Glycol Ethers Category; Toxic Chemical Release Reporting; Community Right-to-Know

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 372

[OPPTS-400073B; FRL-4864-8]

Glycol Ethers Category; Toxic Chemical Release Reporting;

Community Right-to-Know

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is redefining the glycol ethers category list of toxic

chemicals subject to reporting under section 313 of the Emergency

Planning and Community Right-to-Know Act of 1986 (EPCRA). EPA is

changing the present definition of the glycol ethers category to

exclude the high molecular weight glycol ethers that do not, in EPA's

judgement, meet the criteria set out in EPCRA section 313(d). This

redefinition of the glycol ethers category, which is based on EPA's

review of available human health data on short-chain length glycol

ethers, eliminates the EPCRA section 313 reporting requirements for

those glycol ethers known as surfactant glycol ethers.

EFFECTIVE DATE: This rule is effective June 28, 1994.

FOR FURTHER INFORMATION CONTACT: Maria J. Doa, Petitions Coordinator,

202-260-9592, for specific information regarding this final rule. For

further information on EPCRA section 313, contact the Emergency

Planning and Community Right-to-Know Information Hotline, Environmental

Protection Agency, Mail Stop 5101, 401 M St., SW., Washington, DC

20460, Toll free: 800-535-0202, Toll free TDD: 800-553-7672.

SUPPLEMENTARY INFORMATION:

I. Introduction

A. Statutory Authority

This action is issued under section 313(d) of the Emergency

Planning and Community Right-to-Know Act of 1986 (42 U.S.C. 11023,

``EPCRA''). EPCRA is also referred to as Title III of the Superfund

Amendments and Reauthorization Act (SARA) of 1986.

B. Background

Section 313 of EPCRA requires certain facilities manufacturing,

processing, or otherwise using toxic chemicals to report their

environmental releases of such chemicals annually. Beginning with the

1991 reporting year, such facilities also must report pollution

prevention and recycling data for such chemicals, pursuant to section

6607 of the Pollution Prevention Act (42 U.S.C. 13106). Section 313

established an initial list of toxic chemicals that was comprised of

more than 300 chemicals and 20 chemical categories. Section 313(d)

authorizes EPA to add chemicals to or delete chemicals from the list,

and sets forth criteria for these actions. Under section 313(e), any

person may petition EPA to add chemicals to or delete chemicals from

the list. EPA has added to and deleted chemicals from the original

statutory list.

EPA issued a statement of petition policy and guidance in the

Federal Register of February 4, 1987 (52 FR 3479), to provide guidance

regarding the recommended content and format for petitions. On May 23,

1991 (56 FR 23703), EPA published guidance regarding the recommended

content of petitions to delete individual members of the section 313

metal compound categories.

II. Effective Date

This action becomes effective immediately. Thus, the last year in

which facilities had to report releases of high molecular weight glycol

ethers now excluded from the list was 1993, covering releases that

occurred in 1992. The effect of this category redefinition is that,

since the high molecular weight glycol ethers being excluded from the

category will not be on the section 313 list when facilities report in

1994 for releases that occurred in 1993, these reports and all

subsequent reports need not include release data for these glycol

ethers. Facilities will therefore not have to collect release

information for any releases of the excluded glycol ethers that

occurred during the 1993 reporting year or for any releases that occur

in the future.

Section 313(d)(4) provides that ``[a]ny revision [to the section

313 list] made on or after January 1 and before December 1 of any

calendar year shall take effect beginning with the next calendar year.

Any revision made on or after December 1 and before January 1 shall

take effect beginning with the calendar year following the next

calendar year.'' The Agency interprets this delayed effective date

provision to apply only to actions that add chemicals to the section

313 list. For deletions, the Agency may, in its discretion, make such

actions immediately effective. An immediate effective date is

authorized, in these circumstances, under 5 U.S.C. section 553(d)(1)

since a deletion from the section 313 list relieves a regulatory

restriction.

