Export Notification; Proposed Change to Reporting Requirements, 6733-6743 [E6-1797]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 71, Number 27 (Thursday, February 9, 2006)]
[Proposed Rules]
[Pages 6733-6743]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-1797]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 707 and 799

 [EPA-HQ-OPPT-2005-0058; FRL-7752-2]
RIN 2070-AJ01


Export Notification; Proposed Change to Reporting Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing amendments to the Toxic Substances Control 
Act (TSCA) section 12(b) export notification regulations at subpart D 
of 40 CFR part 707. One amendment would change the current annual 
notification requirement to a one-time requirement for exporters of 
chemical substances or mixtures (hereinafter referred to as 
``chemicals'') for which certain actions have been taken under TSCA. 
Relatedly, for the same TSCA actions, EPA is proposing to change the 
current requirement that the Agency notify foreign governments annually 
after the Agency's receipt of export notifications from exporters to a 
requirement that the Agency notify foreign governments once after it

[[Page 6734]]

receives the first export notification from an exporter. EPA is also 
proposing de minimis concentration levels below which notification 
would not be required for the export of any chemical for which export 
notification under TSCA section 12(b) is otherwise required, proposing 
other minor amendments (to update the EPA addresses to which export 
notifications must be sent, to indicate that a single export 
notification may refer to more than one section of TSCA where the 
exported chemical is the subject of multiple TSCA actions, and to 
correct an error), and clarifying exporters' and EPA's obligations 
where an export notification-triggering action is taken with respect to 
a chemical previously or currently subject to export notification due 
to the existence of a previous triggering action.

DATES: Comments must be received on or before April 10, 2006.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2005-0058, by one of the following methods:
      https://www.regulations.gov: Follow the on-line 
instructions for submitting comments.
     Agency Website: EDOCKET, EPA's electronic public docket 
and comment system, was replaced on November 25, 2005, by an enhanced 
Federal-wide electronic docket management and comment system located at 
https://www.regulations.gov. Follow the on-line instructions.
     E-mail: oppt.ncic@epa.gov.
     Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA 
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID number EPA-HQ-OPPT-2005-0058. The DCO is open from 
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the Docket's normal hours of operation, and 
special arrangements should be made for deliveries of boxed 
information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2005-0058. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available on-line 
at www.regulations.gov, including any personal information provided, 
unless the comment includes information claimed to be Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Do not submit information that you consider to 
be CBI or otherwise protected through www.regulations.gov or e-mail. 
The www.regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the public docket and made available 
on the Internet. If you submit an electronic comment, EPA recommends 
that you include your name and other contact information in the body of 
your comment and with any disk or CD ROM you submit. If EPA cannot read 
your comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at https://www.epa.gov/epahome/dockets.htm/.
    Docket: All documents in the docket are listed in the 
www.regulations.gov index. Although listed in the index, some 
information is not publicly available, i.e., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy 
form. Publicly available docket materials are available either 
electronically in www.regulations.gov or in hard copy at the OPPT 
Docket (EPA/DC), EPA West, Rm. B102, 1301 Constitution Ave., NW., 
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 
p.m., Monday through Friday, excluding legal holidays. The telephone 
number for the Public Reading Room is (202) 566-1744, and the telephone 
number for the OPPT Docket is (202) 566-0280.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
    For technical information contact: Kenneth Moss, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-9232; e-mail 
address: moss.kenneth@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you export or 
intend to export any chemical substance or mixture for which any of the 
following actions have been taken under TSCA with respect to that 
chemical substance or mixture: Data are required under TSCA section 4 
or 5(b), an order has been issued under TSCA section 5, a rule has been 
proposed or promulgated under TSCA section 5 or 6, or an action is 
pending, or relief has been granted under TSCA section 5 or 7. 
Potentially affected entities may include, but are not limited to:
     Exporters of chemical substances or mixtures (NAICS codes 
325 and 324110; e.g., chemical manufacturing and processing and 
petroleum refineries).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions at 40 CFR 707.60 for 
TSCA section 12(b)-related obligations. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the technical person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using the electronic docket, you may access this 
Federal Register document electronically through the EPA Internet under 
the ``Federal Register'' listings at https://www.epa.gov/fedrgstr/. A 
frequently updated electronic version of both 40 CFR parts 707 and 799 
are available on E-CFR Beta Site Two at https://www.gpoaccess.gov/ecfr/.

C. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
https://

[[Page 6735]]

