[Federal Register Volume 61, Number 146 (Monday, July 29, 1996)]
[Rules and Regulations]
[Pages 39356-39359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19075]


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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372

[OPPTS-400096A; FRL-5372-6]


Diethyl Phthalate; Toxic Chemical Release Reporting; Community 
Right-to-Know

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is deleting diethyl phthalate (DEP) from the list of 
chemicals subject to the reporting requirements under section 313 of 
the Emergency Planning and Community

[[Page 39357]]

Right-to-Know Act of 1986 (EPCRA) and section 6607 of the Pollution 
Prevention Act of 1990 (PPA). Specifically, EPA is deleting DEP because 
the Agency has concluded that DEP meets the deletion criterion 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 DEP that occurred during the 1995 reporting 
year, and for activities in the future.

DATES: This rule is effective July 29, 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 
Hotline, Environmental Protection Agency, Mail Code 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 diethyl phthalate (DEP) 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 produce     
                                             soaps, detergents,         
                                             cleaners, perfumes,        
                                             cosmetics, other toilet    
                                             preparations, unsupported  
                                             film and sheet plastics,   
                                             other plastic products, and
                                             miscellaneous industrial   
                                             organic chemicals.         
------------------------------------------------------------------------
Federal Government                          Federal Agencies that       
                                             manufacture, process, or   
                                             otherwise use DEP.         
------------------------------------------------------------------------

    This table is not intended 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 of 1986 (SARA) (Pub. L. 99-9499).

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 established an initial list of toxic chemicals 
that was comprised of more than 300 chemicals and 20 chemical 
categories. DEP 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 list. EPA has added and 
deleted 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 compound categories. 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 61432, November 30, 1994) (FRL-4922-2).

II. Description of Petition and Proposed Action

    On February 7, 1995, the Fragrance Materials Association petitioned 
the Agency to delete DEP (Chemical Abstract Service (CAS) Registry No. 
84-66-2) from the EPCRA section 313 list of toxic chemicals. The 
petitioner contends that DEP, which is mainly used as a plasticizer, 
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 September 5, 1995 (60 
FR 46076) (FRL-4970-5) proposing to delete DEP from the list of 
chemicals subject to the reporting requirements under EPCRA section 
313. EPA's proposal was based on its preliminary conclusion that DEP 
meets the deletion criteria of EPCRA section 313(d)(3). 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 DEP does not cause 
adverse acute human health effects at concentration levels that are 
reasonably likely to exist beyond facility cite boundaries, and causes 
systemic, developmental, and reproductive toxicities only at relatively 
high doses and thus has low chronic toxicity. Furthermore, EPA 
preliminarily concluded that DEP exhibits low toxicity to aquatic 
organisms, and is not likely to bioconcentrate. EPA also preliminarily 
concluded that releases of DEP will not result in exposures of concern. 
Therefore, EPA preliminarily concluded that based on the total weight 
of available data, DEP 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 the Fragrance Materials 
Association, EPA is deleting DEP from the list of chemicals for which 
reporting is required under EPCRA section 313 and PPA section 6607. EPA 
is delisting this chemical because the Agency has determined that DEP 
satisfies the delisting criterion of EPCRA section 313(d)(3).

[[Page 39358]]

A. Response to Comments

    EPA received four comments in response to the proposed rule, all in 
support of the proposed deletion. EPA agrees with the commenters that 
DEP satisfies the criterion for delisting. One commenter requests that 
EPA make this action effective as of the date of the proposal, 
September 5, 1995, in order for the deletion to apply for the 1995 
reporting year. While this action is effective as of the date of 
publication of this final rule, not the date of the proposal, EPA 
agrees that DEP should not be reported for the 1995 calendar year. As 
discussed in Unit IV. of this preamble, reporting for DEP is not 
required for the 1995 reporting year, covering activities and releases 
which occurred in 1995.

