid; heptanedioic acid,

dimethyl ester; octanedioic acid;

octanedioic acid, dimethyl ester;

nonanedioic acid, dimethyl ester;

nonanedioic acid, diethyl ester;

decanedioic acid, dimethyl ester;

undecanedioic acid; dodecanedioic

acid; diethyl terephthalate; dimethyl

terephthalate; dimethyl isophthalate; 2-

methyl-1,3-propanediol; diethylene

glycol.

One reactant, terephthaloyl chloride

[CASRN: 100–20–9], was not approved

for inclusion in the list of reactants

because the Agency does not believe it

has had sufficient experience with the

reactant or ones of this type. The

Agency has decided not to include the

following substances in the list of

eligible reactants for polyester because

they are not on the TSCA Inventory:

heptanedioic acid, diethyl ester

[CASRN: 2050–20–6]; octanedioic acid,

diethyl ester [CASRN: 2050–23–9];

undecanedioic acid, dimethyl ester

[CASRN: 4567–98–0]; undecanedioic

acid, diethyl ester [CASRN: 22543–29–

9]; dodecane-dioic acid, dimethyl ester

[CASRN: 1731–79–9]; dodecanedioic

acid, diethyl ester [CASRN: 10471–28–

0].

Comment. CMA commented that the

list of eligible reactants for polyester

polymers under the 1984 rule is

extremely limited, that many analogous

polyols and acids on the Inventory are

worthy of inclusion, and that in practice

polyesters are often made from esters

rather than acids. CMA, Arco, and

Eastman proposed expanding the list to

include a number of additional

substances. CMA, Arco, Dow, Quantum,

and Rohm Haas recommended that EPA

develop and publish procedures for

periodic updating of the ‘‘approved’’

reactants list.

Response. The Agency agrees with the

general tenor of the comments and notes

that the original ‘‘approved’’ reactants

list was compiled from suggestions

submitted by manufacturers, after

review by Agency scientists. The

Agency believes that it would be

appropriate in the future to propose

amendments to this section to allow

expansion of the list of eligible

precursors, when additional candidates

have been identified. To support

requests for additional reactants,

petitioners should provide health and

environmental effects information on

the candidate reactants, which must be

already on the Inventory.

5. Determination of eligibility. The

Agency believes that, when a polymer is

manufactured under the terms of the

exemption, it is reasonable for the

manufacturer to take on a greater burden

to demonstrate eligibility than under the

1984 exemption because EPA is

eliminating its premanufacture review

of these polymers. Under the 1984

exemption, the Agency did not require

that submitters perform analytical

measurements of the physical and

chemical properties of polymers, but

allowed manufacturers to determine

compliance with the exemption

conditions on whatever basis the

manufacturer deemed appropriate.

These included using past experience

by correlating observed or measured

values of the properties of similar

polymers to the polymer in question,

using stoichiometric relationships based

on knowledge of the starting materials

and expected reactions, or using

knowledge of process and purification

steps.

Under the final rule, the Agency will

no longer receive and review exemption

notices prior to manufacture or import

of exempted polymers nor verify a

polymer’s eligibility under terms of the

exemption. Consequently, the

manufacturer must take the steps

necessary to ensure that a chemical

substance is eligible for exemption.

Therefore, the Agency is requiring that

a manufacturer generate appropriate

records and data to demonstrate that a

substance meets the eligibility criteria

set forth at §723.250(e) to ensure

compliance with the exemption.

The final rule requires manufacturers

of exempt substances at §723.250(e)(1)

and (e)(2) to generate appropriate

analytical data, if applicable, or

theoretical calculations if it can be

documented that an analytical

determination can not be made or is not

necessary, to demonstrate that the

polymer meets the minimum number

average MW and corresponding

restrictions on oligomer content. The

Agency has not specified a particular

analytical method to demonstrate

compliance with the eligibility criteria,

but allows the manufacturer to use an

appropriate method of analysis that

generates the data to verify compliance

with the criteria, such as gel permeation

chromatography or vapor pressure

osmometry. Performance of such

analysis is required prior to

commencement of manufacture or

import in accordance with the

exemption. A number of commenters

stated that manufacturers were

concerned about the requirement to

generate updated analyses and

documentation to demonstrate that a

given polymer continues to qualify for

the exemption whenever a

manufacturing process change occurs

that could possibly cause the polymer to

not meet the exemption criteria.

Although the manufacturer is not

required to generate updated analytical

data on the exempted polymer under

the final rule, EPA expects that if

conditions, such as reaction temperature

or sources for feedstock change,

manufacturers will take steps to

determine the effect of such a change so

as to ensure continued compliance with

the exemption. Obviously, if a new

chemical substance is generated during

subsequent manufacture, the

manufacturer would be required to be in

compliance with all the section 5

provisions.

Manufacturers are expected to follow

the provisions of the exemption for

research and development (R&D)

activities during the period of

evaluation of eligibility of a substance

under the exemption criteria prior to

actual manufacture under the

exemption provisions. Such R&D

activities will be subject to the R&D

procedural and recordkeeping

provisions in the PMN rule at 40 CFR

720.36 and 720.78, respectively. To

enhance compliance with the criteria,

EPA is publishing a draft technical

guidance document for this rule and

will hold a series of workshops on these

criteria to facilitate understanding and

compliance with this exemption.

6. Reporting requirements. The

proposed rule would have required that

a notice be filed with EPA within 30

days after manufacture or importation

for commercial purposes instead of 21

days prior to manufacture of an eligible

polymer as under the current

exemption. The Agency also solicited

comment on a ‘‘no reporting’’ option for

this category of substances. In light of

the Agency’s determination that this

class of polymeric substances will not

present an unreasonable risk of injury to

human health or the environment if

manufactured under the criteria

specified in this rule, and in the

interests of reducing the reporting

burdens for both industry and EPA, the

final rule will require only annual

reporting on polymers for which

manufacture or importation under terms

of the exemption has commenced for

the first time during the preceding
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16325

calendar year. This reporting

requirement will allow EPA inspectors

to determine which companies have

manufactured polymers under the

exemption thereby allowing them to

ensure compliance with the provisions

of this rule during site inspections. The

final rule requires that a company file a

polymer exemption report to EPA,

postmarked by January 31, that includes

all chemical substances for which

manufacture or importation commenced

under the terms of the exemption during

the preceding year [§723.250(f)]. Such

report must include submitter identity

information including company name

and address, a technical contact (a

person available in the United States)

and telephone number, and the number

of eligible substances for which

manufacture commenced under the

terms of the exemption during the

previous calendar year.

A company may decide to report by

plant site instead of submitting a single

company report which consolidates

reporting on the number of polymers

manufactured for the first time under

terms of the exemption; however,

reporting on the number of polymers

manufactured under the exemption

should not be duplicated. EPA believes

that an annual report on the number of

polymers being manufactured for the

first time under terms of the exemption

will alleviate industry’s reporting

burden by reducing the information

submission requirements while

providing EPA with a direct mechanism

for monitoring compliance. This type of

reporting will also provide a useful

measure of the utility of the polymer

exemption.

7. Chemical identity information. As

discussed above, an exemption notice is

no longer required under the final rule.

However, manufacturers of polymers

under terms of the exemption are

required to maintain certain information

at the site of manufacture, including

chemical identity and a structural

diagram, to the extent known or

reasonably ascertainable, as specified at

§723.250(g). The 1993 proposal, if

adopted, would have required a

Chemical Abstracts (CA) Index Name or

CA Preferred Name, CAS Registry

number (or EPA Inventory accession or

PMN number) for each reactant used at

greater than 2 percent (by weight) to

manufacture the polymer, or

alternatively, incorporated at greater

than 2 percent (by weight) in the

polymer. Although the Agency

encourages the use of CA nomenclature,

the final rule does not require CA

nomenclature since polymers

manufactured under terms of the

exemption will not be placed on the

TSCA Inventory. For purposes of

determining chemical identity, the

manufacturer may determine whether a

reactant is used or incorporated at

greater than 2 percent (by weight).

However, as discussed earlier in unit II

B.2(d) of this preamble, reactants that

introduce into the polymer elements,

properties, or functional groups that

would render the polymer ineligible for

the exemption are not allowed. The

‘‘two percent rule’’ affects only the

polymer’s identity, not its eligibility

under the exemption criteria.

Under the final polymer exemption

rule, the manufacturer is required to

maintain appropriate analytical data or

other supporting information to

demonstrate that the exempted polymer

meets the specific number-average MW

and restricted oligomer content criteria

at §723.250(e)(1) or (e)(2), as discussed

under unit II.B.5 of this preamble. The

final rule allows the company to make

the polymer with MW ranges, or

residual reactant concentrations, etc., as

the company desires, provided that

these values fall within the exemption

criteria.

8. Certification. The final rule retains

provisions that require that the

manufacturer of an exempt polymer, as

of the date of first manufacture, certify

that the polymer meets the definition of

a polymer, is not specifically excluded

from the exemption, and meets the

conditions of the exemption

[§723.250(h)(3)]. Certification

statements must be retained with the

other required records at the

manufacturing or import site.

9. Recordkeeping. EPA believes that

recordkeeping requirements are an

essential component of an effective

exemption enforcement program and

has retained this provision in the final

rule at §723.250(j), while including

some additional provisions proposed in

1993 since EPA will no longer receive

exemption notices. These additional

provisions include certification

statements, chemical identity

information, and analytical data, as

discussed in this unit. Documentation of

information would be used by

enforcement personnel to determine

compliance with the rule. The

recordkeeping requirements have been

amended to require that the

manufacturer maintain certain

information at the site of manufacture or

the site of import.

Comment. Some commenters

suggested that the present

recordkeeping requirements for the

polymer exemption would be adequate

to ensure industry compliance.