www.regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as 
CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the rulemaking by docket ID number and other 
identifying information (subject heading, Federal Register date and 
page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns, and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing amendments to TSCA section 12(b) export 
notification regulations at subpart D of 40 CFR part 707. The first 
amendment would change the current annual notification requirement for 
exporters of chemicals for which certain actions have been taken under 
TSCA. Currently, the TSCA section 12(b) regulations require exporters 
of chemicals to notify EPA of the first export or intended export to a 
particular country in a calendar year when data are required under TSCA 
section 5(b), an order has been issued under TSCA section 5, a rule has 
been proposed or promulgated under TSCA section 5 or 6, or an action is 
pending, or relief has been granted under TSCA section 5 or 7. For 
chemicals subject to a final TSCA section 4 action, exporters are 
currently required to submit an export notification only for the first 
export or intended export to a particular country. This proposed rule 
would change the current annual export notification requirement to a 
one-time requirement for each of the following TSCA section 12(b)-
triggering actions per each destination country for each exporter of a 
chemical: An order issued, an action pending, or an action granting 
relief under TSCA section 5(e), a proposed or promulgated rule under 
TSCA section 5(a)(2), or an action requiring the submission of data 
under TSCA section 5(b). For exports of chemicals that are the subjects 
of TSCA section 12(b)-triggering actions under TSCA section 5(f), 6, or 
7, however, each exporter would continue to be required to submit 
annual export notifications to EPA.
    Relatedly, EPA is proposing a change in the frequency for which the 
Agency must notify foreign governments after the Agency's receipt of 
export notifications from exporters. Consistent with the current 
requirement that EPA notify foreign governments one time regarding the 
export of chemicals subject to final TSCA section 4 actions, EPA is 
proposing that the Agency provide a one-time (rather than the current 
annual) notice to each foreign government to which exported chemicals 
that are the subjects of any of the following actions are sent: An 
order issued, an action pending, or an action granting relief under 
TSCA section 5(e), a rule proposed or promulgated under TSCA section 
5(a)(2), or an action requiring the submission of data under TSCA 
section 5(b). EPA would continue to notify each foreign government on 
an annual basis regarding the export of chemicals that are the subject 
of TSCA section 5(f), 6, or 7 actions.
    EPA is also proposing de minimis concentration levels below which 
notification would not be required for the export of any chemical for 
which export notification under TSCA section 12(b) is otherwise 
required. Specifically, EPA is proposing that export notification would 
not be required for such chemicals if the chemical is being exported at 
a concentration of less than 1% (by weight or volume), unless that 
chemical is:
    1. Listed as a ``known to be human carcinogen'' or ``reasonably 
anticipated to be human carcinogen'' in the Report on Carcinogens 
issued by the U.S. Department of Health and Human Services National 
Toxicology Program (NTP) (Ref. 1),
    2. Classified as a Group 1, Group 2A, or Group 2B carcinogen by the 
World Health Organization International Agency for Research on Cancer 
(IARC) in the list of IARC Monographs on the Evaluation of Carcinogenic 
Risks to Humans and their Supplements (Ref. 2), or
    3. Characterized as a carcinogen or potential carcinogen in the 
Occupational Safety and Health Administration's (OSHA's) regulations 
related to toxic and hazardous substances (29 CFR part 1910, subpart 
Z).
For paragraphs 1-3 of this unit, a de minimis concentration level of 
less than 0.1% (by weight or volume) would apply. For exports of 
polychlorinated biphenyls (PCBs), notification would not be required if 
such chemicals are being exported at a concentration of less than or 
equal to 50 parts per million (ppm) (by weight or volume).
    EPA believes this proposed rule is needed to further focus 
importing governments' resources and attention on chemicals for which 
EPA has proposed to make or has made a finding under TSCA that a 
chemical substance or mixture ``presents or will present'' an 
unreasonable risk, and to reduce overall burden on exporters and the 
Agency. EPA requests comments on these proposed amendments, and is 
particularly interested in receiving comments discussing whether the 
proposed changes would continue to provide adequate notice and 
information to foreign governments about chemicals imported from the 
United States. EPA is also interested in receiving specific, well 
supported, information regarding how the proposed changes would affect 
exporters.
    In this Federal Register document, EPA is also updating the 
instructions for the submission of export notifications to the Agency 
(40 CFR 707.65(c)), clarifying exporters' and EPA's obligations when 
subsequent TSCA section 12(b)-triggering actions are taken with respect 
to a chemical previously or currently subject to export notification 
due to a separate triggering action, indicating in 40 CFR 707.67 that a 
single export notification may refer to more than one section of TSCA 
where the exported chemical is the subject of multiple TSCA actions, 
and correcting 40 CFR 799.19 to make it clear that final multi-chemical 
TSCA section 4 rules also trigger export notification (see Unit IV.).

[[Page 6736]]

B. What is the Agency's Authority for Taking this Action?

    EPA is proposing these amendments pursuant to TSCA section 12(b), 
15 U.S.C. 2611(b). Section 12(b) of TSCA requires that any person who 
exports or intends to export to a foreign country a chemical for which 
the submission of data is required under TSCA section 4 or 5(b), an 
order has been issued under TSCA section 5, a rule has been proposed or 
promulgated under TSCA section 5 or 6, or with respect to which an 
action is pending or relief has been granted under TSCA section 5 or 7 
must notify the Administrator of EPA of such exportation or intent to 
export. Upon receipt of such notification, EPA must furnish the 
government of the importing country with:
    1. Notice of the availability of data received pursuant to an 
action under TSCA section 4 or 5(b) or
    2. Notice of such rule, order, action, or relief under TSCA section 
5, 6, or 7.

C. History

    In the Federal Register of December 16, 1980, EPA promulgated rules 
at 40 CFR part 707, subpart D, implementing TSCA section 12(b) (Ref. 
3). Under these rules, exporters were required to submit a written 
notification to EPA for the first export or intended export to a 
particular country in a calendar year for any chemical that was the 
subject of a TSCA section 12(b)-triggering action. Upon receipt of such 
notification from an exporter, the implementing rules required (and 
still require) that EPA provide the importing country with, among other 
things, a summary of the action taken or an indication of the 
availability of data received pursuant to action under TSCA section 4 
or 5(b) (see 40 CFR 707.70(b)).
    To facilitate foreign governments' consideration of export notices 
for chemicals exported from the United States and to reduce the burden 
on EPA and exporters, EPA promulgated a rule in the Federal Register of 
July 27, 1993, that amended the regulations in 40 CFR part 707, subpart 
D (Ref. 4). The amendment limited the notification requirement for each 
exporter of chemicals subject to a final TSCA section 4 action to a 
one-time notification to EPA for the export of each such chemical to 
each particular country, instead of requiring annual notification to 
EPA for shipments of the chemical to that country. The amended rule 
also limited EPA's notice to foreign governments to one time for the 
export of each chemical subject to a final TSCA section 4 action. The 
1993 amendment did not change the export notification requirements for 
chemicals that are the subject of an action under TSCA section 5, 6, or 
7; that is, exporters are currently required to provide annual 
notification of the export of each chemical that is the subject of an 
action under TSCA section 5, 6, or 7. The 1993 amendment also did not 
change the frequency of EPA's notice to foreign governments for 
chemicals subject to TSCA section 5, 6, or 7; EPA notice is provided 
upon receipt of the first annual export notification for each such 
chemical to each country.
    In support of the 1993 amendment, EPA indicated that an increase in 
the number of TSCA section 12(b) export notifications during the 1980s 
made import monitoring more difficult for many foreign countries, and 
imposed an increasing burden upon foreign governments, industry, and 
EPA resources. EPA had determined that much of the increase in 
notifications was associated with the export or intended export of 
chemicals subject to final TSCA section 4 actions. At the time, EPA 
believed that the increasing volume of notices made it difficult for 
foreign countries which receive a large number of notices to generally 
distinguish between those chemicals for which, for example, EPA had 
taken an action to restrict use and those chemicals for which EPA has 
required the generation of data but has not taken an action to restrict 
use. By decreasing the volume of notices importing countries receive on 
chemicals subject to final TSCA section 4 actions, EPA believed that 
the 1993 amendment could increase the relative effectiveness of notices 
by allowing foreign governments to better focus their efforts on 
notices for chemicals that are the subject of actions under TSCA 
section 5, 6, or 7.
    To further reduce the information collection burden for TSCA 
section 12(b) export notification, EPA developed and periodically 
updates a website that provides a list of chemicals subject to TSCA 
section 12(b) export notification requirements (see ``Current List of 
Chemical Substances Subject to TSCA Section 12(b) Export Notification 
Requirements'' at https://www.epa.gov/opptintr/chemtest/main12b.htm). In 
addition, exporters' obligation to submit a one-time export 
notification to EPA for the export of a chemical subject to a final 
TSCA section 4 action terminates once the reimbursement period for that 
particular action expires. OPPT has made available a comprehensive 
listing of these ``sunset'' dates for all such chemicals (see ``Sunset 
Date/Status of TSCA Section 4 Testing, Reimbursement, and Reporting 
Requirements and TSCA Section 4-Triggered TSCA Section 12(b) Export 
Notification Requirements'' at https://www.epa.gov/opptintr/chemtest/
sunset.htm). The regulated community has indicated that these lists 
serve as useful tools to assist exporters in complying with TSCA and 
EPA believes that they have resulted in an overall reduction of the 
information collection burden associated with TSCA section 12(b) export 
notification requirements.

