[Federal Register Volume 61, Number 148 (Wednesday, July 31, 1996)]
[Rules and Regulations]
[Pages 39891-39894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19452]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372

[OPPTS-400095A; FRL-5389-6]


Di-(2-ethylhexyl) Adipate; Toxic Chemical Release Reporting; 
Community Right-to-Know

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is deleting di-(2-ethylhexyl) adipate (DEHA) (CAS No. 103-
23-1), also known as bis(2-ethylhexyl) adipate, from the list of 
chemicals subject to reporting requirements under section 313 of the 
Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) and 
section 6607 of the Pollution Prevention Act of 1990 (PPA). 
Specifically, EPA is deleting DEHA because the Agency has concluded 
that DEHA meets the deletion criteria of EPCRA section 313(d)(3). By 
promulgating this rule, EPA is relieving facilities of their obligation 
to report releases of and other waste management information on DEHA 
that occurred during the 1995 reporting year, and for activities in the 
future.


[[Page 39892]]


EFFECTIVE DATE: This rule is effective July 31, 1996.

FOR FURTHER INFORMATION CONTACT: Daniel R. Bushman, Acting Petitions 
Coordinator, 202-260-3882, e-mail: [email protected], for 
specific information on this final rule, or for more information on 
EPCRA section 313, 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: 1-800-535-0202, in 
Virginia and Alaska: 703-412-9877, or Toll free TDD: 1-800-553-7672.

SUPPLEMENTARY INFORMATION:

I. Introduction

A. Affected Entities

    Entities potentially affected by this action are those which 
manufacture, process, or otherwise use di-(2-ethylhexyl) adipate (DEHA) 
and which are subject to the reporting requirements of section 313 of 
the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA), 
42 U.S.C. 11023 and section 6607 of the Pollution Prevention Act of 
1990 (PPA), 42 U.S.C. 13106. Some of the affected categories and 
entities include:

                                                                        
------------------------------------------------------------------------
                                                Examples of affected    
                 Category                             entities          
------------------------------------------------------------------------
Industry                                    Facilities that compound,   
                                             shape, or manufacture      
                                             plastic and rubber         
                                             products. Metal working    
                                             industries including       
                                             foundries, automotive      
                                             plants, coating and        
                                             engraving shops, and metal 
                                             products companies. Firms  
                                             that formulate or produce  
                                             adhesives and sealants;    
                                             lubricants for jet engines;
                                             pharmaceuticals, perfumes, 
                                             and cosmetics; and other   
                                             organic chemicals.         
------------------------------------------------------------------------
Federal Government                          Federal Agencies that       
                                             manufacture, process, or   
                                             otherwise use DEHA.        
------------------------------------------------------------------------

    This table is not meant to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be affected by this 
action. This table lists the types of entities that EPA is now aware 
could potentially be affected by this action. Other types of entities 
not listed in the table could also be affected. To determine whether 
your facility is affected by this action, you should carefully examine 
the applicability criteria in part 372 subpart B of Title 40 of the 
Code of Federal Regulations.

B. Statutory Authority

    This action is taken under sections 313(d) and (e)(1) of EPCRA. 
EPCRA is also referred to as Title III of the Superfund Amendments and 
Reauthorization Act (SARA) of 1986 (Pub. L. 9909-499).

C. Background

    Section 313 of EPCRA requires certain facilities manufacturing, 
processing, or otherwise using listed toxic chemicals to report their 
environmental releases of such chemicals annually. Beginning with the 
1991 reporting year, such facilities must also report pollution 
prevention and recycling data for such chemicals, pursuant to section 
6607 of PPA. Section 313 of EPCRA established an initial list of toxic 
chemicals that was comprised of more than 300 chemicals and 20 chemical 
categories. DEHA was included in the initial list of chemicals and 
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)(1), any person may petition EPA to add 
chemicals to or delete chemicals from the original statutory list. 
Pursuant to EPCRA section 313(e)(1), EPA must respond to petitions 
within 180 days either by initiating a rulemaking or by publishing an 
explanation of why the petition has been denied.
    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 issued a statement of policy and guidance 
regarding the recommended content of petitions to delete individual 
members of the section 313 metal compounds category. EPA has published 
a statement clarifying its interpretation of the section 313(d)(2) and 
(3) criteria for adding and deleting chemicals from the section 313 
toxic chemical list (59 FR 61439, November 30, 1994) (FRL-4922-2).