Response. Since the Agency will not

conduct any premanufacturing review

of exempted polymers, EPA believes

that it is important for manufacturers to

develop and maintain more detailed and

comprehensive records than are

required by the current polymer

exemption. EPA believes that the

recordkeeping requirements are

necessary to ensure that manufacturers

are able to demonstrate compliance by

documenting that the exempted

polymers meet the eligibility criteria.

10. Inspections. The Agency will

continue to periodically inspect

companies to ensure compliance with

TSCA section 5. Those companies with

past violations may be inspected more

frequently. To determine compliance

with the polymer exemption, the EPA

inspector will focus on the information

in the company’s records, including the

analytical data documenting the

substance’s eligibility under the

exemption.

11. Deletion of proposed revocation

provisions. The 1993 proposal

contained provisions to allow EPA to

revoke the exemption for an exempted

polymer and require a full PMN review

if EPA obtains information indicating

that a particular polymer or category of

polymers may present an unreasonable

risk of injury to human health or the

environment.

The Agency has determined, for the

reasons outlined below, to delete the

proposed revocation provision in its

entirety. When the Agency proposed

amendments to the polymer rule in

1993, development of the revocation

provisions was predicated on EPA’s

evaluation of the section 8(e) data on

certain high MW water-insoluble

polymers previously discussed in this

unit. EPA believed it was prudent, given

its evaluation of the data at the time of

the proposal, to ensure it had a

mechanism in place to identify eligible

polymers which may pose an

unreasonable risk of injury to human

health or the environment. Specifically,

the Agency was concerned that

additional section 8(e) data or other

adverse data would be received which

might compromise the ability of the

Agency to prevent unreasonable risk of

injury to human health or the

environment in a timely fashion.

The Agency received numerous

comments reflecting general

dissatisfaction with the proposed

revocation provisions. Specifically, the

comments received by the Agency, both

in writing and in conjunction with the

public hearing on the proposed rule,

were as follows:

(1) The provisions do not provide

recourse for the submitter and allow

insufficient time for objections to be

lodged with the Agency;
16326 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

(2) The provisions will discourage

many companies from developing new

products;

(3) Specialty chemical companies in

particular would not be as willing to

develop new products under the threat

that they would be banned from the

marketplace;

(4) The revocation provisions of the

proposal reduce the commercial

acceptability of the exemption process

and business managers will prefer the

stability and certainty of clearance

through submission of a PMN, rather

than risk potential business

interruptions under the terms of the

proposed exemption; and

(5) The provision will threaten the

utility of the entire exemption

procedure as a vehicle for reducing the

number of PMNs that are filed for

substances that pose no reasonable

likelihood of harm to health or the

environment.

Based on consideration of these

adverse comments and in light of the

Agency’s conclusion that the likelihood

of eligible polymers posing an

unreasonable risk is low, the Agency

has determined that these provisions are

not necessary to support the Agency’s

statutory finding that polymers

manufactured under terms of the

exemption will not present an

unreasonable risk of injury to human

health and the environment. Should

evidence be received by the Agency that

casts reasonable doubt on the

appropriateness of a criterion or set of

criteria, the Agency has other regulatory

options available, such as publication of

a proposed amendment to the polymer

exemption rule to either refine the

criteria or impose new restrictions,

similar to EPA’s treatment of waterabsorbing high MW polymers in this

rulemaking. Specifically, EPA proposed

an amendment to the 1984 exemption

that would exclude this category of

polymers from eligibility for the

exemption based on the Agency’s

evaluation of certain section 8(e) data as

discussed in unit II.B.2(e) of this

preamble. After publishing its 1993

proposal and providing an opportunity

for public comment, the Agency

amended the 1984 exemption in this

rulemaking to exclude high MW waterabsorbing polymers from eligibility.

Similarly, any future proposed revisions

would also be subject to notice in the

Federal Register and comment in

accordance with the Administrative

Procedure Act.

12. Inventory status of exempted

polymer. Polymers that were reviewed

under the terms of the 1984 polymer

exemption rule and included on the

Inventory will remain on the Inventory,

with the restrictions concerning low

MW species content and maximum

residual amounts of reactants specified

for each exempted polymer still in force.

Polymers manufactured under the

amended exemption will not be

included on the Inventory. A number of

commenters argued that exempt

polymers warrant inclusion on the

TSCA Inventory, since customers rely

on Inventory listings to confirm a

product’s regulatory compliance. Since

the Agency will not be receiving

information on the chemical identity of

the exempted polymer as part of the

reporting requirement, the Agency will

not have a mechanism for including

exempted polymers on the Inventory.

However, the Agency recognizes that it

is essential that manufacturers have an

adequate method to assure their

customers that their products are in

compliance with TSCA regulations and

agrees that an Inventory listing of the

substance would simplify this process.

Under the final rule, an exempted

polymer remains a new chemical

substance (although legitimately

manufactured under terms of the

exemption) until a PMN has been

submitted for the substance and has

completed the PMN review period,

followed by manufacture for nonexempt commercial purpose and

subsequent NOC. Nonetheless, it is

current practice that manufacturers

employ a variety of methods to assure

customers that a chemical substance is

in compliance, particularly in situations

where the Agency does not include an

exempted substance on the Inventory, as

is the case for low volume, test

marketing, and R&D substances. Since

the Agency will neither be receiving

notices for exempted polymers nor

providing receipt numbers (similar to

the status of R&D substances),

manufacturers who use this exemption

should rely on practices similar to ones

currently used for R&D substances.

These include appropriate labeling and

reference to the polymer exemption rule

at 40 CFR 723.250 and this Federal

Register document. A company might

also consider setting up a system for

identifying exempted polymers which

relates back to the exemption and use

this identification code to identify

polymers in any commercial activity or

Material Safety Data Sheet (MSDS).

The Agency believes that use of the

polymer exemption provides significant

benefits to polymer manufacturers for a

number of reasons discussed in this

document. Moreover, polymers

manufactured under this exemption

have been identified by EPA as some of

the least hazardous substances in

commerce. In light of pollution

prevention and product stewardship

initiatives undertaken by the regulated

community, the Agency believes that

the marketing of safer chemical

substances should enhance the

commercial viability of these

substances.

Comment. CMA states that customers

rely on TSCA Inventory listings to

confirm a product’s regulatory

compliance. Elf Atochem argues that

inclusion on a separate list leaves the

regulatory status of exempt polymers

rather ambiguous.

Response. As discussed above, the

Agency believes that manufacturers who

use the exemption will be able to

develop adequate methods of assuring

their customers that these polymers are

not only in compliance with TSCA

regulations but meet the Agency’s lowrisk criteria.

13. Transition period until final rule

becomes effective. The Agency will

continue to accept and review polymer

exemption applications under the terms

of the 1984 exemption at 40 CFR

723.250 until the effective date of this

final rule. No new exemption

applications will be accepted after the

effective date of this rule.

If a manufacturer who submitted a

polymer exemption application under

the 1984 exemption rule but has not yet

submitted a NOC wishes to add its

polymer to the Inventory, the person

may submit the NOC in accordance with

40 CFR 720.102. The exempt polymer

will then be listed on the Inventory with

the applicable 1984 polymer exemption

criteria and exemption category

restrictions on residual monomers/

reactants and low MW species content.

The manufacturer may instead choose to

manufacture under the terms of the new

exemption.

III. Response to Other Alternatives

Considered

EPA requested comments and data on

all aspects of the 1993 proposal,

including the following specific issues

discussed below:

Other Polymers Considered for

Exemption

1. Polymer salts. The Agency has also

considered a proposal to exempt certain

salts of polymers that are listed on the

TSCA inventory but was unable to make

the determination that, as a class, all of

these polymers will not present an

unreasonable risk of injury to human

health or the environment. However,

EPA believes that many individual

polymer salts will be eligible for

exemption under the amended criteria.
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16327

2. Polymers containing high cationic

functional group. The Agency

considered allowing, under the

exemption, polymers which contain

high percentages of amine (low amine

equivalent weight) in their structures

but decided against this approach.

Accordingly, polymers with high

cationic functional groups continue to

be subject to the restrictions under

§723.250(d)(1) for the following reason.

In the past, the main concern for

cationic polymers was for ecotoxicity,

specifically, aquatic toxicity. There has

been a significant amount of data

generated by industry in response to

section 5(e) consent orders or on a

voluntary basis, which after EPA

review, was concluded to demonstrate

that for the category of polymers with a

high amine or cationic content,

equivalent weight of 425 daltons or less,

there is sufficient mitigation of the risk,

through the mechanism of dissolvedorganic-carbon (DOC), to render this

polymer class of low risk for ecotoxicity

if used according to current standard

practices. The Agency believes that

these data sufficiently support the

conclusion that high amine content

polymers, as specified above, will not

pose an unreasonable risk of injury for

aquatic toxicity.

However, as discussed in the 1993

proposal, EPA received section 8(e) data

on a polymer with high cationic

functional group content in which test

results demonstrated lethality in

standard eye irritation tests in rabbits.

This study has resulted in high concerns

for acute lethality as demonstrated by

this polymer. The polymer used in the

study met all provisions of the proposed

polymer exemption and would have

qualified for exemption if the low

cationic functional group equivalent

weight (high cationic content) provision

was incorporated as part of the

exemption criteria. It is for this reason

that EPA believes that it would be

inappropriate to include the high

cationic functional group content

allowance in the final rule at this time

and will continue to restrict these

polymers under the final rule.

Comment. One commenter stated that

the exclusion of the polymers with high

cationic functional group content is

based upon the assumption that all high

cationic charge polymers have similar

physical-chemical, steric, structural and

toxicological properties and that the

concern should be more focused on the

class of polymers that cause the adverse

effect.