D. Rotterdam Convention

    EPA notes as further background the Rotterdam Convention on the 
Prior Informed Consent Procedure for Certain Hazardous Chemicals and 
Pesticides in International Trade (Rotterdam Convention) (Ref. 5), a 
multi-lateral environmental agreement that the United States signed in 
September of 1998 but has not yet ratified (and thus is not a Party 
to). This Rotterdam Convention, which went into force in February of 
2004, includes the following major obligations:
    1. Notification of control action and imposition of export 
notification requirement on exporters. The Rotterdam Convention 
requires exporting parties to: Determine whether a pesticide or 
industrial chemical is ``banned'' or ``severely restricted'' (BSR); 
notify the Secretariat of that determination; and notify importing 
parties of the export of those chemicals from their country prior to 
their export after making the BSR determination and thereafter for the 
first export of every calendar year.
    2. Impose export restrictions consistent with importing parties 
response. Once a BSR chemical (and its use category, i.e., use as a 
pesticide or industrial chemical) is, by consensus of the Parties, 
added to Annex III of the Rotterdam Convention, the Rotterdam 
Convention requires importing parties to identify any conditions/
restrictions on the import of these substances and exporting parties to 
make sure exports occur consistent with conditions/restrictions 
identified by importing countries. Annex III of the Rotterdam 
Convention contains a list of chemicals that are subject to the Prior 
Informed Consent Procedures described by the Rotterdam Convention (Ref. 
5).
    3. Label exported products. For countries' domestic BSR chemicals 
and the Rotterdam Convention's Annex III chemicals, the Rotterdam 
Convention requires labeling to ``ensure adequate availability of 
information with regard to risks and/or hazards to human health or the 
environment.'' For the Rotterdam Convention's Annex III chemicals, 
labels must also include a Harmonized

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System Code if available (Ref. 6). For an exporting country's BSR 
chemicals and the Rotterdam Convention's Annex III chemicals that are 
to be used in an occupational setting, each exporting Party must send 
the most up-to-date safety data sheet for the chemical to each 
importer.
    EPA believes the export notification mechanism in the Rotterdam 
Convention broadly reflects importing governments' interests and that 
this proposal to amend the TSCA section 12(b) export notification rule 
is not inconsistent with the export notification provisions of the 
Rotterdam Convention.
    EPA wishes to note that the Administration is committed to the 
United States becoming a Party to the Rotterdam Convention, as well as 
two other chemicals-related multi-lateral environmental agreements: the 
Stockholm Convention on Persistent Organic Pollutants (POPs) (Stockholm 
Convention) (Ref. 7) and the POPs Protocol to the United Nations 
Economic Commission for Europe Convention on Long Range Transboundary 
Air Pollution (LRTAP) (Ref. 8). The Administration has been and intends 
to continue working with Congress to facilitate the development of 
legislation that would provide the authority needed for the United 
States to fully implement and become a Party to those agreements. If 
and when such legislation is enacted, and depending on the nature of 
the legislation, it may be appropriate or necessary to further amend 
the TSCA section 12(b) regulations.