II. Description of Petition and Proposed Action

    On January 18, 1995, EPA received a petition from the Chemical 
Manufacturers Association (CMA) to exclude DEHA from the EPCRA section 
313 list of toxic chemicals. Specifically, the petition requests that 
DEHA be deleted from the list of reportable chemicals and not be 
subject to the annual reporting requirements under EPCRA section 313 
and section 6607 of PPA. The petitioner contends that DEHA should be 
deleted from the EPCRA section 313 list because it does not meet any of 
the EPCRA section 313(d)(2) criteria.
    Following a review of the petition, EPA granted the petition and 
issued a proposed rule in the Federal Register of August 1, 1995 (60 FR 
39132) (FRL-4958-8), proposing to delete DEHA from the list of toxic 
chemicals subject to the reporting requirements under EPCRA section 
313. EPA's proposal was based on its preliminary conclusion that DEHA 
meets the EPCRA section 313(d)(3) criteria for deletion from the list. 
With respect to deletions, EPCRA provides at section 313(d)(3) that 
``[a] chemical may be deleted if the Administrator determines there is 
not sufficient evidence to establish any of the criteria described in 
paragraph [(d)(2)(A)-(C)].'' In the proposed rule, EPA preliminarily 
concluded that the available toxicological data indicates that DEHA 
does not cause adverse acute human health effects at concentration 
levels that are reasonably likely to exist beyond facility site 
boundaries, and causes systemic, developmental, and reproductive 
toxicities only at relatively high doses and thus has low chronic 
toxicity. Furthermore, EPA preliminarily concluded that DEHA does not 
pose a significant hazard to the environment. EPA also preliminarily 
concluded that releases of DEHA will not result in exposures of 
concern. Therefore, EPA preliminarily concluded that based on the total 
weight of available data, DEHA cannot reasonably be anticipated to 
cause a significant adverse effect on human health or the environment.

III. Final Rule and Rationale for Delisting

    In response to the petition from CMA, EPA is deleting DEHA from the 
list of chemicals for which reporting is required under section 313 of 
EPCRA and PPA section 6607. EPA is delisting this chemical because the 
Agency has determined that DEHA satisfies the delisting criteria of 
EPCRA section 313(d)(3).

A. Response to Comments

    EPA received three comments in response to the proposed rule. All 
three of the commenters noted their support for the deletion of DEHA 
from the EPCRA section 313 list. EPA agrees with the commenters that 
DEHA satisfies the criterion for delisting.

[[Page 39893]]