Response. The Agency agrees that it

may be more appropriate to use the

definition of the class of cationic

polymers to exclude the polymers of

concern from the exemption in lieu of

the broader-based exclusion. However,

this preliminary assessment is based on

section 8(e) data that are claimed as CBI.

(At the time of the proposal, EPA

believed that it would be able to resolve

the CBI claim in a way that would allow

the public an opportunity to comment

on the data.) To date, the submitter of

the 8(e) data has declined to rescind the

CBI claim on the chemical structure

despite repeated requests. Nor were

publicly accessible data received during

the comment period that support

narrowing the category of polymers

excluded from the exemption.

Therefore, because the public has not

had an opportunity to comment on the

basis for such an exemption and in

order not to delay issuance of this final

rule until the CBI issues can be

resolved, the Agency has elected not to

include a more narrow category in this

rulemaking. The Agency may continue

discussions with the submitter of the

section 8(e) data and amend this section

as appropriate in the future.

IV. Regulatory Analysis

A. Summary of Risk Assessment

1. Introduction. The Agency has

determined that polymers defined by

the exemption criteria set forth in this

rule are of low concern due to their lack

of reactivity and their molecular size.

These criteria have been developed

based on the Agency’s review of over

5,000 polymer submissions since the

original polymer exemption rule in 1984

(49 FR 46066). The Agency believes that

polymers eligible for this exemption are

generally of low risk and that sufficient

information exists on the potential risks

of other polymers with certain

characteristics to make them ineligible

for the exemption.

2. Approach to risk analysis. The

Agency based its risk analysis on (a) the

effect MW has on the overall risk a

polymer poses, (b) the specific concerns

the Agency has had in the past for

polymers submitted as PMNs, (c)

toxicological data available on

particular polymers, (d) an analysis of

the Agency’s database on over 500

polymers received in the last 3 years

under the current polymer exemption to

determine the potential for exposure to

respirable particles of insoluble high

MW polymers, and (e) an analysis of the

Agency’s experience to date in assessing

potential risks of new polymers

submitted as PMNs or exemption

applications. The 1993 proposal

contains an extensive discussion of the

Agency’s approach and limitations to

that approach. The proposal also details

EPA’s extensive evaluation of

ecotoxicity considerations for polymers.

The discussion below is limited to an

analysis of the inhalation toxicity

concerns associated with exposure to

respirable polymeric particles.

3. Inhalation toxicity. As discussed in

the 1993 proposal, health concerns exist

for certain types of polymers that have

been found to produce lung toxicity if

inhaled. Based on section 8(e) data on

a water-absorbing polyacrylate polymer

with a MW in excess of 1 million

daltons that indicated a potential

oncogenic (cancer) concern for this type

of high MW water-absorbing polymer,

the Agency has excluded waterabsorbing polymers of MW equal to or

greater than 10,000 daltons from the

exemption. Other section 8(e) data on

high MW water-insoluble polymers

were indicative of a lung-overload

phenomenon and did not demonstrate

any carcingenic response under

conditions of the studies. Please consult

units II.B.4(b) and IV.C of this preamble

and the preamble to the proposed rule

for a full discussion of this issue.

The final rule does not impose a

condition in the exemption on high MW

water-insoluble polymers linked to the

evaluation of the potential for inhalation

exposure to respirable particles as was

contemplated in the 1993 proposal.

Based on numerous comments received

on these proposed limitations on high

MW water-insoluble polymers, the

Agency reevaluated the existing

scientific data and its own experience in

reviewing the potential for inhalation

exposure to such polymers submitted

under the current polymer exemption.

Based on these analyses, EPA has

determined that there is an exceedingly

low probability that potential inhalation

exposure to high MW water-insoluble

polymers, as a class, will result in

unreasonable risk of injury to human

health or the environment. This

conclusion reaffirms EPA’s finding at

the time of promulgation of the 1984

exemption that exposure to polymer

particulates was generally limited and

expected to be of low risk.

Based on over 15 years experience

with polymers, EPA considers that the

criteria set forth in this exemption

define polymers of low-concern and that

the potential risk from respirable

particles of high MW water-insoluble

polymers is low. Therefore, the Agency

has not retained in this rulemaking the

requirement that companies evaluate

the potential for inhalation exposure to

respirable particles for this specific

category. However, EPA believes that as

part of responsible health and safety and

product stewardship programs in

general, manufacturers and their

customers should be aware of the
16328 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

potential for toxicity from any respirable

particle and when producing or using

such materials take measures to keep

their workplace free of respirable dusts

of any type.

B. Summary of Regulatory Impact

Analysis

EPA has evaluated the potential costs

of the final amendments for potential

manufacturers of exempt polymers. The

Agency’s complete economic analysis is

available in the public record for this

rule (OPPTS–50594B).

The regulatory impact analysis

estimates the costs and benefits

attributable to the final regulation. In

this case, the analysis also contains

estimates for the three additional final

amendments to section 5 regulations

that are published elsewhere in this

Federal Register. These rules amend the

PMN regulations, the Low Volume

Exemption Rule, and the Expedited

Process for Issuing Significant New Use

Rules. Because these final regulations

are amendments to current regulations,

the costs and benefits are incremental

and estimate the effect of the final rule

with respect to the current regulations.

The costs and benefits associated with

the polymer exemption amendments are

partially quantified; many of the

benefits are unquantified but are

expected to be of significant importance

as discussed later in this unit.

Considering only the quantified costs

and benefits, there is a cost saving.

Since the number of section 5

submissions received by the Agency

varies, this analysis used three

scenarios, assuming either 1,000, 2,000,

or 3,000 annual submissions, to reflect

the expected range of submissions. The

savings as compared to the current

regulation are estimated to be:

Annual Number

of Submissions

Annual Cost Savings

($ Million)

Industry Government

1,000 ................ 4.7 – 6.8 0.2 – 0.4

2,000 ................ 9.4 – 13.5 0.4 – 0.8

3,000 ................ 14.2 – 20.3 0.6 – 1.2

The industry costs associated with

these amendments are labor

requirements for preparation of an

annual report and recordkeeping costs.

Reporting and delay costs are

eliminated due to the elimination of

submission requirements. The user fee

is no longer applicable since exemption

notices will not be required. Moreover,

the amendment makes a larger number

of polymers eligible for the exemption,

further reducing the reporting and delay

costs for those substances.

The unquantified benefits include

increased flexibility for industry due to

the expanded exemption criteria. In

addition, Agency resources will be

focused on those substances more likely

to pose an unreasonable risk.

C. EPA’s Approach to Making the No

Unreasonable Risk Finding

1. Statutory background. Pursuant to

section 5(h)(4) of TSCA, EPA is

authorized to exempt the manufacturer

of any new chemical substance from all

or part of the requirements of section 5

if EPA determines that the manufacture,

processing, distribution in commerce,

use, or disposal of the substance, or any

combination of such activities, will not

present an unreasonable risk of injury to

human health or the environment.

Section 26(c) of TSCA provides that any

action authorized under TSCA for an

individual chemical may be taken for a

category of such substances.

While TSCA does not contain a

definition of ‘‘unreasonable risk,’’ the

legislative history indicates that the

determination of unreasonable risk

requires a balancing of the

considerations of both the severity and

the probability that harm will occur

against the effect of the final regulatory

action on the availability to society of

the benefits of the chemical substance

[House Report 1341, 94th Cong., 2nd

Session, 14 (1976)]. This analysis can

include an estimate of factors such as

market potential, the effect of the

regulation on promoting or hindering

the economic appeal of a substance,

environmental effects, and many other

factors which are difficult to define and

quantify precisely. EPA may rely not

only on data available to it, but also on

its professional judgment. Congress

recognized that the implementation of

the unreasonable risk standard ‘‘will

vary on the specific regulatory authority

which the Administrator seeks to

exercise’’ [Ibid.]

2. EPA’s approach. In determining

whether the category of polymeric

substances being considered for

exemption presents an unreasonable

risk of injury to human health or the

environment, the Agency considers

more than just the inherent risks

presented by the overall category of

polymers. The Agency also considers

how the criteria of the exemption

maintain full regulatory oversight on

higher risk polymers while promoting

the manufacture of low-risk polymers by

providing regulatory relief for them.

The amended polymer exemption

modifies the requirements for eligible

polymers from the current polymer

exemption requirements and the general

PMN requirements. EPA therefore

compares the risks posed by the

substances being considered for an

amended exemption with the risks

which would have resulted from the

same category of substances, if that

category of substances had been subject

to full notice submission requirements

and 90–day EPA review or, where

applicable, the reporting requirements

of the current polymer exemption and

the abbreviated 21–day review.

Certainly it is not possible to eliminate

all risks associated with the

manufacture, processing, distribution in

commerce, use, and disposal of any new

chemical substance nor was this

Congress’ intent. The standard

embodied by a section 5(h)(4)

exemption does not require the Agency

to ensure absolute safety from the

activities associated with an exempted

substance.

3. Application of no unreasonable risk

factors. The following is an explanation

of the factors and their analysis relevant

to the no unreasonable risk finding. The

design of the final polymer exemption

together with intrinsic properties of

polymers significantly limit the risks of

injury to human health or the

environment that exempt polymers may

present. Polymers as a general class are

relatively unreactive and, at or above a

MW of 10,000, are not easily absorbed

by body tissue because they do not

easily transport across human

membranes. As originally discussed in

the Agency’s 1984 polymer exemption

rule:

...for a chemical to elicit a toxic response

within an organism, it must come into direct

contact with the biological cells from which

it elicits the response. Because all organisms

are encased in protective membranes, a

chemical must usually penetrate these

membranes and be translocated to various

parts of the organism to gain access to target

sites. Therefore, it can be reasoned that if a

chemical cannot penetrate the protective

membranes to gain access to a target site, it

usually cannot elicit a response in the

organism no matter what inherent potential

it may have to do so. It can be further

reasoned that if a chemical cannot elicit a

response, it will generally not present a risk.