III. Rationale for This Proposed Rule

    EPA believes this proposed rule is a reasonable supplement to the 
1993 amendments to EPA's export notification regulations because it 
would further reduce overall burden on exporters and the Agency and 
would further focus importing governments' resources and attention on 
chemicals for which EPA has proposed to make or has made a definitive 
finding that a chemical ``presents or will present'' an unreasonable 
risk to human health or the environment.
    In the 1993 amendments, it was EPA's view that TSCA section 5(a)(2) 
and 5(e) actions, which are based on exposure or risk concerns for 
identified use scenarios, ``restrict'' in a limited sense, regulated 
uses. The 1993 amendments further stated that the Agency has authority 
to take follow-up action under TSCA section 5(a)(2) via TSCA section 
5(e) and because there is no similar provision under TSCA section 4 
(with the exception of a separate proceeding under TSCA section 6 or 
7), there was a reasonable basis for treating the export notification 
requirement for chemicals regulated under TSCA sections 4 and 5 
differently (Ref. 4, p. 40240). This proposed rule, however, would 
treat actions under TSCA sections 5(a)(2) and 5(e) similarly to final 
actions under TSCA section 4 for purposes of export notification, such 
that a one-time notice would be required. Although TSCA sections 
5(a)(2) and 5(e) restrict use in some sense, the statutory finding for 
such actions is based on consideration of ``factors'' relating to a 
``significant new use'' determination under TSCA section 5(a)(2) or, 
for TSCA section 5(e), the same ``may present an reasonable risk'' or 
``substantial production/significant/substantial exposure'' findings 
required under TSCA section 4 rulemakings. EPA believes foreign 
governments will want to focus greater attention on chemicals for which 
the Agency has made a finding that a chemical ``presents or will 
present'' an unreasonable risk to human health or the environment (TSCA 
sections 5(f)(1), 6(a), and 7). This finding represents a definitive 
determination and thus is different from a finding that a chemical 
``may present'' an unreasonable risk (TSCA sections 4(a)(1)(A)(i) and 
5(e)(1)(A)(ii)(I)), substantial production and substantial or 
significant exposure/release findings (``exposure-based'' findings; 
TSCA sections 4(a)(1)(B)(i), 5(b)(4)(A)(i), and 5(e)(1)(A)(ii)(II)), or 
factors determining a significant new use (TSCA section 5(a)(2)). 
Because ``presents or will present'' an unreasonable risk to human 
health or the environment is a definitive risk determination, EPA 
believes that it is reasonable to require more frequent notification 
for those chemicals that are the subject of each export notification-
triggering action under TSCA sections 5(f), 6, and 7. Therefore, EPA 
would continue to require annual export notification by exporters of 
chemicals that are the subject of each action under TSCA section 5(f), 
6, or 7, and EPA is similarly amending the regulatory provision 
regarding EPA's notice to foreign governments to limit annual notices 
to chemicals that are the subject of each TSCA section 5(f), 6, or 7 
action.
    EPA is also proposing de minimis concentration levels below which 
notification would not be required for the export of any chemical that 
is the subject of an action under TSCA section 4, 5, 6, or 7. In 1993, 
EPA considered but did not adopt a de minimis concentration exemption 
from its TSCA section 12(b) regulations, although the Agency expected 
to re-examine that option if further experience indicated that such an 
exemption would be warranted. Accordingly, this proposed rule provides 
background on the use of de minimis concentration levels under an 
international chemical classification and labeling scheme as a basis 
for incorporation of a de minimis concentration level under TSCA 
section 12(b).
    The 1992 United Nations Conference on Environment and Development 
(Ref. 9), provided the international mandate for development of the 
Globally Harmonized System of Classification and Labelling of Chemicals 
(GHS) (Ref. 10). The GHS was adopted by the United Nations Economic and 
Social Council in July 2003 and is an internationally agreed upon tool 
for chemical hazard communication that incorporates a harmonized 
approach to hazard classification and provisions for standardized 
labels and safety data sheets. The GHS labeling is intended to provide 
a foundation for national programs to promote safer use, transport and 
disposal of chemicals, and to facilitate international trade in 
chemicals whose hazards have been properly assessed and identified 
based on internationally agreed upon criteria. As with TSCA section 
12(b), one of the primary purposes of the GHS labeling scheme is to 
communicate information on chemicals to foreign governments. 
Accordingly, EPA believes it is appropriate to look to GHS for guidance 
on establishing a de minimis concentration exemption under TSCA section 
12(b).
    Classification of chemical mixtures under the GHS for several 
health and environmental hazard classes is triggered when generic cut-
off values or concentration limits are exceeded, for example, >=1.0% 
for target organ systemic toxicity, >=0.1% for known or presumed human 
carcinogens, etc. (See Ref. 10, chapter 1.5. The cut-off levels for 
each hazard class are provided in chapters 3.1-3.10 and chapter 4.1 of 
Ref. 10.) When a chemical is present below these cut-off levels, the 
GHS does not require that the chemical appear on labeling or other 
information sources. The GHS represents international consensus on 
appropriate de minimis concentrations below which governments do not 
find information useful for hazard communication on chemicals in 
international (or domestic) commerce. The focus of GHS is relevant to 
that of TSCA section 12(b), which is primarily intended to alert and 
inform foreign governments, in a general manner, of hazards that may be 
associated with a chemical substance or mixture. As a result, EPA 
believes it is logical to refer to GHS as a guide to

[[Page 6738]]