B. Rationale for Delisting and Conclusions

    EPA has concluded that the assessment set out in the proposed rule 
should be affirmed. Because of questions raised recently about the 
ability of DEHA to produce hormone disruption, EPA has looked at this 
issue. EPA is aware of limited and preliminary in vitro data indicating 
that DEHA reduced the binding of the tritiated natural estrogen, 
17-estradiol, to the rainbow trout estrogen receptor (Ref. 1). 
However, these results were obtained only at high concentrations and 
indicated that DEHA's potential binding activity is very weak compared 
to the estradiol. In addition, EPA is not aware of any data that 
demonstrate that DEHA produces estrogenic effects in vivo. The in vivo 
toxicity data on DEHA, discussed below, also indicate that DEHA is a 
weak developmental and reproductive toxicant. However, at this time, 
there is no indication that these effects are due to binding to the 
estrogen receptor. Accordingly, EPA has determined that there is 
insufficient evidence, at this time, to demonstrate that DEHA causes 
hormone disruption. In summary, based on the total weight of available 
data, EPA has concluded that DEHA cannot reasonably be anticipated to 
cause a significant adverse effect on human health or the environment, 
and therefore DEHA meets the delisting criterion of section 313(d)(3). 
A more detailed discussion of the rationale for delisting is given in 
the proposed rule (August 1, 1995, 60 FR 39134) (FRL-4958-8).
    Based on current data, EPA concludes that DEHA does not meet the 
toxicity criterion of EPCRA section 313(d)(2)(A) because DEHA exhibits 
acute oral toxicity only at levels that greatly exceed estimated 
exposures outside the facility. Specifically, DEHA cannot reasonably be 
anticipated to cause ``. . . significant adverse acute human health 
effects at concentration levels that are reasonably likely to exist 
beyond facility site boundaries as a result of continuous, or 
frequently recurring, releases.''
    EPA has concluded that there is not sufficient evidence to 
establish that DEHA meets the criterion of EPCRA section 313(d)(2)(B). 
The lowest-observed-adverse-effect-level (LOAEL) for systemic toxicity, 
in rats, is 1,125 milligrams/kilogram/day (mg/kg/day) for both chronic 
and 13-week studies. In mice, the LOAELs ranged from 2,800 mg/kg/day 
(chronic study) to 900 mg/kg/day (13-week study). Also, based on 
limited data, the LOAEL for developmental toxicity is 1,080 mg/kg/day 
and the no-observed-adverse-effect-level (NOAEL) is 170 mg/kg/day. 
Based on limited data, the LOAEL and NOAEL for reproductive toxicity 
are 1,080 and 170 mg/kg/day. EPA has no information indicating that 
DEHA causes any other section 313(d)(2)(B) effects. EPA considers the 
above doses where DEHA caused adverse effects to be relatively high and 
concludes that DEHA has low chronic toxicity. Therefore, EPA conducted 
an exposure assessment for chronic human exposure and found that 
exposures at the estimate levels are not likely to result in adverse 
health risks in humans. EPA has estimated that releases of DEHA will 
not result in exposures of concern. Therefore, EPA has concluded that 
DEHA does not meet the EPCRA section 313(d)(2)(B) listing criterion.
    EPA has also concluded that DEHA does not meet the toxicity 
criterion of EPCRA section 313(d)(2)(C) because it cannot reasonably be 
anticipated to cause adverse effects on the environment of sufficient 
seriousness to warrant continued reporting. EPA considers DEHA to 
exhibit low toxicity to aquatic organisms. Based on structure activity 
relationships (SARs), no toxic effects are anticipated for both 
freshwater and saltwater species at saturation. For sediment species, 
acute and chronic toxicity are expected to occur only at high 
concentrations: 1,000 and 100 mg/kg (dry weight), respectively. 
Therefore, DEHA is not expected to pose a significant hazard to the 
environment.
    Thus, in accordance with EPCRA section 313(d)(3), EPA is deleting 
DEHA from the section 313 list of toxic chemicals. Today's action is 
not intended, and should not be inferred, to affect the status of DEHA 
under any other statute or program other than the reporting 
requirements under EPCRA section 313 and PPA section 6607.

IV. Effective Date

    This action becomes effective July 31, 1996. Thus, the last year in 
which facilities had to file a Toxics Release Inventory (TRI) report 
for DEHA was 1995, covering releases and other activities that occurred 
in 1994.
    EPCRA section 313(d)(4) provides that ``[a]ny revision'' to the 
section 313 list of toxic chemicals shall take effect on a delayed 
basis. EPA interprets this delayed effective date provision to apply 
only to actions that add chemicals to the section 313 list. For 
deletions, EPA 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) because a deletion from 
the section 313 list relieves a regulatory restriction.
    EPA believes that where the Agency had determined, as it has with 
this chemical, that a chemical does not satisfy any of the criteria of 
section 313(d)(2)(A)-(C), no purpose is served by requiring facilities 
to collect data or file TRI reports for that chemical, or, therefore, 
by leaving that chemical on the section 313 list for any additional 
period of time. This construction of section 313(d)(4) is consistent 
with previous rules deleting chemicals from the section 313 list. For 
further discussion of the rationale for immediate effective dates for 
EPCRA section 313 delistings, see 59 FR 33205 (June 28, 1994).