[49 FR 46081 (November 21, 1984].

EPA’s conclusions regarding low risk

potential for polymers that meet the

eligibility criteria are supported by the

available data as well as EPA’s scientific

professional judgment based on 15 years

experience reviewing polymers under

the PMN and current polymer

exemption requirements. Pursuant to

the final rule, certain polymers will be

automatically ineligible for the polymer

exemption. EPA has excluded those

polymers for which: (a) The Agency still

has insufficient data and review
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16329

experience to find that they will not

present an unreasonable risk of injury,

or (b) the Agency has found that, under

certain conditions, based on data on the

polymers in question, a polymer, or

subset of polymers, may present an

unreasonable risk, thereby requiring a

closer examination of the conditions of

manufacturing, processing, distribution

in commerce, use, and disposal during

a full 90–day PMN review. This level of

analysis would be necessary to make an

appropriate determination about risk.

In 1982, when the Risk Analysis and

Evaluation of PMN Regulatory Decisions

for Polymers was performed for the

original polymer rule, the Agency

determined that high MW polymers

containing small amounts of low MW

species were not considered an

unreasonable risk to humans or the

environment. Extensive discussion on

this topic can be found in the 1982

proposed polymer exemption rule and

the preamble to the final rule

promulgated in 1984. The Agency has

assumed that monomers would be of

greater concern than oligomers, and that

oligomers would be of greater concern

than polymers based on the probability

that the monomer would be more

readily absorbed and, on a weight basis,

be more reactive than the resulting

oligomer or polymer. In its 1982

proposal, the Agency proposed to allow

polymers with MW greater than 20,000

daltons to be manufactured without any

premanufacture review by EPA but

determined in the final rule that an

abbreviated review period was

necessary due to concerns for unreacted

monomers and low MW species. The

Agency is now modifying this approach,

based on the review and hazard

assessment of polymers reviewed as

PMNs or polymer exemptions since the

1984 polymer exemption was

promulgated. The Agency now believes

that it has sufficient experience with

high MW polymers such that a ‘‘no

unreasonable risk’’ finding may be made

for a broader class of these substances

without EPA premanufacture review.

Over the past 15 years, the Agency

has reviewed over 10,000 polymers in

the New Chemicals Program (over

approximately 50 percent of all PMNs

are polymers). Of these 10,000, the

polymers that would have qualified for

the final polymer exemption rule have

consistently been characterized as

posing low concern for both adverse

health and environmental risks by the

Agency during the course of PMN

review. The characteristics of a

significant number of polymers (i.e.,

their MW and/or physical/chemical

properties), are such that they are

neither absorbed by biological systems

nor do they interact with biological

systems, as described above. (A more

detailed discussion is provided in the

preambles to the 1984 polymer

exemption and the 1993 proposal.)

Furthermore, these polymers do not

degrade to toxic species in the

environment.

The Agency has developed specific

criteria which define low-risk polymeric

substances. Such criteria include

limitations on low MW species, reactive

functional groups, and cationic

polymers. Many of these criteria are

outgrowths of the criteria used to

determine eligibility under the current

polymer exemption that has been in

effect since 1984. Further, the Agency

uses these same criteria to identify lowrisk polymers in its PMN review

process. The 1984 polymer exemption,

which uses the same types of criteria as

these final exemption criteria to

determine eligibility, required a 21–day

premanufacture review period. The

Agency believes that this review period

for polymers that meet the final

exemption criteria is unnecessary based

on EPA’s finding that these exemption

criteria place sufficient constraints on

risk, such that EPA review of these

eligible polymers would not result in

any additional protection. Accordingly,

exempting polymers that meet the lowrisk eligibility criteria will allow the

Agency to refocus its limited resources

on those non-exempt substances which,

by comparison, may pose a considerable

risk to society.

In its 1993 proposal, the Agency

expressed concern for potential lung

toxicity due to inhalation of respirable

high MW polymers. Toxicity studies, in

the form of section 8(e) submissions on

a water-absorbing high MW polymer

and certain water-insoluble high MW

polymers, indicated two areas of

potential concern with high MW

polymers.

The data set on the water-absorbing

polymer, which is discussed in detail in

unit II.B.2(e) of this preamble, included

a 2-year chronic inhalation study

reporting squamous cell carcinoma and

bronchio-alveolar carcinomas at

concentrations of 0.2 mg/m3 and 0.8 mg/

m3 for the tested polymer, which was a

water-absorbing polyacrylate polymer

having a MW of greater than 1 million

daltons. The tested polymer lacked both

reactive functionalities and low MW

species (below a MW of 1,000 daltons),

factors that could have played a role in

the reported carcinogenicity. In the

absence of these factors, the Agency

concluded that the water-absorbing

properties of the polymer may have

played a role in the reported

carcinogenicity findings. Although the

Agency was unable to establish a link

between MW and toxicity for waterabsorbing polymers, the Agency set the

number average MW exclusion at 10,000

daltons which the Agency believes is a

reasonable value at which absorption is

a sufficiently slow process that a

substance can persist in the lung. This

MW level is also two orders of

magnitude below that of the tested

polymer. At 10,000 daltons and greater,

these water-absorbing polymers are not

likely to be absorbed, so mechanisms for

detoxification which are available for

lower MW polymers may not be

available. Thus the respirable particles

are expected to remain in the lung for

extended periods. As stated earlier in

unit II of this preamble, EPA believes

that polymers with MW less than 10,000

daltons can be expected to be absorbed

by the lung and therefore have different

detoxification mechanisms available to

mitigate potential health hazards. Based

on these findings, the Agency has

determined that exposure to respirable

fractions of these polymers might

present an unreasonable risk to human

health and has excluded waterabsorbing polymers with MW of 10,000

daltons or greater from the exemption

eligibility.

Moreover, in response to comments

requesting a definition of ‘‘waterabsorbing’’ that more accurately defines

this parameter for polymers of concern

and based on further evaluation of the

2-year inhalation study on the

polyacrylate polymer, the final rule

defines a ‘‘water-absorbing polymer’’ as

a polymer capable of absorbing its

weight of water. Although the subject

polyacrylate polymer absorbs

approximately 100 times its weight of

water, the Agency lowered the threshold

for exclusion in this rule to absorbing its

weight of water by using a hundredfold

factor. This definition more accurately

bounds the category of polymers that

the Agency believes should be subject to

the full PMN review process, pending

the development of data that would

mitigate the Agency’s concern. These

two limitations allow the Agency to

conclude that the non-excluded waterabsorbing polymers will not present an

unreasonable risk of injury to human

health. Accordingly, the final rule

defines the term ‘‘water-absorbing’’ and

excludes such polymers with MW of

10,000 or greater from the exemption.

The section 8(e) data on high MW

water-insoluble polymers, which are

discussed in detail in the 1993 proposal,

indicated that inhalation of respirable

particles of certain high MW waterinsoluble polymers resulted in

irreversible lung damage (fibrosis) but,

under the conditions of the study, no
16330 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

carcinogenic response to experimental

animals. Numerous comments received

on this issue questioned the Agency’s

use of a limited set of data to impose

restrictions on an entire class of waterinsoluble high MW polymers that are

generally recognized as polymers of

low-concern. In the proposed rule, the

Agency itself recognized that imposing

conditions under the exemption on high

MW water-insoluble polymers may not

have been appropriate and had

requested comments on the alternative

of imposing no limitations on the

exemption eligibility of this category of

polymers. In light of this and in

response to numerous comments, the

Agency re-examined its proposal to

impose conditions on this category of

high MW water-insoluble polymers.

Please consult unit II.B of this preamble

for an extensive discussion of this issue.

Based on its evaluation of 553

polymers that were the subject of

polymer exemption applications during

the past 3 years, as previously discussed

in unit II.B.4(b) of this preamble, EPA

concluded that there is an exceedingly

low probability that potential exposure

to high MW water-insoluble polymers,

as a class, would result in an

unreasonable risk of injury to human

health or the environment. EPA reached

a similar conclusion during

promulgation of the 1984 exemption

that exposure to polymer particulates

was generally limited and expected to

be of low risk. In its 1984 rule, EPA had

recognized that particulate inhalation

exposure was a potential source of

toxicity which was not explained by

MW, stating then that the review

experience developed in the PMN

program had demonstrated that

exposure to polymer particulates was

generally limited and therefore expected

to be of low concern. 49 FR 46082

(November 21, 1984).

Further, EPA reviewed the section

8(e) data that were the basis of the

Agency’s concern regarding potential

inhalation toxicity of high MW waterinsoluble polymers. The studies on a

toner for copy machines that was a

water-insoluble polymer with a MW of

70,000 daltons included chronic

inhalation studies in both rats and

hamsters. These studies indicated that

both species suffered similar lung

damage when respirable dusts were

inhaled at levels that also produced

lung overloading. Other studies were

performed on clearance rates that

demonstrated that impaired clearance

occurred without regard to particle

concentration in the air once

overloading had taken place. Other

section 8(e) data on water-insoluble

high MW polymers did not include

chronic studies, but were shorter term

studies that resulted in lung damage

consistent with the damage seen when

‘‘lung overloading’’ occurred on a

chronic basis.

Based on the above mentioned limited

data and uncertainty as to all the factors

contributing to the identified effects, the

Agency determined that it could not

draw any broad scientific conclusions in

which lung toxicity is linked

affirmatively with any specific chemical

class or category of high MW waterinsoluble polymers. In addition, it

should be recognized that the chronic

toxicity endpoint being addresssed for

water-insoluble polymers was only seen

under conditions of lung overload

(which suggests the presence of a

threshold for this type of toxicity). In

the case of the water-absorbing

polymers, which exhibit a cancer

endpoint, the exemption criteria reflect

the more conservative approach which

the Agency has historically adopted for

oncogenicity concerns. Further, it is

clear from the Agency’s experience in

assessing high MW water-insoluble

polymers that members of this class of

polymers have rarely been subject to

control action as a result of PMN

review.