The Agency believes that the purpose behind the section 313(d)(4)

effective date provision is to allow facilities adequate planning time

to incorporate newly added chemicals to their Toxic Release Inventory

(TRI) release data collection processes. A facility would not need

additional planning time to not report releases of a given chemical.

Thus, a reasonable construction of section 313(d)(4), given the overall

purpose and structure of EPCRA -- to provide the public with

information about chemicals which meet the criteria for inclusion on

the section 313 list -- is to apply the delayed effective date

requirement only to additions to the list. Where the Agency has

determined, as it has with the excluded glycol ethers, that a chemical

does not satisfy the criteria of section 313(d)(2)(A)-(C), no purpose

is served by requiring facilities to collect release data or file

release reports for that chemical, or, therefore, by leaving that

chemical on the section 313 list for any additional period of time.

Nothing in the legislative history suggests that section 313(d)(4) was

intended to apply to deletions as well as additions; indeed, such a

construction would be incongruous, since deleted chemicals, by

definition, do not satisfy the criteria for being on the section 313

list and their deletion from that list should not be delayed in the

absence of any compelling reason to the contrary. This construction of

section 313(d)(4) is also consistent with previous rules deleting

chemicals from the section 313 list. Indeed, the Agency has not given

any of its rules deleting chemicals from the section 313 list the

delayed effective dates specified in section 313(d)(4).

EPA has not deleted all glycol ethers from reporting requirements

under EPCRA section 313. Reporting will still be required for those

glycol ethers which meet the revised definition.

III. Description of the EPCRA Section 313 Glycol Ethers Category

In the Federal Register of July 6, 1993 (58 FR 36180), EPA issued a

proposed rule to redefine the glycol ethers category on the EPCRA

section 313 list of toxic chemicals. EPA has evaluated the current

scope of the section 313 glycol ethers category and believes that it is

overly broad. The existing category includes substances that

traditionally have not been considered glycol ethers. Also, it is

apparent that this category contains members that do not meet the EPCRA

section 313(d)(2) criteria for listing. EPA has reviewed the current

glycol ethers category and is redefining it to exclude the surfactant

glycol ethers. Surfactant glycol ethers are those glycol ethers with

pendant alkyl groups which typically consist of eight or more carbon

atoms (i.e., high molecular weight glycol ethers). However, EPA does

not believe that the category can be more narrowly defined at this

time.

EPA's revised glycol ethers category for which section 313

reporting is required, consists of those glycol ethers which meet the

following definition:

Certain Glycol Ethers:

R - (OCH2CH2)n - OR'

Where:

n = 1, 2, or 3;

R = alkyl C7 or less, or

R = phenyl or alkyl substituted phenyl;

R' = H or alkyl C7 or less; or

OR' consisting of carboxylic acid ester, sulfate, phosphate,

nitrate, or sulfonate.

IV. Rationale for Redefinition

EPA's concerns for the included chemicals is based on a review of

available human health data on short-chain length glycol ethers.

Specifically, EPA believes that these chemicals meet the criterion of

EPCRA section 313(d)(2)(B) because the individual members of this

category can be reasonably anticipated to cause one or more of the

following effects: Kidney toxicity, liver toxicity, adverse blood

effects, adverse central nervous system effects, reproductive effects,

and developmental effects. EPA believes that the category can be

redefined to exclude those glycol ethers known as surfactant glycol

ethers because these high molecular weight glycol ethers do not meet

the listing criteria in section 313(d)(2)(A) or (B). None of the

chemicals in the current glycol ethers category meet the toxicity

criterion of section 313(d)(2)(C) based on their ecotoxicity. EPA's

rationale for this redefinition is detailed in the proposed rule and is

based on the Agency's review of various relevant materials.

V. Response to Comments

EPA received 11 comments on the proposed rule, all in support of

the proposed redefinition of the glycol ethers category. However,

several of the commenters expressed the opinion that the proposed rule

does not narrow the definition sufficiently, and that EPA should

consider a further narrowing of the definition in the future. As

discussed below, EPA does not believe that it currently has sufficient

data to further narrow the category definition.

