[Federal Register Volume 71, Number 219 (Tuesday, November 14, 2006)]
[Rules and Regulations]
[Pages 66234-66245]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19182]


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ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Parts 707 and 799

[EPA-HQ-OPPT-2005-0058; FRL-8101-3]
RIN 2070-AJ01


Export Notification; Change to Reporting Requirements

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is promulgating amendments to the Toxic Substances Control 
Act (TSCA) section 12(b) export notification regulations at subpart D 
of 40 CFR part 707. One amendment changes 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 changing 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 
receives the first export notification from an exporter. EPA is also 
promulgating de minimis concentration levels below which notification 
will not be required for the export of any chemical for which export 
notification under TSCA section 12(b) is otherwise required, 
promulgating 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 in 40 CFR 799.19 that currently omits mentioning 
multi-chemical test rules as being among those final TSCA section 4 
actions that trigger export notification), 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:  This rule is effective January 16, 2007. In accordance with 40 
CFR 23.5, this rule shall be promulgated for purposes of judicial 
review at 1 p.m. eastern daylight/standard time on November 28, 2006.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2005-0058. All documents in the 
docket are listed on the regulations.gov web site. Although listed in 
the index, some information is not publicly available, e.g., 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Certain other material, such as 
copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. The EPA Docket Center (EPA/
DC) suffered structural damage due to flooding in June 2006. Although 
the EPA/DC is continuing operations, there will be temporary changes to 
the EPA/DC during the clean-up. The EPA/DC Public Reading Room, which 
was temporarily closed due to flooding, has been relocated in the EPA 
Headquarters Library, Infoterra Room (Room Number 3334) in EPA West, 
located at 1301 Constitution Ave., NW., Washington, DC. The EPA/DC 
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 EPA/DC 
Public Reading Room is (202) 566-1744, and the telephone number for the 
OPPT Docket is (202) 566-0280. EPA visitors are required to show

[[Page 66235]]

photographic identification and sign the EPA visitor log. Visitors to 
the EPA/DC Public Reading Room will be provided with an EPA/DC badge 
that must be visible at all times while in the EPA Building and 
returned to the guard upon departure. In addition, security personnel 
will escort visitors to and from the new EPA/DC Public Reading Room 
location. Up-to-date information about the EPA/DC is on the EPA website 
at http://www.epa.gov/epahome/dockets.htm.

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: [email protected].
    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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

    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 section 5 or 7. Potentially 
affected entities, identified using the North American Industrial 
Classification System (NAICS) codes, 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 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. You may obtain a copy of both the U.S. Department 
of Health and Human Services National Toxicology Program (NTP) Report 
on Carcinogens (latest edition) (Ref. 1) and the World Health 
Organization International Agency for Research on Cancer (IARC) 
Monographs on the Evaluation of Carcinogenic Risks to Humans and their 
Supplements (latest editions) (Ref. 2) on-line.

II. Background

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

    EPA is promulgating 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.

B. Currently Existing Regulations

    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.
    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 TSCA 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 published 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. 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.

C. What Action is the Agency Taking?

    EPA is amending TSCA section 12(b) export notification regulations 
at subpart D of 40 CFR part 707. The first amendment changes 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

[[Page 66236]]

notification only for the first export or intended export to a 
particular country.
    This final rule changes 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 12(b)-triggering 
actions under TSCA section 5(f), 6, or 7, however, each exporter will 
continue to be required to submit annual export notifications to EPA.
    EPA is also changing the frequency with 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 requiring 
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 
will 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, 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.
    EPA believes this rule will 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.
    In addition, EPA is setting de minimis concentration levels below 
which notification would not be required for the export of any chemical 
substance or mixture for which export notification under TSCA section 
12(b) is otherwise required. Specifically, EPA is finalizing the 
requirement that export notification will not be required for such 
chemical substances or mixtures if the chemical is being exported at a 
concentration of less than 1% (by weight or volume), unless that 
chemical substance or mixture is a known or potential human carcinogen. 
A chemical is considered to be a known or potential human carcinogen, 
for purposes of TSCA section 12(b) export notification, if 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) (latest edition) (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 IARC Monographs on the Evaluation of Carcinogenic Risks 
to Humans and their Supplements (latest editions) (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 such chemicals in paragraph 1., 2., or 3. of this unit, a de 
minimis concentration level of less than 0.1% (by weight or volume) 
will apply.
    4. A polychlorinated biphenyl (PCB), for which notification will 
not be required if such PCBs are being exported at a concentration of 
less than or equal to 50 parts per million (ppm) (by weight or volume).
    In this final rule, 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.