In the present rulemaking, based on

numerous comments on this issue and

the Agency’s finding that exposure to

respirable particles of high MW waterinsoluble particles is expected to be

limited, the Agency has concluded that

it can make its statutory finding that

polymers meeting the eligibility criteria

will not present an unreasonable risk of

injury to human health or the

environment. The Agency believes that

the criteria set forth in this exemption

are sufficient to mitigate risk,

particularly when compared to the

benefits, in toto, of encouraging further

development of comparatively lower

risk classes of chemicals, such as

polymers. Furthermore, the expedited

manufacture of eligible new polymers

will provide essential benefits to

industry and to the public, which

comprise an important element in the

finding of no unreasonable risk.

4. Benefits. The following discussion

describes the benefits of this rule in a

qualitative manner; for a more

quantitative approach, see the economic

analysis discussion in unit V.B of this

preamble. It is reasonable to assume that

a newly developed polymer will either

possess a new function or serve an

existing function more efficiently or less

expensively. The reduction in delay for

that polymer to be introduced into

commerce is a benefit to both

manufacturers and the general public,

who will have access to the substance

in a more timely manner.

The benefits analyzed encompass

more than the costs associated with

submitting the polymer for review in a

full PMN. Rather, EPA’s benefit analysis

included a consideration of the broader

benefits of reduction of costs to society

by providing a less burdensome

alternative for polymer manufacturers,

including a reduction in the burden

associated with both full PMN and

current polymer exemption

requirements. EPA’s unreasonable risk

determination is based on broader

benefits to society as well as those

benefits attributable to the substance

itself.

Some of the costs directly attributable

to the substance include the preparation

of the PMN or polymer exemption form

as well as the delay in the commercial

market introduction of the new

chemical substance. On the other hand,

there are broad societal benefits that can

not be directly attributed to any one

chemical substance or category of

substances. Such benefits include a

reduction in Agency review resources

being dedicated to a category of

compounds determined to be of low

risk, and a concomitant shift in those

resources to the review of substances of

greater known concern. While factors

such as these are generally not of the

type that EPA would take into account

when making an individual control

decision on a new chemical substance,

they have a significant effect on society

which is directly linked to EPA’s

exercise of its exemption authority, and

are therefore appropriately considered

in a section 5(h)(4) unreasonable risk

finding for a category of substances. The

costs of reporting requirements will also

be eliminated since companies will be

able to manufacture polymers under

terms of the exemption without

submitting PMNs or exemption notices.

These savings are detailed in the

Regulatory Impact Analysis report

which is available in the public docket

for this rulemaking (docket control

number OPPTS–50594B).

Manufacturers of polymers for which

there is little concern bear a significant

regulatory burden. By incorporating into

the exemption those criteria that the

EPA uses internally to judge the risks

posed by polymers, the Agency removes

the regulatory impediments to the

design, manufacture, and

commercialization of this large class of

chemical substances and substantially

reduces costs associated with industry’s

reporting burden for polymers meeting

these low–risk criteria.

In addition, if the exemption is used

to its greatest advantage, more than 31
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16331

percent of the resources allocated to the

PMN program by EPA could be shifted

from this category of low concern to

those chemicals considered to pose a

considerably greater risk to society.

Finally, manufacturers of these

polymeric substances will be given

greater flexibility provided they meet

the terms of the criteria of the

exemption.

One of the benefits of the rule is that

it incorporates exactly those criteria that

delineate the areas of concern to EPA.

By including this level of specificity in

the rule, EPA provides industry with an

understanding of which specific

chemicals and chemical properties

within the general class of polymers are

considered to be hazards and which are

considered relatively innocuous.

Industry can use this information to

design future polymeric products or

classes of polymers that can supply the

function that is desired while

minimizing or eliminating any hazard.

Supplying this information as criteria in

the rule allows industry to engage in upfront risk-reduction activities by

designing new products that conform

with the provisions of the polymer

exemption while reducing regulatory

compliance costs.

Further, this rule provides pollution

prevention benefits as well in three

areas: the functional group equivalent

weight specifications, the acceptable

monomers list, and the water

absorbability criteria. Pollution

prevention principles have the goal of

reducing or eliminating the use or

generation of hazardous feedstocks, byproducts, or products. By adherence to

the lists of feedstocks and reactants of

low concern contained in this rule,

companies will be able to accomplish

these pollution prevention goals while

minimizing their regulatory compliance

costs.

In view of the extensive and

continually increasing use of polymers

in commerce, encouraging industry to

expand the use of low risk polymers can

result in significant benefits to society.

In general, such low risk polymers can,

and often do, function as replacements

for heavy metals, many of which can

cause detrimental human health effects

to multiple organ systems as well as

permanently contaminating the

ecosystem with subsequent damage to

the flora and fauna. The benefits of

encouraging the development of new

chemical substances of low concern in

place of those existing substances with

known hazards touch on all aspects of

human activity and the environment

including less hazardous work place

environments, safer products available

for the consumer, and materials that

will not decompose to toxic products in

the disposal sites.

5. Risk/benefit balance. Determining

the presence or absence of an

unreasonable risk requires balancing of

the benefits and risks posed by a

regulatory action. EPA has determined

that the risks are low based on the

inherent properties of this class of

substances and the additional

safeguards provided by the risk-based

ineligibility provisions.

EPA believes that the benefits of this

action are quite significant. Promoting

the development of this category of

polymeric substances by reducing the

regulatory burden in both reporting

requirements and in eliminating the

delay of these products into commerce

will have discernible benefits to society.

The added benefit of concentrating

limited EPA resources on regulation of

substances which have a greater

potential to present significant risks,

rather than a category such as polymers,

which have a minimal potential for

significant risk, is difficult to quantify,

but is considered substantial

nonetheless.

Given the above analysis, EPA

concludes that the polymers covered by

the scope of this final rule will not

present an unreasonable risk of injury to

human health or the environment when

manufactured under the conditions of

this exemption.

V. Rulemaking Record

EPA has established a record for this

rulemaking (docket control number

OPPTS–50594B). The record includes

basic information considered by the

Agency in developing this final rule. A

public version of the record without any

confidential business information is

available in the TSCA Nonconfidential

Information Center (also known as the

TSCA Public Docket Office) from 12

noon to 4 p.m., Monday through Friday,

except legal holidays. The TSCA

Nonconfidential Information Center is

located at EPA Headquarters in Rm. NE–

B307, 401 M St., SW., Washington, DC.

VI. Regulatory Assessment

Requirements

A. Executive Order 12866

Under Executive Order 12866 (58 FR

51835, October 4, 1993), the Agency

must determine whether the regulatory

action is ‘‘significant’’ and therefore

subject to review by the Office of

Management and Budget (OMB) and the

requirements of the Executive Order.

Under section 3(f), the Order defines a

‘‘significant regulatory action’’ as an

action that is likely to (1) have an

annual effect on the economy of $100

million or more, or adversely and

materially affect a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or state, local or tribal

governments or communities (also

referred to as ‘‘economically

significant’’) (2) create serious

inconsistency or otherwise interfering

with an action taken or planned by

another agency; (3) materially alter the

budgetary impacts of entitlement,

grants, user fees, or load programs or the

rights and obligations of recipients

thereof; or (4) raise novel legal or policy

issues arising out of legal mandates, the

President’s priorities, or the principles

set forth in this Executive Order.

Pursuant to the terms of this

Executive Order, it has been determined

that this rule is not a ‘‘significant

regulatory action’’ under section 3(f) of

the Order. This action is therefore not

subject to OMB review.

B. Regulatory Flexibility Act

Pursuant to the Regulatory Flexibility

Act (5 U.S.C. 601 et seq.), the Agency

has determined that this regulatory

action will not impose any adverse

economic impacts on small entities.

EPA believes that, even if all of the

polymer exemption notice submitters

were small firms, the number of small

businesses affected by this action will

not be substantial. In addition, since

this action will generally reduce the

existing burden and cost imposed on

PMN submitters, the impact of this

action on small entities should be an

overall positive one.

C. Paperwork Reduction Act

The information collection

requirements in this rule have been

approved under the provisions of the

Paperwork Reduction Act, 44 U.S.C.

3502 et. seq. and have been assigned

OMB control number 2070–0012. The

public reporting burden for this

exemption has been eliminated. The

public reporting burden for a PMN

submission is estimated to vary from 95

to 110 hours; the burden for the 1984

polymer exemption is estimated to vary

from 29.5 to 40 hours.

List of Subjects in 40 CFR Part 723

Chemicals, Environmental protection,

Hazardous materials, Premanufacture

notification, Reporting and

recordkeeping requirements.

Dated: March 21, 1995.

Carol M. Browner,

Administrator.

Therefore, 40 CFR chapter I,

subchapter R, part 723 is amended as

follows:
16332 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

PART 723—[AMENDED]

1. The authority citation for part 723

continues to read as follows:

Authority: 15 U.S.C. 2604

2. By revising §723.250 to read as

follows:

§723.250 Polymers.

(a) Purpose and scope. (1) This

section grants an exemption from

certain of the premanufacture notice

requirements of section 5(a)(1)(A) of the

Toxic Substances Control Act (15 U.S.C.

2604(a)(1)(A)) for the manufacture of

certain polymers.

(2) To manufacture a new chemical

substance under the terms of this

section, a manufacturer must:

(i) Determine that the substance meets

the definition of polymer in paragraph

(b) of this section.