V. Rulemaking Record

    The record supporting this final rule is contained in docket 
control number OPPTS-400095A. All documents, including an index of the 
docket and the reference listed in Unit VI. of this preamble, are 
available in the TSCA Nonconfidential Information Center (NCIC), also 
known as, TSCA Public Docket Office, from 12 noon to 4 p.m., Monday 
through Friday, excluding legal holidays. TSCA NCIC is located at EPA 
Headquarters, Rm. NE-B607, 401 M St., SW., Washington, DC 20460.

VI. References

    1. Jobling, S., Reynolds, T., White, R., Parker, M. G., Sumpter, J. 
P., ``A Variety of Environmentally Persistent Chemicals, Including Some 
Phthalate Plasticizers Are Weakly Estrogenic,'' Environmental Health 
Perspectives, 103, (1995), pp. 582-587.

VII. Regulatory Assessment Requirements

    It has been determined that this action is not a ``significant 
regulatory action'' within the meaning of Executive Order 12866 (58 FR 
51735, October 4, 1993), because this action eliminates an existing 
regulatory requirement. The Agency estimates the total cost savings to 
industry from this action to be approximately $322,620 and the savings 
to EPA would be approximately $8,664.
    This action does not impose any Federal mandate on State, local or 
tribal governments or the private sector within the meaning of the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 1041). Also, given its 
deregulatory nature, I hereby certify pursuant to the Regulatory 
Flexibility Act (5 U.S.C. 605(b)), that this action does not have a 
significant economic impact on a substantial number of small entities. 
As required, information to this effect has been

[[Page 39894]]

forwarded to the Small Business Administration.
    This action does not have any information collection requirements 
subject to the provisions of the Paperwork Reduction Act of 1980, 44 
U.S.C. 3501 et seq. The elimination of the information collection 
components for this action is expected to result in the elimination of 
6,383 paperwork reduction hours.
    In addition, pursuant to Executive Order 12898 (59 FR 7629, 
February 16, 1994), entitled ``Federal Actions to Address Environmental 
Justice in Minority Populations and Low-Income Populations,'' the 
Agency has determined that there are no environmental justice-related 
issues with regard to this action since this final rule simply 
eliminates reporting requirements for a chemical that, under the 
criteria of EPCRA section 313, does not pose a concern for human health 
or the environment.
    Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act 
(APA) as amended by the Small Business Regulatory Enforcement Fairness 
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted 
a report containing this rule and other required information to the 
U.S. Senate, the U.S. House of Representatives and the Comptroller 
General of the General Accounting Office prior to publication of the 
rule in today's Federal Register. This rule is not a ``major rule'' as 
defined by 5 U.S.C. 804(2) of the APA as amended.

List of Subjects in 40 CFR Part 372

    Environmental protection, Community right-to-know, Reporting and 
recordkeeping requirements, and Toxic chemicals.

    Dated: July 25, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.
    Therefore, 40 CFR part 372 is amended as follows:
    1. The authority citation for part 372 continues to read as 
follows:

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

Sec. 372.65 [Amended]

    2. Sections 372.65(a) and (b) are amended by removing the entry for 
bis(2-ethylhexyl) adipate under paragraph (a) and the entire CAS number 
entry for 103-23-1 under paragraph (b).

[FR Doc. 96-19452 Filed 7-31-96; 8:45 am]
BILLING CODE 6560-50-F