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 System Code if available (Ref. 
6). 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 World 
Customs Organization. For an exporting country's BSR chemicals and the 
Rotterdam Convention's Annex III chemicals that are to be used in an 
occupational setting, the Rotterdam Convention requires that a safety 
data sheet setting out the most up-to-date information available be 
sent 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.

[[Page 66237]]

    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 Rule

    EPA believes this rule is a reasonable supplement to the export 
notification regulations at 40 CFR parts 707 and 799 because it further 
reduces overall burden on exporters and the Agency and helps to further 
focus importing governments' resources and attention on chemicals for 
which EPA has proposed to make or has made a finding that a chemical 
``presents or will present'' an unreasonable risk to human health or 
the environment.

A. This Rule

    This rule treats 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 will be required. 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 
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).
    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 unreasonable 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), 6, 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 is continuing 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 these chemicals.

B. De Minimis Exemption

    EPA is also promulgating de minimis concentration levels below 
which notification will not be required for the export of any chemical 
that is the subject of an action under TSCA section 4, 5, 6, or 7. This 
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 Labeling of Chemicals 
(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, table 1.5.1; the cut-off 
levels for each hazard class are provided in chapters 3.1-3.10 (health 
hazards) and chapter 4.1 (environmental hazards) 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 reflects 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. TSCA section 12(b) 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 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 establishing 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, export notification will 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

[[Page 66238]]

exceptions. The first exception would be made for chemicals treated for 
export notification purposes as known or potential human carcinogens. 
These chemicals are 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) (latest edition) (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 IARC Monographs on the Evaluation of Carcinogenic Risks 
to Humans and their Supplements (latest editions) (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 III.B.1., 2. and 3., a de minimis concentration level of 
less than 0.1% (by weight or volume) will apply, except for PCBs 
regarding which a de minimis concentration level of 50 ppm or less will 
apply, as in this unit. For purposes of monitoring compliance with 
notice requirements for chemical substances or mixtures subject to this 
rule as covered in 40 CFR 707.60(c)(2)(i) and (ii) of the regulatory 
text, EPA will consider the lists maintained by the World Health 
Organization, International Agency for Research on Cancer (IARC) and 
the US Department of Health and Human Services, Public Health Service, 
National Toxicology Program (NTP) as the definitive sources.
    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, the Public Health Service Act was amended by Public Law 95-
622 to change the frequency of publication of the 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.
    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, this rule incorporates at 40 CFR 
707.60(c)(2)(iii) the two chemicals characterized by OSHA as 
carcinogens or potential carcinogens that are not already included on 
either the NTP or IARC lists referenced. The rest of the chemicals 
characterized by OSHA as carcinogens or potential carcinogens are 
included on either or both the NTP Report on Carcinogens (latest 
edition) (Ref. 1) and/or IARC Monographs and their Supplements (latest 
editions) (Ref. 2).
    Concentration threshold levels like those used in the GHS context 
are also generally accepted or recognized in other United States 
Federal regulatory contexts. The 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) (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 0.1% or 1.0% 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 will 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 promulgating 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 in this rule, so 
the de minimis concentration thresholds established 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 rule is only a reflection of 
the circumstances under which EPA believes foreign governments want to 
receive information regarding chemicals imported into their countries.
    In addition to paragraphs III.B.1., 2, and 3., the second exception 
to the generally applicable de minimis concentration level of 1% is 
made for PCBs, which, when exported in a concentration of greater than 
50 ppm, 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 general 1% and 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 128 Parties and 151 Signatories as of August 
2006 (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 (Ref. 7). Annex A of the Stockholm Convention 
lists

[[Page 66239]]

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 transboundary 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/kilogram (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 
cutoff 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 use 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 will not desire 
export notices from the United States for PCBs at levels of 50 ppm or 
less.
    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, the quality of the information provided to them will not be 
substantially affected.

C. Additional Amendments and Clarifications

    In addition to the amendments to the TSCA section 12(b) regulations 
regarding the scope of exporters' and EPA's responsibilities, the 
Agency is promulgating 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, and to correct an error in 40 CFR 799.19 that 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 rule, EPA is amending 40 
CFR 707.65 and 707.70 in order to make these obligations clear.