(ii) Determine that the substance is

not specifically excluded by paragraph

(d) of this section.

(iii) Ensure that the substance meets

the exemption criteria of paragraph (e)

of this section.

(iv) Submit a report as required under

paragraph (f) of this section.

(v) Comply with the recordkeeping

requirements of paragraph (j) of this

section.

(b) Definitions. In addition to the

definitions under section 3 of the Act,

15 U.S.C. 2602, the following

definitions apply to this part.

Act means the Toxic Substances

Control Act (15 U.S.C. 2601 et seq.).

Biopolymer means a polymer directly

produced by living or once-living cells

or cellular components.

Category of chemical substances has

the same meaning as in section 26(c)(2)

of the Act (15 U.S.C. 2625).

Cationic polymer means a polymer

that contains a net positively charged

atom(s) or associated groups of atoms

covalently linked to its polymer

molecule.

Chemical substance, Director, EPA,

importer, impurity, Inventory, known to

or reasonably ascertainable,

manufacture, manufacturer, mixture,

new chemical, person, possession or

control, process and test data have the

same meanings as in §720.3 of this

chapter.

Equivalent weight of a functional

group means the ratio of the molecular

weight to the number of occurrences of

that functional group in the molecule. It

is the weight of substance that contains

one formula-weight of the functional

group.

Internal monomer unit means a

monomer unit that is covalently bonded

to at least two other molecules. Internal

monomer units of polymer molecules

are chemically derived from monomer

molecules that have formed covalent

bonds between two or more other

monomer molecules or other reactants.

Monomer means a chemical substance

that is capable of forming covalent

bonds with two or more like or unlike

molecules under the conditions of the

relevant polymer-forming reaction used

for the particular process.

Monomer Unit means the reacted

form of the monomer in a polymer.

Number-average molecular weight

means the arithmetic average (mean) of

the molecular weight of all molecules in

a polymer.

Oligomer means a polymer molecule

consisting of only a few monomer units

(dimer, trimer, tetramer)

Other reactant means a molecule

linked to one or more sequences of

monomer units but which, under the

relevant reaction conditions used for the

particular process, cannot become a

repeating unit in the polymer structure.

Polyester means a chemical substance

that meets the definition of polymer and

whose polymer molecules contain at

least two carboxylic acid ester linkages,

at least one of which links internal

monomer units together.

Polymer means a chemical substance

consisting of molecules characterized by

the sequence of one or more types of

monomer units and comprising a simple

weight majority of molecules containing

at least 3 monomer units which are

covalently bound to at least one other

monomer unit or other reactant and

which consists of less than a simple

weight majority of molecules of the

same molecular weight. Such molecules

must be distributed over a range of

molecular weights wherein differences

in the molecular weight are primarily

attributable to differences in the number

of monomer units. In the context of this

definition, sequence means that the

monomer units under consideration are

covalently bound to one another and

form a continuous string within the

molecule, uninterrupted by units other

than monomer units.

Polymer molecule means a molecule

which contains a sequence of at least 3

monomer units which are covalently

bound to at least one other monomer

unit or other reactant.

Reactant means a chemical substance

that is used intentionally in the

manufacture of a polymer to become

chemically a part of the polymer

composition.

Reactive functional group means an

atom or associated group of atoms in a

chemical substance that is intended or

can reasonably be anticipated to

undergo further chemical reaction.

Reasonably anticipated means that a

knowledgeable person would expect a

given physical or chemical composition

or characteristic to occur based on such

factors as the nature of the precursors

used to manufacture the polymer, the

type of reaction, the type of

manufacturing process, the products

produced in polymerization, the

intended uses of the substance, or

associated use conditions.

(c) Applicability. This section applies

to manufacturers of new chemical

substances that otherwise must submit a

premanufacture notice to EPA under

§720.22 of this chapter. New substances

are eligible for exemption under this

section if they meet the definition of

‘‘polymer’’ in paragraph (b) of this

section, and the criteria in paragraph (e)

of this section, and if they are not

excluded from the exemption under

paragraph (d) of this section.

(d) Polymers that cannot be

manufactured under this section— (1)

Cationic polymers. A polymer cannot be

manufactured under this section if the

polymer is a cationic polymer as

defined under paragraph (b) of this

section or if the polymer is reasonably

anticipated to become a cationic

polymer in a natural aquatic

environment (e.g., rivers, lakes) unless:

(i) The polymer is a solid material that

is not soluble or dispersible in water

and will be used only in the solid phase

(e.g., polymers that will be used as ion

exchange beads), or

(ii) The combined (total) functional

group equivalent weight of cationic

groups in the polymer is equal to or

greater than 5,000.

(2) Elemental limitations. (i) A

polymer manufactured under this

section must contain as an integral part

of its composition at least two of the

atomic elements carbon, hydrogen,

nitrogen, oxygen, silicon, and sulfur.

(ii) A polymer cannot be

manufactured under this section if it

contains as an integral part of its

composition, except as impurities, any

elements other than the following:

(A) The elements listed in paragraph

(d)(2)(i) of this section.

(B) Sodium, magnesium, aluminum,

potassium, calcium, chlorine, bromine,

and iodine as the monatomic

counterions Na∂, Mg∂2, Al∂3, K∂,

Ca∂2, Cl-

, Br-, or I-.

(C) Fluorine, chlorine, bromine, and

iodine covalently bound to carbon.

(D) Less than 0.20 weight percent of

any combination of the atomic elements

lithium, boron, phosphorus, titanium,

manganese, iron, nickel, copper, zinc,

tin, and zirconium.

(3) Polymers which degrade,

decompose, or depolymerize. A polymer
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16333

cannot be manufactured under this

section if the polymer is designed or is

reasonably anticipated to substantially

degrade, decompose, or depolymerize,

including those polymers that could

substantially decompose after

manufacture and use, even though they

are not actually intended to do so. For

the purposes of this section,

degradation, decomposition, or

depolymerization mean those types of

chemical change that convert a

polymeric substance into simpler,

smaller substances, through processes

including but not limited to oxidation,

hydrolysis, attack by solvents, heat,

light, or microbial action.

(4) Polymers manufactured or

imported from monomers and reactants

not on the TSCA Chemical Substance

Inventory. A polymer cannot be

manufactured under this section if the

polymer being manufactured or

imported is prepared from monomers

and/or other reactants (that are either

charged to the reaction vessel or

incorporated in the polymer at levels of

greater than 2 weight percent) that are

not already included on the TSCA

Chemical Substance Inventory or

manufactured under an applicable

TSCA section 5 exemption.

(5) Water absorbing polymers with

number average molecular weight (MW)

10,000 and greater. A polymer cannot

be manufactured under this section if

the polymer being manufactured or

imported is a water absorbing polymer

and has a number average MW greater

than or equal to 10,000 daltons. For

purposes of this section, a waterabsorbing polymer is a polymeric

substance that is capable of absorbing its

weight of water.

(e) Exemption criteria. To be

manufactured under this section, the

polymer must meet one of the following

criteria:

(1) Polymers with number average

MW greater than or equal to 1,000 and

less than 10,000 daltons (and oligomer

content less than 10 percent below MW

500 and less than 25 percent below MW

1,000). (i) The polymer must have a

number average MW greater than or

equal to 1,000 and less than 10,000

daltons and contain less than 10 percent

oligomeric material below MW 500 and

less than 25 percent oligomeric material

below MW 1,000.

(ii) The polymer cannot contain

reactive functional groups unless it

meets one of the following criteria:

(A) The polymer contains only the

following reactive functional groups:

carboxylic acid groups, aliphatic

hydroxyl groups,unconjugated olefinic

groups that are considered

‘‘ordinary,’’(i.e., not specially activated

either by being part of a larger

functional group, such as a vinyl ether,

or by other activating influences, e.g.,

strongly electron-withdrawing sulfone

group with which the olefinic groups

interact), butenedioic acid groups, those

conjugated olefinic groups contained in

naturally-occurring fats, oils, and

carboxylic acids, blocked isocyanates

(including ketoxime-blocked

isocyanates), thiols, unconjugated nitrile

groups, and halogens (except that

reactive halogen-containing groups such

as benzylic or allylichalides cannot be

included).

(B) The polymer has a combined

(total) reactive group equivalent weight

greater than or equal to 1,000 for the

following reactive functional groups:

acidhalides; acid anhydrides;

aldehydes, hemiacetals;

methylolamides,- amines or,- ureas;

alkoxysilanes with alkoxy greater than

C2-alkoxysilanes; allyl ethers;

conjugated olefins;cyanates; epoxides;

imines; or unsubstituted positions ortho

or para to phenolic hydroxyl; or

(C) If any reactive functional groups

not included in paragraph (e)(1)(ii)(A)

and (B) of this section are present, the

combined (total) reactive group

equivalent weight, including any groups

listed in paragraph (e)(1)(ii)(B), is

greater than or equal to 5,000.

(2) Polymers with number average

MW greater than or equal to 10,000 (and

oligomer content less than 2 percent

below MW 500 and less than 5 percent

below MW 1,000) . The polymer must

have a number average MW greater than

or equal to 10,000 daltons and contain

less than 2 percent oligomeric material

below MW 500 and less than 5 percent

oligomeric material below MW 1000.

(3) Polyester polymers. The polymer is

a polyester as defined in paragraph (b)

of this section and is manufactured

solely from one or more of the reactants

in the following Table 1:

TABLE 1.— LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE

Reactant CAS No.