B. Rationale for Delisting and Conclusions

    EPA has concluded that the assessment set out in the proposed rule 
should be affirmed. Further, because of questions raised recently about 
the ability of phthalates to produce hormone disruption, EPA has looked 
at this issue as it relates to DEP. While EPA is aware of limited and 
preliminary in vitro data indicating that some phthalates bind/activate 
estrogen receptors at high concentrations, EPA has not located any such 
information on DEP. Further, for those few phthalates tested in vitro, 
there is no indication that any common structural feature of these 
compounds is responsible for the observed activity. In addition, EPA is 
not aware of any data that demonstrate that DEP produces estrogenic 
effects in vivo. Accordingly, EPA has determined that there is 
insufficient evidence, at this time, to demonstrate that DEP causes 
hormone disruption. In summary, based on the total weight of available 
data, EPA has concluded that DEP cannot reasonably be anticipated to 
cause a significant adverse effect on human health or the environment, 
and therefore DEP meets the delisting criterion of 313(d)(3). A more 
detailed discussion of the rationale for delisting is given in the 
proposed rule (60 FR 46076, September 5, 1995) (FRL-4970-5).
    Based on current data, EPA concludes that DEP does not meet the 
toxicity criterion of EPCRA section 313(d)(2)(A) because DEP exhibits 
acute oral toxicity only at levels that greatly exceed estimated 
exposures outside the facility. Specifically, DEP 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 DEP meets the criterion of EPCRA section 313(d)(2)(B). 
The lowest-observed-adverse-effect-level (LOAEL) for systemic toxicity 
is 3,160 milligrams/kilogram/day (mg/kg/day) and the no-observed-
adverse-effect-level (NOAEL) is 750 mg/kg/day. The LOAEL for 
developmental toxicity is 3,210 mg/kg/day and the NOAEL is 1,910 mg/kg/
day. The NOAEL for reproductive toxicity is approximately 3,750 mg/kg/
day, which was the highest dose tested. EPA has no information 
indicating that DEP causes any other section 313(d)(2)(B) effects. EPA 
considers the above doses where DEP caused adverse effects to be 
relatively high and concludes that DEP has low chronic toxicity. 
Therefore, EPA conducted an exposure assessment for chronic human 
exposure and found that exposure to DEP at the estimated levels is not 
likely to result in adverse health risks in humans. EPA has estimated 
that releases of DEP will not result in exposures of concern. 
Therefore, EPA has concluded that DEP does not meet the EPCRA section 
313(d)(2)(B) listing criterion.
    EPA has also concluded that DEP 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. DEP exhibits low toxicity 
to aquatic organisms (fish 96 hr median lethal concentration 
(LC50), 12 to 100 milligrams/liter (mg/l); daphnid 48 hr 
LC50, 50 to 90 mg/l; and algae 96 hr median effective 
concentration (EC50), 30 to 86 mg/l, and is not likely to 
bioconcentrate.
    Thus, in accordance with EPCRA section 313(d)(3), EPA is deleting 
DEP from the section 313 list of toxic chemicals. Today's action is not 
intended, and should not be inferred, to affect the status of DEP under 
any other statute or program other than the reporting requirements 
under EPCRA section 313.

IV. Effective Date

    This action becomes effective July 29, 1996. Thus, the last year in 
which facilities had to file a Toxic Release Inventory (TRI) report for 
DEP was 1995, covering releases and other activities that occurred in 
1994.
    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 has determined, as it has with 
DEP, 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 decision is contained in docket control 
number OPPTS-400096A. All documents, including an index of the docket, 
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. 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 $124,000 per year. The cost savings to 
EPA is estimated at $3,000 per year.
    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. 104-4). And, 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 forwarded to the Small 
Business Administration.
    This action does not have any information collection requirements 
subject to the provisions of the

[[Page 39359]]

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 2,305 paperwork burden 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, Toxic chemicals.

    Dated: July 19, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

    Therefore, 40 CFR part 372 is amended to read as follows:
    1. The authority citation for part 372 continues to read as 
follows:

    Authority: 42 U.S.C. 11013 and 11028.

Sec. 372.65  [Amended]

    Sections 372.65(a) and (b) are amended by removing the entire entry 
for diethyl phthalate under paragraph (a) and removing the entire CAS 
No. entry for 84-66-2 under paragraph (b).

[FR Doc. 96-19075 Filed 7-26-96; 8:45 am]
BILLING CODE 6560-50-F