IV. Response to Public Comments

    The Agency received 48 comments on the proposed rule that was 
issued in the Federal Register of February 9, 2006 (71 FR 6733) (FRL-
7752-2). Copies of all comments received are available in the public 
docket for this action. A discussion of the comments germane to the 
rulemaking and the Agency's response follows:
    1. Comment--Response to Four Questions Listed in Unit VI of the 
Proposed Rule. Unit VI. of the proposed rule provided four issues on 
which the Agency was specifically requested public comment. These 
issues were:
     Whether the proposed reporting thresholds (1.0%, 0.1%, and 
50 ppm) 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?
     Whether it is appropriate to look to GHS for guidance on 
establishing a de minimis concentration exemption under TSCA section 
12(b).
     Whether the Stockholm Convention is an appropriate basis 
for selecting a 50 ppm threshold for PCBs.
     EPA estimated that the de minimis concentration exemption 
would reduce the burden of TSCA section 12(b) reporting by 5%. EPA 
sought information that might further inform the Agency's burden 
estimate.
    Response. Public comments received overwhelmingly supported the 
proposed de minimis reporting thresholds, the use of GHS as guidance 
for these thresholds, and the use of the Stockholm Convention as a 
basis for selecting a 50 ppm threshold for PCBs. All commenters agreed 
that there would be burden reduction, although

[[Page 66240]]

quantifying this was difficult and there were suggestions for other 
amendments that could result in further or ``more meaningful'' burden 
reduction. Estimates ranged from at least the 5% Agency estimate in the 
proposed rule to much greater than 50%. EPA is adjusting its burden 
reduction estimates in response to comments received. Following are 
more specific burden-related comments.
    2. Comment. The concept of establishing three separate thresholds 
is cumbersome and likely more resource intensive than what is in place 
today. A more accurate estimate of cost or burden is needed. Commenters 
questioned the Agency's choice of 5% for its estimate of burden 
reduction or decrease in TSCA 12(b) reporting for an individual company 
resulting from the proposed rule, and EPA received a number of 
estimates, ranging from greater than the Agency's estimate of 5% up to 
one commenter stating that its TSCA section 12(b) reporting will 
decrease by 100% if the de minimis exemption is adopted. Some 
commenters noted that costs incurred in reprogramming computerized 
systems that ensure compliance with TSCA reporting may be such that 
several years will be required before a net burden reduction will be 
achieved for some business entities, and noted that these do not seem 
to have been recognized in the economic analysis. The point was also 
made that if industry does what is needed in order to not `over-report' 
without the use of a consolidated EPA master list of chemicals subject 
to reporting requirements, then companies will likely add burden to 
their current operations, while EPA will see a reduction in 
notifications received.
    Response. While the public responses to EPA's request to quantify 
the potential burden reduction as a result of the de minimis exemption 
varied greatly, the responses appear to assert that the reduction may 
be larger than the Agency's previously estimated 5%. Taking into 
account the range of comments, including seven firms that estimated a 
reduction of at least 50%, EPA is now estimating that the overall 
reduction will be 20%. EPA disagrees with the implication, by one 
commenter, that the addition of the new de minimis reporting thresholds 
will not achieve meaningful burden reduction, and points to the 
overwhelming support of the public comments received on the proposed 
rule, including support for the thresholds themselves as technically 
appropriate. With regards to potential computer reprogramming costs, 
EPA does not at this time have enough information, and the commenter 
did not provide specific estimates, to gauge such costs. Such costs are 
not part of the Agency's burden estimates because they are not imposed 
by EPA; they are activities that companies may engage in on their own.
    3. Comment-- No expected burden reduction. While supporting the 
expansion of one-time notification in this rule, one commenter did not 
think that the associated burden reduction will be significant. The 
commenter stated that the change may somewhat reduce the number of 