implementation of TSCA section 12(b). EPA believes the inclusion of de 
minimis concentration thresholds in GHS is indicative of foreign 
governments' likely preference not to be notified by the United States 
about its export of chemicals present in low concentrations.
    In order to implement an exemption from export notification 
requirements for chemicals exported in de minimis concentrations EPA is 
proposing de minimis concentration levels below which notification 
would not be required for the export of any chemical for which export 
notification under TSCA section 12(b) is otherwise required. 
Specifically, EPA is proposing that export notification would not be 
required for such chemicals if the chemical is being exported at a 
concentration of less than 1% (by weight or volume), with two 
exceptions. The first exception would be made for chemicals treated for 
export notification purposes as carcinogens or potential carcinogens. 
These chemicals would be identified in the regulation based on the 
three sources referred to in OSHA's regulations related to hazard 
communication (29 CFR 1910.1200(d)(4)), i.e.,:
    1. Listed as a ``known to be human carcinogen'' or ``reasonably 
anticipated to be human carcinogen'' in the Report on Carcinogens 
issued by the U.S. Department of Health and Human Services National 
Toxicology Program (NTP) (Ref. 1),
    2. Classified as a Group 1, Group 2A, or Group 2B carcinogen by the 
World Health Organization International Agency for Research on Cancer 
(IARC) in the list of IARC Monographs on the Evaluation of Carcinogenic 
Risks to Humans and their Supplements (Ref. 2), or
    3. Characterized as a carcinogen or potential carcinogen in OSHA's 
regulations related to toxic and hazardous substances (29 CFR part 
1910, subpart Z).
For paragraphs 1-3 of this unit, a de minimis concentration level of 
less than 0.1% (by weight or volume) would apply.
    The NTP Report on Carcinogens is mandated by section 301(b)(4) of 
the Public Health Service Act, as amended (42 U.S.C. 201 et seq.), 
which stipulates that the Secretary of the Department of Health and 
Human Services shall publish an annual report which contains a list of 
all substances:
     Which either are known to be carcinogens in humans or may 
reasonably be anticipated to be human carcinogens.
     To which a significant number of persons residing in the 
United States are exposed.
In 1993, Public Law 95-622 was amended to change the frequency of 
publication of the NTP Report on Carcinogens from an annual to a 
biennial report.
    The IARC Monographs on the Evaluation of Carcinogenic Risks to 
Humans are independent assessments prepared by international working 
groups of experts of the evidence on the carcinogenicity of a wide 
range of agents, mixtures, and exposures. The evaluations of IARC 
Working Groups are scientific, qualitative judgments on the evidence 
for or against carcinogenicity provided by the available data. The 
Monographs are used by national and international authorities to make 
risk assessments, formulate decisions concerning preventive measures, 
provide effective cancer control programs, and decide among alternative 
options for public health decisions.
    Copies of the NTP and IARC lists referenced in this proposed rule 
have been placed in the public version of the official record for this 
rulemaking. In the final rule, EPA intends to seek approval from the 
Director of the Office of the Federal Register for the incorporation by 
reference of the NTP and IARC lists used in the final rule in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
    The third source of carcinogens or potential carcinogens which is 
referred to in OSHA's regulations related to hazard communication (29 
CFR 1910.1200(d)(4)) is the group of carcinogens or potential 
carcinogens in OSHA's toxic and hazardous substances regulations (29 
CFR part 1910, subpart Z). In lieu of referencing OSHA's regulations 
directly in the regulatory text of this proposed rule, this proposed 
rule republishes the two chemicals characterized by OSHA as carcinogens 
or potential carcinogens that are not already included on either the 
NTP or IARC lists referenced in this proposed rule. The rest of the 
chemicals characterized by OSHA as carcinogens or potential carcinogens 
are included on either or both the NTP and/or IARC lists.
    EPA would update the lists of chemicals identified in its export 
notification regulation as carcinogens or potential carcinogens, as 
appropriate, in order to reflect changes made to the sources referred 
to in OSHA's hazard communication regulations at 29 CFR 
1910.1200(d)(4).
    Concentration threshold levels like those used in the GHS context 
are also generally accepted or recognized in other United States 
Federal regulatory contexts. OSHA has established 1.0% and 0.1% 
concentration thresholds as a basis for requiring the development of 
Material Safety Data Sheets (MSDSs) and workplace labeling under the 
OSHA's Hazard Communication (HAZCOM) Standard (29 CFR 1910.1200 and 
Ref. 11). The Emergency Planning and Community Right-to-Know Act, 
section 313 (Toxic Release Inventory (TRI)) regulations use the OSHA 
HAZCOM Standard for purposes of establishing a chemical's de minimis 
concentration as either 1.0% or 0.1% for chemical substances when 
present in a mixture (40 CFR 372.38(a)). EPA's TSCA New Chemicals 
Program also uses concentration limits of 1.0% and 0.1% in TSCA section 
5(e) consent orders as thresholds for hazard communication and personal 
protective equipment requirements (Ref. 12).
    EPA believes that in the context of TSCA section 12(b) export 
notification, foreign governments would have little interest in notices 
regarding exports of chemicals present in de minimis concentrations, 
and that notices for such exports may divert attention from notices for 
exports of chemicals in higher concentrations that potentially may 
warrant more serious consideration. Thus, EPA believes that de minimis 
concentration thresholds are justified in the context of its TSCA 
section 12(b) regulations and is proposing that the export of chemicals 
present at a concentration below the specified de minimis concentration 
levels be exempt from notification requirements.
    As EPA has noted in the past, some chemicals retain their toxic 
properties at levels less than the general thresholds proposed, so the 
de minimis concentration thresholds proposed in this TSCA section 12(b) 
context are not an indication that EPA has determined that chemicals 
are generally not toxic at lesser concentrations. The de minimis 
concentration exemption in this proposal is only a reflection of the 
circumstances under which EPA believes foreign governments want to 
receive information regarding chemicals imported into their countries.
    In this proposed rule, the second exception to the proposed 
generally applicable de minimis concentration levels would be made for 
PCBs, which, when exported in a concentration of greater than 50 ppm, 
would require the submission of an export notification. EPA believes it 
is appropriate to include a different de minimis concentration level 
for PCBs in its TSCA section 12(b) regulations (i.e., levels less than 
or equal to 50 ppm versus the proposed general

[[Page 6739]]

1%/0.1% for carcinogens levels) after considering the coverage of PCBs 
under certain international treaties and/or guidance materials 
developed thereunder, including the Stockholm Convention and the Basel 
Convention on the Control of Transboundary Movements of Hazardous 
Wastes and their Disposal (Basel Convention) (Ref. 13). Note that the 
manufacture and distribution in commerce of PCBs for use within the 
United States or for export from the United States are generally 
prohibited, with certain exceptions (see, for example, 40 CFR 761.20(b) 
and (c)).
    The Stockholm Convention, which entered into force on May 17, 2004, 
and for which there were 113 Parties and 151 Signatories as of November 
2005 (the United States is a Signatory but not yet a Party), includes, 
among other things, provisions that require Parties to reduce and/or 
eliminate the production and use of listed intentionally produced 
chemicals or pesticides. Annex A of the Stockholm Convention lists 
chemicals subject to elimination, including PCBs which are listed with 
a specific exemption for ``articles in use in accordance with the 
provisions of Part II of this Annex.'' Part II of Annex A of the 
Stockholm Convention states, in part:
    ``Each Party shall:
    (a) With regard to the elimination of the use of polychlorinated 
biphenyls in equipment (e.g., transformers, capacitors or other 
receptacles containing liquid stocks) by 2025, subject to review by the 
Conference of the Parties, take action in accordance with the following 
priorities . . .
    (iii) Endeavour to identify and remove from use equipment 
containing greater than 0.005 percent [50 ppm] polychlorinated 
biphenyls and volumes greater than 0.05 litres
    . . .
    (d) Except for maintenance and servicing operations, not allow 
recovery for the purpose of reuse in other equipment of liquids with 
polychlorinated biphenyls content above 0.005 per cent;
    (e) Make determined efforts designed to lead to environmentally 
sound waste management of liquids containing polychlorinated biphenyls 
and equipment contaminated with polychlorinated biphenyls having a 
polychlorinated biphenyls content above 0.005 per cent, in accordance 
with paragraph 1 of Article 6, as soon as possible but no later than 
2028, subject to review by the Conference of the Parties;
    (f) In lieu of note (ii) in Part I of this Annex, endeavour to 
identify other articles containing more than 0.005 per cent 
polychlorinated biphenyls (e.g., cable-sheaths, cured caulk and painted 
objects) and manage them in accordance with paragraph 1 of Article 6;''
    Annex A of the Stockholm Convention thus focuses attention on PCBs 
in equipment or articles where the PCBs are at a concentration of more 
than 50 ppm.
    In addition, the Basel Convention, which entered into force on May 
5, 1992, and for which there were 166 governments that were Parties as 
of November 2005 (the United States is a Signatory but not yet a 
Party), stipulates that any trans-boundary movement of wastes (export, 
import, or transit) is permitted only when the movement itself and the 
disposal of the concerned hazardous or other wastes are environmentally 
sound. The Stockholm Convention directs close cooperation with the 
Basel Convention to define a ``low POPs content'' for purposes of safe 
disposal of wastes contaminated with POPs. Under the Basel Convention, 
``General Technical Guidelines for the Environmentally Sound Management 
of Wastes Consisting of, Containing or Contaminated with Persistent 
Organic Pollutants'' (Basel POPs Guidelines) have been developed that 
provisionally identify the level of 50 milligrams/kilograms (mg/kg) (50 
ppm) as ``low POPs content'' for PCBs (Ref. 14).
    Because the 50 ppm level is used in the Stockholm Convention as a 
cut-off level for purposes of obligations associated with PCB-
containing equipment and has been further supported by the Basel POPs 
Guidelines as a low level not warranting the attention and control 
required for higher PCB levels, EPA believes it reasonable to propose 
using it as the basis of a de minimis concentration level for PCBs 
under TSCA section 12(b). Thus, at this time, EPA believes importing 
governments would not desire export notices from the United States for 
PCBs at levels of 50 ppm or less. EPA specifically seeks comment on 
whether 50 ppm is a reasonable level for the purposes of TSCA section 
12(b), and if not, what other, if any, level may be appropriate and why 
(see Unit VI.).
    EPA believes that the most practical means of maintaining the 
quality of notification, of improving the scrutiny importing countries 
give to notices, and of reducing burden on both exporters and EPA, is 
to amend the TSCA section 12(b) regulations under 40 CFR part 707 to 
reduce the frequency of certain export notifications submitted by 
exporters to EPA as well as EPA notices sent to foreign governments. 
EPA's responsibility is both to alert and to make information and data 
available to the importing government. EPA believes that although the 
frequency of EPA's notices to foreign governments may be reduced by 
this rule, if finalized as proposed, the quality of the information 
provided to them would not be substantially affected.