Two commenters, the Chemical Manufacturers Association (CMA),

Propylene Glycol Ethers Panel, and CMA Ethylene Glycol Ethers Panel,

stated that the name of the category should be changed to ``certain

glycol ethers'' to more accurately characterize the chemicals that are

within the category. EPA has incorporated this comment, since this

category does not consist of all chemicals that contain the glycol

ether functionality.

One commenter, General Electric, suggested that the definition

should not identify reportable glycol ethers by molecular structure.

Instead, the commenter recommended listing the glycol ethers of concern

individually, and identifying those which must be reported on an

individual basis. All remaining glycol ethers would then be reported in

an aggregate form. EPA believes this approach to defining the category

is inappropriate and unnecessary. EPA has identified by molecular

formula a specific group of glycol ethers having a common structure

that pose similar hazards. EPA currently believes that the most

appropriate way to report on this group of glycol ethers is in

aggregate by category. A listing of glycol ethers as proposed by the

commenter may exclude from reporting certain glycol ethers within the

scope of the definition in this rulemaking that meet the section

313(d)(2) criterion. Therefore, EPA is adopting the redefinition of the

glycol ethers category based on a molecular structure formula. A

reporting facility must make aggregate reporting threshold and

estimated release determinations for all glycol ethers in the category.

The Soap and Detergent Association proposed that the revised

definition exclude sulfonate in the category of OR' because ``carbon

sulfur bonds are not easily broken and, therefore, sulfonates are not

readily hydrolyzable from surfactants.'' EPA proposed the inclusion of

sulfonate not because of the possible reaction at the carbon sulfur

bond in the sulfonate, e.g., desulfonation of aromatic sulfonates, but

rather because the sulfonate ion is a reactive leaving group and thus

can reasonably be anticipated to be hydrolyzed to yield a glycol ether

of concern. Specifically hydrolysis of R-

(OCH2CH2)nOSO2R'' (where R'' is any organic

substituent) yields R-(OCH2CH2)nOH and R''SO2OH.

Therefore, EPA reaffirms its inclusion of sulfonate as an appropriate

member in the category of OR'.

The Chemical Manufacturers Association stated that the category

should be limited to four specific ethylene glycol ether solvents: 2-

Methoxyethanol, 2-ethoxyethanol, and their acetates. As stated in the

proposed rule, with respect to the glycol ethers and developmental

effects, there is evidence that the toxicity is reduced going from the

methyl to the butyl ether. However, data for other toxic effects on

glycol ethers with pendant alkyl groups of one to seven carbons or a

phenyl group do not indicate a trend towards increased toxicity based

on chain length for other toxic effects. Low molecular weight ethylene

glycol ethers disturb the hemopoiesis and the blood picture at low

doses. Hemolysis has been reported in varying degrees for ethylene

glycol ethers of one to five carbons in the alkyl chain. The optimum

alkyl chain length for hemolysis is four carbons. 2-Phenoxyethanol has

also been found to cause intravascular hemolysis. Therefore, the

concerns for ethylene glycol ethers are not limited to the four

specific compounds mentioned by the commenter.

In the proposed rule, EPA requested comment on whether the

definition of R' should include only straight chained alkyl groups of

seven of fewer carbons or both straight and branched alkyl groups of

seven or fewer carbons. No comments on this issue were received.

Therefore, the definition of R' will include both straight and branched

alkyl groups of seven or fewer carbons.

Rochester Midland, Soap and Detergent Association, Henkel

Corporation, and Union Carbide Corporation asked that the definition

also exclude alkylated phenols containing seven or more carbon atoms.

As stated in the proposed rule, 2-phenoxyethanol is known to cause

hemolysis. No data have been found for alkyl substituted phenoxyethanol

derivatives. Henkel Corporation stated that ``[t]he C8, C9,

and C12 alkyl phenol ethoxylates have also been used for many

years as surfactants. There is no evidence that they present adverse

human effects such as those which caused the listing of the glycol

ether category or would otherwise meet the section 313 criteria.''