notification letters submitted, but it does not fundamentally affect 
the steps necessary for compliance and the burden associated with it.
    Response. EPA agrees with this commenter that the fundamental steps 
necessary to comply with the regulations are not changed by the 
amendments to the rule. However, the reduction in the frequency and 
number of notification letters will lead to a reduction in the burden 
and costs associated with submitting those letters.
    4. Comment. The proposed rule is silent as to the management costs 
that are incurred for compliance with TSCA section 12(b) reporting 
obligations. The coordination required to identify known and trace 
ingredients in various chemical products and mixtures, along with 
supervision of the complex processes required to communicate this 
information to the export administration and regulatory compliance 
personnel is not adequately presented in the proposed rule. The costs 
of compliance with TSCA section 12(b) reporting requirements for small 
and medium sized facilities are not sufficiently considered by the 
proposed rule. For substances such as pigments that are manufactured 
from complex intermediate ingredient products that may in turn be 
manufactured from many more ingredients, the proposed rule does not 
consider the cost of analyzing all of these sources for the possible 
substances present or known to be potentially present in finished 
products. As a result, the costs of compliance with the existing TSCA 
section 12(b) reporting rule is underestimated significantly by EPA. 
Therefore compliance with TSCA section 12(b) is not a simple exercise 
in collecting a list of products which might be exported, as the 
proposed rule indicates. Nor is the task complete when such a list of 
products is identified for TSCA section 12(b) compliance. Additionally, 
industry has been required to prepare clarification letters for EPA to 
provide to foreign governments when shipments subject to notification 
are received and the notification covers only trace contaminants in the 
product. Many foreign governments have, and continue to, request 
clarification, since the notice provided by EPA does not indicate that 
only trace de minimis amounts of regulated substances are present. In 
summary, the cost of compliance with the current regulatory scheme is 
extensive and underestimated by EPA in its proposed rule.
    Response. EPA has presented the costs and burdens more fully in the 
Economic Analysis for the rule, including costs and burdens associated 
with anticipated activities involved in compliance determination. As 
the TSCA section 12(b) regulations apply identically regardless of 
company size, EPA assumes that small and medium-sized companies would 
go through the same process that larger companies would to comply with 
the TSCA section 12(b) regulations. Since the burden and cost figures 
presented by EPA represent an average, EPA also recognizes that certain 
companies, such as pigment manufacturers, may have higher-than-average 
burdens, and thus exceed the estimates in the Economic Analysis, while 
other companies may have lower than average burdens and thus experience 
lower costs than the EPA estimates. EPA never intended the estimates to 
represent a worst-case scenario as presented by the commenter. The 
clarification letters mentioned by the commenter are not required by 
the TSCA section 12(b) reporting regulations, and as such are not 
included in the estimated costs of the TSCA section 12(b) regulations. 
Further, because de minimis concentrations are not subject to export 
notification, future notices would all pertain to exports exceeding the 
de minimis concentrations, and it should also be noted that the 
requirement for notice covers only substances known to be in the 
exported material.
    5. Comment-- Timing of export notification: Seven days is not a 
long enough time to develop and submit export notification to EPA. 
Commenters noted that the ``within seven days of forming the intent to 
export'' timing in 40 CFR 707.65(a)(3) for submitting export 
notification to EPA does not originate in the TSCA section 12(b) 
statutory language. One commenter stated ``Compliance with this 
timeframe requires an ongoing system of identifying exports, checking 
them for potential 12(b) components, and generating letters almost 
immediately.'' One commenter requested that the phrase ``or on the date 
of export, whichever is earlier'' be removed from 40 CFR 707.65(a)(3), 
stating that many companies have automated systems