Monobasic Acids and Natural Oils

Benzoic acid ......................................................................................................................................................................... 65–85–0

Canola oil ............................................................................................................................................................................. 120962–03–0

Coconut oil ........................................................................................................................................................................... 8001–31–8*

Corn oil ................................................................................................................................................................................. 8001–30–7*

Cottonseed oil ...................................................................................................................................................................... 8001–29–4*

Dodecanoic acid ................................................................................................................................................................... 143–07–7

Fats and glyceridic oils, anchovy ......................................................................................................................................... 128952–11–4*

Fats and glyceridic oils, babassu ......................................................................................................................................... 91078–92–1*

Fats and glyceridic oils, herring ........................................................................................................................................... 68153–06–0*

Fats and glyceridic oils, menhaden ..................................................................................................................................... 8002–50–4*

Fats and glyceridic oils, sardine ........................................................................................................................................... 93334–41–9*

Fats and glyceridic oils, oiticica ........................................................................................................................................... 8016–35–1*

Fatty acids,C16-18 and C18-unsatd. ....................................................................................................................................... 67701–08–0*

Fatty acids, castor-oil ........................................................................................................................................................... 61789–44–4*

Fatty acids, coco .................................................................................................................................................................. 61788–47–4*

Fatty acids, dehydrated castor-oil ........................................................................................................................................ 61789–45–5*

Fatty acids, linseed oil .......................................................................................................................................................... 68424–45–3*

Fatty acids, safflower oil .......................................................................................................................................................

Fatty acids, soya .................................................................................................................................................................. 68308–53–2*

Fatty acids, sunflower oil ...................................................................................................................................................... 84625–38–7*

Fatty acids, sunflower-oil, conjugated .................................................................................................................................. 68953–27–5*

Fatty acids, tall-oil ................................................................................................................................................................ 61790–12–3*

Fatty acids, tall-oil, conjugated* ...........................................................................................................................................

Fatty acids, vegetable oil ..................................................................................................................................................... 61788–66–7*

Glycerides, C16-18 and C18-unsatd. ....................................................................................................................................... 67701–30–8*

Heptanoic acid ...................................................................................................................................................................... 111–14–8
16334 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

TABLE 1.— LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE—Continued

Reactant CAS No.

Hexanoic acid ....................................................................................................................................................................... 142–62–1

Hexanoic acid, 3,3,5-trimethyl- ............................................................................................................................................. 3302–10–1

Linseed oil ............................................................................................................................................................................ 8001–26–1*

Linseed oil, oxidized ............................................................................................................................................................. 68649–95–6*

Nonanoic acid ....................................................................................................................................................................... 112–05–0

Oils, Cannabis* .....................................................................................................................................................................

Oils, palm kernel .................................................................................................................................................................. 8023–79–8*

Oils, perilla ............................................................................................................................................................................ 68132–21–8*

Oils, walnut ........................................................................................................................................................................... 8024–09–7

Safflower oil .......................................................................................................................................................................... 8001–23–8*

Soybean oil ........................................................................................................................................................................... 8001–22–7*

Sunflower oil ......................................................................................................................................................................... 8001–21–6*

Tung oil ................................................................................................................................................................................. 8001–20–5*

Di and Tri Basic Acids:.

1,2-Benzenedicarboxylic acid ............................................................................................................................................... 88–99–3

1,3-Benzenedicarboxylic acid ............................................................................................................................................... 121–91–5

1,3-Benzenedicarboxylic acid, dimethyl ester ...................................................................................................................... 1459–93–4

1,4-Benzenedicarboxylic acid ............................................................................................................................................... 100–21–0

1,4-Benzenedicarboxylic acid, diethyl ester ......................................................................................................................... 636–09–9

1,4-Benzenedicarboxylic acid, dimethyl ester ...................................................................................................................... 120–61–6

1,2,4-Benzenetricarboxylic acid ........................................................................................................................................... 528–44–9

Butanedioic acid ................................................................................................................................................................... 110–15–6

Butanedioic acid, diethyl ester ............................................................................................................................................. 123–25–1

Butanedioic acid, dimethyl ester .......................................................................................................................................... 106–65–0

2-Butenedioic acid (E)– ........................................................................................................................................................ 110–17–8

Decanedioic acid .................................................................................................................................................................. 111–20–6

Decanedioic acid, diethyl ester ............................................................................................................................................ 110–40–7

Decanedioic acid, dimethyl ester ......................................................................................................................................... 106–79–6

Dodecanedioic acid .............................................................................................................................................................. 693–23–2

Fatty acids, C18-unsatd., dimers .......................................................................................................................................... 61788–89–4*

Heptanedioic acid ................................................................................................................................................................. 111–16–0

Heptanedioic acid, dimethyl ester ........................................................................................................................................ 1732–08–7

Hexanedioic acid .................................................................................................................................................................. 124–04–9

Hexanedioic acid, dimethyl ester ......................................................................................................................................... 627–93–0

Hexanedioic acid, diethyl ester ............................................................................................................................................ 141–28–6

Nonanedioic acid .................................................................................................................................................................. 123–99–9

Nonanedioic acid, dimethyl ester ......................................................................................................................................... 1732–10–1

Nonanedioic acid, diethyl ester ............................................................................................................................................ 624–17–9

Octanedioic acid ................................................................................................................................................................... (505–48–6)

Octanedioic acid, dimethyl ester .......................................................................................................................................... 1732–09–8

Pentanedioic acid ................................................................................................................................................................. (110–94–1)

Pentanedioic acid, dimethyl ester ........................................................................................................................................ 1119–40–0

Pentanedioic acid, diethyl ester ........................................................................................................................................... 818–38–2

Undecanedioic acid .............................................................................................................................................................. 1852–04–6

Polyols

1,3-Butanediol ...................................................................................................................................................................... 107–88–0

1,4-Butanediol ...................................................................................................................................................................... 110–63–4

1,4-Cyclohexanedimethanol ................................................................................................................................................. 105–08–8

1,2-Ethanediol ...................................................................................................................................................................... 107–21–1

Ethanol, 2,2′-oxybis- ............................................................................................................................................................. 111–46–6

1,6-Hexanediol ..................................................................................................................................................................... 629–11–8

1,3-Pentanediol, 2,2,4-trimethyl- .......................................................................................................................................... 144–19–4

1,2-Propanediol, ................................................................................................................................................................... 57–55–6

1,3-Propanediol, 2,2-bis(hydroxymethyl)- ............................................................................................................................ 115–77–5

1,3-Propanediol, 2,2-dimethyl- ............................................................................................................................................. 126–30–7

1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)- ........................................................................................................................ 77–99–6

1,3-Propanediol, 2-(hydroxymethyl)-2-methyl- ..................................................................................................................... 77–85–0

1,3-propanediol, 2-methyl ..................................................................................................................................................... 2163–42–0

1,2,3-Propanetriol ................................................................................................................................................................. 56–81–5

1,2,3-Propanetriol, homopolymer ......................................................................................................................................... 25618–55–7

2-Propen-1-ol, polymer with ethenylbenzene ...................................................................................................................... 25119-62–4

Modifiers

Acetic acid, 2,2′-oxybis- ....................................................................................................................................................... 110–99–6

1-Butanol .............................................................................................................................................................................. 71–36–3**

Cyclohexanol ........................................................................................................................................................................ 108–93–0

Cyclohexanol, 4,4′-(1-methylethylidene)bis- ........................................................................................................................ 80–04–6

Ethanol, 2-(2-butoxyethoxy)- ................................................................................................................................................ 112–34–5

1-Hexanol ............................................................................................................................................................................. 111–27–3

Methanol, hydrolysis products with trichlorohexylsilane and trichlorophenylsilane ............................................................. 72318–84–4*

1-Phenanthrenemethanol, tetradecahydro-1,4a-dimethyl-7-(1-methylethyl)- ....................................................................... 13393–93–6
Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations 16335

TABLE 1.— LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE—Continued

Reactant CAS No.

Phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2,2′- [(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]

bis[oxirane].

25036-25–3

Siloxanes and Silicones, di-Me, di-Ph, polymers with Ph silsesquioxanes, methoxy-terminated ....................................... 68440–65–3*

Siloxanes and Silicones, di-Me, methoxy Ph, polymers with Ph silsesquioxanes, methoxy-terminated ............................ 68957–04–0*

Siloxanes and Silicones, Me Ph, methoxy Ph, polymers with Ph silsesquioxanes, methoxy- and Ph-terminated ............. 168957–06–2*

Silsesquioxanes, Ph Pr ........................................................................................................................................................ 168037–90–1*

* Chemical substance of unknown or variable composition,complex reaction products, and biological materials (UVCB). The CAS Registry

Numbers for UVCB substances are not used in CHEMICAL ABSTRACTS and its indexes. ** These substances may not be used in a substance manufactured from fumaric or maleic acid because of potential risks associated with

esters, which may be formed by reaction of these reactants.

(f) Exemption report for polymers

manufactured under the terms of this

section. For substances exempt under

paragraphs (e)(1), (e)(2), and (e)(3) of

this section a report of manufacture or

import must be submitted (postmarked)

by January 31 of the year subsequent to

initial manufacture. The notice must

include:

(1) Manufacturer’s name. This

includes the name and address of the

manufacturer and the name and

telephone number of a technical

contact.

(2) Number of substances

manufactured. Number of substances

manufactured. The manufacturer must

identify the number of polymers

manufactured under terms of the

exemption for the first time in the year

preceding the notice.

(g) Chemical identity information. For

substances exempt under paragraph (e)

of this section the manufacturer must to

the extent known to or reasonably

ascertainable by the manufacturer

identify the following and maintain the

records in accordance with paragraph (j)

of this section:

(1) A specific chemical name and CAS

Registry Number (or EPA assigned

Accession Number) for each ‘‘reactant,’’

as that term is defined in paragraph (b)

of this section, used at any weight in the

manufacture of the polymer. For

purposes of determining chemical

identity, the manufacturer may

determine whether a reactant is used at

greater than two weight percent

according to either the weight of the

reactant charged to the reaction vessel

or the weight of the chemically

combined (incorporated) reactant in the

polymer. Manufacturers who choose the

‘‘incorporated’’ method must have

analytical data, or theoretical

calculations (if it can be documented

that an analytical determination cannot

be made or is not necessary), to

demonstrate compliance with this

paragraph. Reactants that introduce into

the polymer elements, properties, or

functional groups that would render the

polymer ineligible for the exemption are

not allowed at any level.