However, this commenter did not supply data to substantiate this

assertion. The Soap and Detergent Corporation provided two studies to

support its position (Smyth and Calandra, 1969; Dudek and Ribelin,

1988). Neither of these studies specifies the composition of the test

material by number of ethylene oxide units. The commenter did provide

the typical weight percent of the test substances as sold in commerce.

Even if EPA assumed these typical compositions represent the test

materials of these two studies, the dose levels presented in the

studies would not be considered adequate to establish the lack of

toxicity associated with ethylene glycol ethers with alkyl groups

consisting of seven or greater carbon atoms.

Because only phenoxyethanol has been tested for systemic toxicity,

change in the glycol ethers category definition which would exclude

alkylphenol ethoxylates is not supportable, based on the available

data. To evaluate the alkylphenol ethoxylates subcategory of the

ethylene glycol ether category, EPA would require subchronic toxicity

data for one or more specific members of the category (e.g., 2-

nonylphenoxyethanol). In the absence of these data, the Agency believes

that the glycol ethers category should continue to include these

substances.

General Electric contended that individual glycol ethers should be

listed in lieu of a category because EPCRA section 313 ``clearly states

that additions to the EPCRA section 313 list must be done on a

chemical-by-chemical basis. Each statutory provision that deals with

revising the section 313 list speaks only in terms of a chemical-by-

chemical basis, and EPCRA is silent on the issue of regulating by

chemical categories.'' The Agency believes that the statutory authority

to add ``a chemical'' to the list may be reasonably interpreted to

include the authority to add groups or categories of chemicals to the

list, particularly in light of the fact that the original list adopted

by Congress in section 313(c) of EPCRA included 20 chemical categories.

These consist mostly of metal compounds categories, but also include

categories of organic chemicals, such as glycol ethers (as noted in the

proposed rule, Congress listed this category without a delimiting

definition).

General Electric further contended that Congress listed ``glycol

ethers'' in addition to the two individually listed glycol ethers, ``2-

methoxyethanol'' and ``2-ethoxyethanol,'' to allow facilities the

option of aggregating the releases of the two individually listed

glycol ether chemicals and filing one TRI Form R report for ``glycol

ether'' rather than two separate Form R reports. EPA does not accept

this interpretation of Congress' intent in listing 20 chemical

categories on the original EPCRA section 313(c) list of chemicals

subject to TRI reporting. There is no clear statement of Congressional

intent to adopt the type of ``optional'' reporting scheme advocated by

General Electric. Indeed, the legislative history cited by General

Electric supports EPA's current interpretation and implementation of

EPCRA's reporting structure, i.e., persons manufacturing, processing,

or otherwise using more than one member of a chemical category above

the applicable reporting threshold may report the releases of all such

chemicals, in the aggregate, on a single Form R report, rather than

listing data separately for each chemical in the group.

Furthermore, contrary to General Electric's contention, several of

the original chemical categories did not have corresponding

``individual'' chemicals listed on the original (CAS number specific)

section 313(c) list. In their comments, General Electric acknowledged

this to be the case only with regard to the polybrominated biphenyls

(PBBs) category. However, there was no individual listing for any

barium compounds, cadmium compounds, chromium compounds, or several

other metal compounds in the original list transmitted to EPA by

Congress. See 53 FR 4500; February 16, 1988. Taken to its logical

conclusion, General Electric's interpretation would result in no

reporting of any members of the PBBs category unless and until EPA

listed individual members of that category. EPA does not believe that

this would be consistent with Congress' intent in listing this category

on the initial section 313(c) list. If Congress had intended to include

category listings as an optional method of reporting individually

listed chemicals, it could have clearly stated so in the statute. At a

minimum, some members of all the listed chemical categories would have

been included in the CAS number specific list. In sum, EPA believes

that its interpretation of the category reporting structure is a

reasonable reading of EPCRA.

General Electric objected to the continued listing of a glycol

ethers category because categories are difficult for EPA to administer

and/or for the public and industry to understand. In addition, the

commenter contended that industry compliance with reporting and

supplier notification requirements is more difficult for categories,

such as glycol ethers, because facilities are not provided with

discrete chemical names and Chemical Abstract Service (CAS) registry

numbers. The commenter contended that these problems are magnified in

the case of the glycol ethers category because the category is defined

by molecular structure formula.