[[Page 66241]]

which track composition and distribution of products, integrated with 
regulatory data systems that address international regulatory elements. 
As to not interfere with systems running in multi-national 
environments, companies typically briefly suspend sytem operations to 
allow for data extracts and maintenance after normal business hours. 
The commenter stated that phrase in 40 CFR 707.65(a)(3) has the effect 
of requiring companies to implement separate processes, usually manual, 
to ``catch'' those samples/products that trigger an export notification 
where processing of an order after hours would not allow compliance 
with the ``postmarked on the date of export'' requirement for 
notification to EPA. This is especially relevant with overnight sample 
shipments. Other commenters suggested changing 7 days to 30 days (as is 
currently the case for TSCA section 8(e) reporting), quarterly, 
annually or some other reasonable timeframe.
    Response. The proposed rule did not address timing of submission of 
export notification and the Agency may investigate this issue further. 
If EPA decides to initiate additional amendments to TSCA section 12(b) 
export notification requirements, it may consider further adjusting 
this timeframe.
    6. Comment-- Allow Electronic Reporting Under TSCA Section 12(b). 
Commenters suggested adding ``either in written or electronic form'' at 
40 CFR 707.65(a)(1), that such reporting would be easier, less time 
consuming than by letter, especially for non-CBI.
    Response. EPA agrees with the commenter that there are technologies 
and solutions that can streamline the export notification submission 
process. In fact, EPA is putting in place such a process for the 
upcoming Inventory Update Reporting (http://www.epa.gov/iur) and hopes 
to use this type of technological solution for other TSCA data 
submissions, including TSCA section 12(b), in the future.
    7. Comment-- EPA Should Maintain an Official List of Chemicals 
Subject to TSCA 12(b) Reporting. Commenters requested that, to avoid 
confusion and possible over-reporting, EPA should maintain an official 
list of chemicals subject to TSCA section12(b) reporting, identifying 
which ones qualify for the various new de minimis thresholds.
    Response. The Agency does make publicly available on the Internet 
the ``Current List of Chemical Substances Subject to TSCA Section 12(b) 
Export Notification Requirements,'' at http://www.epa.gov/opptintr/chemtest/pubs/main12b.htm. However, this listing is intended simply as 
an information resource to facilitate compliance with TSCA section 
12(b). It does identify which chemicals are subject to TSCA section 4, 
section 5 generally, section 6, and section 7 actions. This list will 
be revised to distinguish chemicals subject to TSCA section 5(f) 
(annual export notification requirement) from the remainder of the 
section 5 chemicals (subject to actions under TSCA section 5(e), 
5(a)(2), or 5(b), for which there is now a one-time TSCA section 12(b) 
export notification requirement). The list does not identify those 
substances considered to be known or potential human carcinogens for 
purposes of TSCA section 12(b) export notification (i.e., those 
substances for which reporting would be required at concentrations of 
0.1% or more (by weight or volume)). That information is available from 
the IARC and NTP documents cited in the 40 CFR 707.60(c)(2)(i) and 
(ii), and from 40 CFR 707.60(c)(2)(iii), which lists the two chemicals 
characterized by OSHA as carcinogens or potential carcinogens and which 
are currently not included in either the NTP or IARC documents.
    8. Comment-- Accept one-time reporting, per country, per chemical. 
Comments requested that one notification for a particular chemical to a 
country suffice for subsequent notifications on that same chemical to 
the same country but from a different chemical exporter. This would 
avoid duplicative reporting.
    Response. 40 CFR 707.60(a) and TSCA section 12(b) state that ``any 
person'' who exports or intends to export a chemical subject to TSCA 
section 12(b) triggering action must notify EPA. Thus, the statute 
specifies that the notification requirement pertains to each exporter. 
EPA believes the commenters' suggestion is not consistent with TSCA, or 
the intended function of this required notification in terms of the 
receiving countries.
    9. Comment-- The proposed exemption should also include Research 
and Development samples, byproducts, and impurities. Commenter claimed 
that domestic manufacturers, batch manufacturers of pigments in 
particular, are at disadvantage under the current and proposed 
reporting scheme. Exported samples for customer evaluation and testing 
represent small quantities and are sent to foreign manufacturers with 
expertise in evaluating products and as a result should not require 
formal TSCA export notification.
    Response. EPA has not completely foreclosed the creation of some or 
all of these additional exemptions. EPA will consider this suggestion 
if it undertakes another, future amendment to the 12(b) regulations.
    10. Comment--Eligibility prior to effective date of final rule. 
Allow TSCA section 5(e), 5(a)(2), or 5(b) notifications submitted prior 
to the effective date of the final rule to also be eligible to qualify 
for the new one-time notification.
    Response. The Agency believes this suggestion is consistent with 
the Agency's goal of focusing foreign government attention on certain 
TSCA actions. Therefore, any export notice for a chemical subject to a 
TSCA section 5(e), 5(a)(2), or 5(b) action submitted prior to the 
effective date of this final rule would satisfy the one-time reporting 
requirement established in the new rule.
    11. Comment--Objection to a notification requirement for future, 
multiple TSCA actions. Two commenters stated that companies should not 
have to re-notify EPA when a chemical already subject to a TSCA section 
12(b) triggering action becomes subject to a new action.
    Response. EPA's intention is to clarify that exporters need to 
notify EPA with respect to each TSCA section 12(b)-triggering action 
under TSCA 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 
12(b)-triggering action. EPA will re-notify the receiving country. EPA 
has amended 40 CFR 707.65 and 707.70 in order to make these obligations 
clear.
    12. Comment-- Notification on Class 2 substances. One commenter 
requested that EPA state that export notifications are not required for 
Class 2 substances that contain TSCA section 12(b)-subject chemicals.
    Response. It is EPA's position that the export of a Class 2 
substance that contains a component that is subject to a TSCA section 
12(b)-triggering action triggers export notification. Neither the 
statutory nor the regulatory language restricts the export notification 
requirement to exporters of chemical substances and mixtures in 
particular forms, but instead generally extends export notification 
requirements to exporters of chemical substances and mixtures without 
regard to the form in which the chemical substances and mixtures are 
being or will be exported. Accordingly, any person who exports, or who 
intends to export, one of the chemical substances contained in a TSCA 
12(b)-triggering action in any form is subject to the export 
notification

[[Page 66242]]

requirements. This is consistent with the Agency's view regarding the 
scope of TSCA section 12(b) since the export notification regulations 
were initially published in the Federal Register of December 16, 1980 
(Ref. 3).
    13. Comment-- Exempt chemicals that are only subject to 
``information collection rules.'' One commenter suggested an exemption 
for chemicals subject to ``information collection rules,'' such as TSCA 
section 4 actions or section 5 SNURs pending information collection--
anything but established risk chemicals--TSCA section 5(f), 6, and 7 
actions.
    Response. The commenter's suggestion is inconsistent with TSCA 
section 12(b).