IV. Additional Proposed Amendments and Clarifications

    In addition to the proposed amendments to the TSCA section 12(b) 
regulations regarding the scope of exporters' and EPA's 
responsibilities, the Agency is proposing minor amendments to update 
the EPA addresses to which export notifications must be sent (40 CFR 
707.65(c)), to indicate that a single export notification may refer to 
more than one section of TSCA where the exported chemical is the 
subject of multiple TSCA actions(40 CFR 707.67), and to correct an 
error in 40 CFR 799.19, which currently omits mentioning multi-chemical 
test rules as being among those final TSCA section 4 actions that 
trigger export notification.
    EPA is also clarifying exporters' and EPA's obligations where a 
TSCA section 12(b)-triggering action is taken with respect to a 
chemical previously or currently subject to export notification due to 
the existence of a previous triggering action. EPA's intention is that 
exporters notify EPA with respect to each TSCA section 12(b)-triggering 
action to which the chemical becomes subject (as long as the exporter 
in fact still exports or intends to export the chemical to that 
country) even if they have previously notified EPA about the export of 
that chemical to that country as a result of an earlier TSCA section 
12(b)-triggering action. Note that an export notification may indicate 
more than one triggering action, i.e., separate export notifications 
need not be submitted where the need for export notification as a 
result of more than one triggering action at the same time exists with 
respect to a given chemical. Similarly, EPA would notify a foreign 
government with respect to each TSCA section 12(b)-triggering action to 
which the chemical becomes subject (as long as the Agency continues to 
receive an export notification from any exporter for the export of the 
chemical to that country) even if it has previously notified that 
government about the export of the chemical as a result of an earlier 
TSCA section 12(b)-triggering action. In this proposed rule, EPA is 
amending 40 CFR 707.65 and 707.70 in order to make these obligations 
clear.

[[Page 6740]]

V. Economic Impact

    EPA has evaluated the potential costs of these proposed amendments. 
The Agency anticipates that these proposed amendments would reduce the 
number of export notifications sent to EPA by exporters of chemicals 
that are the subject of actions under TSCA section 5(e), 5(a)(2), or 
5(b), and that they would also eliminate the submission of export 
notifications from exporters of chemicals otherwise subject to TSCA 
section 12(b) where they are present at a concentration below the 
relevant de minimis concentration threshold. The amendments would also 
potentially reduce the number of export notices sent by EPA to foreign 
governments. These reductions would save both exporter and EPA 
resources.
    For the period 1996-2004, EPA received an average of approximately 
8,600 export notifications from exporters annually. On average, each 
year nearly 60% of those export notifications were for chemicals 
subject to final TSCA section 4 actions, 25% for chemicals that were 
the subject of actions under TSCA section 5, and the remainder were 
primarily for chemicals that were the subject of actions under TSCA 
section 6 and a very few for chemicals subject to actions under TSCA 
section 7. At this time, EPA is unable to predict with certainty the 
reduction in export notifications received by EPA from exporters due to 
the de minimis concentration exemption of this proposed rule, but based 
on personal communication with the American Chemistry Council (ACC) 
(Ref. 15), EPA is estimating a 5% across-the-board reduction in TSCA 
section 12(b) notification burden to exporters due to the de minimis 
concentration exemption. Based on historical reporting, EPA is able to 
estimate, after the first year, a 50% reduction in export notifications 
triggered by TSCA section 5(e), 5(a)(2), or 5(b) actions as a result of 
the one-time-only provision, if these amendments are finalized as 
proposed. Thus, EPA expects to receive roughly 8,170 export 
notifications in the first year, and 7,125 in all subsequent years. 
These reductions are expected to save the regulated community over 
$12,000 in the first year of the proposed rule (3%), and over $41,000 
in subsequent years (12%). Over 20 years, if finalized as proposed, 
these proposed amendments would save the regulated community 
approximately $440,000 at a 7% discount rate, and over $600,000 at a 3% 
discount rate. See the Economic Analysis of the Proposed Change to TSCA 
Section 12(b) Export Notification Requirements (Ref. 16) for details on 
all cost and burden calculations.
    The costs to EPA would also likely be reduced based on these 
proposed amendments, as EPA incurs costs for processing export 
notifications received, and for sending export notices to foreign 
governments. While EPA has been sending roughly 1,600 notices to 
foreign governments annually, that number is expected to drop as a 
result of these proposed amendments, if finalized as proposed, to an 
estimated 1,520 notice during the first year in which the rule is 
effective, and an estimated 980 notices sent in all subsequent years. 
These reductions are expected to save the Federal Government over 
$7,500 during the first year in which the rule is effective (4% of 
current costs), and over $43,000 in subsequent years (24% of current 
costs). Over 20 years, these proposed amendments, if finalized as 
proposed, would save the Federal Government approximately $450,000 at a 
7% discount rate, and roughly $630,000 at a 3% discount rate.