Since the glycol ethers category consists of chemicals that are

similar chemically and in potential effect, EPA believes that this

category will not be difficult for the public or industry to understand

or for the Agency to administer. The Agency will work with the public

and the regulated community to develop, as appropriate, any

interpretations and guidance the Agency determines are necessary to

facilitate accurate reporting for the ``certain glycol ethers''

category. The Agency does not believe that the glycol ethers category

is unique in that it is defined by molecular structure formula. All of

the metal compound categories are defined based on molecular structure

formula, i.e., to be considered a member of a metal compound category,

the compound must consist of the parent metal and at least one

substituent group. Both the chlorophenols and cyanide compound

categories are defined by molecular structure formulas on the EPCRA

section 313 list. EPA believes that defining the category by molecular

structure formula ensures that all members of the category that meet

the EPCRA section 313(d)(2) criteria are included and thus reportable.

Three commenters, the Soap and Detergent Association, Proctor and

Gamble Co., and Union Carbide contended that EPA should be consistent

between EPCRA and TSCA on its treatment of identical materials. Union

Carbide cited the TSCA section 8(b) Inventory provisions. EPA believes

that the differing treatment of glycol ether species with a low degree

of ethoxylation under EPCRA and TSCA is appropriate given the differing

purposes and standards of TSCA section 8(b) and EPCRA section 313. TSCA

is concerned with the regulation of unreasonable risks to human health

and the environment posed by chemical substances and mixtures in

commerce; the section 8(b) Inventory, with few exceptions, provides a

list of those chemical substances and mixtures. For purposes of

developing an inventory of chemical substances in commerce, it is less

important to specify whether those substances consist of a discrete

species, e.g., chloroform, or a species with a range of molecular

weights. EPCRA's goal is to provide the general public with a broad

range of information on releases of certain chemicals.

Under TSCA, for example, glycol ether surfactant ``mixtures'' are

considered as a single entity for purposes of entry on the Inventory;

however, for purposes of reviewing the potential health or

environmental unreasonable risks posed by activities involving such

chemical substances, the impacts of their various components would be

considered. Because the intent of EPCRA section 313 is community right-

to-know, EPA wants to ensure that the public has access to information

on each listed toxic chemical or chemical category to which the public

could be exposed, regardless of whether it is in a mixture. Therefore,

where a surfactant contains species with a low degree of ethoxylation

that fit the glycol ether category definition, EPA requires that those

chemicals be reported.

Union Carbide also contended that ``[a]s a legal matter, the

current and proposed definitions exclude polymers from the category of

glycol ethers. Since polymers potentially include their low molecular

weight species (n = 1, 2, 3), the exemption for polymers precludes the

need to report low molecular weight species under [s]ection 313.''

EPA disagrees with Union Carbide's conclusion regarding species

with low degrees of ethoxylation. The proposed definition being

finalized today continues to exclude polymer molecules (i.e., those

molecules which include at least four covalently linked subunits at

least two of which are internal subunits), and to include low molecular

weight glycol ethers with a low degree of ethoxylation. The change in

regulatory text deleting the phrase ``polymers are excluded from this

category,'' does not change EPA's position regarding the scope of the

glycol ethers category.

One commenter, the Cosmetic, Toiletry, and Fragrance Association,

stated support for the proposal to change the definition of glycol

ethers on other EPA lists. Today's action is not intended, and should

not be inferred to affect the definition or regulatory requirements for

glycol ethers under any statute or EPA program other than the Toxic

Release Inventory reporting requirements under EPCRA section 313 and

the Pollution Prevention Act section 6607. Specifically, the

redefinition of glycol ethers on the EPCRA section 313 list does not in

any way alter their definition under section 112(b) of the Clean Air

Act (CAA), 42 U.S.C. section 7412(b) as amended, or, by virtue of their

status as ``hazardous air pollutants'' (HAP) under the CAA, as

``hazardous substances'' under section 101(14) of the Comprehensive

Environmental Response, Compensation and Liability Act (CERCLA), 42

U.S.C section 9601(14).