V. Economic Impact

    EPA has evaluated the potential costs of these amendments. The 
Agency anticipates that these amendments will 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 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 will also reduce the number of export notices 
sent by EPA to foreign governments. These reductions will 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 rule, but based on 
comments received on the proposed rule, EPA is estimating a 20% 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. 
Thus, EPA expects to receive approximately 6,000 export notifications 
annually. These reductions are expected to save the regulated community 
over $75,000 per year, or over 20% of industry costs. Over 20 years, 
these amendments should save the regulated community approximately 
$800,000 at a 7% discount rate, and over $1.1 million at a 3% discount 
rate. See the Final Economic Analysis of the Amendments to TSCA Section 
12(b) Export Notification Requirements (Ref. 15) for details on all 
cost and burden calculations. The costs to EPA should also be reduced 
based on these 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 amendments to an estimated 824 yearly. These reductions 
are expected to save the Federal Government over $60,000 annually (34% 
of current costs). Over 20 years, these amendments should save the 
Federal Government approximately $650,000 at a 7% discount rate, and 
roughly $900,000 at a 3% discount rate. Over 20 years these amendments 
should yield a total cost savings to both EPA and industry of $1.46 
million at a 7% discount rate and $2.05 million at 3% (Ref. 15).

VI. References

    The official record for this 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. The 
following is a listing of the documents referenced in this preamble 
that have been placed in the official docket for this rule (see http://www.regulations.gov, docket ID number EPA-HQ-OPPT-2005-0058):
    1. United States Department of Health and Human Services, Public 
Health Service. National Toxicology Program. Report on Carcinogens 
(latest edition). Available on-line at http://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. Lists 
of All Agents Evaluated as Being in Group 1 (carcinogenic to humans), 
Group 2A (probably carcinogenic to humans), and Group 2B (possibly 
carcinogenic to humans) (latest editions). Available on-line at http://www-cie.iarc.fr/monoeval/allmonos.html.
    3. EPA. Chemical Imports and Exports; Notification of Export. Final 
Rule. Federal Register (45 FR 82844, December 16, 1980). Available on-
line at http://www.regulations.gov, docket ID number EPA-HQ-OPPT-2005-
0058.
    4. EPA. Export Notification Requirement; Change to Reporting 
Requirements. Final Rule. Federal Register (58 FR 40238, July 27, 1993) 
(FRL-4067-2). Available on-line at http://www.regulations.gov, docket 
ID number EPA-HQ-OPPT-2005-0058.
    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 http://www.pic.int/en/viewpage.asp?id_cat=0. Annex III: Chemicals Subject to 
the Prior Informed Consent Procedure. Available on-line at http://www.pic.int/en/ViewPage.asp?id=104#III%20Annex.
    6. Harmonized System Convention, World Customs Organization (WCO). 
Available on-line at http://www.wcoomd.org/ie/En/Topics_Issues/topics_issues.html. June 14, 1983.
    7. Stockholm Convention on Persistent Organic Pollutants (POPs). 
May 22, 2001. Available on-line at http://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 http://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 http://www.un.org/esa/sustdev/documents/agenda21/english/agenda21chapter19.htm.
    10. GHS. Globally Harmonized System of Classification and Labelling 
of Chemicals (GHS). United Nations. 2003. Available on-line at http://www.unece.org/trans/danger/publi/ghs/ghs_rev00/00files_e.html.
    11. OSHA. Hazard Communication. Final Rule. Federal Register (48 FR 
53280-53348, November 25, 1983). For discussion of 1% and 0.1% cut-off, 
see pp. 53290-53293.
    12. EPA. New Chemicals Program Boilerplate TSCA Section 5(e) 
Consent Orders. Available on-line at http://www.epa.gov/opptintr/newchems/boilerpl.htm.

[[Page 66243]]

    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. Available 
on-line at http://www.basel.int/about.html.
    14. Basel Convention General Technical Guidelines for 
Environmentally Sound Management of wastes consisting of, containing or 
contaminated with Persistent Organic Pollutants (POPs). April 2005. 
Available on-line at http://www.basel.int/techmatters/techguid/frsetmain.php.
    15. Economic and Policy Analysis Branch, Office of Pollution 
Prevention and Toxics, EPA. August 2006. Final Economic Analysis of the 
Amendments to TSCA Section 12(b) Export Notification Requirements.

VII. 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 final rule is not a ``significant 
regulatory action'' subject to review by OMB, because it does not meet 
the criteria in section 3(f) of the Executive Order.