(2) A representative structural

diagram, if possible.

(h) Certification. To manufacture a

substance under the terms of this

section, a manufacturer must as of the

date of first manufacture, make the

following certification statements and

maintain them in accordance with

paragraph (j) of this section:

(1) The substance is manufactured or

imported for a commercial purpose

other than for research and

development.

(2) All information in the certification

is truthful.

(3) The new chemical substance meets

the definition of a polymer, is not

specifically excluded from the

exemption in paragraph (d) of this

section, and meets the conditions of the

exemption in paragraph (e) of this

section.

(i) Exemptions granted under

superseded regulations. Manufacturers

granted exemptions under the

superseded requirements of §723.250

(as in effect on May 26, 1995) shall

either continue to comply with those

requirements or follow all procedural

and recordkeeping requirements

pursuant to this section. If an exemption

holder continues to follow the

superseded regulations, the Notice of

Commencement requirements apply and

the exempt polymer will continue to be

listed on the Inventory with exclusion

criteria and exemption category

restrictions on residual monomer/

reactant and low molecular weight

species content limitations.

(j) Recordkeeping. (1) A manufacturer

of a new polymer under paragraphs (e)

of this section, must retain the records

described in this paragraph at the

manufacturing site for a period of 5

years from the date of commencement of

manufacture or import.

(2) The records must include the

following to demonstrate compliance

with the terms of this section:

(i) Chemical identity information as

required in paragraph (g) of this section.

(ii) Information to demonstrate that

the new polymer is not specifically

excluded from the exemption.

(iii) Records of production volume for

the first 3 years of manufacture and the

date of commencement of manufacture.

(iv) Information to demonstrate that

the new polymer meets the exemption

criteria in paragraphs (e)(1), (e)(2), or

(e)(3) of this section.

(v) Analytical data, or theoretical

calculations (if it can be documented

that an analytical determination cannot

be made or is not necessary), to

demonstrate that the polymer meets the

number-average MW exemption criteria

in paragraphs (e)(1) or (e)(2) of this

section.The analytical tests may include

gel permeation chromatography

(GPC).vapor pressure osmometry (VPO),

or other such tests which will

demonstrate that the polymer meets the

number-average MW criterion.

(vi) Analytical data, or theoretical

calculations (if it can be documented

that an analytical determination cannot

be made or is not necessary), to

demonstrate that the polymer meets the

criteria in paragraphs (e)(1) or (e)(2) of

this section, meets the low MW content

criteria in paragraphs (e)(1) or (e)(2) of

this section.

(vii) If applicable, analytical data, or

theoretical calculations (if it can be

documented that an analytical

determination cannot be made or is not

necessary) required in paragraph (g) of

this section for determining monomers

or reactants charged to the reaction

vessel at greater than 2 weight percent

but incorporated at 2 weight percent or

less in the manufactured polymer.

(viii) The certification statements as

required under paragraph (h) of this

section.

(3) The manufacturer must submit the

records listed in paragraph (j)(2) of this

section to EPA upon written request by

EPA. The manufacturer must provide

these records within 15 working days of

receipt of this request. In addition, any

person who manufactures a new

chemical substance under the terms of

this section, upon request of EPA, must
16336 Federal Register / Vol. 60, No. 60 / Wednesday, March 29, 1995 / Rules and Regulations

permit such person at all reasonable

times to have access to and to copy

these records.

(k) Submission of information.

Information submitted to EPA under

this section must be sent in writing to:

TSCA Document Control Officer, (7407),

Office of Pollution Prevention and

Toxics, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460.

(l) Compliance. (1) A person who

manufactures or imports a new

chemical substance and fails to comply

with any provision of this section is in

violation of section 15 of the Act (15

U.S.C. 2614).

(2) Using for commercial purposes a

chemical substance or mixture which a

person knew or had reason to know was

manufactured, processed, or distributed

in commerce in violation of section 5 of

the Act is a violation of section 15 of the

Act (15 U.S.C. 2614).

(3) Failure or refusal to establish and

maintain records or to permit access to

or copying of records, as required by

this section and section 11 of the Act,

is a violation of section 15 of the Act (15

U.S.C. 2614).

(4) Failure or refusal to permit entry

or inspection as required by section 11

of the Act is a violation of section 15 of

the Act (15 U.S.C. 2614).

(5) Violators may be subject to the

civil and criminal penalties insection 16

of the Act (15 U.S.C. 2615) for each

violation. Persons who submit

materially misleading or false

information in connection with the

requirements of any provision of this

section may be subject to penalties

calculated as if they never filed their

notices.

(6) EPA may seek to enjoin the

manufacture or processing of a chemical

substance in violation of this section or

act to seize any chemical substance

manufactured or processed in violation

of this section or take other actions

under the authority of section 7 of the

Act (15 U.S.C. 2606) or section 17 of the

Act (15 U.S.C. 2616).

(m) Inspections. EPA will conduct

inspections under section 11 ofthe Act

to assure compliance with section 5 and

this section, to verify that information

submitted to EPA under this section is

true and correct, and to audit data

submitted to EPA under this section.

(n) Confidentiality. If a manufacturer

submits information to EPA under this

section which the manufacturer claims

to be confidential business information,

the manufacturer must clearly identify

the information at the time of

submission to EPA by bracketing,

circling, or underlining it and stamping

it with ‘‘CONFIDENTIAL’’ or some other

appropriate designation. Any

information so identified will be treated

in accordance with the procedures in 40

CFR part 2. Any information not

claimed confidential at the time of

submission may be made available to

the public without further notice.

[FR Doc. 95–7712 Filed 3–24–95; 3:32 pm]

BILLING CODE 6560–50–F

40 CFR Part 723

[OPTS–50596B; FRL–4923–1]

RIN 2070–AC14

Premanufacture Notification

Exemption; Revision of Exemption for

Chemical Substances Manufactured in

Small Quantities; Low Release and

Exposure Exemption; Final Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: Section 5(a)(1) of the Toxic

Substances Control Act (TSCA) requires

that persons notify EPA before they

manufacture or import a new chemical

substance for commercial purposes.

Section 5(h)(4) of TSCA authorizes EPA,

upon application and by rule to exempt

the manufacturer or importer of any

new chemical substance from some or

all of the provisions of section 5 if the

Agency determines that the

manufacture, processing, distribution in

commerce, use, or disposal of the

substance will not present an

unreasonable risk of injury to health or

the environment. EPA is amending the

current TSCA section 5(h)(4) limited

exemption defined at 40 CFR 723.50 for

persons who manufacture certain

chemical substances in quantities of

1,000 kilograms or less per year. This

amendment will increase the volume

limit to 10,000 kilograms or less a year.

Also, this amendment adds a new

section 5(h)(4) exemption category for

certain chemical substances with low

environmental releases and human

exposures. This amendment will

significantly reduce administrative

burdens on EPA and industry and will

expedite the Agency review process so

that lower risk chemical substances may

be marketed more quickly. To ensure

that these chemical substances will not

present an unreasonable risk, EPA has

included procedural safeguards,

including a 30–day review, and other

conditions in the exemption.

DATES: This rule is effective May 30,

1995. This rule shall be promulgated for

purposes of judicial review at 1 p.m.

eastern time, on April 12, 1995.

FOR FURTHER INFORMATION CONTACT:

Susan B. Hazen, Director,

Environmental Assistance Division

(7408), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460, Telephone: (202) 554–1404,

TDD: (202) 554–0551.

SUPPLEMENTARY INFORMATION: The

original exemption for chemical

substances manufactured in quantities

of 1,000 kilograms or less per year

became effective on August 26, 1985.

The supporting rationale and

background for that exemption were

published at 50 FR 16477 on April 26,

1985 and 47 FR 33896, August 4, 1982.

This rule was proposed in the Federal

Register on February 8, 1993 (58 FR

7646). Public hearings on this and

related PMN exemptions were held in

Washington, DC. on April 26–28, 1993.

While general background information

is presented here, readers should also

consult the preambles for those notices

for further information on the objectives

and rationale for the rule and the basis

for finding under TSCA section 5(h)(4)

that activities involving the exempt

chemical substances will not present an

unreasonable risk of injury to human

health or the environment.

I. Background

Section 5(a)(1) of TSCA (15 U.S.C.

2604 (a)(1)) requires any person who

intends to manufacture or import a new

chemical substance to notify EPA 90

days before manufacture or importation

begins. Section 5(h)(4) of TSCA (15

U.S.C. 2604(h)(4)) allows the EPA, by

rule, to grant an exemption from any or

all of the requirements of section 5 if

EPA determines that the manufacture,

processing, distribution in commerce,

use, or disposal of a substance will not

present an unreasonable risk of injury to

health or the environment.

II. Final Exemption

A. Summary of the Rule

1. Chemical substances manufactured

at 10,000 kg or less per year.

Manufacturers of all new chemical

substances manufactured in quantities

of 10,000 kilograms or less per year are

eligible to apply for a new category of

exemption. (Note that throughout 40

CFR parts 720, 721, and 723, the term

‘‘manufacturer’’ is defined in TSCA

section 3(8), 15 U.S.C. 2602(8), to

include persons who import the

specified chemical substance; the term

‘‘manufacture’’ is defined to include

importation.) Upon approval,

manufacturers will be permitted to

manufacture up to 10,000 kilograms of

the new chemical substance during