VI. Rulemaking Record

The record supporting this final rule is contained in the docket

number OPPTS-400073B. All documents, including an index of the docket,

are available for viewing and photocopying in the TSCA Nonconfidential

Information Center (NCIC), also known as the TSCA Public Docket Office,

from noon to 4 p.m., Monday through Friday, excluding legal holidays.

The TSCA NCIC is located at EPA Headquarters, Rm. NE-B607, 401 M St.,

SW., Washington, DC 20460.

VII. Regulatory Assessment Requirements

A. Executive Order 12866

Under Executive Order (E.O.) 12866 (58 FR 51735, 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. Section 3(f) of the Order defines a ``significant regulatory

action'' as an action likely to lead to a rule (1) Having an annual

effect on the economy of $100 million or more, or adversely and

materially affecting 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) creating serious inconsistency or

otherwise interfering with an action taken or planned by another

agency; (3) materially altering the budgetary impacts of entitlements,

grants, user fees, or loan programs; or (4) raising 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 final rule is not ``significant'' and therefore

not subject to OMB review.

B. Regulatory Flexibility Act

The Regulatory Flexibility Act of 1980 requires each Federal agency

to perform a Regulatory Flexibility Analysis for all rules that are

likely to have a ``significant impact on a substantial number of small

entities.''

40 CFR part 372 exempts certain small businesses (specifically,

those facilities with fewer than 10 full-time employees) from

reporting. This exclusion exempts about one-half of all manufacturing

facilities in Standard Industrial Classification (SIC) codes 20 through

39 from section 313 reporting. Additionally, facilities which

manufacture or process less than 25,000 pounds or otherwise use less

than 10,000 pounds of these chemicals annually are not required to

report for these chemicals. Thus, many small facilities will not incur

any regulatory costs in association with this rule. Small businesses

are not expected to be adversely affected by this rule, since the rule

would increase the likelihood that they would not be required to report

glycol ether releases. Therefore, EPA certifies that this rule is not

likely to significantly impact small entities.

C. Paperwork Reduction Act

There are no unique reporting requirements associated with this

final rule because it redefines the glycol ethers category to exclude

certain high molecular weight glycol ethers from reporting under

section 313. Reporting of chemicals that are subject to section 313 has

been approved by OMB under the provisions of the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq., and has been assigned the OMB control

number 2070-0093.

The public reporting burden for section 313 chemicals is estimated

to average 43 hours per response, including time for reviewing

instructions, searching existing data sources, gathering and

maintaining the data needed, and completing and reviewing the

collection of information. This rule's redefinition will reduce the

number of responses required, thus reducing overall burden.

List of Subjects in 40 CFR Part 372

Environmental protection, Community right-to-know, Reporting and

recordkeeping requirements, Toxic chemicals.

Dated: June 28, 1994.

Lynn R. Goldman,

Assistant Administrator for Prevention, Pesticides and Toxic

Substances.

Therefore, 40 CFR part 372 is amended as follows:

PART 372--[AMENDED]

1. The authority citation for part 372 continues to read as

follows:

Authority: 42 U.S.C. 11023 and 11048.

2. In Sec. 372.65(c) by amending the category, glycol ethers to

read as follows:

Sec. 372.65 Chemicals and chemical categories to which the part

applies.

* * * * *

(c) * * *

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Category Name Effective Date

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*****

Certain Glycol Ethers................................ 1/1/95

R - (OCH2CH2)n - OR'

Where:

n = 1, 2, or 3;

R = alkyl C7 or less; or

R = phenyl or alkyl substituted phenyl;

R' = H or alkyl C7 or less; or

OR' consisting of carboxylic acid ester, sulfate,

phosphate, nitrate, or sulfonate.

*****

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[FR Doc. 94-16173 Filed 6-29-94; 1:07 pm]

BILLING CODE 6560-50-F