B. Paperwork Reduction Act

    The information collection activities associated with export 
notification under TSCA section 12(b) are already approved by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq. That Information Collection Request (ICR) 
document has been assigned EPA ICR number 0795, and OMB control number 
2070-0030. This final rule does not impose any new information 
collection burdens that would require additional approval by OMB under 
PRA, and is expected to reduce existing burden estimates.
    The currently approved annual public burden for the collection of 
information covered by OMB Control No. 2070-0030 is estimated to be 
0.878 hours per response. Under 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.
    Under PRA, an agency may not conduct or sponsor, and a person is 
not required to respond to a collection of information unless it 
displays a currently valid OMB control number. The OMB control numbers 
for EPA's regulations codified in chapter 40 of the CFR, after 
appearing in the preamble of the final rule, 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. For the ICR activity 
contained in this final rule, in addition to displaying the applicable 
OMB control number in this Unit, the Agency has also included it on the 
list in 40 CFR 9.1.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this 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 economic analysis prepared 
for this rule (Ref. 15), a copy of which is available in the docket for 
this rulemaking. The following is a brief summary of the factual basis 
for this certification.
    Under RFA, small entities include small businesses, small 
organizations, and small governmental jurisdictions. For purposes of 
assessing the impacts of this 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, which for the 
pesticide industry consists of businesses with fewer than 500 to 1,000 
employees (range is based on NAICS sector variations).
    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 by this rule, i.e., the export of chemical 
substances or mixtures. As such, the Agency's expects that only small 
businesses will benefit from the burden reduction in this rule.
    This final rule amends an existing requirement and result in a 
reduction of burden and costs for all chemical exporters, regardless of 
the size of the business. 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 rule 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.
    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 
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 such governments, nor will it have these 
impacts on the private sector. EPA has determined that this rule does 
not significantly or uniquely affect small governments. Accordingly, 
this rule is not subject to the requirements of sections 202, 203, 204, 
or 205 of UMRA.

E. Executive Order 13132

    This rule does not have a federalism implications because it is not 
expected to have substantial direct effects on 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 Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999).

F. Executive Order 13175

    This rule does not have tribal implications because it is not 
expected to have substantial direct any affect on tribal governments, 
on the relationship between the Federal government and the Indian 
tribes, or on the distribution of power and responsibilities between 
the Federal government and Indian tribes, as specified in the Order. 
Thus, Executive Order 13175, entitled Consultation and Coordination 
with

[[Page 66244]]

Indian Tribal Governments (65 FR 67249, November 6, 2000), do not apply 
to this rule.

G. Executive Order 13045

    This action is not subject to Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997), because this is not an economically 
significant regulatory action as defined by Executive Order 12866, and 
this action does not address environmental health or safety risks 
disproportionately affecting children.

H. Executive Order 13211

    This rule is not subject to Executive Order 13211, entitled Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use (66 FR 28355, May 22, 2001), because this action 
is not expected to affect energy supply, distribution, or use.

I. National Technology Transfer Advancement Act

    Since this action does not involve any technical standards, section 
12(d) of the National Technology Transfer and Advancement Act of 1995 
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does 
not apply to this action.

J. Executive Order 12898

    This rule does not have an adverse impact on the environmental and 
health conditions in low-income and minority communities. Therefore, 
the Agency does not need to consider environmental justice-related 
issues as delineated by Executive Order 12898, entitled Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit 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 United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Parts 707 and 799

     Environmental protection, Chemicals, Exports, Hazardous 
substances, Imports, Incorporation by reference, Reporting and 
recordkeeping requirements.

    Dated: November 2, 2006.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.


0
Therefore, 40 CFR chapter I is amended as follows:

PART 707--[AMENDED]

0
1. The authority citation for part 707 continues to read as follows:

    Authority: 15 U.S.C. 2611(b) and 2612.


0
2. In Sec. 707.60, redesignate paragraphs (c) through (e) as paragraphs 
(d) through (f), add a new paragraph (c), and revise newly redesignated 
paragraphs (d), (e), and (f) to read as follows:


Sec. 707.60  Applicability and compliance.

* * * * *
    (c)(1) Except as provided in paragraphs (c)(2) and (3) of this 
section no notice of export is required for the export of a chemical 
substance or mixture for which export notification is otherwise 
required, where such chemical substance or mixture is present in a 
concentration of less than 1% (by weight or volume).
    (2) No notice of export is required for the export of a chemical 
substance or mixture that is a known or potential human carcinogen. A 
chemical is considered to be a known or potential human carcinogen, for 
purposes of TSCA section 12(b) export notification, if that chemical 
is:
    (i) A chemical substance or mixture listed as a ``known to be human 
carcinogen'' or ``reasonably anticipated to be human carcinogen'' in 
the Report on Carcinogens (latest edition) issued by the U.S. 
Department of Health and Human Services, Public Heath Service, National 
Toxicology Program,
    (ii) A chemical substance or mixture is classified as 
``carcinogenic to humans'' (Group 1), ``probably carcinogenic to 
humans'' (Group 2A), or ``probably carcinogenic to humans'' (Group 2B) 
in the Monographs and Supplements on the Evaluation of Carcinogenic 
Risks to Humans issued by the World Health Organization International 
Agency for Research on Cancer (IARC), Lyons, France (latest editions), 
or
    (iii) Alpha-naphthylamine (Chemical Abstract Service Registry 
Number (CAS No.) 134-32-7) or 4-nitrobiphenyl (CAS No. 92-93-3).
    (3) No notice of export is required for the export of 
polychlorinated biphenyl chemicals (PCBs) (see definition in 40 CFR 
761.3), where such chemical substances are present in a concentration 
of less than or equal to 50 ppm (by weight or volume).
    (d) Any person who exports or intends to export PCBs or PCB 
articles (see definition in 40 CFR 761.3), for any purpose other than 
disposal, shall notify EPA of such intent or exportation under TSCA 
section 12(b), except as specified in Sec. 707.60(c)(3). PCBs and PCB 
articles have the definitions published in 40 CFR 761.3.
    (e) Any person who would be prohibited by a TSCA section 5 or 6 
regulation from exporting a chemical substance or mixture, but who is 
granted an exemption by EPA to export that chemical substance or 
mixture, shall notify EPA under TSCA section 12(b) of such intent to 
export or exportation.
    (f) Failure to comply with TSCA section 12(b) as set forth in this 
part will be considered a violation of TSCA section 15(3), and will 
subject the exporter to the penalty, enforcement, and seizure 
provisions of TSCA sections 16 and 17.