VI. Request for Comment

    The following is a list of issues on which the Agency is 
specifically requesting public comment. EPA encourages all interested 
persons to submit comments on these issues, and to identify any other 
relevant issues as well. This input will assist the Agency in 
developing a rule that successfully addresses information needs while 
minimizing potential reporting burdens associated with the rule. EPA 
requests that commenters making specific recommendations include 
supporting documentation where appropriate.
    1. Based on certain international efforts, specifically GHS and the 
Stockholm Convention (and the Basel POPs Guidelines), EPA believes 
foreign governments would have little interest in TSCA section 12(b) 
notices regarding exports of chemicals present in low concentrations 
(i.e., 1%, 0.1%, or, for PCBs, 50 ppm or less). EPA specifically seeks 
comment on whether the proposed thresholds are set at a reasonable 
level for the purposes of TSCA section 12(b), and if not, what other, 
if any, level(s) may be appropriate and why.
    2. This proposal makes the point that GHS represents international 
consensus on appropriate de minimis concentrations below which foreign 
governments do not find information useful for hazard communication on 
chemicals in international commerce. As with TSCA section 12(b), one of 
the primary purposes of the GHS labeling scheme is to communicate 
information on chemicals to foreign governments. Accordingly, EPA 
believes it is appropriate to look to GHS for guidance on establishing 
a de minimis concentration exemption under TSCA section 12(b). EPA is 
specifically seeking comment on the appropriateness of using GHS.
    3. The proposal uses the Stockholm Convention as a basis for 
selecting a 50 ppm threshold for PCBs. Is this appropriate?
    4. EPA estimates that the proposed de minimis concentration 
exemption would reduce the burden of TSCA section 12(b) reporting by 
5%. However, since EPA does not currently require exporters to consider 
the concentration of chemicals they are exporting, the potential burden 
reduction is difficult to estimate. EPA is seeking information that 
might further inform the Agency's burden estimate.

VII. References

    The official record for this proposed rule has been established 
under docket ID number EPA-HQ-OPPT-2005-0058, and the public version of 
the official record is available for inspection as specified under 
ADDRESSES. These references have been placed in the public docket.
    1. Report on Carcinogens, Eleventh Edition; United States 
Department of Health and Human Services, Public Health Service, 
National Toxicology Program. Available online at https://
ntp.niehs.nih.gov/index.cfm?objectid=32BA9724-F1F6-975E- 
7FCE50709CB4C932.
    2. International Agency for Research on Cancer Monographs on the 
Evaluation of Carcinogenic Risks to Humans and their Supplements. 
Available online at https://www-cie.iarc.fr/monoeval/allmonos.html.
    3. EPA. 1980. Chemical Imports and Exports; Notification of Export. 
Final Rule. Federal Register (45 FR 82844, December 16, 1980). 
Available on-line at https://www.heinonline.org/HOL/Index?index=fedreg/
fedreg&collection=fedreg.
    4. EPA. 1993. Export Notification Requirement; Change to Reporting 
Requirements. Final Rule. Federal Register (58 FR 40238, July 27, 
1993). Available on-line at https://www.heinonline.org/HOL/
Index?index=fedreg/fedreg&collection=fedreg.
    5. Rotterdam Convention on the Prior Informed Consent Procedure for 
Certain Hazardous Chemicals and Pesticides in International Trade. 
September, 1998 (amended September 2004). Available on-line at https://
www.pic.int/en/viewpage.asp?id--cat=0. Annex III: Chemicals Subject to 
the Prior Informed

[[Page 6741]]

Consent Procedure. Available on-line at https://www.pic.int/en/
ViewPage.asp?id=104#III%20Annex.
    6. Harmonized System Convention, World Customs Organization (WCO). 
Available on-line at https://www.wcoomd.org/ie/En/Topics_Issues/
topics_issues.html. June 14, 1983. The Harmonized Commodity 
Description and Coding System, generally referred to as ``Harmonized 
System'' or simply ``HS,'' is a multi-purpose international product 
nomenclature developed by the WCO.
    7. Stockholm Convention on Persistent Organic Pollutants (POPs). 
May 22, 2001. Available on-line at https://www.pops.int.
    8. United Nations Economic Commission for Europe Convention on Long 
Range Transboundary Air Pollution (LRTAP) Protocol on Persistent 
Organic Pollutants (POPs), June 24, 1998. Available on-line at https://
www.unece.org/env/lrtap/pops_h1.htm.
    9. United Nations Conference on Environment and Development (Earth 
Summit) Agenda 21; Chapter 19: Environmentally Sound Management of 
Toxic Chemicals, Including Prevention of Illegal International Traffic 
in Toxic and Dangerous Products. Rio de Janeiro, June 1992. Available 
on-line at https://www.un.org/esa/sustdev/documents/agenda21/english/
agenda21chapter19.htm.
    10. GHS. Available on-line at https://www.unece.org/trans/danger/
publi/ghs/ghs_welcome_e.html. United Nations, 2003. GHS Chapter 1.5: 
Hazard Communication: Safety Data Sheets Table 1.5.1: Cut-off values/
concentration limits for each health and environmental hazard class. 
See https://www.unece.org/trans/danger/publi/ghs/ghs_rev01/English/
01e_part1.pdf.GHS Chapter 1.3: Classification of Hazardous Substances 
and Mixtures Subparagraph 1.3.3.2: Use of cut-off values/concentration 
limits. See https://www.unece.org/trans/danger/publi/ghs/ghs_rev00/
English/GHS-PART-3e.pdf.
    11. OSHA. Hazard Communication, Final Rule. Federal Register (48 FR 
53280-53348, November 25, 1983). For discussion of 1% and 0.1% 
concentration thresholds, see pages 53290-53293.
    12. New Chemicals Program Boilerplate TSCA Section 5(e) Consent 
Orders. Available on-line at https://www.epa.gov/opptintr/newchems/
boilerpl.htm.
    13. Basel Convention on the Control of Transboundary Movements of 
Hazardous Wastes and their Disposal Adopted by the Conference of the 
Plenipotentiaries March 22 1989. Entry into force May 1992.
    14. Basel Convention General Technical Guidelines for 
Environmentally Sound Management of wastes consisting of, containing or 
contaminated with Persistent Organic Pollutants (POPs). April 2005. See 
https://www.basel.int/techmatters/techguid/frsetmain.php.
    15. Personal Communication. James Miller, EPA Economist, and 
members of the American Chemistry Council's TSCA Action Group. November 
15, 2005.
    16. Economic and Policy Analysis Branch, Office of Pollution 
Prevention and Toxics, EPA. November 2005. Economic Analysis of the 
Proposed Change to TSCA Section 12(b) Export Notification Requirements.