0
3. In Sec. 707.65, revise paragraph (a) introductory text, (a)(2), and 
(c) to read as follows:


Sec. 707.65  Submission to agency.

    (a) For each action under TSCA triggering export notification, 
exporters must notify EPA of their export or intended export of each 
subject chemical substance or mixture for which export notice is 
required under Sec. 707.60 in accordance with the following:
* * * * *
    (2) (i) The notice must be for the first export or intended export 
by an exporter to a particular country in a calendar year when the 
chemical substance or mixture is the subject of an order issued, an 
action that is pending, or relief that has been granted under TSCA 
section 5(f), a rule that has been proposed or promulgated under TSCA 
section 6, or an action that is pending or relief that has been granted 
under TSCA section 7.
    (ii) The notice must only be for the first export or intended 
export by an exporter to a particular country when the chemical 
substance or mixture is the subject of an order issued, an action that 
is pending, or relief that has been granted under TSCA section 5(e), a 
rule that has been proposed or promulgated under TSCA section 5(a)(2), 
or when the submission of data is required under

[[Page 66245]]

TSCA section 4 or 5(b). Under this paragraph, notice of export to a 
particular country is not required if an exporter previously submitted 
to EPA a notice of export to that country prior to January 16, 2007.
* * * * *
    (c) Notices shall be marked ``TSCA Section 12(b) Notice'' and sent 
to EPA by mail or delivered by hand or courier. Send notices by mail 
to: Document Control Office (7407M), Office of Pollution Prevention and 
Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW., Washington, DC 20460-0001 (Attention: TSCA Section 12(b) Notice). 
Hand delivery of TSCA section 12(b) notices should be made to: OPPT 
Document Control Office (DCO), EPA East., Rm. 6428, Environmental 
Protection Agency, 1201 Constitution Ave., NW., Washington, DC 
(Attention: TSCA Section 12(b) Notice). 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 DCO's normal hours of operation.


Sec. 707.67  [Amended]

0
4. In Sec. 707.67, add ``and/'' before ``or'' in the first sentence of 
paragraph (a) after ``6,'' and in the parenthetical in paragraph (e) 
after ``6,''.

0
5. In Sec. 707.70, revise paragraph (a) to read as follows:


Sec. 707.70  EPA notice to foreign governments.

    (a)(1) Notice by EPA to the importing country shall be sent no 
later than 5 working days after receipt by the TSCA Document Processing 
Center of the first annual notification from any exporter for each 
chemical substance or mixture that is the subject of an order issued, 
an action that is pending, or relief that has been granted under TSCA 
section 5(f), a rule that has been proposed or promulgated under TSCA 
section 6, or an action that is pending or relief that has been granted 
under TSCA section 7.
    (2) Notice by EPA to the importing country shall be sent no later 
than 5 working days after receipt by the TSCA Document Processing 
Center of the first notification from any exporter for each chemical 
substance or mixture that is the subject of an order issued, an action 
that is pending, or relief that has been granted under TSCA section 
5(e), a rule that has been proposed or promulgated under TSCA section 
5(a)(2), or for which the submission of data is required under TSCA 
section 4 or 5(b).
* * * * *

PART 799--[AMENDED]

0
6. The authority citation for part 799 continues to read as follows:

    Authority: 15 U.S.C. 2603, 2611, 2625.

0
7. By revising Sec. 799.19 to read as follows:


Sec. 799.19  Chemical imports and exports.

    Persons who export or who intend to export chemical substances or 
mixtures listed in subpart B, subpart C, or subpart D of this part are 
subject to the requirements of 40 CFR part 707.
[FR Doc. E6-19182 Filed 11-13-06; 8:45 am]
BILLING CODE 6560-50-S