VIII. Statutory and Executive Order Reviews

A. Executive Order 12866

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), the Office of Management and 
Budget (OMB) has determined that this proposed rule is not a 
``significant regulatory action'' under section 3(f) of the Executive 
Order.
    In addition, EPA has prepared an economic assessment of the 
potential costs and benefits associated with this proposed action, 
which is contained in a document entitled Economic Analysis of the 
Proposed Change to TSCA Section 12(b) Export Notification Requirements 
(Ref. 16). This document is available in the docket, and is briefly 
summarized in Unit V.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden 
that would require additional approval by OMB under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq. This rule is expected to 
reduce the existing burden that is approved under OMB Control No. 2070-
0030 (EPA ICR No. 0795), which covers the information collection 
activities contained in the existing regulations at 40 CFR part 707, 
related to export notification under TSCA section 12(b).
    The annual respondent burden for the collection of information 
currently approved by OMB is estimated to be about 1 hour per response. 
A copy of the OMB approved Information Collection Request (ICR) has 
been placed in the docket for this rulemaking, and the Agency's 
estimated burden reduction is presented in the Economic Analysis (Ref. 
16) that has been prepared for this rule.
    Under the PRA, ``burden'' means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
or disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; develop, acquire, 
install, and utilize technology and systems for the purposes of 
collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information; 
adjust the existing ways to comply with any previously applicable 
instructions and requirements; train personnel to be able to respond to 
a collection of information; search data sources; complete and review 
the collection of information; and transmit or otherwise disclose the 
information.
    An agency may not conduct or sponsor, and a person is not required 
to respond to, a collection of information that is subject to approval 
under the PRA, unless it displays a currently valid OMB control number. 
The OMB control numbers for EPA's regulations in title 40 of the CFR, 
after appearing in the Federal Register when approved, are listed in 40 
CFR part 9, are displayed either by publication in the Federal Register 
or by other appropriate means, such as on the related collection 
instrument or form, if applicable. The display of OMB control numbers 
in certain EPA regulations is consolidated in 40 CFR part 9.
    Submit any comments on the Agency's need for this information, the 
accuracy of the provided burden estimates, and any suggested methods 
for minimizing respondent burden, including the use of automated 
collection techniques, along with your comments on the proposed rule. 
The Agency will consider any comments related to the information 
collection requirements contained in this proposal as it develops a 
final rule. Any changes to the burden estimate for the ICR will be 
effectuated with the final rule.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 
5 U.S.C. 601 et seq., due to the burden-reducing nature of this rule, 
the Agency hereby certifies that this proposed rule will not have a 
significant adverse economic impact on a substantial number of small 
entities. The factual basis for the Agency's determination is presented 
in the small entity impact analysis prepared as part of the Economic 
Analysis for this proposed rule (Ref. 16), which is summarized in Unit 
V., and a copy of which is available in the docket for this rulemaking. 
The

[[Page 6742]]

following is a brief summary of the factual basis for this 
certification.
    For purposes of assessing the impacts of this proposed rule on 
small entities, small entity is defined as:
    1. A small business as defined by the Small Business 
Administration's (SBA) regulations at 13 CFR 121.201 based on the 
applicable NAICS code for the business sector impacted.
    2. A small governmental jurisdiction that is a government of a 
city, county, town, school district or special district with a 
population of less than 50,000.
    3. A small organization that is any not-for-profit enterprise which 
is independently owned and operated and is not dominant in its field. 
Available information indicates that small governmental jurisdictions 
and small not-for-profit organizations would not generally engage in 
the activities regulated. As such, the Agency assessed the impacts on 
small exporters of chemical substances or mixtures within NAICS codes 
325 (chemical manufactures and processors) and 324110 (petroleum 
refineries).
    As discussed in Unit V., this proposed rule, if finalized as 
proposed, will amend an existing requirement and result in a reduction 
of burden and costs for exporters, regardless of the size of the firm. 
As such, these amendments will not have a significant adverse economic 
impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 
(UMRA), Public Law 104-4, EPA has determined that this proposed rule, 
which would result in a burden reduction upon being finalized, does not 
contain a Federal mandate that may result in expenditures of $100 
million or more for State, local, and tribal governments, in the 
aggregate, or the private sector in any 1 year. It is estimated that 
the total cost reduction of the rule, which is summarized in Unit V. 
and presented in the Economic Analysis (Ref. 16), over 20 years, would 
be $440,000 to $600,000 to the regulated community and $450,000 to 
$630,000 to the Federal Government. In addition, based on EPA's 
experience with the TSCA 12(b) reporting, State, local, and tribal 
governments have not been affected by this reporting requirement, and 
EPA does not have any reason to believe that any State, local, or 
tribal government will be affected by these proposed amendments. As 
such, EPA has determined that this regulatory action does not impose 
any enforceable duty, contain any unfunded mandate, or otherwise have 
any affect on small governments subject to the requirements of UMRA 
sections 202, 203, 204, or 205.

E. Executive Order 13132

    Pursuant to Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999), EPA has determined that this proposed rule 
does not have ``federalism implications,'' because it will not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or on the distribution of power 
and responsibilities among the various levels of government, as 
specified in the Order. As indicated previously, EPA does not have any 
reason to believe that any State or local government will be affected 
by these proposed amendments. Thus, Executive Order 13132 does not 
apply to this proposed rule.

F. Executive Order 13175

    As re